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.
Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin
Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.
Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.
Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in
Witvliet, M.; van Lier, P.A.C.; Cuijpers, P.; Koot, H.M.
In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal
Birken, Sarah A; Urquhart, Robin; Munoz-Plaza, Corrine; Zizzi, Alexandra R; Haines, Emily; Stover, Angela; Mayer, Deborah K; Hahn, Erin E
The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes. We identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes. RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives. RCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders. SCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.
Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen
Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Partici...
Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike
Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R
Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.
Ruble, Lisa A; McGrew, John H; Toland, Michael; Dalrymple, Nancy; Adams, Medina; Snell-Rood, Claire
The postsecondary outcomes of individuals with autism spectrum disorder (ASD) are significantly worse than peers with other disabilities. One problem is the lack of empirically-supported transition planning interventions to guide services and help produce better outcomes. We applied an implementation science approach to adapt and modify an evidence-based consultation intervention originally tested with young children called the Collaborative Model for Promoting Competence and Success (COMPASS; Ruble et al., The collaborative model for promoting competence and success for students with ASD. Springer, New York, 2012a) and evaluate it for efficacy in a randomized controlled trial for transition-age youth. Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1). Consultant fidelity was high and teacher adherence improved over time, replicating the importance of ongoing teacher coaching.
Gaudry, Stéphane; Messika, Jonathan; Ricard, Jean-Damien; Guillo, Sylvie; Pasquet, Blandine; Dubief, Emeline; Boukertouta, Tanissia; Dreyfuss, Didier; Tubach, Florence
Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients. Literature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other). Of the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge. Patient-important outcomes are rarely primary
Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard
To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.
Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy
To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.
Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George
To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.
Littlewood, Rae A; Claus, Eric D; Wilcox, Claire E; Mickey, Jessica; Arenella, Pamela B; Bryan, Angela D; Hutchison, Kent E
Varenicline has gained a reputation as the optimal intervention for treatment resistant smokers, yet more than half of those who try it do not succeed. To better understand individual differences in the effectiveness of varenicline, this study evaluates the effectiveness of varenicline for smoking cessation in a double-blind, placebo-controlled, randomized clinical trial and examines the influence of psychological factors on treatment outcome. Two hundred five cigarette smokers interested in quitting were randomly assigned to 12 weeks of varenicline or placebo. Outcomes examined were CO-confirmed continuous abstinence for the past month, average number of cigarettes smoked per day, and 7-day point prevalence. Varenicline-treated participants were more likely than placebo to achieve continuous abstinence at the end of treatment (OR = 3.29; RR = 2.62), and 7-day point prevalence rates showed an effect of medication at each time point. Participants in both groups significantly reduced their smoking during the course of treatment and follow-up, and the medication by visit interaction was significant in the expected direction. Impulsivity and personality style emerged as moderators of the relationship between medication condition and treatment outcome. In addition to replicating efficacy results for varenicline versus placebo, the present study shows that the efficacy of pharmacotherapy is influenced by psychological factors. In an era where pharmacotherapy is often perceived as the "silver bullet," we are reminded that smoking cessation is a dynamic process and intervention must be adaptable to address individual differences.
Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette
Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793
Sroiwatana, Suttikamon; Puapornpong, Pawin
Latching is an important process of breastfeeding and should be taught and practiced by the postpartum mother. The objective is to compare latching outcomes between video-assisted and routine teaching methods among postpartum women. A randomized controlled trial was conducted. Postpartum women who had deliveries without complications were randomized into two groups: 14 cases in the video-assisted teaching group and 14 cases in a routine teaching group. In the first group, the mothers were taught breastfeeding benefits, latching methods, and breastfeeding positions and practiced breastfeeding in a controlled setting for a 30-minute period and watched a 6-minute video with consistent content. In the second group, the mothers were taught a normal 30-minute period and then practiced breastfeeding. In both groups, Latching on, Audible swallowing, the Type of nipples, Comfort, and Help (LATCH) scores were assessed at 24-32 and 48-56 hours after the breastfeeding teaching modals. Demographic data and LATCH scores were collected and analyzed. There were no statistically significant differences in the mothers' ages, occupations, marital status, religion, education, income, infants' gestational age, body mass index, nipple length, route of delivery, and time to first latching between the video-assisted and routine breastfeeding teaching groups. First and second LATCH score assessments had shown no significant differences between both breastfeeding teaching groups. The video-assisted breastfeeding teaching did not improve latching outcomes when it was compared with routine teaching.
Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh
To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding. Cross sectional study of randomized controlled trials (RCTs). Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013. Random sample of RCTs focused on drug efficacy. Association between financial ties of principal investigators and study outcome. A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1
Harris, Anthony Wf; Kosic, Tanya; Xu, Jean; Walker, Chris; Gye, William; Redoblado Hodge, Antoinette
Finding work is a top priority for most people; however, this goal remains out of reach for the majority of individuals with a severe mental illness (SMI) who remain on benefits or are unemployed. Supported employment (SE) programs aimed at returning people with a severe mental illness to work are successful; however, they still leave a significant number of people with severe mental illness unemployed. Cognitive deficits are commonly found in SMI and are a powerful predictor of poor outcome. Fortunately, these deficits are amenable to treatment with cognitive remediation therapy (CRT) that significantly improves cognition in SMI. CRT combined with SE significantly increases the likelihood of individuals with severe mental illness obtaining and staying in work. However, the availability of CRT is limited in many settings. The aim of this study was to examine whether Web-based CRT combined with a SE program can improve the rate return to work of people with severe mental illness. A total of 86 people with severe mental illness (mean age 39.6 years; male: n=55) who were unemployed and who had joined a SE program were randomized to either a Web-based CRT program (CogRem) or an Internet-based control condition (WebInfo). Primary outcome measured was hours worked over 6 months post treatment. At 6 months, those participants randomized to CogRem had worked significantly more hours (P=.01) and had earned significantly more money (P=.03) than those participants randomized to the WebInfo control condition. No change was observed in cognition. This study corroborates other work that has found a synergistic effect of combining CRT with a SE program and extends this to the use of Web-based CRT. The lack of any improvement in cognition obscures the mechanism by which an improved wage outcome for participants randomized to the active treatment was achieved. However, the study substantially lowers the barrier to the deployment of CRT with other psychosocial interventions for
Witvliet, Miranda; van Lier, Pol A C; Cuijpers, Pim; Koot, Hans M
In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal classroom-based preventive intervention, or a control condition. Children's acceptance by peers, their number of mutual friends, and their proximity to others were assessed annually through peer ratings. Externalizing behavior was annually rated by teachers. Reductions in children's externalizing behavior and improvements in positive peer relations were found among GBG children, as compared with control-group children. Reductions in externalizing behavior appeared to be partly mediated by the improvements in peer acceptance. This mediating role of peer acceptance was found for boys only. The results suggest that positive peer relations are not just markers, but they are environmental mediators of boys' externalizing behavior development. Implications for research and prevention are discussed. (c) 2009 APA, all rights reserved.
Full Text Available Background: Decreased core stability displaces center of gravity away from base of support reducing activity participation of athlete. Present study was conducted to study the effect of core stabilization exercises after reconstruction surgery of ACL on functional outcomes. Methods: 30 subjects following 5 months of ACL reconstruction were randomly assigned to either group that performed (study group or did not performed (control group additional core stabilization exercises in conjugation with standard rehabilitation protocol. Outcome measures were: activity level using Tegnar activity level scale and functional performance using triple hop test. Outcome measures were compared at day 1 and day 42 of the treatment. Result: Significant improvement was seen in the study group for Tegnar score with mean difference changing from 4.5 to 1.5 from day 1 to day 42 of treatment (p=0.039 while the control group showed improvement in mean difference changing from 3.8 to 1.4 (p=.045 from day 1 to day 42 of treatment. Highly significant improvement was seen in the study group for triple hop test with mean difference changing from 25 to 6.7 (p<.001 compared to the control group with mean difference changing from 15.2 to 9.7(p=.005 from day 1 to day 42 of treatment. Conclusions: Both the groups showed improvement for activity level and functional performance but highly significant improvement was seen in the study group for functional performance. Core stabilization exercises in conjugation with the standard ACL rehabilitation protocol results better improvement in the triple hop test.
Full Text Available Stacy Calhoun,1,2 Emma Conner,2 Melodi Miller,3 Nena Messina1 1UCLA Integrated Substance Abuse Programs, Los Angeles, CA, USA; 2Department of Criminology, Law and Society, University of California, Irvine, CA, USA; 3Social Solutions International, Inc., Silver Spring, MD, USA Abstract: Substance abuse is a major public health concern that impacts not just the user but also the user's family. The effect that parental substance abuse has on children has been given substantial attention over the years. Findings from the literature suggest that children of substance-abusing parents have a high risk of developing physical and mental health and behavioral problems. A number of intervention programs have been developed for parents who have a substance abuse problem. There have also been a number of interventions that have been developed for children who have at least one parent with a substance abuse problem. However, it remains unclear how we can best mitigate the negative effects that parental substance abuse has on children due to the scarcity of evaluations that utilize rigorous methodologies such as experimental designs. The purpose of this study is to review randomized controlled trials of intervention programs targeting parents with substance abuse problems and/or children with at least one parent with a substance abuse problem in order to identify programs that show some promise in improving the behavioral and mental health outcomes of children affected by parental substance abuse. Four randomized controlled trials that met our eligibility criteria were identified using major literature search engines. The findings from this review suggest that interventions that focus on improving parenting practices and family functioning may be effective in reducing problems in children affected by parental substance abuse. However, further research utilizing rigorous methodologies are needed in order to identify other successful interventions that can
Raquel Pei Chen Chan
Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.
Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun
Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. Clinical
Logan, Diane E; Kilmer, Jason R; King, Kevin M; Larimer, Mary E
This study investigated the effectiveness of three single-session interventions with high-risk mandated students while considering the influence of motivational interviewing (MI) microskills. This randomized, controlled pilot trial evaluated single-session interventions: Alcohol Skills Training Program (ASTP), Brief Alcohol Screening and Intervention for College Students (BASICS) feedback sessions, and treatment-as-usual Alcohol Diversion Program (ADP) educational groups. Participants were 61 full-time undergraduates at a southern U.S. campus sanctioned to a clinical program following violation of an on-campus alcohol policy (Mage = 19.16 years; 42.6% female). RESULTS revealed a significant effect of time for reductions in estimated blood alcohol concentration (eBAC) and number of weekly drinks but not in alcohol-related consequences. Although ASTP and BASICS participants reported significant decreases in eBAC over time, ADP participant levels did not change (with no intervention effects on quantity or consequences). MI microskills were not related to outcomes. RESULTS from this study suggest equivalent behavioral impacts for the MI-based interventions, although individual differences in outcome trajectories suggest that research is needed to further customize mandated interventions. Given the overall decrease in eBAC following the sanction, the lack of reduction in the ADP condition warrants caution when using education-only interventions.
Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun
Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.
Schuster, Corina; Maunz, Gerd; Lutz, Karin; Kischka, Udo; Sturzenegger, Rolf; Ettlin, Thierry
For early inpatient stroke rehabilitation, the effectiveness of amphetamine combined with physiotherapy varies across studies. To investigate whether the recovery of activities of daily living (ADL, primary outcome) and motor function (secondary outcome) can be improved by dexamphetamine added to physiotherapy. In a double-blind, placebo-controlled trial, 16 patients, from 918 who were screened, were randomized to the experimental group (EG, dexamphetamine + physiotherapy) or control group (CG, placebo + physiotherapy). Both groups received multidisciplinary inpatient rehabilitation. Dexamphetamine (10 mg oral) or placebo was administered 2 days per week before physiotherapy. ADL and motor function were measured using the Chedoke-McMaster Stroke Assessment (CMSA) twice during baseline, every week during the 5-week treatment period, and at follow-up 1 week, 6 months, and 12 months after intervention. The majority of ineligible patients had too little paresis, were on anticoagulants, or had a stroke >60 days prior to entry. Participants (EG, n = 7, age 70.3 ± 10 years, 5 women, 37.9 ± 9 days after stroke; CG, n = 9, age 65.2 ± 17 years, 3 women, 40.3 ± 9 days after stroke) did not differ at baseline except for the leg subscale. Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL (P = .023) and arm function (P = .020) at end of treatment. No adverse events were detected. In this small trial that was based on prior positive trials, significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy. Effect size calculation suggests inclusion of at least 25 patients per group in future studies.
Full Text Available The purpose of this present study was to examine the effect of Taichi softball (TCSB on physical function in Chinese older adults. Eighty Chinese older adults were randomly assigned into either an experimental group experiencing four 90-minute TCSB sessions weekly for seven consecutive weeks or a control group. At baseline and 7 weeks later, all participants were asked to perform physical functional tests for both lower and upper limbs. Multiple separate Analyses of Variance (ANOVA with repeated measures were applied to evaluate the effects of TCSB on function-related outcomes between baseline and postintervention in the two groups. The findings indicate that a short-term and intensive TCSB training program does not only improve low limb-related physical function such as dynamic balance and leg strength, but also strengthen upper limb-related physical function (e.g., arm and forearm strength, shoulder mobility, fine motor control, handgrip strength, and fine motor function. Health professionals could take into account TCSB exercise as an alternative method to help maintain or alleviate the inevitable age-related physical function degeneration in healthy older adults. In addition, researchers could investigate the effect of TCSB exercise on physical function in special populations such as patients with different chronic diseases or neurological disorder (e.g., Parkinson’s disease.
Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl
The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.
Breusegem, Christophe; Spielberg, Leigh; Van Ginderdeuren, Rita; Vandewalle, Evelien; Renier, Charlotte; Van de Veire, Sara; Fieuws, Steffen; Zeyen, Thierry; Stalmans, Ingeborg
To investigate the benefit of preoperative treatment with either topical nonsteroidal anti-inflammatory drug (NSAID) or steroid in terms of clinical outcomes following trabeculectomy. Prospective, randomized placebo-controlled trial. Sixty-one patients. Between July 2005 and October 2007, 61 consecutive medically uncontrolled glaucoma patients scheduled for first-time trabeculectomy were randomized to 1 of 3 study topical medication groups: nonsteroidal anti-inflammatory drugs (ketorolac), steroids (fluorometholone), or placebo (artificial tears). Patients instilled 1 drop 4 times daily for 1 month before the procedure and were examined on days 1 and 2, at weeks 1, 2, and 4, and at months 3, 6, 12, 18, and 24 after trabeculectomy. Incidence of postoperative surgical or medical interventions (needling, laser suture lysis, needling revision, and intraocular pressure [IOP]-lowering medication). Fifty-four patients (54 eyes) were entered for analysis. The mean number of preoperative medications was 2.3+/-0.9. The mean baseline IOP was 21.0+/-6.0 mmHg. The mean postoperative target IOP was 16.5+/-1.8 mmHg. The mean follow-up was 23.6+/-4.0 months. The percentage of patients requiring needling within the first year was 41% in the placebo group, 6% in the NSAID, and 5% in the steroid group (P = 0.006). The percentage of patients requiring IOP-lowering medication to reach the target IOP at 1 year was 24% in the placebo group, 18% in the NSAID group, and 0% in the steroid group (P = 0.054 overall; P = 0.038 for steroids vs. others). The log-rank test showed a significant (P = 0.019) difference in medication-free survival curves between the different groups. More specifically, patients in the steroid group needed significantly less medication over the total follow-up (P = 0.007). Topical ketorolac or fluorometholone for 1 month before surgery was associated with improved trabeculectomy outcomes in terms of likelihood of postoperative needling. In the steroid group, there was
Full Text Available Göran Eriksson,1 Peter M Calverley,2 Christine R Jenkins,3,4 Antonio R Anzueto,5 Barry J Make,6 Magnus Lindberg,7 Malin Fagerås,7 Dirkje S Postma8 1Department of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden; 2Pulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK; 3Concord Clinical School, University of Sydney, 4The George Institute for Global Health, Sydney, Australia; 5Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans’ Health Care System, San Antonio, Texas, 6Division of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado, Denver, Colorado, USA; 7AstraZeneca R&D, Mölndal, Sweden; 8Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, GRIAC Research Institute, University of Groningen, Groningen, the Netherlands Background: When discontinuation in COPD randomized controlled trials (RCTs is unevenly distributed between treatments (differential dropout, the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in RCTs, in relation to study duration and COPD severity.Methods: A post hoc analysis of 2,345 patients from three RCTs of 6- and 12-month duration was performed to compare budesonide/formoterol and formoterol in moderate, severe, and very severe COPD. Outcomes were exacerbation rate, time-to-first exacerbation, or discontinuation; patients were stratified by disease severity. Outcomes were studied by censoring data monthly from 1 to 12 months.Results: In patients treated with budesonide/formoterol, annualized exacerbation rates (AERs were comparable for each study duration (rate ratio [RR] =0.6. With formoterol, the AER decreased with study duration (RR =1.20 at 1 month to RR =0.86 at 12 months. There was a treatment-related difference in
Best, Raymond; Böhle, Caroline; Schiffer, Thorsten; Petersen, Wolf; Ellermann, Andree; Brueggemann, Gert Peter; Liebau, Christian
Purpose of the study was the evaluation of the early functional outcome of patients with an acute ankle sprain treated either with a semirigid, variable, phase-adapted modular ankle orthosis or an invariable orthotic reference device. Forty-seven patients with acute ankle sprain grade II or more were included. In addition, 77 healthy controls as a reference were investigated. The injured subjects were treated with one of the two devices by random for 6 weeks. Ankle scores (FAOS, AOFAS) were taken at baseline after injury, 1 and 3 months after injury. Functional performance tests (balance platform, zig zag run, shuttle run, vertical drop jump) were performed at 1 and 3 months after injury. No significant score differences could be found between the two intervention groups except for achieving a preinjury activity level after 3 months only in the modular orthosis group. Postural functional performances (balance test) also showed no significant differences whereas the results of the agility tests revealed small but significant better results in the modular orthosis group in comparison to the invariable orthosis group. Cohen's effect sizes were high. Differences between the two intervention groups were marginal and very small but significant and--regarding Cohen's effect sizes--effective. Especially relating to functional performance, this might be a careful indication that a more effective strategy for promoting a protected, rapid recovery to physical activity after ankle sprains might be achieved by applying a phase-adapted ankle orthosis. Especially in athletic patients, phase-adapted orthosis should be further investigated and considered to ensure fully protected ligament healing as well as to regain early functional recovery.
Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W
The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record (c) 2017 APA, all rights reserved).
Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E; Vocci, Frank J
Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pPrison buprenorphine Treatment Condition (47.5% vs. 33.7%). Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Walker Bruce F
Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial
Lee, Gun Woo; Yang, Han Seok; Yeom, Jin S; Ahn, Myun-Whan
Vitamin C has critical features relavant to postoperative pain management and functional improvement; however, no study has yet evaluated the effectiveness of vitamin C on improving the surgical outcomes for spine pathologies. Thus, this study aimed to explore the impact of vitamin C on postoperative outcomes after single-level posterior lumbar interbody fusion (PLIF) for lumbar spinal stenosis in prospectively randomized design. We conducted a 1-year prospective, randomized, placebo-controlled, double-blind study to evaluate the impact of vitamin C on the postoperative outcomes after PLIF surgery. A total of 123 eligible patients were randomly assigned to either group A (62 patients with vitamin C) or group B (61 patients with placebo). Patient follow-up was continued for at least 1 year after surgery. The primary outcome measure was pain intensity in the lower back using a visual analogue scale. The secondary outcome measures were: (1) the clinical outcome assessed using the Oswestry Disability Index (ODI); (2) the fusion rate assessed using dynamic radiographs and computed tomography scans; and (3) complications. Pain intensity in the lower back was significantly improved in both groups compared with preoperative pain intensity, but no significant difference was observed between the 2 groups over the follow-up period. The ODI score of group A at the third postoperative month was significantly higher than the score of group B. After the sixth postoperative month, the ODI score of group A was slightly higher than the score of group B; however, this difference was not significant. The fusion rates at 1 year after surgery and the complication rates were not significantly different between the 2 groups. Postoperative pain intensity, the primary outcome measure, was not significantly different at 1 year after surgery between the 2 groups. However, vitamin C may be associated with improving functional status after PLIF surgery, especially during the first 3
Liu, Ning; Cadilhac, Dominique A; Andrew, Nadine E; Zeng, Lingxia; Li, Zongfang; Li, Jin; Li, Yan; Yu, Xuewen; Mi, Baibing; Li, Zhe; Xu, Honghai; Chen, Yangjing; Wang, Juan; Yao, Wanxia; Li, Kuo; Yan, Feng; Wang, Jue
Mechanisms, acute management, and outcomes for patients who experience intracerebral hemorrhage may differ from patients with ischemic stroke. Studies of very early rehabilitation have been mainly undertaken in patients with ischemic stroke, and it is unknown if benefits apply to those with intracerebral hemorrhage. We hypothesized that early rehabilitation, within 48 hours of stroke, would improve survival and functional outcomes in patients with intracerebral hemorrhage. This was a multicenter, randomized controlled study, with blinded assessment of outcome at 3 and 6 months. Eligible patients were randomized to receive standard care or standard care plus early rehabilitation. Primary outcome includes survival. Secondary outcomes includes health-related quality of life using the 36-item Short Form Questionnaire, function measured with the modified Barthel Index, and anxiety measured with the Zung Self-Rated Anxiety Scale. Two hundred forty-three of 326 patients were randomized (mean age, 59 years; 56% men). At 6 months, patients receiving standard care were more likely to have died (adjusted hazard ratio, 4.44; 95% confidence interval [CI], 1.24-15.87); for morbidity outcomes, a 6-point difference in the Physical Component Summary score of the 36-item Short Form Questionnaire (95% CI, 4.2-8.7), a 7-point difference for the Mental Component Summary score (95% CI, 4.5-9.5), a 13-point difference in Modified Barthel Index scores (95% CI, 6.8-18.3), and a 6-point difference in Self-Rating Anxiety Scale scores (95% CI, 4.4-8.3) was reported in favor of the intervention groups. For the first time, we have shown that commencing rehabilitation within 48 hours of intracerebral hemorrhage improves survival and functional outcomes at 6 months after stroke in hospitalized patients in China. http://www.chictr.org/en. Unique identifier: ChiCTR-TRC-13004039. © 2014 American Heart Association, Inc.
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
Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D
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
Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan
To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity 6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting.Trial Registration
Bernard, Stephen A; Nguyen, Vina; Cameron, Peter; Masci, Kevin; Fitzgerald, Mark; Cooper, David J; Walker, Tony; Std, B Paramed; Myles, Paul; Murray, Lynne; David; Taylor; Smith, Karen; Patrick, Ian; Edington, John; Bacon, Andrew; Rosenfeld, Jeffrey V; Judson, Rodney
To determine whether paramedic rapid sequence intubation in patients with severe traumatic brain injury (TBI) improves neurologic outcomes at 6 months compared with intubation in the hospital. Severe TBI is associated with a high rate of mortality and long-term morbidity. Comatose patients with TBI routinely undergo endo-tracheal intubation to protect the airway, prevent hypoxia, and control ventilation. In many places, paramedics perform intubation prior to hospital arrival. However, it is unknown whether this approach improves outcomes. In a prospective, randomized, controlled trial, we assigned adults with severe TBI in an urban setting to either prehospital rapid sequence intubation by paramedics or transport to a hospital emergency department for intubation by physicians. The primary outcome measure was the median extended Glasgow Outcome Scale (GOSe) score at 6 months. Secondary end-points were favorable versus unfavorable outcome at 6 months, length of intensive care and hospital stay, and survival to hospital discharge. A total of 312 patients with severe TBI were randomly assigned to paramedic rapid sequence intubation or hospital intubation. The success rate for paramedic intubation was 97%. At 6 months, the median GOSe score was 5 (interquartile range, 1-6) in patients intubated by paramedics compared with 3 (interquartile range, 1-6) in the patients intubated at hospital (P = 0.28).The proportion of patients with favorable outcome (GOSe, 5-8) was 80 of 157 patients (51%) in the paramedic intubation group compared with 56 of 142 patients (39%) in the hospital intubation group (risk ratio, 1.28; 95% confidence interval, 1.00-1.64; P = 0.046). There were no differences in intensive care or hospital length of stay, or in survival to hospital discharge. In adults with severe TBI, prehospital rapid sequence intubation by paramedics increases the rate of favorable neurologic outcome at 6 months compared with intubation in the hospital.
Edwards, Meghan K; Loprinzi, Paul D
No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.
Maddison, Ralph; Roberts, Vaughan; McRobbie, Hayden; Bullen, Christopher; Prapavessis, Harry; Glover, Marewa; Jiang, Yannan; Brown, Paul; Leung, William; Taylor, Sue; Tsai, Midi
Regular exercise has been proposed as a potential smoking cessation aid. This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks. A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone. There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01). Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.).
Full Text Available Abstract Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm ( Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651
Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial
Magee, Laura A.; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Gruslin, Andrée; Helewa, Michael; Hutton, Eileen; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean Marie
Introduction. For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes. Material and methods. This was a planned, secondary analysis
Ter Kuile, Moniek M; Melles, Reinhilde J; Tuijnman-Raasveld, Charlotte C; de Groot, Helen E; van Lankveld, Jacques J D M
Therapist-aided exposure seems an effective treatment for lifelong vaginismus, but mechanisms of action have not yet been established. The purpose of the present study was to investigate whether treatment outcome of a therapist-aided exposure treatment was mediated by changes in positive and negative penetration beliefs or feelings of sexual disgust. Participants with lifelong vaginismus were allocated at random to a 3-month exposure (n = 35) or a waiting list control condition (n = 35). Full intercourse was assessed daily during 12 weeks. Secondary outcome measures (complaints about vaginismus and coital pain) were assessed at baseline and after 12 weeks. Possible mediators: penetration beliefs (catastrophic pain beliefs, genital incompatibility beliefs, perceived control beliefs) and feelings of sexual disgust were assessed at baseline and 6 weeks. Treatment outcome (coital frequency, symptoms of vaginismus, and coital pain) at 12 weeks was mediated by changes in negative and positive penetration beliefs at 6 weeks, in particular by more pronounced reduction of catastrophic pain penetration beliefs. No evidence was found that changes in feelings of sexual disgust mediated treatment outcome. The results strongly suggest that therapist-aided exposure affects negative penetration beliefs and that these changes in negative penetration beliefs mediate treatment outcome in women with lifelong vaginismus. Implications for treatment are discussed. © 2015 International Society for Sexual Medicine.
Falk Delgado, Alberto; Falk Delgado, Anna
Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.
Taniguchi, Chie; Sato, Chifumi
We examined the effects of home-based walking on sedentary Japanese women's pregnancy outcomes and mood. A randomized controlled trial was conducted, involving 118 women aged 22-36 years. Participants were randomly assigned to walking intervention (n = 60) or control (n = 58) groups. The walking group was instructed to walk briskly for 30 min, three times weekly from 30 weeks' gestation until delivery. Both groups counted their daily steps using pedometers. Pregnancy and delivery outcomes were assessed, participants completed the Profile of Mood States, and we used the intention-to-treat principle. Groups showed no differences regarding pregnancy or delivery outcomes. The walking group exhibited decreased scores on the depression-dejection and confusion subscales of the Profile of Mood States. Five of the 54 women in the intervention group who remained in the study (9.2%) completed 100% of the prescribed walking program; 32 (59.3%) women completed 80% or more. Unsupervised walking improves sedentary pregnant women's mood, indicating that regular walking during pregnancy should be promoted in this group. © 2016 John Wiley & Sons Australia, Ltd.
Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran
Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and
Badeea S. Soliman
Full Text Available Background: Interaction between the embryo and endometrium plus endometrial receptivity is considered as two strong issues affecting the implantation outcome. Purpose: To investigate the effect of local endometrial scratching on pregnancy rate after failed previous intra uterine insemination. Study design: A prospective, randomized, control trial. Setting: At Cytogenetic and Endoscopy Unit, Zagazig University Hospital. Patients and methods: A total of 226 women either with unexplained or with mild male factor infertility were divided randomly into approximately two groups: in study group, 114 women and in control group, 112 women. For both groups, folliculometry was started at cycle day 7 additionally and at the same setting; endometrial scratching was done only for the study group. Outcome results: Biochemical and clinical pregnancy rates. Results: The biochemical and clinical pregnancy rates were significantly higher in the endometrial scratching group compared to the control group [27/106 (25.5% vs. 15/106 (14.1% p = 0.03 and 24/106 (22.6% vs. 12/106 (11.3%; p = 0.02] respectively. Also, ongoing pregnancy rate was statistically significantly different between both groups [22/106 (20.7% vs. 11/106 (10.4%; p = 0.03]. Conclusion: Endometrial scratching is useful in increasing pregnancy rates after failed previous intra uterine insemination trials when it is performed in the mid proliferative phase.
Crane, Anna M; Roberts, Marion E; Treasure, Janet
Obsessive-compulsive personality disorder (OCPD) traits are commonly associated with anorexia nervosa (AN). The aim of this review was to systematically search the literature to examine whether OCPD traits have an impact on the outcome of AN. A systematic electronic search of the literature (using Medline, PsycINFO, and the Cochrane Central Register of Controlled Trials) was undertaken to identify relevant publications (randomized controlled trials (RCT's) and naturalistic studies), until February 2006. Eleven prospective longitudinal studies and 12 RCT's met criteria for inclusion. A meta-analysis was not feasible as the studies were too heterogeneous. Just over half of published longitudinal studies found that OCPD traits were associated with a negative outcome in AN. Additionally, results from three RCTs suggested that these traits may moderate outcome. OCPD traits were reduced after treatment in five RCTs. There is tentative support to suggest that individuals with AN and concomitant OCPD traits have a poorer prognosis, and that these traits moderate outcome. A reduction in these traits may mediate this change. An individualized case formulation with treatment tailored to OCPD traits may improve the outcome of AN. (c) 2007 by Wiley Periodicals, Inc.
Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan
Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.
Asimakopoulou, Koula; Newton, Jonathon Tim; Daly, Blánaid; Kutzer, Yvonne; Ide, Mark
In a two arm randomized controlled trial this study compared the effects of a routine periodontal assessment consultation versus a routine consultation + individualized risk assessment communication intervention on patient thoughts and emotions about periodontal disease. Adults (N = 102) with moderate/advanced chronic periodontitis referred to a Periodontology Department of a large UK dental school, completed psychological measures before a periodontal assessment and again at the end of the visit. Intervention participants received an individualized calculation of their periodontal disease risk using PreViser Risk Calculator in addition to their routine assessment consultation. In routine care, patients' thoughts about periodontal disease seriousness (p periodontal disease. These effects were also seen in intervention participants. Additionally, the individualized risk communication intervention led to patients reporting i) periodontal disease treatment as more effective than they did pre-consultation (p periodontal management (p periodontal disease risk communication influences psychological variables that underpin adherence with periodontal instructions. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Wang, Sophia; Hammes, Jessica; Khan, Sikandar; Gao, Sujuan; Harrawood, Amanda; Martinez, Stephanie; Moser, Lyndsi; Perkins, Anthony; Unverzagt, Frederick W; Clark, Daniel O; Boustani, Malaz; Khan, Babar
Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms
Craske, Michelle G; Niles, Andrea N; Burklund, Lisa J; Wolitzky-Taylor, Kate B; Vilardaga, Jennifer C Plumb; Arch, Joanna J; Saxbe, Darby E; Lieberman, Matthew D
Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Implications for clinical practice and future research are discussed.
Craske, Michelle G; Niles, Andrea N.; Burklund, Lisa J.; Wolitzky-Taylor, Kate B.; Vilardaga, Jennifer C. Plumb; Arch, Joanna J.; Saxbe, Darby E.; Lieberman, Matthew D.
Objective Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. Method The current study (N=87) was a 3-arm randomized clinical trial comparing CBT, Acceptance and Commitment therapy (ACT), and a waitlist control group (WL) in participants with a DSM-IV diagnosis of social phobia. Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and post-treatment, and participants assigned to CBT and ACT also completed assessments at 6 and 12 months following baseline. Assessments consisted of self-report measures, a public speaking task, and clinician ratings. Results Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-mo follow-up in CBT compared to ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control, and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Conclusions Implications for clinical practice and future research are discussed. PMID:24999670
Adam D Gepner
Full Text Available 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.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.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.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.
Full Text Available Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking.By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population.PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data.By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial results under proportional and
Cortese, Samuele; Ferrin, Maite; Brandeis, Daniel; Holtmann, Martin; Aggensteiner, Pascal; Daley, David; Santosh, Paramala; Simonoff, Emily; Stevenson, Jim; Stringaris, Argyris; Sonuga-Barke, Edmund J S
We performed meta-analyses of randomized controlled trials to examine the effects of neurofeedback on attention-deficit/hyperactivity disorder (ADHD) symptoms and neuropsychological deficits in children and adolescents with ADHD. We searched PubMed, Ovid, Web of Science, ERIC, and CINAHAL through August 30, 2015. Random-effects models were employed. Studies were evaluated with the Cochrane Risk of Bias tool. We included 13 trials (520 participants with ADHD). Significant effects were found on ADHD symptoms rated by assessors most proximal to the treatment setting, that is, the least blinded outcome measure (standardized mean difference [SMD]: ADHD total symptoms = 0.35, 95% CI = 0.11-0.59; inattention = 0.36, 95% CI = 0.09-0.63; hyperactivity/impulsivity = 0.26, 95% CI = 0.08-0.43). Effects were not significant when probably blinded ratings were the outcome or in trials with active/sham controls. Results were similar when only frequency band training trials, the most common neurofeedback approach, were analyzed separately. Effects on laboratory measures of inhibition (SMD = 0.30, 95% CI = -0.10 to 0.70) and attention (SMD = 0.13, 95% CI = -0.09 to 0.36) were not significant. Only 4 studies directly assessed whether learning occurred after neurofeedback training. The risk of bias was unclear for many Cochrane Risk of Bias domains in most studies. Evidence from well-controlled trials with probably blinded outcomes currently fails to support neurofeedback as an effective treatment for ADHD. Future efforts should focus on implementing standard neurofeedback protocols, ensuring learning, and optimizing clinically relevant transfer. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott
Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.
Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R
To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.
Full Text Available Shiyuan Zhang,1 James Paul,2 Manyat Nantha-Aree,2 Norman Buckley,2 Uswa Shahzad,2 Ji Cheng,2 Justin DeBeer,5 Mitchell Winemaker,5 David Wismer,5 Dinshaw Punthakee,5 Victoria Avram,5 Lehana Thabane1–41Department of Clinical Epidemiology and Biostatistics, 2Department of Anesthesia, McMaster University, Hamilton, ON, Canada; 3Biostatistics Unit/Centre for Evaluation of Medicines, St Joseph's Healthcare - Hamilton, Hamilton, ON, Canada; 4Population Health Research Institute, Hamilton Health Science/McMaster University, 5Department of Surgery, Division of Orthopaedics, McMaster University, Hamilton, ON, CanadaBackground: Although seemingly straightforward, the statistical comparison of a continuous variable in a randomized controlled trial that has both a pre- and posttreatment score presents an interesting challenge for trialists. We present here empirical application of four statistical methods (posttreatment scores with analysis of variance, analysis of covariance, change in scores, and percent change in scores, using data from a randomized controlled trial of postoperative pain in patients following total joint arthroplasty (the Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study [MOBILE] trials.Methods: Analysis of covariance (ANCOVA was used to adjust for baseline measures and to provide an unbiased estimate of the mean group difference of the 1-year postoperative knee flexion scores in knee arthroplasty patients. Robustness tests were done by comparing ANCOVA with three comparative methods: the posttreatment scores, change in scores, and percentage change from baseline.Results: All four methods showed similar direction of effect; however, ANCOVA (-3.9; 95% confidence interval [CI]: -9.5, 1.6; P=0.15 and the posttreatment score (-4.3; 95% CI: -9.8, 1.2; P=0.12 method provided the highest precision of estimate compared with the change score (-3.0; 95% CI: -9.9, 3.8; P=0
Nada, Adel Mohamed; El-Noury, Amr; Al-Inany, Hesham; Bibars, Mamdouh; Taha, Tamer; Salama, Sameh; Hassan, Fatma; Zein, Eman
To compare the ICSI-ET outcomes in patients with endometriosis with or without laser-assisted zona pellucida thinning. Randomized controlled trial. The study was conducted in the Obstetrics & Gynecology Department, Cairo University hospital, and two private IVF centers in Cairo & Beni-Suif from July 2015 to January 2017 upon infertile and known endometriosis patients who planned to do ICSI-ET. Before randomization, all patients received the same ovarian stimulation preparation, oocyte retrieval procedures, and the same intracytoplasmic sperm injection procedures. After randomization, laser-assisted hatching was performed only for embryos of 158 patients, while the other group (n = 150) no laser-assisted hatching was made. The verification of pregnancy was achieved by the serum hCG concentration 14 days after the embryo transfer, and the clinical pregnancy was confirmed 2 weeks later by the presence of gestational sac with pulsating fetal pole on vaginal ultrasonography. The main outcome measures were the clinical pregnancy rate and the clinical implantation rate. Both groups were comparable with regard their baseline characteristics, baseline hormonal profile, the ovarian stimulation characteristics, and the ovulation characteristics. The mean number of embryos developed per patient and the mean transferred number of embryos per patient were comparable between groups (p value > 0.05). The implantation rate was significantly higher (p value 0.002) in the study group than the control group with an odds ratio of 1.86 (CI 95% 1.24-2.80) and NNT 13.81 (CI 95% 8.35-39.94). The clinical pregnancy rate, was significantly (p value 0.022) higher in the study group than in the control group with an odds ratio of 1.79 (CI 95% 1.05-3.06) and NNT 9.57 (CI 95% 5.03-98.99). That laser-assisted hatching by thinning of the zona pellucida may be a suitable method to improve the ICSI-ET outcomes, in term of the implantation and the pregnancy rates, in cases of endometriosis. Pan
Jiang, Hong; Xiong, Xu; Su, Yi; Zhang, Yiming; Wu, Hongqiao; Jiang, Zhijun; Qian, Xu
Background Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized cont...
Foster, Byron A.; Escaname, Elia; Powell, Theresa L.; Larsen, Benjamin; Siddiqui, Sartaj K.; Menchaca, John; Aquino, Christian; Ramamurthy, Rajam; Hale, Daniel E.
Investigating safe and effective interventions in pregnancy that lower offspring adiposity is important given the burden of obesity and subsequent metabolic derangements. Our objective was to determine if docosahexaenoic acid (DHA) given during pregnancy to obese mothers results in lower offspring adiposity. This study was a long-term follow-up of a randomized trial of mothers with gestational diabetes or obesity who were randomized to receive DHA supplementation at 800 mg/day or placebo (corn/soy oil) starting at 25–29 weeks gestation. Anthropometric measures were collected at birth and maternal erythrocyte DHA and arachidonic (AA) levels were measured at 26 and 36 weeks gestation. At two- and four-year follow-up time points, offspring adiposity measures along with a diet recall were assessed. A significant increase in erythrocyte DHA levels was observed at 36 weeks gestation in the supplemented group (p < 0.001). While no significant differences by measures of adiposity were noted at birth, two or four years by randomization group, duration of breastfeeding (p < 0.001), and DHA level at 36 weeks (p = 0.002) were associated with body mass index z-score. Our data suggest that DHA supplementation during pregnancy in obese mothers may have long-lasting effects on offspring measures of adiposity. PMID:28574453
Full Text Available Evidence based public health requires knowledge about successful dissemination of public health measures. This study analyses (a the changes in worksite tobacco prevention (TP in the Canton of Zurich, Switzerland, between 2007 and 2009; (b1 the results of a multistep versus a “brochure only” dissemination strategy; (b2 the results of a monothematic versus a comprehensive dissemination strategy that aim to get companies to adopt TP measures; and (c whether worksite TP is associated with health-related outcomes. A longitudinal design with randomized control groups was applied. Data on worksite TP and health-related outcomes were gathered by a written questionnaire (baseline n=1627; follow-up n=1452 and analysed using descriptive statistics, nonparametric procedures, and ordinal regression models. TP measures at worksites improved slightly between 2007 and 2009. The multistep dissemination was superior to the “brochure only” condition. No significant differences between the monothematic and the comprehensive dissemination strategies were observed. However, improvements in TP measures at worksites were associated with improvements in health-related outcomes. Although dissemination was approached at a mass scale, little change in the advocated adoption of TP measures was observed, suggesting the need for even more aggressive outreach or an acceptance that these channels do not seem to be sufficiently effective.
Rozental, Alexander; Shafran, Roz; Wade, Tracey; Egan, Sarah; Nordgren, Lise Bergman; Carlbring, Per; Landström, Andreas; Roos, Stina; Skoglund, Malin; Thelander, Elisabet; Trosell, Linnéa; Örtenholm, Alexander; Andersson, Gerhard
Being highly attentive to details can be a positive feature. However, for some individuals, perfectionism can lead to distress and is associated with many psychiatric disorders. Cognitive behavior therapy has been shown to yield many benefits for those experiencing problems with perfectionism, but the access to evidence-based care is limited. The current study investigated the efficacy of guided Internet-based Cognitive Behavior Therapy (ICBT) and predictors of treatment outcome. In total, 156 individuals were included and randomized to an eight-week treatment or wait-list control. Self-report measures of perfectionism, depression, anxiety, self-criticism, self-compassion, and quality of life were distributed during screening and at post-treatment. Intention-to-treat were used for all statistical analyses. Moderate to large between-group effect sizes were obtained for the primary outcome measures, Frost Multidimensional Perfectionism Scale, subscales Concerns over Mistakes and Personal Standards, Cohen's d = 0.68-1.00, 95% Confidence Interval (CI) [0.36-1.33], with 35 (44.9%) of the patients in treatment being improved. Predictors were also explored, but none were related to treatment outcome. In sum, guided ICBT can be helpful for addressing problems with clinical perfectionism, but research of its long-term benefits is warranted. Copyright © 2017 Elsevier Ltd. All rights reserved.
Friedrich, Verena; Brügger, Adrian; Bauer, Georg F
Evidence based public health requires knowledge about successful dissemination of public health measures. This study analyses (a) the changes in worksite tobacco prevention (TP) in the Canton of Zurich, Switzerland, between 2007 and 2009; (b1) the results of a multistep versus a "brochure only" dissemination strategy; (b2) the results of a monothematic versus a comprehensive dissemination strategy that aim to get companies to adopt TP measures; and (c) whether worksite TP is associated with health-related outcomes. A longitudinal design with randomized control groups was applied. Data on worksite TP and health-related outcomes were gathered by a written questionnaire (baseline n = 1627; follow-up n = 1452) and analysed using descriptive statistics, nonparametric procedures, and ordinal regression models. TP measures at worksites improved slightly between 2007 and 2009. The multistep dissemination was superior to the "brochure only" condition. No significant differences between the monothematic and the comprehensive dissemination strategies were observed. However, improvements in TP measures at worksites were associated with improvements in health-related outcomes. Although dissemination was approached at a mass scale, little change in the advocated adoption of TP measures was observed, suggesting the need for even more aggressive outreach or an acceptance that these channels do not seem to be sufficiently effective.
Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Nohr, Ellen A
To examine the effect of a brief course in self-hypnosis for childbirth on duration of the labor and other birth outcomes. A randomized, controlled, single-blind trial. Aarhus University Hospital Skejby, Denmark. A total of 1222 healthy nulliparous women. A hypnosis group receiving three 1-h lessons in self-hypnosis with additional audio-recordings to ease childbirth, a relaxation group receiving three 1-h lessons in various relaxation methods and mindfulness with audio-recordings for additional training, and a usual-care group receiving only the usual antenatal care were compared. Duration of labor, birth complications, lactation success, caring for the child, and preferred future mode of delivery. No differences were found across the three groups on duration from arriving at the birth department until the expulsive phase of second stage of labor, the duration of the expulsive phase, or other birth outcomes. Fewer emergency and more elective cesarean sections occurred in the hypnosis group. No difference was seen across the groups for lactation success or caring for the child but fewer women in the hypnosis group preferred a cesarean section in future pregnancies because of fear of childbirth and negative birth experiences. Learning self-hypnosis to ease childbirth taught as a brief course failed to show any effects on duration of childbirth and other birth outcomes. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.
Ortiz Collado, Maria Assumpta; Saez, Marc; Favrod, Jérôme; Hatem, Marie
Postpartum depression (PPD) and poor childbirth outcomes are associated with poverty; these variables should be addressed by an adapted approach. The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery, regarding the risk of PPD and childbirth outcomes in disadvantaged women. A multi-centre, randomized, controlled trial comparing a novel to standard antenatal programme. Primary outcome was depressive symptoms (using EPDS) and secondary outcome was preterm childbirth (fewer 37 weeks). The sample comprised 184 couples in which the women were identified to be at PPD risk by validated interview. The study was conducted in three public hospitals with comparable standards of perinatal care. Women were randomly distributed in to an experimental group (EG) or a control group (CG), and evaluated twice: during pregnancy (T1) and four weeks post-partum (T2). At T2, the variables were compared using the chi square test. Data analysis was based on intention to treat. The novel programme used the Tourné psychosomatic approach focusing on body awareness sensations, construction of an individualized childbirth model, and attachment. The 10 group antenatal sessions each lasted two hours, with one telephone conversation between sessions. In the control group, the participants choose the standard model of antenatal education, i.e., 8 to 10 two-hour sessions focused on childbirth by obstetrical prophylaxis. A difference of 11.2% was noted in postpartum percentages of PPD risk (EPDS ≥ 12): 34.3% (24) in EG and 45.5% (27) in CG (p = 0.26). The number of depressive symptoms among EG women decreased at T2 (intragroup p = 0.01). Premature childbirth was four times less in EG women: three (4.4%) compared to 13 (22.4%) among CG women (p = 0.003). Birth weight was higher in EG women (p = 0.01). The decrease of depressive symptoms in women was not conclusive. However, because birth weight was higher and
Fernell, Elisabeth; Wilson, Philip; Hadjikhani, Nouchine; Bourgeron, Thomas; Neville, Brian; Taylor, David; Minnis, Helen; Gillberg, Christopher
We draw attention to a number of important considerations in the arguments about screening and outcome of intervention in children with autism and other developmental disorders. Autism screening in itself never provides a final clinical diagnosis, but may well identify developmental deviations indicative of autism—or of other developmental disorders—that should lead to referral for further clinical assessment. Decisions regarding population or clinic screening cannot be allowed to be based on...
