The use of propensity scores to assess the generalizability of results from randomized trials

PubMed Central

Stuart, Elizabeth A.; Cole, Stephen R.; Bradshaw, Catherine P.; Leaf, Philip J.

2014-01-01

Randomized trials remain the most accepted design for estimating the effects of interventions, but they do not necessarily answer a question of primary interest: Will the program be effective in a target population in which it may be implemented? In other words, are the results generalizable? There has been very little statistical research on how to assess the generalizability, or “external validity,” of randomized trials. We propose the use of propensity-score-based metrics to quantify the similarity of the participants in a randomized trial and a target population. In this setting the propensity score model predicts participation in the randomized trial, given a set of covariates. The resulting propensity scores are used first to quantify the difference between the trial participants and the target population, and then to match, subclassify, or weight the control group outcomes to the population, assessing how well the propensity score-adjusted outcomes track the outcomes actually observed in the population. These metrics can serve as a first step in assessing the generalizability of results from randomized trials to target populations. This paper lays out these ideas, discusses the assumptions underlying the approach, and illustrates the metrics using data on the evaluation of a schoolwide prevention program called Positive Behavioral Interventions and Supports. PMID:24926156

Internet-based guided self-help for glioma patients with depressive symptoms: design of a randomized controlled trial

PubMed Central

2014-01-01

Background Among glioma patients, depression is estimated to be more prevalent than in both the general population and the cancer patient population. This can have negative consequences for both patients and their primary informal caregivers (e.g., a spouse, family member or close friend). At present, there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients. Furthermore, the possibility of delivering mental health care through the internet has not yet been explored in this population. Therefore, a randomized controlled trial is warranted to evaluate the effects of an internet-based, guided self-help intervention for depressive symptoms in glioma patients. Methods/design The intervention is based on problem-solving therapy. An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms (Center for Epidemiology Studies Depression Scale score ≥12). Sample size calculations yield 126 glioma patients to be included, who are randomly assigned to either the intervention group or a waiting list control group. In addition, we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group. Assessments take place at baseline, after 6 and 12 weeks, and after 6 and 12 months. Primary outcome measure is the change in depressive symptoms. Secondary outcome measures include health-related quality of life, fatigue, costs and patient satisfaction. In addition, all patients are asked to assign a primary informal caregiver, who does not participate in the intervention but who is asked to complete similar assessments. Their mood, health-related quality of life and fatigue is evaluated as well. Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients. If proven effective, this treatment will contribute to the mental health care of glioma patients in clinical practice. Trial registration Netherlands Trial Register NTR3223 PMID:24721108

A school-based peer-led smoking prevention intervention with extracurricular activities: the LILT-LdP cluster randomized controlled trial design and study population.

PubMed

Bosi, Sandra; Gorini, Giuseppe; Tamelli, Marco; Monti, Claudia; Storani, Simone; Carreras, Giulia; Martini, Andrea; Allara, Elias; Angelini, Paola; Faggiano, Fabrizio

2013-01-01

Few school programs are effective in preventing adolescents' tobacco smoking initiation. The "Lega contro i Tumori - Luoghi di Prevenzione" is a cluster randomized controlled trial designed to evaluate a school-based peer-led smoking prevention intervention with extracurricular activities for students aged 14-15 years. This paper presents the study design and the baseline characteristics of the study population. Twenty secondary schools located in the Reggio Emilia province took part in the study. Five schools were excluded because they already participated in smoking prevention interventions. The schools were randomized to control or intervention arms. The study population consisted of students attending the first grade. Components of the intervention included 1) the out-of-school "Smoking Prevention Tour" (SPT) at the "Luoghi di Prevenzione" Center, a 4-hour (4 sessions) extracurricular activity; 2) the "Smoke-free Schools" intervention, combining a life-skills-based peer-led intervention at school, an in-depth lesson on one of the SPT sessions, and enforcement surveillance of the school antismoking policy. Tobacco use was studied through a questionnaire administered before and 6 months after the intervention. Eleven high schools and 9 vocational secondary schools took part in the study for a total of 2,476 out of 3,050 eligible students (81.2%). The proportions of respondents in high schools and vocational secondary schools were 90.9% and 64.5%, respectively (P <0.001). Intervention and control arms showed a different distribution of gender and school type, whereas no difference was observed in any tobacco-use characteristic. This study is one of the few Italian trials to evaluate the effectiveness of a school-based program for preventing smoking initiation.

Immunoglobulin G antibodies against indoor dampness-related microbes and adult-onset asthma: a population-based incident case–control study

PubMed Central

JAAKKOLA, M S; LAITINEN, S; PIIPARI, R; UITTI, J; NORDMAN, H; HAAPALA, A-M; JAAKKOLA, J J K

2002-01-01

Immunoglobulin G (IgG) antibodies against microbes related to indoor dampness problems have been used as potential biomarkers of fungal exposure in clinical investigations. There is limited information on their relation to asthma. We conducted a population-based incident case–control study to assess the risk of asthma in relation to specific IgG antibodies to eight dampness-related microbes: Aspergillus fumigatus, A. versicolor, Cladosporium cladosporioides, Fusarium oxysporum, Sporobolomyces salmonicolor, Stachybotrys chartarum, Streptomyces albus and Trichoderma citrinoviride. We recruited systematically all new cases of asthma during a 2·5-year study period and randomly selected controls from a source population of adults 21–63 years of age living in the Pirkanmaa Hospital District, South Finland. The clinically diagnosed case series consisted of 521 adults with newly diagnosed asthma and the control series of 932 controls selected randomly from the source population. IgG antibodies were analysed with ELISA. An increased risk of developing asthma in adulthood was significantly related to IgG antibodies to T. citrinoviride, but not to the other moulds. There was no evidence of a dose–response relation between the IgG antibody level and the risk of asthma. T. citrinoviride may play a role in the aetiology of adult-onset asthma or serve as an indicator of other causal factors. PMID:12100029

Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial.

PubMed

Samuels, Aaron M; Awino, Nobert; Odongo, Wycliffe; Abong'o, Benard; Gimnig, John; Otieno, Kephas; Shi, Ya Ping; Were, Vincent; Allen, Denise Roth; Were, Florence; Sang, Tony; Obor, David; Williamson, John; Hamel, Mary J; Patrick Kachur, S; Slutsker, Laurence; Lindblade, Kim A; Kariuki, Simon; Desai, Meghna

2017-06-07

Most human Plasmodium infections in western Kenya are asymptomatic and are believed to contribute importantly to malaria transmission. Elimination of asymptomatic infections requires active treatment approaches, such as mass testing and treatment (MTaT) or mass drug administration (MDA), as infected persons do not seek care for their infection. Evaluations of community-based approaches that are designed to reduce malaria transmission require careful attention to study design to ensure that important effects can be measured accurately. This manuscript describes the study design and methodology of a cluster-randomized controlled trial to evaluate a MTaT approach for malaria transmission reduction in an area of high malaria transmission. Ten health facilities in western Kenya were purposively selected for inclusion. The communities within 3 km of each health facility were divided into three clusters of approximately equal population size. Two clusters around each health facility were randomly assigned to the control arm, and one to the intervention arm. Three times per year for 2 years, after the long and short rains, and again before the long rains, teams of community health volunteers visited every household within the intervention arm, tested all consenting individuals with malaria rapid diagnostic tests, and treated all positive individuals with an effective anti-malarial. The effect of mass testing and treatment on malaria transmission was measured through population-based longitudinal cohorts, outpatient visits for clinical malaria, periodic population-based cross-sectional surveys, and entomological indices.

Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol.

PubMed

Cunningham, John A; Leatherdale, Scott T; Selby, Peter L; Tyndale, Rachel F; Zawertailo, Laurie; Kushnir, Vladyslav

2011-09-28

Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline. The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment. ClinicalTrials.gov: NCT01429129.

Framing preventive care messaging and cervical cancer screening in a health-insured population in South Africa: Implications for population-based communication?

PubMed

Adonis, Leegale; Paramanund, Jithen; Basu, Debashis; Luiz, John

2017-09-01

The impact of health message framing on cervical cancer screening uptake is poorly understood. In a prospective randomized control study with 748 females, aged 21-65 years with no Pap smear in the previous 3 years, they randomly received a loss-framed, gain-framed, or neutral health message (control) regarding cervical cancer screening by email. Screening rate in the control group was 9.58 percent (CI: 9.29%-9.87%), 5.71 percent (CI: 5.48%-6.98%) in the gain-framed group, and 8.53 percent (CI: 8.24%-8.81%) in the loss-framed group. Statistically there was no difference between the three screening rates. Framing of health messages may not be a significant consideration when communicating through emails.

Randomized Clinical Trial of the Effectiveness of a Home-Based Advanced Practice Psychiatric Nurse Intervention: Outcomes for Individuals with Serious Mental Illness and HIV

PubMed Central

Hanrahan, Nancy P.; Wu, Evan; Kelly, Deena; Aiken, Linda H.; Blank, Michael B.

2011-01-01

Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI) were randomly assigned to an intervention group (n=128) or to a control group (n=110). Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012) and the physical component of health-related quality of life (P=.03) from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population. PMID:21935499

Randomized Controlled Trial of Hospital-Based Hygiene and Water Treatment Intervention (CHoBI7) to Reduce Cholera.

PubMed

George, Christine Marie; Monira, Shirajum; Sack, David A; Rashid, Mahamud-ur; Saif-Ur-Rahman, K M; Mahmud, Toslim; Rahman, Zillur; Mustafiz, Munshi; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Zhang, Xiaotong; Jung, Danielle; Sack, R Bradley; Alam, Munirul

2016-02-01

The risk for cholera infection is >100 times higher for household contacts of cholera patients during the week after the index patient seeks hospital care than it is for the general population. To initiate a standard of care for this high-risk population, we developed Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), which promotes hand washing with soap and treatment of water. To test CHoBI7, we conducted a randomized controlled trial among 219 intervention household contacts of 82 cholera patients and 220 control contacts of 83 cholera patients in Dhaka, Bangladesh, during 2013-2014. Intervention contacts had significantly fewer symptomatic Vibrio cholerae infections than did control contacts and 47% fewer overall V. cholerae infections. Intervention households had no stored drinking water with V. cholerae and 14 times higher odds of hand washing with soap at key events during structured observation on surveillance days 5, 6, or 7. CHoBI7 presents a promising approach for controlling cholera among highly susceptible household contacts of cholera patients.

On the evidentiary standards for nutrition advice.

PubMed

Jukola, Saana

2018-06-01

This paper evaluates the application of evidentiary standards originating from evidence-based medicine in nutrition advice. It shows that it is problematic to criticize nutrition recommendations for not being based on randomized controlled trials. Due to practical, ethical and methodological and reasons, it is difficult to conduct rigorous randomized controlled trials for acquiring evidence that is relevant for achieving the goals of population-level nutrition recommendations. Given the non-epistemic goals of the dietary recommendations, criteria of acceptable evidence should be adapted to the goals of the practice and the practical, ethical, and methodological constraints of the situation. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed Central

2014-01-01

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

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

PubMed

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

2014-07-08

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

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

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. PMID:21988774

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial.

PubMed

Doyle, Conor; Panda, Pradeep; Van de Poel, Ellen; Radermacher, Ralf; Dror, David M

2011-10-11

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. 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. 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. © 2011 Doyle et al; licensee BioMed Central Ltd.

The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

PubMed

Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

2015-03-01

Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled Trials ISRCTN19287682 , 21 December 2012.

Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

PubMed

Yan, Lijing L; Fang, Weigang; Delong, Elizabeth; Neal, Bruce; Peterson, Eric D; Huang, Yining; Sun, Ningling; Yao, Chen; Li, Xian; MacMahon, Stephen; Wu, Yangfeng

2014-04-11

The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China. The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged≥50 years and 20 women aged≥60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted. This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries. The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

Positive Outlook as a Moderator of the Effectiveness of an HIV/STI Intervention with Adolescents in Detention

ERIC Educational Resources Information Center

Schmiege, Sarah J.; Ewing, Sarah W. Feldstein; Hendershot, Christian S.; Bryan, Angela D.

2011-01-01

Justice-involved adolescents engage in high levels of risky sexual behavior, underscoring the need for targeted, effective, prevention interventions geared toward this population. In a randomized controlled trial, 484 detained adolescents received a theory-based intervention or an information-only control. We have previously demonstrated that the…

Deferred Pre-Emptive Switch from Calcineurin Inhibitor to Sirolimus Leads to Improvement in GFR and Expansion of T Regulatory Cell Population: A Randomized, Controlled Trial

PubMed Central

Bansal, Dinesh; Yadav, Ashok K.; Kumar, Vinod; Minz, Mukut; Sakhuja, Vinay; Jha, Vivekanand

2013-01-01

Background Measures to prevent chronic calcineurin inhibitor (CNI) toxicity have included limiting exposure by switching to sirolimus (SIR). SIR may favorably influence T regulator cell (Treg) population. This randomized controlled trial compares the effect of switching from CNI to SIR on glomerular filtration rate (GFR) and Treg frequency. Methods In this prospective open label randomized trial, primary living donor kidney transplant recipients on CNI-based immunosuppression were randomized to continue CNI or switched to sirolimus 2 months after surgery; 29 were randomized to receive CNI and 31 to SIR. All patients received mycophenolate mofetil and steroids. The main outcome parameter was estimated GFR (eGFR) at 180 days. Treg population was estimated by flowcytometry. Results Baseline characteristics in the two groups were similar. Forty-eight patients completed the trial. At six months, patients in the SIR group had significantly higher eGFR as compared to those in the CNI group (88.94±11.78 vs 80.59±16.51 mL/min, p = 0.038). Patients on SIR had a 12 mL/min gain of eGFR of at the end of six months. Patients in the SIR group showed significant increase in Treg population at 30 days, which persisted till day 180. There was no difference in the adverse events in terms of number of acute rejection episodes, death, infections, proteinuria, lipid profile, blood pressure control and hematological parameters between the two groups. Four patients taking SIR developed enthesitis. No patient left the study or switched treatment because of adverse event. Conclusions A deferred pre-emptive switch over from CNI to SIR safely improves renal function and Treg population at 6 months in living donor kidney transplant recipients. Registered in Clinical Trials Registry of India (CTRI/2011/091/000034) PMID:24146762

Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial.

PubMed

Cunha-Cruz, Joana; Milgrom, Peter; Shirtcliff, R Michael; Bailit, Howard L; Huebner, Colleen E; Conrad, Douglas; Ludwig, Sharity; Mitchell, Melissa; Dysert, Jeanne; Allen, Gary; Scott, JoAnna; Mancl, Lloyd

2015-06-20

To improve the oral health of low-income children, innovations in dental delivery systems are needed, including community-based care, the use of expanded duty auxiliary dental personnel, capitation payments, and global budgets. This paper describes the protocol for PREDICT (Population-centered Risk- and Evidence-based Dental Interprofessional Care Team), an evaluation project to test the effectiveness of new delivery and payment systems for improving dental care and oral health. This is a parallel-group cluster randomized controlled trial. Fourteen rural Oregon counties with a publicly insured (Medicaid) population of 82,000 children (0 to 21 years old) and pregnant women served by a managed dental care organization are randomized into test and control counties. In the test intervention (PREDICT), allied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The delivery system intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on the following: 1) identifying eligible children and gaining caregiver consent for services in community settings (for example, schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks. In the control intervention, care is delivered in dental offices without performance incentives. The primary outcome is the prevalence of untreated dental caries. Other outcomes are related to process, structure and cost. Data are collected through patient and staff surveys, clinical examinations, and the review of health and administrative records. If effective, PREDICT is expected to substantially reduce disparities in dental care and oral health. PREDICT can be disseminated to other care organizations as publicly insured clients are increasingly served by large practice organizations. ClinicalTrials.gov NCT02312921 6 December 2014. The Robert Wood Johnson Foundation and Advantage Dental Services, LLC, are supporting the evaluation.

Knee osteoarthritis and role for surgical intervention: lessons learned from randomized clinical trials and population-based cohorts.

PubMed

Buchbinder, Rachelle; Richards, Bethan; Harris, Ian

2014-03-01

Over the last decade, there has been increased recognition of the importance of high-quality randomized controlled trials in determining the role of surgery for knee osteoarthritis. This review highlights key findings from the best available studies, and considers whether or not this knowledge has resulted in better evidence-based care. Use of arthroscopy to treat knee osteoarthritis has not declined despite strong evidence-based recommendations that do not sanction its use. A large randomized controlled trial has demonstrated that arthroscopic partial meniscectomy followed by a standardized physical therapy program results in similar improvements in pain and function at 6 and 12 months in comparison to physical therapy alone in patients with knee osteoarthritis and a symptomatic meniscal tear, confirming the findings of two previous trials. Two recent randomized controlled trials have demonstrated that decision aids help people to reach better-informed decisions about total knee arthroplasty. A majority of studies have indicated that for people with obesity the positive results of total knee arthroplasty may be compromised by postoperative complications, particularly infection. More efforts are needed to overcome significant evidence-practice gaps in the surgical management of knee osteoarthritis, particularly arthroscopy. Decision aids are a promising tool.

LETTER TO THE EDITOR: Mixed population Minority Game with generalized strategies

NASA Astrophysics Data System (ADS)

Jefferies, P.; Hart, M.; Johnson, N. F.; Hui, P. M.

2000-11-01

We present a quantitative theory, based on crowd effects, for the market volatility in a Minority Game played by a mixed population. Below a critical concentration of generalized strategy players, we find that the volatility in the crowded regime remains above the random coin-toss value regardless of the `temperature' controlling strategy use. Our theory yields good agreement with numerical simulations.

Risk factors for operated carpal tunnel syndrome: a multicenter population-based case-control study

PubMed Central

Mattioli, Stefano; Baldasseroni, Alberto; Bovenzi, Massimo; Curti, Stefania; Cooke, Robin MT; Campo, Giuseppe; Barbieri, Pietro G; Ghersi, Rinaldo; Broccoli, Marco; Cancellieri, Maria Pia; Colao, Anna Maria; dell'Omo, Marco; Fateh-Moghadam, Pirous; Franceschini, Flavia; Fucksia, Serenella; Galli, Paolo; Gobba, Fabriziomaria; Lucchini, Roberto; Mandes, Anna; Marras, Teresa; Sgarrella, Carla; Borghesi, Stefano; Fierro, Mauro; Zanardi, Francesca; Mancini, Gianpiero; Violante, Francesco S

2009-01-01

Background Carpal tunnel syndrome (CTS) is a socially and economically relevant disease caused by compression or entrapment of the median nerve within the carpal tunnel. This population-based case-control study aims to investigate occupational/non-occupational risk factors for surgically treated CTS. Methods Cases (n = 220) aged 18-65 years were randomly drawn from 13 administrative databases of citizens who were surgically treated with carpal tunnel release during 2001. Controls (n = 356) were randomly sampled from National Health Service registry records and were frequency matched by age-gender-specific CTS hospitalization rates. Results At multivariate analysis, risk factors were blue-collar/housewife status, BMI ≥ 30 kg/m2, sibling history of CTS and coexistence of trigger finger. Being relatively tall (cut-offs based on tertiles: women ≥165 cm; men ≥175 cm) was associated with lower risk. Blue-collar work was a moderate/strong risk factor in both sexes. Raised risks were apparent for combinations of biomechanical risk factors that included frequent repetitivity and sustained force. Conclusion This study strongly underlines the relevance of biomechanical exposures in both non-industrial and industrial work as risk factors for surgically treated CTS. PMID:19758429

Study design and "evidence" in patient-oriented research.

PubMed

Concato, John

2013-06-01

Individual studies in patient-oriented research, whether described as "comparative effectiveness" or using other terms, are based on underlying methodological designs. A simple taxonomy of study designs includes randomized controlled trials on the one hand, and observational studies (such as case series, cohort studies, and case-control studies) on the other. A rigid hierarchy of these design types is a fairly recent phenomenon, promoted as a tenet of "evidence-based medicine," with randomized controlled trials receiving gold-standard status in terms of producing valid results. Although randomized trials have many strengths, and contribute substantially to the evidence base in clinical care, making presumptions about the quality of a study based solely on category of research design is unscientific. Both the limitations of randomized trials as well as the strengths of observational studies tend to be overlooked when a priori assumptions are made. This essay presents an argument in support of a more balanced approach to evaluating evidence, and discusses representative examples from the general medical as well as pulmonary and critical care literature. The simultaneous consideration of validity (whether results are correct "internally") and generalizability (how well results apply to "external" populations) is warranted in assessing whether a study's results are accurate for patients likely to receive the intervention-examining the intersection of clinical and methodological issues in what can be called a medicine-based evidence approach. Examination of cause-effect associations in patient-oriented research should recognize both the strengths and limitations of randomized trials as well as observational studies.

Effects of an internet-based cognitive behavioral therapy intervention on improving work engagement and other work-related outcomes: an analysis of secondary outcomes of a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A; Matsuyama, Yutaka; Shimazu, Akihito; Umanodan, Rino; Kawakami, Sonoko; Kasai, Kiyoto

2015-05-01

This study reported a randomized controlled trial of the effectiveness of an Internet-based cognitive behavioral therapy (iCBT) program on work engagement and secondary work-related outcomes. Participants who fulfilled the inclusion criteria were randomly allocated to an intervention or a control group (N = 381 for each). A 6-week, 6-lesson iCBT program using a Manga (Japanese comic) story was provided only to the intervention group. Work engagement was assessed at baseline and at 3- and 6-month follow-ups for both groups. The iCBT program showed a significant intervention effect on work engagement (P = 0.04) with small effect sizes (Cohen's d = 0.16 at 6-month follow-up). The study showed computerized cognitive behavior therapy delivered via the Internet to be effective (with a small effect size) in increasing work engagement in the general working population. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006210.

Recruiting Filipino Immigrants in a Randomized Controlled Trial Promoting Enrollment in an Evidence-Based Parenting Intervention.

PubMed

Javier, Joyce R; Reyes, Angela; Coffey, Dean M; Schrager, Sheree M; Samson, Allan; Palinkas, Lawrence; Kipke, Michele D; Miranda, Jeanne

2018-05-17

Filipinos, the second largest Asian subgroup in the U.S., experience significant youth behavioral health disparities but remain under-represented in health research. We describe lessons learned from using the Matching Model of Recruitment to recruit 215 Filipinos to participate in a large, randomized controlled trial of a culturally tailored video aimed at increasing enrollment in the Incredible Years® Parent Program. We recruited participants from schools, churches, clinics, community events, and other community-based locations. Facilitators of participation included: partnership with local community groups, conducting research in familiar settings, building on existing social networks, and matching perspectives of community members and researchers. Findings suggest recruitment success occurs when there is a match between goals of Filipino parents, grandparents and the research community. Understanding the perspectives of ethnic minority communities and effectively communicating goals of research studies are critical to successful recruitment of hard-to-reach immigrant populations in randomized controlled trials.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

Does marital status predict the odds of suicidal death in taiwan? A seven-year population-based study.

PubMed

Yeh, Jui-Yuan; Xirasagar, Sudha; Liu, Tsai-Ching; Li, Chong-Yi; Lin, Herng-Ching

2008-06-01

Using nationwide, 7-year population-based data for 1997-2003, we examined marital status to see if it predicted suicide among the ethnic Chinese population of Taiwan. Using cause of death data, with a case-control design, two groups-total adult suicide deaths, n = 17,850, the study group, and adult deaths other than suicide, n = 71,400 (randomly selected from age, sex, and geographic region matched controls, four per suicide)-were studied. Using multiple logistic regression analysis including age-marital status interaction, adjusted estimates show divorced status to be the most detrimental for suicide propensity, with males showing stronger effect size. Females never married, aged below 35 and 65-plus, and widowed 65-plus had lower suicide odds.

A pilot randomized controlled trial of a depression and disease management program delivered by phone.

PubMed

Aburizik, Arwa; Dindo, Lilian; Kaboli, Peter; Charlton, Mary; Dawn, Klein; Turvey, Carolyn

2013-11-01

Depression in medically ill patients occurs at twice the rate found in the general population. Though pharmacologic and psychotherapeutic interventions for depression are effective, response to treatment and access to care are barriers for this population. A multidimensional telehealth intervention was designed to focus on these barriers by delivering a phone based intervention that addressed managing one's illness and coping emotionally. Veterans with diabetes, hypertension, or chronic pain and depressive symptoms were randomized to one of three conditions: Usual Care (n=23), Illness Management Only (n=31), or Combined Psychotherapy and Illness Management (n=29). Those randomized to the Combined or Illness Management Only intervention group received 10 phone visits. Veterans in the Combined group received all aspects of the illness management program plus a manualized depression intervention. Subjects completed assessments at baseline, week 5, and 10 to test the main hypothesis that veterans in the Combined condition would have a greater decline in depressive symptoms. The Combined intervention yielded a significant decline in depressive symptoms when compared with Usual Care. However, the there was no significant difference between the Combined and Illness Management Only groups. This is a pilot study with a small sample size relative to a standard randomized controlled trial in psychotherapy. This telephone-based intervention succeeded in reducing depressive symptoms in veterans with chronic illness. It adds to the building evidence base for providing phone-delivered mental health services. © 2013 Elsevier B.V. All rights reserved.

E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

PubMed

Antypas, Konstantinos; Wangberg, Silje C

2012-07-09

Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority. Trial registry http://www.clinicaltrials.gov: NCT01223170.

Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support.

PubMed

Nelson, Karin; Drain, Nathan; Robinson, June; Kapp, Janet; Hebert, Paul; Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Lessler, Dan; Krieger, James

2014-07-01

Community health workers (CHWs) may be an important mechanism to provide diabetes self-management to disadvantaged populations. We describe the design and baseline results of a trial evaluating a home-based CHW intervention. Peer Support for Achieving Independence in Diabetes (Peer-AID) is a randomized, controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care. The study recruited participants from 3 health systems. Change in A1c measured at 12 months is the primary outcome. Changes in blood pressure, lipids, health care utilization, health-related quality of life, self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes. A total of 1438 patients were identified by a medical record review as potentially eligible, 445 patients were screened by telephone for eligibility and 287 were randomized. Groups were comparable at baseline on socio-demographic and clinical characteristics. All participants were low-income and were from diverse racial and ethnic backgrounds. The mean A1c was 8.9%, mean BMI was above the obese range, and non-adherence to diabetes medications was high. The cohort had high rates of co-morbid disease and low self-reported health status. Although one-third reported no health insurance, the mean number of visits to a physician in the past year was 5.7. Trial results are pending. Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program. If effective, replication of the Peer-AID intervention in community based settings could contribute to improved control of diabetes in vulnerable populations. Published by Elsevier Inc.

Peer Support for Achieving Independence in Diabetes (Peer-AID): Design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support

PubMed Central

Nelson, Karin; Drain, Nathan; Robinson, June; Kapp, Janet; Hebert, Paul; Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Lessler, Dan; Krieger, James

2014-01-01

Background & Objectives Community health workers (CHWs) may be an important mechanism to provide diabetes self-management to disadvantaged populations. We describe the design and baseline results of a trial evaluating a home-based CHW intervention. Methods & Research Design Peer Support for Achieving Independence in Diabetes (Peer-AID) is a randomized, controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care. The study recruited participants from 3 health systems. Change in A1c measured at 12 months is the primary outcome. Change in blood pressure, lipids, health care utilization, health-related quality of life, self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes. Results A total of 1,438 patients were identified by medical record review as potentially eligible, 445 patients were screened by telephone for eligibility and 287 were randomized. Groups were comparable at baseline on socio-demographic and clinical characteristics. All participants were low-income and were from diverse racial and ethnic backgrounds. The mean A1c was 8.9%, mean BMI was above the obese range, and non-adherence to diabetes medications was high. The cohort had high rates of co-morbid disease and low self-reported health status. Although one-third reported no health insurance, the mean number of visits to a physician in the past year was 5.7. Trial results are pending. Conclusions Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program. If effective, replication of the Peer-AID intervention in community based settings could contribute to improved control of diabetes in vulnerable populations. PMID:24956324

Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial.

PubMed

O'Dea, Angela; Tierney, Marie; McGuire, Brian E; Newell, John; Glynn, Liam G; Gibson, Irene; Noctor, Eoin; Danyliv, Andrii; Connolly, Susan B; Dunne, Fidelma P

2015-01-01

To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

Computer-aided system of evaluation for population-based all-in-one service screening (CASE-PASS): from study design to outcome analysis with bias adjustment.

