intervention and baseline periods, we will use random effects logistic regression models, which take the clustered nature of the data within nurses and hospitals into account. We will assess attitudes of staff nurses toward cessation counseling by questionnaire and will identify barriers and facilitators to implementation by using clinician focus groups. To determine the short-term incremental cost per quitter from the perspective of the VA health care system, we will calculate cessation-related costs incurred during the initial hospitalization and six-month follow-up period. Trial number NCT00816036
Full Text Available Abstract Background The use of oral anticoagulant therapy (OAT to prevent non-valvular atrial fibrillation (NVAF related-strokes is often sub-optimal. We aimed to evaluate whether implementing guidelines on antithrombotic therapy (AT by a multifaceted strategy may improve appropriateness of its prescription in NVAF-patients discharged from a large tertiary-care hospital. Methods A survey was conducted on all consecutive NVAF patients discharged before (1st January–30th June 2000, n = 313 and after (1st January–30th June 2004, n = 388 guideline development and implementation. Results When strongly recommended, OAT use increased from 56.6% (60/106 in 2000 to 81.9% (86/105 in 2004, with an absolute difference of +25.3% (95%CI: 15% 35%. In patients for whom the choice OAT/acetylsalicylic acid should be individualised, those discharged without any AT were 33.7% (34/101 in 2000 and 16.9% (21/124 in 2004 (-16.7%;95%CI: -26.2% -7.2%. In a logistic regression model, OAT prescription in 2004 was increased by 2.11 times (95%CI: 1.47 3.04, after accounting for stroke risk, presence of contraindications (OR = 0.18; 0.13 0.27, older age (OR = 0.30; 0.21 0.45, prophylaxis at admission (OR = 3.03; 2.08 4.43. OAT was positively associated with the stroke risk in the 2004 sample only. Conclusion The guideline implementation has substantially improved the appropriateness of OAT at discharge, through a better evaluation at patient's individual level of the benefit-to-risk ratio.
Hess, Sascha; Sidler, Patrick; Chmiel, Corinne; Bögli, Karin; Senn, Oliver; Eichler, Klaus
The increasing number of patients requiring emergency care is a challenge and leads to decreased satisfaction of health professionals at emergency departments (EDs). Thus, a Swiss hospital implemented a hospital-associated primary care centre at the ED. The study aim was to investigate changes in job satisfaction of ED staff before and after the implementation of this new service model and to measure hospital GPs' (HGPs) satisfaction at the hospital-associated primary care centre. This study was embedded in a large prospective before-after study over two years. We examined changes in job satisfaction with a questionnaire followed by selected interviews approaching all of the involved 25 ED staff members and 38 HGPs. The new emergency care model increased job satisfaction of ED staff and HGPs in all measured dimensions. The overall job satisfaction of ED employees improved from 76.5 to 83.9 points (visual analogue scale 0-100; difference 7.4 points [95% CI: 1.3 to 13.5, p = 0.02]). 86% of 29 HGPs preferred to provide their out-of-hours service at the new hospital-associated primary care centre. The hospital-associated primary care centre is a promising option to improve job satisfaction of different health professionals in emergency care. Copyright © 2015 Elsevier Ltd. All rights reserved.
Full Text Available Abstract Background Presumptive treatment of all febrile patients with anti-malarials leads to massive over-treatment. The aim was to assess the effect of implementing malaria rapid diagnostic tests (mRDTs on prescription of anti-malarials in urban Tanzania. Methods The design was a prospective collection of routine statistics from ledger books and cross-sectional surveys before and after intervention in randomly selected health facilities (HF in Dar es Salaam, Tanzania. The participants were all clinicians and their patients in the above health facilities. The intervention consisted of training and introduction of mRDTs in all three hospitals and in six HF. Three HF without mRDTs were selected as matched controls. The use of routine mRDT and treatment upon result was advised for all patients complaining of fever, including children under five years of age. The main outcome measures were: (1 anti-malarial consumption recorded from routine statistics in ledger books of all HF before and after intervention; (2 anti-malarial prescription recorded during observed consultations in cross-sectional surveys conducted in all HF before and 18 months after mRDT implementation. Results Based on routine statistics, the amount of artemether-lumefantrine blisters used post-intervention was reduced by 68% (95%CI 57-80 in intervention and 32% (9-54 in control HF. For quinine vials, the reduction was 63% (54-72 in intervention and an increase of 2.49 times (1.62-3.35 in control HF. Before-and-after cross-sectional surveys showed a similar decrease from 75% to 20% in the proportion of patients receiving anti-malarial treatment (Risk ratio 0.23, 95%CI 0.20-0.26. The cluster randomized analysis showed a considerable difference of anti-malarial prescription between intervention HF (22% and control HF (60% (Risk ratio 0.30, 95%CI 0.14-0.70. Adherence to test result was excellent since only 7% of negative patients received an anti-malarial. However, antibiotic
Li, James; Reaven, Nancy L; Funk, Susan E; McGaughey, Karen; Neovius, Martin
Our objective was to estimate 4-year healthcare costs associated with the metabolic profile of patients before and after 1 year of treatment with phentermine (15 mg) and topiramate extended-release (92 mg) [phentermine-topiramate ER]. Using a medical records database, we created two patient cohorts reflecting metabolic profiles of subjects before and after phentermine-topiramate ER therapy during the 1-year CONQUER trial. We matched database patients with trial subjects by age, sex, body mass index (BMI), and hypertension, glycemic, and triglyceride status. We collected real-world data on emergency department and outpatient visits, hospitalizations, and drug prescriptions over 4 years, linking them to reimbursements to estimate US private insurance costs for post-trial (n = 2295) versus pre-trial intention-to-treat (ITT) patients (n = 2295). Secondary analysis assessed responders (completers losing ≥5 % body weight [n = 1285]). Over 4 years, the mean cost per patient in the post- versus pre-trial ITT-group was $US32,432 versus $US34,725 (mean difference -2292; 95 % confidence interval [CI] -4776 to 209). In responders, corresponding costs were $US30,558 versus $US33,936 (mean difference -3378; 95 % CI -6496 to -464). Costs for post- versus pre-trial responders were lower for outpatient visits, emergency visits, and medications (all P < 0.05). Excluding treatment cost and potential side effects, patients matched to profiles of phentermine-topiramate ER responders had lower costs than patients matched to pre-treatment profiles.
The implementation of NICE guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England.
Bateman, Alice G; Sheaff, Rod; Child, Susan; Boiko, Olga; Ukoumunne, Obioha C; Nokes, Tim; Copplestone, Adrian; Gericke, Christian A
Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference -3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis.
Fuller, Brian M; Ferguson, Ian; Mohr, Nicholas M; Stephens, Robert J; Briscoe, Cristopher C; Kolomiets, Angelina A; Hotchkiss, Richard S; Kollef, Marin H
In critically ill patients, acute respiratory distress syndrome (ARDS) and ventilator-associated conditions (VACs) are associated with increased mortality, survivor morbidity and healthcare resource utilisation. Studies conclusively demonstrate that initial ventilator settings in patients with ARDS, and at risk for it, impact outcome. No studies have been conducted in the emergency department (ED) to determine if lung-protective ventilation in patients at risk for ARDS can reduce its incidence. Since the ED is the entry point to the intensive care unit for hundreds of thousands of mechanically ventilated patients annually in the USA, this represents a knowledge gap in this arena. A lung-protective ventilation strategy was instituted in our ED in 2014. It aims to address the parameters in need of quality improvement, as demonstrated by our previous research: (1) prevention of volutrauma; (2) appropriate positive end-expiratory pressure setting; (3) prevention of hyperoxia; and (4) aspiration precautions. The lung-protective ventilation initiated in the emergency department (LOV-ED) trial is a single-centre, quasi-experimental before-after study testing the hypothesis that lung-protective ventilation, initiated in the ED, is associated with reduced pulmonary complications. An intervention cohort of 513 mechanically ventilated adult ED patients will be compared with over 1000 preintervention control patients. The primary outcome is a composite outcome of pulmonary complications after admission (ARDS and VACs). Multivariable logistic regression with propensity score adjustment will test the hypothesis that ED lung-protective ventilation decreases the incidence of pulmonary complications. Approval of the study was obtained prior to data collection on the first patient. As the study is a before-after observational study, examining the effect of treatment changes over time, it is being conducted with waiver of informed consent. This work will be disseminated by
Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence; Bouwes Bavinck, Jan Nico; Coenraads, Pieter-Jan; Diepgen, T.L.; Elsner, Peter; Garcia-Doval, Ignacio; Grob, J.J.; Langan, Sinead; Naldi, L.
textabstractBackground:In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series.Methods:For this quasi-experimental study, original articles reporting...
S. Bastuji-Garin (Sylvie); E. Sbidian (Emilie); C. Gaudy-Marqueste (Caroline); E. Ferrat (Emilie); J.C. Roujeau (Jean-Claude); M.A. Richard (Marie-Aleth); F. Canoui-Poitrine (Florence); J.N. Bouwes Bavinck (Jan Nico); P.J. Coenraads (Pieter-Jan); T.L. Diepgen; P. Elsner (Peter); I. Garcia-Doval (Ignacio); J.J. Grob; S. Langan (Sinead); L. Naldi; T.E.C. Nijsten (Tamar); J. Schmitt (Julien); Å. Svensson (Åke); H. Williams
textabstractBackground:In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement
Muller-Staub, M.; Needham, I.; Odenbreit, M.; Lavin, M.A.; Achterberg, T. van
AIM: This paper is a report of a study to investigate the effect of guided clinical reasoning. This method was chosen as a follow-up educational measure (refresher) after initial implementation of standardized language. BACKGROUND: Research has demonstrated nurses' need for education in diagnostic
Paul, Amy; Merritt, Maria W; Sugarman, Jeremy
Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. © 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.
Effect of chlorhexidine/silver sulfadiazine-impregnated central venous catheters in an intensive care unit with a low blood stream infection rate after implementation of an educational program: a before-after trial.
Schuerer, Douglas J E; Zack, Jeanne E; Thomas, James; Borecki, Ingrid B; Sona, Carrie S; Schallom, Marilyn E; Venker, Melissa; Nemeth, Jennifer L; Ward, Myrna R; Verjan, Linda; Warren, David K; Fraser, Victoria J; Mazuski, John E; Boyle, Walter A; Buchman, Timothy G; Coopersmith, Craig M
Current guidelines recommend using antiseptic- or antibiotic-impregnated central venous catheters (CVCs) if, following a comprehensive strategy to prevent catheter-related blood stream infection (CR-BSI), infection rates remain above institutional goals based on benchmark values. The purpose of this study was to determine if chlorhexidine/silver sulfadiazine-impregnated CVCs could decrease the CR-BSI rate in an intensive care unit (ICU) with a low baseline infection rate. Pre-intervention and post-intervention observational study in a 24-bed surgical/trauma/burn ICU from October, 2002 to August, 2005. All patients requiring CVC placement after March, 2004 had a chlorhexidine/silver sulfadiazine-impregnated catheter inserted (post-intervention period). Twenty-three CR-BSIs occurred in 6,960 catheter days (3.3 per 1,000 catheter days)during the 17-month control period. After introduction of chlorhexidine/silver sulfadiazine-impregnated catheters, 16 CR-BSIs occurred in 7,732 catheter days (2.1 per 1,000 catheter days; p = 0.16). The average length of time required for an infection to become established after catheterization was similar in the two groups (8.4 vs. 8.6 days; p = 0.85). Chlorhexidine/silver sulfadiazine-impregnated catheters did not result in a statistically significant change in the microbiological profile of CR-BSIs, nor did they increase the incidence of resistant organisms. Although chlorhexidine/silver sulfadiazine-impregnated catheters are useful in specific patient populations, they did not result in a statistically significant decrease in the CR-BSI rate in this study, beyond what was achieved with education alone.
Mills, S M; Mallmann, J; Santacruz, A M; Fuqua, A; Carril, M; Aisen, P S; Althage, M C; Belyew, S; Benzinger, T L; Brooks, W S; Buckles, V D; Cairns, N J; Clifford, D; Danek, A; Fagan, A M; Farlow, M; Fox, N; Ghetti, B; Goate, A M; Heinrichs, D; Hornbeck, R; Jack, C; Jucker, M; Klunk, W E; Marcus, D S; Martins, R N; Masters, C M; Mayeux, R; McDade, E; Morris, J C; Oliver, A; Ringman, J M; Rossor, M N; Salloway, S; Schofield, P R; Snider, J; Snyder, P; Sperling, R A; Stewart, C; Thomas, R G; Xiong, C; Bateman, R J
The Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) was formed to direct the design and management of interventional therapeutic trials of international DIAN and autosomal dominant Alzheimer's disease (ADAD) participants. The goal of the DIAN-TU is to implement safe trials that have the highest likelihood of success while advancing scientific understanding of these diseases and clinical effects of proposed therapies. The DIAN-TU has launched a trial design that leverages the existing infrastructure of the ongoing DIAN observational study, takes advantage of a variety of drug targets, incorporates the latest results of biomarker and cognitive data collected during the observational study, and implements biomarkers measuring Alzheimer's disease (AD) biological processes to improve the efficiency of trial design. The DIAN-TU trial design is unique due to the sophisticated design of multiple drugs, multiple pharmaceutical partners, academics servings as sponsor, geographic distribution of a rare population and intensive safety and biomarker assessments. The implementation of the operational aspects such as home health research delivery, safety magnetic resonance imagings (MRIs) at remote locations, monitoring clinical and cognitive measures, and regulatory management involving multiple pharmaceutical sponsors of the complex DIAN-TU trial are described. Published by Elsevier Masson SAS.
Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first
Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first national randomised
Engers, AJ; Wensing, M.; van Tulder, M.; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.
STUDY DESIGN.: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES.: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence
Engers, A.J.; Wensing, M.J.P.; Tulder, M.W. van; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.
STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to
Full Text Available In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series.For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥ 4 were selected. We compared the proportions of STROBE items (STROBE score adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007 and one post STROBE period (2008-2010. Segmented regression analysis of interrupted time series was also performed.Of the 456 included articles, 187 (41% reported cohort studies, 166 (36.4% cross-sectional studies, and 103 (22.6% case-control studies. The median STROBE score was 57% (range, 18%-98%. Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-05 48% versus median score2008-10 58%, p<0.001 but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-07 58% versus median score2008-10 58%, p = 0.42. In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016. By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64 in the post STROBE statement publication.The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after
Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence
In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series. For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥ 4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007) and one post STROBE period (2008-2010). Segmented regression analysis of interrupted time series was also performed. Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%-98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-05 48% versus median score2008-10 58%, pSTROBE period and the post-STROBE period (median score2006-07 58% versus median score2008-10 58%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64) in the post STROBE statement publication. The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after analysis for estimating the impact of
Bordet, Régis; Lang, Marie; Dieu, Christelle; Billon, Nathalie; Duffet, Jean-Pierre
A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials. We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of <15 % of trials sites without patients enrolled. In 2013, the median delay to contract signature was: 55 days, compared with 76 days in 2008 (27.6 % reduction), 50.5 % of all sites and 58 % of sites with a dedicated CRA included ≥80 % of the planned number of patients compared with 44.8 % in 2008 (12.7 % increase) and 21.3 % of all sites and 9 % of sites with a dedicated CRA closed with no patients included, compared with 26.4 % in 2008 (19.3 and 65.9 %, respectively). These results provide evidence that it is possible to improve a country's attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western
Pinheiro, José; Kuznetsova, Olga
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, t...
Introduction. Researchers, practitioners and policymakers make decisions at all levels – from local to international. Accessible, integrated and up-to-date evidence is essential for successful and responsive decision-making. A current trials register of randomised and clinically controlled trials of HIV/AIDS interventions can ...
Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David
To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.
Rajmil, Luis; Medina-Bustos, Antonia; Fernández de Sanmamed, María-José; Mompart-Penina, Anna
To analyse changes in the family living conditions of children in Catalonia between 2006 and the 2010-2012 period, and to study associations between these changes and health outcomes. A before-after analysis of two cross-sectional surveys. Population younger than 15 years of age from Catalonia, Spain. Representative samples of children in the 2006 Catalan Health Survey (ESCA), baseline, before the crisis; n=2200) and the first four waves of ESCA 2010-2012 (after start of the crisis, n=1967). Overweight/obesity, health behaviour, mental health and health-related quality of life (HRQOL). Logistic regression and multiple linear regression models were used to analyse the influence of changes in family conditions on outcome measures, including interaction terms to describe the potential influence of the study period on the results. The percentage of unemployed families rose from 9.1% (2006) to 20.6% (2010-2012), with inequalities by level of education. Overweight/obesity increased from 18.4% (95% CI 16.5% to 20.4%) to 26.9% (24.6% to 29.2%) in 2010-2012, and inequalities related to maternal education and employment status persisted. Eating habits have improved in 2010-2012 in disadvantaged families (ie, junk food consumption improved in families with a maternal primary education level; beta (B)=2.85; 0.83 to 4.88, for the survey interaction by primary education level). An improvement in HRQOL was found in the second survey (B=6.07; 4.15 to 7.99), although children whose mothers had a primary education showed poorer HRQOL scores in this survey than in 2006 (B=-4.14; -7.17 to -1.12). Although some health-related behaviour improved during the study period, childhood obesity increased and inequalities in HRQOL appeared. Policy measures that fight against these inequalities should be urgently implemented to avoid their negative impact on the health of future generations of Catalans.
Lykke, Jørn; Oestrich, I.; Austin, Stephen
Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...
Jun 19, 2008 ... The building of a functioning HIV/AIDS trials management system can provide policymakers, re- searchers and practitioners with accessible, ... GIS technology and a relational database management system to locate HIV/AIDS ..... Available at the Sunnyside Park Hotel—. For rates and further information ...
Saillour-Glénisson, Florence; Duhamel, Sylvie; Fourneyron, Emmanuelle; Huiart, Laetitia; Joseph, Jean Philippe; Langlois, Emmanuel; Pincemail, Stephane; Ramel, Viviane; Renaud, Thomas; Roberts, Tamara; Sibé, Matthieu; Thiessard, Frantz; Wittwer, Jerome; Salmi, Louis Rachid
Improvement of coordination of all health and social care actors in the patient pathways is an important issue in many countries. Health Information (HI) technology has been considered as a potentially effective answer to this issue. The French Health Ministry first funded the development of five TSN ("Territoire de Soins Numérique"/Digital health territories) projects, aiming at improving healthcare coordination and access to information for healthcare providers, patients and the population, and at improving healthcare professionals work organization. The French Health Ministry then launched a call for grant to fund one research project consisting in evaluating the TSN projects implementation and impact and in developing a model for HI technology evaluation. EvaTSN is mainly based on a controlled before-after study design. Data collection covers three periods: before TSN program implementation, during early TSN program implementation and at late TSN program implementation, in the five TSN projects' territories and in five comparison territories. Three populations will be considered: "TSN-targeted people" (healthcare system users and people having characteristics targeted by the TSN projects), "TSN patient users" (people included in TSN experimentations or using particular services) and "TSN professional users" (healthcare professionals involved in TSN projects). Several samples will be made in each population depending on the objective, axis and stage of the study. Four types of data sources are considered: 1) extractions from the French National Heath Insurance Database (SNIIRAM) and the French Autonomy Personalized Allowance database, 2) Ad hoc surveys collecting information on knowledge of TSN projects, TSN program use, ease of use, satisfaction and understanding, TSN pathway experience and appropriateness of hospital admissions, 3) qualitative analyses using semi-directive interviews and focus groups and document analyses and 4) extractions of TSN
Bishop, Crystal D.; Snyder, Patricia A.; Crow, Robert E.
We used a multi-component single-subject experimental design across three preschool teachers to examine the effects of video self-monitoring with graduated training and feedback on the accuracy with which teachers monitored their implementation of embedded instructional learning trials. We also examined changes in teachers' implementation of…
Mohr, D.C.; Ho, J.; Hart, T.L.; Baron, K.G.; Berendsen, M.; Beckner, V.; Cai, X.; Cuijpers, P.; Spring, B.; Kinsinger, S.W.; Schroder, K.E.; Duffecy, J.
Abstract: Control conditions are the primary methodology used to reduce threats to internal validity in randomized controlled trials (RCTs). This meta-analysis examined the effects of control arm design and implementation on outcomes in RCTs examining psychological treatments for depression. A
Prout, Hayley; Butler, Christopher; Kinnersley, Paul; Robling, Mike; Hood, Kerenza; Tudor-Jones, Rhiannedd
For findings of randomized controlled trials in primary care to be applicable, both the sample of clinicians implementing the trial and the recruited patients should be as representative as possible. The processes of conducting trials should be made "user-friendly" to clinician investigators in order to maximize their participation in research. Formal evaluations of trial implementation are unusual. This study reports clinicians' perspectives on acting as a clinician investigator in a randomized controlled trial (the SAVIT study) in general practice. Our purpose was to explore clinicians' accounts of taking part in a randomized controlled trial in which subjects were recruited opportunistically during general practice consultations. Individual semi-structured interviews were conducted with nine GPs and one practice nurse practising in the Bro Taf area of South Wales who recruited children into the SAVIT study. A structured interview guide was used and data were analysed using the qualitative method of pattern coding. Major emerging themes included recruitment difficulties and concerns about the safety of the study medication. Participants also outlined positive aspects of the study (clarity and simplicity of the study, potential benefits to clinicians and patients and study team follow-up of recruited patients). Recommendations for possible improvements in study implementation included the simplification and reduction of patient reading materials and improved presentation of study materials. Difficulty in recruiting patients was the most frequently mentioned problem by clinician investigators. Insufficient time in the consultation was perceived as the main barrier. Ingredients of successful trial implementation include good organization, simple documentation and study procedures, and the ability to allay concerns about patient safety. Findings from this evaluation may assist researchers in the design and implementation of future community-based randomized
Poe, Stephanie S; Abbott, Patricia; Pronovost, Peter
Use of peer coaches may be effective in building and maintaining competencies bedside nurses need to safely use electronic health records (EHRs). A nonexperimental design with before-after measures was used to evaluate the effectiveness of peer coaches in increasing learner satisfaction and confidence in EHR use on 9 units at an academic medical center. Survey findings suggested that nurses experienced higher than expected satisfaction with training and increased self-confidence in the EHR use following program implementation.
O'Brien, James; Finch, Caroline F
Recently, the use of specific exercise programmes to prevent musculoskeletal injuries in team ball sports has gained considerable attention, and the results of large-scale, randomised controlled trials have supported their efficacy. To enhance the translation of these interventions into widespread use, research trials must be reported in a way that allows the players, staff and policymakers associated with sports teams to implement these interventions effectively. In particular, information is needed on core implementation components, which represent the essential and indispensable aspects of successful implementation. To assess the extent to which team ball sport injury prevention trial reports have reported the core implementation components of the intervention, the intervention target and the use of any delivery agents (ie, staff or other personnel delivering the intervention). To summarise which specific types of intervention, intervention target and delivery agents are reported. To develop consensus between reviewers on the reporting of these components. Six electronic databases were systematically searched for English-language, peer-reviewed papers on injury prevention exercise programme (IPEP) trials in team ball sports. The reporting of all eligible trials was assessed by two independent reviewers. The reporting of the three core implementation components were coded as 'yes', 'no' or 'unclear'. For cases coded as 'yes', the specific types of interventions, intervention targets and delivery agents were extracted and summarised. The search strategy identified 52 eligible trials. The intervention and the intervention target were reported in all 52 trials. The reporting of 25 trials (48%) specified the use of delivery agents, the reporting of three trials (6%) specified not using delivery agents, and in the reporting of the remaining 24 trials (46%) the use of delivery agents was unclear. The reported intervention type was an IPEP alone in 43 trials (83
Schnock, Kumiko O; Dykes, Patricia C; Albert, Jennifer; Ariosto, Deborah; Cameron, Caitlin; Carroll, Diane L; Donahue, Moreen; Drucker, Adrienne G; Duncan, Rosemary; Fang, Linda; Husch, Marla; McDonald, Nicole; Maddox, Ray R; McGuire, Julie; Rafie, Sally; Robertson, Emilee; Sawyer, Melinda; Wade, Elizabeth; Yoon, Catherine S; Lipsitz, Stuart; Bates, David W
We previously found a high rate of errors in the administration of intravenous medications using smart infusion pumps. An infusion safety intervention bundle was developed in response to the high rate of identified errors. A before-after observational study with a prospective point-prevalence approach was conducted in nine hospitals to measure the preliminary effects of the intervention. Primary outcome measures were overall errors and medication errors, with the secondary outcome defined as potentially harmful error rates. We assessed a total of 418 patients with 972 medication administrations in the pre-intervention period and 422 patients with 1059 medication administrations in the post-intervention period. The overall error rate fell from 146 to 123 per 100 medication administrations (p < 0.0001), and the medication error rate also decreased from 39 to 29 per 100 medication administrations (p = 0.001). However, there was no significant change in the potentially harmful error rate (from 0.5 to 0.8 per 100 medication administrations, p = 0.37). An intervention component aiming to reduce labeling-not-completed errors was effective in reducing targeted error rates, but other components of the intervention bundle did not show significant improvement in the targeted errors. Development and implementation of the intervention bundle was successful at reducing overall and medication error rates, but some errors remained and the potentially harmful error rate did not change. The error-rate reductions were not always correlated with the specific individual interventions. Further investigation is needed to identify the best strategies to reduce the remaining errors. Registered at ClinicalTrials.gov, identifier: NCT02359734.
Murdoch, Jamie; Varley, Anna; Fletcher, Emily; Britten, Nicky; Price, Linnie; Calitri, Raff; Green, Colin; Lattimer, Valerie; Richards, Suzanne H; Richards, David A; Salisbury, Chris; Taylor, Rod S; Campbell, John L
Telephone triage represents one strategy to manage demand for face-to-face GP appointments in primary care. However, limited evidence exists of the challenges GP practices face in implementing telephone triage. We conducted a qualitative process evaluation alongside a UK-based cluster randomised trial (ESTEEM) which compared the impact of GP-led and nurse-led telephone triage with usual care on primary care workload, cost, patient experience, and safety for patients requesting a same-day GP consultation. The aim of the process study was to provide insights into the observed effects of the ESTEEM trial from the perspectives of staff and patients, and to specify the circumstances under which triage is likely to be successfully implemented. Here we report perspectives of staff. The intervention comprised implementation of either GP-led or nurse-led telephone triage for a period of 2-3 months. A qualitative evaluation was conducted using staff interviews recruited from eight general practices (4 GP triage, 4 Nurse triage) in the UK, implementing triage as part of the ESTEEM trial. Qualitative interviews were undertaken with 44 staff members in GP triage and nurse triage practices (16 GPs, 8 nurses, 7 practice managers, 13 administrative staff). Staff reported diverse experiences and perceptions regarding the implementation of telephone triage, its effects on workload, and on the benefits of triage. Such diversity were explained by the different ways triage was organised, the staffing models used to support triage, how the introduction of triage was communicated across practice staff, and by how staff roles were reconfigured as a result of implementing triage. The findings from the process evaluation offer insight into the range of ways GP practices participating in ESTEEM implemented telephone triage, and the circumstances under which telephone triage can be successfully implemented beyond the context of a clinical trial. Staff experiences and perceptions of telephone
Elvik, Rune; Ulstein, Heidi; Wifstad, Kristina; Syrstad, Ragnhild S; Seeberg, Aase R; Gulbrandsen, Magnus U; Welde, Morten
This paper presents an Empirical Bayes before-after evaluation of the road safety effects of a new motorway (freeway) in Østfold county, Norway. The before-period was 1996-2002. The after-period was 2009-2015. The road was rebuilt from an undivided two-lane road into a divided four-lane road. The number of killed or seriously injured road users was reduced by 75 percent, controlling for (downward) long-term trends and regression-to-the-mean (statistically significant at the 5 percent level; recorded numbers 71 before, 11 after). There were small changes in the number of injury accidents (185 before, 123 after; net effect -3%) and the number of slightly injured road users (403 before 279 after; net effect +5%). Motorways appear to mainly reduce injury severity, not the number of accidents. The paper discusses challenges in implementing the Empirical Bayes design when less than ideal data are available. Copyright © 2017 Elsevier Ltd. All rights reserved.
Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.
Cathleen E. Willging
Full Text Available Abstract Background Reducing youth suicide in the United States (U.S. is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ youth are at elevated risk. The Centers for Disease Control and Prevention (CDC endorses six evidence-based (EB strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, “RLAS” (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide, builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS conceptual framework and the Dynamic Adaptation Process (DAP to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Methods/Design Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20 report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20. Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. Discussion The DAP represents a data-informed, collaborative, multiple stakeholder
Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O'Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R; Hillier, Sharon L; Beigi, Richard
Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.
Lykke, Jørn; Oestrich, I.; Austin, Stephen
milieu therapy (CMT) among a group of dual diagnosis inpatients. CMT is an integrated treatment for both mental illness and substance abuse based on cognitive behavioral principles and carried out within a supportive inpatient environment. A convenience sample of dual diagnosis inpatients (N = 136......Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...
Atwere, Pearl; McIntyre, Lauralyn; Carroll, Kelly; Hayes, Tavis; Brehaut, Jamie C
Informed consent documents are often poorly understood by research participants. In critical care, issues such as time pressure, patient capacity, and surrogate decision making complicate the consent process further. Recommendations exist for addressing critical care-specific consent issues; we examined how well existing practice implements these recommendations. We conducted a systematic search of the literature for recommendations specific to critical care informed consent and rated existing informed consent documents on their implementation of 1) 18 of these critical care recommendations and 2) 36 previously developed general informed consent recommendations. Four hundred twelve registered critical care trials were identified and a request sent to the principal investigators for an example of the informed consent document associated with the trial. Each consent document was rated on both set of recommendations. We evaluated informed consent documents for trials conducted in English or French registered with clinicaltrials.gov. Not applicable. Not applicable. Independent coders rated implementation of each recommendation on a four-point scale. Of 412 requests, 137 informed consent documents were returned, for a response rate of 34.1%. Of these, 86 met inclusion criteria and were assessed. Overall agreement between raters was 90.6% (weighted κ = 0.79; 0.77-0.81). Implementation of the 18 critical care recommendations was highly variable, ranging between 2% and 96.5%. Critical care studies often do not provide the information recommended for those providing consent for research. These clear recommendations provide testable hypotheses about how to improve the consent process for patients and family members considering trial participation in the critical care setting.
Salzmann, M; Gaucherand, P; Doret, M
To compare gestational age at birth and incidence of preterm birth inferior to 37 weeks of gestation (WG) in single pregnancies with either prolonged hospitalization, or early home discharge after arrested preterm labour. Management of preterm labour was changed in our public academic hospital because no evidence of benefits for prolonged hospitalization was found and because adverse effects related to long-term hospitalization were described. In this retrospective before-after study, we compare the attitude A (December 2006 to April 2008), a prolonged hospitalization until 32 or 34WG, with new attitude B (May 2008 to February 2010), an early discharge home if the cervical exam was unchanged since admission. A total of 140 patients were included: 70 in each group. Initial hospitalization stay was significantly shorter in Group B (respectively, 5.4±5.4 days and 11.4±12.1 days; P0.05). Gestational ages at birth were 33(5/7) and 33(0/7) WG in groups A and B, respectively (P>0.05). If we focus on patients who were discharged home in the two groups (women who did not deliver no matter the hospitalization length), the gestational age at birth (38(4/7) and 38WG; ns) and the prematurity rate inferior to 37WG (17.2% and 22.4%; ns) were statistically similar. This study suggests that shorter hospitalization does not decrease the delivery term, nor does it increase the premature delivery incidence. Copyright © 2012 Elsevier Masson SAS. All rights reserved.
Willging, Cathleen E; Green, Amy E; Ramos, Mary M
Reducing youth suicide in the United States (U.S.) is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) youth are at elevated risk. The Centers for Disease Control and Prevention (CDC) endorses six evidence-based (EB) strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, "RLAS" (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide), builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS) conceptual framework and the Dynamic Adaptation Process (DAP) to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs) to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20) report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20). Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. The DAP represents a data-informed, collaborative, multiple stakeholder approach to progress from exploration to sustainment and obtain
Zatzick, Douglas F; Russo, Joan; Darnell, Doyanne; Chambers, David A; Palinkas, Lawrence; Van Eaton, Erik; Wang, Jin; Ingraham, Leah M; Guiney, Roxanne; Heagerty, Patrick; Comstock, Bryan; Whiteside, Lauren K; Jurkovich, Gregory
Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the
Rokuda, Mitsuhiro; Matsumaru, Naoki; Tsukamoto, Katsura
Multiregional clinical trials (MRCT) are a standard strategy used to improve global drug approval efficiency and the feasibility of clinical trials. Japan is the world's third largest drug market with a unique health care system, making it a key inclusion as an operational region for MRCT (MRCT-JP) for global drug development. We aimed to identify the factors required for efficient drug development by comprehensively reviewing the clinical trials of drugs approved in Japan to identify the factors associated with whether or not MRCT-JP is implemented. We surveyed the review reports and summaries of application data published by the Pharmaceuticals and Medical Devices Agency. We identified drugs for which the clinical trial data package included MRCT-JP and selected the same number of drugs for which the clinical trial data package did not include MRCT-JP from the most recent survey period for comparison. We also examined other publication information, in addition to the review reports, as necessary. The influence of each explanatory variable was analyzed by logistic regression analysis, with whether or not MRCT-JP was implemented as the explanatory variable. Statistical significance was set at 5%. In the survey period up to September 2017, 165 drugs developed with MRCT-JP were approved for manufacture and sale in Japan. "Respiratory system," "inhalation," "biological drug," and "under review" evaluation status for the United States, European Union, and other areas, "approved" evaluation status for the United States, "new ingredients," "priority review," "non-Japanese firm," and "Top 1-10" and "Top 11-20" drug sales rankings for pharmaceutical companies were identified as potential factors leading to the implementation of MRCT-JP. In contrast, "general anti-infectives for systemic use," "various," "external," "chemical compound," "unsubmitted" evaluation status for both the United States and European Union, and "Top 51+" drug sales rankings were potential factors for
Albright, Karen; Gechter, Katherine; Kempe, Allison
With increased attention to the importance of translating research to clinical practice and policy, recent years have seen a proliferation of particular types of research, including pragmatic trials and dissemination and implementation research. Such research seeks to understand how and why interventions function in real-world settings, as opposed to highly controlled settings involving conditions not likely to be repeated outside the research study. Because understanding the context in which interventions are implemented is imperative for effective pragmatic trials and dissemination and implementation research, the use of mixed methods is critical to understanding trial results and the success or failure of implementation efforts. This article discusses a number of dimensions of mixed methods research, utilizing at least one qualitative method and at least one quantitative method, that may be helpful when designing projects or preparing grant proposals. Although the strengths and emphases of qualitative and quantitative approaches differ substantially, methods may be combined in a variety of ways to achieve a deeper level of understanding than can be achieved by one method alone. However, researchers must understand when and how to integrate the data as well as the appropriate order, priority, and purpose of each method. The ability to demonstrate an understanding of the rationale for and benefits of mixed methods research is increasingly important in today's competitive funding environment, and many funding agencies now expect applicants to include mixed methods in proposals. The increasing demand for mixed methods research necessitates broader methodological training and deepened collaboration between medical, clinical, and social scientists. Although a number of challenges to conducting and disseminating mixed methods research remain, the potential for insight generated by such work is substantial. Copyright © 2013 Academic Pediatric Association. Published by
Diehl, Heinz; Graverholt, Birgitte; Espehaug, Birgitte
BACKGROUND: Research on guideline implementation strategies has mostly been conducted in settings which differ significantly from a nursing home setting and its transferability to the nursing home setting is therefore limited. The objective of this study was to systematically review the effects...... of interventions to improve the implementation of guidelines in nursing homes. METHODS: A systematic literature search was conducted in the Cochrane Library, CINAHL, Embase, MEDLINE, DARE, HTA, CENTRAL, SveMed + and ISI Web of Science from their inception until August 2015. Reference screening and a citation...... search were performed. Studies were eligible if they evaluated any type of guideline implementation strategy in a nursing home setting. Eligible study designs were systematic reviews, randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted...
Gritsaj, K.I.; Isupov, A.Yu.
A trial of distributed portable data acquisition and processing system qdpb is issued. An experimental setup data and hardware dependent code is separated from the generic part of the qdpb system. The generic part implementation is described
von Wasielewski, Reinhard; Krusche, Claudia A; Rüschoff, Joseph; Fisseler-Eckhoff, Anette; Kreipe, Hans
Besides typing and grading of breast cancer, Pathologists are involved in the determination of biomarkers, such as steroid hormone receptors and HER2, which are of utmost importance in adjuvant therapy. There have been concerns with regard to security and reproducibility of the biomarker assays done on tissue sections applying either immunohistochemistry or in-situ hybridisation. In order to assure the quality of these biomarker assays, a number of measures are required, among them external proficiency testing. Therefore, external quality assurance trials have been implemented in Germany. In the period of 2002-2007, 5 consecutive trials were conducted with up to 180 participating laboratories. Tissue microarrays with 20-24 different breast cancer samples including cell lines enabled that a huge number of pathologists were challenged with identical samples which provides the prerequisite for comparability. Because there is no legal duress to undergo external proficiency testing in histopathology, all laboratories that took part volunteered to do so. These innovative quality assurance trials (Qualitätsinitiative Pathologie, QuIP) will be continued in the future on an annual or bi-annual basis. Participation is recommended for pathology departments involved in the service for breast units. The organisational frame work of the trials is described here.
-saving £−93.20 (£406.51 vs. £499.71 per patient after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p = 0.004]. Conclusions Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines. Trial registration ClinicalTrials.gov, NCT01699256
Gold, Rachel; Hollombe, Celine; Bunce, Arwen; Nelson, Christine; Davis, James V; Cowburn, Stuart; Perrin, Nancy; DeVoe, Jennifer; Mossman, Ned; Boles, Bruce; Horberg, Michael; Dearing, James W; Jaworski, Victoria; Cohen, Deborah; Smith, David
Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting. This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices. Having a better understanding of how different
Lombard, Catherine B; Harrison, Cheryce L; Kozica, Samantha L; Zoungas, Sophia; Keating, Catherine; Teede, Helena J
To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies
Chang, Larry W; Serwadda, David; Quinn, Thomas C; Wawer, Maria J; Gray, Ronald H; Reynolds, Steven J
The promise of combination HIV prevention-the application of multiple HIV prevention interventions to maximise population-level effects-has never been greater. However, to succeed in achieving significant reductions in HIV incidence, an additional concept needs to be considered: combination implementation. Combination implementation for HIV prevention is the pragmatic, localised application of evidence-based strategies to enable high sustained uptake and quality of interventions for prevention of HIV. In this Review, we explore diverse implementation strategies including HIV testing and counselling models, task shifting, linkage to and retention in care, antiretroviral therapy support, behaviour change, demand creation, and structural interventions, and discusses how they could be used to complement HIV prevention efforts such as medical male circumcision and treatment as prevention. HIV prevention and treatment have arrived at a pivotal moment when combination efforts might result in substantial enough population-level effects to reverse the epidemic and drive towards elimination of HIV. Only through careful consideration of how to implement and operationalise HIV prevention interventions will the HIV community be able to move from clinical trial evidence to population-level effects. Copyright © 2013 Elsevier Ltd. All rights reserved.