Baldwin, Mike; Spong, Andrew; Doward, Lynda; Gnanasakthy, Ari
Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which differs from the usual patient-reported outcomes (PRO). These new emergent data from the social web have important implications for decision making, at both an individual and a population level. We discuss new emergent technologies that will help aggregate this information and discuss how this will be assessed alongside the use of PROs in randomized controlled trials and how these new emergent data will be one facet of changing the relationship between the various stakeholders in achieving better co-created health.
Full Text Available Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1 evaluate the probability of imbalance in a binary prognostic factor (PF between two treatment arms, (2 investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3 examine the effect of sample size (n in relation to the first two objectives.We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power.For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5 leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2, adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF.The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed.
Chu, Rong; Walter, Stephen D.; Guyatt, Gordon; Devereaux, P. J.; Walsh, Michael; Thorlund, Kristian; Thabane, Lehana
Background Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1) evaluate the probability of imbalance in a binary prognostic factor (PF) between two treatment arms, (2) investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3) examine the effect of sample size (n) in relation to the first two objectives. Methods We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power. Results For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5) leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2), adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF. Conclusions The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed. PMID:22629322
Full Text Available Abstract Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes. Methods An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR. A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals were identified from EMRs, and 1535 patients (59% gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80% participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA1c for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm. Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%. No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm. Conclusions Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care. Trial registration
Sadhwani, Anjali; Asaro, Lisa A.; Goldberg, Caren; Ware, Janice; Butcher, Jennifer; Gaies, Michael; Smith, Cynthia; Alexander, Jamin L.; Wypij, David; Agus, Michael S. D.
Objective To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age. Study design A 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment. Results Neurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes. Conclusion For infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age. PMID:27112038
Ghodsi, Z.; Asltoghiri, M.
Objective: To assess the effect of aerobic exercise training on maternal and neonatal outcome. Methods: The case-control study was conducted between January and July, 2011. It was approved by the Research Ethics Committee of Toyserkan Azad University, and data was collected at prenatal clinics and delivery centres located in Hamedan, Iran. It comprised 80 pregnant women between 20-26 weeks of gestation randomly assigned to two equal and matching groups of cases and controls. The intervention group did exercise continuously on a bicycle ergometre for 15 minutes, three times a week; the intensity being 50-60% of maximal heart rate. The control group did not do any exercise training. All information was obtained from the clinics, delivery centres, and from the reports of delivery room midwives. Results: No statistically significant difference was found between the two groups in gestational weight gain, pregnancy length, mode of delivery, first and second stage of labour, perineal tear, and 1st and 5th min Apgar score. Mean neonatal weight was significantly less in the intervention group than the control group (p<0.001). Conclusion: Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate. (author)
Fernell, Elisabeth; Wilson, Philip; Hadjikhani, Nouchine; Bourgeron, Thomas; Neville, Brian; Taylor, David; Minnis, Helen; Gillberg, Christopher
We draw attention to a number of important considerations in the arguments about screening and outcome of intervention in children with autism and other developmental disorders. Autism screening in itself never provides a final clinical diagnosis, but may well identify developmental deviations indicative of autism-or of other developmental disorders-that should lead to referral for further clinical assessment. Decisions regarding population or clinic screening cannot be allowed to be based on the fact that prospective longitudinal RCT designs over decades could never be performed in complex developmental disorders. We propose an alternative approach. Early screening for autism and other developmental disorders is likely to be of high societal importance and should be promoted and rigorously evaluated.
Ang, Dennis C; Kaleth, Anthony S; Bigatti, Silvia; Mazzuca, Steven A; Jensen, Mark P; Hilligoss, Janna; Slaven, James; Saha, Chandan
Regular exercise is associated with important benefits in patients with fibromyalgia (FM). Unfortunately, long-term maintenance of exercise after a structured program is rare. The present study tested the efficacy of Motivational Interviewing (MI) to promote exercise and improve symptoms in patients with FM. A total of 216 patients with FM were randomized to 6 MI sessions (n=107) or an equal number of FM self-management lessons (education control/EC, n=109). Co-primary endpoints were an increase of 30 minutes in moderate-vigorous physical activity and improvement in the Fibromyalgia Impact Questionnaire (FIQ)-Physical Impairment score, assessed at pretreatment, posttreatment, and 3-month and 6-month follow-up. Secondary outcomes included clinically meaningful improvements in FIQ score, pain severity ratings, and a 6-minute walk test. There were no significant treatment group differences in either co-primary endpoint at 6-month follow-up. However, more MI participants than controls exhibited meaningful improvements in FIQ score at 6-month follow-up (62.9% vs. 49.5%, P=0.06). Compared with EC participants, MI participants also displayed a larger increment in their 6-minute walk test (43.9 vs. 24.8 m, P=0.03). In addition, MI was superior to EC in increasing the number of hours of physical activity immediately postintervention and in reducing pain severity both immediately after the intervention and at 3-month follow-up. Despite a lack of benefits on long-term outcome, MI seems to have short-term benefits with respect to self-report physical activity and clinical outcomes. This is the first study in FM that explicitly addresses exercise maintenance as a primary aim.
Background Chronic work-related stress is an independent risk factor for cardiometabolic diseases and associated mortality, particularly when compounded by a sedentary work environment. The purpose of this study was to determine if an office worksite-based hatha yoga program could improve physiological stress, evaluated via heart rate variability (HRV), and associated health-related outcomes in a cohort of office workers. Methods Thirty-seven adults employed in university-based office positions were randomized upon the completion of baseline testing to an experimental or control group. The experimental group completed a 10-week yoga program prescribed three sessions per week during lunch hour (50 min per session). An experienced instructor led the sessions, which emphasized asanas (postures) and vinyasa (exercises). The primary outcome was the high frequency (HF) power component of HRV. Secondary outcomes included additional HRV parameters, musculoskeletal fitness (i.e. push-up, side-bridge, and sit & reach tests) and psychological indices (i.e. state and trait anxiety, quality of life and job satisfaction). Results All measures of HRV failed to change in the experimental group versus the control group, except that the experimental group significantly increased LF:HF (p = 0.04) and reduced pNN50 (p = 0.04) versus control, contrary to our hypotheses. Flexibility, evaluated via sit & reach test increased in the experimental group versus the control group (p yoga sessions (n = 11) to control (n = 19) yielded the same findings, except that the high adherers also reduced state anxiety (p = 0.02) and RMSSD (p = 0.05), and tended to improve the push-up test (p = 0.07) versus control. Conclusions A 10-week hatha yoga intervention delivered at the office worksite during lunch hour did not improve HF power or other HRV parameters. However, improvements in flexibility, state anxiety and musculoskeletal fitness were noted with high adherence
Donkin, Liesje; Hickie, Ian B; Christensen, Helen; Naismith, Sharon L; Neal, Bruce; Cockayne, Nicole L; Glozier, Nick
There is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program. The objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. Cardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥ 5 points. In all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the
Full Text Available BACKGROUND: Observational studies suggest that B vitamin supplementation reduces cardiovascular risk in adults, but this association remains controversial. This study aimed to summarize the evidence from randomized controlled trials (RCTs investigating B vitamin supplementation for the primary or secondary prevention of major adverse cardiovascular outcomes and to perform a cumulative meta-analysis to determine the evidence base. METHODOLOGY AND PRINCIPAL FINDINGS: In April 2013, we searched PubMed, Embase, and the Cochrane Library to identify relevant RCTs. We included RCTs investigating the effect of B vitamin supplementation on cardiovascular outcome. Relative risk (RR was used to measure the effect using a random-effect model. Statistical heterogeneity scores were assessed using the Q statistic. We included data on 57,952 individuals from 24 RCTs: 12 primary prevention trials and 12 secondary prevention trials. In 23 of these trials, 10,917 major adverse cardiovascular events (MACE occurred; in 20 trials, 7,203 deaths occurred; in 15 trials, 3,422 cardiac deaths occurred; in 19 trials, 3,623 myocardial infarctions (MI occurred; and in 18 trials, 2,465 strokes occurred. B vitamin supplementation had little or no effect on the incidence of MACE (RR, 0.98; 95% confidence interval [CI]: 0.93-1.03; P = 0.37, total mortality (RR, 1.01; 95% CI: 0.97-1.05; P = 0.77, cardiac death (RR, 0.96; 95% CI: 0.90-1.02; P = 0.21, MI (RR, 0.99; 95% CI: 0.93-1.06; P = 0.82, or stroke (RR, 0.94; 95% CI: 0.85-1.03; P = 0.18. CONCLUSION/SIGNIFICANCE: B vitamin supplementation, when used for primary or secondary prevention, is not associated with a reduction in MACE, total mortality, cardiac death, MI, or stroke.
Tyrer, Peter; Wang, Duolao; Tyrer, Helen; Crawford, Mike; Cooper, Sylvia
The personality trait of dependence is common in health-seeking behaviour. We therefore examined its impact in a large randomized controlled trial of psychological treatment for health anxiety. To test whether dependent personality traits were positive or negative in determining the outcome of an adapted form of cognitive behaviour therapy for health anxiety (CBT-HA) over the course of 5 years and whether dependent personality dysfunction could be viewed dimensionally in a similar way to the new ICD-11 diagnostic system for general personality disorder. Dependent personality dysfunction was assessed using a self-rated questionnaire, the Dependent Personality Questionnaire, at baseline in a randomized controlled trial of 444 patients from medical clinics with pathological health anxiety treated with a modified form of CBT-HA or standard treatment in the medical clinics, with assessment on five occasions over 5 years. Dependent personality dysfunction was assessed using four severity groups. Patients with mild and moderate dependent personality disorder treated with CBT-HA showed the greatest reduction in health anxiety compared with standard care, and those with no dependent dysfunction showed the least benefit. Patients with higher dependent traits received significantly more treatment sessions (8.6) than those with low trait levels (5.4) (p dependent personality. The reasons for this may be related to better adherence to psychological treatment and greater negative effects of frequent reassurance and excessive consultation in those treated in standard care. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
El-Khayat, Waleed; Elsadek, Mostafa; Saber, Waleed
To evaluate the role of endometrial injury in the cycle preceding ovarian stimulation for intrauterine insemination (IUI) cycle on the clinical pregnancy rate. This was a prospective randomized controlled trial which included three hundred and thirty two infertile women with an indication for IUI. The subjects were randomly divided into two groups. The intervention group (group A) (n=166) subjects underwent office hysteroscopy with endometrial injury using grasping forceps with teeth, while the control group (group B) (n=166) subjects underwent office hysteroscopy alone without endometrial injury. Primary outcome was clinical pregnancy rate. There were no significant differences in baseline or clinical characteristics between the groups. There were no significant differences in clinical pregnancy rate [13.8% (23/166) versus 12% (20/166); RR 1.15 (95% CI 0.66-2.01), p=0.62]. The abortion rate [4.3% (1/23) versus 15% (3/20); RR 0.29 (95% CI 0.03-2.57), p=0.27], the multiple pregnancy rate [13% (3/23) versus 15% (3/20); RR 0.87 (95% CI 0.20-3.83), p=0.85] and the live birth rate [13.6% (22/166) versus 10.4% (17/166); RR 1.28 (95% CI 0.71-2.32), p=0.42]. There is no evidence of significant difference on the clinical pregnancy rate when endometrial scratching during hysteroscopy is compared to only hysteroscopy in women undergoing IUI. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Berlucchi, Marco; Castelnuovo, Paolo; Vincenzi, Andrea; Morra, Bruno; Pasquini, Ernesto
Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.
Background Delirium is a frequent disorder in intensive care unit (ICU) patients with serious consequences. Therefore, preventive treatment for delirium may be beneficial. Worldwide, haloperidol is the first choice for pharmacological treatment of delirious patients. In daily clinical practice, a lower dose is sometimes used as prophylaxis. Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality, but evidence for effectiveness in ICU patients is limited. The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival. Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis. Methods This will be a multicenter three-armed randomized, double-blind, placebo-controlled, prophylactic intervention study in critically ill patients. We will include consecutive non-neurological ICU patients, aged ≥18 years with an expected ICU length of stay >1 day. To be able to demonstrate a 15% increase in 28-day survival time with a power of 80% and alpha of 0.05 in both intervention groups, a total of 2,145 patients will be randomized; 715 in each group. The anticipated mortality rate in the placebo group is 12%. The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h, and patients in the control group will receive placebo (sodium chloride 0.9%), both for a maximum period of 28-days. In patients who develop delirium, study medication will be stopped and patients will subsequently receive open label treatment with a higher (therapeutic) dose of haloperidol. We will use descriptive summary statistics as well as Cox proportional hazard regression analyses, adjusted for covariates. Discussion This will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium, adequately
Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we
Full Text Available Binge drinking is associated with numerous negative consequences. The prevalence and intensity of binge drinking is highest among young adults. This randomized trial tested the efficacy of a 12-week interactive text message intervention to reduce binge drinking up to 6 months after intervention completion among young adults.Young adult participants (18-25 y; n = 765 drinking above the low-risk limits (AUDIT-C score >3/4 women/men, but not seeking alcohol treatment, were enrolled from 4 Emergency Departments (EDs in Pittsburgh, PA. Participants were randomized to one of three conditions in a 2:1:1 allocation ratio: SMS Assessments + Feedback (SA+F, SMS Assessments (SA, or control. For 12 weeks, SA+F participants received texts each Thursday querying weekend drinking plans and prompting drinking limit goal commitment and each Sunday querying weekend drinking quantity. SA+F participants received tailored feedback based on their text responses. To contrast the effects of SA+F with self-monitoring, SA participants received texts on Sundays querying drinking quantity, but did not receive alcohol-specific feedback. The control arm received standard care. Follow-up outcome data collected through web-based surveys were provided by 78% of participants at 3- months, 63% at 6-months and 55% at 9-months. Multiple imputation-derived, intent-to-treat models were used for primary analysis. At 9-months, participants in the SA+F group reported greater reductions in the number of binge drinking days than participants in the control group (incident rate ratio [IRR] 0.69; 95% CI .59 to.79, lower binge drinking prevalence (odds ratio [OR] 0.52; 95% CI 0.26 to 0.98], less drinks per drinking day (beta -.62; 95% CI -1.10 to -0.15 and lower alcohol-related injury prevalence (OR 0.42; 95% CI 0.21 to 0.88. Participants in the SA group did not reduce drinking or alcohol-related injury relative to controls. Findings were similar using complete case analyses.An interactive
Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.
Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…
McBride, Carolina; Atkinson, Leslie; Quilty, Lena C.; Bagby, R. Michael
Anxiety and avoidance dimensions of adult attachment insecurity were tested as moderators of treatment outcome for interpersonal psychotherapy (IPT) and cognitive-behavioral therapy (CBT). Fifty-six participants with major depression were randomly assigned to these treatment conditions. Beck Depression Inventory-II, Six-Item Hamilton Rating Scale…
Bennell, Kim L; Kyriakides, Mary; Hodges, Paul W; Hinman, Rana S
Enhancing exercise adherence over the longer term is an important goal in self-management of knee osteoarthritis (OA). Following an initial period of more intensive exercise supervision, this study investigated whether 2 additional physiotherapy visits improved outcomes with continued home exercise over a subsequent 24-week period. A total of 78 people with medial knee OA (mean ± SD age 62.1 ± 6.9 years, mean ± SD body mass index 29.4 ± 4.0 kg/m(2) , and radiographic disease severity 19% mild, 49% moderate, and 32% severe) who completed a 12-week physiotherapist-supervised exercise trial were randomly allocated to 2 30-minute physiotherapy booster sessions (delivered by 8 physiotherapists in private clinics) or no booster sessions for the subsequent 24 weeks. All participants were asked to continue home exercises 4 times weekly. Primary outcomes were change in pain, using a 100-mm visual analog scale, and self-reported physical function, measured using the Western Ontario McMaster Universities Osteoarthritis Index. Participants and physiotherapists were unblinded to group allocation, although participants were blinded to the study hypothesis. A total of 74 participants (95%) completed the trial. There was no significant difference between groups for change in pain (mean difference [95% confidence interval (95% CI)] 0.7 mm [-9.4, 8.0]; P = 0.88) or physical function (-0.3 units [95% CI -4.0, 3.5]; P = 0.88). The mean ± SD percentage of home exercise sessions completed was 56% ± 34% in the booster group and 51% ± 37% in the control group (P > 0.05). Two booster sessions with a physiotherapist did not influence pain or physical function outcomes, or measures of home exercise adherence. These findings suggest other more effective strategies are needed to maximize longer-term adherence with the aim to achieve greater improvements in clinical outcomes from exercise in this patient population. Copyright © 2014 by the American College of Rheumatology.
Byrd-Bredbenner, Carol; Delaney, Colleen; Martin-Biggers, Jennifer; Koenings, Mallory; Quick, Virginia
Despite the critical importance of successful recruitment and retention to study integrity, reporting of recruitment and retention strategies along with factors associated with successful recruitment and retention of participants in health-related interventions remain rare, especially for health and obesity prevention programs. Thus, the purpose of this article is to retrospectively examine the recruitment and retention marketing plan used in the online HomeStyles randomized controlled trial (RCT) and discuss outcomes associated with completion of the intervention. The HomeStyles RCT is an online intervention developed to motivate parents of young children to gain the skills and self-confidence needed to shape home environments and lifestyles to be protective against childhood obesity. Using the seven Ps of services marketing (i.e., people, place, product, physical evidence, price, promotion, and process), a comprehensive and systematic plan for recruitment and retention was implemented and outcomes assessed. A total of 489 parents with a young child aged 2 to attractiveness, interestingness, and usefulness. Despite all the retention efforts, the average monthly recruitment accrual rate of ~ 33 eligible enrolled participants at baseline (i.e., 489 participants/15-month recruitment period), declined to ~ 18, 11, 9, and 8 remaining recruited participants/month at midpoint, post, follow-up, and long-term follow-up surveys, respectively. In general, survey completers were significantly more likely to be female and perceived their child's health status to be better, and they were significantly less likely to be restrictive of their child's food intake. The findings of the present study highlight the need for far-reaching, concentrated, and varied recruitment strategies; sufficient time in the research plan for recruitment and retention activities; and creative, tireless, flexible, persistent project staff for health-related interventions.
Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D
While high levels of activity and exercise training have been associated with improvements in sleep quality, minimum levels of activity likely to improve sleep outcomes have not been explored. A two-armed parallel randomized controlled trial (N=41; 30 females) was designed to assess whether increasing physical activity to the level recommended in public health guidelines can improve sleep quality among inactive adults meeting research diagnostic criteria for insomnia. The intervention consisted of a monitored program of ≥150 min of moderate- to vigorous-intensity physical activity per week, for 6 months. The principal end-point was the Insomnia Severity Index at 6 months post-baseline. Secondary outcomes included measures of mood, fatigue and daytime sleepiness. Activity and light exposure were monitored throughout the trial using accelerometry and actigraphy. At 6 months post-baseline, the physical activity group showed significantly reduced insomnia symptom severity (F(8,26) = 5.16, P = 0.03), with an average reduction of four points on the Insomnia Severity Index; and significantly reduced depression and anxiety scores (F(6,28) = 5.61, P = 0.02; and F(6,28) = 4.41, P = 0.05, respectively). All of the changes were independent of daily light exposure. Daytime fatigue showed no significant effect of the intervention (F(8,26) = 1.84, P = 0.18). Adherence and retention were high. Internationally recommended minimum levels of physical activity improve daytime and night-time symptoms of chronic insomnia independent of daily light exposure levels. © 2015 European Sleep Research Society.
van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G
had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.
Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory
Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.
Moein, C. M. Ansari; ten Duis, H. J.; Oey, P. L.; de Kort, G. A. P.; van der Meulen, W.; van der Werken, Chr
In a level 1 university trauma center, an explorative randomized controlled study was performed to compare soft tissue damage and functional outcome after antegrade femoral nailing through a trochanteric fossa (also known as piriform fossa) entry point to a greater trochanter entry point in patients
Allart-van Dam, E.; Hosman, C.M.H.; Hoogduin, C.A.L.; Schaap, C.P.D.R.
This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were
Allart-van Dam, E; Hosman, CMH; Hoogduin, CAL; Schaap, CPDR
This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were
Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial.
Magee, Laura A; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Gruslin, Andrée; Helewa, Michael; Hutton, Eileen; Lee, Shoo K; Logan, Alexander G; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G; Moutquin, Jean Marie
For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes. This was a planned, secondary analysis of data from the 987 women in the CHIPS Trial. Logistic regression was used to examine the impact of 19 candidate predictors on the probability of adverse perinatal (pregnancy loss or high level neonatal care for >48 h, or birthweight hypertension, preeclampsia, or delivery at blood pressure within 1 week before randomization. Continuous variables were represented continuously or dichotomized based on the smaller p-value in univariate analyses. An area-under-the-receiver-operating-curve (AUC ROC) of ≥0.70 was taken to reflect a potentially useful model. Point estimates for AUC ROC were hypertension (0.70, 95% CI 0.67-0.74) and delivery at hypertension develop an elevated blood pressure in pregnancy, or formerly normotensive women develop new gestational hypertension, maternal and current pregnancy clinical characteristics cannot predict adverse outcomes in the index pregnancy. © 2016 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).
Ganesh, Praveen; Murthy, Jyotsna; Ulaghanathan, Navitha; Savitha, V H
To study the growth and speech outcomes in children who were operated on for unilateral cleft lip and palate (UCLP) by a single surgeon using two different treatment protocols. A total of 200 consecutive patients with nonsyndromic UCLP were randomly allocated to two different treatment protocols. Of the 200 patients, 179 completed the protocol. However, only 85 patients presented for follow-up during the mixed dentition period (7-10 years of age). The following treatment protocol was followed. Protocol 1 consisted of the vomer flap (VF), whereby patients underwent primary lip nose repair and vomer flap for hard palate single-layer closure, followed by soft palate repair 6 months later; Protocol 2 consisted of the two-flap technique (TF), whereby the cleft palate (CP) was repaired by two-flap technique after primary lip and nose repair. GOSLON Yardstick scores for dental arch relation, and speech outcomes based on universal reporting parameters, were noted. A total of 40 patients in the VF group and 45 in the TF group completed the treatment protocols. The GOSLON scores showed marginally better outcomes in the VF group compared to the TF group. Statistically significant differences were found only in two speech parameters, with better outcomes in the TF group. Our results showed marginally better growth outcome in the VF group compared to the TF group. However, the speech outcomes were better in the TF group. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Michael H Chung
Full Text Available Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine were randomized to one of four arms: counseling (three counseling sessions around HAART initiation, alarm (pocket electronic pill reminder carried for 6 months, counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055 and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml (HR 0.41; 95% CI 0.21-0.81; p = 0.01 compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7 or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0 compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and
Cortese, Samuele; Ferrin, Maite; Brandeis, Daniel; Buitelaar, Jan; Daley, David; Dittmann, Ralf W.; Holtmann, Martin; Santosh, Paramala; Stevenson, Jim; Stringaris, Argyris; Zuddas, Alessandro; Sonuga-Barke, Edmund J.S.
Objective The authors performed meta-analyses of randomized controlled trials to examine the effects of cognitive training on attention-deficit/hyperactivity disorder (ADHD) symptoms, neuropsychological deficits, and academic skills in children/adolescents with ADHD. Method The authors searched Pubmed, Ovid, Web of Science, ERIC, and CINAHAL databases through May 18, 2014. Data were aggregated using random-effects models. Studies were evaluated with the Cochrane risk of bias tool. Results Sixteen of 695 nonduplicate records were analyzed (759 children with ADHD). When all types of training were considered together, there were significant effects on total ADHD (standardized mean difference [SMD] = 0.37, 95% CI = 0.09–0.66) and inattentive symptoms (SMD = 0.47, 95% CI = 0.14–0.80) for reports by raters most proximal to the treatment setting (i.e., typically unblinded). These figures decreased substantially when the outcomes were provided by probably blinded raters (ADHD total: SMD = 0.20, 95% CI = 0.01–0.40; inattention: SMD = 0.32, 95% CI = −0.01 to 0.66). Effects on hyperactivity/impulsivity symptoms were not significant. There were significant effects on laboratory tests of working memory (verbal: SMD = 0.52, 95% CI = 0.24–0.80; visual: SMD = 0.47, 95% CI = 0.23–0.70) and parent ratings of executive function (SMD = 0.35, 95% CI = 0.08–0.61). Effects on academic performance were not statistically significant. There were no effects of working memory training, specifically on ADHD symptoms. Interventions targeting multiple neuropsychological deficits had large effects on ADHD symptoms rated by most proximal assessors (SMD = 0.79, 95% CI = 0.46–1.12). Conclusion Despite improving working memory performance, cognitive training had limited effects on ADHD symptoms according to assessments based on blinded measures. Approaches targeting multiple neuropsychological processes may optimize the transfer of effects from cognitive deficits to
Shaun W. H. Lee
Full Text Available Importance: Telemedicine has been shown to be an efficient and effective means of providing care to patients with chronic disease especially in remote and undeserved regions, by improving access to care and reduce healthcare cost. However, the evidence surrounding its applicability in type 1 diabetes remains scarce and conflicting.Objective: To synthesize evidence and quantify the effectiveness of telemedicine interventions for the management of glycemic and clinical outcomes in type 1 diabetes patients, relative to comparator conditions.Data Sources: MEDLINE, EMBASE, Cochrane Library, Web of Science, PsycINFO, and CINAHL were searched for published articles since inception until December 2016.Study Selection: Original articles reporting the results of randomized controlled studies on the effectiveness of telemedicine in people with type 1 diabetes were included.Data Extraction and Synthesis: Two reviewers independently extracted data, assessed quality, and strength of evidence. Interventions were categorized based upon the telemedicine focus (monitoring, education, consultation, case-management, and peer mentoring.Main Outcome and Measure: Absolute change in glycosylated hemoglobin A1c (HbA1c from baseline to follow-up assessment.Results: A total of 38 studies described in 41 articles were identified. Positive effects on glycemic control were noted with studies examining telemedicine, with a mean reduction of 0.18% at the end of intervention. Studies with longer duration (>6 months who had recruited patients with a higher baseline HbA1c (≥9% were associated with larger effects. Telemedicine interventions that involve individualized assessments, audit with feedback and skill building were also more effective in improving glycemic control. However, no benefits were observed on blood pressure, lipids, weight, quality of life, and adverse events.Conclusions and Relevance: There is insufficient evidence to support telemedicine use for glycemic
Hill, Darryl V.; Lenard, Matthew A.; Page, Lindsay Coleman
School districts are increasingly adopting technology-based resources in an attempt to improve student achievement. This paper reports the two-year results from randomized control trial of Achieve3000 in the Wake County Public School System (WCPSS) in Raleigh, North Carolina. Achieve3000 is an early literacy program that differentiates non-fiction…
Cortese, S.; Ferrin, M.; Brandeis, D.; Buitelaar, J.K.; Daley, D.; Dittmann, R.W.; Holtmann, M.; Santosh, P.; Stevenson, J.; Stringaris, A.; Zuddas, A.; Sonuga-Barke, E.J.
OBJECTIVE: The authors performed meta-analyses of randomized controlled trials to examine the effects of cognitive training on attention-deficit/hyperactivity disorder (ADHD) symptoms, neuropsychological deficits, and academic skills in children/adolescents with ADHD. METHOD: The authors searched
Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.
Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…
Bolzan, Douglas W; Trimer, Renata; Begot, Isis; Nasrala, Mara L S; Forestieri, Patricia; Mendez, Vanessa M F; Arena, Ross; Gomes, Walter J; Guizilini, Solange
To compare pulmonary function, functional capacity, and clinical outcomes among conventional mechanical ventilation (CMV), early open-lung (EOL), and late open-lung (LOL) strategies after off-pump coronary artery bypass surgery (OPCAB). Prospective, randomized, and double-blinded study. Two hospitals of the Federal University of Sao Paulo, Brazil. Ninety-three patients undergoing elective first-time OPCAB. Patients were randomized into 3 groups: CMV (n=31); LOL (n=32) initiated upon intensive care unit (ICU) arrival; EOL (n = 30) initiated after intubation. Spirometry was performed at bedside preoperatively and on postoperative days (PODs) 1, 3, and 5. Partial pressure of arterial oxygen (PaO2) and pulmonary shunt fraction were evaluated presurgically and on POD 1; 6-minute walk test (6MWT) was performed presurgically and on POD 5. Both open-lung groups demonstrated higher forced vital capacity and forced expiratory volume in 1 second on PODs 1, 3 and 5 compared to the CMV group (pLOL groups were compared. Both open-lung strategies were able to promote higher pulmonary function preservation and greater recovery of functional capacity with better clinical outcomes after OPCAB. No difference in outcome was found when comparing initiation of OLS intraoperatively or after ICU arrival. Copyright © 2016 Elsevier Inc. All rights reserved.
White, Harvey D; Gruber, Michael; Feyzi, Jan
BACKGROUND: Warfarin sodium reduces stroke risk in patients with atrial fibrillation, but international normalized ratio (INR) monitoring is required. Target INRs are frequently not achieved, and the risk of death, bleeding, myocardial infarction (MI), and stroke or systemic embolism event (SEE......) may be related to INR control. METHODS: We analyzed the relationship between INR control and the rates of death, bleeding, MI, and stroke or SEE among 3587 patients with atrial fibrillation randomized to receive warfarin treatment in the SPORTIF (Stroke Prevention Using an Oral Thrombin Inhibitor...... control group (1.69% and 1.58%, respectively) (Pwarfarin, the risks of death...
Uchendu, C; Blake, H
Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes. An electronic search was conducted in PubMed, Embase, MEDLINE, PsycINFO, CINAHL, Web of Knowledge, Cochrane Central Register of Controlled Trials and references in reviews. Twelve randomized controlled trials (RCTs) were identified that evaluated the effectiveness of CBT on at least one of: glycaemic control, diabetes-related distress, anxiety, depression or quality of life in adults with Type 1 or Type 2 diabetes. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias assessment and meta-analysis, respectively. CBT is effective in reducing short-term and medium-term glycaemic control, although no significant effect was found for long-term glycaemic control. CBT improved short- and medium-term anxiety and depression, and long-term depression. Mixed results were found for diabetes-related distress and quality of life. CBT is beneficial in improving depression for adults with diabetes. It may have benefits for improving glycaemic control and other aspects of psychological health, although the findings are inconclusive. © 2016 Diabetes UK.
Galal, Sherif; Safwat, Wael
The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.
Full Text Available Abstract Background There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs in primary care settings in Canada. Methods/design This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c of ≥8%. Clusters (that is, primary care sites will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months. Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators’ field notes and debriefing sessions will be undertaken to assess the implementation process and effectiveness of the MDET intervention. Trial registration ClinicalTrials.gov NCT01553266
Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C
The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.
Marino, Miguel; Killerby, Marie; Lee, Soomi; Klein, Laura Cousino; Moen, Phyllis; Olson, Ryan; Kossek, Ellen Ernst; King, Rosalind; Erickson, Leslie; Berkman, Lisa F; Buxton, Orfeu M
To evaluate the effects of a workplace-based intervention on actigraphic and self-reported sleep outcomes in an extended care setting. Cluster randomized trial. Extended-care (nursing) facilities. US employees and managers at nursing homes. Nursing homes were randomly selected to intervention or control settings. The Work, Family and Health Study developed an intervention aimed at reducing work-family conflict within a 4-month work-family organizational change process. Employees participated in interactive sessions with facilitated discussions, role-playing, and games designed to increase control over work processes and work time. Managers completed training in family-supportive supervision. Primary actigraphic outcomes included: total sleep duration, wake after sleep onset, nighttime sleep, variation in nighttime sleep, nap duration, and number of naps. Secondary survey outcomes included work-to-family conflict, sleep insufficiency, insomnia symptoms and sleep quality. Measures were obtained at baseline, 6-months and 12-months post-intervention. A total of 1,522 employees and 184 managers provided survey data at baseline. Managers and employees in the intervention arm showed no significant difference in sleep outcomes over time compared to control participants. Sleep outcomes were not moderated by work-to-family conflict or presence of children in the household for managers or employees. Age significantly moderated an intervention effect on nighttime sleep among employees (p=0.040), where younger employees benefited more from the intervention. In the context of an extended-care nursing home workplace, the intervention did not significantly alter sleep outcomes in either managers or employees. Moderating effects of age were identified where younger employees' sleep outcomes benefited more from the intervention.
Lim, Siew Hoon; Chan, Sally Wai-Chi; Lai, Jiunn Herng; He, Hong-Gu
To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. A randomized controlled trial is planned. Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4 weeks after discharge (postintervention 1) and at 4 months after discharge (postintervention 2). This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life. © 2014 John Wiley & Sons Ltd.
Jiang, Hong; Xiong, Xu; Su, Yi; Zhang, Yiming; Wu, Hongqiao; Jiang, Zhijun; Qian, Xu
Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized controlled trial (RCT) has examined if treating periodontal disease before pregnancy reduces adverse birth outcomes. This study aims to examine if the pre-conception treatment of periodontal disease will lead to improved periodontal status during late pregnancy and subsequent birth outcomes. A sample of 470 (235 in each arm of the study) pre-conception women who plan to conceive within one year and with periodontal disease will be recruited for the study. All participants will be randomly allocated to the intervention or control group. The intervention group will receive free therapy including dental scaling and root planning (the standard therapy), supragingival prophylaxis, and oral hygiene education. The control group will only receive supragingival prophylaxis and oral hygiene education. Women will be followed throughout their pregnancy and then to childbirth. The main outcomes include periodontal disease status in late pregnancy and birth outcomes measured such as mean birth weight (grams), and mean gestational age (weeks). Periodontal disease will be diagnosed through a dental examination by measuring probing depth, clinical attachment loss and percentage of bleeding on probing (BOP) between gestational age of 32 and 36 weeks. Local and systemic inflammatory mediators are also included as main outcomes. This will be the first RCT to test whether treating periodontal disease among pre-conception women reduces periodontal disease during pregnancy and prevents adverse birth outcomes. If
Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio
Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical
Gullo, Sara; Galavotti, Christine; Sebert Kuhlmann, Anne; Msiska, Thumbiko; Hastings, Phil; Marti, C Nathan
Social accountability approaches, which emphasize mutual responsibility and accountability by community members, health care workers, and local health officials for improving health outcomes in the community, are increasingly being employed in low-resource settings. We evaluated the effects of a social accountability approach, CARE's Community Score Card (CSC), on reproductive health outcomes in Ntcheu district, Malawi using a cluster-randomized control design. We matched 10 pairs of communities, randomly assigning one from each pair to intervention and control arms. We conducted two independent cross-sectional surveys of women who had given birth in the last 12 months, at baseline and at two years post-baseline. Using difference-in-difference (DiD) and local average treatment effect (LATE) estimates, we evaluated the effects on outcomes including modern contraceptive use, antenatal and postnatal care service utilization, and service satisfaction. We also evaluated changes in indicators developed by community members and service providers in the intervention areas. DiD analyses showed significantly greater improvements in the proportion of women receiving a home visit during pregnancy (B = 0.20, P reproductive health-related outcomes. Further, the CSC builds mutual accountability, and ensures that solutions to problems are locally-relevant, locally-supported and feasible to implement.
Mak, Jennifer Sze Man; Chung, Cathy Hoi Sze; Chung, Jacqueline Pui Wah; Kong, Grace Wing Shan; Saravelos, Sotirios H; Cheung, Lai Ping; Li, Tin-Chiu
The benefit of endometrial scratch (ES) prior to embryo transfer is controversial. Systemic analysis has confirmed its potential benefit, especially in women with repeated IVF failures, yet most studies have focused on fresh embryo transfer, and its effect on vitrified-warmed embryo transfer (FET) cycles is yet to be explored. We hereby present our prospective, double-blind, randomized controlled study on the evaluation of the implantation and pregnancy rate after ES prior to natural-cycle FET. A total of 299 patients underwent natural-cycle FET and were randomized to receive ES (n = 115) or endocervical manipulation as control (n = 114) prior to FET cycle, and a total of 196 patients had embryo transfer (93 patients in each group). Our study showed no significant difference in the implantation and pregnancy rate, as well as the clinical and ongoing pregnancy or live birth rates between the two groups. It appears that ES does not have any beneficial effect on an unselected group of women undergoing FET in natural cycles. Further studies on its effect in women with recurrent implantation failure after IVF are warranted. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.
Jensen-Johansen, Mikael B; O'Toole, Mia S; Christensen, Søren
or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints......The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related......, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about...
McBain, Ryan K; Salhi, Carmel; Hann, Katrina; Kellie, Jim; Kamara, Alimamy; Salomon, Joshua A; Kim, Jane J; Betancourt, Theresa S
To measure the benefits to household caregivers of a psychotherapeutic intervention for adolescents and young adults living in a war-affected area. Between July 2012 and July 2013, we carried out a randomized controlled trial of the Youth Readiness Intervention--a cognitive-behavioural intervention for war-affected young people who exhibit depressive and anxiety symptoms and conduct problems--in Freetown, Sierra Leone. Overall, 436 participants aged 15-24 years were randomized to receive the intervention (n = 222) or care as usual (n = 214). Household caregivers for the participants in the intervention arm (n = 101) or control arm (n = 103) were interviewed during a baseline survey and again, if available (n = 155), 12 weeks later in a follow-up survey. We used a burden assessment scale to evaluate the burden of care placed on caregivers in terms of emotional distress and functional impairment. The caregivers' mental health--i.e. internalizing, externalizing and prosocial behaviour--was evaluated using the Oxford Measure of Psychosocial Adjustment. Difference-in-differences multiple regression analyses were used, within an intention-to-treat framework, to estimate the treatment effects. Compared with the caregivers of participants of the control group, the caregivers of participants of the intervention group reported greater reductions in emotional distress (scale difference: 0.252; 95% confidence interval, CI: 0.026-0.4782) and greater improvements in prosocial behaviour (scale difference: 0.249; 95% CI: 0.012-0.486) between the two surveys. A psychotherapeutic intervention for war-affected young people can improve the mental health of their caregivers.
Full Text Available Abstract Background This intervention aimed to ascertain whether a low-cost, accessible, physical activity and nutrition program could improve physical activity and nutrition behaviours of insufficiently active 60–70 year olds residing in Perth, Australia. Methods A 6-month home-based randomised controlled trial was conducted on 478 older adults (intervention, n = 248; control, n = 230 of low to medium socioeconomic status. Both intervention and control groups completed postal questionnaires at baseline and post-program, but only the intervention participants received project materials. A modified fat and fibre questionnaire measured nutritional behaviours, whereas physical activity was measured using the International Physical Activity Questionnaire. Generalised estimating equation models were used to assess the repeated outcomes over both time points. Results The final sample consisted of 176 intervention participants and 199 controls (response rate 78.5% with complete data. After controlling for demographic and other confounding factors, the intervention group demonstrated increased participation in strength exercise (p Conclusions A minimal contact, low-cost and home-based physical activity program can positively influence seniors’ physical activity and nutrition behaviours. Trial registration anzctr.org.au Identifier: ACTRN12609000735257
Milette, Katherine; Roseman, Michelle; Thombs, Brett D
The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.
Aubry, Tim; Tsemberis, Sam; Adair, Carol E; Veldhuizen, Scott; Streiner, David; Latimer, Eric; Sareen, Jitender; Patterson, Michelle; McGarvey, Kathleen; Kopp, Brianna; Hume, Catharine; Goering, Paula
Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness. This article presents one-year findings from a multisite randomized controlled trial (RCT) comparing Housing First with treatment as usual. The study was a nonblind, parallel-group RCT conducted in five Canadian cities. A sample of 950 high-need participants with severe mental illness, who were either absolutely homeless or precariously housed, was randomly assigned to Housing First (N=469) or treatment as usual (N=481). Housing First participants received a rent supplement, assistance to find housing, and assertive community treatment. Treatment-as-usual participants had access to all other existing programs. At one-year follow-up, 73% of Housing First participants and 31% of treatment-as-usual participants resided in stable housing (plife was significantly greater among Housing First participants compared with treatment-as-usual participants (pHousing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants (p=.003, d=.25, CI=.09-.41). Compared with treatment as usual, Housing First produced greater improvements in housing stability, quality of life, and community functioning after one year of enrollment. The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness, even if they are actively symptomatic or using substances.
Mozaffari-Khosravi, Hassan; Naderi, Zahra; Dehghan, Ali; Nadjarzadeh, Azadeh; Fallah Huseini, Hassan
There is limited evidence that ginger powder consumption can relieve pain and inflammation due to specific anti-inflammatory phytochemical constitutents. This study investigates the effect of ginger supplementation on proinflammatory factors in participants (n = 120) of a randomized double-blind placebo-controlled 3-month clinical trial investigating knee osteoarthritis. Patients were randomly assigned to one of two groups: the ginger group (GG) or the placebo group (PG). Administered daily for 3 months, participants in the GG intervention received capsules containing 500 mg of ginger powder, while PG participants received capsules filled with 500 mg starch. Serum samples collected at baseline and 3 months were analyzed for serum levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). At baseline, proinflammatory cytokine concentrations did not differ by group. However, at 3 months, both cytokines decreased in the GG relative to the PG. The results of this study indicate that ginger supplementation may have a promising benefits for knee osteoarthritis and may, therefore, may warrant further study.
Jensen-Johansen, Mikael B; O'Toole, Mia S; Christensen, Søren; Valdimarsdottir, Heiddis; Zakowski, Sandra; Bovbjerg, Dana H; Jensen, Anders B; Zachariae, Robert
The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia.
Jensen-Johansen, Mikael B.; Christensen, Søren; Valdimarsdottir, Heiddis; Zakowski, Sandra; Bovbjerg, Dana H.; Jensen, Anders B.; Zachariae, Robert
The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia. PMID:29474441
Vilela, Bianca Lima; Benedito Silva, Ana Amélia; de Lira, Claudio Andre Barbosa; Andrade, Marília dos Santos
To investigate the effects of a workplace fitness and education program intervention on physical fitness of workers. Employees from a chemical plant (n = 60) participated in a 4-month longitudinal study. They were randomly distributed in control and experimental groups. The experimental group had 4 months of exercise training in 15-minute sessions. The following evaluations were performed before and after the training period: body composition, localized muscle strength, and flexibility. The experimental group showed a significant decrease in body fat (24.7%) and a significant increase in lean mass (6.1%), flexibility (17.9%), sit-up test performance (39.8%), and push-up test performance (29.8%) after the workplace fitness and education program compared with initial values. A structured program of physical exercise was effective in improving body composition, abdominal strength, upper limb strength, and flexibility in workers.
Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang
This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10 mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20 mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30 mg daily, Group B: DAPT + atorvastatin 20 mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30 mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 ligand (sCD40L)) were assessed before randomization and at 15- and 30-day follow-up visits. All patients were maintained on treatment for 6 months and observed for bleeding and ischemic events. A total of 104 patients were enrolled, 27 patients in group A, 26 patients in Group B/C, 25 patients in Group D separately, and all the patients were analyzed. There were no differences in platelet function and the levels of platelet activation markers (P-selectin, TXB2, and sCD40L) among or within the 4 groups at the 3 time points of interest (P > 0.05). In the subsequent 6 months, no significant bleeding events occurred, and 12 patients experienced ischemic events, these results were also not significantly different among the groups (P > 0.05). In patients diagnosed with NSTE-ACS who have had drug-eluting stent implantation
Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia
Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible
Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios
The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the
Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the
Shorey, Shefaly; Ng, Yvonne Peng Mei; Danbjørg, Dorthe Boe; Dennis, Cindy-Lee; Morelius, Evalotte
The aim of this study was to describe a study protocol that evaluates the effectiveness of the 'Home-but not Alone' educational programme delivered via a mobile health application in improving parenting outcomes. The development in mobile-based technology gives us the opportunity to develop an accessible educational programme that can be potentially beneficial to new parents. However, there is a scarcity of theory-based educational programmes that have incorporated technology such as a mobile health application in the early postpartum period. A randomized controlled trial with a two-group pre-test and post-test design. The data will be collected from 118 couples. Eligible parents will be randomly allocated to either a control group (receiving routine care) or an intervention group (routine care plus access to the 'Home-but not Alone' mobile health application. Outcome measures comprise of parenting self-efficacy, social support, parenting satisfaction and postnatal depression. Data will be collected at the baseline (on the day of discharge) and at four weeks postpartum. This will be an empirical study that evaluates a theory-based educational programme delivered via an innovative mobile health application on parental outcomes. Results from this study will enhance parenting self-efficacy, social support and parenting satisfaction, which may then reduce parental risks of postnatal depression. © 2016 John Wiley & Sons Ltd.
Viester, Laura; Verhagen, Evert A L M; Bongers, Paulien M; van der Beek, Allard J
The objective of the present study is to investigate the effects of a worksite health promotion intervention on musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence. In a randomized controlled design, 314 construction workers were randomized into an intervention group (n = 162) receiving personal coaching, tailored information, and materials, and a control group (n = 152) receiving usual care. Sickness absence was recorded continuously in company records, and questionnaires were completed before, directly after the 6-month intervention period, and 12 months after baseline measurements. Linear and logistic regression analyses were performed to determine intervention effects. No significant changes at 6 or 12 months of follow-up were observed in musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence as a result of the intervention. This study shows that the intervention was not statistically significantly effective on secondary outcomes. Although the intervention improved physical activity, dietary, and weight-related outcomes, it was not successful in decreasing musculoskeletal symptoms and improving other work-related measures. Presumably, more multifaceted interventions are required to establish significant change in these outcomes.
Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily
Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. Results The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. Conclusion The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences
Dorgo, Sandor; King, George A.; Bader, Julia O.; Limon, John S.
