Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial.

PubMed

Armour, Carol L; Reddel, Helen K; LeMay, Kate S; Saini, Bandana; Smith, Lorraine D; Bosnic-Anticevich, Sinthia Z; Song, Yun Ju Christine; Alles, M Chehani; Burton, Deborah L; Emmerton, Lynne; Stewart, Kay; Krass, Ines

2013-04-01

To test the feasibility, effectiveness, and sustainability of a pharmacy asthma service in primary care. A pragmatic cluster randomized trial in community pharmacies in four Australian states/territories in 2009. Specially trained pharmacists were randomized to deliver an asthma service in two groups, providing three versus four consultations over 6 months. People with poorly controlled asthma or no recent asthma review were included. Follow-up for 12 months after service completion occurred in 30% of randomly selected completing patients. Outcomes included change in asthma control (poor and fair/good) and Asthma Control Questionnaire (ACQ) score, inhaler technique, quality of life, perceived control, adherence, asthma knowledge, and asthma action plan ownership. Ninety-six pharmacists enrolled 570 patients, with 398 (70%) completing. Asthma control significantly improved with both the three- and four-visit service, with no significant difference between groups (good/fair control 29% and 21% at baseline, 61% and 59% at end, p = .791). Significant improvements were also evident in the ACQ (mean change 0.56), inhaler technique (17-33% correct baseline, 57-72% end), asthma action plan ownership (19% baseline, 56% end), quality of life, adherence, perceived control, and asthma knowledge, with no significant difference between groups for any variable. Outcomes were sustained at 12 months post-service. The pharmacy asthma service delivered clinically important improvements in both a three-visit and four-visit service. Pharmacists were able to recruit and deliver the service with minimal intervention, suggesting it is practical to implement in practice. The three-visit service would be feasible and effective to implement, with a review at 12 months.

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial.

PubMed

Coronado, Gloria D; Vollmer, William M; Petrik, Amanda; Taplin, Stephen H; Burdick, Timothy E; Meenan, Richard T; Green, Beverly B

2014-07-01

Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California. STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age- and screening-eligible patients completing a FIT within 12months; and cost, cost-effectiveness, and return on investment of the intervention. This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates. Copyright © 2014 Elsevier Inc. All rights reserved.

From cytokines to pragmatic designs: changing paradigms.

PubMed

Heddle, Nancy M

2017-10-01

Emily Cooley was a well-respected medical technologist and morphologist with a remarkable skill set. She was highly regarded both professionally and personally. The "Emily Cooley Lectureship and Award" was established to honor her in particular and medical technologists in general. This article first reviews how a medical laboratory technologist was inspired to become a clinical researcher, then goes on to describe research that led to the discovery of cytokines as the cause of febrile nonhemolytic transfusion and the use of a pragmatic randomized controlled trial design to address evidence of harm when stored red blood cells were transfused. Important lessons for performing quality, meaningful research are highlighted. © 2017 AABB.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

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

PubMed Central

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

2015-01-01

Cluster randomized trials (CRTs) randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic CRTs in routine healthcare settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic CRTs but challenges remain, including some arising from the current U.S. research and healthcare regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic CRTs in healthcare settings, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland in July of 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the NIH, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of CRTs, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic CRTs in healthcare settings. PMID:25733677

Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: The electronic games to aid motivation to exercise (eGAME) study

PubMed Central

Maddison, Ralph; Foley, Louise; Ni Mhurchu, Cliona; Jull, Andrew; Jiang, Yannan; Prapavessis, Harry; Rodgers, Anthony; Vander Hoorn, Stephen; Hohepa, Maea; Schaaf, David

2009-01-01

Background Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children. Methods/Design Three hundred and thirty participants aged 10–14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention). Discussion An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000632493 PMID:19450288

Focal muscle vibration as a possible intervention to prevent falls in elderly women: a pragmatic randomized controlled trial.

PubMed

Celletti, Claudia; Fattorini, Luigi; Camerota, Filippo; Ricciardi, Diego; La Torre, Giuseppe; Landi, Francesco; Filippi, Guido Maria

2015-12-01

Different and new approaches have been proposed to prevent the risk of falling of elderly people, particularly women. This study investigates the possibility that a new protocol based on the focal mechanical muscle vibration may reduce the risk of falling of elderly women. A pragmatic randomized controlled triple-blind trial with a 6-month follow-up after intervention randomized 350 women (mean age 73.4 years + 3.11), members of local senior citizen centers in Rome, into two groups: vibrated group (VG) and control group (CG). For VG participants a mechanical vibration (lasting 10 min) was focally applied on voluntary contracted quadriceps muscles, three times a day during three consecutive days. CG subjects received a placebo vibratory stimulation. Subjects were tested immediately before (T0) and 30 (T1) and 180 (T2) days after the intervention with the Performance-Oriented Mobility Assessment (POMA) test. All subjects were asked not to change their lifestyle during the study. CG underwent sham vibratory treatment. While CG did not show any statistically significant change of POMA at T1 and T2, VG revealed significant differences. At T2, ≈47% of the subjects who completed the study obtained the full score on the POMA test and ≈59% reached the full POMA score. The new protocol seems to be promising in reducing the risk of falling of elderly subjects.

Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

PubMed

Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

2015-08-01

Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.

PubMed

Winer, Rachel L; Tiro, Jasmin A; Miglioretti, Diana L; Thayer, Chris; Beatty, Tara; Lin, John; Gao, Hongyuan; Kimbel, Kilian; Buist, Diana S M

2018-01-01

Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial.

PubMed

Hurley, M V; Walsh, N E; Mitchell, H; Nicholas, J; Patel, A

2012-02-01

Chronic joint pain is a major cause of pain and disability. Exercise and self-management have short-term benefits, but few studies follow participants for more than 6 months. We investigated the long-term (up to 30 months) clinical and cost effectiveness of a rehabilitation program combining self-management and exercise: Enabling Self-Management and Coping of Arthritic Knee Pain Through Exercise (ESCAPE-knee pain). In this pragmatic, cluster randomized, controlled trial, 418 people with chronic knee pain (recruited from 54 primary care surgeries) were randomized to usual care (pragmatic control) or the ESCAPE-knee pain program. The primary outcome was physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function), with a clinically meaningful improvement in physical function defined as a ≥15% change from baseline. Secondary outcomes included pain, psychosocial and physiologic variables, costs, and cost effectiveness. Compared to usual care, ESCAPE-knee pain participants had large initial improvements in function (mean difference in WOMAC function -5.5; 95% confidence interval [95% CI] -7.8, -3.2). These improvements declined over time, but 30 months after completing the program, ESCAPE-knee pain participants still had better physical function (difference in WOMAC function -2.8; 95% CI -5.3, -0.2); lower community-based health care costs (£-47; 95% CI £-94, £-7), medication costs (£-16; 95% CI £-29, £-3), and total health and social care costs (£-1,118; 95% CI £-2,566, £-221); and a high probability (80-100%) of being cost effective. Clinical and cost benefits of ESCAPE-knee pain were still evident 30 months after completing the program. ESCAPE-knee pain is a more effective and efficient model of care that could substantially improve the health, well-being, and independence of many people, while reducing health care costs. Copyright © 2012 by the American College of Rheumatology.

Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial.

PubMed

Garland, Eric L; Roberts-Lewis, Amelia; Tronnier, Christine D; Graves, Rebecca; Kelley, Karen

2016-02-01

In many clinical settings, there is a high comorbidity between substance use disorders, psychiatric disorders, and traumatic stress. Novel therapies are needed to address these co-occurring issues efficiently. The aim of the present study was to conduct a pragmatic randomized controlled trial comparing Mindfulness-Oriented Recovery Enhancement (MORE) to group Cognitive-Behavioral Therapy (CBT) and treatment-as-usual (TAU) for previously homeless men residing in a therapeutic community. Men with co-occurring substance use and psychiatric disorders, as well as extensive trauma histories, were randomly assigned to 10 weeks of group treatment with MORE (n = 64), CBT (n = 64), or TAU (n = 52). Study findings indicated that from pre-to post-treatment MORE was associated with modest yet significantly greater improvements in substance craving, post-traumatic stress, and negative affect than CBT, and greater improvements in post-traumatic stress and positive affect than TAU. A significant indirect effect of MORE on decreasing craving and post-traumatic stress by increasing dispositional mindfulness was observed, suggesting that MORE may target these issues via enhancing mindful awareness in everyday life. This pragmatic trial represents the first head-to-head comparison of MORE against an empirically-supported treatment for co-occurring disorders. Results suggest that MORE, as an integrative therapy designed to bolster self-regulatory capacity, may hold promise as a treatment for intersecting clinical conditions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial.

PubMed

Frass, Michael; Friehs, Helmut; Thallinger, Christiane; Sohal, Narinderjit Kaur; Marosi, Christine; Muchitsch, Ilse; Gaertner, Katharina; Gleiss, Andreas; Schuster, Ernst; Oberbaum, Menachem

2015-06-01

The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial.

PubMed

Choudhry, Niteesh K; Isaac, Thomas; Lauffenburger, Julie C; Gopalakrishnan, Chandrasekar; Khan, Nazleen F; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M; Naseem, Samrah; Gagne, Joshua J; Jackevicius, Cynthia A; Fischer, Michael A; Solomon, Daniel H; Sequist, Thomas D

2016-10-01

Approximately half of patients with chronic cardiometabolic conditions are nonadherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may not need adherence assistance. To evaluate the effect of a multicomponent, behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. The STIC2IT trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multicomponent intervention that uses behavioral interviewing, text messaging, mailed progress reports, and video visits. Targeted patients are those who are nonadherent to glucose-lowering, antihypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients' individual health barriers and their level of health activation. We cluster-randomized 14 practice sites of a large multispecialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients who will be followed up for 12months after randomization. The trial's primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and health care resource utilization. This trial will determine whether a technologically enabled, behaviorally targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

PubMed

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core.

PubMed

Cook, Andrea J; Delong, Elizabeth; Murray, David M; Vollmer, William M; Heagerty, Patrick J

2016-10-01

Pragmatic clinical trials embedded within health care systems provide an important opportunity to evaluate new interventions and treatments. Networks have recently been developed to support practical and efficient studies. Pragmatic trials will lead to improvements in how we deliver health care and promise to more rapidly translate research findings into practice. The National Institutes of Health (NIH) Health Care Systems Collaboratory was formed to conduct pragmatic clinical trials and to cultivate collaboration across research areas and disciplines to develop best practices for future studies. Through a two-stage grant process including a pilot phase (UH2) and a main trial phase (UH3), investigators across the Collaboratory had the opportunity to work together to improve all aspects of these trials before they were launched and to address new issues that arose during implementation. Seven Cores were created to address the various considerations, including Electronic Health Records; Phenotypes, Data Standards, and Data Quality; Biostatistics and Design Core; Patient-Reported Outcomes; Health Care Systems Interactions; Regulatory/Ethics; and Stakeholder Engagement. The goal of this article is to summarize the Biostatistics and Design Core's lessons learned during the initial pilot phase with seven pragmatic clinical trials conducted between 2012 and 2014. Methodological issues arose from the five cluster-randomized trials, also called group-randomized trials, including consideration of crossover and stepped wedge designs. We outlined general themes and challenges and proposed solutions from the pilot phase including topics such as study design, unit of randomization, sample size, and statistical analysis. Our findings are applicable to other pragmatic clinical trials conducted within health care systems. Pragmatic clinical trials using the UH2/UH3 funding mechanism provide an opportunity to ensure that all relevant design issues have been fully considered in order to reliably and efficiently evaluate new interventions and treatments. The integrity and generalizability of trial results can only be ensured if rigorous designs and appropriate analysis choices are an essential part of their research protocols. © The Author(s) 2016.

A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.

PubMed

Donovan, Jenny L; Young, Grace J; Walsh, Eleanor I; Metcalfe, Chris; Lane, J Athene; Martin, Richard M; Tazewell, Marta K; Davis, Michael; Peters, Tim J; Turner, Emma L; Mills, Nicola; Khazragui, Hanan; Khera, Tarnjit K; Neal, David E; Hamdy, Freddie C

2018-04-01

Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. Population-based cluster randomization created a prospective study of prostate-specific antigen (PSA) testing and a comprehensive-cohort study including groups choosing treatment or excluded from the RCT, as well as those randomized. Baseline information assessed selection and response during RCT conduct. The prospective study (82,430 PSA-tested men) represented healthy men likely to respond to a screening invitation. The extended comprehensive cohort comprised 1,643 randomized, 997 choosing treatment, and 557 excluded with advanced cancer/comorbidities. Men choosing treatment were very similar to randomized men except for having more professional/managerial occupations. Excluded men were similar to the randomized socio-demographically but different clinically, representing less healthy men with more advanced PCa. The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial.

PubMed

McMurran, Mary; Day, Florence; Reilly, Joseph; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Moran, Paul; Crawford, Mike J

2017-12-01

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.

Pragmatic communication is impaired in Parkinson disease.

PubMed

Hall, Deborah; Ouyang, Bichun; Lonnquist, Eryn; Newcombe, Jill

2011-05-01

The purpose of this study was to determine whether severity of disease, cognitive function, age, gender, or amount of social interaction were associated with pragmatic dysfunction in Parkinson disease. No studies have previously been done to investigate variables that may be associated with pragmatic dysfunction in Parkinson disease. A case-control study was conducted with 17 Parkinson disease patients and 17 convenience controls. Each Parkinson disease patient and a control were interviewed, and their pragmatic skills were evaluated using a scale of pragmatic communication skills. Correlation analysis was used to determine what factors were associated with pragmatic dysfunction in the Parkinson disease patients. Cases scored lower on the pragmatic scale with a mean of 29.7 compared with 38.9 in the controls (p < .001) out of 40 possible points. The score on the scale of pragmatic communication skills had moderate to strong correlations with the MMSE (r = .81, p = .002), Unified Parkinson's Disease Rating Scale score (r = -.71, p = .002), and duration of disease (r = -.53, p = .03). These results show that Parkinson disease patients have impaired pragmatic function compared with controls on both verbal and nonverbal sections, and this impairment correlates with mental state, duration, and severity of disease.

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

PubMed

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

2018-01-26

Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators. Although we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials. Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial.

PubMed

Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

2013-01-01

Restorative home care services are short-term and aimed at maximizing a person's ability to live independently. They are multidimensional and often include an exercise program to improve strength, mobility, and balance. The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults. A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service. Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE (as this was a new program, the intervention) or the structured exercise program currently being used in the service (control). Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance, strength, mobility, falls efficacy, vitality, function, and disability. There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period. Outcome measurement indicated that the LiFE program was as effective, and on 40% of the measures, more effective, than the structured exercise program. Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes.

Effects of a lifestyle intervention on psychosocial well-being of severe mentally ill residential patients: ELIPS, a cluster randomized controlled pragmatic trial.

PubMed

Stiekema, Annemarie P M; Looijmans, Anne; van der Meer, Lisette; Bruggeman, Richard; Schoevers, Robert A; Corpeleijn, Eva; Jörg, Frederike

2018-03-01

Large studies investigating the psychosocial effects of lifestyle interventions in patients with a severe mental illness (SMI) are scarce, especially in residential patients. This large, randomized controlled, multicentre pragmatic trial assessed the psychosocial effects of a combined diet-and-exercise lifestyle intervention targeting the obesogenic environment of SMI residential patients. Twenty-nine sheltered and clinical care teams were randomized into intervention (n=15) or control (n=14) arm. Team tailored diet-and-exercise lifestyle plans were set up to change the obesogenic environment into a healthier setting, and team members were trained in supporting patients to make healthier choices. The control group received care-as-usual. The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Health of the Nation Outcome Scales (HoNOS) and the Manchester Short Assessment of Quality of Life (MANSA) were assessed at baseline and after three and twelve months. Data were available for 384 intervention and 386 control patients (48.6±12.5years old, 62.7% males, 73.7% psychotic disorder). Linear mixed model analysis showed no psychosocial improvements in the intervention group compared to care-as-usual; the intervention group showed a slightly reduced quality of life (overall) and a small increase in depressive symptoms (clinical care facilities) and psychotic symptoms (sheltered facilities). This may be due to difficulties with implementation, the intervention not being specifically designed for improvements in mental well-being, or the small change approach, which may take longer to reach an effect. Further research might elucidate what type of lifestyle intervention under what circumstances positively affects psychosocial outcomes in this population. Copyright © 2018 Elsevier B.V. All rights reserved.

The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review.

PubMed

Aves, Theresa; Allan, Katherine S; Lawson, Daeria; Nieuwlaat, Robby; Beyene, Joseph; Mbuagbaw, Lawrence

2017-09-03

There has been increasing interest in pragmatic trials methodology. As a result, tools such as the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) are being used prospectively to help researchers design randomised controlled trials (RCTs) within the pragmatic-explanatory continuum. There may be value in applying the PRECIS-2 tool retrospectively in a systematic review setting as it could provide important information about how to pool data based on the degree of pragmatism. To investigate the role of pragmatism as a source of heterogeneity in systematic reviews by (1) identifying systematic reviews with meta-analyses of RCTs that have moderate to high heterogeneity, (2) applying PRECIS-2 to RCTs of systematic reviews, (3) evaluating the inter-rater reliability of PRECIS-2, (4) determining how much of this heterogeneity may be explained by pragmatism. A cross-sectional methodological review will be conducted on systematic reviews of RCTs published in the Cochrane Library from 1 January 2014 to 1 January 2017. Included systematic reviews will have a minimum of 10 RCTs in the meta-analysis of the primary outcome and moderate to substantial heterogeneity (I 2 ≥50%). Of the eligible systematic reviews, a random selection of 10 will be included for quantitative evaluation. In each systematic review, RCTs will be scored using the PRECIS-2 tool, in duplicate. Agreement between raters will be measured using the intraclass correlation coefficient. Subgroup analyses and meta-regression will be used to evaluate how much variability in the primary outcome may be due to pragmatism. This review will be among the first to evaluate the PRECIS-2 tool in a systematic review setting. Results from this research will provide inter-rater reliability information about PRECIS-2 and may be used to provide methodological guidance when dealing with pragmatism in systematic reviews and subgroup considerations. On completion, this review will be submitted to a peer-reviewed journal for publication. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

PubMed

Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

2017-05-01

This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

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

PubMed

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

2014-09-01

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

In a rural area of Bangladesh, traditional birth attendant training improved early infant feeding practices: a pragmatic cluster randomized trial.

PubMed

Talukder, Shamim; Farhana, Dina; Vitta, Bineti; Greiner, Ted

2017-01-01

In rural Bangladesh, most births take place at home. There is little evidence regarding the influence of traditional birth attendants (TBAs) or community volunteers (CVs) on early infant feeding practices. We conducted a pragmatic cluster randomized controlled trial in Panchagarh District to examine the effects of training and post-training supervision of TBAs/CVs on early breastfeeding practices. Nine unions were randomized into three groups of three unions. We compared outcomes between mothers in a control group (CG), those living in unions where TBAs/CVs had received a 5-day training in early feeding practices (TG) and those living in unions where TBAs/CVs were both trained and supervised (SG). A total of 1182 mothers of infants aged 0-6 months were interviewed at baseline. After 6 months of intervention, an endline survey was conducted on a different sample of 1148 mothers of infants aged 0-6 months in the same areas. In both intervention areas, TBAs/CVs made regular home visits and attended births whenever possible. Rates of early initiation of breastfeeding, avoidance of prelacteal feeds and exclusive breastfeeding were compared between groups using cluster-controlled mixed model logistic regression. At endline, both intervention groups had significantly higher proportions of mothers who reported early initiation of breastfeeding (CG: 88%, TG: 96%, SG: 96%) and avoidance of prelacteal feeds (CG: 48%, TG: 80%, SG: 88%) compared with the control group; there were no significant differences between the two intervention groups. The endline rates of reported exclusive breastfeeding were not significantly different among groups (CG: 67%, TG: 76%, SG: 83%). © 2016 John Wiley & Sons Ltd.

An avatar based education application to improve patients' knowledge of and response to heart attack symptoms: a pragmatic randomized controlled trial protocol.

PubMed

Tongpeth, Jintana; Du, Huiyun; Clark, Robyn

2018-06-19

To evaluate the effectiveness of an interactive, avatar based education application to improve knowledge of and response to heart attack symptoms in people who are at risk of a heart attack. Poor knowledge of heart attack symptoms is recognised as a significant barrier to timely medical treatment. Numerous studies have demonstrated that technology can assist in patient education to improve knowledge and self-care. A single-center, non-blinded, two parallel groups, pragmatic randomized controlled trial. Seventy patients will be recruited from the coronary care unit of a public hospital. Eligible participants will be randomised to either the usual care or the intervention group (usual care plus avatar-based heart attack education app). The primary outcome of this study is knowledge. Secondary outcomes include response to heart attack symptoms, health service use and satisfaction. Study participants will be followed-up for six months. This study will evaluate the avatar based education app as a method to deliver vital information to patients. Participants' knowledge of and response to heart attack symptoms, as well as their health service use, will be assessed to evaluate the intervention effectiveness. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Outcomes of the Smoker's Health Project: A Pragmatic Comparative Effectiveness Trial of Tobacco-Dependence Interventions Based on Self-Determination Theory

ERIC Educational Resources Information Center

Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.

2016-01-01

A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…

Effectiveness of a mood management component as an adjunct to a telephone counselling smoking cessation intervention for smokers with a past major depression: a pragmatic randomized controlled trial.

PubMed

van der Meer, Regina M; Willemsen, Marc C; Smit, Filip; Cuijpers, Pim; Schippers, Gerard M

2010-11-01

To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Pragmatic randomized controlled trial with two conditions, with follow-up at 6 and 12 months. The control intervention consisted of eight sessions of proactive telephone counselling. The mood management intervention was an integration of the control intervention with a mood management component. This component consisted of a self-help mood management manual, two more preparatory proactive telephone counselling sessions and supplementary homework assignments and advice. Dutch national smoking cessation quitline. A total of 485 daily smokers with past major depression, according to the DSM-IV. The primary outcome measure was prolonged abstinence and secondary outcome measures were 7-day point prevalence abstinence and depressive symptoms. The mood management intervention resulted in significantly higher prolonged abstinence rates at 6- and 12-month follow-up (30.5% and 23.9% in experimental condition, 22.3% and 14.0% in the control condition). The odds ratios were 1.60 (95% CI 1.06-2.42) and 1.96 (95% CI 1.22-3.14) for both follow-ups. The mood management intervention did not seem to prevent recurrence of depressive symptoms. Adding a mood management component to telephone counselling for smoking cessation in smokers with a past major depression increases cessation rates without necessarily reducing depressive symptoms. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial.

PubMed

Levenson, Jessica C; Rollman, Bruce L; Ritterband, Lee M; Strollo, Patrick J; Smith, Kenneth J; Yabes, Jonathan G; Moore, Charity G; Harvey, Allison G; Buysse, Daniel J

2017-06-06

Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

The PRECIS-2 tool has good interrater reliability and modest discriminant validity.

PubMed

Loudon, Kirsty; Zwarenstein, Merrick; Sullivan, Frank M; Donnan, Peter T; Gágyor, Ildikó; Hobbelen, Hans J S M; Althabe, Fernando; Krishnan, Jerry A; Treweek, Shaun

2017-08-01

PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 is a tool that could improve design insight for trialists. Our aim was to validate the PRECIS-2 tool, unlike its predecessor, testing the discriminant validity and interrater reliability. Over 80 international trialists, methodologists, clinicians, and policymakers created PRECIS-2 helping to ensure face validity and content validity. The interrater reliability of PRECIS-2 was measured using 19 experienced trialists who used PRECIS-2 to score a diverse sample of 15 randomized controlled trial protocols. Discriminant validity was tested with two raters to independently determine if the trial protocols were more pragmatic or more explanatory, with scores from the 19 raters for the 15 trials as predictors of pragmatism. Interrater reliability was generally good, with seven of nine domains having an intraclass correlation coefficient over 0.65. Flexibility (adherence) and recruitment had wide confidence intervals, but raters found these difficult to rate and wanted more information. Each of the nine PRECIS-2 domains could be used to differentiate between trials taking more pragmatic or more explanatory approaches with better than chance discrimination for all domains. We have assessed the validity and reliability of PRECIS-2. An elaboration study and web site provide guidance to help future users of the tool which is continuing to be tested by trial teams, systematic reviewers, and funders. Copyright © 2017 Elsevier Inc. All rights reserved.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

PubMed

Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

PubMed

Adams, Alyce S; Bayliss, Elizabeth A; Schmittdiel, Julie A; Altschuler, Andrea; Dyer, Wendy; Neugebauer, Romain; Jaffe, Marc; Young, Joseph D; Kim, Eileen; Grant, Richard W

2016-06-01

Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy. We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (standard deviation = 12) years. The racial ethnic make-up is 56% White, 8% Asian, 13% Black or African American, and 19% Hispanic or Latino. Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology. © The Author(s) 2016.

Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial

PubMed Central

2010-01-01

Background Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD) loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength) are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks. Methods/Design A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen), bone formation (osteocalcin), and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16) to explore the feasibility of modeling skeletal mechanical loads and postural control as mediators of fracture risk. Discussion Results of this study will provide preliminary evidence regarding the value of Tai Chi as an intervention for decreasing fracture risk in osteopenic women. They will also inform the feasibility, value and potential limitations related to the use of pragmatic designs for the study of Tai Chi and related mind-body exercise. If the results are positive, this will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study. Trial registration This trial is registered in Clinical Trials.gov, with the ID number of NCT01039012. PMID:20193083

Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial.

PubMed

Molenaar, Nina M; Brouwer, Marlies E; Bockting, Claudi L H; Bonsel, Gouke J; van der Veere, Christine N; Torij, Hanneke W; Hoogendijk, Witte J G; Duvekot, Johannes J; Burger, Huibert; Lambregtse-van den Berg, Mijke P

2016-03-18

Approximately 6.2 % of women in the USA and 3.7 % of women in the UK, use Selective Serotonin Reuptake Inhibitors (SSRIs) during their pregnancies because of depression and/or anxiety. In the Netherlands, this prevalence is around 2 %. Nonetheless, SSRI use during pregnancy is still controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, while on the other hand relapse or recurrence of depression during pregnancy poses risks for both mother and child. Among patients and professionals there is an urgent need for evidence from randomized studies to make rational decisions regarding continuation or tapering of SSRIs during pregnancy. At present, no such studies exist. 'Stop or Go' is a pragmatic multicentre randomized non-inferiority trial among 200 pregnant women with a gestational age of less than 16 weeks who use SSRIs without clinically relevant depressive symptoms. Women allocated to the intervention group will receive preventive cognitive therapy with gradual, guided discontinuation of SSRIs under medical management (STOP). Women in the control group will continue the use of SSRIs (GO). Primary outcome will be the (cumulative) incidence of relapse or recurrence of maternal depressive disorder (as assessed by the Structured Clinical Interview for DSM disorders) during pregnancy and up to three months postpartum. Secondary outcomes will be child outcome (neonatal outcomes and psychomotor and behavioural outcomes up to 24 months postpartum), and health-care costs. Total study duration for participants will be therefore be 30 months. We specified a non-inferiority margin of 15 % difference in relapse risk. This study is the first to investigate the effect of guided tapering of SSRIs with preventive cognitive therapy from early pregnancy onwards as compared to continuation of SSRIs during pregnancy. We will study the effects on both mother and child with a pragmatic approach. Additionally, the study examines cost effectiveness. If non-inferiority of preventive cognitive therapy with guided tapering of SSRIs compared to intended continuation of SSRIs is demonstrated for the primary outcome, this may be the preferential strategy during pregnancy. Netherlands Trial Register (NTR): NTR4694 ; registration date: 16-jul-2014.

Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial.

PubMed

Lutge, Elizabeth; Lewin, Simon; Volmink, Jimmy; Friedman, Irwin; Lombard, Carl

2013-05-28

Poverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa. This was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n = 2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n = 1,984) received usual tuberculosis care. Intention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P = 0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose-response relationship between frequency of receipt of the voucher and treatment success (P <0.001). Our pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it.

Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial.

PubMed

Du, Yu-Zheng; Gao, Xin-Xin; Wang, Cheng-Ting; Zheng, Hai-Zhen; Lei, Yun; Wu, Meng-Han; Shi, Xue-Min; Ban, Hai-Peng; Gu, Wen-Long; Meng, Xiang-Gang; Wei, Mao-Ti; Hu, Chun-Xiao

2017-09-15

Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke. This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group. The experimental group will receive "HuoXueSanFeng" acupuncture combined with one antihypertensive medication in addition to routine ischemic stroke treatment. The control group will only receive one antihypertensive medication and basic treatments for ischemic stroke. HuoXueSanFeng acupuncture will be given for six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will, thereafter, be conducted. Antihypertensive medication will be adjusted based on BP levels. The primary outcome will be the recurrence of stroke. The secondary outcomes including 24-h ambulatory BP, the TCM syndrome score, the Short Form 36-item Health Survey (SF-36), the National Institute of Health Stroke Scale (NIHSS), as well as the Barthel Index (BI) scale will be assessed at baseline, 6 weeks and 12 weeks post initiating treatments; cardiac ultrasound, carotid artery ultrasound, transcranial Doppler, and lower extremity ultrasound will be evaluated at baseline and 12 weeks after treatment. The safety of acupuncture will also be assessed. We aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment. ClinicalTrials.gov, ID: NCT02967484 . Registered on 13 February 2017; last updated on 27 June 2017.

Pragmatic Competency and Obsessive-Compulsive Disorder: A Comparative Assessment with Normal Controls

ERIC Educational Resources Information Center

Ghahari, Shima; Hassani, Hamidreza; Purmofrad, Maryam

2017-01-01

Unlike such cognitive impairments as autism and schizophrenia, the speech pattern in obsessive-compulsive disorder (OCD) has largely remained underrepresented. We examined the pragmatic competence of OCD-affected individuals under two variant modes: pragmatic recognition and pragmatic production. In the recognition phase, the informants completed…

Structural language, pragmatic communication, behavior, and social competence in children adopted internationally: A pilot study.

PubMed

Petranovich, Christine L; Walz, Nicolay Chertkoff; Staat, Mary Allen; Chiu, Chung-Yiu Peter; Wade, Shari L

2017-01-01

The objectives of this study were to examine the association of structural language and pragmatic communication with behavior problems and social competence in girls adopted internationally. Participants included girls between 6-12 years of age who were internationally adopted from China (n = 32) and Eastern-Europe (n = 25) and a control group of never-adopted girls (n = 25). Children completed the Wechsler Abbreviated Scale of Intelligence. Parents completed the Child Communication Checklist- second edition, the Child Behavior Checklist, and the Home and Community Social Behavior Scales. Compared to the controls, parents in the Eastern European group reported more problems with social competence, externalizing behaviors, structural language, and pragmatic communication. The Chinese group evidenced more internalizing problems. Using generalized linear regression, interaction terms were examined to determine if the associations of pragmatic communication and structural language with behavior problems and social competence varied across groups. Controlling for general intellectual functioning, poorer pragmatic communication was associated with more externalizing problems and poorer social competence. In the Chinese group, poorer pragmatic communication was associated with more internalizing problems. Post-adoption weaknesses in pragmatic communication are associated with behavior problems and social competence. Internationally adopted children may benefit from interventions that target pragmatic communication.

Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.

PubMed

Krist, Alex H; Glenn, Beth A; Glasgow, Russell E; Balasubramanian, Bijal A; Chambers, David A; Fernandez, Maria E; Heurtin-Roberts, Suzanne; Kessler, Rodger; Ory, Marcia G; Phillips, Siobhan M; Ritzwoller, Debra P; Roby, Dylan H; Rodriguez, Hector P; Sabo, Roy T; Sheinfeld Gorin, Sherri N; Stange, Kurt C

2013-06-25

There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. Clinicaltrials.gov: NCT01825746.

Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care.

PubMed

Gesell, Sabina B; Klein, Karen Potvin; Halladay, Jacqueline; Bettger, Janet Prvu; Freburger, Janet; Cummings, Doyle M; Lutz, Barbara J; Coleman, Sylvia; Bushnell, Cheryl; Rosamond, Wayne; Duncan, Pamela W

2017-04-01

The Comprehensive Post-Acute Stroke Services (COMPASS) Study is one of the first large pragmatic randomized-controlled clinical trials using comparative effectiveness research methods, funded by the Patient-Centered Outcomes Research Institute. In the COMPASS Study, we compare the effectiveness of a patient-centered, transitional care intervention versus usual care for stroke patients discharged home from acute care. Outcomes include stroke patient post-discharge functional status and caregiver strain 90 days after discharge, and hospital readmissions. A central tenet of Patient-Centered Outcomes Research Institute-funded research is stakeholder engagement throughout the research process. However, evidence on how to successfully implement a pragmatic trial that changes systems of care in combination with robust stakeholder engagement is limited. This combination is not without challenges. We present our approach for broad-based stakeholder engagement in the context of a pragmatic trial with the participation of patients, caregivers, community stakeholders, including the North Carolina Stroke Care Collaborative hospital network, and policy makers. To maximize stakeholder engagement throughout the COMPASS Study, we employed a conceptual model with the following components: (1) Patient and Other Stakeholder Identification and Selection; (2) Patient and Other Stakeholder Involvement Across the Spectrum of Research Activities; (3) Dedicated Resources for Patient and Other Stakeholder Involvement; (4) Support for Patient and Other Stakeholder Engagement Through Organizational Processes; (5) Communication with Patients and Other Stakeholders; (6) Transparent Involvement Processes; (7) Tracking of Engagement; and (8) Evaluation of Engagement. In this paper, we describe how each component of the model is being implemented and how this approach addresses existing gaps in the literature on strategies for engaging stakeholders in meaningful and useful ways when conducting pragmatic trials.

Development and Standardization of a Test for Pragmatic Language Skills in Egyptian Arabic: The Egyptian Arabic Pragmatic Language Test (EAPLT).

PubMed

Khodeir, Mona S; Hegazi, Mona A; Saleh, Marwa M

2018-03-19

The aim of this study was to standardize an Egyptian Arabic Pragmatic Language Test (EAPLT) using linguistically and socially suitable questions and pictures in order to be able to address specific deficits in this language domain. Questions and pictures were designed for the EAPLT to assess 3 pragmatic language subsets: pragmatic skills, functions, and factors. Ten expert phoniatricians were asked to review the EAPLT and complete a questionnaire to assess the validity of the test items. The EAPLT was applied in 120 typically developing Arabic-speaking Egyptian children (64 females and 56 males) randomly selected by inclusion and exclusion criteria in the age range between 2 years, 1 month, 1 day and 9 years, 12 months, 31 days. Children's scores were used to calculate the means and standard deviations and the 5th and 95th percentiles to determine the age of the pragmatic skills acquisition. All experts have mostly agreed that the EAPLT gives a general idea about children's pragmatic language development. Test-retest reliability analysis proved the high reliability and internal consistency of the EAPLT subsets. A statistically significant correlation was found between the test subsets and age. The EAPLT is a valid and reliable Egyptian Arabic test that can be applied in order to detect a pragmatic language delay. © 2018 S. Karger AG, Basel.

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

PubMed

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial.

PubMed

Askim, Torunn; Langhammer, Birgitta; Ihle-Hansen, Hege; Gunnes, Mari; Lydersen, Stian; Indredavik, Bent

2018-02-01

The evidence for interventions to prevent functional decline in the long term after stroke is lacking. The aim of this trial was to evaluate the efficacy and safety of an 18-month follow-up program of individualized regular coaching on physical activity and exercise. This was a multicentre, pragmatic, single-blinded, randomized controlled trial. Adults (age ≥18 years) with first-ever or recurrent stroke, community dwelling, with modified Rankin Scale <5, and no serious comorbidities were included 10 to 16 weeks poststroke. The intervention group received individualized regular coaching on physical activity and exercise every month for 18 consecutive months. The control group received standard care. Primary outcome was the Motor Assessment Scale at end of intervention (18-month follow-up). Secondary measures were Barthel index, modified Rankin Scale, item 14 from Berg Balance Scale, Timed Up and Go test, gait speed, 6-minute walk test, and Stroke Impact Scale. Other outcomes were adverse events and compliance to the intervention assessed by training diaries and the International Physical Activity Questionnaire. Three hundred and eighty consenting participants were randomly assigned to individualized coaching (n=186) or standard care (n=194). The mean estimated difference on Motor Assessment Scale in favor of control group was -0.70 points (95% confidence interval, -2.80, 1.39), P =0.512. There were no differences between the groups on Barthel index, modified Rankin Scale, or Berg Balance Scale. The frequency of adverse events was low in both groups. Results from International Physical Activity Questionnaire and training diaries showed increased activity levels but low intensity of the exercise in the intervention group. The regular individualized coaching did not improve maintenance of motor function or the secondary outcomes compared with standard care. The intervention should be regarded as safe. Despite the neutral results, the health costs related to the intervention should be investigated. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01467206. © 2017 American Heart Association, Inc.

Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol

PubMed Central

2011-01-01

Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention) or control (no change). At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI) and standardized body mass index (zBMI). Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous), Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight management programs. Trial Registration ACTRN12611000164998 PMID:21718543

Financial Incentives to Increase Advance Care Planning Among Medicaid Beneficiaries: Lessons Learned From Two Pragmatic Randomized Trials.

PubMed

Barnato, Amber E; Moore, Robert; Moore, Charity G; Kohatsu, Neal D; Sudore, Rebecca L

2017-07-01

Medicaid populations have low rates of advance care planning (ACP). Potential policy interventions include financial incentives. To test the effectiveness of patient plus provider financial incentive compared with provider financial incentive alone for increasing ACP discussions among Medicaid patients. Between April 2014 and July 2015, we conducted two sequential assessor-blinded pragmatic randomized trials in a health plan that pays primary care providers (PCPs) $100 to discuss ACP: 1) a parallel cluster trial (provider-delivered patient incentive) and 2) an individual-level trial (mail-delivered patient incentive). Control and intervention arms included encouragement to complete ACP, instructions for using an online ACP tool, and (in the intervention arm) $50 for completing the online ACP tool and a small probability of $1000 (i.e., lottery) for discussing ACP with their PCP. The primary outcome was provider-reported ACP discussion within three months. In the provider-delivered patient incentive study, 38 PCPs were randomized to the intervention (n = 18) or control (n = 20) and given 10 patient packets each to distribute. Using an intention-to-treat analysis, there were 27 of 180 ACP discussions (15%) in the intervention group and 5 of 200 (2.5%) in the control group (P = .0391). In the mail-delivered patient incentive study, there were 5 of 187 ACP discussions (2.7%) in the intervention group and 5 of 189 (2.6%) in the control group (P = .99). ACP rates were low despite an existing provider financial incentive. Adding a provider-delivered patient financial incentive, but not a mail-delivered patient incentive, modestly increased ACP discussions. PCP encouragement combined with a patient incentive may be more powerful than either encouragement or incentive alone. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial

PubMed Central

van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.; Vernooij-Dassen, Myrra J. F. J.

2013-01-01

Background The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Methods Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents’ neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. Results 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI −2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Conclusions Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Trial Registration Dutch Trials Registry NTR2314. PMID:23844003

Effects of dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial.

PubMed

van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M M; Donders, Rogier; Zuidema, Sytse U; Koopmans, Raymond T C M; Vernooij-Dassen, Myrra J F J

2013-01-01

The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents' neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Dutch Trials Registry NTR2314.

A randomised controlled trial of a computerised intervention for children with social communication difficulties to support peer collaboration.

PubMed

Murphy, Suzanne M; Faulkner, Dorothy M; Reynolds, Laura R

2014-11-01

An intervention aiming to support children with social communication difficulties was tested using a randomised controlled design. Children aged 5-6 years old (n=32) were tested and selected for participation on the basis of their scores on the Test of Pragmatic Skills (TPS) and were then randomly assigned to the intervention arm or to the delayed intervention control group. Following previous research which suggested that computer technology may be particularly useful for this group of children, the intervention included a collaborative computer game which the children played with an adult. Subsequently, children's performance as they played the game with a classmate was observed. Micro-analytic observational methods were used to analyse the audio-recorded interaction of the children as they played. Pre- and post-intervention measures comprised the Test of Pragmatic Skills, children's performance on the computer game and verbal communication measures that the children used during the game. This evaluation of the intervention shows promise. At post-test, the children who had received the intervention, by comparison to the control group who had not, showed significant gains in their scores on the Test of Pragmatic Skills (p=.009, effect size r=-.42), a significant improvement in their performance on the computer game (p=.03, r=-.32) and significantly greater use of high-quality questioning during collaboration (p<.001, r=-.60). Furthermore, the children who received the intervention made significantly more positive statements about the game and about their partners (p=.02, r=-.34) suggesting that the intervention increased their confidence and enjoyment. Copyright © 2014 Elsevier Ltd. All rights reserved.

The inositols and polycystic ovary syndrome

PubMed Central

Kalra, Bharti; Kalra, Sanjay; Sharma, J. B.

2016-01-01

This review describes the rationale, biochemical, and clinical data related to the use of inositols in polycystic ovary syndrome (PCOS). It covers studies related to the mechanism of action of myo-inositol and D-chiro-inositol (MDI), with randomized controlled trials conducted in women with PCOS, and utilizes these data to suggest pragmatic indications and methods for using MDI combination in PCOS. Rationally crafted inositol combinations have a potential role to play in maintaining metabolic, endocrine, and reproductive health in women with PCOS. PMID:27730087

Rationale and design of the ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic trial.

PubMed

Lauffenburger, Julie C; Lewey, Jennifer; Jan, Saira; Nanchanatt, Gina; Makanji, Sagar; Ferro, Christina A; Sheehan, John; Wittbrodt, Eric; Morawski, Kyle; Lee, Jessica; Ghazinouri, Roya; Choudhry, Niteesh K

2017-08-01

Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making). To test the impact of a novel telephone-based patient-centered intervention on glycemic control for patients with poorly-controlled diabetes. ENGAGE-DM (ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus) is a pragmatic trial of patients with poorly-controlled diabetes receiving treatment with an oral hypoglycemic agent. We randomized 1400 patients in a large health insurer to intervention or usual care. The intervention is delivered over the telephone by a pharmacist and consists of a 2-step process that integrates brief negotiated interviewing and shared decision-making to identify patient-concordant goals and options for enhancing patients' diabetes management. The trial's primary outcome is disease control, assessed using glycosylated hemoglobin values. Secondary outcomes include medication adherence measures, assessed using pharmacy claims data. This trial will determine whether a novel highly-scalable patient engagement strategy improves disease control and adherence to medications among individuals with poorly-controlled diabetes. Copyright © 2017. Published by Elsevier Inc.

Approaches to answering critical CER questions.

PubMed

Kinnier, Christine V; Chung, Jeanette W; Bilimoria, Karl Y

2015-01-01

While randomized controlled trials (RCTs) are the gold standard for research, many research questions cannot be ethically and practically answered using an RCT. Comparative effectiveness research (CER) techniques are often better suited than RCTs to address the effects of an intervention under routine care conditions, an outcome otherwise known as effectiveness. CER research techniques covered in this section include: effectiveness-oriented experimental studies such as pragmatic trials and cluster randomized trials, treatment response heterogeneity, observational and database studies including adjustment techniques such as sensitivity analysis and propensity score analysis, systematic reviews and meta-analysis, decision analysis, and cost effectiveness analysis. Each section describes the technique and covers the strengths and weaknesses of the approach.

The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice.

PubMed

Meuldijk, D; Carlier, I V E; van Vliet, I M; van Veen, T; Wolterbeek, R; van Hemert, A M; Zitman, F G

2016-03-01

Depressive and anxiety disorders contribute to a high disease burden. This paper investigates whether concise formats of cognitive behavioral- and/or pharmacotherapy are equivalent with longer standard care in the treatment of depressive and/or anxiety disorders in secondary mental health care. A pragmatic randomized controlled equivalence trial was conducted at five Dutch outpatient Mental Healthcare Centers (MHCs) of the Regional Mental Health Provider (RMHP) 'Rivierduinen'. Patients (aged 18-65 years) with a mild to moderate anxiety and/or depressive disorder, were randomly allocated to concise or standard care. Data were collected at baseline, 3, 6 and 12 months by Routine Outcome Monitoring (ROM). Primary outcomes were the Brief Symptom Inventory (BSI) and the Web Screening Questionnaire (WSQ). We used Generalized Estimating Equations (GEE) to assess outcomes. Between March 2010 and December 2012, 182 patients, were enrolled (n=89 standard care; n=93 concise care). Both intention-to-treat and per-protocol analyses demonstrated equivalence of concise care and standard care at all time points. Severity of illness reduced, and both treatments improved patient's general health status and subdomains of quality of life. Moreover, in concise care, the beneficial effects started earlier. Concise care has the potential to be a feasible and promising alternative to longer standard secondary mental health care in the treatment of outpatients with a mild to moderate depressive and/or anxiety disorder. For future research, we recommend adhering more strictly to the concise treatment protocols to further explore the beneficial effects of the concise treatment. The study is registered in the Netherlands Trial Register, number NTR2590. Clinicaltrials.gov identifier: NCT01643642. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

PubMed Central

2013-01-01

Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Trials registration Current Controlled Trials ISRCTN76061874 PMID:23953975

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group.

PubMed

Pradhan, Menno; Brinkman, Sally A; Beatty, Amanda; Maika, Amelia; Satriawan, Elan; de Ree, Joppe; Hasan, Amer

2013-08-16

This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Current Controlled Trials ISRCTN76061874.

Effects of manual therapy and exercise targeting the hips in patients with low-back pain-A randomized controlled trial.

PubMed

Bade, Michael; Cobo-Estevez, Manuel; Neeley, Darren; Pandya, Jeevan; Gunderson, Travis; Cook, Chad

2017-08-01

The benefits of providing manual therapy and exercise targeting the hips in individuals with mechanical low-back pain (LBP) are not well established. The objective in this study is to determine whether a formal prescriptive treatment protocol for the hips improves outcomes in patients with a primary complaint of mechanical LBP. Eighty-four (84) subjects (50 males, 46.1 ± 16.2 years) were randomized to 1 of 2 groups: pragmatic treatment of the lumbar spine only (LBP) (n = 39) or pragmatic treatment of the lumbar spine and prescriptive treatment of bilateral hips (LBP + HIP) (n = 45). Pragmatic treatment of the lumbar spine was based upon published clinical guidelines. Prescriptive treatment of the hips involved the use of 3 hip exercises targeting the gluteal musculature and 3 mobilization techniques targeting the hips. Subjects were assessed at baseline, 2 weeks, and at discharge with the following measures: Modified Oswestry Disability Index, Numeric Pain Rating Scale, a global rating of change (GRoC) score, the patient acceptable symptom state (PASS), and patient satisfaction. At 2 weeks, significant differences between groups differences were found in GRoC and patient satisfaction (P < .05) favoring the LBP + HIP group. At discharge, there were significant differences on the Modified Oswestry Disability Index, numeric pain rating scale, GRoC, and patient satisfaction favoring the LBP + HIP group (P < .05). Effect sizes were small to medium. Our findings suggest that a prescriptive treatment of the hips may be of clinical value to individuals presenting with the primary complaint of mechanical LBP. © 2017 John Wiley & Sons, Ltd.

The assessment of pragmatics in Iranian patients with right brain damage

PubMed Central

Sobhani-Rad, Davood; Ghorbani, Askar; Ashayeri, Hassan; Jalaei, Shohereh; Mahmoodi-Bakhtiari, Behrooz

2014-01-01

Background: Pragmatics is appropriate use of language across a variety of social contexts that provides accurate interpretation of intentions. The occurrence of the right hemisphere lesions can interfere with pragmatic abilities, and particularly with the processing of nonliteral speech acts. Methods: Since the objective of this study was to assess different aspects of pragmatic competence in the right hemisphere damage (RHD) patients, 20 Iranian patients with right hemisphere lesions were examined by adult pragmatic profile (APP) and a novel checklist was introduced for Persian language speaking individuals. Meanwhile, 40 healthy adult individuals, who were age and gender matched with RHD patients, were considered as the control group. After obtaining video records, all subjects were evaluated for 35 pragmatic skills, including 24 verbal, 5 paralinguistic, and 6 nonverbal aspects, by a two-point scale system. Results: Studying RHD patients and their healthy counterparts revealed that the performance by participants with right hemisphere lesions exhibited a high degree of inappropriate pragmatic abilities compared with controls in all domains. Furthermore, RHD patients showed a trend of increasing difficulty in understanding and producing different pragmatic phenomena, including standard communication acts. Conclusion: Present results indicated that the right hemisphere lesions significantly affected pragmatic abilities in verbal, paralinguistic and nonverbal aspects. Such a pattern of performance, which is in line with deficits previously reported for RHD, proved the unquestioned role of the right hemisphere in processing nonliteral language. PMID:25295151

The assessment of pragmatics in Iranian patients with right brain damage.

PubMed

Sobhani-Rad, Davood; Ghorbani, Askar; Ashayeri, Hassan; Jalaei, Shohereh; Mahmoodi-Bakhtiari, Behrooz

2014-04-03

Pragmatics is appropriate use of language across a variety of social contexts that provides accurate interpretation of intentions. The occurrence of the right hemisphere lesions can interfere with pragmatic abilities, and particularly with the processing of nonliteral speech acts. Since the objective of this study was to assess different aspects of pragmatic competence in the right hemisphere damage (RHD) patients, 20 Iranian patients with right hemisphere lesions were examined by adult pragmatic profile (APP) and a novel checklist was introduced for Persian language speaking individuals. Meanwhile, 40 healthy adult individuals, who were age and gender matched with RHD patients, were considered as the control group. After obtaining video records, all subjects were evaluated for 35 pragmatic skills, including 24 verbal, 5 paralinguistic, and 6 nonverbal aspects, by a two-point scale system. Studying RHD patients and their healthy counterparts revealed that the performance by participants with right hemisphere lesions exhibited a high degree of inappropriate pragmatic abilities compared with controls in all domains. Furthermore, RHD patients showed a trend of increasing difficulty in understanding and producing different pragmatic phenomena, including standard communication acts. Present results indicated that the right hemisphere lesions significantly affected pragmatic abilities in verbal, paralinguistic and nonverbal aspects. Such a pattern of performance, which is in line with deficits previously reported for RHD, proved the unquestioned role of the right hemisphere in processing nonliteral language.

Evidence of Pragmatic Impairments in Speech and Proverb Interpretation in Schizophrenia.

PubMed

Haas, Marc H; Chance, Steven A; Cram, David F; Crow, Tim J; Luc, Aslan; Hage, Sarah

2015-08-01

Schizophrenia has been suggested to involve linguistic pragmatic deficits. In this study, two aspects of pragmatic ability were assessed; comprehension and production. Drawing on relevance theory and Gricean implicatures to assess shared attention and interpretation in a linguistic context, discourse samples and proverb interpretation were transcribed from recorded interviews with patients with schizophrenia and control subjects. The productive aspect of implicatures was assessed by quantifying the use of 'connectors' in discourse. Receptive aspects were assessed by scoring interpretations of four common proverbs. Statistically significant effects were found: patients with schizophrenia used connectors less than controls as well as performing worse in proverb comprehension. Positive correlations between connectors and proverb interpretation in all subjects suggested an underlying pragmatic root for both productive and receptive aspects. The relative number of connectors (as a percentage of words used) provided a better index of pragmatic ability than total number because total output appeared to be influenced by additional factors such as IQ. Deficits were found in the use of connectors and in proverb interpretation even when controlling for verbal IQ, suggesting that pragmatic aspects of language are particularly vulnerable in schizophrenia compared with other verbal abilities.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Pragmatic inferences in high-functioning adults with autism and Asperger syndrome.

PubMed

Pijnacker, Judith; Hagoort, Peter; Buitelaar, Jan; Teunisse, Jan-Pieter; Geurts, Bart

2009-04-01

Although people with autism spectrum disorders (ASD) often have severe problems with pragmatic aspects of language, little is known about their pragmatic reasoning. We carried out a behavioral study on high-functioning adults with autistic disorder (n = 11) and Asperger syndrome (n = 17) and matched controls (n = 28) to investigate whether they are capable of deriving scalar implicatures, which are generally considered to be pragmatic inferences. Participants were presented with underinformative sentences like "Some sparrows are birds". This sentence is logically true, but pragmatically inappropriate if the scalar implicature "Not all sparrows are birds" is derived. The present findings indicate that the combined ASD group was just as likely as controls to derive scalar implicatures, yet there was a difference between participants with autistic disorder and Asperger syndrome, suggesting a potential differentiation between these disorders in pragmatic reasoning. Moreover, our results suggest that verbal intelligence is a constraint for task performance in autistic disorder but not in Asperger syndrome.

Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial

PubMed Central

Little, Paul; Stuart, Beth; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Rabago, David; Richards-Hall, Samantha; Williamson, Ian; Yao, Guiqing; Raftery, James; Zhu, Shihua; Moore, Michael

2016-01-01

Background: Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms. Methods: We conducted a pragmatic randomized controlled trial involving adults (age 18–65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a “moderate to severe” impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods. Results: Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients’ RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change −7.42 v. −5.23; estimated adjusted mean difference between groups −2.51, 95% confidence interval −4.65 to −0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups. Interpretation: Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit. Trial registration: ISRCTN, no. 88204146. PMID:27431306

Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial.

PubMed

Little, Paul; Stuart, Beth; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Rabago, David; Richards-Hall, Samantha; Williamson, Ian; Yao, Guiqing; Raftery, James; Zhu, Shihua; Moore, Michael

2016-09-20

Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms. We conducted a pragmatic randomized controlled trial involving adults (age 18-65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a "moderate to severe" impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods. Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients' RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change -7.42 v. -5.23; estimated adjusted mean difference between groups -2.51, 95% confidence interval -4.65 to -0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups. Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit. ISRCTN, no. 88204146. © 2016 Canadian Medical Association or its licensors.

The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

PubMed

Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

2011-07-01

To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial

PubMed Central

PETRELLA, ROBERT J.; GILL, DAWN P.; ZOU, GUANGYONG; DE CRUZ, ASHLEIGH; RIGGIN, BRENDAN; BARTOL, CASSANDRA; DANYLCHUK, KAREN; HUNT, KATE; WYKE, SALLY; GRAY, CINDY M.; BUNN, CHRISTOPHER; ZWARENSTEIN, MERRICK

2017-01-01

ABSTRACT Introduction Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Methods Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Results Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Conclusions Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial. PMID:28719494

The effect of myofascial release and microwave diathermy combined with acupuncture versus acupuncture therapy in tension-type headache patients: A pragmatic randomized controlled trial.

PubMed

Georgoudis, George; Felah, Bledjana; Nikolaidis, Pantelis; Damigos, Dimitrios

2018-04-01

Nonpharmacological therapies for tension-type headache (TTH) and cervicogenic cephalalgia are often a treatment choice, despite the weak to moderate evidence. The aim of this study was to compare the effectiveness of an acupuncture/stretching protocol versus acupuncture/stretching plus physiotherapy techniques, in patients with TTH cephalalgia. A single-blind, prospective, multicentre, randomized controlled trial was designed considering the pragmatic situation of administering such protocols and treating the 44 headache patients participating in this study. The patients were randomly assigned in 2 treatment groups (control group, n = 20, acupuncture/stretching; experimental group, n = 24, acupuncture/stretching plus physiotherapy) and completed 10 treatment sessions within 4 weeks with measurements taking place before treatment, after the fifth treatment and after the 10th treatment. The mechanical pressure pain threshold (PPT) was considered as the main outcome measure, using a mechanical algometer to measure 7 bilateral somatic points. Acupuncture in both groups included 17-20 acupuncture points, whereas stretching was initially taught and subsequently self-administered (self-stretches), following a standardized set of movements of the cervical spine. Physiotherapy consisted of microwave diathermy and myofascial release with hands-on techniques. An improvement was noted in both groups/treatments regarding the main outcome measure PPT, all the way from the first to fifth and the 10th treatment, at all measuring sites and at all measurements in both groups (p < .001). When comparing the 2 groups, differences were noted after the 10th treatment (p < .05). In conclusion, patients with TTH headache were benefited from acupuncture and stretching but further PPT improvements were evidenced when physiotherapy hands-on techniques were added. In clinical terms, the combination of physiotherapy in the form of myofascial release and microwave diathermy with acupuncture and stretching in order to improve the analgesic effect (PPT) is strongly recommended. Copyright © 2017 John Wiley & Sons, Ltd.

Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

PubMed

Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

2016-09-01

Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).