Horigian, Viviana E; Marín-Navarrete, Rodrigo A; Verdeja, Rosa E; Alonso, Elizabeth; Perez, María A; Fernández-Mondragón, José; Berlanga, Carlos; Medina-Mora, María Elena; Szapocznik, José
Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.
Wolfenden, Luke; Nathan, Nicole; Janssen, Lisa M; Wiggers, John; Reilly, Kathryn; Delaney, Tessa; Williams, Christopher M; Bell, Colin; Wyse, Rebecca; Sutherland, Rachel; Campbell, Libby; Lecathelinais, Christophe; Oldmeadow, Chris; Freund, Megan; Yoong, Sze Lin
Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group. The intervention sought to increase implementation of a state-wide healthy canteen policy which required schools to remove unhealthy items (classified as 'red' or 'banned') from regular sale and encouraged schools to 'fill the menu' with healthy items (classified as 'green'). The intervention strategies included allocation of a support officer to assist with policy implementation, engagement of school principals and parent committees, consensus processes with canteen managers, training, provision of tools and resources, academic detailing, performance feedback, recognition and marketing initiatives. Data were collected at baseline (April to September, 2013) and at completion of the implementation period (November, 2014 to April, 2015). Seventy schools participated in the trial. Relative to control, at follow-up, intervention schools were significantly more likely to have menus without 'red' or 'banned' items (RR = 21.11; 95% CI 3.30 to 147.28; p ≤ 0.01) and to have at least 50% of menu items classified as 'green' (RR = 3.06; 95% CI 1.64 to 5.68; p ≤ 0.01). At follow-up, student purchases from intervention school canteens were significantly lower in total fat (difference = -1.51 g; 95% CI -2.84 to -0.18; p = 0.028) compared to controls, but not in energy (difference = -132.32 kJ; 95% CI -280.99 to 16.34; p = 0.080) or sodium (difference = -46
Frangou, Eleni; Holmes, Jane; Love, Sharon; McGregor, Naomi; Hawkins, Maria
For a clinical trials unit to run its first model-based, phase I trial, the statistician, chief investigator, and trial manager must all acquire a new set of skills. These trials also require a different approach to funding and data collection. From the statisticians' viewpoint, we highlight what is needed to move from running rule-based, early-phase trials to running a model-based phase I study as we experienced it in our trials unit located in the United Kingdom. Our example is CHARIOT, a dose-finding trial using the time-to-event continual reassessment method. It consists of three stages and aims to discover the maximum tolerated dose of the combination of radiotherapy, chemotherapy, and the ataxia telangiectasia mutated Rad3-related inhibitor M6620 (previously known as VX-970) in patients with oesophageal cancer. We present the challenges we faced in designing this trial and how we overcame them as a way of demystifying the conduct of a model-based trial in a grant-funded clinical trials unit. Although we appreciate that undertaking model-based trials requires additional time and effort, they are feasible to implement and, once suitable tools such as guiding publications and document templates become available, the design and set-up process will be easier and more efficient.
Kemper, Peter F; de Bruijne, Martine; van Dyck, Cathy; So, Ralph L; Tangkau, Peter; Wagner, Cordula
There is a growing awareness today that adverse events in the intensive care unit (ICU) are more often caused by problems related to non-technical skills than by a lack of technical, or clinical, expertise. Team training, such as crew resource management (CRM), aims to improve these non-technical skills. The present study evaluated the effectiveness of CRM in the ICU. Six ICUs participated in a paired controlled trial, with one pretest and two post-test measurements (after 3 and 12 months). Three ICUs received CRM training and were compared with a matched control unit. The 2-day classroom-based training was delivered to multidisciplinary groups (ie, ICU physicians, nurses, managers). All levels of Kirkpatrick's evaluation framework were assessed using a mixed method design, including questionnaires, observations and routinely administered patient outcome data. Level I-reaction: participants were very positive directly after the training. Level II-learning: attitudes towards behaviour aimed at optimising situational awareness were relatively high at baseline and remained stable. Level III-behaviour: self-reported behaviour aimed at optimising situational awareness improved in the intervention group. No changes were found in observed explicit professional oral communication. Level IV-organisation: patient outcomes were unaffected. Error management culture and job satisfaction improved in the intervention group. Patient safety culture improved in both control and intervention units. We can conclude that CRM, as delivered in the present study, does not change behaviour or patient outcomes by itself, yet changes how participants think about errors and risks. This indicates that CRM requires a combination with other initiatives in order to improve clinical outcomes. 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/
White, Kirsten; Garner, Will; Wei, Lilian; Eron, Joseph J; Zhong, Lijie; Miller, Michael D; Martin, Hal; Plummer, Andrew; Tran-Muchowski, Cecilia; Lindstrom, Kim; Porter, James; Piontkowsky, David; Light, Angela; Reiske, Heinz; Quirk, Erin
Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. Prospective and retrospective analysis of randomized clinical trial samples and reference standards. To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of at least 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50-200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50-200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested at least 50 copies/ml. The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low-drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source
Full Text Available An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories and the severity of 36 barriers (grouped in 6 topical categories to implementing pediatric antibacterial drug trials. Analysis focused on the identification of key factors that facilitate the successful implementation of pediatric antibacterial drug trials and the key barriers to implementation. Almost all investigators identified two factors as very important facilitators: having site personnel for enrollment and having adequate funding. Other top factors were related to staffing. Among the barriers, factors related to parent concerns and consent were prominent, particularly obtaining parental consent when there was disagreement between parents, concerns about the number of blood draws, and concerns about the number of invasive procedures. Having overly narrow eligibility criteria was also identified as a major barrier. The survey findings suggest three areas in which to focus efforts to help facilitate ongoing drug development: (1 improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial, (2 broadening inclusion criteria to allow more participants to enroll, and (3 ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks. The pediatric antibacterial drug trials enterprise is likely to benefit from focused efforts by all stakeholders to remove barriers and enhance facilitation.
Slockers, Marcel T; Nusselder, Wilma J; Looman, Caspar W N; Slockers, Colette J T; Krol, Luuk; van Beeck, Ed F
Homeless people have a 3-5-fold increased risk of mortality compared with general populations. After 2005, policy actions being implemented in Rotterdam, the Netherlands, have improved the living conditions of this group. This study examines the effect of policies aimed at improving living conditions on mortality risks of the homeless. Register-based 10-year follow-up study of homeless in Rotterdam, the Netherlands. The participants are homeless adults (aged 18+ years) who visited one or more services for homeless people in Rotterdam in 2001. The intervention of local policies after 2005 was to get homeless people into housing, increase their participation in employment and other regular daytime activities, and controlling drug and alcohol addictions. The main outcome measure is mortality rate ratios calculated using Poisson regression. Differences in mortality between the periods 2001-05 vs. 2006-10 were assessed. The cohort of homeless adults in 2001 consisted of 1870 men and 260 women, with a mean age of 40.3 years. During the 10 years of follow-up, 265 persons (232 male and 33 female) died. Adjusted for age and sex, no significant difference in mortality was observed between the periods 2001-05 and 2006-10 (P = 0.9683). A different splitting in periods did not change the results. Five years of local policy efforts improved their living conditions, but left the mortality rate of a homeless cohort unchanged. Incomplete reach of the program and long previous histories of homelessness ask for additional policies beyond the provision of housing and other services. Attention to the prevention of homelessness seems needed. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.
Lykke, Jørn; Oestrich, Irene; Austin, Stephen
) was assessed pre- and post-intervention from an inpatient setting where CMT was the mode of treatment. Psychopathology was measured using the Brief Psychiatric Rating Scale and substance abuse measured with the DrugCheck scale, breath/urine samples, and the Severity of Dependence Scale. Functioning......Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...... milieu therapy (CMT) among a group of dual diagnosis inpatients. CMT is an integrated treatment for both mental illness and substance abuse based on cognitive behavioral principles and carried out within a supportive inpatient environment. A convenience sample of dual diagnosis inpatients (N = 136...
Background Although leisure-time physical activity is important for health, adherence to regular exercise is challenging for many adults. The workplace may provide an optimal setting to reach a large proportion of the adult population needing regular physical exercise. This study evaluates the effect of implementing strength training at the workplace on non-specific neck and shoulder pain among industrial workers. Methods Cluster-randomized controlled trial involving 537 adults from occupations with high prevalence of neck and shoulder pain (industrial production units). Participants were randomized to 20 weeks of high-intensity strength training for the neck and shoulders three times a week (n = 282) or a control group receiving advice to stay physically active (n = 255). The strength training program followed principles of progressive overload and periodization. The primary outcome was changes in self-reported neck and shoulder pain intensity (scale 0-9). Results 85% of the participants followed the strength training program on a weekly basis. In the training group compared with the control group, neck pain intensity decreased significantly (-0.6, 95% CI -1.0 to -0.1) and shoulder pain intensity tended to decrease (-0.2, 95% CI -0.5 to 0.1, P = 0.07). For pain-cases at baseline (pain intensity > = 3) the odds ratio - in the training group compared with the control group - for being a non-case at follow-up (pain intensity < 3) was 2.0 (95% CI 1.0 to 4.2) for the neck and 3.9 (95% CI 1.7 to 9.4) for the shoulders. Conclusion High-intensity strength training relying on principles of progressive overload can be successfully implemented at industrial workplaces, and results in significant reductions of neck and shoulder pain. Trial registration NCT01071980. PMID:21936939
Full Text Available Abstract Background With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature. Results The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy. Conclusion We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.
Simon, S; Higginson, I J
Hospital palliative care teams (HPCTs) are well established as multi-professional services to provide palliative care in an acute hospital setting and are increasing in number. However, there is still limited evaluation of them, in terms of efficacy and effectiveness. The gold standard method of evaluation is a randomised control trial, but because of methodological (e.g., randomisation), ethical and practical difficulties such trials are often not possible. HPCT is a complex intervention, and the specific situation in palliative care makes it challenging to evaluate (e.g., distress and cognitive impairment of patients). The quasi-experimental before-after study design has the advantage of enabling an experimental character without randomisation. But this has other weaknesses and is prone to bias, for example, temporal trends and selection bias. As for every study design, avoidance and minimisation of bias is important to improve validity. Therefore, strategies of selecting an appropriate control group or time series and applying valid outcomes and measurement tools help reducing bias and strengthen the methods. Special attention is needed to plan and define the design and applied method.
Riley, Therese; Hawe, Penelope
Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions.
Background Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. Methods We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Results Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. Conclusions The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions. PMID:20003399
Berkel, Cady; Murry, Velma McBride; Roulston, Kathryn J; Brody, Gene H
The purpose of this paper is to demonstrate the importance of considering both fidelity and adaptation in assessing the implementation of evidence-based programs. The current study employs a multi-method strategy to understand two dimensions of implementation (fidelity and adaptation) in the Strong African American Families (SAAF) program. Data were video recordings of program delivery and pre-test and post-test interviews from the efficacy trial. Multilevel regression in Mplus was used to assess the impact of fidelity to the manual, coded by independent observers, on racial socialization outcomes. One activity on racial socialization, a core component of the program, was selected for an in-depth examination using conversation analysis (a qualitative method of analyzing talk in interactions). Results of the quantitative analyses demonstrated that fidelity of the selected activity was associated with increases in parent's use of racial socialization from pre-test to post-test, but only when participant attendance was included in the model. Results of the qualitative analyses demonstrated that facilitators were making adaptations to the session and that these adaptations appeared to be in line with cultural competence. The development of quantitative fidelity measures can be problematic, with many decision points to consider. The current study contributes to the evidence base to develop a quantitative measure of adaptation for family-based parenting programs. Many researchers examining implementation of evidence-based programs consider fidelity and adaptation to be polar ends of a single spectrum. This paper provides evidence for the importance of examining each independently.
Kanno, Taro; Milleding, Percy; Wennerberg, Ann
Sintering porcelain on a ceramic abutment may change the microstructure and result in aging processes that influence the mechanical properties, internal strain, and the three-dimensional form of the abutment, thus causing a possible misfit between the abutment and the fixture. The aim was to investigate topography, microhardness, and precision of fit on yttrium-stabilized zirconia (Y-TZP) abutments before/after the sintering process. Ten Y-TZP abutment samples were ground to a shape used in the clinical situation and divided at random into two groups: before/after sintering. After the surface roughness was measured on all abutments, the abutments were connected to fixture replicas, embedded in resin, and cut in the longitudinal axis. Both sides of the cut samples were measured with respect to microhardness and minimum distance between fixture and abutment surface. t-Test, one-way analysis of variance, and Bonferroni multiple comparisons were used to investigate statistical significant differences. The surface roughness (S(a) and S(dr)) after sintering was significantly higher than before sintering. The total average values of microhardness after sintering were statistically lower than before sintering with a difference of 2%. The total distance between abutment/fixture before/after sintering demonstrated no statistically significant difference. Contact between abutment/fixture was most common at the top area of the fixture. A slight decrease of microhardness and contamination of porcelain particles immediately below the veneered part were found on the Y-TZP abutment after sintering. The sintering process did not affect the precision of fit.
Pollard, Joy S.; Higbee, Thomas S.; Akers, Jessica S.; Brodhead, Matthew T.
Discrete-trial instruction (DTI) is a teaching strategy that is often incorporated into early intensive behavioral interventions for children with autism. Researchers have investigated time- and cost-effective methods to train staff to implement DTI, including self-instruction manuals, video modeling, and interactive computer training (ICT). ICT…
Piper, Benjamin; Zuilkowski, Stephanie S.; Ong'ele, Salome
Research in sub-Saharan Africa investigating the effect of mother tongue (MT) literacy instruction at medium scale is limited. A randomized controlled trial of MT literacy instruction was implemented in 2013 and 2014 as part of the Primary Math and Reading (PRIMR) Initiative in Kenya. We compare the effect of two treatment groups--the base PRIMR…
Geiger, Kaneen Barbara
Discrete trial teaching is an effective procedure for teaching a variety of skills to children with autism. However, it must be implemented with high integrity to produce optimal learning. Behavioral Skills Training (BST) is a staff training procedure that has been demonstrated to be effective. However, BST is time and labor intensive, and with…
LoCasale-Crouch, Jennifer; Williford, Amanda; Whittaker, Jessica; DeCoster, Jamie; Alamos, Pilar
This study examined fidelity of implementation in a randomized trial of Banking Time, a classroom-based intervention intended to improve children's behavior, specifically for those at risk for developing externalizing behavior problems, through improving the quality of teacher-child interactions. The study sample comes from a randomized controlled…
Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.
Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias
This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....
Chavane, Leonardo; Merialdi, Mario; Betrán, Ana Pilar; Requejo-Harris, Jennifer; Bergel, Eduardo; Aleman, Alicia; Colomar, Mercedes; Cafferata, Maria Luisa; Carbonell, Alicia; Crahay, Beatrice; Delvaux, Therese; Geelhoed, Diederike; Gülmezoglu, Metin; Malapende, Celsa Regina; Melo, Armando; Nguyen, My Huong; Osman, Nafissa Bique; Widmer, Mariana; Temmerman, Marleen; Althabe, Fernando
relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country's health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in 'habits' will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study. Pan African Clinical Trial Registry database. Identification number: PACTR201306000550192.
Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W
The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process
Full Text Available Background and objectives: Migraine is the seventh most common cause of disability among all ailments according to the World Health Organization. Despite the availability of some medicines for prevention of migraine, their complications are a cause for concern. Traditional system of medicine and use of medicinal herbs can be beneficial in management of migraine. “Gol-e-ghand” is one of the most commonly prescribed products for the management of headaches in the Iranian traditional medicine. The present study was designed to evaluate the effect of “Ghol-e-ghand” on decreasing the frequency of migraine attacks. Methods: Nineteen migraine patients, who met the eligibility criteria, according to the International Headache Society diagnostic criteria were assigned to the intervention. The study was conducted as a before-after clinical trial and included two phases of drug administration. Propranolol was given during the first phase, while “Ghol-e-ghand” was administered along with propranolol in the second phase. The severity, duration, and frequency of headaches were measured before and after the intervention. Results: The analysis showed that “Ghol-e-ghand” decreased the frequency of migraine (20%, p=0.04, but it was not effective in decreasing the duration and severity of the attacks. Conclusion: “Ghol-e-ghand”can be suggested in migraine patients for reducing frequency of attacks.
Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Naznin, Farhana; Currie, Graham; Logan, David; Sarvi, Majid
Tram stops in mixed traffic environments present a variety of safety, accessibility and transport efficiency challenges. In Melbourne, Australia the hundred year-old electric tram system is progressively being modernized to improve passenger accessibility. Platform stops, incorporating raised platforms for level entry into low floor trams, are being retro-fitted system-wide to replace older design stops. The aim of this study was to investigate the safety impacts of platform stops over older design stops (i.e. Melbourne safety zone tram stops) on pedestrians in the context of mixed traffic tram operation in Melbourne, using an advanced before-after crash analysis approach, the comparison group (CG) method. The CG method evaluates safety impacts by taking into account the general trends in safety and the unobserved factors at treatment and comparison sites that can alter the outcomes of a simple before-after analysis. The results showed that pedestrian-involved all injury crashes reduced by 43% after platform stop installation. This paper also explores a concern that the conventional CG method might underestimate safety impacts as a result of large differences in passenger stop use between treatment and comparison sites, suggesting differences in crash risk exposure. To adjust for this, a modified analysis explored crash rates (crash counts per 10,000 stop passengers) for each site. The adjusted results suggested greater reductions in pedestrian-involved crashes after platform stop installation: an 81% reduction in pedestrian-involved all injury crashes and 86% reduction in pedestrian-involved FSI crashes, both are significant at the 95% level. Overall, the results suggest that platform stops have considerable safety benefits for pedestrians. Implications for policy and areas for future research are explored. Copyright © 2015 Elsevier Ltd. All rights reserved.
Feasibility and acceptability of two incentive-based implementation strategies for mental health therapists implementing cognitive-behavioral therapy: a pilot study to inform a randomized controlled trial.
Beidas, Rinad S; Becker-Haimes, Emily M; Adams, Danielle R; Skriner, Laura; Stewart, Rebecca E; Wolk, Courtney Benjamin; Buttenheim, Alison M; Williams, Nathaniel J; Inacker, Patricia; Richey, Elizabeth; Marcus, Steven C
Informed by our prior work indicating that therapists do not feel recognized or rewarded for implementation of evidence-based practices, we tested the feasibility and acceptability of two incentive-based implementation strategies that seek to improve therapist adherence to cognitive-behavioral therapy for youth, an evidence-based practice. This study was conducted over 6 weeks in two community mental health agencies with therapists (n = 11) and leaders (n = 4). Therapists were randomized to receive either a financial or social incentive if they achieved a predetermined criterion on adherence to cognitive-behavioral therapy. In the first intervention period (block 1; 2 weeks), therapists received the reward they were initially randomized to if they achieved criterion. In the second intervention period (block 2; 2 weeks), therapists received both rewards if they achieved criterion. Therapists recorded 41 sessions across 15 unique clients over the project period. Primary outcomes included feasibility and acceptability. Feasibility was assessed quantitatively. Fifteen semi-structured interviews were conducted with therapists and leaders to assess acceptability. Difference in therapist adherence by condition was examined as an exploratory outcome. Adherence ratings were ascertained using an established and validated observational coding system of cognitive-behavioral therapy. Both implementation strategies were feasible and acceptable-however, modifications to study design for the larger trial will be necessary based on participant feedback. With respect to our exploratory analysis, we found a trend suggesting the financial reward may have had a more robust effect on therapist adherence than the social reward. Incentive-based implementation strategies can be feasibly administered in community mental health agencies with good acceptability, although iterative pilot work is essential. Larger, fully powered trials are needed to compare the effectiveness of
Amemori, Masamitsu; Korhonen, Tellervo; Kinnunen, Taru; Michie, Susan; Murtomaa, Heikki
intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers. Current Controlled Trials ISRCTN15427433.
Presseau, Justin; Ivers, Noah M; Newham, James J; Knittle, Keegan; Danko, Kristin J; Grimshaw, Jeremy M
Methodological guidelines for intervention reporting emphasise describing intervention content in detail. Despite this, systematic reviews of quality improvement (QI) implementation interventions continue to be limited by a lack of clarity and detail regarding the intervention content being evaluated. We aimed to apply the recently developed Behaviour Change Techniques Taxonomy version 1 (BCTTv1) to trials of implementation interventions for managing diabetes to assess the capacity and utility of this taxonomy for characterising active ingredients. Three psychologists independently coded a random sample of 23 trials of healthcare system, provider- and/or patient-focused implementation interventions from a systematic review that included 142 such studies. Intervention content was coded using the BCTTv1, which describes 93 behaviour change techniques (BCTs) grouped within 16 categories. We supplemented the generic coding instructions within the BCTTv1 with decision rules and examples from this literature. Less than a quarter of possible BCTs within the BCTTv1 were identified. For implementation interventions targeting providers, the most commonly identified BCTs included the following: adding objects to the environment, prompts/cues, instruction on how to perform the behaviour, credible source, goal setting (outcome), feedback on outcome of behaviour, and social support (practical). For implementation interventions also targeting patients, the most commonly identified BCTs included the following: prompts/cues, instruction on how to perform the behaviour, information about health consequences, restructuring the social environment, adding objects to the environment, social support (practical), and goal setting (behaviour). The BCTTv1 mapped well onto implementation interventions directly targeting clinicians and patients and could also be used to examine the impact of system-level interventions on clinician and patient behaviour. The BCTTv1 can be used to characterise
Morello, Renata T; Barker, Anna L; Ayton, Darshini R; Landgren, Fiona; Kamar, Jeannette; Hill, Keith D; Brand, Caroline A; Sherrington, Catherine; Wolfe, Rory; Rifat, Sheral; Stoelwinder, Johannes
When tested in a randomized controlled trial (RCT) of 31,411 patients, the nurse-led 6-PACK falls prevention program did not reduce falls. Poor implementation fidelity (i.e., program not implemented as intended) may explain this result. Despite repeated calls for the examination of implementation fidelity as an essential component of evaluating interventions designed to improve the delivery of care, it has been neglected in prior falls prevention studies. This study examined implementation fidelity of the 6-PACK program during a large multi-site RCT. Based on the 6-PACK implementation framework and intervention description, implementation fidelity was examined by quantifying adherence to program components and organizational support. Adherence indicators were: 1) falls-risk tool completion; and for patients classified as high-risk, provision of 2) a 'Falls alert' sign; and 3) at least one additional 6-PACK intervention. Organizational support indicators were: 1) provision of resources (executive sponsorship, site clinical leaders and equipment); 2) implementation activities (modification of patient care plans; training; implementation tailoring; audits, reminders and feedback; and provision of data); and 3) program acceptability. Data were collected from daily bedside observation, medical records, resource utilization diaries and nurse surveys. All seven intervention components were delivered on the 12 intervention wards. Program adherence data were collected from 103,398 observations and medical record audits. The falls-risk tool was completed each day for 75% of patients. Of the 38% of patients classified as high-risk, 79% had a 'Falls alert' sign and 63% were provided with at least one additional 6-PACK intervention, as recommended. All hospitals provided the recommended resources and undertook the nine outlined program implementation activities. Most of the nurses surveyed considered program components important for falls prevention. While implementation
Mello, Michael J; Becker, Sara J; Bromberg, Julie; Baird, Janette; Zonfrillo, Mark R; Spirito, Anthony
The American College of Surgeons mandates universal screening for alcohol misuse and delivery of an intervention for those screening positive as a requirement for certification as a level 1 trauma center. Though this requirement has been mandated for over a decade, its implementation has been challenging. Our research team completed an implementation study supporting seven pediatric trauma centers' compliance with the requirement by developing and implementing an institutional alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) policy for adolescent trauma patients. A mixed-methods approach indicated that SBIRT adoption rates increased at all sites; however, providers' fidelity to the SBIRT intervention was variable, and providers reported a number of barriers to SBIRT implementation. The goal of this study is to conduct a fully powered type III hybrid effectiveness-implementation trial to test the effectiveness of a comprehensive implementation strategy in increasing the implementation of SBIRT for alcohol and other drug use (AOD) in pediatric trauma centers. Our implementation strategy is based on the Science to Service Laboratory (SSL), an approach developed by the SAMHSA-funded Addiction Technology Transfer Centers that consists of three core elements (i.e., didactic training + performance feedback + leadership coaching). Utilizing a stepped wedge design, a national cohort of 10 pediatric trauma centers will receive the SSL implementation strategy. At six distinct time points, each of the 10 sites will provide data from 30 electronic medical records (n = 1800 in total). A subset of adolescents will also report on fidelity of intervention delivery and linkage to care (i.e., continued AOD discussion and/or treatment with a primary care provider) 1 month after hospital discharge. In addition, nurses, social workers, and leaders will report on organizational readiness for implementation at four distinct time points. This protocol proposes a
Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike
To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research
Ezenwa, Miriam O; Suarez, Marie L; Carrasco, Jesus D; Hipp, Theresa; Gill, Anayza; Miller, Jacob; Shea, Robert; Shuey, David; Zhao, Zhongsheng; Angulo, Veronica; McCurry, Timothy; Martin, Joanna; Yao, Yingwei; Molokie, Robert E; Wang, Zaijie Jim; Wilkie, Diana J
This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.
Catania, Cynthia N.; Almeida, Daniel; Liu-Constant, Brian; Reed, Florence D. DiGennaro
Three new direct-service staff participated in a program that used a video model to train target skills needed to conduct a discrete-trial session. Percentage accuracy in completing a discrete-trial teaching session was evaluated using a multiple baseline design across participants. During baseline, performances ranged from a mean of 12% to 63%…
randomised controlled design, we aim to provide further evidence on intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers. Trial registration Current Controlled Trials ISRCTN15427433
Eiraldi, Ricardo; Khanna, Muniya S; Jawad, Abbas F; Fishman, Jessica; Glick, Henry A; Schwartz, Billie S; Cacia, Jaclyn; Wandersman, Abraham; Beidas, Rinad
Schools present a context with great potential for the implementation of psychosocial evidence-based practices. Cognitive behavioral therapy (CBT) is an evidence-based practice that has been found to be very effective in treating anxiety in various community settings, including schools. Friends for Life (FRIENDS) is an efficacious group CBT protocol for anxiety. Unfortunately, evidence-based practices for anxiety are seldom employed in under-resourced urban schools, because many treatment protocols are not a good fit for the urban school context or the population, existing behavioral health staff do not receive adequate training or support to allow them to implement the treatment with fidelity, or school districts do not have the resources to contract with external consultants. In our prior work, we adapted FRIENDS to create a more culturally sensitive, focused, and feasible CBT protocol for anxiety disorders (CBT for Anxiety Treatment in Schools (CATS)). The aim of this 5-year study is to evaluate both the effectiveness of CATS for urban public schools compared to the original FRIENDS as well as compare the implementation strategies (train-the-trainer vs. train-the-trainer + ongoing consultation) by conducting a three-arm, parallel group, type 2 hybrid effectiveness-implementation trial in 18 K-8 urban public schools. We will also assess the cost-effectiveness and the mediators and moderators of fidelity. Ninety therapists, 18 agency supervisors, and 360 children will participate. The interactive systems framework for dissemination and implementation guides the training and support procedures for therapists and supervisors. This study has the potential to demonstrate that agency therapists and supervisors who have had little to no prior exposure to evidence-based practices (EBPs) can implement an anxiety disorder EBP with fidelity. Comparisons of the implementation strategies would provide large urban mental health systems with data to make decisions about the
Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285
Porras-Hernandez, Juan; Bracho-Blanchet, Eduardo; Tovilla-Mercado, Jose; Vilar-Compte, Diana; Nieto-Zermeño, Jaime; Davila-Perez, Roberto; Teyssier-Morales, Gustavo; Lule-Dominguez, Martha
We report on the effectiveness of a standardized perioperative care process for lowering surgical site infection (SSI) rates among children with stoma closure at a tertiary-care public pediatric teaching hospital in Mexico City. All consecutive children with stoma closure operated on between November 2003 and October 2005 were prospectively followed for 30 days postoperatively. We conducted a before-after study to evaluate standardized perioperative bowel- and abdominal-wall care process results on SSI rates. Seventy-one patients were operated on, and all completed follow-up. SSI rates declined from 42.8% (12/28) before to 13.9% (6/43) after the standardization procedure (relative risk (RR) = 3.1; 95% confidence interval (CI) = 1.3-7.2; p = 0.006). SSI independently associated risk factors comprised peristomal skin inflammation >3 mm (odds ratio (OR) = 9.6; 95% CI = 1.8-49.6; p = 0.007) and intraoperative complications (OR = 13.3; 95% CI = 1.4-127.2; p = 0.02). Being operated on during the after-study period was shown to be a protective factor against SSI (OR = 0.2; 95% CI = 0.4-0.97; p = 0.04). Standardization was able to reduce SSI rates threefold in children with stoma closure in a short period of time.
Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J
Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees' dietary intakes, nutrition knowledge and health status in four large manufacturing workplaces. The study aimed to examine barriers to and facilitators of implementing complex workplace interventions, from the perspectives of key workplace stakeholders and researchers involved in implementation. A detailed process evaluation monitored and evaluated intervention implementation. Interviews were conducted at baseline (27 interviews) and at 7-9 month follow-up (27 interviews) with a purposive sample of workplace stakeholders (managers and participating employees). Topic guides explored factors which facilitated or impeded implementation. Researchers involved in recruitment and data collection participated in focus groups at baseline and at 7-9 month follow-up to explore their perceptions of intervention implementation. Data were imported into NVivo software and analysed using a thematic framework approach. Four major themes emerged; perceived benefits of participation, negotiation and flexibility of the implementation team, viability and intensity of interventions and workplace structures and cultures. The latter three themes either positively or negatively affected implementation, depending on context. The implementation team included managers involved in coordinating and delivering the interventions and the researchers who collected data and delivered intervention elements. Stakeholders' perceptions of the benefits of participating, which facilitated implementation, included managers' desire to improve company
Janssen, Ellen M; Jerome, Gerald J; Dalcin, Arlene T; Gennusa, Joseph V; Goldsholl, Stacy; Frick, Kevin D; Wang, Nae-Yuh; Appel, Lawrence J; Daumit, Gail L
In the ACHIEVE randomized controlled trial, an 18-month behavioral intervention accomplished weight loss in persons with serious mental illness who attended community psychiatric rehabilitation programs. This analysis estimates costs for delivering the intervention during the study. It also estimates expected costs to implement the intervention more widely in a range of community mental health programs. Using empirical data, costs were calculated from the perspective of a community psychiatric rehabilitation program delivering the intervention. Personnel and travel costs were calculated using time sheet data. Rent and supply costs were calculated using rent per square foot and intervention records. A univariate sensitivity analysis and an expert-informed sensitivity analysis were conducted. With 144 participants receiving the intervention and a mean weight loss of 3.4 kg, costs of $95 per participant per month and $501 per kilogram lost in the trial were calculated. In univariate sensitivity analysis, costs ranged from $402 to $725 per kilogram lost. Through expert-informed sensitivity analysis, it was estimated that rehabilitation programs could implement the intervention for $68 to $85 per client per month. Costs of implementing the ACHIEVE intervention were in the range of other intensive behavioral weight loss interventions. Wider implementation of efficacious lifestyle interventions in community mental health settings will require adequate funding mechanisms. © 2017 The Obesity Society.
Flückiger, Christoph; Forrer, Lena; Schnider, Barbara; Bättig, Isabelle; Bodenmann, Guy; Zinbarg, Richard E
Despite long-standing calls to disseminate evidence-based treatments for generalized anxiety (GAD), modest progress has been made in the study of how such treatments should be implemented. The primary objective of this study was to test three competing strategies on how to implement a cognitive behavioral treatment (CBT) for out-patients with GAD (i.e., comparison of one compensation vs. two capitalization models). For our three-arm, single-blinded, randomized controlled trial (implementation of CBT for GAD [IMPLEMENT]), we recruited adults with GAD using advertisements in high-circulation newspapers to participate in a 14-session cognitive behavioral treatment (Mastery of your Anxiety and Worry, MAW-packet). We randomly assigned eligible patients using a full randomization procedure (1:1:1) to three different conditions of implementation: adherence priming (compensation model), which had a systematized focus on patients' individual GAD symptoms and how to compensate for these symptoms within the MAW-packet, and resource priming and supportive resource priming (capitalization model), which had systematized focuses on patients' strengths and abilities and how these strengths can be capitalized within the same packet. In the intention-to-treat population an outcome composite of primary and secondary symptoms-related self-report questionnaires was analyzed based on a hierarchical linear growth model from intake to 6-month follow-up assessment. This trial is registered at ClinicalTrials.gov (identifier: NCT02039193) and is closed to new participants. From June 2012 to Nov. 2014, from 411 participants that were screened, 57 eligible participants were recruited and randomly assigned to three conditions. Forty-nine patients (86%) provided outcome data at post-assessment (14% dropout rate). All three conditions showed a highly significant reduction of symptoms over time. However, compared with the adherence priming condition, both resource priming conditions indicated
Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R
There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout
Blonigen, Daniel M; Cucciare, Michael A; Timko, Christine; Smith, Jennifer S; Harnish, Autumn; Kemp, Lakiesha; Rosenthal, Joel; Smelson, David
Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention aimed at reducing risk for criminal recidivism by restructuring antisocial attitudes and cognitions (i.e., "criminogenic thinking"). MRT has empirical support for reducing risk for criminal recidivism among civilian offenders. Recently, a version of MRT was developed for military veterans; however, no randomized controlled trials (RCT) have been conducted with the veteran-specific protocol, and the effectiveness and implementation potential of MRT outside of correctional settings has not been established. Using a Hybrid Type 1 RCT design, this study will test the effectiveness of MRT to reduce risk for criminal recidivism and improve health-related outcomes among justice-involved veterans entering mental health residential treatment at three US Veterans Health Administration (VHA) Medical Centers. Upon admission to the treatment program, justice-involved veterans will complete a baseline assessment, be randomized to usual care (UC) or UC + MRT, and be followed 6 and 12 months post-baseline. A process evaluation will also be conducted to identify barriers and facilitators to implementation of MRT in residential treatment. The primary aim of this study is to evaluate the effectiveness of MRT with justice-involved veterans. If MRT proves effective in this trial, the findings can provide large healthcare systems that serve veterans with an evidence-based intervention for addressing criminogenic thinking among justice-involved adults, as well as guidance on how to facilitate future implementation of MRT in non-correctional settings. This trial is funded by the VA Health Services Research & Development Program (IIR 14-081) and is registered with ClinicalTrials.gov (ID: NCT02524171 ).
Full Text Available of randomised and clinically controlled trials of HIV/AIDS interventions can provide invaluable information to decision-making processes. Using the newly emerging geographical information systems (GIS) technology, researchers have developed a tool which assists...
Full Text Available Abstract Background The increasing attention on functional assessments in medical and vocational rehabilitation requires a focus change for the general practitioners (GP into paying attention to patient resources, possibilities and coping instead of symptoms, problems and limitations. The GPs report difficulties in performing the requested explicit functional assessments. The purpose of this study was to implement a structured method in general practice for assessing functional ability in persons with long-term sick leave. The study aim was to evaluate intervention effects on important GP parameters; knowledge, attitudes, self-efficacy towards functional assessments and knowledge about patient work factors. Methods Fifty-seven GPs were randomly assigned to an intervention or a control group. The intervention group GPs attended an introductory one-day work-shop and implemented structured functional assessments during an eight months intervention period. GP knowledge, GP attitudes, and GP self-efficacy towards functional assessments, as well as GP knowledge of patient work factors, were collected before, after and six months after the intervention period started. Evaluation score-sheets were filled in by both the intervention GPs and their patients immediately after the consultation to evaluate the GPs' knowledge of patient work factors. Results The intervention GPs reported increased knowledge (B: 0.56, 95% CI (0.19, 0.91 and self-efficacy (B: 0.90, 95% CI (0.53, 1.26 towards functional assessments, and increased knowledge about their patients' workplace (B: 0.75, 95% CI (0.35, 1.15 and perceived stressors (B: 0.55, 95% CI (0.23, 0.88 with lasting effects at the second follow-up. No intervention effect was seen in relation to GP attitudes. Both before and after the intervention, the GPs were most informed about physical stressors, and less about mental and work organisational stressors (Guttman's reproducibility coefficient: 0.95 and 1.00. After
Background People living with chronic disease currently account for the majority of the total healthcare costs. The Central Denmark Region implemented a disease management programme (DMP) for chronic obstructive pulmonary disease (COPD) in 2008. This presented an opportunity to examine the effect of an evidence-based, planned and proactive implementation of a DMP compared to the usual implementation strategy. Methods We performed a block- and cluster-randomised controlled trial with two groups and an extra external control group. The primary outcome was patients’ assessment of their care after using an active implementation model for a DMP for COPD measured with the Patient-Assessment-of-Chronic-Illness-Care (PACIC) instrument. At baseline, questionnaires were sent to 2,895 patients identified by an algorithm based on health registry data on lung-related contacts to the healthcare system. Patients were asked to confirm or refute their diagnosis of COPD. Of those who responded, 1,445 (72.8%) confirmed their diagnosis. PACIC data were collected at baseline and at a 12-month follow-up for 744 (51.1%) patients. Results Comparing the three groups after the implementation of the DMP, we found a statistically significantly higher change in the PACIC score in the intervention group than in the control groups. No statistically significant differences were found between the control and the external control groups in any of the dimensions. Conclusions Reinforcing the role of general practice as coordinator for care-and self-management-support with an active implementation of a DMP for COPD made patients score higher on the PACIC instrument, which indicates a better experience of the received healthcare. Trial registration NCT01228708. PMID:24088417
Ojo-Fati, Olamide; Joseph, Anne M; Ig-Izevbekhai, Jed; Thomas, Janet L; Everson-Rose, Susan A; Pratt, Rebekah; Raymond, Nancy; Cooney, Ned L; Luo, Xianghua; Okuyemi, Kolawole S
There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers. ClinicalTrials.gov, ID: NCT00786149 . Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996 . Registered on 20 November 2014.
Kher, Sucharita; Roberts, Russel J; Garpestad, Erik; Kunkel, Chris; Howard, William; Didominico, Dorothy; Fergusson, Anne; Devlin, John W
While one controlled trial found that a daily awakening and spontaneous breathing trial (DA-SBT) decreases time on mechanical ventilation (MV), there is a paucity of real-world data surrounding the development, implementation, and impact of DA-SBT protocols. We describe a multidisciplinary process improvement effort in 2, 10-bed medical intensive care units (MICUs) at a 330-bed academic medical center that focused on the development, implementation, and evaluation of a new DA-SBT protocol. A DA-SBT protocol, developed using results from a nursing survey literature and available institutional resources, was implemented after extensive clinician education and institution of quality reminders to boost use. Postprotocol compliance was evaluated. Use of sedation, DA and SBT practices, and clinical outcomes were retrospectively compared between the before and after DA-SBT protocol groups (ie, consecutive MICU patients requiring a continuously infused sedative [CIS] ≥24 hours). In the after group (n = 32), the DA and SBT compliances were 44% and 84%, respectively. Compared with the before group (n = 33), after group patients received CIS on fewer days of MV (100% vs 67%, P = .003) and had their CIS down-titrated by ≥25% on more days of CIS (40% vs 71%, P = .006). Neither total CIS dose (P = .49), total MV days (P = .75), days of MV where a SBT occurred (P = .38), nor episodes of self-extubation (15% vs 6%, P = .43) differed between the 2 groups. Despite the implementation of a DA-SBT protocol that was individualized to clinician preferences and institutional resources and accompanied by substantial education and reminders for use, compliance to the DA component of this protocol was low and duration of MV remained unchanged. Additional quality improvement strategies are needed to overcome barriers to DA-SBT protocol use that may not exist in controlled clinical trials.