Objectives To investigate the effectiveness of different applications of mentoring in an older adult exercise program, this study compared the physical fitness scores, the retention and participation rates of older adults trained by student mentors, peer mentors, peer mentors working independently of the researchers, and a non-exercising control group. Methods 106 older adults were recruited and assigned to one of the groups using quasi-randomization. All three experimental groups completed a 14-week intervention. Pre- and post-training assessments of fitness were completed, and retention and participation rates were compared. Results High retention and participation rates, as well as significant improvements in fitness scores from baseline to post-test were observed in all three mentored groups. While the control group showed improvement only in one fitness test, subjects in the mentored groups improved similarly in all measures, regardless of the type of mentoring received. Discussion These findings indicated effectiveness of the peer mentor model and suggested that with adequate preparation peer mentors may be capable of guiding older adult participants effectively without assistance from professional staff. PMID:23279966
Dodd, Lori E; Korn, Edward L; Freidlin, Boris; Gu, Wenjuan; Abrams, Jeffrey S; Bushnell, William D; Canetta, Renzo; Doroshow, James H; Gray, Robert J; Sridhara, Rajeshwari
Measurement error in time-to-event end points complicates interpretation of treatment effects in clinical trials. Non-differential measurement error is unlikely to produce large bias . When error depends on treatment arm, bias is of greater concern. Blinded-independent central review (BICR) of all images from a trial is commonly undertaken to mitigate differential measurement-error bias that may be present in hazard ratios (HRs) based on local evaluations. Similar BICR and local evaluation HRs may provide reassurance about the treatment effect, but BICR adds considerable time and expense to trials. We describe a BICR audit strategy  and apply it to five randomized controlled trials to evaluate its use and to provide practical guidelines. The strategy requires BICR on a subset of study subjects, rather than a complete-case BICR, and makes use of an auxiliary-variable estimator. When the effect size is relatively large, the method provides a substantial reduction in the size of the BICRs. In a trial with 722 participants and a HR of 0.48, an average audit of 28% of the data was needed and always confirmed the treatment effect as assessed by local evaluations. More moderate effect sizes and/or smaller trial sizes required larger proportions of audited images, ranging from 57% to 100% for HRs ranging from 0.55 to 0.77 and sample sizes between 209 and 737. The method is developed for a simple random sample of study subjects. In studies with low event rates, more efficient estimation may result from sampling individuals with events at a higher rate. The proposed strategy can greatly decrease the costs and time associated with BICR, by reducing the number of images undergoing review. The savings will depend on the underlying treatment effect and trial size, with larger treatment effects and larger trials requiring smaller proportions of audited data.
Ma, Sunyoung; Tawse-Smith, Andrew; De Silva, Rohana K; Atieh, Momen A; Alsabeeha, Nabeel H M; Payne, Alan G T
The surgical placement of four maxillary implants for overdentures may not be obligatory when opposing mandibular two-implant overdentures. To determine 10-year surgical outcomes and implant success of three narrow diameter implants in edentulous maxillae with conventional loading. Forty participants with mandibular two-implant overdentures were randomly allocated for surgery for maxillary overdentures. Using osteotomes, three implants of similar systems were placed with a one-stage procedure and 12-week loading with splinted and unsplinted prosthodontic designs. Marginal bone and stability measurements were done at surgery, 12 weeks, 1-, 2-, 5-, 7-, 10 years. One hundred seventeen implants were placed in 39 participants, with 35 being seen at 1 year; 29 at 2 years; 28 at 5 years; 26 at 7 years; and 23 (59%) at 10 years. Marginal bone loss was 1.35 mm between surgery and 12 weeks; 0.36 mm between 12 weeks and 1 year; 0.48 mm between 1 and 5 years; and 0.22 mm between 5 and 10 years. Implant stability quotients were 56.05, 57.54, 60.88, 58.80, 61.17 at surgery, 12 weeks, 1 year, 5 years, and 10 years. Four-field tables by implant showed success rates of 82% at 1 year; 69.2% at 2 years; 66.7% at 5 years; 61.5% at 7 years; 51.3% at 10 years. Data showed no differences between surgical technique, systems, or prosthodontic designs. Surgical placement with osteotomes of three narrow diameter implants for maxillary overdentures, opposing mandibular two-implant overdentures, is an acceptable approach, subject to strict patient selection. Implant success is independent of prosthodontic design. © 2015 Wiley Periodicals, Inc.
Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will
Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos
Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues) in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will provide important information
Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.
Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles
A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI. For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years. For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.
Linn, Annemiek J; van Dijk, Liset; van Weert, Julia C M; Gebeyehu, Beniam G; van Bodegraven, Ad A; Smit, Edith G
Improving adherence is a challenge and multiple barriers are likely to explain non-adherence. These barriers differ per patient and over course of the regimen. Hence, personalized interventions tailored to the specific barriers are needed. In a theoretical and evidence-based Tailored Multimedia Intervention, technology (online preparatory assessment, text messaging) was used as an add-on to a tailored counseling session (learned during a communication skills training), with the expectation of synergistic effects. A cluster randomized controlled trial was conducted in six hospitals, eight nurses and 160 chronic patients. Patient satisfaction with communication, beliefs about medication, self-efficacy and medication adherence were assessed at initiation of the treatment and after six months. Intervention effects were found for patient satisfaction with nurses' affective communication and self-efficacy at the initiation of treatment. The effect on self-efficacy remained after six months. By combining tailored counseling with technology, this intervention resulted in positive changes in important prerequisites of medication adherence. Technology can contribute significantly to health care providers' ability to tailor information to the patients' needs. Copyright © 2018. Published by Elsevier B.V.
Armstrong, April W; Idriss, Nayla Z; Kim, Randie H
To compare online video and pamphlet education at improving patient comprehension and adherence to sunscreen use, and to assess patient satisfaction with the two educational approaches. In a randomized controlled trial, 94 participants received either online, video-based education or pamphlet-based education that described the importance and proper use of sunscreen. Sun protective knowledge and sunscreen application behaviors were assessed at baseline and 12 weeks after group-specific intervention. Participants in both groups had similar levels of baseline sunscreen knowledge. Post-study analysis revealed significantly greater improvement in the knowledge scores from video group members compared to the pamphlet group (p=0.003). More importantly, video group participants reported greater sunscreen adherence (peducation vehicle more useful and appealing than the pamphlet group (peducational tool for teaching sun protective knowledge and encouraging sunscreen use than written materials. More effective patient educational methods to encourage sun protection activities, such as regular sunscreen use, have the potential to increase awareness and foster positive, preventative health behaviors against skin cancers. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Full Text Available Bente Thoft Jensen,1,2 Jørgen Bjerggaard Jensen,1,2 Sussie Laustsen,2,3 Annemette Krintel Petersen,2,4 Ingrid Søndergaard,2 Michael Borre1,2 1Department of Urology, 2Department of Clinical Medicine, Centre of Research in Rehabilitation, 3Department of Cardiothoracic and Vascular Surgery, 4Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark Purpose: Health related quality of life (HRQoL is an important outcome in cancer care, although it is not well reported in surgical uro-oncology. Radical cystectomy (RC with lymph-node dissection is the standard treatment of muscle-invasive bladder cancer and high-risk noninvasive bladder cancer. A wide range of impairments are reported postsurgery. The aims were to evaluate whether a standardized pre- and postoperative physical exercise program and enhanced mobilization can impact on HRQoL and inpatient satisfaction in RC, as defined by the European Organisation for Research and Treatment of Cancer (EORTC. Materials and methods: Patients were randomized to fast-track RC and intervention (nI=50 or fast-track standard treatment (ns=57. HRQoL and inpatient satisfaction was measured using valid questionnaires: EORTC Quality of Life Questionnaire Core 30 (QLQ-C30 combined with the disease-specific EORTC BLS24 (baseline, and EORTC BLM30 (follow-up, and IN-PATSAT32 inpatient-satisfaction survey at discharge. Efficacy was defined as the differences in HRQoL-scores between treatment groups at the 4-month follow-up. Results: The intervention group significantly improved HRQoL scores in dyspnea (P≤0.05, constipation (P<0.02, and abdominal flatulence (P≤0.05 compared to the standard group. In contrast, the standard group reported significantly reduced symptoms in sleeping pattern (P≤0.04 and clinically relevant differences in role function, body function, and fatigue. The intervention did not compromise inpatient satisfaction. Conclusion: We found no overall impact
Gu, Wan-Jie; Wang, Fei; Liu, Jing-Chen
In anesthetized patients undergoing surgery, the role of lung-protective ventilation with lower tidal volumes is unclear. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of this ventilation strategy on postoperative outcomes. We searched electronic databases from inception through September 2014. We included RCTs that compared protective ventilation with lower tidal volumes and conventional ventilation with higher tidal volumes in anesthetized adults undergoing surgery. We pooled outcomes using a random-effects model. The primary outcome measures were lung injury and pulmonary infection. We included 19 trials (n=1348). Compared with patients in the control group, those who received lung-protective ventilation had a decreased risk of lung injury (risk ratio [RR] 0.36, 95% confidence interval [CI] 0.17 to 0.78; I2=0%) and pulmonary infection (RR 0.46, 95% CI 0.26 to 0.83; I2=8%), and higher levels of arterial partial pressure of carbon dioxide (standardized mean difference 0.47, 95% CI 0.18 to 0.75; I2=65%). No significant differences were observed between the patient groups in atelectasis, mortality, length of hospital stay, length of stay in the intensive care unit or the ratio of arterial partial pressure of oxygen to fraction of inspired oxygen. Anesthetized patients who received ventilation with lower tidal volumes during surgery had a lower risk of lung injury and pulmonary infection than those given conventional ventilation with higher tidal volumes. Implementation of a lung-protective ventilation strategy with lower tidal volumes may lower the incidence of these outcomes. © 2015 Canadian Medical Association or its licensors.
Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul
Background Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. Objective The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. Methods We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Results Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. Conclusions A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement
Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z
To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy
A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design
Thorsen, Lene; Nilsen, Tormod S; Raastad, Truls; Courneya, Kerry S; Skovlund, Eva; Fosså, Sophie D
Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass) measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness) assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life) assessed by questionnaires. Muscle cellular outcomes are a) muscle fiber size b) regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy) and c) regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes are measured on muscle cross sections and
Schrijver, H.M.; Gerritsen, A.A.M.; Strijers, R.L.; Uitdehaag, B.M.J.; Scholten, R.J.P.M.; Vet, de H.C.W.; Bouter, L.M.
0.4) were found between the neurophysiologic and clinical outcome measures after 12 months, and between the changes in these different categories of outcome measures. This study confirms that the parameters of NCS improve significantly after treatment for CTS, but the modest correlations between
Balayla, Jacques; Bujold, Emmanuel; Lapensée, Louise; Mayrand, Marie-Hélène; Sansregret, Andrée
To compare early versus delayed postoperative feeding in women undergoing major gynaecological surgery with regard to clinical outcomes, duration of postoperative stay, and patient satisfaction. We conducted a parallel-randomized controlled trial at a tertiary care centre in Montreal, Quebec, between June 2000 and July 2001. Patients undergoing major gynaecological surgery were randomized following a 1:1 allocation ratio to receive either early postoperative feeding in which oral clear fluids were begun up to six hours after surgery followed by solid foods as tolerated, or delayed postoperative feeding, in which clear fluids were begun on the first postoperative day and solid foods on the second or third day as tolerated. The primary outcomes analyzed were duration of postoperative stay and patient satisfaction. Secondary outcomes included mean time to appetite, passage of flatus, and bowel movement, as well as the presence of symptoms of paralytic ileus. A total of 119 patients were randomized; 61 patients were assigned to the early feeding group and 58 to the delayed feeding group. Demographic characteristics, including age, weight, smoking status, and prior surgical history were comparable between both groups. There was no difference in length of postoperative stay between the two groups (86.4 ± 21.0 hours in the early feeding group vs. 85.6 ± 26.2 hours in the delayed feeding group; P > 0.05). No significant difference was noted in patient satisfaction (P > 0.05). No difference was found in the frequency of postoperative ileus, mean time to appetite, passage of flatus, or first bowel movement. The introduction of early postoperative feeding appears to be safe and well tolerated by patients undergoing major gynaecological surgery. The duration of postoperative stay, patient satisfaction, and gastrointestinal symptoms are comparable between patients undergoing early or delayed postoperative feeding.
Rotheram-Borus, Mary Jane; Le Roux, Karl; Le Roux, Ingrid M; Christodoulou, Joan; Laurenzi, Christina; Mbewu, Nokwanele; Tomlinson, Mark
Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting. In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones. The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes
Murphy, Barbara M; Worcester, Marian U C; Higgins, Rosemary O; Elliott, Peter C; Le Grande, Michael R; Mitchell, Fiona; Navaratnam, Hema; Turner, Alyna; Grigg, Leeanne; Tatoulis, James; Goble, Alan J
While behavior change can improve risk factor profiles and prognosis after an acute cardiac event, patients need assistance to achieve sustained lifestyle changes. We developed the "Beating Heart Problems" cognitive-behavioral therapy and motivational interviewing program to support patients to develop behavioral and cognitive self-management skills. We report the results of a randomized controlled trial of the program. Patients (n = 275) consecutively admitted to 2 Melbourne hospitals after acute myocardial infarction (32%), coronary artery bypass graft surgery (40%), or percutaneous coronary intervention (28%) were randomized to treatment (T; n = 139) or control (C; n = 136). T group patients were invited to participate in the 8-week group-based program. Patients underwent risk factor screening 6 weeks after hospital discharge (before randomization) and again 4 and 12 months later. At both the followups, T and C groups were compared on 2-year risk of a recurrent cardiac event and key behavioral outcomes, using both intention-to-treat and "completers only" analyses. Patients ranged in age from 32 to 75 years (mean = 59.0 years; SD - 9.1 years). Most patients (86%) were men. Compared with the C group patients, T group patients tended toward greater reduction in 2-year risk, at both the 4- and 12-month followups. Significant benefits in dietary fat intake and functional capacity were also evident. The "Beating Heart Problems" program showed modest but important benefit over usual care at 4 and, to a lesser extent, 12 months. Modifications to the program such as the inclusion of booster sessions and translation to online delivery are likely to improve outcomes.
Cherpitel, Cheryl J.; Moskalewicz, Jacek; Swiatkiewicz, Grazyna; Ye, Yu; Bond, Jason
Objective: A randomized, controlled trial of screening, brief intervention, and referral to treatment (SBIRT) for drinking and related problems among at-risk and dependent drinkers was conducted in an emergency department (ED) in Sosnowiec, Poland, among patients ages 18 years and older. Method: Data were collected over a 23-week period, from 4:00 pm to midnight, and resulted in 446 patients being recruited into the study (90% of those who screened positive) and randomized to three conditions following a two-stage process: screened only (n = 147), assessed (n = 152), and received intervention (n = 147). Patients in the assessment (85%) and intervention (83%) conditions were blindly reassessed at 3 months via a telephone interview. Results: At 3-month follow-up, both groups showed significant decreases in the proportion who were positive for at-risk drinking, the primary outcome variable. Both groups also showed significant decreases in drinking days per week, drinks per drinking day, maximum drinks per occasion, and negative consequences of drinking. Using analysis of covariance to control for baseline measures and demographic characteristics, no difference in outcome measures was found between intervention and assessment conditions. Subgroup analysis found some significant interactions between intervention and secondary outcomes. Conclusions: Although the main findings were similar to those from other brief-intervention studies in Western cultures, findings here also suggest that intervention may have differential benefits for specific subgroups of patients in the ED, an area of research that may warrant additional study of brief intervention in the ED setting. PMID:19895777
Background Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Results Acute hyperthermia developed after ABT-116 treatment (P carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs. PMID:23035739
Pleural subxyphoid drain confers better pulmonary function and clinical outcomes in chronic obstructive pulmonary disease after off-pump coronary artery bypass grafting: a randomized controlled trial.
Guizilini, Solange; Viceconte, Marcela; Esperança, Gabriel Tavares da M; Bolzan, Douglas W; Vidotto, Milena; Moreira, Rita Simone L; Câncio, Andréia Azevedo; Gomes, Walter J
To evaluate the lung function and clinical outcome in severe chronic obstructive pulmonary disease in patients undergoing off-pump coronary artery bypass grafting with left internal thoracic artery graft, comparing the pleural drain insertion in the intercostal versus subxyphoid region. A randomized controlled trial. Chronic obstructive pulmonary disease patients were randomized into two groups according pleural drain site: II group (n=27) - pleural drain in intercostal space; SI group (n=29) - pleural drain in the subxyphoid region. Spirometry values (Forced Vital Capacity - and Forced expiratory volume in 1 second) were obtained on preoperative and 1, 3 and 5 postoperative days. Chest x-ray from preoperative until postoperative day 5 (POD5) was performed for monitoring respiratory events, such as atelectasis and pleural effusion. Pulmonary shunt fraction and pain score was evaluate preoperatively and on postoperative day 1. In both groups there was a significant decrease of the spirometry values (Forced Vital Capacity and Forced expiratory volume in 1 second) until POD5 (Ppleural drainage in severe Chronic obstructive pulmonary disease patients determined better preservation and recovery of pulmonary capacity and volumes with lower pulmonary shunt fraction and better clinical outcomes on early postoperative off-pump coronary artery bypass grafting.
Meijer, Henny J.A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco
Abstract Background Single‐tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. Purpose This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient‐based outcome measures. Material and Methods Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri‐implant bone level (primary outcome), Plaque‐index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. Results No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. Conclusion The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. PMID:27476829
Skeppholm, Martin; Lindgren, Lars; Henriques, Thomas; Vavruch, Ludek; Löfgren, Håkan; Olerud, Claes
Several previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study. To compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years. This is a randomized controlled multicenter trial, including three spine centers in Sweden. The study included patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included. Self-assessment with Neck Disability Index (NDI) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables. Patients were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both patient and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up. Data were available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with NDI values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent
Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M
The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.
Verwoerd, Annemieke J H; Luijsterburg, Pim A J; Koes, Bart W; el Barzouhi, Abdelilah; Verhagen, Arianne P
A higher level of kinesiophobia appears to be associated with poor recovery in patients with sciatica. The aim of this study was to investigate whether kinesiophobia modifies the effect of physical therapy on outcomes in patients with sciatica. This was a subgroup analysis from a randomized controlled trial. The study was conducted in a primary care setting. A total of 135 patients with acute sciatica participated. Patients were randomly assigned to groups that received (1) physical therapy plus general practitioners' care (intervention group) or (2) general practitioners' care alone (control group). Kinesiophobia at baseline was measured with the Tampa Scale for Kinesiophobia (TSK) and a single substitute question for kinesiophobia (SQK). Pain and recovery were assessed at 3- and 12-month follow-ups. Regression analysis was used to test for interaction between the level of kinesiophobia at baseline and treatment allocation. Subgroup results were calculated for patients classified with high fear of movement and for those classified with low fear of movement. Kinesiophobia at baseline interacted with physical therapy in the analysis with leg pain intensity at 12-month follow-up. Kinesiophobia at baseline did not interact with physical therapy regarding any outcome at 3-month follow-up or recovery at 12-month follow-up. When comparing both treatment groups in the subgroup of patients with high fear of movement (n=73), the only significant result was found for leg pain intensity difference from baseline at 12-month follow-up (intervention group: X̅=-5.0, SD=2.6; control group: X̅=-3.6, SD=2.7). The post hoc study design and relatively small sample size were limitations of the study. In 135 patients with sciatica, evidence shows that patients with a higher level of kinesiophobia at baseline may particularly benefit from physical therapy with regard to decreasing leg pain intensity at 12-month follow-up. © 2015 American Physical Therapy Association.
Schrijver, H.M.; Gerritsen, A.A.M.; Strijers, R.L.; Uitdehaag, B.M.J.; Scholten, R.J.P.M.; de Vet, H.C.W.; Bouter, L.M.
The reported relationships between nerve conduction studies (NCS) and outcome measures in carpal tunnel syndrome (CTS) are weak to moderate. However, selection of patients may have confounded nonrandomized studies. NCS have potentially great value in selecting patients for a specific treatment and
Full Text Available Abstract Background One in five Americans under age 18 lives in a family below the Federal poverty threshold. These more than 15 million children are at increased risk of a wide variety of adverse long-term health and developmental outcomes. The early years of life are critical to short- and long-term health and well-being. The Legacy for ChildrenTM model was developed in response to this need and marries the perspectives of epidemiology and public health to developmental psychology theory in order to better address the needs of children at environmental risk for poor developmental outcomes. Methods/design The Legacy for ChildrenTM group-based parenting intervention model was evaluated as a pair of randomized controlled trials among low-income families in Miami and Los Angeles. The study was designed to allow for site-stratified analysis in order to evaluate each model implementation separately. Evaluation domains include comprehensive assessments of family, maternal, and child characteristics, process outcomes, and prospective programmatic cost. Data collection began prenatally or at birth and continues into school-age. Discussion The societal costs of poor developmental outcomes are substantial. A concerted effort from multiple sectors and disciplines, including public health, is necessary to address these societal concerns. Legacy uses a public health model to engage parents and promote overall child well-being in families in poverty through rigorous evaluation methodologies and evidence-based intervention strategies. This study collects rich and modular information on maternal and child outcomes, process, and cost that will enable a detailed understanding of how Legacy works, how it can be refined and improved, and how it can be translated and disseminated. Taken together, these results will inform public policy and help to address issues of health disparities among at-risk populations. Trial registration NCT00164697
Hawkes, Anna L; Chambers, Suzanne K; Pakenham, Kenneth I; Patrao, Tania A; Baade, Peter D; Lynch, Brigid M; Aitken, Joanne F; Meng, Xingqiong; Courneya, Kerry S
Colorectal cancer survivors are at risk for poor health outcomes because of unhealthy lifestyles, but few studies have developed translatable health behavior change interventions. This study aimed to determine the effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes among colorectal cancer survivors. In this two-group randomized controlled trial, 410 colorectal cancer survivors were randomly assigned to the health coaching intervention (11 theory-based telephone-delivered health coaching sessions delivered over 6 months focusing on physical activity, weight management, dietary habits, alcohol, and smoking) or usual care. Assessment of primary (ie, physical activity [Godin Leisure Time Index], health-related quality of life [HRQoL; Short Form-36], and cancer-related fatigue [Functional Assessment of Chronic Illness Therapy Fatigue Scale]) and secondary outcomes (ie, body mass index [kg/m(2)], diet and alcohol intake [Food Frequency Questionnaire], and smoking) were conducted at baseline and 6 and 12 months. At 12 months, significant intervention effects were observed for moderate physical activity (28.5 minutes; P = .003), body mass index (-0.9 kg/m(2); P = .001), energy from total fat (-7.0%; P = .006), and energy from saturated fat (-2.8%; P = .016). A significant intervention effect was reported for vegetable intake (0.4 servings per day; P = .001) at 6 months. No significant group differences were found at 6 or 12 months for HRQoL, cancer-related fatigue, fruit, fiber, or alcohol intake, or smoking. The CanChange intervention was effective for improving physical activity, dietary habits, and body mass index in colorectal cancer survivors. The intervention is translatable through existing telephone cancer support and information services in Australia and other countries.
Mina, George S; Firouzbakht, Tina; Modi, Kalgi; Dominic, Paari
We aimed to perform a gender-based meta-analysis of the outcome of bivalirudin versus heparin in patients undergoing percutaneous coronary interventions (PCI). Bivalirudin has been shown to decrease major bleeding when compared to heparin ± glycoprotein IIb/IIIa inhibitors (GPI) in patients undergoing PCI. It is unclear, however, if those differences in outcomes are the same for men and women. We included randomized controlled trials (RCTs) that compared bivalirudin to heparin with or without GPI in patients undergoing PCI and reported outcome data that were stratified by gender. Random effect model was used to pool odds ratio (OR) and 95% confidence intervals (CI). We included 9 trials with 33,224 patients. Bivalirudin decreased major bleeding when compared to heparin plus routine GPI in both men (OR: 0.51, P < 0.001) and women (OR: 0.55, P < 0.001). However, when GPI were used selectively with heparin, the bleeding lowering effect of bivalirudin was statistically significant in men (OR: 0.69, P = 0.02) but not in women (OR: 0.71, P = 0.21). When compared to heparin ± GPI, there was a nonstatistically significant trend toward lower all-cause mortality with bivalirudin in both men (OR: 0.76, P = 0.055) and women (OR: 0.79, P = 0.21). There were no significant differences in major adverse cardiovascular events between heparin and bivalirudin in both men and women. Bivalirudin decreases major bleeding in both men and women when compared to heparin plus routine GPI. However, when compared to heparin alone, the bleeding lowering benefit of bivalirudin is less evident in women. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.
Full Text Available Introduction: Evidence suggests a high prevalence of calcium and vitamin D deficiencies exists in both pregnant women and babies. Adequate intake of micronutrients has great importance especially during pregnancy and lactation period. Thus, the present study aimed at assessing the effect of vitamin D and calcium-vitamin D on pregnancy and birth outcomes (including duration of pregnancy, type of delivery and infant anthropometric indicators. Methods: A randomized, controlled, clinical, triple-blind trial conducted on 126 pregnant women referring to Tabriz health centers in 2013-14. Subjects were allocated into three groups using block randomization. Interventional groups received vitamin D, calcium-vitamin D and placebo pills daily for 60 days. ANCOVA and Chi-square tests were used for data analysis. Results: By controlling BMI before and during pregnancy, there were no significant differences between the group in average neonatal weight, height and head circumference, duration of pregnancy, type of delivery and gestational age at the time of delivery. Conclusion: The results show that calcium-vitamin D and vitamin D have no effect on duration of pregnancy, type of delivery and infant anthropometric indicators.
Full Text Available Przemyslaw KardasThe First Department of Family Medicine, Medical University of LodzBackground: A randomized, controlled trial was conducted in an outpatient setting to examine the effect of beta-blocker dosing frequency on patient compliance, clinical outcome, and health-related quality of life in patients with stable angina pectoris.Methods: One hundred and twelve beta-blockers-naive outpatients with stable angina pectoris were randomized to receive betaxolol, 20 mg once daily or metoprolol tartrate, 50 mg twice daily for 8 weeks. The principal outcome measure was overall compliance measured electronically, whereas secondary outcome measures were drug effectiveness and health-related quality of life.Results: The overall compliance was 86.5 ± 21.3% in the betaxolol group versus 76.1 ± 26.3% in the metoprolol group (p < 0.01, and the correct number of doses was taken on 84.4 ± 21.6% and 64.0 ± 31.7% of treatment days, respectively (p < 0.0001. The percentage of missed doses was 14.5 ± 21.5% in the once-daily group and 24.8 ± 26.4% in the twice-daily group (p < 0.01. The percentage of doses taken in the correct time window (58.6% vs 42.0%, p = 0.01, correct interdose intervals (77.4% v 53.1%, p < 0.0001, and therapeutic coverage (85.6% vs 73.7%, p < 0.001 were significantly higher in the once-daily group. Both studied drugs had similar antianginal effectiveness. Health-related quality of life improved in both groups, but this increase was more pronounced in the betaxolol arm in some dimensions.Conclusions: The study demonstrates that patient compliance with once-daily betaxolol is significantly better than with twice daily metoprolol. Similarly, this treatment provides better quality of life. These results demonstrate possible therapeutic advantages of once-daily over twice-daily beta-blockers in the treatment of stable angina pectoris.Keywords: patient compliance, quality of life, stable angina pectoris, randomized controlled trial
Aşkın, Ayhan; Tosun, Aliye; Demirdal, Ümit Seçil
Repetitive transcranial magnetic stimulation (rTMS) was suggested as a preconditioning method that would increase brain plasticity and that it would be optimal to combine rTMS with intensive rehabilitation. To assess the efficacy of inhibitory rTMS on upper extremity motor recovery and functional outcomes in chronic ischemic stroke patients. In this randomized controlled trial, experimental group received low-frequency (LF) rTMS to the primary motor cortex of the unaffected side + physical therapy (PT), and control group received PT. No statistically significant difference was found in baseline demographical and clinical characteristics of the subjects including stroke severity or severity of paralysis prior to intervention. There were statistically significant improvements in all clinical outcome measures except for the Brunnstrom Recovery Stages. Fugl-Meyer Assessment, Box and Block test, motor and total scores of Functional Independence Measurement (FIM), and Functional Ambulation Scale (FAS) scores were significantly increased in both groups, however, these changes were significantly greater in the rTMS group except for FAS score. FIM cognitive scores and standardized mini-mental test scores were significantly increased and distal and hand Modified Ashworth Scale scores were significantly decreased only in the rTMS group (p functional, and cognitive deficits in chronic stroke. Further studies with a larger number of patients with longer follow-up periods are needed to establish its effectiveness in stroke rehabilitation.
Quality of life, clinical outcomes and safety of early prophylactic levothyroxine administration in patients with Graves' hyperthyroidism undergoing radioiodine therapy: a randomized controlled study.
Taïeb, David; Bournaud, Claire; Eberle, Marie-Claude; Catargi, Bogdan; Schvartz, Claire; Cavarec, Marie-Béatrice; Faugeron, Isabelle; Toubert, Marie-Elisabeth; Benisvy, Danielle; Archange, Cendrine; Mundler, Olivier; Caron, Philippe; Abdullah, Ahmad Esmaeel; Baumstarck, Karine
While radioiodine therapy is commonly used for treating Graves' disease, a prolonged and clinical hypothyroidism may result in disabling symptoms leading to deterioration of quality of life (QoL) of patients. Introducing levothyroxine (LT4) treatment in the early post-therapeutic period may be an interesting approach to limit this phenomenon. A multicenter, prospective, open-label randomized controlled trial enrolled 94 patients with Graves' hyperthyroidism randomly assigned to the experimental group (n=46) (group A: early prophylactic LT4 treatment) or the control group (n=48) (group B: standard follow-up). The primary endpoint was the 6-month QoL. The secondary endpoints were other QoL scores such as Graves' ophthalmopathy (GO) outcomes, thyroid function tests and safety. The primary endpoint at 6 months was achieved: the mental composite score (MCS) of Short Form 36 (SF-36) was significantly higher in group A compared to group B (P=0.009). Four other dimension scores of the SF-36 and four dimension scores of the thyroid-specific patient-reported outcome (ThyPRO) significantly differed between the two groups, indicating better QoL in group A. After adjustment for variables, the early LT4 administration strategy was found as an independent factor for only two scores of SF-36: the MCS and the general health (GH) score. There were no differences in GO, final thyroid status and changes in the anti-TSH receptor antibodies (TRAbs) levels between the two groups. No adverse cardiovascular event was reported. Early LT4 administration post-radioactive iodine (RAI) could represent a safe potential benefit for patients with regard to QoL. The optimal strategy taking into account administered RAI activities and LT4 treatment dosage and timing remains to be determined. © 2016 European Society of Endocrinology.
Ebert, David Daniel; Gollwitzer, Mario; Riper, Heleen; Cuijpers, Pim; Baumeister, Harald; Berking, Matthias
Recent studies provide evidence for the effectiveness of Internet-based maintenance treatments for mental disorders. However, it is still unclear which participants might or might not profit from this particular kind of treatment delivery. The study aimed to identify moderators of treatment outcome in a transdiagnostic Internet-based maintenance treatment (TIMT) offered to patients after inpatient psychotherapy for mental disorders in routine care. Using data from a randomized controlled trial (N=400) designed to test the effectiveness of TIMT, we performed secondary analyses to identify factors moderating the effects of TIMT (intervention) when compared with those of a treatment-as-usual control condition. TIMT involved an online self-management module, asynchronous patient-therapist communication, a peer support group, and online-based progress monitoring. Participants in the control condition had unstructured access to outpatient psychotherapy, standardized outpatient face-to-face continuation treatment, and psychotropic management. Self-reports of psychopathological symptoms and potential moderators were assessed at the start of inpatient treatment (T1), at discharge from inpatient treatment/start of TIMT (T2), and at 3-month (T3) and 12-month follow-up (T4). Education level, positive outcome expectations, and diagnoses significantly moderated intervention versus control differences regarding changes in outcomes between T2 and T3. Only education level moderated change differences between T2 and T4. The effectiveness of the intervention (vs control) was more pronounced among participants with a low (vs high) education level (T2-T3: B=-0.32, SE 0.16, P=.049; T2-T4: B=-0.42, SE 0.21, P=.049), participants with high (vs low) positive outcome expectations (T2-T3: B=-0.12, SE 0.05, P=.02) and participants with anxiety disorder (vs mood disorder) (T2-T3: B=-0.43, SE 0.21, P=.04). Simple slope analyses revealed that despite some subgroups benefiting less from the
Humes, Larry E; Rogers, Sara E; Quigley, Tera M; Main, Anna K; Kinney, Dana L; Herring, Christine
The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models. The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups. Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic. Participants were adults, ages 55-79 years, with mild-to-moderate hearing loss. There were 188 eligible participants: 163 enrolled as a volunteer sample, and 154 completed the intervention. All participants received the same high-end digital mini-behind-the-ear hearing aids fitted bilaterally. AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model. Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Benefit (Cox & Gilmore, 1990). Secondary outcome measure was the Connected Speech Test (Cox, Alexander, & Gilmore, 1987) benefit. Additional measures of hearing-aid benefit, satisfaction, and usage were also obtained. Per-protocol analyses were performed. AB service-delivery model was found to be efficacious for most of the outcome measures, with moderate or large effect sizes (Cohen's d). CD service-delivery model was efficacious, with similar effect sizes. However, CD group had a significantly (p purchase hearing aids after the trial. Hearing aids are efficacious in
Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D
Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at Clinical
Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian
Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks
Berglind, Daniel; Nyberg, Gisela; Willmer, Mikaela; Persson, Margareta; Wells, Michael; Forsell, Yvonne
Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors. The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability. There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1). International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.
Coghill, David R; Banaschewski, Tobias; Soutullo, César; Cottingham, Matthew G; Zuddas, Alessandro
Children, adolescents and adults with attention-deficit/hyperactivity disorder (ADHD) experience functional impairment and poor health-related quality of life (HRQoL) in addition to symptoms of inattention/hyperactivity-impulsivity. To synthesize qualitatively the published evidence from randomized, double-blind, placebo-controlled trials of the effectiveness of pharmacotherapy on functional impairment or HRQoL in patients with ADHD, a systematic PubMed searching and screening strategy was designed to identify journal articles meeting pre-specified criteria. Post hoc analyses and meta-analyses were excluded. HRQoL outcomes, functional outcomes and the principal ADHD symptom-based outcome were extracted from included studies. An effect size of 0.5 versus placebo was used as a threshold for potential clinical relevance (unreported effect sizes were calculated when possible). Of 291 records screened, 35 articles describing 34 studies were included. HRQoL/functioning was usually self-rated in adults and proxy-rated in children/adolescents. Baseline data indicated substantial HRQoL deficits in children/adolescents. Placebo-adjusted effects of medication on ADHD symptoms, HRQoL and functioning, respectively, were statistically or nominally significant in 18/18, 10/12 and 7/9 studies in children/adolescents and 14/16, 9/11 and 9/10 studies in adults. Effect sizes were ≥0.5 versus placebo for symptoms, HRQoL and functioning, respectively, in 14/16, 7/9 and 4/8 studies in children/adolescents; and 6/12, 1/6 and 1/8 studies in adults. Effect sizes were typically larger for stimulants than for non-stimulants, for symptoms than for HRQoL/functioning, and for children/adolescents than for adults. The efficacy of ADHD medication extends beyond symptom control and may help reduce the related but distinct functional impairments and HRQoL deficits in patients with ADHD.
Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran Dk; Bird, Marie-Louise
To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Randomized controlled clinical trial. Two subacute hospital rehabilitation units in Australia. In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8-40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (-3.0 to 5.0) cm) with no difference between groups ( P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) ( P = 0.04). No adverse events were recorded during therapy. Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant.
Apter, Andrea J.; Morales, Knashawn H.; Han, Xiaoyan; Perez, Luzmercy; Huang, Jingru; Ndicu, Grace; Localio, Anna; Nardi, Alyssa; Klusaritz, Heather; Rogers, Marisa; Phillips, Alexis; Cidav, Zuleyha; Schwartz, J. Sanford
Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices. The PA coaches, models, and assists participants with preparations for a visit with the asthma clinician; attends the visit with permission of participant and provider; and confirms participants’ understanding of what transpired at the visit. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients’ unique social and administrative barriers to carrying out medical advice and transfer of information between providers and patients. PA activities are individualized, take account of comorbidities, and are generalizable to other chronic diseases. PAs are recent college graduates interested in health-related careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential participants. We test whether the PA intervention, compared to usual care, is associated with improved and sustained asthma control and other asthma outcomes (prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline. Mediators and moderators of the PA-asthma outcome relationship are examined along with the intervention’s cost-effectiveness. PMID:28315481
Boyle, R J; Umasunthar, T; Smith, J G; Hanna, H; Procktor, A; Phillips, K; Pinto, C; Gore, C; Cox, H E; Warner, J O; Vickers, B; Hodes, M
Mothers of children with food allergy have increased anxiety, which may be influenced by healthcare professionals' communication of risk. To evaluate a brief psychological intervention for reducing anxiety in mothers of children with food allergy. Two hundred mothers of children with food allergy were recruited from allergy clinics. A computer-generated randomization list was used to allocate participants to a single-session cognitive behavioural therapy intervention including a risk communication module, or standard care. Anxiety and risk perception were assessed at 6 weeks and 1 year. Primary outcome was state anxiety at 6 weeks. Secondary outcomes included state anxiety at 1 year, risk perception at 6 weeks and 1 year, and salivary cortisol response to a simulated anaphylaxis scenario at 1 year. We found no significant difference in the primary outcome state anxiety at 6 weeks, with mean 31.9 (SD 10.2) intervention, 34.0 (10.2) control; mean difference 2.1 (95% CI -0.9, 5.0; P=.17). There was significantly reduced state anxiety at 6 weeks in the intervention group, in the subgroup of participants with moderate/high anxiety at enrolment (103/200, 52%), with mean 33.0 (SD 9.3) intervention, 37.8 (SD 10.0) control; mean difference 4.8 (95% CI 0.9, 8.7; P=.016; Cohen's d effect size 0.50). The psychological intervention also reduced risk perception and salivary cortisol response (P=.032; effect size 0.36). We found evidence that a brief psychological intervention which incorporates accurate risk information may impact on anxiety, risk perception and physiological stress response in mothers of children with food allergy. © 2017 John Wiley & Sons Ltd.
Tanner, Jeremy A; Black, Betty S; Johnston, Deirdre; Hess, Edward; Leoutsakos, Jeannie-Marie; Gitlin, Laura N; Rabins, Peter V; Lyketsos, Constantine G; Samus, Quincy M
To assess whether MIND at Home, a community-based, multicomponent, care coordination intervention, reduces unmet caregiving needs and burden in informal caregivers of persons with memory disorders. An 18-month randomized controlled trial of 289 community-living care recipient (CR)-caregiver (informal caregivers, i.e., unpaid individuals who regularly assisted the CR) dyads from 28 postal code areas of Baltimore, Maryland was conducted. All dyads and the CR's primary care physician received the written needs assessment results and intervention recommendations. Intervention dyads then received an 18-month care coordination intervention delivered by nonclinical community workers to address unmet care needs through individualized care planning, referral and linkage to dementia services, provision of caregiver dementia education and skill-building strategies, and care progress monitoring by an interdisciplinary team. Primary outcome was total percent of unmet caregiver needs at 18 months. Secondary outcomes included objective and subjective caregiver burden measures, quality of life (QOL), and depression. Total percent of unmet caregiver needs declined in both groups from baseline to 18 months, with no statistically significant between-group difference. No significant group differences occurred in most caregiver burden measures, depression, or QOL. There was a potentially clinically relevant reduction in self-reported number of hours caregivers spent with the CR for MIND participants compared with control subjects. No statistically significant impacts on caregiver outcomes were found after multiple comparison adjustments. However, MIND at Home appeared to have had a modest and clinically meaningful impact on informal caregiver time spent with CRs. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.
Deady, Mark; Mills, Katherine L; Teesson, Maree; Kay-Lambkin, Frances
Depression and problematic alcohol use represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this is associated with increased harm and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective; however, there remains a significant gap between those in need of treatment and those receiving it. The increased availability of eHealth programs presents a unique opportunity to treat these conditions. This study aimed to evaluate the feasibility and preliminary efficacy of an automated Web-based self-help intervention (DEAL Project) in treating co-occurring depressive symptoms and problematic alcohol use in young people. Young people (aged 18 to 25 years) with moderate depression symptoms and drinking at hazardous levels (recruited largely via social media) were randomly allocated to the DEAL Project (n=60) or a Web-based attention-control condition (HealthWatch; n=44). The trial consisted of a 4-week intervention phase with follow-up assessment at posttreatment and at 3 and 6 months postbaseline. The primary outcomes were change in depression severity according to the Patient Health Questionnaire-9 as well as quantity and frequency of alcohol use (TOT-AL). The DEAL Project was associated with statistically significant improvement in depression symptom severity (d=0.71) and reductions in alcohol use quantity (d=0.99) and frequency (d=0.76) in the short term compared to the control group. At 6-month follow-up, the improvements in the intervention group were maintained; however, the differences between the intervention and control groups were no longer statistically significant, such that between-group effects were in the small to moderate range at 6 months (depression symptoms: d=0.39; alcohol quantity: d=-0.09; alcohol frequency: d=0.24). Overall, the DEAL Project was associated with more rapid improvement in both depression symptoms and alcohol use outcomes in young
Gallo, Agatha M; Wilkie, Diana J; Yao, Yingwei; Molokie, Robert E; Stahl, Christiane; Hershberger, Patricia E; Zhao, Zhongsheng; Suarez, Marie L; Johnson, Bonnye; Angulo, Rigoberto; Carrasco, Jesus; Angulo, Veronica; Thompson, Alexis A
Interventions to assist reproductive health decision-making in populations affected by sickle cell disease (SCD) or trait (SCT) lack proven efficacy over time. Our aim was to compare effects of CHOICES, a Web-based multimedia education program on implementing informed reproductive plans, and usual care education (e-Book) on reproductive knowledge, intention, and behavior over 24 months. We randomized 234 participants with SCD (n = 138) or SCT (n = 96) (age 18-35 years, 35 % male, 94 % African American) to CHOICES and e-Book groups. Participants completed a sickle cell-specific reproductive measure before and four times after the intervention (6, 12, 18 and 24 months). Compared to the e-Book group the CHOICES group had significantly more improvement in knowledge over time (p = .004) but not intention (p = .18) or behavior (p = .69). At baseline, 114 (48.7 %) participants reported having partners who would not put the couple at risk for their children inheriting SCD. Of the 116 (49.6 %) at-risk participants, a higher poroportion of those who were in the CHOICES group chose partners that reduced their risk by the last visit than the e-Book group (p = .04). Study findings provide important insights for designing a national trial of the CHOICES intervention focusing on subjects whose partner status puts them at risk for having a child with SCD.
Shorey, Shefaly; Ng, Yvonne Peng Mei; Siew, An Ling; Yoong, Joanne; Mörelius, Evalotte
Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period. The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program. A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth. Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017. This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents' social support-seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore's ailing birth rate. International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; https://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http
Van Arendonk Kyle J
Full Text Available Abstract Background The emergence of multi-drug resistant Gram-negatives (MDRGNs coupled with an alarming scarcity of new antibiotics has forced the optimization of the therapeutic potential of available antibiotics. To exploit the time above the minimum inhibitory concentration mechanism of β-lactams, prolonging their infusion may improve outcomes. The primary objective of this meta-analysis was to determine if prolonged β-lactam infusion resulted in decreased mortality and improved clinical cure compared to intermittent β-lactam infusion. Methods Relevant studies were identified from searches of MEDLINE, EMBASE, and CENTRAL. Heterogeneity was assessed qualitatively, in addition to I2 and Chi-square statistics. Pooled relative risks (RR and 95% confidence intervals (CI were calculated using Mantel-Haenszel random-effects models. Results Fourteen randomized controlled trials (RCTs were included. Prolonged infusion β-lactams were not associated with decreased mortality (n= 982; RR 0.92; 95% CI:0.61-1.37 or clinical cure (n = 1380; RR 1.00 95% CI:0.94-1.06 compared to intermittent infusions. Subgroup analysis for β-lactam subclasses and equivalent total daily β-lactam doses yielded similar results. Most studies had notable methodological flaws. Conclusions No clinical advantage was observed for prolonged infusion β-lactams. The limited number of studies with MDRGNs precluded evaluation of prolonged infusion of β-lactams for this subgroup. A large, multicenter RCT with critically ill patients infected with MDRGNs is needed.
Yang, Yongzhi; Xia, Yang; Chen, Hongqi; Hong, Leiming; Feng, Junlan; Yang, Jun; Yang, Zhe; Shi, Chenzhang; Wu, Wen; Gao, Renyuan; Wei, Qing; Qin, Huanlong; Ma, Yanlei
This study was designed to mainly evaluate the anti-infective effects of perioperative probiotic treatment in patients receiving confined colorectal cancer (CRC) respective surgery. From November 2011 to September 2012, a total of 60 patients diagnosed with CRC were randomly assigned to receive probiotic (n = 30) or placebo (n = 30) treatment. The operative and post-operative clinical results including intestinal cleanliness, days to first - flatus, defecation, fluid diet, solid diet, duration of pyrexia, average heart rate, length of intraperitoneal drainage, length of antibiotic therapy, blood index changes, rate of infectious and non-infectious complications, postoperative hospital stay, and mortality were investigated. The patient demographics were not significantly different (p > 0.05) between the probiotic treated and the placebo groups. The days to first flatus (3.63 versus 3.27, p = 0.0274) and the days to first defecation (4.53 versus 3.87, p = 0.0268) were significantly improved in the probiotic treated patients. The incidence of diarrhea was significantly lower (p = 0.0352) in probiotics group (26.67%, 8/30) compared to the placebo group (53.33%, 16/30). There were no statistical differences (p > 0.05) in other infectious and non-infectious complication rates including wound infection, pneumonia, urinary tract infection, anastomotic leakage, and abdominal distension. In conclusion, for those patients undergoing confined CRC resection, perioperative probiotic administration significantly influenced the recovery of bowel function, and such improvement may be of important clinical significance in reducing the short-term infectious complications such as bacteremia.