PubMed

Chen, Li-Sheng; Yen, Amy Ming-Fang; Duffy, Stephen W; Tabar, Laszlo; Lin, Wen-Chou; Chen, Hsiu-Hsi

2010-10-01

Population-based routine service screening has gained popularity following an era of randomized controlled trials. The evaluation of these service screening programs is subject to study design, data availability, and the precise data analysis for adjusting bias. We developed a computer-aided system that allows the evaluation of population-based service screening to unify these aspects and facilitate and guide the program assessor to efficiently perform an evaluation. This system underpins two experimental designs: the posttest-only non-equivalent design and the one-group pretest-posttest design and demonstrates the type of data required at both the population and individual levels. Three major analyses were developed that included a cumulative mortality analysis, survival analysis with lead-time adjustment, and self-selection bias adjustment. We used SAS AF software to develop a graphic interface system with a pull-down menu style. We demonstrate the application of this system with data obtained from a Swedish population-based service screen and a population-based randomized controlled trial for the screening of breast, colorectal, and prostate cancer, and one service screening program for cervical cancer with Pap smears. The system provided automated descriptive results based on the various sources of available data and cumulative mortality curves corresponding to the study designs. The comparison of cumulative survival between clinically and screen-detected cases without a lead-time adjustment are also demonstrated. The intention-to-treat and noncompliance analysis with self-selection bias adjustments are also shown to assess the effectiveness of the population-based service screening program. Model validation was composed of a comparison between our adjusted self-selection bias estimates and the empirical results on effectiveness reported in the literature. We demonstrate a computer-aided system allowing the evaluation of population-based service screening programs with an adjustment for self-selection and lead-time bias. This is achieved by providing a tutorial guide from the study design to the data analysis, with bias adjustment. Copyright © 2010 Elsevier Inc. All rights reserved.

A robust and efficient statistical method for genetic association studies using case and control samples from multiple cohorts

PubMed Central

2013-01-01

Background The theoretical basis of genome-wide association studies (GWAS) is statistical inference of linkage disequilibrium (LD) between any polymorphic marker and a putative disease locus. Most methods widely implemented for such analyses are vulnerable to several key demographic factors and deliver a poor statistical power for detecting genuine associations and also a high false positive rate. Here, we present a likelihood-based statistical approach that accounts properly for non-random nature of case–control samples in regard of genotypic distribution at the loci in populations under study and confers flexibility to test for genetic association in presence of different confounding factors such as population structure, non-randomness of samples etc. Results We implemented this novel method together with several popular methods in the literature of GWAS, to re-analyze recently published Parkinson’s disease (PD) case–control samples. The real data analysis and computer simulation show that the new method confers not only significantly improved statistical power for detecting the associations but also robustness to the difficulties stemmed from non-randomly sampling and genetic structures when compared to its rivals. In particular, the new method detected 44 significant SNPs within 25 chromosomal regions of size < 1 Mb but only 6 SNPs in two of these regions were previously detected by the trend test based methods. It discovered two SNPs located 1.18 Mb and 0.18 Mb from the PD candidates, FGF20 and PARK8, without invoking false positive risk. Conclusions We developed a novel likelihood-based method which provides adequate estimation of LD and other population model parameters by using case and control samples, the ease in integration of these samples from multiple genetically divergent populations and thus confers statistically robust and powerful analyses of GWAS. On basis of simulation studies and analysis of real datasets, we demonstrated significant improvement of the new method over the non-parametric trend test, which is the most popularly implemented in the literature of GWAS. PMID:23394771

Environmental Tobacco Smoke and Adult-Onset Asthma: A Population-Based Incident Case–Control Study

PubMed Central

Jaakkola, Maritta S.; Piipari, Ritva; Jaakkola, Niina; Jaakkola, Jouni J. K.

2003-01-01

Objectives. The authors assessed the effects of environmental tobacco smoke (ETS) on the development of asthma in adults. Methods. In the Pirkanmaa district of South Finland, all 21- to 63-year-old adults with new cases of asthma diagnosed during a 2.5-year period (n = 521 case patients, out of 441 000 inhabitants) and a random sample of control subjects from the source population (932 control subjects) participated in a population-based incident case–control study. Results. Risk of asthma was related to workplace ETS exposure (adjusted odds ratio [OR] = 2.16; 95% confidence interval [CI] = 1.26, 3.72) and home exposure (OR = 4.77; 95% CI = 1.29, 17.7) in the past year. Cumulative ETS exposure over a lifetime at work and at home increased the risk. Conclusions. This study indicates for the first time that both cumulative lifetime and recent ETS exposures increase the risk of adult-onset asthma. PMID:14652334

A random spatial sampling method in a rural developing nation

Treesearch

Michelle C. Kondo; Kent D.W. Bream; Frances K. Barg; Charles C. Branas

2014-01-01

Nonrandom sampling of populations in developing nations has limitations and can inaccurately estimate health phenomena, especially among hard-to-reach populations such as rural residents. However, random sampling of rural populations in developing nations can be challenged by incomplete enumeration of the base population. We describe a stratified random sampling method...

Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States.

PubMed

McElfish, Pearl Anna; Long, Christopher R; Kaholokula, Joseph Keawe'aimoku; Aitaoto, Nia; Bursac, Zoran; Capelle, Lucy; Laelan, Melisa; Bing, Williamina Ioanna; Riklon, Sheldon; Rowland, Brett; Ayers, Britni L; Wilmoth, Ralph O; Langston, Krista N; Schootman, Mario; Selig, James P; Yeary, Karen Hye-Cheon Kim

2018-05-01

Pacific Islander populations, including Marshallese, face a disproportionately high burden of health disparities relative to the general population. A community-based participatory research (CBPR) approach was utilized to engage Marshallese participants in a comparative effectiveness trial testing 2 Diabetes Prevention Program (DPP) interventions designed to reduce participant's weight, lower HbA1c, encourage healthy eating, and increase physical activity. To compare the effectiveness of the faith-based (WORD) DPP to the culturally adapted (Pacific Culturally Adapted Diabetes Prevention Program [PILI]) DPP, a clustered randomized controlled trial (RCT) with 384 Marshallese participants will be implemented in 32 churches located in Arkansas, Kansas, Missouri, and Oklahoma. Churches will be randomly assigned to WORD DPP arm or to PILI DPP arm. WORD DPP focuses on connecting faith and health to attain a healthy weight, eat healthy, and be more physically active. In contrast, PILI DPP is a family and community focused DPP curriculum specifically adapted for implementation in Pacific Islander communities. PILI focuses on engaging social support networks to maintain a healthy weight, eat healthy, and be more physically active. All participants are assessed at baseline, immediate post intervention, and 12 months post intervention. Both interventions aim to cause weight loss through improving physical activity and healthy eating, with the goal of preventing the development of T2D. The clustered RCT will determine which intervention is most effective with the Marshallese population. The utilization of a CBPR approach that involves local stakeholders and engages faith-based institutions in Marshallese communities will increase the potential for success and sustainability. This study is registered at clinicaltrials.gov (NCT03270436).

Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States

PubMed Central

McElfish, Pearl Anna; Long, Christopher R.; Kaholokula, Joseph Keawe‘aimoku; Aitaoto, Nia; Bursac, Zoran; Capelle, Lucy; Laelan, Melisa; Bing, Williamina Ioanna; Riklon, Sheldon; Rowland, Brett; Ayers, Britni L.; Wilmoth, Ralph O.; Langston, Krista N.; Schootman, Mario; Selig, James P.; Yeary, Karen Hye-cheon Kim

2018-01-01

Abstract Background: Pacific Islander populations, including Marshallese, face a disproportionately high burden of health disparities relative to the general population. Objectives: A community-based participatory research (CBPR) approach was utilized to engage Marshallese participants in a comparative effectiveness trial testing 2 Diabetes Prevention Program (DPP) interventions designed to reduce participant's weight, lower HbA1c, encourage healthy eating, and increase physical activity. Design: To compare the effectiveness of the faith-based (WORD) DPP to the culturally adapted (Pacific Culturally Adapted Diabetes Prevention Program [PILI]) DPP, a clustered randomized controlled trial (RCT) with 384 Marshallese participants will be implemented in 32 churches located in Arkansas, Kansas, Missouri, and Oklahoma. Churches will be randomly assigned to WORD DPP arm or to PILI DPP arm. Methods: WORD DPP focuses on connecting faith and health to attain a healthy weight, eat healthy, and be more physically active. In contrast, PILI DPP is a family and community focused DPP curriculum specifically adapted for implementation in Pacific Islander communities. PILI focuses on engaging social support networks to maintain a healthy weight, eat healthy, and be more physically active. All participants are assessed at baseline, immediate post intervention, and 12 months post intervention. Summary: Both interventions aim to cause weight loss through improving physical activity and healthy eating, with the goal of preventing the development of T2D. The clustered RCT will determine which intervention is most effective with the Marshallese population. The utilization of a CBPR approach that involves local stakeholders and engages faith-based institutions in Marshallese communities will increase the potential for success and sustainability. This study is registered at clinicaltrials.gov (NCT03270436). PMID:29742712

HOME-BASED BLOOD PRESSURE INTERVENTIONS FOR AFRICAN AMERICANS

PubMed Central

Feldman, Penny H.; McDonald, Margaret V.; Mongoven, Jennifer M.; Peng, Timothy R.; Gerber, Linda M.; Pezzin, Liliana E.

2009-01-01

Background Efforts to increase blood pressure (BP) control rates in African Americans, a traditionally underserved, high risk population must address both provider practice and patient adherence issues. The Home-Based BP Intervention for African Americans study is a three-arm randomized controlled trial designed to test two strategies to improve HTN management and outcomes in a decentralized service setting serving a vulnerable and complex home care population. The primary study outcomes are systolic BP, diastolic BP, and BP control; secondary outcomes are nurse adherence to HTN management recommendations, and patient adherence to medication, healthy diet and other self-management strategies. Methods and Results Nurses (N=312) in a nonprofit Medicare-certified home health agency are randomized along with their eligible hypertensive patients (N=845). The two interventions being tested are: (i) a “basic” intervention delivering key evidence-based reminders to home care nurses and patients while the patient is receiving traditional post-acute home health care; and (ii) an “augmented” intervention that includes that same as the basic intervention, plus transition to an ongoing HTN Home Support Program that extends support for 12 months. Outcomes are measured at 3 and 12 months post baseline interview. The interventions will be assessed relative to usual care and to each other. Conclusions Systems change to improve BP management and outcomes in home health will not easily occur without new intervention models and rigorous evaluation of their impact. Results from this trial will provide important information on potential strategies to improve BP control in a low income, chronically ill patient population. PMID:20031844

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

PubMed

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

2014-02-01

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

Influence of Problem Based Learning on Critical Thinking Skills and Competence Class VIII SMPN 1 Gunuang Omeh, 2016/2017

NASA Astrophysics Data System (ADS)

Aswan, D. M.; Lufri, L.; Sumarmin, R.

2018-04-01

This research intends to determine the effect of Problem Based Learning models on students' critical thinking skills and competences. This study was a quasi-experimental research. The population of the study was the students of class VIII SMPN 1 Subdistrict Gunuang Omeh. Random sample selection is done by randomizing the class. Sample class that was chosen VIII3 as an experimental class given that treatment study based on problems and class VIII1 as control class that treatment usually given study. Instrument that used to consist of critical thinking test, cognitive tests, observation sheet of affective and psychomotor. Independent t-test and Mann Whitney U test was used for the analysis. Results showed that there was significant difference (sig <0.05) between control and experimental group. The conclusion of this study was Problem Based Learning models affected the students’ critical thinking skills and competences.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Generalizing Evidence From Randomized Clinical Trials to Target Populations

PubMed Central

Cole, Stephen R.; Stuart, Elizabeth A.

2010-01-01

Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

Effectiveness of the Heart Age tool for improving modifiable cardiovascular risk factors in a Southern European population: a randomized trial.

PubMed

Lopez-Gonzalez, Angel A; Aguilo, Antoni; Frontera, Margalida; Bennasar-Veny, Miquel; Campos, Irene; Vicente-Herrero, Teofila; Tomas-Salva, Matias; De Pedro-Gomez, Joan; Tauler, Pedro

2015-03-01

To test whether communicating cardiovascular diseases (CVD) risk using a novel risk assessment tool (Heart Age) will be able to motivate a population to adopt healthier lifestyles and improve CVD risk profile over the use of a traditional percentage-based tool. A single-blind randomized intervention study was carried out in a Caucasian population. A total of 3153 subjects were randomly allocated to one of three study groups: control (conventional medical advice was given to the subjects), Framingham REGICOR (10-year percentage risk score, calibrated to Spanish population was given to the subjects), or Heart Age group (Heart Age tool was administered to the subjects). Anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and 12-months post intervention. Both the Framingham REGICOR and the Heart Age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group, with the improvement being of a greater magnitude in the Heart Age group. No differences per gender were observed in the Heart Age group. Informing patients about their CVD risk expressed as the new Heart Age tool results in a reduction in their CVD risk higher than the one observed when the Framingham REGICOR risk score was used. © The European Society of Cardiology 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Uncertainty, learning, and the optimal management of wildlife

USGS Publications Warehouse

Williams, B.K.

2001-01-01

Wildlife management is limited by uncontrolled and often unrecognized environmental variation, by limited capabilities to observe and control animal populations, and by a lack of understanding about the biological processes driving population dynamics. In this paper I describe a comprehensive framework for management that includes multiple models and likelihood values to account for structural uncertainty, along with stochastic factors to account for environmental variation, random sampling, and partial controllability. Adaptive optimization is developed in terms of the optimal control of incompletely understood populations, with the expected value of perfect information measuring the potential for improving control through learning. The framework for optimal adaptive control is generalized by including partial observability and non-adaptive, sample-based updating of model likelihoods. Passive adaptive management is derived as a special case of constrained adaptive optimization, representing a potentially efficient suboptimal alternative that nonetheless accounts for structural uncertainty.

The WORD (Wholeness, Oneness, Righteousness, Deliverance): design of a randomized controlled trial testing the effectiveness of an evidence-based weight loss and maintenance intervention translated for a faith-based, rural, African American population using a community-based participatory approach.

PubMed

Yeary, Karen Hye-cheon Kim; Cornell, Carol E; Prewitt, Elaine; Bursac, Zoran; Tilford, J Mick; Turner, Jerome; Eddings, Kenya; Love, ShaRhonda; Whittington, Emily; Harris, Kimberly

2015-01-01

The positive effects of weight loss on obesity-related risk factors diminish unless weight loss is maintained. Yet little work has focused on the translation of evidence-based weight loss interventions with the aim of sustaining weight loss in underserved populations. Using a community-based participatory approach (CBPR) that engages the strong faith-based social infrastructure characteristic of rural African American communities is a promising way to sustain weight loss in African Americans, who bear a disproportionate burden of the obesity epidemic. Led by a collaborative community-academic partnership, The WORD aims to change dietary and physical activity behaviors to produce and maintain weight loss in rural, African American adults of faith. The WORD is a randomized controlled trial with 450 participants nested within 30 churches. All churches will receive a 16-session core weight loss intervention. Half of the churches will be randomized to receive an additional 12-session maintenance component. The WORD is a cultural adaptation of the Diabetes Prevention Program, whereby small groups will be led by trained church members. Participants will be assessed at baseline, 6, 12, and 18 months. A detailed cost-effectiveness and process evaluation will be included. The WORD aims to sustain weight loss in rural African Americans. The utilization of a CBPR approach and the engagement of the faith-based social infrastructure of African American communities will maximize the intervention's sustainability. Unique aspects of this trial include the focus on weight loss maintenance and the use of a faith-based CBPR approach in translating evidence-based obesity interventions. Copyright © 2014 Elsevier Inc. All rights reserved.

Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types.

PubMed

Kim, Jeong Eun; Jang, Joung-Soon; Kim, Jae-Weon; Sung, Yong Lee; Cho, Chi-Heum; Lee, Myung-Ah; Kim, Do-Jin; Ahn, Myung-Ju; Lee, Kil Yeon; Sym, Sun Jin; Lim, Myong Choel; Jung, Hun; Cho, Eun Kim; Min, Kyung Wan

2017-03-01

This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients. This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase. Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0%; p = 0.191; CR 73.4 vs 70.4%; p = 0.458). Both the aprepitant and control regimens were generally well tolerated. A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines. ClinicalTrials.gov NCT01636947 ( https://clinicaltrials.Gov/ct2/show/NCT01636947 ).

Rapid case-based mapping of seasonal malaria transmission risk for strategic elimination planning in Swaziland

PubMed Central

2013-01-01

Background As successful malaria control programmes move towards elimination, they must identify residual transmission foci, target vector control to high-risk areas, focus on both asymptomatic and symptomatic infections, and manage importation risk. High spatial and temporal resolution maps of malaria risk can support all of these activities, but commonly available malaria maps are based on parasite rate, a poor metric for measuring malaria at extremely low prevalence. New approaches are required to provide case-based risk maps to countries seeking to identify remaining hotspots of transmission while managing the risk of transmission from imported cases. Methods Household locations and travel histories of confirmed malaria patients during 2011 were recorded through routine surveillance by the Swaziland National Malaria Control Programme for the higher transmission months of January to April and the lower transmission months of May to December. Household locations for patients with no travel history to endemic areas were compared against a random set of background points sampled proportionate to population density with respect to a set of variables related to environment, population density, vector control, and distance to the locations of identified imported cases. Comparisons were made separately for the high and low transmission seasons. The Random Forests regression tree classification approach was used to generate maps predicting the probability of a locally acquired case at 100 m resolution across Swaziland for each season. Results Results indicated that case households during the high transmission season tended to be located in areas of lower elevation, closer to bodies of water, in more sparsely populated areas, with lower rainfall and warmer temperatures, and closer to imported cases than random background points (all p < 0.001). Similar differences were evident during the low transmission season. Maps from the fit models suggested better predictive ability during the high season. Both models proved useful at predicting the locations of local cases identified in 2012. Conclusions The high-resolution mapping approaches described here can help elimination programmes understand the epidemiology of a disappearing disease. Generating case-based risk maps at high spatial and temporal resolution will allow control programmes to direct interventions proactively according to evidence-based measures of risk and ensure that the impact of limited resources is maximized to achieve and maintain malaria elimination. PMID:23398628

Rapid case-based mapping of seasonal malaria transmission risk for strategic elimination planning in Swaziland.

PubMed

Cohen, Justin M; Dlamini, Sabelo; Novotny, Joseph M; Kandula, Deepika; Kunene, Simon; Tatem, Andrew J

2013-02-11

As successful malaria control programmes move towards elimination, they must identify residual transmission foci, target vector control to high-risk areas, focus on both asymptomatic and symptomatic infections, and manage importation risk. High spatial and temporal resolution maps of malaria risk can support all of these activities, but commonly available malaria maps are based on parasite rate, a poor metric for measuring malaria at extremely low prevalence. New approaches are required to provide case-based risk maps to countries seeking to identify remaining hotspots of transmission while managing the risk of transmission from imported cases. Household locations and travel histories of confirmed malaria patients during 2011 were recorded through routine surveillance by the Swaziland National Malaria Control Programme for the higher transmission months of January to April and the lower transmission months of May to December. Household locations for patients with no travel history to endemic areas were compared against a random set of background points sampled proportionate to population density with respect to a set of variables related to environment, population density, vector control, and distance to the locations of identified imported cases. Comparisons were made separately for the high and low transmission seasons. The Random Forests regression tree classification approach was used to generate maps predicting the probability of a locally acquired case at 100 m resolution across Swaziland for each season. Results indicated that case households during the high transmission season tended to be located in areas of lower elevation, closer to bodies of water, in more sparsely populated areas, with lower rainfall and warmer temperatures, and closer to imported cases than random background points (all p < 0.001). Similar differences were evident during the low transmission season. Maps from the fit models suggested better predictive ability during the high season. Both models proved useful at predicting the locations of local cases identified in 2012. The high-resolution mapping approaches described here can help elimination programmes understand the epidemiology of a disappearing disease. Generating case-based risk maps at high spatial and temporal resolution will allow control programmes to direct interventions proactively according to evidence-based measures of risk and ensure that the impact of limited resources is maximized to achieve and maintain malaria elimination.

Ten-year mortality and cardiovascular morbidity in the Finnish Diabetes Prevention Study--secondary analysis of the randomized trial.

PubMed

Uusitupa, Matti; Peltonen, Markku; Lindström, Jaana; Aunola, Sirkka; Ilanne-Parikka, Pirjo; Keinänen-Kiukaanniemi, Sirkka; Valle, Timo T; Eriksson, Johan G; Tuomilehto, Jaakko

2009-05-21

The Finnish Diabetes Prevention Study (DPS) was a randomized controlled trial, which showed that it is possible to prevent type 2 diabetes by lifestyle changes. The aim of the present study was to examine whether the lifestyle intervention had an effect on the ten-year mortality and cardiovascular morbidity in the DPS participants originally randomized either into an intervention or control group. Furthermore, we compared these results with a population-based cohort comprising individuals of varying glucose tolerance states. Middle-aged, overweight people with IGT (n = 522) were randomized into intensive intervention (including physical activity, weight reduction and dietary counseling), or control "mini-intervention" group. Median length of the intervention period was 4 years and the mean follow-up was 10.6 years. The population-based reference study cohort included 1881 individuals (1570 with normal glucose tolerance, 183 with IGT, 59 with screen-detected type 2 diabetes, 69 with previously known type 2 diabetes) with the mean follow-up of 13.8 years. Mortality and cardiovascular morbidity data were collected from the national Hospital Discharge Register and Causes of Death Register. Among the DPS participants who consented for register linkage (n = 505), total mortality (2.2 vs. 3.8 per 1000 person years, hazard ratio HR = 0.57, 95% CI 0.21-1.58) and cardiovascular morbidity (22.9 vs. 22.0 per 1000 person years, HR = 1.04, 95% CI 0.72-1.51) did not differ significantly between the intervention and control groups. Compared with the population-based cohort with impaired glucose tolerance, adjusted HRs were 0.21 (95% CI 0.09-0.52) and 0.39 (95% CI 0.20-0.79) for total mortality, and 0.89 (95% CI 0.62-1.27) and 0.87 (0.60-1.27) for cardiovascular morbidity in the intervention and control groups of the DPS, respectively. The risk of death in DPS combined cohort was markedly lower than in FINRISK IGT cohort (adjusted HR 0.30, 95% CI 0.17-0.54), but there was no significant difference in the risk of CVD (adjusted HR 0.88, 95% CI 0.64-1.21). Lifestyle intervention among persons with IGT did not decrease cardiovascular morbidity during the first 10 years of follow-up. However, the statistical power may not be sufficient to detect small differences between the intervention and control groups. Low total mortality among participants of the DPS compared with individuals with IGT in the general population could be ascribed to a lower cardiovascular risk profile at baseline and regular follow-up. ClinicalTrials.gov NCT00518167.

Guided self-help on the Internet for Turkish migrants with depression: the design of a randomized controlled trial.

PubMed

Unlü, Burçin; Riper, Heleen; van Straten, Annemieke; Cuijpers, Pim

2010-11-04

The Turkish population living in The Netherlands has a high prevalence of psychological complaints and has a high threshold for seeking professional help for these problems. Seeking help through the Internet can overcome these barriers. This project aims to evaluate the effectiveness of a guided self-help problem-solving intervention for depressed Turkish migrants that is culturally adapted and web-based. This study is a randomized controlled trial with two arms: an experimental condition group and a wait list control group. The experimental condition obtains direct access to the guided web-based self-help intervention, which is based on Problem Solving Treatment (PST) and takes 6 weeks to complete. Turkish adults with mild to moderate depressive symptoms will be recruited from the general population and the participants can choose between a Turkish and a Dutch version. The primary outcome measure is the reduction of depressive symptoms, the secondary outcome measures are somatic symptoms, anxiety, acculturation, quality of life and satisfaction. Participants are assessed at baseline, post-test (6 weeks), and 4 months after baseline. Analysis will be conducted on the intention-to-treat sample. This study evaluates the effectiveness of a guided problem-solving intervention for Turkish adults living in The Netherlands that is culturally adapted and web-based. Nederlands Trial Register: NTR2303.

The Danish Cardiovascular Screening Trial (DANCAVAS): study protocol for a randomized controlled trial.

PubMed

Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke; Lambrechtsen, Jess; Steffensen, Flemming Hald; Frost, Lars; Egstrup, Kenneth; Urbonaviciene, Grazina; Busk, Martin; Olsen, Michael Hecht; Mickley, Hans; Hallas, Jesper; Lindholt, Jes Sanddal

2015-12-05

The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. Population-based randomized clinically controlled screening trial. 45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used. One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective. Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group. Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014. A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%. The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. Current Controlled Trials: ISRCTN12157806 (21 March 2015).

The Japanese Guidelines for Breast Cancer Screening.

PubMed

Hamashima, Chisato; Hamashima C, Chisato; Hattori, Masakazu; Honjo, Satoshi; Kasahara, Yoshio; Katayama, Takafumi; Nakai, Masahiro; Nakayama, Tomio; Morita, Takako; Ohta, Koji; Ohnuki, Koji; Sagawa, Motoyasu; Saito, Hiroshi; Sasaki, Seiju; Shimada, Tomoyuki; Sobue, Tomotaka; Suto, Akihiko

2016-05-01

The incidence of breast cancer has progressively increased, making it the leading cause of cancer deaths in Japan. Breast cancer accounts for 20.4% of all new cancers with a reported age-standardized rate of 63.6 per 100 000 women. The Japanese guidelines for breast cancer screening were developed based on a previously established method. The efficacies of mammography with and without clinical breast examination, clinical breast examination and ultrasonography with and without mammography were evaluated. Based on the balance of the benefits and harms, recommendations for population-based and opportunistic screenings were formulated. Five randomized controlled trials of mammographic screening without clinical breast examination were identified for mortality reduction from breast cancer. The overall relative risk for women aged 40-74 years was 0.75 (95% CI: 0.67-0.83). Three randomized controlled trials of mammographic screening with clinical breast examination served as eligible evidence for mortality reduction from breast cancer. The overall relative risk for women aged 40-64 years was 0.87 (95% confidence interval: 0.77-0.98). The major harms of mammographic screening were radiation exposure, false-positive cases and overdiagnosis. Although two case-control studies evaluating mortality reduction from breast cancer were found for clinical breast examination, there was no study assessing the effectiveness of ultrasonography for breast cancer screening. Mammographic screening without clinical breast examination for women aged 40-74 years and with clinical breast examination for women aged 40-64 years is recommended for population-based and opportunistic screenings. Clinical breast examination and ultrasonography are not recommended for population-based screening because of insufficient evidence regarding their effectiveness. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Kā-HOLO Project: a protocol for a randomized controlled trial of a native cultural dance program for cardiovascular disease prevention in Native Hawaiians.

PubMed

Kaholokula, Joseph Keawe'aimoku; Look, Mele A; Wills, Thomas A; de Silva, Māpuana; Mabellos, Tricia; Seto, Todd B; Ahn, Hyeong Jun; Sinclair, Ka'imi A; Buchwald, Dedra

2017-04-17

As a major risk factor for cardiovascular and cerebrovascular disease (CVD), hypertension affects 33% of U.S. adults. Relative to other US races and ethnicities, Native Hawaiians have a high prevalence of hypertension and are 3 to 4 times more likely to have CVD. Effective, culturally-relevant interventions are needed to address CVD risk in this population. Investigators of the Kā-HOLO Project developed a study design to test the efficacy of an intervention that uses hula, a traditional Hawaiian dance, to increase physical activity and reduce CVD risk. A 2-arm randomized controlled trial with a wait-list control design will be implemented to test a 6-month intervention based on hula to manage blood pressure and reduce CVD risk in 250 adult Native Hawaiians with diagnosed hypertension. Half of the sample will be randomized to each arm, stratified across multiple study sites. Primary outcomes are reduction in systolic blood pressure and improvement in CVD risk as measured by the Framingham Risk Score. Other psychosocial and sociocultural measures will be included to determine mediators of intervention effects on primary outcomes. Assessments will be conducted at baseline, 3 months, and 6 months for all participants, and at 12 months for intervention participants only. This trial will elucidate the efficacy of a novel hypertension management program designed to reduce CVD risk in an indigenous population by using a cultural dance form as its physical activity component. The results of this culturally-based intervention will have implications for other indigenous populations globally and will offer a sustainable, culturally-relevant means of addressing CVD disparities. ClinicalTrials.gov: NCT02620709 , registration date November 23, 2015.

Does daily vitamin D 800 IU and calcium 1000 mg supplementation decrease the risk of falling in ambulatory women aged 65-71 years? A 3-year randomized population-based trial (OSTPRE-FPS).