The Effectiveness of Alcohol Screening and Brief Intervention in Emergency Departments: A Multicentre Pragmatic Cluster Randomized Controlled Trial

PubMed Central

Drummond, Colin; Deluca, Paolo; Coulton, Simon; Bland, Martin; Cassidy, Paul; Crawford, Mike; Dale, Veronica; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; McGovern, Ruth; Myles, Judy; Newbury-Birch, Dorothy; Oyefeso, Adenekan; Parrott, Steve; Patton, Robert; Perryman, Katherine; Phillips, Tom; Shepherd, Jonathan; Touquet, Robin; Kaner, Eileen

2014-01-01

Background Alcohol misuse is common in people attending emergency departments (EDs) and there is some evidence of efficacy of alcohol screening and brief interventions (SBI). This study investigated the effectiveness of SBI approaches of different intensities delivered by ED staff in nine typical EDs in England: the SIPS ED trial. Methods and Findings Pragmatic multicentre cluster randomized controlled trial of SBI for hazardous and harmful drinkers presenting to ED. Nine EDs were randomized to three conditions: a patient information leaflet (PIL), 5 minutes of brief advice (BA), and referral to an alcohol health worker who provided 20 minutes of brief lifestyle counseling (BLC). The primary outcome measure was the Alcohol Use Disorders Identification Test (AUDIT) status at 6 months. Of 5899 patients aged 18 or more presenting to EDs, 3737 (63·3%) were eligible to participate and 1497 (40·1%) screened positive for hazardous or harmful drinking, of whom 1204 (80·4%) gave consent to participate in the trial. Follow up rates were 72% (n = 863) at six, and 67% (n = 810) at 12 months. There was no evidence of any differences between intervention conditions for AUDIT status or any other outcome measures at months 6 or 12 in an intention to treat analysis. At month 6, compared to the PIL group, the odds ratio of being AUDIT negative for brief advice was 1·103 (95% CI 0·328 to 3·715). The odds ratio comparing BLC to PIL was 1·247 (95% CI 0·315 to 4·939). A per protocol analysis confirmed these findings. Conclusions SBI is difficult to implement in typical EDs. The results do not support widespread implementation of alcohol SBI in ED beyond screening followed by simple clinical feedback and alcohol information, which is likely to be easier and less expensive to implement than more complex interventions. Trial Registration Current Controlled Trials ISRCTN 93681536 PMID:24963731

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Andresen, Andrew A; Jones, Mark E; Lyons, Kevin J; Hondras, Maria A; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2013-01-16

Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.

The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial.

PubMed

Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Sarang, Aseefa; Connelly, Jo; Whisler, Adam; McKenzie, Kwame

2016-10-21

Little is known about the effectiveness of Housing First (HF) among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135) or usual care (n = 102) and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81) vs. 41 % (95 % CI 35 to 48), respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3). Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72). Housing First enhanced with anti-racism and anti-oppression practices can improve housing stability and community functioning among ethnically diverse homeless adults with mental illness. International Standard Randomized Control Trial Number Register Identifier: ISRCTN42520374 , assigned August 18, 2009.

Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials.

PubMed

Blödt, Susanne; Pach, Daniel; Roll, Stephanie; Witt, Claudia M

2014-12-15

Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone. Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of ≥ 4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0 = no pain, 10 = worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events. The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals. ClinicalTrials.gov identifier Relaxback NCT02019498, Relaxneck NCT02019134 registered on 18 December 2013.

Effectiveness of a partnership-based self-management programme for patients with mild and moderate chronic obstructive pulmonary disease: a pragmatic randomized controlled trial.

PubMed

Jonsdottir, Helga; Amundadottir, Olof R; Gudmundsson, Gunnar; Halldorsdottir, Bryndis S; Hrafnkelsson, Birgir; Ingadottir, Thorbjorg Soley; Jonsdottir, Rosa; Jonsson, Jon Steinar; Sigurjonsdottir, Ellen D; Stefansdottir, Ingibjorg K

2015-11-01

To evaluate the effectiveness of a 6-month, partnership-based self-management programme for patients with mild and moderate chronic obstructive pulmonary disease. Self-management is a widely valued concept used to address contemporary issues of chronic health problems. Findings of self-management programmes for people with chronic obstructive pulmonary disease are inconclusive. Pragmatic randomized control trial. Patients, 45-65 years old, with mild and moderate chronic obstructive pulmonary disease were invited with a family member. Experimental group (n = 48) participated in a 6-month, partnership-based self-management programme consisting of: (a) three to four conversations between nurse and patient-family member; (b) 6 months of smoking cessation; and (c) interdisciplinary team-patient-family member group meeting. Control group (n = 52) received usual care. Data were collected at months zero, six and 12. The trial lasted from June 2009-March 2013. Patients with mild and moderate chronic obstructive pulmonary disease who participated in the partnership-based self-management programme perceived less intrusiveness of the disease and its treatment than patients in the control group. Patients in the experimental group did not have better health-related quality of life, less anxiety or depression, increased physical activity, fewer exacerbations or better smoking status than patients in the control group. Patients in both groups found participation in the research useful and important. The partnership-based self-management programme had benefits concerning perception of the intrusiveness of chronic obstructive pulmonary disease and its treatment on lifestyles, activities and interests for young patients with the disease in its early stages. High satisfaction in control group, low family attendance and the relatively short treatment period may explain the less than expected benefits of the programme. © 2015 John Wiley & Sons Ltd.

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

PubMed

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

2014-09-19

To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

Talking Health, A pragmatic randomized-controlled health literacy trial targeting sugar-sweetened beverage consumption among adults: Rationale, design & methods

PubMed Central

Zoellner, Jamie; Chen, Yvonnes; Davy, Brenda; You, Wen; Hedrick, Valisa; Corsi, Terri; Estabrooks, Paul

2014-01-01

High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤8 ounces per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings. PMID:24246819

Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

PubMed

Udsen, Flemming Witt; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars Holger

2014-05-21

Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone. The present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight). There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial. Clinicaltrials.gov, http://NCT01984840, November 14, 2013.

Pragmatic Inferences in High-Functioning Adults with Autism and Asperger Syndrome

ERIC Educational Resources Information Center

Pijnacker, Judith; Hagoort, Peter; Buitelaar, Jan; Teunisse, Jan-Pieter; Geurts, Bart

2009-01-01

Although people with autism spectrum disorders (ASD) often have severe problems with pragmatic aspects of language, little is known about their pragmatic reasoning. We carried out a behavioral study on high-functioning adults with autistic disorder (n = 11) and Asperger syndrome (n = 17) and matched controls (n = 28) to investigate whether they…

Reducing Clinical Inertia in Hypertension Treatment: a Pragmatic Randomized Controlled Trial

PubMed Central

Huebschmann, Amy G.; Mizrahi, Trina; Soenksen, Alyssa; Beaty, Brenda L.; Denberg, Thomas D.

2012-01-01

Clinical inertia is a major contributor to poor blood pressure (BP) control. We tested the effectiveness of an intervention targeting physician, patient, and office system factors with regard to outcomes of clinical inertia and BP control. We randomized 591 adult primary care patients with elevated BP (mean systolic BP ≥140 or mean diastolic BP ≥90 mm Hg) to intervention or usual care. An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused primary care clinic visits, and furnished providers with treatment decision support. The intervention reduced clinical inertia (−29% vs. −11%, p=0.001). Nonetheless, ΔBP did not differ between intervention and usual care (−10.1/−4.1 vs. −9.1/−4.5 mm Hg, p = 0.50 and 0.71 for systolic and diastolic BP, respectively). Future primary care-focused interventions might benefit from the use of specific medication titration protocols, treatment adherence support, and more sustained patient follow-up visits. PMID:22533659

Lumbar Imaging with Reporting of Epidemiology (LIRE)- Protocol for a Pragmatic Cluster Randomized Trial

PubMed Central

Jarvik, Jeffrey G.; Comstock, Bryan A.; James, Kathryn T.; Avins, Andrew L.; Bresnahan, Brian W.; Deyo, Richard A.; Luetmer, Patrick H.; Friedly, Janna L.; Meier, Eric N.; Cherkin, Daniel C.; Gold, Laura S.; Rundell, Sean D.; Halabi, Safwan S.; Kallmes, David F.; Tan, Katherine W.; Turner, Judith A.; Kessler, Larry G.; Lavallee, Danielle C.; Stephens, Kari A.; Heagerty, Patrick J.

2015-01-01

Background Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a “gateway” to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these “abnormalities” may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions. Methods/Design We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging. Discussion If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic. PMID:26493088

Pragmatics as Metacognitive Control.

PubMed

Kissine, Mikhail

2015-01-01

The term "pragmatics" is often used to refer without distinction, on one hand, to the contextual selection of interpretation norms and, on the other hand, to the context-sensitive processes guided by these norms. Pragmatics in the first acception depends on language-independent contextual factors that can, but need not, involve Theory of Mind; in the second acception, pragmatics is a language-specific metacognitive process, which may unfold at an unconscious level without involving any mental state (meta-)representation. Distinguishing between these two kinds of ways context drives the interpretation of communicative stimuli helps dissolve the dispute between proponents of an entirely Gricean pragmatics and those who claim that some pragmatic processes do not depend on mind-reading capacities. According to the model defended in this paper, the typology of pragmatic processes is not entirely determined by a hierarchy of meanings, but by contextually set norms of interpretation.

Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial).

PubMed

Fieten, Karin B; Zijlstra, Wieneke T; van Os-Medendorp, Harmieke; Meijer, Yolanda; Venema, Monica Uniken; Rijssenbeek-Nouwens, Lous; l'Hoir, Monique P; Bruijnzeel-Koomen, Carla A; Pasmans, Suzanne G M A

2014-03-26

About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD. Current Controlled Trials ISRCTN88136485.

Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial

PubMed Central

Bo, Linna; Lao, Lixing; Chen, Jiao; Yu, Siyi; Yu, Zheng; Tang, Hongzhi; Yi, Ling; Wu, Xi; Yang, Jie; Liang, Fanrong

2017-01-01

Background Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty. Methods This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary. Results 152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (P<0.01). Three months after treatment, the effectiveness of moxibustion sustained and started to be superior to the drug’s effect (-0.87, 95%CI -1.32 to -0.42, P<0.01). Secondary outcome analyses showed that moxibustion was as effective as drugs in alleviating menstrual pain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (P<0.05). No adverse events were reported in this trial. Conclusions Both moxibustion and conventional drug showed desirable merits in managing menstrual pain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can’t rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians. Trial registration ClinialTrials.gov NCT01972906 PMID:28170396

Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial)

PubMed Central

2014-01-01

Background About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. Methods/Design This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children’s Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children’s Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. Discussion The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD. Trial Registration Current Controlled Trials ISRCTN88136485. PMID:24670079

Phase II Pragmatic Randomized Controlled Trial of Patient-Led Therapies (Mirror Therapy and Lower-Limb Exercises) During Inpatient Stroke Rehabilitation.

PubMed

Tyson, Sarah; Wilkinson, Jack; Thomas, Nessa; Selles, Ruud; McCabe, Candy; Tyrrell, Pippa; Vail, Andy

2015-10-01

Patient-led therapy has the potential to increase the amount of therapy patients undertake during stroke rehabilitation and to enhance recovery. Our objective was to assess the feasibility and acceptability of 2 patient-led therapies during the acute stages of stroke care: mirror therapy for the upper limb and lower-limb exercises for the lower limb. This was a blind assessed, multicenter, pragmatic randomized controlled trial of patient-led upper-limb mirror therapy and patient-led lower leg exercises. Stroke survivors with upper and lower limb limitations, undergoing inpatient rehabilitation and able to consent were recruited at least 1 week poststroke. Both interventions proved feasible, with >90% retention. No serious adverse events were reported. Both groups did less therapy than recommended; typically 5 to 15 minutes for 7 days or less. Participants receiving mirror therapy (n = 63) tended to do less practice than those doing lower-limb exercises (n = 31). Those with neglect did 69% less mirror therapy than those without (P = .02), which was not observed in the exercise group. Observed between-group differences were modest but neglect, upper-limb strength, and dexterity showed some improvement in the mirror therapy group. No changes were seen in the lower-limb group. Both patient-led mirror therapy and lower-limb exercises during inpatient stroke care are safe, feasible, and acceptable and warrant further investigation. Practice for 5 to 15 minutes for 7 days is a realistic prescription unless strategies to enhance adherence are included. © The Author(s) 2015.

Problem-solving in caregiver-counselling (PLiP Study): study protocol of a cluster randomized pragmatic trial.

PubMed

Pfeiffer, Klaus; Hautzinger, Martin; Patak, Margarete; Grünwald, Julia; Becker, Clemens; Albrecht, Diana

2017-03-06

Despite the positive evaluation of various caregiver interventions over the past 3 decades, only very few intervention protocols have been translated to delivery in service contexts. The purpose of this study is to train care counsellors of statutory long term care insurances in problem-solving and to evaluate this approach as an additional component in the statutory care counselling in Germany. A pragmatic cluster randomized controlled trial in which 38 sites with 58 care counsellors are randomly assigned to provide either routine counselling plus additional problem-solving for caregivers or routine counselling alone. The counsellor training comprises an initial 2-day training, a follow-up day after 4 months, and biweekly supervision contacts with a psychotherapist for 6 months over the phone. The agreed minimum counselling intensity is one initial face-to-face contact including a caregiver assessment and at least one telephone follow-up contact. Caregivers who are positively screened for significant strain in their role are followed up at 3 and 6 months after baseline assessment. Main outcome are caregivers' depressive symptoms. While it is unclear if the expected very low amount of additional counselling time is sufficient to yield any additional effects on caregiver depression, it is also unclear if the additional problem-solving component yields to synergies with routine counselling that is based on information and case management. There are different potential individual and organisational barriers to a consistent intervention delivery like gratification for participation, time for extra work or internal motivation to participate. ( ISRCTN23635523 ).

Improvement of spontaneous language in stroke patients with chronic aphasia treated with music therapy: a randomized controlled trial.

PubMed

Raglio, Alfredo; Oasi, Osmano; Gianotti, Marta; Rossi, Agnese; Goulene, Karine; Stramba-Badiale, Marco

2016-01-01

The aim of this research is to evaluate the effects of active music therapy (MT) based on free-improvisation (relational approach) in addition to speech language therapy (SLT) compared with SLT alone (communicative-pragmatic approach: Promoting Aphasic's Communicative Effectiveness) in stroke patients with chronic aphasia. The experimental group (n = 10) was randomized to 30 MT individual sessions over 15 weeks in addition to 30 SLT individual sessions while the control group (n = 10) was randomized to only 30 SLT sessions during the same period. Psychological and speech language assessment were made before (T0) and after (T1) the treatments. The study shows a significant improvement in spontaneous speech in the experimental group (Aachener Aphasie subtest: p = 0.020; Cohen's d = 0.35); the 50% of the experimental group showed also an improvement in vitality scores of Short Form Health Survey (chi-square test = 4.114; p = 0.043). The current trial highlights the possibility that the combined use of MT and SLT can lead to a better result in the rehabilitation of patients with aphasia than SLT alone.

A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

PubMed

Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

2018-01-01

This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

A pragmatic randomized controlled trial of the Flinders Program of chronic condition management in community health care services.

PubMed

Battersby, Malcolm; Harris, Melanie; Smith, David; Reed, Richard; Woodman, Richard

2015-11-01

To evaluate the Flinders Program in improving self-management in common chronic conditions. To examine properties of the Partners in Health scale (PIH). Participants were randomized to usual care or Flinders Program plus usual care. Self-management competency, quality of life, and other outcomes were measured at baseline, 6 months, and 12 months. Of 231 participants, 172 provided data at 6 months and 61 at 12 months. At 6 months, intention-to-treat outcomes favoured the intervention group for SF-12 physical health (p=0.043). Other pre-determined outcomes did not show significance. At 6 months intervention participants' problem severity scores reduced (p<0.001) and goal achievement scores increased (p<0.001). Only 55% of the intervention group received a Flinders Program, compromising study power. The PIH was associated with other measures at baseline and for change over time. In a pragmatic community trial, the Flinders Program improved quality of life at 6 months. Incomplete in-practice intervention delivery limited trial power. Studies are now needed on improving delivery. The PIH has potential as a generic risk screening tool and predictive measure of change in self-management and chronic condition outcomes over time. Better implementation including service integration is required for improved chronic disease management. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Use of altered informed consent in pragmatic clinical research.

PubMed

McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

2015-10-01

There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

A pragmatic trial to improve adherence with scheduled appointments in an inner-city pain clinic by human phone calls in the patient's preferred language.

PubMed

Andreae, Michael H; Nair, Singh; Gabry, Jonah S; Goodrich, Ben; Hall, Charles; Shaparin, Naum

2017-11-01

We investigated if human reminder phone calls in the patient's preferred language increase adherence with scheduled appointments in an inner-city chronic pain clinic. We hypothesized that language and cultural incongruence is the underlying mechanism to explain poor attendance at clinic appointments in underserved Hispanic populations. Pragmatic randomized controlled clinical trial SETTING: Innercity academic chronic pain clinic with a diverse, predominantly African-American and Hispanic population PATIENTS: All (n=963) adult patients with a scheduled first appointment between October 2014 and October 2015 at the Montefiore Pain Center in the Bronx, New York were enrolled. Patients were randomized to receive a human reminder call in their preferred language before their appointment, or no contact. We recorded patients' demographic characteristics and as primary outcome attendance as scheduled, failure to attend and/or cancellation calls. We fit Bayesian and classical multinomial logistic regression models to test if the intervention improved adherence with scheduled appointments. Among the 953 predominantly African American and Hispanic/Latino patients, 475 patients were randomly selected to receive a language-congruent, human reminder call, while 478 were assigned to receive no prior contact, (after we excluded 10 patients, scheduled for repeat appointments). In the experimental group, 275 patients adhered to their scheduled appointment, while 84 cancelled and 116 failed to attend. In the control group, 249 patients adhered to their scheduled appointment, 31 cancelled and 198 failed to attend. Human phone reminders in the preferred language increased adherence (RR 1.89, CI95% [1.42, 1.42], (p<0.01). The intervention seemed particularly effective in Hispanic patients, supporting our hypothesis of cultural congruence as possible underlying mechanism. Human reminder phone calls prior in the patient's preferred language increased adherence with scheduled appointments. The intervention facilitated access to much needed care in an ethnically diverse, resource poor population, presumably by overcoming language barriers. Copyright © 2017 Elsevier Inc. All rights reserved.

Randomized controlled trials and neuro-oncology: should alternative designs be considered?

PubMed

Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

2015-09-01

Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the quality of design/reporting of RCTs in neuro-oncology persist. Quality improvement is necessary. Consideration of alternative strategies should be considered.

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

PubMed

Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

2017-10-11

There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle-income countries. ClinicalTrials.gov, ID: NCT02763345 . Registered on 3 May 2016.

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

Pragmatics as Metacognitive Control

PubMed Central

Kissine, Mikhail

2016-01-01

The term “pragmatics” is often used to refer without distinction, on one hand, to the contextual selection of interpretation norms and, on the other hand, to the context-sensitive processes guided by these norms. Pragmatics in the first acception depends on language-independent contextual factors that can, but need not, involve Theory of Mind; in the second acception, pragmatics is a language-specific metacognitive process, which may unfold at an unconscious level without involving any mental state (meta-)representation. Distinguishing between these two kinds of ways context drives the interpretation of communicative stimuli helps dissolve the dispute between proponents of an entirely Gricean pragmatics and those who claim that some pragmatic processes do not depend on mind-reading capacities. According to the model defended in this paper, the typology of pragmatic processes is not entirely determined by a hierarchy of meanings, but by contextually set norms of interpretation. PMID:26834671

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. Discussion This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain. Trial registration This trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233. PMID:23324133

Integration of chronic disease prevention and management services into primary care: a pragmatic randomized controlled trial (PR1MaC).

PubMed

Fortin, Martin; Chouinard, Maud-Christine; Dubois, Marie-France; Bélanger, Martin; Almirall, José; Bouhali, Tarek; Sasseville, Maxime

2016-01-01

Chronic disease prevention and management programs are usually single-disease oriented. Our objective was to evaluate an intervention that targeted multiple chronic conditions and risk factors. We conducted a pragmatic randomized controlled trial involving patients aged 18-75 years with at least 1 of the targeted chronic conditions or risk factors from 8 primary care practices in the Saguenay region of Quebec, Canada, to evaluate an intervention that included self-management support and patient-centred motivational approaches. Self-management (primary outcome) was evaluated using the Health Education Impact Questionnaire (heiQ). Secondary outcomes included self-efficacy, health-related quality of life, psychological distress and health behaviours. Three hundred thirty-two patients were recruited and randomly assigned ( n = 166 for both intervention and control groups) and evaluated after 3 months. The intervention group showed improvement in 6 of the 8 heiQ domains: health-directed behaviour (relative risk [RR] 1.71, 95% confidence interval [CI] 1.13 to 2.59), emotional well-being (RR 1.73, 95% CI 1.07 to 2.79), self-monitoring and insight (RR 2.40, 95% CI 1.19 to 4.86), constructive attitudes and approaches (RR 2.40, 95% CI 1.37 to 4.21), skill and technique acquisition (RR 1.70, 95% CI 1.14 to 2.53), and health service navigation (RR 1.93, 95% CI 1.08 to 3.47). Improvement was also observed in the Physical Component Summary ( p = 0.017) and the Single Index ( p = 0.041) of the 12-Item Short Form Health Survey (version 2). The intervention group improved in fruit and vegetable consumption (odds ratio [OR] 2.36, 95% CI 1.41 to 3.95) and physical activity (OR 3.81, 95% CI 1.65 to 8.76). One-year improvement was maintained in the intervention group for several outcomes. It is possible to implement an intervention integrating chronic disease prevention and management services into primary care settings. We obtained positive and promising results using this intervention. Trial registration: ClinicalTrials.gov, no.: NCT01319656.

HealtheSteps™ Study Protocol: a pragmatic randomized controlled trial promoting active living and healthy lifestyles in at-risk Canadian adults delivered in primary care and community-based clinics.

PubMed

Gill, Dawn P; Blunt, Wendy; Bartol, Cassandra; Pulford, Roseanne W; De Cruz, Ashleigh; Simmavong, P Karen; Gavarkovs, Adam; Newhouse, Ian; Pearson, Erin; Ostenfeldt, Bayley; Law, Barbi; Karvinen, Kristina; Moffit, Pertice; Jones, Gareth; Watson, Cori; Zou, Guangyong; Petrella, Robert J

2017-02-07

Physical inactivity is one of the leading causes of chronic disease in Canadian adults. With less than 50% of Canadian adults reaching the recommended amount of daily physical activity, there is an urgent need for effective programs targeting this risk factor. HealtheSteps™ is a healthy lifestyle prescription program, developed from an extensive research base to address risk factors for chronic disease such as physical inactivity, sedentary behaviour and poor eating habits. HealtheSteps™ participants are provided with in-person lifestyle coaching and access to eHealth technologies delivered in community-based primary care clinics and health care organizations. To determine the effectiveness of Healthesteps™, we will conduct a 6-month pragmatic randomized controlled trial with integrated process and economic evaluations of HealtheSteps™ in 5 clinic settings in Southwestern Ontario. 110 participants will be individually randomized (1:1; stratified by site) to either the intervention (HealtheSteps™ program) or comparator (Wait-list control). There are 3 phases of the HealtheSteps™ program, lasting 6 months each. The active phase consists of bi-monthly in-person coaching with access to a full suite of eHealth technology supports. During the maintenance phase I, the in-person coaching will be removed, but participants will still have access to the full suite of eHealth technology supports. In the final stage, maintenance phase II, access to the full suite of eHealth technology supports is removed and participants only have access to publicly available resources and tools. This trial aims to determine the effectiveness of the program in increasing physical activity levels and improving other health behaviours and indicators, the acceptability of the HealtheSteps™ program, and the direct cost for each person participating in the program as well as the costs associated with delivering the program at the different community sites. These results will inform future optimization and scaling up of the program into additional community-based primary care sites. NCT02413385 (Clinicaltrials.gov). Date Registered: April 6, 2015.

A randomized waitlist control community study of Social Cognition and Interaction Training for people with schizophrenia.

PubMed

Gordon, Anne; Davis, Penelope J; Patterson, Susan; Pepping, Christopher A; Scott, James G; Salter, Kerri; Connell, Melissa

2018-03-01

Social Cognition and Interaction Training (SCIT) has demonstrated effectiveness in improving social cognition and functioning of people with schizophrenia. This pilot study examines the acceptability, feasibility, and effectiveness of SCIT with individuals who have schizophrenia-spectrum disorders and are receiving care through a public mental health service. In a pragmatic randomized waitlist controlled trial, 36 participants (aged 19-55 years) with a schizophrenia spectrum disorder were randomly allocated to SCIT or treatment as usual (TAU). Measures of theory of mind, emotion perception, attributional bias, social skills, quality of life, life skills, depression, anxiety, and stress were administered pre- and post-intervention with follow-up conducted 4 months later. All wait-list controls subsequently received the intervention and a secondary within-group analysis was conducted including these participants. While no significant differences were found between groups on any outcomes, there was strong engagement with the SCIT intervention. Of the 21 participants in the intervention group, the completion rate was 85.71% with a median attendance rate of 17 sessions. Within subject analyses of SCIT participants over time showed significant improvements in quality of life, emotion recognition, social skills, and a trend towards better life skills from pre- to post-intervention. These gains were sustained at the 4-month follow-up time. Although this study showed limited benefits in outcomes associated with SCIT compared with TAU, it demonstrated the acceptability of SCIT to participants in a real world public health setting shown by high retention, attendance, and positive feedback. This pilot shows SCIT can be implemented in routine clinical practice and lays the foundation for a larger pragmatic study. SCIT can be implemented successfully in a real-world community mental health setting. SCIT had high levels of acceptability to these participants. Limitations The small sample size meant there was insufficient power to detect differences between groups on outcome measures. The study did not include measures of psychiatric symptoms or neuropsychological functioning which may have influenced participants' capacity to benefit from SCIT. © 2017 The British Psychological Society.

The postcard intervention against depression among community-dwelling older adults: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Depression in older adults deteriorates quality of life and increases morbidity, mortality, and medical expenses. Medicine and social policy should work together to decrease this burden. Existing prevention studies are often based on time-consuming psychotherapies, which therefore are not feasible for a wide application at the community level. Postcard interventions have been shown to be effective for patients after hospitalization for major depression, drug overdose, or self-harm. This paper describes the protocol of a pragmatic, randomized controlled trial designed to examine the efficacy of a postcard intervention for depression among community-dwelling individuals aged 65 years or older. Methods/Design This is a pragmatic, non-blinded, parallel comparison, randomized controlled trial using Zelen’s design in a community setting. Participants will include community-dwelling older adults (aged 65 years or older) with limited social support (indicated by eating meals alone) and with symptoms of depression (scoring 4 or higher on the 15-item Geriatric Depression Scale (GDS)). The intervention will consist of sending postcards with handwritten messages and seasonal reports from a historical city to participants once a month for eight consecutive months. Self-addressed, stamped envelopes will be enclosed to facilitate non-obligatory replies. Primary outcomes will be changes in the GDS scores that are administered to all elderly inhabitants of the community every year as part of annual health checks. Secondary outcomes include quality of life as measured by a visual analogue scale, and self-rated basic and advanced activities of daily living. We will also examine the subjective sense of effectiveness of the intervention, recollection of the number of intervention mailings received, and the number of mailed replies as the index of the acceptability of the postcard intervention. The time × group interaction for two consecutive years will be analyzed using a generalized linear mixed model. To detect an effect size of 0.5 at alpha error of 0.05 and statistical power of 0.80, 63 participants per group are required. Based on an estimated consent and dropout rate of 70%, a total of 180 subjects will be recruited. Trial registration UMIN000010529 PMID:23837527

Life review therapy for older adults with moderate depressive symptomatology: a pragmatic randomized controlled trial.

PubMed

Korte, J; Bohlmeijer, E T; Cappeliez, P; Smit, F; Westerhof, G J

2012-06-01

BACKGROUND. Although there is substantial evidence for the efficacy of life review therapy as an early treatment of depression in later life, its effectiveness in natural settings has not been studied. The present study evaluates an intervention based on life review and narrative therapy in a large multi-site, pragmatic randomized controlled trial(RCT). METHOD. Life review therapy was compared with care as usual. The primary outcome was depressive symptoms;secondary outcomes were anxiety symptoms, positive mental health, quality of life, and current major depressive episode (MDE). To identify groups for whom the intervention was particularly effective, moderator analyses were carried out (on sociodemographic variables, personality traits, reminiscence functions, clinically relevant depressive and anxiety symptoms, and past MDEs). RESULTS. Compared with care as usual (n=102), life review therapy (n=100) was effective in reducing depressive symptoms, at post-treatment (d=0.60, B= -5.3, p<0.001), at 3-month follow-up (d=0.50, B= -5.0, p<0.001) and for the intervention also at 9-month follow-up (t=5.7, p<0.001). The likelihood of a clinically significant change in depressive symptoms was significantly higher [odds ratio (OR) 3.77, p<0.001 at post-treatment ; OR 3.76, p<0.001 at the 3-month follow-up]. Small significant effects were found for symptoms of anxiety and positive mental health.Moderator analyses showed only two significant moderators, the personality trait of extraversion and the reminiscence function of boredom reduction. CONCLUSIONS. This study shows the effectiveness of life review therapy as an early intervention for depression in an ecologically valid context, supporting its applicability to a broad target group. The intervention is also effective in reducing anxiety symptoms and strengthening positive mental health.

Understanding Implementation of Complex Interventions in Primary Care Teams.

PubMed

Luig, Thea; Asselin, Jodie; Sharma, Arya M; Campbell-Scherer, Denise L

2018-01-01

The implementation of interventions to support practice change in primary care settings is complex. Pragmatic strategies, grounded in empiric data, are needed to navigate real-world challenges and unanticipated interactions with context that can impact implementation and outcomes. This article uses the example of the "5As Team" randomized control trial to explore implementation strategies to promote knowledge transfer, capacity building, and practice integration, and their interaction within the context of an interdisciplinary primary care team. We performed a qualitative evaluation of the implementation process of the 5As Team intervention study, a randomized control trial of a complex intervention in primary care. We conducted thematic analysis of field notes of intervention sessions, log books of the practice facilitation team members, and semistructured interviews with 29 interdisciplinary clinician participants. We used and further developed the Interactive Systems Framework for dissemination and implementation to interpret and structure findings. Three themes emerged that illuminate interactions between implementation processes, context, and outcomes: (1) facilitating team communication supported collective and individual sense-making and adoption of the innovation, (2) iterative evaluation of the implementation process and real-time feedback-driven adaptions of the intervention proved crucial for sustainable, context-appropriate intervention impact, (3) stakeholder engagement led to both knowledge exchange that contributes to local problem solving and to shaping a clinical context that is supportive to practice change. Our findings contribute pragmatic strategies that can help practitioners and researchers to navigate interactions between context, intervention, and implementation factors to increase implementation success. We further developed an implementation framework that includes sustained engagement with stakeholders, facilitation of team sense-making, and dynamic evaluation and intervention design as integral parts of complex intervention implementation. NCT01967797. 18 October 2013. © Copyright 2018 by the American Board of Family Medicine.

Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial.

PubMed

Moja, Lorenzo; Passardi, Alessandro; Capobussi, Matteo; Banzi, Rita; Ruggiero, Francesca; Kwag, Koren; Liberati, Elisa Giulia; Mangia, Massimo; Kunnamo, Ilkka; Cinquini, Michela; Vespignani, Roberto; Colamartini, Americo; Di Iorio, Valentina; Massa, Ilaria; González-Lorenzo, Marien; Bertizzolo, Lorenzo; Nyberg, Peter; Grimshaw, Jeremy; Bonovas, Stefanos; Nanni, Oriana

2016-11-25

Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care. ClinicalTrials.gov, NCT02645357.

A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

PubMed

Selby, Peter; Brosky, Gerald; Oh, Paul; Raymond, Vincent; Arteaga, Carmen; Ranger, Suzanne

2014-05-07

Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters. A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (≥10 cigarettes/day) without insurance coverage who were motivated to quit within 14 days were randomized (1:1) in a blinded manner to receive either full coverage eligibility for 26 weeks or no coverage. Pharmacotherapies covered were varenicline, bupropion, or nicotine patches/gum. Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method(s). All subjects received brief smoking cessation counseling. The primary outcome measure was self-reported 7-day point prevalence of abstinence (PPA) at week 26. Of the 1380 randomized subjects (coverage, 696; no coverage, 684), 682 (98.0%) and 435 (63.6%), respectively, were dispensed at least one smoking cessation medication dose. The 7-day PPA at week 26 was higher in the full coverage versus no coverage group: 20.8% (n = 145) and 13.9% (n = 95), respectively; odds ratio (OR) = 1.64, 95% confidence interval (CI) 1.23-2.18; p = 0.001. Urine cotinine-confirmed 7-day PPA at week 26 was 15.7% (n = 109) and 10.1% (n = 69), respectively; OR = 1.68, 95% CI 1.21-2.33; p = 0.002. After pharmacotherapy, coverage eligibility was withdrawn from the full coverage group, continuous abstinence between weeks 26 and 52 was 6.6% (n = 46) and 5.6% (n = 38), in the full coverage and no coverage groups, respectively; OR = 1.19, 95% CI 0.76-1.87; p = 0.439. In this study, the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada. The advantages were lost once coverage was discontinued. Further study is required on the duration of coverage to prevent relapse to smoking. (clinicaltrials.gov identifier: NCT00818207; the study was sponsored by Pfizer Inc.).

Improving quality of care and long-term health outcomes through continuity of care with the use of an electronic or paper patient-held portable health file (COMMUNICATE): study protocol for a randomized controlled trial.

PubMed

Lassere, Marissa Nichole; Baker, Sue; Parle, Andrew; Sara, Anthony; Johnson, Kent Robert

2015-06-04

The advantages of patient-held portable health files (PHF) and personal health records (PHR), paper or electronic, are said to include improved health-care provider continuity-of-care and patient empowerment in maintaining health. Top-down approaches are favored by public sector government and health managers. Bottom-up approaches include systems developed directly by health-care providers, consumers and industry, implemented locally on devices carried by patient-consumers or shared via web-based portals. These allow individuals to access, manage and share their health information, and that of others for whom they are authorized, in a private, secure and confidential environment. Few medical record technologies have been evaluated in randomized trials to determine whether there are important clinical benefits of these interventions. The COMMUNICATE trial will assess the acceptability and long-term clinical outcomes of an electronic and paper patient-held PHF. This is a 48-month, open-label pragmatic, superiority, parallel-group design randomized controlled trial. Subjects (n = 792) will be randomized in a 1:1:1 ratio to each of the trial arms: the electronic PHF added to usual care, the paper PHF added to usual care and usual care alone (no PHF). Inclusion criteria include those 60 years or older living independently in the community, but who have two or more chronic medical conditions that require prescription medication and regular care by at least three medical practitioners (general and specialist care). The primary objective is whether use of a PHF compared to usual care reduces a combined endpoint of deaths, overnight hospitalizations and blindly adjudicated serious out-of-hospital events. All primary analyses will be undertaken masked to randomized arm allocation using intention-to-treat principles. Secondary outcomes include quality of life and health literacy improvements. Lack of blinding creates potential for bias in trial conduct and ascertainment of clinical outcomes. Mechanisms are provided to reduce bias, including balanced study contact with all participants, a blinded adjudication committee determining which out-of-hospital events are serious and endpoints that are objective (overnight hospitalizations and mortality). The PRECIS tool provides a summary of the trial's design on the Pragmatic-Explanatory Continuum. Registered with Clinicaltrials.gov (identifier: NCT01082978) on 8 March 2010.

Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial.

PubMed

Lamontagne, Marie-Eve; Perreault, Kadija; Gagnon, Marie-Pierre

2014-04-10

Despite growing interest in the importance of, and challenges associated with the involvement of patient and population (IPP) in the process of developing and adapting clinical practice guidelines (CPGs), there is a lack of knowledge about the best method to use. This is especially problematic in the field of rehabilitation, where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process. The goal of this pilot trial is to document the acceptability, feasibility and effectiveness of two methods of involving patients with a disability (traumatic brain injury) in CPG development. A single-blind, randomized, crossover pragmatic trial will be performed with 20 patients with traumatic brain injury (TBI). They will be randomized into two groups, and each will try two alternative methods of producing recommendations; a discussion group (control intervention) and a Wiki, a webpage that can be modified by those who have access to it (experimental intervention). The participants will rate the acceptability of the two methods, and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods, and the number of support interventions required. Twenty experts, blinded to the method of producing the recommendations, will independently rate the recommendations produced by the participants for clarity, accuracy, appropriateness and usefulness. Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI. Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings. Clinical trial KT Canada 87776.

The effectiveness of a de-implementation strategy to reduce low-value blood management techniques in primary hip and knee arthroplasty: a pragmatic cluster-randomized controlled trial.

PubMed

Voorn, Veronique M A; Marang-van de Mheen, Perla J; van der Hout, Anja; Hofstede, Stefanie N; So-Osman, Cynthia; van den Akker-van Marle, M Elske; Kaptein, Ad A; Stijnen, Theo; Koopman-van Gemert, Ankie W M M; Dahan, Albert; Vliet Vlieland, Thea P M M; Nelissen, Rob G H H; van Bodegom-Vos, Leti

2017-05-30

Perioperative autologous blood salvage and preoperative erythropoietin are not (cost) effective to reduce allogeneic transfusion in primary hip and knee arthroplasty, but are still used. This study aimed to evaluate the effectiveness of a theoretically informed multifaceted strategy to de-implement these low-value blood management techniques. Twenty-one Dutch hospitals participated in this pragmatic cluster-randomized trial. At baseline, data were gathered for 924 patients from 10 intervention and 1040 patients from 11 control hospitals undergoing hip or knee arthroplasty. The intervention included a multifaceted de-implementation strategy which consisted of interactive education, feedback on blood management performance, and a comparison with benchmark hospitals, aimed at orthopedic surgeons and anesthesiologists. After the intervention, data were gathered for 997 patients from the intervention and 1096 patients from the control hospitals. The randomization outcome was revealed after the baseline measurement. Primary outcomes were use of blood salvage and erythropoietin. Secondary outcomes included postoperative hemoglobin, length of stay, allogeneic transfusions, and use of local infiltration analgesia (LIA) and tranexamic acid (TXA). The use of blood salvage (OR 0.08, 95% CI 0.02 to 0.30) and erythropoietin (OR 0.30, 95% CI 0.09 to 0.97) reduced significantly over time, but did not differ between intervention and control hospitals (blood salvage OR 1.74 95% CI 0.27 to 11.39, erythropoietin OR 1.33, 95% CI 0.26 to 6.84). Postoperative hemoglobin levels were significantly higher (β 0.21, 95% CI 0.08 to 0.34) and length of stay shorter (β -0.36, 95% CI -0.64 to -0.09) in hospitals receiving the multifaceted strategy, compared with control hospitals and after adjustment for baseline. Transfusions did not differ between the intervention and control hospitals (OR 1.06, 95% CI 0.63 to 1.78). Both LIA (OR 0.0, 95% CI 0.0 to 0.0) and TXA (OR 0.3, 95% CI 0.2 to 0.5) were significantly associated with the reduction in blood salvage over time. Blood salvage and erythropoietin use reduced over time, but not differently between intervention and control hospitals. The reduction in blood salvage was associated with increased use of local infiltration analgesia and tranexamic acid, suggesting that de-implementation is assisted by the substitution of techniques. The reduction in blood salvage and erythropoietin did not lead to a deterioration in patient-related secondary outcomes. www.trialregister.nl, NTR4044.

Who Is the Agent? The Influence of Pragmatic Leads on Children's Reference Assignment in Non-Obligatory Control

ERIC Educational Resources Information Center

Janke, Vikki

2018-01-01

Non-obligatory control constructions (NOC) are sentences which contain a non-finite clause with a null subject whose reference is determined pragmatically. Little is known about how children assign reference to these subjects, yet this is important as our current understanding of reference-resolution development is limited to less complex…

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

PubMed Central

Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

2015-01-01

OBJECTIVE To analyze the effects of acupressure at the SP6 point on labor duration and cesarean section rates in parturients served in a public maternity hospital. METHODS This controlled, randomized, double-blind, pragmatic clinical trial involved 156 participants with gestational age ≥ 37 weeks, cervical dilation ≥ 4 cm, and ≥ 2 contractions in 10 min. The women were randomly divided into an acupressure, placebo, or control group at a university hospital in an inland city in the state of Sao Paulo, Brazil, in 2013. Acupressure was applied to the SP6 point during contractions for 20 min. RESULTS The average labor duration was significantly different between the SP6 acupressure group [221.5 min (SD = 162.4)] versus placebo [397.9 min (SD = 265.6)] and versus control [381.9 min (SD = 358.3)] (p = 0.0047); however, the groups were similar regarding the cesarean section rates (p = 0.2526) and Apgar scores in the first minute (p = 0.9542) and the fifth minute (p = 0.7218) of life of the neonate. CONCLUSIONS The SP6 acupressure point proved to be a complementary measure to induce labor and may shorten the labor duration without causing adverse effects to the mother or the newborn. However, it did not affect the cesarean section rate. PMID:25741644

Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial.

PubMed

Atreja, Ashish; Khan, Sameer; Rogers, Jason D; Otobo, Emamuzo; Patel, Nishant P; Ullman, Thomas; Colombel, Jean Fred; Moore, Shirley; Sands, Bruce E

2015-02-18

Inflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient's quality of life (QOL) through an application like HealthPROMISE. The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. Participants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). Enrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr).

Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial

PubMed Central

Khan, Sameer; Rogers, Jason D; Otobo, Emamuzo; Patel, Nishant P; Ullman, Thomas; Colombel, Jean Fred; Moore, Shirley; Sands, Bruce E

2015-01-01

Background Inflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. Objective The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. Methods Participants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). Results Enrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. Conclusions HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial Registration ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr). PMID:25693610

A specific inpatient aquatic physiotherapy program improves strength after total hip or knee replacement surgery: a randomized controlled trial.

PubMed

Rahmann, Ann E; Brauer, Sandra G; Nitz, Jennifer C

2009-05-01

To evaluate the effect of inpatient aquatic physiotherapy in addition to usual ward physiotherapy on the recovery of strength, function, and gait speed after total hip or knee replacement surgery. Pragmatic randomized controlled trial with blinded 6-month follow-up. Acute-care private hospital. People (n=65) undergoing primary hip or knee arthroplasty (average age, 69.6+/-8.2y; 30 men). Participants were randomly assigned to receive supplementary inpatient physiotherapy, beginning on day 4: aquatic physiotherapy, nonspecific water exercise, or additional ward physiotherapy. Strength, gait speed, and functional ability at day 14. At day 14, hip abductor strength was significantly greater after aquatic physiotherapy intervention than additional ward treatment (P=.001) or water exercise (P=.011). No other outcome measures were significantly different at any time point in the trial, but relative differences favored the aquatic physiotherapy intervention at day 14. No adverse events occurred with early aquatic intervention. A specific inpatient aquatic physiotherapy program has a positive effect on early recovery of hip strength after joint replacement surgery. Further studies are required to confirm these findings. Our research indicates that aquatic physiotherapy can be safely considered in this early postoperative phase.

The effectiveness of a near-infrared vascular imaging device to support intravenous cannulation in children with dark skin color: a cluster randomized clinical trial.

PubMed

van der Woude, Olga C P; Cuper, Natascha J; Getrouw, Chavalleh; Kalkman, Cor J; de Graaff, Jurgen C

2013-06-01

Poor vein visibility can make IV cannulation challenging in children with dark skin color. In the operating room, we studied the effectiveness of a near-infrared vascular imaging device (VascuLuminator) to facilitate IV cannulation in children with dark skin color. In the operating room of a general hospital in Curacao, all consecutive children (0-15 years of age) requiring IV cannulation were included in a pragmatic cluster randomized clinical trial. The VascuLuminator was made available to anesthesiologists at the operating complex in randomized clusters of 1 week. Success at first attempt was 63% (27/43, 95% confidence interval [CI], 47%-77%) in the VascuLuminator group vs 51% (23 of 45 patients, 95% CI, 36%-66%) in the control group (P = 0.27). Median time to successful cannulation was 53 seconds (interquartile range: 34-154) in the VascuLuminator group and 68 seconds (interquartile range: 40-159) in the control group (P = 0.54), and hazard ratio was 1.12 (95% CI, 0.73-1.71). The VascuLuminator has limited value in improving success at first attempt of facilitating IV cannulation in children with dark skin color.

Social Communication and Theory of Mind in Boys with Autism and Fragile X Syndrome

PubMed Central

Losh, Molly; Martin, Gary E.; Klusek, Jessica; Hogan-Brown, Abigail L.; Sideris, John

2012-01-01

Impairments in the social use of language, or pragmatics, constitute a core characteristic of autism. Problems with pragmatic language have also been documented in fragile X syndrome (FXS), a monogenic condition that is the most common known genetic cause of autism. Evidence suggests that social cognitive ability, or theory of mind, may also be impaired in both conditions, and in autism, may importantly relate to pragmatic language ability. Given the substantial overlap observed in autism and FXS, this study aimed to better define those social-communicative phenotypes that overlap in these two conditions by comparing pragmatic language ability and theory of mind in children with idiopathic autism and children with FXS, with and without autism, as well as children with Down syndrome and typically developing controls. We further examined correlations between these cognitive-behavioral phenotypes and molecular genetic variation related to the Fragile X Mental Retardation-1 gene (FMR1) in the FXS group. Results indicated that children with idiopathic autism and those with FXS and autism performed comparably on direct-assessment measures of pragmatic language and theory of mind, whereas those with FXS only did not differ from controls. Theory of mind was related to pragmatic language ability in all groups. Pragmatic language and theory of mind also correlated with genetic variation at the FMR1 locus (Cytosine-Guanine-Guanine repeats and percent methylation). These results point toward substantial overlap in the social and language phenotypes in autism and FXS and suggest a molecular genetic basis to these phenotypic profiles. PMID:22934085

Social communication and theory of mind in boys with autism and fragile x syndrome.

PubMed

Losh, Molly; Martin, Gary E; Klusek, Jessica; Hogan-Brown, Abigail L; Sideris, John

2012-01-01

Impairments in the social use of language, or pragmatics, constitute a core characteristic of autism. Problems with pragmatic language have also been documented in fragile X syndrome (FXS), a monogenic condition that is the most common known genetic cause of autism. Evidence suggests that social cognitive ability, or theory of mind, may also be impaired in both conditions, and in autism, may importantly relate to pragmatic language ability. Given the substantial overlap observed in autism and FXS, this study aimed to better define those social-communicative phenotypes that overlap in these two conditions by comparing pragmatic language ability and theory of mind in children with idiopathic autism and children with FXS, with and without autism, as well as children with Down syndrome and typically developing controls. We further examined correlations between these cognitive-behavioral phenotypes and molecular genetic variation related to the Fragile X Mental Retardation-1 gene (FMR1) in the FXS group. Results indicated that children with idiopathic autism and those with FXS and autism performed comparably on direct-assessment measures of pragmatic language and theory of mind, whereas those with FXS only did not differ from controls. Theory of mind was related to pragmatic language ability in all groups. Pragmatic language and theory of mind also correlated with genetic variation at the FMR1 locus (Cytosine-Guanine-Guanine repeats and percent methylation). These results point toward substantial overlap in the social and language phenotypes in autism and FXS and suggest a molecular genetic basis to these phenotypic profiles.

High-mix insulins

PubMed Central

Kalra, Sanjay; Farooqi, Mohammad Hamed; El-Houni, Ali E.

2015-01-01

Premix insulins are commonly used insulin preparations, which are available in varying ratios of different molecules. These drugs contain one short- or rapid-acting, and one intermediate- or long-acting insulin. High-mix insulins are mixtures of insulins that contain 50% or more than 50% of short-acting insulin. This review describes the clinical pharmacology of high-mix insulins, including data from randomized controlled trials. It suggests various ways, in which high-mix insulin can be used, including once daily, twice daily, thrice daily, hetero-mix, and reverse regimes. The authors provide a rational framework to help diabetes care professionals, identify indications for pragmatic high-mix use. PMID:26425485

Reliability and validity of the Pragmatics Observational Measure (POM): a new observational measure of pragmatic language for children.

PubMed

Cordier, Reinie; Munro, Natalie; Wilkes-Gillan, Sarah; Speyer, Renée; Pearce, Wendy M

2014-07-01

There is a need for a reliable and valid assessment of childhood pragmatic language skills during peer-peer interactions. This study aimed to evaluate the psychometric properties of a newly developed pragmatic assessment, the Pragmatic Observational Measure (POM). The psychometric properties of the POM were investigated from observational data of two studies - study 1 involved 342 children aged 5-11 years (108 children with ADHD; 108 typically developing playmates; 126 children in the control group), and study 2 involved 9 children with ADHD who attended a 7-week play-based intervention. The psychometric properties of the POM were determined based on the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) taxonomy of psychometric properties and definitions for health-related outcomes; the Pragmatic Protocol was used as the reference tool against which the POM was evaluated. The POM demonstrated sound psychometric properties in all the reliability, validity and interpretability criteria against which it was assessed. The findings showed that the POM is a reliable and valid measure of pragmatic language skills of children with ADHD between the age of 5 and 11 years and has clinical utility in identifying children with pragmatic language difficulty. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

The impact of health coaching on medication adherence in patients with poorly controlled diabetes, hypertension, and/or hyperlipidemia: a randomized controlled trial.

PubMed

Thom, David H; Willard-Grace, Rachel; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Chen, Ellen

2015-01-01

Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes. We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence. This was a nonblinded, randomized, controlled, pragmatic intervention trial. English- or Spanish-speaking patients, age 18 to 75 years, with poorly controlled type 2 diabetes, hypertension, and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care. Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days (of the last 7) on which patient took all prescribed medications. The proportion of medications completely concordant increased in the coached group versus the usual care group (difference in change, 10%; P = .05). The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group (difference in change, 17%; P = .013). The mean number of adherent days increased in the coached but not in the usual care group (difference in change, 1.08; P < .001). Health coaching by medical assistants significantly increases medication concordance and adherence. © Copyright 2015 by the American Board of Family Medicine.

Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes.

PubMed

Oster, Gerry; Sullivan, Sean D; Dalal, Mehul R; Kazemi, Mahmood R; Rojeski, Maria; Wysham, Carol H; Sung, Jennifer; Johnstone, Bryan; Cali, Anna M G; Wei, L J; Traylor, Louise; Anhalt, Henry; Hull, Michelle; Van Vleet, John; Meneghini, Luigi F

2016-11-01

This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia. Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA). Inclusion criteria include a diagnosis of T2D, age ≥18 years, and glycated hemoglobin (HbA1c) between 8.0% and 11.0%. Patients will be assigned to either the Gla-300 or other basal insulin group. The primary end point is the proportion of patients achieving HEDIS HbA1c targets (<8.0% [64 mmol/mol] in patients with comorbidities or aged ≥65 years; <7.0% [58 mmol/mol] in all other patients) without occurrence of symptomatic hypoglycemia (blood glucose ≤70 mg/dL) from baseline to 6 months. Secondary end points include rates of documented symptomatic nocturnal hypoglycemia and severe hypoglycemia; change from baseline in HbA1c, fasting glucose, and body weight; treatment persistence; patient-reported outcomes; and healthcare resource utilization. Planned enrollment is 3270 patients across approximately 400 clinical sites. Pragmatic clinical trials offer the potential to assess comparative effectiveness in broadly based patient populations receiving care (with or without a corresponding educational support program) in real-world clinical settings. The results of Achieve Control should elucidate the benefits of management of T2D with Gla-300 versus other basal insulins in terms of patient outcomes, experiences, and perceptions, and its impact on healthcare resource utilization and cost. www.clinicaltrials.gov identifier is NCT02451137.

Pragmatic competence of children with autism spectrum disorder. Impact of theory of mind, verbal working memory, ADHD symptoms, and structural language.

PubMed

Baixauli-Fortea, Inmaculada; Miranda Casas, Ana; Berenguer-Forner, Carmen; Colomer-Diago, Carla; Roselló-Miranda, Belén

2017-11-21

The primary aim of this study is to increase the existing knowledge about the pragmatic skills of children with autism spectrum disorders (ASD). Specifically, the study has two objectives. The first is to provide a profile of characteristics based on The Children's Communication Checklist (CCC-2) pragmatics scales (inappropriate initiation, stereotyped language, use of context, nonverbal communication, and general pragmatics) and narrative task indicators. To this end, children with ASD will be compared to children with typical development (TD), controlling the effects of sex and structural language (speech, syntax, semantics, coherence). The second objective is to analyze whether theory of mind (ToM), verbal working memory, ADHD symptoms, and structural language can predict pragmatic competence in children with ASD without intellectual disability (ID). The results showed worse performance in the group with ASD on the majority of the pragmatic aspects evaluated. In addition, the application of ToM skills and structural language were significant predictors of the pragmatic skills of the children with ASD. These findings reinforce the importance of focusing intervention programs on mentalist abilities through experiences in real social scenarios, along with strengthening structural language components.

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

PubMed

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

2018-01-01

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

A pragmatic approach to infection prevention and control guidelines in an ambulatory care setting.

PubMed

Ng, Jessica; Le-Abuyen, Sheila; Mosley, Jane; Gardam, Michael

2014-06-01

The vast majority of infection prevention and control (IPAC) experience and practice guidance relates to the inpatient setting. We have taken a pragmatic approach to applying IPAC guidance in our ambulatory setting, and here we identify and describe the 4 key areas where we modified our IPAC program and adapted current guidelines to fit with our setting. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Effectiveness of maternal counseling in reducing caries in Cree children.

PubMed

Harrison, R L; Veronneau, J; Leroux, B

2012-11-01

This cluster-randomized pragmatic (effectiveness) trial tested maternal counseling based on Motivational Interviewing (MI) as an approach to control caries in indigenous children. Nine Cree communities in Quebec, Canada were randomly allocated to test or control. MI-style counseling was delivered in test communities to mothers during pregnancy and at well-baby visits. Data on outcomes were collected when children were 30 months old. Two hundred seventy-two mothers were recruited from the 5 test and 4 control communities. Baseline characteristics were comparable but not equivalent for both groups. At trial's end, 241 children had follow-up. The primary analysis outcome was enamel caries with substance loss (d2); no statistically significant treatment effect was detected. Prevalence of treated and untreated caries at the d2 level was 76% in controls vs. 65% in test (p = 0.17). Exploratory analyses suggested a substantial preventive effect for untreated decay at or beyond the level of the dentin, d3 (prevalences: 60% controls vs. 35% test), and a particularly large treatment effect when mothers had 4 or more MI-style sessions. Overall, these results provide preliminary evidence that, for these young, indigenous children, an MI-style intervention has an impact on severity of caries (clinical trial registration ISRCTN41467632).

A pragmatic randomized comparative effectiveness trial of transitional care for a socioeconomically diverse population: Design, rationale and baseline characteristics.

PubMed

Schaeffer, Christine; Teter, Caroline; Finch, Emily A; Hurt, Courtney; Keeter, Mary Kate; Liss, David T; Rogers, Angela; Sheth, Avani; Ackermann, Ronald

2018-02-01

Transitional care programs have been widely used to reduce readmissions and improve the quality and safety of the handoff process between hospital and outpatient providers. Very little is known about effective transitional care interventions among patients who are uninsured or with Medicaid. This paper describes the design and baseline characteristics of a pragmatic randomized comparative effectiveness trial of transitional care. Northwestern Medical Group- Transitional Care (NMG-TC) care model was developed to address the needs of patients with multiple medical problems that required lifestyle changes and were amenable to office-based management. We present the design, evaluation methods and baseline characteristics of NMG-TC trial patients. Baseline demographic characteristics indicate that our patient population is predominantly male, Medicaid insured and non-white. This study will evaluate two methods for implementing an effective transitional care model in a medically complex and socioeconomically diverse population. Copyright © 2017 Elsevier Inc. All rights reserved.

FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial.

PubMed

Baumgaertner, Annette; Grewe, Tanja; Ziegler, Wolfram; Floel, Agnes; Springer, Luise; Martus, Peter; Breitenstein, Caterina

2013-09-23

Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia. Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative.The primary analysis tests for differences between the therapy group and an untreated (waiting list) control group with respect to pre- versus post 3-week-therapy (or waiting period, respectively) scores on the ANELT A-scale. Statistical between-group comparisons of primary and secondary outcome measures will be conducted in intention-to-treat analyses.Long-term stability of treatment effects will be assessed six months post intensive SLT (primary and secondary endpoints). Registered in ClinicalTrials.gov with the Identifier NCT01540383.