Solomon, Daniel H; Lee, Sara B; Zak, Agnes; Corrigan, Cassandra; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie; Losina, Elena; Lu, Bing; Pincus, Ted; Radner, Helga; Smolen, Josef; Katz, Jeffrey N; Fraenkel, Liana
Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1-9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10-18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan-do-study-act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely. Copyright © 2016 Elsevier Inc. All rights reserved.
Full Text Available The reintroduction of wolves (Canis lupus to Yellowstone provided the unusual opportunity for a quasi-experimental test of the effects of wolf predation on their primary prey (elk--Cervus elaphus in a system where top-down, bottom-up, and abiotic forces on prey population dynamics were closely and consistently monitored before and after reintroduction. Here, we examined data from 33 years for 12 elk population segments spread across southwestern Montana and northwestern Wyoming in a large scale before-after-control-impact analysis of the effects of wolves on elk recruitment and population dynamics. Recruitment, as measured by the midwinter juvenile∶female ratio, was a strong determinant of elk dynamics, and declined by 35% in elk herds colonized by wolves as annual population growth shifted from increasing to decreasing. Negative effects of population density and winter severity on recruitment, long recognized as important for elk dynamics, were detected in uncolonized elk herds and in wolf-colonized elk herds prior to wolf colonization, but not after wolf colonization. Growing season precipitation and harvest had no detectable effect on recruitment in either wolf treatment or colonization period, although harvest rates of juveniles∶females declined by 37% in wolf-colonized herds. Even if it is assumed that mortality due to predation is completely additive, liberal estimates of wolf predation rates on juvenile elk could explain no more than 52% of the total decline in juvenile∶female ratios in wolf-colonized herds, after accounting for the effects of other limiting factors. Collectively, these long-term, large-scale patterns align well with prior studies that have reported substantial decrease in elk numbers immediately after wolf recolonization, relatively weak additive effects of direct wolf predation on elk survival, and decreased reproduction and recruitment with exposure to predation risk from wolves.
Full Text Available Abstract Background As the US population ages, there is an increasing need for evidence based, peer-led physical activity programs, particularly in ethnically diverse, low income senior centers where access is limited. Methods/design The Peer Empowerment Program 4 Physical Activity’ (PEP4PA is a hybrid Type II implementation-effectiveness trial that is a peer-led physical activity (PA intervention based on the ecological model of behavior change. The initial phase is a cluster randomized control trial randomized to either a peer-led PA intervention or usual center programming. After 18 months, the intervention sites are further randomized to continued support or no support for another 6 months. This study will be conducted at twelve senior centers in San Diego County in low income, diverse communities. In the intervention sites, 24 peer health coaches and 408 adults, aged 50 years and older, are invited to participate. Peer health coaches receive training and support and utilize a tablet computer for delivery and tracking. There are several levels of intervention. Individual components include pedometers, step goals, counseling, and feedback charts. Interpersonal components include group walks, group sharing and health tips, and monthly celebrations. Community components include review of PA resources, walkability audit, sustainability plan, and streetscape improvements. The primary outcome of interest is intensity and location of PA minutes per day, measured every 6 months by wrist and hip accelerometers and GPS devices. Secondary outcomes include blood pressure, physical, cognitive, and emotional functioning. Implementation measures include appropriateness & acceptability (perceived and actual fit, adoption & penetration (reach, fidelity (quantity & quality of intervention delivered, acceptability (satisfaction, costs, and sustainability. Discussion Using a peer led implementation strategy to deliver a multi-level community based PA
Husnik, Marla J; Brown, Elizabeth R; Marzinke, Mark; Livant, Edward; Palanee-Phillips, Thesla; Hendrix, Craig W; Matovu Kiweewa, Flavia; Nair, Gonasagrie; Soto-Torres, Lydia E; Schwartz, Katie; Hillier, Sharon L; Baeten, Jared M
Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. An upward trend in adherence was observed (P 95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.
Ross-Degnan, Dennis; Chalker, John; Liana, Jafary; Kajoka, Mwikemo Deborah; Valimba, Richard; Kimatta, Suleiman; Dillip, Angel; Vialle-Valentin, Catherine; Embrey, Martha; Lieber, Rachel; Johnson, Keith
Introduction: In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic. Methods: We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment ...
Pas, Elise T; Waasdorp, Tracy E; Bradshaw, Catherine P
Although it is widely recognized that variation in implementation fidelity influences the impact of preventive interventions, little is known about how specific contextual factors may affect the implementation of social and behavioral interventions in classrooms. Theoretical research highlights the importance of multiple contextual influences on implementation, including factors at the classroom and school level (Domitrovich et al., Advances in School Mental Health Promotion, 1, 6-28, 2008). The current study used multi-level modeling to empirically examine the influence of teacher, classroom, and school characteristics on the implementation of classroom-based positive behavior support strategies over the course of 4 years. Data were collected in the context of a 37-school randomized controlled trial examining the effectiveness of school-wide Positive Behavioral Interventions and Supports. Multi-level results identified several school-level contextual factors (e.g., school size, behavioral disruptions) and teacher-level factors (perceptions of school organizational health and grade level taught) associated with variability in the implementation of classroom-based positive behavior supports. Implications for prevention research and practice are discussed.
Bautista-Molano, Wilson; Navarro-Compán, Victoria; Landewé, Robert B. M.; Boers, Maarten; Kirkham, Jamie J.; van der Heijde, Désirée
This study aims to investigate how well the Assessment of SpondyloArthritis international Society (ASAS)/Outcome Measures in Rheumatology Clinical Trials (OMERACT) core set and response criteria for ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing
Andrew J Stewardson
Full Text Available INTRODUCTION: Hand hygiene is a key component of infection control in healthcare. WHO recommends that healthcare workers perform six specific poses during each hand hygiene action. SureWash (Glanta Ltd, Dublin, Ireland is a novel device that uses video-measurement technology and immediate feedback to teach this technique. We assessed the impact of self-directed SureWash use on healthcare worker hand hygiene technique and evaluated the device's diagnostic capacity. METHODS: A controlled before-after study: subjects in Group A were exposed to the SureWash for four weeks followed by Group B for 12 weeks. Each subject's hand hygiene technique was assessed by blinded observers at baseline (T0 and following intervention periods (T1 and T2. Primary outcome was performance of a complete hand hygiene action, requiring all six poses during an action lasting ≥20 seconds. The number of poses per hand hygiene action (maximum 6 was assessed in a post-hoc analysis. SureWash's diagnostic capacity compared to human observers was assessed using ROC curve analysis. RESULTS: Thirty-four and 29 healthcare workers were recruited to groups A and B, respectively. No participants performed a complete action at baseline. At T1, one Group A participant and no Group B participants performed a complete action. At baseline, the median number of poses performed per action was 2.0 and 1.0 in Groups A and B, respectively (p = 0.12. At T1, the number of poses per action was greater in Group A (post-intervention than Group B (control: median 3.8 and 2.0, respectively (p<0.001. In Group A, the number of poses performed twelve weeks post-intervention (median 3.0 remained higher than baseline (p<0.001. The area under the ROC curves for the 6 poses ranged from 0.59 to 0.88. DISCUSSION: While no impact on complete actions was demonstrated, SureWash significantly increased the number of poses per hand hygiene action and demonstrated good diagnostic capacity.
Dempsey Mary E
Full Text Available Abstract Background In many parts of the world, salt marshes play a key ecological role as the interface between the marine and the terrestrial environments. Salt marshes are also exceedingly important for public health as larval habitat for mosquitoes that are vectors of disease and significant biting pests. Although grid ditching and pesticides have been effective in salt marsh mosquito control, marsh degradation and other environmental considerations compel a different approach. Targeted habitat modification and biological control methods known as Open Marsh Water Management (OMWM had been proposed as a viable alternative to marsh-wide physical alterations and chemical control. However, traditional larval sampling techniques may not adequately assess the impacts of marsh management on mosquito larvae. To assess the effectiveness of integrated OMWM and marsh restoration techniques for mosquito control, we analyzed the results of a 5-year OMWM/marsh restoration project to determine changes in mosquito larval production using GIS and geostatistical methods. Methods The following parameters were evaluated using "Before-After-Control-Impact" (BACI design: frequency and geographic extent of larval production, intensity of larval production, changes in larval habitat, and number of larvicide applications. The analyses were performed using Moran's I, Getis-Ord, and Spatial Scan statistics on aggregated before and after data as well as data collected over time. This allowed comparison of control and treatment areas to identify changes attributable to the OMWM/marsh restoration modifications. Results The frequency of finding mosquito larvae in the treatment areas was reduced by 70% resulting in a loss of spatial larval clusters compared to those found in the control areas. This effect was observed directly following OMWM treatment and remained significant throughout the study period. The greatly reduced frequency of finding larvae in the treatment
Rochlin, Ilia; Iwanejko, Tom; Dempsey, Mary E; Ninivaggi, Dominick V
In many parts of the world, salt marshes play a key ecological role as the interface between the marine and the terrestrial environments. Salt marshes are also exceedingly important for public health as larval habitat for mosquitoes that are vectors of disease and significant biting pests. Although grid ditching and pesticides have been effective in salt marsh mosquito control, marsh degradation and other environmental considerations compel a different approach. Targeted habitat modification and biological control methods known as Open Marsh Water Management (OMWM) had been proposed as a viable alternative to marsh-wide physical alterations and chemical control. However, traditional larval sampling techniques may not adequately assess the impacts of marsh management on mosquito larvae. To assess the effectiveness of integrated OMWM and marsh restoration techniques for mosquito control, we analyzed the results of a 5-year OMWM/marsh restoration project to determine changes in mosquito larval production using GIS and geostatistical methods. The following parameters were evaluated using "Before-After-Control-Impact" (BACI) design: frequency and geographic extent of larval production, intensity of larval production, changes in larval habitat, and number of larvicide applications. The analyses were performed using Moran's I, Getis-Ord, and Spatial Scan statistics on aggregated before and after data as well as data collected over time. This allowed comparison of control and treatment areas to identify changes attributable to the OMWM/marsh restoration modifications. The frequency of finding mosquito larvae in the treatment areas was reduced by 70% resulting in a loss of spatial larval clusters compared to those found in the control areas. This effect was observed directly following OMWM treatment and remained significant throughout the study period. The greatly reduced frequency of finding larvae in the treatment areas led to a significant decrease (approximately 44%) in
Huang, Grant D; Altemose, Jane K; O'Leary, Timothy J
Efforts to make clinical trials and their results more publicly available have been increasing in recent years. However, there is a need to better understand ways to achieve these goals aimed at benefiting a diverse set of stakeholders. Since 2005, the U.S. Department of Veterans Affairs Office of Research and Development (ORD), part of the nation's largest integrated health care system, has required the clinical trials its funds to be registered in ClinicalTrials.gov as a condition of the award. Furthermore, summary results of studies active since 2007 have been included in the registry. This paper highlights ORD activities, challenges and lessons at investigator, study, and organizational levels. Key factors in ORD's approach include: a mission-oriented approach; leadership support; a working group for organizational policies and practices; prioritizing communication; and recognizing the needs of investigators. Making clinical trials available to the public should represent a focal point for groups desiring to maximize the contributions from such research. The ability to do so must involve a commitment by sponsors and a critical evaluation of the reasons, requirements and resources at multiple levels. Published by Elsevier Inc.
Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.
The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…
Jensen, Kjeld; Laursen, Morten Stigaard; Midtiby, Henrik
of weed detection algorithms and spraying strategies is developed. The front part of the cell sprayer implement is a camera module mounted in a shock absorbing frame. The camera module is followed by a spraying module containing nozzles with individual valve control. The implement is designed for use......Precision weeding is one of the most promising applications for autonomous service robots in biological production. Herbicides have been the default weeding solution during the past decades, but there is a growing concern about the environmental impact on drinking water reservoirs etc. The use...... with an Armadillo robotic tool carrier consisting of two battery powered track modules mounted on each side of the implement. This paper focus on the cell sprayer implement design including camera system, sprayer module and integration with the service robot and the robot software. The FroboMind software platform...
In between the description of the methodology and the discussion of assessment results, lies a crucial area, namely that of implementation. If assessment methods cannot be implemented, there will be no assessment report, and no recommendations for intervention or policy development. Implementation is a critical, yet neglected, area of drug policy delivery. This paper describes some of the problems associated with the implementation of rapid assessment studies commissioned by the United Nations International Drug Control Programme (UNDCP) over the last 5 years. Drawing on the author's experience of commissioning rapid assessments on the extent and nature of drug use in a variety of international settings and political contexts, the paper draws eight main lessons for rapid assessments commissioned within the context of international development programmes. These are: (1) the need to get high level political support; (2) the need to employ competent social scientists to run the assessment; (3) the need to define exactly the object of the assessment; (4) the necessity of spelling out the methodology and the time scale; (5) the careful establishment of the financial framework; (6) the importance of cultivating contacts; (7) the necessity of actually getting a report; and (8) the danger of accepting an unseen or unread consultant's report as the basis for programme implementation. The paper emphasises the critical importance of planning prior to implementation and flexibility during it.
Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul
Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord
Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul
Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we
Francke Anneke L
Full Text Available Abstract Background Pain (physical discomfort and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP! in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol. Methods/Design The study is a cluster randomized controlled trial in 168 older people (aged >65 years with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach. Measurements take place at baseline, after 3 months (end of the STA OP! training period and after 6 months. Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH, and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI pain scale. Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale, Quality of Live (Qualidem, changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy. Discussion The transfer from the American design to
Aarons, Gregory A; Ehrhart, Mark G; Moullin, Joanna C; Torres, Elisa M; Green, Amy E
Evidence-based practice (EBP) implementation represents a strategic change in organizations that requires effective leadership and alignment of leadership and organizational support across organizational levels. As such, there is a need for combining leadership development with organizational strategies to support organizational climate conducive to EBP implementation. The leadership and organizational change for implementation (LOCI) intervention includes leadership training for workgroup leaders, ongoing implementation leadership coaching, 360° assessment, and strategic planning with top and middle management regarding how they can support workgroup leaders in developing a positive EBP implementation climate. This test of the LOCI intervention will take place in conjunction with the implementation of motivational interviewing (MI) in 60 substance use disorder treatment programs in California, USA. Participants will include agency executives, 60 program leaders, and approximately 360 treatment staff. LOCI will be tested using a multiple cohort, cluster randomized trial that randomizes workgroups (i.e., programs) within agency to either LOCI or a webinar leadership training control condition in three consecutive cohorts. The LOCI intervention is 12 months, and the webinar control intervention takes place in months 1, 5, and 8, for each cohort. Web-based surveys of staff and supervisors will be used to collect data on leadership, implementation climate, provider attitudes, and citizenship. Audio recordings of counseling sessions will be coded for MI fidelity. The unit of analysis will be the workgroup, randomized by site within agency and with care taken that co-located workgroups are assigned to the same condition to avoid contamination. Hierarchical linear modeling (HLM) will be used to analyze the data to account for the nested data structure. LOCI has been developed to be a feasible and effective approach for organizations to create a positive climate and
Full Text Available Concerns about the appropriate use of EBP with ethnic minority clients and the ability of community agencies to implement and sustain EBP persist and emphasize the need for community-academic research partnerships that can be used to develop, adapt, and test culturally responsive EBP in community settings. In this paper, we describe the processes of developing a community-academic partnership that implemented and pilot tested an evidence-based telephone cognitive behavioral therapy program. Originally demonstrated to be effective for urban, middle-income, English-speaking primary care patients with major depression, the program was adapted and pilot tested for use with rural, uninsured, low-income, Latino (primarily Spanish-speaking primary care patients with major depressive disorder in a primary care site in a community health center in rural Eastern Washington. The values of community-based participatory research and community-partnered participatory research informed each phase of this randomized clinical trial and the development of a community-academic partnership. Information regarding this partnership may guide future community practice, research, implementation, and workforce development efforts to address mental health disparities by implementing culturally tailored EBP in underserved communities.
Kozica, Samantha L; Teede, Helena J; Harrison, Cheryce L; Klein, Ruth; Lombard, Catherine B
The prevalence of obesity in rural and remote areas is elevated in comparison to urban populations, highlighting the need for interventions targeting obesity prevention in these settings. Implementing evidence-based obesity prevention programs is challenging. This study aimed to investigate factors influencing the implementation of obesity prevention programs, including adoption, program delivery, community uptake, and continuation, specifically within rural settings. Nested within a large-scale randomized controlled trial, a qualitative exploratory approach was adopted, with purposive sampling techniques utilized, to recruit stakeholders from 41 small rural towns in Australia. In-depth semistructured interviews were conducted with clinical health professionals, health service managers, and local government employees. Open coding was completed independently by 2 investigators and thematic analysis undertaken. In-depth interviews revealed that obesity prevention programs were valued by the rural workforce. Program implementation is influenced by interrelated factors across: (1) contextual factors and (2) organizational capacity. Key recommendations to manage the challenges of implementing evidence-based programs focused on reducing program delivery costs, aided by the provision of a suite of implementation and evaluation resources. Informing the scale-up of future prevention programs, stakeholders highlighted the need to build local rural capacity through developing supportive university partnerships, generating local program ownership and promoting active feedback to all program partners. We demonstrate that the rural workforce places a high value on obesity prevention programs. Our results inform the future scale-up of obesity prevention programs, providing an improved understanding of strategies to optimize implementation of evidence-based prevention programs. © 2015 National Rural Health Association.
Tirindelli Danesi, D.; Altavista, P.; Marino, C.; Benassi, M.
The basis for all controlled clinical trials is the comparison of a new treatment with the standard treatment. The effect of the experimental procedure on the natural history of the disease is the result observed; but the interpretation of the results in cancer clinical experimentation is often difficult due to the variability of the clinical course of individual cancers in a given category. It has been possible to categorize cancers by means of prognostic factors and evaluate the results of therapy within each prognostic category, but there is still much variability within each category. The only way to determine whether or not a new treatment can be used for a particular form of cancer is to try it out on patients in clinical trials. The cooperative practice was originally induced by the realistic need for large sample sizes, but the variability in the interpretation of the results increased due to difficulties in comparing data. This is one of the main problems in cancer literature. These problems originate from inconsistent or incomplete reporting of the patient population under study, the treatment administered, the statistical methods employed to assess treatment efficacy and from differences in the definition of response criteria. This paper tries to outline the impact on the results evaluation of the lack of standardized prognostic factors and standardized therapeutic modalities in the selection and treatment of patients included in clinical trials
Full Text Available Caleb Parker,1 Amy Corneli,1 Kawango Agot,2 Jacob Odhiambo,2 Jesse Asewe,2 Khatija Ahmed,3 Joseph Skhosana,3 Malebo Ratlhagana,3 Michele Lanham,1 Christina Wong,1 Jennifer Deese,1 Rachel Manongi,4 Lut Van Damme,1On behalf of the FEM-PrEP recruitment group 1FHI 360, Global Health, Population and Nutrition, Durham, NC, USA; 2Impact Research and Development Organization, Kisumu, Kenya; 3Setshaba Research Centre, Soshanguve, Pretoria, South Africa; 4Kilimanjaro Christian Medical Centre, Moshi, Tanzania Abstract: We implemented an empirically informed, geographically based recruitment approach for FEM-PrEP, a human immunodeficiency virus (HIV prevention clinical trial of daily oral emtricitabine (FTC and tenofovir disoproxil fumarate (TDF for HIV prevention. During the formative research phase, we conducted a modification of the Priorities for Local AIDS Control Efforts (PLACE method and used those data and staff experiences to identify and prioritize for recruitment geographic areas where HIV incidence might be high. During the clinical trial, we implemented a routinely monitored and flexible recruitment plan in the geographical areas identified in the formative research. We describe three lessons learnt from implementing this approach: 1 the PLACE data were critical in identifying places presumed to be high risk; 2 staff experiences, in combination with PLACE data, were needed to inform a practical recruitment strategy; and 3 recruiting in establishments in priority areas identified by the PLACE data led to screening many HIV-positive women at the Bondo site (Kenya, placing additional burden on clinic staff. These lessons learnt highlight the critical importance of having a flexible and monitored recruitment strategy. Although we successfully recruited a study population at higher risk for HIV, FEM-PrEP was unable to determine the effectiveness of FTC/TDF for HIV prevention, due to low adherence to the study product among participants. We must
Harrison, Rosamund; Veronneau, Jacques; Leroux, Brian
The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings. Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age. The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups. In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects. This paper explains the challenges of conducting randomized trials in remote settings, the importance of thorough
Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene
The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…
Feng, Mingyu; Roschelle, Jeremy; Heffernan, Neil; Fairman, Janet; Murphy, Robert
Much research has been done on the development of an intelligent tutoring system (ITS), and small empirical studies have demonstrated the effectiveness of ITS at promoting student learning. However, large-scale implementation of ITS in school settings has not been researched thoroughly. In this paper, we describe an ongoing randomized controlled…
Full Text Available Abstract Background Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction. The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montréal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University. The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options. Methods The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives. Results and conclusion As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get
Sterling, Stacy; Kline-Simon, Andrea H; Satre, Derek D; Jones, Ashley; Mertens, Jennifer; Wong, Anna; Weisner, Constance
Early intervention for substance use is critical to improving adolescent outcomes. Studies have found promising results for Screening, Brief Intervention, and Referral to Treatment (SBIRT), but little research has examined implementation. To compare SBIRT implementation in pediatric primary care among trained pediatricians, pediatricians working in coordination with embedded behavioral health care practitioners (BHCPs), and usual care (UC). The study is a 2-year (November 1, 2011, through October 31, 2013), nonblinded, cluster randomized, hybrid implementation and effectiveness trial examining SBIRT implementation outcomes across 2 modalities of implementation and UC. Fifty-two pediatricians from a large general pediatrics clinic in an integrated health care system were randomized to 1 of 3 SBIRT implementation arms; patients aged 12 to 18 years were eligible. Two modes of SBIRT implementation, (1) pediatrician only (pediatricians trained to provide SBIRT) and (2) embedded BHCP (BHCP trained to provide SBIRT), and (3) UC. Implementation of SBIRT (primary outcome), which included assessments, brief interventions, and referrals to specialty substance use and mental health treatment. The final sample included 1871 eligible patients among 47 pediatricians; health care professional characteristics did not differ across study arms. Patients in the pediatrician-only (adjusted odds ratio [AOR], 10.37; 95% CI, 5.45-19.74; P < .001) and the embedded BHCP (AOR, 18.09; 95% CI, 9.69-33.77; P < .001) arms had higher odds of receiving brief interventions compared with patients in the UC arm. Patients in the embedded BHCP arm were more likely to receive brief interventions compared with those in the pediatrician-only arm (AOR, 1.74; 95% CI, 1.31-2.31; P < .001). The embedded BHCP arm had lower odds of receiving a referral compared with the pediatrician-only (AOR, 0.58; 95% CI, 0.43-0.78; P < .001) and UC (AOR, 0.65; 95% CI, 0.48-0.89; P = .006) arms; odds of
Witte, Susan S; Wu, Elwin; El-Bassel, Nabila; Hunt, Timothy; Gilbert, Louisa; Medina, Katie Potocnik; Chang, Mingway; Kelsey, Ryan; Rowe, Jessica; Remien, Robert
resources and staff exposure, especially when paired with a couple-based modality. Manual-based and traditional programs may hold some advantage or ease for implementation, particularly at a time of low economic resources. ClinicalTrials.gov identifier: NCT01863537.
Eiraldi, Ricardo; McCurdy, Barry; Khanna, Muniya; Mautone, Jennifer; Jawad, Abbas F; Power, Thomas; Cidav, Zuleyha; Cacia, Jaclyn; Sugai, George
Urban schools lag behind non-urban schools in attending to the behavioral health needs of their students. This is especially evident with regard to the level of use of evidence-based interventions with school children. Increased used of evidence-based interventions in urban schools would contribute to reducing mental health services disparities in low-income communities. School-wide positive behavioral interventions and supports (SWPBIS) is a service delivery framework that can be used to deliver universal preventive interventions and evidence-based behavioral health treatments, such as group cognitive behavioral therapy. In this article, we describe our ongoing research on creating internal capacity for program implementation. We also examine the cost-effectiveness and resulting school climate when two different levels of external support are provided to personnel as they implement a two-tier SWPBIS program. The study follows six K - 8 schools in the School District of Philadelphia randomly assigned to consultation support or consultation-plus-coaching support. Participants are: approximately 48 leadership team members, 180 school staff and 3,900 students in Tier 1, and 12 counselors, and 306 child participants in Tier 2. Children who meet inclusion criteria for Tier 2 will participate in group cognitive behavioral therapy for externalizing or anxiety disorders. The study has three phases, baseline/training, implementation, and sustainability. We will measure implementation outcomes, service outcomes, child outcomes, and cost. Findings from this study will provide evidence as to the appropriateness of school-wide prevention and treatment service delivery models for addressing services disparities in schools. The effectiveness and cost-effectiveness analyses of the two levels of training and consultation should help urban school districts and policymakers with the planning and deployment of cost-effective strategies for the implementation of evidence
Tokunaga, Jin; Takamura, Norito; Ogata, Kenji; Setoguchi, Nao; Sato, Keizo
Bedside training for fourth-year students, as well as seminars in hospital pharmacy (vital sign seminars) for fifth-year students at the Department of Pharmacy of Kyushu University of Health and Welfare have been implemented using patient training models and various patient simulators. The introduction of simulation-based pharmaceutical education, where no patients are present, promotes visually, aurally, and tactilely simulated learning regarding the evaluation of vital signs and implementation of physical assessment when disease symptoms are present or adverse effects occur. A patient simulator also promotes the creation of training programs for emergency and critical care, with which basic as well as advanced life support can be practiced. In addition, an advanced objective structured clinical examination (OSCE) trial has been implemented to evaluate skills regarding vital signs and physical assessments. Pharmacists are required to examine vital signs and conduct physical assessment from a pharmaceutical point of view. The introduction of these pharmacy clinical skills will improve the efficacy of drugs, work for the prevention or early detection of adverse effects, and promote the appropriate use of drugs. It is considered that simulation-based pharmaceutical education is essential to understand physical assessment, and such education will ideally be applied and developed according to on-site practices.
Full Text Available Abstract Background A growing body of literature shows that patients accept the use of computers in clinical care. Nonetheless, studies have shown that computers unequivocally change both verbal and non-verbal communication style and increase patients' concerns about the privacy of their records. We found no studies which evaluated the use of Electronic Health Records (EHRs specifically on psychiatric patient satisfaction, nor any that took place exclusively in a psychiatric treatment setting. Due to the special reliance on communication for psychiatric diagnosis and evaluation, and the emphasis on confidentiality of psychiatric records, the results of previous studies may not apply equally to psychiatric patients. Method We examined the association between EHR use and changes to the patient-psychiatrist relationship. A patient satisfaction survey was administered to psychiatric patient volunteers prior to and following implementation of an EHR. All subjects were adult outpatients with chronic mental illness. Results Survey responses were grouped into categories of "Overall," "Technical," "Interpersonal," "Communication & Education,," "Time," "Confidentiality," "Anxiety," and "Computer Use." Multiple, unpaired, two-tailed t-tests comparing pre- and post-implementation groups showed no significant differences (at the 0.05 level to any questionnaire category for all subjects combined or when subjects were stratified by primary diagnosis category. Conclusions While many barriers to the adoption of electronic health records do exist, concerns about disruption to the patient-psychiatrist relationship need not be a prominent focus. Attention to communication style, interpersonal manner, and computer proficiency may help maintain the quality of the patient-psychiatrist relationship following EHR implementation.
Detroyer, Elke; Dobbels, Fabienne; Teodorczuk, Andrew; Deschodt, Mieke; Depaifve, Yves; Joosten, Etienne; Milisen, Koen
Education of healthcare workers is a core element of multicomponent delirium strategies to improve delirium care and, consequently, patient outcomes. However, traditional educational strategies are notoriously difficult to implement. E-learning is hypothesised to be easier and more cost effective, but research evaluating effectiveness of delirium education through e-learning is scarce at present. Aim is to determine the effect of a nursing e-learning tool for delirium on: (1) in-hospital prevalence, duration and severity of delirium or mortality in hospitalized geriatric patients, and (2) geriatric nurses' knowledge and recognition regarding delirium. A before-after study in a sample of patients enrolled pre-intervention (non-intervention cohort (NIC); n = 81) and post-intervention (intervention cohort (IC); n = 79), and nurses (n = 17) of a geriatric ward (university hospital). The intervention included an information session about using the e-learning tool, which consisted of 11 e-modules incorporating development of knowledge and skills in the prevention, detection and management of delirium, and the completion of a delirium e-learning tool during a three-month period. Key patient outcomes included in-hospital prevalence and duration of delirium (Confusion Assessment Method), delirium severity (Delirium Index) and mortality (in-hospital; 12 months post-admission); key nurse outcomes included delirium knowledge (Delirium Knowledge Questionnaire) and recognition (Case vignettes). Logistic regression and linear mixed models were used to analyse patient data; Wilcoxon Signed Rank tests, McNemar's or paired t-tests for nursing data. No significant difference was found between the IC and NIC for in-hospital prevalence (21.5% versus 25.9%; p = 0.51) and duration of delirium (mean 4.2 ± SD 4.8 days versus 4.9 ± SD 4.8 days; p = 0.38). A trend towards a statistically significant lower delirium severity (IC versus NIC: difference estimate
Hooper Stephen R
Full Text Available Abstract Background Lithium is a benchmark treatment for bipolar illness in adults. However, there has been relatively little methodologically stringent research regarding the use of lithium in youth suffering from bipolarity. Methods Under the auspices of the Best Pharmaceuticals for Children Act (BPCA, a Written Request (WR pertaining to the study of lithium in pediatric mania was issued by the United States Food and Drug Administration (FDA to the National Institute of Child Health and Human Development (NICHD in 2004. Accordingly, the NICHD issued a Request for Proposals (RFP soliciting submissions to pursue this research. Subsequently, the NICHD awarded a contract to a group of investigators in order to conduct these studies. Results The Collaborative Lithium Trials (CoLT investigators, the BPCA-Coordinating Center, and the NICHD developed protocols to provide data that will: (1 establish evidence-based dosing strategies for lithium; (2 characterize the pharmacokinetics and biodisposition of lithium; (3 examine the acute efficacy of lithium in pediatric bipolarity; (4 investigate the long-term effectiveness of lithium treatment; and (5 characterize the short- and long-term safety of lithium. By undertaking two multi-phase trials rather than multiple single-phase studies (as was described in the WR, the feasibility of the research to be undertaken was enhanced while ensuring all the data outlined in the WR would be obtained. The first study consists of: (1 an 8-week open-label, randomized, escalating dose Pharmacokinetic Phase; (2 a 16-week Long-Term Effectiveness Phase; (3 a 28-week double-blind Discontinuation Phase; and (4 an 8-week open-label Restabilization Phase. The second study consists of: (1 an 8-week, double-blind, parallel-group, placebo-controlled Efficacy Phase; (2 an open-label Long-Term Effectiveness lasting either 16 or 24 weeks (depending upon blinded treatment assignment during the Efficacy Phase; (3 a 28-week double
Full Text Available Abstract Background Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. Methods A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the software Results From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261 had significant pathology, compared with 19% (49/253 in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15. In the combined educational outreach arms 15% (38/258 had significant pathology compared with 19% (48/256 in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24. Pro forma practices documented better assessment of patients at referral. Conclusion There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of
Aryanto, Kadek Y E; Broekema, André; Oudkerk, Matthijs; van Ooijen, Peter M A
To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two methods are presented for an adapted CTP test set-up. In the first method, images are pushed from the Picture Archiving and Communication System (PACS) using the DICOM protocol through a local network. In the second method, images are transferred through the internet using the HTTPS protocol. In total 25,000 images from 50 patients were moved from the PACS, anonymised and stored within roughly 2 h using the first method. In the second method, an average of 10 images per minute were transferred and processed over a residential connection. In both methods, no duplicated images were stored when previous images were retransferred. The anonymised images are stored in appropriate directories. The CTP can transfer and process DICOM images correctly in a very easy set-up providing a fast, secure and stable environment. The adapted CTP allows easy integration into an environment in which patient data are already included in an existing information system.
Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N
Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.
E. A. Zupanets
Full Text Available At the modern stage of the pharmaceutical industry development quality risk management becomes an integral part of all the processes of drug development and clinical trials (CT. Aim of paper is to study the opinion of competent experts in the field of CT of drugs and formation of strategic ways of risk management at the clinical site as well as to identify possible complications in the practical implementation of these approaches. Materials and methods: the survey of the expert group (17 people to select the indicators and the parameters measuring the risks of CT at clinical site, as well as their acceptable levels. The assessment of survey results was done using non-parametric statistics methods. Results of research. There were established the differences of various stakeholders’ notion of conceptual content and practical importance of quality management and the application of risk-oriented approaches at the clinical site in relation to CT quality that can become an obstacle to their implementation. The introduction of risk-based monitoring into the system for CT management at the clinical site corresponds to the interests of all stakeholders involved in the study. General concernment of the customer’s representatives, regulatory authority and researchers should be an important basis for the implementation of the risk-based management at the clinical site. So, it is necessary to create a common understanding of the terminology, objectives and expected outcomes of risk management at the clinical site, as well as a clear allocation of the duties and responsibilities of each side. Conclusions. The expediency of the concept of risk management application at the clinical site, practical orientation, as well as the need to develop scientific and methodological approaches for its implementation, contributing to the formation of a common basis for action and coordinated interaction of stakeholders involved in the management of CT were proved.
Burns, Karen E A; Devlin, John W; Hill, Nicholas S
The call for meaningful patient and family engagement in research has recently gained considerable momentum. This article defines patient and family engagement broadly and specifically in clinical research. Using a multicenter, North American weaning trial as an exemplar, we describe our early experiences as clinical researchers with patient and family engagement. The role of our Patient and Family Advisory Committee in trial design and implementation is illustrated. Through our experiences, we share our insights regarding the perceived opportunities and also highlight some challenges associated with engaging patients and family engagement in critical care research. Although "engagement science" is in its infancy, engaging patients and families in research holds promise as a novel research paradigm that will not only provide new insights into the questions, methods, and outcomes used in ICU research, but it will also make investments in research more accountable and ensure a strong "patient- and family-centered focus" of our research. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
Jensen, C. E.; Riis, A.; Pedersen, Kjeld Møller
to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations......Background: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy...... on the design of the health economic evaluation. Methods/design: The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis...
GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.
Heslehurst, Nicola; Rankin, Judith; McParlin, Catherine; Sniehotta, Falko F; Howel, Denise; Rice, Stephen; McColl, Elaine
Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines. GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A
Hernandez, Arthur E; Marcus, Marsha D; Hirst, Kathryn; Faith, Myles S; Goldberg, Linn; Treviño, Roberto P
To determine whether a school-wide intervention program to reduce risk factors for type 2 diabetes (T2D) affected student achievement, rates of disciplinary actions, and attendance rates. The HEALTHY primary prevention trial was designed to evaluate a comprehensive school-based intervention to reduce factors for T2D, especially overweight and obesity. Students were followed up from beginning of sixth grade (Fall 2006) through end of eighth grade (Spring 2009). Forty-two middle schools at seven U.S. sites. Schools were randomized in equal numbers at each site to intervention (21 schools, 2307 students) or control (21 schools, 2296 students). Intervention . An integrated school-wide program that focused on (1) foods and beverages, (2) physical education, (3) classroom-based behavior change and education, and (4) social marketing communication and promotional campaigns. Aggregate (grade- and school-wide) test performance (passing rate), attendance, and referrals for disciplinary actions. Descriptive statistics and tests of intervention versus control using mixed linear models methods to adjust for the clustering of students within schools. There were no differences between intervention and control schools in test performance for mathematics (p = .7835) or reading (p = .6387), attendance (p = .5819), or referrals for disciplinary action (p = .8671). The comprehensive HEALTHY intervention and associated research procedures did not negatively impact student achievement test scores, attendance, or referrals for disciplinary action.
Saiz-Vinuesa, M D; Rodríguez-Moreno, E; Carrilero-López, C; García Vitoria, J; Garrido-Moya, D; Claramonte-Monedero, R; Piqueras-Carrión, A M
Admission to intensive care unit (ICU) is a difficult and stressful time for the patient, with the application of different techniques, such as intubation and ventilation support withdrawal or "weaning", which may fail due to anxiety. To determine whether Reiki is useful in reducing weaning failure, as well as reducing the number of days of mechanical ventilation (MV), length of stay in ICU, amount of sedatives, amines, and antipsychotics. Randomized clinical trial. ICU of a Level III University Hospital. ICU patients connected to Mechanical Ventilation for more than 48hours, with a signed informed consent. Patients in a terminal condition or potential organ donors were excluded. 256 patients divided into two groups: intervention group (GI) and placebo (GP). The intervention involves the application of Reiki, and a simulated technique within the placebo group. An analysis was made of the absolute and relative frequencies, with a significance level of PReiki reduces the agitation of patients. A decrease was objectively observed in the number of days of Mechanical Ventilation, length of stay, lower doses of sedatives, and a slight decrease in the weaning failure in the GI. No statistically significant difference was found in the main variable. Copyright © 2015 Elsevier España, S.L.U. y SEEIUC. All rights reserved.
Törmä, Johanna; Winblad, Ulrika; Saletti, Anja; Cederholm, Tommy
Suboptimal nutritional practices in elderly care settings may be resolved by an efficient introduction of nutritional guidelines. To compare two different implementation strategies, external facilitation (EF) and educational outreach visits (EOVs), when introducing nutritional guidelines in nursing homes (NHs), and study the impact on staff performance. A quasi-experimental study with baseline and follow-up measurements. The primary outcome was staff performance as a function of mealtime ambience and food service routines. The EF strategy was a 1-year, multifaceted intervention that included support, guidance, practice audit and feedback in two NH units. The EOV strategy comprised one-three-hour lecture about nutritional guidelines in two other NH units. Both strategies were targeted to selected NH teams, which consisted of a unit manager, a nurse and 5-10 care staff. Mealtime ambience was evaluated by 47 observations using a structured mealtime instrument. Food service routines were evaluated by 109 food records performed by the staff. Mealtime ambience was more strongly improved in the EF group than in the EOV group after the implementation. Factors improved were laying a table (p = 0.03), offering a choice of beverage (p = 0.02), the serving of the meal (p = 0.02), interactions between staff and residents (p = 0.02) and less noise from the kitchen (p = 0.01). Food service routines remained unchanged in both groups. An EF strategy that included guidance, audit and feedback improved mealtime ambience when nutritional guidelines were introduced in a nursing home setting, whereas food service routines were unchanged by the EF strategy. © 2017 Nordic College of Caring Science.