PubMed

Kärkkäinen, Matti K; Tuppurainen, Marjo; Salovaara, Kari; Sandini, Lorenzo; Rikkonen, Toni; Sirola, Joonas; Honkanen, Risto; Arokoski, Jari; Alhava, Esko; Kröger, Heikki

2010-04-01

The hypothesis was that the calcium and vitamin D supplementation prevents falls at the population level. The OSTPRE-FPS was a randomized population-based open-trial with 3-year follow-up. The supplementation group (n=1566) received daily cholecalciferol 800IU+calcium carbonate 1000mg, while the control group (n=1573) received no supplementation or placebo. A randomly selected subsample of 593 subjects underwent a detailed measurement program including serum 25(OH)D measurements. The occurrence of falls was the primary outcome of the study. The participants in the subsample were telephoned at 4 months intervals and the rest of the trial population was interviewed by phone once a year. In the entire trial population (ETP), there were 812 women with 1832 falls in the intervention group and 833 women with 1944 falls in the control group (risk ratio was 0.98, 95% CI 0.92-1.05, P=0.160). The supplementation was not associated with single or multiple falls in the ETP. However, in the subsample, multiple fall incidence decreased by 30% (odds ratio (OR) 0.70, 95% CI 0.50-0.97, P=0.034) in the supplementation group. Further, the supplementation decreased the incidence of multiple falls requiring medical attention (OR 0.72, 95% CI 0.53-0.97, P=0.031) in the ETP. The mean compliance in the entire trial population was 78% and in the subsample 79%. Overall, the primary analysis showed no association between calcium and vitamin D supplementation and risk of falls. However, the results of a post hoc analysis suggested that there was a decreased risk of multiple falls requiring medical attention: this finding requires confirmation. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Chieh Mei Ching Yi: A randomized controlled trial of a culturally tailored HIV prevention intervention for Chinese massage parlor women in Los Angeles.

PubMed

Takahashi, Lois M; Tobin, Karin E; To, Stacy; Ou, Samuel; Ma, Chui Hing Helen; Ao, Fiona Ka Wa; Candelario, Jury

2013-12-01

Asian heterosexual women in the U.S. have experienced relative rising HIV case rates, but there remain few studies and no evidence-based interventions that focus on this population. This study was a randomized controlled trial of a gender and ethnically tailored HIV prevention intervention for monolingual Chinese-speaking women who work as masseuses in Los Angeles. The intervention was two group-based sessions focused on HIV risk and prevention knowledge and condom skills. The control condition was a single-session HIV review. Participants were recruited using newspaper advertisements and referrals from agencies and massage schools. Two hundred women were randomly assigned to one of each condition. Retention in both conditions exceeded 90% at 3-month follow-up. Participants in both conditions demonstrated increases in knowledge on how to use male and female condoms. These effects were sustained at 3-month follow-up. The results highlight the possible efficacy of a one-workshop intervention in increasing HIV knowledge, but that more intensive participant interaction may be needed for improved condom use knowledge.

Preliminary evaluation of a self-directed video-based 1-2-3 Magic parenting program: a randomized controlled trial.

PubMed

Porzig-Drummond, Renata; Stevenson, Richard J; Stevenson, Caroline

2015-03-01

The current study examined the effectiveness of a self-directed video-based format of the 1-2-3 Magic parenting program in reducing dysfunctional parenting and child problem behaviors. Eighty-four parents of children aged 2-10 were randomly assigned to either the intervention group (n = 43) or the waitlist control group (n = 41). Participants in the intervention group reported significantly less problem behaviors for their children, and significantly less dysfunctional parenting, at post-intervention when compared to the control group. The results were maintained at 6-month follow-up. There was no significant change on measures of parental adjustment for either group. The current results provide preliminary support for the conclusion that the video-based self-directed format of the 1-2-3 Magic parenting program is suitable as an entry-level intervention in a multi-level intervention model and is suitable for inclusion in a population approach to parenting program delivery. Copyright © 2015 Elsevier Ltd. All rights reserved.

Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.

PubMed

Brody, Carinne; Tuot, Sovannary; Chhoun, Pheak; Swendenman, Dallas; Kaplan, Kathryn C; Yi, Siyan

2018-04-19

In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia. A two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV). If the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile-phone-based behavior change intervention using SMS/VMs to support linkage to SRH services in Cambodia. Lastly, we are working with a hidden, hard-to-reach, and dynamic population with which existing methods of outreach have not been fully successful. Clinical trials.gov, NCT03117842 . Registered on 31 March 2017.

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

PubMed

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

2015-03-01

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

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

PubMed Central

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

2015-01-01

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

Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada).

PubMed

McGrath, Patrick J; Sourander, Andre; Lingley-Pottie, Patricia; Ristkari, Terja; Cunningham, Charles; Huttunen, Jukka; Filbert, Katharine; Aromaa, Minna; Corkum, Penny; Hinkka-Yli-Salomäki, Susanna; Kinnunen, Malin; Lampi, Katja; Penttinen, Anne; Sinokki, Atte; Unruh, Anita; Vuorio, Jenni; Watters, Carolyn

2013-10-21

Oppositional Defiant Disorder (ODD) is characterized by angry and noncompliant behaviour. It is the most common disruptive behaviour disorder (DBD), with prevalence estimates of 6-9% for preschoolers and is closely linked to several long-term difficulties, including disorders of conduct, mood, anxiety, impulse-control, and substance abuse. ODD in children is related to parental depression, family dysfunction, and impairments in parental work performance. Children displaying early DBDs exhibit more symptoms of greater severity, more frequent offences, and commit more serious crimes later in life. The goal of the Strongest Families Finland Canada (SFFC) Smart Website intervention research program is to develop and evaluate an affordable, accessible, effective secondary prevention parent training program for disruptive behaviour in preschoolers to prevent the negative sequelae of ODD. Strongest Families is an 11-session program with two booster sessions that focuses on teaching skills to: strengthen parent-child relationships; reinforce positive behaviour; reduce conflict; manage daily transitions; plan for potentially problematic situations; promote emotional regulation and pro-social behaviour and decrease antisocial behaviour. This protocol paper describes an ongoing population-based randomized controlled trial (RCT) of high-risk 4 year-olds attending well-child clinics in Turku, Finland and environs to examine the effectiveness of the Strongest Families Smart Website intervention compared to an Education Control condition. Randomization consists of a 1:1 ratio for intervention versus the education group, stratified by the child's sex. The participants randomized to the intervention group receive access to the Strongest Families Smart Website and weekly telephone coaching sessions. The participants randomized to the Education Control condition receive access to a static website with parenting tips. Children are followed using parental and daycare teacher measures at 6 and 12 months after randomization. The Strongest Families Smart Website intervention is hypothesized to improve parenting skills, reduce child disruptive behaviour, reduce parental distress and improve family functioning. These results will likely inform subsequent investigations, public policy, and early treatment of childhood disruptive behaviour problems. ClinicalTrials.gov # NCT01750996.

Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada)

PubMed Central

2013-01-01

Background Oppositional Defiant Disorder (ODD) is characterized by angry and noncompliant behaviour. It is the most common disruptive behaviour disorder (DBD), with prevalence estimates of 6-9% for preschoolers and is closely linked to several long-term difficulties, including disorders of conduct, mood, anxiety, impulse-control, and substance abuse. ODD in children is related to parental depression, family dysfunction, and impairments in parental work performance. Children displaying early DBDs exhibit more symptoms of greater severity, more frequent offences, and commit more serious crimes later in life. The goal of the Strongest Families™ Finland Canada (SFFC) Smart Website intervention research program is to develop and evaluate an affordable, accessible, effective secondary prevention parent training program for disruptive behaviour in preschoolers to prevent the negative sequelae of ODD. Strongest Families is an 11-session program with two booster sessions that focuses on teaching skills to: strengthen parent–child relationships; reinforce positive behaviour; reduce conflict; manage daily transitions; plan for potentially problematic situations; promote emotional regulation and pro-social behaviour and decrease antisocial behaviour. Methods/design This protocol paper describes an ongoing population-based randomized controlled trial (RCT) of high-risk 4 year-olds attending well-child clinics in Turku, Finland and environs to examine the effectiveness of the Strongest Families Smart Website intervention compared to an Education Control condition. Randomization consists of a 1:1 ratio for intervention versus the education group, stratified by the child’s sex. The participants randomized to the intervention group receive access to the Strongest Families Smart Website and weekly telephone coaching sessions. The participants randomized to the Education Control condition receive access to a static website with parenting tips. Children are followed using parental and daycare teacher measures at 6 and 12 months after randomization. Discussion The Strongest Families Smart Website intervention is hypothesized to improve parenting skills, reduce child disruptive behaviour, reduce parental distress and improve family functioning. These results will likely inform subsequent investigations, public policy, and early treatment of childhood disruptive behaviour problems. Trial registration ClinicalTrials.gov # NCT01750996 PMID:24139323

Hierarchical model analysis of the Atlantic Flyway Breeding Waterfowl Survey

USGS Publications Warehouse

Sauer, John R.; Zimmerman, Guthrie S.; Klimstra, Jon D.; Link, William A.

2014-01-01

We used log-linear hierarchical models to analyze data from the Atlantic Flyway Breeding Waterfowl Survey. The survey has been conducted by state biologists each year since 1989 in the northeastern United States from Virginia north to New Hampshire and Vermont. Although yearly population estimates from the survey are used by the United States Fish and Wildlife Service for estimating regional waterfowl population status for mallards (Anas platyrhynchos), black ducks (Anas rubripes), wood ducks (Aix sponsa), and Canada geese (Branta canadensis), they are not routinely adjusted to control for time of day effects and other survey design issues. The hierarchical model analysis permits estimation of year effects and population change while accommodating the repeated sampling of plots and controlling for time of day effects in counting. We compared population estimates from the current stratified random sample analysis to population estimates from hierarchical models with alternative model structures that describe year to year changes as random year effects, a trend with random year effects, or year effects modeled as 1-year differences. Patterns of population change from the hierarchical model results generally were similar to the patterns described by stratified random sample estimates, but significant visibility differences occurred between twilight to midday counts in all species. Controlling for the effects of time of day resulted in larger population estimates for all species in the hierarchical model analysis relative to the stratified random sample analysis. The hierarchical models also provided a convenient means of estimating population trend as derived statistics from the analysis. We detected significant declines in mallard and American black ducks and significant increases in wood ducks and Canada geese, a trend that had not been significant for 3 of these 4 species in the prior analysis. We recommend using hierarchical models for analysis of the Atlantic Flyway Breeding Waterfowl Survey.

A randomized controlled open trial of population-based disease and case management in a Medicare Plus Choice health maintenance organization.

PubMed

Martin, David C; Berger, Marc L; Anstatt, David T; Wofford, Jonathan; Warfel, DeAnn; Turpin, Robin S; Cannuscio, Carolyn C; Teutsch, Steven M; Mansheim, Bernard J

2004-10-01

The object of this study was to examine the effect of population-based disease management and case management on resource use, self-reported health status, and member satisfaction with and retention in a Medicare Plus Choice health maintenance organization (HMO). Study design consisted of a prospective, randomized controlled open trial of 18 months' duration. Participants were 8504 Medicare beneficiaries aged 65 and older who had been continuously enrolled for at least 12 months in a network model Medicare Plus Choice HMO serving a contiguous nine-county metropolitan area. Members were care managed with an expert clinical information system and frequent telephone contact. Main outcomes included self-reported health status measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), resource use measured by admission rates and bed-days per thousand per year, member satisfaction, and costs measured by paid claims. More favorable outcomes occurred in the intervention group for satisfaction with the health plan (P < .01) and the social function domain as measured by SF-36 (P = .04). There was no difference in member retention or mortality between groups. Use of skilled nursing home services was significantly lower in the intervention group than in the control (616 vs 747 days per thousand members per year, P = .02). This reduction, however, did not lead to lower mean total expenditures in the intervention group compared with the control (6828 dollars per member for 18 months vs 7001 dollars, P = .61). Population-based disease management and case management led to improved self-reported satisfaction and social function but not to a global net decrease in resource use or improved member retention.

Insulation workers in Belfast. 1. Comparison of a random sample with a control population1

PubMed Central

Wallace, William F. M.; Langlands, Jean H. M.

1971-01-01

Wallace, W. F. M., and Langlands, J. H. M. (1971).Brit. J. industr. Med.,28, 211-216. Insulation workers in Belfast. 1. Comparison of a random sample with a control population. A sample of 50 men was chosen at random from the population of asbestos insulators in Belfast and matched with a control series of men of similar occupational group with respect to age, height, and smoking habit. Significantly more of the insulators complained of cough and sputum and had basal rales on examination. Clubbing was assessed by means of measurements of the hyponychial angle of both index fingers. These angles were significantly greater in the group of insulators. Twenty-one insulators had ϰ-rays which showed pleural calcification with or without pulmonary fibrosis; one control ϰ-ray showed pulmonary fibrosis. The insulators had no evidence of airways obstruction but static lung volume was reduced and their arterial oxygen tension was lower than that of the controls and their alveolar-arterial oxygen gradient was greater. PMID:5557841

Healthy Learning Mind - a school-based mindfulness and relaxation program: a study protocol for a cluster randomized controlled trial.

PubMed

Volanen, Salla-Maarit; Lassander, Maarit; Hankonen, Nelli; Santalahti, Päivi; Hintsanen, Mirka; Simonsen, Nina; Raevuori, Anu; Mullola, Sari; Vahlberg, Tero; But, Anna; Suominen, Sakari

2016-07-11

Mindfulness has shown positive effects on mental health, mental capacity and well-being among adult population. Among children and adolescents, previous research on the effectiveness of mindfulness interventions on health and well-being has shown promising results, but studies with methodologically sound designs have been called for. Few intervention studies in this population have compared the effectiveness of mindfulness programs to alternative intervention programs with adequate sample sizes. Our primary aim is to explore the effectiveness of a school-based mindfulness intervention program compared to a standard relaxation program among a non-clinical children and adolescent sample, and a non-treatment control group in school context. In this study, we systematically examine the effects of mindfulness intervention on mental well-being (primary outcomes being resilience; existence/absence of depressive symptoms; experienced psychological strengths and difficulties), cognitive functions, psychophysiological responses, academic achievements, and motivational determinants of practicing mindfulness. The design is a cluster randomized controlled trial with three arms (mindfulness intervention group, active control group, non-treatment group) and the sample includes 59 Finnish schools and approx. 3 000 students aged 12-15 years. Intervention consists of nine mindfulness based lessons, 45 mins per week, for 9 weeks, the dose being identical in active control group receiving standard relaxation program called Relax. The programs are delivered by 14 educated facilitators. Students, their teachers and parents will fill-in the research questionnaires before and after the intervention, and they will all be followed up 6 months after baseline. Additionally, students will be followed 12 months after baseline. For longer follow-up, consent to linking the data to the main health registers has been asked from students and their parents. The present study examines systematically the effectiveness of a school-based mindfulness program compared to a standard relaxation program, and a non-treatment control group. A strength of the current study lies in its methodologically rigorous, randomized controlled study design, which allows novel evidence on the effectiveness of mindfulness over and above a standard relaxation program. ISRCTN18642659 . Retrospectively registered 13 October 2015.

Prevalence of sexually transmitted infections and bacterial vaginosis among women in sub-Saharan Africa: An individual participant data meta-analysis of 18 HIV prevention studies

PubMed Central

Morrison, Charles S.; Chen, Pai-Lien; Kwok, Cynthia; McCormack, Sheena; McGrath, Nuala; Watson-Jones, Deborah; Gottlieb, Sami L.

2018-01-01

Background Estimates of sexually transmitted infection (STI) prevalence are essential for efforts to prevent and control STIs. Few large STI prevalence studies exist, especially for low- and middle-income countries (LMICs). Our primary objective was to estimate the prevalence of chlamydia, gonorrhea, trichomoniasis, syphilis, herpes simplex virus type 2 (HSV-2), and bacterial vaginosis (BV) among women in sub-Saharan Africa by age, region, and population type. Methods and findings We analyzed individual-level data from 18 HIV prevention studies (cohort studies and randomized controlled trials; conducted during 1993–2011), representing >37,000 women, that tested participants for ≥1 selected STIs or BV at baseline. We used a 2-stage meta-analysis to combine data. After calculating the proportion of participants with each infection and standard error by study, we used a random-effects model to obtain a summary mean prevalence of each infection and 95% confidence interval (CI) across ages, regions, and population types. Despite substantial study heterogeneity for some STIs/populations, several patterns emerged. Across the three primary region/population groups (South Africa community-based, Southern/Eastern Africa community-based, and Eastern Africa higher-risk), prevalence was higher among 15–24-year-old than 25–49-year-old women for all STIs except HSV-2. In general, higher-risk populations had greater prevalence of gonorrhea and syphilis than clinic/community-based populations. For chlamydia, prevalence among 15–24-year-olds was 10.3% (95% CI: 7.4%, 14.1%; I2 = 75.7%) among women specifically recruited from higher-risk settings for HIV in Eastern Africa and was 15.1% (95% CI: 12.7%, 17.8%; I2 = 82.3%) in South African clinic/community-based populations. Among clinic/community-based populations, prevalence was generally greater in South Africa than in Southern/Eastern Africa for most STIs; for gonorrhea, prevalence among 15–24-year-olds was 4.6% (95% CI: 3.3%, 6.4%; I2 = 82.8%) in South Africa and was 1.7% (95% CI: 1.2%, 2.6%; I2 = 55.2%) in Southern/Eastern Africa. Across the three primary region/population groups, HSV-2 and BV prevalence was high among 25–49-year-olds (ranging from 70% to 83% and 33% to 44%, respectively). The main study limitation is that the data are not from random samples of the target populations. Conclusions Combining data from 18 HIV prevention studies, our findings highlight important features of STI/BV epidemiology among sub-Saharan African women. This methodology can be used where routine STI surveillance is limited and offers a new approach to obtaining critical information on STI and BV prevalence in LMICs. PMID:29485986

Immunization of Epidemics in Multiplex Networks

PubMed Central

Zhao, Dawei; Wang, Lianhai; Li, Shudong; Wang, Zhen; Wang, Lin; Gao, Bo

2014-01-01

Up to now, immunization of disease propagation has attracted great attention in both theoretical and experimental researches. However, vast majority of existing achievements are limited to the simple assumption of single layer networked population, which seems obviously inconsistent with recent development of complex network theory: each node could possess multiple roles in different topology connections. Inspired by this fact, we here propose the immunization strategies on multiplex networks, including multiplex node-based random (targeted) immunization and layer node-based random (targeted) immunization. With the theory of generating function, theoretical analysis is developed to calculate the immunization threshold, which is regarded as the most critical index for the effectiveness of addressed immunization strategies. Interestingly, both types of random immunization strategies show more efficiency in controlling disease spreading on multiplex Erdös-Rényi (ER) random networks; while targeted immunization strategies provide better protection on multiplex scale-free (SF) networks. PMID:25401755

Immunization of epidemics in multiplex networks.

PubMed

Zhao, Dawei; Wang, Lianhai; Li, Shudong; Wang, Zhen; Wang, Lin; Gao, Bo

2014-01-01

Up to now, immunization of disease propagation has attracted great attention in both theoretical and experimental researches. However, vast majority of existing achievements are limited to the simple assumption of single layer networked population, which seems obviously inconsistent with recent development of complex network theory: each node could possess multiple roles in different topology connections. Inspired by this fact, we here propose the immunization strategies on multiplex networks, including multiplex node-based random (targeted) immunization and layer node-based random (targeted) immunization. With the theory of generating function, theoretical analysis is developed to calculate the immunization threshold, which is regarded as the most critical index for the effectiveness of addressed immunization strategies. Interestingly, both types of random immunization strategies show more efficiency in controlling disease spreading on multiplex Erdös-Rényi (ER) random networks; while targeted immunization strategies provide better protection on multiplex scale-free (SF) networks.

[Use of new antidiabetics in the elderly population].

PubMed

Besse, Sarah; Besse, Arun; Jornayvaz, François R

2016-06-01

Over the last few years, we have noticed the arrival on the market of new antidiabetic treatments. These represent an potential advantage because of the increase in the prevalence of type 2 diabetes, particularly in the elderly population. Nevertheless, elderly patients have a number of frailties that should be considered in the treatment of this condition. There is a lack of literature in this population as elderly are frequently excluded from randomized controlled trials. Therefore, guidelines were developed based on the consensus of experts in geriatrics and diabetology for this specific population. We have to consider the potential benefits and adverse effects of the new antidiabetics in older patients.

Erectile Dysfunction in Patients with Sleep Apnea--A Nationwide Population-Based Study.

PubMed

Chen, Chia-Min; Tsai, Ming-Ju; Wei, Po-Ju; Su, Yu-Chung; Yang, Chih-Jen; Wu, Meng-Ni; Hsu, Chung-Yao; Hwang, Shang-Jyh; Chong, Inn-Wen; Huang, Ming-Shyan

2015-01-01

Increased incidence of erectile dysfunction (ED) has been reported among patients with sleep apnea (SA). However, this association has not been confirmed in a large-scale study. We therefore performed a population-based cohort study using Taiwan National Health Insurance (NHI) database to investigate the association of SA and ED. From the database of one million representative subjects randomly sampled from individuals enrolled in the NHI system in 2010, we identified adult patients having SA and excluded those having a diagnosis of ED prior to SA. From these suspected SA patients, those having SA diagnosis after polysomnography were defined as probable SA patients. The dates of their first SA diagnosis were defined as their index dates. Each SA patient was matched to 30 randomly-selected, age-matched control subjects without any SA diagnosis. The control subjects were assigned index dates as their corresponding SA patients, and were ensured having no ED diagnosis prior to their index dates. Totally, 4,835 male patients with suspected SA (including 1,946 probable SA patients) were matched to 145,050 control subjects (including 58,380 subjects matched to probable SA patients). The incidence rate of ED was significantly higher in probable SA patients as compared with the corresponding control subjects (5.7 vs. 2.3 per 1000 patient-year; adjusted incidence rate ratio = 2.0 [95% CI: 1.8-2.2], p<0.0001). The cumulative incidence was also significantly higher in the probable SA patients (p<0.0001). In multivariable Cox regression analysis, probable SA remained a significant risk factor for the development of ED after adjusting for age, residency, income level and comorbidities (hazard ratio = 2.0 [95%CI: 1.5-2.7], p<0.0001). In line with previous studies, this population-based large-scale study confirmed an increased ED incidence in SA patients in Chinese population. Physicians need to pay attention to the possible underlying SA while treating ED patients.

Complementary nonparametric analysis of covariance for logistic regression in a randomized clinical trial setting.

PubMed

Tangen, C M; Koch, G G

1999-03-01

In the randomized clinical trial setting, controlling for covariates is expected to produce variance reduction for the treatment parameter estimate and to adjust for random imbalances of covariates between the treatment groups. However, for the logistic regression model, variance reduction is not obviously obtained. This can lead to concerns about the assumptions of the logistic model. We introduce a complementary nonparametric method for covariate adjustment. It provides results that are usually compatible with expectations for analysis of covariance. The only assumptions required are based on randomization and sampling arguments. The resulting treatment parameter is a (unconditional) population average log-odds ratio that has been adjusted for random imbalance of covariates. Data from a randomized clinical trial are used to compare results from the traditional maximum likelihood logistic method with those from the nonparametric logistic method. We examine treatment parameter estimates, corresponding standard errors, and significance levels in models with and without covariate adjustment. In addition, we discuss differences between unconditional population average treatment parameters and conditional subpopulation average treatment parameters. Additional features of the nonparametric method, including stratified (multicenter) and multivariate (multivisit) analyses, are illustrated. Extensions of this methodology to the proportional odds model are also made.

Influence of population versus convenience sampling on sample characteristics in studies of cognitive aging.

PubMed

Brodaty, Henry; Mothakunnel, Annu; de Vel-Palumbo, Melissa; Ames, David; Ellis, Kathryn A; Reppermund, Simone; Kochan, Nicole A; Savage, Greg; Trollor, Julian N; Crawford, John; Sachdev, Perminder S

2014-01-01

We examined whether differences in findings of studies examining mild cognitive impairment (MCI) were associated with recruitment methods by comparing sample characteristics in two contemporaneous Australian studies, using population-based and convenience sampling. The Sydney Memory and Aging Study invited participants randomly from the electoral roll in defined geographic areas in Sydney. The Australian Imaging, Biomarkers and Lifestyle Study of Ageing recruited cognitively normal (CN) individuals via media appeals and MCI participants via referrals from clinicians in Melbourne and Perth. Demographic and cognitive variables were harmonized, and similar diagnostic criteria were applied to both samples retrospectively. CN participants recruited via convenience sampling were younger, better educated, more likely to be married and have a family history of dementia, and performed better cognitively than those recruited via population-based sampling. MCI participants recruited via population-based sampling had better memory performance and were less likely to carry the apolipoprotein E ε4 allele than clinically referred participants but did not differ on other demographic variables. A convenience sample of normal controls is likely to be younger and better functioning and that of an MCI group likely to perform worse than a purportedly random sample. Sampling bias should be considered when interpreting findings. Copyright © 2014 Elsevier Inc. All rights reserved.

Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial.

PubMed

Ruggiero, Kenneth J; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F; Davidson, Tatiana M; Amstadter, Ananda B; Carpenter, Matthew J; Saunders, Benjamin E; Kilpatrick, Dean G; Resnick, Heidi S

2015-09-01

To assess the efficacy of Bounce Back Now (BBN), a modular, Web-based intervention for disaster-affected adolescents and their parents. A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and several areas in Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study Web portal irrespective of mental health status at baseline. Families who accessed the Web portal were assigned randomly to 1 of 3 groups: BBN, which featured modules for adolescents and parents targeting adolescents' mental health symptoms; BBN plus additional modules targeting parents' mental health symptoms; or assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Nearly 50% of families accessed the Web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B = -0.24, SE = 0.08, p < .01) and depressive symptoms (B = -0.23, SE = 0.09, p < .01). Post hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental versus control conditions at 12-month follow-up (PTSD: B = -0.36, SE = 0.19, p = .06; depressive symptoms: B = -0.42, SE = 0.19, p = 0.03). A time × condition interaction also was found that favored the BBN versus BBN + parent self-help condition for PTSD symptoms (B = 0.30, SE = 0.12, p = .02) but not depressive symptoms (B = 0.12, SE = 0.12, p = .33). Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. Web-based Intervention for Disaster-Affected Youth and Families; http://clinicaltrials.gov; NCT01606514. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. All rights reserved.

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

The NordICC Study: Rationale and design of a randomized trial on colonoscopy screening for colorectal cancer

PubMed Central

F.Kaminski, Michal; Bretthauer, Michael; Zauber, Ann G.; Kuipers, Ernst J.; Adami, Hans-Olov; van Ballegooijen, Marjolein; Regula, Jaroslaw; van Leerdam, Monique; Stefansson, Tryggvi; Påhlman, Lars; Dekker, Evelien; Hernán, Miguel A.; Garborg, Kjetil; Hoff, Geir

2017-01-01

Background While colonoscopy screening is widely used in several European countries and the United States, no randomised trials exist to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on CRC incidence and mortality. This paper describes the rationale and design of the NordICC trial. Material and methods Men and women age 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. Results The primary endpoints of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow up. We hypothesize a 50% CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50% compliance, yielding a 25% mortality reduction among those invited to screening. For 90% power and a two-sided alpha level of 0.05, using a 2:1 randomisation, 45,600 individuals will be randomised to control, and 22,800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10 years follow-up. Conclusions The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population. PMID:22723185

Acceptance and Commitment Therapy versus Cognitive Therapy for the Treatment of Comorbid Eating Pathology

ERIC Educational Resources Information Center

Juarascio, Adrienne S.; Forman, Evan M.; Herbert, James D.

2010-01-01

Previous research has indicated that although eating pathology is prevalent in college populations, both CBT and non-CBT-based therapies achieve only limited effectiveness. The current study examined several questions related to the treatment of eating pathology within the context of a larger randomized controlled trial that compared standard CBT…

Internet Therapy versus Internet Self-Help versus No Treatment for Problematic Alcohol Use: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Blankers, Matthijs; Koeter, Maarten W. J.; Schippers, Gerard M.

2011-01-01

Objective: Problematic alcohol use is the third leading contributor to the global burden of disease, partly because the majority of problem drinkers are not receiving treatment. Internet-based alcohol interventions attract an otherwise untreated population, but their effectiveness has not yet been established. The current study examined the…

Mindfulness Training for Health Profession Students-The Effect of Mindfulness Training on Psychological Well-Being, Learning and Clinical Performance of Health Professional Students: A Systematic Review of Randomized and Non-randomized Controlled Trials.

PubMed

McConville, Janet; McAleer, Rachael; Hahne, Andrew

High levels of stress have been identified in medical students and increasingly in other health profession student population groups. As stress can affect psychological well-being and interfere with learning and clinical performance, there is a clear argument for universities to include health professional student well-being as an outcome in core curriculum. Mindfulness training is a potential construct to manage stress and enhance academic success. The aims of this systematic review were to assess the effectiveness of mindfulness training in medical and other health professional student population groups and to compare the effectiveness of the different mindfulness-based programs. A literature search was completed using The Cochrane library, Medline, Cinahl, Embase, Psychinfo, and ERIC (proquest) electronic databases from inception to June 2016. Randomized and non-randomized controlled trials were included. Of the potential 5355 articles, 19 met the inclusion criteria. Studies focused on medical (n = 10), nursing (n = 4), social work (n = 1), psychology (n = 1), and medical plus other health (n = 3) students. Interventions were based on mindfulness. The 19 studies included 1815 participants. Meta-analysis was performed evaluating the effect of mindfulness training on mindfulness, anxiety, depression, stress, mood, self-efficacy, and empathy. The effect of mindfulness on academic performance was discussed. Mindfulness-based interventions decrease stress, anxiety, and depression and improve mindfulness, mood, self-efficacy, and empathy in health profession students. Due to the range of presentation options, mindfulness training can be relatively easily adapted and integrated into health professional training programs. Copyright © 2017 Elsevier Inc. All rights reserved.