Apnea after awake-regional and general anesthesia in infants: The General Anesthesia compared to Spinal anesthesia (GAS) study: comparing apnea and neurodevelopmental outcomes, a randomized controlled trial
Davidson, Andrew J.; Morton, Neil S.; Arnup, Sarah J.; de Graaff, Jurgen C.; Disma, Nicola; Withington, Davinia E.; Frawley, Geoff; Hunt, Rodney W.; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S.; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen
Background Post-operative apnea is a complication in young infants. Awake-regional anesthesia (RA) may reduce the risk; however the evidence is weak. The General Anesthesia compared to Spinal anesthesia (GAS) study is a randomized, controlled, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Methods Infants ≤ 60 weeks postmenstrual age scheduled for inguinal herniorraphy were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born < 26 weeks’ gestation. The primary outcome of this analysis was any observed apnea up to 12 hours post-operatively. Apnea assessment was unblinded. Results 363 patients were assigned to RA and 359 to GA. Overall the incidence of apnea (0 to 12 hours) was similar between arms (3% in RA and 4% in GA arms, Odds Ratio (OR) 0.63, 95% Confidence Intervals (CI): 0.31 to 1.30, P=0.2133), however the incidence of early apnea (0 to 30 minutes) was lower in the RA arm (1% versus 3%, OR 0.20, 95%CI: 0.05 to 0.91, P=0.0367). The incidence of late apnea (30 minutes to 12 hours) was 2% in both RA and GA arms (OR 1.17, 95%CI: 0.41 to 3.33, P=0.7688). The strongest predictor of apnea was prematurity (OR 21.87, 95% CI 4.38 to 109.24) and 96% of infants with apnea were premature. Conclusions RA in infants undergoing inguinal herniorraphy reduces apnea in the early post-operative period. Cardio-respiratory monitoring should be used for all ex-premature infants. PMID:26001033
García, B; Llurba, E; Valle, L; Gómez-Roig, M D; Juan, M; Pérez-Matos, C; Fernández, M; García-Hernández, J A; Alijotas-Reig, J; Higueras, M T; Calero, I; Goya, M; Pérez-Hoyos, S; Carreras, E; Cabero, L
To ascertain whether screening for pre-eclampsia (PE) and intrauterine growth restriction (IUGR) by uterine artery (UtA) Doppler in the second trimester of pregnancy and targeted surveillance improve maternal and perinatal outcomes in an unselected population. This was a multicenter randomized open-label controlled trial. At the routine second-trimester anomaly scan, women were assigned randomly to UtA Doppler or non-Doppler groups. Women with abnormal UtA Doppler were offered intensive surveillance at high-risk clinics of the participating centers with visits every 4 weeks that included measurement of maternal blood pressure, dipstick proteinuria, fetal growth and Doppler examination. The primary outcome was a composite score for perinatal complications, defined as the presence of any of the following: PE, IUGR, spontaneous labor 90(th) percentile was able to detect 59% of early-onset PE and 60% of early-onset IUGR with a false-positive rate of 11.1%. When perinatal and maternal data according to assigned group (UtA Doppler vs non-Doppler) were compared, no differences were found in perinatal or maternal complications. However, screened patients had more medical interventions, such as corticosteroid administration (relative risk (RR), 1.79 (95% CI, 1.4-2.3)) and induction of labor for IUGR (RR, 1.36 (95% CI, 1.07-1.72)). In women developing PE or IUGR, there was a trend towards fewer maternal complications (RR, 0.46 (95% CI, 0.19-1.11)). Routine second-trimester UtA Doppler ultrasound in an unselected population identifies approximately 60% of women at risk for placental complications; however, application of this screening test failed to improve short-term maternal and neonatal morbidity and mortality. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
Full Text Available Objective: To evaluate the lung function and clinical outcome in severe chronic obstructive pulmonary disease in patients undergoing off-pump coronary artery bypass grafting with left internal thoracic artery graft, comparing the pleural drain insertion in the intercostal versus subxyphoid region. Methods: A randomized controlled trial. Chronic obstructive pulmonary disease patients were randomized into two groups according pleural drain site: II group (n=27 - pleural drain in intercostal space; SI group (n=29 - pleural drain in the subxyphoid region. Spirometry values (Forced Vital Capacity - and Forced expiratory volume in 1 second were obtained on preoperative and 1, 3 and 5 postoperative days. Chest x-ray from preoperative until postoperative day 5 (POD5 was performed for monitoring respiratory events, such as atelectasis and pleural effusion. Pulmonary shunt fraction and pain score was evaluate preoperatively and on postoperative day 1. Results: In both groups there was a significant decrease of the spirometry values (Forced Vital Capacity and Forced expiratory volume in 1 second until POD5 (P<0.05. However, when compared, SI group presented less decrease in these parameters (P<0.05. Pulmonary shunt fraction was significantly lower in SI group (P<0.05. Respiratory events, pain score, orotracheal intubation time and postoperative length of hospital stay were lower in the SI group (P<0.05. Conclusion: Subxyphoid pleural drainage in severe Chronic obstructive pulmonary disease patients determined better preservation and recovery of pulmonary capacity and volumes with lower pulmonary shunt fraction and better clinical outcomes on early postoperative off-pump coronary artery bypass grafting.
Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.
Strand, Vibeke; Kremer, Joel M; Gruben, David; Krishnaswami, Sriram; Zwillich, Samuel H; Wallenstein, Gene V
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). In a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with ≥1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). At month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo. © 2016, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.
Raphaelis, Silvia; Mayer, Hanna; Ott, Stefan; Mueller, Michael D; Steiner, Enikö; Joura, Elmar; Senn, Beate
To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written information received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporadically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial. Copyright © 2017 Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Pain and impaired mobility because of osteoarthritis (OA is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1 antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID, Tramadol - synthetic opiate, or Placebo for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Results Acute hyperthermia developed after ABT-116 treatment (P P ≤ 0.01 and tramadol (P ≤ 0.001 led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01. Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P R ≥ ±0.40, P ≤ 0.005. Placebo treatment effects were evident with all variables studied. Conclusion Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying
Holroyd-Leduc Jayna M
Full Text Available Abstract Background Heart failure is the most common cause of hospitalization among adults over 65. Over 60% of patients die within 10 years of first onset of symptoms. The objective of this study is to determine the effectiveness of self-management interventions on hospital readmission rates, mortality, and health-related quality of life in patients diagnosed with heart failure. Methods The study is a systematic review of randomized controlled trials. The following data sources were used: MEDLINE (1966-11/2005, EMBASE (1980-11/2005, CINAHL (1982-11/2005, the ACP Journal Club database (to 11/2005, the Cochrane Central Trial Registry and the Cochrane Database of Systematic Reviews (to 11/2005; article reference lists; and experts in the field. We included randomized controlled trials of self-management interventions that enrolled patients 18 years of age or older who were diagnosed with heart failure. The primary outcomes of interest were all-cause hospital readmissions, hospital readmissions due to heart failure, and mortality. Secondary outcomes were compliance with treatment and quality of life scores. Three reviewers independently assessed the quality of each study and abstracted the results. For each included study, we computed the pooled odds ratios (OR for all-cause hospital readmission, hospital readmission due to heart failure, and death. We used a fixed effects model to quantitatively synthesize results. We were not able to pool effects on health-related quality of life and measures of compliance with treatment, but we summarized the findings from the relevant studies. We also summarized the reported cost savings. Results From 671 citations that were identified, 6 randomized trials with 857 patients were included in the review. Self-management decreased all-cause hospital readmissions (OR 0.59; 95% confidence interval (CI 0.44 to 0.80, P = 0.001 and heart failure readmissions (OR 0.44; 95% CI 0.27 to 0.71, P = 0.001. The effect on
Campo, Rebecca A; Light, Kathleen C; O'Connor, Kathleen; Nakamura, Yoshio; Lipschitz, David; LaStayo, Paul C; Pappas, Lisa M; Boucher, Kenneth M; Irwin, Michael R; Hill, Harry R; Martins, Thomas B; Agarwal, Neeraj; Kinney, Anita Y
Older cancer survivors are a vulnerable population due to an increased risk for chronic diseases (e.g., cardiovascular disease) compounded with treatment late-effects and declines in physical functioning. Therefore, interventions that reduce chronic disease risk factors (i.e., blood pressure, chronic inflammation, and cortisol) are important in this population. Tai chi chih (TCC) is a mind-body exercise associated with reductions in chronic disease risk factors, but has not been examined with older cancer survivors. In a feasibility randomized controlled trial of TCC, we examined secondary outcomes of blood pressure, salivary cortisol, and inflammatory cytokines (interleukin (IL)-6, IL-12, tumor necrosis factor-α, IL-10, IL-4) due to their implications in chronic diseases. Sixty-three senior female cancer survivors (M age = 67 years, SD = 7.15) with physical functioning limitations (SF-12 physical functioning ≤80 or role-physical ≤72) were randomized to 12-weeks (60-min, three times a week) of TCC or Health Education control (HEC) classes. Resting blood pressure, 1-day salivary cortisol samples, and fasting plasma samples for cytokine multiplex assays were collected at baseline and 1-week post-intervention. Controlling for baseline values, the TCC group had significantly lower systolic blood pressure (SBP, p = 0.002) and cortisol area-under-curve (AUC, p = 0.02) at post-intervention than the HEC group. There was no intervention effect on inflammatory cytokines (p's > 0.05). This TCC feasibility trial was associated with significant reductions in SBP and cortisol AUC in senior female cancer survivors. Larger, definitive trials are needed to confirm these findings. Senior survivors' have an increased risk for chronic diseases; however, TCC interventions may help reduce associated risk factors.
Kneipp, Shawn M; Kairalla, John A; Sheely, Amanda L
The high prevalence of health conditions among U.S. women receiving Temporary Assistance for Needy Families (TANF, or 'welfare') impedes the ability of many in this group to move from 'welfare-to-work', and the economic recession has likely exacerbated this problem. Despite this, few interventions have been developed to improve employment outcomes by addressing the health needs of women receiving TANF, and little is known about the impact of economic downturns on the employment trajectory of this group. Using data from a recent randomized controlled trial (RCT) that tested the efficacy of a public health nursing (PHN) intervention to address the chronic health condition needs of 432 American women receiving TANF, we examine the effect of the intervention and of recession exposure on employment. We further explore whether intervention effects were modified by select sociodemographic and health characteristics. Both marginal and more robust intervention effects were noted for employment-entry outcomes (any employment, p = 0.05 and time-to-employment, p = 0.01). There were significant effects for recession exposure on employment-entry (any employment, p = 0.002 and time-to-employment, p understanding of the health and employment dynamics among this group of disadvantaged women under variable macroeconomic conditions, and have implications for guiding health and TANF-related policy. Copyright © 2012 Elsevier Ltd. All rights reserved.
Full Text Available Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs, a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting.We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA, for low-resource settings, compared with wait-list control (WLC. CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS. Participants were randomly assigned to CETA (n = 182 or WLC (n = 165. Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes. Primary analysis was intent-to-treat (n = 347, including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers. The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 (95% CI: -0.59, -0.40 for depression, -0.43 (95% CI: -0.51, -0.35 for PTS, -0.42 (95% CI: -0.58, -0.27 for
Kon, Elizaveta; Engebretsen, Lars; Verdonk, Peter; Nehrer, Stefan; Filardo, Giuseppe
Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study. Randomized controlled trial; Level of evidence, 2. Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form-36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively). The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group ( P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain
Gilbert, Alexandra, E-mail: firstname.lastname@example.org [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Ziegler, Lucy; Martland, Maisie [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Davidson, Susan [The Christie Hospital, Manchester (United Kingdom); Efficace, Fabio [Italian Group for Adult Hematologic Diseases, Rome (Italy); Sebag-Montefiore, David; Velikova, Galina [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom)
The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses of Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and
Ranta, Annemarei; Dovey, Susan; Gommans, John; Tilyard, Murray; Weatherall, Mark
Many patients with transient ischemic attack (TIA) receive initial assessments by general practitioners (GPs) who may lack TIA management experience. In a randomized controlled trial (RCT), we showed that electronic decision support for GPs improves patient outcomes and guideline adherence. Some stroke services prefer to improve referrer expertise through TIA/stroke education sessions instead of promoting TIA decision aids or triaging tools. This is a secondary analysis of whether a GP education session influenced TIA management and outcomes. Post hoc analysis of a multicenter, single blind, parallel group, cluster RCT comparing TIA/stroke electronic decision support guided GP management with usual care to assess whether a pretrial TIA/stroke education session also affected RCT outcomes. Of 181 participating GPs, 79 (43.7%) attended an education session and 140 of 291 (48.1%) trial patients were managed by these GPs. There were fewer 90-day stroke events and 90-day vascular events or deaths in patients treated by GPs who attended education; 2 of 140 (1.4%) and 10 of 140 (7.1%) respectively, compared with those who did not; 5 of 151 (3.3%), and 14 of 151 (9.3%), respectively. Logistic regression for association between 90-day stroke and 90-day vascular events or death and education, however, was nonsignificant (odds ratio [OR] .42 (.08 to 2.22), P = .29 and .59 (95% confidence interval [CI] .27 to 1.29), P = .18 respectively. Guideline adherence was not improved by the education session: OR .84 (95% CI .49 to 1.45), P = .54. In the described setting, a GP TIA/stroke education session did not significantly enhance guideline adherence or reduce 90-day stroke or vascular events following TIA. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.
Barlow, Allison; Mullany, Britta; Neault, Nicole; Goklish, Novalene; Billy, Trudy; Hastings, Ranelda; Lorenzo, Sherilynn; Kee, Crystal; Lake, Kristin; Redmond, Cleve; Carter, Alice; Walkup, John T
The Affordable Care Act provides funding for home-visiting programs to reduce health care disparities, despite limited evidence that existing programs can overcome implementation and evaluation challenges with at-risk populations. The authors report 36-month outcomes of the paraprofessional-delivered Family Spirit home-visiting intervention for American Indian teen mothers and children. Expectant American Indian teens (N=322, mean age=18.1 years) from four southwestern reservation communities were randomly assigned to the Family Spirit intervention plus optimized standard care or optimized standard care alone. Maternal and child outcomes were evaluated at 28 and 36 weeks gestation and 2, 6, 12, 18, 24, 30, and 36 months postpartum. At baseline the mothers had high rates of substance use (>84%), depressive symptoms (>32%), dropping out of school (>57%), and residential instability (51%). Study retention was ≥83%. From pregnancy to 36 months postpartum, mothers in the intervention group had significantly greater parenting knowledge (effect size=0.42) and parental locus of control (effect size=0.17), fewer depressive symptoms (effect size=0.16) and externalizing problems (effect size=0.14), and lower past month use of marijuana (odds ratio=0.65) and illegal drugs (odds ratio=0.67). Children in the intervention group had fewer externalizing (effect size=0.23), internalizing (effect size=0.23), and dysregulation (effect size=0.27) problems. The paraprofessional home-visiting intervention promoted effective parenting, reduced maternal risks, and improved child developmental outcomes in the U.S. population subgroup with the fewest resources and highest behavioral health disparities. The methods and results can inform federal efforts to disseminate and sustain evidence-based home-visiting interventions in at-risk populations.
Periasamy, Ummavathy; Mohd Sidik, Sherina; Rampal, Lekhraj; Fadhilah, Siti Irma; Akhtari-Zavare, Mehrnoosh; Mahmud, Rozi
Cancer is now becoming a leading cause of death. Chemotherapy is an important treatment for cancer patients. These patients also need consultation during their treatment to improve quality of life and decrease psychological disorders. The objectives of the study were to develop, implement and evaluate the effectiveness of a chemotherapy counseling module by pharmacists among oncology patients on their quality of life and psychological outcomes in Malaysia. A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses. In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ 2 = 0.66), psychological (p = 0.001, partial Ƞ 2 = 0.65), social relationships (p = 0.001, partial Ƞ 2 = 0.30), and environment (p = 0.001, partial Ƞ 2 = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ 2 = 0.23), depression (p = 0.000; partial Ƞ 2 = 0.40). The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy
Thompson, Tom Paul; Greaves, Colin J; Ayres, Richard; Aveyard, Paul; Warren, Fiona C; Byng, Richard; Taylor, Rod S; Campbell, John L; Ussher, Michael; Green, Colin; Michie, Susan; West, Robert; Taylor, Adrian
Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: email@example.com.
Full Text Available Jack Parker,1 Gill Wales,2 Nevyne Chalhoub,1 Val Harpin2 1Child and Adolescent Mental Health Service, Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 2Paediatric Neurodisability, Ryegate Children’s Centre, Sheffield Children’s NHS Foundation Trust, Sheffield, UK Purpose: To systematically identify and review the currently available evidence on the long-term outcomes of recommended attention-deficit hyperactivity disorder (ADHD interventions following randomized controlled trials with children and young people. Method: A systematic search was conducted to identify trials >1 year in length using the following databases: CINAHL (January 1982– July 2012, MEDLINE (Ovid and Cambridge Scientific Abstracts [CSA], Psych info, Science Direct (Elsevier, and Cochrane Library. Hand searches of key journals in the subject, book chapters, and conference proceedings were also carried out. Relevant papers were critically appraised using the Cochrane risk of bias tool. Results: Eight controlled trials were identified as being relevant, of duration ranging from 1 year to 8 years (at follow up. The total number of participants in the studies was 1,057, of whom 579 (54.7% were from one cohort and included 26 different outcome measures. Results suggest there is moderate-to-high-level evidence that combined pharmacological and behavioral interventions, and pharmacological interventions alone can be effective in managing the core ADHD symptoms and academic performance at 14 months. However, the effect size may decrease beyond this period. Conclusion: This review has highlighted the paucity and limitations of the evidence investigating the long-term outcomes of recommended interventions for managing ADHD symptoms. There is little evidence to suggest that the effects observed over the relatively short term are maintained throughout longer periods of impairment. Furthermore, much of the existing evidence examining effectiveness beyond 12 months does not
Fottrell Edward F
Full Text Available Abstract Background Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups. Methods A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home
Flynn, Angela C; Dalrymple, Kathryn; Barr, Suzanne; Poston, Lucilla; Goff, Louise M; Rogozińska, Ewelina; van Poppel, Mireille N M; Rayanagoudar, Girish; Yeo, SeonAe; Barakat Carballo, Ruben; Perales, Maria; Bogaerts, Annick; Cecatti, Jose G; Dodd, Jodie; Owens, Julie; Devlieger, Roland; Teede, Helena; Haakstad, Lene; Motahari-Tabari, Narges; Tonstad, Serena; Luoto, Riitta; Guelfi, Kym; Petrella, Elisabetta; Phelan, Suzanne; Scudeller, Tânia T; Hauner, Hans; Renault, Kristina; Sagedal, Linda Reme; Stafne, Signe N; Vinter, Christina; Astrup, Arne; Geiker, Nina R W; McAuliffe, Fionnuala M; Mol, Ben W; Thangaratinam, Shakila
Interventions targeting maternal obesity are a healthcare and public health priority. The objective of this review was to evaluate the adequacy and effectiveness of the methodological designs implemented in dietary intervention trials for obesity in pregnancy. A systematic review of the literature, consistent with PRISMA guidelines, was performed as part of the International Weight Management in Pregnancy collaboration. Thirteen randomized controlled trials, which aimed to modify diet and physical activity in overweight and obese pregnant women, were identified. There was significant variability in the content, delivery, and dietary assessment methods of the dietary interventions examined. A number of studies demonstrated improved dietary behavior in response to diet and/or lifestyle interventions. Nine studies reduced gestational weight gain. This review reveals large methodological variability in dietary interventions to control gestational weight gain and improve clinical outcomes in overweight and obese pregnant women. This lack of consensus limits the ability to develop clinical guidelines and apply the evidence in clinical practice. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: firstname.lastname@example.org.
Full Text Available Background: Tunisia has the highest prevalence of hemodialysis patients compared to the other countries in North Africa. Dialysis centers rarely offer an exercise program to prevent physiological and psychological dialysis therapy-related alterations in chronic hemodialysis patients.Aim: To examine the effect of combined endurance-resistance training program on physiological and psychological outcomes in patients undergoing hemodialysis.Methods: We designed a single blinded, randomized, controlled study for a period of 4 months. Patients were randomized to intervention group or control group. Intervention group patients received 4 training sessions per week, held on non-hemodialysis days for a period of 4 months, whereas control group patients continued their regular lifestyle practice without direct intervention from the personnel of this investigation. Patients were evaluated at baseline (initial assessment and after the four-month study period (final assessment by the same investigator blinded to treatment group assignment using physical, physiological, and psychological measurements.Results: Compared with control group, intervention group showed significant improvement in physical performance during the sit-to-stand-to-sit tests (STS-10: −16.2%, ES = −1.65; STS-60: +23.43%, ES = 1.18, handgrip force task (+23.54%, ES = 1.16, timed up and go test (−13.86%, ES = −1.13, and 6-min walk test (+15.94%, ES = 2.09. Likewise, mini nutritional assessment long form scores after intervention period were significantly higher in the intervention group compared to the control group (ES = 1.43. Physical and mental component scores of SF-36 questionnaire increased significantly in the intervention group (ES = 1.10 and ES = 2.06, respectively, whereas hospital anxiety and depression scale scores decreased significantly (ES = −1.65 and ES = −2.72, respectively. Regarding biological parameters, intervention group displayed improvement in systolic
Mathiesen, Elisabeth R; Hod, Moshe; Ivanisevic, Marina
OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized an...
Middelburg, Karin J.; van der Heide, Maaike; Houtzager, Bregje; Pereboom, Marjolein; Fidler, Vaclav; Bos, Arend F.; Kok, Joke; Hadders-Algra, Mijna
Objective: To evaluate the effect of preimplantation genetic screening (PGS) on neurodevelopmental outcomes in children. Design: Prospective, assessor-blinded, follow-up study of children born to women randomly assigned to in vitro fertilization or intracytoplasmic sperm injection (IVF/ICSI) with or
Summers, Matthew J; Chapple, Lee-anne S; McClave, Stephen A; Deane, Adam M
There is a lack of high-quality evidence that proves that nutritional interventions during critical illness reduce mortality. We evaluated whether power calculations for randomized controlled trials (RCTs) of nutritional interventions that used mortality as the primary outcome were realistic, and whether overestimation was systematic in the studies identified to determine whether this was due to overestimates of event rate or delta. A systematic review of the literature between 2005 and 2015 was performed to identify RCTs of nutritional interventions administered to critically ill adults that had mortality as the primary outcome. Predicted event rate (predicted mortality during the control), predicted mortality during intervention, predicted delta (predicted difference between mortality during the control and intervention), actual event rate (observed mortality during control), observed mortality during intervention, and actual delta (difference between observed mortality during the control and intervention) were recorded. The event-rate gap (predicted event rate minus observed event rate), the delta gap (predicted delta minus observed delta), and the predicted number needed to treat were calculated. Data are shown as median (range). Fourteen articles were extracted, with power calculations provided for 10 studies. The predicted event rate was 29.9% (20.0–52.4%), and the predicted delta was 7.9% (3.0–20.0%). If the study hypothesis was proven correct then, on the basis of the power calculations, the number needed to treat would have been 12.7 (5.0–33.3) patients. The actual event rate was 25.3% (6.1–50.0%), the observed mortality during the intervention was 24.4% (6.3–39.7%), and the actual delta was 0.5% (−10.2–10.3%), such that the event-rate gap was 2.6% (−3.9–23.7%) and delta gap was 7.5% (3.2–25.2%). Overestimates of delta occur frequently in RCTs of nutritional interventions in the critically ill that are powered to determine a mortality
Full Text Available Foot drop is a quite common problem in nervous system disorders. Neuromuscular electrical stimulation (NMES has showed to be an alternative approach to correct foot drop improving walking ability in patients with stroke. In this study, twenty patients with stroke in subacute phase were enrolled and randomly divided in two groups: one group performing the NMES (i.e. Walkaide Group, WG and the Control Group (CG performing conventional neuromotor rehabilitation. Both groups underwent the same amount of treatment time. Significant improvements of walking speed were recorded for WG (% than for CG (%, as well as in terms of locomotion (Functional Ambulation Classification score: . In terms of mobility and force, ameliorations were recorded, even if not significant (Rivermead Mobility Index: ; Manual Muscle Test: . Similar changes between groups were observed for independence in activities of daily living, neurological assessments, and spasticity reduction. These results highlight the potential efficacy for patients affected by a droop foot of a walking training performed with a neurostimulator in subacute phase.
Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe
Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.
Adewole, Olanisun O; Oladele, T; Osunkoya, Arinola H; Erhabor, Greg E; Adewole, Temitayo O; Adeola, Oluwaseun; Obembe, Olufemi; Ota, Martin O C
Directly observed treatment short-course (DOTS) strategy is an effective mode of treating TB. We aimed to study the cost effectiveness and patients' satisfaction with home based direct observation of treatment (DOT), an innovative approach to community-based DOT (CBDOT) and hospital based DOT (HBDOT). A randomized controlled trial involving 150 newly diagnosed pulmonary TB patients in four TB clinics in Ile Ife , Nigeria, was done. They were randomly assigned to receive treatment with anti TB drugs for the intensive phase administered at home by a TB worker (CBDOT) or at the hospital (HBDOT). Outcome measures were treatment completion/default rates, cost effectiveness and patients' satisfaction with care using a 13 item patients satisfaction questionnaire (PS-13) at 2 months. This trial was registered with pactr.org: number PACTR 201503001058381. At the end of intensive phase, 15/75 (20%) and 2/75 (3%) of patients in the HBDOT and CBDOT, respectively had defaulted from treatment, p= 0.01. Of those with pretreatment positive sputum smear, 97% (68/70) on CBDOT and 54/67 (81%) on HBDOT were sputum negative for AFB at the end of 2 months of treatment, p=0.01. The CBDOT method was associated with a higher patient satisfaction score compared with HBDOT (OR 3.1; 95% CI 1.25-7.70), p=0.001.The total cost for patients was higher in HBDOT (US$159.38) compared with the CBDOT (US$89.52). The incremental cost effectiveness ratio was US$410 per patient who completed the intensive phase treatment with CBDOT. CBDOT is a cost effective approach associated with better compliance to treatment and better patient satisfaction compared to HBDOT. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: email@example.com.
Fandiño-Del-Rio, Magdalena; Goodman, Dina; Kephart, Josiah L; Miele, Catherine H; Williams, Kendra N; Moazzami, Mitra; Fung, Elizabeth C; Koehler, Kirsten; Davila-Roman, Victor G; Lee, Kathryn A; Nangia, Saachi; Harvey, Steven A; Steenland, Kyle; Gonzales, Gustavo F; Checkley, William
Biomass fuel smoke is a leading risk factor for the burden of disease worldwide. International campaigns are promoting the widespread adoption of liquefied petroleum gas (LPG) in resource-limited settings. However, it is unclear if the introduction and use of LPG stoves, in settings where biomass fuels are used daily, reduces pollution concentration exposure, improves health outcomes, or how cultural and social barriers influence the exclusive adoption of LPG stoves. We will conduct a randomized controlled, field intervention trial of LPG stoves and fuel distribution in rural Puno, Peru, in which we will enroll 180 female participants aged 25-64 years and follow them for 2 years. After enrollment, we will collect information on sociodemographic characteristics, household characteristics, and cooking practices. During the first year of the study, LPG stoves and fuel tanks will be delivered to the homes of 90 intervention participants. During the second year, participants in the intervention arm will keep their LPG stoves, but the gas supply will stop. Control participants will receive LPG stoves and vouchers to obtain free fuel from distributors at the beginning of the second year, but gas will not be delivered. Starting at baseline, we will collect longitudinal measurements of respiratory symptoms, pulmonary function, blood pressure, endothelial function, carotid artery intima-media thickness, 24-h dietary recalls, exhaled carbon monoxide, quality-of-life indicators, and stove-use behaviors. Environmental exposure assessments will occur six times over the 2-year follow-up period, consisting of 48-h personal exposure and kitchen concentration measurements of fine particulate matter and carbon monoxide, and 48-h kitchen concentrations of nitrogen dioxide for a subset of 100 participants. Findings from this study will allow us to better understand behavioral patterns, environmental exposures, and cardiovascular and pulmonary outcomes resulting from the adoption of
Full Text Available Ganglioside has a neuroprotective role in neonatal hypoxic-ischemic encephalopathy (HIE. This study aimed to evaluate the neurological outcomes of monosialoganglioside as adjuvant treatment for neonatal HIE by conducting a meta-analysis.A comprehensive literature search was made in the Pubmed, EMBASE, Cochrane Library, Wanfang, CNKI, VIP databases through October 2016. Randomized controlled trials comparing monosialoganglioside with the usual treatment for newborns having HIE deemed eligible. Weighted mean difference (WMD and risk ratio (RR with 95% confidence interval (CI were calculated for continuous and dichotomous data, respectively.Ten trials consisting of 787 neonates were included. Adjuvant treatment with monosialoganglioside significantly reduced major neurodevelopmental disabilities (RR = 0.35; 95% CI = 0.21-0.57, cerebral palsy (RR = 0.32; 95% CI = 0.12-0.87, mental retardation (RR = 0.31; 95% CI = 0.11-0.88 as well as improved the mental (WMD = 14.95; 95% CI = 7.44-22.46 and psychomotive (WMD = 13.40; 95% CI = 6.69-20.11 development index during the follow-up. Also, monosialoganglioside significantly improved Neonatal Behavioral Neurological Assessment scores (WMD = 2.91; 95% CI = 2.05-3.78 compared with the usual treatment. However, adverse effects associated with monosialoganglioside were poorly reported in the included trials.Adjuvant treatment with monosialoganglioside had beneficial effects in improving neurological outcomes in neonatal HIE. However, these findings should be interpreted with caution because of methodological flaws in the included trials. Furthermore, safety of monosialoganglioside use should also be further evaluated.
Annan, Jeannie; Sim, Amanda; Puffer, Eve S; Salhi, Carmel; Betancourt, Theresa S
The negative effects of displacement and poverty on child mental health are well-known, yet research on prevention interventions in low- and middle-income countries, especially fragile states, remains limited. We examined the effectiveness of a parenting skills intervention on mental health outcomes among Burmese migrant and displaced children living in 20 communities in Thailand. Participants were primary caregivers and children aged 7 to 15 years (n = 479 families). Families were randomly assigned to receive an adapted version of the Strengthening Families Program (n = 240) or a wait-list control condition (n = 239). Assessments were conducted at baseline and 1-month post-intervention for both conditions and at 6 months for treatment group only. One month after the program, children in the treatment condition showed significant reductions in externalizing problems (caregiver effect size (ES) -0.22, p = 0.02; child report ES -0.11, p = 0.02) and child attention problems compared with controls (caregiver report ES -0.23, p = 0.03). There was no significant treatment effect on children's internalizing problems (ES -0.06; p = 0.31). Children reported a significant increase in prosocial protective factors relative to controls (ES 0.20, p skills intervention adapted for a displaced and migrant Burmese population facing high levels of adversity can have positive effects on children's externalizing symptoms and protective psychosocial factors. Clinicaltrials.gov: https://clinicaltrials.gov/show/NCT01829815.
Daniel eSanta Mina
Full Text Available Purpose: Regular exercise improves psychological wellbeing in men treated for prostate cancer. For this population and among cancer survivors in general, the effect of a single bout of exercise on self-report or objective measures of psychological wellbeing has not been examined. We examined the acute effect of a single bout of exercise on the cortical silent period (CSP and on self-reported mood in men that have received treatment for prostate cancer. Methods: Thirty-six prostate cancer survivors were randomly assigned to 60 minutes of low to moderate intensity exercise or to a control condition. Outcomes were assessed immediately before and after either the exercise or the control condition. Results: No significant differences in baseline CSP or mood were observed following the exercise session or control conditions. Participants with higher scores of trait anxiety had significantly shorter CSP at baseline, as well as those receiving androgen deprivation therapy. Age and baseline CSP had a low-moderate, but significant negative correlation. Changes in CSP following the exercise condition were strongly negatively correlated with changes in self-reported vigor. Conclusions: While we did not observe any acute effect of exercise on the CSP in this population, the associations between CSP and trait anxiety, age, and vigor are novel findings requiring further examination.Implications for Cancer Survivors: Exercise did not acutely affect our participants in measures of psychological wellbeing. Additional mechanisms to explain the chronic psychosocial benefits of exercise previously observed in men with prostate cancer require further exploration.Clinicaltrials.gov Identifier: NCT01715064 (http://clinicaltrials.gov/show/NCT01715064
Davis, Sally M; Myers, Orrin B; Cruz, Theresa H; Morshed, Alexandra B; Canaca, Glenda F; Keane, Patricia C; O'Donald, Elena R
We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2years to achieve. Copyright © 2016 Elsevier Inc. All rights reserved.
Roese, Neal J.; Olson, James M.
Examined impact of outcome controllability on counterfactual thoughts (thoughts of what could have been). Two studies showed that outcome controllability affected counterfactual direction: thoughts on how things could have been better were more frequent following controllable outcomes, and thoughts on how things could have been worse followed…
Forde, Katherine; Storey, Madeleine; Littlewood, Simon J; Scott, Paul; Luther, Friedy; Kang, Jing
There is a shortage of evidence on the best type of retainer. Evaluate upper and lower bonded retainers (BRs) versus upper and lower vacuum-formed retainers (VFRs) over 12 months, in terms of stability, retainer survival, and patient satisfaction. Two-arm parallel group multi-centre randomized controlled clinical trial. Sixty consecutive patients completing fixed appliance therapy and requiring retainers were recruited from 3 hospital departments. They were randomly allocated to either upper and lower labial segment BRs (n = 30) or upper and lower full-arch VFRs (n = 30). Primary outcome was stability. Secondary outcomes were retainer survival and patient satisfaction. A random sequence of treatment allocation was computer-generated and implemented by sealing in sequentially numbered opaque sealed envelopes independently prepared in advance. Patients, operators and outcome could not be blinded due to the nature of the intervention. Thirty patients received BRs (median [Mdn] age 16 years, inter-quartile range [IQR] = 2) and 30 received VFRs (Mdn age 17 years, IQR = 4). Baseline characteristics were similar between groups. At 12 months, there were no statistically significant inter-group differences in post-treatment change of maxillary labial segment alignment (BR = 1.1 mm, IQR = 1.56, VFR = 0.76 mm, IQR = 1.55, P = 0.61); however, there was greater post-treatment change in the mandibular VFR group (BR = 0.77 mm, IQR = 1.46, VFR = 1.69mm, IQR = 2.00, P = 0.008). The difference in maxillary retainer survival rates were statistically non-significant, P = 0.34 (BR = 63.6%, 239.3 days, 95% confidence interval [CI] = 191.1-287.5, VFR = 73.3%, 311.1 days, 95% CI = 278.3-344.29). The mandibular BR had a lower survival rate (P = 0.01) at 12 months (BR = 50%, 239.3 days 95% CI = 191.1-287.5, VFR = 80%, 324.9 days 95% CI = 295.4-354.4). More subjects with VFRs reported discomfort (P = 0.002) and speech difficulties (P = 0.004) but found them easier to clean than those with
Lutz, Wolfgang; Zimmermann, Dirk; Müller, Viola N L S; Deisenhofer, Anne-Katharina; Rubel, Julian A
Psychotherapy is successful for the majority of patients, but not for every patient. Hence, further knowledge is needed on how treatments should be adapted for those who do not profit or deteriorate. In the last years prediction tools as well as feedback interventions were part of a trend to more personalized approaches in psychotherapy. Research on psychometric prediction and feedback into ongoing treatment has the potential to enhance treatment outcomes, especially for patients with an increased risk of treatment failure or drop-out. The research project investigates in a randomized controlled trial the effectiveness as well as moderating and mediating factors of psychometric feedback to therapists. In the intended study a total of 423 patients, who applied for a cognitive-behavioral therapy at the psychotherapy clinic of the University Trier and suffer from a depressive and/or an anxiety disorder (SCID interviews), will be included. The patients will be randomly assigned either to one therapist as well as to one of two intervention groups (CG, IG2). An additional intervention group (IG1) will be generated from an existing archival data set via propensity score matching. Patients of the control group (CG; n = 85) will be monitored concerning psychological impairment but therapists will not be provided with any feedback about the patients assessments. In both intervention groups (IG1: n = 169; IG2: n = 169) the therapists are provided with feedback about the patients self-evaluation in a computerized feedback portal. Therapists of the IG2 will additionally be provided with clinical support tools, which will be developed in this project, on the basis of existing systems. Therapists will also be provided with a personalized treatment recommendation based on similar patients (Nearest Neighbors) at the beginning of treatment. Besides the general effectiveness of feedback and the clinical support tools for negatively developing patients, further mediating and
Muhlhausler, Beverly S; Yelland, Lisa N; McDermott, Robyn; Tapsell, Linda; McPhee, Andrew; Gibson, Robert A; Makrides, Maria
The omega-3 (n-3) long-chain polyunsaturated fatty acid (LCPUFA) docosahexaenoic acid (DHA) has proven effective at reducing fat storage in animal studies. However, a systematic review of human trials showed a lack of quality data to support or refute this hypothesis. We sought to determine whether maternal DHA supplementation during the second half of pregnancy results in a lower body mass index (BMI) and percentage of body fat in children. We conducted a follow-up at 3 and 5 y of age of children who were born to mothers enrolled in the DOMInO (DHA to Optimize Mother Infant Outcome) double-blind, randomized controlled trial, in which women with a singleton pregnancy were provided with DHA-rich fish-oil capsules (800 mg DHA/d) or vegetable-oil capsules (control group) in the second half of pregnancy. Primary outcomes were the BMI z score and percentage of body fat at 3 and 5 y of age. Potential interactions between prenatal DHA and the peroxisome proliferator-activated receptor-γ (PPARγ) genotype as a measure of the genetic predisposition to obesity were investigated. A total of 1614 children were eligible for the follow-up. Parent or caregiver consent was obtained for 1531 children (95%), and these children were included in the analysis. BMI z scores and percentages of body fat of children in the DHA group did not differ from those of children in the control group at either 3 y of age [BMI z score adjusted mean difference: 0.03 (95% CI: -0.07, 0.13; P = 0.61); percentage of body fat adjusted mean difference: -0.26 (95% CI: -0.99, 0.46; P = 0.47)] or 5 y of age [BMI z score adjusted mean difference: 0.02 (95% CI: -0.08, 0.12; P = 0.66); percentage of body fat adjusted mean difference: 0.11 (95% CI: -0.60, 0.82; P = 0.75)]. No treatment effects were modified by the PPARγ genotype of the child. Independent of a genetic predisposition to obesity, maternal intake of DHA-rich fish oil during the second half of pregnancy does not affect the growth or body composition
de Witte, Pieter Bas; Kolk, Arjen; Overes, Ferdinand; Nelissen, Rob G H H; Reijnierse, Monique
Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)-guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Randomized controlled trial; Level of evidence, 1. Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, -8.9 to 21.5), but without statistical significance. Follow-up scores
Verweij, L.M.; Proper, K.I.; Weel, A.N.H.; Hulshof, C.T.J.; Mechelen, W. van
Objective This study aims to evaluate the effectiveness of a draft occupational health guideline, aimed at preventing weight gain, on employees' body weight-related outcomes, cardiovascular disease (CVD) risk factors, and quality of life. Methods In a cluster randomized controlled trial including 16
Keating Jennifer L
Full Text Available Abstract Background Non-specific chronic low back pain (NSCLBP has become a significant problem due to high healthcare utilization, rising costs of care and perceived limitations of effectiveness of many current treatments. Systematic reviews have repeatedly concluded that, on average across participants, exercise for NSCLBP appears effective in decreasing pain and improving function. Not all people with NSCLBP benefit from exercise programs and it would assist care-providers and care-seekers if factors that impact on program effectiveness and success were identified. Methods and design The study will be a randomised controlled trial comparing an exercise rehabilitation program informed by a participant preferences questionnaire compared to a program without this guideline for patients with chronic low back pain. A sample of 150 patients will be recruited in Melbourne, Australia through community-based healthcare clinics that provide supervised exercise rehabilitation programs for people with non-specific chronic low back pain. Clinicians will be randomly assigned to exercise preferences questionnaire or no questionnaire and participants will be allocated in a concealed manner. A qualitative focus group study of exercise instructor feedback about the exercise preferences instrument will be embedded in the research design. Two qualitative focus group studies will also be conducted for participants in the intervention and the control groups to obtain feedback about participants' experiences of the two types of exercise programs. The primary outcomes will be functional ability, pain, fear avoidance, exercise adherence. Discussion This trial will evaluate the effectiveness of individualised exercise prescription compared to usual exercise prescription for NSCLP and, using feedback following the trial, refine the exercise preferences questionnaire.
Full Text Available Numerous randomized controlled trials (RCTs have arrived at conflicting conclusions on expressive writing (EW as an intervention for breast cancer (BC patients, but there has been no meta-analysis of these studies to assess the effectiveness of EW in BC population.PubMed, Web of Science, The Cochrane Library, EMBASE, and CINAHL and the www.clinicaltrial.gov database on ongoing clinical trials were searched to identify all the RCTs investigating efficacy of EW on the physical and psychological health in BC patients. The risk of bias of the original studies was assessed using the Cochrane Collaboration's tool. Our primary outcomes for physical and psychological health were respectively negative somatic symptoms and negative mood which were stratified by emotional, benefit-finding and multiple prompts in sub-group analyses. The data were analyzed using Review Manager 5.2 and Stata version 12.0 statistical software.Of the 5,232 titles screened, we identified 11 RCTs with a total of 1,178 participants. The pooled results showed a significant effect of EW using either an emotional prompt or a benefit-finding prompt on reducing negative somatic symptoms in BC patients in the ≤3-month follow-up group [Mean Difference (MD, -13.03, 95% CI, -19.23 to -6.83, P3-month follow-up group. There were no significant differences regarding psychological health indexes between EW intervention and control groups at any of the follow-up time-points (P>0.05.This systematic review and meta-analysis reveals that EW intervention may have a significantly positive impact on the physical health but not the psychological health in BC patients, but this benefit may not last long. However, further high-quality studies with more homogeneity are needed to confirm the current findings.
Li, Zhanguo; An, Yuan; Su, Houheng; Li, Xiangpei; Xu, Jianhua; Zheng, Yi; Li, Guiye; Kwok, Kenneth; Wang, Lisy; Wu, Qizhe
Abstract Aim Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We assess the effect of tofacitinib + conventional synthetic disease‐modifying anti rheumatic drugs (csDMARDs) on patient‐reported outcomes in Chinese patients with RA and inadequate response to DMARDs. Methods This analysis of data from the Phase 3 study ORAL Sync included Chinese patients randomized 4 : 4 : 1 : 1 to receive tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily, p...