Impact of a nutrition and physical activity intervention (ENRICH: Exercise and Nutrition Routine Improving Cancer Health) on health behaviors of cancer survivors and carers: a pragmatic randomized controlled trial.

PubMed

James, E L; Stacey, F G; Chapman, K; Boyes, A W; Burrows, T; Girgis, A; Asprey, G; Bisquera, A; Lubans, D R

2015-10-15

Physical activity and consuming a healthy diet have clear benefits to the physical and psychosocial health of cancer survivors, with guidelines recognising the importance of these behaviors for cancer survivors. Interventions to promote physical activity and improve dietary behaviors among cancer survivors and carers are needed. The aim of this study was to determine the effects of a group-based, face-to-face multiple health behavior change intervention on behavioral outcomes among cancer survivors of mixed diagnoses and carers. The Exercise and Nutrition Routine Improving Cancer Health (ENRICH) intervention was evaluated using a two-group pragmatic randomized controlled trial. Cancer survivors and carers (n = 174) were randomly allocated to the face-to-face, group-based intervention (six, theory-based two-hour sessions delivered over 8 weeks targeting healthy eating and physical activity [PA]) or wait-list control (after completion of 20-week data collection). Assessment of the primary outcome (pedometer-assessed mean daily step counts) and secondary outcomes (diet and alcohol intake [Food Frequency Questionnaire], self-reported PA, weight, body mass index, and waist circumference) were assessed at baseline, 8-and 20-weeks. There was a significant difference between the change over time in the intervention group and the control group. At 20 weeks, the intervention group had increased by 478 steps, and the control group had decreased by 1282 steps; this represented an adjusted mean difference of 1761 steps (184 to 3337; P = 0.0028). Significant intervention effects for secondary outcomes, included a half serving increase in vegetable intake (difference 39 g/day; 95 % CI: 12 to 67; P = 0.02), weight loss (kg) (difference -1.5 kg; 95 % CI, -2.6 to -0.3; P = 0.014) and change in body mass index (kg/m(2)) (difference -0.55 kg/m(2); 95 % CI, -0.97 to -0.13; P = 0.012). No significant intervention effects were found for self-reported PA, total sitting time, waist circumference, fruit, energy, fibre, alcohol, meat, or fat consumption. The ENRICH intervention was effective for improving PA, weight, body mass index, and vegetable consumption even with the inclusion of multiple cancer types and carers. As an example of successful research translation, the Cancer Council NSW has subsequently adopted ENRICH as a state-wide program. Australian New Zealand Clinical Trials Register identifier: ANZCTRN1260901086257.

Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.

PubMed

van der Zweerde, Tanja; Lancee, Jaap; Slottje, Pauline; Bosmans, Judith; Van Someren, Eus; Reynolds, Charles; Cuijpers, Pim; van Straten, Annemieke

2016-04-02

Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual. In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life. The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed. Netherlands Trial register NTR 5202 (registered April 17(st) 2015).

Pragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD.

PubMed

Navaneethan, Sankar D; Jolly, Stacey E; Schold, Jesse D; Arrigain, Susana; Nakhoul, Georges; Konig, Victoria; Hyland, Jennifer; Burrucker, Yvette K; Dann, Priscilla Davis; Tucky, Barbara H; Sharp, John; Nally, Joseph V

2017-09-07

Patient navigators and enhanced personal health records improve the quality of health care delivered in other disease states. We aimed to develop a navigator program for patients with CKD and an electronic health record-based enhanced personal health record to disseminate CKD stage-specific goals of care and education. We also conducted a pragmatic randomized clinical trial to compare the effect of a navigator program for patients with CKD with enhanced personal health record and compare their combination compared with usual care among patients with CKD stage 3b/4. Two hundred and nine patients from six outpatient clinics (in both primary care and nephrology settings) were randomized in a 2×2 factorial design into four-study groups: ( 1 ) enhanced personal health record only, ( 2 ) patient navigator only, ( 3 ) both, and ( 4 ) usual care (control) group. Primary outcome measure was the change in eGFR over a 2-year follow-up period. Secondary outcome measures included acquisition of appropriate CKD-related laboratory measures, specialty referrals, and hospitalization rates. Median age of the study population was 68 years old, and 75% were white. At study entry, 54% of patients were followed by nephrologists, and 88% were on renin-angiotensin system blockers. After a 2-year follow-up, rate of decline in eGFR was similar across the four groups ( P =0.19). Measurements of CKD-related laboratory parameters were not significantly different among the groups. Furthermore, referral for dialysis education and vascular access placement, emergency room visits, and hospitalization rates were not statistically significant different between the groups. We successfully developed a patient navigator program and an enhanced personal health record for the CKD population. However, there were no differences in eGFR decline and other outcomes among the study groups. Larger and long-term studies along with cost-effectiveness analyses are needed to evaluate the role of patient navigators and patient education through an enhanced personal health record in those with CKD. Copyright © 2017 by the American Society of Nephrology.

The Effect of Corpus-Based Instruction on Pragmatic Routines

ERIC Educational Resources Information Center

Bardovi-Harlig, Kathleen; Mossman, Sabrina; Su, Yunwen

2017-01-01

This study compares the effect of using corpus-based materials and activities for the instruction of pragmatic routines under two conditions: implementing direct corpus searches by learners during classroom instruction and working with teacher-developed corpus-based materials. The outcome is compared to a repeated-test control group. Pragmatic…

The Effect of Instruction on Pragmatic Routines in Academic Discussion

ERIC Educational Resources Information Center

Bardovi-Harlig, Kathleen; Mossman, Sabrina; Vellenga, Heidi E.

2015-01-01

This study investigates the effect of instruction on the acquisition of pragmatic routines used in academic discussion, specifically expressions of agreement, disagreement, and clarification. Thirty-seven learners, including an experimental group of 26 students and a control group of 11 students, participated in the study. Five intact classes…

Effect of personalised citizen assistance for social participation (APIC) on older adults’ health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT)

PubMed Central

Levasseur, Mélanie; Dubois, Marie-France; Filliatrault, Johanne; Vasiliadis, Helen-Maria; Lacasse-Bédard, Joanie; Tourigny, André; Levert, Marie-Josée; Gabaude, Catherine; Lefebvre, Hélène; Berger, Valérie; Eymard, Chantal

2018-01-01

Introduction The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d’Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. Methods and analysis A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults’ health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. Ethics and dissemination The Research Ethics Committee of the CIUSSS Estrie – CHUS has approved the study (MP-31-2018-2424). An informed consent form will be read and signed by all study participants. Findings will be published and presented at conferences. Trial registration number NCT03161860; Pre-results. PMID:29605819

What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

PubMed

Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

2015-11-01

Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Explaining pragmatic performance in traumatic brain injury: a process perspective on communicative errors.

PubMed

Bosco, Francesca M; Angeleri, Romina; Sacco, Katiuscia; Bara, Bruno G

2015-01-01

The purpose of this study is to investigate the pragmatic abilities of individuals with traumatic brain injury (TBI). Several studies in the literature have previously reported communicative deficits in individuals with TBI, however such research has focused principally on communicative deficits in general, without providing an analysis of the errors committed in understanding and expressing communicative acts. Within the theoretical framework of Cognitive Pragmatics theory and Cooperative principle we focused on intermediate communicative errors that occur in both the comprehension and the production of various pragmatic phenomena, expressed through both linguistic and extralinguistic communicative modalities. To investigate the pragmatic abilities of individuals with TBI. A group of 30 individuals with TBI and a matched control group took part in the experiment. They were presented with a series of videotaped vignettes depicting everyday communicative exchanges, and were tested on the comprehension and production of various kinds of communicative acts (standard communicative act, deceit and irony). The participants' answers were evaluated as correct or incorrect. Incorrect answers were then further evaluated with regard to the presence of different intermediate errors. Individuals with TBI performed worse than control participants on all the tasks investigated when considering correct versus incorrect answers. Furthermore, a series of logistic regression analyses showed that group membership (TBI versus controls) significantly predicted the occurrence of intermediate errors. This result holds in both the comprehension and production tasks, and in both linguistic and extralinguistic modalities. Participants with TBI tend to have difficulty in managing different types of communicative acts, and they make more intermediate errors than the control participants. Intermediate errors concern the comprehension and production of the expression act, the comprehension of the actors' meaning, as well as the respect of the Cooperative principle. © 2014 Royal College of Speech and Language Therapists.

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

PubMed

Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-08-01

We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

Cluster Randomized Controlled Trial

PubMed Central

Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-01-01

Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults.

PubMed

Dolovich, Lisa; Oliver, Doug; Lamarche, Larkin; Agarwal, Gina; Carr, Tracey; Chan, David; Cleghorn, Laura; Griffith, Lauren; Javadi, Dena; Kastner, Monika; Longaphy, Jennifer; Mangin, Dee; Papaioannou, Alexandra; Ploeg, Jenny; Raina, Parminder; Richardson, Julie; Risdon, Cathy; Santaguida, P Lina; Straus, Sharon; Thabane, Lehana; Valaitis, Ruta; Price, David

2016-04-05

Healthcare systems are not well designed to help people maintain or improve their health. They are generally not person-focused or well-coordinated. The objective of this study is to evaluate the effectiveness of the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) approach in older adults. The overarching hypothesis is that using the Health TAPESTRY approach to achieve better integration of the health and social care systems into a person's life that centers on meeting a person's health goals and needs will result in optimal aging. This is a 12-month delayed intervention pragmatic randomized controlled trial. The study will be performed in Hamilton, Ontario, Canada in the two-site McMaster Family Health Team. Participants will include 316 patients who are 70 years of age or older. Participants will be randomized to the Health TAPESTRY approach or control group. The Health TAPESTRY approach includes intentional, proactive conversations about a person's life and health goals and health risks and then initiation of congruent tailored interventions that support achievement of those goals and addressing of risks through (1) trained volunteers visiting clients in their homes to serve as a link between the primary care team and the client; (2) the use of novel technology including a personal health record from the home to link directly with the primary healthcare team; and (3) improved processes for connections, system navigation, and care delivery among interprofessional primary care teams, community service providers, and informal caregivers. The primary outcome will be the goal attainment scaling score. Secondary outcomes include self-efficacy for managing chronic disease, quality of life, the participant perspective on their own aging, social support, access to health services, comprehensiveness of care, patient empowerment, patient-centeredness, caregiver strain, satisfaction with care, healthcare resource utilization, and cost-effectiveness. Implementation processes will also be evaluated. The main comparative analysis will take place at 6 months. Evidence of the individual elements of the Health TAPESTRY platform has been shown in isolation in the previous research. However, this study will better understand how to best integrate them to maximize the system's transformation of person-focused, primary care for older adults. ClinicalTrials.gov NCT02283723.

[The Spanish adapted version of the Children's Communication Checklist identifies disorders of pragmatic use of language and differentiates between clinical subtypes].

PubMed

Crespo-Eguilaz, N; Magallon, S; Sanchez-Carpintero, R; Narbona, J

2016-01-01

The Children's Communication Checklist (CCC) by Bishop is a useful scale for evaluation of pragmatic verbal abilities in school children. The aim of the study is to ascertain the validity and reliability of the CCC in Spanish. Answers to the CCC items by parents of 360 children with normal intelligence were analyzed. There were five groups: 160 control children; 68 children with attention deficit hyperactivity disorder, 77 with procedural non-verbal disorder, 25 children with social communication disorder and 30 with autism spectrum disorder. Investigations included: factorial analysis in order to cluster checklist items, reliability analyses of the proposed scales and discriminant analysis to check whether the scale correctly classifies children with pragmatic verbal abilities. Seven factors were obtained (Kaiser-Meyer-Olkin: 0.852) with moderate similarity with those of the original scale: social relationships, interests, and five more that can be grouped into pragmatic verbal ability (conversational abilities, coherence-comprehension, empathy nonverbal communication and appropriateness). All factors are significantly correlated with each other in the control group, and the five that compose pragmatic verbal ability correlate with each other in the clinical groups (Pearson r). The scales have good reliability (Cronbach's alpha: 0.914). The questionnaire correctly classifies 98.9% of grouped cases with and without pragmatic disorder and 78% of subjects in their appropriate clinical group. Besides, the questionnaire allows to differentiate the pathologies according to the presence and intensity of the symptoms. This Spanish version of the CCC is highly valid and reliable. The proposed statistics can be used as normative-reference values.

The role of pragmatics in mediating the relationship between social disadvantage and adolescent behavior.

PubMed

Law, James; Rush, Robert; Clegg, Judy; Peters, Tim; Roulstone, Susan

2015-06-01

The relationship between social disadvantage, behavior, and communication in childhood is well established. Less is known about how these 3 interact across childhood and specifically whether pragmatic language skills act as a mediator between early social disadvantage and adolescent behavior. The sample was the Avon Longitudinal Study of Parents and Children, a representative birth cohort initially recruited in England in 1991/1992 and followed through to adolescence and beyond. Of the original 13,992 live births, data were available for 2926 children at 13 years. Univariable analysis was first used to identify sociodemographic and other predictors of the Strengths and Difficulties Questionnaire (SDQ) at 13 years. The mediational role of the pragmatics scale of the Children's Communication Checklist (CCC) at 9 years was then tested, controlling for age, gender, and IQ. There was evidence of both a direct effect from social disadvantage (path C') to SDQ Total Behavior Score at 13 years (-.205; p < .001) and an indirect effect from social disadvantage to SDQ Total (-.225; p < .001) after adjusting for the CCC pragmatics scale as a mediator. The latter represents a reduction in the magnitude of the unadjusted effect or "total effect" (-.430), demonstrating that the pragmatics scale partially mediates the relationship of early social disadvantage and adolescent behavior (even after controlling for other covariates). The same relationship held for all but the pro-social subscale of the SDQ. The results provide evidence to suggest that there maybe a causal relationship between these variables, suggesting that interventions targeting pragmatic skills have the potential to reduce adolescent behavioral symptoms.

Study protocol: pragmatic randomized control trial of an internet-based intervention (My tools 4 care) for family carers.

PubMed

Duggleby, Wendy; Ploeg, Jenny; McAiney, Carrie; Fisher, Kathryn; Swindle, Jenny; Chambers, Tracey; Ghosh, Sunita; Peacock, Shelley; Markle-Reid, Maureen; Triscott, Jean; Williams, Allison; Forbes, Dorothy; Pollard, Lori

2017-08-14

Family carers of older persons with Alzheimer's' disease and related dementia (ADRD) and multiple chronic conditions (MCC) experience significant, complex, and distressing transitions such as changes to their environment, roles and relationships, physical health, and mental health. An online intervention (My Tools 4 Care) was developed for family carers of persons with ADRD and MCC living at home, with the aim of supporting these carers through transitions and increasing their self-efficacy, hope, and health related quality of life (HRQoL). This study will evaluate My Tools 4 Care (MT4C) by asking the following research questions: 1. Does use of MT4C result in a 3 month (immediately post intervention) and 6-month (3 months after intervention) increase in HRQoL, self-efficacy, and hope, in carers of persons with ADRD and MCC compared to an educational control group? 2. Does use of MT4C help carers of community-dwelling older adults with ADRD and MCC deal with significant changes they experience as carers? and 3. Are the effects/benefits of the MT4C intervention achieved at no additional cost compared to an educational control group? Using a pragmatic mixed methods randomized controlled trial design, 180 family carers of community dwelling older persons (65 years of age and older) with ADRD and MCC will participate in the study. Data will be collected from the intervention and an educational control group at four time points: baseline, 1 month, 3 and 6 months. We expect to find that family carers using MT4C will show greater improvement in hope, self-efficacy and HRQoL, at no additional cost from a societal perspective, compared to those in the educational control group. General estimating equations will be used to determine differences between groups and over time. Data collection began in Ontario and Alberta Canada in June 2015 and is expected to be completed in June 2017. The results will inform policy and practice as MT4C can be easily revised for local contexts and is scalable in terms of posting on websites such as those hosted by the Alzheimer Society. ClinicalTrials.gov Identifier: NCT02428387.

Improving youth question-asking and provider education during pediatric asthma visits.

PubMed

Sleath, Betsy; Carpenter, Delesha M; Davis, Scott A; Watson, Claire Hayes; Lee, Charles; Loughlin, Ceila E; Garcia, Nacire; Reuland, Daniel S; Tudor, Gail

2018-06-01

We conducted a pragmatic randomized controlled trial to test the effectiveness of an asthma question prompt list with video intervention to increase youth question-asking and provider education during visits. English or Spanish-speaking youth ages 11-17 with persistent asthma and their parents were enrolled from four rural and suburban pediatric clinics. Youth were randomized to the intervention or usual care groups. Intervention group adolescents watched the video on an iPad and then completed an asthma question prompt list before their visits. Generalized estimating equations were used to analyze the data. Forty providers and 359 patients participated. Intervention group youth were significantly more likely to ask one or more questions about medications, triggers, and environmental control than usual care youth. Providers were significantly more likely to educate intervention group youth about rescue medications, triggers, and environmental control. Intervention group caregivers were not significantly more likely to ask questions. The intervention increased youth question-asking and provider education about medications, triggers, and environmental control. The intervention did not impact caregiver question-asking. Providers/practices should consider having youth complete question prompt lists and watch the video with their parents before visits to increase youth question-asking during visits. Copyright © 2018 Elsevier B.V. All rights reserved.

A Comparative Study of Exact versus Propensity Matching Techniques Using Monte Carlo Simulation

ERIC Educational Resources Information Center

Itang'ata, Mukaria J. J.

2013-01-01

Often researchers face situations where comparative studies between two or more programs are necessary to make causal inferences for informed policy decision-making. Experimental designs employing randomization provide the strongest evidence for causal inferences. However, many pragmatic and ethical challenges may preclude the use of randomized…

Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial.

PubMed

Urquhart, Donna M; Wluka, Anita E; Sim, Malcolm R; van Tulder, Maurits; Forbes, Andrew; Gibson, Stephen J; Arnold, Carolyn; Fong, Chris; Anthony, Shane N; Cicuttini, Flavia M

2016-10-22

Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain. One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations. They will be randomly allocated to receive either low-dose amitriptyline (25 mg) or an active placebo (benztropine mesylate, 1 mg) for 6 months. The primary outcome measure of pain intensity will be assessed at baseline, 3 and 6 months using validated questionnaires. Secondary measures of self-reported low back disability, work absence and hindrance in the performance of paid/unpaid work will also be examined. Intention-to-treat analyses will be performed. This pragmatic, double-blind, randomised, placebo-controlled trial will provide evidence regarding the effectiveness of low-dose antidepressants compared with placebo in reducing pain, disability, work absenteeism and hindrance in work performance in individuals with chronic low back pain. This trial has major public health and clinical importance as it has the potential to provide an effective approach to the management of chronic low back pain. Australian New Zealand Clinical Trials Registry: ACTRN12612000131853 ; registered on 30 January 2012.

How young adults with autism spectrum disorder watch and interpret pragmatically complex scenes.

PubMed

Lönnqvist, Linda; Loukusa, Soile; Hurtig, Tuula; Mäkinen, Leena; Siipo, Antti; Väyrynen, Eero; Palo, Pertti; Laukka, Seppo; Mämmelä, Laura; Mattila, Marja-Leena; Ebeling, Hanna

2017-11-01

The aim of the current study was to investigate subtle characteristics of social perception and interpretation in high-functioning individuals with autism spectrum disorders (ASDs), and to study the relation between watching and interpreting. As a novelty, we used an approach that combined moment-by-moment eye tracking and verbal assessment. Sixteen young adults with ASD and 16 neurotypical control participants watched a video depicting a complex communication situation while their eye movements were tracked. The participants also completed a verbal task with questions related to the pragmatic content of the video. We compared verbal task scores and eye movements between groups, and assessed correlations between task performance and eye movements. Individuals with ASD had more difficulty than the controls in interpreting the video, and during two short moments there were significant group differences in eye movements. Additionally, we found significant correlations between verbal task scores and moment-level eye movement in the ASD group, but not among the controls. We concluded that participants with ASD had slight difficulties in understanding the pragmatic content of the video stimulus and attending to social cues, and that the connection between pragmatic understanding and eye movements was more pronounced for participants with ASD than for neurotypical participants.

Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.

PubMed

Kalkman, Shona; van Thiel, Ghislaine J M W; Grobbee, Diederick E; Meinecke, Anna-Katharina; Zuidgeest, Mira G P; van Delden, Johannes J M

2016-08-22

We explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders' attitudes towards the implementation of pragmatic trials in the drug development process. We conducted semistructured, in-depth interviews among individuals from different key stakeholder groups (academia and independent research institutions, the pharmaceutical industry, regulators, Health Technology Assessment (HTA) agencies and patients' organizations) through telephone or face-to-face sessions. Interviews were structured around the question "what challenges were experienced or perceived during the design, conduct and/or review of pragmatic trials." Respondents were additionally asked about their views on implementation of pragmatic trials in the drug development process. Thematic analysis was used to identify the ethically relevant features across data sets. We interviewed 34 stakeholders in 25 individual sessions and four group sessions. The four perceived challenges of ethical relevance were: (1) less controlled conditions creating safety concerns, (2) comparison with usual care potentially compromising clinical equipoise, (3) tailored or waivers of informed consent affecting patient autonomy, and (4) minimal interference with "real-world" practice reducing the knowledge value of trial results. We identified stakeholder concerns regarding risk assessment, use of suboptimal usual care as a comparator, tailoring of informed consent procedures and ensuring the social value of pragmatic trials. These concerns increased when respondents were asked about pragmatic trials conducted before market authorization.

Relation of executive functioning to pragmatic outcome following severe traumatic brain injury.

PubMed

Douglas, Jacinta M

2010-04-01

This study was designed to explore the behavioral nature of pragmatic impairment following severe traumatic brain injury (TBI) and to evaluate the contribution of executive skills to the experience of pragmatic difficulties after TBI. Participants were grouped into 43 TBI dyads (TBI adults and close relatives) and 43 control dyads. All TBI participants had sustained severe injury (mean posttraumatic amnesia duration = 45.19 days, SD = 39.15) due to a moving vehicle-related trauma. A minimum of 2 years had elapsed since injury (M = 5.36 years, SD = 3.61). The La Trobe Communication Questionnaire (LCQ; Douglas, O'Flaherty, & Snow, 2000) was administered to all participants. Measures of executive function included the following: the FAS verbal fluency task (Spreen & Benton, 1969), the Speed and Capacity of Language Processing test (Baddeley, Emslie, & Nimmo-Smith, 1992), and the Rey Auditory Verbal Learning Task (Rey, 1964). Perceptions of TBI participants and their relatives were significantly correlated (r = .63, p < .001) and significantly different from those of controls, F(1, 84) = 37.2, p < .001. Pragmatic difficulties represented violations in 3 domains of Grice's (1975) Cooperative Principle (Quantity, Relation, and Manner), and executive function measures predicted 37% (32% adjusted) of the variability in LCQ scores. The study demonstrates evidence of a significant association between executive impairment and the pragmatic communication difficulties experienced by individuals with TBI.

Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

PubMed

Arnfred, Sidse M; Aharoni, Ruth; Hvenegaard, Morten; Poulsen, Stig; Bach, Bo; Arendt, Mikkel; Rosenberg, Nicole K; Reinholt, Nina

2017-01-23

Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect. Clinicaltrials.gov NCT02954731 . Registered 25 October 2016.

Evaluating a Serious Gaming Electronic Medication Administration Record System Among Nursing Students: Protocol for a Pragmatic Randomized Controlled Trial.

PubMed

Booth, Richard; Sinclair, Barbara; McMurray, Josephine; Strudwick, Gillian; Watson, Gavan; Ladak, Hanif; Zwarenstein, Merrick; McBride, Susan; Chan, Ryan; Brennan, Laura

2018-05-28

Although electronic medication administration record systems have been implemented in settings where nurses work, nursing students commonly lack robust learning opportunities to practice the skills and workflow of digitalized medication administration during their formative education. As a result, nursing students' performance in administering medication facilitated by technology is often poor. Serious gaming has been recommended as a possible intervention to improve nursing students' performance with electronic medication administration in nursing education. The objectives of this study are to examine whether the use of a gamified electronic medication administration simulator (1) improves nursing students' attention to medication administration safety within simulated practice, (2) increases student self-efficacy and knowledge of the medication administration process, and (3) improves motivational and cognitive processing attributes related to student learning in a technology-enabled environment. This study comprised the development of a gamified electronic medication administration record simulator and its evaluation in 2 phases. Phase 1 consists of a prospective, pragmatic randomized controlled trial with second-year baccalaureate nursing students at a Canadian university. Phase 2 consists of qualitative focus group interviews with a cross-section of nursing student participants. The gamified medication administration simulator has been developed, and data collection is currently under way. If the gamified electronic medication administration simulator is found to be effective, it could be used to support other health professional simulated education and scaled more widely in nursing education programs. ClinicalTrials.gov NCT03219151; https://clinicaltrials.gov/show/NCT03219151 (Archived by WebCite at http://www.webcitation.org/6yjBROoDt). RR1-10.2196/9601. ©Richard Booth, Barbara Sinclair, Josephine McMurray, Gillian Strudwick, Gavan Watson, Hanif Ladak, Merrick Zwarenstein, Susan McBride, Ryan Chan, Laura Brennan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.05.2018.

Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry.

PubMed

Milne, Christopher-Paul; Cohen, Joshua P; Felix, Abigail; Chakravarthy, Ranjana

2015-08-01

Meeting marketplace demands for proving the value of new products requires more data than the industry has routinely produced. These data include evidence from comparative effectiveness research (CER), including randomized, controlled trials; pragmatic clinical trials; observational studies; and meta-analyses. We designed and conducted a survey to examine the industry's perceptions on new data requirements regarding CER evidence, the acceptability of postapproval study types, payer-specific issues related to CER, communication of data being generated postapproval, and methods used for facilitating postapproval evidence generation. CER is being used by payers for most types of postapproval decisions. Randomized, controlled trials were indicated as the most acceptable form of evidence. At the same time, there was support for the utility of other types of studies, such as pragmatic clinical trials and observational studies. Respondents indicated the use of multiple formats for communicating postapproval data with many different stakeholders including regulators, payers, providers, and patients. Risk-sharing agreements with payers were unanimously supported by respondents with regard to certain products with unclear clinical and economic outcomes at launch. In these instances, conditional reimbursement through coverage with evidence development was considered a constructive option. The Food and Drug Administration's initiative called Regulatory Science was considered by the respondents as having the most impact on streamlining the generation of postapproval research-related evidence. The biopharmaceutical industry is faced with a broad and complex set of challenges related to evidence generation for postapproval decisions by a variety of health care system stakeholders. Uncertainty remains as to how the industry and payers use postapproval studies to guide decision making with regard to pricing and reimbursement status. Correspondingly, there is uncertainty regarding whether the industry's investment in CER will have a positive return on investment in terms of reimbursement and market access. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Treating Procrastination Using Cognitive Behavior Therapy: A Pragmatic Randomized Controlled Trial Comparing Treatment Delivered via the Internet or in Groups.

PubMed

Rozental, Alexander; Forsström, David; Lindner, Philip; Nilsson, Simon; Mårtensson, Lina; Rizzo, Angela; Andersson, Gerhard; Carlbring, Per

2018-03-01

Procrastination is a common problem among university students, with at least half of the population reporting great difficulties initiating or completing tasks and assignments. Procrastination can have a negative impact on course grades and the ability to achieve a university degree, but can also lead to psychological distress. Cognitive behavior therapy (CBT) is believed to reduce procrastination, but few studies have investigated its effectiveness in a regular clinical setting. The current study explored its effects using a pragmatic randomized controlled trial comparing treatment delivered during 8 weeks as self-guided CBT via the Internet (ICBT) or as group CBT. In total, 92 university students with severe procrastination were included in the study (registered as a clinical trial on Clinicaltrials.gov: NCT02112383). Outcome measures on procrastination, depression, anxiety, and well-being were distributed at pre- and posttreatment as well as 6-month follow-up. An outcome measure of procrastination was administered weekly. Linear mixed and fixed effects models were calculated, along with improvement and deterioration rates. The results showed large within-group effect sizes on procrastination, Cohen's d of 1.29 for ICBT, 95% Confidence Interval (CI) [0.81, 1.74], and d of 1.24 for group CBT, 95% CI [0.76, 1.70], and small to moderate benefits for depression, anxiety, and well-being. In total, 33.7% were regarded as improved at posttreatment and 46.7% at follow-up. No differences between conditions were observed after the treatment period, however, participants in group CBT continued or maintained their improvement at follow-up, while participants in self-guided ICBT showed some signs of deterioration. The findings from the current study suggest that CBT might be an effective treatment for those struggling with severe procrastination, but that a group format may be better for some to sustain their benefits over time and that the clinical significance of the results need to be investigated further. Copyright © 2017. Published by Elsevier Ltd.

An Argument for Fewer Clinical Trials.

PubMed

Borgerson, Kirstin

2016-11-01

The volume of clinical research is increasing exponentially-far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because "quality" is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in "usual" care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. © 2016 The Hastings Center.

Influence of ultrasound determination of fetal head position on mode of delivery: a pragmatic randomized trial.

PubMed

Popowski, T; Porcher, R; Fort, J; Javoise, S; Rozenberg, P

2015-11-01

To evaluate the influence of ultrasound determination of fetal head position on mode of delivery. This was a pragmatic open-label randomized controlled trial that included women with a singleton pregnancy in the vertex presentation at ≥ 37 weeks' gestation, cervical dilation ≥ 8 cm and who received epidural anesthesia. Women were assigned randomly to undergo either digital vaginal examination (VE group) or both digital vaginal and ultrasound examinations (VE+US group) to determine fetal head position. When the ultrasound and digital vaginal findings were inconsistent in the VE+US group, the ultrasound result was used for clinical management. The primary outcome assessed was operative delivery (Cesarean or instrumental vaginal delivery), and maternal and fetal morbidity were also assessed. The VE and VE+US groups included 959 and 944 women, respectively. The overall rate of operative delivery was significantly higher in the VE+US group than in the VE group: 33.7% vs 27.1%, respectively (relative risk (RR), 1.24 (95% CI, 1.08-1.43)), as was the rate of Cesarean delivery: 7.8% vs 4.9%, respectively (RR, 1.60 (95% CI, 1.12-2.28)). The rate of instrumental vaginal delivery was also higher, albeit not significantly: 25.8% in the VE+US group vs 22.2% in the VE group (RR, 1.16 (95% CI, 0.99-1.37)). Neonatal outcomes did not differ between the two groups. When analysis was restricted to instrumental vaginal deliveries only, maternal and neonatal morbidity outcomes were similar in both groups. Correction of fetal occiput position, determined initially by digital vaginal examination, using systematic ultrasound examination did not improve management of labor and increased the rate of operative delivery without decreasing maternal and neonatal morbidity. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Social problem-solving plus psychoeducation for adults with personality disorder: pragmatic randomised controlled trial.

PubMed

Huband, Nick; McMurran, Mary; Evans, Chris; Duggan, Conor

2007-04-01

Social problem-solving therapy may be relevant in the treatment of personality disorder, although assessments of its effectiveness are uncommon. To determine the effectiveness of a problem-solving intervention for adults with personality disorder in the community under conditions resembling routine clinical practice. Participants were randomly allocated to brief psychoeducation plus 16 problem-solving group sessions (n=87) or to waiting-list control (n=89). Primary outcome was comparison of scores on the Social Problem Solving Inventory and the Social Functioning Questionnaire between intervention and control arms at the conclusion of treatment, on average at 24 weeks after randomisation. In intention-to-treat analysis, those allocated to intervention showed significantly better problem-solving skills (P<0.001), higher overall social functioning (P=0.031) and lower anger expression (P=0.039) compared with controls. No significant differences were found on use of services during the intervention period. Problem-solving plus psychoeducation has potential as a preliminary intervention for adults with personality disorder.

Virtual Task-Based Situated Language-Learning with "Second Life": Developing EFL Pragmatic Writing and Technological Self-Efficacy

ERIC Educational Resources Information Center

Abdallah, Mahmoud M. S.; Mansour, Marian M.

2015-01-01

This paper reports on an experimental research study that aimed at investigating the effectiveness of employing a virtual task-based situated language learning (TBSLL) environment mediated by Second Life (SL) in developing EFL student teachers' pragmatic writing skills and their technological self-efficacy. To reach this goal, a control-only…

Narrative Competence and Underlying Mechanisms in Children with Pragmatic Language Impairment

ERIC Educational Resources Information Center

Ketelaars, Mieke Pauline; Jansonius, Kino; Cuperus, Juliane; Verhoeven, Ludo

2012-01-01

This study investigated narrative competence in children with pragmatic language impairment (PLI) and the extent to which it is related to impairments in theory of mind and executive functioning (EF). Narrative competence was assessed using a retelling design in a group of 77 children with PLI and a control group of 77 typically developing…

Interpretation of Logical Words in Mandarin-Speaking Children with Autism Spectrum Disorders: Uncovering Knowledge of Semantics and Pragmatics.

PubMed

Su, Yi Esther; Su, Lin-Yan

2015-07-01

This study investigated the interpretation of the logical words 'some' and 'every…or…' in 4-15-year-old high-functioning Mandarin-speaking children with autism spectrum disorders (ASD). Children with ASD performed similarly to typical controls in demonstrating semantic knowledge of simple sentences with 'some', and they had delayed knowledge of the complex sentences with 'every…or…'. Interestingly, the children with ASD had pragmatic knowledge of the scalar implicatures of these logical words, parallel to those of the typical controls. Taken together, the interpretation of logical words may be a relative strength in children with ASD. It is possible that some aspects of semantics and pragmatics may be selectively spared in ASD, due to the contribution the language faculty makes to language acquisition in the ASD population.

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial

PubMed Central

Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-01-01

Background Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. Objective The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. Methods A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association–recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators’ monitoring of patients’ adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A1c levels, weight, and the usability of the connected system. Results An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. Conclusions If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. Trial Registration ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5) PMID:29610111

Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol

PubMed Central

Nash, Danielle M.; Ivers, Noah M.; Young, Jacqueline; Jaakkimainen, R. Liisa; Garg, Amit X.; Tu, Karen

2017-01-01

Background: Many patients with or at risk for chronic kidney disease (CKD) in the primary care setting are not receiving recommended care. Objective: The objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting. Design: A pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted. Setting: The study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group. Intervention: The intervention group will receive resources from the “CKD toolkit” to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support. Measurements: Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of physicians in the intervention group to understand why the intervention achieved the observed effects. Conclusions: If our intervention improves care, then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records. Trial Registration: ClinicalTrials.gov Identifier: NCT02274298 PMID:28607686

Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study.

PubMed

Aravind, S R; Ismail, Shaiful Bahari; Balamurugan, R; Gupta, Jugal Bihari; Wadhwa, Tarun; Loh, Sze Min; Suryawanshi, Shailaja; Davies, Michael J; Girman, Cynthia J; Katzeff, Harvey L; Radican, Larry; Engel, Samuel S; Wolthers, Troels

2012-08-01

To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan. In a multicenter, pragmatic, randomized study, patients with type 2 diabetes were recruited from clinical centers in India (n = 765) and Malaysia (n = 105). Eligible patients (age ≥ 18 yrs) expressed their intention to daytime fast during Ramadan, were treated with a stable dose of sulfonylurea with or without metformin for ≥3 months prior to screening visit, and had an HbA(1c) ≤ 10%. Patients were randomized in a 1:1 ratio to either switch to sitagliptin 100 mg q.d. or remain on their pre-study sulfonylurea. Daily diary cards were completed to document information on hypoglycemic symptoms and complications. The primary endpoint was the overall incidence of symptomatic hypoglycemia during Ramadan. Of the 870 patients randomized, 848 (n = 421 for sitagliptin and 427 for sulfonylurea) returned ≥1 completed diary card and were included in the analysis. The proportion of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan was lower with sitagliptin (3.8%) compared to sulfonylurea (7.3%). The risk of symptomatic hypoglycemia was significantly lower with sitagliptin (risk ratio [95% CI] = 0.52 [0.29, 0.94]; p = 0.028). By country, the proportions of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan were 4.1% vs. 7.7% in India and 1.9% vs. 3.8% in Malaysia for sitagliptin and sulfonylurea, respectively. No patient discontinued treatment due to a hypoglycemic event. One patient on sitagliptin and seven on sulfonylurea had an event that required non-medical assistance. No events required medical assistance. Both treatments were generally well tolerated. Symptomatic hypoglycemic events did not require a confirmatory blood glucose measurement, which may have overestimated hypoglycemic events. Measures of glycemic control and body weight were not assessed. Switching antihyperglycemic treatment to sitagliptin from a sulfonylurea reduced the risk of symptomatic hypoglycemia by approximately 50% for Muslim patients with type 2 diabetes who fasted during Ramadan. Clinicaltrials.gov: NCT01340768.

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

PubMed

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

2016-09-08

One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation. Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally. Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care.

PubMed

Francis, Nick A; Ridd, Matthew J; Thomas-Jones, Emma; Butler, Christopher C; Hood, Kerenza; Shepherd, Victoria; Marwick, Charis A; Huang, Chao; Longo, Mirella; Wootton, Mandy; Sullivan, Frank

2017-03-01

Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema. We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Children with clinical, non-severely infected eczema were randomized to receive oral and topical placebos (control), oral antibiotic (flucloxacillin) and topical placebo, or topical antibiotic (fusidic acid) and oral placebo, for 1 week. We compared Patient Oriented Eczema Measure (POEM) scores at 2 weeks using analysis of covariance (ANCOVA). We randomized 113 children (40 to control, 36 to oral antibiotic, and 37 to topical antibiotic). Mean (SD) baseline Patient Oriented Eczema Measure scores were 13.4 (5.1) for the control group, 14.6 (5.3) for the oral antibiotic group, and 16.9 (5.5) for the topical antibiotic group. At baseline, 104 children (93%) had 1 or more of the following findings: weeping, crusting, pustules, or painful skin. Mean (SD) POEM scores at 2 weeks were 6.2 (6.0) for control, 8.3 (7.3) for the oral antibiotic group, and 9.3 (6.2) for the topical antibiotic group. Controlling for baseline POEM score, neither oral nor topical antibiotics produced a significant difference in mean (95% CI) POEM scores (1.5 [-1.4 to 4.4] and 1.5 [-1.6 to 4.5] respectively). There were no significant differences in adverse effects and no serious adverse events. We found rapid resolution in response to topical steroid and emollient treatment and ruled out a clinically meaningful benefit from the addition of either oral or topical antibiotics. Children seen in ambulatory care with mild clinically infected eczema do not need treatment with antibiotics. © 2017 Annals of Family Medicine, Inc.

Reliability and validity evidence of the Assessment of Language Use in Social Contexts for Adults (ALUSCA).

PubMed

Valente, Ana Rita S; Hall, Andreia; Alvelos, Helena; Leahy, Margaret; Jesus, Luis M T

2018-04-12

The appropriate use of language in context depends on the speaker's pragmatic language competencies. A coding system was used to develop a specific and adult-focused self-administered questionnaire to adults who stutter and adults who do not stutter, The Assessment of Language Use in Social Contexts for Adults, with three categories: precursors, basic exchanges, and extended literal/non-literal discourse. This paper presents the content validity, item analysis, reliability coefficients and evidences of construct validity of the instrument. Content validity analysis was based on a two-stage process: first, 11 pragmatic questionnaires were assessed to identify items that probe each pragmatic competency and to create the first version of the instrument; second, items were assessed qualitatively by an expert panel composed by adults who stutter and controls, and quantitatively and qualitatively by an expert panel composed by clinicians. A pilot study was conducted with five adults who stutter and five controls to analyse items and calculate reliability. Construct validity evidences were obtained using the hypothesized relationships method and factor analysis with 28 adults who stutter and 28 controls. Concerning content validity, the questionnaires assessed up to 13 pragmatic competencies. Qualitative and quantitative analysis revealed ambiguities in items construction. Disagreement between experts was solved through item modification. The pilot study showed that the instrument presented internal consistency and temporal stability. Significant differences between adults who stutter and controls and different response profiles revealed the instrument's underlying construct. The instrument is reliable and presented evidences of construct validity.

Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

PubMed

Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

2018-01-08

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial.

PubMed

Boshuisen, Kim; Lamberink, Herm J; van Schooneveld, Monique Mj; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg; Geleijns, Karin; Uiterwaal, Cuno Spm; Braun, Kees Pj

2015-10-26

The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at the cost of long-term seizure outcome. Moreover, AED withdrawal seemed to improve cognitive outcome. A randomized trial is needed to confirm these findings. We hypothesized that early AED withdrawal in children is not only safe, but also beneficial with respect to cognitive functioning. This is a multi-center pragmatic randomized clinical trial to investigate whether early AED withdrawal improves cognitive function, in terms of attention, executive function and intelligence, quality of life and behavior, and to confirm safety in terms of eventual seizure freedom, seizure recurrences and "seizure and AED freedom." Patients will be randomly allocated in parallel groups (1:1) to either early or late AED withdrawal. Randomization will be concealed and stratified for preoperative IQ and medical center. In the early withdrawal arm reduction of AEDs will start 4 months after surgery, while in the late withdrawal arm reduction starts 12 months after surgery, with intended complete cessation of drugs after 12 and 20 months respectively. Cognitive outcome measurements will be performed preoperatively, and at 1 and 2 years following surgery, and consist of assessment of attention and executive functioning using the EpiTrack Junior test and intelligence expressed as IQ (Wechsler Intelligence Scales). Seizure outcomes will be assessed at 24 months after surgery, and at 20 months following start of AED reduction. We aim to randomize 180 patients who underwent anticipated curative epilepsy surgery below 16 years of age, were able to perform the EpiTrack Junior test preoperatively, and have no predictors of poor postoperative seizure prognosis (multifocal magnetic resonance imaging (MRI) abnormalities, incomplete resection of the lesion, epileptic postoperative electroencephalogram (EEG) abnormalities, or more than three AEDs at the time of surgery). Growing experience with epilepsy surgery has changed the view towards postoperative medication policy. In a European collaboration, we designed a multi-center pragmatic randomized clinical trial comparing early with late AED withdrawal to investigate benefits and safety of early AED withdrawal. The TTS trial is supported by the Dutch Epilepsy Fund (NL 08-10) ISRCTN88423240/ 08/05/2013.

Exceptional Children and Microcomputers, A Survey of Public School Applications.

ERIC Educational Resources Information Center

Crowner, T. Timothy

Telephone interviews on the use of microcomputers in special education were administered to personnel in 25 districts (drawn from a random sample of the largest school districts in the United States) on the following topics: coordination of microcomputers; numbers of microcomputers owned and used; pragmatic uses; funding; brands used; selection,…

Mobile Seamless Technology Enhanced CSL Oral Communication

ERIC Educational Resources Information Center

Lan, Yu-Ju; Lin, Yen-Ting

2016-01-01

The current study aimed at investigating how mobile seamless technology can be used to enhance the pragmatic competence of learners of Chinese as a second language (CSL). 34 overseas CSL learners participated in this study. They were randomly assigned into two groups: the classroom group, executing language tasks in fake contexts in a traditional…

Placing Texts, Placing Writers: Sources of Readers' Judgments in University Placement-Testing.

ERIC Educational Resources Information Center

Sullivan, Francis J.

A study examined how pragmatic form influences evaluation of student essays in university placement testing. Specifically, the study documented how patterns in students' use of information (assumed to be either old, inferable, or new for readers) affected the holistic scores for quality given to the essays. Subjects, 99 randomly selected entering…

Study of Tomography Of Nephrolithiasis Evaluation (STONE): methodology, approach and rationale.

PubMed

Valencia, Victoria; Moghadassi, Michelle; Kriesel, Dana R; Cummings, Steve; Smith-Bindman, Rebecca

2014-05-01

Urolithiasis (kidney stones) is a common reason for Emergency Department (ED) visits, accounting for nearly 1% of all visits in the United States. Computed tomography (CT) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound. This paper describes the rationale and methods of STONE (Study of Tomography Of Nephrolithiasis Evaluation), a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis. STONE is a multi-center, non-blinded pragmatic randomized comparative effectiveness trial of patients between ages 18 and 75 with suspected nephrolithiasis seen in an ED setting. Patients were randomized to one of three initial imaging examinations: point-of-care ultrasound, ultrasound performed by a radiologist or CT. Participants then received diagnosis and treatment per usual care. The primary aim is to compare the rate of severe SAEs (Serious Adverse Events) between the three arms. In addition, a broad range of secondary outcomes was assessed at baseline and regularly for six months post-baseline using phone, email and mail questionnaires. Excluding 17 patients who withdrew after randomization, a total of 2759 patients were randomized and completed a baseline questionnaire (n=908, 893 and 958 in the point-of-care ultrasound, radiology ultrasound and radiology CT arms, respectively). Follow-up is complete, and full or partial outcomes were assessed on over 90% of participants. The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting. Published by Elsevier Inc.

Communicative-pragmatic disorders in traumatic brain injury: The role of theory of mind and executive functions.

PubMed

Bosco, Francesca M; Parola, Alberto; Sacco, Katiuscia; Zettin, Marina; Angeleri, Romina

2017-05-01

Previous research has shown that communicative-pragmatic ability, as well as executive functions (EF) and Theory of Mind (ToM), may be impaired in individuals with traumatic brain injury (TBI). However, the role of such cognitive deficits in explaining communicative-pragmatic difficulty in TBI has still not been fully investigated. The study examined the relationship between EF (working memory, planning and flexibility) and ToM and communicative-pragmatic impairment in patients with TBI. 30 individuals with TBI and 30 healthy controls were assessed using the Assessment Battery of Communication (ABaCo), and a set of cognitive, EF and ToM, tasks. The results showed that TBI participants performed poorly in comprehension and production tasks in the ABaCo, using both linguistic and extralinguistic means of expression, and that they were impaired in EF and ToM abilities. Cognitive difficulties were able to predict the pragmatic performance of TBI individuals, with both executive functions and ToM contributing to explaining patients' scores on the ABaCo. Copyright © 2017 Elsevier Inc. All rights reserved.

A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: pragmatics, recruitment, and demographics.

PubMed

Jones, L A T; Lammertse, D P; Charlifue, S B; Kirshblum, S C; Apple, D F; Ragnarsson, K T; Poonian, D; Betz, R R; Knoller, N; Heary, R F; Choudhri, T F; Jenkins, A L; Falci, S P; Snyder, D A

2010-11-01

Post hoc analysis from a randomized controlled cellular therapy trial in acute, complete spinal cord injury (SCI). Description and quantitative review of study logistics, referral patterns, current practice patterns and subject demographics. Subjects were recruited to one of six international study centers. Data are presented from 1816 patients pre-screened, 75 participants screened and 50 randomized. Of the 1816 patients pre-screened, 53.7% did not meet initial study criteria, primarily due to an injury outside the time window (14 days) or failure to meet neurological criteria (complete SCI between C5 motor/C4 sensory and T11). MRIs were obtained on 339 patients; 51.0% were ineligible based on imaging criteria. Of the 75 participants enrolled, 25 failed screening (SF), leaving 50 randomized. The primary reason for SF was based on the neurological exam (51.9%), followed by failure to meet MRI criteria (22.2%). Of the 50 randomized subjects, there were no significant differences in demographics in the active versus control arms. In those participants for whom data was available, 93.8% (45 of 48) of randomized participants received steroids before study entry, whereas 94.0% (47 of 50) had spine surgery before study enrollment. The 'funnel effect' (large numbers of potentially eligible participants with a small number enrolled) impacts all trials, but was particularly challenging in this trial due to eligibility criteria and logistics. Data collected may provide information on current practice patterns and the issues encountered and addressed may facilitate design of future trials.

Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials.

PubMed

Mathes, Tim; Buehn, Stefanie; Prengel, Peggy; Pieper, Dawid

2018-01-01

The objective of this study was to analyze the features of registry-based randomized trials (rRCTs). We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics. The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%. rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: Protocol for a randomized, placebo-controlled trial.

PubMed

Sprigg, Nikola; Robson, Katie; Bath, Philip; Dineen, Robert; Roberts, Ian; Robinson, Tom; Roffe, Christine; Werring, David; Al-Shahi Salman, Rustam; Pocock, Stuart; Duley, Lelia; England, Tim; Whynes, David; Ciccone, Alfonso; Laska, Ann Charlotte; Christensen, Hanne; Ozturk, Serefnur; Collins, Ronan; Bereczki, Daniel; Egea-Guerrero, Juan Jose; Law, Zhe Kang; Czlonkowska, Anna; Seiffge, David; Beredzie, Maia

2016-08-01

Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions. This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency. Phase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo. A trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79. The primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization. This pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214. © 2016 World Stroke Organization.

Contrasting Complement Control, Temporal Adjunct Control and Controlled Verbal Gerund Subjects in ASD: The Role of Contextual Cues in Reference Assignment.

PubMed

Janke, Vikki; Perovic, Alexandra

2017-01-01

This study examines two complex syntactic dependencies (complement control and sentence-final temporal adjunct control) and one pragmatic dependency (controlled verbal gerund subjects) in children with ASD. Sixteen high-functioning (HFA) children (aged 6-16) with a diagnosis of autism and no language impairment, matched on age, gender and non-verbal MA to one TD control group, and on age, gender and verbal MA to another TD control group, undertook three picture-selection tasks. Task 1 measured their base-line interpretations of the empty categories ( ec ). Task 2 preceded these sentence sets with a weakly established topic cueing an alternative referent and Task 3 with a strongly established topic cueing an alternative referent. In complement control (Ron persuaded Hermione ec to kick the ball) and sentence-final temporal adjunct control (Harry tapped Luna while ec feeding the owl), the reference of the ec is argued to be related obligatorily to the object and subject respectively. In controlled verbal-gerund subjects (VGS) ( ec Rowing the boat clumsily made Luna seasick), the ec 's reference is resolved pragmatically. Referent choices across the three tasks were compared. TD children chose the object uniformly in complement control across all tasks but in adjunct control, preferences shifted toward the object in Task 3. In controlled VGSs, they exhibited a strong preference for an internal-referent interpretation in Task 1, which shifted in the direction of the cues in Tasks 2 and 3. HFA children gave a mixed performance. They patterned with their TD counterparts on complement control and controlled VGSs but performed marginally differently on adjunct control: no TD groups were influenced by the weakly established topic in Task 2 but all groups were influenced by the strongly established topic in Task 3. HFA children were less influenced than the TD children, resulting in their making fewer object choices overall but revealing parallel patterns of performance. In this first study of three sub-types of control in ASD, we demonstrate that HFA children consult the same pragmatic cues to the same degree as TD children, in spite of the diverse pragmatic deficits reported for this population.

Contrasting Complement Control, Temporal Adjunct Control and Controlled Verbal Gerund Subjects in ASD: The Role of Contextual Cues in Reference Assignment

PubMed Central

Janke, Vikki; Perovic, Alexandra

2017-01-01

This study examines two complex syntactic dependencies (complement control and sentence-final temporal adjunct control) and one pragmatic dependency (controlled verbal gerund subjects) in children with ASD. Sixteen high-functioning (HFA) children (aged 6–16) with a diagnosis of autism and no language impairment, matched on age, gender and non-verbal MA to one TD control group, and on age, gender and verbal MA to another TD control group, undertook three picture-selection tasks. Task 1 measured their base-line interpretations of the empty categories (ec). Task 2 preceded these sentence sets with a weakly established topic cueing an alternative referent and Task 3 with a strongly established topic cueing an alternative referent. In complement control (Ron persuaded Hermione ec to kick the ball) and sentence-final temporal adjunct control (Harry tapped Luna while ec feeding the owl), the reference of the ec is argued to be related obligatorily to the object and subject respectively. In controlled verbal-gerund subjects (VGS) (ec Rowing the boat clumsily made Luna seasick), the ec's reference is resolved pragmatically. Referent choices across the three tasks were compared. TD children chose the object uniformly in complement control across all tasks but in adjunct control, preferences shifted toward the object in Task 3. In controlled VGSs, they exhibited a strong preference for an internal-referent interpretation in Task 1, which shifted in the direction of the cues in Tasks 2 and 3. HFA children gave a mixed performance. They patterned with their TD counterparts on complement control and controlled VGSs but performed marginally differently on adjunct control: no TD groups were influenced by the weakly established topic in Task 2 but all groups were influenced by the strongly established topic in Task 3. HFA children were less influenced than the TD children, resulting in their making fewer object choices overall but revealing parallel patterns of performance. In this first study of three sub-types of control in ASD, we demonstrate that HFA children consult the same pragmatic cues to the same degree as TD children, in spite of the diverse pragmatic deficits reported for this population. PMID:28400743

A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

PubMed

Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

2014-03-01

India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

Medication adherence and tolerability of Alzheimer's disease medications: study protocol for a randomized controlled trial.

PubMed

Campbell, Noll L; Dexter, Paul; Perkins, Anthony J; Gao, Sujuan; Li, Lang; Skaar, Todd C; Frame, Amie; Hendrie, Hugh C; Callahan, Chris M; Boustani, Malaz A

2013-05-04

The class of acetylcholinesterase inhibitors (ChEI), including donepezil, rivastigmine, and galantamine, have similar efficacy profiles in patients with mild to moderate Alzheimer's disease (AD). However, few studies have evaluated adherence to these agents. We sought to prospectively capture the rates and reasons for nonadherence to ChEI and determine factors influencing tolerability and adherence. We designed a pragmatic randomized clinical trial to evaluate the adherence to ChEIs among older adults with AD. Participants include AD patients receiving care within memory care practices in the greater Indianapolis area. Participants will be followed at 6-week intervals up to 18 weeks to measure the primary outcome of ChEI discontinuation and adherence rates and secondary outcomes of behavioral and psychological symptoms of dementia. The primary outcome will be assessed through two methods, a telephone interview of an informal caregiver and electronic medical record data captured from each healthcare system through a regional health information exchange. The secondary outcome will be measured by the Healthy Aging Brain Care Monitor and the Neuropsychiatric Inventory. In addition, the trial will conduct an exploratory evaluation of the pharmacogenomic signatures for the efficacy and the adverse effect responses to ChEIs. We hypothesized that patient-specific factors, including pharmacogenomics and pharmacokinetic characteristics, may influence the study outcomes. This pragmatic trial will engage a diverse population from multiple memory care practices to evaluate the adherence to and tolerability of ChEIs in a real world setting. Engaging participants from multiple healthcare systems connected through a health information exchange will capture valuable clinical and non-clinical influences on the patterns of utilization and tolerability of a class of medications with a high rate of discontinuation. Clinicaltrials.gov: NCT01362686.

Language and pragmatic functions in school-age children on the autism spectrum.

PubMed

Ramberg, C; Ehlers, S; Nydén, A; Johansson, M; Gillberg, C

1996-01-01

This study examined group differences in language and pragmatic functions across sex-, age- and IQ-matched samples of Asperger syndrome (N = 22), high-functioning autism (N = 11), deficits in attention, motor control and perception (DAMP) (N = 11), and speech and language disorder (SLD) (N = 11) groups. The purpose was to explore possible differentiating features in the fields of vocabulary, comprehension and pragmatics and, in addition, to determine whether Asperger syndrome could be reliably separated from high-functioning autism on these variables. The findings suggest that Asperger syndrome may be associated with higher full-scale and verbal IQ than high-functioning autism; Asperger syndrome may not be associated with better pragmatic skills (as defined in this context) than high-functioning autism; language comprehension may not clearly separate Asperger syndrome and high-functioning autism once the effects of very low IQ are partialled out; both DAMP and SLD can be distinctly separated from Asperger syndrome and autism.

Hypnosis for childbirth: a retrospective comparative analysis of outcomes in one obstetrician's practice.

PubMed

VandeVusse, Leona; Irland, Jacqueline; Healthcare, Wheaton Franciscan; Berner, Margaret A; Fuller, Shauna; Adams, Debra

2007-10-01

This exploratory, descriptive study, done retrospectively from perinatal medical records, compared childbirth outcomes in one obstetrician's caseload between 50 women who elected antepartal hypnosis preparation (usually a 5-class series) and 51 who did not. The groups were demographically similar. To achieve similar numbers to the hypnosis group, the control group was randomly selected from the women in the caseload who opted not to take hypnosis preparation, based on characteristics of parity and delivery mode. Prenatal hypnosis preparation resulted in significantly less use of sedatives, analgesia, and regional anesthesia during labor and in higher 1-minute neonatal Apgar scores. Other physiologic and outcome measures did not reveal statistical significance, although some trends were of clinical interest. Well-controlled studies are warranted for clinicians to offer hypnosis more frequently as a pain relief option for childbirth. Additional information provided includes pragmatic, clinical, and cost information about incorporating hypnosis into a physician's practice.

The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance.