A Randomized Trial of a Diet and Exercise Intervention for Overweight and Obese Women from Economically Disadvantaged Neighborhoods: Sisters Taking Action for Real Success (STARS)

PubMed Central

Wilcox, Sara; Sharpe, Patricia A.; Parra-Medina, Deborah; Granner, Michelle; Hutto, Brent

2011-01-01

Background Lower socioeconomic status at both the individual and neighborhood level is associated with increased health risks. Weight loss can reduce this risk, but few high quality weight loss studies target this population. Objectives STARS tests a culturally-appropriate, group-based behavioral and social support intervention on body weight and waist circumference in women from financially disadvantaged neighborhoods. Design A stratified (by BMI) randomized trial. Randomization to group was generated by a random numbers table with allocation concealment by opaque envelopes. Methods Participants 25–50 years who had a BMI ≥ 25 kg/m2 and a waist circumference ≥ 88 cm were recruited from 18 census tracts in Columbia, SC with high rates of poverty between November 2008 and November 2010. All participants received a dietary and exercise counseling session. Intervention participants then receive 16 theoretically-based and tailored weekly group sessions followed by 8 weeks of telephone maintenance counseling. Control participants receive 16 weekly health education mailings. Measurements correspond to baseline, post-group intervention, and post-telephone counseling, and for intervention participants, after a 12-week no-contact period. Measurement staff was blinded to group assignment. Results Participants (N=155; n=80 intervention, n=75 minimal intervention control) were primarily African American (86.5%) and averaged 38.9 years with a mean BMI of 40.1 kg/m2 and waist circumference of 115.4 cm. Food insecurity was reported by 43% of participants. Summary STARS targets an underserved population with an innovative, tailored, and theoretically-grounded, group-based intervention followed by telephone maintenance. If effective, the approach has the potential to be feasible and cost-effective for community delivery. PMID:21864718

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

PubMed Central

2010-01-01

Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302 PMID:20334685

Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.

PubMed

Hirai, Kei; Ishikawa, Yoshiki; Fukuyoshi, Jun; Yonekura, Akio; Harada, Kazuhiro; Shibuya, Daisuke; Yamamoto, Seiichiro; Mizota, Yuri; Hamashima, Chisato; Saito, Hiroshi

2016-05-24

The purpose of this study was to examine the effectiveness and cost-efficiency of a tailored message intervention compared with a non-tailored message intervention for increasing colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program. After a baseline survey for psychological segmentation, 2140 eligible individuals were randomly assigned either to a group with a tailored matched-message condition (N = 356), a group with a non-tailored unmatched-message condition (N = 355), or to two control groups, one using a typical message with a professional design (N = 717) and one without a professional design (N = 712). The main outcome measure was attendance rates in a community-organized CRC screening program within five months of receiving a print reminder. There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219). The cost of a one-person increase in FOBT screening was 3,740 JPY for the tailored matched-message condition, while it was 2,747 JPY for the control. A tailored-message intervention for segmented individuals designed to increase CRC screening rates in a community-based client reminder program was significantly effective compared to a usual reminder, but not more effective than an unmatched message in a randomized controlled trial, and was not sufficiently effective to highlight its value from a cost perspective. Therefore, the tailored intervention including target segmentation needs to be improved for future implementation in a CRC screening program for a non-adherent population. UMIN Clinical Trials Registry UMIN000004384 . Date of Registration: March 2011.

Babies Living Safe & Smokefree: randomized controlled trial of a multilevel multimodal behavioral intervention to reduce low-income children's tobacco smoke exposure.

PubMed

Collins, Bradley N; Lepore, Stephen J

2017-03-14

Addressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations. This trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the "Ask, Advise, Refer (AAR)" best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1) The multimodal behavioral intervention (MBI) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling, mobile app, and multimedia text messages about improving nutrition. The control condition also receives a referral to the state smoking cessation quitline. This study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. Clinicaltrials.gov NCT02602288 . Registered 9 November 2015.

A Community-Based Randomized Trial of Hepatitis B Screening Among High-Risk Vietnamese Americans.

PubMed

Ma, Grace X; Fang, Carolyn Y; Seals, Brenda; Feng, Ziding; Tan, Yin; Siu, Philip; Yeh, Ming Chin; Golub, Sarit A; Nguyen, Minhhuyen T; Tran, Tam; Wang, Minqi

2017-03-01

To evaluate the effectiveness of a community-based liver cancer prevention program on hepatitis B virus (HBV) screening among low-income, underserved Vietnamese Americans at high risk. We conducted a cluster randomized trial involving 36 Vietnamese community-based organizations and 2337 participants in Pennsylvania, New Jersey, and New York City between 2009 and 2014. We randomly assigned 18 community-based organizations to a community-based multilevel HBV screening intervention (n = 1131). We randomly assigned the remaining 18 community-based organizations to a general cancer education program (n = 1206), which included information about HBV-related liver cancer prevention. We assessed HBV screening rates at 6-month follow-up. Intervention participants were significantly more likely to have undergone HBV screening (88.1%) than were control group participants (4.6%). In a Cochran-Mantel-Haenszel analysis, the intervention effect on screening outcomes remained statistically significant after adjustment for demographic and health care access variables, including income, having health insurance, having a regular health provider, and English proficiency. A community-based, culturally appropriate, multilevel HBV screening intervention effectively increases screening rates in a high-risk, hard-to-reach Vietnamese American population.

Sexual risk reduction among non-injection drug users: report of a randomized controlled trial.

PubMed

Castor, Delivette; Pilowsky, Daniel J; Hadden, Bernadette; Fuller, Crystal; Ompad, Danielle C; de Leon, Cora L; Neils, Greg; Hoepner, Lori; Andrews, Howard F; Latkin, Carl; Hoover, Donald R

2010-01-01

We conducted a randomized controlled trial of a sexual risk-reduction intervention targeting non-injection drug users (NIDUs) and members of their drug-use/sexual networks (N=270). The intervention was based primarily on the social-influencing approach, and was delivered in four sessions. Sexual risk behaviors were examined at baseline, and 3, 6, 9, and 12 months after the completion of the intervention using the vaginal equivalent episodes (VEE), a weighted sexual risk behavior index. VEE scores decreased in both the active and control conditions in the first six months post-intervention and continued to decline in the control group. However, in the active condition, VEE scores increased after the nine-month assessment and approached baseline levels by the 12-month assessment. There was no evidence of significant differences in high-risk sexual behaviors between the intervention and control conditions. Future studies are needed to improve behavioral interventions in this population.

Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population

PubMed Central

2014-01-01

Background Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional ‘fixing-what-is-wrong’ approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals’ mental health and work performance, as well as organizations’ return-on-investment. Methods/Design A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals’ psychological capital level; secondary outcomes include individuals’ well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers’ perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. Discussion This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals’ work productivity from absenteeism and presenteeism, this will be one of the few studies that quantify productivity gains from any type of mental health promotion. By demonstrating effectiveness in improving mental well-being and a positive return-on-investment rate, the study may help convince more uptake of similar positive psychology interventions at workplace in Asia and elsewhere. Trail Registration Number (assigned by Centre for Clinical Trials, Clinical Trials Registry, The Chinese University of Hong Kong): CUHK_CCT00396. Registration Date: 2014/02/13 PMID:24997007

Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population.

PubMed

Yuan, Qi; Liu, Su; Tang, Szehang; Zhang, Dexing

2014-07-04

Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional 'fixing-what-is-wrong' approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals' mental health and work performance, as well as organizations' return-on-investment. A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals' psychological capital level; secondary outcomes include individuals' well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers' perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals' work productivity from absenteeism and presenteeism, this will be one of the few studies that quantify productivity gains from any type of mental health promotion. By demonstrating effectiveness in improving mental well-being and a positive return-on-investment rate, the study may help convince more uptake of similar positive psychology interventions at workplace in Asia and elsewhere. Number (assigned by Centre for Clinical Trials, Clinical Trials Registry, The Chinese University of Hong Kong): CUHK_CCT00396. Registration Date: 2014/02/13.

The efficacy of smartphone‐based mental health interventions for depressive symptoms: a meta‐analysis of randomized controlled trials

PubMed Central

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

2017-01-01

The rapid advances and adoption of smartphone technology presents a novel opportunity for delivering mental health interventions on a population scale. Despite multi‐sector investment along with wide‐scale advertising and availability to the general population, the evidence supporting the use of smartphone apps in the treatment of depression has not been empirically evaluated. Thus, we conducted the first meta‐analysis of smartphone apps for depressive symptoms. An electronic database search in May 2017 identified 18 eligible randomized controlled trials of 22 smartphone apps, with outcome data from 3,414 participants. Depressive symptoms were reduced significantly more from smartphone apps than control conditions (g=0.38, 95% CI: 0.24‐0.52, p<0.001), with no evidence of publication bias. Smartphone interventions had a moderate positive effect in comparison to inactive controls (g=0.56, 95% CI: 0.38‐0.74), but only a small effect in comparison to active control conditions (g=0.22, 95% CI: 0.10‐0.33). Effects from smartphone‐only interventions were greater than from interventions which incorporated other human/computerized aspects along the smartphone component, although the difference was not statistically significant. The studies of cognitive training apps had a significantly smaller effect size on depression outcomes (p=0.004) than those of apps focusing on mental health. The use of mood monitoring softwares, or interventions based on cognitive behavioral therapy, or apps incorporating aspects of mindfulness training, did not affect significantly study effect sizes. Overall, these results indicate that smartphone devices are a promising self‐management tool for depression. Future research should aim to distil which aspects of these technologies produce beneficial effects, and for which populations. PMID:28941113

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

PubMed Central

Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

2015-01-01

Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

Demonstrating the robustness of population surveillance data: implications of error rates on demographic and mortality estimates.

PubMed

Fottrell, Edward; Byass, Peter; Berhane, Yemane

2008-03-25

As in any measurement process, a certain amount of error may be expected in routine population surveillance operations such as those in demographic surveillance sites (DSSs). Vital events are likely to be missed and errors made no matter what method of data capture is used or what quality control procedures are in place. The extent to which random errors in large, longitudinal datasets affect overall health and demographic profiles has important implications for the role of DSSs as platforms for public health research and clinical trials. Such knowledge is also of particular importance if the outputs of DSSs are to be extrapolated and aggregated with realistic margins of error and validity. This study uses the first 10-year dataset from the Butajira Rural Health Project (BRHP) DSS, Ethiopia, covering approximately 336,000 person-years of data. Simple programmes were written to introduce random errors and omissions into new versions of the definitive 10-year Butajira dataset. Key parameters of sex, age, death, literacy and roof material (an indicator of poverty) were selected for the introduction of errors based on their obvious importance in demographic and health surveillance and their established significant associations with mortality. Defining the original 10-year dataset as the 'gold standard' for the purposes of this investigation, population, age and sex compositions and Poisson regression models of mortality rate ratios were compared between each of the intentionally erroneous datasets and the original 'gold standard' 10-year data. The composition of the Butajira population was well represented despite introducing random errors, and differences between population pyramids based on the derived datasets were subtle. Regression analyses of well-established mortality risk factors were largely unaffected even by relatively high levels of random errors in the data. The low sensitivity of parameter estimates and regression analyses to significant amounts of randomly introduced errors indicates a high level of robustness of the dataset. This apparent inertia of population parameter estimates to simulated errors is largely due to the size of the dataset. Tolerable margins of random error in DSS data may exceed 20%. While this is not an argument in favour of poor quality data, reducing the time and valuable resources spent on detecting and correcting random errors in routine DSS operations may be justifiable as the returns from such procedures diminish with increasing overall accuracy. The money and effort currently spent on endlessly correcting DSS datasets would perhaps be better spent on increasing the surveillance population size and geographic spread of DSSs and analysing and disseminating research findings.

Effect of Bacillus amyloliquefaciens-based Direct-fed Microbial on Performance, Nutrient Utilization, Intestinal Morphology and Cecal Microflora in Broiler Chickens

PubMed Central

Lei, Xinjian; Piao, Xiangshu; Ru, Yingjun; Zhang, Hongyu; Péron, Alexandre; Zhang, Huifang

2015-01-01

The present study was conducted to evaluate the effect of the dietary supplementation of Bacillus amyloliquefaciens-based direct-fed microbial (DFM) on growth performance, nutrient utilization, intestinal morphology and cecal microflora in broiler chickens. A total of two hundred and eighty eight 1-d-old Arbor Acres male broilers were randomly allocated to one of four experimental treatments in a completely randomized design. Each treatment was fed to eight replicate cages, with nine birds per cage. Dietary treatments were composed of an antibiotic-free basal diet (control), and the basal diet supplemented with either 15 mg/kg of virginiamycin as antibiotic growth promoter (AGP), 30 mg/kg of Bacillus amyloliquefaciens-based DFM (DFM 30) or 60 mg/kg of Bacillus amyloliquefaciens-based DFM (DFM 60). Experimental diets were fed in two phases: starter (d 1 to 21) and finisher (d 22 to 42). Growth performance, nutrient utilization, morphological parameters of the small intestine and cecal microbial populations were measured at the end of the starter (d 21) and finisher (d 42) phases. During the starter phase, DFM and virginiamycin supplementation improved the feed conversion ratio (FCR; p<0.01) compared with the control group. For the finisher phase and the overall experiment (d 1 to 42) broilers fed diets with the DFM had better body weight gain (BWG) and FCR than that of control (p<0.05). Supplementation of virginiamycin and DFM significantly increased the total tract apparent digestibility of crude protein (CP), dry matter (DM) and gross energy during both starter and finisher phases (p<0.05) compared with the control group. On d 21, villus height, crypt depth and villus height to crypt depth ratio of duodenum, jejunum, and ileum were significantly increased for the birds fed with the DFM diets as compared with the control group (p<0.05). The DFM 30, DFM 60, and AGP groups decreased the Escherichia coli population in cecum at d 21 and d 42 compared with control group (p<0.01). In addition, the population of Lactobacillus was increased in DFM 30 and DFM 60 groups as compared with control and AGP groups (p<0.01). It can be concluded that Bacillus amyloliquefaciens-based DFM could be an alternative to the use of AGPs in broilers diets based on plant protein. PMID:25557820

Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in Argentina.

PubMed

Mills, Katherine T; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A; He, Jiang

2014-08-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This article summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure [BP], health education for medication adherence and lifestyle modification) conducted by community health workers and a mobile health intervention. The primary outcome is net change in systolic BP from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic BP, BP control and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries.

Comprehensive Approach for Hypertension Control in Low-income Populations: Rationale and Study Design for the Hypertension Control Program in Argentina (HCPIA)

PubMed Central

Mills, Katherine T.; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A.; He, Jiang

2014-01-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This paper summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure, health education for medication adherence and lifestyle modification) conducted by community health workers, and a mobile health intervention. The primary outcome is net change in systolic blood pressure from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic blood pressure, blood pressure control, and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical, and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries. PMID:24978148

Efficacy of an internet-based intervention for burnout: a randomized controlled trial in the German working population.

PubMed

Jonas, Benjamin; Leuschner, Fabian; Tossmann, Peter

2017-03-01

Internet-based interventions are a viable treatment option for various mental problems. However, their effects on the burnout syndrome yielded mixed results. In this paper, we examine the efficacy of a structured and therapist-guided internet intervention, based on solution-focused and cognitive-behavioral therapy, for individuals with symptoms of burnout. Two-arm, Internet-based, randomized, wait-list controlled trial (RCT). Participants were recruited through in-house events and online advertising. They were randomly assigned to the intervention or a wait-list. Group comparison was conducted three months after randomization. Outcomes were the burnout level according to the Maslach Burnout Inventory (MBI-GS) and the levels of depression, anxiety and stress according to the DASS-21. Thirty-nine participants were included in the trial; 36 (92.3%) took part at the 3-months-follow-up. Intention-to-treat analyses revealed significant group differences in favor of the intervention group in depression (d = 0.66), cynicism (d = 0.87) and personal accomplishment (d = 0.75). The intervention helped ameliorate symptoms of work-related stress and burnout. Although limited by a small sample size, the study suggests that the program provides effective support for affected individuals. However, further studies with bigger sample sizes should be conducted to examine the effects of such programs more precisely.

Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness.

PubMed

O'Connor, C M; Clemson, L; Brodaty, H; Jeon, Y H; Mioshi, E; Gitlin, L N

2014-05-01

Behavioral and psychological symptoms of dementia (BPSD) are often considered to be the greatest challenge in dementia care, leading to increased healthcare costs, caregiver burden, and placement into care facilities. With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality, the development and rigorous testing of non-pharmacological interventions is vital. A pilot of the Tailored Activities Program (TAP) for reducing problem behaviors in people with dementia was conducted in the United States with promising results. This randomized trial will investigate the effectiveness of TAP for reducing the burden of BPSD on persons with dementia and family caregivers within an Australian population. This trial will also examine the cost-effectiveness and willingness to pay for TAP compared with a control group. This randomized trial aims to recruit 180 participant dyads of a person with dementia and their caregivers. Participants will have a diagnosis of dementia, exhibit behaviors as scored by the Neuropsychiatric Inventory, and the caregiver must have at least 7 h per week contact. Participants will be randomly allocated to intervention (TAP) or control (phone-based education sessions) groups, both provided by a trained occupational therapist. Primary outcome measure will be the revised Neuropsychiatric Inventory - Clinician rating scale (NPI-C) to measure BPSD exhibited by the person with dementia. This trial investigates the effectiveness and cost-effectiveness of TAP within an Australian population. Results will address a significant gap in the current Australian community-support base for people living with dementia and their caregivers.

Community-wide interventions for tobacco control.

PubMed

Cummings, K M

1999-01-01

This article describes the rationale and evidence supporting community-wide interventions for tobacco control. Data were collected from published evaluation studies, government reports, and commentaries that describe the use of community-based approaches to tobacco control. Community-wide interventions attempt to change tobacco use in populations--not just individuals--and have increasingly begun to focus on influencing policies that promote and/or tolerate tobacco use. Examples of community-based tobacco-control activities include organizing community groups to advocate adoption of tobacco-control ordinances (e.g., smoke-free restaurants, ban on self-service tobacco displays); media advocacy to raise public awareness about illegal tobacco sales to minors; paid counter-advertising; and sponsorship of community-wide stop-smoking events such as a quit-and-win contest. Evidence in support of the effectiveness of community-based interventions to reduce smoking is found in the consistently sharper decline in tobacco consumption observed in states that have invested in comprehensive tobacco-prevention and control programs compared to those that have not. However, the results from several randomized controlled trials of community-based tobacco-control interventions have been disappointing in demonstrating large-scale changes in tobacco use. Although there appears to be a wide consensus that community-based approaches to tobacco control are an important part of a comprehensive program to reduce tobacco use, the essential elements and methods of implementation of some community-based tobacco-control efforts are less well defined. Also, given the dynamic nature of community tobacco-control interventions, the traditional randomized controlled trial model probably is not applicable for evaluation purposes. It is more likely that research models based on time-series designs will be most applicable for evaluating the impact of community-based interventions.

Evaluation of a sexual health approach to prevent HIV among low income, urban, primarily African American women: results of a randomized controlled trial.

PubMed

Robinson, Beatrice Bean E; Uhl, Gary; Miner, Michael; Bockting, Walter O; Scheltema, Karen E; Rosser, B R Simon; Westover, Bonita

2002-06-01

This randomized controlled trial evaluated an innovative culturally specific sexual health intervention-targeting, but not limited to, low-income African American women-in which HIV and sexually transmitted disease prevention strategies were combined with comprehensive sexuality education. The intervention was delivered and evaluated in community-based settings to 218 participants randomly assigned to treatment or a no-treatment control group. Participants were interviewed at pretest and 3 and 9 months after the intervention to assess changes in both sexuality and HIV risk variables. The intervention was effective in improving sexual anatomy knowledge at both 3- and 9-month follow-up. For a subset of women engaging in unprotected sex at pretest, the intervention group reported an increase in positive attitudes toward the female condom at 9-month follow-up. Reasons for the weak treatment effect are discussed in the context of challenges inherent in conducting community-based research with high-risk populations and sensitive topics. Recommendations are provided for improving sample attrition, statistical power, and response bias and for altering the intervention so as to strengthen its impact.

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations.

PubMed

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-08-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = -.20] and active (SMD = -0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = -1.06) and anxiety (SMD = -1.24). Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. © 2016 American Academy of Pain Medicine.

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

Cardiovascular disease and risk of acute pancreatitis in a population-based study.

PubMed

Bexelius, Tomas Sjöberg; Ljung, Rickard; Mattsson, Fredrik; Lagergren, Jesper

2013-08-01

The low-grade inflammation that characterizes cardiovascular disorders may facilitate the development of pancreatitis; therefore, we investigated the connection between cardiovascular disorders and acute pancreatitis. A nested population-based case-control study was conducted in Sweden in 2006-2008. Cases had a first episode of acute pancreatitis diagnosed in the nationwide Patient Register. Controls were matched on age, sex, and calendar year and randomly selected from all Swedish residents (40-84 years old). Exposure to cardiovascular diseases (hypertension, ischemic heart disease, congestive heart failure, and stroke) was identified in the Patient Register. Relative risk of acute pancreatitis was estimated by odds ratios with 95% confidence intervals using logistic regression adjusting for confounders (matching variables, alcohol disease, chronic obstructive pulmonary disease, type 2 diabetes, number of distinct medications, and other cardiovascular diseases). The study included 6161 cases and 61,637 control subjects. Cardiovascular disorders were positively associated with acute pancreatitis (adjusted odds ratio, 1.35; 95% confidence interval, 1.25-1.45). This population-based study indicates an association between cardiovascular disease and acute pancreatitis. Specifically, ischemic heart disease and hypertension seem to increase the risk of acute pancreatitis. Further research is needed to determine causality.

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

PubMed

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

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins.

PubMed

Atar, Dan; Ong, Seleen; Lansberg, Peter J

2015-01-01

It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions). To examine the role that observational studies can play in complementing data from RCTs, we reviewed published studies for statins, a class of drugs that have been widely used to reduce the risk of cardiovascular (CV) events by lowering low-density lipoprotein cholesterol levels. RCTs have consistently demonstrated the benefits of statin treatment in terms of CV risk reduction and have demonstrated that more intensive statin therapy has incremental benefits over less intensive treatment. Observational studies of statin use in 'real-world' populations have served to augment the evidence base generated from statin RCTs in preselected populations of patients who are often at high CV risk and have led to similar safety and efficacy findings. They have also raised questions about factors affecting medication adherence, under-treatment, switching between statins, and failure to reach low-density lipoprotein cholesterol target levels, questions for which the answers could lead to improved patient care.

Randomized controlled trial of a computer-based module to improve contraceptive method choice.

PubMed

Garbers, Samantha; Meserve, Allison; Kottke, Melissa; Hatcher, Robert; Ventura, Alicia; Chiasson, Mary Ann

2012-10-01

Unintended pregnancy is common in the United States, and interventions are needed to improve contraceptive use among women at higher risk of unintended pregnancy, including Latinas and women with low educational attainment. A three-arm randomized controlled trial was conducted at two family planning sites serving low-income, predominantly Latina populations. The trial tested the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients choosing an effective method of contraception (<10 pregnancies/100 women per year, typical use). Participants were randomized to complete the module and receive tailored health materials, to complete the module and receive generic health materials, or to a control condition. In intent-to-treat analyses adjusted for recruitment site (n=2231), family planning patients who used the module were significantly more likely to choose an effective contraceptive method: 75% among those who received tailored materials [odds ratio (OR)=1.56; 95% confidence interval (CI): 1.23-1.98] and 78% among those who received generic materials (OR=1.74; 95% CI: 1.35-2.25), compared to 65% among control arm participants. The findings support prior research suggesting that patient-centered interventions can positively influence contraceptive method choice. Copyright © 2012 Elsevier Inc. All rights reserved.

Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population.

PubMed

Post, Janisse M; Ali, Shozab S; Roberson, Lara L; Aneni, Ehimen C; Shaharyar, Sameer; Younus, Adnan; Jamal, Omar; Ahmad, Rameez; Aziz, Muhammad A; Malik, Rehan; Spatz, Erica S; Feldman, Theodore; Fialkow, Jonathan; Veledar, Emir; Cury, Ricardo C; Agatston, Arthur S; Nasir, Khurram

2016-07-01

Metabolic syndrome (MetS) and diabetes confer a high risk for developing subsequent cardiovascular disease (CVD). Persons with MetS constitute 24-34 % of the employee population at Baptist Health South Florida (BHSF), a self-insured healthcare organization. The Baptist Employee Healthy Heart Study (BEHHS) aims to assess the addition of a personalized, interactive, web-based, nutrition-management and lifestyle-management program to the existing health-expertise web platform available to BHSF employees in reducing and/or stabilizing CVD and lifestyle risk factors and markers of subclinical CVD. Subjects with MetS or Type II Diabetes will be recruited from an employee population at BHSF and randomized to either an intervention or a control arm. The intervention arm will be given access to a web-based personalized diet-modification and weight-modification program. The control arm will be reminded to use the standard informational health website available and accessible to all BHSF employees. Subjects will undergo coronary calcium testing, carotid intima-media thickness scans, peripheral arterial tonometry, and advanced lipid panel testing at visit 1, in addition to lifestyle and medical history questionnaires. All tests will be repeated at visits 2 and 4 with the exception of the coronary calcium test, which will only be performed at baseline and visit 4. Visit 3 will capture vitals, anthropometrics, and responses to the questionnaires only. Results of this study will provide information on the effectiveness of personalized, web-based, lifestyle-management tools in reducing healthcare costs, promoting healthy choices, and reducing cardiovascular risk in an employee population. It will also provide information about the natural history of carotid atherosclerosis and endothelial dysfunction in asymptomatic but high-risk populations. ClinicalTrials.gov registry, NCT01912209 . Registered on 3 July 2013.

Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial Study Protocol

PubMed Central

Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

2015-01-01

Background Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. Objective The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. Methods A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as “On the Road to Quitting” (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. Results This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. Conclusions This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that drive change in smoking behavior using an app, and improve the design of cessation apps. This trial is among the first to assess the effect of a comprehensive and evidence-informed mHealth smoking cessation app on a large sample of young adult smokers. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the intervention. If effective, the trial has the potential to demonstrate that including mHealth technology as a population-based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit. Trial Registration ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i). PMID:25599695

Effect of a mobile phone intervention on quitting smoking in a young adult population of smokers: randomized controlled trial study protocol.

PubMed

Baskerville, Neill Bruce; Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

2015-01-19

Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as "On the Road to Quitting" (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that drive change in smoking behavior using an app, and improve the design of cessation apps. This trial is among the first to assess the effect of a comprehensive and evidence-informed mHealth smoking cessation app on a large sample of young adult smokers. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the intervention. If effective, the trial has the potential to demonstrate that including mHealth technology as a population-based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit. ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i).

Effects of a home-based physical rehabilitation program on physical disability after hip fracture: a randomized controlled trial.