Riper, Heleen; Kramer, Jeannet; Keuken, Max; Smit, Filip; Schippers, Gerard; Cuijpers, Pim
Web-based self-help interventions for problem drinking are coming of age. They have shown promising results in terms of cost-effectiveness, and they offer opportunities to reach out on a broad scale to problem drinkers. The question now is whether certain groups of problem drinkers benefit more from such Web-based interventions than others. We sought to identify baseline, client-related predictors of the effectiveness of Drinking Less, a 24/7, free-access, interactive, Web-based self-help intervention without therapist guidance for problem drinkers who want to reduce their alcohol consumption. The intervention is based on cognitive-behavioral and self-control principles. We conducted secondary analysis of data from a pragmatic randomized trial with follow-up at 6 and 12 months. Participants (N = 261) were adult problem drinkers in the Dutch general population with a weekly alcohol consumption above 210 g of ethanol for men or 140 g for women, or consumption of at least 60 g (men) or 40 g (women) one or more days a week over the past 3 months. Six baseline participant characteristics were designated as putative predictors of treatment response: (1) gender, (2) education, (3) Internet use competence (sociodemographics), (4) mean weekly alcohol consumption, (5) prior professional help for alcohol problems (level of problem drinking), and (6) participants' expectancies of Web-based interventions for problem drinking. Intention-to-treat (ITT) analyses, using last-observation-carried-forward (LOCF) data, and regression imputation (RI) were performed to deal with loss to follow-up. Statistical tests for interaction terms were conducted and linear regression analysis was performed to investigate whether the participants' characteristics as measured at baseline predicted positive treatment responses at 6- and 12-month follow-ups. At 6 months, prior help for alcohol problems predicted a small, marginally significant positive treatment outcome in the RI model only (beta = .18
Morey, Miriam C; Snyder, Denise C; Sloane, Richard; Cohen, Harvey Jay; Peterson, Bercedis; Hartman, Terryl J; Miller, Paige; Mitchell, Diane C; Demark-Wahnefried, Wendy
Five-year survival rates for early stage colorectal, breast, and prostate cancer currently exceed 90% and are increasing. Cancer survivors are at greater risk for second malignancies, other comorbidities, and accelerated functional decline. Lifestyle interventions may provide benefit, but it is unknown whether long-term cancer survivors can modify their lifestyle behaviors sufficiently to improve functional status. To determine whether a telephone counseling and mailed print material-based diet and exercise intervention is effective in reorienting functional decline in older, overweight cancer survivors. Randomized controlled trial of 641 overweight (body mass index > or = 25 and or = 5 years) survivors (aged 65-91 years) of colorectal, breast, and prostate cancer, who were randomly assigned to an intervention group (n = 319) or delayed intervention (control) group (n = 322) in Canada, the United Kingdom, and 21 US states. Individuals were recruited for the Reach out to Enhance Wellness (RENEW) trial from July 1, 2005, through May 17, 2007. A 12-month, home-based tailored program of telephone counseling and mailed materials promoting exercise, improved diet quality, and modest weight loss. The control group was wait-listed for 12 months. Change in self-reported physical function on the Short-Form 36 physical function subscale (score range, 0-100; a high score indicates better functioning) from baseline to 12 months was the primary end point. Secondary outcomes included changes in function on the basic and advanced lower extremity function subscales of the Late Life Function and Disability Index (score range, 0-100), physical activity, body mass index, and overall health-related quality of life. The mean baseline Short-Form 36 physical function score was 75.7. At the 12-month follow-up, the mean function scores declined less rapidly in the intervention group (-2.15; 95% confidence interval [CI], -0.36 to -3.93) compared with the control group (-4.84; 95% CI, -3
Raheja, Amol; Sinha, Sumit; Samson, Neha; Bhoi, Sanjeev; Subramanian, Arulselvi; Sharma, Pushpa; Sharma, Bhawani Shankar
OBJECTIVE There has been increased interest in the potential importance of biochemical parameters as predictors of outcome in severe traumatic brain injury (sTBI). METHODS Of 107 patients with sTBI (age 18-65 years with a Glasgow Coma Scale score of 4-8 presenting within 8 hours after injury) who were randomized for a placebo-controlled Phase II trial of progesterone with or without hypothermia, the authors serially analyzed serum biomarkers (S100-B, glial fibrillary acidic protein [GFAP], neuron-specific enolase [NSE], tumor necrosis factor-α, interleukin-6 [IL-6], estrogen [Eg], and progesterone [Pg]). This analysis was performed using the sandwich enzyme-linked immunosorbent assay technique at admission and 7 days later for 86 patients, irrespective of assigned group. The long-term predictive values of serum biomarkers for dichotomized Glasgow Outcome Scale (GOS) score, functional independence measure, and survival status at 6 and 12 months were analyzed using an adjusted binary logistic regression model and receiver operating characteristic curve. RESULTS A favorable GOS score (4-5) at 1 year was predicted by higher admission IL-6 (above 108.36 pg/ml; area under the curve [AUC] 0.69, sensitivity 52%, and specificity 78.6%) and Day 7 Pg levels (above 3.15 ng/ml; AUC 0.79, sensitivity 70%, and specificity 92.9%). An unfavorable GOS score (1-3) at 1 year was predicted by higher Day 7 GFAP levels (above 9.50 ng/ml; AUC 0.82, sensitivity 78.6%, and specificity 82.4%). Survivors at 1 year had significantly higher Day 7 Pg levels (above 3.15 ng/ml; AUC 0.78, sensitivity 66.7%, and specificity 90.9%). Nonsurvivors at 1 year had significantly higher Day 7 GFAP serum levels (above 11.14 ng/ml; AUC 0.81, sensitivity 81.8%, and specificity 88.9%) and Day 7 IL-6 serum levels (above 71.26 pg/ml; AUC 0.87, sensitivity 81.8%, and specificity 87%). In multivariate logistic regression analysis, independent predictors of outcome at 1 year were serum levels of Day 7 Pg (favorable
Vinereanu, Dragos; Stevens, Susanna R; Alexander, John H; Al-Khatib, Sana M; Avezum, Alvaro; Bahit, Marıa Cecilia; Granger, Christopher B; Lopes, Renato D; Halvorsen, Sigrun; Hanna, Michael; Husted, Steen; Hylek, Elaine M; Mărgulescu, Andrei D; Wallentin, Lars; Atar, Dan
To assess clinical outcomes, efficacy, and safety according to sex during anticoagulation with apixaban compared with warfarin in patients with atrial fibrillation. Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) was a randomized, double-blind, placebo-controlled, multicentre trial that included 11 785 (64.7%) men and 6416 (35.3%) women with atrial fibrillation or flutter randomized to receive either warfarin or apixaban. The primary efficacy endpoint was stroke or systemic embolism; secondary efficacy endpoints were death from any cause and cardiovascular death. The primary safety endpoint was major bleeding; secondary safety endpoints were a composite of major bleeding and non-major clinically relevant bleeding. The risk of stroke or systemic embolism was similar in women vs. men [adjusted hazard ratio (adjHR): 0.91; 95% confidence interval (CI): 0.74-1.12; P = 0.38]. However, among patients with history of stroke or transient ischaemic attack, women had a lower risk of recurrent stroke compared with men (adjHR: 0.70; 95% CI: 0.50-0.97; P = 0.036). Women also had a lower risk of all-cause death (adjHR: 0.63; 95% CI: 0.55-0.73; P < 0.0001) and cardiovascular death (adjHR: 0.62; 95% CI: 0.51-0.75; P < 0.0001), and a trend towards less major bleeding (adjHR: 0.86; 95% CI: 0.74-1.01; P = 0.066) and major or non-major clinically relevant bleeding (adjHR: 0.89; 95% CI: 0.80-1.00; P = 0.049). The efficacy and safety benefits of apixaban compared with warfarin were consistent regardless of sex. In the ARISTOTLE trial, women had a similar rate of stroke or systemic embolism but a lower risk of mortality and less clinically relevant bleeding than men. The efficacy and safety benefits of apixaban compared with warfarin were consistent in men and women. ARISTOTLE ClinicalTrials.gov number, NCT00412984. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please
Swofford, John; Whang, Peter G.; Frank, Clay J.; Glaser, John A.; Limoni, Robert P.; Cher, Daniel J.; Wine, Kathryn D.; Sembrano, Jonathan N.
Background Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. Objective To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. Methods One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. Results In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period. Conclusions In this Level
Polly, David W; Swofford, John; Whang, Peter G; Frank, Clay J; Glaser, John A; Limoni, Robert P; Cher, Daniel J; Wine, Kathryn D; Sembrano, Jonathan N
Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period. In this Level 1 multicenter prospective randomized controlled
Jensen, Bente Thoft; Kiesbye, Berit; Soendergaard, Ingrid; Jensen, Jørgen B; Kristensen, Susanne Ammitzboell
Radical Cystectomy with a creation of an uro-stoma is first line treatment in advanced bladder-cancer. Enhancing or maintaining an individual's condition, skills and physical wellbeing before surgery has been defined as prehabilitation. Whether preoperative stoma-education is an effective element in prehabilitation is yet to be documented. In a prospective randomized controlled design (RCT) the aim was to investigate the efficacy of a standardised preoperative stoma-education program on an individual's ability to independently change a stoma-appliance. A parent RCT-study investigated the efficacy of a multidisciplinary rehabilitation program on length of stay following cystectomy. A total of 107 patients were included in the intension-to-treat-population. Preoperatively, the intervention-group was instructed to a standardized stoma-education program consisting of areas recognized necessary to change a stoma appliance. The Urostomy Education Scale was used to measure stoma self-care at day 35, 120 and 365 postoperatively. Efficacy was expressed as a positive difference in UES-score between treatment-groups. A significant difference in mean score was found in the intervention group compared to standard of 2.7 (95% CI: 0.9; 4.5), 4.3 (95% CI: 2.1; 6.5) and 5.1 (95% CI: 2.3; 7.8) at day 35, 120 and 365 postoperatively. For the first time a study in a RCT-design have reported a positive efficacy of a short-term preoperative stoma intervention. Preoperative stoma-education is an effective intervention and adds to the evidence base of prehabilitation. Further RCT-studies powered with self-efficacy as the primer outcome are requested. Copyright © 2017 Elsevier Ltd. All rights reserved.
Full Text Available Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm 2 in 3 sessions at weekly intervals or sham therapy (n = 20 in each group. Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients′ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results : The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P < 0.001, but slightly increased in the sham group (4.1 ± 0.8 to 4.5 ± 0.9 mm, P = 0.03. Both groups showed significant pain improvement over the course of the study (P < 0.001, though pain scores were significantly more reduced in the ESWT than the sham group (-4.2 ± 2.9 vs. -2.7 ± 1.8, P = 0.049. Conclusions: Extracorporeal shock wave therapy contributes to healing and pain reduction in plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy.
Lin, Yu-Ching; Gau, Meei-Ling; Kao, Ghi-Hwei; Lee, Hung-Chang
The physical positions that are adopted by women during childbirth significantly impact their childbirth outcomes and experiences. Literature studies have associated using a squatting position with reduced childbirth pain and increased comfort and pushing efficiency. However, the major disadvantage of the squatting position is that women may lack the muscular fitness and stamina necessary to sustain this position for a long period. The aim of this study was to compare the pushing experiences and birth outcomes of three different pushing positions during the second stage of labor. A randomized controlled trial was conducted at a regional teaching hospital in northern Taiwan. Data were collected from 168 primiparous women during the 38th to 42nd gestational weeks. None of the participants received epidural analgesia during labor, and all were free of pregnancy and labor-related complications. During labor, after full cervical dilation and when the fetal head had descended to at least the +1 station and had turned to the occiput anterior position, the experimental group was asked to push in the squatting position while using the ergonomically designed ankle support. For purposes of comparison, Comparison Group A was asked to push in the squatting position without the use of the support, and Comparison Group B was asked to push in a standard semirecumbent position. All of the participants completed a demographic and obstetrics data sheet, the short-form McGill Pain Questionnaire, and the Labor Pushing Experience scale within 4 hours postpartum. In terms of delivery time, the duration between the start of pushing to crowning for the experimental group (squatting with ankle supports) averaged 25.79 minutes less (F = 6.02, p pushing to infant birth averaged 25.21 minutes less for the experimental group than for Comparison Group B (F = 6.14, p pushing experiences than the comparison groups (F = 14.69, p pushing, squatting with the aid of ergonomically designed ankle
Koniak-Griffin, Deborah; Brecht, Mary-Lynn; Takayanagi, Sumiko; Villegas, Juan; Melendrez, Marylee; Balcázar, Héctor
Low-income Latinas (Hispanics) face risk for cardiovascular disease due to high rates of overweight/obesity, sedentary lifestyle, and other factors. Limited access to health care and language barriers may prevent delivery of health promotion messages. Targeted approaches, including the integration of community health workers, may be required to promote healthy lifestyle and prevent chronic disease in underserved ethnic minority groups. The term commonly used to refer to female community health workers in Latino communities is "promotora(s)." This study evaluates the outcomes and feasibility of a promotora-led lifestyle behavior intervention for overweight, immigrant Latinas. A community prevention model was employed in planning and implementing this study. A randomized controlled trial design was used. A Community Advisory Board provided expertise in evaluating feasibility of study implementation in the community and other important guidance. The sample was comprised of 223 women aged 35-64 years, predominantly with low income and ≤8th grade education. The culturally tailored Lifestyle Behavior Intervention included group education (8 classes based upon Su Corazon, Su Vida), followed by 4 months of individual teaching and coaching (home visits and telephone calls). The control group received a comparable length educational program and follow-up contacts. Evaluations were conducted at baseline and at 6 and 9 months using a dietary habits questionnaire, accelerometer readings of physical activity, and clinical measures (body mass index, weight, waist circumference, blood pressure, lipids, blood glucose). Data were collected between January 2010 and August 2012. Women in the intervention group improved significantly in dietary habits, waist circumference, and physical activity in comparison to those in the control group. A treatment dosage effect was observed for weight and waist circumference. Knowledge about heart disease increased. High attendance at classes and
Zhou, Ye-Ping; Jiang, Zhu-Ming; Sun, Yong-Hua; Wang, Xiu-Rong; Ma, En-Ling; Wilmore, Douglas
This research was conducted to evaluate the effect of enterally administered glutamine (gln) dipeptide on metabolic, gastrointestinal, and outcome parameters after severe burn injury. Forty thermally injured patients with total body surface burns ranging between 50% and 80%, and third-degree burns ranging between 20% and 40% and without respiratory injuries, were randomized into a prospective, double-blind, controlled clinical trial. One group received gln-enriched enteral nutrition and the other group received the standard enteral formulation. Tube feedings were initiated on postburn day 1 (PBD +1), and isocaloric and isonitrogenous feedings were administered to both groups until PBD +12. The gln was given as the dipeptide of alanyl-gln (Ajinomoto, Tokyo, Japan), which provided 0.35 g gln/kg body weight/d. Plasma amino acid profiles, serum endotoxin concentrations, and the lactulose/mannitol absorption ratio (which reflects gut permeability) were measured at specific times throughout the clinical course. Wound healing at day 30 was assessed, and length of hospital stay and total costs were determined at discharge. The 2 groups were similar in terms of age and extent of injury. Plasma gln concentrations were approximately 300 umol/L in both groups on PBD +1 and remained low in the control group (399 +/- 40 umol/L, mean +/- SD) but increased toward normal in the supplemented group to 591 +/- 74 (p = .048). Lactulose/mannitol ratios were increased above normal on POD +1 (control, 0.221 +/- 0.169; gln, 0.268 +/- 0.202; not significant), reflecting increased intestinal permeability after burn injury. On POD +3, the ratio in the gln group was lower than control (0.025 +/- 0.008 versus 0.049 +/- 0.016; p = .0001), and both groups returned toward normal ratios with time. Endotoxin levels on PBD +1 were elevated in both groups (control, 0.089 +/- 0.023 EU/mL; gln, 0.103 +/- 0.037 EU/mL; NS) but decreased significantly on PBD +3 in the patients receiving gln. Hospital stay
Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.
Full Text Available OBJECTIVE: To test the hypothesis that preoperative Valsalva leak point pressure (VLPP predicts long-term outcome of mid-urethra slings for female stress urinary incontinence (SUI. MATERIALS AND METHODS: One hundred and forty-five patients with SUI were prospectively randomized to two mid-urethra sling treatments: Tension free vaginal tape (TVT or transobturator tape (TOT. They were followed-up at 3, 6, 12 months post-operatively and then annually for the primary outcome variable, i.e. dry or wet and secondary outcome variables such as scores on the urogenital distress inventory (UDI-6 and the impact of incontinence on quality of life (IIQ-7 questionnaire as well as patient satisfaction as scored on a visual analogue scale (VAS. Preoperative VLPP was correlated with primary and secondary outcome variables. RESULTS: Mean follow-ups were 32 + 12 months (range 12-55 for TVT and 31 + 15 months (range 12-61 for TOT. When patients were analyzed according to VLPP stratification, 95 (65.5% patients showed a VLPP > 60 cm H2O and 50 (34.5% patients had a VLPP 60 cm H2O and 72% for those with VLPP 60 cm H2O (82 % vs. 68.9% p of 60 cm H2O, preoperative VLPP was not linked to outcome after TVT or TOT procedures.
Capozzi, Lauren C; McNeely, Margaret L; Lau, Harold Y; Reimer, Raylene A; Giese-Davis, Janine; Fung, Tak S; Culos-Reed, S Nicole
Patients with head and neck cancer experience loss of weight and muscle mass, decreased functioning, malnutrition, depression, and declines in quality of life during and after treatment. The purpose of this exploratory randomized study was to determine the optimal timing for the initiation of a lifestyle and progressive resistance exercise training intervention (during or after radiation therapy), as determined by intervention adherence and by comparing between-group outcomes across 24 weeks. Sixty patients with head and neck cancer were randomized to engage in a 12-week lifestyle intervention and progressive resistance-training program either during radiation treatment or immediately after completion. The primary outcome of body composition--specifically, lean body mass, body mass index, and body fat--as well as secondary outcomes of fitness, quality of life, depression, and nutrition status were evaluated. The progressive resistance-training intervention carried out during treatment did not significantly influence the primary outcome of body composition, despite a significant increase in weekly physical activity reported by the intervention group. A small-to-medium intervention effect was noted for some secondary outcomes, including fitness, quality of life, and nutrition status. Regardless of whether patients received the immediate or delayed progressive resistance-training intervention, the analysis revealed a main effect of time on body composition, fitness, quality of life, depression, and nutritional scores. Although the intervention during treatment did not reduce the loss of lean body mass, delaying the exercise program until after treatment completion was associated with improved intervention adherence, a finding with important clinical implications. © 2016 American Cancer Society.
Schepke, Ulf; Meijer, Henny J. A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco
BackgroundSingle-tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. PurposeThis randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant
Landsheer, Johannes A.; Smit, Johannes H.; van Oppen, Patricia; van Balkom, Anton J L M
The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply
Shokry, Mahmoud; Manaa, Essam M; Shoukry, Randa Ali; Shokeir, Mohamed Hossam; Elsedfy, Ghada O; Abd El-Aziz, Abd El-Salam
To investigate whether intrapartum epidural analgesics (bupivacaine or ropivacaine) have an influence (safety and efficacy) on mothers, fetuses, or newborns at high altitudes (2,200 m above the sea level). Prospective randomized trial. A tertiary referral hospital in Aseer region, Saudi Arabia. Eighty parturient women with normal full term pregnancy (37-40 weeks) were randomly allocated to a group receiving epidural bupivacaine 0.125% and the other receiving ropivacaine 0.2%, with fentanyl 100 microg given to both groups. Intra- and postpartum clinical management of the pregnant women and newborns and fetal Doppler assessments were performed. Severity of pain, onset and duration of analgesia, and occurrence of motor blockade were primary outcomes. Progress of labor, need for oxytocin augmentation, mode of delivery, and neonatal condition were secondary outcomes. Demographic, labor characteristics, and neonatal outcomes of the two groups were comparable. The onset of analgesia was relatively more rapid for ropivacaine group (p = 0.067). Duration of analgesia after the first bolus dose was longer and the need for supplemental epidural analgesic doses was lesser in the bupivacaine group (p = 0.041 and 0.045, respectively). In both groups, the fetal umbilical and middle cerebral artery pulsatility indices showed significant change when compared to the baseline of the same group. At high altitudes, no major advantage was found for epidural ropivacaine over bupivacaine in addition to fentanyl for labor analgesia and no harmful effects of the medications were found on mothers, fetuses, or newborns.
Banga, Shreshtha; Datta, Vikram; Rehan, Harmeet Singh; Bhakhri, Bhanu Kiran
Safety of oral sucrose, commonly used procedural analgesic in neonates, is questioned. To evaluate the effect of sucrose analgesia, for repeated painful procedures, on short-term neurobehavioral outcome of preterm neonates. Stable preterm neonates were randomized to receive either sucrose or distilled water orally, for every potentially painful procedure during the first 7 days after enrollment. Neurodevelopmental status at 40 weeks postconceptional age (PCA) measured using the domains of Neurobehavioral Assessment of Preterm Infants scale. A total of 93 newborns were analyzed. The baseline characteristics of the groups were comparable. No statistically significant difference was observed in the assessment at 40 weeks PCA, among the groups. Use of sucrose analgesia, for repeated painful procedures on newborns, does not lead to any significant difference in the short-term neurobehavioral outcome. © The Author . Published by Oxford University Press. All rights reserved. For Permissions, please email: firstname.lastname@example.org.
Lardenoye, Sacha; Theunissen, Ed; Cleffken, Berry; Brink, Peter Rg; de Bie, Rob A; Poeze, Martijn
Functional treatment is a widely used and generally accepted treatment for ankle sprain. A meta-analysis comparing the different functional treatment options could not make definitive conclusions regarding the effectiveness, and until now, little was known about patient satisfaction in relation to the outcome. Patients with acute ankle sprain received rest, ice, compression and elevation with an compressive bandage at the emergency department. After 5-7 days, 100 patients with grade II and III sprains were randomized into two groups: one group was treated with tape and the other with a semi-rigid ankle brace, both for 4 weeks. Post-injury physical and proprioceptive training was standardized. As primary outcome parameter patient satisfaction and skin complications were evaluated using a predefined questionnaire and numeric rating scale. As secondary outcome parameter the ankle joint function was assessed using the Karlsson scoring scale and range of motion. Patient-reported comfort and satisfaction during treatment with a semi-rigid brace was significantly increased. The rate of skin complication in this group was significantly lower compared to the tape group (14.6% versus 59.1%, P ankle joint was similar between the two treatment groups, as well as reported pain. Treatment of acute ankle sprain with semi-rigid brace leads to significantly higher patient comfort and satisfaction, both with similar good outcome.
Full Text Available Abstract Background Functional treatment is a widely used and generally accepted treatment for ankle sprain. A meta-analysis comparing the different functional treatment options could not make definitive conclusions regarding the effectiveness, and until now, little was known about patient satisfaction in relation to the outcome. Methods Patients with acute ankle sprain received rest, ice, compression and elevation with an compressive bandage at the emergency department. After 5-7 days, 100 patients with grade II and III sprains were randomized into two groups: one group was treated with tape and the other with a semi-rigid ankle brace, both for 4 weeks. Post-injury physical and proprioceptive training was standardized. As primary outcome parameter patient satisfaction and skin complications were evaluated using a predefined questionnaire and numeric rating scale. As secondary outcome parameter the ankle joint function was assessed using the Karlsson scoring scale and range of motion. Results Patient-reported comfort and satisfaction during treatment with a semi-rigid brace was significantly increased. The rate of skin complication in this group was significantly lower compared to the tape group (14.6% versus 59.1%, P Conclusion Treatment of acute ankle sprain with semi-rigid brace leads to significantly higher patient comfort and satisfaction, both with similar good outcome.
Direct versus Indirect and Individual versus Group Modes of Language Therapy for Children with Primary Language Impairment: Principal Outcomes from a Randomized Controlled Trial and Economic Evaluation
Boyle, James M.; McCartney, Elspeth; O'Hare, Anne; Forbes, John
Background: Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and…
Pan, Wen-Harn; Lai, Ying-Ho; Yeh, Wen-Ting; Chen, Jiunn-Rong; Jeng, Jiann-Shing; Bai, Chyi-Huey; Lin, Ruey-Tay; Lee, Tsong-Hai; Chang, Ku-Chou; Lin, Huey-Juan; Hsiao, Chin-Fu; Chern, Chang-Ming; Lien, Li-Ming; Liu, Chung-Hsiang; Chen, Wei-Hung; Chang, Anna
Background: Stroke is one of the leading causes of mortality and neurologic deficits. Management measures to improve neurologic outcomes are in great need. Our previous intervention trial in elderly subjects successfully used salt as a carrier for potassium, demonstrating a 41% reduction in cardiovascular mortality by switching to potassium-enriched salt. Dietary magnesium has been associated with lowered diabetes and/or stroke risk in humans and with neuroprotection in animals. Objective: Because a large proportion of Taiwanese individuals are in marginal deficiency states for potassium and for magnesium and salt is a good carrier for minerals, it is justifiable to study whether further enriching salt with magnesium at an amount near the Dietary Reference Intake (DRI) amount may provide additional benefit for stroke recovery. Design: This was a double-blind, randomized controlled trial comprising 291 discharged stroke patients with modified Rankin scale (mRS) ≤4. There were 3 arms: 1 ) regular salt (Na salt) ( n = 99), 2 ) potassium-enriched salt (K salt) ( n = 97), and 3 ) potassium- and magnesium-enriched salt (K/Mg salt) ( n = 95). The NIH Stroke Scale (NIHSS), Barthel Index (BI), and mRS were evaluated at discharge, at 3 mo, and at 6 mo. A good neurologic performance was defined by NIHSS = 0, BI = 100, and mRS ≤1. Results: After the 6-mo intervention, the proportion of patients with good neurologic performance increased in a greater magnitude in the K/Mg salt group than in the K salt group and the Na salt group, in that order. The K/Mg salt group had a significantly increased OR (2.25; 95% CI: 1.09, 4.67) of achieving good neurologic performance compared with the Na salt group. But the effect of K salt alone (OR: 1.58; 95% CI: 0.77, 3.22) was not significant. Conclusions: This study suggests that providing the DRI amount of magnesium and potassium together long term is beneficial for stroke patient recovery from neurologic deficits. This trial was
Neuropsychological Outcome of Children Treated for Standard Risk Medulloblastoma in the PNET4 European Randomized Controlled Trial of Hyperfractionated Versus Standard Radiation Therapy and Maintenance Chemotherapy
Câmara-Costa, Hugo; Resch, Anika; Kieffer, Virginie; Lalande, Clémence; Poggi, Geraldina; Kennedy, Colin; Bull, Kim; Calaminus, Gabriele; Grill, Jacques; Doz, François; Rutkowski, Stefan; Massimino, Maura; Kortmann, Rolf-Dieter; Lannering, Birgitta; Dellatolas, Georges; Chevignard, Mathilde
Purpose: In the European HIT-SIOP PNET4 randomized controlled trial, children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy (HFRT arm, including a partially focused boost) or standard radiation therapy (STRT arm), followed, in both arms, by maintenance chemotherapy. Event-free survival was similar in both arms. Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function, especially in children <8 years of age at diagnosis. Therefore, the aim of this study was to compare performance-based cognitive outcomes between treatment arms. Methods and Materials: Neuropsychological data were collected prospectively in 137 patients. Using the Wechsler Intelligence Scales, Kaufman Assessment Battery for Children, and Raven's Progressive Matrices, we estimated full-scale intelligence quotient (FSIQ) and, when available, verbal IQ (VIQ), performance IQ (PIQ), working memory index (WMI), and processing speed index (PSI). Results: Among the 137 participants (HFRT arm n=71, STRT arm n=66, 63.5% males), mean (±SD) ages at diagnosis and assessment respectively were 9.3 (±3.2) years of age (40.8% < 8 years of age at diagnosis) and 14.6 (±4.3) years of age. Mean (±SD) FSIQ was 88 (±19), and mean intergroup difference was 3.88 (95% confidence interval: −2.66 to 10.42, P=.24). No significant differences were found in children >8 years of age at diagnosis. In children <8 years of age at diagnosis, a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm; a similar trend was found for PSI but not for PIQ, WMI, or FSIQ (mean intergroup differences were: 12.02 for VIQ [95% CI: 2.37-21.67; P=.02]; 3.77 for PIQ [95% CI: −5.19 to 12.74; P>.10]; 5.20 for WMI [95% CI: −2.07 to 12.47; P>.10]; 10.90 for PSI [95% CI: −1.54 to 23.36; P=.08]; and 5.28 for FSIQ [95% CI: −4.23 to 14.79; P>.10]). Conclusions: HFRT was associated with
Neuropsychological Outcome of Children Treated for Standard Risk Medulloblastoma in the PNET4 European Randomized Controlled Trial of Hyperfractionated Versus Standard Radiation Therapy and Maintenance Chemotherapy
Câmara-Costa, Hugo, E-mail: email@example.com [National Institute of Health and Medical Research, INSERM U1178, Paris (France); Resch, Anika [University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kieffer, Virginie [Saint Maurice Hospitals, Saint Maurice (France); Lalande, Clémence [Institut Gustave Roussy, Villejuif (France); Poggi, Geraldina [Scientific Institute, IRCCS Eugenio Medea, Bosisio Parini, Lecco (Italy); Kennedy, Colin; Bull, Kim [University of Southampton, Faculty of Medicine, Southampton (United Kingdom); Calaminus, Gabriele [Paediatric Oncology, University of Muenster, Muenster (Germany); Grill, Jacques [Institut Gustave Roussy, Villejuif (France); Doz, François [Institut Curie and University Paris Descartes, Sorbonne Paris Cité, Paris (France); Rutkowski, Stefan [University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Massimino, Maura [Fondazione IRCCS, Istituto Nazionale Tumori, Milan (Italy); Kortmann, Rolf-Dieter [Department of Radiation Therapy, University of Leipzig, Leipzig (Germany); Lannering, Birgitta [Paediatric Oncology, University of Gothenburg, Gothenburg (Sweden); Dellatolas, Georges [National Institute of Health and Medical Research, INSERM U1178, Paris (France); Chevignard, Mathilde [Rehabilitation Department for Children With Acquired Neurological Injury, Saint Maurice Hospitals, Saint Maurice, and Sorbonne Universités, UPMC Universités Paris, INSERM CNRS, Paris (France)
Purpose: In the European HIT-SIOP PNET4 randomized controlled trial, children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy (HFRT arm, including a partially focused boost) or standard radiation therapy (STRT arm), followed, in both arms, by maintenance chemotherapy. Event-free survival was similar in both arms. Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function, especially in children <8 years of age at diagnosis. Therefore, the aim of this study was to compare performance-based cognitive outcomes between treatment arms. Methods and Materials: Neuropsychological data were collected prospectively in 137 patients. Using the Wechsler Intelligence Scales, Kaufman Assessment Battery for Children, and Raven's Progressive Matrices, we estimated full-scale intelligence quotient (FSIQ) and, when available, verbal IQ (VIQ), performance IQ (PIQ), working memory index (WMI), and processing speed index (PSI). Results: Among the 137 participants (HFRT arm n=71, STRT arm n=66, 63.5% males), mean (±SD) ages at diagnosis and assessment respectively were 9.3 (±3.2) years of age (40.8% < 8 years of age at diagnosis) and 14.6 (±4.3) years of age. Mean (±SD) FSIQ was 88 (±19), and mean intergroup difference was 3.88 (95% confidence interval: −2.66 to 10.42, P=.24). No significant differences were found in children >8 years of age at diagnosis. In children <8 years of age at diagnosis, a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm; a similar trend was found for PSI but not for PIQ, WMI, or FSIQ (mean intergroup differences were: 12.02 for VIQ [95% CI: 2.37-21.67; P=.02]; 3.77 for PIQ [95% CI: −5.19 to 12.74; P>.10]; 5.20 for WMI [95% CI: −2.07 to 12.47; P>.10]; 10.90 for PSI [95% CI: −1.54 to 23.36; P=.08]; and 5.28 for FSIQ [95% CI: −4.23 to 14.79; P>.10]). Conclusions: HFRT was associated with
Lai, Ta-Wei; Ma, Hsiao-Li; Lee, Meng-Shiunn; Chen, Po-Ming; Ku, Ming-Chou
Objectives: Extracorporeal shockwave therapy (ESWT) and corticosteroid injection (CSI) are treatment options for plantar fasciitis. Their clinical outcome comparison remains a debate. Also, the thickness changes of the plantar fascia on objective evaluation under the medium energy ESWT and CSI therapy are elusive. Methods: A total of 97 patients with chronic plantar fasciitis were enrolled in the randomized prospective trial. Forty-seven patients received extracorporeal shock wave therapy (ESWT), and fifty patients received corticosteroid injection (CSI). The thickness of the plantar fascia was evaluated respectively before ESWT and CSI, and at the 4th and 12th week after ESWT and CSI by ultrasonography. Pain level and clinical outcomes were recorded using visual analogue scale (VAS) and 100-points scoring systems. Correlation analysis was performed between the thickness change and clinical outcome. Results: Under ultrasonography, we observed more increase of plantar fascia thickness of ESWT group than CSI group at 4th week (p=0.048). VAS of plantar fasciitis patients receiving ESWT was lower than those who received corticosteroid injection (0.001 and pplantar fascia thickness at 4th week was positively correlated with the decrease of VAS score at 12th week follow-up (R=0.302, P=0.039). Conclusions: At 4th week after treatment, the thickness of plantar fascia increased. Then it decreased gradually, but not to the baseline at 12th week. On the pain level outcome at 12th week, extracorporeal shockwave therapy (ESWT) was more efficient than corticosteroid injection (CSI) on chronic plantar fasciitis. The more change of plantar fascia after ESWT, the more efficient on clinical outcome. PMID:29504578
Sachin A Narvekar
Full Text Available Background: Management of repeated implantation failure despite transfer of good-quality embryos still remains a dilemma for ART specialists. Scrapping of endometrium in the nontransfer cycle has been shown to improve the pregnancy rate in the subsequent IVF/ET cycle in recent studies. Aim: The objective of this randomized controlled trial (RCT was to determine whether endometrial injury caused by Pipelle sampling in the nontransfer cycle could improve the probability of pregnancy in the subsequent IVF cycle in patients who had previous failed IVF outcome. Setting: Tertiary assisted conception center. Design: Randomized controlled study. Materials and Methods: 100 eligible patients with previous failed IVF despite transfer of good-quality embryos were randomly allocated to the intervention group and control groups. In the intervention group, Pipelle endometrial sampling was done twice: One in the follicular phase and again in the luteal phase in the cycle preceding the embryo transfer cycle. Outcome Measure: The primary outcome measure was live birth rate. The secondary outcome measures were implantation and clinical pregnancy rates. Results: The live birth rate was significantly higher in the intervention group compared to control group (22.4% and 9.8% P = 0.04. The clinical pregnancy rate in the intervention group was 32.7%, while that in the control group was 13.7%, which was also statistically significant ( P = 0.01. The implantation rate was significantly higher in the intervention group as compared to controls (13.07% vs 7.1% P = 0.04. Conclusions: Endometrial injury in nontransfer cycle improves the live birth rate,clinical pregnancy and implantation rates in the subsequent IVF-ET cycle in patients with previous unsuccessful IVF cycles.
Courneya, Kerry S; Segal, Roanne J; Gelmon, Karen; Reid, Robert D; Mackey, John R; Friedenreich, Christine M; Proulx, Caroline; Lane, Kirstin; Ladha, Aliya B; Vallance, Jeffrey K; Liu, Qi; Yasui, Yutaka; McKenzie, Donald C
Few exercise trials in cancer patients have reported longer-term follow-up. Here, we report a 6-month follow-up of exercise behavior and patient-rated outcomes from an exercise trial in breast cancer patients. Breast cancer patients initiating adjuvant chemotherapy (n = 242) were randomly assigned to usual care (n = 82), resistance exercise training (RET; n = 82), or aerobic exercise training (AET; n = 78) for the duration of their chemotherapy. At 6-month follow-up, participants were mailed a questionnaire that assessed quality of life, self-esteem, fatigue, anxiety, depression, and exercise behavior. Two hundred one (83.1%) participants provided 6-month follow-up data. Adjusted linear mixed-model analyses showed that, at 6-month follow-up, the RET group reported higher self-esteem [adjusted mean difference, 1.6; 95% confidence interval (95% CI), 0.1-3.2; P = 0.032] and the AET group reported lower anxiety (adjusted mean difference, -4.7; 95% CI, -0.0 to -9.3; P = 0.049) compared with the usual care group. Moreover, compared with participants reporting no regular exercise during the follow-up period, those reporting regular aerobic and resistance exercise also reported better patient-rated outcomes, including quality of life (adjusted mean difference, 9.5; 95% CI, 1.2-17.8; P = 0.025). Improvements in self-esteem observed with RET during breast cancer chemotherapy were maintained at 6-month follow-up whereas reductions in anxiety not observed with AET during breast cancer chemotherapy emerged at 6-month follow-up. Moreover, adopting a combined aerobic and resistance exercise program after breast cancer chemotherapy was associated with further improvements in patient-rated outcomes. Exercise training during breast cancer chemotherapy may result in some longer-term and late effects for selected patient-rated outcomes.
Sampselle, Carolyn M; Newman, Diane K; Miller, Janis M; Kirk, Keri; DiCamillo, Mary Ann; Wagner, Todd H; Raghunathan, Trivellor E; Diokno, Ananias C
We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Bassan, Milan S; Sundaralingam, Praka; Fanning, Scott B; Lau, James; Menon, Jayaram; Ong, Evan; Rerknimitr, Rungsun; Seo, Dong-Wan; Teo, Eng Kiong; Wang, Hsiu-Po; Reddy, D Nageshwar; Goh, Khean Lee; Bourke, Michael J
Wire-guided biliary cannulation has been demonstrated to improve cannulation rates and reduce post-ERCP pancreatitis (PEP), but the impact of wire caliber has not been studied. This study compares successful cannulation rates and ERCP adverse events by using a 0.025-inch and 0.035-inch guidewire. A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied. A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes. Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.). Copyright © 2018. Published by Elsevier Inc.
Muzaffar, Henna; Castelli, Darla M; Scherer, Jane; Chapman-Novakofski, Karen
The HOT (Healthy Outcome for Teens) Project is an innovative online educational intervention for middle school children for prevention of diabetes and obesity by balancing food intake with physical activity. The objective was to improve knowledge, outcome expectations, self-efficacy, and self-reported food intake and skills and to compare a passive online learning (POL) control group with an active online learning (AOL) treatment group by implementing a social cognitive theory (SCT)-grounded online intervention. In total, 214 participants were recruited from three middle schools. Full data were secured for 181 students. Six valid, reliable questionnaires were administered online, pre/post, to both the AOL and POL groups to assess knowledge gain, self-reported intake, and meal planning skills, as well as change in SCT constructs. Subjects in the AOL group improved significantly for all five categories of planning a meal questionnaire (P=0.001) and also for outcome expectations for exercise (P=0.001). At postintervention, no significant differences were found for composite scores of exercise self-efficacy, weight efficacy lifestyle, and rapid eating assessment plan questionnaires between AOL versus POL (by Mann-Whitney test). We conclude that teens participating in the AOL version of the HOT Project intervention acquired skills for planning a meal and improved outcome expectations for exercise.
Balakrishnan, Maya; Jennings, Alishia; Przystac, Lynn; Phornphutkul, Chanika; Tucker, Richard; Vohr, Betty; Stephens, Bonnie E; Bliss, Joseph M
Administration of high-dose parenteral amino acids (AAs) to premature infants within hours of delivery is currently recommended. This study compared the effect of lower and higher AA administration starting close to birth on short-term growth and neurodevelopmental outcomes at 18-24 months corrected gestational age (CGA). Infants Toddler Development, Third Edition at 18-24 months CGA. Secondary outcomes were growth parameters at 36 weeks CGA among infants surviving to hospital discharge, serum bicarbonate, serum urea nitrogen, creatinine, AA profiles in the first week of life, and incidence of major morbidities and mortality. No differences in neurodevelopmental outcome were detected between the high and low AA groups. Infants in the high AA group had significantly lower mean weight, length, and head circumference percentiles than those in the standard AA group at 36 weeks CGA and at hospital discharge. These differences did not persist after controlling for birth growth parameters, except for head circumference. Infants in the high AA group had higher mean serum urea nitrogen than the standard group on each day throughout the first week. Current recommendations for high-dose AA starting at birth are not associated with improved growth or neurodevelopmental outcomes.
Boettcher, Johanna; Berger, Thomas; Renneberg, Babette
Numerous studies suggest that Internet-based self-help treatments are effective in treating anxiety disorders. Trials evaluating such interventions differ in their screening procedures and in the amount of clinician contact in the diagnostic assessment phase. The present study evaluates the impact of a pre-treatment diagnostic interview on the outcome of an Internet-based treatment for Social Anxiety Disorder (SAD). One hundred and nine participants seeking treatment for SAD were randomized to either an interview-group (IG, N = 53) or to a non-interview group (NIG, N = 56). All participants took part in the same 10-week cognitive-behavioural unguided self-help programme. Before receiving access to the programme, participants of the IG underwent a structured diagnostic interview. Participants of the NIG started directly with the programme. Participants in both groups showed significant and substantial improvement on social anxiety measures from pre- to post-assessment (d IG = 1.30-1.63; d NIG = 1.00-1.28) and from pre- to 4-month follow-up assessment (d IG = 1.38-1.87; d NIG = 1.10-1.21). Significant between-groups effects in favour of the IG were found on secondary outcome measures of depression and general distress (d = 0.18-0.42). These findings suggest that Internet-based self-help is effective in treating SAD, whether or not a diagnostic interview is involved. However, the pre-treatment interview seems to facilitate change on secondary outcomes such as depression and general distress.
Bell, Morris D; Laws, Holly B; Petrakis, Ismene B
Cognitive remediation therapy (CRT) is reported to improve neurocognitive and substance use disorder (SUD) outcomes in residential treatments. This National Institute of Drug Abuse funded pilot study reports on CRT as an augmentation to outpatient treatment for SUD. Recovering outpatient veterans were randomized into CRT + Work Therapy (n = 24) or work therapy (n = 24) with treatment-as-usual. Blind assessments of neurocognition and substance use were performed at baseline, 3 months (end of treatment), and 6-month follow-up. Baseline assessments revealed high rates of cognitive impairment with 87.5% showing significant decline from premorbid IQ on at least 1 measure (median = 3/14 measures). Adherence to treatment was excellent. Follow-up rates were 95.7% at 3 months and 87.5% at 6 months. Mixed effects models of cognitive change over time revealed significant differences favoring CRT + Work Therapy on working memory (WM) and executive function indices. Global index of cognition showed a nonsignificant trend (effect size [ES] = .37) favoring CRT + Work Therapy. SUD outcomes were excellent for both conditions. CRT + Work Therapy had a mean of 97% days of abstinence at 3 months, 94% in the 30 days prior to 6-month follow-up, and 24/26 weeks of total abstinence; differences between conditions were not significant. CRT was well accepted by outpatient veterans with SUDs and led to significant improvements in WM and executive functions beyond that of normal cognitive recovery. No difference between conditions was found for SUD outcomes, perhaps because work therapy obscured the benefits of CRT. (PsycINFO Database Record (c) 2017 APA, all rights reserved).
Stefanini, Martina; Jepsen, Karin; de Sanctis, Massimo; Baldini, Nicola; Greven, Björn; Heinz, Bernd; Wennström, Jan; Cassel, Björn; Vignoletti, Fabio; Sanz, Mariano; Jepsen, Søren; Zucchelli, Giovanni
To assess patient-reported outcome measures (PROMs), aesthetics and stability of root coverage procedures from a previous 6-month RCT after 1 year. Forty-five patients (90 recessions) had received a coronally advanced flap (CAF = control) only or a xenogeneic collagen matrix in addition (CAF + CMX = test). Visual analogue scales (VAS) and questionnaires were used for PROMs and the root coverage aesthetic score (RES) for professional aesthetic evaluations. VAS scores (patient satisfaction) amounted to 8.58 ± 1.86 (test) versus 8.38 ± 2.46 (control). Six patients preferred CAF + CMX concerning surgical procedure and aesthetics, six preferred CAF and 29 were equally satisfied. RES was 7.85 ± 2.42 for the test group versus 7.34 ± 2.90 for the controls. Root coverage (RC) was 76.28% for test and 75.05% for control defects. The mean increase in keratinized tissue width was higher in test (from 1.97 to 3.02 mm) than in controls (from 2.00 to 2.64 mm) (p = 0.0413). Likewise, test sites showed more gain in gingival thickness (0.52 mm) than control sites (0.27 mm) (p = 0.0023). Compared to 6 months, clinical outcomes were stable. Results for PROMs, RES and RC did not significantly differ between treatment groups. Thickness and width of keratinized tissue were enhanced following CAF + CMX compared to CAF alone. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.
Duval, Karine; Langlois, Marie-France; Carranza-Mamane, Belina; Pesant, Marie-Hélène; Hivert, Marie-France; Poder, Thomas G; Lavoie, Hélène B; Ainmelk, Youssef; St-Cyr Tribble, Denise; Laredo, Sheila; Greenblatt, Ellen; Sagle, Margaret; Waddell, Guy; Belisle, Serge; Riverin, Daniel; Jean-Denis, Farrah; Belan, Matea; Baillargeon, Jean-Patrice
Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information
Or, Calvin K L; Tao, Da
To assess whether the use of consumer health information technologies (CHITs) improves outcomes in the patient self-management of diabetes. The evidence from randomized controlled trials (RCTs) on the effects of CHITs on patient outcomes was analyzed using either meta-analysis or a narrative synthesis approach. A systematic search of seven electronic databases was conducted to identify relevant reports of RCTs for the analysis. In the meta-analyses, standardized mean differences in patient outcomes were calculated and random-effects models were applied in cases where the heterogeneity of the results was moderate or high, otherwise fixed-effects models were used. Sixty-two studies, representing 67 RCTs, met the inclusion criteria. The results of the meta-analyses showed that the use of CHITs was associated with significant reductions in HbA1c, blood pressure, total cholesterol, and triglycerides levels when compared with the usual care. The findings from the narrative synthesis indicated that only a small proportion of the trials reported positive effects of CHITs on patient outcomes. The use of CHITs in supporting diabetes self-management appears to have potential benefits for patients' self-management of diabetes. However, the effectiveness of the technologies in improving patient outcomes still awaits confirmation in future studies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Wang, Kai; Cao, Liang; Deng, Qian; Sun, Li-Qiang; Gu, Tian-Yu; Song, Jie; Qi, Dun-Yi
Epidural/spinal opioids are increasingly used to relieve parturients' pain in labour. Some studies indicate that opioids can induce side effects in neonates, such as respiratory depression and neurobehavioural changes. This meta-analysis aimed to clarify the effects of opioids in labour analgesia on neonates. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and EMBASE™ were searched for relevant randomized controlled trials (RCTs). The neonatal data of Apgar scores, Neurological and Adaptive Capacity Scores (NACS), and umbilical cord pH values were extracted. Statistical analyses were carried out using Review Manager 5.2 and Stata(®) 10. Twenty-one trials with 2,859 participants were included in our meta-analysis. No difference in the incidence of Apgar scores analgesia are safe for neonates up to 24 hr after delivery. In future studies, more attention should be paid to the long-term side effects in neonates.
Full Text Available Rupture of the anterior cruciate ligament (ACL is a high incidence injury usually treated surgically. According to common knowledge, it does not heal spontaneously, although some claim the opposite. Regeneration therapy by Khalifa was developed for injuries of the musculoskeletal system by using specific pressure to the skin. This randomized, controlled, observer-blinded, multicentre study was performed to validate this assumption. Thirty patients with complete ACL rupture, magnetic resonance imaging (MRI verified, were included. Study examinations (e.g., international knee documentation committee (IKDC score were performed at inclusion (t0. Patients were randomized to receive either standardised physiotherapy (ST or additionally 1 hour of Khalifa therapy at the first session (STK. Twenty-four hours later, study examinations were performed again (t1. Three months later control MRI and follow-up examinations were performed (t2. Initial status was comparable between both groups. There was a highly significant difference of mean IKDC score results at t1 and t2. After 3 months, 47% of the STK patients, but no ST patient, demonstrated an end-to-end homogeneous ACL in MRI. Clinical and physical examinations were significantly different in t1 and t2. ACL healing can be improved with manual therapy. Physical activity can be performed without pain and nearly normal range of motion after one treatment of specific pressure.
Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W
Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.