PubMed

Shaw, Pamela A; Yancy, William S; Wesby, Lisa; Ulrich, Victoria; Troxel, Andrea B; Huffman, David; Foster, Gary D; Volpp, Kevin

2017-02-01

Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. Purpose Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive for weight-loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. Methods Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants in total. Eligible participants were those aged 30-80 who lost at least 11 lb (5 kg) during the first 4 months of participation in Weight Watchers, a national weight-loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for an additional 6 months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled, and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. Results Using the study web-based platform, we integrated recruitment, enrollment, and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than 1 year. We describe the design of Keep It Off and implementation of enrollment. Lessons Learned We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. Limitations Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. Conclusions Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight-loss maintenance strategy.

The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight loss maintenance

PubMed Central

Shaw, Pamela A; Yancy, William S; Wesby, Lisa; Ulrich, Victoria; Troxel, Andrea B; Huffman, David; Foster, Gary D; Volpp, Kevin

2016-01-01

Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. Purpose Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive, for weight loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. Methods Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants total. Eligible participants were those aged 30–80 who lost at least 11 pounds (lb, 5 kilograms (kg)) during the first 4 months of participation in Weight Watchers, a national weight loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for 6 additional months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. Results Using the study web-based platform, we integrated recruitment, enrollment and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than one year. We describe the design of Keep It Off and implementation of enrollment. Lessons Learned We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. Limitations Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. Conclusions Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight loss maintenance strategy. PMID:27646508

Comparison of a low-energy diet and a very low-energy diet in sedentary obese individuals: a pragmatic randomized controlled trial.

PubMed

Christensen, P; Bliddal, H; Riecke, B F; Leeds, A R; Astrup, A; Christensen, R

2011-02-01

There is no consensus on whether 'very low-energy diets' (VLED; <800 kcal d(-1) ) cause greater weight loss in obese individuals than 'low-energy diets' (LED; 800-1200 kcal d(-1) ). The objective was to determine whether a very low-energy formula diet would cause greater weight loss than a formula 810 kcal d(-1) LED in older sedentary individuals. This is a pragmatic randomized controlled trial. obesity (body mass index [BMI] > 30); age >50 years, with knee osteoarthritis. Participants were randomized to VLED (420-554 kcal d(-1) ) or LED (810 kcal d(-1) ) for 8 weeks, followed by a fixed-energy (1200 kcal d(-1) ) diet with food and two diet products daily for 8 weeks. In all, 192 participants were randomized. Mean age was 63 years (standard deviation: 6), mean weight 103.2 kg (15.0) and BMI of 37.3 kg m(-2) (4.8) at baseline. Mean weight losses in VLED and LED groups were 11.4 kg (standard error: 0.5) and 10.7 kg (0.5) at week 8 and 13.3 kg (0.7) and 12.2 kg (0.6) at week 16. Mean differences between groups were 0.76 kg (95% confidence interval: -0.59 to 2.10; P = 0.27) and 1.08 kg (-0.66 to 2.81; P = 0.22) at 8 and 16 weeks, respectively. Loss of lean body mass was 2.1 kg (0.2) and 1.2 kg (0.4) (17% and 11% of the weight lost, respectively) at week 16 in the VLED and LED group with a mean difference of 0.85 kg (0.01 to 1.69; P = 0.047). Significant adverse effects comparing VLED and LED, were bad breath: 34 (35%) vs. 21 (22%), intolerance to cold: 39 (41%) vs. 17 (18%) and flatulence: 43 (45%) vs. 28 (29%) for VLED and LED at 8 weeks (P < 0.05 in all cases). The VLED and LED regimens were equally successful in inducing weight loss. The significantly lower loss of lean tissue in the LED group together with more frequently reported side effects in the VLED group, favours the choice of low-energy diet (LED) for the treatment of obesity. © 2011 The Authors. Clinical Obesity © 2011 International Association for the Study of Obesity.

A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol.

PubMed

Hensel, Jennifer M; Shaw, Jay; Jeffs, Lianne; Ivers, Noah M; Desveaux, Laura; Cohen, Ashley; Agarwal, Payal; Wodchis, Walter P; Tepper, Joshua; Larsen, Darren; McGahan, Anita; Cram, Peter; Mukerji, Geetha; Mamdani, Muhammad; Yang, Rebecca; Wong, Ivy; Onabajo, Nike; Jamieson, Trevor; Bhatia, R Sacha

2016-10-18

Mental illness is a substantial and rising contributor to the global burden of disease. Access to and utilization of mental health care, however, is limited by structural barriers such as specialist availability, time, out-of-pocket costs, and attitudinal barriers including stigma. Innovative solutions like virtual care are rapidly entering the health care domain. The advancement and adoption of virtual care for mental health, however, often occurs in the absence of rigorous evaluation and adequate planning for sustainability and spread. A pragmatic randomized controlled trial with a nested comparative effectiveness arm, and concurrent realist process evaluation to examine acceptability, effectiveness, and cost-effectiveness of the Big White Wall (BWW) online platform for mental health self-management and peer support among individuals aged 16 and older who are accessing mental health services in Ontario, Canada. Participants will be randomized to 3 months of BWW or treatment as usual. At the end of the 3 months, participants in the intervention group will have the opportunity to opt-in to an intervention extension arm. Those who opt-in will be randomized to receive an additional 3 months of BWW or no additional intervention. The primary outcome is recovery at 3 months as measured by the Recovery Assessment Scale-revised (RAS-r). Secondary outcomes include symptoms of depression and anxiety measured with the Personal Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7) respectively, quality of life measured with the EQ-5D-5L, and community integration assessed with the Community Integration Questionnaire. Cost-effectiveness evaluations will account for the cost of the intervention and direct health care costs. Qualitative interviews with participants and stakeholders will be conducted throughout. Understanding the impact of virtual strategies, such as BWW, on patient outcomes and experience, and health system costs is essential for informing whether and how health system decision-makers can support these strategies system-wide. This requires clear evidence of effectiveness and an understanding of how the intervention works, for whom, and under what circumstances. This study will produce such effectiveness data for BWW, while simultaneously exploring the characteristics and experiences of users for whom this and similar online interventions could be helpful. Clinicaltrials.gov NCT02896894 . Registered on 31 August 2016 (retrospectively registered).

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

PubMed

Donovan, Jenny L; de Salis, Isabel; Toerien, Merran; Paramasivan, Sangeetha; Hamdy, Freddie C; Blazeby, Jane M

2014-08-01

The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs). In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs. All six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having "hunches" about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment. Recruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Effectiveness of oncogenetics training on general practitioners' consultation skills: a randomized controlled trial

PubMed Central

Houwink, Elisa J.F.; Muijtjens, Arno M.M.; van Teeffelen, Sarah R.; Henneman, Lidewij; Rethans, Jan Joost; van der Jagt, Liesbeth E.J.; van Luijk, Scheltus J.; Dinant, Geert Jan; van der Vleuten, Cees; Cornel, Martina C.

2014-01-01

Purpose: General practitioners are increasingly called upon to deliver genetic services and could play a key role in translating potentially life-saving advancements in oncogenetic technologies to patient care. If general practitioners are to make an effective contribution in this area, their genetics competencies need to be upgraded. The aim of this study was to investigate whether oncogenetics training for general practitioners improves their genetic consultation skills. Methods: In this pragmatic, blinded, randomized controlled trial, the intervention consisted of a 4-h training (December 2011 and April 2012), covering oncogenetic consultation skills (family history, familial risk assessment, and efficient referral), attitude (medical ethical issues), and clinical knowledge required in primary-care consultations. Outcomes were measured using observation checklists by unannounced standardized patients and self-reported questionnaires. Results: Of 88 randomized general practitioners who initially agreed to participate, 56 completed all measurements. Key consultation skills significantly and substantially improved; regression coefficients after intervention were equivalent to 0.34 and 0.28 at 3-month follow-up, indicating a moderate effect size. Satisfaction and perceived applicability of newly learned skills were highly scored. Conclusion: The general practitioner–specific training proved to be a feasible, satisfactory, and clinically applicable method to improve oncogenetics consultation skills and could be used as an educational framework to inform future training activities with the ultimate aim of improving medical care. PMID:23722870

A Randomized Trial Assessing the Impact of a Personal Printed Feedback Portrait on Statin Prescribing in Primary Care

ERIC Educational Resources Information Center

Dormuth, Colin R.; Carney, Greg; Taylor, Suzanne; Bassett, Ken; Maclure, Malcolm

2012-01-01

Introduction: Knowledge translation (KT) initiatives have the potential to improve prescribing quality and produce savings that exceed the cost of the KT program itself, including the cost of evaluation using pragmatic study methods. Our objective was to measure the impact and estimated savings resulting from the distribution of individualized…

The Effects of Practice Modality on Pragmatic Development in L2 Chinese

ERIC Educational Resources Information Center

Li, Shuai; Taguchi, Naoko

2014-01-01

This study investigated the effects of input-based and output-based practice on the development of accuracy and speed in recognizing and producing request-making forms in L2 Chinese. Fifty American learners of Chinese with intermediate level proficiency were randomly assigned to an input-based training group, an output-based training group, or a…

Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial.

PubMed

McWilliams, Andrew; Roberge, Jason; Moore, Charity G; Ashby, Avery; Rossman, Whitney; Murphy, Stephanie; McCall, Stephannie; Brown, Ryan; Carpenter, Shannon; Rissmiller, Scott; Furney, Scott

2016-12-19

Hospital readmissions remain highly prevalent despite being the target of policies and financial penalties. Evidence comparing the effectiveness and costs of interventions to reduce readmissions is lacking, leaving healthcare systems with little guidance on how to improve quality and avoid costly penalties. Effective interventions likely need to bridge inpatient and outpatient settings, incorporate information technology, and use dedicated providers. Such complex innovations will require rigorous evaluation. The framework of quality improvement research provides an approach that both improves care locally and contributes to closing the current knowledge gaps for readmissions. In this trial, we will study a comprehensive intervention that incorporates these recommendations into an integrated practice unit, called transition services, with an aim of reducing 30-day readmission rates. We describe a nonblinded, pragmatic, controlled trial with two parallel groups comprising an evaluation of the effect of referral to a provider-led integrated practice unit, inclusive of comprehensive multidisciplinary care, dedicated paramedicine providers, and virtual visits, on 30-day readmission rates for high-risk hospitalized patients. An automated risk-scoring system will randomly generate referrals to either transition services or usual care for 1520 hospitalized patients who score as high-risk for readmission. Transition services will then engage with patients in the hospital setting using a patient navigator and provide bridging outpatient services for the 30 days following discharge. All outcome data are retrieved electronically from administrative medical records. After reapplication of inclusion and exclusion criteria at the time of hospital discharge, analyses will follow the intention-to-treat principle such that patients will be analyzed on the basis of the referral group to which they were initially randomized. The hospital transition program under study is complex and integrates the latest recommendations for readmission reduction strategies. As healthcare systems innovate to address readmissions through such complex interventions, there is significant benefit for stakeholders to have a clear understanding of the potential reach, cost, and real-world effectiveness. The pragmatic methods described here provide a template for conducting quality improvement research that fits seamlessly into existing care delivery and improvement efforts, leading to better-informed strategic decisions and the investments necessary to transform care and value for patients. ClinicalTrials.gov, NCT02763202 . Registered 3 March 2016 (retrospectively registered).

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

PubMed Central

2012-01-01

Background Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in ‘real-world’ services. Methods/Design The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers’ patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrolment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms’ severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in ‘real-world’ clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction. Trial registration ClinicalTrials.gov Identifier NCT01436331 PMID:22647399

Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

PubMed

Levasseur, Mélanie; Dubois, Marie-France; Filliatrault, Johanne; Vasiliadis, Helen-Maria; Lacasse-Bédard, Joanie; Tourigny, André; Levert, Marie-Josée; Gabaude, Catherine; Lefebvre, Hélène; Berger, Valérie; Eymard, Chantal

2018-03-31

The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d'Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. The Research Ethics Committee of the CIUSSS Estrie - CHUS has approved the study (MP-31-2018-2424). An informed consent form will be read and signed by all study participants. Findings will be published and presented at conferences. NCT03161860; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials.

PubMed

Firth, Joseph; Torous, John; Nicholas, Jennifer; Carney, Rebekah; Rosenbaum, Simon; Sarris, Jerome

2017-08-15

Various psychological interventions are effective for reducing symptoms of anxiety when used alone, or as an adjunct to anti-anxiety medications. Recent studies have further indicated that smartphone-supported psychological interventions may also reduce anxiety, although the role of mobile devices in the treatment and management of anxiety disorders has yet to be established. We conducted a systematic review and meta-analysis of all randomized clinical trials (RCTs) reporting the effects of psychological interventions delivered via smartphone on symptoms of anxiety (sub-clinical or diagnosed anxiety disorders). A systematic search of major electronic databases conducted in November 2016 identified 9 eligible RCTs, with 1837 participants. Random-effects meta-analyses were used to calculate the standardized mean difference (as Hedges' g) between smartphone interventions and control conditions. Significantly greater reductions in total anxiety scores were observed from smartphone interventions than control conditions (g=0.325, 95% C.I.=0.17-0.48, p<0.01), with no evidence of publication bias. Effect sizes from smartphone interventions were significantly greater when compared to waitlist/inactive controls (g=0.45, 95% C.I.=0.30-0.61, p<0.01) than active control conditions (g=0.19, 95% C.I.=0.07-0.31, p=0.003). The extent to which smartphone interventions can match (or exceed) the efficacy of recognised treatments for anxiety has yet to established. This meta-analysis shows that psychological interventions delivered via smartphone devices can reduce anxiety. Future research should aim to develop pragmatic methods for implementing smartphone-based support for people with anxiety, while also comparing the efficacy of these interventions to standard face-to-face psychological care. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Therapeutic alliance in psychological therapy for people with recent onset psychosis who use cannabis.

PubMed

Berry, Katherine; Gregg, Lynsey; Lobban, Fiona; Barrowclough, Christine

2016-05-01

This paper examines the role of therapeutic alliance in predicting outcomes in a Randomized Controlled Trial of Motivational Interviewing and Cognitive Behavioral Therapy (MICBT) for problematic cannabis use in recent onset psychosis. All clients were participating in a three arm pragmatic rater-blind randomized controlled trial of brief MICBT plus standard care compared with longer term MICBT plus standard care and standard care alone. Participants completed measures to assess clinical symptoms, global functioning and substance misuse at baseline, 4.5months, 9months and 18months. Clients and therapists completed the Working Alliance Inventory approximately one month into therapy. Client alliance data was available for 35 participants randomized to therapy and therapist alliance data was available for 52 participants randomized to therapy. At baseline, poorer client-rated alliance was associated with more negative symptoms, poorer insight and greater cannabis use, whereas poorer therapist-rated alliance was only associated with amount of cannabis used per cannabis using day. Alliance ratings were also positively associated with amount of therapy: client-rated alliance was higher in the longer compared to the briefer therapy; therapist-rated alliance was associated with greater number of sessions attended (controlling for type of therapy) and therapy completion. In predicting outcome, client-rated alliance predicted total symptom scores and global functioning scores at follow-up. Neither client nor therapist alliance predicted changes in substance misuse at any time point. Findings demonstrate that individuals with psychosis and substance misuse who form better alliances with their therapists gain greater benefits from therapy, at least in terms of improvements in global functioning. Copyright © 2016 Elsevier Inc. All rights reserved.

Doxycycline versus prednisolone as an initial treatment strategy for bullous pemphigoid: a pragmatic, non-inferiority, randomised controlled trial.

PubMed

Williams, Hywel C; Wojnarowska, Fenella; Kirtschig, Gudula; Mason, James; Godec, Thomas R; Schmidt, Enno; Chalmers, Joanne R; Childs, Margaret; Walton, Shernaz; Harman, Karen; Chapman, Anna; Whitham, Diane; Nunn, Andrew J

2017-04-22

Bullous pemphigoid is a blistering skin disorder with increased mortality. We tested whether a strategy of starting treatment with doxycycline gives acceptable short-term blister control while conferring long-term safety advantages over starting treatment with oral corticosteroids. We did a pragmatic, multicentre, parallel-group randomised controlled trial of adults with bullous pemphigoid (three or more blisters at two or more sites and linear basement membrane IgG or C3). Participants were randomly assigned to doxycycline (200 mg per day) or prednisolone (0·5 mg/kg per day) using random permuted blocks of randomly varying size, and stratified by baseline severity (3-9, 10-30, and >30 blisters for mild, moderate, and severe disease, respectively). Localised adjuvant potent topical corticosteroids (<30 g per week) were permitted during weeks 1-3. The non-inferiority primary effectiveness outcome was the proportion of participants with three or fewer blisters at 6 weeks. We assumed that doxycycline would be 25% less effective than corticosteroids with a 37% acceptable margin of non-inferiority. The primary safety outcome was the proportion with severe, life-threatening, or fatal (grade 3-5) treatment-related adverse events by 52 weeks. Analysis (modified intention to treat [mITT] for the superiority safety analysis and mITT and per protocol for non-inferiority effectiveness analysis) used a regression model adjusting for baseline disease severity, age, and Karnofsky score, with missing data imputed. The trial is registered at ISRCTN, number ISRCTN13704604. Between March 1, 2009, and Oct 31, 2013, 132 patients were randomly assigned to doxycycline and 121 to prednisolone from 54 UK and seven German dermatology centres. Mean age was 77·7 years (SD 9·7) and 173 (68%) of 253 patients had moderate-to-severe baseline disease. For those starting doxycycline, 83 (74%) of 112 patients had three or fewer blisters at 6 weeks compared with 92 (91%) of 101 patients on prednisolone, an adjusted difference of 18·6% (90% CI 11·1-26·1) favouring prednisolone (upper limit of 90% CI, 26·1%, within the predefined 37% margin). Related severe, life-threatening, and fatal events at 52 weeks were 18% (22 of 121) for those starting doxycycline and 36% (41 of 113) for prednisolone (mITT), an adjusted difference of 19·0% (95% CI 7·9-30·1), p=0·001. Starting patients on doxycycline is non-inferior to standard treatment with oral prednisolone for short-term blister control in bullous pemphigoid and significantly safer in the long-term. NIHR Health Technology Assessment Programme. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Conducting Rapid, Relevant Research

PubMed Central

Glasgow, Russell E.; Kessler, Rodger S.; Ory, Marcia G.; Roby, Dylan; Gorin, Sherri Sheinfeld; Krist, Alex

2015-01-01

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current “gold standard” clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation–focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include: use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions. PMID:24953520

Conducting rapid, relevant research: lessons learned from the My Own Health Report project.

PubMed

Glasgow, Russell E; Kessler, Rodger S; Ory, Marcia G; Roby, Dylan; Gorin, Sherri Sheinfeld; Krist, Alex

2014-08-01

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current "gold standard" clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation-focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions. Published by Elsevier Inc.

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

PubMed Central

Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

2014-01-01

Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial.

PubMed

Wang, Jing; Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-04-02

Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association-recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators' monitoring of patients' adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A 1c levels, weight, and the usability of the connected system. An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5). ©Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2018.

Comparison of efficacy and tolerance between combination therapy and monotherapy as first-line chemotherapy in elderly patients with advanced gastric cancer: Study protocol for a randomized controlled trial.

PubMed

Lee, Keun-Wook; Zang, Dae Young; Ryu, Min-Hee; Kim, Ki Hyang; Kim, Mi-Jung; Han, Hye Sook; Koh, Sung Ae; Park, Jin Hyun; Kim, Jin Won; Nam, Byung-Ho; Choi, In Sil

2017-12-01

The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy. This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety. We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.

Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

PubMed

Gerber, David E; Hamann, Heidi A; Santini, Noel O; Abbara, Suhny; Chiu, Hsienchang; McGuire, Molly; Quirk, Lisa; Zhu, Hong; Lee, Simon J Craddock

2017-09-01

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016. Copyright © 2017 Elsevier Inc. All rights reserved.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

PubMed

DeBar, Lynn; Benes, Lindsay; Bonifay, Allison; Deyo, Richard A; Elder, Charles R; Keefe, Francis J; Leo, Michael C; McMullen, Carmit; Mayhew, Meghan; Owen-Smith, Ashli; Smith, David H; Trinacty, Connie M; Vollmer, William M

2018-04-01

Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial

PubMed Central

DeBar, Lynn; Benes, Lindsay; Bonifay, Allison; Deyo, Richard A.; Elder, Charles R.; Keefe, Francis J.; Leo, Michael C.; McMullen, Carmit; Mayhew, Meghan; Owen-Smith, Ashli; Smith, David H.; Trinacty, Connie M.; Vollmer, William M.

2018-01-01

Background Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. Methods/design This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. Discussion This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592 PMID:29522897

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

PubMed

Pontes, Caridad; Gratacós, Jordi; Torres, Ferran; Avendaño, Cristina; Sanz, Jesús; Vallano, Antoni; Juanola, Xavier; de Miguel, Eugenio; Sanmartí, Raimon; Calvo, Gonzalo

2015-08-20

Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT 2011-005871-18 (21 December 2011).

Neural correlates of pragmatic language comprehension in autism spectrum disorders.

PubMed

Tesink, C M J Y; Buitelaar, J K; Petersson, K M; van der Gaag, R J; Kan, C C; Tendolkar, I; Hagoort, P

2009-07-01

Difficulties with pragmatic aspects of communication are universal across individuals with autism spectrum disorders (ASDs). Here we focused on an aspect of pragmatic language comprehension that is relevant to social interaction in daily life: the integration of speaker characteristics inferred from the voice with the content of a message. Using functional magnetic resonance imaging (fMRI), we examined the neural correlates of the integration of voice-based inferences about the speaker's age, gender or social background, and sentence content in adults with ASD and matched control participants. Relative to the control group, the ASD group showed increased activation in right inferior frontal gyrus (RIFG; Brodmann area 47) for speaker-incongruent sentences compared to speaker-congruent sentences. Given that both groups performed behaviourally at a similar level on a debriefing interview outside the scanner, the increased activation in RIFG for the ASD group was interpreted as being compensatory in nature. It presumably reflects spill-over processing from the language dominant left hemisphere due to higher task demands faced by the participants with ASD when integrating speaker characteristics and the content of a spoken sentence. Furthermore, only the control group showed decreased activation for speaker-incongruent relative to speaker-congruent sentences in right ventral medial prefrontal cortex (vMPFC; Brodmann area 10), including right anterior cingulate cortex (ACC; Brodmann area 24/32). Since vMPFC is involved in self-referential processing related to judgments and inferences about self and others, the absence of such a modulation in vMPFC activation in the ASD group possibly points to atypical default self-referential mental activity in ASD. Our results show that in ASD compensatory mechanisms are necessary in implicit, low-level inferential processes in spoken language understanding. This indicates that pragmatic language problems in ASD are not restricted to high-level inferential processes, but encompass the most basic aspects of pragmatic language processing.

Communication in conversation in stroke patients.

PubMed

Rousseaux, Marc; Daveluy, Walter; Kozlowski, Odile

2010-07-01

In stroke patients, it has been suggested that communication disorders could result from lexical and syntactic disorders in left hemisphere lesions and from pragmatics problems in right lesions. However, we have little information on patient behaviour in dyadic communication, especially in conversation. Here, we analyzed the various processes participating in communication difficulties at the rehabilitation phase (1-6 months) post-stroke, in order to define the main mechanisms of verbal and non-verbal communication (VC, NVC) disorders and their relationship with aphasic disorders. Sixty-three patients were recruited, who belonged to six groups, with left or right cortico-sub-cortical (L-CSC, R-CSC) or sub-cortical (L-SC, R-SC), frontal (Fro) or posterior fossa (PF) lesions. They were compared with an equivalent control group (gender, age, education level). We used the Lille Communication Test, which comprises three parts: participation to communication (greeting, attention, engagement), verbal communication (verbal comprehension, speech outflow, intelligibility, word production, syntax, verbal pragmatics and verbal feedback) and non-verbal communication (understanding gestures, affective expressivity, producing gestures, pragmatics and feedback). We also used the Functional Communication Profile and the Boston Diagnostic Aphasia Examination (BDAE). Decrease in participation was found in L-CSC, R-CSC and Fro patients. Verbal communication was essentially disrupted in L-SCS and L-SC groups, including by verbal pragmatic disorders, and to a lesser degree in frontal patients. Nonverbal communication was mainly affected in R-CSC patients, especially by pragmatic difficulties. L-CSC patients showed an increase in gesture production, compensating for aphasia. In conclusion, communication disorders were relatively complex and could not be summarised by syntactical and lexical difficulties in left stroke and pragmatic problems in right stroke. The former also showed severe verbal pragmatic difficulties. Frontal stroke also resulted in evident verbal and non-verbal disorders.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial.

PubMed

Poirier, Josée; Bennett, Wendy L; Jerome, Gerald J; Shah, Nina G; Lazo, Mariana; Yeh, Hsin-Chieh; Clark, Jeanne M; Cobb, Nathan K

2016-02-09

The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale. Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant. A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test. Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike. The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable. Clinicaltrials.gov NCT02229409, https://clinicaltrials.gov/ct2/show/NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe).

Effect of a pragmatic, cluster-randomized controlled trial on patient experience with care: The Transforming Outcomes for Patients through Medical home Evaluation and reDesign (TOPMED) study

PubMed Central

Dorr, David A.; Anastas, Tracy; Ramsey, Katrina; Wagner, Jesse; Sachdeva, Bhavaya; Michaels, LeAnn; Fagnan, Lyle

2016-01-01

Background Health reform programs like the Patient-Centered Medical Home (PCMH) are intended to improve the Triple Aim. Previous studies on PCMHs have shown mixed effects, but High Value Elements (HVEs) are expected to improve the Triple Aim. Objective To understand whether focusing on high value elements (HVEs) would improve patient experience with care. Methods Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for QI goals. To assess patient experience, 1,597 Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys were sent pre- and post-trial to a stratified random sample of patients. Difference in difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. Results The response rate was 43% (n=686). Non-respondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in Follow-up on test results (p=.091) and Patients’ rating of the provider (p=.091), while the control performed better in Access to care (p=.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. Discussion Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms. PMID:27116107

A patient navigation intervention for drug-involved former prison inmates.

PubMed

Binswanger, Ingrid A; Whitley, Elizabeth; Haffey, Paul-Ryan; Mueller, Shane R; Min, Sung-Joon

2015-01-01

Former prison inmates experience high rates of hospitalizations and death during the transition from prison to the community, particularly from drug-related causes and early after release. The authors designed a randomized controlled trial (RCT) of patient navigation to reduce barriers to health care and hospitalizations for former prison inmates. Forty former prison inmates with a history of drug involvement were recruited and randomized within 15 days after prison release. Participants were randomized to receive 3 months of patient navigation (PN) with facilitated enrollment into an indigent care discount program (intervention) or facilitated enrollment into an indigent care discount program alone (control). Structured interviews were conducted at baseline, 3 months, and 6 months. Outcomes were measured as a change in self-reported barriers to care and as the rate of health service use per 100 person-days. The mean number of reported barriers to care was reduced at 3 and 6 months in both groups. At 6 months, the rate of emergency department/urgent care visits per 100 person-days since baseline was 1.1 among intervention participants and 0.5 among control participants (P = .04), whereas the rate of hospitalizations per 100 person-days was 0.2 in intervention participants and 0.6 in control participants (P = .04). Recruitment of former inmates into an RCT of patient navigation was highly feasible, but follow-up was limited by rearrests. Results suggest a significantly lower rate of hospitalizations among navigation participants, although the rate of emergency department/urgent care visits was not improved. Patient navigation is a promising, pragmatic intervention that may be effective at reducing high-cost health care utilization in former prison inmates.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

PubMed

Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

2018-06-01

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

The effectiveness of high-intensity versus low-intensity back schools in an occupational setting: a pragmatic randomized controlled trial.

PubMed

Heymans, Martijn W; de Vet, Henrica C W; Bongers, Paulien M; Knol, Dirk L; Koes, Bart W; van Mechelen, Willem

2006-05-01

Randomized controlled trial. To compare high- and low-intensity back schools with usual care in occupational health care. The content and intensity of back schools vary widely and the methodologic quality of randomized controlled trials is generally weak. Until now, no back school has proven to be superior for workers sick-listed because of subacute nonspecific low back pain. Workers (n = 299) sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain were recruited by the occupational physician and randomly assigned to a high-intensity back school, a low-intensity back school, or care as usual. Outcome measures were days until return to work, total days of sick-leave, pain, functional status, kinesiophobia, and perceived recovery and were assessed at baseline and at 3 and 6 months of follow-up. Principal analyses were performed according to the intention-to-treat principle. We randomly allocated 299 workers. Workers in the low-intensity back school returned to work faster compared with usual care and the high-intensity back school, with hazard ratios of 1.4 (P = 0.06) and 1.3 (P = 0.09), respectively. The comparison between high-intensity back school and usual care resulted in a hazard ratio of 1.0 (P = 0.83). The median number of sick-leave days was 68, 75, and 85 in the low-intensity back school, usual care, and high-intensity back school, respectively. Beneficial effects on functional status and kinesiophobia were found at 3 months in favor of the low-intensity back school. No substantial differences on pain and perceived recovery were found between groups. The low-intensity back school was most effective in reducing work absence, functional disability, and kinesiophobia, and more workers in this group scored a higher perceived recovery during the 6-month follow-up.

Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

PubMed

Thilly, Nathalie; Chanliau, Jacques; Frimat, Luc; Combe, Christian; Merville, Pierre; Chauveau, Philippe; Bataille, Pierre; Azar, Raymond; Laplaud, David; Noël, Christian; Kessler, Michèle

2017-04-05

Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014).

Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach.

PubMed

Cowan, James F; Micek, Mark; Cowan, Jessica F Greenberg; Napúa, Manuel; Hoek, Roxanne; Gimbel, Sarah; Gloyd, Stephen; Sherr, Kenneth; Pfeiffer, James T; Chapman, Rachel R

2015-04-30

Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy. This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care. This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa. ClinicalTrials.gov: NCT02371265.

Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

PubMed

Carrieri, Patrizia Maria; Michel, Laurent; Lions, Caroline; Cohen, Julien; Vray, Muriel; Mora, Marion; Marcellin, Fabienne; Spire, Bruno; Morel, Alain; Roux, Perrine

2014-01-01

Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC. In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively. In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively). Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence. Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511.

Testing feedback message framing and comparators to address prescribing of high-risk medications in nursing homes: protocol for a pragmatic, factorial, cluster-randomized trial.

PubMed

Ivers, Noah M; Desveaux, Laura; Presseau, Justin; Reis, Catherine; Witteman, Holly O; Taljaard, Monica K; McCleary, Nicola; Thavorn, Kednapa; Grimshaw, Jeremy M

2017-07-14

Audit and feedback (AF) interventions that leverage routine administrative data offer a scalable and relatively low-cost method to improve processes of care. AF interventions are usually designed to highlight discrepancies between desired and actual performance and to encourage recipients to act to address such discrepancies. Comparing to a regional average is a common approach, but more recipients would have a discrepancy if compared to a higher-than-average level of performance. In addition, how recipients perceive and respond to discrepancies may depend on how the feedback itself is framed. We aim to evaluate the effectiveness of different comparators and framing in feedback on high-risk prescribing in nursing homes. This is a pragmatic, 2 × 2 factorial, cluster-randomized controlled trial testing variations in the comparator and framing on the effectiveness of quarterly AF in changing high-risk prescribing in nursing homes in Ontario, Canada. We grouped homes that share physicians into clusters and randomized these clusters into the four experimental conditions. Outcomes will be assessed after 6 months; all primary analyses will be by intention-to-treat. The primary outcome (monthly number of high-risk medications received by each patient) will be analysed using a general linear mixed effects regression model. We will present both four-arm and factorial analyses. With 160 clusters and an average of 350 beds per cluster, assuming no interaction and similar effects for each intervention, we anticipate 90% power to detect an absolute mean difference of 0.3 high-risk medications prescribed. A mixed-methods process evaluation will explore potential mechanisms underlying the observed effects, exploring targeted constructs including intention, self-efficacy, outcome expectations, descriptive norms, and goal prioritization. An economic analysis will examine cost-effectiveness analysis from the perspective of the publicly funded health care system. This protocol describes the rationale and methodology of a trial testing manipulations of theory-informed components of an audit and feedback intervention to determine how to improve an existing intervention and provide generalizable insights for implementation science. NCT02979964.

Appropriate prescribing in nursing homes demonstration project (APDP) study protocol: pragmatic, cluster-randomized trial and mixed methods process evaluation of an Ontario policy-maker initiative to improve appropriate prescribing of antipsychotics.

PubMed

Desveaux, Laura; Gomes, Tara; Tadrous, Mina; Jeffs, Lianne; Taljaard, Monica; Rogers, Jess; Bell, Chaim M; Ivers, Noah M

2016-03-29

Antipsychotic medications are routinely prescribed in nursing homes to address the behavioral and psychological symptoms of dementia. Unfortunately, inappropriate prescribing of antipsychotic medications is common and associated with increased morbidity, adverse drug events, and hospitalizations. Multifaceted interventions can achieve a 12-20 % reduction in antipsychotic prescribing levels in nursing homes. Effective interventions have featured educational outreach and ongoing performance feedback. This pragmatic, cluster-randomized control trial and embedded process evaluation seeks to determine the effect of adding academic detailing to audit and feedback on prescribing of antipsychotic medications in nursing homes, compared with audit and feedback alone. Nursing homes within pre-determined regions of Ontario, Canada, are eligible if they express an interest in the intervention. The academic detailing intervention will be delivered by registered health professionals following an intensive training program including relevant clinical issues and techniques to support health professional behavior change. Physicians in both groups will have the opportunity to access confidential reports summarizing their prescribing patterns for antipsychotics in comparison to the local and provincial average. Participating homes will be allocated to one of the two arms of the study (active/full intervention versus standard audit and feedback) in two waves, with a 2:1 allocation ratio. Homes will be randomized after stratifying for geography, baseline antipsychotic prescription rates, and size, to ensure a balance of characteristics. The primary outcome is antipsychotic dispensing in nursing homes, measured 6 months after allocation; secondary outcomes include clinical outcomes and healthcare utilization. Policy-makers and the public have taken note that antipsychotics are used in nursing homes in Ontario far more than other jurisdictions. Academic detailing can be an effective technique to address challenges in appropriate prescribing in nursing homes, but effect sizes vary widely. This opportunistic, policy-driven evaluation, embedded within a government-initiated demonstration project, was designed to ensure policy-makers receive the best evidence possible regarding whether and how to scale up the intervention. ClinicalTrials.gov NLM Identifier: NCT02604056 .

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.

PubMed

Woodcock, Ashley; Bakerly, Nawar Diar; New, John P; Gibson, J Martin; Wu, Wei; Vestbo, Jørgen; Leather, David

2015-12-10

Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings. The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors. Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data. The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings. Clinicaltrials.gov, NCT01706198; 04 October 2012.

Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy.

PubMed

Hartzler, Bryan; Peavy, K Michelle; Jackson, T Ron; Carney, Molly

2016-01-22

Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM. Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation. Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures. It is hoped this discussion offers ideas for how to impact local clinical and policy decisions via effective behavior therapy dissemination.

Multidisciplinary, multi-modal nutritional care in acute hip fracture inpatients - results of a pragmatic intervention.

PubMed

Bell, Jack J; Bauer, Judith D; Capra, Sandra; Pulle, Ranjeev Chrys

2014-12-01

Malnutrition is highly prevalent and resistant to intervention following hip fracture. This study investigated the impact of individualised versus multidisciplinary nutritional care on nutrition intake and outcomes in patients admitted to a metropolitan hospital acute hip fracture unit. A prospective, controlled before and after comparative interventional study aligning to the CONSORT guidelines for pragmatic clinical trials. Randomly selected patients receiving individualised nutritional care (baseline) were compared with post-interventional patients receiving a new model of nutritional care promoting nutrition as a medicine, multidisciplinary nutritional care, foodservice enhancements, and improved nutrition knowledge and awareness. Malnutrition was diagnosed using the Academy of Nutrition and Dietetics criteria. Fifty-eight weighed food records were available for each group across a total of 82 patients (n = 44, n = 38). Group demographics were not significantly different with predominantly community dwelling (72%), elderly (82.2 years), female (70%), malnourished (51.0%) patients prone to co-morbidities (median 5) receiving early surgical intervention (median D1). Multidisciplinary nutritional care reduced intake barriers and increased total 24-h energy (6224 vs. 2957 kJ; p < 0.001) and protein (69.0 vs. 33.8 g; p < 0.001) intakes, reduced nutritional deterioration over admission (5.4 vs. 20.5%; p = 0.049), and increased discharge directly back to the community setting (48.0 vs. 17.6%; p = 0.012). Trends suggested a reduction in median length of stay (D13 vs. D14). Inpatient mortality remained low across groups (5.2%, 2.3%). Multidisciplinary nutritional care improves nutrition intake and outcomes in acute hip fracture inpatients. Similar pragmatic study designs should be considered in other elderly inpatient populations perceived resistant to nutritional intervention. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

PubMed

Borland, Ron; Balmford, James; Benda, Peter

2013-03-01

To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

PubMed Central

2012-01-01

Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention. Trial registration ClinicalTrials.gov NCT01089296 PMID:22336194

A Pilot Randomized Controlled Trial of a Holistic Needs Assessment Questionnaire in a Supportive and Palliative Care Service.

PubMed

Ahmed, Nisar; Hughes, Philippa; Winslow, Michelle; Bath, Peter A; Collins, Karen; Noble, Bill

2015-11-01

At present, there is no widely used systematic evidence-based holistic approach to assessment of patients' supportive and palliative care needs. To determine whether the use of a holistic needs assessment questionnaire, Sheffield Profile for Assessment and Referral for Care (SPARC), will lead to improved health care outcomes for patients referred to a palliative care service. This was an open, pragmatic, randomized controlled trial. Patients (n = 182) referred to the palliative care service were randomized to receive SPARC at baseline (n = 87) or after a period of two weeks (waiting-list control n = 95). Primary outcome measure is the difference in score between Measure Yourself Concerns and Wellbeing (MYCAW) patient-nominated Concern 1 on the patient self-scoring visual analogue scale at baseline and the two-week follow-up. Secondary outcomes include difference in scores in the MYCAW, EuroQoL (EQ-5D), and Patient Enablement Instrument (PEI) scores at Weeks 2, 4, and 6. There was a significant association between change in MYCAW score and whether the patients were in the intervention or control group (χ(2)trend = 5.51; degrees of freedom = 1; P = 0.019). A higher proportion of patients in the control group had an improvement in MYCAW score from baseline to Week 2: control (34 of 70 [48.6%]) vs. intervention (19 of 66 [28.8%]). There were no significant differences (no detectable effect) between the control and intervention groups in the scores for EQ-5D and Patient Enablement Instrument at 2-, 4-, or 6-week follow-up. This trial result identifies a potential negative effect of SPARC in specialist palliative care services, raising questions that standardized holistic needs assessment questionnaires may be counterproductive if not integrated with a clinical assessment that informs the care plan. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Pragmatics and Language Learning. Monograph Series Volume 7.

ERIC Educational Resources Information Center

Bouton, Lawrence F., Ed.

Papers on aspects of pragmatics include: "Pragmatics and Language Learning" (Lawrence F. Bouton); "Pragmatics and Language Teaching: Bringing Pragmatics and Pedagogy Together" (Kathleen Bardovi-Harlig); "Cross-Cultural Communication and Interlanguage Pragmatics: American vs. European Requests" (Jasone Cenoz, Jose F.…

Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial.

PubMed

Messier, Stephen P; Callahan, Leigh F; Beavers, Daniel P; Queen, Kate; Mihalko, Shannon L; Miller, Gary D; Losina, Elena; Katz, Jeffrey N; Loeser, Richard F; Quandt, Sara A; DeVita, Paul; Hunter, David J; Lyles, Mary F; Newman, Jovita; Hackney, Betsy; Jordan, Joanne M

2017-02-22

Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown. Thus, the policy relevant and clinically important question is: Can we adapt this successful solution to a pervasive public health problem in real-world clinical and community settings? This study aims to develop a systematic, practical, cost-effective diet-induced weight loss and exercise intervention implemented in community settings and to determine its effectiveness in reducing pain and improving other clinical outcomes in persons with knee OA. This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m 2 ) men and women aged ≥ 50 years who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a community-based 18-month diet-induced weight loss and exercise intervention based on social cognitive theory and implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to a nutrition and health attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, mobility, and is cost-effective. Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments as recommended by numerous OA treatment guidelines. This study will establish the effectiveness of a community program that will serve as a blueprint and exemplar for clinicians and public health officials in urban and rural communities to implement a diet-induced weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA. clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.

Evaluation of complex community-based childhood obesity prevention interventions.

PubMed

Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

2018-05-16

Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

Patient Acceptance of Sexual Orientation and Gender Identity Questions on Intake Forms in Outpatient Clinics: A Pragmatic Randomized Multisite Trial.

PubMed

Rullo, Jordan E; Foxen, Jilian L; Griffin, Joan M; Geske, Jennifer R; Gonzalez, Cesar A; Faubion, Stephanie S; van Ryn, Michelle

2018-03-09

To (1) test whether patient attitudes toward intake forms at three Midwestern outpatient clinics are significantly more negative among those who are asked to complete SOGI questions versus those who are not; and (2) gain an in-depth understanding of patient concerns about SOGI questions. Data were collected between 6/29/2015 and 2/29/2016 from new patients (N = 491) who presented at three outpatient clinics in a large academic medical center. This study was originally a quality improvement project, and later, institutional review board approval was obtained for secondary data analysis. Two-stage mixed-methods study. (1) Experimental: New patients at three sites were randomly assigned to complete either routine intake forms (control) or routine intake forms with SOGI questions (experimental); and (2) qualitative: interviews with patients who responded negatively to SOGI questions. There were no significant differences in patient attitudes between experimental and control groups (p > .05). Of those who received SOGI questions, only 3 percent reported being distressed, upset, or offended by the SOGI questions. Collection of SOGI data as a part of the routine clinical patient intake process is not distressing to 97 percent of patients who are heterosexual, cisgender, and older than 50 years. © Health Research and Educational Trust.

Design and Implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART)

PubMed Central

Wang, Henry E.; Prince, David; Stephens, Shannon W.; Herren, Heather; Daya, Mohamud; Richmond, Neal; Carlson, Jestin; Warden, Craig; Colella, M. Riccardo; Brienza, Ashley; Aufderheide, Tom P.; Idris, Ahamed; Schmicker, Robert; May, Susanne; Nichol, Graham

2016-01-01

Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-hour survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include 1) initial airway management with ETI and 2) initial airway management with LT. The primary and secondary trial outcomes are 72-hour survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3,000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA. PMID:26851059

Interlanguage Pragmatic Motivation: Its Construct and Impact on Speech Act Production

ERIC Educational Resources Information Center

Tajeddin, Zia; Moghadam, Amir Zand

2012-01-01

The aim of this pioneering study was to define and describe motivation for the acquisition of interlanguage pragmatic competence. Interlanguage pragmatic motivation was investigated from two perspectives: (1) general pragmatic motivation, displaying L2 learners' motivation to acquire pragmatic strategies, pragmatic routines, politeness strategies,…

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

PubMed

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

2018-01-01

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

Theory of mind and specific language impairment in school-age children.

PubMed

Spanoudis, George

2016-01-01

Research on the relationship between aspects of language development and Theory of Mind (ToM) in children with language impairments suggests that children with language impairment show a delay in ToM development. This study aimed to examine the relationships of the syntactic, semantic, and pragmatic skills with ToM in school-age children. Twenty children with Specific Language Impairment (SLI) aged 9-12 years and two control groups, one matched for chronological age (CA) and one for language ability (LA) (aged 8-10 years) were compared on a set of language tasks tapping syntactic, semantic, and pragmatic skills and on an advanced test of ToM. Results showed that children with SLI performed poorly on the ToM task compared to the CA matches. Also, analysis showed that language skills and ToM are related and that syntactic and pragmatic abilities contributed significantly to the prediction of ToM performance in the SLI group. It is concluded that the syntax/pragmatic aspects of the language impact on ToM understanding in children with SLI. Copyright © 2016 Elsevier Inc. All rights reserved.

Serious gaming technology in major incident triage training: a pragmatic controlled trial.

PubMed

Knight, James F; Carley, Simon; Tregunna, Bryan; Jarvis, Steve; Smithies, Richard; de Freitas, Sara; Dunwell, Ian; Mackway-Jones, Kevin

2010-09-01

By exploiting video games technology, serious games strive to deliver affordable, accessible and usable interactive virtual worlds, supporting applications in training, education, marketing and design. The aim of the present study was to evaluate the effectiveness of such a serious game in the teaching of major incident triage by comparing it with traditional training methods. Pragmatic controlled trial. During Major Incident Medical Management and Support Courses, 91 learners were randomly distributed into one of two training groups: 44 participants practiced triage sieve protocol using a card-sort exercise, whilst the remaining 47 participants used a serious game. Following the training sessions, each participant undertook an evaluation exercise, whereby they were required to triage eight casualties in a simulated live exercise. Performance was assessed in terms of tagging accuracy (assigning the correct triage tag to the casualty), step accuracy (following correct procedure) and time taken to triage all casualties. Additionally, the usability of both the card-sort exercise and video game were measured using a questionnaire. Tagging accuracy by participants who underwent the serious game training was significantly higher than those who undertook the card-sort exercise [Chi2=13.126, p=0.02]. Step accuracy was also higher in the serious game group but only for the numbers of participants that followed correct procedure when triaging all eight casualties [Chi2=5.45, p=0.0196]. There was no significant difference in time to triage all casualties (card-sort=435+/-74 s vs video game=456+/-62 s, p=0.155). Serious game technologies offer the potential to enhance learning and improve subsequent performance when compared to traditional educational methods. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

Nursing Case Management and Glycemic Control Among Brazilians With Type 2 Diabetes: Pragmatic Clinical Trial.

PubMed

Moreira, Ricardo Castanho; Mantovani, Maria de Fátima; Soriano, José Verdú

2015-01-01

Type 2 diabetes mellitus is a chronic condition that requires ongoing, life-long care in order to be controlled. The aims of the study were to assess the effect of nursing case management on glycated hemoglobin (HbA1c) levels compared to usual care in people with type 2 diabetes mellitus and to determine if effects of nursing case management varied by gender, age, duration of disease, education, and income. This is a pragmatic clinical trial, conducted in the municipality of Bandeirantes, Paraná, Brazil, in 2011 and 2012. Eighty individuals were recruited and randomized equally to receive nursing case management or usual care. Covariates were sociodemographic and clinical factors. The outcome was HbA1c measured at baseline, 6 months, and 12 months. The sample consisted predominately of women; most had been diagnosed with type 2 diabetes mellitus within the previous 5 years. Mean age was 50.14 (SD = 7.00), with 5.27 (SD = 4.39) years of schooling and an average HbA1c of 9.90% (SD = 2.49). Hemoglobin A1c was reduced from an average of 10.33% to 9.0% (p < .01) in the nursing case management group and from 9.57% to 8.93% (p = .05) in the usual care group; the group by time effect was not significant. Case management effects varied by younger age (p = .05), duration of type 2 diabetes less than 5 years (p = .03), up to 4 years of schooling (p = .04), and being in the lowest-income stratum (p = .02). Both groups showed a statistically significant reduction of HbA1c at 6 and 12 months following baseline. The difference in proportional reduction of HbA1c between groups was not statistically significant.

The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH): From Theory to Clinical Trial Implementation

PubMed Central

Boutin-Foster, Carla; Scott, Ebony; Rodriguez, Anna; Ramos, Rosio; Kanna, Balavenkatesh; Michelen, Walid; Charlson, Mary; Gbenga, Ogedegbe

2014-01-01

This paper describes the application of a translational research model in developing The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH), a theoretically-based, randomized controlled trial. TRIUMPH targets blood pressure control among African-Americans with hypertension in a community health center and public hospital setting. TRIUMPH applies positive affect, self-affirmation, and motivational interviewing as strategies to increase medication adherence and blood pressure control. A total of 220 participants were recruited in TRIUMPH and are currently being followed. This paper provides a detailed description of the theoretical framework and study design of TRIUMPH and concludes with a critical reflection of the lessons learned in the process of implementing a health behavior intervention in a community-based setting. TRIUMPH provides a model for incorporating the translational science research paradigm to conducting pragmatic behavioral trials in a real-world setting in a vulnerable population. Lessons learned through interactions with our community partners reinforce the value of community engagement in research. PMID:23403073

The efficacy of problem-solving treatments after deliberate self-harm: meta-analysis of randomized controlled trials with respect to depression, hopelessness and improvement in problems.

PubMed

Townsend, E; Hawton, K; Altman, D G; Arensman, E; Gunnell, D; Hazell, P; House, A; Van Heeringen, K

2001-08-01

Brief problem-solving therapy is regarded as a pragmatic treatment for deliberate self-harm (DSH) patients. A recent meta-analysis of randomized controlled trials (RCTs) evaluating this approach indicated a trend towards reduced repetition of DSH but the pooled odds ratio was not statistically significant. We have now examined other important outcomes using this procedure, namely depression, hopelessness and improvement in problems. Six trials in which problem-solving therapy was compared with control treatment were identified from an extensive literature review of RCTs of treatments for DSH patients. Data concerning depression, hopelessness and improvement in problems were extracted. Where relevant statistical data (e.g. standard deviations) were missing these were imputed using various statistical methods. Results were pooled using meta-analytical procedures. At follow-up, patients who were offered problem-solving therapy had significantly greater improvement in scores for depression (standardized mean difference = -0.36; 95% CI -0.61 to -0.11) and hopelessness (weighted mean difference =-3.2; 95% CI -4.0 to -2.41), and significantly more reported improvement in their problems (odds ratio = 2.31; 95% CI 1.29 to 4.13), than patients who were in the control treatment groups. Problem-solving therapy for DSH patients appears to produce better results than control treatment with regard to improvement in depression, hopelessness and problems. It is desirable that this finding is confirmed in a large trial, which will also allow adequate testing of the impact of this treatment on repetition of DSH.

Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol).

PubMed

Clyne, Barbara; Bradley, Marie C; Smith, Susan M; Hughes, Carmel M; Motterlini, Nicola; Clear, Daniel; McDonnell, Ronan; Williams, David; Fahey, Tom

2013-03-13

Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care. This study is a pragmatic cluster randomized controlled trial, conducted in primary care (OPTI-SCRIPT trial), involving 22 practices (clusters) and 220 patients. Practices will be allocated to intervention or control arms using minimization, with intervention participants receiving a complex multifaceted intervention incorporating academic detailing, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, and tailored patient information leaflets. Control practices will deliver usual care and receive simple patient-level feedback on potentially inappropriate prescribing. Routinely collected national prescribing data will also be analyzed for nonparticipating practices, acting as a contemporary national control. The primary outcomes are the proportion of participant patients with potentially inappropriate prescribing and the mean number of potentially inappropriate prescriptions per patient. In addition, economic and qualitative evaluations will be conducted. This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges. Current controlled trials ISRCTN41694007.

Approaches to the Study of Pragmatism in Today's China

ERIC Educational Resources Information Center

Chengbing, Wang

2017-01-01

To explore the key approaches to pragmatism is not only a logical requirement of the development of pragmatism itself, but also necessary for Chinese pragmatism to progress. There are three major necessary and feasible approaches to the study of pragmatism, which will play a very important role in the development of Pragmatism in today's China:…

Inhaled Cannabis for Chronic Neuropathic Pain: A Meta-analysis of Individual Patient Data.

PubMed

Andreae, Michael H; Carter, George M; Shaparin, Naum; Suslov, Kathryn; Ellis, Ronald J; Ware, Mark A; Abrams, Donald I; Prasad, Hannah; Wilsey, Barth; Indyk, Debbie; Johnson, Matthew; Sacks, Henry S

2015-12-01

Chronic neuropathic pain, the most frequent condition affecting the peripheral nervous system, remains underdiagnosed and difficult to treat. Inhaled cannabis may alleviate chronic neuropathic pain. Our objective was to synthesize the evidence on the use of inhaled cannabis for chronic neuropathic pain. We performed a systematic review and a meta-analysis of individual patient data. We registered our protocol with PROSPERO CRD42011001182. We searched in Cochrane Central, PubMed, EMBASE, and AMED. We considered all randomized controlled trials investigating chronic painful neuropathy and comparing inhaled cannabis with placebo. We pooled treatment effects following a hierarchical random-effects Bayesian responder model for the population-averaged subject-specific effect. Our evidence synthesis of individual patient data from 178 participants with 405 observed responses in 5 randomized controlled trials following patients for days to weeks provides evidence that inhaled cannabis results in short-term reductions in chronic neuropathic pain for 1 in every 5 to 6 patients treated (number needed to treat = 5.6 with a Bayesian 95% credible interval ranging between 3.4 and 14). Our inferences were insensitive to model assumptions, priors, and parameter choices. We caution that the small number of studies and participants, the short follow-up, shortcomings in allocation concealment, and considerable attrition limit the conclusions that can be drawn from the review. The Bayes factor is 332, corresponding to a posterior probability of effect of 99.7%. This novel Bayesian meta-analysis of individual patient data from 5 randomized trials suggests that inhaled cannabis may provide short-term relief for 1 in 5 to 6 patients with neuropathic pain. Pragmatic trials are needed to evaluate the long-term benefits and risks of this treatment. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

Testing the evidence integration triangle for implementation of interventions to manage behavioral and psychological symptoms associated with dementia: Protocol for a pragmatic trial.

PubMed

Resnick, Barbara; Kolanowski, Ann; Van Haitsma, Kimberly; Galik, Elizabeth; Boltz, Marie; Ellis, Jeanette; Behrens, Liza; Flanagan, Nina M; Eshraghi, Karen J; Zhu, Shijun

2018-06-01

Behavioral and psychological symptoms of dementia (BPSD) include aggression, agitation, resistiveness to care, depression, anxiety, apathy, and hallucinations. BPSD are common in nursing home residents and can be ameliorated using person-centered approaches. Despite regulatory requirements, less than 2% of nursing homes consistently implement person-centered behavioral approaches. In a National Institute of Nursing Research-funded research protocol, we are implementing a pragmatic cluster randomized clinical trial designed to enable staff in nursing homes to reduce BPSD using behavioral approaches while optimizing function, preventing adverse events, and improving quality of life of residents. The implementation is based on use of the Evidence Integration Triangle (EIT), a parsimonious, community-engaged participatory framework that is well suited to the complexity and variability in the nursing home environment. A total of 50 nursing home communities will be randomized to EIT-4-BPSD or education only. Primary Aim 1 is to determine if communities exposed to EIT-4-BPSD demonstrate evidence of implementation evaluated by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) criteria. Primary Aim 2 is to evaluate the feasibility, utility, and cost of the EIT approach in EIT-4-BPSD communities. © 2018 Wiley Periodicals, Inc.

Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol.

PubMed

Blödt, Susanne; Schützler, Lena; Huang, Wenjing; Pach, Daniel; Brinkhaus, Benno; Hummelsberger, Josef; Kirschbaum, Barbara; Kuhlmann, Kirsten; Lao, Lixing; Liang, Fanrong; Mietzner, Anna; Mittring, Nadine; Müller, Sabine; Paul, Anna; Pimpao-Niederle, Carolina; Roll, Stephanie; Wu, Huangan; Zhu, Jiang; Witt, Claudia M

2013-04-11

Self-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement. The study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design. Stakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start. Stakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group. Clinicaltrials.gov identifier http://NCT01582724.

The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions

PubMed Central

Esserman, Denise; Allore, Heather G.; Travison, Thomas G.

2016-01-01

Cluster-randomized clinical trials (CRT) are trials in which the unit of randomization is not a participant but a group (e.g. healthcare systems or community centers). They are suitable when the intervention applies naturally to the cluster (e.g. healthcare policy); when lack of independence among participants may occur (e.g. nursing home hygiene); or when it is most ethical to apply an intervention to all within a group (e.g. school-level immunization). Because participants in the same cluster receive the same intervention, CRT may approximate clinical practice, and may produce generalizable findings. However, when not properly designed or interpreted, CRT may induce biased results. CRT designs have features that add complexity to statistical estimation and inference. Chief among these is the cluster-level correlation in response measurements induced by the randomization. A critical consideration is the experimental unit of inference; often it is desirable to consider intervention effects at the level of the individual rather than the cluster. Finally, given that the number of clusters available may be limited, simple forms of randomization may not achieve balance between intervention and control arms at either the cluster- or participant-level. In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC). CRTs, which are often pragmatic, may eschew such restrictions. Failure to account for imbalance may induce bias and reducing validity. This article focuses on the complexities of randomization in the design of CRTs, such as the inclusion of patients with MCC, and imbalances in covariate factors across clusters. PMID:27478520

Preventing Depression in Adults With Subthreshold Depression: Health-Economic Evaluation Alongside a Pragmatic Randomized Controlled Trial of a Web-Based Intervention

PubMed Central

Berking, Matthias; Smit, Filip; Lehr, Dirk; Nobis, Stephanie; Riper, Heleen; Cuijpers, Pim; Ebert, David

2017-01-01

Background Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. Objective To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). Methods A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). Results In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention’s likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. Conclusions Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. Trial registration German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9) PMID:28052841

Is a school-based physical activity intervention effective for increasing tibial bone strength in boys and girls?