Bast, Lotus Sofie; Due, Pernille; Bendtsen, Pernille; Ringgard, Lene; Wohllebe, Louise; Damsgaard, Mogens Trab; Grønbæk, Morten; Ersbøll, Annette Kjær; Andersen, Anette
Implementation fidelity describes how well an intervention is implemented in the real-world setting. Assessing implementation fidelity is essential in the understanding of intervention results. In most studies, implementation fidelity is measured insufficiently, though, not taking into account the complexity of the concept nor the intervention. The objective of the present study was to develop an overall quantitative measure of implementation fidelity, to examine the degree of implementation fidelity and the association of implementation and effect of a randomized school-based smoking prevention trial-the X:IT study. A cluster-randomized trial testing is a multi-component intervention to prevent smoking among adolescents in 94 Danish elementary schools (51 intervention, 43 control schools). Participants were grade 7 pupils (mean age 12.5 years). Data was collected by electronic questionnaires among pupils at baseline (n = 4161), the first follow-up (n = 3764), and the second follow-up (n = 3269) and among school coordinators at intervention schools at the first and second follow-up (50 and 39 coordinators). The intervention included three components: (1) smoke-free school grounds, (2) smoke-free curriculum, and (3) parental involvement, contracts, and dialogues. Implementation fidelity was assessed by four domains: adherence, dose, quality of delivery, and participant responsiveness. These were combined into an overall school-wise implementation index. The association of implementation and smoking was examined by logistic regression analyses. One fourth of the schools was characterized as high implementers of the program (all three components) at both first (12 schools, 24.0 %) and second follow-up (11 schools, 28.2 %). Implementation fidelity was strongly associated with smoking at the first and second follow-up, e.g., the odds for smoking at schools with high implementation both years were OR = 0.44 (95 % CI 0.32 to 0.68). Using an overall
Noboa-Ortega, Patricia; Figueroa-Cosme, Wanda I; Feldman-Soler, Alana; Miranda-Díaz, Christine
"Arte con Salud" is an HIV/AIDS prevention intervention tailored for Puerto Rican women who have sex with men. The intervention curriculum was refined through a community-academic collaboration between Taller Salud, the UPRCayey Campus, and the UCC-School of Medicine, subsided in 2012-13 by PRCTRC. The collaboration has been crucial to validate the impact of using art as a tool to facilitate sexual negotiation skills and safer sexual practices among adult women have sex with men participating in HIV prevention education. This article describes the vision, valley, victory phases endured to establish a community-academia partnership based on the CPPR framework as an effective mean to implement a randomized controlled trial intervention (RCT). We also discuss the barriers, outcomes, and lessons learned from this partnership. Some of the identified solutions include: setting goals to secure funding, regular meetings, and the inclusion of undergraduate level students to assist in the implementation of the intervention. These solutions helped to build trust among the community and academic partners. As a result of this collaboration, a total of 86 participants were enrolled and 5 competitive research grants have been submitted. The community-academic collaboration was essential in order to build a solid research infrastructure that addresses the complexities of HIV prevention education among groups of Puerto Rican women.
Becker, Sara J; Squires, Daniel D; Strong, David R; Barnett, Nancy P; Monti, Peter M; Petry, Nancy M
Few prospective studies have evaluated theory-driven approaches to the implementation of evidence-based opioid treatment. This study compared the effectiveness of an implementation model (Science to Service Laboratory; SSL) to training as usual (TAU) in promoting the adoption of contingency management across a multisite opioid addiction treatment program. We also examined whether the SSL affected putative mediators of contingency management adoption (perceived innovation characteristics and organizational readiness to change). Sixty treatment providers (39 SSL, 21 TAU) from 15 geographically diverse satellite clinics (7 SSL, 8 TAU) participated in the 12-month study. Both conditions received didactic contingency management training and those in the predetermined experimental region received 9 months of SSL-enhanced training. Contingency management adoption was monitored biweekly, whereas putative mediators were measured at baseline, 3 months, and 12 months. Relative to providers in the TAU region, treatment providers in the SSL region had comparable likelihood of contingency management adoption in the first 20 weeks of the study, and then significantly higher likelihood of adoption (odds ratios = 2.4-13.5) for the remainder of the study. SSL providers also reported higher levels of one perceived innovation characteristic (Observability) and one aspect of organizational readiness to change (Adequacy of Training Resources), although there was no evidence that the SSL affected these putative mediators over time. Results of this study indicate that a fully powered randomized trial of the SSL is warranted. Considerations for a future evaluation are discussed.
Jones, Jannah; Wolfenden, Luke; Wyse, Rebecca; Finch, Meghan; Yoong, Sze Lin; Dodds, Pennie; Pond, Nicole; Gillham, Karen; Freund, Megan; McElduff, Patrick; Wye, Paula; Wiggers, John
Childhood overweight and obesity tracks into adulthood, increasing the risk of developing future chronic disease. Implementing initiatives promoting healthy eating and physical activity in childcare settings has been identified as a priority to prevent excessive child weight gain. Despite this, few trials have been conducted to assess the effectiveness of interventions to support population-wide implementation of such initiatives. The aim of this study is to assess the effectiveness of a multicomponent intervention in increasing the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study will employ a parallel group randomised controlled trial design. A sample of 128 childcare services in the Hunter region of New South Wales, Australia, will be recruited to participate in the trial. 64 services will be randomly allocated to a 12-month implementation intervention. The remaining 64 services will be allocated to a usual care control group. The intervention will consist of a number of strategies to facilitate childcare service implementation of healthy eating and physical activity policies and practices. Intervention strategies will include implementation support staff, securing executive support, consensus processes, staff training, academic detailing visits, performance monitoring and feedback, tools and resources, and a communications strategy. The primary outcome of the trial will be the prevalence of services implementing all healthy eating and physical activity policies and practices targeted by the intervention. To assess the effectiveness of the intervention, telephone surveys with nominated supervisors and room leaders of childcare services will be conducted at baseline and immediately postintervention. The study was approved by the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. Study findings will be disseminated widely
Kennedy, Sarah G; Smith, Jordan J; Morgan, Philip J; Peralta, Louisa R; Hilland, Toni A; Eather, Narelle; Lonsdale, Chris; Okely, Anthony D; Plotnikoff, Ronald C; Salmon, J O; Dewar, Deborah L; Estabrooks, Paul A; Pollock, Emma; Finn, Tara L; Lubans, David R
Guidelines recommend that young people engage in muscle-strengthening activities on at least 3 d·wk. The purpose of this study was to examine the effect of a school-based intervention focused on resistance training (RT) for adolescents. The "Resistance Training for Teens" intervention was evaluated using a cluster-randomized, controlled trial with 607 adolescents (50.1% girls; 14.1 ± 0.5 yr) from 16 secondary schools. Teachers were trained to deliver the intervention, which included the following: (i) an interactive student seminar; (ii) a structured physical activity program, focused on RT; (iii) lunchtime fitness sessions; and (iv) Web-based smartphone apps. The primary outcome was muscular fitness (MF) and secondary outcomes included body mass index, RT skill competency, flexibility, physical activity, self-efficacy, and motivation. Assessments were conducted at baseline, 6 months (postprogram; primary end point), and 12 months (follow-up). Outcomes were assessed using linear mixed models, with three potential moderators tested using interaction terms (and subgroup analyses where appropriate). For the primary outcome (MF), a group-time effect was observed at 6 months for the upper body (2.0 repetitions; 95% confidence interval (CI), 0.8-3.2), but not the lower body (-1.4 cm; 95% CI, -4.7-1.9). At 6 months, there were intervention effects for RT skill competency and self-efficacy, but no other secondary outcomes. Effects for upper body MF and RT skill competency were sustained at 12 months. Despite overall no effect for body mass index, there was a group-time effect at 12 months among students who were overweight/obese at baseline (-0.55 kg·m; 95% CI, -1.01 to -0.08). The school-based RT intervention resulted in immediate and sustained improvements in upper body MF and RT skill competency, demonstrating an effective and scalable approach to delivering RT within secondary schools.
Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger
Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results
Mior, Silvano; Gamble, Brian; Barnsley, Jan; C?t?, Pierre; C?t?, Elie
Abstract Background Tracking how clinicians treat patients provides an opportunity to explore how the clinical management of common musculoskeletal disorders evolves over time. We present an uncontrolled before-after study of a primary care physician’s management of low back pain and describe how his involvement in an interprofessional collaborative practice was associated with a change in the management of patients with low back pain. Method Data from the electronic medical record of one pri...
Kho, Madeleine Huei Tze; Chew, Keng Sheng; Azhar, Muhaimin Noor; Hamzah, Mohd Lotfi; Chuah, Kee Man; Bustam, Aida; Chan, Hiang Chuan
While emergency airway management training is conventionally conducted via face-to-face learning (F2FL) workshops, there are inherent cost, time, place and manpower limitations in running such workshops. Blended learning (BL) refers to the systematic integration of online and face-to-face learning aimed to facilitate complex thinking skills and flexible participation at a reduced financial, time and manpower cost. This study was conducted to evaluate its effectiveness in emergency airway management training. A single-center prospective randomised controlled trial involving 30 doctors from Sarawak General Hospital, Malaysia was conducted from September 2016 to February 2017 to compare the effectiveness of BL versus F2FL for emergency airway management training. Participants in the BL arm were given a period of 12 days to go through the online materials in a learning management system while those in the F2FL arm attended a-day of face-to-face lectures (8 h). Participants from both arms then attended a day of hands-on session consisting of simulation skills training with airway manikins. Pre- and post-tests in knowledge and practical skills were administered. E-learning experience and the perception towards BL among participants in the BL arm were also assessed. Significant improvements in post-test scores as compared to pre-test scores were noted for participants in both BL and F2FL arms for knowledge, practical, and total scores. The degree of increment between the BL group and the F2FL arms for all categories were not significantly different (total scores: 35 marks, inter-quartile range (IQR) 15.0 - 41.0 vs. 31 marks, IQR 24.0 - 41.0, p = 0.690; theory scores: 18 marks, IQR 9 - 24 vs. 19 marks, IQR 15 - 20, p = 0.992; practical scores: 11 marks, IQR 5 -18 vs. 10 marks, IQR 9 - 20, p = 0.461 respectively). The overall perception towards BL was positive. Blended learning is as effective as face-to-face learning for emergency airway management training
Gask, Linda; Bower, Peter; Lovell, Karina; Escott, Diane; Archer, Janine; Gilbody, Simon; Lankshear, Annette J; Simpson, Angela E; Richards, David A
There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM) to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy. Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression. Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration) and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so. The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation.
Jensen, Cathrine Elgaard; Riis, Allan; Pedersen, Kjeld Møller; Jensen, Martin Bach; Petersen, Karin Dam
In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. ClinicalTrials.gov: NCT01699256.
Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M
Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop
Duke, Trevor; Hwaihwanje, Ilomo; Kaupa, Magdalynn; Karubi, Jonah; Panauwe, Doreen; Sa'avu, Martin; Pulsan, Francis; Prasad, Peter; Maru, Freddy; Tenambo, Henry; Kwaramb, Ambrose; Neal, Eleanor; Graham, Hamish; Izadnegahdar, Rasa
Pneumonia is the largest cause of child deaths in Papua New Guinea (PNG), and hypoxaemia is the major complication causing death in childhood pneumonia, and hypoxaemia is a major factor in deaths from many other common conditions, including bronchiolitis, asthma, sepsis, malaria, trauma, perinatal problems, and obstetric emergencies. A reliable source of oxygen therapy can reduce mortality from pneumonia by up to 35%. However, in low and middle income countries throughout the world, improved oxygen systems have not been implemented at large scale in remote, difficult to access health care settings, and oxygen is often unavailable at smaller rural hospitals or district health centers which serve as the first point of referral for childhood illnesses. These hospitals are hampered by lack of reliable power, staff training and other basic services. We report the methodology of a large implementation effectiveness trial involving sustainable and renewable oxygen and power systems in 36 health facilities in remote rural areas of PNG. The methodology is a before-and after evaluation involving continuous quality improvement, and a health systems approach. We describe this model of implementation as the considerations and steps involved have wider implications in health systems in other countries. The implementation steps include: defining the criteria for where such an intervention is appropriate, assessment of power supplies and power requirements, the optimal design of a solar power system, specifications for oxygen concentrators and other oxygen equipment that will function in remote environments, installation logistics in remote settings, the role of oxygen analyzers in monitoring oxygen concentrator performance, the engineering capacity required to sustain a program at scale, clinical guidelines and training on oxygen equipment and the treatment of children with severe respiratory infection and other critical illnesses, program costs, and measurement of processes and
Peart, L. W.; Orcutt, B. N.; Fisher, A. T.; Tsuji, T.; Petronotis, K. E.; Iodp Expedition 327 Participants
During the summer of 2010, Integrated Ocean Drilling Program (IODP) Expedition 327 conducted coring and observatory installations on the Juan de Fuca Plate to characterize the hydrogeology of ridge-flank ocean crust. Due to the nature of the expedition, a smaller science party than usual was needed. IODP took this opportunity to expand education, outreach, and communication (EOC) activities with a previously untested model. Up to now, the IODP U.S. Implementing Organization had sailed either individual teachers on regular (2-month long) expeditions or groups of teachers and informal educators during short (2-week long) transits (School of Rock workshops). After two shipboard (Expeditions 312 and 321T) and two shore-based (Gulf Coast Repository) programs, we have recognized that sailing a group of educators is a beneficial model for IODP and the participants. What has been unavoidable is that these workshops took place outside typical expedition activities. Expedition 327 provided a unique opportunity to sail a diverse group of outreach officers on a regular expedition with a full range of scientific activities. The group included individuals with a wide variety of skills and backgrounds. US participants included a late-career high school physics teacher, a visualization graduate student, an undergraduate engineering student from an historically black university, and an artist. French participants included two middle and high school earth and life science teachers. This diversity made the group more dynamic but it also posed a challenge. Numerous scientific and technical staff also participated in EOC activity design and leadership, including development of dedicated web sites and blogs. After a seminar on constructivist and inquiry-based methods, we spent the first few weeks investigating earth science concepts so EOC participants could gain a basic understanding of the regional geology and the scientific objectives of the expedition. Close to the beginning of the
Bekkering, G.E.; Hendriks, H.J.M.; van Tulder, M.; Knol, D.L.; Hoeijenbos, M.; Oostendorp, R.A.B.; Bouter, L.M.
Objectives: To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain. Design: A cluster randomised controlled trial comparing an active strategy with standard dissemination. Setting: Primary care physiotherapy practices.
Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project
Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny
Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…
Lazo-Porras, Maria; Bernabe-Ortiz, Antonio; Sacksteder, Katherine A; Gilman, Robert H; Malaga, German; Armstrong, David G; Miranda, J Jaime
will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability. This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .
Jones, Jannah; Wyse, Rebecca; Finch, Meghan; Lecathelinais, Christophe; Wiggers, John; Marshall, Josephine; Falkiner, Maryann; Pond, Nicole; Yoong, Sze Lin; Hollis, Jenna; Fielding, Alison; Dodds, Pennie; Clinton-McHarg, Tara; Freund, Megan; McElduff, Patrick; Gillham, Karen; Wolfenden, Luke
The primary aim of this study was to evaluate the effectiveness of an intervention to increase the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study also sought to determine if the intervention was effective in improving child dietary intake and increasing child physical activity levels while attending childcare. A parallel group, randomised controlled trial was conducted in a sample of 128 childcare services. Intervention strategies included provision of implementation support staff, securing executive support, staff training, consensus processes, academic detailing visits, tools and resources, performance monitoring and feedback and a communications strategy. The primary outcome of the trial was the proportion of services implementing all seven healthy eating and physical activity policies and practices targeted by the intervention. Outcome data were collected via telephone surveys with nominated supervisors and room leaders at baseline and immediately post-intervention. Secondary trial outcomes included the differences between groups in the number of serves consumed by children for each food group within the Australian Guide to Healthy Eating and in the proportion of children engaged in sedentary, walking or very active physical activity assessed via observation in a random subsample of 36 services at follow-up. There was no significant difference between groups for the primary trial outcome (p = 0.44). Relative to the control group, a significantly larger proportion of intervention group services reported having a written nutrition and physical activity policy (p = 0.05) and providing adult-guided activities to develop fundamental movement skills (p = 0.01). There were no significant differences between groups at follow-up on measures of child dietary intake or physical activity. The findings of the trial were equivocal. While there was no significant difference between groups
Hamilton, Alison B; Brunner, Julian; Cain, Cindy; Chuang, Emmeline; Luger, Tana M; Canelo, Ismelda; Rubenstein, Lisa; Yano, Elizabeth M
The Veterans Health Administration (VHA) has undertaken primary care transformation based on patient-centered medical home (PCMH) tenets. VHA PCMH models are designed for the predominantly male Veteran population, and require tailoring to meet women Veterans' needs. We used evidence-based quality improvement (EBQI), a stakeholder-driven implementation strategy, in a cluster randomized controlled trial across 12 sites (eight EBQI, four control) that are members of a Practice-Based Research Network. EBQI involves engaging multilevel, inter-professional leaders and staff as stakeholders in reviewing evidence and setting QI priorities. The goal of this analysis was to examine processes of engaging stakeholders in early implementation of EBQI to tailor VHA's medical home for women. Four inter-professional regional stakeholder planning meetings were conducted; these meetings engaged stakeholders by providing regional data about gender disparities in Veterans' care experiences. Subsequent to each meeting, qualitative interviews were conducted with 87 key stakeholders (leaders and staff). Stakeholders were asked to describe QI efforts and the use of data to change aspects of care, including women's health care. Interview transcripts were summarized and coded using a hybrid deductive/inductive analytic approach. The presentation of regional-level data about gender disparities resulted in heightened awareness and stakeholder buy-in and decision-making related to women's health-focused QI. Interviews revealed that stakeholders were familiar with QI, with regional and facility leaders aware of inter-disciplinary committees and efforts to foster organizational change, including PCMH transformation. These efforts did not typically focus on women's health, though some informal efforts had been undertaken. Barriers to engaging in QI included lack of communication across clinical service lines, fluidity in staffing, and lack of protected time. Inter-professional, multilevel
Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive
Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover
Wolfenden, Luke; Nathan, Nicole; Williams, Christopher M; Delaney, Tessa; Reilly, Kathryn L; Freund, Megan; Gillham, Karen; Sutherland, Rachel; Bell, Andrew C; Campbell, Libby; Yoong, Serene; Wyse, Rebecca; Janssen, Lisa M; Preece, Sarah; Asmar, Melanie; Wiggers, John
The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain. Internationally, research suggests that schools often fail to implement practices consistent with healthy school canteen policies. Without a population wide implementation, the potential benefits of these policies will not be realised. The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales (NSW), Australia, government known as the 'Fresh Tastes @ School NSW Healthy School Canteen Strategy'. The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales, Australia. Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy. Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel. Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff, staff training, resources, recognition and incentives, consensus and leadership strategies, follow-up support and implementation feedback. The 35 schools allocated to the control group will not receive any intervention support as part of the research trial. The primary outcome measures will be i) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ('red' and 'banned' items) and ii) the proportion of schools where healthy canteen items ('green' items) represent the majority (>50%) of products listed on the menu. Outcome data will be collected via a comprehensive menu audit, conducted by dietitians blind to group allocation. Intervention effectiveness will be assessed using
Full Text Available Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB, which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation.We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+, IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre.1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20. However, significantly more
Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise
Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre. 1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in
Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise
Background Many developed countries have high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children’s services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. Methods We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children’s centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children’s centre. Results 1112 parents at 36 children’s centres participated. There was no significant effect of the intervention on families’ possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2
Kolko, David J; Baumann, Barbara L; Herschell, Amy D; Hart, Jonathan A; Holden, Elizabeth A; Wisniewski, Stephen R
The Partnerships for Families project is a randomized clinical trial designed to evaluate the implementation of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT), an evidence-based treatment for family conflict, coercion, and aggression, including child physical abuse. To evaluate the effectiveness of a training program in this model, 182 community practitioners from 10 agencies were randomized to receive AF-CBT training (n = 90) using a learning community model (workshops, consultation visits) or Training as Usual (TAU; n = 92) which provided trainings per agency routine. Practitioners completed self-report measures at four time points (0, 6, 12, and 18 months following baseline). Of those assigned to AF-CBT, 89% participated in at least one training activity and 68% met a "training completion" definition. A total of 80 (44%) practitioners were still active clinicians in the study by 18-month assessment in that they had not met our staff turnover or study withdrawal criteria. Using an intent-to-train design, hierarchical linear modeling analyses revealed significantly greater initial improvements for those in the AF-CBT training condition (vs. TAU condition) in CBT-related knowledge and use of AF-CBT teaching processes, abuse-specific skills, and general psychological skills. In addition, practitioners in both groups reported significantly more negative perceptions of organizational climate through the intervention phase. These significant, albeit modest, findings are discussed in the context of treatment training, research, and work force issues as they relate to the diverse backgrounds, settings, and populations served by community practitioners.
Barrio, Pablo; Ortega, Lluisa; Bona, Xavier; Gual, Antoni
Information and communication technologies (ICT) have become one of the main pathways to the new paradigm of increased self-management of chronic conditions such as alcohol dependence. Validation of some mobile phone apps has begun, while validation of many others is forthcoming. To describe the protocol for validation of a new app called SIDEAL (an acronym of the Spanish name "Soporte Innovador a la persona con DEpendencia del ALcohol," or innovative support for people with alcohol dependence). The project consists of 3 complementary, consecutive studies, including a pilot feasibility study, a qualitative study using focus groups, and, finally, a randomized controlled trial where patients will be randomized to standard treatment or standard treatment plus SIDEAL. During the pilot study, feasibility, usability, and acceptance by users will be the main outcomes explored. An electronic questionnaire will be sent to patients asking for their opinions. Focus groups will be the next step, after which improvements and refinements will be implemented in the app. During the final phase, consumption variables (heavy drinking days per month, mean standard drinks per day) will be investigated, in order to test app efficacy. Because of the encouraging results with previous similar apps, we expect patients to widely accept and incorporate SIDEAL into their therapeutic options. Significant reductions in drinking-related variables are also expected. The pilot study has concluded with the inclusion of 29 patients. Results are expected to be available soon (expected mid-2016). SIDEAL may represent a useful, reliable, effective, and efficient tool to complement therapeutic options available to both patients and professionals.
Amemori, Masamitsu; Virtanen, Jorma; Korhonen, Tellervo; Kinnunen, Taru H; Murtomaa, Heikki
Tobacco use adversely affects oral health. Clinical guidelines recommend that oral health professionals promote tobacco abstinence and provide patients who use tobacco with brief tobacco use cessation counselling. Research shows that these guidelines are seldom implemented successfully. This study aimed to evaluate two interventions to enhance tobacco use prevention and cessation (TUPAC) counselling among oral health professionals in Finland. We used a cluster-randomized community trial to test educational and fee-for-service interventions in enhancing TUPAC counselling among a sample of dentists (n=73) and dental hygienists (n=22) in Finland. Educational intervention consisted of 1 day of training, including lectures, interactive sessions, multimedia demonstrations and a role play session with standard patient cases. Fee-for-service intervention consisted of monetary compensation for providing tobacco use prevention or cessation counselling. TUPAC counselling procedures provided were reported and measured using an electronic dental records system. In data analysis, intent-to-treat principles were followed at both individual and cluster levels. Descriptive analysis included chi-square and t-tests. A general linear model for repeated measures was used to compare the outcome measures by intervention group. Of 95 providers, 73 participated (76.8%). In preventive counselling, there was no statistically significant time effect or group-by-time interaction. In cessation counselling, statistically significant group-by-time interaction was found after a 6-month follow-up (F=2.31; P=0.007), indicating that counselling activity increased significantly in intervention groups. On average, dental hygienists showed greater activity in tobacco prevention (F=12.13; P=0.001) and cessation counselling (F=30.19; PTUPAC counselling performance. Other approaches than monetary incentives may be needed to enhance the effectiveness of educational intervention. Further studies with focus
Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This
A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.
de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy
Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary
Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.
The inter-play between facilitation and context in the promoting action on research implementation in health services framework: A qualitative exploratory implementation study embedded in a cluster randomized controlled trial to reduce restraint in nursing homes.
Mekki, Tone Elin; Øye, Christine; Kristensen, Bodil; Dahl, Helen; Haaland, Astrid; Nordin, Kristin Aas; Strandos, Marta; Terum, Toril Marie; Ydstebø, Arnt Egil; McCormack, Brendan
To explore the inter-play between external facilitation and nursing home contexts relative to intervention outcomes. The Promoting Action on Research Implementation in Health Services framework is frequently used to theoretically inform implementation and research in nursing and recent reviews indicate high face validity for health services. However, the inter-play and relationship between framework sub-elements of evidence, context and facilitation and the prospective utility in non-English speaking contexts warrant further illumination. In an overarching single-blind cluster-randomized controlled trial, we applied participatory action research and ethnography from August 2011-June 2015 to evaluate a standardized education intervention to reduce restraint and agitation in nursing home residents living with dementia. The trial results are published elsewhere. Prospectively informed by the PARIHS framework, a research team and eight facilitators participating in dual roles as action researchers designed, implemented, and evaluated the intervention. How contextual factors influenced the facilitation processes were explored in focus group interviews (1), reflection notes (84) written by the facilitators' after each education session, ethnographic field studies (6 homes), and co-analysis workshops (5). Directed content analysis was used to analyse data. Clinical leaders taking roles of internal facilitator influenced the success of implementation, while complex and fluctuating context elements determined whether restraint use was reduced- or not. The PARIHS framework was found to be relevant in a non-English nursing home setting, albeit some elements merit further conceptualization. Our findings confirm the prospective utility of the PARIHS framework for implementation in a non-English context, particularly the notion of implementation processes as dynamic and multifaceted. © 2017 John Wiley & Sons Ltd.
Testing the implementation and sustainment facilitation (ISF) strategy as an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy: study protocol for a cluster randomized trial.
Garner, Bryan R; Zehner, Mark; Roosa, Mathew R; Martino, Steve; Gotham, Heather J; Ball, Elizabeth L; Stilen, Patricia; Speck, Kathryn; Vandersloot, Denna; Rieckmann, Traci R; Chaple, Michael; Martin, Erika G; Kaiser, David; Ford, James H
Improving the extent to which evidence-based practices (EBPs)-treatments that have been empirically shown to be efficacious or effective-are integrated within routine practice is a well-documented challenge across numerous areas of health. In 2014, the National Institute on Drug Abuse funded a type 2 effectiveness-implementation hybrid trial titled the substance abuse treatment to HIV Care (SAT2HIV) Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care within AIDS service organizations (ASOs) as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF) as an adjunct to the Addiction Technology Transfer Center (ATTC) model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the ISF Experiment. Using a cluster randomized design, case management and leadership staff from 39 ASOs across the United States were randomized to receive either the ATTC strategy (control condition) or the ATTC + ISF strategy (experimental condition). The ATTC strategy is staff-focused and includes 10 discrete strategies (e.g., provide centralized technical assistance, conduct educational meetings, provide ongoing consultation). The ISF strategy is organization-focused and includes seven discrete strategies (e.g., use an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change). Building upon the exploration-preparation-implementation-sustainment (EPIS) framework, the effectiveness of the ISF strategy is examined via three staff-level measures: (1) time-to-proficiency (i.e., preparation phase outcome), (2) implementation effectiveness (i.e., implementation phase outcome), and (3) level of sustainment (i.e., sustainment phase outcome). Although not without limitations, the ISF
Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.
Jemmott, John B; Jemmott, Loretta S; Fong, Geoffrey T; Morales, Knashawn H
We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (beta = 0.06; 95% CI = 0.00, 0.12) than did the control group. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established.
Bryan R. Garner
Full Text Available Abstract Background Improving the extent to which evidence-based practices (EBPs—treatments that have been empirically shown to be efficacious or effective—are integrated within routine practice is a well-documented challenge across numerous areas of health. In 2014, the National Institute on Drug Abuse funded a type 2 effectiveness–implementation hybrid trial titled the substance abuse treatment to HIV Care (SAT2HIV Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI for substance use as an adjunct to usual care within AIDS service organizations (ASOs as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF as an adjunct to the Addiction Technology Transfer Center (ATTC model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the ISF Experiment. Methods Using a cluster randomized design, case management and leadership staff from 39 ASOs across the United States were randomized to receive either the ATTC strategy (control condition or the ATTC + ISF strategy (experimental condition. The ATTC strategy is staff-focused and includes 10 discrete strategies (e.g., provide centralized technical assistance, conduct educational meetings, provide ongoing consultation. The ISF strategy is organization-focused and includes seven discrete strategies (e.g., use an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change. Building upon the exploration–preparation–implementation–sustainment (EPIS framework, the effectiveness of the ISF strategy is examined via three staff-level measures: (1 time-to-proficiency (i.e., preparation phase outcome, (2 implementation effectiveness (i.e., implementation phase outcome, and (3 level of sustainment (i.e., sustainment phase outcome
Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088
Majhail, Navneet S; Giralt, Sergio; Bonagura, Anthony; Crawford, Stephen; Farnia, Stephanie; Omel, James L; Pasquini, Marcelo; Saber, Wael; LeMaistre, Charles F
The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
Karimi-Shahanjarini, Akram; Rashidian, Arash; Omidvar, Nasrin; Majdzadeh, Reza
The evidence for the effectiveness of theory of planned behavior (TPB)-based interventions is mixed. There is also mixed evidence on the effectiveness of adding implementation intentions to TPB-based interventions. In this study we assessed and compared the short-term effects of TPB-only intervention and TPB plus implementation intentions intervention on snacking behavior and intention to consume unhealthy snacks in Iranian adolescent girls. Three-arm cluster randomized controlled trial. Ten middle schools in Tehran (Iran). A total of 29 classes included 739 female adolescents (age range: 12-15 years). Intervention. Two brief interventions including TPB-only intervention and TPB plus implementation intentions intervention. Food frequency questionnaire and intentions at baseline, 10 days, and 3 months measuring snacking behavior and cognitions about unhealthy snack consumption, respectively. Hierarchical linear modeling to assess the interventions' effects. Both interventions successfully decreased intention to consume and consumption of unhealthy snacks at postintervention. Calculation of the effect sizes revealed that the TPB plus implementation intentions intervention was more effective than the TPB-only intervention. The effects remained significant at 3-month follow-up in the TPB plus implementation intentions intervention group only, although the effect size decreased. Overall, the study suggests that adding implementation intentions on top of TPB-based persuasive messages improves effectiveness and sustainability of desirable changes.
Scholl, Isabelle; Hahlweg, Pola; Lindig, Anja; Bokemeyer, Carsten; Coym, Anja; Hanken, Henning; Müller, Volkmar; Smeets, Ralf; Witzel, Isabell; Kriston, Levente; Härter, Martin
Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. This study is the first large study on routine implementation of
Simon D French
Full Text Available INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control or facilitated interactive workshops (intervention. We measured behavioural predictors (e.g. knowledge, attitudes and intentions and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP level: behavioural simulation (clinical decision about vignettes and rates of x-ray and CT-scan (medical administrative data. All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs were randomised to the control and 45 practices (59 GPs to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05 and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60. Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10 for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant
Randomized trials of web-based and mobile interventions pose very specific issues and challenges. A set of best practices on how to conduct and report such trials was recently summarized in the CONSORT-EHEALTH statement (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), published in August 2011 as draft and in December 2011 as journal article (V1.6.1). The purpose of this presentation is to review the results of the pilot implementation at the Journal of Medical Internet Research (JMIR), a leading eHealth journal, where reporting of trials in accordance with CONSORT-EHEALTH became mandatory in late 2011. Authors of all randomized trials submitted to JMIR were asked to complete an electronic questionnaire, which involved copying pertinent manuscript sections into a CONSORT EHEALTH database form, were asked to score the importance of CONSORT EHEALTH items, and were asked to provide narrative feedback on the value of the process. Between August 2011 and November 2012, 67 randomized trials were submitted, of which 61 were intended for publication in JMIR. Authors reported that it took between 1 and 16 hours to complete the checklist including making required changes to their manuscripts. 72% (48/67) of authors reported they made minor changes to the manuscript, 6% (4/67) made major changes. Most authors felt it was a useful process that improved their manuscripts: 63% (42/67) said it improved their manuscript, 13% (9/67) said it did not, 12% (8/67) indicated that it had improved a little. The CONSORT EHEALTH statement and checklist appeared successful in improving the quality of reporting. The checklist should be endorsed and used by authors and editors of other journals.
Nathan, Nicole; Yoong, Sze Lin; Sutherland, Rachel; Reilly, Kathryn; Delaney, Tessa; Janssen, Lisa; Robertson, Katie; Reynolds, Renee; Chai, Li Kheng; Lecathelinais, Christophe; Wiggers, John; Wolfenden, Luke
The implementation of school nutrition policies, which govern the provision of food in schools, is recommended as a public health strategy to support the development of healthy dietary behaviours in school-aged children. Despite this, research internationally and in Australia indicates that few schools implement such policies. This study aims to examine whether a theoretically designed, multi-strategy intervention was effective in increasing the implementation of a healthy canteen policy in Australian primary schools. A parallel group randomised controlled trial was conducted with all government and Catholic primary schools within one region in New South Wales, Australia who had an operational canteen that provided food to primary school aged children (5-12 years) and were not currently receiving an intervention to change their canteen practices. Schools randomised to the intervention arm received a 9-month multicomponent intervention including ongoing support, provision of resources, performance monitoring and feedback, executive support and recognition. The primary outcomes were the proportion of the schools with a canteen menu that: i) did not include 'red' or 'banned' items according to the healthy canteen policy; and ii) had more than 50 % 'green' items. The primary outcome was assessed via menu audit at baseline and follow up by dietitians blinded to group allocation. Fifty-three eligible schools were randomised to either the intervention or control group (28 intervention; 25 control). Analyses with 51 schools who returned school menus found that intervention schools were significantly more likely relative to control schools to have a menu without 'red' or 'banned' items (RR = 5.78 (1.45-23.05); p = 0.002) and have at least 50 % of menu items classified as green (RR = 2.03 (1.01-4.08); p = 0.03). This study found that a multi-component intervention was effective in improving primary schools' compliance with a healthy canteen policy. Given
Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.
Bryant, Maria; Burton, Wendy; Cundill, Bonnie; Farrin, Amanda J; Nixon, Jane; Stevens, June; Roberts, Kim; Foy, Robbie; Rutter, Harry; Hartley, Suzanne; Tubeuf, Sandy; Collinson, Michelle; Brown, Julia
Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot
Mertens, Jennifer R; Chi, Felicia W; Weisner, Constance M; Satre, Derek D; Ross, Thekla B; Allen, Steve; Pating, David; Campbell, Cynthia I; Lu, Yun Wendy; Sterling, Stacy A
Unhealthy alcohol use is a major contributor to the global burden of disease and injury. The US Preventive Services Task Force has recommended alcohol screening and intervention in general medical settings since 2004. Yet less than one in six US adults report health care professionals discussing alcohol with them. Little is known about methods for increasing implementation; different staffing models may be related to implementation effectiveness. This implementation trial compared delivery of alcohol screening, brief intervention and referral to specialty treatment (SBIRT) by physicians versus non-physician providers receiving training, technical assistance, and feedback reports. The study was a cluster randomized implementation trial (ADVISe [Alcohol Drinking as a Vital Sign]). Within a private, integrated health care system, 54 adult primary care clinics were stratified by medical center and randomly assigned in blocked groups of three to SBIRT by physicians (PCP arm) versus non-physician providers and medical assistants (NPP and MA arm), versus usual care (Control arm). NIH-recommended screening questions were added to the electronic health record (EHR) to facilitate SBIRT. We examined screening and brief intervention and referral rates by arm. We also examined patient-, physician-, and system-level factors affecting screening rates and, among those who screened positive, rates of brief intervention and referral to treatment. Screening rates were highest in the NPP and MA arm (51 %); followed by the PCP arm (9 %) and the Control arm (3.5 %). Screening increased over the 12 months after training in the NPP and MA arm but remained stable in the PCP arm. The PCP arm had higher brief intervention and referral rates (44 %) among patients screening positive than either the NPP and MA arm (3.4 %) or the Control arm (2.7 %). Higher ratio of MAs to physicians was related to higher screening rates in the NPP and MA arm and longer appointment times to screening and
van Gaalen Johanna L
Full Text Available Abstract Background Internet-based self-management (IBSM support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. Methods/design This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS: dissemination of the IBSM program; intermediate strategy (IS: MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals; and extended strategy (ES: IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions are primarily targeted at general practices, randomisation will occur at practice level. In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations; self-management related outcomes (health education impact, medication adherence, and illness perceptions; and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption
Gude, Wouter T; Roos-Blom, Marie-José; van der Veer, Sabine N; de Jonge, Evert; Peek, Niels; Dongelmans, Dave A; de Keizer, Nicolette F
Audit and feedback is often used as a strategy to improve quality of care, however, its effects are variable and often marginal. In order to learn how to design and deliver effective feedback, we need to understand their mechanisms of action. This theory-informed study will investigate how electronic audit and feedback affects improvement intentions (i.e. information-intention gap), and whether an action implementation toolbox with suggested actions and materials helps translating those intentions into action (i.e. intention-behaviour gap). The study will be executed in Dutch intensive care units (ICUs) and will be focused on pain management. We will conduct a laboratory experiment with individual ICU professionals to assess the impact of feedback on their intentions to improve practice. Next, we will conduct a cluster randomised controlled trial with ICUs allocated to feedback without or feedback with action implementation toolbox group. Participants will not be told explicitly what aspect of the intervention is randomised; they will only be aware that there are two variations of providing feedback. ICUs are eligible for participation if they submit indicator data to the Dutch National Intensive Care Evaluation (NICE) quality registry and agree to allocate a quality improvement team that spends 4 h per month on the intervention. All participating ICUs will receive access to an online quality dashboard that provides two functionalities: gaining insight into clinical performance on pain management indicators and developing action plans. ICUs with access to the toolbox can develop their action plans guided by a list of potential barriers in the care process, associated suggested actions, and supporting materials to facilitate implementation of the actions. The primary outcome measure for the laboratory experiment is the proportion of improvement intentions set by participants that are consistent with recommendations based on peer comparisons; for the randomised
French, Simon D; McKenzie, Joanne E; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Francis, Jill J; Michie, Susan; Spike, Neil; Schattner, Peter; Kent, Peter; Buchbinder, Rachelle; Page, Matthew J; Green, Sally E
This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. Australian New Zealand
Van de Steeg Lotte
Full Text Available Abstract Background Delirium occurs frequently in elderly hospitalised patients and is associated with higher mortality, increased length of hospital stay, functional decline, and admission to long-term care. Healthcare professionals frequently do not recognise delirium, indicating that education can play an important role in improving delirium care for hospitalised elderly. Previous studies have indicated that e-learning can provide an effective way of educating healthcare professionals and improving quality of care, though results are inconsistent. Methods and design This stepped wedge cluster randomised trial will assess the effects of a complementary delirium e-learning course on the implementation of quality improvement initiative, which aims to enhance the recognition and management of delirium in elderly patients. The trial will be conducted in 18 Dutch hospitals and last 11 months. Measurements will be taken in all participating wards using monthly record reviews, in order to monitor delivered care. These measurements will include the percentage of elderly patients who were screened for the risk of developing delirium, use of the Delirium Observation Screening scale, use of nursing or medical interventions, and the percentage of elderly patients who were diagnosed with delirium. Data regarding the e-learning course will be gathered as well. These data will include user characteristics, information regarding use of the course, delirium knowledge before and after using the course, and the attitude and intentions of nurses concerning delirium care. Setting The study will be conducted in internal medicine and surgical wards of eighteen hospitals that are at the beginning stages of implementing the Frail Elderly Project in the Netherlands. Discussion Better recognition of elderly patients at risk for delirium and subsequent care is expected from the introduction of an e-learning course for nurses that is complementary to an existing quality
Full Text Available Abstract Background There is a need to find innovative approaches for translating best practices for chronic disease care into daily primary care practice routines. Primary care plays a crucial role in the prevention and management of cardiovascular disease. There is, however, a substantive care gap, and many challenges exist in implementing evidence-based care. The Improved Delivery of Cardiovascular Care (IDOCC project is a pragmatic trial designed to improve the delivery of evidence-based care for the prevention and management of cardiovascular disease in primary care practices using practice outreach facilitation. Methods The IDOCC project is a stepped-wedge cluster randomized control trial in which Practice Outreach Facilitators work with primary care practices to improve cardiovascular disease prevention and management for patients at highest risk. Primary care practices in a large health region in Eastern Ontario, Canada, were eligible to participate. The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period. Starting with audit and feedback, consensus building, and goal setting, the practices are supported in changing practice behavior by incorporating chronic care model elements. These elements include (a evidence-based decision support for providers, (b delivery system redesign for practices, (c enhanced self-management support tools provided to practices to help them engage patients, and (d increased community resource linkages for practices to enhance referral of patients. The primary outcome is a composite score measured at the level of the patient to represent each practice's adherence to evidence-based guidelines for cardiovascular care. Qualitative analysis of the Practice Outreach Facilitators' written narratives of their ongoing practice interactions will be done. These textual analyses will add further insight into understanding critical factors impacting
Noome, Marijke; Dijkstra, Boukje M; van Leeuwen, Evert; Vloet, Lilian C M
The aim of this study was to examine the effectiveness of supporting intensive care units on implementing the guidelines. Quality of care can be achieved through evidence-based practice. Guidelines can facilitate evidence-based practice, such as the guidelines 'End-of-life care in the intensive care unit, nursing care'. Before intensive care nurses are able to use these guidelines, they needs to be implemented in clinical practice. Implementation is a complex process and may need support. Cluster randomized controlled trial. Intensive care nurses of eight intensive care units in the intervention group followed a supportive programme that educated them on implementation, strategies, goals, project management and leadership. The intervention group focused on a stepwise approach to implement the guidelines. The control group (n = 5) implemented the guidelines independently or used the standard implementation plan supplementary to the guideline. The effectiveness of the programme was measured using questionnaires for nurses, interviews with nurses and a questionnaire for family of deceased patients, in the period from December 2014-December 2015. Overall, an increase in adherence to the guidelines was found in both groups. Overall, use of the guidelines in the intervention group was higher, but on some aspects the control group showed a higher score. Care for the patient and the overall nursing care scored significantly higher according to family in the intervention group. The increase in adherence to the guidelines and the significantly higher satisfaction of family in the intervention group indicate that the supportive programme had a more positive effect. © 2016 John Wiley & Sons Ltd.