David Daniel Ebert
Full Text Available Anxiety and depression in children and adolescents are undertreated. Computer- and Internet-based cognitive behavioral treatments (cCBT may be an attractive treatment alternative to regular face-to-face treatment.This meta-analysis aims to evaluate whether cCBT is effective for treating symptoms of anxiety and depression in youth.We conducted systematic searches in bibliographical databases (Pubmed, Cochrane controlled trial register, PsychInfo up to December 4, 2013. Only randomized controlled trials in which a computer-, Internet- or mobile-based cognitive behavioral intervention targeting either depression, anxiety or both in children or adolescents up to the age of 25 were compared to a control condition were selected. We employed a random-effects pooling model in overall effect analyses and a mixed effect model for sub-group analyses. Searches resulted in identifying 13 randomized trials, including 796 children and adolescents that met inclusion criteria. Seven studies were directed at treating anxiety, four studies at depression, and two were of a transdiagnostic nature, targeting both anxiety and depression. The overall mean effect size (Hedges' g of cCBT on symptoms of anxiety or depression at post-test was g=0.72 (95% CI:0.55-0.90, numbers needed to be treated (NNT=2.56. Heterogeneity was low (I²=20.14%, 95% CI: 0-58%. The superiority of cCBT over controls was evident for interventions targeting anxiety (g=0.68; 95% CI: 0.45-0.92; p < .001; NNT=2.70 and for interventions targeting depression (g=0.76; 95% CI: 0.41-0.12; p < .001; NNT=2.44 as well as for transdiagnostic interventions (g=0.94; 95% CI: 0.23-2.66; p < .001; NNT=2.60.Results provide evidence for the efficacy of cCBT in the treatment of anxiety and depressive symptoms in youth. Hence, such interventions may be a promising treatment alternative when evidence based face-to-face treatment is not feasible. Future studies should examine long-term effects of treatments and should
Polly, David W.; Wine, Kathryn D.; Whang, Peter G.; Frank, Clay J.; Harvey, Charles F.; Lockstadt, Harry; Glaser, John A.; Limoni, Robert P.; Sembrano, Jonathan N.
BACKGROUND: Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE: To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS: A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS: Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P Sacroiliac Fusion Treatment MCS, mental component summary NSM, nonsurgical management ODI, Oswestry Disability Index PCS, physical component summary RFA, radiofrequency ablation SF-36, Short Form-36 SIJ, sacroiliac joint TTO, time trade-off VAS, visual analog scale PMID:26291338
Polly, David W; Cher, Daniel J; Wine, Kathryn D; Whang, Peter G; Frank, Clay J; Harvey, Charles F; Lockstadt, Harry; Glaser, John A; Limoni, Robert P; Sembrano, Jonathan N
Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.
Zhang, Yue; Wang, Yi-Zhao; Huang, Li-Ping; Bai, Bei; Zhou, Shi; Yin, Miao-Miao; Zhao, Hua; Zhou, Xiao-Na; Wang, Hong-Tu
The aim of this study was to evaluate the effects of an aquatic exercise program designed to enhance muscular strength in paretic lower limbs in subacute stroke patients. Thirty-six subacute stroke patients were randomly divided to a conventional or an aquatic group (n = 18 each). Outcome measures were assessed at baseline and after 8 wks of training. For the paretic lower limbs, maximum isometric voluntary contraction strength of the rectus femoris and biceps femoris caput longus and the tibialis anterior and lateral gastrocnemius was measured. Cocontraction ratios during knee extension and flexion and ankle dorsiflexion and plantarflexion were calculated respectively. In addition, Modified Ashworth Scale, Functional Ambulation Category, and Barthel Index were assessed. Compared with the conventional intervention, the aquatic intervention resulted in significantly higher knee extension (P = 0.002) and ankle plantarflexion torque (P = 0.002), accompanied with a significantly lower knee extension cocontraction ratio in the paretic limb (P = 0.000). Functional Ambulation Category (P = 0.009) and Barthel Index (P = 0.024) were greater in aquatic group than conventional group posttreatment. Modified Ashworth Scale scores did not show any differences between groups. Aquatic exercise enhanced muscle strength in paretic lower limbs and improved muscle cocontraction without increasing spasticity in subacute stroke patients.
Rampalli Viswa Chandra
Full Text Available Context: Electrosurgery offers many unique advantages such as hemostasis and precise tissue cutting; however, there are a number of disadvantages including thermal injury and delayed wound healing. Aims: The aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip, and surgical blade during periodontal surgery. Settings and Design: Twenty-two individuals participated in this study. Three quadrants in each individual were randomly assigned into each of the following experimental groups: Colorado® microdissection needle (CMD, electrosurgery tip (EC and surgical blade (BP, in which, incisions were given with Colorado® microdissection needle, straight electrocautery tip, and a scalpel blade, respectively. Materials and Methods: Blood loss (BL was measured immediately after surgery, and changes in interdental papilla dimensions were recorded at baseline, 7, 30, 120, and 180 days after surgery. Measures of periodontal disease were recorded at baseline, 120, and 180 days after surgery. Postoperative pain and wound healing were recorded at 1, 7, and 15 days after surgery. Results: The use of CMD for periodontal surgery showed better results over EC in all parameters. CMD resulted in lesser bleeding and less postoperative pain and attained similar results to that of BP in clinical parameters of periodontal disease. Conclusions: Colorado® microdissection needle may be a better choice for incisions as it seems to show less tissue damage than cautery and offers tissue healing comparable to scalpel blade.
Initiating Nutritional Support Before 72 Hours Is Associated With Favorable Outcome After Severe Traumatic Brain Injury in Children: A Secondary Analysis of a Randomized, Controlled Trial of Therapeutic Hypothermia.
Meinert, Elizabeth; Bell, Michael J; Buttram, Sandra; Kochanek, Patrick M; Balasubramani, Goundappa K; Wisniewski, Stephen R; Adelson, P David
To understand the relationship between the timing of initiation of nutritional support in children with severe traumatic brain injury and outcomes. Secondary analysis of a randomized, controlled trial of therapeutic hypothermia (Pediatric Traumatic Brain Injury Consortium: Hypothermia, also known as "the Cool Kids Trial" (NCT 00222742). Fifteen clinical sites in the United States, Australia, and New Zealand. Inclusion criteria included 1) age less than 18 years, 2) postresuscitation Glasgow Coma Scale less than or equal to 8, 3) Glasgow Coma Scale motor score less than 6, and 4) available to be randomized within 6 hours after injury. Exclusion criteria included normal head CT, Glasgow Coma Scale equals to 3, hypotension for greater than 10 minutes ( 30 min), pregnancy, penetrating injury, and unavailability of a parent or guardian to consent at centers without emergency waiver of consent. Therapeutic hypothermia (32-33°C for 48 hr) followed by slow rewarming for the primary study. For this analysis, the only intervention was the extraction of data regarding nutritional support from the existing database. Timing of initiation of nutritional support was determined and patients stratified into four groups (group 1-no nutritional support over first 7 d; group 2-nutritional support initiated group 3-nutritional support initiated 48 to group 4-nutritional support initiated 72-168 hr after injury). Outcomes were also stratified (mortality and Glasgow Outcomes Scale-Extended for Pediatrics; 1-4, 5-7, 8) at 6 and 12 months. Mixed-effects models were performed to define the relationship between nutrition and outcome. Children (n = 90, 77 randomized, 13 run-in) were enrolled (mean Glasgow Coma Scale = 5.8); the mortality rate was 13.3%. 57.8% of subjects received hypothermia Initiation of nutrition before 72 hours was associated with survival (p = 0.01), favorable 6 months Glasgow Outcomes Scale-Extended for Pediatrics (p = 0.03), and favorable 12 months Glasgow
The impact of an hematocrit of 20% during normothermic cardiopulmonary bypass for elective low risk coronary artery bypass graft surgery on oxygen delivery and clinical outcome – a randomized controlled study [ISRCTN35655335
von Heymann, Christian; Sander, Michael; Foer, Achim; Heinemann, Anja; Spiess, Bruce; Braun, Jan; Krämer, Michael; Grosse, Joachim; Dohmen, Pascal; Dushe, Simon; Halle, Jürgen; Konertz, Wolfgang F; Wernecke, Klaus-Dieter; Spies, Claudia
Introduction Cardiopulmonary bypass (CPB) induces hemodilutional anemia, which frequently requires the transfusion of blood products. The objective of this study was to evaluate oxygen delivery and consumption and clinical outcome in low risk patients who were allocated to an hematocrit (Hct) of 20% versus 25% during normothermic CPB for elective coronary artery bypass graft (CABG) surgery. Methods This study was a prospective, randomized and controlled trial. Patients were subjected to normothermic CPB (35 to 36°C) and were observed until discharge from the intensive care unit (ICU). Outcome measures were calculated whole body oxygen delivery, oxygen consumption and clinical outcome. A nonparametric multivariate analysis of variance for repeated measurements and small sample sizes was performed. Results In a total of 54 patients (25% Hct, n = 28; 20% Hct, n = 26), calculated oxygen delivery (p = 0.11), oxygen consumption (p = 0.06) and blood lactate (p = 0.60) were not significantly different between groups. Clinical outcomes were not different between groups. Conclusion These data indicate that an Hct of 20% during normothermic CPB maintained calculated whole body oxygen delivery above a critical level after elective CABG surgery in low risk patients. The question of whether a transfusion trigger in excess of 20% Hct during normothermic CPB is still supported requires a larger prospective and randomized trial. PMID:16606474
Gibbons, Robert D; Hur, Kwan; Brown, C Hendricks; Davis, John M; Mann, J John
Some meta-analyses suggest that efficacy of antidepressants for major depression is overstated and limited to severe depression. To determine the short-term efficacy of antidepressants for treating major depressive disorder in youth, adult, and geriatric populations. Reanalysis of all intent-to-treat person-level longitudinal data during the first 6 weeks of treatment of major depressive disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine hydrochloride. All sponsor-conducted randomized controlled trials of fluoxetine and venlafaxine. Children's Depression Rating Scale-Revised scores (youth population), Hamilton Depression Rating Scale scores (adult and geriatric populations), and estimated response and remission rates at 6 weeks were analyzed for 2635 adults, 960 geriatric patients, and 708 youths receiving fluoxetine and for 2421 adults receiving immediate-release venlafaxine and 2461 adults receiving extended-release venlafaxine. Patients in all age and drug groups had significantly greater improvement relative to control patients receiving placebo. The differential rate of improvement was largest for adults receiving fluoxetine (34.6% greater than those receiving placebo). Youths had the largest treated vs control difference in response rates (24.1%) and remission rates (30.1%), with adult differences generally in the 15.6% (remission) to 21.4% (response) range. Geriatric patients had the smallest drug-placebo differences, an 18.5% greater rate of improvement, 9.9% for response and 6.5% for remission. Immediate-release venlafaxine produced larger effects than extended-release venlafaxine. Baseline severity could not be shown to affect symptom reduction. To our knowledge, this is the first research synthesis in this area to use complete longitudinal person-level data from a large set of published and unpublished studies. The results do not support previous findings that
Baker, Graham; Gray, Stuart R; Wright, Annemarie; Fitzsimons, Claire; Nimmo, Myra; Lowry, Ruth; Mutrie, Nanette
Recent systematic reviews have suggested that pedometers may be effective motivational tools to promote walking. However, studies tend to be of a relatively short duration, with small clinical based samples. Further research is required to demonstrate their effectiveness in adequately powered, community based studies. Using a randomized controlled trial design, this study assessed the impact of a 12-week graduated pedometer-based walking intervention on daily step-counts, self-reported physical activity and health outcomes in a Scottish community sample not meeting current physical activity recommendations. Sixty-three women and 16 men (49.2 years +/- 8.8) were randomly assigned to either an intervention (physical activity consultation and 12-week pedometer-based walking program) or control (no action) group. Measures for step-counts, 7-day physical activity recall, affect, quality of life (n = 79), body mass, BMI, % body fat, waist and hip circumference (n = 76), systolic/diastolic blood pressure, total cholesterol and HDL cholesterol (n = 66) were taken at baseline and week 12. Analyses were performed on an intention to treat basis using 2-way mixed factorial analyses of variance for parametric data and Mann Whitney and Wilcoxon tests for non-parametric data. Significant increases were found in the intervention group for step-counts (p lack of significant changes in health outcomes. Continued follow-up of this study will examine adherence to the intervention and possible resulting effects on health outcomes.
The Effect of Stabilization Exercises on Objective Outcome Measures in Patients with Chronic Non-Specific Low Back Pain: A Systematic Review with Particular Emphasis On Randomized Controlled Clinical Trial
Full Text Available Objective: Low back pain (LBP is one of the most common and costly health problems. Changes in muscle activity and recruitment of lumbar deep muscles which are responsible for lumbar spine stability have been reported in patients with LBP. Different exercise programs are used in the treatment of such patients to improve spinal stability. The purpose of this study was to systematically review the effect of stabilization exercises on objective outcome measures in patients with non-specific chronic LBP in previous randomized controlled trials. Materials & Methods: A literature search for the period of 2000-2012 was performed, using MEDLINE, PubMed, Google scholar, Science Direct, OVID and CINAHL databases. Low back pain, stabilization exercise, motor control exercise, segmental stabilization, transverse abdominis muscle, multifidus muscle, electromyography, ultrasound, ultrasonography, and randomized controlled trial were used as keywords. Muscle recruitment, postural balance control, muscle endurance, muscle size and lumbar range of motion were studied as objective outcome measures. Results: In total, of 158 articles, 13 articles were selected according to the inclusion criteria of the study. There was a wide variation among studies in terms of methodology, main outcome measures, sample size, procedure, etc. The results demonstrated that stabilization exercise was more effective than other interventions on activity pattern of deep muscles, postural balance control, muscle endurance and range of motion, while it was not significantly different with other interventions on deep muscle size. Conclusion: It seems that stabilization exercise has considerable effect on activity pattern of deep muscles, postural control, muscle endurance and range of motion and can be considered as an effective intervention in the treatment of patients with non-specific chronic LBP
Hall, Franziska van
Introduction: Repetitive transcranial magnetic stimulation (rTMS) is a well-tolerated non-invasive method, which has also been proved to have mild antidepressant effects and is used as “add-on“-therapy in treating pharmaco-resistant major depression. Objective: The efficacy of an escitalopram plus rTMS-combination-treatment was evaluated and compared to escitalopram plus sham rTMS. Methods: We designed a four week-, randomized, rater-blinded, and controlled add-on study with two trea...
Durell, Todd M; Adler, Lenard A; Williams, Dave W; Deldar, Ahmed; McGough, James J; Glaser, Paul E; Rubin, Richard L; Pigott, Teresa A; Sarkis, Elias H; Fox, Bethany K
Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine. Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use. Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P < 0.001), Clinical Global Impression-ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P < 0.001), and CAARS Self-Report (atomoxetine [-11.9 ± 0.8] vs placebo [-7.8 ± 0.7], 95% confidence interval [-5.94 to -2.15], P < 0.001) but not on Patient Global Impression-Improvement. In addition, atomoxetine was superior to placebo on Adult ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo. Atomoxetine reduced
Full Text Available Introduction: While off pump coronary artery bypass surgery is practiced with an intention to reduce the morbidity associated with cardiopulmonary bypass, the resultant ′hypercoagulability′ needs to be addressed. Complications such as cavitary thrombus possibly due to the hyper coagulability after off pump coronary artery bypass surgery have been described. Many clinicians use higher doses of heparin - up to 5 mg/kg in order to thwart this fear. Overall, there appears to be no consensus on the dose of heparin in off pump coronary artery bypass surgeries. Aim of the Study: The aim of the study was understand the differences in outcome of such as transfusion requirement, myocardial ischemia, and morbidity when two different doses were used for systemic heparinization. Methods: Elective patients scheduled for off pump coronary artery bypass surgery were included. Ongoing anti platelet medication was not an exclusion criteria, however, anti platelet medications were ceased about a week prior to surgery when possible. Thoracic epidural anesthesia was administered as an adjunct in patients who qualified for it. By computer generated randomization chart, patients were chosen to receive either 2 or 3 mg/kg of intravenous unfractioned heparin to achieve systemic heparinization with activated clotting time targeted at >240 secs. Intraoperative blood loss, postoperative blood loss, myocardial ischemic episodes, requirement of intraaortic balloon counter pulsation and transfusion requirement were analyzed. Results: Sixty two patients participated in the study. There was one conversion to cardiopulmonary bypass. The groups had comparable ACT at baseline (138.8 vs. 146.64 seconds, P = 0.12; 3 mg/kg group had significantly higher values after heparin, as expected. But after reversal with protamine, ACT and need for additional protamine was similar among the groups. Intraoperative (685.56 ± 241.42 ml vs. 675.15 ± 251.86 ml, P = 0.82 and postoperative
Hahlweg, Kurt; Heinrichs, Nina; Kuschel, Annett; Bertram, Heike; Naumann, Sebastian
Approximately 20% of children experience internalizing or externalizing DSM-IV-TR disorders. This prevalence rate cannot be reduced through treatment only. Effective preventive interventions are therefore urgently needed. The aim of the current investigation is to evaluate the two-year efficacy of the group Triple P parenting program administered universally for the prevention of child behavior problems. Based on their respective preschool, N = 280 families were randomly assigned either to the parent training or to the control group. The efficacy was analyzed using multi-source assessments, including questionnaires by mother and father, behavioral observation of mother-child interaction, and teacher evaluations. At the 2-year follow-up, both parents in the Triple P intervention reported significant reductions in dysfunctional parenting behavior, and mothers also an increase in positive parenting behavior. In addition, mothers reported significant reductions in internalizing and externalizing child behavior. Single-parent mothers in the Triple P intervention did not report significant changes in parenting or child problem behavior which is primarily due to inexplicable high positive effects in single parent mothers of the control group. Neither mother-child interactions nor teacher ratings yielded significant results. The results support the long-term efficacy of the Triple P - group program as a universal prevention intervention for changing parenting behavior in two-parent households, but not necessarily in single-parent mothers.
Full Text Available Abstract Background Approximately 20% of children experience internalizing or externalizing DSM-IV-TR disorders. This prevalence rate cannot be reduced through treatment only. Effective preventive interventions are therefore urgently needed. The aim of the current investigation is to evaluate the two-year efficacy of the group Triple P parenting program administered universally for the prevention of child behavior problems. Methods Based on their respective preschool, N = 280 families were randomly assigned either to the parent training or to the control group. The efficacy was analyzed using multi-source assessments, including questionnaires by mother and father, behavioral observation of mother-child interaction, and teacher evaluations. Results At the 2-year follow-up, both parents in the Triple P intervention reported significant reductions in dysfunctional parenting behavior, and mothers also an increase in positive parenting behavior. In addition, mothers reported significant reductions in internalizing and externalizing child behavior. Single-parent mothers in the Triple P intervention did not report significant changes in parenting or child problem behavior which is primarily due to inexplicable high positive effects in single parent mothers of the control group. Neither mother-child interactions nor teacher ratings yielded significant results. Conclusions The results support the long-term efficacy of the Triple P - group program as a universal prevention intervention for changing parenting behavior in two-parent households, but not necessarily in single-parent mothers.
Di Pierro F
Full Text Available Francesco Di Pierro,1 Alberto Zanvit,2 Piero Nobili,2 Paolo Risso,3 Carlo Fornaini4 1Scientific Department, Velleja Research, 2Stomatology Institute, Milan, Italy; 3Department of Health Science, University of Genoa, Genoa, Italy; 4Teleo Laboratory, Faculty of Dentistry, University of Nice, Nice, France Abstract: Dental caries is the most common chronic disease of childhood. Cariogram is a well-recognized algorithm-based software program based on different caries-related risk factors and intended to aid clinicians in performing more objective and consistent dental caries risk assessments. This type of approach precedes the diagnosis of caries and allows the dentist to identify at-risk patients and then take appropriate preventive measures before caries develop further. One of the etiological factors favoring the development of dental caries is the mutans streptococci. These acidogenic dental plaque inhabitants can be effectively antagonized by the activity of bacteriocins released by the probiotic Streptococcus salivarius M18 (salivarius M18. Moreover, salivarius M18 after colonizing the human oral mucosa produces the enzymes dextranase and urease that are able to counteract plaque formation and saliva acidity, respectively. Seventy-six subjects at high risk of dental caries were randomized and then either treated or not treated for 90 days with an oral formulation containing the oral probiotic salivarius M18 (Carioblis®. The results indicate that the use of salivarius M18 increases the chances of avoiding new dental caries development in children, and its application could be proposed as a new tool in the dentist's armory to be adopted in subjects considered at high risk on the basis of their Cariogram outcome. Keywords: BLIS M18, caries prediction, dextranase, urease, Streptococcus mutans, Streptococcus sobrinus, plaque, salivary pH, bacteriocins
Iserbyt, Peter; Mols, Liesbet; Charlier, Nathalie; De Meester, Sophie
Basic Life Support (BLS) education in secondary schools and universities is often neglected or outsourced because teachers indicate not feeling competent to teach this content. Investigate reciprocal learning with task cards as instructional model for teaching BLS and the effect of instructor expertise in BLS on learning outcomes. There were 175 students (mean age = 18.9 years) randomized across a reciprocal/BLS instructor (RBI) group, a reciprocal/non-BLS instructor (RNI) group, and a traditional/BLS instructor group (TBI). In the RBI and RNI group, students were taught BLS through reciprocal learning with task cards. The instructor in the RBI group was certified in BLS by the European Resuscitation Council. In the TBI, students were taught BLS by a certified instructor according to the Belgian Red Cross instructional model. Student performance was assessed 1 day (intervention) and 3 weeks after intervention (retention). At retention, significantly higher BLS performances were found in the RBI group (M = 78%), p = 0.007, ES = 0.25, and the RNI group (M = 80%), p < 0.001, Effect Size (ES) = .36, compared to the TBI (M = 73%). Significantly more students remembered and performed all BLS skills in the experimental groups at intervention and retention. No differences in BLS performance were found between the reciprocal groups. Ventilation volumes and flow rates were significantly better in the TBI at intervention and retention. Reciprocal learning with task cards is a valuable model for teaching BLS when instructors are not experienced or skilled in BLS. Copyright © 2014 Elsevier Inc. All rights reserved.
Li, Zhanguo; An, Yuan; Su, Houheng; Li, Xiangpei; Xu, Jianhua; Zheng, Yi; Li, Guiye; Kwok, Kenneth; Wang, Lisy; Wu, Qizhe
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We assess the effect of tofacitinib + conventional synthetic disease-modifying anti rheumatic drugs (csDMARDs) on patient-reported outcomes in Chinese patients with RA and inadequate response to DMARDs. This analysis of data from the Phase 3 study ORAL Sync included Chinese patients randomized 4 : 4 : 1 : 1 to receive tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily, placebo→tofacitinib 5 mg twice daily, or placebo→tofacitinib 10 mg twice daily, with csDMARDs. Placebo non-responders switched to tofacitinib at 3 months; the remaining placebo patients switched at 6 months. Least squares mean changes from baseline were reported for Health Assessment Questionnaire-Disability Index (HAQ-DI), patient assessment of arthritis pain (Pain), patient global assessment of disease activity (PtGA), physician global assessment of disease activity (PGA), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores, Short Form 36 (SF-36), and Work Limitations Questionnaire (WLQ), using a mixed-effects model for repeated measures. Overall, 216 patients were included (tofacitinib 5 mg twice daily, n = 86; tofacitinib 10 mg twice daily, n = 86; placebo→tofacitinib 5 mg twice daily, n = 22; placebo→tofacitinib 10 mg twice daily, n = 22). At month 3, tofacitinib elicited significant improvements in HAQ-DI, Pain, PtGA, PGA and SF-36 Physical Component Summary scores. Improvements were generally maintained through 12 months. Tofacitinib 5 and 10 mg twice daily + csDMARDs resulted in improvements in health-related quality of life, physical function and Pain through 12 months in Chinese patients with RA. © 2018 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.
North, James M; Hong, Kyung-Soo Jason; Cho, Philip Young
Pain relief via spinal cord stimulation (SCS) has historically revolved around producing paresthesia to replace pain, with success measured by the extent of paresthesia-pain overlap. In a recent murine study, by Shechter et al., showed the superior efficacy of high frequency SCS (1 kHz and 10 kHz) at inhibiting the effects of mechanical hypersensitivity compared to sham or 50 Hz stimulation. In the same study, authors report there were no differences in efficacy between 1 kHz and 10 kHz delivered at subperception stimulation strength (80% of motor threshold). Therefore, we designed a randomized, 2 × 2 crossover study of low frequency supra-perception SCS vs. subperception SCS at 1 kHz frequency in order to test whether subperception stimulation at 1 kHz was sufficient to provide effective pain relief in human subjects. Twenty-two subjects with SCS, and inadequate pain relief based on numeric pain rating scale (NPRS) scores (>5) were enrolled, and observed for total of seven weeks (three weeks of treatment, one week wash off, and another three weeks of treatment). Subjects were asked to rate their pain on NPRS as a primary efficacy variable, and complete the Oswestry Disability Index (ODI) and Patient's Global Impression of Change (PGIC) as secondary outcome measures. Out of 22 subjects that completed the study, 21 subjects (95%) reported improvements in average, best, and worst pain NPRS scores. All NPRS scores were significantly lower with subperception stimulation compared to paresthesia-based stimulation (p paresthesia based stimulation on ODI scores (p = 3.9737 × 10 -5 ) and PGIC scores (p = 3.0396 × 10 -5 ). © 2016 International Neuromodulation Society.
Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...
Angela M. Devlin
Full Text Available Little is known about arachidonic acid (ARA and docosahexaenoic acid (DHA requirements in toddlers. A longitudinal, double blind, controlled trial in toddlers (n = 133 age 13.4 ± 0.9 months (mean ± standard deviation, randomized to receive a DHA (200 mg/day and ARA (200 mg/day supplement (supplement or a corn oil supplement (control until age 24 months determined effects on neurodevelopment. We found no effect of the supplement on the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III cognitive and language composites and Beery–Buktenica Developmental Test of Visual–Motor Integration (Beery VMI at age 24 months. Supplemented toddlers had higher RBC phosphatidylcholine (PC, phosphatidylethanolamine (PE, and plasma DHA and ARA compared to placebo toddlers at age 24 months. A positive relationship between RBC PE ARA and Bayley III Cognitive composite (4.55 (0.21–9.00, B (95% CI, p = 0.045 in supplemented boys, but not in control boys, was observed in models adjusted for baseline fatty acid, maternal non-verbal intelligence, and BMI z-score at age 24 months. A similar positive relationship between RBC PE ARA and Bayley III Language composite was observed for supplemented boys (11.52 (5.10–17.94, p < 0.001 and girls (11.19 (4.69–17.68, p = 0.001. These findings suggest that increasing the ARA status in toddlers is associated with better neurodevelopment at age 24 months.
Devlin, Angela M.; Chau, Cecil M. Y.; Matheson, Julie; McCarthy, Deanna; Yurko-Mauro, Karin; Innis, Sheila M.; Grunau, Ruth E.
Little is known about arachidonic acid (ARA) and docosahexaenoic acid (DHA) requirements in toddlers. A longitudinal, double blind, controlled trial in toddlers (n = 133) age 13.4 ± 0.9 months (mean ± standard deviation), randomized to receive a DHA (200 mg/day) and ARA (200 mg/day) supplement (supplement) or a corn oil supplement (control) until age 24 months determined effects on neurodevelopment. We found no effect of the supplement on the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III) cognitive and language composites and Beery–Buktenica Developmental Test of Visual–Motor Integration (Beery VMI) at age 24 months. Supplemented toddlers had higher RBC phosphatidylcholine (PC), phosphatidylethanolamine (PE), and plasma DHA and ARA compared to placebo toddlers at age 24 months. A positive relationship between RBC PE ARA and Bayley III Cognitive composite (4.55 (0.21–9.00), B (95% CI), p = 0.045) in supplemented boys, but not in control boys, was observed in models adjusted for baseline fatty acid, maternal non-verbal intelligence, and BMI z-score at age 24 months. A similar positive relationship between RBC PE ARA and Bayley III Language composite was observed for supplemented boys (11.52 (5.10–17.94), p < 0.001) and girls (11.19 (4.69–17.68), p = 0.001). These findings suggest that increasing the ARA status in toddlers is associated with better neurodevelopment at age 24 months. PMID:28878181
Full Text Available In recent years, several studies with large sample sizes and recent follow-up data have been published comparing outcomes between laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication. It is now timely to be re-evaluated and synthesized long-term efficacy and adverse events of both total and partial posterior fundoplication.Electronic searches for RCTs comparing the outcome after laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication were performed in the databases of MEDLINE, EMBASE, and the Cochrane Center Register of Controlled Trials. The data of evaluation in positive and adverse results of laparoscopic Nissen fundoplication and laparoscopic Nissen fundoplication were extracted and compared using meta-analysis.13 RCTs were ultimately identified involving 814 (52.05% and 750 (47.95% patients who underwent laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication, respectively. The operative time, perioperative complications, postoperative satisfaction, recurrence, and the rates of medication adoption or re-operation due to recurrence were not significantly different between two groups. The two types of fundoplication both reinforced the anti-reflux barrier and elevated the lower esophageal sphincter pressure. However, rates of adverse results involving dysphasia, gas-bloat syndrome, inability to belch and re-operation due to severe dysphasia were significantly higher after LNF. In the subgroup analysis of wrap length≤2 cm, laparoscopic Nissen fundoplication was associated with a significantly higher incidence of postoperative dysphagia. However, in the subgroup wrap length>2 cm, the difference was not statistically significant.Laparoscopic Toupet fundoplication might be the better surgery approach for gastroesophageal reflux disease with a lower rate of postoperative adverse results and equal effectiveness as Laparoscopic Nissen fundoplication.
Sammour, Tarik; Hill, Andrew G
Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA.
Sammour, Tarik; Hill, Andrew G.
Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA. PMID:25875541
Porter, Susann; Bejerholm, Ulrika
To evaluate the effect of Individual Enabling and Support (IES) on empowerment and depression severity as compared to Traditional Vocational Rehabilitation (TVR) in people with affective disorders at 12 months follow-up. Additionally, longitudinal changes within the intervention groups and the correlation over time between empowerment and depression severity were evaluated. A single-blind randomized controlled trial of two intervention groups, IES (n = 33) and TVR (n = 28), was performed with measurement points at baseline, 6, and 12 months. Individuals with affective disorders, including depression and bipolar disorder diagnoses were included. The Empowerment Scale and Montgomery-Åsberg Depression Self-Rating Scale were administered, and Intention-To-Treat analysis was applied. The study was registered with the trial number ISRCTN93470551. There was a statistically significant difference between the intervention groups on empowerment and depression severity at 12 months. Within-group analysis showed that IES-participants increased their perceived empowerment and decreased their depression severity between measurement points, this was not seen among TVR-participants. A moderate, inverse relationship was detected between empowerment and depression. IES is more effective in increasing empowerment and decreasing depression severity after a 12-month intervention than is TVR. This study was limited by a small sample size and larger trials in different contexts are needed.
Chan, Angelique; Matchar, David B; Tsao, Mary Ann; Harding, Susana; Chiu, Chi-Tsun; Tay, Bryan; Raman, Prassanna; Pietryla, Zachary; Klein, Mara K; Haldane, Victoria Elizabeth
Population aging is associated with a higher prevalence of chronic health conditions. Previous studies have shown that older persons, specifically those with chronic conditions, often lack sufficient knowledge about their condition and thus frequently have poor self-care skills. Efforts to increase general health screenings and improve access to chronic condition management resources are hampered by a lack of disease and health awareness. Self-Care for Older People (SCOPE) study, a cluster randomized controlled trial in Singapore, was designed to evaluate the impact of a self-care program for chronic disease awareness and management of specific health measures and quality of life of older people over eighteen months. SCOPE provided self-care education targeted at older people with low income and low education in order to improve health-related knowledge. A total of 378 low-income older people with no or minimal disability, defined as having difficulty in one or more activities of daily living (ADL), were recruited from senior activity centers. The measurements taken included self-reported health conditions, health and disease knowledge questions, and biomarkers (HbA1c, blood pressure, peak expiratory flow, lipid panel, albumin, and creatinine). SCOPE was also designed to provide information for policy makers on chronic disease burden and healthcare facility utilization among community-dwelling older adults. NCT01672177. Copyright © 2015 Elsevier Inc. All rights reserved.
Kumar B. Rajan
Full Text Available Purpose: This study examined secondary benefits of an individualized physical activity intervention on improving dementia family caregivers’ subjective burden, depressive symptoms and positive affect. Design and Methods: A community-based randomized controlled trial (RCT was implemented with family caregivers of persons with dementia (N = 211 who received the Enhanced Physical Activity Intervention (EPAI: treatment intervention, n = 106 or the Caregiver Skill Building Intervention (CSBI: control intervention, n = 105. Interventions were delivered over 12 months, including a baseline home visit and regularly spaced telephone calls. Data were collected in person at baseline, 6 and 12-months; and telephonically at 3 and 9-months. The EPAI integrated physical activity and caregiving content while the CSBI focused only on caregiving content. Descriptive, bivariate and intention-to-treat analyses using generalized estimating equations (GEE were performed to examine secondary benefits of the EPAI on family caregiver burden, depressive symptoms and positive affect. Results: Compared to caregivers in the CSBI group, caregivers in the EPAI significantly increased their overall and total moderate physical activity and showed a positive interaction between the intervention and time for positive affect at both six (p = 0.01 and 12-months (p = 0.03. The EPAI was significantly associated with improving burden at 3 months (p = 0.03 but had no significant effect on depressive symptoms. Implications: Caregiver involvement in an individualized physical activity intervention was associated with increased overall and total moderate physical activity and improved positive affect from baseline to 12 months. Improved positive affect may help caregivers to feel better about themselves and their situation, and better enable them to continue providing care for their family member for a longer time at lower risk to their own mental health.
Family Home Food Environment and Nutrition-Related Parent and Child Personal and Behavioral Outcomes of the Healthy Home Offerings via the Mealtime Environment (HOME) Plus Program: A Randomized Controlled Trial.
Fulkerson, Jayne A; Friend, Sarah; Horning, Melissa; Flattum, Colleen; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Garwick, Ann; Story, Mary; Kubik, Martha Y
Research has demonstrated a significant positive association between frequent family meals and children's dietary intake; however, the promotion of healthful family meals has not been rigorously tested for key food environment and nutrition-related behavioral outcomes in a randomized trial. To describe family home food environment and nutrition-related parent and child personal and behavioral outcomes of the Healthy Home Offerings via the Mealtime Environment Plus program, the first rigorously tested family meals intervention targeting childhood obesity prevention. Randomized controlled trial. Baseline, postintervention (12 months, 93% retention), and follow-up (21 months, 89% retention) data (surveys and dietary recalls) were collected. Children aged 8 to 12 years (N=160) and their parents were randomized to intervention (n=81) or control (n=79) groups. The intervention included five parent goal-setting calls and 10 monthly sessions delivered to families in community settings that focused on experiential nutrition activities and education, meal planning, cooking skill development, and reducing screen time. Family home food environment outcomes and nutrition-related child and parent personal and behavioral outcomes. Analyses used generalized linear mixed models. Primary comparisons were contrasts between intervention and control groups at postintervention and follow-up, with adjustments for child age and parent education. Compared with control parents, intervention parents showed greater improvement over time in scores of self-efficacy for identifying appropriate portion sizes, with significant differences in adjusted means at both post-intervention (P=0.002) and follow-up (P=0.01). Intervention children were less likely to consume at least one sugar-sweetened beverage daily at post-intervention than control children (P=0.04). The Healthy Home Offerings via the Mealtime Environment Plus program involved the entire family and targeted personal, behavioral, and
Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial.
Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit
This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from baseline (2002) to one-year post trial (2007) revealed that intervention schools scored 9.8% better on the TerraNova (2 nd ed.) test for reading and 8.8% on math; 20.7% better in Hawai'i Content and Performance Standards scores for reading and 51.4% better in math; and that intervention schools reported 15.2% lower absenteeism and fewer suspensions (72.6%) and retentions (72.7%). Overall, effect sizes were moderate to large (range 0.5-1.1) for all of the examined outcomes. Sensitivity analyses using permutation models and random-intercept growth curve models substantiated results. The results provide evidence that a comprehensive school-based program, specifically developed to target student behavior and character, can positively influence school-level achievement, attendance, and disciplinary outcomes concurrently.
Altomare, D F; Pecorella, G; Tegon, G; Aquilino, F; Pennisi, D; De Fazio, M
The study aimed in a multicentric randomized controlled trial to define the role of a more extensive mucosal resection on recurrence of mucosal prolapse in patients with Stage III haemorrhoids undergoing stapled haemorrhoidopexy. In all, 135 patients were randomized to treatment with a PPH-01/03 (Ethicon EndoSurgery) or an EEA (Covidien) stapler. They were reviewed after a minimum follow-up of 4 years to determine the rate of recurrent mucosal prolapse and general condition (wellness evaluation score). Postoperative bowel dysfunction was assessed using the Rome III criteria. Eighty-seven (65%) of the 135 patients (48 in the EEA stapler group and 37 in the PPH group) were available for long-term follow-up. The two groups were comparable for age, gender and duration of follow-up (mean 49.3 ± 5.4 months and 49.0 ± 5.3 months respectively). In the EEA group, 11 (23%) patients had some degree of recurrent prolapse compared with 12 (32%) in the PPH group (P = 0.409). Persistence of anal bleeding was significantly higher in the PPH group (P = 0.04) while the postoperative Haemorrhoid Symptom Score was significantly better in the EEA group (1.73 ± 1.65 vs 3.17 ± 1.94, P < 0.001). The wellness evaluation score was significantly better in the EEA group (1.2 ± 1.27 vs 0.6 ± 1.0, P = 0.028). Furthermore, 7 (15%) of the patients in the EEA group complained of some evacuation disturbance compared with 13 (36%) in the PPH group (P = 0.021). The study failed to demonstrate any significant difference in the long-term recurrence rate of Stage III haemorrhoids using EEA or PPH. Nevertheless, use of the larger volume EEA provides better symptom resolution compared with PPH. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.
Mijwel, Sara; Backman, Malin; Bolam, Kate A; Jervaeus, Anna; Sundberg, Carl Johan; Margolin, Sara; Browall, Maria; Rundqvist, Helene; Wengström, Yvonne
Exercise training is an effective and safe way to counteract cancer-related fatigue (CRF) and to improve health-related quality of life (HRQoL). High-intensity interval training has proven beneficial for the health of clinical populations. The aim of this randomized controlled trial was to compare the effects of resistance and high-intensity interval training (RT-HIIT), and moderate-intensity aerobic and high-intensity interval training (AT-HIIT) to usual care (UC) in women with breast cancer undergoing chemotherapy. The primary endpoint was CRF and the secondary endpoints were HRQoL and cancer treatment-related symptoms. Two hundred and forty women planned to undergo chemotherapy were randomized to supervised RT-HIIT, AT-HIIT, or UC. Measurements were performed at baseline and at 16 weeks. Questionnaires included Piper Fatigue Scale, EORTC-QLQ-C30, and Memorial Symptom Assessment Scale. The RT-HIIT group was superior to UC for CRF: total CRF (p = 0.02), behavior/daily life (p = 0.01), and sensory/physical (p = 0.03) CRF. Role functioning significantly improved while cognitive functioning was unchanged for RT-HIIT compared to declines shown in the UC group (p = 0.04). AT-HIIT significantly improved emotional functioning versus UC (p = 0.01) and was superior to UC for pain symptoms (p = 0.03). RT-HIIT reported a reduced symptom burden, while AT-HIIT remained stable compared to deteriorations shown by UC (p HIIT was superior to UC for total symptoms (p HIIT was effective in preventing increases in CRF and in reducing symptom burden for patients during chemotherapy for breast cancer. These findings add to a growing body of evidence supporting the inclusion of structured exercise prescriptions, including HIIT, as a vital component of cancer rehabilitation. Clinicaltrials.gov Registration Number: NCT02522260.
Naclerio, Fernando; Seijo-Bujia, Marco; Larumbe-Zabala, Eneko; Earnest, Conrad P
Beef powder is a new high-quality protein source scarcely researched relative to exercise performance. The present study examined the impact of ingesting hydrolyzed beef protein, whey protein, and carbohydrate on strength performance (1RM), body composition (via plethysmography), limb circumferences and muscular thickness (via ultrasonography), following an 8-week resistance-training program. After being randomly assigned to one of the following groups: Beef, Whey, or Carbohydrate, twenty four recreationally physically active males (n = 8 per treatment) ingested 20 g of supplement, mixed with orange juice, once a day (immediately after workout or before breakfast). Post intervention changes were examined as percent change and 95% CIs. Beef (2.0%, CI, 0.2-2.38%) and Whey (1.4%, CI, 0.2-2.6%) but not Carbohydrate (0.0%, CI, -1.2-1.2%) increased fat-free mass. All groups increased vastus medialis thickness: Beef (11.1%, CI, 6.3-15.9%), Whey (12.1%, CI, 4.0, -20.2%), Carbohydrate (6.3%, CI, 1.9-10.6%). Beef (11.2%, CI, 5.9-16.5%) and Carbohydrate (4.5%, CI, 1.6-7.4%), but not Whey (1.1%, CI, -1.7-4.0%), increased biceps brachialis thickness, while only Beef increased arm (4.8%, CI, 2.3-7.3%) and thigh (11.2%, 95%CI 0.4-5.9%) circumferences. Although the three groups significantly improved 1RM Squat (Beef 21.6%, CI 5.5-37.7%; Whey 14.6%, CI, 5.9-23.3%; Carbohydrate 19.6%, CI, 2.2-37.1%), for the 1RM bench press the improvements were significant for Beef (15.8% CI 7.0-24.7%) and Whey (5.8%, CI, 1.7-9.8%) but not for carbohydrate (11.4%, CI, -0.9-23.6%). Protein-carbohydrate supplementation supports fat-free mass accretion and lower body hypertrophy. Hydrolyzed beef promotes upper body hypertrophy along with similar performance outcomes as observed when supplementing with whey isolate or maltodextrin.
Oliveira, Julicristie M; Rondó, Patrícia H C; Yudkin, John S; Souza, José M P; Pereira, Tatiane N; Catalani, Andrea W; Picone, Camila M; Segurado, Aluisio A C
Although antiretroviral therapy has revolutionized the care of HIV-infected patients, it has been associated with metabolic abnormalities. Hence, this study was planned to investigate the effects of fish oil on lipid profile, insulin resistance, and body fat distribution in HIV-infected Brazilian patients on antiretroviral therapy, considering that marine omega-3 fatty acids seem to improve features of the metabolic syndrome. We conducted a randomized, parallel, placebo-controlled trial that assessed the effects of 3 g fish oil/day (540 mg of eicosapentaenoic acid plus 360 mg of docosahexaenoic acid) or 3 g soy oil/day (placebo) on 83 HIV-infected Brazilian men and non-pregnant women on antiretroviral therapy. No statistically significant relationships between fish oil supplementation and longitudinal changes in triglyceride (p = 0.335), low-density lipoprotein cholesterol (p = 0.078), high-density lipoprotein cholesterol (p = 0.383), total cholesterol (p = 0.072), apolipoprotein B (p = 0.522), apolipoprotein A1 (p = 0.420), low-density lipoprotein cholesterol/apolipoprotein B ratio (p = 0.107), homeostasis model assessment for insulin resistance index (p = 0.387), body mass index (p = 0.068), waist circumference (p = 0.128), and waist/hip ratio (p = 0.359) were observed. A low dose of fish oil did not alter lipid profile, insulin resistance, and body fat distribution in HIV-infected patients on antiretroviral therapy.
Lau, M; Kristensen, Ellids
Research suggests that group psychotherapy for adults with a history of child sexual abuse (CSA) is generally beneficial. Only few studies have included random assignment. This study compared the effects of analytic (A) and systemic group psychotherapy (S) on CSA.......Research suggests that group psychotherapy for adults with a history of child sexual abuse (CSA) is generally beneficial. Only few studies have included random assignment. This study compared the effects of analytic (A) and systemic group psychotherapy (S) on CSA....
Full Text Available Mutahir Tunio,1 Mushabbab Al Asiri,1 Abdulrehman Al Hadab,1 Yasser Bayoumi2 1Radiation Oncology, Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia; 2Radiation Oncology, National Cancer Institute, Cairo University, Cairo, Egypt Background: A meta-analysis was conducted to assess the impact of radiopharmaceuticals (RPs in castration-resistant prostate cancer (CRPC on pain control, symptomatic skeletal events (SSEs, toxicity profile, quality of life (QoL, and overall survival (OS.Materials and methods: The PubMed/MEDLINE, CANCERLIT, EMBASE, Cochrane Library database, and other search engines were searched to identify randomized controlled trials (RCTs comparing RPs with control (placebo or radiation therapy in metastatic CRPC. Data were extracted and assessed for the risk of bias (Cochrane’s risk of bias tool. Pooled data were expressed as odds ratio (OR, with 95% confidence intervals (CIs; Mantel–Haenszel fixed-effects model.Results: Eight RCTs with a total patient population of 1,877 patients were identified. The use of RP was associated with significant reduction in pain intensity and SSE (OR: 0.63, 95% CI: 0.51–0.78, I2=27%, P<0.0001, improved QoL (OR: 0.71, 95% CI: 0.55–0.91, I2=65%, three trials, 1,178 patients, P=0.006, and a minimal improved OS (OR: 0.84, 95% CI: 0.64–1.04, I2=47%, seven trials, 1,845 patients, P=0.11. A subgroup analysis suggested an improved OS with radium-223 (OR: 0.68, 95% CI: 0.51–0.90, one trial, 921 patients and strontium-89 (OR: 0.21, 95% CI: 0.05–0.91, one trial, 49 patients. Strontium-89 (five trials was associated with increased rates of grade 3 and 4 thrombocytopenia (OR: 4.26, 95% CI: 2.22–8.18, P=0.01, leucopenia (OR: 7.98, 95% CI: 1.82–34.95, P=0.02, pain flare (OR: 6.82, 95% CI: 3.42–13.55, P=0.04, and emesis (OR: 3.61, 95% CI: 1.76–7.40, P=0.02.Conclusion: The use of RPs was associated with significant reduction in SSEs and improved QoL, while the radium-223
Mohr, J.P.; Overbey, J.R.; Kummer, R. von; Stefani, M.A.; Libman, R.; Stapf, C.; Parides, M.K.; Pile-Spellman, J.; Moquete, E.; Moy, C.S.; Vicaut, E.; Moskowitz, A.J.; Harkness, K.; Cordonnier, C.; Biondi, A.; Houdart, E.; Berkefeld, J.; Klijn, C.J.M.; Barreau, X.; Kim, H.; Hartmann, A.
OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults >/=18
Mohr, J P; Overbey, Jessica R; von Kummer, Ruediger; Stefani, Marco A; Libman, Richard; Stapf, Christian; Parides, Michael K; Pile-Spellman, John; Moquete, Ellen; Moy, Claudia S; Vicaut, Eric; Moskowitz, Alan J; Harkness, Kirsty; Cordonnier, Charlotte; Biondi, Alessandra; Houdart, Emmanuel; Berkefeld, Joachim; Klijn, Karin J M; Barreau, Xavier; Kim, Helen; Hartmann, Andreas; van Dijk, J. Marc C.; Luijckx, Gert Jan
OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18
Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).
Kamal, Ayeesha Kamran; Khoja, Adeel; Usmani, Bushra; Muqeet, Abdul; Zaidi, Fabiha; Ahmed, Masood; Shakeel, Saadia; Soomro, Nabila; Gowani, Ambreen; Asad, Nargis; Ahmed, Asma; Sayani, Saleem; Azam, Iqbal; Saleem, Sarah
Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention
A randomized controlled trial on the long-term effects of proprioceptive neuromuscular facilitation training, on pain-related outcomes and back muscle activity, in patients with chronic low back pain.
Areeudomwong, Pattanasin; Wongrat, Witchayut; Neammesri, Nertnapa; Thongsakul, Thanaporn
The role of exercise therapy in improving pain-related clinical outcomes and trunk muscle activity in patients with chronic low back pain (CLBP) has been widely reported. There is little information on the effect of proprioceptive neuromuscular facilitation (PNF) training in patients with CLBP. The purpose of the present study was therefore to investigate the persistence of the effects of PNF training on pain intensity, functional disability, patient satisfaction, health-related quality of life (HRQOL) and lower back muscle activity in patients with CLBP. Forty-two participants with CLBP were randomly assigned either to 4-week PNF training or to a control group receiving a Low back pain educational booklet. Pain-related outcomes, including pain intensity, functional disability, patient satisfaction, HRQOL and lumbar erector spinae (LES) muscle activity, were measured before and after the intervention, and at a follow-up session 12 weeks after the last intervention session. Compared with the control group, after undergoing a 4-week PNF training intervention, participants showed a significant reduction in pain intensity and functional disability, and improved patient satisfaction and HRQOL (p pain-related outcomes, and increases lower back muscle activity in patients with CLBP. Copyright © 2016 John Wiley & Sons, Ltd.
Moustgaard, Helene; Bello, Segun; Miller, Franklin G
explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......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...
Whang, Peter; Cher, Daniel; Polly, David; Frank, Clay; Lockstadt, Harry; Glaser, John; Limoni, Robert; Sembrano, Jonathan
Sacroiliac (SI) joint pain is a prevalent, underdiagnosed cause of lower back pain. SI joint fusion can relieve pain and improve quality of life in patients who have failed nonoperative care. To date, no study has concurrently compared surgical and non-surgical treatments for chronic SI joint dysfunction. We conducted a prospective randomized controlled trial of 148 subjects with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions who were assigned to either minimally invasive SI joint fusion with triangular titanium implants (N=102) or non-surgical management (NSM, n=46). SI joint pain scores, Oswestry Disability Index (ODI), Short-Form 36 (SF-36) and EuroQol-5D (EQ-5D) were collected at baseline and at 1, 3 and 6 months after treatment commencement. Six-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in SI joint pain in the absence of severe device-related or neurologic SI joint-related adverse events or surgical revision, were compared using Bayesian methods. Subjects (mean age 51, 70% women) were highly debilitated at baseline (mean SI joint VAS pain score 82, mean ODI score 62). Six-month follow-up was obtained in 97.3%. By 6 months, success rates were 81.4% in the surgical group vs. 23.9% in the NSM group (difference of 56.6%, 95% posterior credible interval 41.4-70.0%, posterior probability of superiority >0.999). Clinically important (≥15 point) ODI improvement at 6 months occurred in 75% of surgery subjects vs. 27.3% of NSM subjects. At six months, quality of life improved more in the surgery group and satisfaction rates were high. The mean number of adverse events in the first six months was slightly higher in the surgical group compared to the non-surgical group (1.3 vs. 1.0 events per subject, p=0.1857). Six-month follow-up from this level 1 study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than non-surgical management
Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial
Rejeski W Jack
Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155
Rahouma, Mohamed; Kamel, Mohamed; Jodeh, Diana; Kelley, Thomas; Ohmes, Lucas B; de Biasi, Andreas R; Abouarab, Ahmed A; Benedetto, Umberto; Guy, T Sloane; Lau, Christopher; Lee, Paul C; Girardi, Leonard N; Gaudino, Mario
The effect of high transfusion ratios of fresh frozen plasma (FFP): packed red blood cell (RBC) on mortality is still controversial. Observational evidence contradicts a recent randomized controlled trial regarding mortality benefit. This is an updated meta-analysis, including a non-trauma cohort. Patients were grouped into high vs. low based on FFP:RBC ratio. Primary outcomes were 24-h and 30-day/in-hospital mortality. Secondary outcomes were acute respiratory distress syndrome and acute lung injury rates. Random model and leave-one-out-analyses were used. In 36 studies, lower ratio showed poorer 24-h and 30-day survival (p ratio was associated with worse 24-h and 30-day mortality (P ratio of 1:1.5 provided the largest 24-h and 30-day survival benefit (p ratio was not associated with ARDS or ALI. High FFP:RBC ratio confers survival benefits in trauma and non-trauma settings, with the highest survival benefit at 1:1.5. Copyright © 2017 Elsevier Inc. All rights reserved.
Sudfeld, Christopher R; Manji, Karim P; Duggan, Christopher P; Aboud, Said; Muhihi, Alfa; Sando, David M; Al-Beity, Fadhlun M Alwy; Wang, Molin; Fawzi, Wafaie W
Vitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D 3 supplementation may improve the health of HIV-infected pregnant women and their children. The Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D 3 (cholecalciferol) supplementation conducted among 2300 HIV-infected pregnant women receiving triple-drug ART under Option B+ in Dar es Salaam, Tanzania. HIV-infected pregnant women of 12-27 weeks gestation are randomized to either: 1) 3000 IU vitamin D 3 taken daily from randomization in pregnancy until trial discharge at 12 months postpartum; or 2) a matching placebo regimen. Maternal participants are followed-up at monthly clinic visits during pregnancy, at delivery, and then with their children at monthly postpartum clinic visits. The primary efficacy outcomes of the trial are: 1) maternal HIV disease progression or death; 2) risk of small-for-gestational age (SGA) births; and 3) risk of infant stunting at 1 year of age. The primary safety outcome of the trial is incident maternal hypercalcemia. Secondary outcomes include a range of clinical and biological maternal and child health outcomes. The ToV5 will provide causal evidence on the effect of vitamin D 3 supplementation on HIV progression and death, SGA births, and infant stunting at 1 year of age. The results of the trial are likely generalizable to HIV-infected pregnant women and their children in similar resource-limited settings utilizing the Option B+ approach. ClinicalTrials.gov identifier: NCT02305927
Full Text Available Abstract Background Recent systematic reviews have suggested that pedometers may be effective motivational tools to promote walking. However, studies tend to be of a relatively short duration, with small clinical based samples. Further research is required to demonstrate their effectiveness in adequately powered, community based studies. Objective Using a randomized controlled trial design, this study assessed the impact of a 12-week graduated pedometer-based walking intervention on daily step-counts, self-reported physical activity and health outcomes in a Scottish community sample not meeting current physical activity recommendations. Method Sixty-three women and 16 men (49.2 years ± 8.8 were randomly assigned to either an intervention (physical activity consultation and 12-week pedometer-based walking program or control (no action group. Measures for step-counts, 7-day physical activity recall, affect, quality of life (n = 79, body mass, BMI, % body fat, waist and hip circumference (n = 76, systolic/diastolic blood pressure, total cholesterol and HDL cholesterol (n = 66 were taken at baseline and week 12. Analyses were performed on an intention to treat basis using 2-way mixed factorial analyses of variance for parametric data and Mann Whitney and Wilcoxon tests for non-parametric data. Results Significant increases were found in the intervention group for step-counts (p p = .02 and positive affect (p = .027. Significant decreases were found in this group for time spent in weekday (p = .003, weekend (p = .001 and total sitting (p = .001 with no corresponding changes in the control group. No significant changes in any other health outcomes were found in either group. In comparison with the control group at week 12, the intervention group reported a significantly greater number of minutes spent in leisure time (p = .008, occupational (p = .045 and total walking (p = .03, and significantly fewer minutes in time spent in weekend (p = .003 and
Ursoniu, Sorin; Mikhailidis, Dimitri P.; Serban, Maria-Corina; Penson, Peter; Toth, Peter P.; Ridker, Paul M.; Ray, Kausik K.; Kees Hovingh, G.; Kastelein, John J.; Hernandez, Adrian V.; Manson, JoAnn E.; Rysz, Jacek; Banach, Maciej
Smoking is an important risk factor for cardiovascular disease (CVD) morbidity and mortality. The impact of statin therapy on CVD risk by smoking status has not been fully investigated. Therefore we assessed the impact of statin therapy on CVD outcomes by smoking status through a systematic review
Harrison, Sayward E.; Li, Xiaoming; Zhang, JiaJia; Zhao, Junfeng; Zhao, Guoxiang
Children of parents with human immunodeficiency virus (HIV) are at-risk for a variety of negative outcomes, including poor educational achievement. The multi-level, resilience-based "ChildCARE" intervention has been found to yield short-term improvement in a number of school-related variables for children affected by parental HIV.…
Epoetin alfa improves anemia and anemia-related, patient-reported outcomes in patients with breast cancer receiving myelotoxic chemotherapy: Results of a european, multicenter, randomized, controlled trial
P. Pronzato (Paolo); E. Cortesi (Enrico); C.C.D. van der Rijt (Carin); A. Bols (Alain); J.A. Moreno-Nogueira (José); C.F. de Oliveira; P. Barrett-Lee (Peter); P.J. Ostler (Peter); R. Rosso (Ricardo)
textabstractPurpose. To evaluate the effects of epoetin alfa on patient- reported outcomes (PROs) in patients with breast cancer receiving myelotoxic chemotherapy. Materials and Methods. Women with hemoglobin concentrations ≤12.0 g/dl and an Eastern Cooperative Oncology Group performance status
Aaronson, Justine A.; Hofman, Winni F.; van Bennekom, Coen A. M.; van Bezeij, Tijs; van den Aardweg, Joost G.; Groet, Erny; Kylstra, Wytske A.; Schmand, Ben
Obstructive sleep apnea (OSA) in stroke patients is associated with worse functional and cognitive status during inpatient rehabilitation. We hypothesized that a four-week period of continuous positive airway pressure (CPAP) treatment would improve cognitive and functional outcomes. We performed a
Serpa Neto, Ary; Filho, Roberto Rabello; Cherpanath, Thomas; Determann, Rogier; Dongelmans, Dave A.; Paulus, Frederique; Tuinman, Pieter Roel; Pelosi, Paolo; de Abreu, Marcelo Gama; Schultz, Marcus J.
The aim of this investigation was to compare ventilation at different levels of positive end-expiratory pressure (PEEP) with regard to clinical important outcomes of intensive care unit (ICU) patients without acute respiratory distress syndrome (ARDS) at onset of ventilation. Meta-analysis of
van der Werf, Anne; Blauwhoff-Buskermolen, Susanne; Langius, Jacqueline A. E.; Berkhof, Johannes; Verheul, Henk M. W.; de van der Schueren, Marian A. E.
A low muscle mass is prevalent in patients with metastatic colorectal cancer (mCRC) and has been associated with poor treatment outcome. Chemotherapeutic treatment has an additional unfavorable effect on muscle mass. Sufficient protein intake and physical activity are known to induce muscle protein
Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.
Saber-Tehrani, Ali Shabahang; Springer, Sandra A; Qiu, Jingjun; Herme, Maua; Wickersham, Jeffrey; Altice, Frederick L
HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners. Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VLHIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences. Copyright © 2011 Elsevier Inc. All rights reserved.
Full Text Available Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education.To investigate women's acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India.Secondary outcome of a randomised, controlled, non-inferiority trial.Outpatient primary health care clinics in rural and urban Rajasthan, India.Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85 mg/l and were below 18 years.Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1 in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol, using opaque sealed envelopes. Blinding during outcome assessment was not possible.Women's acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups.731 women were randomized to the clinic follow-up group (n = 353 or home-assessment group (n = 378. 623 (85% women were successfully followed up, of those 597 (96% were satisfied and 592 (95% found the abortion better or as expected, with no difference between study groups. The majority, 355 (57% women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%, in the home-assessment group preferred
Anna eChapman; Anna eChapman; Shuo eLiu; Stephanie eMerkouris; Stephanie eMerkouris; Joanne C Enticott; Joanne C Enticott; Hui eYang; Colette Joy Browning; Colette Joy Browning; Shane Andrew Thomas
IntroductionChina has the largest number of type 2 diabetes mellitus (T2DM) cases globally and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM related outcomes; howev...
Deady, Mark; Mills, Katherine L; Teesson, Maree; Kay-Lambkin, Frances
Background Depression and problematic alcohol use represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this is associated with increased harm and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective; however, there remains a significant gap between those in need of treatment and those receiving it. The increased availability of eHealth programs presents a unique opportunity to treat th...
Effects of web-based stress and depression literacy intervention on improving work engagement among workers with low work engagement: An analysis of secondary outcome of a randomized controlled trial.
Imamura, Kotaro; Kawakami, Norito; Tsuno, Kanami; Tsuchiya, Masao; Shimada, Kyoko; Namba, Katsuyuki; Shimazu, Akihito
The purpose of this randomized, controlled trial was to examine the effects of a psychoeducational information website on improving work engagement among individual workers with low work engagement, where work engagement was measured as a secondary outcome. Participants were recruited from registered members of a web survey site in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Immediately after the baseline survey, the intervention group was invited to study a psychoeducational website called the "UTSMed," which provided general mental health literacy and cognitive behavioral skills. Work engagement was assessed by using the Utrecht Work Engagement Scale at baseline, 1-, and 4-month follow-ups for both intervention and control groups. An exploratory analysis was conducted for a subgroup with low (lower than the median scores) work engagement scores at baseline. A total of 1,236 workers completed the baseline survey. In the low work engagement subgroup, a total of 313 and 300 participants were allocated to an intervention and control group, respectively. In the high work engagement subgroup, 305 and 318 participants were allocated to an intervention and control group, respectively. The program showed a significant effect on work engagement (t = 1.98, P = 0.048) at the 4-month follow-up in the low work engagement subgroup, with a small effect size (d = 0.17). A web-based psychoeducation resource of mental health literacy and cognitive behavioral skills may be effective for improving work engagement among individual workers with low work engagement.
Taïeb, D; Sebag, F; Cherenko, M; Baumstarck-Barrau, K; Fortanier, C; Farman-Ara, B; De Micco, C; Vaillant, J; Thomas, S; Conte-Devolx, B; Loundou, A; Auquier, P; Henry, J F; Mundler, O
Recombinant human TSH (rhTSH) has become the modality of choice for radioiodine remnant ablation (RRA) in low-risk thyroid cancer patients. The aims of the present prospective randomized study were to evaluate the impact of TSH stimulation procedure (hypothyroidism vs. rhTSH) on quality of life (QoL) of thyroid cancer patients undergoing RRA and to evaluate efficacy of both procedures. L-T4 was initiated in both groups after thyroidectomy. After randomization, L-T4 was discontinued in hypothyroid (hypo) group and continued in rhTSH group. A measure of 3.7 GBq of radioiodine was given to both groups. The functional assessment of chronic illness therapy-fatigue (FACIT-F) was administered from the early postoperative period to 9 months. Socio-demographic parameters, anxiety and depression scales were also evaluated (CES-D, BDI and Spielberger state-trait questionnaires). At 9 months, patients underwent an rhTSH stimulation test, diagnostic (131)I whole body scan (dxWBS) and neck ultrasonography. A total of 74 patients were enrolled for the study. There was a significant decrease in QoL from baseline (t0) to t1 (RRA period) in the hypothyroid group with significant differences in FACIT-F TOI (P hypothyrodism. However, there is a wide heterogeneity in the clinical impact of hypothyroidism.
Goyal, Mayank; Jadhav, Ashutosh P; Bonafe, Alain; Diener, Hans; Mendes Pereira, Vitor; Levy, Elad; Baxter, Blaise; Jovin, Tudor; Jahan, Reza; Menon, Bijoy K; Saver, Jeffrey L
Purpose To study the relationship between functional independence and time to reperfusion in the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial in patients with disabling acute ischemic stroke who underwent endovascular therapy plus intravenous tissue plasminogen activator (tPA) administration versus tPA administration alone and to investigate variables that affect time spent during discrete steps. Materials and Methods Data were analyzed from the SWIFT PRIME trial, a global, multicenter, prospective study in which outcomes were compared in patients treated with intravenous tPA alone or in combination with the Solitaire device (Covidien, Irvine, Calif). Between December 2012 and November 2014, 196 patients were enrolled. The relation between time from (a) symptom onset to reperfusion and (b) imaging to reperfusion and clinical outcome was analyzed, along with patient and health system characteristics that affect discrete steps in patient workflow. Multivariable logistic regression was used to assess relationships between time and outcome; negative binomial regression was used to evaluate effects on workflow. The institutional review board at each site approved the trial. Patients provided written informed consent, or, at select sites, there was an exception from having to acquire explicit informed consent in emergency circumstances. Results In the stent retriever arm of the study, symptom onset to reperfusion time of 150 minutes led to 91% estimated probability of functional independence, which decreased by 10% over the next hour and by 20% with every subsequent hour of delay. Time from arrival at the emergency department to arterial access was 90 minutes (interquartile range, 69-120 minutes), and time to reperfusion was 129 minutes (interquartile range, 108-169 minutes). Patients who initially arrived at a referring facility had longer symptom onset to groin puncture times compared with
Alfonsson, Sven; Olsson, Erik; Hursti, Timo
In previous research, variables such as age, education, treatment credibility, and therapeutic alliance have shown to affect patients' treatment adherence and outcome in Internet-based psychotherapy. A more detailed understanding of how such variables are associated with different measures of adherence and clinical outcomes may help in designing more effective online therapy. The aims of this study were to investigate demographical, psychological, and treatment-specific variables that could predict dropout, treatment adherence, and treatment outcomes in a study of online relaxation for mild to moderate stress symptoms. Participant dropout and attrition as well as data from self-report instruments completed before, during, and after the online relaxation program were analyzed. Multiple linear and logistical regression analyses were conducted to predict early dropout, overall attrition, online treatment progress, number of registered relaxation exercises, posttreatment symptom levels, and reliable improvement. Dropout was significantly predicted by treatment credibility, whereas overall attrition was associated with reporting a focus on immediate consequences and experiencing a low level of intrinsic motivation for the treatment. Treatment progress was predicted by education level and treatment credibility, whereas number of registered relaxation exercises was associated with experiencing intrinsic motivation for the treatment. Posttreatment stress symptoms were positively predicted by feeling external pressure to participate in the treatment and negatively predicted by treatment credibility. Reporting reliable symptom improvement after treatment was predicted by treatment credibility and therapeutic bond. This study confirmed that treatment credibility and a good working alliance are factors associated with successful Internet-based psychotherapy. Further, the study showed that measuring adherence in different ways provides somewhat different results, which
Rationale and study protocol for the supporting children's outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: a physical activity and fundamental movement skills intervention for primary schools in low-income communities.
Lubans, David R; Morgan, Philip J; Weaver, Kristen; Callister, Robin; Dewar, Deborah L; Costigan, Sarah A; Finn, Tara L; Smith, Jordan; Upton, Lee; Plotnikoff, Ronald C
Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. The Supporting Children's Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The findings from the study may be used to
Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities
Background Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. Methods/design The Supporting Children’s Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. Discussion SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The
Enav Z. Zusman MSc
Full Text Available Objective: To test the effect of a follow-up clinic on urinary incontinence (UI and nocturia among older adults with hip fracture. Method: Fifty-three older adults (≥65 years 3 to 12 months following hip fracture were enrolled and randomized to receive usual care plus the intervention (B4, or usual care (UC only. The B4 group received management by health professionals, with need-based referrals. UI, nocturia, and quality of life were measured with questionnaires at baseline, 6 months, and 12 months. Results: There were 48 participants included in this analysis, and at baseline, 44% of study participants self-reported UI. At final assessment, six out of 24 B4 participants and 12 out of 24 UC participants reported UI. Four out of five study participants reported nocturia at baseline; this did not decrease during the study. Discussion : Following hip fracture, many older adults report UI and most report nocturia. Health professionals should be aware of the high occurrence of urinary symptoms among older adults post hip fracture.
Introduction Antibiotic resistance decreases success of Helicobacter pylori (Hp) eradication. Recently published results show low rate of resistance and better compliance with moxifloxacin based regiments. Aims&methods Whether 7 days moxifloxacin with lansoprasole and amoxycillin can be compared with 10 days moxifloxacin with lansoprasole and amoxycillin according to moxifloxacin resistance. Patients with non-ulcer dyspepsia who had culture and histology positive Hp infection (n = 150) were randomly assigned into two groups. The first group (n = 75) received moxifloxacin 400 mg/d during 7 days and the other (n = 75) received moxifloxacin 400 mg/d during 10 days. All patients received amoxycillin 1 g twice daily, lansoprasole 30 mg twice daily. All Hp cultures were tested for sensitivity to moxifloxacin. Results 138 patients (92%) completed the study, 68 in the first group and 70 in the second. Eradication rates were 84% (57/68) and 76% (57/75) in the 7 days moxifloxacin group and 90% and 84% in the second group (63/70, 63/75) according to the PP and ITT analysis; p = n.s. Among 129 patients (86% of study group), 6% of strains were primary resistant to moxifloxacin. Eradication of moxifloxacin sensitive/resistant strains was 98%/66%, p < 0.05 Conclusion According to our results we recommend 7 days moxiflixacin based triple therapy. PMID:20398300
Furze, David; Byrne, Ashley; Alam, Sonia; Wittneben, Julia-Gabriela
Achieving an optimal esthetic result using dental implants is challenging. Fixed implant-supported provisional crowns are often used to customize the emergence profile and to individualize the surrounding peri-implant soft tissue. The objective of this study is to evaluate whether the use of a provisional implant-supported crown leads to an esthetic benefit on implants that are placed in the esthetic zone. The null hypothesis is that there is no-difference between the two study groups. Twenty single implants (Bone Level, Straumann AG, Basel, Switzerland) were inserted in consecutive patients. After reopening, a randomization process assigned them to either cohort group 1: a provisional phase with soft tissue conditioning using the "dynamic compression technique" or cohort group 2: without a provisional. Implants were finally restored with an all-ceramic crown. Follow-up examinations were performed at 3 and 12 months including implant success and survival, clinical, and radiographic parameters. After 1 year all implants successfully integrated, mean values of combined modPES and WES were 16.7 for group 1 and 10.5 for Group 2. This was statistically significant. Mean bone loss after 1 year was -0.09 and -0.08 for groups 1 and 2, respectively, without being statistically significant. A provisional phase with soft tissue conditioning does improve the final esthetic result. © 2016 Wiley Periodicals, Inc.
Effect of pelvic floor muscle training on labour and newborn outcomes: a randomized controlled trial Efeitos do treinamento da musculatura do assoalho pélvico sobre o parto e recém-nascido: estudo controlado randomizado
Letícia A. R. Dias
Full Text Available BACKGROUND: The use of the pelvic floor muscle training for urinary incontinence treatment is well established but little is known about its effects in labor and newborn outcomes. OBJECTIVES: To evaluate the effects of antenatal pelvic floor muscle training and strength in labor and newborn outcomes in low-income pregnant women. METHODS: This is a randomized controlled trial that recruited forty-two nulliparous healthy pregnant women aged between 18-36 years old and able to contract the pelvic floor muscles. The participants were included in the study with 20 weeks of gestational age and had their pelvic floor muscles measured by vaginal squeeze pressure. They were randomly allocated into two groups: training group and a non-intervention control group. Then, all participants had their labor and newborn outcomes evaluated through consultation of medical records by a blinded researcher. RESULTS: There were no statistically significant differences between the groups regarding gestational age at birth, type of labor, duration of the second stage of labor, total time of labor, prevalence of laceration, weight and size of the baby, and Apgar score. No correlation was observed between pelvic floor muscle strength and the second stage or the total length of labor. CONCLUSIONS: This randomized controlled trial did not find any effect of pelvic floor muscle training or pelvic floor muscle strength on labor and newborn outcomes.CONTEXTUALIZAÇÃO: O treinamento da musculatura do assoalho pélvico para tratamento da incontinência urinária é bem estabelecida, mas pouco se sabe sobre seus efeitos sobre o parto e o recém-nascido. OBJETIVOS: Avaliar se os desfechos do parto e os resultados dos recém-nascidos são influenciados pelo treinamento e força da musculatura do assoalho pélvico realizados por gestantes de baixa renda. MÉTODOS: Trata-se de um ensaio clínico randomizado que incluiu 42 gestantes nulíparas de baixo risco, com idade entre 18 e 36
Telford, Rohan M; Olive, Lisa S; Cochrane, Thomas; Davey, Rachel; Telford, Richard D
The objective of this study was to investigate the effect of a 4-year specialist-taught Physical Education (PE) program on physical activity (PA) among primary school children. A 4-year cluster randomised controlled trial was conducted in children (initially aged 8 years) from 29 primary schools (13 Intervention, 16 Control). Intervention students (N = 457) received 2 × 45 min PE lessons per week from specialist-trained PE teachers (68 lessons per year, 272 lessons over 4 years). Control group students (N = 396) received usual practice PE from generalist classroom teachers. PA during PE lessons was examined using the System for Observing Fitness Instruction Time (SOFIT). Pedometers (steps/day) were worn for 7 days each year, and accelerometers were worn concurrently in the final two years to assess moderate to vigorous (MVPA) and sedentary activity. Linear and generalized mixed models were used to determine differences in Intervention and Control student PA and the proportion of students meeting PA guidelines. The intervention increased SOFIT-observed student MVPA during PE lessons by 6.5 mins (16.7 v 10.2, p strategy. Our finding of a reduction in sedentary time among Intervention boys warrants further investigation into the potential role PE could play in influencing sedentary behaviour.
Statistical power in parallel group point exposure studies with time-to-event outcomes: an empirical comparison of the performance of randomized controlled trials and the inverse probability of treatment weighting (IPTW) approach.
Austin, Peter C; Schuster, Tibor; Platt, Robert W
Estimating statistical power is an important component of the design of both randomized controlled trials (RCTs) and observational studies. Methods for estimating statistical power in RCTs have been well described and can be implemented simply. In observational studies, statistical methods must be used to remove the effects of confounding that can occur due to non-random treatment assignment. Inverse probability of treatment weighting (IPTW) using the propensity score is an attractive method for estimating the effects of treatment using observational data. However, sample size and power calculations have not been adequately described for these methods. We used an extensive series of Monte Carlo simulations to compare the statistical power of an IPTW analysis of an observational study with time-to-event outcomes with that of an analysis of a similarly-structured RCT. We examined the impact of four factors on the statistical power function: number of observed events, prevalence of treatment, the marginal hazard ratio, and the strength of the treatment-selection process. We found that, on average, an IPTW analysis had lower statistical power compared to an analysis of a similarly-structured RCT. The difference in statistical power increased as the magnitude of the treatment-selection model increased. The statistical power of an IPTW analysis tended to be lower than the statistical power of a similarly-structured RCT.
Frew, Paula M; Shapiro, Eve T; Lu, Lu; Edupuganti, Srilatha; Keyserling, Harry L; Mulligan, Mark J
This investigation evaluated several factors associated with diverse participant enrollment of a clinical trial assessing safety, immunogenicity, and comparative viremia associated with administration of 17-D live, attenuated yellow fever vaccine given alone or in combination with human immune globulin. We obtained baseline participant information (e.g., sociodemographic, medical) and followed recruitment outcomes from 2005 to 2007. Of 355 potential Yellow Fever vaccine study participants, 231 cases were analyzed. Strong interest in study participation was observed among racial and ethnically diverse persons with 36.34% eligible following initial study screening, resulting in 18.75% enrollment. The percentage of white participants increased from 63.66% (prescreened sample) to 81.25% (enrollment group). The regression model was significant with white race as a predictor of enrollment (OR=2.744, 95% CI=1.415-5.320, p=0.003).In addition, persons were more likely to enroll via direct outreach and referral mechanisms compared to mass advertising (OR=2.433, 95% CI=1.102-5.369). The findings indicate that racially diverse populations can be recruited to vaccine clinical trials, yet actual enrollment may not reflect that diversity.
Mohammad Ebrahim Parsanezhad
Full Text Available Background: Despite the large number of papers published on the efficiency of different exogenous gonadotropins, no confirmed protocol exists. Therefore, the aim of the present study was to compare the efficacy of 4 exogenous gonadotropins in IVF/ICSI cycles. Methods: This study, performed from January 2014 to May 2014, recruited 160 women referred to Ghadir Mother and Child Hospital and Dena Hospital, Shiraz, Iran. The patients underwent standard downregulation and were randomly divided into 4 groups of A, B, C, and D and were administered hMG, hFSH, rFSH, and combined sequential hFSH/rFSH, respectively. Then, the duration of stimulation, number of oocytes and embryos as well as their quality, implantation rate, biochemical and clinical pregnancy rate, and live birth rate in each group were evaluated. Results: Group D patients required significantly fewer ampoules of FSH than did the women in groups A, B, and C (P=0.004. The duration of stimulation was significantly longer in group C than in groups A and D (P=0.030. The serum estradiol level was significantly higher in group D than in groups B and C (P=0.005. A significantly higher number of large-sized follicles was observed in group D than in group B (P=0.036. Conclusion: Our data revealed no statistically significant differences in the mean oocyte number, embryo quality, clinical pregnancy rate, or live birth rate between the hMG, hFSH, rFSH, and sequential hFSH/rFSH protocols. However, several differences in the duration of stimulation, serum estradiol levels, and number of large-sized follicles were detected between the groups. Trial Registration Number: IRCT201408116541N7
The favorable effects of garlic intake on metabolic profiles, hs-CRP, biomarkers of oxidative stress and pregnancy outcomes in pregnant women at risk for pre-eclampsia: randomized, double-blind, placebo-controlled trial.
Aalami-Harandi, Rezvan; Karamali, Maryam; Asemi, Zatollah
This study was performed to determine the favorable effects of garlic on metabolic status and pregnancy outcomes among pregnant women at risk for pre-eclampsia. This randomized, double-blind, placebo-controlled trial was conducted among 44 pregnant women, primigravida, aged 18-40 years old at 27 weeks' gestation with positive roll-over test. Participants were randomly assigned to receive either one garlic tablet (equal to 400 mg garlic and 1 mg allicin) (n = 22) or placebo (n = 22) once daily for 9 weeks. Fasting blood samples were taken at baseline and after 9 weeks' intervention to measure metabolic profiles and biomarkers of oxidative stress. Administration of garlic compared with the placebo resulted in decreased levels of serum high sensitivity C-reactive protein (hs-CRP) (-1425.90 versus 1360.50 ng/mL, p = 0.01) and increased plasma glutathione (GSH) (+98.10 versus. -49.87 µmol/l, p = 0.03). A trend toward a significant effect of garlic intake on reducing fasting plasma glucose (FPG) (p = 0.07), insulin (p = 0.09) and increasing quantitative insulin sensitivity check (QUICKI) (p = 0.05) was also observed. Consumption of garlic for 9 weeks among pregnant women at risk for pre-eclampsia led to decreased hs-CRP and increased GSH, but did not affect lipid profiles, total antioxidant capacity (TAC) and pregnancy outcomes.
The immediate and long-term effects of exercise and patient education on physical, functional, and quality-of-life outcome measures after single-level lumbar microdiscectomy: a randomized controlled trial protocol.
Selkowitz, David M; Kulig, Kornelia; Poppert, Elizabeth M; Flanagan, Sean P; Matthews, Ndidiamaka D; Beneck, George J; Popovich, John M; Lona, Jose R; Yamada, Kimiko A; Burke, Wendy S; Ervin, Carolyn; Powers, Christopher M
Low back pain remains a costly quality-of-life-related health problem. Microdiscectomy is often the surgical procedure of choice for a symptomatic, single-level, lumbar disc herniation in younger and middle-aged adults. The question of whether a post-microdiscectomy exercise program enhances function, quality of life, and disability status has not been systematically explored. Thus, the overall purpose of this study is to assess immediate and long-term outcomes of an exercise program, developed at University of Southern California (USC), targeting the trunk and lower extremities (USC Spine Exercise Program) for persons who have undergone a single-level microdiscectomy for the first time. One hundred individuals between the ages of 18 and 60 who consent to undergo lumbar microdiscectomy will be recruited to participate in this study. Subjects will be randomly assigned to one of two groups: 1) one session of back care education, or 2) a back care education session followed by the 12-week USC Spine Exercise Program. The outcome examiners (evaluators), as well as the data managers, will be blinded to group allocation. Education will consist of a one-hour "one-on-one" session with the intervention therapist, guided by an educational booklet specifically designed for post-microdiscectomy care. This session will occur four to six weeks after surgery. The USC Spine Exercise Program consists of two parts: back extensor strength and endurance, and mat and upright therapeutic exercises. This exercise program is goal-oriented, performance-based, and periodized. It will begin two to three days after the education session, and will occur three times a week for 12 weeks. Primary outcome measures include the Oswestry Disability Questionnaire, Roland-Morris Disability Questionnaire, SF-36 quality of life assessment, Subjective Quality of Life Scale, 50-foot Walk, Repeated Sit-to-Stand, and a modified Sorensen test. The outcome measures in the study will be assessed before and after
Kek Khee Loo
Full Text Available Objective: To determine if meat or soy protein dietary supplementation will enhance the neurocognitive performance of HIV-affected children at-risk of malnutrition and food insecurity. Methods: A randomized, double-blind, controlled intervention trial evaluated the effect of nutritional supplementation on the neurocognitive outcomes of 49 HIV-affected school-age children in western Kenya. The intervention consisted in providing the mother, target child, and siblings with one of three isocaloric biscuit-type supplements – soy, wheat, or beef – on 5 days per week for 18 months. Neurocognitive outcomes of the target children were assessed by a battery of eight measures and followed up longitudinally for up to 24 months. Results: Mixed effects modeling demonstrated significant differences in the rates of increase over time among all three groups (F test degrees of freedom of 2, P<0.05 for Raven’s progressive matrices performance, but not for verbal meaning, arithmetic, digit span backward, forward, and total, embedded figure test, and Beery visual–motor integration scores. Conclusion: HIV-affected school-age children provided with soy protein supplementation showed greater improvement in nonverbal cognitive (fluid intelligence performance compared with peers who received isocaloric beef or wheat biscuits. Soy nutrients may have an enhancing effect on neurocognitive skills in HIV-affected school-age children.
Randomized controlled multicenter study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 2: clinical and radiographic outcomes at 1 year of loading.
Schincaglia, Gian Pietro; Thoma, Daniel S; Haas, Robert; Tutak, Marcin; Garcia, Abel; Taylor, Thomas D; Hämmerle, Christoph H F
To compare, clinically and radiographically, short dental implants (6 mm) to long implants (11-15 mm) placed with sinus grafting. Participants with 5-7 mm of bone height in the posterior maxilla were randomly allocated to receive short implants (GS) or long implants with sinus grafting (GG). Implants were loaded with single crowns 6 months after placement (PR). Patients were re-evaluated 12 months after loading (FU-1). Outcome variables included: Implant survival rate (CSR), marginal bone level alteration (MBL), periodontal probing depth (PPD), bleeding on probing (BoP), plaque control record (PCR) and crown-to-implant ratios (C/I). Statistical analysis was performed using parametric tests. In 97 subjects, 132 implants were re-evaluated at FU-1. The CSR was 100%. The MBL from implant placement (IP) to (PR) was -0.22 ± 0.4 mm for GG and -0.3 ± 0.45 mm for GS (p 0.05), PPD (p = 1) and PCR (p = 0.09). BoP was higher in the GS (p = 0.04). The C/I was 0.99 ± 0.17 for GG and 1.86 ± 0.23 for GS (p < 0.001). No correlation was observed between C/I and MBL, (GG: p = 0.13; GS: p = 0.38). Both treatment modalities provided similar outcomes. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).
Simpson, Eric L; Gadkari, Abhijit; Worm, Margitta; Soong, Weily; Blauvelt, Andrew; Eckert, Laurent; Wu, Richard; Ardeleanu, Marius; Graham, Neil M H; Pirozzi, Gianluca; Sutherland, E Rand; Mastey, Vera
Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD. Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Acute glucoregulatory and vascular outcomes of three strategies for interrupting prolonged sitting time in postmenopausal women: A pilot, laboratory-based, randomized, controlled, 4-condition, 4-period crossover trial.
Full Text Available Prolonged sitting is associated with cardiometabolic and vascular disease. Despite emerging evidence regarding the acute health benefits of interrupting prolonged sitting time, the effectiveness of different modalities in older adults (who sit the most is unclear.In preparation for a future randomized controlled trial, we enrolled 10 sedentary, overweight or obese, postmenopausal women (mean age 66 years ±9; mean body mass index 30.6 kg/m2 ±4.2 in a 4-condition, 4-period crossover feasibility pilot study in San Diego to test 3 different sitting interruption modalities designed to improve glucoregulatory and vascular outcomes compared to a prolonged sitting control condition. The interruption modalities included: a 2 minutes standing every 20 minutes; b 2 minutes walking every hour; and c 10 minutes standing every hour. During each 5-hr condition, participants consumed two identical, standardized meals. Blood samples, blood pressure, and heart rate were collected every 30 minutes. Endothelial function of the superficial femoral artery was measured at baseline and end of each 5-hr condition using flow-mediated dilation (FMD. Participants completed each condition on separate days, in randomized order. This feasibility pilot study was not powered to detect statistically significant differences in the various outcomes, however, analytic methods (mixed models were used to test statistical significance within the small sample size.Nine participants completed all 4 study visits, one participant completed 3 study visits and then was lost to follow up. Net incremental area under the curve (iAUC values for postprandial plasma glucose and insulin during the 5-hr sitting interruption conditions were not significantly different compared to the control condition. Exploratory analyses revealed that the 2-minute standing every 20 minutes and the 2-minute walking every hour conditions were associated with a significantly lower glycemic response to the second
De Nunzio, Cosimo; Brassetti, Aldo; Bellangino, Mariangela; Trucchi, Alberto; Petta, Stefano; Presicce, Fabrizio; Tubaro, Andrea
The role of α-blockers after shockwave lithotripsy (SWL) is controversial. The aim of our study was to evaluate the effect of tamsulosin and silodosin after SWL for kidney stones. From 2012 onward, a consecutive series of patients undergoing SWL were prospectively enrolled and randomized by closed envelopes in three groups receiving tamsulosin 0.4 mg (A), silodosin 8 mg (B), and placebo (C) daily for 21 days after SWL. Anthropometrics, stone size, and location were recorded before SWL. Visual analogue scale (VAS) score was collected at 6, 12, and 24 hours after treatment to evaluate patients' discomfort. Stone-free rate was assessed 1 and 3 weeks postoperatively. Complications and medical treatment-related adverse events (AEs) were recorded. Differences in VAS score, stone-free rate, and complications were compared among the groups. Overall, 60 patients were enrolled. Mean stone sizes were 10.28 ± 2.46 mm, 10.45 ± 1.73 mm, and 9.23 ± 2.04 mm in groups A, B, and C, respectively (p = 0.474). There was no significant difference between the three groups with regard to stone location. Comparable energy was used to treat patients from the three groups. The overall 3-week stone-free rate was 53%: 58% in the tamsulosin group, 47% in the silodosin group, and 55% in the placebo group (p = 0.399). No significant differences were observed in the VAS scores reported by the groups at 6 hours (p = 1.254), 12 hours (p = 0.075), and 24 hours (p = 0.490). Overall, 12 complications were reported: 11 patients (7 in group C and 4 in group B) needed analgesics for colic, and 1 patient (group B) was surgically treated for Steinstrasse. Tamsulosin was superior to placebo (p = 0.008) and silodosin (p = 0.021) in preventing complications; no difference between silodosin and placebo (p = 0.629) was noted. Tamsulosin and silodosin are ineffective in increasing stone-free rate as well as early patients' discomfort after extracorporeal
Effects of a nurse-led transitional care program on clinical outcomes, health-related knowledge, physical and mental health status among Chinese patients with coronary artery disease: A randomized controlled trial.
Zhang, Pan; Hu, Yu-Ding; Xing, Feng-Mei; Li, Chang-Zai; Lan, Wang-Feng; Zhang, Xiao-Li
Coronary artery disease is a major cause of morbidity and mortality among adults worldwide, including China. After a hospital stay, transitional care could help to ensure improved patient care and outcomes, and reduce Medicare costs. Nevertheless, the results of the existing transitional care are not always satisfactory and our knowledge of how to perform effective transitional care for patients with coronary artery disease is limited in mainland China. To examine the effectiveness of a nurse-led transitional care program on clinical outcomes, health-related knowledge, and physical and mental health status among Chinese patients with coronary artery disease. Randomized controlled trial. The Omaha system and Pender's health promoting model were employed in planning and implementing this nurse-led transitional care program. The sample was comprised of 199 Chinese patients with coronary artery disease. The experimental group (n=100) received nurse-led transitional care intervention in addition to routine care. The nurse-led transitional care intervention included a structured assessment and health education, followed by 7 months of individual teaching and coaching (home visits, telephone follow-up and group activity). The control group (n=99) received a comparable length routine care and follow-up contacts. Evaluations were conducted at baseline and completion of the interventions using the perceived knowledge scale for coronary heart disease, the medical outcomes study 36-item short-form health survey and clinical measures (blood pressure, blood glucose, lipids, body mass index). Data were collected between March and October 2014. Compared with the control group, participants in the experimental group showed significant better clinical outcomes (systolic blood pressure, t=5.762, P=0.000; diastolic blood pressure, t=4.250, P=0.000; fasting blood glucose, t=2.249, P=0.027; total cholesterol, t=4.362, P=0.000; triglyceride, t=3.147, P=0.002; low density lipoprotein
Ball, Kylie; McNaughton, Sarah A; Le, Ha N D; Gold, Lisa; Ni Mhurchu, Cliona; Abbott, Gavin; Pollard, Christina; Crawford, David
Fiscal strategies are increasingly considered upstream nutrition promotion measures. However, few trials have investigated the effectiveness or cost effectiveness of pricing manipulations on diet in real-world settings. We assessed the effects on fruit, vegetable, and beverage purchasing and consumption of a 20% price-reduction intervention, a tailored skills-based behavior-change intervention, and a combined intervention compared with a control condition. The Supermarket Healthy Eating for Life trial was a randomized controlled trial conducted over 3 mo [baseline (time 1) to postintervention (time 2) with a 6-mo follow-up (time 3)]. Female primary household shoppers in Melbourne, Australia, were randomly assigned to a 1) skill-building (n = 160), 2) price-reduction (n = 161), 3) combined skill-building and price-reduction (n = 160), or 4) control (n = 161) group. Supermarket transaction data and surveys were used to measure the following study outcomes: fruit, vegetable, and beverage purchases and self-reported fruit and vegetable consumption at each time point. At 3 mo (time 2), price reduction-alone participants purchased more total vegetables and frozen vegetables than did controls. Price reduction-alone and price reduction-plus-skill-building participants purchased more fruit than did controls. Relative to controls, in the price-reduction group, total vegetable consumption increased by 233 g/wk (3.1 servings or 15% more than at baseline), and fruit purchases increased by 364 g/wk (2.4 servings; 35% more than at baseline). Increases were not maintained 6 mo postintervention (time 3). Price reduction-alone participants showed a tendency for a slight increase in fruit consumption at time 2 (P = 0.09) that was maintained at time 3 (P = 0.014). No intervention improved purchases of bottled water or low-calorie beverages. A 20% price reduction in fruit and vegetables resulted in increased purchasing per household of 35% for fruit and 15% for vegetables over the
Randomized controlled trial of a book-sharing intervention in a deprived South African community: effects on carer-infant interactions, and their relation to infant cognitive and socioemotional outcome.
Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J
Consistent with evidence from high-income countries (HICs), we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book sharing with their infants benefitted infant language and attention (Vally, Murray, Tomlinson, & Cooper, ). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socioemotional development benefitted from book sharing. We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14-16-month-old infants were randomized to 8 weeks' training in book sharing (n = 49) or a wait-list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book sharing and toy play. Assessments were also made, at follow-up only, of infant prosocial behaviour in a 'help task', and of infant imitation of doll characters' nonsocial actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of prosocial behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also shows promise for
Randomized controlled trial of a book-sharing intervention in a deprived South African community: effects on carer-infant interactions, and their relation to infant cognitive and socio-emotional outcome
Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J.
Background Consistent with evidence from high income countries, we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book-sharing with their infants benefitted infant language and attention (Vally et al., 2015). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socio-emotional development benefitted from book-sharing. Methods We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14–16 month-old infants were randomized to 8 weeks’ training in book-sharing (n = 49) or a wait list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book-sharing and toy play. Assessments were also made, at follow-up only, of infant pro-social behaviour in a ‘help task’, and of infant imitation of doll characters’ non-social actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Results Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of pro-social behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book-sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Conclusions Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also
Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial.