PubMed

Macdonald, Heather M; Kontulainen, Saija A; Khan, Karim M; McKay, Heather A

2007-03-01

This 16-month randomized, controlled school-based study compared change in tibial bone strength between 281 boys and girls participating in a daily program of physical activity (Action Schools! BC) and 129 same-sex controls. The simple, pragmatic intervention increased distal tibia bone strength in prepubertal boys; it had no effect in early pubertal boys or pre or early pubertal girls. Numerous school-based exercise interventions have proven effective for enhancing BMC, but none have used pQCT to evaluate the effects of increased loading on bone strength during growth. Thus, our aim was to determine whether a daily program of physical activity, Action Schools! BC (AS! BC) would improve tibial bone strength in boys and girls who were pre- (Tanner stage 1) or early pubertal (Tanner stage 2 or 3) at baseline. Ten schools were randomized to intervention (INT, 7 schools) or control (CON, 3 schools). The bone-loading component of AS! BC included a daily jumping program (Bounce at the Bell) plus 15 minutes/day of classroom physical activity in addition to regular physical education. We used pQCT to compare 16-month change in bone strength index (BSI, mg2/mm4) at the distal tibia (8% site) and polar strength strain index (SSIp, mm3) at the tibial midshaft (50% site) in 281 boys and girls participating in AS! BC and 129 same-sex controls. We used a linear mixed effects model to analyze our data. Children were 10.2+/-0.6 years at baseline. Intervention boys tended to have a greater increase in BSI (+774.6 mg2/mm4; 95% CI: 672.7, 876.4) than CON boys (+650.9 mg2/mm4; 95% CI: 496.4, 805.4), but the difference was only significant in prepubertal boys (p=0.03 for group x maturity interaction). Intervention boys also tended to have a greater increase in SSIp (+198.6 mm3; 95% CI: 182.9, 214.3) than CON boys (+177.1 mm3; 95% CI: 153.5, 200.7). Change in BSI and SSIp was similar between CON and INT girls. Our findings suggest that a simple, pragmatic program of daily activity enhances bone strength at the distal tibia in prepubertal boys. The precise exercise prescription needed to elicit a similar response in more mature boys or in girls might be best addressed in a dose-response trial.

Imitation (rather than core language) predicts pragmatic development in young children with ASD: a preliminary longitudinal study using CDI parental reports.

PubMed

Miniscalco, Carmela; Rudling, Maja; Råstam, Maria; Gillberg, Christopher; Johnels, Jakob Åsberg

2014-01-01

Research in the last decades has clearly pointed to the important role of language and communicative level when trying to understand developmental trajectories in children with autism spectrum disorders (ASD). The purpose of this longitudinal study was to investigate whether (1) core language skills, measured as expressive vocabulary and grammar, and/or (2) pre-linguistic social-communicative skills, including gestures and imitation abilities, drive pragmatic language development in young children with ASD. We examined correlates and longitudinal predictors of pragmatic growth in a sample of 34 children with Autism spectrum disorder (ASD), whose parents were given parts of two MacArthur Communicative Developmental Inventories (CDI: Words & Gestures and CDI: Words & Sentences) for completion at two time points (at time 1 the mean child age was 41 months, and at time 2 it was 54 months). A novel feature in this study is that the relevant parts from both CDI forms were included at both time points, allowing us to examine whether pre-linguistic social-communication skills (e.g. imitation and gesturing) and/or core language skills (i.e. grammar and vocabulary) predict pragmatic language growth. The results show that basically all pre-linguistic, linguistic and pragmatic skills were associated concurrently. When controlling for possible confounders and for the autoregressive effect, imitation skills predicted pragmatic growth over time, whereas core language did not. This could only have been shown by the use of both CDI forms. This preliminary study may be of both conceptual and methodological importance for research in the field of language and communication development in ASD. Imitation may play a pivotal role in the development of subsequent conversational pragmatic abilities in young children with ASD. Future research should be directed at unravelling the mechanisms underlying this association. © 2014 Royal College of Speech and Language Therapists.

HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections.

PubMed

Heinemann, Lutz; Deiss, Dorothee; Hermanns, Norbert; Graham, Claudia; Kaltheuner, Matthias; Liebl, Andreas; Price, David

2015-05-01

Systems for continuous glucose monitoring (CGM) have been available for a number of years, and numerous clinical studies have been performed with them. Interestingly, in many of these studies patients with an increased risk of hypoglycemic events were excluded. In addition, in most studies subjects were using a pump for insulin delivery. Therefore our knowledge about the benefit of CGM in patients employing multiple daily injections (MDI) of insulin is limited, especially when it comes to a reduction in the risk of low glucose events in high-risk individuals. We are planning to run a 26-week randomized controlled study in Germany (HypoDE, Hypoglycemia in Deutschland) that is focused on evaluating if such a reduction can be observed in patients on MDI with an increased risk of low glucose events. In all, 160 patients will participate in the study, randomized into the intervention group and control group. Ideally one would study if the frequency of severe hypoglycemic events is different between both groups. However, this would require such a large sample size and study duration, so for pragmatic reasons we will use low glucose levels <55 mg/dl (measured by CGM) for at least 20 minutes as a risk marker for severe hypoglycemic events. The results from the HypoDE study shall help determine the advantage of using CGM in subjects with type 1 diabetes with an increased risk of low glucose events treated with MDI. © 2015 Diabetes Technology Society.

Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

PubMed

Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

2014-07-01

The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

Cost effectiveness of a pragmatic exercise intervention (EXIMS) for people with multiple sclerosis: economic evaluation of a randomised controlled trial.

PubMed

Tosh, J; Dixon, S; Carter, A; Daley, A; Petty, J; Roalfe, A; Sharrack, B; Saxton, J M

2014-07-01

Exercise is a safe, non-pharmacological adjunctive treatment for people with multiple sclerosis but cost-effective approaches to implementing exercise within health care settings are needed. The objective of this paper is to assess the cost effectiveness of a pragmatic exercise intervention in conjunction with usual care compared to usual care only in people with mild to moderate multiple sclerosis. A cost-utility analysis of a pragmatic randomised controlled trial over nine months of follow-up was conducted. A total of 120 people with multiple sclerosis were randomised (1:1) to the intervention or usual care. Exercising participants received 18 supervised and 18 home exercise sessions over 12 weeks. The primary outcome for the cost utility analysis was the incremental cost per quality-adjusted life year (QALY) gained, calculated using utilities measured by the EQ-5D questionnaire. The incremental cost per QALY of the intervention was £10,137 per QALY gained compared to usual care. The probability of being cost effective at a £20,000 per QALY threshold was 0.75, rising to 0.78 at a £30,000 per QALY threshold. The pragmatic exercise intervention is highly likely to be cost effective at current established thresholds, and there is scope for it to be tailored to particular sub-groups of patients or services to reduce its cost impact. © The Author(s) 2013.

Effects of Mobile Augmented Reality Learning Compared to Textbook Learning on Medical Students: Randomized Controlled Pilot Study

PubMed Central

2013-01-01

Background By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. Objective To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). Methods A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the “Profile of Mood States” questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Results Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a selectivity of RPB=0.2. For mARble, fatigue (z=2.214, P=.03) and numbness (z=2.07, P=.04) decreased with statistical significance when comparing pre- and post-tests. Vigor rose slightly, while irritability did not increase significantly. Changes in the control group were insignificant. Regarding hedonic quality (identification, stimulation, attractiveness), there were significant differences between mARble (mean 1.179, CI −0.440 to 0.440) and the book chapter (mean −0.982, CI −0.959 to 0.959); the pragmatic quality mean only differed slightly. Conclusions The mARble group performed considerably better regarding learning efficiency; there are hints for activating components of the mAR concept that may serve to fascinate the participants and possibly boost interest in the topic for the remainder of the class. While the small sample size reduces our study’s conclusiveness, its design seems appropriate for determining the effects of interactive eLearning material with respect to emotions, learning efficiency, and hedonic and pragmatic qualities using a larger group. Trial Registration German Clinical Trial Register (DRKS), DRKS-ID: DRKS00004685; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004685. PMID:23963306

Effects of mobile augmented reality learning compared to textbook learning on medical students: randomized controlled pilot study.

PubMed

Albrecht, Urs-Vito; Folta-Schoofs, Kristian; Behrends, Marianne; von Jan, Ute

2013-08-20

By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the "Profile of Mood States" questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a selectivity of RPB=0.2. For mARble, fatigue (z=2.214, P=.03) and numbness (z=2.07, P=.04) decreased with statistical significance when comparing pre- and post-tests. Vigor rose slightly, while irritability did not increase significantly. Changes in the control group were insignificant. Regarding hedonic quality (identification, stimulation, attractiveness), there were significant differences between mARble (mean 1.179, CI -0.440 to 0.440) and the book chapter (mean -0.982, CI -0.959 to 0.959); the pragmatic quality mean only differed slightly. The mARble group performed considerably better regarding learning efficiency; there are hints for activating components of the mAR concept that may serve to fascinate the participants and possibly boost interest in the topic for the remainder of the class. While the small sample size reduces our study's conclusiveness, its design seems appropriate for determining the effects of interactive eLearning material with respect to emotions, learning efficiency, and hedonic and pragmatic qualities using a larger group. German Clinical Trial Register (DRKS), DRKS-ID: DRKS00004685; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004685.

Metacognition in speech and language therapy for children with social (pragmatic) communication disorders: implications for a theory of therapy.

PubMed

Gaile, Jacqueline; Adams, Catherine

2018-01-01

Metacognition is a significant component of complex interventions for children who have developmental language disorders. Research into how metacognition operates in the content or process of developmental language therapy delivery is limited. Identification and description of proposed active therapy components, such as metacognition, may contribute to our understanding of how to deliver complex communication interventions in an optimal manner. To analyse aspects of metacognition during therapy derived from a manualized speech and language intervention (the Social Communication Intervention Programme-SCIP) as delivered to children who have social (pragmatic) communication disorder (SPCD) and to examine the dynamic process of delivering therapy. A purposive sample of eight filmed therapy sessions was selected from the video data corpus of intervention-arm participants within a randomized controlled trial. The child-therapist interactions during therapy sessions from five children (aged between 5;11 and 10;3) in the SCIP trial were transcribed. Filmed sessions represented a variety of communication profiles and SCIP therapy content. Starting from existing theory on metacognition, cycles of iterative analysis were performed using a mixed inductive-deductive qualitative analysis. A preliminary list of metacognitive content embedded in the intervention was developed into a metacognitive coding framework (MCF). A thematic analysis of the identified metacognitive content of the intervention was then carried out across the whole sample. Thematic analysis revealed the presence of metacognition in the content and delivery of SCIP intervention. Four main themes of metacognitive person, task and strategy knowledge, and monitoring/control were identified. Metacognition was a feature of how children's ability to monitor language, pragmatic and social interaction skills, in themselves and other people, was developed. Task design and delivery methods were found to play a particular role in adjusting the metacognitive content of the therapy activities. This study makes explicit the metacognitive content and delivery within a complex developmental communication intervention. Discussion of the findings about metacognitive content provides an explanation of how the skilled speech and language therapist manipulates task demands, person knowledge and therapy methods towards the therapy goal. Clinical applications of the metacognitive framework are discussed. We suggest that the process of making the tacit knowledge of the therapist explicit can contribute to the implementation of complex evidence-based interventions. © 2017 Royal College of Speech and Language Therapists.

Wellness-Promoting Practices Through Girl Scouts: A Pragmatic Superiority Randomized Controlled Trial With Additional Dissemination.

PubMed

Cull, Brooke J; Dzewaltowski, David A; Guagliano, Justin M; Rosenkranz, Sara K; Knutson, Cassandra K; Rosenkranz, Richard R

2018-01-01

To evaluate the effectiveness of in-person versus online Girl Scout leader wellness training for implementation of wellness-promoting practices during troop meetings (phase I) and to assess training adoption and current practices across the council (phase II). Pragmatic superiority trial (phase 1) followed by serial cross-sectional study (phase II). Girl Scout troop meetings in Northeast Kansas. Eighteen troop leaders from 3 counties (phase 1); 113 troop leaders from 7 counties (phase II). Phase I: Troop leaders attended 2 wellness training sessions (first in groups, second individually), wherein leaders set wellness-promoting practice implementation goals, self-monitored progress, and received guidance and resources for implementation. Leaders received the intervention in person or online. Phase I: At baseline and postintervention, leaders completed a wellness-promoting practice implementation questionnaire assessing practices during troop meetings (max score = 11). Phase II: Leaders completed a survey about typical troop practices and interest in further training. Phase I: Generalized linear mixed modeling. Phase I: In-person training increased wellness-promoting practice implementation more than online training (in person = 2.1 ± 1.8; online = 0.2 ± 1.2; P = .022). Phase II: Fifty-six percent of leaders adopted the training. For 8 of 11 wellness categories, greater than 50% of leaders employed wellness-promoting practices. In-person training was superior to online training for improvements in wellness-promoting practices. Wellness training was adopted by the majority of leaders across the council.

Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial

PubMed Central

Jiang, Yannan; Whittaker, Robyn; Maddison, Ralph

2015-01-01

Background Given the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app. Objective The aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels. Methods Apps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps. Results A total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was –28.4 seconds shorter (95% CI –66.5 to 9.82, P=.20) for the immersive app group and –24.7 seconds (95% CI –63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes. Conclusions Although apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12613001030763; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613001030763 (Archived by WebCite at http://www.webcitation.org/6aasfJVTJ). PMID:26316499

Towards a Convergent Account of Pragmatic Language Deficits in Children with High-Functioning Autism: Depicting the Phenotype Using the Pragmatic Rating Scale

ERIC Educational Resources Information Center

Lam, Yan Grace; Yeung, Siu Sze Susanna

2012-01-01

Despite its prominence, pragmatic characteristic associated with autism is under-explored and thus was not well defined. The present study attempted to depict a relatively comprehensive profile of language pragmatics in children with high-functioning autism (HFA) using the Pragmatic Rating Scale (PRS). Pragmatic behaviors of 26 HFA children were…

The effect of targeted treatment on people with patellofemoral pain: a pragmatic, randomised controlled feasibility study.

PubMed

Drew, Benjamin T; Conaghan, Philip G; Smith, Toby O; Selfe, James; Redmond, Anthony C

2017-08-04

Targeted treatment, matched according to specific clinical criteria e.g. hip muscle weakness, may result in better outcomes for people with patellofemoral pain (PFP). However, to ensure the success of future trials, a number of questions on the feasibility of a targeted treatment need clarification. The aim of the study was to explore the feasibility of matched treatment (MT) compared to usual care (UC) management for a subgroup of people with PFP determined to have hip weakness and to explore the mechanism of effect for hip strengthening. In a pragmatic, randomised controlled feasibility study, 24 participants with PFP (58% female; mean age 29 years) were randomly allocated to receive either MT aimed specifically at hip strengthening, or UC over an eight-week period. The primary outcomes were feasibility outcomes, which included rates of adherence, attrition, eligibility, missing data and treatment efficacy. Secondary outcomes focused on the mechanistic outcomes of the intervention, which included hip kinematics. Conversion to consent (100%), missing data (0%), attrition rate (8%) and adherence to both treatment and appointments (>90%) were deemed successful endpoints. The analysis of treatment efficacy showed that the MT group reported a greater improvement for the Global Rating of Change Scale (62% vs. 9%) and the Anterior Knee Pain Scale (-5.23 vs. 1.18) but no between-group differences for either average or worst pain. Mechanistic outcomes showed a greatest reduction in peak hip internal rotation angle for the MT group (13.1% vs. -2.7%). This feasibility study indicates that a definitive randomised controlled trial investigating a targeted treatment approach is achievable. Findings suggest the mechanism of effect of hip strengthening may be to influence kinematic changes in hip function in the transverse plane. This study was registered retrospectively. ISRCTN74560952 . Registration date: 2017-02-06.

Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty

PubMed Central

Blikman, T; Rienstra, W; van Raaij, T M; ten Hagen, A J; Dijkstra, B; Zijlstra, W P; Bulstra, S K; van den Akker-Scheek, I; Stevens, M

2016-01-01

Introduction Residual pain is a major factor in patient dissatisfaction following total hip arthroplasty or total knee arthroplasty (THA/TKA). The proportion of patients with unfavourable long-term residual pain is high, ranging from 7% to 34%. There are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. It is thus hypothesised that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine has been shown to be effective for several chronic pain syndromes, including knee osteoarthritis (OA), in which CS is most likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain compared with care-as-usual. Methods and analysis This multicentre, pragmatic, prospective, open-label, randomised controlled trial includes patients with idiopathic hip/knee OA who are on a waiting list for primary THA/TKA. Patients at risk for CS will be randomly allocated to the preoperative duloxetine treatment programme group or the care-as-usual control group. The primary end point is the degree of postoperative pain 6 months after THA/TKA. Secondary end points at multiple time points up to 12 months postoperatively are: pain, neuropathic pain-like symptoms, (pain) sensitisation, pain catastrophising, joint-associated problems, physical activity, health-related quality of life, depressive and anxiety symptoms, and perceived improvement. Data will be analysed on an intention-to-treat basis. Ethics and dissemination The study is approved by the local Medical Ethics Committee (METc 2014/087) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard (GCP), and in compliance with the Medical Research Involving Human Subjects Act (WMO). Trial registration number 2013-004313-41; Pre-results. PMID:26932142

Long-term effect of population screening for diabetes on cardiovascular morbidity, self-rated health, and health behavior.

PubMed

Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Prevost, A Toby; Williams, Kate M; Kinmonth, Ann-Louise; Wareham, Nicholas J; Griffin, Simon J

2015-03-01

There is limited trial evidence concerning the long-term effects of screening for type 2 diabetes on population morbidity. We examined the effect of a population-based diabetes screening program on cardiovascular morbidity, self-rated health, and health-related behaviors. We conducted a pragmatic, parallel-group, cluster-randomized controlled trial of diabetes screening (the ADDITION-Cambridge study) including 18,875 individuals aged 40 to 69 years at high risk of diabetes in 32 general practices in eastern England (27 practices randomly allocated to screening, 5 to no-screening for control). Of those eligible for screening, 466 (2.9%) were diagnosed with diabetes. Seven years after randomization, a random sample of patients was sent a postal questionnaire: 15% from the screening group (including diabetes screening visit attenders and non-attenders) and 40% from the no-screening control group. Self-reported cardiovascular morbidity, self-rated health (using the SF-8 Health Survey and EQ-5D instrument), and health behaviors were compared between trial groups using an intention-to-screen analysis. Of the 3,286 questionnaires mailed out, 1,995 (61%) were returned, with 1,945 included in the analysis (screening: 1,373; control: 572). At 7 years, there were no significant differences between the screening and control groups in the proportion of participants reporting heart attack or stroke (OR = 0.90, 95% CI, 0.71-1.15); SF-8 physical health summary score as an indicator of self-rated health status (β -0.33, 95% CI, -1.80 to 1.14); EQ-5D visual analogue score (β: 0.80, 95% CI, -1.28 to 2.87); total physical activity (β 0.50, 95% CI, -4.08 to 5.07); current smoking (OR 0.97, 95% CI, 0.72 to 1.32); and alcohol consumption (β 0.14, 95% CI, -1.07 to 1.35). Invitation to screening for type 2 diabetes appears to have limited impact on population levels of cardiovascular morbidity, self-rated health status, and health behavior after 7 years. © 2015 Annals of Family Medicine, Inc.

Long-Term Effect of Population Screening for Diabetes on Cardiovascular Morbidity, Self-Rated Health, and Health Behavior

PubMed Central

Echouffo-Tcheugui, Justin B.; Simmons, Rebecca K.; Prevost, A. Toby; Williams, Kate M.; Kinmonth, Ann-Louise; Wareham, Nicholas J.; Griffin, Simon J.

2015-01-01

PURPOSE There is limited trial evidence concerning the long-term effects of screening for type 2 diabetes on population morbidity. We examined the effect of a population-based diabetes screening program on cardiovascular morbidity, self-rated health, and health-related behaviors. METHODS We conducted a pragmatic, parallel-group, cluster-randomized controlled trial of diabetes screening (the ADDITION-Cambridge study) including 18,875 individuals aged 40 to 69 years at high risk of diabetes in 32 general practices in eastern England (27 practices randomly allocated to screening, 5 to no-screening for control). Of those eligible for screening, 466 (2.9%) were diagnosed with diabetes. Seven years after randomization, a random sample of patients was sent a postal questionnaire: 15% from the screening group (including diabetes screening visit attenders and non-attenders) and 40% from the no-screening control group. Self-reported cardiovascular morbidity, self-rated health (using the SF-8 Health Survey and EQ-5D instrument), and health behaviors were compared between trial groups using an intention-to-screen analysis. RESULTS Of the 3,286 questionnaires mailed out, 1,995 (61%) were returned, with 1,945 included in the analysis (screening: 1,373; control: 572). At 7 years, there were no significant differences between the screening and control groups in the proportion of participants reporting heart attack or stroke (OR = 0.90, 95% CI, 0.71–1.15); SF-8 physical health summary score as an indicator of self-rated health status (β −0.33, 95% CI, −1.80 to 1.14); EQ-5D visual analogue score (β: 0.80, 95% CI, −1.28 to 2.87); total physical activity (β 0.50, 95% CI, −4.08 to 5.07); current smoking (OR 0.97, 95% CI, 0.72 to 1.32); and alcohol consumption (β 0.14, 95% CI, −1.07 to 1.35). CONCLUSIONS Invitation to screening for type 2 diabetes appears to have limited impact on population levels of cardiovascular morbidity, self-rated health status, and health behavior after 7 years. PMID:25755036

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

PubMed Central

2015-01-01

OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention.

PubMed

Yousefi, Hadi; Chopra, Arvind; Farrokhseresht, Reza; Sarmukaddam, Sanjeev; Noghabi, Fariba Asadi; Bedekar, Nilima; Madani, Abdolhosain

2015-01-01

Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

Automatic processing of pragmatic information in the human brain: a mismatch negativity study.

PubMed

Zhao, Ming; Liu, Tao; Chen, Feiyan

2018-05-23

Language comprehension involves pragmatic information processing, which allows world knowledge to influence the interpretation of a sentence. This study explored whether pragmatic information can be automatically processed during spoken sentence comprehension. The experiment adopted the mismatch negativity (MMN) paradigm to capture the neurophysiological indicators of automatic processing of spoken sentences. Pragmatically incorrect ('Foxes have wings') and correct ('Butterflies have wings') sentences were used as the experimental stimuli. In condition 1, the pragmatically correct sentence was the deviant and the pragmatically incorrect sentence was the standard stimulus, whereas the opposite case was presented in condition 2. The experimental results showed that, compared with the condition that the pragmatically correct sentence is the deviant stimulus, when the condition that the pragmatically incorrect sentence is the deviant stimulus MMN effects were induced within 60-120 and 220-260 ms. The results indicated that the human brain can monitor for incorrect pragmatic information in the inattentive state and can automatically process pragmatic information at the beginning of spoken sentence comprehension.

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions

PubMed Central

Walach, Harald; Falkenberg, Torkel; Fønnebø, Vinjar; Lewith, George; Jonas, Wayne B

2006-01-01

Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform. PMID:16796762

The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

PubMed

Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; da Silva, Jacqueline Tereza; Galante, Andrea Polo; Lara, Enilda de Sousa; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Moriguchi, Emilio H; Bruscato, Neide M; Kesties; Vivian, Lilian; Schumacher, Marina; de Carli, Waldemar; Backes, Luciano M; Reolão, Bruna R; Rodrigues, Milena P; Baldissera, Dúnnia M B; Tres, Glaucia S; Lisbôa, Hugo R K; Bem, João B J; Reolão, Jose B C; Deucher, Keyla L A L; Cantarelli, Maiara; Lucion, Aline; Rampazzo, Daniela; Bertoni, Vanessa; Torres, Rosileide S; Verríssimo, Adriana O L; Guterres, Aldair S; Cardos, Andrea F R; Coutinho, Dalva B S; Negrão, Mayara G; Alencar, Mônica F A; Pinho, Priscila M; Barbosa, Socorro N A A; Carvalho, Ana P P F; Taboada, Maria I S; Pereira, Sheila A; Heyde, Raul V; Nagano, Francisca E Z; Baumgartner, Rebecca; Resende, Fernanda P; Tabalipa, Ranata; Zanini, Ana C; Machado, Michael J R; Araujo, Hevila; Teixeira, Maria L V; Souza, Gabriela C; Zuchinali, Priccila; Fracasso, Bianca M; Ulliam, Karen; Schumacher, Marina; Pierotto, Moara; Hilário, Thamires; Carlos, Daniele M O; Cordeiro, Cintia G N C; Carvalho, Daniele A; Gonçalves, Marília S; Vasconcelos, Valdiana B; Bosquetti, Rosa; Pagano, Raira; Romano, Marcelo L P; Jardim, César A; de Abreu, Bernardo N A; Marcadenti, Aline; Schmitt, Alessandra R; Tavares, Angela M V; Faria, Christiane C; Silva, Flávia M; Fink, Jaqueline S; El Kik, Raquel M; Prates, Clarice F; Vieira, Cristiane S; Adorne, Elaine F; Magedanz, Ellen H; Chieza, Fernanda L; Silva, Ingrid S; Teixeira, Joise M; Trescastro, Eduardo P; Pellegrini, Lívia A; Pinto, Jéssika C; Telles, Cristina T; Sousa, Antonio C S; Almeida, Andreza S; Costa, Ariane A; Carmo, José A C; Silva, Juliana T; Alves, Luciana V S; Sales, Saulo O C; Ramos, Maria E M; Lucas, Marilia C S; Damiani, Monica; Cardoso, Patricia C; Ramos, Salvador S; Dantas, Clenise F; Lopes, Amanda G; Cabral, Ana M P; Lucena, Ana C A; Medeiros, Auriene L; Terceiro, Bernardino B; Leda, Neuma M F S; Baía, Sandra R D; Pinheiro, Josilene M F; Cassiano, Alexandra N; Melo, Andressa N L; Cavalcanti, Anny K O; Souza, Camila V S; Queiroz, Dayanna J M; Farias, Hercilla N C F; Souza, Larissa C F; Santos, Letícia S; Lima, Luana R M; Hoffmann, Meg S; Ribeiro, Átala S Silva; Vasconcelos, Daniel F; Dutra, Eliane S; Ito, Marina K; Neto, José A F; Santos, Alexsandro F; Sousa, Rosângela M L; Dias, Luciana Pereira P; Lima, Maria T M A; Modanesi, Victor G; Teixeira, Adriana F; Estrada, Luciana C N C D; Modanesi, Paulo V G; Gomes, Adriana B L; Rocha, Bárbara R S; Teti, Cristina; David, Marta M; Palácio, Bruna M; Junior, Délcio G S; Faria, Érica H S; Oliveira, Michelle C F; Uehara, Rose M; Sasso, Sandramara; Moreira, Annie S B; Cadinha, Ana C A H; Pinto, Carla W M; Castilhos, Mariana P; Costa, Mariana; Kovacs, Cristiane; Magnoni, Daniel; Silva, Quênia; Germini, Michele F C A; da Silva, Renata A; Monteiro, Aline S; dos Santos, Karina G; Moreira, Priscila; Amparo, Fernanda C; Paiva, Catharina C J; Poloni, Soraia; Russo, Diana S; Silveira, Izabele V; Moraes, Maria A; Boklis, Mirena; Cardoso, Quinto I; Moreira, Annie S B; Damaceno, Aline M S; Santos, Elisa M; Dias, Glauber M; Pinho, Cláudia P S; Cavalcanti, Adrilene C; Bezerra, Amanda S; Queiroga, Andrey V; Rodrigues, Isa G; Leal, Tallita V; Sahade, Viviane; Amaral, Daniele A; Souza, Diana S; Araújo, Givaldo A; Curvello, Karine; Heine, Manuella; Barretto, Marília M S; Reis, Nailson A; Vasconcelos, Sandra M L; Vieira, Danielly C; Costa, Francisco A; Fontes, Jessica M S; Neto, Juvenal G C; Navarro, Laís N P; Ferreira, Raphaela C; Marinho, Patrícia M; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo G; Ferreira, Lauren S; Borges, Lúcia R; Azevedo, Norlai A; Martins, Celma M; Kato, Juliana T; Izar, Maria C O; Asoo, Marina T; de Capitani, Mariana D; Machado, Valéria A; Fonzar, Waléria T; Pinto, Sônia L; Silva, Kellen C; Gratão, Lúcia H A; Machado, Sheila D; de Oliveira, Susane R U; Bressan, Josefina; Caldas, Ana P S; Lima, Hatanne C F M; Hermsdorff, Helen H M; Saldanha, Tânia M; Priore, Sílvia E; Feres, Naoel H; Neves, Adila de Queiroz; Cheim, Loanda M G; Silva, Nilma F; Reis, Silvia R L; Penafort, Andreza M; de Queirós, Ana Paula O; Farias, Geysa M N; de los Santos, Mônica L P; Ambrozio, Cíntia L; Camejo, Cirília N; dos Santos, Cristiano P; Schirmann, Gabriela S; Boemo, Jorge L; Oliveira, Rosane E C; Lima, Súsi M B; Bortolini, Vera M S; Matos, Cristina H; Barretta, Claiza; Specht, Clarice M; de Souza, Simone R; Arruda, Cristina S; Rodrigues, Priscila A; Berwanger, Otávio

2016-01-01

This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease. Copyright © 2015 Elsevier Inc. All rights reserved.

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

PubMed

Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

2017-11-01

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

Pragmatics: The Social Functions of Language--Implications for the Social Studies.

ERIC Educational Resources Information Center

Turner, Thomas N.

Social studies instruction will improve if educators understand and integrate information gained from pragmatics into social studies curriculum and methods. Pragmatics is an area of linguistic study based on the philosophy of pragmatism which emphasizes social consequences of events and actions. Pragmatics deals particularly with the relationships…

Pragmatics Fragmented: The Factor Structure of the Dutch Children's Communication Checklist (CCC)

ERIC Educational Resources Information Center

Geurts, Hilde M.; Hartman, Catharina; Verte, Sylvie; Oosterlaan, Jaap; Roeyers, Herbert; Sergeant, Joseph A.

2009-01-01

Background: A number of disorders are associated with pragmatic difficulties. Instruments that can make subdivisions within the larger construct of pragmatics could be important tools for disentangling profiles of pragmatic difficulty in different disorders. The deficits underlying the observed pragmatic difficulties may be different for different…

Simulation improves procedural protocol adherence during central venous catheter placement: a randomized-controlled trial

PubMed Central

Peltan, Ithan D.; Shiga, Takashi; Gordon, James A.; Currier, Paul F.

2015-01-01

Background Simulation training may improve proficiency at and reduces complications from central venous catheter (CVC) placement, but the scope of simulation’s effect remains unclear. This randomized controlled trial evaluated the effects of a pragmatic CVC simulation program on procedural protocol adherence, technical skill, and patient outcomes. Methods Internal medicine interns were randomized to standard training for CVC insertion or standard training plus simulation-based mastery training. Standard training involved a lecture, a video-based online module, and instruction by the supervising physician during actual CVC insertions. Intervention-group subjects additionally underwent supervised training on a venous access simulator until they demonstrated procedural competence. Raters evaluated interns’ performance during internal jugular CVC placement on actual patients in the medical intensive care unit. Generalized estimating equations were used to account for outcome clustering within trainees. Results We observed 52 interns place 87 CVCs. Simulation-trained interns exhibited better adherence to prescribed procedural technique than interns who received only standard training (p=0.024). There were no significant differences detected in first-attempt or overall cannulation success rates, mean needle passes, global assessment scores or complication rates. Conclusions Simulation training added to standard training improved protocol adherence during CVC insertion by novice practitioners. This study may have been too small to detect meaningful differences in venous cannulation proficiency and other clinical outcomes, highlighting the difficulty of patient-centered simulation research in settings where poor outcomes are rare. For high-performing systems, where protocol deviations may provide an important proxy for rare procedural complications, simulation may improve CVC insertion quality and safety. PMID:26154250

Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: a randomized controlled trial and economics analysis.

PubMed

Adie, Katja; Schofield, Christine; Berrow, Margie; Wingham, Jennifer; Humfryes, John; Pritchard, Colin; James, Martin; Allison, Rhoda

2017-02-01

The Trial of Wii™ in Stroke investigated the efficacy of using the Nintendo Wii Sports™ (Wii TM ) to improve affected arm function after stroke. Multicentre, pragmatic, parallel group, randomized controlled trial. Home-based rehabilitation. A total of 240 participants aged 24-90 years with arm weakness following a stroke within the previous six months. Participants were randomly assigned to exercise daily for six weeks using the Wii TM or arm exercises at home. Primary outcome was change in the affected arm function at six weeks follow-up using the Action Research Arm Test. Secondary outcomes included occupational performance, quality of life, arm function at six months and a cost effectiveness analysis. The study was completed by 209 participants (87.1%). There was no significant difference in the primary outcome of affected arm function at six weeks follow-up (mean difference -1.7, 95% CI -3.9 to 0.5, p = 0.12) and no significant difference in secondary outcomes, including occupational performance, quality of life or arm function at six months, between the two groups. No serious adverse events related to the study treatment were reported. The cost effectiveness analysis showed that the Wii TM was more expensive than arm exercises £1106 (SD 1656) vs. £730 (SD 829) (probability 0.866). The trial showed that the Wii TM was not superior to arm exercises in home-based rehabilitation for stroke survivors with arm weakness. The Wii TM was well tolerated but more expensive than arm exercises.

A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial.

PubMed

Wayne, Peter M; Manor, Brad; Novak, Vera; Costa, Madelena D; Hausdorff, Jeffrey M; Goldberger, Ary L; Ahn, Andrew C; Yeh, Gloria Y; Peng, C-K; Lough, Matthew; Davis, Roger B; Quilty, Mary T; Lipsitz, Lewis A

2013-01-01

Aging is typically associated with progressive multi-system impairment that leads to decreased physical and cognitive function and reduced adaptability to stress. Due to its capacity to characterize complex dynamics within and between physiological systems, the emerging field of complex systems biology and its array of quantitative tools show great promise for improving our understanding of aging, monitoring senescence, and providing biomarkers for evaluating novel interventions, including promising mind-body exercises, that treat age-related disease and promote healthy aging. An ongoing, two-arm randomized clinical trial is evaluating the potential of Tai Chi mind-body exercise to attenuate age-related loss of complexity. A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30). Our primary outcomes are complexity-based measures of heart rate, standing postural sway and gait stride interval dynamics assessed at 3 and 6months. Multiscale entropy and detrended fluctuation analysis are used as entropy- and fractal-based measures of complexity, respectively. Secondary outcomes include measures of physical and psychological function and tests of physiological adaptability also assessed at 3 and 6months. Results of this study may lead to novel biomarkers that help us monitor and understand the physiological processes of aging and explore the potential benefits of Tai Chi and related mind-body exercises for healthy aging. Copyright © 2012 Elsevier Inc. All rights reserved.

Context Effects in Western Herbal Medicine: Fundamental to Effectiveness?

PubMed

Snow, James

2016-01-01

Western herbal medicine (WHM) is a complex healthcare system that uses traditional plant-based medicines in patient care. Typical preparations are individualized polyherbal formulae that, unlike herbal pills, retain the odor and taste of whole herbs. Qualitative studies in WHM show patient-practitioner relationships to be collaborative. Health narratives are co-constructed, leading to assessments, and treatments with personal significance for participants. It is hypothesized that the distinct characteristics of traditional herbal preparations and patient-herbalist interactions, in conjunction with the WHM physical healthcare environment, evoke context (placebo) effects that are fundamental to the overall effectiveness of herbal treatment. These context effects may need to be minimized to demonstrate pharmacological efficacy of herbal formulae in randomized, placebo-controlled trials, optimized to demonstrate effectiveness of WHM in pragmatic trials, and consciously harnessed to enhance outcomes in clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.

PubMed

Avis, Nancy E; Coeytaux, Remy R; Isom, Scott; Prevette, Kristen; Morgan, Timothy

2016-06-01

The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

Short structured general mental health in service training programme in Kenya improves patient health and social outcomes but not detection of mental health problems - a pragmatic cluster randomised controlled trial

PubMed Central

2013-01-01

Trial design A pragmatic cluster randomised controlled trial. Methods Participants: Clusters were primary health care clinics on the Ministry of Health list. Clients were eligible if they were aged 18 and over. Interventions: Two members of staff from each intervention clinic received the training programme. Clients in both intervention and control clinics subsequently received normal routine care from their health workers. Objective: To examine the impact of a mental health inservice training on routine detection of mental disorder in the clinics and on client outcomes. Outcomes: The primary outcome was the rate of accurate routine clinic detection of mental disorder and the secondary outcome was client recovery over a twelve week follow up period. Randomisation: clinics were randomised to intervention and control groups using a table of random numbers. Blinding: researchers and clients were blind to group assignment. Results Numbers randomised: 49 and 50 clinics were assigned to intervention and control groups respectively. 12 GHQ positive clients per clinic were identified for follow up. Numbers analysed: 468 and 478 clients were followed up for three months in intervention and control groups respectively. Outcome: At twelve weeks after training of the intervention group, the rate of accurate routine clinic detection of mental disorder was greater than 0 in 5% versus 0% of the intervention and control groups respectively, in both the intention to treat analysis (p = 0.50) and the per protocol analysis (p =0.50). Standardised effect sizes for client improvement were 0.34 (95% CI = (0.01,0.68)) for the General Health Questionnaire, 0.39 ((95% CI = (0.22, 0.61)) for the EQ and 0.49 (95% CI = (0.11,0.87)) for WHODAS (using ITT analysis); and 0.43 (95% CI = (0.09,0.76)) for the GHQ, 0.44 (95% CI = (0.22,0.65)) for the EQ and 0.58 (95% CI = (0.18,0.97)) for WHODAS (using per protocol analysis). Harms: None identified. Conclusion The training programme did not result in significantly improved recorded diagnostic rates of mental disorders in the routine clinic consultation register, but did have significant effects on patient outcomes in routine clinical practice. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN53515024. PMID:24188964

Contrastive Lexical Pragmatics as an Effective Strategy in Teaching Pragmatics: A Review Article

ERIC Educational Resources Information Center

Ghaemi, Farid; Ziafar, Meisam

2011-01-01

Pragmatic aspect of formulaic language must be emphasized and employed in second language acquisition. Translation of formulaic speech can help learners better understand the pragmatic nature of L2 prefabricated language through comparing them with their L1 (first language) equivalents. This study proposes a contrastive lexical pragmatic approach…

Exploring the Validity of a Second Language Intercultural Pragmatics Assessment Tool

ERIC Educational Resources Information Center

Timpe-Laughlin, Veronika; Choi, Ikkyu

2017-01-01

Pragmatics has been a key component of language competence frameworks. While the majority of second/foreign language (L2) pragmatics tests have targeted productive skills, the assessment of receptive pragmatic skills remains a developing field. This study explores validation evidence for a test of receptive L2 pragmatic ability called the American…

The Status of Pragmatics among Iranian EFL Learners

ERIC Educational Resources Information Center

Mohammad-Bagheri, Mehri

2015-01-01

The present study attempted to investigate the status of pragmatics among Iranian EFL learners. Status of pragmatics was analyzed in terms of the amount of pragmatic knowledge EFL learners believed to have and the amount of pragmatic knowledge they believed to receive from teachers, classmates, course books, and exams. Additionally, attempts were…

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

PubMed

Thompson, Carl

2004-01-01

Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Baduanjin Exercise Prevents post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER trial): Design and Rationale of a Pragmatic Randomized Controlled Trial.

PubMed

Mao, Shuai; Zhang, Xiaoxuan; Shao, Biying; Hu, Xiyan; Hu, Yanan; Li, Winny; Guo, Liheng; Zhang, Minzhou

2016-06-01

Left ventricular (LV) remodeling following myocardial infarction (MI) is an established prognostic factor for adverse cardiovascular events and the leading cause of heart failure. Empirical observations have suggested that Baduanjin exercise, an important component of traditional Chinese Qigong, may exert potential benefits on cardiopulmonary function. However, the impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from a recent MI has yet to be assessed. The aim of this trial is to evaluate the potential role of Baduanjin exercise in preventing the maladaptive progression to adverse LV remodeling in patients post-MI. A total of 110 clinically stable patients following an MI after undergoing successful infarct-related artery reperfusion will be randomly assigned to the Baduanjin exercise group or usual exercise control group. In addition to usual physical activity, participants in the Baduanjin exercise group will participate in a 45 min Baduanjin exercise training session twice a week, for a total of 12 weeks. The primary endpoint will be the percentage change in LV end-diastolic volume index (LVEDVi) assessed using echocardiography from baseline to 6 months. The results of this study may provide novel evidence on the efficacy of Baduanjin exercise therapy in post-MI patients in reversing adverse LV remodeling and improving clinical outcome. Clinical Trials.gov: NCT02693795.

Effectiveness of a training program for police officers who come into contact with people with mental health problems: A pragmatic randomised controlled trial.

PubMed

Scantlebury, Arabella; Fairhurst, Caroline; Booth, Alison; McDaid, Catriona; Moran, Nicola; Parker, Adwoa; Payne, Rebecca; Scott, William J; Torgerson, David; Webber, Martin; Hewitt, Catherine

2017-01-01

Police officers frequently come into contact with individuals with mental health problems. Specialist training in this area for police officers may improve how they respond to individuals with mental health problems; however, evidence to support this is sparse. This study evaluated the effectiveness of one bespoke mental health training package for frontline police officers relative to routine training. Pragmatic, two-armed cluster randomised controlled trial in one police force in England. Police stations in North Yorkshire were randomised with frontline police officers receiving either a bespoke mental health training package or routine training. The primary outcome was the number of incidents which resulted in a police response reported to the North Yorkshire Police control room up to six months after delivery of training. Secondary outcomes included: likelihood of incidents using Section 136 of the Mental Health Act; likelihood of incidents having a mental health tag applied; and number of individuals with a mental health warning marker involved in incidents. The appropriateness of mental health tags applied to a random sample of incidents was checked by an independent mental health professional. Routinely collected data were used. Twelve police stations were recruited and randomised (Intervention group n = 6; Control group n = 6), and 249 officers received the bespoke mental health training intervention. At follow-up, a median of 397 incidents were assigned to trial stations in the intervention group, and 498 in the control group. There was no evidence of a difference in the number of incidents with a police response (adjusted incidence rate ratio (IRR) 0.92, 95% CI 0.61 to 1.38, p = 0.69), or in the number of people with mental health warning markers involved in incidents (adjusted IRR 1.39, 95% CI 0.91 to 2.10, p = 0.13) between the intervention and control groups up to six months following the intervention; however, incidents assigned to stations in the intervention group were more likely to have a mental health tag applied to them than incidents assigned to control stations (adjusted odds ratio 1.41, 95% CI 1.16 to 1.71, p = 0.001). The review of 100 incidents suggests that there may be incidents involving individuals with mental health issues that are not being recorded as such (Kappa coefficient 0.65). There was no statistically significant difference in the likelihood of Section 136 of the Mental Health Act being applied to an incident. The bespoke one day mental health training delivered to frontline officers by mental health professionals did not reduce the number of incidents reported to the police control room up to six months after its delivery; however training may have a positive effect on how the police record incidents involving individuals with mental health problems. Our trial has shown that conducting pragmatic trials within the police setting is feasible and acceptable. There is a wealth of routinely collected police data that can be utilised for research and further collaboration between police forces and academia is encouraged. ISRCTN (ISRCTN11685602). The authors confirm that all ongoing and related trials for this drug/intervention are registered.

Effect of "Focus on Form" versus "Focus on Forms" Pragmatic Instruction on Development of Pragmatic Comprehension and Production

ERIC Educational Resources Information Center

Rafieyan, Vahid

2016-01-01

To develop target language pragmatic competence, language learners' attention must be directed toward not only linguistic but also pragmatic aspect of the target language expressions (Schmidt, 2001). Thus, some sorts of pragmatic awareness-raising instruction, using either explicit "Focus on Forms" or implicit "Focus on Form"…

Pragmatic clinical trials: ethical imperatives and opportunities.

PubMed

Kalkman, Shona; van Thiel, Ghislaine J M W; Grobbee, Diederick E; van Delden, Johannes J M

2018-06-12

Pragmatic clinical trials generate robust real-world evidence that holds great potential to better inform decision making regarding new medicines. For clinicians, patients and regulators, this evidence would preferably be available sooner rather than later. This means that, ideally, market authorization of any given medicine is accompanied by evidence obtained from a pragmatic trial. Given the operational and regulatory complexities of pragmatic trials in general, stakeholders tend to be hesitant to employ more pragmatism at the time of market approval. One prominent hurdle for the conduct of pragmatic trials is the concern that pragmatic design features conflict with ethical standards for clinical trials. To encourage timely yet responsible generation of real-world evidence through clinical trials, it is important to delineate exactly which areas, from a societal point of view, demand early pragmatic evaluations. We also urge stakeholders to recognize how the current system of trial ethics oversight already accommodates for more-pragmatic approaches, and how new ideas about their permissibility have progressed in the bioethics literature. Copyright © 2018. Published by Elsevier Ltd.

Cognitive correlates of pragmatic language comprehension in adult traumatic brain injury: A systematic review and meta-analyses.

PubMed

Rowley, Dane A; Rogish, Miles; Alexander, Timothy; Riggs, Kevin J

2017-01-01

Effective pragmatic comprehension of language is critical for successful communication and interaction, but this ability is routinely impaired following Traumatic Brain Injury (TBI) (1,2). Individual studies have investigated the cognitive domains associated with impaired pragmatic comprehension, but there remains little understanding of the relative importance of these domains in contributing to pragmatic comprehension impairment following TBI. This paper presents a systematic meta-analytic review of the observed correlations between pragmatic comprehension and cognitive processes following TBI. Five meta-analyses were computed, which quantified the relationship between pragmatic comprehension and five key cognitive constructs (declarative memory; working memory; attention; executive functions; social cognition). Significant moderate-to-strong correlations were found between all cognitive measures and pragmatic comprehension, where declarative memory was the strongest correlate. Thus, our findings indicate that pragmatic comprehension in TBI is associated with an array of domain general cognitive processes, and as such deficits in these cognitive domains may underlie pragmatic comprehension difficulties following TBI. The clinical implications of these findings are discussed.

Practitioner review: the assessment of language pragmatics.

PubMed

Adams, Catherine

2002-11-01

The assessment of pragmatics expressed in spoken language is a central issue in the evaluation of children with communication impairments and related disorders. A developmental approach to assessment has remained problematic due to the complex interaction of social, linguistic, cognitive and cultural influences on pragmatics. A selective review and critique of current formal and informal testing methods and pragmatic analytic procedures. Formal testing of pragmatics has limited potential to reveal the typical pragmatic abnormalities in interaction but has a significant role to play in the assessment of comprehension of pragmatic intent. Clinical assessment of pragmatics with the pre-school child should focus on elicitation of communicative intent via naturalistic methods as part of an overall assessment of social communication skills. Assessments for older children should include a comprehensive investigation of speech acts, conversational and narrative abilities, the understanding of implicature and intent as well as the child's ability to employ contextual cues to understanding. Practical recommendations are made regarding the choice of a core set of pragmatic assessments and elicitation techniques. The practitioner's attention is drawn to the lack of the usual safeguards of reliability and validity that have persisted in some language pragmatics assessments. A core set of pragmatic assessment tools can be identified from the proliferation of instruments in current use. Further research is required to establish clearer norms and ranges in the development of pragmatic ability, particularly with respect to the understanding of inference, topic management and coherence.

Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.

PubMed

Arrow, Peter; Klobas, Elizabeth

2015-12-01

A pragmatic randomized control trial was undertaken to compare the minimum intervention dentistry (MID) approach, based on the atraumatic restorative treatment procedures (MID-ART: Test), against the standard care approach (Control) to treat early childhood caries in a primary care setting. Consenting parent/child dyads were allocated to the Test or Control group using stratified block randomization. Inclusion and exclusion criteria were applied. Participants were examined at baseline and at follow-up by two calibrated examiners blind to group allocation status (κ = 0.77), and parents completed a questionnaire at baseline and follow-up. Dental therapists trained in MID-ART provided treatment to the Test group and dentists treated the Control group using standard approaches. The primary outcome of interest was the number of children who were referred for specialist pediatric care. Secondary outcomes were the number of teeth treated, changes in child oral health-related quality of life and dental anxiety and parental perceptions of care received. Data were analyzed on an intention to treat basis; risk ratio for referral for specialist care, test of proportions, Wilcoxon rank test and logistic regression were used. Three hundred and seventy parents/carers were initially screened; 273 children were examined at baseline and 254 were randomized (Test = 127; Control = 127): mean age = 3.8 years, SD 0.90; 59% male, mean dmft = 4.9, SD 4.0. There was no statistically significant difference in age, sex, baseline caries experience or child oral health-related quality of life between the Test and Control group. At follow-up (mean interval 11.4 months, SD 3.1 months), 220 children were examined: Test = 115, Control = 105. Case-notes review of 231 children showed Test = 6 (5%) and Control = 53 (49%) were referred for specialist care, P < 0.0001. More teeth were filled in the Test group (mean = 2.93, SD 2.48) than in the Control group (mean = 1.54, SD 2.20), Wilcoxon's test, P < 0.0001. Logistic regression, after controlling for age and baseline caries experience, showed a higher risk of referral by allocation to control group, OR 32.6, 95% CI 10.8-98.4, P < 0.0001. The MID-ART approach reduced significantly the likelihood of referral for specialist care, and more children and teeth were provided with treatment. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

PubMed

Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

2012-03-01

Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

Doing Mixed Methods Research Pragmatically: Implications for the Rediscovery of Pragmatism as a Research Paradigm

ERIC Educational Resources Information Center

Feilzer, Martina Yvonne

2010-01-01

This article explores the practical relevance of pragmatism as a research paradigm through the example of a piece of pragmatic research that not only used both quantitative and qualitative research methods but also exploited the inherent duality of the data analyzed. Thus, the article aims to make the case that pragmatism as a research paradigm…

What Does It Mean to Be Pragmatic? Pragmatic Methods, Measures, and Models to Facilitate Research Translation

ERIC Educational Resources Information Center

Glasgow, Russell E.

2013-01-01

Background: One of the reasons for the slow and uncertain translation of research into practice is likely due to the emphasis in science on explanatory models and efficacy designs rather than more pragmatic approaches. Methods: Following a brief definition of what constitutes a pragmatic approach, I provide examples of pragmatic methods, measures,…

A Study of Relationships between L1 Pragmatic Transfer and L2 Proficiency

ERIC Educational Resources Information Center

Bu, Jiemin

2012-01-01

Studies in interlanguage pragmatics have shown that L2 learners' proficiency has an influence on the occurrences of L1 pragmatic transfer. However, questions remain whether the relationship between L1 pragmatic transfer and L2 proficiency is positive or negative. This paper is designed to study L1 pragmatic transfer in requests made by Chinese…

Children with Cerebral Palsy, Spina Bifida and Pragmatic Language Impairment: Differences and Similarities in Pragmatic Ability

ERIC Educational Resources Information Center

Holck, Pernille; Nettelbladt, Ulrika; Sandberg, Annika Dahlgren

2009-01-01

Pragmatically related abilities were studied in three clinical groups of children from 5 to 11 years of age; children with cerebral palsy (CP; n = 10), children with spina bifida and hydrocephalus (SBH; n = 10) and children with pragmatic language impairment (PLI; n = 10), in order to explore pragmatic abilities within each group. A range of…

A Comparison of Pragmatic Language in Boys with Autism and Fragile X Syndrome

PubMed Central

Klusek, Jessica; Martin, Gary E.; Losh, Molly

2014-01-01

Purpose Impaired pragmatic language (i.e., language use for social interaction) is a hallmark feature of both autism spectrum disorder (ASD) and fragile X syndrome (FXS), the most common known monogenic disorder associated with ASD. However, few cross-population comparisons of ASD and FXS have been conducted, and it is unclear whether pragmatic language profiles in these conditions overlap. Method This study used semi-naturalistic and standardized assessment methods to characterize pragmatic language abilities of 29 school-aged boys with idiopathic ASD, 38 with FXS and comorbid ASD, 16 with FXS without ASD, 20 with Down syndrome and 20 with typical development. Results Similar severity of pragmatic language deficits was observed in both of the groups with ASD (idiopathic and fragile X-associated). ASD comorbidity had a detrimental effect on the pragmatic language skills of boys with FXS. Some different patterns emerged across the two pragmatic assessment tools, with more robust group differences observed in pragmatics assessed in a semi-naturalistic conversational context. Conclusions These findings have implications for pragmatic language assessment and intervention, as well as for understanding the potential role of the fragile X gene, Fragile X Mental Retardation-1, in the pragmatic language phenotype of ASD. PMID:24686468

Is Principled Pragmatism a Viable Framework for Addressing Complex Problems?

NASA Astrophysics Data System (ADS)

Islam, S.

2017-12-01

Complex water problems are connected with many competing and often conflicting values, interests, and tools. These problems can't be addressed through simply applying dogmatic principles or a deal-making pragmatic approach. Because these problems are interconnected and interdependent, a final solution can't be pre-specified. Any intervention to a complex problem requires attention to both principles and pragmatism. Strict adherence to principles without pragmatism is often not actionable; pure pragmatism exercised without guiding principles is not sustainable. In a colloquial sense, pragmatism is often taken to suggest practical, opportunistic, and expedient approaches at the expense of principles. This perception appears to be rooted in the dichotomy between "being pragmatic" and "being ideological". The notion of principled pragmatism attempts to get away from this duality by focusing on how to make ideas clear and actionable. In other words, how to connect our thoughts to action given the context, constraints, and capacity. Principled pragmatism - rooted in equity and sustainability as guiding principles for water management - approach attempts to synthesize symbolic aspirations with realistic assessment to chart a trajectory of actionable subset of implementable solutions. Case studies from the Ganges Basin will show the utility of principled pragmatism for water management in a changing world.

Effectiveness of intensive practice nurse counselling versus brief general practitioner advice, both combined with varenicline, for smoking cessation: a randomized pragmatic trial in primary care.

PubMed

van Rossem, Carolien; Spigt, Mark; Viechtbauer, Wolfgang; Lucas, Annelies E M; van Schayck, Onno C P; Kotz, Daniel

2017-12-01

To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. A multi-site (n = 10), two-group, parallel, pragmatic randomized controlled trial. A network of primary health-care centres in the Netherlands. A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Patients were randomized to receive individual counselling by a practice nurse (PN) (n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Abstinence rates in the PN versus GP groups were 32.2% (n = 48) versus 39.0% [n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% (n = 38) versus 28.8% (n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. © 2017 Society for the Study of Addiction.

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

PubMed Central

2013-01-01

Background Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. Methods We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial. Results The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices. Conclusions We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions. PMID:24160371

Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO)

PubMed Central

Khan, Khalid S.; Wilson, Matthew J.; Hooper, Richard; Allard, Shubha; Wrench, Ian; Geoghegan, James; Catling, Sue; Clark, Vicki A.; Ayuk, Paul; Robson, Stephen; Gao-Smith, Fang; Hogg, Matthew; Dodds, Julie

2017-01-01

Background Excessive haemorrhage at cesarean section requires donor (allogeneic) blood transfusion. Cell salvage may reduce this requirement. Methods and findings We conducted a pragmatic randomised controlled trial (at 26 obstetric units; participants recruited from 4 June 2013 to 17 April 2016) of routine cell salvage use (intervention) versus current standard of care without routine salvage use (control) in cesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2 ml in RhD-negative women with RhD-positive babies (a secondary outcome) between groups. Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) versus 3.9% of 1,492 assigned to control. Donor blood transfusion rate was 3.5% in the control group versus 2.5% in the intervention group (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p = 0.056; adjusted risk difference −1.03, 95% CI −2.13 to 0.06). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control versus 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% versus 1.8% among elective cesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46). No case of amniotic fluid embolism was observed. The rate of fetomaternal haemorrhage was higher with the intervention (10.5% in the control group versus 25.6% in the intervention group, adjusted OR 5.63, 95% CI 1.43 to 22.14, p = 0.013). We are unable to comment on long-term antibody sensitisation effects. Conclusions The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during cesarean section was not statistically significant. Trial registration This trial was prospectively registered on ISRCTN as trial number 66118656 and can be viewed on http://www.isrctn.com/ISRCTN66118656. PMID:29261655

Effect of adding systematic family history enquiry to cardiovascular disease risk assessment in primary care: a matched-pair, cluster randomized trial.