Van Reijen, Miriam; Vriend, Ingrid I; Zuidema, Victor; van Mechelen, Willem; Verhagen, Evert A
Ankle sprains continue to pose a significant burden to the individual athlete, as well as to society as a whole. However, despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures, large-scale community uptake of these preventive measures, and thus actual prevention of ankle sprains, is lagging well behind. In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App ('Strenghten your ankle' translated in Dutch as: 'Versterk je enkel; available for iOS and Android) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program. The 'Strengthen your ankle' App has not been evaluated against the 'regular' prevention approach in which the neuromuscular program is advocated through written material. The aim of the current project is to evaluate the implementation value of the 'Strengthen your ankle' App as compared to the usual practice of providing injured athletes with written materials. In addition, as a secondary outcome measure, the cost-effectiveness will be assessed against usual practice. The proposed study will be a randomised controlled trial. After stratification for medical caregiver, athletes will be randomised to two study groups. One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries, consisting of a balance board (machU/ MSG Europe BVBA), and a traditional instructional booklet. The other group will receive the same exercise program and balance board. However, for this group the instructional booklet is exchanged by the interactive 'Strengthen your ankle' App. This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to
Kombe, Francis; Folayan, Morenike O; Ambe, Jennyfer; Igonoh, Adaora; Abayomi, Akin
Ebola virus is categorized as one of the most dangerous pathogens in the world. Although there is no known cure for Ebola virus, there is some evidence that the severity of the disease can be curtailed using plasma from survivors. Although there is a general consensus on the importance of research, methodological and ethical challenges for conducting research in an emergency situation have been identified. Performing clinical trials is important, especially for health conditions that are of public health significance (including rare epidemics) to develop new therapies as well as to test the efficacy and effectiveness of new interventions. However, routine clinical trial procedures can be difficult to apply in emergency public health crises hence require a consideration of alternative approaches on how therapies in these situations are tested and brought to the market. This paper examines some of the ethical issues that arise when conducting clinical trials during a highly dangerous pathogen outbreak, with a special focus on the Ebola virus outbreak in West Africa. The issues presented here come from a review of a protocol that was submitted to the Global Emerging Pathogens Treatment Consortium (GET). In reviewing the proposal, which was about conducting a clinical trial to evaluate the safety and efficacy of using convalescent plasma in the management of Ebola virus disease, the authors deliberated on various issues, which were documented as minutes and later used as a basis for this paper. The experiences and reflections shared by the authors, who came from different regions and disciplines across Africa, present wide-ranging perspectives on the conduct of clinical trials during a dangerous disease outbreak in a resource-poor setting. Copyright © 2015 Elsevier Ltd. All rights reserved.
Mason, Rose A; Schnitz, Alana G; Wills, Howard P; Rosenbloom, Raia; Kamps, Debra M; Bast, Darcey
Ensuring educational progress for students with moderate-to-severe developmental disabilities requires exposure to well executed evidence-based practices. This necessitates that the special education workforce, including paraprofessionals, be well-trained. Yet evidence regarding effective training mechanisms for paraprofessionals is limited. A multiple baseline design across five teachers was used to evaluate the impact of online instructional modules and a Practice-Based Coaching (PBC) model with teacher-as-coach on their paraprofessionals' fidelity of discrete trial training (DTT). Implementation of the instructional modules yielded little to no change in paraprofessionals' DTT fidelity, however, a clear functional relation between PBC and improvement in paraprofessionals' fidelity of implementation of DTT was demonstrated. Implications for future research and practice are discussed.
de Baat Cees
Full Text Available Abstract Background The increase of the proportion of elderly people has implications for health care services. Advances in oral health care and treatment have resulted in a reduced number of edentulous individuals. An increasing number of dentate elderly people have tooth wear, periodontal disease, oral implants, and sophisticated restorations and prostheses. Hence, they are in need of both preventive and curative oral health care continuously. Weakened oral health due to neglect of self care and professional care and due to reduced oral health care utilization is already present when elderly people are still community-dwelling. At the moment of (residential care home admittance, many elderly people are in need of oral health care urgently. The key factor in realizing and maintaining good oral health is daily oral hygiene care. For proper daily oral hygiene care, many residents are dependent on nurses and nurse aides. In 2007, the Dutch guideline "Oral health care in (residential care homes for elderly people" was developed. Previous implementation research studies have revealed that implementation of a guideline is very complicated. The overall aim of this study is to compare a supervised versus a non-supervised implementation of the guideline in The Netherlands and Flanders (Belgium. Methods/Design The study is a cluster randomized intervention trial with an institution as unit of randomization. A random sample of 12 (residential care homes accommodating somatic as well as psycho-geriatric residents in The Netherlands as well as in Flanders (Belgium are randomly allocated to an intervention or control group. Representative samples of 30 residents in each of the 24 (residential care homes are monitored during a 6-months period. The intervention consists of supervised implementation of the guideline and a daily oral health care protocol. Primary outcome variable is the oral hygiene level of the participating residents. To determine the
van Nassau, Femke; Singh, Amika S; Cerin, Ester; Salmon, Jo; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai Jm
The Dutch Obesity Intervention in Teenagers (DOiT) programme is an evidence-based obesity prevention programme tailored to adolescents attending the first two years of prevocational education in the Netherlands. The initial programme showed promising results during an effectiveness trial. The programme was adapted and prepared for nationwide dissemination. To gain more insight into the process of translating evidence-based approaches into 'real world' (i.e., 'natural') conditions, our research aims were to evaluate the impact of the DOiT-implementation programme on adolescents' adiposity and energy balance-related behaviours during natural dissemination and to explore the mediating and moderating factors underlying the DOiT intervention effects. We conducted a cluster-controlled implementation trial with 20 voluntary intervention schools (n=1002 adolescents) and 9 comparable control schools (n = 484 adolescents). We measured adolescents' body height and weight, skinfold thicknesses, and waist circumference. We assessed adolescents' dietary and physical activity behaviours by means of self-report. Data were collected at baseline and at 20-months follow-up. We used multivariable multilevel linear or logistic regression analyses to evaluate the intervention effects and to test the hypothesised behavioural mediating factors. We checked for potential effect modification by gender, ethnicity and education level. We found no significant intervention effects on any of the adiposity measures or behavioural outcomes. Furthermore, we found no mediating effects by any of the hypothesised behavioural mediators. Stratified analyses for gender showed that the intervention was effective in reducing sugar-containing beverage consumption in girls (B = -188.2 ml/day; 95% CI = -344.0; -32.3). In boys, we found a significant positive intervention effect on breakfast frequency (B = 0.29 days/week; 95% CI = 0.01; 0.58). Stratified analyses for education level showed
Peralta, Carmen A; Frigaard, Martin; Rubinsky, Anna D; Rolon, Leticia; Lo, Lowell; Voora, Santhi; Seal, Karen; Tuot, Delphine; Chao, Shirley; Lui, Kimberly; Chiao, Phillip; Powe, Neil; Shlipak, Michael
Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a "triple marker" CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital. Non-diabetic hypertensive veterans age 18-80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months. A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61-72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and
Huang, Keng-Yen; Nakigudde, Janet; Calzada, Esther; Boivin, Michael J; Ogedegbe, Gbenga; Brotman, Laurie Miller
study will produce important information regarding the value of an evidence-based early intervention, and a theory-guided implementation process and tools designed for use in implementing early childhood evidence-based programs in SSA countries or resource-constrained community settings. This trial was registered with ClinicalTrials.gov (registration number: NCT097115) on 15 May 2013.
Menberu, Meseret Walle; Marttila, Hannu; Tahvanainen, Teemu; Kotiaho, Janne S.; Hokkanen, Reijo; Kløve, Bjørn; Ronkanen, Anna-Kaisa
Drainage is known to affect peatland natural hydrology and water quality, but peatland restoration is considered to ameliorate peatland degradation. Using a replicated BACIPS (Before-After-Control-Impact Paired Series) design, we investigated 24 peatlands, all drained for forestry and subsequently restored, and 19 pristine control boreal peatlands with high temporal and spatial resolution data on hydroclimate and pore water quality. In drained conditions, total nitrogen (Ntot), total phosphorus (Ptot), and dissolved organic carbon (DOC) in pore water were several-fold higher than observed at pristine control sites, highlighting the impacts of long-term drainage on pore water quality. In general, pore water DOC and Ntot decreased after restoration measures but still remained significantly higher than at pristine control sites, indicating long time lags in restoration effects. Different peatland classes and trophic levels (vegetation gradient) responded differently to restoration, primarily due to altered hydrology and varying acidity levels. Sites that were hydrologically overrestored (inundated) showed higher Ptot, Ntot, and DOC than well-restored or insufficiently restored sites, indicating the need to optimize natural-like hydrological regimes when restoring peatlands drained for forestry. Rich fens (median pH 6.2-6.6) showed lower pore water Ptot, Ntot, and DOC than intermediate and poor peats (pH 4.0-4.6) both before and after restoration. Nutrients and DOC in pore water increased in the first year postrestoration but decreased thereafter. The most important variables related to pore water quality were trophic level, peatland class, water table level, and soil and air temperature.
Sacchi, Emanuele; Sayed, Tarek; El-Basyouny, Karim
Recently, important advances in road safety statistics have been brought about by methods able to address issues other than the choice of the best error structure for modeling crash data. In particular, accounting for spatial and temporal interdependence, i.e., the notion that the collision occurrence of a site or unit times depend on those of others, has become an important issue that needs further research. Overall, autoregressive models can be used for this purpose as they can specify that the output variable depends on its own previous values and on a stochastic term. Spatial effects have been investigated and applied mostly in the context of developing safety performance functions (SPFs) to relate crash occurrence to highway characteristics. Hence, there is a need for studies that attempt to estimate the effectiveness of safety countermeasures by including the spatial interdependence of road sites within the context of an observational before-after (BA) study. Moreover, the combination of temporal dynamics and spatial effects on crash frequency has not been explored in depth for SPF development. Therefore, the main goal of this research was to carry out a BA study accounting for spatial effects and temporal dynamics in evaluating the effectiveness of a road safety treatment. The countermeasure analyzed was the installation of traffic signals at unsignalized urban/suburban intersections in British Columbia (Canada). The full Bayes approach was selected as the statistical framework to develop the models. The results demonstrated that zone variation was a major component of total crash variability and that spatial effects were alleviated by clustering intersections together. Finally, the methodology used also allowed estimation of the treatment's effectiveness in the form of crash modification factors and functions with time trends. Copyright © 2016 Elsevier Ltd. All rights reserved.
Jarl, Johan; Desatnik, Peter; Peetz Hansson, Ulrika; Prütz, Karl Göran; Gerdtham, Ulf-G
The health care costs of kidney transplantation and dialysis are generally unknown. This study estimates the Swedish health care costs of kidney transplantation and dialysis over 10 years from a health care perspective. A before-after design was used, in which the patients served as their own controls. Health care costs the year before transplantation were assumed to continue in the absence of a transplant and the cost savings was therefore calculated as the difference between the expected costs and the actual costs during the 10-year follow-up period. Factors associated with the size of the cost savings were studied using ordinary least-squares regression. Altogether 66-79% of the expected health care costs over 10 years were avoided through kidney transplantation, resulting in a cost savings of €380 000 (2012 price-year) per patient. Savings were the highest for successful transplantations, but on average the treatment was cost-saving also for patients who returned to dialysis. No gender or age differences could be found, with the exception of a higher cost of transplantation for children and a generally higher cost for younger compared with older patients on dialysis. A negative association was also found between age at the time of transplantation and the size of the cost savings for the younger part of the sample. Kidney transplantations have led to substantial cost savings for the Swedish health care system. An increase in donated kidneys has the potential to further reduce the cost of renal replacement therapy.
Cadilhac, Dominique A; Andrew, Nadine E; Stroil Salama, Enna; Hill, Kelvin; Middleton, Sandy; Horton, Eleanor; Meade, Ian; Kuhle, Sarah; Nelson, Mark R; Grimley, Rohan
Provision of a discharge care plan and prevention therapies is often suboptimal. Our objective was to design and pilot test an interdisciplinary, organisational intervention to improve discharge care using stroke as the case study using a mixed-methods, controlled before-after observational study design. Acute care public hospitals in Queensland, Australia (n=15). The 15 hospitals were ranked against a benchmark based on a composite outcome of three discharge care processes. Clinicians from a 'top-ranked' hospital participated in a focus group to elicit their success factors. Two pilot hospitals then participated in the organisational intervention that was designed with experts and consumers. Hospital clinicians involved in discharge care for stroke and patients admitted with acute stroke or transient ischaemic attack. A four-stage, multifaceted organisational intervention that included data reviews, education and facilitated action planning. Three discharge processes collected in Queensland hospitals within the Australian Stroke Clinical Registry were used to select study hospitals: (1) discharge care plan; (2) antihypertensive medication prescription and (3) antiplatelet medication prescription (ischaemic events only). Primary measure: composite outcome. Secondary measures: individual adherence changes for each discharge process; sensitivity analyses. The performance outcomes were compared 3 months before the intervention (preintervention), 3 months postintervention and at 12 months (sustainability). Data from 1289 episodes of care from the two pilot hospitals were analysed. Improvements from preintervention adherence were: antiplatelet therapy (88%vs96%, p=0.02); antihypertensive prescription (61%vs79%, pvs94%, pvs89%, pvs 85% sustainability period, p=0.08). Discharge care in hospitals may be effectively improved and sustained through a staged and peer-informed, organisational intervention. The intervention warrants further application and trialling on a
Full Text Available Abstract Background Tracking how clinicians treat patients provides an opportunity to explore how the clinical management of common musculoskeletal disorders evolves over time. We present an uncontrolled before-after study of a primary care physician’s management of low back pain and describe how his involvement in an interprofessional collaborative practice was associated with a change in the management of patients with low back pain. Method Data from the electronic medical record of one primary care physician who participated in a study of a model of chiropractic-medical collaboration were retrospectively collected. Records of a sample of consecutive patients prior to the start (i.e. pre-study, n = 51 and at the end of the collaborative study (i.e. study, n = 49 were collected. Results Demographics were similar in both groups but median number of physician visits (2.5 and 1.0, average prescriptions per patients (1.24 and 0.47, and total number of narcotic prescriptions (14 and 6 differed between pre-study and study groups, respectively. Separate analysis of only the records of low back pain study patients revealed that 61% were referred for chiropractic care during the study period. Patients who were not referred had more neurological deficits and leg pain but back pain severity and average number of prescriptions was about the same. Referred patients in the study group had about 25% fewer physician visits and imaging requests. Conclusion Based on this study of a single primary care physician, we hypothesize that doctors may change their prescribing behaviours and consultation rate for patients with low back pain when engaged in interprofessional collaborative care. Further research is required to test this observation in the population.
Solomon, Daniel H; Lu, Bing; Yu, Zhi; Corrigan, Cassandra; Harrold, Leslie R; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N; Losina, Elena
We conducted a two-phase randomized controlled trial of a Learning Collaborative (LC) to facilitate implementation of treat to target (TTT) to manage rheumatoid arthritis (RA). We found substantial improvement in implementation of TTT in Phase I. Herein, we report on a second 9 months (Phase II) where we examined maintenance of response in Phase I and predictors of greater improvement in TTT adherence. We recruited 11 rheumatology sites and randomized them to either receive the LC during Phase I or to a wait-list control group that received the LC intervention during Phase II. The outcome was change in TTT implementation score (0 to 100, 100 is best) from pre- to post-intervention. TTT implementation score is defined as a percent of components documented in visit notes. Analyses examined: 1) the extent that the Phase I intervention teams sustained improvement in TTT; and, 2) predictors of TTT improvement. The analysis included 636 RA patients. At baseline, mean TTT implementation score was 11% in Phase I intervention sites and 13% in Phase II sites. After the intervention, TTT implementation score improved to 57% in the Phase I intervention sites and to 58% in the Phase II sites. Intervention sites from Phase I sustained the improvement during the Phase II (52%). Predictors of greater TTT improvement included only having rheumatologist providers at the site, academic affiliation of the site, fewer providers per site, and the rheumatologist provider being a trainee. Improvement in TTT remained relatively stable over a post-intervention period. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J.
Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees? dietary intakes, nutri...
Corbell, B.H.; Moran, B.W.; Pickett, C.A.; Whitaker, J.M.; Resnik, W.; Landreth, D.
A remote monitoring system (RMS) field trial will be conducted for the International Atomic Energy Agency (IAEA) on highly enriched uranium materials in a vault at the Oak Ridge Y-12 Plant. Remote monitoring technologies are being evaluated to verify their capability to enhance the effectiveness and timeliness of IAEA safeguards in storage facilities while reducing the costs of inspections and burdens on the operator. Phase one of the field trial, which involved proving the satellite transmission of sensor data and safeguards images from a video camera activated by seals and motion sensors installed in the vault, was completed in September 1995. Phase two involves formal testing of the RMS as a tool for use by the IAEA during their tasks of monitoring the storage of nuclear material. The field trial to be completed during early 1997 includes access and item monitoring of nuclear materials in two storage trays. The RMS includes a variety of Sandia, Oak Ridge, and Aquila sensor technologies that provide video monitoring, radiation attribute measurements, and container identification to the on-site data acquisition system (DAS) by way of radio-frequency and Echelon LONWorks networks. The accumulated safeguards information will be transmitted to the IAEA via satellite (COMSAT/RSI) and international telephone lines
Full Text Available This study aims to assess whether a standard intervention package of cardiovascular disease (CVD care was being delivered effectively, and if it was associated with improved lifestyle and biomedical indicators.In rural China, we implemented a pragmatic cluster randomized controlled trial for 12 months, randomized at the township hospital level, and compared with usual care. Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1 prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2 advice about specific lifestyle interventions; and 3 advice about medication adherence. Participants were 50-74 years old, had hypertension and CVD risk scores >20% or diabetes, but were excluded if a history of severe CVD events. We also randomly selected 100 participants from six selected clusters per arm as a panel to collect intermediate biomedical indicators over time.A total of 28,130 participants, in 33 intervention and 34 control township hospitals, were recruited. Compared with the control arm, participants in the intervention arm had substantially improved prescribing rates of anti-hypertensives, statins and aspirin (P0.05.Implementation of the package by family doctors was feasible and improved prescribing and some lifestyle changes. Additional measures such as reducing medication costs and patient education are required.Current Controlled Trials ISRCTN58988083.
Mazumder, Sarmila; Taneja, Sunita; Bahl, Rajiv; Mohan, Pavitra; Strand, Tor A; Sommerfelt, Halvor; Kirkwood, Betty R; Goyal, Nidhi; Van Den Hombergh, Henri; Martines, Jose
Objective To determine the effect of implementation of the Integrated Management of Neonatal and Childhood Illness strategy on treatment seeking practices and on neonatal and infant morbidity. Design Cluster randomised trial. Setting Haryana, India. Participants 29 667 births in nine intervention clusters and 30 813 births in nine control clusters. Main outcome measures The pre-specified outcome was the effect on treatment seeking practices. Post hoc exploratory analyses assessed morbidity, hospital admission, post-neonatal infant care, and nutritional status outcomes. Interventions The Integrated Management of Neonatal and Childhood Illness intervention included home visits by community health workers, improved case management of sick children, and strengthening of health systems. Outcomes were ascertained through interviews with randomly selected caregivers: 6204, 3073, and 2045 in intervention clusters and 6163, 3048, and 2017 in control clusters at ages 29 days, 6 months, and 12 months, respectively. Results In the intervention cluster, treatment was sought more often from an appropriate provider for severe neonatal illness (risk ratio 1.76, 95% confidence interval 1.38 to 2.24), for local neonatal infection (4.86, 3.80 to 6.21), and for diarrhoea at 6 months (1.96, 1.38 to 2.79) and 12 months (1.22, 1.06 to 1.42) and pneumonia at 6 months (2.09, 1.31 to 3.33) and 12 months (1.44, 1.00 to 2.08). Intervention mothers reported fewer episodes of severe neonatal illness (risk ratio 0.82, 0.67 to 0.99) and lower prevalence of diarrhoea (0.71, 0.60 to 0.83) and pneumonia (0.73, 0.52 to 1.04) in the two weeks preceding the 6 month interview and of diarrhoea (0.63, 0.49 to 0.80) and pneumonia (0.60, 0.46 to 0.78) in the two weeks preceding the 12 month interview. Infants in the intervention clusters were more likely to still be exclusively breast fed in the sixth month of life (risk ratio 3.19, 2.67 to 3.81). Conclusion Implementation of the Integrated Management
Boeckmann, Melanie; Nohavova, Iveta; Dogar, Omara; Kralikova, Eva; Pankova, Alexandra; Zvolska, Kamila; Huque, Rumana; Fatima, Razia; Noor, Maryam; Elsey, Helen; Sheikh, Aziz; Siddiqi, Kamran; Kotz, Daniel
Tuberculosis (TB) remains a significant public health problem in South Asia. Tobacco use increases the risks of TB infection and TB progression. The TB& Tobacco placebo-controlled randomised trial aims to (1) assess the effectiveness of the tobacco cessation medication cytisine versus placebo when combined with behavioural support and (2) implement tobacco cessation medication and behavioural support as part of general TB care in Bangladesh and Pakistan. This paper summarises the process and context evaluation protocol embedded in the effectiveness-implementation hybrid design. We are conducting a mixed-methods process and context evaluation informed by an intervention logic model that draws on the UK Medical Research Council's Process Evaluation Guidance. Our approach includes quantitative and qualitative data collection on context, recruitment, reach, dose delivered, dose received and fidelity. Quantitative data include patient characteristics, reach of recruitment among eligible patients, routine trial data on dose delivered and dose received, and a COM-B ('capability', 'opportunity', 'motivation' and 'behaviour') questionnaire filled in by participating health workers. Qualitative data include semistructured interviews with TB health workers and patients, and with policy-makers at district and central levels in each country. Interviews will be analysed using the framework approach. The behavioural intervention delivery is audio recorded and assessed using a predefined fidelity coding index based on behavioural change technique taxonomy. The study complies with the guidelines of the Declaration of Helsinki. Ethics approval for the study and process evaluation was granted by the University of Leeds (qualitative components), University of York (trial data and fidelity assessment), Bangladesh Medical Research Council and Bangladesh Drug Administration (trial data and qualitative components) and Pakistan Medical Research Council (trial data and qualitative
van Gaalen, Johanna L; Bakker, Moira J; van Bodegom-Vos, Leti; Snoeck-Stroband, Jiska B; Assendelft, Willem J J; Kaptein, Ad A; van der Meer, Victor; Taube, Christian; Thoonen, Bart P; Sont, Jacob K
Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient. This study
Aust, Birgit; Nielsen, Maj Britt D.; Grundtvig, Gry; Buchardt, Helle L.; Ferm, Linnea; Andersen, Irene; Lund, Trine L.; Jelle, Martin Ohmann Claudio; Andersen, Malene F.; Hansen, Jorgen V.; Tverborgvik, Torill; Helverskov, Trine; Bjorner, Jakob Bue; Rugulies, Reiner; Orbaek, Palle; Winzor, Glen; Bultmann, Ute; Poulsen, Otto M.
Objectives The aim of this study was to evaluate the implementation of the Danish national return-to-work (RTW) program in 21 Danish municipalities. Methods We conducted a structured process evaluation on (i) reach and recruitment, (ii) fidelity, (iii) dose-delivered, (iv) dose-received, and (v)
Riecke, Jenny; Holzapfel, Sebastian; Rief, Winfried; Glombiewski, Julia Anna
The purpose of the present study is to introduce an adapted protocol of in vivo exposure for fear avoidant back pain patients and its implementation in the German health care system without multidisciplinary teams. Case studies demonstrated promising effects but three preceding randomized controlled trials (RCTs) could not support the former results. More empirical support is necessary to further substantiate the effectiveness of in vivo exposure. A total of 108 chronic low back pain patients are randomly assigned to one out of three conditions (A: exposure_long (15 sessions), B: exposure_short (10 sessions) or C: control condition cognitive behavioral therapy (15 sessions)). The inclusion criteria are: back pain ≥3 months and a sufficient level of fear-avoidance. An effect evaluation, a process evaluation and an economic evaluation are conducted. Primary outcomes are pain-related disability and pain intensity. Secondary outcomes are: emotional distress, fear avoidance, catastrophizing and costs. Data are collected at baseline, upon completion of the intervention, after 10 sessions, and at six months following completion of treatment. Besides the comparison of exposure in vivo and cognitive behavioral therapy (CBT), we additionally compare a short and a long version of exposure to analyze dose response effects. This is, to our knowledge, the first RCT comparing in vivo exposure to psychological treatment as usual in terms of cognitive behavioral therapy. Results will help to find out whether a tailored treatment for fear avoidant back pain patients is more effective than a general pain management treatment. The trial has been registered to ClinicalTrial.gov. The trial registration number is NCT01484418.
Mavhu, Webster; Larke, Natasha; Hatzold, Karin; Ncube, Getrude; Weiss, Helen A; Mangenah, Collin; Mugurungi, Owen; Mufuka, Juliet; Samkange, Christopher A; Sherman, Judith; Gwinji, Gerald; Cowan, Frances M; Ticklay, Ismail
Early infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. Between January and June 2013, eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. Participants were followed for 14 days post-EIMC. Primary outcomes for the trial were EIMC safety and acceptability. One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. All mothers, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next son. This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents. There was no difference in the rate of AEs by device.
Cui Yunfeng [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States); Parker, William [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada); Breen, Stephen [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada); Yin Fangfang; Cai Jing [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States); Papiez, Lech S. [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Li, X. Allen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Bednarz, Greg [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Chen Wenzhou [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Xiao Ying, E-mail: firstname.lastname@example.org [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States)
Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA
Kinley, Julie; Stone, Louisa; Dewey, Michael; Levy, Jean; Stewart, Robert; McCrone, Paul; Sykes, Nigel; Hansford, Penny; Begum, Aysha; Hockley, Jo
The provision of quality end-of-life care is increasingly on the national agenda in many countries. In the United Kingdom, the Gold Standards Framework for Care Homes programme has been promoted as a national framework for improving end-of-life care. While its implementation is recommended, there are no national guidelines for facilitators to follow to undertake this role. It was hypothesised that action learning alongside high facilitation when implementing the Gold Standards Framework for Care Homes programme will result in a reduced proportion of hospital deaths for residents and improvement in the care home staff ability to facilitate good end-of-life care. A cluster randomised controlled trial where 24 nursing homes received high facilitation to enable them to implement the Gold Standards Framework for Care Homes programme. The managers of 12 nursing homes additionally took part in action learning sets. A third group (14 nursing homes) received the 'standard' Gold Standards Framework for Care Homes facilitation available in their locality. In total, 38 nursing homes providing care for frail older people, their deceased residents and their nurse managers. A greater proportion of residents died in those nursing homes receiving high facilitation and action learning but not significantly so. There was a significant association between the level of facilitation and nursing homes completing the Gold Standards Framework for Care Homes programme through to accreditation. Year-on-year change occurred across all outcome measures. There is a danger that without national guidelines, facilitation of the Gold Standards Framework for Care Homes programme will vary and consequently so will its implementation. The nurse manager of a care home must be actively engaged when implementing the Gold Standards Framework for Care Homes programme. © The Author(s) 2014.
Abidi, L; Oenema, A; Candel, M J J M; van de Mheen, D
Previous studies have shown that alcohol screening and brief intervention (ASBI) in general practices can lead to significant reductions in alcohol consumption among patients, yet ASBI is rarely implemented into routine clinical practice. The aim of this paper is to describe the development and evaluation of an ASBI implementation program aimed at increasing ASBI delivery rates of general practitioners (GPs) and decreasing patients' alcohol consumption. This study protocol describes the step-wise development and evaluation of an ASBI implementation program. A four-step method is used to identify relevant determinants of change and intervention components based on the Behaviour Change Wheel and the Theoretical Domains Framework. The program will be evaluated in general practices in The Netherlands in a two-arm cluster randomised controlled trial which investigates the effect of the program on GPs' ASBI delivery behaviour as well as on patients' alcohol consumption. Effective theory- and practice-based strategies to implement ASBI in general practices are highly needed. Using a stepwise method we described the development of a program consisting of an e-learning module, a tailored feedback module and environmental support and materials. We hypothesize that this program will result in an increase of GPs' ASBI delivery behaviour. Secondly, we expect an overall decrease in percentage of patients with excessive or problematic alcohol use and a higher proportion of patients from GPs receiving the ASBI implementation program decreasing their alcohol consumption, compared to patients from GPs in the control group. NTR5539. Copyright © 2016 Elsevier Inc. All rights reserved.
Emond, Yvette E J J M; Calsbeek, Hiske; Teerenstra, Steven; Bloo, Gerrit J A; Westert, Gert P; Damen, Johan; Wolff, André P; Wollersheim, Hub C
This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is
Harris Mark F
Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.
Wilson, Dawn K.; Griffin, Sarah; St. George, Sara M.; Alia, Kassandra A.; Trumpeter, Nevelyn N.; Wandersman, Abraham K.; Forthofer, Melinda; Robinson, Shamika; Gadson, Barney
Objectives. Evaluating programs targeting physical activity may help to reduce disparate rates of obesity among African Americans. We report formative process evaluation methods and implementation dose, fidelity, and reach in the Positive Action for Today’s Health trial. Methods: We applied evaluation methods based on an ecological framework in 2 community-based police-patrolled walking programs targeting access and safety in underserved African American communities. One program also targeted social connectedness and motivation to walk using a social marketing approach. Process data were systematically collected from baseline to 12 months. Results: Adequate implementation dose was achieved, with fidelity achieved but less stable in both programs. Monthly walkers increased to 424 in the walking-plus-social marketing program, indicating expanding program reach, in contrast to no increase in the walking-only program. Increased reach was correlated with peer-led Pride Strides (r = .92; P social marketing component, and program social interaction was the primary reason for which walkers reported participating. Conclusions: Formative process evaluation demonstrated that the walking programs were effectively implemented and that social marketing increased walking and perceived social connectedness in African American communities. PMID:23078486
Coulon, Sandra M; Wilson, Dawn K; Griffin, Sarah; St George, Sara M; Alia, Kassandra A; Trumpeter, Nevelyn N; Wandersman, Abraham K; Forthofer, Melinda; Robinson, Shamika; Gadson, Barney
Evaluating programs targeting physical activity may help to reduce disparate rates of obesity among African Americans. We report formative process evaluation methods and implementation dose, fidelity, and reach in the Positive Action for Today's Health trial. We applied evaluation methods based on an ecological framework in 2 community-based police-patrolled walking programs targeting access and safety in underserved African American communities. One program also targeted social connectedness and motivation to walk using a social marketing approach. Process data were systematically collected from baseline to 12 months. Adequate implementation dose was achieved, with fidelity achieved but less stable in both programs. Monthly walkers increased to 424 in the walking-plus-social marketing program, indicating expanding program reach, in contrast to no increase in the walking-only program. Increased reach was correlated with peer-led Pride Strides (r = .92; P social marketing component, and program social interaction was the primary reason for which walkers reported participating. Formative process evaluation demonstrated that the walking programs were effectively implemented and that social marketing increased walking and perceived social connectedness in African American communities.
Implementation of a manualized communication intervention for school-aged children with pragmatic and social communication needs in a randomized controlled trial: the Social Communication Intervention Project.
Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny
Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable treatment delivery can be achieved. To present the rationale, structure and content of an intensive manualized intervention as implemented within an RCT for children with complex pragmatic and social communication needs; to investigate factors associated with implementation in a mainstream school environment; and to determine treatment fidelity. The manualized SCIP intervention, including procedures for developing individualized treatment plans, was developed and then implemented within an RCT with 57 school-aged children with complex pragmatic communication needs (CwPLI). The paper describes the delivery protocol, staffing requirements, and content and structure of the intervention. A mapping procedure for individualization of intervention and the implemented components of intervention are presented. The findings from a school-therapy alliance checklist for recording factors affecting implementation in a school context are also reported. Treatment fidelity was carried out using measures of delivered versus planned treatment content and quality of therapy. The manual was effective at detailing intervention procedures and allowing for development of individualized treatment plans whilst maintaining satisfactory treatment fidelity. Treatment planning and delivery required continuous specialist speech and language therapist input with assistants needing substantive training and supervision. Key components of intervention for CwPLI were therapies aimed at improving conversation skills, narrative construction, comprehension monitoring, understanding of social cues and metapragmatic awareness. The school-therapy alliance checklist indicated
Full Text Available Background: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. Methods: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management. Study participants were recruited via tobacco quitlines from August 5, 2013 to December 15, 2014. Results: Statistical analysis on baseline data was conducted in 2015/2016. Among 5082 potentially eligible callers to a tobacco quitline, 2540 were randomized (50% of eligible. Compared with individuals eligible but not randomized, those randomized were significantly more likely to be female (65.7% vs 54.5%, p < 0.01, overweight or obese (76.3% vs 62.5%, p < 0.01, more confident in quitting (p < 0.01, more addicted (first cigarette within 5 min: 50.0% vs 44.4%, p < 0.01, and have a chronic disease (28.6% vs. 24.4%, p < 0.01. Randomized groups were not statistically significantly different on demographics, tobacco or weight variables. Two-thirds of participants were female and white with a mean age of 43. Conclusions: Adding weight management interventions to tobacco cessation quitlines was feasible and acceptable to smokers. If successful for cessation and weight outcomes, a combined intervention may provide a treatment approach for addressing weight gain with smoking cessation through tobacco quitlines. Trial registration: Clinicaltrials.gov NCT01867983. Keywords: Smoking, Weight gain, Quitlines, Simultaneous, Sequential
Patrick, K; Marshall, S J; Davila, E P; Kolodziejczyk, J K; Fowler, J H; Calfas, K J; Huang, J S; Rock, C L; Griswold, W G; Gupta, A; Merchant, G; Norman, G J; Raab, F; Donohue, M C; Fogg, B J; Robinson, T N
To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. A total of 404 overweight or obese college students from three Southern California universities (M(age) = 22( ± 4) years; M(BMI) = 29( ± 2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, text messaging, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, diet, physical activity, sedentary behavior, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Theory-driven, evidence-based strategies for physical activity, sedentary behavior, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. Copyright © 2013 Elsevier Inc. All rights reserved.