PubMed

Edgren, Johanna; Salpakoski, Anu; Sihvonen, Sanna E; Portegijs, Erja; Kallinen, Mauri; Arkela, Marja; Jäntti, Pirkko; Vanhatalo, Jukka; Pekkonen, Mika; Rantanen, Taina; Heinonen, Ari; Sipilä, Sarianna

2015-04-01

Fewer than half of the patients with hip fracture will regain the prefracture level of physical functioning. This secondary analysis of a randomized controlled trial investigated the effects of a multicomponent home-based rehabilitation program (ProMo) on physical disability after hip fracture. Randomized, controlled, parallel-group trial. Rehabilitation in participants' homes; measurements in university-based laboratory and local hospital. Population-based clinical sample of community-dwelling people older than 60 years (n = 81) operated for hip fracture were randomized into intervention and control groups. The year-long intervention aimed at restoring mobility. It included evaluation and modification of environmental hazards, guidance for safe walking, pain management, home exercise, physical activity counseling, and standard care. Physical disability was assessed by a questionnaire at baseline, and 3, 6, and 12 months thereafter. Sum scores were computed for basic (ADLs) and instrumental activities of daily living (IADLs). A higher score indicated more difficulty. GEE models were constructed to analyze the effect of the intervention. In the intention-to-treat analysis, no intervention effect was observed for sum scores. For the single disability items, borderline significant positive effects were observed for preparing food and handling medication (interaction P = .061 and P = .061, respectively). In the per-protocol analysis, the mean differences between groups were -0.4 points (SE 0.5), -1.7 (0.7), and -1.2 (0.7) at 3, 6, and 12 months for ADLs and -1.0 (1.2), -3.2 (1.5), and -2.5 (1.4) for IADLs, correspondingly. The current analyses suggest that home-based rehabilitation may reduce disability among older people after hip fracture. The present results need to be confirmed in a study with larger sample size. Potentially a more task-oriented rehabilitation approach might gain more benefits. Current Controlled Trials (ISRCTN53680197). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Asthma exacerbation and proximity of residence to major roads: a population-based matched case-control study among the pediatric Medicaid population in Detroit, Michigan

PubMed Central

2011-01-01

Background The relationship between asthma and traffic-related pollutants has received considerable attention. The use of individual-level exposure measures, such as residence location or proximity to emission sources, may avoid ecological biases. Method This study focused on the pediatric Medicaid population in Detroit, MI, a high-risk population for asthma-related events. A population-based matched case-control analysis was used to investigate associations between acute asthma outcomes and proximity of residence to major roads, including freeways. Asthma cases were identified as all children who made at least one asthma claim, including inpatient and emergency department visits, during the three-year study period, 2004-06. Individually matched controls were randomly selected from the rest of the Medicaid population on the basis of non-respiratory related illness. We used conditional logistic regression with distance as both categorical and continuous variables, and examined non-linear relationships with distance using polynomial splines. The conditional logistic regression models were then extended by considering multiple asthma states (based on the frequency of acute asthma outcomes) using polychotomous conditional logistic regression. Results Asthma events were associated with proximity to primary roads with an odds ratio of 0.97 (95% CI: 0.94, 0.99) for a 1 km increase in distance using conditional logistic regression, implying that asthma events are less likely as the distance between the residence and a primary road increases. Similar relationships and effect sizes were found using polychotomous conditional logistic regression. Another plausible exposure metric, a reduced form response surface model that represents atmospheric dispersion of pollutants from roads, was not associated under that exposure model. Conclusions There is moderately strong evidence of elevated risk of asthma close to major roads based on the results obtained in this population-based matched case-control study. PMID:21513554

New Beginnings for mothers and babies in prison: A cluster randomized controlled trial

PubMed Central

Sleed, Michelle; Baradon, Tessa; Fonagy, Peter

2013-01-01

Mothers in prison represent a high-risk parenting population. New Beginnings is an attachment-based group intervention designed specifically for mothers and babies in prison. This cluster randomized trial examined the outcomes for 88 mothers and babies participating in the New Beginnings program and 75 dyads residing in prisons where the intervention did not take place. Outcomes were measured in terms of parental reflective functioning, the quality of parent–infant interaction, maternal depression, and maternal representations. Mothers in the control group deteriorated in their level of reflective functioning and behavioral interaction with their babies over time, whereas the mothers in the intervention group did not. There were no significant group effects on levels of maternal depression or mothers' self-reported representations of their babies over time. An attachment-based intervention may mitigate some of the risks to the quality of the parent–infant relationship for these dyads. PMID:23550526

Information technology and medical missteps: evidence from a randomized trial.

PubMed

Javitt, Jonathan C; Rebitzer, James B; Reisman, Lonny

2008-05-01

We analyze the effect of a decision support tool designed to help physicians detect and correct medical "missteps". The data comes from a randomized trial of the technology on a population of commercial HMO patients. The key findings are that the new information technology lowers average charges by 6% relative to the control group. This reduction in resource utilization was the result of reduced in-patient charges (and associated professional charges) for the most costly patients. The rate at which identified issues were resolved was generally higher in the study group than in the control group, suggesting the possibility of improvements in care quality along measured dimensions and enhanced diffusion of new protocols based on new clinical evidence.

Genetic algorithms with memory- and elitism-based immigrants in dynamic environments.

PubMed

Yang, Shengxiang

2008-01-01

In recent years the genetic algorithm community has shown a growing interest in studying dynamic optimization problems. Several approaches have been devised. The random immigrants and memory schemes are two major ones. The random immigrants scheme addresses dynamic environments by maintaining the population diversity while the memory scheme aims to adapt genetic algorithms quickly to new environments by reusing historical information. This paper investigates a hybrid memory and random immigrants scheme, called memory-based immigrants, and a hybrid elitism and random immigrants scheme, called elitism-based immigrants, for genetic algorithms in dynamic environments. In these schemes, the best individual from memory or the elite from the previous generation is retrieved as the base to create immigrants into the population by mutation. This way, not only can diversity be maintained but it is done more efficiently to adapt genetic algorithms to the current environment. Based on a series of systematically constructed dynamic problems, experiments are carried out to compare genetic algorithms with the memory-based and elitism-based immigrants schemes against genetic algorithms with traditional memory and random immigrants schemes and a hybrid memory and multi-population scheme. The sensitivity analysis regarding some key parameters is also carried out. Experimental results show that the memory-based and elitism-based immigrants schemes efficiently improve the performance of genetic algorithms in dynamic environments.

Advancing Our Understanding of the Etiologies and Mutational Landscapes of Basal Like, Luminal A, and Luminal B Breast Cancers

DTIC Science & Technology

2016-10-01

and luminal B tumors. Our original goal was to recruit about 2,700 women in Western Washington who have been diagnosed with breast cancer to compare...to 900 women who have never been diagnosed with breast cancer, but control ascertainment has been unacceptably low, so on 8/25/15 we submitted a...cases,1800 randomly selected age-matched estrogen receptor positive (ER+) cases, and for comparison, a population-based control group of 900 women

Social networking technologies as an emerging tool for HIV prevention: a cluster randomized trial.

PubMed

Young, Sean D; Cumberland, William G; Lee, Sung-Jae; Jaganath, Devan; Szekeres, Greg; Coates, Thomas

2013-09-03

Social networking technologies are an emerging tool for HIV prevention. To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). Randomized, controlled trial with concealed allocation. (ClinicalTrials.gov: NCT01701206). Online. 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement were monitored. Participants could request a free, home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more than 93%. Only 2 Facebook communities were included for each group. Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. National Institute of Mental Health.

Effectiveness of a fully automated internet-based smoking cessation program: a randomized controlled trial (STAMP).

PubMed

Nguyen Thanh, Viet; Guignard, Romain; Lancrenon, Sylvie; Bertrand, Camille; Delva, Catherine; Berlin, Ivan; Pasquereau, Anne; Arwidson, Pierre

2018-01-23

The internet offers an interesting alternative to face-to-face and telephone-based support for smoking cessation. This study was designed to assess the effectiveness of a personalized and automated internet-based program. French current adult smokers willing to quit within 2 weeks were recruited for a randomized controlled trial. The intervention consisted of an automated program of 45 e-mails ("e-coaching") sent over a 3-month period. The control group received a PDF version of a booklet on smoking cessation. Self-reported 7-day point prevalence smoking abstinence was measured at 6 months (primary outcome), at 3 and 12 months of follow-up (secondary outcomes). 2,478 smokers were randomized (1,242 for e-coaching, 1,236 for the booklet). Cessation rate in the intention-to-treat population was not significantly different between the two groups at 6 and 12 months, but was higher in the e-coaching group at 3 months than in the control group (27.5% vs 23.5%, p=0.02, OR=1.24, CI=[1.03-1.49]). After adjustment for baseline conditions, the effect of the intervention in the per-protocol (PP) sample was significant at 3 months (aOR=1.72 [1.31-2.28], p<0.001, N=1042) and at 6 months (aOR=1.27 [1.00-1.60], p=0.05, N=1082). GLM repeated measure analyses showed significant group by time interaction in the ITT and a significant group effect in the PP population. Analyzed intention-to-treat, e-coaching was superior to a booklet at 3 months (end of intervention) but no more superior at 6 and 12 months follow up. Among those who actually followed the program, the effectiveness is also observed 3 months after the intervention is stopped. © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults.

PubMed

Kolmodin MacDonell, Karen; Naar, Sylvie; Gibson-Scipio, Wanda; Lam, Phebe; Secord, Elizabeth

2016-10-01

To conduct a randomized controlled pilot of a multicomponent, technology-based intervention promoting adherence to controller medication in African-American emerging adults with asthma. The intervention consisted of two computer-delivered sessions based on motivational interviewing combined with text messaged reminders between sessions. Participants (N = 49) were 18-29 years old, African-American, with persistent asthma requiring controller medication. Participants had to report poor medication adherence and asthma control. Youth were randomized to receive the intervention or an attention control. Data were collected through computer-delivered self-report questionnaires at baseline, 1, and 3 months. Ecological Momentary Assessment via two-way text messaging was also used to collect "real-time" data on medication use and asthma control. The intervention was feasible and acceptable to the target population, as evidenced by high retention rates and satisfaction scores. Changes in study outcomes from pre- to postintervention favored the intervention, particularly for decrease in asthma symptoms, t (42) = 2.22, p < .05 (Cohen's d = .071). Results suggest that the intervention is feasible and effective. However, findings are preliminary and should be replicated with a larger sample and more sophisticated data analyses. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

System impact research – increasing public health and health care system performance

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background Interventions directed to system features of public health and health care should increase health and welfare of patients and population. Aims To build a new framework for studies aiming to assess the impact of public health or health care system, and to consider the role of Randomized Controlled Trials (RCTs) and of Benchmarking Controlled Trials (BCTs). Methods The new concept is partly based on the author's previous paper on the Benchmarking Controlled Trial. The validity and generalizability considerations were based on previous methodological studies on RCTs and BCTs. Results The new concept System Impact Research (SIR) covers all the studies which aim to assess the impact of the public health system or of the health care system on patients or on population. There are two kinds of studies in System Impact Research: Benchmarking Controlled Trials (observational) and Randomized Controlled Trials (experimental). The term impact covers in particular accessibility, quality, effectiveness, safety, efficiency, and equality. Conclusions System Impact Research – creating the scientific basis for policy decision making - should be given a high priority in medical, public health and health economic research, and should also be used for improving performance. Leaders at all levels of health and social care can use the evidence from System Impact Research for the benefit of patients and population.Key messagesThe new concept of SIR is defined as a research field aiming at assessing the impacts on patients and on populations of features of public health and health and social care systems or of interventions trying to change these features.SIR covers all features of public health and health and social care system, and actions upon these features. The term impact refers to all effects caused by the public health and health and social care system or parts of it, with particular emphasis on accessibility, quality, effectiveness, adverse effects, efficiency, and equality of services.SIR creates the scientific basis for policy decisions. Leaders at all levels of health and social care can use the evidence from SIR for the benefit of the patients and the population. PMID:26977939

System impact research - increasing public health and health care system performance.

PubMed

Malmivaara, Antti

2016-01-01

Interventions directed to system features of public health and health care should increase health and welfare of patients and population. To build a new framework for studies aiming to assess the impact of public health or health care system, and to consider the role of Randomized Controlled Trials (RCTs) and of Benchmarking Controlled Trials (BCTs). The new concept is partly based on the author's previous paper on the Benchmarking Controlled Trial. The validity and generalizability considerations were based on previous methodological studies on RCTs and BCTs. The new concept System Impact Research (SIR) covers all the studies which aim to assess the impact of the public health system or of the health care system on patients or on population. There are two kinds of studies in System Impact Research: Benchmarking Controlled Trials (observational) and Randomized Controlled Trials (experimental). The term impact covers in particular accessibility, quality, effectiveness, safety, efficiency, and equality. System Impact Research - creating the scientific basis for policy decision making - should be given a high priority in medical, public health and health economic research, and should also be used for improving performance. Leaders at all levels of health and social care can use the evidence from System Impact Research for the benefit of patients and population. Key messages The new concept of SIR is defined as a research field aiming at assessing the impacts on patients and on populations of features of public health and health and social care systems or of interventions trying to change these features. SIR covers all features of public health and health and social care system, and actions upon these features. The term impact refers to all effects caused by the public health and health and social care system or parts of it, with particular emphasis on accessibility, quality, effectiveness, adverse effects, efficiency, and equality of services. SIR creates the scientific basis for policy decisions. Leaders at all levels of health and social care can use the evidence from SIR for the benefit of the patients and the population.

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

PubMed

Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

2016-10-01

This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

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

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

PubMed

Carlson, Mike; Vigen, Cheryl Lp; Rubayi, Salah; Blanche, Erna Imperatore; Blanchard, Jeanine; Atkins, Michal; Bates-Jensen, Barbara; Garber, Susan L; Pyatak, Elizabeth A; Diaz, Jesus; Florindez, Lucia I; Hay, Joel W; Mallinson, Trudy; Unger, Jennifer B; Azen, Stanley Paul; Scott, Michael; Cogan, Alison; Clark, Florence

2017-04-17

Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. ClinicalTrials.gov NCT01999816.

A Controlled Evaluation of Family Behavior Therapy in Concurrent Child Neglect and Drug Abuse

PubMed Central

Donohue, Brad; Azrin, Nathan H.; Bradshaw, Kelsey; Van Hasselt, Vincent B.; Cross, Chad L.; Urgelles, Jessica; Romero, Valerie; Hill, Heather H.; Allen, Daniel N.

2015-01-01

Objective Approximately 50% of Child Protective Service (CPS) referrals abuse drugs; yet, existing treatment studies in this population have been limited to case examinations. Therefore, a family-based behavioral therapy was evaluated in mothers referred from CPS for child neglect and drug abuse utilizing a controlled experimental design. Method 72 mothers evidencing drug abuse or dependence and child neglect were randomly assigned to Family Behavior Therapy (FBT) or Treatment as Usual (TAU). Participants were assessed at baseline, 6- month-, and 10-month post-randomization. Results As hypothesized, intent-to-treat repeated measures analyses revealed mothers referred for child neglect not due to their children being exposed to illicit drugs demonstrated better outcomes in child maltreatment potential from baseline to 6- and 10-month post-randomization assessments when assigned to FBT, as compared with TAU mothers and FBT mothers who were referred due to child drug exposure. Similar results occurred for hard drug use from baseline to 6- and 10-month post-randomization. However, TAU mothers referred due to child drug exposure were also found to decrease their hard drug use more than TAU mothers of non-drug exposed children and FBT mothers of drug exposed children at 6- and 10-month post-randomization. Although effect sizes for mothers assigned to FBT were slightly larger for marijuana use than TAU (medium vs. large), these differences were not statistically significant. Specific to secondary outcomes, mothers in FBT, relative to TAU, increased time employed from baseline to 6- and 10-month post-randomization. Mothers in FBT, compared to TAU, also decreased HIV risk from baseline to 6-month post-randomization. There were no differences in outcome between FBT and TAU for number of days children were in CPS custody and alcohol intoxication, although FBT mothers demonstrated marginal decreases (p = .058) in incarceration from baseline to 6-month post-randomization relative to TAU mothers. Conclusion Family-based behavioral treatment programs offer promise in mothers who have been reported to CPS for concurrent substance abuse and child neglect of their children. However, continued intervention development in this population is very much needed. PMID:24841866

Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)—A Randomized Controlled Lifestyle Trial †

PubMed Central

Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

2014-01-01

Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60–77 years, the dementia risk score ≥6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

Stroke Self-Management Support Improves Survivors' Self-Efficacy and Outcome Expectation of Self-Management Behaviors.

PubMed

Lo, Suzanne H S; Chang, Anne M; Chau, Janita P C

2018-03-01

Evidence shows self-management programs are associated with improved recovery outcomes. This article reports on the effectiveness of a new nurse-led self-efficacy-based stroke self-management program. A randomized controlled trial of participants recruited from 3 acute stroke units was conducted. The intervention group received the 4-week stroke self-management program. The control group received usual care. All participants were assessed at baseline and 8 weeks after randomization. Data were analyzed using generalized estimating equations. Outcomes included self-efficacy, outcome expectation, and satisfaction with performance of self-management behaviors. One hundred twenty-eight participants were randomized with mean age, 67.46 years (SD, 11.95); 59% men; and mean duration poststroke, 45 days (SD, 26.16). At 8 weeks of follow-up in the intention-to-treat population, the intervention group improved significantly in self-efficacy (95% confidence interval, 2.55-12.45; P <0.01), outcome expectation (95% confidence interval, 5.47-14.01; P <0.01), and satisfaction with performance of self-management behaviors (95% confidence interval, 3.38-13.87; P <0.01) compared with the control. Similar results were obtained at 8 weeks of follow-up in the per-protocol population. The stroke self-management program improved survivors' self-efficacy, outcome expectation, and satisfaction with performance of self-management behaviors. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02112955. © 2018 American Heart Association, Inc.

Influenza vaccine text message reminders for urban, low-income pregnant women: a randomized controlled trial.

PubMed

Stockwell, Melissa S; Westhoff, Carolyn; Kharbanda, Elyse Olshen; Vargas, Celibell Y; Camargo, Stewin; Vawdrey, David K; Castaño, Paula M

2014-02-01

We evaluated the impact of influenza vaccine text message reminders in a low-income obstetric population. We conducted a randomized controlled trial that enrolled 1187 obstetric patients from 5 community-based clinics in New York City. The intervention group received 5 weekly text messages regarding influenza vaccination starting mid-September 2011 and 2 text message appointment reminders. Both groups received standard automated telephone appointment reminders. The prespecified endpoints were receipt of either pre- or postpartum influenza vaccination calculated cumulatively at the end of each month (September-December 2011). After adjusting for gestational age and number of clinic visits, women who received the intervention were 30% more likely to be vaccinated as of December 2011 (adjusted odds ratio [AOR] = 1.30; 95% confidence interval [CI] = 1.003, 1.69 end of September: AOR = 1.34; 95% CI = 0.98, 1.85; October: AOR = 1.35; 95% CI = 1.05, 1.75; November: AOR = 1.27; 95% CI = 0.98, 1.65). The subgroup of women early in the third trimester at randomization showed the greatest intervention effect (December 31: 61.9% intervention vs 49.0% control; AOR = 1.88; 95% CI = 1.12, 3.15). In this low-income obstetric population, text messaging was associated with increased influenza vaccination, especially in those who received messages early in their third trimester.

həli?dxw/Healthy Hearts Across Generations: Development and Evaluation Design of a Tribally Based Cardiovascular Disease Prevention Intervention for American Indian Families

PubMed Central

LaMarr, June; Levy, Rona L.; Pearson, Cynthia; Maresca, Teresa; Mohammed, Selina A.; Simoni, Jane M.; Evans-Campbell, Teresa; Fredriksen-Goldsen, Karen; Fryberg, Sheryl; Jobe, Jared B.

2012-01-01

American Indian and Alaska Native (AIAN) populations are disproportionately at risk for cardiovascular disease (CVD), diabetes, and obesity, compared with the general US population. This article describes the həli?dxw/Healthy Hearts Across Generations project, an AIAN-run, tribally based randomized controlled trial (January 2010–June 2012) designed to evaluate a culturally appropriate CVD risk prevention program for AI parents residing in the Pacific Northwest of the United States. At-risk AIAN adults (n = 135) were randomly assigned to either a CVD prevention intervention arm or a comparison arm focusing on increasing family cohesiveness, communication, and connectedness. Both year-long conditions included 1 month of motivational interviewing counseling followed by personal coach contacts and family life-skills classes. Blood chemistry, blood pressure, body mass index, food intake, and physical activity were measured at baseline and at 4- and 12-month follow-up times. PMID:22965622

Project həli?dx(w)/Healthy Hearts Across Generations: development and evaluation design of a tribally based cardiovascular disease prevention intervention for American Indian families.

PubMed

Walters, Karina L; LaMarr, June; Levy, Rona L; Pearson, Cynthia; Maresca, Teresa; Mohammed, Selina A; Simoni, Jane M; Evans-Campbell, Teresa; Fredriksen-Goldsen, Karen; Fryberg, Sheryl; Jobe, Jared B

2012-08-01

American Indian and Alaska Native (AIAN) populations are disproportionately at risk for cardiovascular disease (CVD), diabetes, and obesity, compared with the general US population. This article describes the həli?dx(w)/Healthy Hearts Across Generations project, an AIAN-run, tribally based randomized controlled trial (January 2010-June 2012) designed to evaluate a culturally appropriate CVD risk prevention program for AI parents residing in the Pacific Northwest of the United States. At-risk AIAN adults (n = 135) were randomly assigned to either a CVD prevention intervention arm or a comparison arm focusing on increasing family cohesiveness, communication, and connectedness. Both year-long conditions included 1 month of motivational interviewing counseling followed by personal coach contacts and family life-skills classes. Blood chemistry, blood pressure, body mass index, food intake, and physical activity were measured at baseline and at 4- and 12-month follow-up times.

Tamoxifen with ovarian function suppression versus tamoxifen alone as an adjuvant treatment for premenopausal breast cancer: a meta-analysis of published randomized controlled trials

PubMed Central

Yan, Shunchao; Li, Kai; Jiao, Xin; Zou, Huawei

2015-01-01

Background Ovarian function suppression (OFS) significantly downregulates the concentration of plasma estrogens. However, it is unclear whether it offers any survival benefits if combined with adjuvant tamoxifen treatment in premenopausal women. This meta-analysis was designed to assess data from previous studies involving adjuvant tamoxifen treatment plus OFS in premenopausal breast cancer. Methods Electronic literature databases (PubMed, Embase, the Web of Science, and the Cochrane Library) were searched for relevant randomized controlled trials published prior to February 1, 2015. Only randomized controlled trials that compared tamoxifen alone with tamoxifen plus OFS for premenopausal women with breast cancer were selected. The evaluated endpoints were disease-free survival and overall survival. Results Four randomized controlled trials comprising 6,279 patients (OFS combination, n=3,133; tamoxifen alone, n=3,146) were included in the meta-analysis. There was no significant improvement in disease-free survival or overall survival with addition of OFS in either the whole population or the hormone receptor-positive subgroup. The risk of distant recurrence was not reduced with the addition of OFS in the whole population. A subgroup analysis showed that addition of OFS significantly improved overall survival in patients who were administered chemotherapy. Conclusion Based on the available studies, concurrent administration of OFS and adjuvant tamoxifen treatment for premenopausal women with breast cancer has no effect on prolonging disease-free survival and overall survival, excluding patients who were administered chemotherapy. It should not be widely recommended, except perhaps for women who were hormone-receptor positive and who were also administered adjuvant chemotherapy. PMID:26109867

Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol.

PubMed

Quintiliani, Lisa M; Russinova, Zlatka L; Bloch, Philippe P; Truong, Ve; Xuan, Ziming; Pbert, Lori; Lasser, Karen E

2015-11-01

Despite the high risk of tobacco-related morbidity and mortality among low-income persons, few studies have connected low-income smokers to evidence-based treatments. We will examine a smoking cessation intervention integrated into primary care. To begin, we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation. Next, we will conduct a randomized controlled trial combining two interventions: patient navigation and financial incentives. The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital. Our intervention will encourage patients to utilize existing smoking cessation resources (e.g., quit lines, smoking cessation groups, discussing smoking cessation with their primary care providers). To test our intervention, we will conduct a randomized controlled trial, randomizing 352 patients to the intervention condition (patient navigation and financial incentives) or an enhanced traditional care control condition. We will perform follow-up at 6, 12, and 18 months following the start of the intervention. Evaluation of the intervention will target several implementation variables: reach (participation rate and representativeness), effectiveness (smoking cessation at 12 months [primary outcome]), unintended consequences (e.g., purchase of illicit substances with incentive money), adoption (use of intervention across primary care suites), implementation (delivery of intervention), and maintenance (smoking cessation after conclusion of intervention). Improving the implementation of smoking cessation interventions in primary care settings serving large underserved populations could have substantial public health impact, reducing cancer-related morbidity/mortality and associated health disparities. Copyright © 2015 Elsevier Inc. All rights reserved.

Renal Denervation for Treatment of Hypertension: a Second Start and New Challenges.

PubMed

Persu, Alexandre; Kjeldsen, Sverre; Staessen, Jan A; Azizi, Michel

2016-01-01

Following the publication of the randomized controlled but open-label trial Symplicity HTN-2, catheter-based renal sympathetic denervation was proposed as a novel treatment for drug-resistant hypertension. Thousands of procedures were routinely performed in Europe, Australia and Asia, and many observational studies were published. A sudden shift from overoptimistic views to radical scepticism occurred later, when the large US randomized sham-controlled trial Symplicity HTN-3 failed to meet its primary blood pressure lowering efficacy endpoint. Experts are divided on the reasons accounting for the large discrepancy between the results of initial studies and those of Symplicity HTN-3. Indeed, the blood pressure lowering effect associated with renal denervation was overestimated in initial trials due to various patient and physician-related biases, whereas it could have been underestimated in Symplicity HTN-3, which was well designed but not rigorously executed. Still, there is a large consensus on the need to further study catheter-based renal denervation in more controlled conditions, with particular emphasis on identification of predictors of blood pressure response. US and European experts have recently issued very similar recommendations on design of upcoming trials, procedural aspects, drug treatment, patient population and inclusion-exclusion criteria. Application of these new standards may represent a second chance for renal denervation to demonstrate--or not--its efficacy and safety in various patient populations. With its highly standardized treatment regimen, the French trial DENERHTN paved the way for this new approach and may inspire upcoming studies testing novel renal denervation systems in different populations.

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

PubMed

Zhou, Kaina; Wang, Duolao; He, Xiaole; Huo, Lanting; An, Jinghua; Li, Minjie; Wang, Wen; Li, Xiaomei

2016-08-31

Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer. This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer. Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

A Formative Evaluation of Customized Pamphlets to Promote Physical Activity and Symptom Self-Management in Women with Multiple Sclerosis

ERIC Educational Resources Information Center

Plow, Matthew; Bethoux, Francois; Mai, Kimloan; Marcus, Bess

2014-01-01

Inactivity is a prevalent problem in the population affected with multiple sclerosis (MS). Thus, there is a need to develop and test physical activity (PA) interventions that can be widely disseminated. We conducted a formative evaluation as part of a randomized controlled trial of a pamphlet-based PA intervention among 30 women with MS. Pamphlets…

Goal selection versus process control while learning to use a brain-computer interface

NASA Astrophysics Data System (ADS)

Royer, Audrey S.; Rose, Minn L.; He, Bin

2011-06-01

A brain-computer interface (BCI) can be used to accomplish a task without requiring motor output. Two major control strategies used by BCIs during task completion are process control and goal selection. In process control, the user exerts continuous control and independently executes the given task. In goal selection, the user communicates their goal to the BCI and then receives assistance executing the task. A previous study has shown that goal selection is more accurate and faster in use. An unanswered question is, which control strategy is easier to learn? This study directly compares goal selection and process control while learning to use a sensorimotor rhythm-based BCI. Twenty young healthy human subjects were randomly assigned either to a goal selection or a process control-based paradigm for eight sessions. At the end of the study, the best user from each paradigm completed two additional sessions using all paradigms randomly mixed. The results of this study were that goal selection required a shorter training period for increased speed, accuracy, and information transfer over process control. These results held for the best subjects as well as in the general subject population. The demonstrated characteristics of goal selection make it a promising option to increase the utility of BCIs intended for both disabled and able-bodied users.

Tailored telephone counselling to increase participation of underusers in a population-based colorectal cancer-screening programme with faecal occult blood test: A randomized controlled trial.

PubMed

Denis, B; Broc, G; Sauleau, E A; Gendre, I; Gana, K; Perrin, P

2017-02-01

Despite the involvement of general practitioners, the mailing of several recall letters and of the faecal occult blood test (FOBT) kit, the uptake remains insufficient in the French colorectal cancer-screening programme. Some studies have demonstrated a greater efficacy of tailored telephone counselling over usual care, untailored invitation mailing and FOBT kit mailing. We evaluated the feasibility and the effectiveness of telephone counselling on participation in the population-based FOBT colorectal cancer-screening programme implemented in Alsace (France). Underusers were randomized into a control group with untailored invitation and FOBT kit mailing (n=19,756) and two intervention groups for either a computer-assisted telephone interview (n=9367), system for tailored promotion of colorectal cancer screening, or a telephone-based motivational interview (n=9374). Only 5691 (19.9%) people were actually counseled, so that there was no difference in participation between the intervention groups taken together (13.9%, 95% confidence interval [CI] [13.5-14.4]) and the control group (13.9%, 95% CI [13.4-14.4]) (P=1.0) in intent-to-treat analysis. However, in per-protocol analysis, participation was significantly higher in the two intervention groups than in the control group (12.9%, 95% CI [12.6-13.2]) (P<0.01), with no difference between computer-assisted telephone interview (24.6%, 95% CI [22.7-26.4]) and motivational interview (23.6%, 95% CI [21.8-25.4]) (P=0.44). There was no difference of effectiveness between tailored telephone counselling and untailored invitation and FOBT kit mailing on participation of underusers in an organized population-based colorectal cancer screening programme. A greater efficacy of telephone counselling, around twice that of invitation and FOBT kit mailing, was observed only in people who could actually be counseled, without difference between computer-assisted telephone interview and motivational interview. However, technical failures hampered telephone counselling, so that there was no difference in intent-to-treat analysis. The rate of technical success of telephone interviews should be evaluated, and enhanced if insufficient, before implementation of telephone counselling in population-based cancer screening programmes. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Translation of an Effective Tai Chi Intervention Into a Community-Based Falls-Prevention Program

PubMed Central

Li, Fuzhong; Harmer, Peter; Glasgow, Russell; Mack, Karin A.; Sleet, David; Fisher, K. John; Kohn, Melvin A.; Millet, Lisa M.; Mead, Jennifer; Xu, Junheng; Lin, Mei-Li; Yang, Tingzhong; Sutton, Beth; Tompkins, Yvaughn

2008-01-01

Tai Chi—Moving for Better Balance, a falls-prevention program developed from a randomized controlled trial for community-based use, was evaluated with the RE-AIM framework in 6 community centers. The program had a 100% adoption rate and 87% reach into the target older adult population. All centers implemented the intervention with good fidelity, and participants showed significant improvements in health-related outcome measures. This evidence-based tai chi program is practical to disseminate and can be effectively implemented and maintained in community settings. PMID:18511723

Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.