Ambrosy, Andrew P; Bhatt, Ankeet S; Stebbins, Amanda L; Wruck, Lisa M; Fudim, Marat; Greene, Stephen J; Kraus, William E; O'Connor, Christopher M; Piña, Ileana L; Whellan, David J; Mentz, Robert J
Despite more than 200 years of clinical experience and a pivotal trial, recently published research has called into question the safety and efficacy of digoxin therapy in heart failure (HF). HF-ACTION (ClinicalTrials.gov Number: NCT00047437) enrolled 2331 outpatients with HF and an EF ≤35% between April 2003 and February 2007 and randomized them to aerobic exercise training versus usual care. Patients were grouped according to prevalent digoxin status at baseline. The association between digoxin therapy and outcomes was assessed using Cox proportional hazard and inverse-probability weighted (IPW) regression models adjusted for demographics, medical history, medications, laboratory values, quality of life, and exercise parameters. The prevalence of digoxin therapy decreased from 52% during the first 6 months of enrollment to 35% at the end of the HF-ACTION trial (P <0.0001). Study participants were 59± 13 years of age, 72% were male, and approximately half had an ischemic etiology of HF. Patients receiving digoxin at baseline tended to be younger and were more likely to report New York Heart Association functional class III/IV symptoms (rather than class II) compared to those not receiving digoxin. Patients taking digoxin had worse baseline exercise capacity as measured by peak VO 2 and 6-min walk test and greater impairments in health status as reflected by the Kansas City Cardiomyopathy Questionnaire. The association between digoxin and the risk of death or hospitalization differed depending on whether Cox proportional hazard (Hazard Ratio 1.03, 95% Confidence Interval 0.92-1.16; P = .62) or IPW regression models (HR 1.08, 95% CI 1.00-1.17; P = .057) were used to adjust for potential confounders. Although digoxin use was associated with high-risk clinical features, the association between digoxin therapy and outcomes was dependent on the statistical methods used for multivariable adjustment. Clinical equipoise exists and additional prospective research is
Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.
Woelk, Godfrey B; Kieffer, Mary Pat; Walker, Damilola; Mpofu, Daphne; Machekano, Rhoderick
Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. Implementation of the protocol necessitated changes in the
Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities
Lubans David R
Full Text Available Abstract Background Many Australian children are insufficiently active to accrue health benefits and physical activity (PA levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS may serve as a protective factor against this trend. Methods/design The Supporting Children’s Outcomes Using Rewards Exercise and Skills (SCORES intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles, PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers, FMS (Test of Gross Motor Development II and cardiorespiratory fitness (multi-stage fitness test. Secondary outcomes include body mass index [using weight (kg/height (m2], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. Discussion SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled
Mahu, Ioan T.; Doucet, Christine; O'Leary?Barrett, Maeve; Conrod, Patricia J.
Aims To examine the effectiveness of a personality?targeted intervention program (Adventure trial) delivered by trained teachers to high?risk (HR) high?school students on reducing marijuana use and frequency of use. Design A cluster?randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty?one secondary schools were randomized to intervention (n?=?12) or control (n?=?9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard devi...
Nishida, Atsushi; Ando, Shuntaro; Yamasaki, Syudo; Koike, Shinsuke; Ichihashi, Kayo; Miyakoshi, Yuji; Maekawa, Sanae; Nakamura, Tomohisa; Natsubori, Tatsunobu; Ichikawa, Eriko; Ishigami, Hiroki; Sato, Kojiro; Matsunaga, Asami; Smith, Jo; French, Paul; Harima, Hirohiko; Kishi, Yoshiki; Fujita, Izumi; Kasai, Kiyoto; Okazaki, Yuji
The first episode of psychosis represents a critical period wherein comprehensive early intervention in psychosis (EIP) may alter the course of illness. However, evidence from randomized controlled trials that have examined the impact of comprehensive EIP care on clinical and functional recovery assessed by independent blinded raters is limited. The objective of this study was to conduct a single-blinded multicenter trial comparing comprehensive EIP care and standard care in young patients with first-episode psychosis (FEP) in Japan (J-CAP Study). A total of 77 participants with FEP (aged 15-35 years) were randomized to receive standard care or specialized comprehensive EIP care and were followed up for 1.5 years (trial no.: UMIN000005092). Function (measured with the Global Assessment of Functioning) and clinical remission (defined by internationally standardized criteria proposed by the Remission in Schizophrenia Working Group) were evaluated by independent raters who were blinded to group assignment. Dropout rate and other secondary outcomes were also examined. The specialized EIP care group had a higher clinical remission rate (odds ratio, 6.3; 95% confidence interval, 1.0-37.9) and lower treatment dropout rate (odds ratio, 0.038; 95% confidence interval, 0.002-0.923) than the standard care group, even after adjusting for baseline characteristics. Functional improvement in the specialized EIP care group was slightly higher than that in the standard care group, but this difference was not statistically significant (p = 0.195). From the results, we conclude that comprehensive EIP care may provide advantages over standard care in patients with FEP. Copyright © 2018. Published by Elsevier Ltd.
Full Text Available This paper investigates the dynamic output feedback control for nonlinear networked control systems with both random packet dropout and random delay. Random packet dropout and random delay are modeled as two independent random variables. An observer-based dynamic output feedback controller is designed based upon the Lyapunov theory. The quantitative relationship of the dropout rate, transition probability matrix, and nonlinear level is derived by solving a set of linear matrix inequalities. Finally, an example is presented to illustrate the effectiveness of the proposed method.
Weisel, Kiona Krueger; Lehr, Dirk; Heber, Elena; Zarski, Anna-Carlotta; Berking, Matthias; Riper, Heleen; Ebert, David Daniel
Although internet-based and mobile-based stress management interventions (iSMIs) may be a promising strategy to reach employees suffering from high chronic stress, it remains unknown whether participants with high symptom severity of depression or anxiety also benefit from iSMIs or should be excluded. This study aimed to evaluate the efficacy of iSMIs in subgroups with high symptom severity and to test whether baseline symptom severity moderates treatment outcome. Data from three randomized controlled trials (N=791) were pooled to identify effect modifiers and to evaluate efficacy in subgroups with different levels of initial symptom severity. The outcomes perceived stress (Perceived Stress Scale, PSS), depression severity (Center for Epidemiological Depression Scale, CES-D), and anxiety (Hospital Anxiety and Depression Scale, HADS) symptom severity were assessed at baseline, 7-week postassessment, and 6-month follow-up. Potential moderators were tested in predicting differences in the change of outcome in multiple moderation analyses. Simple slope analyses evaluated efficacy of the iSMI comparing the intervention group with the waitlist control group in subgroups with low, moderate, and severe initial symptomology based on means and SDs of the study population. In addition, subgroups with clinical values of depression (CES-D≥16) and anxiety (HADS≥8) at baseline were explored, and response rates (RRs; 50% symptom reduction) and symptom-free (SF) status (CES-Dhttps://www.drks.de/DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6zmIZwvdA); 2) German Clinical Trials Register DRKS00005384; https://www.drks.de/ DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6zmIerdtr); and 3) German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6zmIjDQPx). ©Kiona Krueger Weisel, Dirk Lehr, Elena Heber, Anna-Carlotta Zarski, Matthias Berking, Heleen Riper, David Daniel Ebert
Early detection and intervention using neutrophil gelatinase-associated lipocalin (NGAL) may improve renal outcome of acute contrast media induced nephropathy: a randomized controlled trial in patients undergoing intra-arterial angiography (ANTI-CIN Study).
Schilcher, Gernot; Ribitsch, Werner; Otto, Ronald; Portugaller, Rupert H; Quehenberger, Franz; Truschnig-Wilders, Martini; Zweiker, Robert; Stiegler, Philipp; Brodmann, Marianne; Weinhandl, Klemens; Horina, Joerg H
Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated lipocalin (NGAL), a new biomarker predictive for acute kidney injury (AKI), has been shown to be useful for earlier diagnosis of CIN; however, urinary NGAL values may be markedly increased in chronic renal failure at baseline. Results from those studies suggested that urinary NGAL values may not be helpful for the clinician. An intravenous volume load is a widely accepted prophylactic measure and possibly a reasonable intervention to prevent deterioration of renal function. The aim of our study is to evaluate NGAL as an early predictor of CIN and to investigate the clinical benefit of early post-procedural i.v. hydration. The study will follow a prospective, open-label, randomized controlled design. Patients requiring intra-arterial contrast media (CM) application will be included and receive standardized, weight-based, intravenous hydration before investigation. Subjects with markedly increased urinary NGAL values after CM application will be randomized into one of two study groups. Group A will receive 3-4 ml/kg BW/h 0.9% saline intravenously for 6 hours. Group B will undergo only standard treatment consisting of unrestricted oral fluid intake. The primary outcome measure will be CIN defined by an increase greater than 25% of baseline serum creatinine. Secondary outcomes will include urinary NGAL values, cystatin C values, contrast media associated changes in cardiac parameters such as NT-pro-BNP/troponin T, changes in urinary cytology, need for renal replacement treatment, length of stay in hospital and death.We assume that 20% of the included patients will show a definite rise in urinary NGAL. Prospective statistical power calculations indicate that the study will have 80% statistical power to detect a clinically significant decrease of CIN of 40% in the treatment arm if 1200 patients are recruited into the
Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen
AIM: Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. METHODS: We searched major databases without language restrictions for randomized controlled...... trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting...... as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. RESULTS: Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60...
A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder
Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie
The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…
Short and long-term effects of supervised versus unsupervised exercise training on health-related quality of life and functional outcomes following lung cancer surgery - a randomized controlled trial.
Brocki, Barbara Cristina; Andreasen, Jane; Nielsen, Lene Rodkjaer; Nekrasas, Vytautas; Gorst-Rasmussen, Anders; Westerdahl, Elisabeth
Surgical resection enhances long-term survival after lung cancer, but survivors face functional deficits and report on poor quality of life long time after surgery. This study evaluated short and long-term effects of supervised group exercise training on health-related quality of life and physical performance in patients, who were radically operated for lung cancer. A randomized, assessor-blinded, controlled trial was performed on 78 patients undergoing lung cancer surgery. The intervention group (IG, n=41) participated in supervised out-patient exercise training sessions, one hour once a week for ten weeks. The sessions were based on aerobic exercises with target intensity of 60-80% of work capacity, resistance training and dyspnoea management. The control group (CG, n=37) received one individual instruction in exercise training. Measurements consisted of: health-related quality of life (SF36), six minute walk test (6MWT) and lung function (spirometry), assessed three weeks after surgery and after four and twelve months. Both groups were comparable at baseline on demographic characteristic and outcome values. We found a statistically significant effect after four months in the bodily pain domain of SF36, with an estimated mean difference (EMD) of 15.3 (95% CI:4 to 26.6, p=0.01) and a trend in favour of the intervention for role physical functioning (EMD 12.04, 95% CI: -1 to 25.1, p=0.07) and physical component summary (EMD 3.76, 95% CI:-0.1 to 7.6, p=0.06). At 12 months, the tendency was reversed, with the CG presenting overall slightly better measures. We found no effect of the intervention on 6MWT or lung volumes at any time-point. Supervised compared to unsupervised exercise training resulted in no improvement in health-related quality of life, except for the bodily pain domain, four months after lung cancer surgery. No effects of the intervention were found for any outcome after one year. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
Full Text Available Abstract Background Post-abortion contraceptive use in India is low and the use of modern methods of contraception is rare, especially in rural areas. This study primarily compares contraceptive use among women whose abortion outcome was assessed in-clinic with women who assessed their abortion outcome at home, in a low-resource, primary health care setting. Moreover, it investigates how background characteristics and abortion service provision influences contraceptive use post-abortion. Methods A randomized controlled, non-inferiority, trial (RCT compared clinic follow-up with home-assessment of abortion outcome at 2 weeks post-abortion. Additionally, contraceptive-use at 3 months post-abortion was investigated through a cross-sectional follow-up interview with a largely urban sub-sample of women from the RCT. Women seeking abortion with a gestational age of up to 9 weeks and who agreed to a 2-week follow-up were included (n = 731. Women with known contraindications to medical abortions, Hb < 85 mg/l and aged below 18 were excluded. Data were collected between April 2013 and August 2014 in six primary health-care clinics in Rajasthan. A computerised random number generator created the randomisation sequence (1:1 in blocks of six. Contraceptive use was measured at 2 weeks among women successfully followed-up (n = 623 and 3 months in the sub-set of women who were included if they were recruited at one of the urban study sites, owned a phone and agreed to a 3-month follow-up (n = 114. Results There were no differences between contraceptive use and continuation between study groups at 3 months (76 % clinic follow-up, 77 % home-assessment, however women in the clinic follow-up group were most likely to adopt a contraceptive method at 2 weeks (62 ± 12 %, while women in the home-assessment group were most likely to adopt a method after next menstruation (60 ± 13 %. Fifty-two per cent of women who initiated a
Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.
Full Text Available The North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis.To determine the effect of a six-month Schroth PSSE intervention added to standard of care (Experimental group on the Cobb angle compared to standard of care alone (Control group in patients with AIS.Fifty patients with AIS aged 10-18 years, with curves of 10°-45° and Risser grade 0-5 were recruited from a single pediatric scoliosis clinic and randomized to the Experimental or Control group. Outcomes included the change in the Cobb angles of the Largest Curve and Sum of Curves from baseline to six months. The intervention consisted of a 30-45 minute daily home program and weekly supervised sessions. Intention-to-treat and per protocol linear mixed effects model analyses are reported.In the intention-to-treat analysis, after six months, the Schroth group had significantly smaller Largest Curve than controls (-3.5°, 95% CI -1.1° to -5.9°, p = 0.006. Likewise, the between-group difference in the square root of the Sum of Curves was -0.40°, (95% CI -0.03° to -0.8°, p = 0.046, suggesting that an average patient with 51.2° at baseline, will have a 49.3° Sum of Curves at six months in the Schroth group, and 55.1° in the control group with the difference between groups increasing with severity. Per protocol analyses produced similar, but larger differences: Largest Curve = -4.1° (95% CI -1.7° to -6.5°, p = 0.002 and [Formula: see text] (95% CI -0.8 to 0.2, p = 0.006.Schroth PSSE added to the standard of care were superior compared to standard of care alone for reducing the curve severity in patients with AIS.NCT01610908.
Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten
Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... to existing pain relief methods. (BIRTH 36:1 March 2009)...
Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study.
Ascher, B; Hoffmann, K; Walker, P; Lippert, S; Wollina, U; Havlickova, B
Unwanted submental fat (SMF) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non-surgical method for SMF reduction is lacking. To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study. Patients (n = 360) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm(2) or placebo injected into their SMF for up to four treatments ~28 days apart, with a 12-week follow-up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale (SSRS score ≥4). Secondary efficacy endpoints included a ≥1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and changes in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored. Compared with placebo, a greater proportion of patients treated with ATX-101 1 and 2 mg/cm(2) showed a ≥1-point improvement in CR-SMFRS (58.3% and 62.3%, respectively, vs. 34.5% with placebo; P < 0.001) and patient satisfaction (SSRS score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; P < 0.001). Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm(2) , P < 0.001 for ATX-101 2 mg/cm(2) vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area. ATX
Are written information or counseling (WOMAN-PRO II program) able to improve patient satisfaction and the delivery of health care of women with vulvar neoplasms? Secondary outcomes of a multicenter randomized controlled trial
Gehrig, Larissa; Kobleder, Andrea; Werner, Birgit; Denhaerynck, Kris; Senn, Beate
Background: Patients with vulvar neoplasms report a lack of information, missing support in self-management and a gap in delivery of health care. Aim: The aim of the study was to investigate if written information or counseling based on the WOMAN-PRO II program are able to improve patient satisfaction and the delivery of health care from the health professional's perspective of women with vulvar neoplasms. Method: Patient satisfaction and the delivery of health care have been investigated as two secondary outcomes in a multicenter randomized controlled parallel-group phase II study (Clinical Trial ID: NCT01986725). In total, 49 women, from four hospitals (CH, AUT), completed the questionnaire PACIC-S11 after written information (n = 13) and counseling (n = 36). The delivery of health care was evaluated by ten Advanced Practice Nurses (APNs) by using the G-ACIC before and after implementing counseling based on the WOMAN-PRO II program. Results: There were no significant differences between the two groups identified (p = 0.25). Only few aspects were rated highly by all women, such as the overall satisfaction (M = 80.3 %) and satisfaction with organization of care (M = 83.0 %). The evaluation of delivery of health care by APNs in women who received counseling improved significantly (p = 0.031). Conclusions: There are indications, that the practice of both interventions might have improved patient satisfaction and counseling the delivery of health care. The aspects that have been rated low in the PACIC-S11 and G-ACIC indicate possibilities to optimize the delivery of health care.
Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil
In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…
Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk.
Rosenstock, Julio; Perkovic, Vlado; Alexander, John H; Cooper, Mark E; Marx, Nikolaus; Pencina, Michael J; Toto, Robert D; Wanner, Christoph; Zinman, Bernard; Baanstra, David; Pfarr, Egon; Mattheus, Michaela; Broedl, Uli C; Woerle, Hans-Juergen; George, Jyothis T; von Eynatten, Maximilian; McGuire, Darren K
Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA ® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. CARMELINA ® is a randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries in T2D patients at high risk of CV and/or kidney events. Participants with evidence of CKD with or without CV disease and HbA1c 6.5-10.0% (48-86 mmol/mol) were randomized 1:1 to receive linagliptin once daily or matching placebo, added to standard of care adjusted according to local guidelines. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. The key secondary outcome is a composite of time to first sustained occurrence of end-stage kidney disease, ≥ 40% decrease in estimated glomerular filtration rate (eGFR) from baseline, or renal death. CV and kidney events are prospectively adjudicated by independent, blinded clinical event committees. CARMELINA ® was designed to continue until at least 611 participants had confirmed primary outcome events. Assuming a hazard ratio of 1.0, this provides 90% power to demonstrate non-inferiority of linagliptin versus placebo within the pre-specified non-inferiority margin of 1.3 at a one-sided α-level of 2.5%. If non-inferiority of linagliptin for the primary outcome is demonstrated, then its superiority for both the primary outcome and the key secondary outcome will be investigated with a sequentially rejective multiple test procedure. Between July 2013 and August 2016, 6980 patients were randomized and took ≥ 1 dose of study drug (40.6, 33.1, 16.9, and 9.4% from Europe, South America, North America, and Asia, respectively). At baseline, mean ± SD age was 65.8 ± 9.1 years, HbA1c
Farzanegan, Gholam Reza; Derakhshan, Nima; Khalili, Hosseinali; Ghaffarpasand, Fariborz; Paydar, Shahram
The aim of the current study was to investigate the effects of atorvastatin on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injury (TBI). The study was conducted as a randomized clinical trial during a 16-month period from May 2015 and August 2016 in a level I trauma center in Shiraz, Southern Iran. We included 65 patients with moderate (GCS: 9-13) to severe (GCS: 5-8) TBI who had brain contusions of less than 30cc volume. We excluded those who required surgical intervention. Patients were randomly assigned to receive daily 20mg atorvastatin for 10days (n=21) or placebo in the same dosage (n=23). The brain contusion volumetry was performed on days 0, 3 and 7 utilizing spiral thin-cut brain CT-Scan (1-mm thickness). The outcome measured included modified Rankin scale (MRS), Glasgow Outcome Scale (GOS) and Disability rating Scale (DRS) which were all evaluated 3months post-injury. There was no significant difference between two study group regarding the baseline, 3rd day and 7th day of the contusion volume and the rate of contusion expansion. However, functional outcome scales of GOS, MRS and DRS at 3-months post-injury were significantly better in atorvastatin arm of the study compared to placebo (p values of 0.043, 0.039 and 0.030 respectively). Even though atorvastatin was not found to be more effective than placebo in reducing contusion expansion rate, it was associated with improved functional outcomes at 3-months following moderate to severe TBI. Copyright © 2017 Elsevier Ltd. All rights reserved.
Hill, Darryl V.; Lenard, Matthew A.
In 2013-14, the Wake County Public School System (WCPSS) launched Achieve3000 as a randomized controlled trial in 16 elementary schools. Achieve3000 is an early literacy program that differentiates non-fiction reading passages based on individual students' Lexile scores. Twoyear results show that Achieve3000 did not have a significant impact on…
Guo, Jing; Lam, Tsz Ping; Wong, Man Sang; Ng, Bobby Kin Wah; Lee, Kwong Man; Liu, King Lok; Hung, Lik Hang; Lau, Ajax Hong Yin; Sin, Sai Wing; Kwok, Wing Kwan; Yu, Fiona Wai Ping; Qiu, Yong; Cheng, Jack Chun Yiu
SpineCor is a relatively innovative brace for non-operative treatment of adolescent idiopathic scoliosis (AIS). However, the effectiveness of SpineCor still remains controversial. The objective of the current study was to compare the treatment outcomes of SpineCor brace with that of rigid brace following the standardized Scoliosis Research Society (SRS) criteria on AIS brace study. Females subjects with AIS and aged 10-14 were randomly allocated into two groups undergoing treatment of SpineCor (S Group, n = 20) or rigid brace (R Group, n = 18). During SpineCor treatment, patients who had curve progression of >5° would be required to switch to rigid brace treatment. The effectiveness of the two brace treatments was assessed using the SRS standardized criteria. Before skeletal maturity, 7 (35.0%) patients in the S Group and 1 (5.6%) patient in the R Group had curve progression >5° (P = 0.026). At skeletal maturity, 5 of the 7 (71.4%) patients who failed with SpineCor bracing showed control from further progression by changing to rigid bracing. At the latest follow-up with a mean duration of 45.1 months after skeletally maturity, 29.4% of patients who were successfully treated by rigid brace showed further curve progression beyond skeletal maturity, versus 38.5% of patients in the SpineCor group (P > 0.05). For both groups, the primary curves were slightly improved at the time of brace weaning, but additionally increased at the latest follow-up, with a rate of 1.5° per year for post-maturity progression. Curve progression rate was found to be significantly higher in the SpineCor group when compared with the rigid brace group. Changing to rigid bracing could control further curve progression for majority of patients who previously failed with SpineCor bracing. For both SpineCor and rigid brace treatments, 30-40% of patients who were originally successfully treated by bracing would exhibit further curve progression beyond skeletal maturity. The post
Paul, Mandira; Iyengar, Sharad D; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Kirti; Bring, Johan; Klingberg-Allvin, Marie
Post-abortion contraceptive use in India is low and the use of modern methods of contraception is rare, especially in rural areas. This study primarily compares contraceptive use among women whose abortion outcome was assessed in-clinic with women who assessed their abortion outcome at home, in a low-resource, primary health care setting. Moreover, it investigates how background characteristics and abortion service provision influences contraceptive use post-abortion. A randomized controlled, non-inferiority, trial (RCT) compared clinic follow-up with home-assessment of abortion outcome at 2 weeks post-abortion. Additionally, contraceptive-use at 3 months post-abortion was investigated through a cross-sectional follow-up interview with a largely urban sub-sample of women from the RCT. Women seeking abortion with a gestational age of up to 9 weeks and who agreed to a 2-week follow-up were included (n = 731). Women with known contraindications to medical abortions, Hb Contraceptive use was measured at 2 weeks among women successfully followed-up (n = 623) and 3 months in the sub-set of women who were included if they were recruited at one of the urban study sites, owned a phone and agreed to a 3-month follow-up (n = 114). There were no differences between contraceptive use and continuation between study groups at 3 months (76 % clinic follow-up, 77 % home-assessment), however women in the clinic follow-up group were most likely to adopt a contraceptive method at 2 weeks (62 ± 12 %), while women in the home-assessment group were most likely to adopt a method after next menstruation (60 ± 13 %). Fifty-two per cent of women who initiated a method at 2 weeks chose the 3-month injection or the copper intrauterine device. Only 4 % of women preferred sterilization. Caste, educational attainment, or type of residence did not influence contraceptive use. Simplified follow-up after early medical abortion will not change women
Markovic, Tania P; Muirhead, Ros; Overs, Shannon; Ross, Glynis P; Louie, Jimmy Chun Yu; Kizirian, Nathalie; Denyer, Gareth; Petocz, Peter; Hyett, Jon; Brand-Miller, Jennie C
Dietary interventions can improve pregnancy outcomes in women with gestational diabetes mellitus (GDM). We compared the effect of a low-glycemic index (GI) versus a conventional high-fiber (HF) diet on pregnancy outcomes, birth weight z score, and maternal metabolic profile in women at high risk of GDM. One hundred thirty-nine women [mean (SD) age 34.7 (0.4) years and prepregnancy BMI 25.2 (0.5) kg/m(2)] were randomly assigned to a low-GI (LGI) diet (n = 72; target GI ∼50) or a high-fiber, moderate-GI (HF) diet (n = 67; target GI ∼60) at 14-20 weeks' gestation. Diet was assessed by 3-day food records and infant body composition by air-displacement plethysmography, and pregnancy outcomes were assessed from medical records. The LGI group achieved a lower GI than the HF group [mean (SD) 50 (5) vs. 58 (5); P diet and a healthy diet produce similar pregnancy outcomes. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.
OBJECTIVE: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. METHOD: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in
Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.
Objective: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. Method: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in
Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.
Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...
van der Waerden, Judith E B; Hoefnagels, Cees; Hosman, Clemens M H; Souren, Pierre M; Jansen, Maria W J
Exercise may have both a preventive and a therapeutic impact on mental health problems. The Exercise without Worries intervention aims to reduce stress and depressive symptoms in low-SES women by means of a group-based program combining physical exercise and psycho-education. Between September 2005 and May 2008, 161 Dutch low-SES women with elevated stress or depressive symptom levels were randomly assigned to the combined exercise/psycho-education intervention (EP), exercise only (E) or a waiting list control condition (WLC). The E condition provided low to moderate intensity stretching, strength, flexibility, and body focused training as well as relaxation, while the EP program integrated the exercise with cognitive-behavioral techniques. Depressive symptoms (CES-D) and perceived stress (PSS) were measured before and immediately after the intervention and at 2, 6 and 12 month follow-up. Multilevel linear mixed-effects models revealed no differential patterns in reduction of CES-D or PSS scores between the EP, E and WLC groups on the short (post-test and 2 month follow-up) or long term (6 and 12 months follow-up). Depressive symptom outcomes were moderated by initial depressive symptom scores: women from the EP and E groups with fewer initial symptoms benefited from participation on the short term. Further, women in the EP and E groups with the lowest educational level reported more stress reduction at post-test than women with higher educational levels. In the overall target population of low-SES women, no indications were found that the Exercise without Worries course reduced depressive symptom and stress levels on the short or long term. The findings do suggest, however, that exercise alone or in combination with psycho-education may be a viable prevention option for certain groups of disadvantaged women. Especially those low-SES women with less severe initial problems or those with low educational attainment should be targeted for future depression prevention
Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John
To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.
Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra
Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.
Prevalence of intrauterine adhesions after the application of hyaluronic acid gel after dilatation and curettage in women with at least one previous curettage: short-term outcomes of a multicenter, prospective randomized controlled trial.
Hooker, Angelo B; de Leeuw, Robert; van de Ven, Peter M; Bakkum, Erica A; Thurkow, Andreas L; Vogel, Niels E A; van Vliet, Huib A A M; Bongers, Marlies Y; Emanuel, Mark H; Verdonkschot, Annelies E M; Brölmann, Hans A M; Huirne, Judith A F
To examine whether intrauterine application of auto-crosslinked hyaluronic acid (ACP) gel, after dilatation and curettage (D&C), reduces the incidence of intrauterine adhesions (IUAs). Multicenter; women and assessors blinded prospective randomized trial. University and university-affiliated teaching hospitals. A total of 152 women with a miscarriage of Gynecological Endoscopy classifications systems of adhesions. Intrauterine application of ACP gel after D&C for miscarriage in women with at least one previous D&C seems to reduce the incidence and severity of IUAs but does not eliminate the process of adhesion formation completely. Future studies are needed to confirm our findings and to evaluate the effect of ACP gel on fertility and reproductive outcomes. NTR 3120. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Benyamin, Ramsin M; Staats, Peter S
Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary
Plasma biomarker analysis in pediatric ARDS: generating future framework from a pilot randomized control trial of methylprednisoloneA framework for identifying plasma biomarkers related to clinical outcomes in pediatric ARDS
Full Text Available Objective: Lung injury activates multiple pro-inflammatory pathways, including neutrophils, epithelial and endothelial injury, and coagulation factors leading to acute respiratory distress syndrome (ARDS. Low-dose methylprednisolone therapy (MPT improved oxygenation and ventilation in early pediatric ARDS without altering duration of mechanical ventilation or mortality. We evaluated the effects of MPT on biomarkers of endothelial (Ang-2, sICAM-1 or epithelial (sRAGE injury, neutrophil activation (MMP-8, and coagulation (PAI-1. Design: Double-blind, placebo-controlled randomized trialSetting: Tertiary-care Pediatric Intensive Care Unit Patients: Mechanically ventilated children (0-18 years with early ARDS.Interventions: Blood samples were collected on Days 0 (before MPT, 7, and 14 during low-dose MPT (n=17 vs. placebo (n=18 therapy. The MPT group received a 2mg/kg loading dose followed by 1mg/kg/day continuous infusions from days 1-7, tapered off over 7 days; placebo group received equivalent amounts of 0.9% saline. We analyzed plasma samples using a multiplex assay for 5 biomarkers of ARDS. Multiple regression models were constructed to predict associations between changes in biomarkers and the clinical outcomes reported earlier including: P/F ratio on days 8&9, plateau pressure on days 1&2, PaCO2 on days 2&3, racemic epinephrine following extubation, and supplemental oxygen at ICU discharge.Results: No differences occurred in biomarker concentrations between the groups on Day 0. On Day 7, reduction in MMP-8 levels (p=0.0016 occurred in the MPT group, whereas increases in sICAM-1 levels (p=0.0005 occurred in the placebo group (no increases in sICAM-1 in the MPT group. sRAGE levels decreased in both MPT and placebo groups (p<0.0001 from Day 0 to Day 7. On Day 7, sRAGE levels were positively correlated with MPT group PaO2/FiO2 ratios on Day 8 (r=0.93, p=0.024. O2 requirements at ICU transfer positively correlated with Day 7 MMP-8 (r=0.85, p=0
Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten
BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...
Borstlap, Waa; Deijen, C. L.; den Dulk, M.; Bonjer, H. J.; van de Velde, C. J.; Bemelman, W. A.; Tanis, P. J.; Aalbers, A.; Acherman, Y.; Algie, G. D.; Alting von Geusau, B.; Amelung, F.; Aukema, T. S.; Bakker, I. S.; Basha, S.; Bastiaansen, A. J. N. M.; Belgers, E.; Bleeker, W.; Blok, J.; Bosker, R. J. I.; Bosmans, J. W.; Boute, M. C.; Bouvy, N. D.; Bouwman, H.; Brandt-Kerkhof, A.; Brinkman, D. J.; Bruin, S.; Bruns, E. R. J.; Burbach, J. P. M.; Burger, J. W. A.; Buskens, C. J.; Clermonts, S.; Coenen, P. P. L. O.; Compaan, C.; Consten, E. C. J.; Darbyshire, T.; de Mik, S. M. L.; de Graaf, E. J. R.; de Groot, I.; de Vos Tot Nederveen Cappel, R. J. L.; de Wilt, J. H. W.; van der Wolde, J.; den Boer, F. C.; Dekker, J. W. T.; Demirkiran, A.; van Duijvendijk, P.; Musters, G. D.; van Rossem, C. C.; Schreuder, A. M.; Swank, H. A.
Aim A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark. Method In this collaborative
Borstlap, W. A. A.; Deijen, C. L.; den Dulk, M.; Bonjer, H. J.; van de Velde, C. J.; Bemelman, W. A.; Tanis, P. J.; Aalbers, A.; Acherman, Y.; Algie, G. D.; von Geu-sau, B. Alting; Amelung, F.; Aukema, T. S.; Bakker, I. S.; Bartels, S. A.; Basha, S.; Bastiaansen, A. J. N. M.; Belgers, E.; Bleeker, W.; Blok, J.; Bosker, R. J. I.; Bosmans, J. W.; Boute, M. C.; Bouvy, N. D.; Bouwman, H.; Brandt-Kerkhof, A.; Brinkman, D. J.; Bruin, S.; Bruns, E. R. J.; Burbach, J. P. M.; Burger, J. W. A.; Buskens, C. J.; Clermonts, S.; Coene, P. P. L. O.; Compaan, C.; Consten, E. C. J.; Darbyshire, T.; de Mik, S. M. L.; de Graaf, E. J. R.; de Groot, I.; Cappel, R. J. L. de Vos Tot Nederveen; de Wilt, J. H. W.; van der Wolde, J.; den Boer, F. C.; Furnee, E. J. B.; Havenga, K.; Klaase, J.; Holzik, M. F. Lutke; Meerdink, M.; Wevers, K.
Aim A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark. Method In this collaborative
Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.
MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.
Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea
Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.
Hamilton, David F; Ohly, Nicholas E; Gaston, Paul
The use of shorter length femoral stems during total hip arthroplasty has been suggested to accommodate wider patient femoral geometry and offer maximal bone preservation. However, cemented short-stem designs may increase the risk of varus stem malalignment and influence patient outcomes. CASINO is a multi-centre randomised equivalence trial that will recruit 220 patients undergoing total hip arthroplasty for osteoarthritis at two NHS hospitals in Scotland. Patients will be aged 45-80, undergoing unilateral primary hip arthroplasty, with no plan for contralateral procedure within the study timeframe, and able to comply with the protocol. Participants will be randomised to receive either a short (125 mm) or a standard (150 mm) Exeter V40 stem. The Contemporary acetabular component will be used in all cases. All implants will be cemented. Patient pain, function and satisfaction will be assessed using change from baseline measurement in Oxford Hip Score, Forgotten Joint Score, EQ-5D, pain numerical rating scores, and patient satisfaction questionnaire at baseline and at 1 and 2 years following surgery. Radiographic assessment will evaluate stem position and will be appraised by independent reviewers. Patients will be blind to implant allocation. Stem length may be associated with outcome; however, we can find no randomised trial in which researchers investigated the effect of stem length on patient outcome following cemented total hip arthroplasty. The aim of this trial is to determine if the use of short cemented stems offers equivalent patient outcomes to those achieved following surgery with standard length stems. International Standard Randomised Controlled Trial Number, ISRCTN13154542 , Registered on 30 June 2017.
Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.
Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673
Garand, Linda; Rinaldo, Donna E; Alberth, Mary M; Delany, Jill; Beasock, Stacey L; Lopez, Oscar L; Reynolds, Charles F; Dew, Mary Amanda
Interventions directed at the mental health of family dementia caregivers may have limited impact when focused on caregivers who have provided care for years and report high burden levels. We sought to evaluate the mental health effects of problem-solving therapy (PST), designed for caregivers of individuals with a recent diagnosis of Mild Cognitive Impairment (MCI) or early dementia. Seventy-three (43 MCI and 30 early dementia) family caregivers were randomly assigned to receive PST or a comparison condition (nutritional education). Depression, anxiety, and problem-solving orientation were assessed at baseline and at 1, 3, 6, and 12 months post intervention. In general, the PST caregiver intervention was feasible and acceptable to family caregivers of older adults with a new cognitive diagnosis. Relative to nutritional education, PST led to significantly reduced depression symptoms, particularly among early dementia caregivers. PST also lowered caregivers' anxiety levels, and led to lessening of negative problem orientation. Enhanced problem-solving skills, learned early after a loved one's cognitive diagnosis (especially dementia), results in positive mental health outcomes among new family caregivers. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.
Comparison of intra-articular injections of Hyaluronic Acid and Corticosteroid in the treatment of Osteoarthritis of the hip in comparison with intra-articular injections of Bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors
Full Text Available Abstract Background Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate. Methods/Design Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine. The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS, Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment and intake of pain rescue medication (number per week. In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered. Discussion This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine. Trial registration NCT01079455
Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition.
Dyck, Dennis G; Weeks, Douglas L; Gross, Sarah; Lederhos Smith, Crystal; Lott, Hilary A; Wallace, Aimee J; Wood, Sonya M
Over 12,000 individuals suffer a spinal cord injury (SCI) annually in the United States, necessitating long-term, complex adjustments and responsibilities for patients and their caregivers. Despite growing evidence that family education and support improves the management of chronic conditions for care recipients as well as caregiver outcomes, few systematic efforts have been made to involve caregivers in psycho-educational interventions for SCI. As a result, a serious gap exists in accumulated knowledge regarding effective, family-based treatment strategies for improving outcomes for individuals with SCI and their caregivers. The proposed research aims to fill this gap by evaluating the efficacy of a structured adaptation of an evidence-based psychosocial group treatment called Multi-Family Group (MFG) intervention. The objective of this study is to test, in a randomized-controlled design, an MFG intervention for the treatment of individuals with SCI and their primary caregivers. Our central hypothesis is that by providing support in an MFG format, we will improve coping skills of persons with SCI and their caregivers as well as supportive strategies employed by caregivers. We will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous 3 years and their primary caregivers. Patient/caregiver pairs will be randomized to the MFG intervention or an active SCI education control (SCIEC) condition in a two-armed randomized trial design. Participants will be assessed pre- and post-program and 6 months post-program. Intent to treat analyses will test two a priori hypotheses: (1) MFG-SCI will be superior to SCIEC for SCI patient activation, health status, and emotion regulation, caregiver burden and health status, and relationship functioning, and (2) MFG will be more effective for individuals with SCI and their caregivers when the person with SCI is within 18 months of discharge from inpatient rehabilitation compared
Overcoming Addictions, a Web-Based Application, and SMART Recovery, an Online and In-Person Mutual Help Group for Problem Drinkers, Part 2: Six-Month Outcomes of a Randomized Controlled Trial and Qualitative Feedback From Participants.
Campbell, William; Hester, Reid K; Lenberg, Kathryn L; Delaney, Harold D
Despite empirical evidence supporting the use of Web-based interventions for problem drinking, much remains unknown about factors that influence their effectiveness. We evaluated the performance of 2 resources for people who want to achieve and maintain abstinence: SMART Recovery (SR) and Overcoming Addictions (OA). OA is a Web application based on SR. We also examined participant and intervention-related factors hypothesized to impact clinical outcomes of Web-based interventions. We recruited 189 heavy drinkers through SR's website and in-person meetings throughout the United States. We began by randomly assigning participants to (1) SR meetings alone, (2) OA alone, and (3) OA and SR (OA+SR). Recruitment challenges compelled us to assign participants only to SR (n=86) or OA+SR (n=102). The experimental hypotheses were as follows: (1) Both groups will reduce their drinking and alcohol-related consequences at follow-up compared with their baseline levels, and (2) The OA+SR condition will reduce their drinking and alcohol or drug-related consequences more than the SR only condition. Additionally, we derived 3 groups empirically (SR, OA, and OA+SR) based on the participants' actual use of each intervention and conducted analyses by comparing them. Primary outcome measures included percent days abstinent (PDA), mean drinks per drinking day (DDD), and alcohol or drug-related consequences. Postbaseline assessments were conducted by phone at 3 and 6 months. Secondary analyses explored whether clinical issues (eg, severity of alcohol problems, level of distress, readiness to change) or intervention-related factors (eg, Internet fluency, satisfaction with site) affected outcomes. Both intent-to-treat analyses and the actual-use analyses showed highly significant improvement from baseline to follow-ups for all 3 groups. Mean within-subject effect sizes were large (d>0.8) overall. There was no significant difference between groups in the amount of improvement from baseline to
Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501
Du, Xing; Hu, Zhiwei; Yan, Chao; Zhang, Chao; Wang, Zhonggao; Wu, Jimin
Laparoscopic Nissen fundoplication (LNF) is the most common surgical procedure for the surgical management of gastro-esophageal reflux disease (GERD). Laparoscopic Toupet fundoplication (LTF) has been reported to have a lower prevalence of postoperative complications yet still obtain a similar level of reflux control. We conducted a meta-analysis to confirm the value of LNF and LTF. PubMed, Medline, Embase, Cochrane Library and Springerlink were searched for randomized controlled trials (RCTs) comparing LNF and LTF. Data regarding the benefits and adverse results of two techniques were extracted and compared using a meta-analysis. Eight eligible RCTs comparing LNF (n = 625) and LTF (n = 567) were identified. There were no significant differences between LNF and LTF with regard to hospitalization duration, perioperative complications, patient satisfaction, postoperative heartburn, regurgitation, postoperative DeMeester scores, or esophagites. A shorter operative time and higher postoperative lower esophageal sphincter pressure were associated with LNF. Prevalence of postoperative dysphagia, gas-bloating, inability to belch, dilatation for dysphagia and reoperation were higher after LNF, but subgroup analyses showed that differences with respect to dysphagia between LNF and LTF disappeared over time. Subgroup analyses did not support "tailored therapy" according to preoperative esophageal motility. LNF and LTF have equivalently good control of GERD and result in a similar prevalence of patient satisfaction. Based on current evidence, it is not rational or advisable to abandon LNF when choosing a surgical procedure for GERD.
Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois
OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects w...
Garbutt Jane M
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
Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar
To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.
Anderson, Timothy; Crowley, Mary Ellen J; Himawan, Lina; Holmberg, Jennifer K; Uhlin, Brian D
Therapist effects, independent of the treatment provided, have emerged as a contributor to psychotherapy outcomes. However, past research largely has not identified which therapist factors might be contributing to these effects, though research on psychotherapy implicates relational characteristics. The present Randomized Clinical Trial tested the efficacy of therapists who were selected by their facilitative interpersonal skills (FIS) and training status. Sixty-five clients were selected from 2713 undergraduates using a screening and clinical interview procedure. Twenty-three therapists met with 2 clients for 7 sessions and 20 participants served in a no-treatment control group. Outcome and alliance differences for Training Status were negligible. High FIS therapists had greater pre-post client outcome, and higher rates of change across sessions, than low FIS therapists. All clients treated by therapists improved more than the silent control, but effects were greater with high FIS than low FIS therapists. From the first session, high FIS therapists also had higher alliances than low FIS therapists as well as significant improvements on client-rated alliance. Results were consistent with the hypothesis that therapists' common relational skills are independent contributors to therapeutic alliance and outcome.
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.
Allan, G Michael; Korownyk, Christina; LaSalle, Kate; Vandermeer, Ben; Ma, Victoria; Klein, Douglas; Manca, Donna
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. 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. 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.
Ge, Weiqing; Leson, Chelsea; Vukovic, Corey
[Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.
Patel, A.; MacMahon, S; Chalmers, J.; Neal, B.; Billot, L.; Woodward, M.; Marre, M.; Cooper, M.; Glasziou, P.; Grobbee, D.E.; Hamet, P.; Harrap, S.; Heller, S.; Liu, L.; Mancia, G.; Mogensen, C.E.; Pan, C.; Poulter, N.; Rodgers, A.; Williams, B.; Bompoint, S.; Galan, B.E. de; Joshi, R.; Travert, F.
BACKGROUND: In patients with type 2 diabetes, the effects of intensive glucose control on vascular outcomes remain uncertain. METHODS: We randomly assigned 11,140 patients with type 2 diabetes to undergo either standard glucose control or intensive glucose control, defined as the use of gliclazide
Li, King King
This paper experimentally investigates preference towards different methods of control in risk taking. Participants are asked to choose between different ways for choosing which numbers to bet on for a gamble. They can choose the numbers themselves (control), let the experimenter choose (no control), or randomize. It is found that in addition to the more conventional preference for control, some participants prefer not to control, or randomization. These preferences are robust as participants...
Using wireless technology in clinical practice: does feedback of daily walking activity improve walking outcomes of individuals receiving rehabilitation post-stroke? Study protocol for a randomized controlled trial
Background Regaining independent ambulation is the top priority for individuals recovering from stroke. Thus, physical rehabilitation post-stroke should focus on improving walking function and endurance. However, the amount of walking completed by individuals with stroke attending rehabilitation is far below that required for independent community ambulation. There has been increased interest in accelerometer-based monitoring of walking post-stroke. Walking monitoring could be integrated within the goal-setting process for those with ambulation goals in rehabilitation. The feedback from these devices can be downloaded to a computer to produce reports. The purpose of this study is to determine the effect of accelerometer-based feedback of daily walking activity during rehabilitation on the frequency and duration of walking post-stroke. Methods Participants will be randomly assigned to one of two groups: feedback or no feedback. Participants will wear accelerometers daily during in- and out-patient rehabilitation and, for participants in the feedback group, the participants’ treating physiotherapist will receive regular reports of walking activity. The primary outcome measures are the amount of daily walking completed, as measured using the accelerometers, and spatio-temporal characteristics of walking (e.g. walking speed). We will also examine goal attainment, satisfaction with progress towards goals, stroke self-efficacy, and community-integration. Discussion Increased walking activity during rehabilitation is expected to improve walking function and community re-integration following discharge. In addition, a focus on altering walking behaviour within the rehabilitation setting may lead to altered behaviour and increased activity patterns after discharge. Trial registration ClinicalTrials.gov NCT01521234 PMID:23865593
Full Text Available Objective: To measure length of hospital stay (LHS in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620. The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety.
Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser
There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.
The effects of observation of walking in a living room environment, on physical, cognitive, and quality of life related outcomes in older adults with dementia: a study protocol of a randomized controlled trial.
Douma, Johanna G; Volkers, Karin M; Vuijk, Jelle Pieter; Sonneveld, Marieke H; Goossens, Richard H M; Scherder, Erik J A
The number of older adults with dementia is expected to increase. Dementia is not only characterized by a decline in cognition, also other functions, for example, physical functioning change. A possible means to decrease the decline in these functions, or even improve them, could be increasing the amount of physical activity. A feasible way hereto may be activation of the mirror neuron system through action observation. This method has already been shown beneficial for the performance of actions in, for example, stroke patients. The primary aim of this study is to examine the effect of observing videos of walking people on physical activity and physical performance, in older adults with dementia. Secondary, effects on cognition and quality of life related factors will be examined. A cluster randomized controlled trial is being performed, in which videos are shown to older adults with dementia (also additional eligibility criteria apply) in shared living rooms of residential care facilities. Due to the study design, living rooms instead of individual participants are randomly assigned to the experimental (videos of walking people) or control (videos of nature) condition, by means of drawing pieces of paper. The intervention has a duration of three months, and takes place on weekdays, during the day. There are four measurement occasions, in which physical activity, physical functioning, activities of daily living, cognition, the rest-activity rhythm, quality of life, and depression are assessed. Tests for participants are administered by a test administrator who is blind to the group the participant is in. This study examines the effect of the observation of walking people on multiple daily life functions and quality of life related factors in older adults with dementi