PubMed

Qureshi, Nadeem; Armstrong, Sarah; Dhiman, Paula; Saukko, Paula; Middlemass, Joan; Evans, Philip H; Kai, Joe

2012-02-21

Evidence of the value of systematically collecting family history in primary care is limited. To evaluate the feasibility of systematically collecting family history of coronary heart disease in primary care and the effect of incorporating these data into cardiovascular risk assessment. Pragmatic, matched-pair, cluster randomized, controlled trial. (International Standardized Randomized Controlled Trial Number Register: ISRCTN 17943542). 24 family practices in the United Kingdom. 748 persons aged 30 to 65 years with no previously diagnosed cardiovascular risk, seen between July 2007 and March 2009. Participants in control practices had the usual Framingham-based cardiovascular risk assessment with and without use of existing family history information in their medical records. Participants in intervention practices also completed a questionnaire to systematically collect their family history. All participants were informed of their risk status. Participants with high cardiovascular risk were invited for a consultation. The primary outcome was the proportion of participants with high cardiovascular risk (10-year risk ≥ 20%). Other measures included questionnaire completion rate and anxiety score. 98% of participants completed the family history questionnaire. The mean increase in proportion of participants classified as having high cardiovascular risk was 4.8 percentage points in the intervention practices, compared with 0.3 percentage point in control practices when family history from patient records was incorporated. The 4.5-percentage point difference between groups (95% CI, 1.7 to 7.2 percentage points) remained significant after adjustment for participant and practice characteristics (P = 0.007). Anxiety scores were similar between groups. Relatively few participants were from ethnic minority or less-educated groups. The potential to explore behavioral change and clinical outcomes was limited. Many data were missing for anxiety scores. Systematically collecting family history increases the proportion of persons identified as having high cardiovascular risk for further targeted prevention and seems to have little or no effect on anxiety. Genetics Health Services Research program of the United Kingdom Department of Health.

Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial

PubMed Central

Navani, Neal; Nankivell, Matthew; Lawrence, David R; Lock, Sara; Makker, Himender; Baldwin, David R; Stephens, Richard J; Parmar, Mahesh K; Spiro, Stephen G; Morris, Stephen; Janes, Sam M

2015-01-01

Summary Background The diagnosis and staging of lung cancer is an important process that identifies treatment options and guides disease prognosis. We aimed to assess endobronchial ultrasound-guided transbronchial needle aspiration as an initial investigation technique for patients with suspected lung cancer. Methods In this open-label, multicentre, pragmatic, randomised controlled trial, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA lung cancer, from six UK centres and randomly assigned them to either endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) or conventional diagnosis and staging (CDS), for further investigation and staging. If a target node could not be accessed by EBUS-TBNA, then endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was allowed as an alternative procedure. Randomisation was stratified according to the presence of mediastinal lymph nodes measuring 1 cm or more in the short axis and by recruiting centre. We used a telephone randomisation method with permuted blocks of four generated by a computer. Because of the nature of the intervention, masking of participants and consenting investigators was not possible. The primary endpoint was the time-to-treatment decision after completion of the diagnostic and staging investigations and analysis was by intention-to-diagnose. This trial is registered with ClinicalTrials.gov, number NCT00652769. Findings Between June 10, 2008, and July 4, 2011, we randomly allocated 133 patients to treatment: 66 to EBUS-TBNA and 67 to CDS (one later withdrew consent). Two patients from the EBUS-TBNA group underwent EUS-FNA. The median time to treatment decision was shorter with EBUS-TBNA (14 days; 95% CI 14–15) than with CDS (29 days; 23–35) resulting in a hazard ratio of 1·98, (1·39–2·82, p<0·0001). One patient in each group had a pneumothorax from a CT-guided biopsy sample; the patient from the CDS group needed intercostal drainage and was admitted to hospital. Interpretation Transbronchial needle aspiration guided by endobronchial ultrasound should be considered as the initial investigation for patients with suspected lung cancer, because it reduces the time to treatment decision compared with conventional diagnosis and staging techniques. Funding UK Medical Research Council. PMID:25660225

Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial.

PubMed

Cottrell, David J; Wright-Hughes, Alexandra; Collinson, Michelle; Boston, Paula; Eisler, Ivan; Fortune, Sarah; Graham, Elizabeth H; Green, Jonathon; House, Allan O; Kerfoot, Michael; Owens, David W; Saloniki, Eirini-Christina; Simic, Mima; Lambert, Fiona; Rothwell, Justine; Tubeuf, Sandy; Farrin, Amanda J

2018-03-01

Self-harm in adolescents is common and repetition occurs in a high proportion of these cases. Scarce evidence exists for effectiveness of interventions to reduce self-harm. This pragmatic, multicentre, randomised, controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services (CAMHS) centres. We recruited young people aged 11-17 years who had self-harmed at least twice and presented to CAMHS after self-harm. Participants were randomly assigned (1:1) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS. Participants and therapists were aware of treatment allocation; researchers were masked. The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment. Primary and safety analyses were done in the intention-to-treat population. The trial is registered at the ISRCTN registry, number ISRCTN59793150. Between Nov 23, 2009, and Dec 31, 2013, 3554 young people were screened and 832 eligible young people consented to participation and were randomly assigned to receive family therapy (n=415) or treatment as usual (n=417). Primary outcome data were available for 795 (96%) participants. Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups (118 [28%] in the family therapy group vs 103 [25%] in the treatment as usual group; hazard ratio 1·14 [95% CI 0·87-1·49] p=0·33). Similar numbers of adverse events occurred in both groups (787 in the family therapy group vs 847 in the treatment as usual group). For adolescents referred to CAMHS after self-harm, having self-harmed at least once before, our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm. Clinicians are therefore still unable to recommend a clear, evidence-based intervention to reduce repeated self-harm in adolescents. National Institute for Health Research Health Technology Assessment programme. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India.

PubMed

Hirschhorn, Lisa Ruth; Semrau, Katherine; Kodkany, Bhala; Churchill, Robyn; Kapoor, Atul; Spector, Jonathan; Ringer, Steve; Firestone, Rebecca; Kumar, Vishwajeet; Gawande, Atul

2015-08-14

Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India. Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4-6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed. In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch. The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality. NCT02148952 .

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

PubMed

Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, Abhay

2017-10-10

Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [32 0/7 ] to 33 6/7 weeks) and late preterm (34 0/7 to 36 6/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

PubMed

Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

2014-03-26

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. ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

PubMed

Brenner, Alison T; Getrich, Christina M; Pignone, Michael; Rhyne, Robert L; Hoffman, Richard M; McWilliams, Andrew; de Hernandez, Brisa Urquieta; Weaver, Mark A; Tapp, Hazel; Harbi, Khalil; Reuland, Daniel

2014-07-08

Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. ClinicalTrials.gov NCT02054598.

Effect of Daikenchuto (TJ-100) on gastrointestinal symptoms following laparoscopic colectomy in patients with colon cancer: study protocol for a randomized controlled trial.

PubMed

Hoshino, Nobuaki; Kawada, Kenji; Hida, Koya; Wada, Toshiaki; Takahashi, Ryo; Yoshitomi, Mami; Sakai, Yoshiharu

2017-11-21

Postoperative paralytic ileus can be a difficult complication for both surgeons and patients. Causes and treatments have been discussed for more than two centuries, but have not yet been fully resolved. Daikenchuto (TJ-100, DKT) is a traditional Japanese herbal medicine. Recently, some beneficial mechanisms of DKT to relieve paralytic ileus have been reported. DKT can suppress inflammation, increase intestinal blood flow, and accelerate bowel movements. Therefore, we have designed a randomized controlled trial to investigate the effects of DKT on postoperative gastrointestinal symptoms following laparoscopic colectomy in patients with left-sided colon cancer at a single institution. As primary endpoints, the following outcomes will be evaluated: (i) grade of abdominal pain determined using the numeric rating scale (NRS), (ii) grade of abdominal distention determined using the NRS, and (iii) quality of life determined using the Gastrointestinal Quality Life Index (GIQLI). As secondary endpoints, the following will be evaluated: (i) postoperative nutritional status (Onodera's Prognostic Nutritional Index (PNI) and the Controlling Nutritional Status score (CONUT score)), (ii) duration to initial flatus, (iii) duration to initial defecation, (iv) bowel gas volume, (v) character of stool (Bristol Stool Form Scale), (vi) defecation frequency per day, (vii) postoperative complications (Clavien-Dindo classification), (viii) length of postoperative hospital stay, and (ix) metabolites in the stool and blood. This trial is an open-label study, and needs to include 40 patients (20 patients per group) and is expected to span 2 years. To our knowledge, this is the first randomized controlled trial to investigate the effects of DKT on postoperative subjective outcomes (i.e., postoperative quality of life) following laparoscopic colectomy as primary endpoints. Exploratory metabolomics analysis of metabolites in stool and blood will be conducted in this trial, which previously has only been performed in a few human studies. The study aims to guide a future full-scale pragmatic randomized trial to assess the overall effectiveness of DKT to improve the postoperative quality of life following laparoscopic colectomy. UMIN-CTR (Japan), UMIN000023318 . Registered on 25 July 2016.

Treating Acute Insomnia: A Randomized Controlled Trial of a “Single-Shot” of Cognitive Behavioral Therapy for Insomnia

PubMed Central

Ellis, Jason G.; Cushing, Toby; Germain, Anne

2015-01-01

Study Objectives: Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. Design: A pragmatic parallel group randomized controlled trial. Setting: Community. Participants: Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. Interventions: A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Measurements and Results: Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P < 0.05) at follow-up. Further, using proposed ISI scores for identifying insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. Conclusions: This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the “stepped care” model of insomnia. Trial Registration: Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695. Citation: Ellis JG, Cushing T, Germain A. Treating acute insomnia: a randomized controlled trial of a “single-shot” of cognitive behavioral therapy for insomnia. SLEEP 2015;38(6):971–978. PMID:25515106

Primary care Identification and Referral to Improve Safety of women experiencing domestic violence (IRIS): protocol for a pragmatic cluster randomised controlled trial

PubMed Central

2010-01-01

Background Domestic violence, which may be psychological, physical, sexual, financial or emotional, is a major public health problem due to the long-term health consequences for women who have experienced it and for their children who witness it. In populations of women attending general practice, the prevalence of physical or sexual abuse in the past year from a partner or ex-partner ranges from 6 to 23%, and lifetime prevalence from 21 to 55%. Domestic violence is particularly important in general practice because women have many contacts with primary care clinicians and because women experiencing abuse identify doctors and nurses as professionals from whom they would like to get support. Yet health professionals rarely ask about domestic violence and have little or no training in how to respond to disclosure of abuse. Methods/Design This protocol describes IRIS, a pragmatic cluster randomised controlled trial with the general practice as unit of randomisation. Our trial tests the effectiveness and cost-effectiveness of a training and support programme targeted at general practice teams. The primary outcome is referral of women to specialist domestic violence agencies. Forty-eight practices in two UK cities (Bristol and London) are randomly allocated, using minimisation, into intervention and control groups. The intervention, based on an adult learning model in an educational outreach framework, has been designed to address barriers to asking women about domestic violence and to encourage appropriate responses to disclosure and referral to specialist domestic violence agencies. Multidisciplinary training sessions are held with clinicians and administrative staff in each of the intervention practices, with periodic feedback of identification and referral data to practice teams. Intervention practices have a prompt to ask about abuse integrated in the electronic medical record system. Other components of the intervention include an IRIS champion in each practice and a direct referral pathway to a named domestic violence advocate. Discussion This is the first European randomised controlled trial of an intervention to improve the health care response to domestic violence. The findings will have the potential to inform training and service provision. Trial registration ISRCTN74012786 PMID:20122266

Pragmatic Transfer.

ERIC Educational Resources Information Center

Kasper, Gabriele

1992-01-01

Attempting to clarify the concept of pragmatic transfer, this article proposes as a basic distinction Leech/Thomas' dichotomy of sociopragmatics versus pragmalinguistics, presenting evidence for transfer at both levels. Issues discussed include pragmatic universals in speech act realization, conditions for pragmatic transfer, communicative…

Pragmatics and adult language disorders: past achievements and future directions.

PubMed

Cummings, Louise

2007-05-01

In this article, the current state of our knowledge of pragmatic disorders in adults with language impairment is assessed. A brief historical background of clinical pragmatics is presented, and the place of adult language pathology within the development of this field is discussed. A comprehensive review is undertaken of pragmatic deficits in adults with language impairments of diverse etiologies. Specifically, pragmatic deficits are examined in adults with left-hemisphere damage, often resulting in aphasia, and in adults with right-hemisphere damage, traumatic brain injury, schizophrenia, and neurodegenerative disorders (principally, Alzheimer's disease). Although many pragmatic phenomena have been examined in these clinical populations, studies have also tended to neglect important areas of pragmatic functioning in adults with these disorders. Several such areas are identified within a wider discussion of how researchers and clinicians can best pursue future investigations of pragmatics in adults with language impairment.

Practical partnered research to improve weight loss among overweight/obese veterans: lessons from the trenches.

PubMed

AuYoung, Mona; Damschroder, Laura J; Kinsinger, Linda; Moin, Tannaz; Richardson, Caroline R

2017-03-29

Obesity and obesity-related conditions, such as type 2 diabetes, are a major issue for Veteran health. Veterans Health Administration (VA) researchers and health systems leaders have worked separately and together to provide more effective weight management programs for Veterans. Although randomized clinical trials are often considered the gold standard for establishing efficacy of interventions in controlled circumstances, pragmatic clinical trials (PCTs) provide agility for translation. VA researchers and health system leaders collaboratively designed a PCT to compare the Diabetes Prevention Program (VA-DPP) to usual care (MOVE!®) in promoting weight loss and glycemic control among overweight/obese Veterans with prediabetes. Together, they navigated the tensions that exist between quality improvement and research activities, facing challenges but reaping significant rewards. Early findings led to updated national guidance for delivering obesity treatment in VA. Partnered research and the use of PCTs can be powerful strategies for accelerating evidence-based findings into practice. Collaborative partnerships between researchers and health systems leaders can help enhance and sustain translation in real-world settings.

pRotective vEntilation with veno-venouS lung assisT in respiratory failure: A protocol for a multicentre randomised controlled trial of extracorporeal carbon dioxide removal in patients with acute hypoxaemic respiratory failure.

PubMed

McNamee, J J; Gillies, M A; Barrett, N A; Agus, A M; Beale, R; Bentley, A; Bodenham, A; Brett, S J; Brodie, D; Finney, S J; Gordon, A J; Griffiths, M; Harrison, D; Jackson, C; McDowell, C; McNally, C; Perkins, G D; Tunnicliffe, W; Vuylsteke, A; Walsh, T S; Wise, M P; Young, D; McAuley, D F

2017-05-01

One of the few interventions to demonstrate improved outcomes for acute hypoxaemic respiratory failure is reducing tidal volumes when using mechanical ventilation, often termed lung protective ventilation. Veno-venous extracorporeal carbon dioxide removal (vv-ECCO 2 R) can facilitate reducing tidal volumes. pRotective vEntilation with veno-venouS lung assisT (REST) is a randomised, allocation concealed, controlled, open, multicentre pragmatic trial to determine the clinical and cost-effectiveness of lower tidal volume mechanical ventilation facilitated by vv-ECCO 2 R in patients with acute hypoxaemic respiratory failure. Patients requiring intubation and mechanical ventilation for acute hypoxaemic respiratory failure will be randomly allocated to receive either vv-ECCO 2 R and lower tidal volume mechanical ventilation or standard care with stratification by recruitment centre. There is a need for a large randomised controlled trial to establish whether vv-ECCO 2 R in acute hypoxaemic respiratory failure can allow the use of a more protective lung ventilation strategy and is associated with improved patient outcomes.

The Influence of Maternal Pragmatics on the Language Skills of Children with Autism.

PubMed

Stern, Yael S; Maltman, Nell; Roberts, Megan Y

2017-06-01

This study examined the relationship between mothers' pragmatics and child language in autism spectrum disorder (ASD) and non-ASD language delay (LD) mother-child dyads. Participants consisted of 20 dyads of mothers and their toddlers aged 24 to 48 months, with ASD (n = 10) or non-ASD LD (n = 10). Groups were matched on child chronological age, language, and cognition. Maternal pragmatic language was qualified based on the degree of pragmatic violations during a semistructured interview, and was examined in relation to both child language, as measured by the Preschool Language Scale-4 and maternal use of language facilitation strategies during play. Lower rates of maternal pragmatic violations were associated with higher expressive language scores in children with ASD, and with higher receptive language scores for children with non-ASD LD. Within ASD dyads, maternal pragmatic violations were negatively related to mothers' use of linguistic expansions. These findings indicate that parental pragmatics likely contribute to early language learning, and that the effects of maternal pragmatics on early language in ASD may be indirect (e.g., through parents' use of facilitative strategies). Parent-mediated language interventions for ASD should therefore consider parent pragmatics, especially given that pragmatic differences have been identified in unaffected family members of individuals with ASD.

The Influence of Maternal Pragmatics on the Language Skills of Children with Autism

PubMed Central

Stern, Yael S.; Maltman, Nell; Roberts, Megan Y.

2017-01-01

Objective This study examined the relationship between mothers’ pragmatics and child language in autism spectrum disorder (ASD) and non-ASD language delay (LD) mother-child dyads. Methods Participants consisted of 20 dyads of mothers and their toddlers aged 24 to 48 months, with ASD (n = 10) or non-ASD LD (n = 10). Groups were matched on child chronological age, language, and cognition. Maternal pragmatic language was qualified based on the degree of pragmatic violations during a semistructured interview, and was examined in relation to both child language, as measured by the Preschool Language Scale-4 and maternal use of language facilitation strategies during play. Results Lower rates of maternal pragmatic violations were associated with higher expressive language scores in children with ASD, and with higher receptive language scores for children with non-ASD LD. Within ASD dyads, maternal pragmatic violations were negatively related to mothers’ use of linguistic expansions. Conclusion These findings indicate that parental pragmatics likely contribute to early language learning, and that the effects of maternal pragmatics on early language in ASD may be indirect (e.g., through parents’ use of facilitative strategies). Parent-mediated language interventions for ASD should therefore consider parent pragmatics, especially given that pragmatic differences have been identified in unaffected family members of individuals with ASD. PMID:28514238

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

PubMed

Conboy, Lisa; Gerke, Travis; Hsu, Kai-Yin; St John, Meredith; Goldstein, Marc; Schnyer, Rosa

2016-01-01

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

Pragmatically Applied Cervical and Thoracic Nonthrust Manipulation Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial.

PubMed

Griswold, David; Learman, Ken; Kolber, Morey J; O'Halloran, Bryan; Cleland, Joshua A

2018-03-01

Study Design Randomized clinical trial. Background The comparative effectiveness between nonthrust manipulation (NTM) and thrust manipulation (TM) for mechanical neck pain has been investigated, with inconsistent results. Objective To compare the clinical effectiveness of concordant cervical and thoracic NTM and TM for patients with mechanical neck pain. Methods The Neck Disability Index (NDI) was the primary outcome. Secondary outcomes included the Patient-Specific Functional Scale (PSFS), numeric pain-rating scale (NPRS), deep cervical flexion endurance (DCF), global rating of change (GROC), number of visits, and duration of care. The covariate was clinical equipoise for intervention. Outcomes were collected at baseline, visit 2, and discharge. Patients were randomly assigned to receive either NTM or TM directed at the cervical and thoracic spines. Techniques and dosages were selected pragmatically and applied to the most symptomatic level. Two-way mixed-model analyses of covariance were used to assess clinical outcomes at 3 time points. Analyses of covariance were used to assess between-group differences for the GROC, number of visits, and duration of care at discharge. Results One hundred three patients were included in the analyses (NTM, n = 55 and TM, n = 48). The between-group analyses revealed no differences in outcomes on the NDI (P = .67), PSFS (P = .26), NPRS (P = .25), DCF (P = .98), GROC (P = .77), number of visits (P = .21), and duration of care (P = .61) for patients with mechanical neck pain who received either NTM or TM. Conclusion NTM and TM produce equivalent outcomes for patients with mechanical neck pain. The trial was registered with ClinicalTrials.gov (NCT02619500). Level of Evidence Therapy, level 1b. J Orthop Sports Phys Ther 2018;48(3):137-145. Epub 6 Feb 2018. doi:10.2519/jospt.2018.7738.

Predictors of longitudinal outcome and recovery of pragmatic language and its relation to externalizing behaviour after pediatric traumatic brain injury.

PubMed

Ryan, Nicholas P; Catroppa, Cathy; Beare, Richard; Coleman, Lee; Ditchfield, Michael; Crossley, Louise; Beauchamp, Miriam H; Anderson, Vicki A

2015-03-01

The purpose of the present investigation was to evaluate the contribution of age-at-insult and brain pathology on longitudinal outcome and recovery of pragmatic language in a sample of children and adolescents with traumatic brain injury (TBI). Children and adolescents with mild to severe TBI (n=112) were categorized according to timing of brain insult: (i) Middle Childhood (5-9 years; n=41); (ii) Late Childhood (10-11 years; n=39); and (iii) Adolescence (12-15 years; n=32) and group-matched for age, gender and socio-economic status (SES) to a typically developing (TD) control group (n=43). Participants underwent magnetic resonance imaging (MRI) including a susceptibility weighted imaging (SWI) sequence 2-8 weeks after injury and were assessed on measures of pragmatic language and behavioural functioning at 6- and 24-months after injury. Children and adolescents with TBI of all severity levels demonstrated impairments in these domains at 6-months injury before returning to age-expected levels at 2-years post-TBI. However, while adolescent TBI was associated with post-acute disruption to skills that preceded recovery to age-expected levels by 2-years post injury, the middle childhood TBI group demonstrated impairments at 6-months post-injury that were maintained at 2-year follow up. Reduced pragmatic communication was associated with frontal, temporal and corpus callosum lesions, as well as more frequent externalizing behaviour at 24-months post injury. Findings show that persisting pragmatic language impairment after pediatric TBI is related to younger age at brain insult, as well as microhemorrhagic pathology in brain regions that contribute to the anatomically distributed social brain network. Relationships between reduced pragmatic communication and more frequent externalizing behavior underscore the need for context-sensitive rehabilitation programs that aim to increase interpersonal effectiveness and reduce risk for maladaptive behavior trajectories into the long-term post injury. Copyright © 2015 Elsevier Inc. All rights reserved.

A pragmatic randomized controlled trial to evaluate the effectiveness of a facilitated exercise intervention as a treatment for postnatal depression: the PAM-PeRS trial.

PubMed

Daley, A J; Blamey, R V; Jolly, K; Roalfe, A K; Turner, K M; Coleman, S; McGuinness, M; Jones, I; Sharp, D J; MacArthur, C

2015-08-01

Postnatal depression affects about 10-15% of women in the year after giving birth. Many women and healthcare professionals would like an effective and accessible non-pharmacological treatment for postnatal depression. Women who fulfilled the International Classification of Diseases (ICD)-10 criteria for major depression in the first 6 months postnatally were randomized to receive usual care plus a facilitated exercise intervention or usual care only. The intervention involved two face-to-face consultations and two telephone support calls with a physical activity facilitator over 6 months to support participants to engage in regular exercise. The primary outcome was symptoms of depression using the Edinburgh Postnatal Depression Scale (EPDS) at 6 months post-randomization. Secondary outcomes included EPDS score as a binary variable (recovered and improved) at 6 and 12 months post-randomization. A total of 146 women were potentially eligible and 94 were randomized. Of these, 34% reported thoughts of self-harming at baseline. After adjusting for baseline EPDS, analyses revealed a -2.04 mean difference in EPDS score, favouring the exercise group [95% confidence interval (CI) -4.11 to 0.03, p = 0.05]. When also adjusting for pre-specified demographic variables the effect was larger and statistically significant (mean difference = -2.26, 95% CI -4.36 to -0.16, p = 0.03). Based on EPDS score a larger proportion of the intervention group was recovered (46.5% v. 23.8%, p = 0.03) compared with usual care at 6 months follow-up. This trial shows that an exercise intervention that involved encouragement to exercise and to seek out social support to exercise may be an effective treatment for women with postnatal depression, including those with thoughts of self-harming.

Electronic Resources: Selection and Bibliographic Control.

ERIC Educational Resources Information Center

Pattie, Ling-yuh W., Ed.; Cox, Bonnie Jean, Ed.

This book is a baseline guide for professionals and library school students on issues that concern the selection and bibliographic control of electronic resources, from both conceptual and pragmatic standpoints. The book includes the following articles: (1) "Foreward" (Lois Mai Chan); (2) "Introduction" (Ling-yuh W. (Miko)…

Action representation: crosstalk between semantics and pragmatics.

PubMed

Prinz, Wolfgang

2014-03-01

Marc Jeannerod pioneered a representational approach to movement and action. In his approach, motor representations provide both, declarative knowledge about action and procedural knowledge for action (action semantics and action pragmatics, respectively). Recent evidence from language comprehension and action simulation supports the claim that action pragmatics and action semantics draw on common representational resources, thus challenging the traditional divide between declarative and procedural action knowledge. To account for these observations, three kinds of theoretical frameworks are discussed: (i) semantics is grounded in pragmatics, (ii) pragmatics is anchored in semantics, and (iii) pragmatics is part and parcel of semantics. © 2013 Elsevier Ltd. All rights reserved.

Between Peirce (1878) and James (1898): G. Stanley Hall, the origins of pragmatism, and the history of psychology.

PubMed

Leary, David E

2009-01-01

This article focuses on the 20-year gap between Charles S. Peirce's classic proposal of pragmatism in 1877-1878 and William James's equally classic call for pragmatism in 1898. It fills the gap by reviewing relevant developments in the work of Peirce and James and by introducing G. Stanley Hall, for the first time, as a figure in the history of pragmatism. In treating Hall and pragmatism, the article reveals a previously unnoted relation between the early history of pragmatism and the early history of the "new psychology" that Hall helped to pioneer. (c) 2009 Wiley Periodicals, Inc.

Preventing Depression in Adults With Subthreshold Depression: Health-Economic Evaluation Alongside a Pragmatic Randomized Controlled Trial of a Web-Based Intervention.

PubMed

Buntrock, Claudia; Berking, Matthias; Smit, Filip; Lehr, Dirk; Nobis, Stephanie; Riper, Heleen; Cuijpers, Pim; Ebert, David

2017-01-04

Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9). ©Claudia Buntrock, Matthias Berking, Filip Smit, Dirk Lehr, Stephanie Nobis, Heleen Riper, Pim Cuijpers, David Ebert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 04.01.2017.

Proficiency Effect on L2 Pragmatic Competence

ERIC Educational Resources Information Center

Xiao, Feng

2015-01-01

This paper synthesizes cross-sectional studies of the effect of proficiency on second language (L2) pragmatics to answer the synthesis question: Does proficiency affect adult learners' pragmatic competence? Findings have revealed an overall positive proficiency effect on pragmatic competence, and in most cases higher proficiency learners have…

Mental Verbs and Pragmatic Language Difficulties

ERIC Educational Resources Information Center

Spanoudis, George; Natsopoulos, Demetrios; Panayiotou, Georgia

2007-01-01

Background: Pragmatic language impairment has recently been the subject of a number of studies that attempted to illuminate classification and diagnostic issues, and identify the profile of children with pragmatic language difficulties. Although much progress has been made, the nature of pragmatic difficulties remains unclear. Aims: To contrast…

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

PubMed Central

2012-01-01

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

The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing.

PubMed

Wayne, Peter M; Gagnon, Margaret M; Macklin, Eric A; Travison, Thomas G; Manor, Bradley; Lachman, Margie; Thomas, Cindy P; Lipsitz, Lewis A

2017-09-01

Supporting the health of growing numbers of frail older adults living in subsidized housing requires interventions that can combat frailty, improve residents' functional abilities, and reduce their health care costs. Tai Chi is an increasingly popular multimodal mind-body exercise that incorporates physical, cognitive, social, and meditative components in the same activity and offers a promising intervention for ameliorating many of the conditions that lead to poor health and excessive health care utilization. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study is an ongoing two-arm cluster randomized, attention-controlled trial designed to examine the impact of Tai Chi on functional indicators of health and health care utilization. We are enrolling participants from 16 urban subsidized housing facilities (n=320 participants), conducting the Tai Chi intervention or education classes and social calls (attention control) in consenting subjects within the facilities for one year, and assessing these subjects at baseline, 6months, and 1year. Physical function (quantified by the Short Physical Performance Battery), and health care utilization (emergency visits, hospitalizations, skilled nursing and nursing home admissions), assessed at 12months are co-primary outcomes. Our discussion highlights our strategy to balance pragmatic and explanatory features into the study design, describes efforts to enhance site recruitment and participant adherence, and summarizes our broader goal of post study dissemination if effectiveness and cost-effectiveness are demonstrated, by preparing training and protocol manuals for use in housing facilities across the U.S. Copyright © 2017 Elsevier Inc. All rights reserved.

A review on adult pragmatic assessments

PubMed Central

Sobhani Rad, Davood

2014-01-01

Pragmatics is defined as appropriate use of language either to comprehend ideas or to interact in social situations effectively. Pragmatic competence, which is processed in the right hemisphere, comprises a number of interrelated skills that manifest in a range of adaptive behaviors. Due to the widespread influence of language in communication, studying pragmatic profiles, by developing appropriate tools, is of importance. Here, a range of pragmatic theories and assessment instruments available for use in adult patients is reviewed. PMID:25422728

Assessing pragmatic communication in children with Down syndrome.

PubMed

Smith, Elizabeth; Næss, Kari-Anne B; Jarrold, Christopher

2017-07-01

Successful communication depends on language content, language form, and language use (pragmatics). Children with Down syndrome (DS) experience communication difficulties, however little is known about their pragmatic profile, particularly during early school years. The purpose of the present study was to explore the nature of pragmatic communication in children with DS. Twenty-nine six-year-old children with DS were assessed, in the areas of 1) initiation, 2) scripted language, 3) understanding context and 4) nonverbal communication, as reported by children's parents via the Children's Communication Checklist-2 (Bishop, 2003). Additionally, the relationships between pragmatics and measures of vocabulary, nonverbal mental ability and social functioning were explored. Children with DS were impaired relative to norms from typically developing children in all areas of pragmatics. A profile of relative strengths and weaknesses was found in the children with DS; the area of nonverbal communication was significantly stronger, while the area of understanding context was significantly poorer, relative to the other areas of pragmatics assessed in these children. Relationships between areas of pragmatics and other linguistic areas, as well as aspects of vocabulary and social functioning were observed. By the age of six children with DS experience significantly impaired pragmatic communication, with a clear profile of relative strengths and weaknesses. The study highlights the need to teach children with DS pragmatic skills as a component of communication, alongside language content and form. Copyright © 2017. Published by Elsevier Inc.

The impact of a mobile application-based treatment for urinary incontinence in adult women: Design of a mixed-methods randomized controlled trial in a primary care setting.

PubMed

Loohuis, Anne M M; Wessels, Nienke J; Jellema, Petra; Vermeulen, Karin M; Slieker-Ten Hove, Marijke C; van Gemert-Pijnen, Julia E W C; Berger, Marjolein Y; Dekker, Janny H; Blanker, Marco H

2018-02-02

We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI ≥ 2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment. © 2018 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.

Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy

PubMed Central

2009-01-01

Background Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN), however systematic reviews of these studies do not provide conclusive answers. Therefore, a large randomized controlled trial (RCT) is needed to provide a reliable answer as to whether acetylcysteine is effective in decreasing the risk of CIN in high-risk patients undergoing angiographic procedures. Methods ACT is a RCT of acetylcysteine versus placebo in 2,300 patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list will be concealed. Participants, health care staff, investigators and outcome assessors will be blinded to whether patients receive acetylcysteine or placebo. All analysis will follow the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo) will be administered orally twice daily for two doses before and two doses after the procedure. The primary outcome is the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography. Discussion The first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10), 18% had a baseline serum creatinine >1.5 mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography. Trial registration Clinicaltrials.gov NCT00736866 PMID:19497091

Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial.

PubMed

Busard, C I; Menting, S P; van Bezooijen, J S; van den Reek, J M; Hutten, B A; Prens, E P; de Jong, E M; van Doorn, M B; Spuls, P I

2017-02-02

The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases. This is an investigator-initiated, multicenter randomized controlled trial (RCT) designed to compare the combination treatment of adalimumab and methotrexate with adalimumab monotherapy in patients with psoriasis. The primary outcome is adalimumab drug survival at week 49. Other outcomes include improvement in disease severity and quality of life, tolerability, and safety. Moreover, anti-adalimumab antibodies and adalimumab serum concentrations will be measured and correlations between genotypes and clinical outcomes will be assessed. Patient recruitment started in March 2014. Up to now, 36 patients have been randomized. Many more patients have been (pre)screened. A total of 93 patients is desired to meet an adequate sample size. In our experience, the main limitation for recruitment is prior adalimumab therapy and intolerability or toxicity for methotrexate in the past. OPTIMAP is the first RCT to examine combination therapy with adalimumab and methotrexate in a psoriasis population. With data derived from this study we expect to provide valuable clinical data on long-term treatment outcomes. These data will be supported by assessment of the impact of concomitant methotrexate on adalimumab pharmacokinetics. Furthermore, the influence of several single nucleotide polymorphisms on adalimumab response will be analyzed in order to support the development of a more personalized approach for this targeted therapy. NTR4499 . Registered on 7 April 2014.

Is it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA Trial (ISRCTN51046698).

PubMed

Lemcke, J; Meier, U; Müller, C; Fritsch, M; Eymann, R; Kiefer, M; Kehler, U; Langer, N; Rohde, V; Ludwig, H-Ch; Weber, F; Remenez, V; Schuhmann, M; Stengel, D

2010-01-01

Overdrainage is a common complication observed after shunting patients with idiopathic normal-pressure hydrocephalus (iNPH), with an estimated incidence up to 25%. Gravitational units that counterbalance intracranial pressure changes were developed to overcome this problem. We will set out to investigate whether the combination of a programmable valve and a gravitational unit (proGAV, Aesculap/Miethke, Germany) is capable of reducing the incidence of overdrainage and improving patient-centered outcomes compared to a conventional programmable valve (Medos-Codman, Johnson & Johnson, Germany). SVASONA is a pragmatic randomized controlled trial conducted at seven centers in Germany. Patients with a high probability of iNPH (based on clinical signs and symptoms, lumbar infusion and/or tap test, cranial computed tomography [CCT]) and no contraindications for surgical drainage will randomly be assigned to receive (1) a shunt assistant valve (proGAV) or (2) a conventional, programmable shunt valve (programmable Medos-Codman).We will test the primary hypothesis that the experimental device reduces the rate of overdrainage from 25% to 10%. As secondary analyses, we will measure iNPH-specific outcomes (i.e., the Black grading scale and the NPH Recovery Rate), generic quality of life (Short Form 36), and complications and serious adverse events (SAE). One planned interim analysis for safety and efficacy will be performed halfway through the study. To detect the hypothesized difference in the incidence of overdrainage with a type I error of 5% and a type II error of 20%, correcting for multiple testing and an anticipated dropout rate of 10%, 200 patients will be enrolled.The presented trial is currently recruiting patients, with the first results predicted to be available in late 2008.

Rationale and design of a randomized trial of automated hovering for post-myocardial infarction patients: The HeartStrong program.

PubMed

Troxel, Andrea B; Asch, David A; Mehta, Shivan J; Norton, Laurie; Taylor, Devon; Calderon, Tirza A; Lim, Raymond; Zhu, Jingsan; Kolansky, Daniel M; Drachman, Brian M; Volpp, Kevin G

2016-09-01

Coronary artery disease is the single leading cause of death in the United States, and medications can significantly reduce the rate of repeat cardiovascular events and treatment procedures. Adherence to these medications, however, is very low. HeartStrong is a national randomized trial offering 3 innovations. First, the intervention is built on concepts from behavioral economics that we expect to enhance its effectiveness. Second, the implementation of the trial takes advantage of new technology, including wireless pill bottles and remote feedback, to substantially automate procedures. Third, the trial's design includes an enhancement of the standard randomized clinical trial that allows rapid-cycle innovation and ongoing program enhancement. Using a system involving direct data feeds from 6 insurance partners followed by mail, telephone, and email contact, we enrolled 1,509 patients discharged from the hospital with acute myocardial infarction in a 2:1 ratio of intervention:usual care. The intervention period lasts 1 year; the primary outcome is time to first fatal or nonfatal acute vascular event or revascularization, including acute myocardial infarction, unstable angina, stroke, acute coronary syndrome admission, or death. Our randomized controlled trial of the HeartStrong program will provide an evaluation of a state-of-the-art behavioral economic intervention with a number of important pragmatic features. These include a tailored intervention responding to patient activity, streamlining of consent and implementation processes using new technologies, outcomes centrally important to patients, and the ability to implement rapid-cycle innovation. Copyright © 2016 Elsevier Inc. All rights reserved.

Higher-order language dysfunctions as a possible neurolinguistic endophenotype for schizophrenia: Evidence from patients and their unaffected first degree relatives.

PubMed

Pawełczyk, Agnieszka; Łojek, Emila; Żurner, Natalia; Gawłowska-Sawosz, Marta; Pawełczyk, Tomasz

2018-05-31

The purpose of the study was to examine the presence of pragmatic dysfunctions in first episode (FE) subjects and their healthy first degree relatives as a potential endophenotype for schizophrenia. Thirty-four FE patients, 34 parents of the patients (REL) and 32 healthy controls (HC) took part in the study. Pragmatic language functions were evaluated with the Right Hemisphere Language Battery, attention and executive functions were controlled, as well as age and education level. The parents differed from HC but not from their FE offspring with regard to overall level of language and communication and the general knowledge component of language processing. The FE participants differed from HC in comprehension of inferred meaning, emotional prosody, discourse dimensions, overall level of language and communication, language processing with regard to general knowledge and communication competences. The FE participants differed from REL regarding discourse dimensions. Our findings suggest that pragmatic dysfunctions may act as vulnerability markers of schizophrenia; their assessment may help in the diagnosis of early stages of the illness and in understanding its pathophysiology. In future research the adoptive and biological parents of schizophrenia patients should be compared to elucidate which language failures reflect genetic vulnerability and which ones environmental factors. Copyright © 2018. Published by Elsevier B.V.

Consciousness, Learning and Interlanguage Pragmatics.

ERIC Educational Resources Information Center

Schmidt, Richard

A discussion of the ways that consciousness may be involved in learning the principles of second-language discourse and pragmatics draws on current theories of the role of consciousness in human learning in general, with suggestions for extension to the learning of pragmatics. First, research on the degree of consciousness in pragmatic learning…

Pragmatic Language Assessment: A Pragmatics-as-Social Practice Model

ERIC Educational Resources Information Center

Hyter, Yvette D.

2007-01-01

Pragmatic language skills are important for developing relationships with others, and for communicating with a range of interlocutors in a variety of contexts, including preschool and elementary school classrooms. Pragmatic language difficulties frequently are a primary area of disability for children diagnosed with autism, Asperger's syndrome,…

Pragmatic Comprehension of High and Low Level Language Learners

ERIC Educational Resources Information Center

Garcia, Paula

2004-01-01

This study compares the performances of 16 advanced and 19 beginning English language learners on a listening comprehension task that focused on linguistic and pragmatic processing. Processing pragmatic meaning differs from processing linguistic meaning because pragmatic meaning requires the listener to understand not only linguistic information,…

Investigating Pragmatic Language Learning in Foreign Language Classrooms

ERIC Educational Resources Information Center

Soler, Eva Alcon

2008-01-01

A lot of research addressing learners' development of pragmatics has recently been conducted (Kasper and Schmidt 1996; Bardovi-Harlig, 2002; Kasper and Rose 2002). From this same approach, a review of theoretical perspectives on pragmatic learning and how they have been operationalised in interlanguage pragmatic research is presented. Second, by…

Effect of Cultural Distance on Pragmatic Comprehension and Production

ERIC Educational Resources Information Center

Rafieyan, Vahid

2016-01-01

National cultural distance is considered to be a strong predictor of language learners' pragmatic competence. To test the actual effect of national cultural distance on pragmatic competence holistically and comprehension and production aspects of pragmatic competence discretely, the current study was conducted on two groups of undergraduate…

Pragmatics in Pre-Schoolers with Language Impairments

ERIC Educational Resources Information Center

Geurts, Hilde; Embrechts, Mariette

2010-01-01

Background: Pragmatic assessment methods are very diverse and differ in informant type. Some rely on parents, others on teachers/professionals and some directly test pragmatic abilities in the children themselves. A widely used pragmatic parent questionnaire is the Children's Communication Checklist-2 (CCC-2). However, it is not known how scores…

Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial

PubMed Central

Broderick, Joan E.; Keefe, Francis J.; Bruckenthal, Patricia; Junghaenel, Doerte U.; Schneider, Stefan; Schwartz, Joseph E.; Kaell, Alan T.; Caldwell, David S.; McKee, Daphne; Reed, Shelby; Gould, Elaine

2014-01-01

A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients’ doctors’ offices (N = 129 patients); the control group received usual care (N = 127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain. PMID:24865795

Effectiveness of exercise intervention and health promotion on cardiovascular risk factors in middle-aged men: a protocol of a randomized controlled trial.

PubMed

From, Svetlana; Liira, Helena; Leppävuori, Jenni; Remes-Lyly, Taina; Tikkanen, Heikki; Pitkälä, Kaisu

2013-02-11

Although cardiovascular disease has decreased, there is still potential for prevention as obesity and diabetes increase. Exercise has a positive effect on many cardiovascular risk factors, and it can significantly reduce the components of metabolic syndrome. The main challenge with exercise in primary care is how to succeed in motivating the patients at risk to change and increase their exercise habits. The objective of this study is to modify the cardiovascular risk in middle-aged men, either through a health promotion intervention alone or combined with an exercise intervention. During a two-year period we recruit 300 men aged from 35 to 45 years with elevated cardiovascular risk (> two traditional risk factors). The men are randomized into three arms: 1) a health promotion intervention alone, 2) both health promotion and exercise intervention, or 3) control with usual community care and delayed health promotion (these men receive the intervention after one year). The main outcome measures will be the existence of metabolic syndrome and physical activity frequency (times per week). The participants are assessed at baseline, and at 3, 6, and 12 months. The follow-up of the study will last 12 months. This pragmatic trial in primary health care aimed to assess the effect of a health promotion programme with or without exercise intervention on cardiovascular risk and physical activity in middle-aged men. The results of this study may help to plan the primary care interventions to further reduce cardiovascular mortality.The study was registered at the Controlled Trials ( http://www.controlled-trials.com). ISRCTN80672011. The study received ethics approval from the Coordinating Ethics Committee at Helsinki University Hospital on 8 June 2009 (ref: 4/13/03/00/09).

Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial.

PubMed

Persell, Stephen D; Brown, Tiffany; Lee, Ji Young; Shah, Shreya; Henley, Eric; Long, Timothy; Luther, Stephanie; Lloyd-Jones, Donald M; Jean-Jacques, Muriel; Kandula, Namratha R; Sanchez, Thomas; Baker, David W

2015-11-01

Many eligible primary cardiovascular disease prevention candidates are not treated with statins. Electronic health record data can identify patients with increased cardiovascular disease risk. We performed a pragmatic randomized controlled trial at community health centers in 2 states. Participants were men aged ≥35 years and women ≥45 years, without cardiovascular disease or diabetes mellitus, and with a 10-year risk of coronary heart disease of at least 10%. The intervention group received telephone and mailed outreach, individualized based on patients' cardiovascular disease risk and uncontrolled risk factors, provided by lay health workers. Main outcomes included: documented discussion of medication treatment for cholesterol with a primary care clinician, receipt of statin prescription within 6 months, and low-density lipoprotein (LDL)-cholesterol repeated and at least 30 mg/dL lower than baseline within 1 year. Six hundred forty-six participants (328 and 318 in the intervention and control groups, respectively) were included. At 6 months, 26.8% of intervention and 11.6% of control patients had discussed cholesterol treatment with a primary care clinician (odds ratio, 2.79; [95% confidence interval, 2.25-3.46]). Statin prescribing occurred for 10.1% in the intervention group and 6.0% in the control group (odds ratio, 1.76; [95% confidence interval, 0.90-3.45]). The cholesterol outcome did not differ, and the majority of patients did not repeat lipid levels during follow-up. Risk communication and lay outreach increased cholesterol treatment discussions with primary care clinicians. However, most discussions did not result in statin prescribing. For outreach to be successful, it should be combined with interventions to encourage clinicians to follow contemporary risk-based cholesterol treatment guidelines. URL: http://www.clincialtrials.gov. Unique identifier: NCT01610609. © 2015 American Heart Association, Inc.

Acupuncture Combined with Hydrotherapy in Diabetes Patients with Mild Lower-Extremity Arterial Disease: A Prospective, Randomized, Nonblinded Clinical Study.

PubMed

Qi, Zhengqin; Pang, Yan; Lin, Lin; Zhang, Bing; Shao, Juntao; Liu, Xiaodong; Zhang, Xin

2018-05-08

BACKGROUND The aim of this pragmatic study was to explore the intervention of acupuncture combined with hydrotherapy and perceived effects in type 2 diabetic patients with recently diagnosed, mild, lower-extremity arterial disease (LEAD) in comparison with a control group. MATERIAL AND METHODS One hundred twenty-six diabetes patients who were diagnosed mild LEAD according to ankle-brachial blood pressure index (ABPI) and peripheral neuropathy symptom were randomly assigned to either an experimental (n=64) or control group (n=62). The experimental group attended and completed (1) a 30-min session of acupuncture in certain selected points, and (2) a 30-min hydrotherapy exercise every 2 days for 15 weeks. The outcome parameters were assessed at baseline, after intervention, and at 6-week follow-up. RESULTS The intervention was associated with an improvement in leg flow conductance and partial physical capacities, including chair-sit-and-reach, the walking impairment questionnaire (WIQ), and physical component summary score (PCS), compared to the control group. The treatment benefits were sustained throughout the 6-week follow-up endpoint. There was no difference in fasting glucose levels, Hb1Ac, blood pressure, or BMI after the intervention. At the endpoint of 6-week follow-up, acupuncture plus hydrotherapy appeared to reduce inflammatory response by decreasing IL-6, TNF-α, malondialdehyde, and SOD, and increasing glutathione. CONCLUSIONS Acupuncture plus hydrotherapy, without significant glycemic-controlling effects in the type 2 diabetic patients with mild LEAD, exerts a measurable benefit in disease-specific physical functions and health-related quality of life. Our results suggest that the combined therapy regulates the inflammatory process and oxidative stress and contributes to immune protection.

Acupuncture Combined with Hydrotherapy in Diabetes Patients with Mild Lower-Extremity Arterial Disease: A Prospective, Randomized, Nonblinded Clinical Study

PubMed Central

Pang, Yan; Lin, Lin; Zhang, Bing; Shao, Juntao; Liu, Xiaodong; Zhang, Xin

2018-01-01

Background The aim of this pragmatic study was to explore the intervention of acupuncture combined with hydrotherapy and perceived effects in type 2 diabetic patients with recently diagnosed, mild, lower-extremity arterial disease (LEAD) in comparison with a control group. Material/Methods One hundred twenty-six diabetes patients who were diagnosed mild LEAD according to ankle-brachial blood pressure index (ABPI) and peripheral neuropathy symptom were randomly assigned to either an experimental (n=64) or control group (n=62). The experimental group attended and completed (1) a 30-min session of acupuncture in certain selected points, and (2) a 30-min hydrotherapy exercise every 2 days for 15 weeks. The outcome parameters were assessed at baseline, after intervention, and at 6-week follow-up. Results The intervention was associated with an improvement in leg flow conductance and partial physical capacities, including chair-sit-and-reach, the walking impairment questionnaire (WIQ), and physical component summary score (PCS), compared to the control group. The treatment benefits were sustained throughout the 6-week follow-up endpoint. There was no difference in fasting glucose levels, Hb1Ac, blood pressure, or BMI after the intervention. At the endpoint of 6-week follow-up, acupuncture plus hydrotherapy appeared to reduce inflammatory response by decreasing IL-6, TNF-α, malondialdehyde, and SOD, and increasing glutathione. Conclusions Acupuncture plus hydrotherapy, without significant glycemic-controlling effects in the type 2 diabetic patients with mild LEAD, exerts a measurable benefit in disease-specific physical functions and health-related quality of life. Our results suggest that the combined therapy regulates the inflammatory process and oxidative stress and contributes to immune protection. PMID:29735963

Pragmatic randomised controlled trial to evaluate the effectiveness and cost effectiveness of a multi-component intervention to reduce substance use and risk-taking behaviour in adolescents involved in the criminal justice system: A trial protocol (RISKIT-CJS).

PubMed

Coulton, Simon; Stockdale, Kelly; Marchand, Catherine; Hendrie, Nadine; Billings, Jenny; Boniface, Sadie; Butler, Steve; Deluca, Paolo; Drummond, Colin; Newbury-Birch, Dorothy; Pellatt-Higgins, Tracy; Stevens, Alex; Sutherland, Alex; Wilson, Ed

2017-03-11

Adolescence is a critical developmental stage when young people make lifestyle choices that have the potential to impact on their current and future health and social wellbeing. The relationship between substance use and criminal activity is complex but there is clear evidence that the prevalence of problematic substance use is far higher among adolescent offenders than the general adolescent population. Adolescent offenders are a marginalized and vulnerable population who are significantly more likely to experience health and social inequalities in later life than their non-offending peers. There is a paucity of evidence on effective interventions to address substance use and risk-taking behaviours in adolescent offender populations but it is clear that preventative or abstinence orientated interventions are not effective. RISKIT-CJS is an intervention developed in collaboration with young people taking account of the current best evidence. Feasibility and pilot studies have found the intervention addresses the needs of adolescents, is acceptable and has demonstrated potential in reducing substance use and risk-taking behavior. The study is a mixed method, two-armed, prospective, pragmatic randomized controlled trial with individual randomisation to either treatment as usual alone or the RISKIT-CJS intervention in addition to treatment as usual. Adolescents, aged 13 to 17 years inclusive, engaged with the criminal justice system who are identified as having problematic substance use are eligible to participate. The study will be conducted across three geographical areas; South and South East England, London and North East England between March 2017 and February 2019. The study represents an ambitious programme of work to address an area of need for a marginalized and vulnerable population. ISRCTN77037777 registered 15/09/2016.

Teaching L2 Pragmatics: Opportunities for Continuing Professional Development

ERIC Educational Resources Information Center

Vellenga, Heidi

2011-01-01

Teaching L2 pragmatics is often not covered in teacher education programs, and is an excellent area for continuing professional development. As part of a larger project on instructed interlanguage pragmatics, volunteer instructor participants were asked to teach a series of lessons on pragmatics to university-aged (19-23) ESL learners in ESL and…

Instructed Pragmatics at a Glance: Where Instructional Studies Were, Are, and Should Be Going

ERIC Educational Resources Information Center

Taguchi, Naoko

2015-01-01

This paper brings together the research and developments of instructed pragmatics over the past three decades by reporting the synthesis findings of instructional intervention studies in interlanguage pragmatics. Two questions have guided this investigation: (1) is instruction effective in learning pragmatics?; and (2) what methods are most…

Is It Rude Language? Children Learning Pragmatics through Visual Narratives

ERIC Educational Resources Information Center

Ishihara, Noriko

2013-01-01

There has been an upsurge of interest in teaching second/foreign language (L2) pragmatics in recent years, but much of this effort has been targeted at adult learners. This article introduces small-scale informal instruction exploring the pragmatic development of 9-year-olds in Tokyo, facilitated through dialogic intervention on pragmatics using…

Cognitive Approach to Assessing Pragmatic Language Comprehension in Children with Specific Language Impairment

ERIC Educational Resources Information Center

Ryder, Nuala; Leinonen, Eeva; Schulz, Joerg

2008-01-01

Background: Pragmatic language impairment in children with specific language impairment has proved difficult to assess, and the nature of their abilities to comprehend pragmatic meaning has not been fully investigated. Aims: To develop both a cognitive approach to pragmatic language assessment based on Relevance Theory and an assessment tool for…

Context in Generalized Conversational Implicatures: The Case of Some

PubMed Central

Dupuy, Ludivine E.; Van der Henst, Jean-Baptiste; Cheylus, Anne; Reboul, Anne C.

2016-01-01

There is now general agreement about the optionality of scalar implicatures: the pragmatic interpretation will be accessed depending on the context relative to which the utterance is interpreted. The question, then, is what makes a context upper- (vs. lower-) bounding. Neo-Gricean accounts should predict that contexts including factual information will enhance the rate of pragmatic interpretations. Post-Gricean accounts should predict that contexts including psychological attributions will enhance the rate of pragmatic interpretations. We tested two factors using the quantifier scale : (1) the existence of factual information that facilitates the computation of pragmatic interpretations in the context (here, the cardinality of the domain of quantification) and (2) the fact that the context makes the difference between the semantic and the pragmatic interpretations of the target sentence relevant, involving psychological attributions to the speaker (here a question using all). We did three experiments, all of which suggest that while cardinality information may be necessary to the computation of the pragmatic interpretation, it plays a minor role in triggering it; highlighting the contrast between the pragmatic and the semantic interpretations, while it is not necessary to the computation of the pragmatic interpretation, strongly mandates a pragmatic interpretation. These results favor Sperber and Wilson's (1995) post-Gricean account over Chierchia's (2013) neo-Gricean account. Overall, this suggests that highlighting the relevance of the pragmatic vs. semantic interpretations of the target sentence makes a context upper-bounding. Additionally, the results give a small advantage to the post-Gricean account. PMID:27047413

Stemming the Tide of Antibiotic Resistance (STAR): A protocol for a trial of a complex intervention addressing the 'why' and 'how' of appropriate antibiotic prescribing in general practice

PubMed Central

Simpson, Sharon A; Butler, Christopher C; Hood, Kerry; Cohen, David; Dunstan, Frank; Evans, Meirion R; Rollnick, Stephen; Moore, Laurence; Hare, Monika; Bekkers, Marie-Jet; Evans, John

2009-01-01

Background After some years of a downward trend, antibiotic prescribing rates in the community have tended to level out in many countries. There is also wide variation in antibiotic prescribing between general practices, and between countries. There are still considerable further gains that could be made in reducing inappropriate antibiotic prescribing, but complex interventions are required. Studies to date have generally evaluated the effect of interventions on antibiotic prescribing in a single consultation and pragmatic evaluations that assess maintenance of new skills are rare. This paper describes the protocol for a pragmatic, randomized evaluation of a complex intervention aimed at reducing antibiotic prescribing by primary care clinicians. Methods and design We developed a Social Learning Theory based, blended learning program (on-line learning, a practice based seminar, and context bound learning) called the STAR Educational Program. The 'why of change' is addressed by providing clinicians in general practice with information on antibiotic resistance in urine samples submitted by their practice and their antibiotic prescribing data, and facilitating a practice-based seminar on the implications of this data. The 'how of change' is addressed through context-bound communication skills training and information on antibiotic indication and choice. This intervention will be evaluated in a trial involving 60 general practices, with general practice as the unit of randomization (clinicians from each practice to either receive the STAR Educational Program or not) and analysis. The primary outcome will be the number of antibiotic items dispensed over one year. An economic and process evaluation will also be conducted. Discussion This trial will be the first to evaluate the effectiveness of this type of theory-based, blended learning intervention aimed at reducing antibiotic prescribing by primary care clinicians. Novel aspects include feedback of practice level data on antimicrobial resistance and prescribing, use of principles from motivational interviewing, training in enhanced communication skills that incorporates context-bound experience and reflection, and using antibiotic dispensing over one year (as opposed to antibiotic prescribing in a single consultation) as the main outcome. Trial registration Current Controlled Trials ISRCTN63355948. PMID:19309493

Stemming the Tide of Antibiotic Resistance (STAR): a protocol for a trial of a complex intervention addressing the 'why' and 'how' of appropriate antibiotic prescribing in general practice.