PubMed

Chambers, Rachel; Tingey, Lauren; Beach, Anna; Barlow, Allison; Rompalo, Anne

2016-04-29

American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States. The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18-49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex. This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other rural and under-resourced health systems. Clinical Trials NCT02513225.

Promotion of Cholera Awareness among Households of Cholera Patients: A Randomized Controlled Trial of the Cholera-Hospital-Based-Intervention-for-7 Days (CHoBI7) Intervention

PubMed Central

Saif-Ur-Rahman, K. M.; Parvin, Tahmina; Bhuyian, Sazzadul Islam; Zohura, Fatema; Begum, Farzana; Rashid, Mahamud-Ur; Biswas, Shwapon Kumar; Sack, David; Sack, R. Bradley; Monira, Shirajum; Alam, Munirul; Shaly, Nusrat Jahan; George, Christine Marie

2016-01-01

Previous studies have demonstrated that household contacts of cholera patients are highly susceptible to cholera infections for a 7-day period after the presentation of the index patient in the hospital. However, there is no standard of care to prevent cholera transmission in this high-risk population. Furthermore, there is limited information available on awareness of cholera transmission and prevention among cholera patients and their household contacts. To initiate a standard of care for this high-risk population, we developed the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), which delivers a handwashing with soap and water treatment intervention to household contacts during the time they spend with the admitted cholera patient in the hospital and reinforces these messages through home visits. To test CHoBI7, we conducted a randomized controlled trial among 302 intervention cholera patient household members and 302 control cholera patient household members in Dhaka, Bangladesh. In this study, we evaluated the effectiveness of the CHoBI7 intervention in increasing awareness of cholera transmission and prevention, and the key times for handwashing with soap. We observed a significant increase in cholera knowledge score in the intervention arm compared with the control arm at both the 1-week follow-up {score coefficient = 2.34 (95% confidence interval [CI] = 1.96, 2.71)} and 6 to 12-month follow-up period (score coefficient = 1.59 [95% CI = 1.05, 2.13]). This 1-week hospital- and home-based intervention led to a significant increase in knowledge of cholera transmission and prevention which was sustained 6 to 12 months post-intervention. These findings suggest that the CHoBI7 intervention presents a promising approach to increase cholera awareness among this high-risk population. PMID:27799644

Promotion of Cholera Awareness Among Households of Cholera Patients: A Randomized Controlled Trial of the Cholera-Hospital-Based-Intervention-for-7 Days (CHoBI7) Intervention.

PubMed

Saif-Ur-Rahman, K M; Parvin, Tahmina; Bhuyian, Sazzadul Islam; Zohura, Fatema; Begum, Farzana; Rashid, Mahamud-Ur; Biswas, Shwapon Kumar; Sack, David; Sack, R Bradley; Monira, Shirajum; Alam, Munirul; Shaly, Nusrat Jahan; George, Christine Marie

2016-12-07

Previous studies have demonstrated that household contacts of cholera patients are highly susceptible to cholera infections for a 7-day period after the presentation of the index patient in the hospital. However, there is no standard of care to prevent cholera transmission in this high-risk population. Furthermore, there is limited information available on awareness of cholera transmission and prevention among cholera patients and their household contacts. To initiate a standard of care for this high-risk population, we developed the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), which delivers a handwashing with soap and water treatment intervention to household contacts during the time they spend with the admitted cholera patient in the hospital and reinforces these messages through home visits. To test CHoBI7, we conducted a randomized controlled trial among 302 intervention cholera patient household members and 302 control cholera patient household members in Dhaka, Bangladesh. In this study, we evaluated the effectiveness of the CHoBI7 intervention in increasing awareness of cholera transmission and prevention, and the key times for handwashing with soap. We observed a significant increase in cholera knowledge score in the intervention arm compared with the control arm at both the 1-week follow-up {score coefficient = 2.34 (95% confidence interval [CI] = 1.96, 2.71)} and 6 to 12-month follow-up period (score coefficient = 1.59 [95% CI = 1.05, 2.13]). This 1-week hospital- and home-based intervention led to a significant increase in knowledge of cholera transmission and prevention which was sustained 6 to 12 months post-intervention. These findings suggest that the CHoBI7 intervention presents a promising approach to increase cholera awareness among this high-risk population. © The American Society of Tropical Medicine and Hygiene.

Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol.

PubMed

Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert

2017-09-16

Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial.

PubMed

Lieberman, Jesse A; McClelland, Jacquelyn W; Goff, David C; Racine, Elizabeth; Dulin, Michael F; Bauman, William A; Niemeier, Janet; Hirsch, Mark A; Norton, H James; Moore, Charity G

2017-12-04

Individuals with chronic spinal cord injuries (SCIs) have an increased prevalence of cardiovascular disease (CVD) and associated risk factors compared with age-matched control subjects. Exercise has been shown to improve selected CVD risk factors in individuals with SCI, but using nutrition education as an intervention has not been evaluated in this population. This paper describes our research plan for evaluating the effect of nutrition education on individuals with SCI. In the present study, called Eat Smart, Live Better, we are using a randomized controlled design to test an intervention adapted from an existing evidence-based program that showed a positive effect on nutrition knowledge and behavior of older adults from the general population. There will be an inpatient group (n = 100) and a community group (n = 100). The aims of our study are to compare the intervention and control groups for (1) changes in nutritional behavior, nutritional knowledge, and dietary quality by participants in the program; (2) levels of adiposity and metabolic CVD risk factors at 12-month follow-up; and (3) differential effects among individuals with SCI in the acute rehabilitation setting and those living in the community. This is a randomized controlled trial of nutrition education. The treatment groups receive six nutrition education sessions. The control groups receive the one "standard of care" nutrition lecture that is required by the Commission on Accreditation of Rehabilitation Facilities. Treatment groups include both an inpatient group, comprising patients who have been admitted to an acute rehabilitation facility because of their recent SCI, and an outpatient group, consisting of community-dwelling adults who are at least 1 year after their SCI. A total of 200 participants will be randomized 1:1 to the intervention or control group, stratified by location (acute rehabilitation facility or community dwelling). To our knowledge, this will be the first reported study of nutrition education in individuals with SCI. The low cost and feasibility of the intervention, if shown to improve nutritional behavior, suggests that it could be implemented in rehabilitation facilities across the country. This has the potential of lowering the burden of CVD and CVD risk factors in this high-risk population. ClinicalTrials.gov, NCT02368405 . Registered on February 10, 2015.

Differences between blood donors and a population sample: implications for case-control studies.

PubMed

Golding, Jean; Northstone, Kate; Miller, Laura L; Davey Smith, George; Pembrey, Marcus

2013-08-01

Selecting appropriate controls for studies of genetic variation in case series is important. The two major candidates involve the use of blood donors or a random sample of the population. We compare and contrast the two different populations of controls for studies of genetic variation using data from parents enrolled in the Avon Longitudinal Study of Parents and Children (ALSPAC). In addition we compute different biases using a series of hypothetical assumptions. The study subjects who had been blood donors differed markedly from the general population in social, health-related, anthropometric, and personality-related variables. Using theoretical examples, we show that blood donors are a poor control group for non-genetic studies of diseases related to environmentally, behaviourally, or socially patterned exposures. However, we show that if blood donors are used as controls in genetic studies, these factors are unlikely to make a major difference in detecting true associations with relatively rare disorders (cumulative incidence through life of <10%). Nevertheless, for more common disorders, the reduction in accuracy resulting from the inclusion in any control population of individuals who have or will develop the disease in question can create a greater bias than can socially patterned factors. Information about the medical history of a control and the parents of the control (as a proxy for whether the control will develop the disease) is more important with regard to the choice of controls than whether the controls are a random population sample or blood donors.

A controlled trial of an expert system and self-help manual intervention based on the stages of change versus standard self-help materials in smoking cessation.

PubMed

Aveyard, Paul; Griffin, Carl; Lawrence, Terry; Cheng, K K

2003-03-01

To examine the population impact and effectiveness of the Pro-Change smoking cessation course based on the Transtheoretical Model (TTM) compared to standard self-help smoking cessation literature. Randomized controlled trial. Sixty-five West Midlands general practices. Randomly sampled patients recorded as smokers by their general practitioners received an invitation letter and 2471 current smokers agreed. Responders were randomized to one of four interventions. The control group received standard self-help literature. In the Manual intervention group, participants received the Pro-Change system, a self-help workbook and three questionnaires at 3-monthly intervals, which generated individually tailored feedback. In the Phone intervention group, participants received the Manual intervention plus three telephone calls. In the Nurse intervention group, participants received the Manual intervention plus three visits to the practice nurse. Biochemically confirmed point prevalence of being quit and 6-month sustained abstinence, 12 months after study commencement. A total of 9.1% of registered current smokers participated, of whom 83.0% were not ready to quit. Less than half of participants returned questionnaires to generate second and third individualized feedback. Telephone calls reached 75% of those scheduled, but few participants visited the nurse. There were small differences between the three Pro-Change arms. The odds ratio (95% confidence intervals) for all Pro-Change arms combined versus the control arm were 1.50 (0.85-2.67) and 1.53 (0.76-3.10), for point prevalence and 6-month abstinence, respectively. This constitutes 2.1% of the TTM group versus 1.4% of the control group achieving confirmed 6-month sustained abstinence. There was no statistically significant benefit of the intervention apparent in this trial and the high relapse of quitters means that any population impact is small.

Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.

PubMed

Pandey, Priyanka; Sehgal, Ashwini R; Riboud, Michelle; Levine, David; Goyal, Madhav

2007-10-24

A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status. To determine the impact of informing resource-poor rural populations about entitled services. Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households. Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters. Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages. At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P < .001), 27% more tetanus vaccinations (95% CI, 12%-41%; P < .001), 24% more prenatal supplements (95% CI, 8%-39%; P = .003), 25% more infant vaccinations (95% CI, 8%-42%; P = .004), and decreased excess school fees of 8 rupees (95% CI, 4-13 rupees; P < .001). In a difference-in-differences analysis, 21% more village council meetings were reported (95% CI, 5%-36%; P = .01). There were no improvements in visits by a nurse midwife or in development work in the villages. Both low-caste and mid- to high-caste intervention households reported significant improvements in service delivery. Informing resource-poor rural populations in India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services. clinicaltrials.gov Identifier: NCT00421291.

Indoor dampness and molds and development of adult-onset asthma: a population-based incident case-control study.

PubMed Central

Jaakkola, Maritta S; Nordman, Henrik; Piipari, Ritva; Uitti, Jukka; Laitinen, Jukka; Karjalainen, Antti; Hahtola, Paula; Jaakkola, Jouni J K

2002-01-01

Previous cross-sectional and prevalent case-control studies have suggested increased risk of asthma in adults related to dampness problems and molds in homes. We conducted a population-based incident case-control study to assess the effects of indoor dampness problems and molds at work and at home on development of asthma in adults. We recruited systematically all new cases of asthma during a 2.5-year study period (1997-2000) and randomly selected controls from a source population consisting of adults 21-63 years old living in the Pirkanmaa Hospital district, South Finland. The clinically diagnosed case series consisted of 521 adults with newly diagnosed asthma and the control series of 932 controls, after we excluded 76 (7.5%) controls with a history of asthma. In logistic regression analysis adjusting for confounders, the risk of asthma was related to the presence of visible mold and/or mold odor in the workplace (odds ratio, 1.54; 95% confidence interval, 1.01-2.32) but not to water damage or damp stains alone. We estimated the fraction of asthma attributable to workplace mold exposure to be 35.1% (95% confidence interval, 1.0-56.9%) among the exposed. Present results provide new evidence of the relation between workplace exposure to indoor molds and adult-onset asthma. PMID:12003761

Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial.

PubMed

Bjorkman, Mikko P; Suominen, Merja H; Pitkälä, Kaisu H; Finne-Soveri, Harriet U; Tilvis, Reijo S

2013-11-14

Age-related muscle loss (that is, sarcopenia) is a common health problem among older people. Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia. Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people. During 2012 the entire 75 and older population (N = 3,275) living in Porvoo, Finland was contacted via a postal questionnaire. Persons at risk of sarcopenia are screened with hand grip strength and gait speed. Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index. Sarcopenic patients (target N = 250) will be enrolled in a 12-month randomized controlled trial with three arms: 1) no supplementation, 2) protein supplementation (20 grams twice a day), and 3) isocaloric placebo. All the participants will receive instructions on simple home-based exercises, dietary protein, and vitamin D supplementation (20 μg/d). The recruitment of patients will be completed during 2013. The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance. Secondary endpoints will be, among other things, changes in muscle functions, nutritional status, body composition, cognition, quality of life, use of health care services, falls, and mortality. The assessment times will be 0, 6, 12 and 24 months. To our knowledge, this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance. ACTRN12612001253897, date of registration 28 October 2012, first patient was randomized 11 April 2012.

Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial.

PubMed

Aftab, Awais; Bhat, Chetan; Gunzler, Douglas; Cassidy, Kristin; Thomas, Charles; McCormick, Richard; Dawson, Neal V; Sajatovic, Martha

2018-05-01

Objective Serious mental illness and type II diabetes mellitus have a high comorbidity, and both have a higher prevalence of anxiety disorders compared to the general population. Targeted Training in Illness Management is a group-based self-management training approach which targets serious mental illness and type II diabetes mellitus concurrently. This analysis examines data from a randomized controlled trial of Targeted Training in Illness Management intervention to examine the impact of comorbid anxiety on baseline psychiatric symptomatology and diabetic control, and on longitudinal treatment outcomes. Methods We conducted secondary analyses on data from a prospective, 60-week, randomized controlled trial testing Targeted Training in Illness Management versus treatment as usual in 200 individuals with serious mental illness and diabetes. Primary outcomes included measures related to serious mental illness symptoms, functional status, general health status, and diabetes control. Measures were compared between those participants with anxiety disorders versus those without anxiety at baseline as well as over time using linear mixed effects analyses. Results Forty seven percent of the participants had one or more anxiety disorders. At baseline, those with an anxiety diagnosis had higher illness severity, depressive, and other psychiatric symptomatology and disability. Diabetic control (HbA1c) was not significantly different at baseline. In the longitudinal analyses, no significant mean slope differences over time (group-by-time interaction effect) between those with anxiety diagnoses and those without in treatment as usual group were found for primary outcomes. Within the Targeted Training in Illness Management arm, those with anxiety disorders had significantly greater improvement in mental health functioning. Those with anxiety comorbidity in the Targeted Training in Illness Management group demonstrated significantly lower HbA1c levels compared to no anxiety comorbidity and also demonstrated a greater improvement in HbA1c over the first 30 weeks compared to those without anxiety comorbidity. Conclusion Comorbid anxiety in serious mental illness and type II diabetes mellitus population is associated with increased psychiatric symptomatology and greater disability. Individuals from this population appear to experience greater improvement in functioning from baseline with the Targeted Training in Illness Management intervention. Anxiety comorbidity in the serious mental illness and type II diabetes mellitus population does not appear to have a negative impact on diabetic control. These complex relationships need further study. Clinical Trials Registration ClinicalTrials.gov: Improving outcomes for individuals with serious mental illness and diabetes (NCT01410357).

Maternal and perinatal mortality by place of delivery in sub-Saharan Africa: a meta-analysis of population-based cohort studies.

PubMed

Chinkhumba, Jobiba; De Allegri, Manuela; Muula, Adamson S; Robberstad, Bjarne

2014-09-28

Facility-based delivery has gained traction as a key strategy for reducing maternal and perinatal mortality in developing countries. However, robust evidence of impact of place of delivery on maternal and perinatal mortality is lacking. We aimed to estimate the risk of maternal and perinatal mortality by place of delivery in sub-Saharan Africa. We conducted a systematic review of population-based cohort studies reporting on risk of maternal or perinatal mortality at the individual level by place of delivery in sub-Saharan Africa. Newcastle-Ottawa Scale was used to assess study quality. Outcomes were summarized in pooled analyses using fixed and random effects models. We calculated attributable risk percentage reduction in mortality to estimate exposure effect. We report mortality ratios, crude odds ratios and associated 95% confidence intervals. We found 9 population-based cohort studies: 6 reporting on perinatal and 3 on maternal mortality. The mean study quality score was 10 out of 15 points. Control for confounders varied between the studies. A total of 36,772 pregnancy episodes were included in the analyses. Overall, perinatal mortality is 21% higher for home compared to facility-based deliveries, but the difference is only significant when produced with a fixed effects model (OR 1.21, 95% CI: 1.02-1.46) and not when produced by a random effects model (OR 1.21, 95% CI: 0.79-1.84). Under best settings, up to 14 perinatal deaths might be averted per 1000 births if the women delivered at facilities instead of homes. We found significantly increased risk of maternal mortality for facility-based compared to home deliveries (OR 2.29, 95% CI: 1.58-3.31), precluding estimates of attributable risk fraction. Evaluating the impact of facility-based delivery strategy on maternal and perinatal mortality using population-based studies is complicated by selection bias and poor control of confounders. Studies that pool data at an individual level may overcome some of these problems and provide better estimates of relative effectiveness of place of delivery in the region.

Dementia Research: Populations, Progress, Problems, and Predictions.

PubMed

Hunter, Sally; Smailagic, Nadja; Brayne, Carol

2018-05-16

Alzheimer's disease (AD) is a clinicopathologically defined syndrome leading to cognitive impairment. Following the recent failures of amyloid-based randomized controlled trials to change the course of AD, there are growing calls for a re-evaluation of basic AD research. Epidemiology offers one approach to integrating the available evidence. Here we examine relationships between evidence from population-based, clinicopathological studies of brain aging and a range of hypotheses from all areas of AD research. We identify various problems, including a lack of systematic approach to measurement of clinical and neuropathological factors associated with dementia in experimental and clinical settings, poor understanding of the strengths and weaknesses of different observational and experimental designs, a lack of clarity in relation to disease definitions from the clinical, neuropathological, and molecular perspectives, inadequate characterization of brain aging in the human population, difficulties in translation between laboratory-based and population-based evidence bases, and a lack of communication between different sections of the dementia research community. Population studies highlight complexity and predict that therapeutic approaches based on single disease features will not be successful. Better characterization of brain aging in the human population is urgently required to select biomarkers and therapeutic targets that are meaningful to human disease. The generation of detailed and reliable evidence must be addressed before progress toward therapeutic interventions can be made.

Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

PubMed

Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

2016-03-01

Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data.

PubMed

Hornbrook, Mark C; Goshen, Ran; Choman, Eran; O'Keeffe-Rosetti, Maureen; Kinar, Yaron; Liles, Elizabeth G; Rust, Kristal C

2017-10-01

Machine learning tools identify patients with blood counts indicating greater likelihood of colorectal cancer and warranting colonoscopy referral. To validate a machine learning colorectal cancer detection model on a US community-based insured adult population. Eligible colorectal cancer cases (439 females, 461 males) with complete blood counts before diagnosis were identified from Kaiser Permanente Northwest Region's Tumor Registry. Control patients (n = 9108) were randomly selected from KPNW's population who had no cancers, received at ≥1 blood count, had continuous enrollment from 180 days prior to the blood count through 24 months after the count, and were aged 40-89. For each control, one blood count was randomly selected as the pseudo-colorectal cancer diagnosis date for matching to cases, and assigned a "calendar year" based on the count date. For each calendar year, 18 controls were randomly selected to match the general enrollment's 10-year age groups and lengths of continuous enrollment. Prediction performance was evaluated by area under the curve, specificity, and odds ratios. Area under the receiver operating characteristics curve for detecting colorectal cancer was 0.80 ± 0.01. At 99% specificity, the odds ratio for association of a high-risk detection score with colorectal cancer was 34.7 (95% CI 28.9-40.4). The detection model had the highest accuracy in identifying right-sided colorectal cancers. ColonFlag ® identifies individuals with tenfold higher risk of undiagnosed colorectal cancer at curable stages (0/I/II), flags colorectal tumors 180-360 days prior to usual clinical diagnosis, and is more accurate at identifying right-sided (compared to left-sided) colorectal cancers.

D-camphor-crataegus berry extract combination increases blood pressure and cognitive functioning in the elderly - a randomized, placebo controlled double blind study.

PubMed

Werner, Natalie S; Duschek, Stefan; Schandry, Rainer

2009-12-01

The present study investigated whether the D-camphor-crataegus berry extract combination Korodin elevates blood pressure and enhances cognitive performance in the elderly population. Eighty women aged between 50 and 80 years were examined based on a randomized, placebo controlled double blind design. Blood pressure was measured sphygmomanometrically and through continuous noninvasive recording. Cognitive performance was assessed by means of two tests measuring general information processing capacity and visuomotor speed. The administration of the drug led to a short term increase in blood pressure as well as in cognitive performance as compared to placebo. Potential physiological mechanisms of action mediating this effect, including hemodynamic alterations, sympathetic stimulation as well as improvement of cerebral metabolism are discussed.

Assessment of generalizability, applicability and predictability (GAP) for evaluating external validity in studies of universal family-based prevention of alcohol misuse in young people: systematic methodological review of randomized controlled trials.

PubMed

Fernandez-Hermida, Jose Ramon; Calafat, Amador; Becoña, Elisardo; Tsertsvadze, Alexander; Foxcroft, David R

2012-09-01

To assess external validity characteristics of studies from two Cochrane Systematic Reviews of the effectiveness of universal family-based prevention of alcohol misuse in young people. Two reviewers used an a priori developed external validity rating form and independently assessed three external validity dimensions of generalizability, applicability and predictability (GAP) in randomized controlled trials. The majority (69%) of the included 29 studies were rated 'unclear' on the reporting of sufficient information for judging generalizability from sample to study population. Ten studies (35%) were rated 'unclear' on the reporting of sufficient information for judging applicability to other populations and settings. No study provided an assessment of the validity of the trial end-point measures for subsequent mortality, morbidity, quality of life or other economic or social outcomes. Similarly, no study reported on the validity of surrogate measures using established criteria for assessing surrogate end-points. Studies evaluating the benefits of family-based prevention of alcohol misuse in young people are generally inadequate at reporting information relevant to generalizability of the findings or implications for health or social outcomes. Researchers, study authors, peer reviewers, journal editors and scientific societies should take steps to improve the reporting of information relevant to external validity in prevention trials. © 2012 The Authors. Addiction © 2012 Society for the Study of Addiction.

Two-Year Outcomes of a Population-Based Intervention for Preschool Language Delay: An RCT.

PubMed

Wake, Melissa; Levickis, Penny; Tobin, Sherryn; Gold, Lisa; Ukoumunne, Obioha C; Goldfeld, Sharon; Zens, Naomi; Le, Ha N D; Law, James; Reilly, Sheena

2015-10-01

We have previously shown short-term benefits to phonology, letter knowledge, and possibly expressive language from systematically ascertaining language delay at age 4 years followed by the Language for Learning intervention. Here, we report the trial's definitive 6-year outcomes. Randomized trial nested in a population-based ascertainment. Children with language scores >1.25 SD below the mean at age 4 were randomized, with intervention children receiving 18 1-hour home-based therapy sessions. Primary outcome was receptive/expressive language. Secondary outcomes were phonological, receptive vocabulary, literacy, and narrative skills; parent-reported pragmatic language, behavior, and health-related quality of life; costs of intervention; and health service use. For intention-to-treat analyses, trial arms were compared using linear regression models. Of 1464 children assessed at age 4, 266 were eligible and 200 randomized; 90% and 82% of intervention and control children were retained respectively. By age 6, mean language scores had normalized, but there was little evidence of a treatment effect for receptive (adjusted mean difference 2.3; 95% confidence interval [CI] -1.2 to 5.7; P = .20) or expressive (0.8; 95% CI -1.6 to 3.2; P = .49) language. Of the secondary outcomes, only phonological awareness skills (effect size 0.36; 95% CI 0.08-0.65; P = .01) showed benefit. Costs were higher for intervention families (mean difference AU$4276; 95% CI: $3424 to $5128). Population-based intervention targeting 4-year-old language delay was feasible but did not have lasting impacts on language, possibly reflecting resolution in both groups. Long-term literacy benefits remain possible but must be weighed against its cost. Copyright © 2015 by the American Academy of Pediatrics.

Effects of yoga, strength training and advice on back pain: a randomized controlled trial.

PubMed

Brämberg, Elisabeth Björk; Bergström, Gunnar; Jensen, Irene; Hagberg, Jan; Kwak, Lydia

2017-03-29

Among the working population, non-specific low-back pain and neck pain are one of the most common reasons for sickness absenteeism. The aim was to evaluate the effects of an early intervention of yoga - compared with strength training or evidence-based advice - on sickness absenteeism, sickness presenteeism, back and neck pain and disability among a working population. A randomized controlled trial was conducted on 159 participants with predominantly (90%) chronic back and neck pain. After screening, the participants were randomized to kundalini yoga, strength training or evidence-based advice. Primary outcome was sickness absenteeism. Secondary outcomes were sickness presenteeism, back and neck pain and disability. Self-reported questionnaires and SMS text messages were completed at baseline, 6 weeks, 6 and 12 months. The results did not indicate that kundalini yoga and strength training had any statistically significant effects on the primary outcome compared with evidence-based advice. An interaction effect was found between adherence to recommendations and sickness absenteeism, indicating larger significant effects among the adherers to kundalini yoga versus evidence-based advice: RR = 0.47 (CI 0.30; 0.74, p = 0.001), strength training versus evidence-based advice: RR = 0.60 (CI 0.38; 0.96, p = 0.032). Some significant differences were also found for the secondary outcomes to the advantage of kundalini yoga and strength training. Guided exercise in the forms of kundalini yoga or strength training does not reduce sickness absenteeism more than evidence-based advice alone. However, secondary analyses reveal that among those who pursue kundalini yoga or strength training at least two times a week, a significantly reduction in sickness absenteeism was found. Methods to increase adherence to treatment recommendations should be further developed and applied in exercise interventions. Clinicaltrials.gov NCT01653782, date of registration: June, 28, 2012, retrospectively registered.

Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

ERIC Educational Resources Information Center

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

Brain Training in Children and Adolescents: Is It Scientifically Valid?

PubMed

Rossignoli-Palomeque, Teresa; Perez-Hernandez, Elena; González-Marqués, Javier

2018-01-01

Background: Brain training products are becoming increasingly popular for children and adolescents. Despite the marketing aimed at their use in the general population, these products may provide more benefits for specific neurologically impaired populations. A review of Brain Training (BT) products analyzing their efficacy while considering the methodological limitations of supporting research is required for practical applications. Method: searches were made of the PubMed database (until March 2017) for studies including: (1) empirical data on the use of brain training for children or adolescents and any effects on near transfer (NT) and/or far transfer (FT) and/or neuroplasticity, (2) use of brain training for cognitive training purposes, (3) commercially available training applications, (4) computer-based programs for children developed since the 1990s, and (5) relevant printed and peer-reviewed material. Results: Database searches yielded a total of 16,402 references, of which 70 met the inclusion criteria for the review. We classified programs in terms of neuroplasticity, near and far transfer, and long-term effects and their applied methodology. Regarding efficacy, only 10 studies (14.2%) have been found that support neuroplasticity, and the majority of brain training platforms claimed to be based on such concepts without providing any supporting scientific data. Thirty-six studies (51.4%) have shown far transfer (7 of them are non-independent) and only 11 (15.7%) maintained far transfer at follow-up. Considering the methodology, 40 studies (68.2%) were not randomized and controlled; for those randomized, only 9 studies (12.9%) were double-blind, and only 13 studies (18.6%) included active controls in their trials. Conclusion: Overall, few independent studies have found far transfer and long-term effects. The majority of independent results found only near transfer. There is a lack of double-blind randomized trials which include an active control group as well as a passive control to properly control for contaminant variables. Based on our results, Brain Training Programs as commercially available products are not as effective as first expected or as they promise in their advertisements.

Brain Training in Children and Adolescents: Is It Scientifically Valid?