Williams, Christopher M; Nathan, Nicole; Delaney, Tessa; Yoong, Sze Lin; Wiggers, John; Preece, Sarah; Lubans, Nicole; Sutherland, Rachel; Pinfold, Jessica; Smith, Kay; Small, Tameka; Reilly, Kathryn L; Butler, Peter; Wyse, Rebecca J; Wolfenden, Luke
Introduction A number of jurisdictions internationally have policies requiring schools to implement healthy canteens. However, many schools have not implemented such policies. One reason for this is that current support interventions cannot feasibly be delivered to large numbers of schools. A promising solution to support population-wide implementation of healthy canteen practices is audit and feedback. The effectiveness of this strategy has, however, not previously been assessed in school canteens. This study aims to assess the effectiveness and cost-effectiveness of an audit and feedback intervention, delivered by telephone and email, in increasing the number of school canteens that have menus complying with a government healthy-canteen policy. Methods and analysis Seventy-two schools, across the Hunter New England Local Health District in New South Wales Australia, will be randomised to receive the multicomponent audit and feedback implementation intervention or usual support. The intervention will consist of between two and four canteen menu audits over 12 months. Each menu audit will be followed by two modes of feedback: a written feedback report and a verbal feedback/support via telephone. Primary outcomes, assessed by dieticians blind to group status and as recommended by the Fresh Tastes @ School policy, are: (1) the proportion of schools with a canteen menu containing foods or beverages restricted for sale, and; (2) the proportion of schools that have a menu which contains more than 50% of foods classified as healthy canteen items. Secondary outcomes are: the proportion of menu items in each category (‘red’, ‘amber’ and ‘green’), canteen profitability and cost-effectiveness. Ethics and dissemination Ethical approval has been obtained by from the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. The findings will be disseminated in usual forums, including peer
Background Studies have shown that communities have not always been able to implement evidence-based prevention programs with quality and achieve outcomes demonstrated by prevention science. Implementation support interventions are needed to bridge this gap between science and practice. The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes (AGTO) intervention in 12 Maine communities engaged in promoting Developmental Assets, a positive youth development approach to prevention. AGTO is an implementation support intervention that consists of: a manual of text and tools; face-to-face training, and onsite technical assistance, focused on activities shown to be associated with obtaining positive results across any prevention program. Methods This study uses a nested and cross-sectional, cluster randomized controlled design. Participants were coalition members and program staff from 12 communities in Maine. Each coalition nominated up to five prevention programs to participate. At random, six coalitions and their respective 30 programs received the two-year AGTO intervention and the other six maintained routine operations. The study assessed prevention practitioner capacity (efficacy and behaviors), practitioner exposure to and use of AGTO, practitioner perceptions of AGTO, and prevention program performance. Capacity of coalition members and performance of their programs were compared between the two groups across the baseline, one-, and two-year time points. Results We found no significant differences between AGTO and control group’s prevention capacity. However, within the AGTO group, significant differences were found between those with greater exposure to and use of AGTO. Programs that received the highest number of technical assistance hours showed the most program improvement. Conclusions This study is the first of its kind to show that use of an implementation support intervention-AGTO -yielded
Implementation of the 2013 American College of Cardiology/American Heart Association Blood Cholesterol Guideline Including Data From the Improved Reduction of Outcomes: Vytorin Efficacy International Trial
Ziaeian, Boback; Dinkler, John; Watson, Karol
Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality in developed countries. The management of blood cholesterol through use of 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitors (statins) in at-risk patients is a pillar of medical therapy for the primary and secondary prevention of cardiovascular disease. The recent 2013 American College of Cardiology/American Heart Association guideline on managing blood cholesterol provides an important framework for the effective implementation of risk-reduction strategies. The guideline identifies four cohorts of patients with proven benefits from statin therapy and streamlines the dosing and monitoring recommendations based on evidence from published, randomized controlled trials. Primary care physicians and cardiologists play key roles in identifying populations at elevated ASCVD risk. In providing a practical management overview of the current blood cholesterol guideline, we facilitate more informed discussions on treatment options between healthcare providers and their patients. PMID:26198559
Streater, Amy; Spector, Aimee; Hoare, Zoe; Aguirre, Elisa; Russell, Ian; Orrell, Martin
There is evidence that Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy are effective in mild to moderate dementia. There is, however, little evidence available for its implementation in practice and the impact of outreach support on the sustainability of the programme. Two hundred and forty-one staff members were randomised from 63 dementia care settings between outreach support including an online forum, email, and telephone support, compared to usual Cognitive Stimulation Therapy control group. The primary outcome was average number of attendees to the Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy programmes. There was no difference in average number of attendees between the intervention and usual Cognitive Stimulation Therapy control groups for the Cognitive Stimulation Therapy (p = 0.82) or the maintenance Cognitive Stimulation Therapy programme (p = 0.97). Outreach support does not affect the average number of people with dementia attending the Cognitive Stimulation Therapy or maintenance Cognitive Stimulation Therapy programme. Irrespective of outreach support, the programmes remain widely implemented and yield perceived benefits for people with dementia. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
Goldberg, Howard S; Paterno, Marilyn D; Grundmeier, Robert W; Rocha, Beatriz H; Hoffman, Jeffrey M; Tham, Eric; Swietlik, Marguerite; Schaeffer, Molly H; Pabbathi, Deepika; Deakyne, Sara J; Kuppermann, Nathan; Dayan, Peter S
To evaluate the architecture, integration requirements, and execution characteristics of a remote clinical decision support (CDS) service used in a multicenter clinical trial. The trial tested the efficacy of implementing brain injury prediction rules for children with minor blunt head trauma. We integrated the Epic(®) electronic health record (EHR) with the Enterprise Clinical Rules Service (ECRS), a web-based CDS service, at two emergency departments. Patterns of CDS review included either a delayed, near-real-time review, where the physician viewed CDS recommendations generated by the nursing assessment, or a real-time review, where the physician viewed recommendations generated by their own documentation. A backstopping, vendor-based CDS triggered with zero delay when no recommendation was available in the EHR from the web-service. We assessed the execution characteristics of the integrated system and the source of the generated recommendations viewed by physicians. The ECRS mean execution time was 0.74 ±0.72 s. Overall execution time was substantially different at the two sites, with mean total transaction times of 19.67 and 3.99 s. Of 1930 analyzed transactions from the two sites, 60% (310/521) of all physician documentation-initiated recommendations and 99% (1390/1409) of all nurse documentation-initiated recommendations originated from the remote web service. The remote CDS system was the source of recommendations in more than half of the real-time cases and virtually all the near-real-time cases. Comparisons are limited by allowable variation in user workflow and resolution of the EHR clock. With maturation and adoption of standards for CDS services, remote CDS shows promise to decrease time-to-trial for multicenter evaluations of candidate decision support interventions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Bouwsma, Esther V A; Huirne, Judith A F; van de Ven, Peter M; Vonk Noordegraaf, Antonie; Schaafsma, Frederieke G; Schraffordt Koops, Steven E; van Kesteren, Paul J M; Brölmann, Hans A M; Anema, Johannes R
To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease. Stepped-wedge cluster randomised controlled trial. Secondary care, nine hospitals in the Netherlands, 2011-2014. 433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery. An internet-based care programme was sequentially rolled out using a multifaceted implementation strategy. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or the care programme (n=227). The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice. The primary outcome was duration until full sustainable return to work (RTW). The degree of implementation of the care programme was evaluated at the level of the patient, healthcare provider and organisation by indicators measuring internet-based actions by patients and providers. Median time until RTW was 49 days (IQR 27-76) in the intervention group and 62 days (42-85) in the control group. A piecewise Cox model was fitted to take into account non-proportionality of hazards. In the first 85 days after surgery, patients receiving the intervention returned to work faster than patients in the control group (HR 2.66, 95% CI 1.88 to 3.77), but this effect was reversed in the small group of patients that did not reach RTW within this period (0.28, 0.17 to 0.46). Indicators showed that the implementation of the care programme was most successful at the level of the patient (82.8%) and professional (81.7%). Implementation of an internet-based care programme has a large potential to lead to accelerated recovery and improved RTW rates following different types of gynaecological surgeries. NTR2933; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use
Patterson Thomas L
intervention will be analyzed, and across CBOs, correlations will be examined between individual and organizational provider characteristics and intervention efficacy. Discussion This cooperative, bi-national research study will provide critical insights into barriers and facilitating factors associated with implementing interventions in CBOs using the ‘train the trainer’ model. Our work builds on similar scale-up strategies that have been effective in the United States. This study has the potential to increase our knowledge of the generalizability of such strategies across health issues, national contexts, and organizational contexts. Trial registration NCT01465607
Koncz, Rebecca; Wolfenden, Fiona; Hassed, Craig; Chambers, Richard; Cohen, Julia; Glozier, Nicholas
The aim of this study was to evaluate the effectiveness of a 6-week mindfulness-based stress release program (SRP) on stress and work engagement in fulltime university employees. Perceived stress, workplace wellbeing, and engagement were measured at baseline and within 1 week of the SRP completion, and contemporaneously 6 weeks apart for a waitlist control group. A second program was implemented to examine reproducibility of results. Fifty participants undertook the SRPs, and 29 participants were waitlisted. A significant improvement in distress, workplace wellbeing, and vigor was observed within the first SRP group, when compared with the control group. The improvement in distress and wellbeing was reproduced in the second SRP group. This study adds to the growing body of research that mindfulness may be an effective method for reducing workplace stress, improving employee wellbeing, and enhancing work engagement.
Dreischulte, Tobias; Grant, Aileen; Hapca, Adrian; Guthrie, Bruce
The cluster randomised trial of the Data-driven Quality Improvement in Primary Care (DQIP) intervention showed that education, informatics and financial incentives for general medical practices to review patients with ongoing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets reduced the primary end point of high-risk prescribing by 37%, where both ongoing and new high-risk prescribing were significantly reduced. This quantitative process evaluation examined practice factors associated with (1) participation in the DQIP trial, (2) review activity (extent and nature of documented reviews) and (3) practice level effectiveness (relative reductions in the primary end point). Invited practices recruited (n=33) and not recruited (n=32) to the DQIP trial in Scotland, UK. (1) Characteristics of recruited versus non-recruited practices. Associations of (2) practice characteristics and 'adoption' (self-reported implementation work done by practices) with documented review activity and (3) of practice characteristics, DQIP adoption and review activity with effectiveness. (1) Recruited practices had lower performance in the quality and outcomes framework than those declining participation. (2) Not being an approved general practitioner training practice and higher self-reported adoption were significantly associated with higher review activity. (3) Effectiveness ranged from a relative increase in high-risk prescribing of 24.1% to a relative reduction of 77.2%. High-risk prescribing and DQIP adoption (but not documented review activity) were significantly associated with greater effectiveness in the final multivariate model, explaining 64.0% of variation in effectiveness. Intervention implementation and effectiveness of the DQIP intervention varied substantially between practices. Although the DQIP intervention primarily targeted review of ongoing high-risk prescribing, the finding that self-reported DQIP adoption was a stronger predictor of
Wijnhoven, S.; Escaravage, V.; Herman, P.M.J.; Smaal, A.C.; Hummel, H.
To study the possible environmental impact of hydraulic cockle-dredging on macrobenthic communities and the environment, a fishing experiment was executed on a tidal mudflat in the Oosterschelde (SW Netherlands) according to a BACI (before-after-control-impact) design. Following the characterization
Yoong, Sze Lin; Nathan, Nicole; Wolfenden, Luke; Wiggers, John; Reilly, Kathryn; Oldmeadow, Christopher; Wyse, Rebecca; Sutherland, Rachel; Delaney, Tessa; Butler, Peter; Janssen, Lisa; Preece, Sarah; Williams, Christopher M
The implementation of nutrition policies in schools has been recommended as a strategy to improve child dietary intake. Internationally, research suggests that the majority of schools do not implement these policies. In New South Wales (NSW), Australia, the NSW Healthy School Canteen Policy requires that school canteens prohibit the sale of 'red' foods (i.e. foods that are typically nutrient poor and high in energy, such as confectionary and deep-fried foods) and 'banned'drinks (i.e. soft drinks); and that the majority of items on the menu are 'green' (i.e. foods that are good sources of nutrients, such fruits, vegetables and lean meats). This study examined the impact of a multicomponent audit and feedback intervention on schools' implementation of the NSW Healthy School Canteen Policy. A secondary aim was to assess the impact of the intervention on menu composition. This study was a parallel group randomised controlled trial with 72 rural and remote primary schools (36 interventions, 36 controls) located in one region within NSW, Australia. Intervention schools received an initial face to face contact and up to four cycles of audit and feedback (consisting of a menu audit, written feedback report and telephone feedback) over a 12-month period. The primary trial outcomes were the proportion of schools with a canteen menu that had: i) no 'red' foods or 'banned' drinks; and ii) >50% 'green' items, as assessed via standardised menu audits undertaken by trained dietitians. For each primary outcome, between-group differences were assessed using Fisher's exact test under an intention to treat approach. There was insufficient evidence to conclude the intervention had a positive impact on the proportion of intervention schools with no 'red' or 'banned' items on their menu (RR = 2.8; 95% CI: 0.9 to 8.9; p = 0.0895), or on the proportion of intervention schools with more than 50% 'green' items (RR = 1.5; 95% CI: 0.7 to 3.2; p = 0.2568). These findings
Jäger, Cornelia; Steinhäuser, Jost; Freund, Tobias; Kuse, Sarah; Szecsenyi, Joachim; Wensing, Michel
We developed and evaluated a tailored programme to implement three evidence-based recommendations for multimorbid patients with polypharmacy into primary care practices: structured medication counselling including brown bag reviews, the use of medication lists and medication reviews. No effect on the primary outcome was found. This process evaluation aimed to identify factors associated with outcomes by exploring nine hypotheses specified in the logic model of the tailored programme. The tailored programme was developed with respect to identified determinants of practice and consisted of a workshop for practice teams, elaboration of implementation action plans, aids for medication reviews, a multilingual info-tool for patients on a tablet PC, posters and brown paper bags as reminders for patients. The tailored programme was evaluated in a cluster randomized trial. The process evaluation was based on various data sources: interviews with general practitioners and medical assistants of the intervention group and a survey with general practitioners of the intervention and control group, written reports on the implementation action plans, documentation forms for structured medication counselling and the log file of the info-tool. We analyzed 12 interviews, 21 questionnaires, 120 documentation forms for medication counselling, 5 implementation action plans and one log file of the info-tool. The most frequently reported effect of the tailored programme was the increase of awareness for the health problem and the recommendations, while implementation of routine processes was only reported for structured medication counselling. The survey largely confirmed the usefulness of the applied strategies, yet the interviews provided a more detailed understanding of the actual use of the strategies and several suggestions for modifications of the tailored programme. The tailored programme seemed to have induced awareness as a first step of behaviour change. Several modifications of
Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel)
Shea, Steven; Starren, Justin; Teresi, Jeanne A; Ganz, Michael L; Burton, Tanya M; Pashos, Chris L; Blustein, Jan; Field, Lesley; Morin, Philip C; Izquierdo, Roberto E; Silver, Stephanie; Eimicke, Joseph P; Lantigua, Rafael A; Weinstock, Ruth S
Objective To determine whether a diabetes case management telemedicine intervention reduced healthcare expenditures, as measured by Medicare claims, and to assess the costs of developing and implementing the telemedicine intervention. Design We studied 1665 participants in the Informatics for Diabetes Education and Telemedicine (IDEATel), a randomized controlled trial comparing telemedicine case management of diabetes to usual care. Participants were aged 55 years or older, and resided in federally designated medically underserved areas of New York State. Measurements We analyzed Medicare claims payments for each participant for up to 60 study months from date of randomization, until their death, or until December 31, 2006 (whichever happened first). We also analyzed study expenditures for the telemedicine intervention over six budget years (February 28, 2000– February 27, 2006). Results Mean annual Medicare payments (SE) were similar in the usual care and telemedicine groups, $9040 ($386) and $9669 ($443) per participant, respectively (p>0.05). Sensitivity analyses, including stratification by censored status, adjustment by enrollment site, and semi-parametric weighting by probability of dropping-out, rendered similar results. Over six budget years 28 821 participant/months of telemedicine intervention were delivered, at an estimated cost of $622 per participant/month. Conclusion Telemedicine case management was not associated with a reduction in Medicare claims in this medically underserved population. The cost of implementing the telemedicine intervention was high, largely representing special purpose hardware and software costs required at the time. Lower implementation costs will need to be achieved using lower cost technology in order for telemedicine case management to be more widely used. PMID:20190064
Glide-Hurst, C; Zheng, W; Kim, J; Wen, N; Chetty, I J [Henry Ford Health System, Detroit, MI (United States)
Purpose: To perform a retrospective virtual clinical trial using an MR-only workflow for a variety of brain cancer cases by incorporating novel imaging sequences, tissue segmentation using phase images, and an innovative synthetic CT (synCT) solution. Methods: Ten patients (16 lesions) were evaluated using a 1.0T MR-SIM including UTE-DIXON imaging (TE = 0.144/3.4/6.9ms). Bone-enhanced images were generated from DIXON-water/fat and inverted UTE. Automated air segmentation was performed using unwrapped UTE phase maps. Segmentation accuracy was assessed by calculating intersection and Dice similarity coefficients (DSC) using CT-SIM as ground truth. SynCTs were generated using voxel-based weighted summation incorporating T2, FLAIR, UTE1, and bone-enhanced images. Mean absolute error (MAE) characterized HU differences between synCT and CT-SIM. Dose was recalculated on synCTs; differences were quantified using planar gamma analysis (2%/2 mm dose difference/distance to agreement) at isocenter. Digitally reconstructed radiographs (DRRs) were compared. Results: On average, air maps intersected 80.8 ±5.5% (range: 71.8–88.8%) between MR-SIM and CT-SIM yielding DSCs of 0.78 ± 0.04 (range: 0.70–0.83). Whole-brain MAE between synCT and CT-SIM was 160.7±8.8 HU, with the largest uncertainty arising from bone (MAE = 423.3±33.2 HU). Gamma analysis revealed pass rates of 99.4 ± 0.04% between synCT and CT-SIM for the cohort. Dose volume histogram analysis revealed that synCT tended to yield slightly higher doses. Organs at risk such as the chiasm and optic nerves were most sensitive due to their proximities to air/bone interfaces. DRRs generated via synCT and CT-SIM were within clinical tolerances. Conclusion: Our approach for MR-only simulation for brain cancer treatment planning yielded clinically acceptable results relative to the CT-based benchmark. While slight dose differences were observed, reoptimization of treatment plans and improved image registration can address
Dalager, Tina; Justesen, Just Bendix; Murray, Mike; Boyle, Eleanor; Sjøgaard, Gisela
The aim was to assess 1-year cardiovascular health effects of Intelligent Physical Exercise Training, IPET. Office workers from six companies were randomized 1:1 to a training group, TG (N = 194) or a control group, CG (N = 195). TG received 1-h supervised high intensity IPET every week within working hours for 1 year, and was recommended to perform 30-min of moderate intensity physical activity 6 days a week during leisure. The training program was based on baseline health check measures of cardiorespiratory fitness (CRF), body composition, blood pressure, blood profile, and musculoskeletal health. There were no baseline differences between groups. CRF assessed as VO2max in absolute values and relative to body weight was (mean ± SD): 3.0 ± 0.8 l/min and 35.4 ± 10.9 ml/min/kg for females, 3.9 ± 1.0 l/min and 37.9 ± 11.79 ml/min/kg for males. Intention to treat analysis demonstrated a significant almost 5 % increase in VO2max in TG compared with CG. A per protocol analysis of those with an adherence of ≥70 % demonstrated a significant increase in CRF of more than 10 % compared with CG, and a significant reduction in systolic blood pressure (-5.3 ± 13.7 mm Hg) compared with CG. High intensity IPET combined with the recommendations of moderate intensity physical activity demonstrated significant clinical relevant improvements in CRF and systolic blood pressure. This underlines the effectiveness of health promotion by implementing physical exercise training at the workplace.
Middleton, Sandy; McElduff, Patrick; Ward, Jeanette; Grimshaw, Jeremy M; Dale, Simeon; D'Este, Catherine; Drury, Peta; Griffiths, Rhonda; Cheung, N Wah; Quinn, Clare; Evans, Malcolm; Cadilhac, Dominique; Levi, Christopher
We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence-based management of fever, hyperglycaemia, and swallowing dysfunction in acute stroke units (ASUs). In the Quality in Acute Stroke Care (QASC) study, a single-blind cluster randomised controlled trial, we randomised ASUs (clusters) in New South Wales, Australia, with immediate access to CT and on-site high dependency units, to intervention or control group. Patients were eligible if they spoke English, were aged 18 years or older, had had an ischaemic stroke or intracerebral haemorrhage, and presented within 48 h of onset of symptoms. Intervention ASUs received treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers. Control ASUs received only an abridged version of existing guidelines. We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency (modified Rankin scale [mRS] ≥2), functional dependency (Barthel index), and SF-36 physical and mental component summary scores. Research assistants, the statistician, and patients were masked to trial groups. All analyses were done by intention to treat. This trial is registered at the Australia New Zealand Clinical Trial Registry (ANZCTR), number ACTRN12608000563369. 19 ASUs were randomly assigned to intervention (n=10) or control (n=9). Of 6564 assessed for eligibility, 1696 patients' data were obtained (687 pre-intervention; 1009 post-intervention). Results showed that, irrespective of stroke severity, intervention ASU patients were significantly less likely to be dead or dependent (mRS ≥2) at 90 days than control ASU patients (236 [42%] of 558 patients in the intervention group vs 259 [58%] of 449 in the control group, p=0·002; number needed to treat 6·4; adjusted absolute difference 15·7% [95% CI 5·8-25·4]). They also had a
Santos, Veruska Andrea; Freire, Rafael; Zugliani, Morená; Cirillo, Patricia; Santos, Hugo Henrique; Nardi, Antonio Egidio; King, Anna Lucia
The growth of the Internet has led to significant change and has become an integral part of modern life. It has made life easier and provided innumerous benefits; however, excessive use has brought about the potential for addiction, leading to severe impairments in social, academic, financial, psychological, and work domains. Individuals addicted to the Internet usually have comorbid psychiatric disorders. Panic disorder (PD) and generalized anxiety disorder (GAD) are prevalent mental disorders, involving a great deal of damage in the patient's life. This open trial study describes a treatment protocol among 39 patients with anxiety disorders and Internet addiction (IA) involving pharmacotherapy and modified cognitive behavioral therapy (CBT). Of the 39 patients, 25 were diagnosed with PD and 14 with GAD, in addition to Internet addiction. At screening, patients responded to the MINI 5.0, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, Clinical Global Impressions Scale, and the Young Internet Addiction Scale. At that time, IA was observed taking into consideration the IAT scale (cutoff score above 50), while anxiety disorders were diagnosed by a psychiatrist. Patients were forwarded for pharmacotherapy and a modified CBT protocol. Psychotherapy was conducted individually, once a week, over a period of 10 weeks, and results suggest that the treatment was effective for anxiety and Internet addiction. Before treatment, anxiety levels suggested severe anxiety, with an average score of 34.26 (SD 6.13); however, after treatment the mean score was 15.03 (SD 3.88) (Paddiction scores was observed, from 67.67 (SD 7.69) before treatment, showing problematic internet use, to 37.56 (SD 9.32) after treatment (Panxiety, the correlation between scores was .724. This study is the first research into IA treatment of a Brazilian population. The improvement was remarkable due to the complete engagement of patients in therapy, which contributed to the success of the
Zablotska, Iryna B; Selvey, Christine; Guy, Rebecca; Price, Karen; Holden, Jo; Schmidt, Heather-Marie; McNulty, Anna; Smith, David; Jin, Fengyi; Amin, Janaki; Cooper, David A; Grulich, Andrew E
The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals. EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW. EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV
Boots, Lizzy Mm; de Vugt, Marjolein E; Smeets, Claudia Mj; Kempen, Gertrudis Ijm; Verhey, Frans Rj
, time, and deviating target population. Participants and coaches were satisfied with the intervention, but adapting the content to specific subgroups, for example, younger caregivers, was recommended. Implementation of the program requires more awareness of the benefits of blended care self-management programs and training in tailored self-management skills. Dutch Trial Register (NTR): NTR4748; http://www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg). ©Lizzy MM Boots, Marjolein E de Vugt, Claudia MJ Smeets, Gertrudis IJM Kempen, Frans RJ Verhey. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.12.2017.
Anna L Barker
Full Text Available There is limited evidence to support the effectiveness of falls prevention interventions in the acute hospital setting. The 6-PACK falls prevention program includes a fall-risk tool; 'falls alert' signs; supervision of patients in the bathroom; ensuring patients' walking aids are within reach; toileting regimes; low-low beds; and bed/chair alarms. This study explored the acceptability of the 6-PACK program from the perspective of nurses and senior staff prior to its implementation in a randomised controlled trial. A mixed-methods approach was applied involving 24 acute wards from six Australian hospitals. Participants were nurses working on participating wards and senior hospital staff including: Nurse Unit Managers; senior physicians; Directors of Nursing; and senior personnel involved in quality and safety or falls prevention. Information on program acceptability (suitability, practicality and benefits was obtained by surveys, focus groups and interviews. Survey data were analysed descriptively, and focus group and interview data thematically. The survey response rate was 60%. Twelve focus groups (n = 96 nurses and 24 interviews with senior staff were conducted. Falls were identified as a priority patient safety issue and nurses as key players in falls prevention. The 6-PACK program was perceived to offer practical benefits compared to current practice. Nurses agreed fall-risk tools, low-low beds and alert signs were useful for preventing falls (>70%. Views were mixed regarding positioning patients' walking aid within reach. Practical issues raised included access to equipment; and risk of staff injury with low-low bed use. Bathroom supervision was seen to be beneficial, however not always practical. Views on the program appropriateness and benefits were consistent across nurses and senior staff. Staff perceived the 6-PACK program as suitable, practical and beneficial, and were open to adopting the program. Some practical concerns were raised
The principal aim of this study was to determine the hospital-acquired pressure injury (HAPI) rate before and after introduction of a repositioning device, measure staff-perceived level of exertion with device use, and assess return on investment. 1 group, before-and-after study. The sample comprised 717 patients cared for in a 17-bed intensive care unit. The study setting was the neonatal intensive care unit at Bon Secours Maryview Medical Center located in the mid-Atlantic United States (Portsmouth, Virginia). A safe patient-handling intervention was implemented as part of a quality improvement initiative. The effect of this system was measured using several outcome measures: (1) HAPI occurrences on the sacral area and buttocks, (2) perceived effort of use by staff, and (3) cost analysis. We used the validated Borg Scale to measure perceived exertion that was ranked on a scale from 6 to 20, where higher scores indicate greater exertion. Cost comparisons were completed before and after introduction of the patient-repositioning system. Cost analysis was determined using internal dollar amounts calculated for each stage of pressure injury. The return on investment was calculated by comparing the cost of HAPIs and the product after the intervention with the costs of HAPIs before the intervention. Analysis revealed a statistically significant reduction in HAPI occurrence from 1.3% to 0% (P = .004) when baseline manual repositioning (standard of care) was compared with use of the repositioning system. Caregivers reported significantly less exertion when using the repositioning device as compared with standard of care repositioning (P return on investment was estimated to be $16,911. Use of a repositioning device resulted in significantly reduced HAPIs. Perceived exertion for repositioning the patient with a repositioning device was significantly less than repositioning with standard of care. A cost analysis estimated a return on investment as a result of the
Delphin Mavinga Phanzu
Full Text Available BACKGROUND: Buruli ulcer (BU is a necrotizing bacterial infection of skin, subcutaneous tissue and bone caused by Mycobacterium ulcerans. Although the functional impairment caused by BU results in severe suffering and in socio-economic problems, the disease remains largely neglected in Africa. The province of Bas-Congo in Democratic Republic of Congo contains one of the most important BU foci of the country, i.e. the Songololo Territory in the District of Cataractes. This study aims to assess the impact of a BU control project launched in 2004 in the Songololo Territory. METHODS: We used a comparative non-randomized study design, comparing clinical profiles and outcomes of the group of patients admitted at the General Reference Hospital (GRH of the "Institut Médical Evangélique" (IME of Kimpese 3 years before the start of the project (2002-2004 with those admitted during the 3 years after the start of the project (2005-2007. RESULTS: The BU control project was associated with a strong increase in the number of admitted BU cases at the GRH of IME/Kimpese and a fundamental change in the profile of those patients; more female patients presented with BU, the proportion of relapse cases amongst all admissions reduced, the proportion of early lesions and simple ulcerative forms increased, more patients healed without complications and the case fatality rate decreased substantially. The median duration since the onset of first symptoms however remained high, as well as the proportion of patients with osteomyelitis or limitations of joint movement, suggesting that the diagnostic delay remains substantial. CONCLUSION: Implementing a specialized program for BU may be effective in improving clinical profiles and outcomes in BU. Despite these encouraging results, our study highlights the need of considering new strategies to better improve BU control in a low resources setting.
Prolonged direct hemoperfusion using a polymyxin B immobilized fiber cartridge provides sustained circulatory stabilization in patients with septic shock: a retrospective observational before-after study
Full Text Available Abstract Background Direct hemoperfusion therapy with polymyxin B immobilized fiber cartridges (PMX-DHP is widely used for septic shock in Japan and parts of Europe. Although this treatment is usually administered for 2 h, the optimal duration has not been established. Methods This retrospective study compared the effects of prolonged and conventional PMX-DHP durations (2 and 12 h, respectively for septic shock. Between October 2013 and March 2015, 18 patients underwent conventional PMX-DHP, and between April 2015 and May 2016, 18 patients underwent prolonged PMX-DHP. The primary outcome was the vasopressor dependency index during the 12 h after starting the first PMX-DHP session. The vasopressor dependency index was calculated as (inotropic score/(mean blood pressure. Results The patients’ characteristics were almost similar in the conventional and prolonged PMX-DHP groups. The major site of infection was the abdomen in both groups (61 and 72%, respectively. The conventional PMX-DHP group had mean blood pressure values of 68.4 ± 8.9 mmHg and 78.2 ± 16.9 mmHg at 0 and 12 h after starting PMX-DHP (P = 0.13. The prolonged PMX-DHP group had mean blood pressure values of 70.3 ± 15.7 mmHg and 87.7 ± 16.9 mmHg at 0 and 12 h after starting PMX-DHP (P = 0.004. The conventional PMX-DHP group had vasopressor dependency index values of 0.52 ± 0.29 and 0.39 ± 0.25 at 0 and 12 h after starting PMX-DHP (P = 0.29. The prolonged PMX-DHP group had vasopressor dependency index values of 0.50 ± 0.26 and 0.28 ± 0.18 at 0 and 12 h after starting PMX-DHP (P = 0.01. Hospital mortality was similar in both groups (8/18 [44%] and 8/18 [44%]. Conclusions These findings suggest that prolonged PMX-DHP provides more sustained circulatory stabilization compared to conventional PMX-DHP. However, our study failed to detect any improvement in mortality. Well-designed prospective trials are needed to examine the
Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden.
Guwatudde, David; Absetz, Pilvikki; Delobelle, Peter; Östenson, Claes-Göran; Olmen Van, Josefien; Alvesson, Helle Molsted; Mayega, Roy William; Ekirapa Kiracho, Elizabeth; Kiguli, Juliet; Sundberg, Carl Johan; Sanders, David; Tomson, Göran; Puoane, Thandi; Peterson, Stefan; Daivadanam, Meena
Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in self-management, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. ISRCTN11913581; Pre-results. © Article author(s) (or their
Benjamins, S Janine; Damen, Maurice L W; van Stel, Henk F
equal level of proficiency but less continuity in person. This experiment shows that task delegation from doctor to nurse in preventive child health care is feasible. It is important to pay attention to the acceptation process of professionals during implementation. More investigation is needed in order to assess effectiveness and efficacy of task delegation.
S Janine Benjamins
experienced an equal level of proficiency but less continuity in person.This experiment shows that task delegation from doctor to nurse in preventive child health care is feasible. It is important to pay attention to the acceptation process of professionals during implementation. More investigation is needed in order to assess effectiveness and efficacy of task delegation.
Full Text Available Studies have shown that early ART initiation in TB/HIV co-infected patients lowers mortality. One way to implement earlier ART commencement could be through integration of TB and HIV services, a more efficient model of care than separate, vertical programs. We present a model of full TB/HIV integration and estimate its effect on time to initiation of ART.We retrospectively reviewed TB registers and clinical notes of 209 TB/HIV co-infected adults with a CD4 count <250 cells/µl and registered for TB treatment at one primary care clinic in a South African township between June 2008 and May 2009. Using Kaplan-Meier and Cox proportional hazard analysis, we compared time between initiation of TB treatment and ART for the periods before and after full, "one-stop shop" integration of TB and HIV services (in December 2009. Potential confounders were determined a priori through directed acyclic graphs. Robustness of assumptions was investigated by sensitivity analyses. The analysis included 188 patients (100 pre- and 88 post-integration, yielding 56 person-years of observation. Baseline characteristics of the two groups were similar. Median time to ART initiation decreased from 147 days (95% confidence interval [CI] 85-188 before integration of services to 75 days (95% CI 52-119 post-integration. In adjusted analyses, patients attending the clinic post-integration were 1.60 times (95% CI 1.11-2.29 more likely to have started ART relative to the pre-integration period. Sensitivity analyses supported these findings.Full TB/HIV care integration is feasible and led to a 60% increased chance of co-infected patients starting ART, while reducing time to ART initiation by an average of 72 days. Although these estimates should be confirmed through larger studies, they suggest that scale-up of full TB/HIV service integration in high TB/HIV prevalence settings may shorten time to ART initiation, which might reduce excess mortality and morbidity.
Clarke, Aleisha M; Bunting, Brendan; Barry, Margaret M
Schools are recognized as one of the most important settings for promoting social and emotional well-being among children and adolescents. This clustered randomized controlled trial evaluated Zippy's Friends, an international school-based emotional well-being programme, with 766 children from designated disadvantaged schools. The purpose of this study was to evaluate the immediate and long term impact of the programme and to determine the impact of implementation fidelity on programme outcomes. Teachers reported emotional literacy outcomes using the Emotional Literacy Checklist, and emotional and behavioural outcomes using the Strengths and Difficulties Questionnaire. Controlling for the hierarchical structure of the data, path analysis using structural equation modelling revealed that the programme had a significant positive impact on the children's emotional literacy scores including significant improvements in the subscale scores of self-awareness (P children's emotional and behavioural problems. Analysis of programme fidelity indicated that high fidelity was directly related to improved emotional literacy scores at post-intervention. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: email@example.com.
Coleman Karen J
Full Text Available Abstract Background The Healthy Options for Nutrition Environments in Schools (Healthy ONES study was an evidence-based public health (EBPH randomized group trial that adapted the Institute for Healthcare Improvement’s (IHI rapid improvement process model to implement school nutrition policy and environmental change. Methods A low-income school district volunteered for participation in the study. All schools in the district agreed to participate (elementary = 6, middle school = 2 and were randomly assigned within school type to intervention (n = 4 and control (n =4 conditions following a baseline environmental audit year. Intervention goals were to 1 eliminate unhealthy foods and beverages on campus, 2 develop nutrition services as the main source on campus for healthful eating (HE, and 3 promote school staff modeling of HE. Schools were followed across a baseline year and two intervention years. Longitudinal assessment of height and weight was conducted with second, third, and sixth grade children. Behavioral observation of the nutrition environment was used to index the amount of outside foods and beverages on campuses. Observations were made monthly in each targeted school environment and findings were presented as items per child per week. Results From an eligible 827 second, third, and sixth grade students, baseline height and weight were collected for 444 second and third grade and 135 sixth grade students (51% reach. Data were available for 73% of these enrolled students at the end of three years. Intervention school outside food and beverage items per child per week decreased over time and control school outside food and beverage items increased over time. The effects were especially pronounced for unhealthy foods and beverage items. Changes in rates of obesity for intervention school (28% baseline, 27% year 1, 30% year 2 were similar to those seen for control school (22% baseline, 22% year 1, 25% year 2 children
Background The Healthy Options for Nutrition Environments in Schools (Healthy ONES) study was an evidence-based public health (EBPH) randomized group trial that adapted the Institute for Healthcare Improvement’s (IHI) rapid improvement process model to implement school nutrition policy and environmental change. Methods A low-income school district volunteered for participation in the study. All schools in the district agreed to participate (elementary = 6, middle school = 2) and were randomly assigned within school type to intervention (n = 4) and control (n =4) conditions following a baseline environmental audit year. Intervention goals were to 1) eliminate unhealthy foods and beverages on campus, 2) develop nutrition services as the main source on campus for healthful eating (HE), and 3) promote school staff modeling of HE. Schools were followed across a baseline year and two intervention years. Longitudinal assessment of height and weight was conducted with second, third, and sixth grade children. Behavioral observation of the nutrition environment was used to index the amount of outside foods and beverages on campuses. Observations were made monthly in each targeted school environment and findings were presented as items per child per week. Results From an eligible 827 second, third, and sixth grade students, baseline height and weight were collected for 444 second and third grade and 135 sixth grade students (51% reach). Data were available for 73% of these enrolled students at the end of three years. Intervention school outside food and beverage items per child per week decreased over time and control school outside food and beverage items increased over time. The effects were especially pronounced for unhealthy foods and beverage items. Changes in rates of obesity for intervention school (28% baseline, 27% year 1, 30% year 2) were similar to those seen for control school (22% baseline, 22% year 1, 25% year 2) children. Conclusions
A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627
Full Text Available Abstract Background A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples. Methods/Design The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin. The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions.
Smidth, Margrethe; Christensen, Morten Bondo; Fenger-Grøn, Morten; Olesen, Frede; Vedsted, Peter
The growing population living with chronic conditions calls for efficient healthcare-planning and effective care. Implementing disease-management-programmes is one option for responding to this demand. Knowledge is scarce about the effect of implementation processes and their effect on patients; only few studies have reported the effectiveness of disease-management-programmes targeting patients with chronic obstructive pulmonary disease (COPD). The objective of this paper was to determine the effect on healthcare-utilization of an active implementation model for a disease-management-programme for patients with one of the major multimorbidity diseases, COPD. The standard implementation of a new disease-management-programme for COPD was ongoing during the study-period from November 2008 to November 2010 in the Central Denmark Region. We wanted to test a strategy using Breakthrough Series, academic detailing and lists of patients with COPD. It targeted GPs and three hospitals serving approx. 60,000 inhabitants aged 35 or older and included interventions directed at professionals, organisations and patients. The study was a non-blinded block- and cluster-randomised controlled trial with GP-practices as the unit of randomisation. In Ringkoebing-Skjern Municipality, Denmark, 16 GP-practices involving 38 GPs were randomised to either the intervention-group or the control-group. A comparable neighbouring municipality acted as an external-control-group which included nine GP-practices with 25 GPs. An algorithm based on health-registry-data on lung-related contacts to the healthcare-system identified 2,736 patients who were alive at the end of the study-period. The population included in this study counted 1,372 (69.2%) patients who responded to the baseline questionnaire and confirmed their COPD diagnosis; 458 (33.4%) patients were from the intervention-group, 376 (27.4%) from the control-group and 538(39.2%) from the external-control-group. The primary outcome was
WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial.