PubMed

Simpson, Sharon A; Butler, Christopher C; Hood, Kerry; Cohen, David; Dunstan, Frank; Evans, Meirion R; Rollnick, Stephen; Moore, Laurence; Hare, Monika; Bekkers, Marie-Jet; Evans, John

2009-03-23

After some years of a downward trend, antibiotic prescribing rates in the community have tended to level out in many countries. There is also wide variation in antibiotic prescribing between general practices, and between countries. There are still considerable further gains that could be made in reducing inappropriate antibiotic prescribing, but complex interventions are required. Studies to date have generally evaluated the effect of interventions on antibiotic prescribing in a single consultation and pragmatic evaluations that assess maintenance of new skills are rare. This paper describes the protocol for a pragmatic, randomized evaluation of a complex intervention aimed at reducing antibiotic prescribing by primary care clinicians. We developed a Social Learning Theory based, blended learning program (on-line learning, a practice based seminar, and context bound learning) called the STAR Educational Program. The 'why of change' is addressed by providing clinicians in general practice with information on antibiotic resistance in urine samples submitted by their practice and their antibiotic prescribing data, and facilitating a practice-based seminar on the implications of this data. The 'how of change' is addressed through context-bound communication skills training and information on antibiotic indication and choice. This intervention will be evaluated in a trial involving 60 general practices, with general practice as the unit of randomization (clinicians from each practice to either receive the STAR Educational Program or not) and analysis. The primary outcome will be the number of antibiotic items dispensed over one year. An economic and process evaluation will also be conducted. This trial will be the first to evaluate the effectiveness of this type of theory-based, blended learning intervention aimed at reducing antibiotic prescribing by primary care clinicians. Novel aspects include feedback of practice level data on antimicrobial resistance and prescribing, use of principles from motivational interviewing, training in enhanced communication skills that incorporates context-bound experience and reflection, and using antibiotic dispensing over one year (as opposed to antibiotic prescribing in a single consultation) as the main outcome. Current Controlled Trials ISRCTN63355948.

2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

PubMed

Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

2017-12-01

3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

PubMed

Zatzick, Douglas; O'Connor, Stephen S; Russo, Joan; Wang, Jin; Bush, Nigel; Love, Jeff; Peterson, Roselyn; Ingraham, Leah; Darnell, Doyanne; Whiteside, Lauren; Van Eaton, Erik

2015-10-01

Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped measurement-based intervention included care management, psychopharmacology, and psychotherapy elements. Embedded within the intervention were a series of information technology (IT) components. PTSD symptoms were assessed with the PTSD Checklist at baseline prerandomization and again, 1-, 3-, and 6-months postinjury. IT utilization was also assessed. The technology-assisted intervention required a median of 2.25 hours (interquartile range = 1.57 hours) per patient. The intervention was associated with modest symptom reductions, but beyond the margin of statistical significance in the unadjusted model: F(2, 204) = 2.95, p = .055. The covariate adjusted regression was significant: F(2, 204) = 3.06, p = .049. The PTSD intervention effect was greatest at the 3-month (Cohen's effect size d = 0.35, F(1, 204) = 4.11, p = .044) and 6-month (d = 0.38, F(1, 204) = 4.10, p = .044) time points. IT-enhanced collaborative care was associated with modest PTSD symptom reductions and reduced delivery times; the intervention model could potentially facilitate efficient PTSD treatment after injury. Copyright © 2015 Wiley Periodicals, Inc., A Wiley Company.

The effect of the emotional intelligence education programme on quality of life in haemodialysis patients.

PubMed

Shahnavazi, Masoome; Parsa-Yekta, Zohreh; Yekaninejad, Mir-Saeed; Amaniyan, Sara; Griffiths, Pauline; Vaismoradi, Mojtaba

2018-02-01

This study investigated the effect of the emotional intelligence education programme on quality of life of haemodialysis patients. Nurses need knowledge development regarding the impact of educational strategies on patients' quality of life suffering from chronic diseases. A pragmatic quasi-randomized controlled trial was conducted with 47 haemodialysis patients attending a university hospital in an urban area of Iran. The patients were randomly assigned to intervention (n=23) and control (n=24) groups. A socio-demographic questionnaire, the Cyberia-Shrink Emotional Intelligence Questionnaire, and the Kidney Disease Quality of Life-Short Form were used to gather data. The intervention group attended an educational programme on emotional intelligence that consisted of six-group discussion sessions. To ensure the continuity of learning and to measure the subsequent expected behavioural changes, the patients filled out the data collection tools six and 12weeks after the completion of the education programme. The mean score of quality of life in the intervention group was 39.94±15.88 in pre-test, 44.87±16.04 six weeks and 52.47±16.07 at the 12weeks after the intervention (p=0.032). The consideration of emotional intelligence educational strategies by nurses requires its incorporation into pre-qualifying nursing degrees and professional development programmes. Nurse managers need to lead nurses for applying emotional intelligence in daily practice with the aim of providing an holistic patient care. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Impact of a web-based prostate cancer treatment decision aid on patient-reported decision process parameters: results from the Prostate Cancer Patient Centered Care trial.

PubMed

Cuypers, Maarten; Lamers, Romy E D; Kil, Paul J M; van de Poll-Franse, Lonneke V; de Vries, Marieke

2018-05-12

To compare patients' evaluation of the treatment decision-making process in localized prostate cancer between counseling that included an online decision aid (DA) and standard counseling. Eighteen Dutch hospitals were randomized to DA counseling (n = 235) or the control group with standard counseling (n = 101) in a pragmatic, cluster randomized controlled trial. The DA was provided to patients at, or soon after diagnosis. Decisional conflict, involvement, knowledge, and satisfaction with information were assessed with a questionnaire after treatment decision-making. Anxiety and depression served as covariates. The levels of decision involvement and conflict were comparable between patients in both groups. Patients with a DA felt more knowledgeable but scored equally well on a knowledge test as patients without a DA. Small significant negative effects were found on satisfaction with information and preparation for decision-making. A preference for print over online and depression and anxiety symptoms was negatively associated with satisfaction and conflict scores in the DA group. The DA aimed to support shared decision-making, while outcomes for a majority of DA users were comparable to patients who received standard counseling. Patients, who are less comfortable with the online DA format or experience anxiety or depression symptoms, could require more guidance toward shared decision-making. To evaluate long-term DA effects, follow-up evaluation on treatment satisfaction and decisional regret will be done.

Effectiveness of a training program for police officers who come into contact with people with mental health problems: A pragmatic randomised controlled trial

PubMed Central

Fairhurst, Caroline; Booth, Alison; McDaid, Catriona; Moran, Nicola; Parker, Adwoa; Payne, Rebecca; Scott, William J.; Torgerson, David; Webber, Martin; Hewitt, Catherine

2017-01-01

Introduction Police officers frequently come into contact with individuals with mental health problems. Specialist training in this area for police officers may improve how they respond to individuals with mental health problems; however, evidence to support this is sparse. This study evaluated the effectiveness of one bespoke mental health training package for frontline police officers relative to routine training. Design Pragmatic, two-armed cluster randomised controlled trial in one police force in England. Police stations in North Yorkshire were randomised with frontline police officers receiving either a bespoke mental health training package or routine training. The primary outcome was the number of incidents which resulted in a police response reported to the North Yorkshire Police control room up to six months after delivery of training. Secondary outcomes included: likelihood of incidents using Section 136 of the Mental Health Act; likelihood of incidents having a mental health tag applied; and number of individuals with a mental health warning marker involved in incidents. The appropriateness of mental health tags applied to a random sample of incidents was checked by an independent mental health professional. Routinely collected data were used. Results Twelve police stations were recruited and randomised (Intervention group n = 6; Control group n = 6), and 249 officers received the bespoke mental health training intervention. At follow-up, a median of 397 incidents were assigned to trial stations in the intervention group, and 498 in the control group. There was no evidence of a difference in the number of incidents with a police response (adjusted incidence rate ratio (IRR) 0.92, 95% CI 0.61 to 1.38, p = 0.69), or in the number of people with mental health warning markers involved in incidents (adjusted IRR 1.39, 95% CI 0.91 to 2.10, p = 0.13) between the intervention and control groups up to six months following the intervention; however, incidents assigned to stations in the intervention group were more likely to have a mental health tag applied to them than incidents assigned to control stations (adjusted odds ratio 1.41, 95% CI 1.16 to 1.71, p = 0.001). The review of 100 incidents suggests that there may be incidents involving individuals with mental health issues that are not being recorded as such (Kappa coefficient 0.65). There was no statistically significant difference in the likelihood of Section 136 of the Mental Health Act being applied to an incident. Conclusions The bespoke one day mental health training delivered to frontline officers by mental health professionals did not reduce the number of incidents reported to the police control room up to six months after its delivery; however training may have a positive effect on how the police record incidents involving individuals with mental health problems. Our trial has shown that conducting pragmatic trials within the police setting is feasible and acceptable. There is a wealth of routinely collected police data that can be utilised for research and further collaboration between police forces and academia is encouraged. Trial registration ISRCTN (ISRCTN11685602). The authors confirm that all ongoing and related trials for this drug/intervention are registered. PMID:28886163

Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial.

PubMed

Boden, Ianthe; Skinner, Elizabeth H; Browning, Laura; Reeve, Julie; Anderson, Lesley; Hill, Cat; Robertson, Iain K; Story, David; Denehy, Linda

2018-01-24

To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected. In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay. Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial

PubMed Central

Skinner, Elizabeth H; Browning, Laura; Reeve, Julie; Anderson, Lesley; Hill, Cat; Robertson, Iain K; Story, David; Denehy, Linda

2018-01-01

Abstract Objective To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. Design Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. Setting Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. Participants 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. Interventions Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. Main outcome measures The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. Results The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected. Conclusion In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay. Trial registration Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741. PMID:29367198

Pragmatic Development as a Dynamic, Complex Process: General Patterns and Case Histories

ERIC Educational Resources Information Center

Taguchi, Naoko

2011-01-01

This longitudinal study asks 2 questions. The first one is: What patterns of pragmatic development can we observe among different pragmatic functions and attributes in a second language (L2)? The second question is: In what ways do individual differences and learning context affect the course of pragmatic development? Forty-eight Japanese college…

Learning English Pragmatics in China: An Investigation into Chinese EFL Learners' Perceptions of Pragmatics

ERIC Educational Resources Information Center

Yuan, Yifeng; Tangen, Donna; Mills, Kathy A.; Lidstone, John

2015-01-01

This paper reports the findings of a study investigating Chinese English language learners' perceptions of pragmatics in the EFL learning context in China. A total of 237 Chinese EFL first--year university students participated in the study. A questionnaire and focus group interviews were used to collect data about learners' pragmatics insights…

Learning by Doing: The Affordances of Task-Based Pragmatics Instruction for Beginning L2 Spanish Learners Studying Abroad

ERIC Educational Resources Information Center

Morris, Kimberly Jane

2017-01-01

The study abroad (SA) context is often assumed to foster pragmatic development in a second language (L2), yet previous scholarship confirms that pragmatic norms are culturally-shaped and often remain imperceptible to uninstructed SA students (Bataller, 2010; Cohen & Shively, 2007; Shively, 2010). Because pragmatics is not traditionally taught…

Social communication impairments: pragmatics.

PubMed

Russell, Robert L

2007-06-01

Social communication or pragmatic impairments are characterized and illustrated as involving inappropriate or ineffective use of language and gesture in social contexts. Three clinical vignettes illustrate different pragmatic impairments and the wealth of diagnostic information that can be garnered from observation of a child's social communication behavior. Definitions of, and developmental milestones in, domains of pragmatic competence are provided. Several screening instruments are suggested for use in assessing pragmatic competence within the time-frame of a pediatric examination. Frequent comorbid psychiatric conditions are described and a sample of current neurobiologic research is briefly summarized.

Relevance theory: pragmatics and cognition.

PubMed

Wearing, Catherine J

2015-01-01

Relevance Theory is a cognitively oriented theory of pragmatics, i.e., a theory of language use. It builds on the seminal work of H.P. Grice(1) to develop a pragmatic theory which is at once philosophically sensitive and empirically plausible (in both psychological and evolutionary terms). This entry reviews the central commitments and chief contributions of Relevance Theory, including its Gricean commitment to the centrality of intention-reading and inference in communication; the cognitively grounded notion of relevance which provides the mechanism for explaining pragmatic interpretation as an intention-driven, inferential process; and several key applications of the theory (lexical pragmatics, metaphor and irony, procedural meaning). Relevance Theory is an important contribution to our understanding of the pragmatics of communication. © 2014 John Wiley & Sons, Ltd.

Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations.

PubMed

McKeever, Tricia; Mortimer, Kevin; Wilson, Andrew; Walker, Samantha; Brightling, Christopher; Skeggs, Andrew; Pavord, Ian; Price, David; Duley, Lelia; Thomas, Mike; Bradshaw, Lucy; Higgins, Bernard; Haydock, Rebecca; Mitchell, Eleanor; Devereux, Graham; Harrison, Timothy

2018-03-08

Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma. We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma. A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group. In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965 .).

Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial.

PubMed

Mungroop, Timothy H; Veelo, Denise P; Busch, Olivier R; van Dieren, Susan; van Gulik, Thomas M; Karsten, Tom M; de Castro, Steve M; Godfried, Marc B; Thiel, Bram; Hollmann, Markus W; Lirk, Philipp; Besselink, Marc G

2015-12-09

Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia are a) perioperative hypotension, frequently requiring additional intravenous fluid boluses or prolonged use of vasopressors; b) relatively high failure rates, with periods of inadequate analgesia; and c) the risk of rare but serious, at times persistent, neurologic complications (hematoma and abscess). In recent years, continuous (subfascial) wound infiltration (CWI) plus patient-controlled analgesia (PCA) has been suggested as a safe and reliable alternative, which does not have the previously mentioned disadvantages, but evidence from multicenter trials targeting a specific surgical population is lacking. We hypothesize that CWI+PCA is equally as effective as CEA, without the mentioned disadvantages. POP-UP is a randomized controlled noninferiority multicenter trial, recruiting adult patients scheduled for elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. A total of 102 patients are being randomly allocated to CWI+PCA or (P)CEA. Our primary endpoint is the Overall Benefit of Analgesic Score (OBAS), a composite endpoint of pain intensity, opioid-related adverse effects and patient satisfaction, during postoperative days 1 to 5. Secondary endpoints include length of the hospital stay, number of patients with severe pain, and the use of rescue medication. POP-UP is a pragmatic trial that will provide evidence of whether CWI+PCA is noninferior as compared to (P)CEA after elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique, especially when the described disadvantages of epidural analgesia are less often observed with CWI+PCA. Netherlands Trial Register NTR4948 (registry date 2 January 2015).

Effectiveness of a structured educational intervention using psychological delivery methods in children and adolescents with poorly controlled type 1 diabetes: a cluster-randomized controlled trial of the CASCADE intervention.

PubMed

Christie, Deborah; Thompson, Rebecca; Sawtell, Mary; Allen, Elizabeth; Cairns, John; Smith, Felicity; Jamieson, Elizabeth; Hargreaves, Katrina; Ingold, Anne; Brooks, Lucy; Wiggins, Meg; Oliver, Sandy; Jones, Rebecca; Elbourne, Diana; Santos, Andreia; Wong, Ian C K; O'Neil, Simon; Strange, Vicki; Hindmarsh, Peter; Annan, Francesca; Viner, Russell M

2016-01-01

Type 1 diabetes (T1D) in children and adolescents is increasing worldwide with a particular increase in children <5 years. Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin (HbA1c) values. A pragmatic, cluster-randomized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control, quality of life and psychosocial functioning in children and adolescents with T1D. 28 pediatric diabetes services were randomized to deliver the intervention or standard care. 362 children (8-16 years) with HbA1c≥8.5% were recruited. Outcomes were HbA1c at 12 and 24 months, hypoglycemia, admissions, self-management skills, intervention compliance, emotional and behavioral adjustment, and quality of life. A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention. 298/362 patients (82.3%) provided HbA1c at 12 months and 284/362 (78.5%) at 24 months. The intervention did not improve HbA1c at 12 months (intervention effect 0.11, 95% CI -0.28 to 0.50, p=0.584), or 24 months (intervention effect 0.03, 95% CI -0.36 to 0.41, p=0.891). There were no significant changes in remaining outcomes. 96/180 (53%) families in the intervention arm attended at least 1 module. The number of modules attended did not affect outcome. Reasons for low uptake included difficulties organizing groups and work and school commitments. Those with highest HbA1cs were less likely to attend. Mean cost of the intervention was £683 per child. Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found. The intervention did not improve HbA1c in children and adolescents with poor control. ISRCTN52537669, results.

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

Background Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. Methods/design The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. Discussion The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

PubMed Central

2011-01-01

Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. Trial registration German Clinical Trial Register Number: DRKS00000040 PMID:21303515

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. NCT01967797.

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/−2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. Trial registration Current Controlled Trials ISRCTN19321911 PMID:23072576

Web-Based Intervention for Family Carers of Persons with Dementia and Multiple Chronic Conditions (My Tools 4 Care): Pragmatic Randomized Controlled Trial.

PubMed

Duggleby, Wendy; Ploeg, Jenny; McAiney, Carrie; Peacock, Shelley; Fisher, Kathryn; Ghosh, Sunita; Markle-Reid, Maureen; Swindle, Jennifer; Williams, Allison; Triscott, Jean Ac; Forbes, Dorothy; Jovel Ruiz, Kathya

2018-06-29

My Tools 4 Care (MT4C) is a Web-based intervention that was developed based on the transitions theory. It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer's disease and related dementia and multiple chronic conditions through their transition experiences. The objective of our study was to evaluate the effectiveness of MT4C with respect to increasing hope, self-efficacy, and health-related quality of life in carers of community-living older persons with Alzheimer's disease and related dementia and multiple chronic conditions. A multisite, pragmatic, mixed methods, longitudinal, repeated-measures, randomized controlled trial was conducted between June 2015 and April 2017. Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C. Trained research assistants collected data from participants via phone on hope (Herth Hope Index [HHI]), self-efficacy (General Self-Efficacy Scale), and health-related quality of life (Short Form-12 item [version 2] health survey; SF-12v2) at baseline, 1, 3, and 6 months. The use and cost of health and social services (Health and Social Services Utilization Inventory) among participants were measured at baseline, 3, and 6 months. Analysis of covariance was used to identify group differences at 3 months, and generalized estimating equations were used to identify group differences over time. A total of 199 carers participated in this study, with 101 participants in the treatment group and 98 in the educational control group. Of all, 23% (45/199) participants withdrew during the study for various reasons, including institutionalization or death of the person with dementia and lack of time from the carer. In the treatment group, 73% (74/101) carers used MT4C at least once over the 3-month period. No significant differences in the primary outcome measure (mental component summary score from the SF-12v2) by group or time were noted at 3 months; however, significant differences were evident for HHI-factor 2 (P=.01), with higher hope scores in the treatment group than in the control group. General estimating equations showed no statistically significant group differences in terms of mental component summary score at all time points. Attrition and the fact that not all carers in the treatment group used MT4C may explain the absence of statistically significant results for the main outcome variable. Despite no significant differences between groups in terms of the primary outcome variable (mental component score), the significant differences in terms of one of the hope factors suggest that MT4C had a positive influence on the lives of participants. ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 (Archived by Webcite at http://www.webcitation.org/708oFCR8h). ©Wendy Duggleby, Jenny Ploeg, Carrie McAiney, Shelley Peacock, Kathryn Fisher, Sunita Ghosh, Maureen Markle-Reid, Jennifer Swindle, Allison Williams, Jean AC Triscott, Dorothy Forbes, Kathya Jovel Ruiz. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 29.06.2018.

Right hemisphere damage: Communication processing in adults evaluated by the Brazilian Protocole MEC - Bateria MAC.

PubMed

Fonseca, Rochele Paz; Fachel, Jandyra Maria Guimarães; Chaves, Márcia Lorena Fagundes; Liedtke, Francéia Veiga; Parente, Maria Alice de Mattos Pimenta

2007-01-01

Right-brain-damaged individuals may present discursive, pragmatic, lexical-semantic and/or prosodic disorders. To verify the effect of right hemisphere damage on communication processing evaluated by the Brazilian version of the Protocole Montréal d'Évaluation de la Communication (Montreal Communication Evaluation Battery) - Bateria Montreal de Avaliação da Comunicação, Bateria MAC, in Portuguese. A clinical group of 29 right-brain-damaged participants and a control group of 58 non-brain-damaged adults formed the sample. A questionnaire on sociocultural and health aspects, together with the Brazilian MAC Battery was administered. Significant differences between the clinical and control groups were observed in the following MAC Battery tasks: conversational discourse, unconstrained, semantic and orthographic verbal fluency, linguistic prosody repetition, emotional prosody comprehension, repetition and production. Moreover, the clinical group was less homogeneous than the control group. A right-brain-damage effect was identified directly, on three communication processes: discursive, lexical-semantic and prosodic processes, and indirectly, on pragmatic process.

Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial.

PubMed

Goodyer, Ian M; Tsancheva, Sonya; Byford, Sarah; Dubicka, Bernadka; Hill, Jonathan; Kelvin, Raphael; Reynolds, Shirley; Roberts, Christopher; Senior, Robert; Suckling, John; Wilkinson, Paul; Target, Mary; Fonagy, Peter

2011-07-13

Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg) with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated. Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry. The objective of this clinical trial is to determine whether there are specific effects of specialist psychotherapy that reduce relapse in unipolar major depression in adolescents and thereby costs of treatment to society. We also anticipate being able to utilise psychotherapy experience, neuroimaging, genetic and hormone measures to reveal what techniques and their protocols may work best for which patients. Current Controlled Trials ISRCTN83033550.

Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty.

PubMed

Blikman, T; Rienstra, W; van Raaij, T M; ten Hagen, A J; Dijkstra, B; Zijlstra, W P; Bulstra, S K; van den Akker-Scheek, I; Stevens, M

2016-03-01

Residual pain is a major factor in patient dissatisfaction following total hip arthroplasty or total knee arthroplasty (THA/TKA). The proportion of patients with unfavourable long-term residual pain is high, ranging from 7% to 34%. There are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. It is thus hypothesised that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine has been shown to be effective for several chronic pain syndromes, including knee osteoarthritis (OA), in which CS is most likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain compared with care-as-usual. This multicentre, pragmatic, prospective, open-label, randomised controlled trial includes patients with idiopathic hip/knee OA who are on a waiting list for primary THA/TKA. Patients at risk for CS will be randomly allocated to the preoperative duloxetine treatment programme group or the care-as-usual control group. The primary end point is the degree of postoperative pain 6 months after THA/TKA. Secondary end points at multiple time points up to 12 months postoperatively are: pain, neuropathic pain-like symptoms, (pain) sensitisation, pain catastrophising, joint-associated problems, physical activity, health-related quality of life, depressive and anxiety symptoms, and perceived improvement. Data will be analysed on an intention-to-treat basis. The study is approved by the local Medical Ethics Committee (METc 2014/087) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard (GCP), and in compliance with the Medical Research Involving Human Subjects Act (WMO). 2013-004313-41; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Prioritising Responses Of Nurses To deteriorating patient Observations (PRONTO) protocol: testing the effectiveness of a facilitation intervention in a pragmatic, cluster-randomised trial with an embedded process evaluation and cost analysis.

PubMed

Bucknall, Tracey K; Harvey, Gill; Considine, Julie; Mitchell, Imogen; Rycroft-Malone, Jo; Graham, Ian D; Mohebbi, Mohammadreza; Watts, Jennifer; Hutchinson, Alison M

2017-07-11

Vital signs are the primary indicator of physiological status and for determining the need for urgent clinical treatment. Yet, if physiological signs of deterioration are missed, misinterpreted or mismanaged, then critical illness, unplanned intensive care admissions, cardiac arrest and death may ensue. Although evidence demonstrates the benefit of early recognition and management of deteriorating patients, failure to escalate care and manage deteriorating patients remains a relatively frequent occurrence in hospitals. A pragmatic cluster-randomised controlled trial design will be used to measure clinical effectiveness and cost of a facilitation intervention to improve nurses' vital sign measurement, interpretation, treatment and escalation of care for patients with abnormal vital signs. A cost consequence analysis will evaluate the intervention cost and effectiveness, and a process evaluation will determine how the implementation of the intervention contributes to outcomes. We will compare clinical outcomes and costs from standard implementation of clinical practice guidelines (CPGs) to facilitated implementation of CPGs. The primary outcome will be adherence to the CPGs by nurses, as measured by escalation of care as per organisational policy. The study will be conducted in four Australian major metropolitan teaching hospitals. In each hospital, eight to ten wards will be randomly allocated to intervention and control groups. Control wards will receive standard implementation of CPGs, while intervention wards will receive standard CPG implementation plus facilitation, using facilitation methods and processes tailored to the ward context. The intervention will be administered to all nursing staff at the ward level for 6 months. At each hospital, two types of facilitators will be provided: a hospital-level facilitator as the lead; and two ward-level facilitators for each ward. This study uses an innovative, networked approach to facilitation to enable uptake of CPGs. Findings will inform the intervention utility and knowledge translation measurement approaches. If successful, the study methodology and intervention has potential for translation to other health care standards. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616000544471p.

Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial.

PubMed

Muth, Christiane; Uhlmann, Lorenz; Haefeli, Walter E; Rochon, Justine; van den Akker, Marjan; Perera, Rafael; Güthlin, Corina; Beyer, Martin; Oswald, Frank; Valderas, Jose Maria; Knottnerus, J André; Gerlach, Ferdinand M; Harder, Sebastian

2018-02-24

Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice. Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation. 72 general practices in Hesse, Germany. 505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study. Intervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care. The primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months' follow-up: quality of life, functioning, medication adherence, and so on. At baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0-5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI -0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence). The intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement. ISRCTN99526053. NCT01171339; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pragmatics in pre-schoolers with language impairments.

PubMed

Geurts, Hilde; Embrechts, Mariëtte

2010-01-01

Pragmatic assessment methods are very diverse and differ in informant type. Some rely on parents, others on teachers/professionals and some directly test pragmatic abilities in the children themselves. A widely used pragmatic parent questionnaire is the Children's Communication Checklist--2 (CCC-2). However, it is not known how scores on the CCC-2 relate to direct measures of pragmatics. The aim of the current study is determine whether children's language patterns on pragmatics obtained with a parent questionnaire were converging with findings when the children were directly tested with a pragmatic test. The CCC-2 and the Nijmegen Pragmatics Test (NPT) were applied to 24 pre-schoolers (aged 4-7 years) with various language impairments and 33 age-matched typically developing pre-schoolers. Both pragmatic language instruments clearly differentiated between pre-schoolers with language impairments and those without language impairments. However, the obtained correlations between the different measures were low to moderate. The specificity of each of the instruments was sufficient, but the sensitivity was generally poor. The instruments were not always converging, but when the instruments did converge the obtained results were valid. However, the obtained high specificity and relatively low sensitivity values for each of the instruments showed that better cut-off scores are needed. When only one of the instruments indicated the absence or presence of language impairments, one needs to be careful in concluding whether or not there are indeed language impairments.

An Investigation into Pragmatic Knowledge in the Reading Section of TOLIMO, TOEFL, and IELTS Examinations

ERIC Educational Resources Information Center

Karbalaei, Alireza; Rahmanzade, Mehrnaz Kashkooli

2015-01-01

The present study focused on the analysis of listening sections of two international English proficiency tests, i.e. IELTS and TOEFL tests, and one local English proficiency test, i.e. TOLIMO from pragmatic perspective. An attempt was made to explore the areas of pragmatic knowledge presented, and to assess test takers' pragmatic knowledge. For…

Acquisition of Pragmatic Routines by Learners of L2 English: Investigating Common Errors and Sources of Pragmatic Fossilization

ERIC Educational Resources Information Center

Tajeddin, Zia; Alemi, Minoo; Pashmforoosh, Roya

2017-01-01

Unlike linguistic fossilization, pragmatic fossilization has received scant attention in fossilization research. To bridge this gap, the present study adopted a typical-error method of fossilization research to identify the most frequent errors in pragmatic routines committed by Persian-speaking learners of L2 English and explore the sources of…

Development of Bengali Audio-Visual Test Battery for Assessment of Pragmatic Skills: Preliminary Normative Data Based on Educational Level

ERIC Educational Resources Information Center

Chakrabarty, Madhushree; Biswas, Atanu; Pal, Sandip; Chatterjee, Amita

2017-01-01

Pragmatic competence may be disrupted due to psychological and neurological causes. For appropriate remedy and rehabilitation, a precise assessment of pragmatic skills is important. However, there is no test battery in the Bengali language, and consequently, there is no published data on pragmatic ability of Bengali speakers. Due to the vast…

Pragmatism as a Philosophy of Education in the Hispanic World: A Response

ERIC Educational Resources Information Center

Pappas, Gregario Fernando; Garrison, Jim

2005-01-01

We concentrate on four questions among the many posed by this special collection of papers on Pragmatism and the Hispanic world. They are, first, what took pragmatism beyond the borders of the United States and into the Hispanic world? Next, what are the ideas of Dewey (or pragmatism) that have had the greatest impact on Hispanic culture? Third,…

An Empirical Study on Pragmatic Transfer in Refusal Speech Act Produced by Chinese High School EFL Learners

ERIC Educational Resources Information Center

Jiang, Lingyun

2015-01-01

Pragmatic competence plays a very significant role in cross-cultural communication. In Chinese high school, many English teachers focus more on lexical and syntactic aspects of English. The aspect of pragmatics, however, is relatively neglected by high school English teachers. The aim of this research is to investigate pragmatic transfer in…

Pragmatic Language Profiles of School-Age Children With Autism Spectrum Disorders and Williams Syndrome

PubMed Central

Philofsky, Amy; Fidler, Deborah J.; Hepburn, Susan

2015-01-01

Purpose To describe and compare the pragmatic language profiles of school-age children with autism spectrum disorders (ASD) and Williams syndrome (WS) on a standardized measure to determine whether a standard pragmatics tool can differentiate between 2 groups of children with opposing social presentations and pragmatic language difficulties. Method Twenty-two parents of school-age children with ASD, 21 parents of school-age children with WS, and 19 parents of school-age typically developing children rated their child on the Children’s Communication Checklist—Second Edition (CCC–2; D. Bishop, 2003), a standardized pragmatic language assessment tool. Results Both clinical groups demonstrated impairment in overall communication and pragmatic language functioning, but children with WS performed significantly better on overall pragmatic language functioning, and the magnitude of the effect was medium. Profile examination revealed equivalent performances between ASD and WS on most CCC–2 subscales; however, significantly better performances on the Coherence, Stereotyped Language, Nonverbal Communication, and Social Relations subscales were observed in WS. Conclusions The CCC–2 appears to provide an effective means to identify and characterize pragmatic language difficulties using a standardized approach in children with ASD and WS. PMID:17971496

The AIDS-related activities of religious leaders in Malawi

PubMed Central

TRINTAPOLI, J.

2010-01-01

The AIDS-related activities of religious leaders in Africa extend far beyond preaching about sexual mortality. This study aims to quantify the involvement of religious leaders in the fight against AIDS and to identify key predictors of the types of prevention strategies they promote. Using data from a random sample of Christian and Muslim leaders in Malawi, I use logistic regression to predict six types of AIDS activities, which correspond to three distinct types: formal messages (i.e., preaching), pragmatic interventions (monitoring the sexual behaviour of members and advising divorce to avoid infection), and the promotion of biomedical prevention strategies (promoting condom use and testing for HIV). Preaching about AIDS is the most common prevention activity, and promoting condom use is the least; sizable proportions of clergy promote testing and engage in pragmatic interventions. Denominational patterns in the type of engagement are weak and inconsistent. However, inquiries into the motivation for leaders' activities show that discussions with members about AIDS is the most consistent predictor, suggesting that religious leaders' engagement with HIV prevention is primarily a demand-driven phenomenon. PMID:20552476

Pragmatics abilities in narrative production: a cross-disorder comparison.

PubMed

Norbury, Courtenay Frazier; Gemmell, Tracey; Paul, Rhea

2014-05-01

We aimed to disentangle contributions of socio-pragmatic and structural language deficits to narrative competence by comparing the narratives of children with autism spectrum disorder (ASD; n = 25), non-autistic children with language impairments (LI; n = 23), and children with typical development (TD; n = 27). Groups were matched for age (6½ to 15 years; mean: 10;6) and non-verbal ability; ASD and TD groups were matched on standardized language scores. Despite distinct clinical presentation, children with ASD and LI produced similarly simple narratives that lacked semantic richness and omitted important story elements, when compared to TD peers. Pragmatic errors were common across groups. Within the LI group, pragmatic errors were negatively correlated with story macrostructure scores and with an index of semantic-pragmatic relevance. For the group with ASD, pragmatic errors consisted of comments that, though extraneous, did not detract from the gist of the narrative. These findings underline the importance of both language and socio-pragmatic skill for producing coherent, appropriate narratives.

A Route to Well-being: Intelligence vs. Wise Reasoning

PubMed Central

Grossmann, Igor; Na, Jinkyung; Varnum, Michael E.W.; Kitayama, Shinobu; Nisbett, Richard E.

2012-01-01

Laypeople and many social scientists assume that superior reasoning abilities lead to greater well-being. However, previous research has been inconclusive. This may be because prior investigators used operationalizations of reasoning that favored analytic as opposed to wise thinking. We assessed wisdom in terms of the degree to which people use various pragmatic schemas to deal with social conflicts. With a random sample of Americans we found that wise reasoning is associated with greater life satisfaction, less negative affect, better social relationships, less depressive rumination, more positive vs. negative words used in speech, and greater longevity. The relationship between wise reasoning and well-being held even when controlling for socio-economic factors, verbal abilities, and several personality traits. As in prior work there was no association between intelligence and well-being. Further, wise reasoning mediated age-related differences in well-being, particularly among the middle-aged and older adults. Implications for research on reasoning, well-being and aging are discussed. PMID:22866683

Distinguishing cause from correlation in tokamak experiments to trigger edge-localised plasma instabilities

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

Webster, Anthony J.; CCFE, Culham Science Centre, Abingdon OX14 3DB

2014-11-15

The generic question is considered: How can we determine the probability of an otherwise quasi-random event, having been triggered by an external influence? A specific problem is the quantification of the success of techniques to trigger, and hence control, edge-localised plasma instabilities (ELMs) in magnetically confined fusion (MCF) experiments. The development of such techniques is essential to ensure tolerable heat loads on components in large MCF fusion devices, and is necessary for their development into economically successful power plants. Bayesian probability theory is used to rigorously formulate the problem and to provide a formal solution. Accurate but pragmatic methods aremore » developed to estimate triggering probabilities, and are illustrated with experimental data. These allow results from experiments to be quantitatively assessed, and rigorously quantified conclusions to be formed. Example applications include assessing whether triggering of ELMs is a statistical or deterministic process, and the establishment of thresholds to ensure that ELMs are reliably triggered.« less

Benchmarking to improve the quality of cystic fibrosis care.

PubMed

Schechter, Michael S

2012-11-01

Benchmarking involves the ascertainment of healthcare programs with most favorable outcomes as a means to identify and spread effective strategies for delivery of care. The recent interest in the development of patient registries for patients with cystic fibrosis (CF) has been fueled in part by an interest in using them to facilitate benchmarking. This review summarizes reports of how benchmarking has been operationalized in attempts to improve CF care. Although certain goals of benchmarking can be accomplished with an exclusive focus on registry data analysis, benchmarking programs in Germany and the United States have supplemented these data analyses with exploratory interactions and discussions to better understand successful approaches to care and encourage their spread throughout the care network. Benchmarking allows the discovery and facilitates the spread of effective approaches to care. It provides a pragmatic alternative to traditional research methods such as randomized controlled trials, providing insights into methods that optimize delivery of care and allowing judgments about the relative effectiveness of different therapeutic approaches.

Pragmatic Computing - A Semiotic Perspective to Web Services

NASA Astrophysics Data System (ADS)

Liu, Kecheng

The web seems to have evolved from a syntactic web, a semantic web to a pragmatic web. This evolution conforms to the study of information and technology from the theory of semiotics. The pragmatics, concerning with the use of information in relation to the context and intended purposes, is extremely important in web service and applications. Much research in pragmatics has been carried out; but in the same time, attempts and solutions have led to some more questions. After reviewing the current work in pragmatic web, the paper presents a semiotic approach to website services, particularly on request decomposition and service aggregation.

Controlling cardiovascular diseases in low and middle income countries by placing proof in pragmatism

PubMed Central

Owolabi, Mayowa; Miranda, Jaime J; Yaria, Joseph; Ovbiagele, Bruce

2016-01-01

Low and middle income countries (LMICs) bear a huge, disproportionate and growing burden of cardiovascular disease (CVD) which constitutes a threat to development. Efforts to tackle the global burden of CVD must therefore emphasise effective control in LMICs by addressing the challenge of scarce resources and lack of pragmatic guidelines for CVD prevention, treatment and rehabilitation. To address these gaps, in this analysis article, we present an implementation cycle for developing, contextualising, communicating and evaluating CVD recommendations for LMICs. This includes a translatability scale to rank the potential ease of implementing recommendations, prescriptions for engaging stakeholders in implementing the recommendations (stakeholders such as providers and physicians, patients and the populace, policymakers and payers) and strategies for enhancing feedback. This approach can help LMICs combat CVD despite limited resources, and can stimulate new implementation science hypotheses, research, evidence and impact. PMID:27840737

Discourse Issues in Cross-Cultural Pragmatics.

ERIC Educational Resources Information Center

Boxer, Diana

2002-01-01

Focuses on recent research in cross-cultural pragmatics as distinct from interlanguage pragmatics. The essential difference between the two lies in the perspective from which each views cross-cultural communication. (Author/VWL)

The Teaching of Pragmatics by Native and Nonnative Language Teachers: What They Know and What They Report Doing

ERIC Educational Resources Information Center

Cohen, Andrew D.

2016-01-01

The paper focuses on how nonnative teachers of a target language (NNTs) deal with pragmatics in their classes. It starts with a discussion of what pragmatics entails. Next, issues relating to the teaching of pragmatics are identified, such as the language background of the teacher, comparisons between second- (L2) and foreign-language (FL)…

Pragmatic Instruction May Not Be Necessary among Heritage Speakers of Spanish: A Study on Requests

ERIC Educational Resources Information Center

Barros García, María J.; Bachelor, Jeremy W.

2018-01-01

This paper studies the pragmatic competence of U.S. heritage speakers of Spanish in an attempt to determine (a) the degree of pragmatic transfer from English to Spanish experienced by heritage speakers when producing different types of requests in Spanish; and (b) how to best teach pragmatics to students of Spanish as a Heritage Language (SHL).…

Measuring Pragmatic Language in Speakers with Autism Spectrum Disorders: Comparing the Children's Communication Checklist-2 and the Test of Pragmatic Language

ERIC Educational Resources Information Center

Volden, Joanne; Phillips, Linda

2010-01-01

Purpose: To compare the Children's Communication Checklist-2 (CCC-2), a parent report instrument, with the Test of Pragmatic Language (TOPL), a test administered to the child, on the ability to identify pragmatic language impairment in speakers with autism spectrum disorders (ASD) who had age-appropriate structural language skills. Method: Sixteen…

Pragmatic Language Assessment in Williams Syndrome: A Comparison of the Test of Pragmatic Language--2 and the Children's Communication Checklist--2

ERIC Educational Resources Information Center

Hoffmann, Anne; Martens, Marilee A.; Fox, Robert; Rabidoux, Paula; Andridge, Rebecca

2013-01-01

Purpose: Individuals with Williams syndrome (WS) are recognized as having a strong desire for social relationships, yet many of them have difficulty forming and maintaining peer relationships. One cause may be impairments in pragmatic language. The current study compared the assessment of pragmatic language skills in individuals with WS using the…

Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

PubMed

Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

2015-07-15

Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.

PubMed

Zatzick, Douglas; Russo, Joan; Lord, Sarah Peregrine; Varley, Christopher; Wang, Jin; Berliner, Lucy; Jurkovich, Gregory; Whiteside, Lauren K; O'Connor, Stephen; Rivara, Frederick P

2014-06-01

Violence and injury risk behaviors, alcohol and drug use problems, and posttraumatic stress disorder (PTSD) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury. To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury. A pragmatic randomized clinical trial was conducted at a single US level I trauma center. Participants included 120 adolescents aged 12 to 18 years randomized to intervention (n = 59) and control (n = 61) conditions. Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms. Adolescents were assessed at baseline before randomization and 2, 5, and 12 months after injury hospitalization. Standardized instruments were used to assess violence risk behaviors, alcohol and drug use, and PTSD and depressive symptoms. The investigation attained more than 95% adolescent follow-up at each assessment point. At baseline, approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon. Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury (group × time effect, F3,344 = 3.0; P = .03). At 12 months after the injury, 4 (7.3%) intervention patients vs 13 (21.3%) control patients reported currently carrying a weapon (relative risk, 0.31; 95% CI, 0.11-0.90). The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury. Other treatment targets, including alcohol and drug use problems and high levels of PTSD and depressive symptoms, occurred less frequently in the cohort relative to weapon carrying and were not significantly affected by the intervention. Collaborative care intervention reduced the risk of adolescent weapon carrying during the year after the injury hospitalization. Future investigation should replicate this preliminary observation. If the finding is replicated, orchestrated investigative and policy efforts could systematically implement and evaluate screening and intervention procedures targeting youth violence prevention at US trauma centers. clinicaltrials.gov identifier: NCT00619255.

A Test for the Assessment of Pragmatic Abilities and Cognitive Substrates (APACS): Normative Data and Psychometric Properties

PubMed Central

Arcara, Giorgio; Bambini, Valentina

2016-01-01

The Assessment of Pragmatic Abilities and Cognitive Substrates (APACS) test is a new tool to evaluate pragmatic abilities in clinical populations with acquired communicative deficits, ranging from schizophrenia to neurodegenerative diseases. APACS focuses on two main domains, namely discourse and non-literal language, combining traditional tasks with refined linguistic materials in Italian, in a unified framework inspired by language pragmatics. The test includes six tasks (Interview, Description, Narratives, Figurative Language 1, Humor, Figurative Language 2) and three composite scores (Pragmatic Productions, Pragmatic Comprehension, APACS Total). Psychometric properties and normative data were computed on a sample of 119 healthy participants representative of the general population. The analysis revealed acceptable internal consistency and good test-retest reliability for almost every APACS task, suggesting that items are coherent and performance is consistent over time. Factor analysis supports the validity of the test, revealing two factors possibly related to different facets and substrates of the pragmatic competence. Finally, excellent match between APACS items and scores and the pragmatic constructs measured in the test was evidenced by experts' evaluation of content validity. The performance on APACS showed a general effect of demographic variables, with a negative effect of age and a positive effect of education. The norms were calculated by means of state-of-the-art regression methods. Overall, APACS is a valuable tool for the assessment of pragmatic deficits in verbal communication. The short duration and easiness of administration make the test especially suitable to use in clinical settings. In presenting APACS, we also aim at promoting the inclusion of pragmatics in the assessment practice, as a relevant dimension in defining the patient's cognitive profile, given its vital role for communication and social interaction in daily life. The combined use of APACS with other neuropsychological tests could also improve our understanding of the cognitive substrates of pragmatic abilities and their breakdown. PMID:26903894

Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose.

PubMed

Loudon, Kirsty; Zwarenstein, Merrick; Sullivan, Frank; Donnan, Peter; Treweek, Shaun

2013-04-27

If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention. The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters' subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of pragmatism. We have concrete suggestions for improving PRECIS and a growing list of enthusiastic individuals interested in contributing to this work. By early 2014 we expect to have a validated PRECIS-2.

The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.

PubMed

Eldabe, Sam; Thomson, Simon; Duarte, Rui; Brookes, Morag; deBelder, Mark; Raphael, Jon; Davies, Ed; Taylor, Rod

2016-01-01

Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial. © 2015 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Pragmatics fragmented: the factor structure of the Dutch children's communication checklist (CCC).

PubMed

Geurts, Hilde M; Hartman, Catharina; Verté, Sylvie; Oosterlaan, Jaap; Roeyers, Herbert; Sergeant, Joseph A

2009-01-01

A number of disorders are associated with pragmatic difficulties. Instruments that can make subdivisions within the larger construct of pragmatics could be important tools for disentangling profiles of pragmatic difficulty in different disorders. The deficits underlying the observed pragmatic difficulties may be different for different disorders. To study the construct validity of a pragmatic language questionnaire. The construct of pragmatics is studied by applying exploratory factor analysis (EFA) and confirmatory factor analysis to the parent version of the Dutch Children's Communication Checklist (CCC; Bishop 1998 ). Parent ratings of 1589 typically developing children and 481 children with a clinical diagnosis were collected. Four different factor models derived from the original CCC scales and five different factor models based on EFA were compared with each other. The models were cross-validated. The EFA-derived models were substantively different from the originally proposed CCC factor structure. EFA models gave a slightly better fit than the models based on the original CCC scales, though neither provided a good fit to the parent data. Coherence seemed to be part of language form and not of pragmatics, which is in line with the adaptation of the CCC, the CCC-2 (Bishop 2003 ). Most pragmatic items clustered together in one factor and these pragmatic items also clustered with items related to social relationships and specific interests. The nine scales of the original CCC do not reflect the underlying factor structure. Therefore, scale composition may be improved on and scores on subscale level need to be interpreted cautiously. Therefore, in interpreting the CCC profiles, the overall measure might be more informative than the postulated subscales as more information is needed to determine which constructs the suggested subscales are actually measuring.

Implementation successes and challenges in participating in a pragmatic study to improve colon cancer screening: perspectives of health center leaders.

PubMed

Coronado, Gloria D; Schneider, Jennifer L; Petrik, Amanda; Rivelli, Jennifer; Taplin, Stephen; Green, Beverly B

2017-09-01

Little is known about the challenges faced by community clinics who must address clinical priorities first when participating in pragmatic studies. We report on implementation challenges faced by the eight community health centers that participated in Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), a large comparative effectiveness cluster-randomized trial to evaluate a direct-mail program to increase the rate of colorectal cancer (CRC) screening. We conducted interviews, at the onset of implementation and 1 year later, with center leaders to identify challenges with implementing and sustaining an electronic medical record (EMR)-driven mailed program to increase CRC screening rates. We used the Consolidated Framework for Implementation Research to thematically analyze the content of meeting discussions and identify anticipated and experienced challenges. Common early concerns were patients' access to colonoscopy, patients' low awareness of CRC screening, time burden on clinic staff to carry out the STOP CRC program, inability to accurately identify eligible patients, and incompatibility of the program's approach with the patient population or organizational culture. Once the program was rolled out, time burden remained a primary concern and new organizational capacity and EMR issues were raised (e.g., EMR staffing resources and turnover in key leadership positions). Cited program successes were improved CRC screening processes and rates, more patients reached, reduced costs, and improved patient awareness, engagement, or satisfaction. These findings may inform any clinic considering mailed fecal testing programs and future pragmatic research efforts in community health centers.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

PubMed

Weinfurt, Kevin P; Hernandez, Adrian F; Coronado, Gloria D; DeBar, Lynn L; Dember, Laura M; Green, Beverly B; Heagerty, Patrick J; Huang, Susan S; James, Kathryn T; Jarvik, Jeffrey G; Larson, Eric B; Mor, Vincent; Platt, Richard; Rosenthal, Gary E; Septimus, Edward J; Simon, Gregory E; Staman, Karen L; Sugarman, Jeremy; Vazquez, Miguel; Zatzick, Douglas; Curtis, Lesley H

2017-09-18

The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped. To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design. In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs. A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

The Effects of Pragmatic Consciousness-Raising Activities on the Development of Pragmatic Awareness and Use of Hearsay Evidential Markers for Learners of Japanese as a Foreign Language

ERIC Educational Resources Information Center

Narita, Ritsuko

2009-01-01

The present study investigates the effectiveness of pragmatic consciousness-raising (PCR) activities in the L2 pragmatic acquisition of hearsay evidential markers by learners of Japanese as a foreign language (JFL). PCR is essentially an inductive approach to facilitating awareness of how language forms are used appropriately in a given context.…

Impact of a Primary Care CKD Registry in a US Public Safety-Net Health Care Delivery System: A Pragmatic Randomized Trial.

PubMed

Tuot, Delphine S; McCulloch, Charles E; Velasquez, Alexandra; Schillinger, Dean; Hsu, Chi-Yuan; Handley, Margaret; Powe, Neil R

2018-04-23

Many individuals with chronic kidney disease (CKD) do not receive guideline-concordant care. We examined the impact of a team-based primary care CKD registry on clinical measures and processes of care among patients with CKD cared for in a public safety-net health care delivery system. Pragmatic trial of a CKD registry versus a usual-care registry for 1 year. Primary care providers (PCPs) and their patients with CKD in a safety-net primary care setting in San Francisco. The CKD registry identified at point of care all patients with CKD, those with blood pressure (BP)>140/90mmHg, those without angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) prescription, and those without albuminuria quantification in the past year. It also provided quarterly feedback pertinent to these metrics to promote "outreach" to patients with CKD. The usual-care registry provided point-of-care cancer screening and immunization data. Changes in systolic BP at 12 months (primary outcome), proportion of patients with BP control, prescription of ACE inhibitors/ARBs, quantification of albuminuria, severity of albuminuria, and estimated glomerular filtration rate. The patient population (n=746) had a mean age of 56.7±12.1 (standard deviation) years, was 53% women, and was diverse (8% non-Hispanic white, 35.7% black, 24.5% Hispanic, and 24.4% Asian). Randomization to the CKD registry (30 PCPs, 285 patients) versus the usual-care registry (49 PCPs, 461 patients) was associated with 2-fold greater odds of ACE inhibitor/ARB prescription (adjusted OR, 2.25; 95% CI, 1.45-3.49) and albuminuria quantification (adjusted OR, 2.44; 95% CI, 1.38-4.29) during the 1-year study period. Randomization to the CKD registry was not associated with changes in systolic BP, proportion of patients with uncontrolled BP, or degree of albuminuria or estimated glomerular filtration rate. Potential misclassification of CKD; missing baseline medication data; limited to study of a public safety-net health care system. A team-based safety-net primary care CKD registry did not improve BP parameters, but led to greater albuminuria quantification and more ACE inhibitor/ARB prescriptions after 1 year. Adoption of team-based CKD registries may represent an important step in translating evidence into practice for CKD management. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial.

PubMed

Pozet, Astrid; Lejeune, Catherine; Bonnet, Magalie; Dabakuyo, Sandrine; Dion, Michèle; Fagnoni, Philippe; Gaimard, Maryse; Imbert, Geneviève; Nerich, Virginie; Foubert, Audrey; Chotard, Morgane; Bonin, Marie; Anota, Amélie; Bonnetain, Franck

2016-11-03

Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers. The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson's disease, Alzheimer's disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken. Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support adapted to caregivers, and provide an impulse for new health care policies. ClinicalTrials.gov Identifier: NCT02626377 . Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.

Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain-study protocol of the PROD-BP multicenter pragmatic RCT.

PubMed

Sander, L; Paganini, S; Lin, J; Schlicker, S; Ebert, D D; Buntrock, C; Baumeister, H

2017-01-21

Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted from a societal and public health perspective. This is the first study examining an IMI for depression prevention in a sample of chronic pain patients. If this implementation of a depression prevention IMI into orthopedic aftercare proves effective, the intervention could be integrated into routine care with minimal costs and extended for use with other chronic diseases. Results will have implications for researchers, health care providers and public health policy makers. The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00007960 . Registered 12 August 2015.

Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial.

PubMed

Direito, Artur; Jiang, Yannan; Whittaker, Robyn; Maddison, Ralph

2015-07-11

Physical activity is a modifiable behavior related to many preventable non-communicable diseases. There is an age-related decline in physical activity levels in young people, which tracks into adulthood. Common interactive technologies such as smartphones, particularly employing immersive features, may enhance the appeal and delivery of interventions to increase levels of physical activity in young people. The primary aim of the Apps for IMproving FITness (AIMFIT) trial is to evaluate the effectiveness of two popular "off-the-shelf" smartphone apps for improving cardiorespiratory fitness in young people. A three-arm, parallel, randomized controlled trial will be conducted in Auckland, New Zealand. Fifty-one eligible young people aged 14-17 years will be randomized to one of three conditions: 1) use of an immersive smartphone app, 2) use of a non-immersive app, or 3) usual behavior (control). Both smartphone apps consist of an eight-week training program designed to improve fitness and ability to run 5 km, however, the immersive app features a game-themed design and adds a narrative. Data are collected at baseline and 8 weeks. The primary outcome is cardiorespiratory fitness, assessed as time to complete the one mile run/walk test at 8 weeks. Secondary outcomes are physical activity levels, self-efficacy, enjoyment, psychological need satisfaction, and acceptability and usability of the apps. Analysis using intention to treat principles will be performed using regression models. Despite the proliferation of commercially available smartphone applications, there is a dearth of empirical evidence to support their effectiveness on the targeted health behavior. This pragmatic study will determine the effectiveness of two popular "off-the-shelf" apps as a stand-alone instrument for improving fitness and physical activity among young people. Adherence to app use will not be closely controlled; however, random allocation of participants, a heterogeneous group, and data analysis using intention to treat principles provide internal and external validity to the study. The primary outcome will be objectively assessed with a valid and reliable field-based test, as well as the secondary outcome of physical activity, via accelerometry. If effective, such applications could be used alongside existing interventions to promote fitness and physical activity in this population. Australian New Zealand Clinical Trials Registry: ACTRN12613001030763. Registered 16 September 2013.

Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial

PubMed Central

2017-01-01

Background Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health–driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. Objective Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK’s National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. Methods A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. Results The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. Conclusions This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of two digital interventions using a fully automated digital enrollment and data collection process are considered for people with depression and anxiety. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428 (Archived by WebCite at http://www.webcitation.org/6uw6ZJk5a) PMID:29254909

Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial

PubMed Central

Smith, Caroline A.; Abbott, Jason; Fahey, Paul; Cheema, Birinder S.; Bensoussan, Alan

2017-01-01

Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first‐line intervention; however, there are barriers to success for this form of self‐care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty‐two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3–42.6, p < 0.01) compared with controls, estimated as a large effect (ηp 2 = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd PMID:28685911

Bridging the "digital divide": A comparison of use and effectiveness of an online intervention for depression between Baby Boomers and Millennials.

PubMed

Schneider, Brooke C; Schröder, Johanna; Berger, Thomas; Hohagen, Fritz; Meyer, Björn; Späth, Christina; Greiner, Wolfgang; Hautzinger, Martin; Lutz, Wolfgang; Rose, Matthias; Vettorazzi, Eik; Moritz, Steffen; Klein, Jan Philipp

2018-08-15

Psychological online interventions (POIs) for depression have demonstrated promising effects. However, there are fewer randomized controlled studies on POIs among older adults with depression. The goal of the present study was to compare the use and efficacy of Deprexis, an online intervention for depression, among Millennials (18-35 years) and Baby Boomers (50-65 years). We completed a secondary data analysis on a subset (N = 577) of participants in the EVIDENT trial, a parallel-groups, pragmatic, randomized, controlled single-blind study, which compared a 12-week POI (Deprexis) to care as usual (CAU). Outcomes were assessed at baseline, 3 months (post-assessment) and 6 months (follow-up). The main outcome of interest was change on self-rated depression severity (PHQ-9). Compared to Millennials, Boomers used the intervention significantly more often (d = 0.45) and for a longer duration (d = 0.46), and endorsed more positive attitudes towards POIs (d = 0.14). There was no significant Age Group by Intervention Group interaction for change in PHQ-9. The post-assessment between-group effect size (intervention vs. CAU control) for Millennials and Boomers were d = 0.26 and d = 0.39, respectively, and were stable at follow-up (d = 0.37 and d = 0.39). Age-based dichotomization may not accurately represent participants' experiences with and use of technology. The POI examined in this trial was superior to CAU and was comparably effective among groups of adults defined as Millennials and Baby Boomers. Adults of the Baby Boomer generation who participate in POIs may have more positive attitudes towards POIs compared to their younger counterparts. Copyright © 2018 Elsevier B.V. All rights reserved.

Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

PubMed

Arentz, Susan; Smith, Caroline A; Abbott, Jason; Fahey, Paul; Cheema, Birinder S; Bensoussan, Alan

2017-09-01

Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (η p 2  = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

Study protocol for a randomized controlled trial of telephone-delivered cognitive behavior therapy compared with befriending for treating depression and anxiety in older adults with COPD.