PubMed Central

Rossignoli-Palomeque, Teresa; Perez-Hernandez, Elena; González-Marqués, Javier

2018-01-01

Background: Brain training products are becoming increasingly popular for children and adolescents. Despite the marketing aimed at their use in the general population, these products may provide more benefits for specific neurologically impaired populations. A review of Brain Training (BT) products analyzing their efficacy while considering the methodological limitations of supporting research is required for practical applications. Method: searches were made of the PubMed database (until March 2017) for studies including: (1) empirical data on the use of brain training for children or adolescents and any effects on near transfer (NT) and/or far transfer (FT) and/or neuroplasticity, (2) use of brain training for cognitive training purposes, (3) commercially available training applications, (4) computer-based programs for children developed since the 1990s, and (5) relevant printed and peer-reviewed material. Results: Database searches yielded a total of 16,402 references, of which 70 met the inclusion criteria for the review. We classified programs in terms of neuroplasticity, near and far transfer, and long-term effects and their applied methodology. Regarding efficacy, only 10 studies (14.2%) have been found that support neuroplasticity, and the majority of brain training platforms claimed to be based on such concepts without providing any supporting scientific data. Thirty-six studies (51.4%) have shown far transfer (7 of them are non-independent) and only 11 (15.7%) maintained far transfer at follow-up. Considering the methodology, 40 studies (68.2%) were not randomized and controlled; for those randomized, only 9 studies (12.9%) were double-blind, and only 13 studies (18.6%) included active controls in their trials. Conclusion: Overall, few independent studies have found far transfer and long-term effects. The majority of independent results found only near transfer. There is a lack of double-blind randomized trials which include an active control group as well as a passive control to properly control for contaminant variables. Based on our results, Brain Training Programs as commercially available products are not as effective as first expected or as they promise in their advertisements. PMID:29780336

Randomly amplified polymorphic DNA linkage relationships in different Norway spruce populations

Treesearch

M. Troggio; Thomas L. Kubisiak; G. Bucci; P. Menozzi

2001-01-01

We tested the constancy of linkage relationships of randomly amplified polymorphic DNA (RAPD) marker loci used to construct a population-based consensus map in material from an Italian stand of Picea abies (L.) Karst. in 29 individuals from three Norwegian populations. Thirteen marker loci linked in the Italian stand did show a consistent locus...

Social networking technologies as emerging tools for HIV prevention: A Cluster Randomized Trial

PubMed Central

Young, Sean D.; Cumberland, William G.; Lee, Sung-Jae; Jaganath, Devan; Szekeres, Greg; Coates, Thomas

2013-01-01

Background Social networking technologies are an emerging tool for HIV prevention. Objective To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). Design Randomized; controlled trial with concealed allocation (ClinicalTrials.gov: NCT01701206). Setting Online. Patients 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. Intervention Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement was monitored. Participants could request a free home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. Measurements Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. Results Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of the 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more 93%. Limitations Only 2 Facebook communities were included for each group. Conclusions Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. Primary funding source National Institute of Mental Health ClinicalTrials.gov Identifier (NCT01701206) PMID:24026317

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Exploration of the association between chronic periodontal disease and erectile dysfunction from a population-based view point.

PubMed

Tsao, C-W; Liu, C-Y; Cha, T-L; Wu, S-T; Chen, S-C; Hsu, C-Y

2015-06-01

Several cross-sectional studies have indicated an association between chronic periodontal disease (CPD) and cardiovascular disease and metabolic syndrome. Erectile dysfunction (ED) also shares pathological mechanisms with these diseases. Using a nationwide population-based data set, we examined the association between ED and CPD and assessed the effect of dental extraction (DE) on ED prevalence in different aged CPD populations in Taiwan. We identified 5105 patients with ED and randomly selected 10 210 patients as controls. Of these patients, 2617 (17.09%) were diagnosed with CPD according to the index data: 1196 (23.43%) in the ED group and 1421 (13.92%) in the control group. After adjusting for comorbid factors, patients with ED were more likely to have been diagnosed with prior CPD than controls (OR = 1.79, 95% CI = 1.64-1.96, P < 0.001). Moreover, the association was much stronger in the populations aged less than 30 years (OR = 2.13, 95% CI = 1.23-3.70, P < 0.001) and more than 59 years (OR = 2.27, 95% CI = 1.99-2.59, P < 0.001). Dental extraction seems to attenuate damage to the penile endothelial beds caused by CPD-related inflammation and overcame the process of ED in the middle-aged and older populations. © 2014 Blackwell Verlag GmbH.

Correction of confounding bias in non-randomized studies by appropriate weighting.

PubMed

Schmoor, Claudia; Gall, Christine; Stampf, Susanne; Graf, Erika

2011-03-01

In non-randomized studies, the assessment of a causal effect of treatment or exposure on outcome is hampered by possible confounding. Applying multiple regression models including the effects of treatment and covariates on outcome is the well-known classical approach to adjust for confounding. In recent years other approaches have been promoted. One of them is based on the propensity score and considers the effect of possible confounders on treatment as a relevant criterion for adjustment. Another proposal is based on using an instrumental variable. Here inference relies on a factor, the instrument, which affects treatment but is thought to be otherwise unrelated to outcome, so that it mimics randomization. Each of these approaches can basically be interpreted as a simple reweighting scheme, designed to address confounding. The procedures will be compared with respect to their fundamental properties, namely, which bias they aim to eliminate, which effect they aim to estimate, and which parameter is modelled. We will expand our overview of methods for analysis of non-randomized studies to methods for analysis of randomized controlled trials and show that analyses of both study types may target different effects and different parameters. The considerations will be illustrated using a breast cancer study with a so-called Comprehensive Cohort Study design, including a randomized controlled trial and a non-randomized study in the same patient population as sub-cohorts. This design offers ideal opportunities to discuss and illustrate the properties of the different approaches. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial.

PubMed

Percac-Lima, Sanja; Ashburner, Jeffrey M; Zai, Adrian H; Chang, Yuchiao; Oo, Sarah A; Guimaraes, Erica; Atlas, Steven J

2016-07-01

Patient navigation (PN) to improve cancer screening in low-income and racial/ethnic minority populations usually focuses on navigating for single cancers in community health center settings. We evaluated PN for breast, cervical, and colorectal cancer screening using a population-based information technology (IT) system within a primary care network. Randomized clinical trial conducted from April 2014 to December 2014 in 18 practices in an academic primary care network. All patients eligible and overdue for cancer screening were identified and managed using a population-based IT system. Those at high risk for nonadherence with completing screening were identified using an electronic algorithm (language spoken, number of overdue tests, no-show visit history), and randomized to a PN intervention (n = 792) or usual care (n = 820). Navigators used the IT system to track patients, contact them, and provide intense outreach to help them complete cancer screening. Mean cancer screening test completion rate over 8-month trial for each eligible patient, with all overdue cancer screening tests combined using linear regression models. Secondary outcomes included the proportion of patients completing any and each overdue cancer screening test. Among 1612 patients (673 men and 975 women; median age, 57 years), baseline patient characteristics were similar among randomized groups. Of 792 intervention patients, patient navigators were unable to reach 151 (19%), deferred 246 (38%) (eg, patient declined, competing comorbidity), and navigated 202 (32%). The mean proportion of patients who were up to date with screening among all overdue screening examinations was higher in the intervention vs the control group for all cancers combined (10.2% vs 6.8%; 95% CI [for the difference], 1.5%-5.2%; P < .001), and for breast (14.7% vs 11.0%; 95% CI, 0.2%-7.3%; P = .04), cervical (11.1% vs 5.7%; 95% CI, 0.8%-5.2%; P = .002), and colon (7.6% vs 4.6%; 95% CI, 0.8%-5.2%; P = .01) cancer compared with control. The proportion of overdue patients who completed any cancer screening during follow-up was higher in the intervention group (25.5% vs 17.0%; 95% CI, 4.7%-12.7%; P < .001). The intervention group had more patients completing screening for breast (23.4% vs 16.6%; 95% CI, 1.8%-12.0%; P = .009), cervical (14.4% vs 8.6%; 95% CI, 1.6%-10.5%; P = .007), and colorectal (13.7% vs 7.0%; 95% CI, 3.2%-10.4%; P < .001) cancer. Patient navigation as part of a population-based IT system significantly increased screening rates for breast, cervical, and colorectal cancer in patients at high risk for nonadherence with testing. Integrating patient navigation into population health management activities for low-income and racial/ethnic minority patients might improve equity of cancer care. clinicaltrials.gov Identifier: NCT02553538.

Evaluation of an integrated treatment for active duty service members with comorbid posttraumatic stress disorder and major depressive disorder: Study protocol for a randomized controlled trial.

PubMed

Walter, Kristen H; Glassman, Lisa H; Michael Hunt, W; Otis, Nicholas P; Thomsen, Cynthia J

2018-01-01

Posttraumatic stress disorder (PTSD) commonly co-occurs with major depressive disorder (MDD) in both civilian and military/veteran populations. Existing, evidence-based PTSD treatments, such as cognitive processing therapy (CPT), often reduce symptoms of both PTSD and depression; however, findings related to the influence of comorbid MDD on PTSD treatment outcomes are mixed, and few studies use samples of individuals with both conditions. Behavioral activation (BA), an approach that relies on behavioral principles, is an effective treatment for depression. We have integrated BA into CPT (BA+CPT), a more cognitive approach, to address depressive symptoms among active duty service members with both PTSD and comorbid MDD. We describe an ongoing randomized controlled trial investigating the efficacy of our innovative, integrated BA+CPT intervention, compared with standard CPT, for active duty service members with PTSD and comorbid MDD. We detail the development of this integrated treatment, as well as the design and implementation of the randomized controlled trial, to evaluate its effect on symptoms. Copyright © 2017 Elsevier Inc. All rights reserved.

A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI 5b. GRANT...forthcoming, The current study addresses this need through a double blind, placebo- controlled , randomized clinical trial (RCT) of a group

Hypothesis: Impregnated school uniforms reduce the incidence of dengue infections in school children.

PubMed

Wilder-Smith, A; Lover, A; Kittayapong, P; Burnham, G

2011-06-01

Dengue infection causes a significant economic, social and medical burden in affected populations in over 100 countries in the tropics and sub-tropics. Current dengue control efforts have generally focused on vector control but have not shown major impact. School-aged children are especially vulnerable to infection, due to sustained human-vector-human transmission in the close proximity environments of schools. Infection in children has a higher rate of complications, including dengue hemorrhagic fever and shock syndromes, than infections in adults. There is an urgent need for integrated and complementary population-based strategies to protect vulnerable children. We hypothesize that insecticide-treated school uniforms will reduce the incidence of dengue in school-aged children. The hypothesis would need to be tested in a community based randomized trial. If proven to be true, insecticide-treated school uniforms would be a cost-effective and scalable community based strategy to reduce the burden of dengue in children. Copyright © 2011 Elsevier Ltd. All rights reserved.

Comorbidity of gout and rheumatoid arthritis in a large population database.

PubMed

Merdler-Rabinowicz, Rona; Tiosano, Shmuel; Comaneshter, Doron; Cohen, Arnon D; Amital, Howard

2017-03-01

Coexistence of rheumatoid arthritis and gout is considered to be unusual. The current study was designed as a population-based cross-sectional study, utilizing the medical database of Clalit Health Services, the largest healthcare provider organization in Israel. Data of adult patients who were previously diagnosed with rheumatoid arthritis was retrieved. For each patient, five age- and sex-matched control patients were randomly selected. Different parameters including BMI, socioeconomic status, and existence of gout as well as smoking and hypertension were examined for both groups. The study included 11,540 patients with rheumatoid arthritis and 56,763 controls. The proportion of gout in the study group was high compared to controls (1.61 vs. 0.92%, P < 0.001). In a multivariate analysis, rheumatoid arthritis was associated with gout (OR = 1.72, 95% CI 1.45-2.05, P = 0.00). The proportion of gout in rheumatoid arthritis patients is not lower than in the general population.

Effectiveness of open versus endovascular abdominal aortic aneurysm repair in population settings: A systematic review of statewide databases.

PubMed

Williams, Christopher R; Brooke, Benjamin S

2017-10-01

Patient outcomes after open abdominal aortic aneurysm and endovascular aortic aneurysm repair have been widely reported from several large, randomized, controlled trials. It is not clear whether these trial outcomes are representative of abdominal aortic aneurysm repair procedures performed in real-world hospital settings across the United States. This study was designed to evaluate population-based outcomes after endovascular aortic aneurysm repair versus open abdominal aortic aneurysm repair using statewide inpatient databases and examine how they have helped improve our understanding of abdominal aortic aneurysm repair. A systematic search of MEDLINE, EMBASE, and CINAHL databases was performed to identify articles comparing endovascular aortic aneurysm repair and open abdominal aortic aneurysm repair using data from statewide inpatient databases. This search was limited to studies published in the English language after 1990, and abstracts were screened and abstracted by 2 authors. Our search yielded 17 studies published between 2004 and 2016 that used data from 29 different statewide inpatient databases to compare endovascular aortic aneurysm repair versus open abdominal aortic aneurysm repair. These studies support the randomized, controlled trial results, including a lower mortality associated with endovascular aortic aneurysm repair extended from the perioperative period up to 3 years after operation, as well as a higher complication rate after endovascular aortic aneurysm repair. The evidence from statewide inpatient database analyses has also elucidated trends in procedure volume, patient case mix, volume-outcome relationships, and health care disparities associated with endovascular aortic aneurysm repair versus open abdominal aortic aneurysm repair. Population analyses of endovascular aortic aneurysm repair and open abdominal aortic aneurysm repair using statewide inpatient databases have confirmed short- and long-term mortality outcomes obtained from large, randomized, controlled trials. Moreover, these analyses have allowed us to assess the effect of endovascular aortic aneurysm repair adoption on population outcomes and patient case mix over time. Published by Elsevier Inc.

Problem-based learning in dental education: a systematic review of the literature.

PubMed

Bassir, Seyed Hossein; Sadr-Eshkevari, Pooyan; Amirikhorheh, Shaden; Karimbux, Nadeem Y

2014-01-01

The purpose of this systematic review was to compare the effectiveness of problem-based learning (PBL) with that of traditional (non-PBL) approaches in dental education. The search strategy included electronic and manual searches of studies published up to October 2012. The PICO (Population, Intervention, Comparator, and Outcome) framework was utilized to guide the inclusion or exclusion of studies. The search strategy identified 436 articles, seventeen of which met the inclusion criteria. No randomized controlled trial was found comparing the effectiveness of PBL with that of lecture-based approach at the level of an entire curriculum. Three randomized controlled trials had evaluated the effectiveness of PBL at a single course level. The quality assessment rated four studies as being of moderate quality, while the other studies were assessed as being of weak quality. This review concludes that there are a very limited number of well-designed controlled studies evaluating the effectiveness of PBL in dental education. The data in those studies reveal that PBL does not negatively influence the acquisition of factual knowledge in dental students and PBL enhances the ability of students in applying their knowledge to clinical situations. In addition, PBL positively affects students' perceived preparedness.

Population-based breast cancer screening in a primary care network

PubMed Central

Atlas, Steven J.; Ashburner, Jeffrey M.; Chang, Yuchiao; Lester, William T.; Barry, Michael J.; Grant, Richard W.

2013-01-01

Objective To assess up to 3-year follow-up of a health information technology system that facilitated population-based breast cancer screening. Study Design Cohort study with 2-year follow-up after completing a 1-year cluster randomized trial. Methods Women 42-69 years old receiving care within a 12-practice primary care network. The trial tested an integrated, non-visit-based population management informatics system that: 1) identified women overdue for mammograms, 2) connected them to primary care providers using a Web-based tool, 3) created automatically-generated outreach letters for patients specified by providers, 4) monitored for subsequent mammography scheduling and completion, and 5) provided practice delegates a list of women remaining unscreened for reminder phone calls. All practices also provided visit-based cancer screening reminders. Eligible women overdue for a mammogram during a one-year study period included those overdue at study start (prevalent cohort) or becoming overdue during follow-up (incident cohort). The main outcome measure was mammography completion rates over three years. Results Among 32,688 eligible women, 9,795 (30%) were overdue for screening including 4,487 in intervention and 5,308 in control practices. Intervention patients were somewhat younger, more likely to be non-Hispanic white, and have health insurance compared to control patients. Among patients in the prevalent cohort (n=6,697), adjusted completion rates were significantly higher among intervention compared to control patients after 3 years (51.7% vs. 45.8%, p=0.002). For patients in the incident cohort (n=3,098), adjusted completion rates after 2 years were 53.8% vs. 48.7%, p=0.052, respectively. Conclusions Population-based informatics systems can enable sustained increases in mammography screening rates beyond that seen with office-based visit reminders. PMID:23286611

Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care.

PubMed

Helmes, Edward; Ward, Bradley G

2017-03-01

Anxiety in older people is under-diagnosed and poorly treated despite significant impairments that arise from anxiety. Mindfulness-based cognitive therapy (MBCT) has been shown to be a promising treatment for anxiety. The aim of this study was to determine the effect of an MBCT program on anxiety symptoms in older people living in residential care. Fifty-two participants (34 females) were randomly allocated into therapy and control groups using a 2 × 3 mixed design. The average age of participants was 83 years. The group effect showed significant improvements on all measures at the end of the seven-week program in the therapy group, while the control group did not show significant changes. This study represents one of the first studies of the effectiveness of an MBCT program on anxiety symptoms for older people using a randomized controlled trial. The study has implications for future research that include the effectiveness of MBCT for the treatment of anxiety symptoms in older people, the utility of group therapy programs in residential care and the benefits of using specialized instruments for older populations.

Results of a Community-Based Randomized Trial to Increase Colorectal Cancer Screening Among Filipino Americans

PubMed Central

Bastani, Roshan; Danao, Leda L.; Antonio, Cynthia; Garcia, Gabriel M.; Crespi, Catherine M.

2010-01-01

Objectives. We conducted 1 of the first community-based trials to develop a multicomponent intervention that would increase colorectal cancer screening among an Asian American population. Methods. Filipino Americans (n = 548) nonadherent to colorectal cancer (CRC) screening guidelines were randomized into an intervention group that received an education session on CRC screening and free fecal occult blood test (FOBT) kits; a second intervention group that received an education session but no free FOBT kits; and a control group that received an education session on the health benefits of physical activity. Results. Self-reported CRC screening rates during the 6-month follow-up period were 30%, 25%, and 9% for participants assigned to intervention with FOBT kit, intervention without the kit, and control group, respectively. Participants in either of the 2 intervention groups were significantly more likely to report screening at follow-up than were participants in the control group. Conclusions. A multicomponent intervention that includes an educational group session in a community setting can significantly increase CRC screening among Filipino Americans, even when no free FOBT kits are distributed. PMID:20864724

A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis.

PubMed

Watson, Helen; Bilton, Diana; Truby, Helen

2008-05-01

Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population.

Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain--study protocol for a randomized controlled trial.

PubMed

Thiart, Hanne; Lehr, Dirk; Ebert, David Daniel; Sieland, Bernhard; Berking, Matthias; Riper, Heleen

2013-06-11

Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs due to, for example, reduced productivity at the work place and absenteeism. Insomnia complaints by people experiencing work-related stress are correlated with a deficient cognitive detachment from work. Diffuse boundaries between work and private life can additionally complicate the use of recreational activities that facilitate cognitive detachment.Cognitive behavioral therapy for insomnia is effective but rarely implemented. Internet-based cognitive behavioral therapy for insomnia could potentially reduce this deficit given its demonstrated effectiveness. Less is known, however, about the efficacy of internet-based cognitive behavioral therapy for insomnia in populations affected by high work stress. Thus, the aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed, guided online training which is based on Cognitive Behavioral Therapy for insomnia and tailored to teachers affected by occupational stress. In a two-arm randomized controlled trial (N = 128), the effects of a guided online sleep training will be compared to a waitlist-control condition. German teachers with significant clinical insomnia complaints (Insomnia Severity Index ≥ 15) and work-related rumination (Irritation Scale, subscale Cognitive Irritation ≥ 15) will be included in the study. The primary outcome measure will be insomnia severity. Additionally, an economic evaluation from a societal perspective will be conducted. Data from the intention-to-treat sample will be analyzed two and six months after randomization. To the best of our knowledge, this is the first study to evaluate an online sleep training tailored to a specific population with work stress, that is, teachers. If this type of intervention is effective, it could reduce the paucity of cognitive behavioral therapy for insomnia and augment the support for teachers in coping with their insomnia problems. German Clinical Trial Register (DRKS): DRKS00004700.

TAILORING A FRUIT AND VEGETABLE INTERVENTION ON ETHNIC IDENTITY: RESULTS OF A RANDOMIZED STUDY

PubMed Central

Resnicow, Ken; Davis, Rachel; Zhang, Nanhua; Saunders, Ed; Strecher, Victor; Tolsma, Dennis; Calvi, Josephine; Alexander, Gwen; Anderson, Julia; Wiese, Cheryl; Cross, William

2009-01-01

Objective Many targeted health interventions have been developed and tested with African American (AA) populations; however, AAs are a highly heterogeneous group. One characteristic that varies across AAs is Ethnic Identity (EI). Despite the recognition that AAs are heterogeneous with regard to EI, little research has been conducted on how to incorporate EI into the design of health messages and programs. Design This randomized trial tested whether tailoring a print-based fruit and vegetable (F & V) intervention based on individual EI would enhance program impact beyond that of social cognitive tailoring alone. AA adults were recruited from two integrated healthcare delivery systems, one based in the Detroit Metro area and the other in the Atlanta Metro area, and then randomized to receive three newsletters focused on F & V behavior change over three months. One set of newsletters was tailored only on demographic, behavioral, and social cognitive variables (control condition) whereas the other (experimental condition) was additionally tailored on EI. Main Outcome Measures The primary outcome for the study was F & V intake, which was assessed at baseline and three months later using the composite of two brief self-report frequency measures. Results A total of 560 eligible participants were enrolled, of which 468 provided complete 3-month follow-up data. The experimental group increased their daily mean F & V intake by 1.1 servings compared to .8 servings in the control group (p = .13). Several variables were found to interact with intervention group. For instance, Afrocentric experimental group participants showed a 1.4 increase in F & V servings per day compared to a .43 servings per day increase among Afrocentric controls (p < .05). Conclusions Although the overall between-group effects were not significant, this study confirms that AAs are a highly diverse population and that tailoring dietary messages on ethnic identity may improve intervention impact for some AA subgroups. PMID:19594262

Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial.

PubMed

Kempe, Allison; Saville, Alison; Dickinson, L Miriam; Eisert, Sheri; Reynolds, Joni; Herrero, Diana; Beaty, Brenda; Albright, Karen; Dibert, Eva; Koehler, Vicky; Lockhart, Steven; Calonge, Ned

2013-06-01

We compared the effectiveness and cost-effectiveness of population-based recall (Pop-recall) versus practice-based recall (PCP-recall) at increasing immunizations among preschool children. This cluster-randomized trial involved children aged 19 to 35 months needing immunizations in 8 rural and 6 urban Colorado counties. In Pop-recall counties, recall was conducted centrally using the Colorado Immunization Information System (CIIS). In PCP-recall counties, practices were invited to attend webinar training using CIIS and offered financial support for mailings. The percentage of up-to-date (UTD) and vaccine documentation were compared 6 months after recall. A mixed-effects model assessed the association between intervention and whether a child became UTD. Ten of 195 practices (5%) implemented recall in PCP-recall counties. Among children needing immunizations, 18.7% became UTD in Pop-recall versus 12.8% in PCP-recall counties (P < .001); 31.8% had documented receipt of 1 or more vaccines in Pop-recall versus 22.6% in PCP-recall counties (P < .001). Relative risk estimates from multivariable modeling were 1.23 (95% confidence interval [CI] = 1.10, 1.37) for becoming UTD and 1.26 (95% CI = 1.15, 1.38) for receipt of any vaccine. Costs for Pop-recall versus PCP-recall were $215 versus $1981 per practice and $17 versus $62 per child brought UTD. Population-based recall conducted centrally was more effective and cost-effective at increasing immunization rates in preschool children.

Male circumcision and HIV infection risk.

PubMed

Krieger, John N

2012-02-01

Male circumcision is being promoted to reduce human immunodeficiency virus type 1 (HIV) infection rates. This review evaluates the scientific evidence suggesting that male circumcision reduces HIV infection risk in high-risk heterosexual populations. We followed the updated International Consultation on Urological Diseases evidence-based medicine recommendations to critically review the scientific evidence on male circumcision and HIV infection risk. Level 1 evidence supports the concept that male circumcision substantially reduces the risk of HIV infection. Three major lines of evidence support this conclusion: biological data suggesting that this concept is plausible, data from observational studies supported by high-quality meta-analyses, and three randomized clinical trials supported by high-quality meta-analyses. The evidence from these biological studies, observational studies, randomized controlled clinical trials, meta-analyses, and cost-effectiveness studies is conclusive. The challenges to implementation of male circumcision as a public health measure in high-risk populations must now be faced.

Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned.

PubMed

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

2017-07-05

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.

Lung Cancer and Occupation in a Population-based Case-Control Study

PubMed Central

Consonni, Dario; De Matteis, Sara; Lubin, Jay H.; Wacholder, Sholom; Tucker, Margaret; Pesatori, Angela Cecilia; Caporaso, Neil E.; Bertazzi, Pier Alberto; Landi, Maria Teresa

2010-01-01

The authors examined the relation between occupation and lung cancer in the large, population-based Environment And Genetics in Lung cancer Etiology (EAGLE) case-control study. In 2002–2005 in the Lombardy region of northern Italy, 2,100 incident lung cancer cases and 2,120 randomly selected population controls were enrolled. Lifetime occupational histories (industry and job title) were coded by using standard international classifications and were translated into occupations known (list A) or suspected (list B) to be associated with lung cancer. Smoking-adjusted odds ratios and 95% confidence intervals were calculated with logistic regression. For men, an increased risk was found for list A (177 exposed cases and 100 controls; odds ratio = 1.74, 95% confidence interval: 1.27, 2.38) and most occupations therein. No overall excess was found for list B with the exception of filling station attendants and bus and truck drivers (men) and launderers and dry cleaners (women). The authors estimated that 4.9% (95% confidence interval: 2.0, 7.8) of lung cancers in men were attributable to occupation. Among those in other occupations, risk excesses were found for metal workers, barbers and hairdressers, and other motor vehicle drivers. These results indicate that past exposure to occupational carcinogens remains an important determinant of lung cancer occurrence. PMID:20047975

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations.

PubMed

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-09-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy's efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = -0.79] and anxiety (SMD = -0.57) compared to active comparators. Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. © 2016 American Academy of Pain Medicine.

Protocol of a randomized controlled trial of the Tobacco Tactics website for operating engineers.

PubMed

Duffy, Sonia A; Ronis, David L; Richardson, Caroline; Waltje, Andrea H; Ewing, Lee A; Noonan, Devon; Hong, Oisaeng; Meeker, John D

2012-05-17

Recent research indicates that 35 percent of blue-collar workers in the US currently smoke while only 20 percent of white-collar workers smoke. Over the last year, we have been working with heavy equipment operators, specifically the Local 324 Training Center of the International Union of Operating Engineers, to study the epidemiology of smoking, which is 29% compared to 21% among the general population. For the current study funded by the National Cancer Institute (1R21CA152247-01A1), we have developed the Tobacco Tactics website which will be compared to the state supported 1-800-QUIT-NOW telephone line. Outcome evaluation will compare those randomized to the Tobacco Tactics web-based intervention to those randomized to the 1-800-QUIT-NOW control condition on: a) 30-day and 6-month quit rates; b) cotinine levels; c) cigarettes smoked/day; d) number of quit attempts; and e) nicotine addiction. Process evaluation will compare the two groups on the: a) contacts with intervention; b) medications used; c) helpfulness of the nurse/coach; and d) willingness to recommend the intervention to others. This will be a randomized controlled trial (N = 184). Both interventions will be offered during regularly scheduled safety training at Local 324 Training Center of the International Union of Operating Engineers and both will include optional provision of over-the-counter nicotine replacement therapy and the same number of telephone contacts. However, the Tobacco Tactics website has graphics tailored to Operating Engineers, tailored cessation feedback from the website, and follow up nurse counseling offered by multimedia options including phone and/or email, and/or e-community. Primary Analysis of Aim 1 will be conducted by using logistic regression to compare smoking habits (e.g., quit rates) of those in the intervention arm to those in the control arm. Primary analyses for Aim 2 will compare process measures (e.g., medications used) between the two groups by linear, logistic, and Poisson regression. Dissemination of an efficacious work-site, web-based smoking cessation intervention has the potential to substantially impact cancer rates among this population. Based on the outcome of this smaller study, wider scale testing in conjunction with the International Environment Technology Testing Center which services Operating Engineers across North America (including US, Mexico, and Canada) will be conducted. NCT01124110.

Role of mtDNA haplogroups in the prevalence of osteoarthritis in different geographic populations: a meta-analysis.