Hamdani, S U; Akhtar, P; Zill-E-Huma; Nazir, H; Minhas, F A; Sikander, S; Wang, D; Servilli, C; Rahman, A
Development disorders and delays are recognised as a public health priority and included in the WHO mental health gap action programme (mhGAP). Parents Skills Training (PST) is recommended as a key intervention for such conditions under the WHO mhGAP intervention guide. However, sustainable and scalable delivery of such evidence based interventions remains a challenge. This study aims to evaluate the effectiveness and scaled-up implementation of locally adapted WHO PST programme delivered by family volunteers in rural Pakistan. The study is a two arm single-blind effectiveness implementation-hybrid cluster randomised controlled trial. WHO PST programme will be delivered by 'family volunteers' to the caregivers of children with developmental disorders and delays in community-based settings. The intervention consists of the WHO PST along with the WHO mhGAP intervention for developmental disorders adapted for delivery using the android application on a tablet device. A total of 540 parent-child dyads will be recruited from 30 clusters. The primary outcome is child's functioning, measured by WHO Disability Assessment Schedule - child version (WHODAS-Child) at 6 months post intervention. Secondary outcomes include children's social communication and joint engagement with their caregiver, social emotional well-being, parental health related quality of life, family empowerment and stigmatizing experiences. Mixed method will be used to collect data on implementation outcomes. Trial has been retrospectively registered at ClinicalTrials.gov (NCT02792894). This study addresses implementation challenges in the real world by incorporating evidence-based intervention strategies with social, technological and business innovations. If proven effective, the study will contribute to scaled-up implementation of evidence-based packages for public mental health in low resource settings. Registered with ClinicalTrials.gov as Family Networks (FaNs) for Children with Developmental
Stafford Randall S
Full Text Available Abstract Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD. However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. Methods The Stanford and San Mateo Heart to Heart (HTH project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. Results We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or
Bruyndonckx, Robin; Verhoeven, Veronique; Anthierens, Sibyl; Cornelis, Koen; Ackaert, Katelijne; Gielen, Birgit; Coenen, Samuel
In Belgium, the debate about the effect of the national academic detailing service (ADS) on prescribing quality in general practice is ongoing. In order to evaluate both the implementation strategies of the ADS and its effectiveness on appropriate prescribing of pain relief medication, we conducted a real-world cluster randomized controlled trial (cRCT). In a pragmatic cRCT, all Belgian general practices previously visited by Farmaka were assessed for eligibility and randomized. Only practices randomized to the intervention group were invited for an academic detailing visit on appropriate prescribing of pain relief medication. GPs were unaware of the study, ensuring the production of real-world evidence but were given the option to opt out from the analysis. An objective outcome assessment was obtained using routinely collected reimbursement data. Primary outcomes were the proportion of patients reimbursed for an analgesic or NSAID, the defined daily dose of paracetamol per patient per month, the proportion of patients reimbursed for a recommended NSAID among those reimbursed for any NSAID and the proportion of patients reimbursed for both an NSAID and a proton pump inhibitor among those reimbursed for an NSAID. The impact of practice, GP and academic detailer characteristics were also assessed. Three thousand five hundred twenty-nine general practices (4530 GPs) were eligible and randomized. One thousand six hundred ninety-eight practices (2171 GPs) in the intervention group and one thousand seven hundred three (2163 GPs) in the control group were included in the analysis. The intervention had a significant impact on the proportion of patients reimbursed for a recommended NSAID among those reimbursed for any NSAID (increase in odds (95% CI): 19% (10-29%)). A clear impact on other outcomes could not be detected. Additionally, we showed that the characteristics of the academic detailers might impact the effectiveness of the visit. National implementation of academic
Brehaut Jamie C
Full Text Available Abstract Background Blood transfusion is an essential part of healthcare and can improve patient outcomes. However, like most therapies, it is also associated with significant clinical risks. In addition, there is some evidence of overuse. Understanding the potential barriers and enablers to reduced prescribing of blood products will facilitate the selection of intervention components likely to be effective, thereby reducing the number of costly trials evaluating different implementation strategies. Using a theoretical basis to understand behaviours targeted for change will contribute to a 'basic science' relating to determinants of professional behaviour and how these inform the selection of techniques for changing behaviour. However, it is not clear which theories of behaviour are relevant to clinicians' transfusing behaviour. The aim of this study is to use a theoretical domains framework to identify relevant theories, and to use these theories to identify factors that predict the decision to transfuse. Methods The study involves two steps: interview study and questionnaire study. Using a previously identified framework, we will conduct semi-structured interviews with clinicians to elicit their views about which factors are associated with waiting and further monitoring the patient rather than transfusing red blood cells. Interviews will cover the following theoretical domains: knowledge; skills; social/professional role and identity; beliefs about capabilities; beliefs about consequences; motivation and goals; memory, attention, and decision processes; environmental context and resources; social influences; emotion; behavioural regulation; nature of the behaviour. The interviews will take place independently in Canada and the UK and involve two groups of physicians in each country (UK: adult and neonatal intensive care physicians; Canada: intensive care physicians and orthopaedic surgeons. We will: analyse interview transcript content to
Matheson, Catriona; Pflanz-Sinclair, Christiane; Almarzouqi, Amna; Bond, Christine M; Lee, Amanda J; Batieha, Anwar; Al Ghaferi, H; El Kashef, A
Aim This project evaluated the effectiveness of screening brief intervention and referral for treatment (SBIRT) in primary care in Abu Dhabi to manage patients with problematic substance use. This study aimed to determine whether: (i) training primary care physicians on the SBIRT model increased the identification of patients using substances at a harmful, hazardous or dependent level; (ii) training improved physicians' knowledge, attitudes and beliefs in self-efficacy in managing substance use. Substance use is increasing in the United Arab Emirates yet there has been no formal primary care intervention. SBIRT was considered an appropriate model given its endorsement by the WHO. A controlled trial (two intervention and two matched control clinics) was undertaken. Intervention physicians (n=17) were trained in SBIRT. Physicians' attitudes were measured before and after training and eight months after implementation. Target recruitment was 900 patients. Inclusion criteria were: consenting UAE national, ⩾18 years, using the 'walk-in' primary care clinic. Patient data was collected by physician-administered questionnaire. Prevalence of drug use was measured through electronic patient records. Findings A total of 906 patients were screened, aged 18-82 years and 496 (55%) were female. Of these, 5.7% reported use of amphetamine, 3.9% alcohol, 3.3%, sedatives, 1.7% opioids and 1.1% cannabis. In all, 21 people had a moderate/high ASSIST score and received a brief intervention, but did not attend follow-up; three high-risk people were referred for specialist treatment. Physicians' attitudes towards patients with problematic substance use and providing treatment improved after training, but returned to pre-training levels after eight months. Including the 21 individuals identified from intervention screening, the prevalence of substance use increased to 0.208% (95% CI 0.154-0.274), significantly higher than in control clinics (PSBIRT and SBIRT increased recorded drug
Steyn, Krisela; Lombard, Carl; Gwebushe, Nomonde; Fourie, Jean M; Everett-Murphy, Katherine; Zwarenstein, Merrick; Levitt, Naomi S
Many clinical management guidelines for chronic diseases have been published, but they have not been put into practice by busy clinicians at primary care levels. This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record (SR) in Cape Town in a randomised controlled trial (RCT). Eighteen public sector community health centres (CHC) were randomly selected and allocated as intervention or control CHC. At each clinic, 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline. Questionnaires were completed, blood samples were collected, blood pressure (BP) and anthropometric measures were taken and patient records were audited. SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records. Contact was maintained during the year of intervention with the clinic staff. A follow-up survey was conducted 1 year later to assess BP and HbA1c, and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics. In-depth interviews were conducted with doctors and nurses to record their response to the intervention. The intervention evaluated in this RCT had no impact on either diabetes or hypertension control. In the intervention clinics, less than 60% of the patient folders contained the SR and when present was seldom used. Although the staff were well disposed to the research team, their workload prohibited them from undertaking a true evaluation of the SR, and overall they did not perceive the SR as supporting their current process of patient care. No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT. The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics.
Franzen, Samuel R P; Chandler, Clare; Enquselassie, Fikre; Siribaddana, Sisira; Atashili, Julius; Angus, Brian; Lang, Trudie
Clinical trials provide 'gold standard' evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Fieldwork took place in Ethiopia during March 2011. Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens
Garrett, H. James
The author uses a trip to a Holocaust museum to explain and illustrate psychoanalytic concepts from Freud to Lacan in order to re-imagine persistent dilemmas in teacher education. The author suggests that psychoanalytic vocabularies provide an additional and productive lens to conceptualize productive possibilities in teacher education.
Orzeck-Byrnes, Natasha A; Aidasani, Sneha R; Moloney, Dana N; Nguyen, Lisa H; Park, Agnes; Hu, Lu; Langford, Aisha T; Wang, Binhuan; Sevick, Mary Ann; Rogers, Erin S
Background The Mobile Insulin Titration Intervention (MITI) program helps patients with type 2 diabetes find their correct basal insulin dose without in-person care. Requiring only basic cell phone technology (text messages and phone calls), MITI is highly accessible to patients receiving care in safety-net settings. MITI was shown in a randomized controlled trial (RCT) to be efficacious at a New York City (NYC) safety-net clinic where patients often have challenges coming for in-person care. In 2016, MITI was implemented as usual care at Bellevue Hospital (the site of the original RCT) and at Gouverneur Health (a second NYC safety-net clinic) under 2 different staffing models. Objective This implementation study examined MITI’s transition into real-world settings. To understand MITI’s flexibility, generalizability, and acceptability among patients and providers, we evaluated whether MITI continued to produce positive outcomes in expanded underserved populations, outside of an RCT setting. Methods Patients enrolled in MITI received weekday text messages asking for their fasting blood glucose (FBG) values and a weekly titration call. The goal was for patients to reach their optimal insulin dose (OID), defined either as the dose of once-daily basal insulin required to achieve either an FBG of 80-130 mg/dL (4.4-7.2 mmol/L) or as the reaching of the maximum dose of 50 units. After 12 weeks, if OID was not reached, the patients were asked to return to the clinic for in-person care and titration. MITI program outcomes, clinical outcomes, process outcomes, and patient satisfaction were assessed. Results MITI was successful at both sites, each with a different staffing model. Providers referred 170 patients to the program—129 of whom (75.9%, 129/170) were eligible. Of these, 113 (87.6%, 113/129) enrolled. Moreover, 84.1% (95/113) of patients reached their OID, and they did so in an average of 24 days. Clinical outcomes show that mean FBG levels fell from 209 mg
Lambert, Joseph M.; Lloyd, Blair P.; Staubitz, Johanna L.; Weaver, Emily S.; Jennings, Chelsea M.
The trial-based functional analysis (FA) is a useful alternative to the traditional FA in contexts in which it is challenging to establish environmental control for extended periods of time. Previous researchers have demonstrated that others can be trained to conduct trial-based FAs with high procedural fidelity by providing a didactic…
van der Meer, Esther W. C.; Boot, Cecile R. L.; van der Gulden, Joost W. J.; Knol, Dirk L.; Jungbauer, Frank H. W.; Coenraads, Pieter Jan; Anema, Johannes R.
Background. Healthcare workers have an increased risk of developing hand eczema. A multifaceted implementation strategy was developed to implement a guideline to prevent hand eczema among healthcare workers. Objectives. To investigate the effects of the implementation strategy on self-reported hand
Development of a theory-informed implementation intervention to improve the triage, treatment and transfer of stroke patients in emergency departments using the Theoretical Domains Framework (TDF): the T3Trial.
Craig, Louise E; Taylor, Natalie; Grimley, Rohan; Cadilhac, Dominique A; McInnes, Elizabeth; Phillips, Rosemary; Dale, Simeon; O'Connor, Denise; Levi, Chris; Fitzgerald, Mark; Considine, Julie; Grimshaw, Jeremy M; Gerraty, Richard; Cheung, N Wah; Ward, Jeanette; Middleton, Sandy
Theoretical frameworks and models based on behaviour change theories are increasingly used in the development of implementation interventions. Development of an implementation intervention is often based on the available evidence base and practical issues, i.e. feasibility and acceptability. The aim of this study was to describe the development of an implementation intervention for the T 3 Trial (Triage, Treatment and Transfer of patients with stroke in emergency departments (EDs)) using theory to recommend behaviour change techniques (BCTs) and drawing on the research evidence base and practical issues of feasibility and acceptability. A stepped method for developing complex interventions based on theory, evidence and practical issues was adapted using the following steps: (1) Who needs to do what, differently? (2) Using a theoretical framework, which barriers and enablers need to be addressed? (3) Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? A researcher panel was convened to review the list of BCTs recommended for use and to identify the most feasible and acceptable techniques to adopt. Seventy-six barriers were reported by hospital staff who attended the workshops (step 1: thirteen TDF domains likely to influence the implementation of the T 3 Trial clinical intervention were identified by the researchers; step 2: the researcher panellists then selected one third of the BCTs recommended for use as appropriate for the clinical context of the ED and, using the enabler workshop data, devised enabling strategies for each of the selected BCTs; and step 3: the final implementation intervention consisted of 27 BCTs). The TDF was successfully applied in all steps of developing an implementation intervention for the T 3 Trial clinical intervention. The use of researcher panel opinion was an essential part of the BCT selection process to incorporate both research
Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.
Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L
Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.
A pragmatic randomised controlled trial of an implementation intervention to increase healthy eating and physical activity-promoting policies, and practices in centre-based childcare services: study protocol.
Finch, Meghan; Yoong, Sze Lin; Thomson, Rebecca J; Seward, Kirsty; Cooney, Mairead; Jones, Jannah; Fielding, Alison; Wiggers, John; Gillham, Karen; Wolfenden, Luke
Promotion of healthy eating and physical activity in early childhood is recommended as a global chronic disease prevention strategy. Centre-based childcare services represent a promising setting to provide children with opportunities to improve healthy eating and physical activity. Evidence to inform implementation of childcare obesity prevention guidelines into routine practice in childcare, however, is lacking. This study aims to assess the effectiveness of an intervention, delivered to childcare staff, aiming to increasing service implementation of healthy eating and physical activity-promoting policies and practices. A pragmatic parallel group randomised controlled trial will be undertaken with 165 childcare services in the Hunter New England region of New South Wales, Australia. Services will be randomised to receive either a 10-month evidence-based performance review intervention with other resources to support practice change, or to a waitlist control group. The primary trial outcome is the proportion of services implementing all of the following recommended healthy eating and physical activity promoting practices: written nutrition, physical activity and small screen recreation policies; providing information to families regarding healthy eating (including breastfeeding), physical activity and small screen time; providing twice weekly healthy eating learning experiences to children; providing water and only plain milk to children; providing fundamental movement skills activities for children every day; and limiting and using electronic screen time more for educational purposes and learning experiences. Effectiveness will be assessed using a telephone interview of practice implementation with childcare staff at baseline and 12 months following baseline. The study was approved by the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. Study findings will be disseminated widely through peer
Boland, Melinde R S; Kruis, Annemarije L; Huygens, Simone A; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H
This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes. PMID:26677770
Schmidt, Barbara; Watt, Kerrianne; McDermott, Robyn; Mills, Jane
Better systems of care are required to address chronic disease in Indigenous people to ensure they can access all their care needs. Health research has produced evidence about effective models of care and chronic disease strategies to address Indigenous health, however the transfer of research findings into routine clinical practice has proven challenging. Complex interventions, such as those related to chronic disease, have many components that are often poorly implemented and hence rarely achieve implementation fidelity. Implementation fidelity is "the degree to which programs are implemented as intended by the program developer". Knowing if an intervention was implemented as planned is fundamental to knowing what has contributed to the success of an intervention. The aim of this study is to adapt the implementation fidelity framework developed by Keith et al. and apply it to the intervention implemented in phase 1 of the Getting Better at Chronic Care in North Queensland study. The objectives are to quantify the level of implementation fidelity achieved during phase 1 of the study, measure the association between implementation fidelity and health outcomes and to explore the features of the primary health care system that contributed to improved health outcomes. A convergent parallel mixed methods study design will be used to develop a process for assessing implementation fidelity. Information collected via a questionnaire and routine data generated during phase 1 of the study will be used to explain the context for the intervention in each site and develop an implementation fidelity score for each component of the intervention. A weighting will be applied to each component of the intervention to calculate the overall implementation score for each participating community. Statistical analysis will assess the level of association between implementation fidelity scores and health outcomes. Health services research seeks to find solutions to social and technical
Jons, Christian; Hansen, Peter Steen; Johannessen, Arne
(MANTRA-PAF) trial is a randomized, controlled, parallel group, multicentre study designed to test whether catheter-based RFA is superior to optimized AAD therapy in suppressing relapse within 24 months of symptomatic and/or asymptomatic AF in patients with paroxysmal AF without prior AAD therapy...... centres in Scandinavia and Germany are participating in the study. Enrolment was started in 2005 and as of November 2008, 260 patients have been enrolled into the study. It is expected that enrolment will end by March 2009, when 300 patients have been included. CONCLUSION: The MANTRA-PAF trial...
Nosik, Melissa R.; Williams, W. Larry; Garrido, Natalia; Lee, Sarah
In the current study, behavior skills training (BST) is compared to a computer based training package for teaching discrete trial instruction to staff, teaching an adult with autism. The computer based training package consisted of instructions, video modeling and feedback. BST consisted of instructions, modeling, rehearsal and feedback. Following…
Mu, Wei; Shang, Hongcai
Objective. To define patient values, identify their manifestations in a randomized clinical trial, and investigate the possible implications for clinical research of traditional Chinese medicine. Methods. We categorized patient values manifestations into patient choice, preference, compliance, and patient-reported outcomes and summarized the underlying personal values through purposeful electronic searches for relevant reports. By hypothesizing a set of positive versus negative circumstances occurring in the enrollment, intervention allocation, treatment, and the follow-up stage of a trial, it is possible to discuss the potential implications of patient values manifestation on a trial with traditional Chinese medicine. Results. Patient values and its manifestations are ubiquitous in the process of clinical research with traditional Chinese medicine. These values may provide motivation for participation or engender the internal and external validity of the study. Conclusions. Trialists should attach sufficient importance to the needs and concerns of individual participant. To incorporate patient values into the design and conduct of a clinical study with traditional Chinese medicine, researchers are recommended to adopt participant-friendly design and use patient-reported outcomes, take convenience-for-patients measures, and help foster rational beliefs and behaviors of trial participants.
Causal Analysis of World Health Organization's Surgical Safety Checklist Implementation Quality and Impact on Care Processes and Patient Outcomes: Secondary Analysis From a Large Stepped Wedge Cluster Randomized Controlled Trial in Norway.
Haugen, Arvid Steinar; Wæhle, Hilde Valen; Almeland, Stian Kreken; Harthug, Stig; Sevdalis, Nick; Eide, Geir Egil; Nortvedt, Monica Wammen; Smith, Ingrid; Søfteland, Eirik
We hypothesize that high-quality implementation of the World Health Organization's Surgical Safety Checklist (SSC) will lead to improved care processes and subsequently reduction of peri- and postoperative complications. Implementation of the SSC was associated with robust reduction in morbidity and length of in-hospital stay in a stepped wedge cluster randomized controlled trial conducted in 2 Norwegian hospitals. Further investigation of precisely how the SSC improves care processes and subsequently patient outcomes is needed to understand the causal mechanisms of improvement. Care process metrics are reported from one of our earlier trial hospitals. Primary outcomes were in-hospital complications and care process metrics, e.g., patient warming and antibiotics. Secondary outcome was quality of SSC implementation. Analyses include Pearson's exact χ test and binary logistic regression. A total of 3702 procedures (1398 control vs. 2304 intervention procedures) were analyzed. High-quality SSC implementation (all 3 checklist parts) improved processes and outcomes of care. Use of forced air warming blankets increased from 35.3% to 42.4% (P administration postincision decreased from 12.5% to 9.8%, antibiotic administration preincision increased from 54.5% to 63.1%, and nonadministration of antibiotics decreased from 33.0% to 27.1%. Surgical infections decreased from 7.4% (104/1398) to 3.6% (P download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.
Ketelaar, S. M.; Schaafsma, F. G.; Geldof, M. F.; Kraaijeveld, R. A.; Boot, C. R. L.; Shaw, W. S.; Bultmann, U.; Anema, J. R.
Purpose To study the effectiveness of a multifaceted strategy to implement the participatory approach (PA) for supervisors to increase their self-efficacy in addressing risk of sick leave of employees. Methods Supervisors from three organizations were invited to participate. Randomization was
Ketelaar, S M; Schaafsma, F G; Geldof, M F; Boot, C R L; Kraaijeveld, R A; Shaw, W S; Bültmann, U; Twisk, J; Anema, J R
Purpose A multifaceted implementation strategy was targeted at supervisors to encourage them to apply a participatory approach (PA) in dealing with employees' work functioning problems due to health concerns. This paper assesses the effect on employees' perceived social norms regarding the use of
Kraaijeveld, R.A.; Schaafsma, F.G.; Boot, C.R.L.; Shaw, W.S.; Bultmann, U.; Anema, J.R.
Background: The burden of sick leave for society and organisations underlines the urgent need to prevent sick leave. An effective workplace intervention for organisations to shorten sick leave episodes is the Participatory Approach (PA). In this study, we hypothesize that implementation of the PA
Full Text Available Aim. The purpose of this study is to evaluate the impact, among nurses in hospital settings, of a questionnaire-based implementation intentions intervention on notification of potential ocular tissue donors to donation stakeholders. Methods. This randomized intervention was clustered at the level of hospital departments with two study arms: questionnaire-based implementation intentions intervention and control. In the intervention group, nurses were asked to plan specific actions if faced with a number of barriers when reporting potential ocular donors. The primary outcome was the potential ocular tissue donors’ notification rate before and after the intervention. Analysis was based on a generalized linear model with an identity link and a binomial distribution. Results. We compared outcomes in 26 departments from 5 hospitals, 13 departments per condition. The implementation intentions intervention did not significantly increase the notification rate of ocular tissue donors (intervention: 23.1% versus control: 21.1%; χ2=1.14, 2; P=0.56. Conclusion. A single and brief implementation intentions intervention among nurses did not modify the notification rate of potential ocular tissue donors to donation stakeholders. Low exposure to the intervention was a major challenge in this study. Further studies should carefully consider a multicomponent intervention to increase exposure to this type of intervention.
Visschere, L. De; Schols, J.; Putten, G.J. van der; Baat, C. de; Vanobbergen, J.
OBJECTIVE: To compare a supervised versus a non-supervised implementation of an oral health care guideline in Flanders (Belgium). BACKGROUND: The key factor in realising good oral health is daily oral hygiene care. In 2007, the Dutch guideline 'Oral health care in care homes for elderly people' was
Noome, M.; Dijkstra, B.M.; Leeuwen, E. van; Vloet, L.C.M.
AIM: The aim of this study was to examine the effectiveness of supporting intensive care units on implementing the guidelines. BACKGROUND: Quality of care can be achieved through evidence-based practice. Guidelines can facilitate evidence-based practice, such as the guidelines 'End-of-life care in
van Gaalen, J.L.; Bakker, M.J.; Bodegom-Vos, L. van; Snoeck-Stroband, J.B.; Assendelft, W.J.J.; Kaptein, A.A.; van der Meer, V.; Taube, C.; Thoonen, B.P.A.; Sont, J.K.; for the, I.s.g.
ABSTRACT: BACKGROUND: Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical
Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars
Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation training...
Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS and interactive voice response (IVR
te Boveldt Nienke
Full Text Available Abstract Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation strategy, Short Message Service with Interactive Voice Response (SVS-IVR, has been developed and pilot tested. This study aims to evaluate on effectiveness of this strategy to improve pain reporting, pain measurement and adequate pain therapy. In addition, whether the active role of the patient and involvement of caregivers in pain management may change. Methods/design A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity. Discussion This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life. Trail registration Netherlands Trial Register (NTR: NTR2739
Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative
Eikelenboom, Nathalie; van Lieshout, Jan; Wensing, Michel; Smeele, Ivo; Jacobs, Annelies E
The number of patients with one or more chronic diseases is rising. In several standards of care there is a focus on enhancing self-management. We applied the concept of personalization on self-management support and developed a self-management screening questionnaire (SeMaS). The main research objective is to assess the effectiveness of the SeMaS questionnaire and subsequent personalized self-management on patients' self-management behaviors. A cluster randomized controlled trial will be set up in 15 general practices in the Netherlands. The practices are all group practices, and member of one care group. The practices will be assigned to the control or intervention arms by stratified randomization. The strata are determined by the participation of the practice nurses in a course for behavioral change, and the nurse's workload. Patients can be included if they are over 18 years of age, have at least one chronic condition and have a checkup appointment with the practice nurse in the inclusion period. The intervention consists of screening patients with the SeMaS questionnaire, producing a graphic profile with the abilities or barriers for self-management. Patients will receive tailored feedback. Practice nurses are trained in using the profile to enhance self-management of the patient and provide personalized self-management support. The use of individual care plans and self-management interventions is stimulated. In the control arm patients will receive care as usual. Patients of both trial arms will be asked to fill in the SeMaS questionnaire and additional questionnaires at inclusion and after 6 months. The primary outcome is the difference in the level of patient activation (PAM-13) between baseline and 6 months. Secondary outcomes include patient measures for lifestyle factors (exercise, diet, smoking), and process measures from medical record data analysis. This manuscript presents the protocol for a cluster randomized clinical trial of personalized self
Patterson, Thomas L; Semple, Shirley J; Chavarin, Claudia V; Mendoza, Doroteo V; Santos, Lorena E; Chaffin, Mark; Palinkas, Lawrence A; Strathdee, Steffanie A; Aarons, Gregory A
Studies of implementation of efficacious human immunodeficiency virus (HIV) prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs) among female sex workers (FSWs) in 12 cities across Mexico. Our protocol will test a 'train-the-trainer' implementation model for transporting the Mujer Segura (Healthy Woman) intervention into community-based organizations (CBOs). We have partnered with Mexican Foundation for Family Planning (Mexfam), a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs). Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia); they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors' fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura intervention will be analyzed, and across CBOs
Increase in EPI vaccines coverage after implementation of intermittent preventive treatment of malaria in infant with Sulfadoxine -pyrimethamine in the district of Kolokani, Mali: Results from a cluster randomized control trial
Full Text Available Abstract Background Even though the efficacy of Intermittent Preventive Treatment in infants (IPTi with Sulfadoxine-Pyrimethamine (SP against clinical disease and the absence of its interaction with routine vaccines of the Expanded Immunization Programme (EPI have been established, there are still some concerns regarding the addition of IPTi, which may increase the work burden and disrupt the routine EPI services especially in Africa where the target immunization coverage remains to be met. However IPTi may also increase the adherence of the community to EPI services and improve EPI coverage, once the benefice of strategy is perceived. Methods To assess the impact of IPTi implementation on the coverage of EPI vaccines, 22 health areas of the district of Kolokani were randomized at a 1:1 ratio to either receive IPTi-SP or to serve as a control. The EPI vaccines coverage was assessed using cross-sectional surveys at baseline in November 2006 and after one year of IPTi pilot-implementation in December 2007. Results At baseline, the proportion of children of 9-23 months who were completely vaccinated (defined as children who received BGG, 3 doses of DTP/Polio, measles and yellow fever vaccines was 36.7% (95% CI 25.3% -48.0%. After one year of implementation of IPTi-SP using routine health services, the proportion of children completely vaccinated rose to 53.8% in the non intervention zone and 69.5% in the IPTi intervention zone (P The proportion of children in the target age groups who received IPTi with each of the 3 vaccinations DTP2, DTP3 and Measles, were 89.2% (95% CI 85.9%-92.0%, 91.0% (95% CI 87.6% -93.7% and 77.4% (95% CI 70.7%-83.2% respectively. The corresponding figures in non intervention zone were 2.3% (95% CI 0.9% -4.7%, 2.6% (95% CI 1.0% -5.6% and 1.7% (95% CI 0.4% - 4.9%. Conclusion This study shows that high coverage of the IPTi can be obtained when the strategy is implemented using routine health services and implementation results
Williams, Christopher M; Nathan, Nicole; Delaney, Tessa; Yoong, Sze Lin; Wiggers, John; Preece, Sarah; Lubans, Nicole; Sutherland, Rachel; Pinfold, Jessica; Smith, Kay; Small, Tameka; Reilly, Kathryn L; Butler, Peter; Wyse, Rebecca J; Wolfenden, Luke
A number of jurisdictions internationally have policies requiring schools to implement healthy canteens. However, many schools have not implemented such policies. One reason for this is that current support interventions cannot feasibly be delivered to large numbers of schools. A promising solution to support population-wide implementation of healthy canteen practices is audit and feedback. The effectiveness of this strategy has, however, not previously been assessed in school canteens. This study aims to assess the effectiveness and cost-effectiveness of an audit and feedback intervention, delivered by telephone and email, in increasing the number of school canteens that have menus complying with a government healthy-canteen policy. Seventy-two schools, across the Hunter New England Local Health District in New South Wales Australia, will be randomised to receive the multicomponent audit and feedback implementation intervention or usual support. The intervention will consist of between two and four canteen menu audits over 12 months. Each menu audit will be followed by two modes of feedback: a written feedback report and a verbal feedback/support via telephone. Primary outcomes, assessed by dieticians blind to group status and as recommended by the Fresh Tastes @ School policy, are: (1) the proportion of schools with a canteen menu containing foods or beverages restricted for sale, and; (2) the proportion of schools that have a menu which contains more than 50% of foods classified as healthy canteen items. Secondary outcomes are: the proportion of menu items in each category ('red', 'amber' and 'green'), canteen profitability and cost-effectiveness. Ethical approval has been obtained by from the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. The findings will be disseminated in usual forums, including peer-reviewed publication and conference presentations. ACTRN12613000543785. Published by the
Scaling-up an efficacious school-based physical activity intervention: Study protocol for the 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) cluster randomized controlled trial and scale-up implementation evaluation.
Lonsdale, Chris; Sanders, Taren; Cohen, Kristen E; Parker, Philip; Noetel, Michael; Hartwig, Tim; Vasconcellos, Diego; Kirwan, Morwenna; Morgan, Philip; Salmon, Jo; Moodie, Marj; McKay, Heather; Bennie, Andrew; Plotnikoff, Ron; Cinelli, Renata L; Greene, David; Peralta, Louisa R; Cliff, Dylan P; Kolt, Gregory S; Gore, Jennifer M; Gao, Lan; Lubans, David R
Despite the health benefits of regular physical activity, most children are insufficiently active. Schools are ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. The aim of this project is to modify, scale up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children's physical activity, fundamental movement skills and cardiorespiratory fitness. The 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) study will focus largely on online delivery to enhance translational capacity. The intervention will be implemented at school and teacher levels, and will include six components: (i) quality physical education and school sport, (ii) classroom movement breaks, (iii) physically active homework, (iv) active playgrounds, (v) community physical activity links and (vi) parent/caregiver engagement. Experienced physical education teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e., Kindergarten - Year 6). These activities will be supported by online learning and resources. Teachers will then deliver the iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools across New South Wales (NSW), Australia. A cluster randomized controlled trial (RCT), involving a representative sample of 20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions), will assess effectiveness and cost-effectiveness at 12 and 24 months. Students' cardiorespiratory fitness will be the primary outcome in this trial. Key secondary outcomes will include students' moderate-to-vigorous physical activity (via accelerometers), fundamental movement skill proficiency, enjoyment of physical education and
Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project: protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations
Full Text Available Abstract Background The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes. Methods/Design A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids, lifestyle (diet, physical activity, smoking, and alcohol, health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months
Simmons, Molly M; Gabrielian, Sonya; Byrne, Thomas; McCullough, Megan B; Smith, Jeffery L; Taylor, Thom J; O'Toole, Tom P; Kane, Vincent; Yakovchenko, Vera; McInnes, D Keith; Smelson, David A
across seven HPACT teams in three sites in the greater Los Angeles VA system. This is a cluster randomized trial. Integrating MISSION-Vet within HPACT has the potential to improve the health of thousands of veterans, but it is crucial to implement the intervention appropriately in order for it to succeed. The lessons learned in this protocol could assist with a larger roll-out of MISSION within HPACT. This protocol is registered with clinicaltrials.gov and was assigned the number NCT 02942979.
Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...
Full Text Available Social, political, and economic factors are directly and indirectly associated with the quality and distribution of health resources across Canada. First Nations (FN women in particular endure a disproportionate burden of ill health in contrast to the mainstream population. The complex relationship of health, social, and historical determinants are inherent to increased cervical cancer in FN women. This can be traced back to the colonial oppression suffered by Canadian FN and the social inequalities they have since faced. Screening - the Papinacolaou (Pap test – and early immunization have rendered cervical cancer almost entirely preventable but despite these options, FN women endure notably higher rates of diagnosis and mortality due to cervical cancer. The Anishinaabek Cervical Cancer Screening Study (ACCSS is a participatory action research project investigating the factors underlying the cervical cancer burden in FN women. ACCSS is a collaboration with 11 FN communities in Northwest Ontario, Canada and a multidisciplinary research team from across Canada with expertise in cancer biology, epidemiology, medical anthropology, public health, virology, women’s health, and pathology. Interviews with healthcare providers and community members revealed that prior to any formal data collection education must be offered. Consequently, an educational component was integrated into the existing quantitative design of the study: a two-armed, community-randomized trial that compares the uptake of two different cervical screening modalities. In ACCSS, the Research Team integrates community engagement and the flexible nature of participatory research with the scientific rigor of a randomized controlled trial. ACCSS findings will inform culturally appropriate screening strategies, aiming to reduce the disproportionate burden of cervical disease in concert with priorities of the partner FN communities.
Langberg, Joshua M; Dvorsky, Melissa R; Molitor, Stephen J; Bourchtein, Elizaveta; Eddy, Laura D; Smith, Zoe R; Oddo, Lauren E; Eadeh, Hana-May
To evaluate the effectiveness of 2 brief school-based interventions targeting the homework problems of adolescents with attention-deficit/hyperactivity disorder (ADHD)-the Homework, Organization, and Planning Skills (HOPS) intervention and the Completing Homework by Improving Efficiency and Focus (CHIEF) intervention, as implemented by school mental health providers during the school day. A secondary goal was to use moderator analyses to identify student characteristics that may differentially predict intervention response. Two-hundred and eighty middle school students with ADHD were randomized to the HOPS or CHIEF interventions or to waitlist, and parent and teacher ratings were collected pre, post, and at a 6-month follow-up. Both interventions were implemented with fidelity by school mental health providers. Participants were pulled from elective periods and sessions averaged less than 20 min. Participants in HOPS and CHIEF demonstrated significantly greater improvements in comparison with waitlist on parent ratings of homework problems and organizational skills and effect sizes were large. HOPS participants also demonstrated moderate effect size improvements on materials management and organized action behaviors according to teachers. HOPS participants made significantly greater improvements in parent- and teacher-rated use of organized actions in comparison with CHIEF, but not on measures of homework problems. Moderation analyses revealed that participants with more severe psychopathology and behavioral dysregulation did significantly better with the HOPS intervention as compared to the CHIEF intervention. Brief school-based interventions implemented by school providers can be effective. This type of service delivery model may facilitate overcoming the oft cited research-to-practice gap. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
Strategies for the introduction and implementation of a guideline for the treatment of type 2 diabetics by general practitioners (GPs of the Lazio region of Italy (IMPLEMEG study: Protocol for a cluster randomised controlled trial [ISRCTN80116232
Full Text Available Abstract Background Despite broad agreement on the necessity to improve quality of diabetic care through implementation of clinical guidelines, in Italy many people with diabetes still lack adequate care in general practice. In addition there is little evidence to support the choice of implementation strategies, especially in the Lazio region (central Italy, where comparative studies among general practitioners (GPs are uncommon. The primary objective of the study is to assess the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes mellitus (DM among GPs of the Lazio region. Methods/Design Three-arm cluster-randomised trial (C-RCT. 252 GPs were randomised either to arm 1 (comprising a training module and administration of the guideline, or to arm 2 (administration of guideline without training, or to arm 3 (control arm, continuing current practice. Arm 1 participants attended a two-day course with CME credits. Data collection will be performed using current information systems. Patients' health data was also collected to describe diabetic populations cared for by GP participants. Process outcomes will be measured at the patient level and at the cluster level one year after the intervention. We will assess GPs' adherence to guideline recommendations for diabetes management relative to: 1 pharmacological management of diabetes; 2 pharmacological management of cardiovascular risk factors (hypertension and dislypidaemia; 3 measurement of glycosilated haemoglobin as the principal indicator of glycaemic control; 4 micro- and macrovascular complications assessment tests. Outcomes will be expressed as proportions of patients cared for by GPs who will have prescriptions of drugs, requests for tests and for outpatient appointment visits. To estimate the efficiency of resource use associated with the intervention a cost-effectiveness analysis will be carried out
Applying normalization process theory to understand implementation of a family violence screening and care model in maternal and child health nursing practice: a mixed method process evaluation of a randomised controlled trial.
Hooker, Leesa; Small, Rhonda; Humphreys, Cathy; Hegarty, Kelsey; Taft, Angela
In Victoria, Australia, Maternal and Child Health (MCH) services deliver primary health care to families with children 0-6 years, focusing on health promotion, parenting support and early intervention. Family violence (FV) has been identified as a major public health concern, with increased prevalence in the child-bearing years. Victorian Government policy recommends routine FV screening of all women attending MCH services. Using Normalization Process Theory (NPT), we aimed to understand the barriers and facilitators of implementing an enhanced screening model into MCH nurse clinical practice. NPT informed the process evaluation of a pragmatic, cluster randomised controlled trial in eight MCH nurse teams in metropolitan Melbourne, Victoria, Australia. Using mixed methods (surveys and interviews), we explored the views of MCH nurses, MCH nurse team leaders, FV liaison workers and FV managers on implementation of the model. Quantitative data were analysed by comparing proportionate group differences and change within trial arm over time between interim and impact nurse surveys. Qualitative data were inductively coded, thematically analysed and mapped to NPT constructs (coherence, cognitive participation, collective action and reflexive monitoring) to enhance our understanding of the outcome evaluation. MCH nurse participation rates for interim and impact surveys were 79% (127/160) and 71% (114/160), respectively. Twenty-three key stakeholder interviews were completed. FV screening work was meaningful and valued by participants; however, the implementation coincided with a significant (government directed) change in clinical practice which impacted on full engagement with the model (coherence and cognitive participation). The use of MCH nurse-designed FV screening/management tools in focussed women's health consultations and links with FV services enhanced the participants' work (collective action). Monitoring of FV work (reflexive monitoring) was limited. The use of
Diagnosing syncope in clinical practice. Implementation of a simplified diagnostic algorithm in a multicentre prospective trial - the OESIL 2 study (Osservatorio Epidemiologico della Sincope nel Lazio)
Ammirati, F; Colivicchi, F; Santini, M
In some patients with syncope health care is inappropriate and ineffective. In a recent observational investigation in community hospitals of the Lazio region of Italy (the OESIL study) 54.4% of patients admitted with syncope from the emergency room were discharged without a conclusive diagnosis. A simplified two-step diagnostic algorithm was developed and prospectively implemented in nine community hospitals of the Lazio region of Italy in order to improve the diagnostic performance of clinicians, thereby reducing the number of undiagnosed patients. The study population included 195 consecutive patients (85 males and 110 females, mean age 62.5 years, range 13-95 years) presenting with a syncopal spell at the emergency room of one of the nine participating hospitals in a 2-month period. The systematic implementation of the proposed diagnostic algorithm resulted in a striking reduction of undiagnosed cases. The percentage of patients discharged without a conclusive diagnosis decreased from 54.4% to 17.5%. Neurally mediated syncope was diagnosed in 35.2% of cases, cardiac syncope in 20.9% and neurological syncope in 13.8%. The use of specific, simplified diagnostic guidelines and algorithms results in an improvement of overall clinical performance. However, the development of such decision-making aids should carefully consider the local circumstances of daily clinical practice. Copyright 2000 The European Society of Cardiology.