PubMed

Doyle, Colleen; Dunt, David; Ames, David; Fearn, Marcia; You, Emily Chuanmei; Bhar, Sunil

2016-01-01

COPD is an umbrella term to describe chronic lung diseases that cause limitations in lung airflow, including emphysema and chronic bronchitis. The prevalence of depression and anxiety in people with COPD is high, although these comorbidities are often undiagnosed, untreated, or undertreated. There is a need to identify efficacious treatments for depression and anxiety in people with COPD. Cognitive behavior therapy (CBT) for the treatment of anxiety and depression has a strong evidence base. There has been some success delivering this treatment over the telephone in limited studies. The aim of this study is to evaluate the efficacy of both telephone-administered CBT and befriending on outcomes for patients with diagnosed COPD who have at least mild levels of depression and/or anxiety. The protocol described in this paper is of a pragmatic randomized controlled trial comparing eight sessions of telephone CBT to an active social control, referred to as befriending. Primary outcome measures will include depression and anxiety symptoms, and secondary outcome measures will include quality of life, self-efficacy, and COPD symptom severity. Participants' satisfaction with the intervention and therapeutic alliance will also be assessed. Measures will be taken pre- and postdelivery of the intervention and again at 8 weeks following the intervention. People with COPD often have limitations to their mobility because of their breathlessness. They are often already attending many medical appointments and could be reluctant to attend for face-to-face psychological treatment. The results of this study should identify the relative efficacy of CBT delivered over the telephone to this population, which, if successful, may be a cost-effective and more palatable alternative to face-to-face treatment of depression or anxiety for this population.

An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial.

PubMed

Hayek, Adina; Joshi, Rohina; Usherwood, Tim; Webster, Ruth; Kaur, Baldeep; Saini, Bandana; Armour, Carol; Krass, Ines; Laba, Tracey-Lea; Reid, Christopher; Shiel, Louise; Hespe, Charlotte; Hersch, Fred; Jan, Stephen; Lo, Serigne; Peiris, David; Rodgers, Anthony; Patel, Anushka

2016-09-23

Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities; availability of a range of CVD polypills (fixed-dose combinations of two blood pressure lowering agents, a statin ± aspirin) for prescription when appropriate; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification. Following a systematic development process, the intervention will be evaluated in a pragmatic cluster randomized controlled trial including 70 general practices for a median period of 18 months. The 35 general practices in the intervention group will work with a nominated partner pharmacy, whereas those in the control group will provide usual care without access to the intervention tools. The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels at the study end. The outcomes will be analyzed using data from electronic medical records, utilizing a validated extraction tool. Detailed process and economic evaluations will also be performed. The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients, pharmacists, and general practitioners (GPs) for CVD prevention. Australian New Zealand Clinical Trials Registry ACTRN12616000233426.

Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial.

PubMed

Nourbakhsh, Bardia; Revirajan, Nisha; Waubant, Emmanuelle

2018-01-01

Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used fatigue medications in patients with MS. The study is a randomized, placebo-controlled, crossover, four-sequence, four-period, double-blind, multicenter trial of three commonly used medications for the treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS. Adult patients with MS, with an Expanded Disability Status Scale of <7.0 are eligible to participate. Participants will be randomized to one of four predefined sequences of medication administration. Each sequence comprises four 6-week periods of treatment with one of the 3 study drugs or placebo, and three 2-week washout periods between medication periods. 136 participants will be randomized over two years in two academic centers in the United States starting in the Summer 2017. Complete enrollment is expected by early 2019. The primary outcome of the study is the modified fatigue impact scale (MFIS) score while participants receive the maximally tolerated dose of each study medication (or placebo). Safety and tolerability of the medications and heterogeneity of treatment effect will also be assessed. Results of the proposed study will provide evidence-based and personalized treatment options for patients affected by MS-related fatigue. Clinicaltrials.gov registration number: NCT03185065. Copyright © 2017 Elsevier Inc. All rights reserved.

Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: A pragmatic cluster randomized controlled trial study protocol.

PubMed

Clouston, Kathleen; Katz, Alan; Martens, Patricia J; Sisler, Jeff; Turner, Donna; Lobchuk, Michelle; McClement, Susan

2012-05-17

Fecal occult blood test screening in Canada is sub-optimal. Family physicians play a central role in screening and are limited by the time constraints of clinical practice. Patients face multiple barriers that further reduce completion rates. Tools that support family physicians in providing their patients with colorectal cancer information and that support uptake may prove useful. The primary objective of the study is to evaluate the efficacy of a patient decision aid (nurse-managed telephone support line and/or colorectal cancer screening website) distributed by community-based family physicians, in improving colorectal cancer screening rates. Secondary objectives include evaluation of (dis)incentives to patient FOBT uptake and internet use among 50 to 74 year old males and females for health-related questions. Challenges faced by family physicians in engaging in collaborative partnerships with primary healthcare researchers will be documented. A pragmatic, two-arm, randomized cluster controlled trial conducted in 22 community-based family practice clinics (36 clusters) with 76 fee-for-service family physicians in Winnipeg, Manitoba, Canada. Each physician will enroll 30 patients attending their periodic health examination and at average risk for colorectal cancer. All physicians will follow their standard clinical practice for screening. Intervention group physicians will provide a fridge magnet to each patient that contains information facilitating access to the study-specific colorectal cancer screening decision aids (telephone help-line and website). The primary endpoint is patient fecal occult blood test completion rate after four months (intention to treat model). Multi-level analysis will include clinic, physician and patient level variables. Patient Personal Health Identification Numbers will be collected from those providing consent to facilitate analysis of repeat screening behavior. Secondary outcome data will be obtained through the Clinic Characterization Form, Patient Tracking Form, In-Clinic Patient Survey, Post-Study Follow-Up Patient Survey, and Family Physician Survey. Study protocol approved by The University of Manitoba Health Research Ethics Board. The study intervention has the potential to increase patient fecal occult blood test uptake, decrease colorectal cancer mortality and morbidity, and improve the health of Manitobans. If utilization of the website and/or telephone support line result in clinically significant increases in colorectal cancer screening uptake, changes in screening at the policy- and system-level may be warranted. Clinical trials.gov identifier NCT01026753.

The Effectiveness of Picture Exchange Communication System (PECS) Training for Teachers of Children with Autism: A Pragmatic, Group Randomised Controlled Trial

ERIC Educational Resources Information Center

Howlin, Patricia; Gordon, R. Kate; Pasco, Greg; Wade, Angie; Charman, Tony

2007-01-01

Objective: To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System (PECS). Method: Design: Group randomised, controlled trial (3 groups: immediate treatment, delayed treatment, no treatment). Participants: 84 elementary school…

"Every Child Counts": Testing Policy Effectiveness Using a Randomised Controlled Trial, Designed, Conducted and Reported to CONSORT Standards

ERIC Educational Resources Information Center

Torgerson, Carole; Wiggins, Andy; Torgerson, David; Ainsworth, Hannah; Hewitt, Catherine

2013-01-01

We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme--"Numbers Count"--which formed part of the previous government's numeracy policy intervention--"Every Child Counts." We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to…

Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

ERIC Educational Resources Information Center

Torgerson, Carole J.

2009-01-01

The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol for a Randomized Controlled Trial.

PubMed

Hassandra, Mary; Lintunen, Taru; Kettunen, Tarja; Vanhala, Mauno; Toivonen, Hanna-Mari; Kinnunen, Kimmo; Heikkinen, Risto

2015-10-22

Results from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings. The primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period. After initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings. Recruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015. If the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment. International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI).

Pragmatics in Teacher Education for Nonnative-Speaking Teachers: A Consciousness-Raising Approach.

ERIC Educational Resources Information Center

Rose, Kenneth R.

1997-01-01

Reviews some of the problems relevant to the teaching of language use and discusses pragmatic consciousness raising (PCR) as one alternative in teacher education for dealing with pragmatics in the classroom. (Author/JL)

Why is it Bad to Make a Mess? Preschoolers' Conceptions of Pragmatic Norms.

PubMed

Dahl, Audun; Kim, Lizbeth

2014-01-01

A common type of transgression in early childhood involves creating inconvenience, for instance by spilling, playing with breakable objects, or otherwise interfering with people's ongoing activities. Despite the prevalence of such pragmatic transgressions, little is known about children's conceptions of norms prohibiting these acts. The present study investigated whether 3-to 5-year-olds ( N = 58) see pragmatic norms as distinct from first-order moral (welfare and rights of others), prudential (welfare of agent), and social conventional norms. Children judged all four types of transgressions to be wrong. Justifications for pragmatic transgressions focused on inconvenience to the transgressor, inconvenience to others, or material disorder. Children rated pragmatic and conventional transgressions as less serious than moral and prudential transgressions. Latent Class Analysis provided further support for the conclusion that preschoolers see pragmatic norms as a category distinct from first-order moral, prudential, and social conventional norms.

On the incrementality of pragmatic processing: An ERP investigation of informativeness and pragmatic abilities

PubMed Central

Nieuwland, Mante S.; Ditman, Tali; Kuperberg, Gina R.

2010-01-01

In two event-related potential (ERP) experiments, we determined to what extent Grice’s maxim of informativeness as well as pragmatic ability contributes to the incremental build-up of sentence meaning, by examining the impact of underinformative versus informative scalar statements (e.g. “Some people have lungs/pets, and…”) on the N400 event-related potential (ERP), an electrophysiological index of semantic processing. In Experiment 1, only pragmatically skilled participants (as indexed by the Autism Quotient Communication subscale) showed a larger N400 to underinformative statements. In Experiment 2, this effect disappeared when the critical words were unfocused so that the local underinformativeness went unnoticed (e.g., “Some people have lungs that…”). Our results suggest that, while pragmatic scalar meaning can incrementally contribute to sentence comprehension, this contribution is dependent on contextual factors, whether these are derived from individual pragmatic abilities or the overall experimental context. PMID:20936088

A plea for pragmatism in clinical research ethics.

PubMed

Brendel, David H; Miller, Franklin G

2008-04-01

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.

Pragmatism, metaphysics, and bioethics: beyond a theory of moral deliberation.

PubMed

Pamental, Matthew

2013-12-01

Pragmatism has been understood by bioethicists as yet another rival in the "methods wars," as yet another theory of moral deliberation. This has led to criticism of pragmatic bioethics as both theoretically and practically inadequate. Pragmatists' responses to these objections have focused mainly on misunderstandings of pragmatism's epistemology. These responses are insufficient. Pragmatism's commitment to radical empiricism gives it theoretical resources unappreciated by critics and defenders alike. Radical empiricism, unlike its more traditional ancestors, undercuts the gaps between theory and practice, and subjective and objective accounts of experience, and in so doing provides the metaphysical and epistemological basis for a thoroughgoing empirical naturalism in ethics. Pragmatism's strength as an approach to moral problems thus emerges as a result of a much wider array of resources than contemporary interpreters have acknowledged, which makes it a richer, deeper framework for understanding moral deliberation in general and bioethical decision making in particular.

A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.

PubMed

Galante, Julieta; Dufour, Géraldine; Vainre, Maris; Wagner, Adam P; Stochl, Jan; Benton, Alice; Lathia, Neal; Howarth, Emma; Jones, Peter B

2018-02-01

The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (β -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Statistical design and analysis plan for an impact evaluation of an HIV treatment and prevention intervention for female sex workers in Zimbabwe: a study protocol for a cluster randomised controlled trial.

PubMed

Hargreaves, James R; Fearon, Elizabeth; Davey, Calum; Phillips, Andrew; Cambiano, Valentina; Cowan, Frances M

2016-01-05

Pragmatic cluster-randomised trials should seek to make unbiased estimates of effect and be reported according to CONSORT principles, and the study population should be representative of the target population. This is challenging when conducting trials amongst 'hidden' populations without a sample frame. We describe a pair-matched cluster-randomised trial of a combination HIV-prevention intervention to reduce the proportion of female sex workers (FSW) with a detectable HIV viral load in Zimbabwe, recruiting via respondent driven sampling (RDS). We will cross-sectionally survey approximately 200 FSW at baseline and at endline to characterise each of 14 sites. RDS is a variant of chain referral sampling and has been adapted to approximate random sampling. Primary analysis will use the 'RDS-2' method to estimate cluster summaries and will adapt Hayes and Moulton's '2-step' method to adjust effect estimates for individual-level confounders and further adjust for cluster baseline prevalence. We will adapt CONSORT to accommodate RDS. In the absence of observable refusal rates, we will compare the recruitment process between matched pairs. We will need to investigate whether cluster-specific recruitment or the intervention itself affects the accuracy of the RDS estimation process, potentially causing differential biases. To do this, we will calculate RDS-diagnostic statistics for each cluster at each time point and compare these statistics within matched pairs and time points. Sensitivity analyses will assess the impact of potential biases arising from assumptions made by the RDS-2 estimation. We are not aware of any other completed pragmatic cluster RCTs that are recruiting participants using RDS. Our statistical design and analysis approach seeks to transparently document participant recruitment and allow an assessment of the representativeness of the study to the target population, a key aspect of pragmatic trials. The challenges we have faced in the design of this trial are likely to be shared in other contexts aiming to serve the needs of legally and/or socially marginalised populations for which no sampling frame exists and especially when the social networks of participants are both the target of intervention and the means of recruitment. The trial was registered at Pan African Clinical Trials Registry (PACTR201312000722390) on 9 December 2013.

Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change.

PubMed

Kangaslampi, Samuli; Garoff, Ferdinand; Peltonen, Kirsi

2015-06-17

Millions of children worldwide suffer from posttraumatic stress disorder (PTSD) symptoms and other mental health problems due to repeated exposure to war or organized violence. Forms of cognitive-behavioral therapy (CBT) are the most commonly used treatment for PTSD and appear to be effective for children as well, but little is known about the mechanisms of change through which they achieve their effectiveness. Here we present the study protocol of a randomized controlled trial (RCT) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy (NET), a CBT-based, manualized, short-term intervention for PTSD symptoms resulting from repeated traumatization, in immigrant children traumatized by war. We are conducting a multicentre, pragmatic RCT in a usual care setting. Up to 80 9-17-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention (NET) and control (treatment as usual, TAU) groups of equal sizes. The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group, on the primary outcomes of PTSD and depressive symptoms, psychological distress, resilience, and level of cognitive performance. The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness. The possible moderating effects of peritraumatic dissociation, level of cognitive performance, and gender on treatment effectiveness will also be considered. We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience, and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions. The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war. The trial will also generate insights into the complex relationships between PTSD, memory functions, posttraumatic cognitions and cognitive performance in children, and help guide the future development and implementation of therapeutic interventions for PTSD in children. ClinicalTrials.gov NCT02425280 . Registered 15 April 2015.

Freiburg Questionnaire of linguistic pragmatics (FQLP): psychometric properties based on a psychiatric sample.

PubMed

Riedel, Andreas; Suh, Heejung; Haser, Verena; Hermann, Ismene; Ebert, Dieter; Riemann, Dieter; Bubl, Emanuel; Tebartz van Elst, Ludger; Hölzel, Lars P

2014-12-24

Asperger's Syndrome (AS) is an autism spectrum disorder that is characterized by significant difficulties in social interaction and nonverbal communication, and restricted and repetitive patterns of behavior and interests. Difficulties with respect to pragmatic speech, reading emotional and social cues, differentiating between fact and fiction, and taking into account the influence of context on a statement are commonly described features. However, hitherto established questionnaires did not focus on these symptoms. In this study we present a short (11 questions) questionnaire which focuses on self-rated pragmatic speech abilities, the Freiburg Questionnaire of linguistic pragmatics (FQLP). Psychometric properties of the questionnaire were explored in a sample of 57 patients with Asperger's Syndrome, 66 patients with other psychiatric disorders, and a convenience sample of 56 people. Reliability analysis showed a high Cronbach's α. Strong correlations could be demonstrated for the FQLP with the Autism Quotient and the Empathy Quotient. Concerning divergent validity a moderate correlation was found between the FQLP and self-rated symptoms of personality disorders. No significant correlation was found between the FQLP and the vocabulary skills. The receiver operating characteristics curve showed an excellent diagnostic accuracy of the FQLP (.97). As the control group consisted of people without mental disorder and patients with different psychiatric disorders, the results indicate that the construct examined by the FQLP is quite specific to the peculiarities of AS. The FQLP is a reliable, brief and valid instrument. First results regarding sensitivity and specificity are highly promising.

Effect of a training and educational intervention for physicians and caregivers on antibiotic prescribing for upper respiratory tract infections in children at primary care facilities in rural China: a cluster-randomised controlled trial.

PubMed

Wei, Xiaolin; Zhang, Zhitong; Walley, John D; Hicks, Joseph P; Zeng, Jun; Deng, Simin; Zhou, Yu; Yin, Jia; Newell, James N; Sun, Qiang; Zou, Guanyang; Guo, Yan; Upshur, Ross E G; Lin, Mei

2017-12-01

Inappropriate antibiotic prescribing contributes to the generation of drug resistance worldwide, and is particularly common in China. We assessed the effectiveness of an antimicrobial stewardship programme aiming to reduce inappropriate antibiotic prescribing in paediatric outpatients by targeting providers and caregivers in primary care hospitals in rural China. We did a pragmatic, cluster-randomised controlled trial with a 6-month intervention period. Clusters were primary care township hospitals in two counties of Guangxi province in China, which were randomly allocated to the intervention group or the control group (in a 1:1 ratio in Rong county and in a 5:6 ratio in Liujiang county). Randomisation was stratified by county. Eligible participants were children aged 2-14 years who attended a township hospital as an outpatient and were given a prescription following a primary diagnosis of an upper respiratory tract infection. The intervention included clinician guidelines and training on appropriate prescribing, monthly prescribing peer-review meetings, and brief caregiver education. In hospitals allocated to the control group, usual care was provided, with antibiotics prescribed at the individual clinician's discretion. Patients were masked to their allocated treatment group but doctors were not. The primary outcome was the antibiotic prescription rate in children attending the hospitals, defined as the cluster-level proportion of prescriptions for upper respiratory tract infections in 2-14-year-old outpatients, issued during the final 3 months of the 6-month intervention period (endline), that included one or more antibiotics. The outcome was based on prescription records and analysed by modified intention-to-treat. This study is registered with the ISRCTN registry, number ISRCTN14340536. We recruited all 25 eligible township hospitals in the two counties (14 hospitals in Rong county and 11 in Liujiang county), and randomly allocated 12 to the intervention group and 13 to the control group. We implemented the intervention in three internal pilot clusters between July 1, 2015, and Dec 31, 2015, and in the remaining nine intervention clusters between Oct 1, 2016 and March 31, 2016. Between baseline (the 3 months before implementation of the intervention) and endline (the final 3 months of the 6-month intervention period) the antibiotic prescription rate at the individual level decreased from 82% (1936/2349) to 40% (943/2351) in the intervention group, and from 75% (1922/2548) to 70% (1782/2552) in the control group. After adjusting for the baseline antibiotic prescription rate, stratum (county), and potentially confounding patient and prescribing doctor covariates, this endline difference between the groups represented an intervention effect (absolute risk reduction in antibiotic prescribing) of -29% (95% CI -42 to -16; p=0·0002). In China's primary care setting, pragmatic interventions on antimicrobial stewardship targeting providers and caregivers substantially reduced prescribing of antibiotics for childhood upper respiratory tract infections. Department of International Development (UKAID) through Communicable Diseases Health Service Delivery. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

[Assessment of pragmatics from verbal spoken data].

PubMed

Gallardo-Paúls, B

2009-02-27

Pragmatic assessment is usually complex, long and sophisticated, especially for professionals who lack specific linguistic education and interact with impaired speakers. To design a quick method of assessment that will provide a quick general evaluation of the pragmatic effectiveness of neurologically affected speakers. This first filter will allow us to decide whether a detailed analysis of the altered categories should follow. Our starting point was the PerLA (perception, language and aphasia) profile of pragmatic assessment designed for the comprehensive analysis of conversational data in clinical linguistics; this was then converted into a quick questionnaire. A quick protocol of pragmatic assessment is proposed and the results found in a group of children with attention deficit hyperactivity disorder are discussed.

Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial

PubMed Central

Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

2015-01-01

Objective To test whether community mobilization adds effectiveness to conventional dengue control. Design Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Setting Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Participants Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85 182 residents in 18 838 households. Interventions A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention—chemical-free prevention of mosquito reproduction—to its own circumstances. All clusters continued the government run dengue control program. Main outcome measures Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. Results With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited (house index) (44.1%, 13.6% to 74.7%), fewer containers with larvae or pupae among containers examined (container index) (36.7%, 24.5% to 44.8%), fewer containers with larvae or pupae among houses visited (Breteau index) (35.1%, 16.7% to 55.5%), and fewer pupae per person (51.7%, 36.2% to 76.1%). The numbers needed to treat were 30 (95% confidence interval 20 to 59) for a lower risk of infection in children, 71 (48 to 143) for fewer reports of dengue illness, 17 (14 to 20) for the house index, 37 (35 to 67) for the container index, 10 (6 to 29) for the Breteau index, and 12 (7 to 31) for fewer pupae per person. Secondary per protocol analysis showed no serological evidence of a protective effect of temephos. Conclusions Evidence based community mobilization can add effectiveness to dengue vector control. Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement. Trial registration ISRCTN27581154 PMID:26156323

Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial.

PubMed

Andersson, Neil; Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de Los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

2015-07-08

To test whether community mobilization adds effectiveness to conventional dengue control. Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85,182 residents in 18,838 households. A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention-chemical-free prevention of mosquito reproduction-to its own circumstances. All clusters continued the government run dengue control program. Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited (house index) (44.1%, 13.6% to 74.7%), fewer containers with larvae or pupae among containers examined (container index) (36.7%, 24.5% to 44.8%), fewer containers with larvae or pupae among houses visited (Breteau index) (35.1%, 16.7% to 55.5%), and fewer pupae per person (51.7%, 36.2% to 76.1%). The numbers needed to treat were 30 (95% confidence interval 20 to 59) for a lower risk of infection in children, 71 (48 to 143) for fewer reports of dengue illness, 17 (14 to 20) for the house index, 37 (35 to 67) for the container index, 10 (6 to 29) for the Breteau index, and 12 (7 to 31) for fewer pupae per person. Secondary per protocol analysis showed no serological evidence of a protective effect of temephos. Evidence based community mobilization can add effectiveness to dengue vector control. Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement. ISRCTN27581154. © Andersson et al 2015.

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats

PubMed Central

Bond, John; Wilson, Janet; Eccles, Martin; Vanoli, Alessandra; Steen, Nick; Clarke, Ray; Zarod, Andrew; Lock, Catherine; Brittain, Katie; Speed, Chris; Rousseau, Nikki

2006-01-01

Background Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. Methods/design A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4–15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001- July 2008). Discussion As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives. PMID:16899123

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats.

PubMed

Bond, John; Wilson, Janet; Eccles, Martin; Vanoli, Alessandra; Steen, Nick; Clarke, Ray; Zarod, Andrew; Lock, Catherine; Brittain, Katie; Speed, Chris; Rousseau, Nikki

2006-08-09

Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.

A framework for analysis of research risks and benefits to participants in standard of care pragmatic clinical trials.

PubMed

Chen, Stephanie C; Kim, Scott Yh

2016-12-01

Standard of care pragmatic clinical trials that compare treatments already in use could improve care and reduce costs, but there is considerable debate about the research risks of standard of care pragmatic clinical trials and how to apply informed consent regulations to such trials. We sought to develop a framework integrating the insights from opposing sides of the debate. We developed a formal risk-benefit analysis framework for standard of care pragmatic clinical trials and then applied it to key provisions of the US federal regulations. Our formal framework for standard of care pragmatic clinical trial risk-benefit analysis takes into account three key considerations: the ex ante estimates of risks and benefits of the treatments to be compared in a standard of care pragmatic clinical trial, the allocation ratios of treatments inside and outside such a trial, and the significance of some participants receiving a different treatment inside a trial than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to standard of care pragmatic clinical trials. Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of standard of care pragmatic clinical trials and can be used to clarify the implications for informed consent. © The Author(s) 2016.

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

PubMed

Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

2015-10-01

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

PubMed

Smalley, Jaye Bea; Merritt, Maria W; Al-Khatib, Sana M; McCall, Debbe; Staman, Karen L; Stepnowsky, Carl

2015-10-01

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the design, planning, and conduct of a pragmatic clinical trial and offer insights regarding the best way to communicate the trial's results to their constituencies. © The Author(s) 2015.

Recruiting community health centers into pragmatic research: Findings from STOP CRC.

PubMed

Coronado, Gloria D; Retecki, Sally; Schneider, Jennifer; Taplin, Stephen H; Burdick, Tim; Green, Beverly B

2016-04-01

Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening. In partnership with STOP CRC's advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with Oregon Community Health Information Network, a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation. From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow-up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements. Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research. © The Author(s) 2015.

Recruiting community health centers into pragmatic research: Findings from STOP CRC

PubMed Central

Coronado, Gloria D; Retecki, Sally; Schneider, Jennifer; Taplin, Stephen H; Burdick, Tim; Green, Beverly B

2015-01-01

Background Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening. Methods In partnership with STOP CRC’s advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with OCHIN (formerly Oregon Community Health Information Network), a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation. Results From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements. Conclusion Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research. PMID:26419905

Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial.

PubMed

Fu, Steven S; van Ryn, Michelle; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Taylor, Brent C; Schlede, Carolyn M; Burke, Randy S; Joseph, Anne M

2014-05-01

Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]). Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates. clinicaltrials.gov Identifier: NCT00608426.

Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).

PubMed

James, Erica L; Ewald, Ben; Johnson, Natalie; Brown, Wendy; Stacey, Fiona G; Mcelduff, Patrick; Booth, Angela; Yang, Fan; Hespe, Charlotte; Plotnikoff, Ronald C

2014-12-29

Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed. This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior, quality of life, and depression. If referral of primary care patients to exercise specialists increases physical activity, this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults. If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations. Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .

Texting to Reduce Alcohol Misuse (TRAM): main findings from a randomized controlled trial of a text message intervention to reduce binge drinking among disadvantaged men.

PubMed

Crombie, Iain K; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Petrie, Dennis; Jones, Claire; Norrie, John; Evans, Josie M M; Emslie, Carol; Rice, Peter M; Slane, Peter W; Humphris, Gerry; Ricketts, Ian W; Melson, Ambrose J; Donnan, Peter T; Hapca, Simona M; McKenzie, Andrew; Achison, Marcus

2018-06-01

To test the effectiveness of a theoretically based text-message intervention to reduce binge drinking among socially disadvantaged men. A multi-centre parallel group, pragmatic, individually randomized controlled trial. Community-based study conducted in four regions of Scotland. A total of 825 men aged 25-44 years recruited from socially disadvantaged areas who had two or more episodes of binge drinking (> 8 UK units on a single occasion) in the preceding 28 days: 411 men were randomized to the intervention and 414 to the control. A series of 112 interactive text messages was delivered by mobile phone during a 12-week period. The intervention was structured around the Health Action Process Approach, a comprehensive model which allows integration of a range of evidence-based behaviour change techniques. The control group received 89 texts on general health, with no mention of alcohol or use of behaviour change techniques. The primary outcome measure was the proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) at 12 months post-intervention. The proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) was 41.5% in the intervention group and 47.8% in the control group. Formal analysis showed that there was no evidence that the intervention was effective [odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.57-1.08; absolute reduction 5.7%, 95% CI = -13.3 to 1.9]. The Bayes factor for this outcome was 1.3, confirming that the results were inconclusive. The retention was high and similar in intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged with the text messages: almost all (92%) replied to text messages and 67% replied more than 10 times. A theoretically based text-messaging intervention aimed at reducing binge drinking in disadvantaged men was not found to reduce prevalence of binge drinking at 12-month follow-up. © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care.

PubMed

Wiegersma, Marian; Panman, Chantal M C R; Kollen, Boudewijn J; Vermeulen, Karin M; Schram, Aaltje J; Messelink, Embert J; Berger, Marjolein Y; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H

2014-02-01

Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged ≥55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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

PubMed Central

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

2017-01-01

Background The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). Objective To describe the data management process and statistical analysis plan. Methods The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. Conclusion According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. Trial registration ClinicalTrials.gov number, NCT01374022. PMID:28977255

Cannabinergic pain medicine: a concise clinical primer and survey of randomized-controlled trial results.

PubMed

Aggarwal, Sunil K

2013-02-01

This article attempts to cover pragmatic clinical considerations involved in the use of cannabinergic medicines in pain practice, including geographical and historical considerations, pharmacokinetics, pharmacodynamics, adverse effects, drug interactions, indications, and contraindications. Topics include molecular considerations such as the 10-fold greater abundance of cannabinoid type 1 receptors compared to µ-opioid receptors in the central nervous system and anatomic distributions of cannabinoid receptors in pain circuits. The article uses a narrative review methodology drawing from authoritative textbooks and journals of cannabinoid medicine, Food and Drug Administration-approved cannabinoid drug labels, and current and historical pain medicine literature to address core clinical considerations. To survey the current evidence base for pain management with cannabinergic medicines, a targeted PubMed search was performed to survey the percentage of positive and negative published randomized-controlled trial (RCT) results with this class of pain medicines, using appropriate search limit parameters and the keyword search string "cannabinoid OR cannabis-based AND pain." Of the 56 hits generated, 38 published RCTs met the survey criteria. Of these, 71% (27) concluded that cannabinoids had empirically demonstrable and statistically significant pain-relieving effects, whereas 29% (11) did not. Cannabis and other cannabinergic medicines' efficacies for relieving pain have been studied in RCTs, most of which have demonstrated a beneficial effect for this indication, although most trials are short-term. Adverse effects are generally nonserious and well tolerated. Incorporating cannabinergic medicine topics into pain medicine education seems warranted and continuing clinical research and empiric treatment trials are appropriate.

Effectiveness of physical and occupational therapy on pain, function and quality of life in patients with trapeziometacarpal osteoarthritis - A systematic review and meta-analysis.

PubMed

Aebischer, Bernhard; Elsig, Simone; Taeymans, Jan

2016-03-01

Trapeziometacarpal osteoarthritis is associated with more pain and restrictions than other hand osteoarthritis due to the functional importance of the thumb. While the effectiveness of surgical and pharmacological interventions has been widely examined, there is a lack of specific evidence about conservative non-pharmacological trapeziometacarpal osteoarthritis therapies. The objective of this systematic review was to provide evidence-based knowledge on the effectiveness of physiotherapy and occupational therapy on pain, function and quality of life. A literature search of Medline, CINAHL, PEDro, OTseeker, EMB Dare Cochrane Database of Systematic Reviews and Cochrane CENTRAL was performed. Randomized and quasi-randomized controlled trials and corresponding systematic reviews, observational studies, pragmatic studies and case-control studies were included. The risk of bias was assessed. Out of 218 studies, 27 were retained. A narrative summary and a series of meta-analyses were performed. Concerning pain reduction, the meta-analysis showed parity of pre-fabricated neoprene and custom-made thermoplastic splints: standardized mean difference (SMD) -0.01 (95%CI -0.43, 0.40) (p=0.95). Multimodal interventions are more effective on pain compared to single interventions: standardized mean difference -3.16 (95%CI -5.56, -0.75) ( p  = 0.01). Physical and occupational therapy-related interventions, especially multimodal interventions, seem to be effective to treat pain in patients with trapeziometacarpal osteoarthritis. Pre-fabricated neoprene splints and custom-made thermoplastic splints may reduce pain equally. Single interventions seem not to be effective. Significant evidence for effectiveness on function and quality of life could not be found.

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

PubMed

Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

PubMed

Wright, N C; Foster, P J; Mudano, A S; Melnick, J A; Lewiecki, M E; Shergy, W J; Curtis, J R; Cutter, G R; Danila, M I; Kilgore, M L; Lewis, E C; Morgan, S L; Redden, D T; Warriner, A H; Saag, K G

2017-08-01

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

Right hemisphere damage: Communication processing in adults evaluated by the Brazilian Protocole MEC – Bateria MAC

PubMed Central

Fonseca, Rochele Paz; Fachel, Jandyra Maria Guimarães; Chaves, Márcia Lorena Fagundes; Liedtke, Francéia Veiga; Parente, Maria Alice de Mattos Pimenta

2007-01-01

Right-brain-damaged individuals may present discursive, pragmatic, lexical-semantic and/or prosodic disorders. Objective To verify the effect of right hemisphere damage on communication processing evaluated by the Brazilian version of the Protocole Montréal d’Évaluation de la Communication (Montreal Communication Evaluation Battery) – Bateria Montreal de Avaliação da Comunicação, Bateria MAC, in Portuguese. Methods A clinical group of 29 right-brain-damaged participants and a control group of 58 non-brain-damaged adults formed the sample. A questionnaire on sociocultural and health aspects, together with the Brazilian MAC Battery was administered. Results Significant differences between the clinical and control groups were observed in the following MAC Battery tasks: conversational discourse, unconstrained, semantic and orthographic verbal fluency, linguistic prosody repetition, emotional prosody comprehension, repetition and production. Moreover, the clinical group was less homogeneous than the control group. Conclusions A right-brain-damage effect was identified directly, on three communication processes: discursive, lexical-semantic and prosodic processes, and indirectly, on pragmatic process. PMID:29213400

Keeping the feet of the gods and the saints warm: mundane pragmatics in times of suffering and uncertainty.

PubMed

van Dongen, Els

2008-12-01

In this article the author writes about mundane pragmatics, or everyday deeds, in times of suffering and uncertainty. Such pragmatics differ from cultural practices such as biomedical therapies or individual health-seeking behaviour patterns. Medical anthropologists and others working in the field of health and illness often overlook such pragmatics. However, these actions are of great social value and express the connectedness and bonds between people. They also express our deep beliefs, hopes, powerlessness and vulnerability.

Narrative discourse in adults with high-functioning autism or Asperger syndrome.

PubMed

Colle, Livia; Baron-Cohen, Simon; Wheelwright, Sally; van der Lely, Heather K J

2008-01-01

We report a study comparing the narrative abilities of 12 adults with high-functioning autism (HFA) or Asperger Syndrome (AS) versus 12 matched controls. The study focuses on the use of referential expressions (temporal expressions and anaphoric pronouns) during a story-telling task. The aim was to assess pragmatics skills in people with HFA/AS in whom linguistic impairments are more subtle than in classic autism. We predicted no significant differences in general narrative abilities between the two groups, but specific pragmatic deficits in people with AS. We predicted they use fewer personal pronouns, temporal expressions and referential expressions, which require theory of mind abilities. Results confirmed both predictions. These findings provide initial evidence of how social impairments can produce mild linguistic impairments.

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease.

PubMed

Bakerly, Nawar Diar; Woodcock, Ashley; New, John P; Gibson, J Martin; Wu, Wei; Leather, David; Vestbo, Jørgen

2015-09-04

New treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy. Patients with chronic obstructive pulmonary disease (COPD), ≥ 40 years old, with exacerbation in the previous 3 years are randomised 1:1 to once-daily fluticasone furoate 100 μg/vilanterol 25 μg in a novel dry-powder inhaler versus continuing their existing therapy. The primary endpoint is the mean annual rate of COPD exacerbations; an electronic medical record allows real-time collection and monitoring of endpoint and safety data. The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in COPD. Clinicaltrials.gov identifier NCT01551758.

FIELD EXPERIENCE IN SAMPLING HAZARDOUS WASTE INCINERATORS

EPA Science Inventory

This paper is for presentation at the 77th annual meeting of the Air Pollution Control Association, June 24-29, 1984. The paper contains much useful, pragmatic information gained through numerous hazardous waste incinerator trial burn-type investigations performed for EPA by the ...

Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.

PubMed

Negussie, Henok; Molla, Meseret; Ngari, Moses; Berkley, James A; Kivaya, Esther; Njuguna, Patricia; Fegan, Greg; Tamiru, Abreham; Kelemework, Abebe; Lang, Trudie; Newport, Melanie J; McKay, Andy; Enquoselassie, Fikre; Davey, Gail

2018-05-14

Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia. We did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210. Between Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported. A simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries. Joint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid). Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

On what it means to know someone: a matter of pragmatics.

PubMed

Gill, Michael J; Swann, William B

2004-03-01

Two studies provide support for W. B. Swann's (1984) argument that perceivers achieve substantial pragmatic accuracy--accuracy that facilitates the achievement of relationship-specific interaction goals--in their social relationships. Study 1 assessed the extent to which group members reached consensus regarding the behavior of a member in familiar (as compared with unfamiliar) contexts and found that groups do indeed achieve this form of pragmatic accuracy. Study 2 assessed the degree of insight romantic partners had into the self-views of their partners on relationship-relevant (as compared with less relevant) traits and found that couples do indeed achieve this form of pragmatic accuracy. Furthermore, pragmatic accuracy was uniquely associated with relationship harmony. Implications for a functional approach to person perception are discussed.

Pragmatics & Language Learning. Volume 12

ERIC Educational Resources Information Center

Kasper, Gabriele, Ed.; Nguyen, Hanh thi, Ed.; Yoshimi, Dina Rudolph, Ed.; Yoshioka, Jim K., Ed.

2010-01-01

This volume examines the organization of second language and multilingual speakers' talk and pragmatic knowledge across a range of naturalistic and experimental activities. Based on data collected on Danish, English, Hawai'i Creole, Indonesian, and Japanese as target languages, the contributions explore the nexus of pragmatic knowledge,…

Pragmatic Communication Deficits in Children with Epilepsy

ERIC Educational Resources Information Center

Broeders, Mark; Geurts, Hilde; Jennekens-Schinkel, Aag

2010-01-01

Background: Various psychiatric and neurological disorders including epilepsy have been associated with language deficits. Pragmatic language deficits, however, have seldom been the focus of earlier studies in children with epilepsy. Moreover, it is unknown whether these pragmatic deficits are related to general intellectual functioning. Both…

Pragmatic Comprehension Development through Telecollaboration

ERIC Educational Resources Information Center

Rafieyan, Vahid; Sharafi-Nejad, Maryam; Khavari, Zahra; Eng, Lin Siew; Mohamed, Abdul Rashid

2014-01-01

Pragmatic comprehension can be ideally developed through contact with target language speakers. This contact can be provided in English as Foreign Language contexts through telecollaboration. To test the actual effect of telecollaboration on the development of pragmatic comprehension, 30 Iranian undergraduates of English as a Foreign Language…

Pragmatics & Language Learning. Volume 13

ERIC Educational Resources Information Center

Greer, Tim, Ed.; Tatsuki, Donna, Ed.; Roever, Carsten, Ed.

2013-01-01

"Pragmatics & Language Learning. Volume 13" examines the organization of second language and multilingual speakers' talk and pragmatic knowledge across a range of naturalistic and experimental activities. Based on data collected among ESL and EFL learners from a variety of backgrounds, the contributions explore the nexus of pragmatic…

A Study on Pragmatic Failure in Cross-Cultural Communication

ERIC Educational Resources Information Center

Fang, Jie

2010-01-01

Through analyzing and comparing the anecdotes of pragmatic failure in cross-cultural communication from the aspects of lexicon, syntax and discourse, some pragmatic strategies are suggested in intercultural communication. To improve learners' cultural awareness and communicative competence, a cultural-linguistic approach in foreign language…

Refining Pragmatically-Appropriate Oral Communication via Computer-Simulated Conversations

ERIC Educational Resources Information Center

Sydorenko, Tetyana; Daurio, Phoebe; Thorne, Steven L.

2018-01-01

To address the problem of limited opportunities for practicing second language speaking in interaction, especially delicate interactions requiring pragmatic competence, we describe computer simulations designed for the oral practice of extended pragmatic routines and report on the affordances of such simulations for learning pragmatically…

Assessing Variation in Permanence/Pragmatism Orientations: Implications for Marital Stability.

ERIC Educational Resources Information Center

Morgan, Mary Y.; Scanzoni, John

1987-01-01

Traces history of construct known as "permanent availability,""universal availability," and "permanence/pragmatism." Connects latter with emerging research tradition labeled "causes and consequences of divorce." Based on data collected from college students, constructed an index of permanence/pragmatism in close relationship. (Author)

Inconsistency prevents the valuable synergism of explanatory and pragmatic trails.

PubMed

Correia, Luis C L; Correia, Vitor C A; Souza, Thiago M B; Cerqueira, Antonio Maurício S; Alexandre, Felipe K B; Garcia, Guilherme; Ferreira, Felipe R M; Lopes, Fernanda O A

2018-05-01

To assess review articles on pragmatic trials in order to describe how authors define the aim of this type of study, how comprehensive methodological topics are covered, and which topics are most valued by authors. Review articles were selected from Medline Database, based on the expression "pragmatic trial" in the titles. Five trained medical students evaluated the articles, based on a list of 15 self-explanatory methodological topics. Each article was evaluated regarding topics covered. Baseline statements on the aim of pragmatic trials were derived. Among 22 articles identified, there was general agreement that the aim of a pragmatic trial is to evaluate if the intervention works under real-world conditions. The mean number of methodological topics addressed by each article was 7.6 ± 3.1. Only one article covered all 15 topics, three articles (14%) responded to at least 75% of topics and 13 articles (59%) mentioned at least 50% of the topics. The relative frequency each of the 15 topics was cited by articles had a mean of 50% ± 25%. No topic was addressed by all articles, only three (20%) were addressed by more than 75% of articles. There is agreement on the different aims of explanatory and pragmatic trials. But there is a large variation on methodological topics used to define a pragmatic trial, which led to inconsistency in defining the typical methodology of a pragmatic trial. © 2018 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Child shyness and peer likeability: The moderating role of pragmatics and vocabulary.

PubMed

Cheung, Hoi Shan; Elliott, John M

2017-11-01

The association between shyness and children's likeability by peers was examined, with pragmatic difficulty and receptive and expressive vocabularies as moderators. Participants were 164 preschoolers (72 boys, 92 girls) between 52 and 79 months old in Singapore. A cross-informant methodology was used, with peers and teachers contributing to separate peer likeability ratings. The findings highlighted a conceptual distinction between peer- and teacher-rated likeability by peers. For the latter only, a 3-way interaction involving shyness, vocabulary, and pragmatic difficulty was found, indicating that for shy children with low vocabulary scores, those who experienced less pragmatic difficulty tended to be seen by teachers as more well-liked by peers than those with more pragmatic difficulty. This suggests that pragmatic skills may serve a protective function especially for shy children with poor vocabulary skills. Statement of contribution What is already known on this subject? Child shyness is related to poorer peer acceptance and social competence Expressive vocabulary and pragmatic competence each has a buffering effect for shy children What the present study adds? Shyness is related to poorer peer likeability as assessed by teachers Shyness is unrelated to peer likeability as assessed by same- or different-sex peers Pragmatic skills buffer the effects of teacher-rated shyness only for children with poor receptive and expressive vocabularies The buffering effect of language ability is shown in a multilingual educational context. © 2017 The British Psychological Society.

Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans' Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial.

PubMed

Menz, Hylton B; Frescos, Nicoletta; Munteanu, Shannon E

2013-04-23

Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans' Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, this article describes the design of a randomized controlled trial to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. One hundred and twenty DVA clients with disabling foot pain residing in Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a 'usual care' control group. The intervention group will continue to receive their usual DVA-subsidized podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort®, Vasyli Medical, Labrador, Queensland, Australia). The control group will also continue to receive DVA-subsidized podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12® Version 2.0), the number of falls experienced during the follow-up period, the Timed Up and Go test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants' perception of overall treatment effect. Data will be analyzed using the intention-to-treat principle. This study is the first randomized controlled trial to evaluate the effectiveness of off-the-shelf footwear in reducing foot pain in DVA recipients. The intervention has been pragmatically designed to ensure that the study findings can be implemented into policy and clinical practice if found to be effective. Australian New Zealand Clinical Trials Registry: ACTRN12612000322831.

Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans’ Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, this article describes the design of a randomized controlled trial to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. Methods One hundred and twenty DVA clients with disabling foot pain residing in Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a ‘usual care’ control group. The intervention group will continue to receive their usual DVA-subsidized podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort®, Vasyli Medical, Labrador, Queensland, Australia). The control group will also continue to receive DVA-subsidized podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12® Version 2.0), the number of falls experienced during the follow-up period, the Timed Up and Go test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of overall treatment effect. Data will be analyzed using the intention-to-treat principle. Discussion This study is the first randomized controlled trial to evaluate the effectiveness of off-the-shelf footwear in reducing foot pain in DVA recipients. The intervention has been pragmatically designed to ensure that the study findings can be implemented into policy and clinical practice if found to be effective. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12612000322831 PMID:23782557

Developing L2 Pragmatics

ERIC Educational Resources Information Center

Bardovi-Harlig, Kathleen

2013-01-01

This article positions research on the acquisition of pragmatics as an inquiry in the greater field of second language acquisition research. Viewing pragmatics from this intersection, I consider five areas of research that are of interest in both fields and have the potential to make significant contributions to second language pragmatics…

Pragmatics and SLA.

ERIC Educational Resources Information Center

Kasper, Gabriele; Rose, Kenneth R.

1999-01-01

Reviews interlanguage pragmatics studies with a focus on learning in a liberal sense; in addition to studies with an explicit focus on development, investigations that examine the effect of proficiency as an independent variable on pragmatic performance are also considered. Two lines of inquiry are suggested for further research. (Author/VWL)

Mindful Storytellers: Emerging Pragmatics and Theory of Mind Development

ERIC Educational Resources Information Center

Fernández, Camila

2013-01-01

Emerging pragmatic language skills involve social, cognitive and linguistic abilities, including children's awareness of the conversational partner's mental states. The present study investigated the relation between children's theory of mind (ToM) and features of pragmatic language skills assessed through narrative discourse. One hundred and…

Effectiveness of using a new polyurethane foam multi-layer dressing in the sacral area to prevent the onset of pressure ulcer in the elderly with hip fractures: A pragmatic randomised controlled trial.

PubMed

Forni, Cristiana; D'Alessandro, Fabio; Gallerani, Pina; Genco, Rossana; Bolzon, Andrea; Bombino, Caterina; Mini, Sandra; Rocchegiani, Laura; Notarnicola, Teresa; Vitulli, Arianna; Amodeo, Alfredo; Celli, Guglielmo; Taddia, Patrizia

2018-06-01

Hip fractures in the elderly are a serious problem for the health service due to the high rate of complications. One of these complications is pressure ulcers that, according to the literature, occur in 8.8% to 55% of patients and mainly arise in the sacral area. The present randomised controlled trial tests whether applying a new innovative multi-layer polyurethane foam dressing (ALLEVYN LIFE™), reduces the onset of pressure ulcers in the sacral area. From March to December 2016, 359 fragility hip fracture patients were randomly divided into 2 groups: 182 in the control group and 177 in the experimental group. Pressure ulcers occurred overall in 36 patients (10%): 8 patients (4.5%) in the experimental group compared to 28 (15.4%) in the control group: P = 0.001, relative risk 0.29 (95% CI 0.14-0.61) with NNT of 9 (95% CI 6-21). In the experimental group the onset of pressure ulcers occurred on average on the 6th day compared to the 4th day in the control group (HR 4.4). Using polyurethane foam is effective at reducing the rate of pressure ulcers in the sacrum in elderly patients with hip fracture. The adhesiveness of this device also enables costs to be kept down. © 2018 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

PubMed

Krishnan, Jerry A; Martin, Molly A; Lohff, Cortland; Mosnaim, Giselle S; Margellos-Anast, Helen; DeLisa, Julie A; McMahon, Kate; Erwin, Kim; Zun, Leslie S; Berbaum, Michael L; McDermott, Michael; Bracken, Nina E; Kumar, Rajesh; Margaret Paik, S; Nyenhuis, Sharmilee M; Ignoffo, Stacy; Press, Valerie G; Pittsenbarger, Zachary E; Thompson, Trevonne M

2017-06-01

Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design. Published by Elsevier Inc.

Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan

PubMed Central

Krishnan, Jerry A.; Martin, Molly A.; Lohff, Cortland; Mosnaim, Giselle S.; Margellos-Anast, Helen; DeLisa, Julie A.; McMahon, Kate; Erwin, Kim; Zun, Leslie S.; Berbaum, Michael L.; McDermott, Michael; Bracken, Nina E.; Kumar, Rajesh; Paik, S. Margaret; Nyenhuis, Sharmilee M.; Ignoffo, Stacy; Press, Valerie G.; Pittsenbarger, Zachary E.; Thompson, Trevonne M.

2017-01-01

Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11 years old presenting to the ED with uncontrolled asthma that compares: (1) an ED-focused intervention to improve the quality of care on discharge to home, (2) the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and (3) enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6 months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design. PMID:28366780

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care

PubMed Central

Kraybill, Ashley; Dember, Laura M.; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S.; Madden, Vanessa; Halpern, Scott D.

2016-01-01

Background Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. Methods We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. Results A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients’ concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. Conclusions This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials. PMID:27833931

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care.

PubMed

Kraybill, Ashley; Dember, Laura M; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S; Madden, Vanessa; Halpern, Scott D

2016-01-01

Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients' concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials.

Long-term outcomes of internet-based self-management support in adults with asthma: randomized controlled trial.

PubMed

van Gaalen, Johanna L; Beerthuizen, Thijs; van der Meer, Victor; van Reisen, Patricia; Redelijkheid, Geertje W; Snoeck-Stroband, Jiska B; Sont, Jacob K

2013-09-12

Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse. The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone. Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale. At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second. Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care. International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).

A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings

PubMed Central

Yeates, Karen; Perkins, Nancy; Boesch, Lisa; Hua-Stewart, Diane; Liu, Peter; Sleeth, Jessica; Tobe, Sheldon W

2017-01-01

Background To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Objective Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Methods Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Results Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. Conclusions Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. Trial Registration ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege) PMID:28428165

Clinical impact of negative-pressure wound therapy: a 1,126-patient observational prospective study.

PubMed

Téot, Luc; Guillot-Masanovic, Margot; Miquel, Pierre; Truchetet, François; Meaume, Sylvie; Dompmartin, Anne; Charles Kerihuel, Jean; Trial, Chloé; Faure, Christine

2014-01-01

Negative-pressure wound therapy (NPWT) was developed in the early 1990s and reported in 1997 by Argenta and Morykwas. Ignored at first, this technique progressively came to be considered as an outstanding advancement in reconstructive surgery. Several randomized controlled studies produced evidence for the effect of NPWT on promotion of granulation tissue formation and prevention of tissue damage and amputation. However, no important longitudinal study has yet produced clinical and economic data on the consequences of integrating NPWT into practice in multiple institutions. This prospective, comparative longitudinal study of NPWT as a clinical-practice innovation was conducted in 1,126 patients between March 2006 and June 2009 in 30 university and nonuniversity public and private hospitals in France. NPWT was proposed in a nonrandomized fashion for various clinical indications, and the patients were divided into two groups, one using NPWT, the second using standard care. Efficacy criteria were spontaneous closure, closure after surgical coverage using skin grafts or flaps, or achievement of 40% wound area regression. The results, observed in a pragmatic but not randomized study, are suggestive of a favorable impact of NPWT in multiple clinical situations. The significance of differences between surgical patients who underwent NPWT and those who did not was unclear, as NPWT had already been adopted by most of the surgical wards. © 2014 by the Wound Healing Society.

Displaced Proximal Humerus Fractures: is a Sling as Good as a Plate?

PubMed

Steinhaus, Michael E; Dare, David M; Gulotta, Lawrence V

2016-10-01

The treatment of displaced proximal humerus fractures is challenging and complex, as its success is predicated on multiple factors. While it is clear that a majority of proximal humerus fractures may be treated nonoperatively, it is less clear which patients benefit from surgical management. The PROFHER trial, a randomized controlled study, used patient-reported outcomes to compare surgical to nonsurgical management of displaced proximal humerus fractures. The purpose of this review is to highlight the strengths and weaknesses of the PROFHER trial and to assess the validity of its conclusion in the context of existing literature. The authors found no difference in the Oxford Shoulder Score (OSS) between the surgical and nonsurgical groups. Additionally, no difference was found between groups in any of the secondary outcomes, which included the Short-Form 12 (SF-12) health survey, surgical and fracture-related complications, additional surgery or therapy, inpatient medical complications, and mortality. They concluded that the recent increase in surgical management of proximal humerus fractures is perhaps unwarranted. While the randomization was successful and the pragmatic design may enable greater generalizability, this study possesses numerous flaws inherent in such an ambitious endeavor, including an inability to identify specific factors which explain the lack of superiority of surgical management. Despite its weaknesses, this study is a valuable datapoint which encourages surgeons to reexamine their surgical indications for this injury.

A tutorial on the LQG/LTR method. [Linear Quadratic Gaussian/Loop Transfer Recovery

NASA Technical Reports Server (NTRS)

Athans, M.

1986-01-01

In this paper the so-called Linear-Quadratic-Gaussian method with Loop-Transfer-Recovery is surveyed. The objective is to provide a pragmatic exposition, with special emphasis on the step-by-step characteristics for designing multivariable feedback control systems.

Managing an Uncontrolled Vocabulary Ex Post Factor

ERIC Educational Resources Information Center

Lefever, Maureen; And Others

1972-01-01

The operational retrospective retrieval service offered by BIOSIS exploits a file created essentially without vocabulary control. A pragmatic program of file building criteria has been persued which has provided improved retrieval and an annual summary of the vocabulary of the literature. (11 references) (Author/KE)

Communicative competence in Alzheimer's disease: metaphor and sarcasm comprehension.

PubMed

Maki, Yohko; Yamaguchi, Tomoharu; Koeda, Tatsuya; Yamaguchi, Haruyasu

2013-02-01

The purpose of this study was to evaluate the deficits of metaphor and sarcasm comprehension in Alzheimer's disease (AD), as pragmatic interpretation such as metaphor and sarcasm comprehension is required in social communication. A total of 31 young normal controls, 104 aged normal controls (ANC), 42 patients with amnesic mild cognitive impairment (aMCI), and 30 patients with mild AD were evaluated by Metaphoric and Sarcastic Scenario Test, which consists of 5 metaphoric and 5 sarcastic questions with 5 answer choices. Scores were analyzed using the repeated measures analysis of variance (metaphor/sarcasm vs 4 participant groups). Sarcasm comprehension, which requires second-order Theory of Mind (ToM), started to deteriorate in ANC, and metaphor comprehension, which requires first-order ToM, started to deteriorate in aMCI, and both deteriorated as disease progressed. Literal interpretation of pragmatic language is characteristic in patients with mild AD. Such misinterpretation would result in social miscommunication, even if they still retained semantic-lexical competence.

Making trials matter: pragmatic and explanatory trials and the problem of applicability

PubMed Central

Treweek, Shaun; Zwarenstein, Merrick

2009-01-01

Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aiming to use the information in them. It is intended to help the former group make their trials more widely useful and to help the latter group make more informed decisions about the wider use of existing trials. We review the differences between the design of most randomised trials (which have an explanatory attitude) and the design of trials more able to inform decision making (which have a pragmatic attitude) and discuss approaches used to assert applicability of trial results. If we want evidence from trials to be used in clinical practice and policy, trialists should make every effort to make their trial widely applicable, which means that more trials should be pragmatic in attitude. PMID:19493350

Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose

PubMed Central

2013-01-01

Background If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention. Methods The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of pragmatism. Discussion We have concrete suggestions for improving PRECIS and a growing list of enthusiastic individuals interested in contributing to this work. By early 2014 we expect to have a validated PRECIS-2. PMID:23782862

Teacher-Based Assessment for Foreign Language Pragmatics

ERIC Educational Resources Information Center

Ishihara, Noriko

2009-01-01

Despite the growing interest in teaching second language (L2) pragmatics, the issue of assessment of learners' pragmatic skills, particularly in the context of the classroom, seems to be less prominently discussed, even though the assessment is an integral part of the instruction. This qualitative case study aims to demonstrate an…

Pragmatic Language Development in Language Impaired and Typically Developing Children: Incorrect Answers in Context

ERIC Educational Resources Information Center

Ryder, Nuala; Leinonen, Eeva

2014-01-01

This study focused on young children's incorrect answers to pragmatically demanding questions. Children with specific language impairment (SLI), including a subgroup with pragmatic language difficulties (PLD) and typically developing children answered questions targeting implicatures, based on a storybook and short verbal scenarios.…

Narrative Competence in Children with Pragmatic Language Impairment: A Longitudinal Study

ERIC Educational Resources Information Center

Ketelaars, Mieke P.; Jansonius, Kino; Cuperus, Juliane; Verhoeven, Ludo

2016-01-01

Background: Children with pragmatic language impairment (PLI) show impairments in the use of language in social contexts. Although the issue has been gaining attention in recent literature, not much is known about the developmental trajectories of children who experience pragmatic language problems. Since narrative competence is an important…

Are Learning Organizations Pragmatic?

ERIC Educational Resources Information Center

Cavaleri, Steven A.

2008-01-01

Purpose: The purpose of this paper is to evaluate the future prospects of the popular concept known as the learning organization; to trace the influence of philosophical pragmatism on the learning organization and to consider its potential impact on the future; and to emphasize how pragmatic theories have shaped the development of Deming's total…