Oddone, Eugene Z; Damschroder, Laura J; Gierisch, Jennifer; Olsen, Maren; Fagerlin, Angela; Sanders, Linda; Sparks, Jordan; Turner, Marsha; May, Carrie; McCant, Felicia; Curry, David; White-Clark, Courtney; Juntilla, Karen
A large proportion of deaths and many illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. Health risk assessments (HRAs) are widely available online but have not been consistently used in healthcare systems to activate patients to participate in prevention programs aimed at improving lifestyle behaviors. The goal of this study is to test whether adding telephone-based coaching to use of a comprehensive HRA increases at-risk patients' activation and enrollment into a prevention program compared to HRA use alone. Participants were randomized to either complete an HRA alone or in conjunction with a telephone coaching intervention. To be eligible Veterans had to have at least one modifiable risk factor (current smoker, overweight/obese, or physically inactive). The primary outcome is enrollment and participation in a prevention program by 6months. Secondary outcomes include change in a Patient Activation Measure and Framingham Risk Score. This study is the first to test a web-based health risk assessment coupled with a health coaching intervention within a large healthcare system. Results from this study will help the Veterans Health Administration (VHA) implement its national plan to include comprehensive health risk assessments as a tool to engage Veterans in prevention. The results will also inform health systems outside VHA who seek to implement Medicare's advisement that health risk assessment become a mandatory component of care under the Affordable Care Act. © 2016.
Hong, Shaohua; Yu, Ping
To explore and compare the effectiveness of two styles of case-based learning methods, unfolding nursing case and usual nursing case, implemented in lectures for developing nursing students' critical thinking ability. 122 undergraduate nursing students in four classes were taught the subject of medical nursing for one year. Two classes were randomly assigned as the experimental group and the other two the control group. The experimental group received the lectures presenting unfolding nursing cases and the control group was taught the usual cases. Nineteen case-based lectures were provided in 8 months in two semesters to each group. The two groups started with a similar level of critical thinking ability as tested by the instrument of Critical Thinking Disposition Inventory-Chinese version (CTDI-CV). After receiving 19 case-based learning lectures for 8 months, both groups of students significantly improved their critical thinking ability. The improvement in the experimental group was significantly higher than that in the control group (with the average total score of 303.77±15.24 vs. 288.34±13.94, pnursing cases appear to be significantly more effective than the usual nursing cases in developing undergraduate nursing students' critical thinking ability in the subject of medical nursing. Further research can implement the unfolding nursing cases in other nursing subjects. Copyright © 2016 Elsevier Ltd. All rights reserved.
Association of Implementation of Practice Standards for Electrocardiographic Monitoring With Nurses' Knowledge, Quality of Care, and Patient Outcomes: Findings From the Practical Use of the Latest Standards of Electrocardiography (PULSE) Trial.
Funk, Marjorie; Fennie, Kristopher P; Stephens, Kimberly E; May, Jeanine L; Winkler, Catherine G; Drew, Barbara J
Although continuous electrocardiographic (ECG) monitoring is ubiquitous in hospitals, monitoring practices are inconsistent. We evaluated implementation of American Heart Association practice standards for ECG monitoring on nurses' knowledge, quality of care, and patient outcomes. The PULSE (Practical Use of the Latest Standards of Electrocardiography) Trial was a 6-year multisite randomized clinical trial with crossover that took place in 65 cardiac units in 17 hospitals. We measured outcomes at baseline, time 2 after group 1 hospitals received the intervention, and time 3 after group 2 hospitals received the intervention. Measurement periods were 15 months apart. The 2-part intervention consisted of an online ECG monitoring education program and strategies to implement and sustain change in practice. Nurses' knowledge (N=3013 nurses) was measured by a validated 20-item online test, quality of care related to ECG monitoring (N=4587 patients) by on-site observation, and patient outcomes (mortality, in-hospital myocardial infarction, and not surviving a cardiac arrest; N=95 884 hospital admissions) by review of administrative, laboratory, and medical record data. Nurses' knowledge improved significantly immediately after the intervention in both groups but was not sustained 15 months later. For most measures of quality of care (accurate electrode placement, accurate rhythm interpretation, appropriate monitoring, and ST-segment monitoring when indicated), the intervention was associated with significant improvement, which was sustained 15 months later. Of the 3 patient outcomes, only in-hospital myocardial infarction declined significantly after the intervention and was sustained. Online ECG monitoring education and strategies to change practice can lead to improved nurses' knowledge, quality of care, and patient outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01269736. © 2017 American Heart Association, Inc.
Nikpour, Fatemeh; Vatandoost, Hassan; Hanafi-Bojd, Ahmad Ali; Raeisi, Ahmad; Ranjbar, Mansour; Enayati, Ahmad Ali; Abai, Mohammad Reza; Shayeghi, Mansoreh; Mojahedi, Abdol Rasoul; Pourreza, Abolghasem
The aim of this study was to evaluate different concentrations of deltamethrin combined with formulated piperonyl butoxide (PBO) synergist on various surfaces against the wild strain of Anopheles stephensi , the main malaria vector in Southern Iran under semi-field condition. Four concentrations of deltamethrin WG 25% (Tagros) and PBO 800EC-UV (Endura) were prepared and sprayed on the pre-designed surfaces in accordance with WHO alliance line of the IRS Micronair®. The WHO's recommended bioassay kit and method was used during this study. Comparing the mortality rate of mosquitoes, the results showed a significant difference between months after treatment of IRS (Indoor Residual Spraying) (P 0.05).Statistical test revealed a significance difference between mortality rate of mosquitoes in exposing to concentrations of 1 and 4 (P< 0.05) which demonstrated effect of synergizing PBO on mortality rate. This research as the first semi-field trial on deltamethrin added to different concentrations of formulated PBO for IRS, indicates that deltamethrin+10X PBO is more effective than other concentrations. Therefore, using synergists can be suggested as a new tool for prevention of pyrethriod resistance, although more studies are recommended.
Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars
training of mastoidectomy. Methods Eighteen novice medical students received 1 h of self-directed virtual reality simulation training of the mastoidectomy procedure randomized for standard instructions (control) or cognitive load theory-based instructions with a worked example followed by a problem......: the intervention group had a significantly lower final-product score than the control group (13.0 vs. 15.4, p instruction using worked examples followed by a problem completion exercise did not reduce the cognitive load or improve the performance of the following procedures in novices......Background Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation...
Amble, Ingunn; Gude, Tore; Stubdal, Sven; Andersen, Bror Just; Wampold, Bruce E
It has been claimed that the monitoring of ongoing psychotherapy is of crucial importance for improving the quality of mental health care. This study investigated the effect of using the Norwegian version of the patient feedback system OQ-Analyst using the Outcome Questionnaire-45.2. Patients from six psychiatric clinics in Southern Norway (N = 259) were randomized to feedback (FB) or no feedback (NFB). The main effect of feedback was statistical significant (p = .027), corroborating the hypothesis that feedback would improve the quality of services, although the size of the effect was small to moderate (d = 0.32). The benefits of feedback have to be considered against the costs of implementation.
Hay, Jennifer L; Berwick, Marianne; Zielaskowski, Kate; White, Kirsten Am; Rodríguez, Vivian M; Robers, Erika; Guest, Dolores D; Sussman, Andrew; Talamantes, Yvonne; Schwartz, Matthew R; Greb, Jennie; Bigney, Jessica; Kaphingst, Kimberly A; Hunley, Keith; Buller, David B
Limited translational genomic research currently exists to guide the availability, comprehension, and appropriate use of personalized genomics in diverse general population subgroups. Melanoma skin cancers are preventable, curable, common in the general population, and disproportionately increasing in Hispanics. Variants in the melanocortin-1 receptor (MC1R) gene are present in approximately 50% of the population, are major factors in determining sun sensitivity, and confer a 2-to-3-fold increase in melanoma risk in the general population, even in populations with darker skin. Therefore, feedback regarding MC1R risk status may raise risk awareness and protective behavior in the general population. We are conducting a randomized controlled trial examining Internet presentation of the risks and benefits of personalized genomic testing for MC1R gene variants that are associated with increased melanoma risk. We will enroll a total of 885 participants (462 participants are currently enrolled), who will be randomized 6:1 to personalized genomic testing for melanoma risk versus waiting list control. Control participants will be offered testing after outcome assessments. Participants will be balanced across self-reported Hispanic versus non-Hispanic ethnicity (n=750 in personalized genomic testing for melanoma risk arm; n=135 in control arm), and will be recruited from a general population cohort in Albuquerque, New Mexico, which is subject to year-round sun exposure. Baseline surveys will be completed in-person with study staff and follow-up measures will be completed via telephone. Aim 1 of the trial will examine the personal utility of personalized genomic testing for melanoma risk in terms of short-term (3-month) sun protection and skin screening behaviors, family and physician communication, and melanoma threat and control beliefs (ie, putative mediators of behavior change). We will also examine potential unintended consequences of testing among those who receive
Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.
be difficult to plan and conduct. It is sometimes assumed that pilot implementations are less complicated and risky than ordinary implementations. Pilot implementations are, however, neither prototyping nor small-scale versions of full-scale implementations; they are fundamentally different and have their own...
An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).
Smith, Justin D; Berkel, Cady; Jordan, Neil; Atkins, David C; Narayanan, Shrikanth S; Gallo, Carlos; Grimm, Kevin J; Dishion, Thomas J; Mauricio, Anne M; Rudo-Stern, Jenna; Meachum, Mariah K; Winslow, Emily; Bruening, Meg M
Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations. This (type II) hybrid effectiveness-implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children's hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption
Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters.
Del Cura-González, Isabel; López-Rodríguez, Juan A; Sanz-Cuesta, Teresa; Rodríguez-Barrientos, Ricardo; Martín-Fernández, Jesús; Ariza-Cardiel, Gloria; Polentinos-Castro, Elena; Román-Crespo, Begoña; Escortell-Mayor, Esperanza; Rico-Blázquez, Milagros; Hernández-Santiago, Virginia; Azcoaga-Lorenzo, Amaya; Ojeda-Ruiz, Elena; González-González, Ana I; Ávila-Tomas, José F; Barrio-Cortés, Jaime; Molero-García, José M; Ferrer-Peña, Raul; Tello-Bernabé, María Eugenia; Trujillo-Martín, Mar
Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6 months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit
Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations.
Jansink, Renate; Braspenning, Jozé; van der Weijden, Trudy; Niessen, Louis; Elwyn, Glyn; Grol, Richard
The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes. A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm) starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids), lifestyle (diet, physical activity, smoking, and alcohol), health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months. Applying motivational interviewing for patients with
Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial
Luitjes Susanne HE
Full Text Available Abstract Background Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed. Methods/Design The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques.
The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial: A cluster randomised trial in primary care.
Christian D Mallen
Full Text Available This study aimed to evaluate whether prompting general practitioners (GPs to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA improves pain outcomes.We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]. The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm. Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices. Follow-up rates were similar in both arms, totalling 1,093 (77.4% at 3 mo, 1,064 (75.4% at 6 mo, and 1,017 (72.0% at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59. Secondary
Price, Joseph M; Roesch, Scott; Walsh, Natalia E; Landsverk, John
Children in foster care are at risk for externalizing behavior problems, which can in turn increase the risk of changes in foster care placement. The KEEP (Keeping Foster Parents Trained and Supported) foster parent training intervention was designed to equip foster parents with strategies for managing externalizing behavior problems. The primary goals of this investigation were to (a) examine the effectiveness of the KEEP intervention in reducing child behavior problems, as delivered by a community agency; (b) determine if the effects of the KEEP intervention generalize to more than one child in the same home; and (c) examine the effectiveness of the KEEP intervention in reducing parental stress associated with child behavior problems. The data from 335 foster and kinship families with children between the ages of 5 and 12 years were analyzed to address these objectives. Families were randomly assigned to the intervention or control condition. The results indicated that the KEEP intervention was effective in reducing child behavior problems when delivered by a community agency. These results expanded prior research on the KEEP intervention, revealing that the intervention was effective in reducing the behavior problems of more than one child in the same household and in reducing parental stress levels associated with the behavioral issues of the focal child. Thus, the KEEP intervention model holds promise for reducing the behavior problems of children in foster care and reducing stress levels of foster and kinship caregivers as it is disseminated and implemented within similar child welfare settings.
Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars; Cayé-Thomasen, Per; Sørensen, Mads Sølvsten
Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation training of mastoidectomy. Eighteen novice medical students received 1 h of self-directed virtual reality simulation training of the mastoidectomy procedure randomized for standard instructions (control) or cognitive load theory-based instructions with a worked example followed by a problem completion exercise (intervention). Participants then completed two post-training virtual procedures for assessment and comparison. Cognitive load during the post-training procedures was estimated by reaction time testing on an integrated secondary task. Final-product analysis by two blinded expert raters was used to assess the virtual mastoidectomy performances. Participants in the intervention group had a significantly increased cognitive load during the post-training procedures compared with the control group (52 vs. 41 %, p = 0.02). This was also reflected in the final-product performance: the intervention group had a significantly lower final-product score than the control group (13.0 vs. 15.4, p virtual reality surgical simulation training of novices.
Wang, Rongmei; Shi, Nianke; Bai, Jinbing; Zheng, Yaguang; Zhao, Yue
The present study was designed to implement an interprofessional simulation-based education program for nursing students and evaluate the influence of this program on nursing students' attitudes toward interprofessional education and knowledge about operating room nursing. Nursing students were randomly assigned to either the interprofessional simulation-based education or traditional course group. A before-and-after study of nursing students' attitudes toward the program was conducted using the Readiness for Interprofessional Learning Scale. Responses to an open-ended question were categorized using thematic content analysis. Nursing students' knowledge about operating room nursing was measured. Nursing students from the interprofessional simulation-based education group showed statistically different responses to four of the nineteen questions in the Readiness for Interprofessional Learning Scale, reflecting a more positive attitude toward interprofessional learning. This was also supported by thematic content analysis of the open-ended responses. Furthermore, nursing students in the simulation-based education group had a significant improvement in knowledge about operating room nursing. The integrated course with interprofessional education and simulation provided a positive impact on undergraduate nursing students' perceptions toward interprofessional learning and knowledge about operating room nursing. Our study demonstrated that this course may be a valuable elective option for undergraduate nursing students in operating room nursing education.
Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ...
Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...
Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...
Full Text Available ... study results. Clinical Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...
Balas, Michele C.; Burke, William J.; Gannon, David; Cohen, Marlene Z.; Colburn, Lois; Bevil, Catherine; Franz, Doug; Olsen, Keith M.; Ely, E. Wesley; Vasilevskis, Eduard E.
Objective The Awakening and Breathing Coordination, Delirium monitoring/management and Early exercise/mobility (ABCDE) bundle is an evidence-based, interprofessional, multicomponent strategy for minimizing sedative exposure, reducing duration of mechanical ventilation and managing intensive care unit (ICU) acquired delirium and weakness. The purpose of this study was to identify facilitators and barriers to ABCDE bundle adoption and to evaluate the extent to which bundle implementation was effective, sustainable, and conducive to dissemination. Design Prospective, before-after, mixed-methods study. Setting Five adult ICUs, 1 step-down unit, and a special care unit located in a 624 bed, academic medical center Subjects Interprofessional ICU team members at participating institution. Interventions and Measurements In collaboration with the participating institution, we developed, implemented, and refined an ABCDE bundle policy. Over the course of an 18 month period, all ICU team members were offered the opportunity to participate in numerous, multimodal educational efforts. Three focus group sessions, 3 online surveys, and 1 educational evaluation were administered in an attempt to identify facilitators and barriers to bundle adoption. Main Results Factors believed to facilitate bundle implementation included: 1) the performance of daily, interdisciplinary, rounds, 2) engagement of key implementation leaders, 3) sustained and diverse educational efforts, and 4) the bundle's quality and strength. Barriers identified included: 1) intervention related issues (e.g. timing of trials, fear of adverse events), 2) communication and care coordination challenges, 3) knowledge deficits, 4) workload concerns, and 5) documentation burden. Despite these challenges, participants believed implementation ultimately benefited patients, improved interdisciplinary communication, and empowered nurses and other ICU team members. Conclusions In this study of the implementation of the ABCDE
A randomized controlled trial of a brief online intervention to reduce alcohol consumption in new university students: Combining self-affirmation, theory of planned behaviour messages, and implementation intentions.
Norman, Paul; Cameron, David; Epton, Tracy; Webb, Thomas L; Harris, Peter R; Millings, Abigail; Sheeran, Paschal
Excessive alcohol consumption increases when students enter university. This study tests whether combining (1) messages that target key beliefs from the theory of planned behaviour (TPB) that underlie binge drinking, (2) a self-affirmation manipulation to reduce defensive processing, and (3) implementation intentions (if-then plans to avoid binge drinking) reduces alcohol consumption in the first 6 months at university. A 2 (self-affirmation) × 2 (TPB messages) × 2 (implementation intention) between-participants randomized controlled trial with 6-month follow-up. Before starting university, students (N = 2,951) completed measures of alcohol consumption and were randomly assigned to condition in a full-factorial design. TPB cognitions about binge drinking were assessed immediately post-intervention (n = 2,682). Alcohol consumption was assessed after 1 week (n = 1,885), 1 month (n = 1,389), and 6 months (n = 892) at university. TPB cognitions were assessed again at 1 and 6 months. Participants who received the TPB messages had significantly less favourable cognitions about binge drinking (except perceived control), consumed fewer units of alcohol, engaged in binge drinking less frequently, and had less harmful patterns of alcohol consumption during their first 6 months at university. The other main effects were non-significant. The findings support the use of TPB-based interventions to reduce students' alcohol consumption, but question the use of self-affirmation and implementation intentions before starting university when the messages may not represent a threat to self-identity and when students may have limited knowledge and experience of the pressures to drink alcohol at university. Statement of contribution What is already known on this subject? Alcohol consumption increases when young people enter university. Significant life transitions represent potential teachable moments to change behaviour. Interventions with a strong theoretical
Implementing a patient education intervention about Methicillin-resistant Staphylococcus aureus prevention and effect on knowledge and behavior in veterans with spinal cord injuries and disorders: a pilot randomized controlled trial.
Evans, Charlesnika T; Hill, Jennifer N; Guihan, Marylou; Chin, Amy; Goldstein, Barry; Richardson, Michael S A; Anderson, Vicki; Risa, Kathleen; Kellie, Susan; Cameron, Kenzie A
To assess the feasibility and effect of a nurse-administered patient educational intervention about Methicillin-resistant Staphylococcus aureus (MRSA) prevention on knowledge and behavior of Veterans with spinal cord injuries and disorders (SCI/D). Blinded, block-randomized controlled pilot trial. Two Department of Veterans Affairs (VA) SCI Centers. Veterans were recruited March-September 2010 through referral by a healthcare provider from inpatient, outpatient, and residential care settings. Thirty participants were randomized to the nurse-administered intervention and 31 to the usual care group. The intervention included a brochure and tools to assist nurses in conducting the education. Pre- and post-intervention measurement of knowledge and behaviors related to MRSA and prevention strategies and feasibility measures related to implementation. Participants were primarily male (95.1%), white (63.9%), with tetraplegia (63.9%) and mean age and duration of injury of 64.3 and 20.5 years, respectively. The intervention groups mean knowledge score significantly increased between pre- and post-test (mean change score = 1.70, 95% confidence interval, CI 0.25-3.15) while the usual care groups score did not significantly change (mean change score = 1.45, 95% CI -0.08-2.98). However, the mean knowledge change between intervention and usual care groups was not significantly different (P = 0.81). Overall behavior scores did not significantly differ between treatment groups; however, the intervention group was more likely to report intentions to clean hands (90.0% vs. 64.5%, P = 0.03) and asking providers about MRSA status (46.7% vs. 16.1%, P = 0.01). Nurse educators reported that the quality of the intervention was high and could be implemented in clinical care. A targeted educational strategy is feasible to implement in SCI/D clinical practices and may improve some participants' knowledge about MRSA and increase intentions to improve hand hygiene and engagement with providers
Full Text Available ... clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ...
Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...
Newhouse, Robin; Bobay, Kathleen; Dykes, Patricia C; Stevens, Kathleen R; Titler, Marita
Putting evidence into practice at the point of care delivery requires an understanding of implementation strategies that work, in what context and how. To identify methodological issues in implementation science using 4 studies as cases and make recommendations for further methods development. Four cases are presented and methodological issues identified. For each issue raised, evidence on the state of the science is described. Issues in implementation science identified include diverse conceptual frameworks, potential weaknesses in pragmatic study designs, and the paucity of standard concepts and measurement. Recommendations to advance methods in implementation include developing a core set of implementation concepts and metrics, generating standards for implementation methods including pragmatic trials, mixed methods designs, complex interventions and measurement, and endorsing reporting standards for implementation studies.
Hegland, Troels Jacob; Raakjær, Jesper
ABSTRACT: Denmark is among the more loyal European Union (EU) member states when it comes to national implementation of the Common Fisheries Policy (CFP). However, even in Denmark several mechanisms contribute to sub-optimal implementation of the CFP. Looking at implementation problems for a rela......ABSTRACT: Denmark is among the more loyal European Union (EU) member states when it comes to national implementation of the Common Fisheries Policy (CFP). However, even in Denmark several mechanisms contribute to sub-optimal implementation of the CFP. Looking at implementation problems...... for a relatively loyal member state, this chapter sheds critical light on national implementation of the CFP in the EU as a whole. The chapter initially provides a description of the institutional set-up for fisheries policy-making and implementation in Denmark, including a short historical account....../networks and prevailing discourses. The inability of the EU to ensure that the conservation goals agreed at the EU level are loyally pursued during national implementation is one of the reasons why the EU has been struggling to keep fishing mortality rates at a sustainable level....
Full Text Available Os programas de gerenciamento da qualidade total (TQM - Total Quality Management têm produzido uma significativa lista de benefícios e continuam acumulando adeptos à sua filosofia. Muitos dos requisitos básicos para uma implementação bem sucedida do TQM estão relacionados a mudanças no trabalho das pessoas na empresa, incluindo: a necessidade de trabalhar em equipe e o incentivo ao gerenciamento participativo, o estimulo à criatividade e ao espírito inovador do empregado, uma apropriada forma de recompensa, a criação de um clima organizacional com comprometimento em todos os níveis, feedback do cliente, um ambiente propício a negociação entre empregado e gerente, o incentivo ao envolvimento e energização do empregado para melhoria das comunicações e agilização da tomada de decisões. Qual é o impacto destes requisitos nas intenções do empregado mudar de empresa? O principal propósito deste estudo foi testar empiricamente várias hipóteses que comparam as intenções do funcionário mudar de empresa, e seus antecedentes, nos momentos anterior e posterior à implantação de um programa de TQM. Para analisar essa diferença, utilizou-se do estudo de 113 empregados de uma empresa, anteriormente a implementação do TQM, e de um conjunto menor de 73 empregados desta mesma empresa depois da implementação. Os resultados indicaram uma significativa melhora na delimitação de funções, na satisfação com o trabalho, no envolvimento com o trabalho, no compromisso com a organização e nas intenções de mudança de empresa do empregado; mas não notou-se uma mudança significativa nos conflitos entre funções, nas características das tarefas e na satisfação com a carreira profissional.Total Quality Management programs have produced an impressive list of claimed benefits and continue to accumulate converts to this philosophy. Many of the basic requirements for successful TQM implementation deal with changes in company
Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...
Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...
Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...
Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...
Full Text Available ... Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found that ... ways, taking part in a clinical trial is different from having regular care from your own doctor. ...
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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...
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Full Text Available ... to the strategies and treatments that work best. How Clinical Trials Work If you take part in ... a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led ...
Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...
Rensink, Arend; Gorrieri, Roberto
We investigate criteria to relate specifications and implementations belonging to conceptually different levels of abstraction. For this purpose, we introduce the generic concept of a vertical implementation relation, which is a family of binary relations indexed by a refinement function that maps
This paper touches on three aspects of the relationship between intelligence and treaty implementation, a two-way association. First the author discusses the role of intelligence as a basis for compliance monitoring and treaty verification. Second the authors discusses payoffs of intelligence gathering and the intelligence process of treaty implementation, in particular on-site inspection. Third, the author goes in another direction and discusses some of the tensions between the intelligence gathering and treaty-implementation processes, especially with regard to extensive use of on-site inspection, such as we are likely to see in monitoring compliance of future arms control treaties
Manikas, Maria Ie
This PhD dissertation engages in the study of pilot (system) implementation. In the field of information systems, pilot implementations are commissioned as a way to learn from real use of a pilot system with real data, by real users during an information systems development (ISD) project and before...... the final system is implemented. Among others, their use is argued to investigate the fit between the technical design and the organisational use. But what is a pilot implementation really? In this dissertation, I set out to address this conceptual question. I initially investigate this question....... The analysis is conducted by means of a theoretical framework that centres on the concept infrastructure. With infrastructure I understand the relation between organised practice and the information systems supporting this practice. Thus, infrastructure is not a thing but a relational and situated concept...
Full Text Available ... list of NHLBI-sponsored clinical trials. NIH Clinical Research Studies Search for studies conducted within other Institutes at the NIH, including trials performed on our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...
Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...
Heering Holt, Ditte; Rod, Morten Hulvej; Waldorff, Susanne Boch
process of intersectoral policymaking in order to gain a better understanding of the challenges posed by implementation. To help conceptualize the process, we apply the theoretical perspective of organizational neo-institutionalism, in particular the concepts of rationalized myth and decoupling. Methods......: On the basis of an explorative study among ten Danish municipalities, we conducted an ethnographic study of the development of a municipal-wide implementation strategy for the intersectoral health policy of a medium-sized municipality. The main data sources consist of ethnographic field notes from participant...... in health. However, despite growing support for intersectoral policymaking, implementation remains a challenge. Critics argue that public health has remained naïve about the policy process and a better understanding is needed. Based on ethnographic data, this paper conducts an in-depth analysis of a local...
Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.
BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health
Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.
Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health
Intervención neurorreflejoterápica para el tratamiento de las enfermedades mecánicas del raquis: Resultados de una experiencia piloto Implementation of neuroreflexotherapy in the treatment of back pain: Results of a pilot trial
favorable y consistente con la observada en los ensayos clínicos previos. Conclusiones: La sistemática de implantación aplicada permite incorporar la intervención NRT a la práctica clínica sistemática del Sistema Nacional de Salud en las condiciones de aplicación en las que ha sido evaluada en estudios previos. El protocolo de derivación definido genera una alta tasa de remisión adecuada, un elevado grado de satisfacción entre pacientes y médicos, y unos resultados clínicos consistentes con la efectividad y seguridad previamente demostrada por esta tecnología.Background: Previous clinical trials have demonstrated the efficacy, safety, effectiveness and efficiency of neuroreflexotherapy (NRT in the treatment of subacute and chronic non-specific low back pain. The goal of this study was to describe the implementation of this method into the Spanish National Health System, to assess the viability of the referral protocol, and to obtain the data required for planning the widespread use of this technology. Method: A referral protocol was established and explained in a single clinical session in 18 health centers in Majorca (Spain. During this session, handouts of the referral protocol and a telephone number for questions were also given. After the session, the centers' physicians were authorized to refer their patients to a unit certified for NRT. Demand for this therapy, the applicability of the referral protocol, the appropriateness of referrals, and patient and physician satisfaction were quantified over a four-month period. Data were also collected on patients' clinical outcomes and on adverse effects of the treatment. Results: Of the 208 physicians, 43 referred 97 patients. The mean rate of referral per 10,000 persons affiliated with each health center was 1.07 patients per month. The rate of appropriate referral was 91.8%, with no physician having to call for assistance. Most of the referred patients had chronic, intense pain, with a poor prognosis and
Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...
Full Text Available ... doing screening tests, such as mammography; and compare two or more screening tests to see which test ... and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found ...
Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...
Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...
Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...
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Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...
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Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...
Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...
Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...
Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ...
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Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...
Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...
Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...
Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...
Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...
Full Text Available ... providers don't always cover all patient care costs for clinical trials. If you're thinking about ... clinical trial, find out ahead of time about costs and coverage. You should learn about the risks ...
Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...
Full Text Available ... In the past, clinical trial participants often were White men. Researchers assumed that trial results were valid ... in different ethnic groups sometimes respond differently than White men to the same medical approach. As a ...
Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...
Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...
Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...
Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...
Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...
Full Text Available ... Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants & ... or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and ...
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...
Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...
Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...
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Full Text Available ... Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ... that does the study uses the same protocol. Key information in a protocol includes how many patients ...
Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...
Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...
Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...
Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...
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Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...
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Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...
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Full Text Available I will give an overview of some technologies that enable pseudonymity - allowing individuals to reveal or prove information about themselves to others without revealing their full identity. I will describe some functionalities relating to pseudonymity that can be implemented, and some that cannot. My intention is to present enough of the mathematics that underlies technology for pseudonymity to show that it is indeed possible to implement some functionalities that at first glance may appear impossible. In particular, I will show that several of the intended functions of the UK national ID could be provided in a pseudonymous fashion, allowing greater privacy. I will also outline some technology developed at HP Labs which ensures that users’ personal data is released only to software that has been checked to conform to their preferred privacy policies.
Hyman, David M.; Taylor, Barry S.; Baselga, José
Early successes in identifying and targeting individual oncogenic drivers, together with the increasing feasibility of sequencing tumor genomes, have brought forth the promise of genome-driven oncology care. As we expand the breadth and depth of genomic analyses, the biological and clinical complexity of its implementation will be unparalleled. Challenges include target credentialing and validation, implementing drug combinations, clinical trial designs, targeting tumor heterogeneity, and deploying technologies beyond DNA sequencing, among others. We review how contemporary approaches are tackling these challenges and will ultimately serve as an engine for biological discovery and increase our insight into cancer and its treatment. PMID:28187282
Sheila M. Bird
Full Text Available The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released.
Teodorescu, R.; Blaabjerg, F.; Asiminoaei, L.; Timbus, A.V.
This report is part of the research contract PSO-Eltra 2524/2003 where Aalborg University did cooperated with PowerLynx A/S for the development of the ENS function for the PowerLynx PV inverters. The work started 01.01.03 and ended 29.02.04 and involved Frede Blaabjerg, Remus Teodorescu, Lucian Asiminoaie and Adrian Timbus from Aalborg University and Uffe Borup from PowerLynx A/S. The objective was to make the PowerLynx PV inverters compatible with the german ENS standard which mainly consist in the requirement to disconnect from the grid in max. 2 seconds if the grid impedance is changed with 0.5 ohms resistive. During 01.07 31.08 2003, an algorithm based on the injection of a voltage of 75 Hz and the on-line measurement the 75Hz component from the grid current and voltage using simplified DFT was developed by Uffe Borup, Remus Teodorescu and Lucian Asiminoaie. The algorithm is described in detail in the report 'ENS design' enclosed in Appendix A and in the two published paper (final paper for APEC'04 and approved digest for PESC'04). Then the algorithm was finally implemented and the experimental tests carried out proved to be satisfactory as shown in chapter 2 'ENS implementation'. Very few missed tests were recorded on very high inductive grid (0.6 + 1.1i) when the reactance is higher than the resistance. In the period 03.02.04 13.02.04 some attempts was done in order to improve the detection by compensating the delay in the voltage measurement but no improvement was noticed. Thus, these last minute changes was not included in the final version of the software. Finally, the detection mechanism of another PV running in parallel that injects t5Hz for ENS grid measurements has been done. The code for parallel ENS is also enclosed. (au)
Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte
controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges......-inferiority or equivalence designs are recommended when comparing viable alternatives and the use of crossover designs, cluster randomisation or stepped wedge trial designs are feasible when studying implementations across several settings. Outcome measures may include variables related to learners, teachers, educational...... administration, quality of care, patient outcomes and cost. CONCLUSIONS: Practical trials in medical education may contribute to bridge the gap between education theory and practice and aid decision makers in making evidence-based choices and priorities. Conducting practical trials is not without challenges...
Full Text Available ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists of a group of research and study topic experts. The NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH ...
Full Text Available ... phase II clinical trials. The risk of side effects might be even greater for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't always ...
Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...
Full Text Available ... harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ... more about the new approach's risks and benefits. A clinical trial ...
Full Text Available ... how these studies should be done. Patient Rights Informed Consent Informed consent is the process of giving clinical trial participants ... part and during the course of the trial. Informed consent includes details about the treatments and tests you ...
Full Text Available ... health closely. In late-phase clinical trials, possible benefits or risks of a treatment can be identified earlier than they would be in general medical practice. This is because late-phase trials have large groups of similar patients taking the same treatment ...
Full Text Available ... NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...
Charrier, Nathanael; Zarca, Kevin; Durand-Zaleski, Isabelle; Calinaud, Christine
With the development of information and communication technologies, telemedicine has been proposed as a way to improve patient management by facilitating access to appropriate diagnosis and treatment. The Paris Ile de France Regional Health Agency is currently funding a comprehensive program of telemedicine experiments. This article describes the protocols for the evaluation of the implementation of telemedicine in the Paris region. Over 2,500 patients have been included in eight studies addressing the use of telemedicine in the context of specific diseases or settings. Two projects are randomized controlled trials, while the six other projects are based on before-after designs (differences in differences studies). Based on the MAST model and the French national framework, we identified endpoints to assess the impact of telemedicine on five dimensions: clinical effectiveness, cost-effectiveness, security of the application, patient satisfaction and quality of life and perception of professionals. Telemedicine encompasses a wide range of services and stakeholders, and thus study protocols must be tailored to the specific constraints and interests of the users. NCT02110433 (03/07/2014), NCT02157740 (05/27/2014), NCT02374697 (02/05/2015), NCT02157727 (05/27/2014), NCT02229279 (08/28/2014), NCT02368769 (02/05/2015), NCT02164747 (NCT02164747), NCT02309905 (11/27/2014).
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
Full Text Available Abstract Background 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. Methods/Design 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT02645357
Scaling-up an efficacious school-based physical activity intervention: Study protocol for the ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY cluster randomized controlled trial and scale-up implementation evaluation
Full Text Available Abstract Background Despite the health benefits of regular physical activity, most children are insufficiently active. Schools are ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. The aim of this project is to modify, scale up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children’s physical activity, fundamental movement skills and cardiorespiratory fitness. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY study will focus largely on online delivery to enhance translational capacity. Methods/Design The intervention will be implemented at school and teacher levels, and will include six components: (i quality physical education and school sport, (ii classroom movement breaks, (iii physically active homework, (iv active playgrounds, (v community physical activity links and (vi parent/caregiver engagement. Experienced physical education teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e., Kindergarten – Year 6. These activities will be supported by online learning and resources. Teachers will then deliver the iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools across New South Wales (NSW, Australia. A cluster randomized controlled trial (RCT, involving a representative sample of 20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions, will assess effectiveness and cost-effectiveness at 12 and 24 months. Students’ cardiorespiratory fitness will be the primary outcome in this trial. Key secondary outcomes will include students’ moderate-to-vigorous physical activity (via accelerometers, fundamental movement
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.
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
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.
Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2: study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression
Full Text Available Abstract Background Depression is a global health challenge. Although there are effective psychological and pharmaceutical interventions, our best treatments achieve remission rates less than 1/3 and limited sustained recovery. Underpinning this efficacy gap is limited understanding of how complex psychological interventions for depression work. Recent reviews have argued that the active ingredients of therapy need to be identified so that therapy can be made briefer, more potent, and to improve scalability. This in turn requires the use of rigorous study designs that test the presence or absence of individual therapeutic elements, rather than standard comparative randomised controlled trials. One such approach is the Multiphase Optimization Strategy, which uses efficient experimentation such as factorial designs to identify active factors in complex interventions. This approach has been successfully applied to behavioural health but not yet to mental health interventions. Methods/Design A Phase III randomised, single-blind balanced fractional factorial trial, based in England and conducted on the internet, randomized at the level of the patient, will investigate the active ingredients of internet cognitive-behavioural therapy (CBT for depression. Adults with depression (operationalized as PHQ-9 score ≥ 10, recruited directly from the internet and from an UK National Health Service Improving Access to Psychological Therapies service, will be randomized across seven experimental factors, each reflecting the presence versus absence of specific treatment components (activity scheduling, functional analysis, thought challenging, relaxation, concreteness training, absorption, self-compassion training using a 32-condition balanced fractional factorial design (2IV 7-2. The primary outcome is symptoms of depression (PHQ-9 at 12 weeks. Secondary outcomes include symptoms of anxiety and process measures related to hypothesized mechanisms
Full Text Available ... involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...
Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ... part in the study? How might this trial affect my daily life? Will I have to be ...
... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...
Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ...
Full Text Available ... symptoms. It also was increasingly being used for prevention of heart disease.) The study found that HT ... enroll healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial ...
Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...
Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...
Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...
Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...
Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... treatment is or how well it works. Children (aged 18 and younger) get special protection as research ...
Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...
Full Text Available ... the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in ... trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ...
Full Text Available ... as gene therapy or new biological treatments. Health insurance and health care providers don't always cover ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...
Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...
Full Text Available ... Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s ... always, parents must give legal consent for their child to take part in a clinical trial. When ...
Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...
Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...
Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug ... life? Will I have to be in the hospital? How long will the trial last? Who will ...
Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...
Full Text Available ... or groups of people; look at the best age and frequency for doing screening tests, such as ... trial. They include factors such as a patient's age and gender, the type and stage of disease, ...
Full Text Available ... final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists ... part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...
Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...
Full Text Available ... as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results ...
Full Text Available ... as gene therapy or new biological treatments. Health insurance and health care providers don't always cover ... oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for ...
Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...
Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...
Full Text Available ... seems promising, the next step may involve animal testing. This shows how the approach affects a living ... FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews ...
Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ...
Full Text Available ... Form Search the NHLBI, use the drop down list to select: the entire site, the Health Topics ... specific trials you're interested in. For a list of questions to ask your doctor and the ...
Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at firstname.lastname@example.org or call ...
Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...
Full Text Available ... IRB is an independent committee created by the institution that sponsors a clinical trial. IRB members are ... provide guidance and oversight to the IRBs, develop educational programs and materials, and offer advice on research- ...
Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...
Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...
Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...
Full Text Available ... sponsor clinical trials that test the safety of products, such as medicines, and how well they work. ... placebo (plah-SE-bo). This is an inactive product that looks like the test product. You'll ...
Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ... in clinical trials at the NIH. The NHLBI conducts a large number of research studies at the ...
Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...
Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...
Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...
Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...
Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...
Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...
Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...
Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ...
Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... and Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs ...
Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...
Full Text Available ... Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit ... public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical trials at ...
Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... how you feel. Some people will need to travel or stay in hospitals to take part in ...
Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...
Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...
Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...
Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...
Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...
Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...
Full Text Available ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ... ClinicalTrials.gov View a database of clinical studies (past and present) funded or sponsored by the NIH ...
Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...
Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...
Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...
Full Text Available ... results. Clinical trials are one of the final stages of a long and careful research process. The ... a patient's age and gender, the type and stage of disease, and whether the patient has had ...
Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...
Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...
Full Text Available ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ... in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to explore NIH ...
Full Text Available ... look at the best age and frequency for doing screening tests, such as mammography; and compare two ... available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" ...
Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...
Full Text Available ... and how often they will get them; what type of data will be collected during the clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical ...
Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... IRBs, develop educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board ...