PubMed

Shen, Jin-Ming; Feng, Lei; Feng, Chun

2014-01-01

Osteoarthritis (OA) is the most common form of arthritis and has become an increasingly important public-health problem. However, the pathogenesis of OA is still unclear. In recent years, its correlation with mtDNA haplogroups attracts much attention. We aimed to perform a meta-analysis to investigate the association between mtDNA haplogroups and OA. Published English or Chinese literature from PubMed, Web of Science, SDOS, and CNKI was retrieved up until April 15, 2014. Case-control or cohort studies that detected the frequency of mtDNA haplogroups in OA patients and controls were included. The quality of the included studies was evaluated by the Newcastle-Ottawa Scale (NOS) assessment. A meta-analysis was conducted to calculate pooled odds ratio (OR) with 95% confidence interval (CI) through the random or fixed effect model, which was selected based on the between-study heterogeneity assessed by Q test and I2 test. Subgroup analysis was performed to explore the origin of heterogeneity. A total of 6 case-control studies (10590 cases and 7161 controls) with an average NOS score of 6.9 were involved. For the analysis between mtDNA haplogroup J and OA, random model was selected due to high heterogeneity. No significant association was found initially (OR = 0.73, 95%CI: 0.52-1.03), however, once any study from UK population was removed the association emerged. Further subgroup analysis demonstrated that there was a significant association in Spain population (OR = 0.57, 95%CI: 0.46-0.71), but not in UK population. Also, subgroup analysis revealed that there was a significant correlation between cluster TJ and OA in Spain population (OR = 0.70, 95%CI: 0.58-0.84), although not in UK population. No significant correlation was found between haplogroup T/cluster HV/cluster KU and OA. Our current meta-analysis suggests that mtDNA haplogroup J and cluster TJ correlate with the risk of OA in Spanish population, but the associations in other populations require further investigation.

The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations

PubMed Central

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

2016-01-01

Abstract Purpose Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = −.20] and active (SMD = −0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = −1.06) and anxiety (SMD = −1.24). Conclusion Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. PMID:27165967

A promotores de salud intervention to reduce cardiovascular disease risk in a high-risk Hispanic border population, 2005-2008.

PubMed

Balcázar, Héctor G; de Heer, Hendrik; Rosenthal, Lee; Aguirre, Melissa; Flores, Leticia; Puentes, Flor A; Cardenas, Victor M; Duarte, Maria O; Ortiz, Melchor; Schulz, Leslie O

2010-03-01

The high prevalence of cardiovascular disease (CVD) in the Hispanic population of the United States, together with low rates of health insurance coverage, suggest a potential cardiovascular health crisis. The objective of Project HEART (Health Education Awareness Research Team) was to promote behavior changes to decrease CVD risk factors in a high-risk Hispanic border population. Project HEART took place from 2005 through 2008 as a randomized community trial with a community-based participatory research framework using promotores de salud (community health workers). A total of 328 participants with at least 1 CVD risk factor were selected by randomizing 10 US Census tracts in El Paso, Texas, to either the experimental or the control group. The experimental group (n = 192) was assigned to a series of 8 health classes using the Su Corazón, Su Vida curriculum. After 2 months of educational sessions, the group was followed for 2 months. The control group (n = 136) was given basic educational materials at baseline, and no other intervention was used. Main outcomes of interest included changes in health behaviors and clinical measures. Participants in the experimental group showed more awareness of CVD risk factors, more confidence in the control of these factors, and improved dietary habits (ie, lower salt and cholesterol intake, better weight-control practices) compared with the control group. Total cholesterol was 3% lower in the experimental than in the control participants, and nonhigh-density lipoprotein cholesterol and low-density lipoprotein cholesterol were both 5% lower. The HEART trial suggests that community health education using promotores de salud is a viable strategy for CVD risk reduction in a Hispanic border community.

Streaming weekly soap opera video episodes to smartphones in a randomized controlled trial to reduce HIV risk in young urban African American/black women.

PubMed

Jones, Rachel; Lacroix, Lorraine J

2012-07-01

Love, Sex, and Choices is a 12-episode soap opera video series created as an intervention to reduce HIV sex risk. The effect on women's HIV risk behavior was evaluated in a randomized controlled trial in 238 high risk, predominately African American young adult women in the urban Northeast. To facilitate on-demand access and privacy, the episodes were streamed to study-provided smartphones. Here, we discuss the development of a mobile platform to deliver the 12-weekly video episodes or weekly HIV risk reduction written messages to smartphones, including; the technical requirements, development, and evaluation. Popularity of the smartphone and use of the Internet for multimedia offer a new channel to address health disparities in traditionally underserved populations. This is the first study to report on streaming a serialized video-based intervention to a smartphone. The approach described here may provide useful insights in assessing advantages and disadvantages of smartphones to implement a video-based intervention.

Advance notification letters increase adherence in colorectal cancer screening: a population-based randomized trial.

PubMed

van Roon, A H C; Hol, L; Wilschut, J A; Reijerink, J C I Y; van Vuuren, A J; van Ballegooijen, M; Habbema, J D F; van Leerdam, M E; Kuipers, Ernst J

2011-06-01

The population benefit of screening depends not only on the effectiveness of the test, but also on adherence, which, for colorectal cancer (CRC) screening remains low. An advance notification letter may increase adherence, however, no population-based randomized trials have been conducted to provide evidence of this. In 2008, a representative sample of the Dutch population (aged 50-74 years) was randomized. All 2493 invitees in group A were sent an advance notification letter, followed two weeks later by a standard invitation. The 2507 invitees in group B only received the standard invitation. Non-respondents in both groups were sent a reminder 6 weeks after the invitation. The advance notification letters resulted in a significantly higher adherence (64.4% versus 61.1%, p-value 0.019). Multivariate logistic regression analysis showed no significant interactions between group and age, sex, or socio-economic status. Cost analysis showed that the incremental cost per additional detected advanced neoplasia due to sending an advance notification letter was € 957. This population-based randomized trial demonstrates that sending an advance notification letter significantly increases adherence by 3.3%. The incremental cost per additional detected advanced neoplasia is acceptable. We therefore recommend that such letters are incorporated within the standard CRC-screening invitation process. Copyright © 2011 Elsevier Inc. All rights reserved.

Household-based ceramic water filters for the prevention of diarrhea: a randomized, controlled trial of a pilot program in Colombia.

PubMed

Clasen, Thomas; Garcia Parra, Gloria; Boisson, Sophie; Collin, Simon

2005-10-01

Household water treatment is increasingly recognized as an effective means of reducing the burden of diarrheal disease among low-income populations without access to safe water. Oxfam GB undertook a pilot project to explore the use of household-based ceramic water filters in three remote communities in Colombia. In a randomized, controlled trial over a period of six months, the filters were associated with a 75.3% reduction in arithmetic mean thermotolerant coliforms (TTCs) (P < 0.0001). A total of 47.7% and 24.2% of the samples from the intervention group had no detectible TTCs/100 mL or conformed to World Health Organization limits for low risk (1-10 TTCs/100 mL), respectively, compared with 0.9% and 7.3% for control group samples. Overall, prevalence of diarrhea was 60% less among households using filters than among control households (odds ratio = 0.40, 95% confidence interval = 0.25, 0.63, P < 0.0001). However, the microbiologic performance and protective effect of the filters was not uniform throughout the study communities, suggesting the need to consider the circumstances of the particular setting before implementing this intervention.

Estimating the Marginal Causal Effect of Fish Consumption during Adolescence on Multiple Sclerosis: A Population-Based Incident Case-Control Study.

PubMed

Abdollahpour, Ibrahim; Nedjat, Saharnaz; Mansournia, Mohammad Ali; Sahraian, Mohammad Ali; Kaufman, Jay S

2018-01-01

Adolescence is considered as a critical time period in multiple sclerosis (MS) etiology. Nonetheless, there are insufficient reports regarding the potential role of fresh and canned fish consumptions during adolescence in MS etiology. The authors investigated the association between fresh and canned fish consumptions and MS. This was a population-based incident case-control study conducted in Tehran. Cases (n = 547) identified from Iranian Multiple Sclerosis Society between August 7, 2013, and November 17, 2015 were included in the study. Population-based controls (n = 1,057) were recruited by random digit telephone dialing without any matching. Inverse-probability-of-treatment weighing (IPTW) using 2 sets of propensity scores and model-based standardization were used to separately estimate the marginal odds ratio between fresh and canned fish consumptions in adolescence and MS. The marginal OR for fresh fish was 0.72 (95% CI 0.58-0.90; p = 0.005) in both IPTW analyses. Similarly, the marginal OR for canned fish consumption was 0.75 (95% CI 0.60-0.95; p = 0.014).The model-based standardized OR was 0.72 (95% CI 0.58-0.91; p = 0.008) for fresh and 0.73 (95% CI 0.59-0.94; p = 0.006) for canned fish consumption in adolescence. Subject to limitation of case-control studies in interpreting associations causally, this study suggests that both fresh and canned fish consumptions in adolescence can decrease the risk of MS. © 2018 S. Karger AG, Basel.

A community-wide campaign to promote physical activity in middle-aged and elderly people: a cluster randomized controlled trial

PubMed Central

2013-01-01

Background We aimed to evaluate the effectiveness of a community-wide campaign (CWC) for promoting physical activity in middle-aged and elderly people. Methods A cluster randomized controlled trial (RCT) with a community as the unit of randomization was performed using a population-based random-sampled evaluation by self-administered questionnaires in the city of Unnan, Shimane Prefecture, Japan. The evaluation sample included 6000 residents aged 40 to 79 years. We randomly allocated nine communities to the intervention group and three to the control group. The intervention was a CWC from 2009 to 2010 to promote physical activity, and it comprised information, education, and support delivery. The primary outcome was a change in engaging in regular aerobic, flexibility, and/or muscle-strengthening activities evaluated at the individual level. Results In total, 4414 residents aged 40–79 years responded to a self-administered questionnaire (73.6% response rate). Awareness of the CWC was 79% in the intervention group. Awareness and knowledge were significantly different between the intervention and control groups, although there were no significant differences in belief and intention. The 1-year CWC did not significantly promote the recommended level of physical activity (adjusted odds ratio: 0.97; 95% confidence interval: 0.84–1.14). Conclusions This cluster RCT showed that the CWC did not promote physical activity in 1 year. Significant differences were observed in awareness and knowledge between intervention and control groups as short-term impacts of the campaign. Trial registration UMIN-CTR UMIN000002683 PMID:23570536

Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial.

PubMed

Fu, Steven S; van Ryn, Michelle; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Taylor, Brent C; Schlede, Carolyn M; Burke, Randy S; Joseph, Anne M

2014-05-01

Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]). Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates. clinicaltrials.gov Identifier: NCT00608426.

Effect Evaluation of a Randomized Trial to Reduce Infectious Illness and Illness-related Absenteeism Among Schoolchildren: The Hi Five Study.

PubMed

Denbæk, Anne Maj; Andersen, Anette; Bonnesen, Camilla Thørring; Laursen, Bjarne; Ersbøll, Annette Kjær; Due, Pernille; Johansen, Anette

2018-01-01

Previous school-based hand hygiene interventions have reported to successfully reduce infectious illness among schoolchildren. But few studies have tested the effect in large populations with adequate statistical power and analyses. The aim of this study was to evaluate whether a school-based multicomponent intervention to improve handwashing among schoolchildren, the Hi Five study, succeeded in reducing infectious illness and illness-related absenteeism in schools. The Hi Five study was a three-armed cluster-randomized controlled trial involving 43 randomly selected Danish schools; two intervention arms involving 14 schools each, and 15 control schools. Infectious illness days, infectious illness episodes and illness-related absenteeism were estimated in multilevel regressions, based on available cases of text messages answered by parents and based on questionnaire data reported by schoolchildren, respectively. At follow-up, children in the intervention schools did not differ from the control schools in number of illness days [odds ratio (OR)I-arm I: 0.91 (0.77-1.07) and ORI-arm II: 0.94 (0.79-1.12)] and illness episodes [ORI-arm I: 0.95 (0.81-1.11) and ORI-arm II: 0.98 (0.84-1.16)] or in reporting illness-related absenteeism [ORI-arm I: 1.09 (0.83-1.43) & ORI-arm II: 1.06 (0.81-1.40)]. The multicomponent Hi Five intervention achieved no difference in the number of illness days, illness episodes or illness-related absenteeism among children in intervention schools compared with control schools. It is noteworthy that one of the main components in the intervention, a mandatory daily handwashing before lunch, was only implemented by 1 of 3 of teachers in intervention schools.

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Methods/design Randomized Controlled Multicentric Trial. Study population: 1060 smokers aged between 18–70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Intervention: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Outcome measures: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Statistical analysis: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. Discussion The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Trial Registration Clinical Trials.gov Identifier: NCT01494246. PMID:23597262

Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

PubMed

Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

2015-03-26

An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

PubMed

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

2010-01-01

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Books and babies: clinical-based literacy programs.

PubMed

Fortman, Kristine K; Fisch, Robert O; Phinney, Margaret Y; Defor, Terese A

2003-01-01

The purpose of this study was to assess parental response to a clinic-based literacy program at a health maintenance organization. It was hypothesized that participation would be associated with increased literacy orientation by children. This randomized community trial took place at a Midwestern health maintenance organization. Six clinics were paired and randomly assigned to participate or not participate in Project Read. The main outcome variable was literacy orientation (book use). The target population was parents of children younger than 12 months (N = 165). After 6 months of participation, parents were surveyed by telephone. Seventy-five percent and 77% of the treatment and control groups, respectively, had positive literacy orientation; this difference was not significant. Persons receiving a videotape were more likely to have a positive literacy orientation (82.9% vs 69.2%; P <.05). The multivariate regression analyses also showed that receiving the free videotape was a significant intervention exposure. The members of the population in this study are reading to their children. Parents who receive a videotape on the importance of reading are likely to read more to their children.

Association of zolpidem use and subsequent increased risk of epilepsy: a population-based, case-control study.

PubMed

Harnod, Tomor; Wang, Yu-Chiao; Sung, Fung-Chang; Kao, Chia-Hung

2014-10-01

To evaluate the impact of long-term zolpidem use on the subsequent risk of epilepsy. We used data from the National Health Insurance system of Taiwan to conduct a population-based case-control study. We identified 4,972 newly diagnosed epilepsy patients (ICD-9-CM code 345) for the period of 2005-2010 as cases. For each epilepsy case, 4 controls without a history of epilepsy were randomly selected from the rest of the population. Zolpidem was used as a predictor of epilepsy. Patients with epilepsy exhibited an adjusted odds ratio (OR) of 1.86 (95% CI, 1.70-2.03) and were, therefore, more strongly associated with zolpidem exposure than control patients were. The adjusted OR of epilepsy increased with the increase of mean zolpidem exposure (g/y). Compared with the OR of nonusers, the adjusted OR was 1.64 (95% CI, 1.44-1.86) for those who had taken < 1.0 g/y of zolpidem and 2.38 (95% CI, 2.06-2.74) for those who had taken ≥ 20.0 g/y of zolpidem. An adjusted OR of 3.55 (95% CI, 2.94-4.28) was noted to be associated with epilepsy when users had stopped taking the drug less than 7 days earlier. The estimated risk declined to an OR of 1.62 (95% CI, 1.47-1.78) when users had stopped taking the drug more than 90 days earlier. This population-based, retrospective case-control study revealed a possible increase in epilepsy risk with zolpidem use, at either typical or supratherapeutic doses. These findings might stimulate public interest in safety issues regarding zolpidem use. © Copyright 2014 Physicians Postgraduate Press, Inc.

Academic Outcomes 2 Years After Working Memory Training for Children With Low Working Memory: A Randomized Clinical Trial.

PubMed

Roberts, Gehan; Quach, Jon; Spencer-Smith, Megan; Anderson, Peter J; Gathercole, Susan; Gold, Lisa; Sia, Kah-Ling; Mensah, Fiona; Rickards, Field; Ainley, John; Wake, Melissa

2016-05-02

Working memory training may help children with attention and learning difficulties, but robust evidence from population-level randomized controlled clinical trials is lacking. To test whether a computerized adaptive working memory intervention program improves long-term academic outcomes of children 6 to 7 years of age with low working memory compared with usual classroom teaching. Population-based randomized controlled clinical trial of first graders from 44 schools in Melbourne, Australia, who underwent a verbal and visuospatial working memory screening. Children were classified as having low working memory if their scores were below the 15th percentile on either the Backward Digit Recall or Mister X subtest from the Automated Working Memory Assessment, or if their scores were below the 25th percentile on both. These children were randomly assigned by an independent statistician to either an intervention or a control arm using a concealed computerized random number sequence. Researchers were blinded to group assignment at time of screening. We conducted our trial from March 1, 2012, to February 1, 2015; our final analysis was on October 30, 2015. We used intention-to-treat analyses. Cogmed working memory training, comprising 20 to 25 training sessions of 45 minutes' duration at school. Directly assessed (at 12 and 24 months) academic outcomes (reading, math, and spelling scores as primary outcomes) and working memory (also assessed at 6 months); parent-, teacher-, and child-reported behavioral and social-emotional functioning and quality of life; and intervention costs. Of 1723 children screened (mean [SD] age, 6.9 [0.4] years), 226 were randomized to each arm (452 total), with 90% retention at 1 year and 88% retention at 2 years; 90.3% of children in the intervention arm completed at least 20 sessions. Of the 4 short-term and working memory outcomes, 1 outcome (visuospatial short-term memory) benefited the children at 6 months (effect size, 0.43 [95% CI, 0.25-0.62]) and 12 months (effect size, 0.49 [95% CI, 0.28-0.70]), but not at 24 months. There were no benefits to any other outcomes; in fact, the math scores of the children in the intervention arm were worse at 2 years (mean difference, -3.0 [95% CI, -5.4 to -0.7]; P = .01). Intervention costs were A$1035 per child. Working memory screening of children 6 to 7 years of age is feasible, and an adaptive working memory training program may temporarily improve visuospatial short-term memory. Given the loss of classroom time, cost, and lack of lasting benefit, we cannot recommend population-based delivery of Cogmed within a screening paradigm. anzctr.org.au Identifier: ACTRN12610000486022.

Efficacy and Safety of Oseltamivir in Children: Systematic Review and Individual Patient Data Meta-analysis of Randomized Controlled Trials.

PubMed

Malosh, Ryan E; Martin, Emily T; Heikkinen, Terho; Brooks, W Abdullah; Whitley, Richard J; Monto, Arnold S

2018-05-02

Oseltamivir has been used to treat children with influenza for nearly 2 decades, with treatment currently approved for infants aged ≥2 weeks. However, efficacy and safety remain controversial. Newer randomized, placebo-controlled trials (RCTs), not included in previous meta-analyses, can add to the evidence base. We conducted a systematic review to identify RCTs of oseltamivir therapy in children. We obtained individual patient data and examined protocol-defined outcomes. We then conducted a 2-stage, random-effects meta-analysis to determine the efficacy of treatment in reducing the duration of illness, estimated using differences in restricted mean survival time (RMST) by treatment group. We also examined complications and safety. We identified 5 trials that included 2561 patients in the intention-to-treat (ITT) and 1598 in the intention-to-treat infected (ITTI) populations. Overall, oseltamivir treatment significantly reduced the duration of illness in the ITTI population (RMST difference, -17.6 hours; 95% confidence interval [CI], -34.7 to -0.62 hours). In trials that enrolled patients without asthma, the difference was larger (-29.9 hours; 95% CI, -53.9 to -5.8 hours). Risk of otitis media was 34% lower in the ITTI population. Vomiting was the only adverse event with a significantly higher risk in the treatment group. Despite substantial heterogeneity in pediatric trials, we found that treatment with oseltamivir significantly reduced the duration of illness in those with influenza and lowered the risk of developing otitis media. Alternative endpoints may be required to evaluate the efficacy of oseltamivir in pediatric patients with asthma.

Opinions of researchers based in the UK on recruiting subjects from developing countries into randomized controlled trials.

PubMed

Newton, Sam K; Appiah-Poku, John

2007-12-01

Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries. Recorded in-depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries. Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty.

Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial.

PubMed

Rydeard, Rochenda; Leger, Andrew; Smith, Drew

2006-07-01

A randomized controlled trial, prestest-posttest design, with a 3-, 6-, and 12-month follow-up. To investigate the efficacy of a therapeutic exercise approach in a population with chronic low back pain (LBP). Therapeutic approaches developed from the Pilates method are becoming increasingly popular; however, there have been no reports on their efficacy. Thirty-nine physically active subjects between 20 and 55 years old with chronic LBP were randomly assigned to 1 of 2 groups. The specific-exercise-training group participated in a 4-week program consisting of training on specialized (Pilates) exercise equipment, while the control group received the usual care, defined as consultation with a physician and other specialists and healthcare professionals, as necessary. Treatment sessions were designed to train the activation of specific muscles thought to stabilize the lumbar-pelvic region. Functional disability outcomes were measured with The Roland Morris Disability Questionnaire (RMQ/RMDQ-HK) and average pain intensity using a 101-point numerical rating scale. There was a significantly lower level of functional disability (P = .023) and average pain intensity (P = .002) in the specific-exercise-training group than in the control group following the treatment intervention period. The posttest adjusted mean in functional disability level in the specific-exercise-training group was 2.0 (95% CI, 1.3 to 2.7) RMQ/RMDQ-HK points compared to a posttest adjusted mean in the control group of 3.2 (95% CI, 2.5 to 4.0) RMQ/RMDQ-HK points. The posttest adjusted mean in pain intensity in the specific-exercise-training group was 18.3 (95% CI, 11.8 to 24.8), as compared to 33.9 (95% CI, 26.9 to 41.0) in the control group. Improved disability scores in the specific-exercise-training group were maintained for up to 12 months following treatment intervention. The individuals in the specific-exercise-training group reported a significant decrease in LBP and disability, which was maintained over a 12-month follow-up period. Treatment with a modified Pilates-based approach was more efficacious than usual care in a population with chronic, unresolved LBP.

Internet-Assisted Parent Training Intervention for Disruptive Behavior in 4-Year-Old Children: A Randomized Clinical Trial.

PubMed

Sourander, Andre; McGrath, Patrick J; Ristkari, Terja; Cunningham, Charles; Huttunen, Jukka; Lingley-Pottie, Patricia; Hinkka-Yli-Salomäki, Susanna; Kinnunen, Malin; Vuorio, Jenni; Sinokki, Atte; Fossum, Sturla; Unruh, Anita

2016-04-01

There is a large gap worldwide in the provision of evidence-based early treatment of children with disruptive behavioral problems. To determine whether an Internet-assisted intervention using whole-population screening that targets the most symptomatic 4-year-old children is effective at 6 and 12 months after the start of treatment. This 2-parallel-group randomized clinical trial was performed from October 1, 2011, through November 30, 2013, at a primary health care clinic in Southwest Finland. Data analysis was performed from August 6, 2015, to December 11, 2015. Of a screened population of 4656 children, 730 met the screening criteria indicating a high level of disruptive behavioral problems. A total of 464 parents of 4-year-old children were randomized into the Strongest Families Smart Website (SFSW) intervention group (n = 232) or an education control (EC) group (n = 232). The SFSW intervention, an 11-session Internet-assisted parent training program that included weekly telephone coaching. Child Behavior Checklist version for preschool children (CBCL/1.5-5) externalizing scale (primary outcome), other CBCL/1.5-5 scales and subscores, Parenting Scale, Inventory of Callous-Unemotional Traits, and the 21-item Depression, Anxiety, and Stress Scale. All data were analyzed by intention to treat and per protocol. The assessments were made before randomization and 6 and 12 months after randomization. Of the children randomized, 287 (61.9%) were male and 79 (17.1%) lived in other than a family with 2 biological parents. At 12-month follow-up, improvement in the SFSW intervention group was significantly greater compared with the control group on the following measures: CBCL/1.5-5 externalizing scale (effect size, 0.34; P < .001), internalizing scale (effect size, 0.35; P < .001), and total scores (effect size, 0.37; P < .001); 5 of 7 syndrome scales, including aggression (effect size, 0.36; P < .001), sleep (effect size, 0.24; P = .002), withdrawal (effect size, 0.25; P = .005), anxiety (effect size, 0.26; P = .003), and emotional problems (effect size, 0.31; P = .001); Inventory of Callous-Unemotional Traits callousness scores (effect size, 0.19; P = .03); and self-reported parenting skills (effect size, 0.53; P < .001). The study reveals the effectiveness and feasibility of an Internet-assisted parent training intervention offered for parents of preschool children with disruptive behavioral problems screened from the whole population. The strategy of population-based screening of children at an early age to offering parent training using digital technology and telephone coaching is a promising public health strategy for providing early intervention for a variety of child mental health problems. clinicaltrials.gov Identifier: NCT01750996.

Inverse Association Between Gluteofemoral Obesity and Risk of Barrett's Esophagus in a Pooled Analysis.

PubMed

Kendall, Bradley J; Rubenstein, Joel H; Cook, Michael B; Vaughan, Thomas L; Anderson, Lesley A; Murray, Liam J; Shaheen, Nicholas J; Corley, Douglas A; Chandar, Apoorva K; Li, Li; Greer, Katarina B; Chak, Amitabh; El-Serag, Hashem B; Whiteman, David C; Thrift, Aaron P

2016-10-01

Gluteofemoral obesity (determined by measurement of subcutaneous fat in the hip and thigh regions) could reduce risks of cardiovascular and diabetic disorders associated with abdominal obesity. We evaluated whether gluteofemoral obesity also reduces the risk of Barrett's esophagus (BE), a premalignant lesion associated with abdominal obesity. We collected data from non-Hispanic white participants in 8 studies in the Barrett's and Esophageal Adenocarcinoma Consortium. We compared measures of hip circumference (as a proxy for gluteofemoral obesity) from cases of BE (n = 1559) separately with 2 control groups: 2557 population-based controls and 2064 individuals with gastroesophageal reflux disease (GERD controls). Study-specific odds ratios (ORs) and 95% confidence intervals (95% CIs) were estimated using individual participant data and multivariable logistic regression and combined using a random-effects meta-analysis. We found an inverse relationship between hip circumference and BE (OR per 5-cm increase, 0.88; 95% CI, 0.81-0.96), compared with population-based controls in a multivariable model that included waist circumference. This association was not observed in models that did not include waist circumference. Similar results were observed in analyses stratified by frequency of GERD symptoms. The inverse association with hip circumference was statistically significant only among men (vs population-based controls: OR, 0.85; 95% CI, 0.76-0.96 for men; OR, 0.93; 95% CI, 0.74-1.16 for women). For men, within each category of waist circumference, a larger hip circumference was associated with a decreased risk of BE. Increasing waist circumference was associated with an increased risk of BE in the mutually adjusted population-based and GERD control models. Although abdominal obesity is associated with an increased risk of BE, there is an inverse association between gluteofemoral obesity and BE, particularly among men. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

PubMed

Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

2011-01-01

PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also significantly improved self-reported productivity. CONCLUSION. An effective intervention can change employee health risk status and activation both at the population level and at the individual high risk level. However, program engagement at the population level was low, indicating that additional promotional strategies, such as greater use of incentives, need to be examined. Less intensive coaching can be as effective as more intensive, albeit both interventions produced modest behavior change and retention in the consumer activation arm was most difficult. Further research is needed concerning recruitment and retention methods that will enable populations to realize the full potential of activated consumerism.

Revisiting typhoid fever surveillance in low and middle income countries: lessons from systematic literature review of population-based longitudinal studies.

PubMed

Mogasale, Vittal; Mogasale, Vijayalaxmi V; Ramani, Enusa; Lee, Jung Seok; Park, Ju Yeon; Lee, Kang Sung; Wierzba, Thomas F

2016-01-29

The control of typhoid fever being an important public health concern in low and middle income countries, improving typhoid surveillance will help in planning and implementing typhoid control activities such as deployment of new generation Vi conjugate typhoid vaccines. We conducted a systematic literature review of longitudinal population-based blood culture-confirmed typhoid fever studies from low and middle income countries published from 1(st) January 1990 to 31(st) December 2013. We quantitatively summarized typhoid fever incidence rates and qualitatively reviewed study methodology that could have influenced rate estimates. We used meta-analysis approach based on random effects model in summarizing the hospitalization rates. Twenty-two papers presented longitudinal population-based and blood culture-confirmed typhoid fever incidence estimates from 20 distinct sites in low and middle income countries. The reported incidence and hospitalizations rates were heterogeneous as well as the study methodology across the sites. We elucidated how the incidence rates were underestimated in published studies. We summarized six categories of under-estimation biases observed in these studies and presented potential solutions. Published longitudinal typhoid fever studies in low and middle income countries are geographically clustered and the methodology employed has a potential for underestimation. Future studies should account for these limitations.

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

PubMed

Koutoukidis, Dimitrios A; Beeken, Rebecca J; Manchanda, Ranjit; Burnell, Matthew; Knobf, M Tish; Lanceley, Anne

2016-03-10

Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity. This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention. The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population. ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.

An adaptive random search for short term generation scheduling with network constraints.

PubMed

Marmolejo, J A; Velasco, Jonás; Selley, Héctor J

2017-01-01

This paper presents an adaptive random search approach to address a short term generation scheduling with network constraints, which determines the startup and shutdown schedules of thermal units over a given planning horizon. In this model, we consider the transmission network through capacity limits and line losses. The mathematical model is stated in the form of a Mixed Integer Non Linear Problem with binary variables. The proposed heuristic is a population-based method that generates a set of new potential solutions via a random search strategy. The random search is based on the Markov Chain Monte Carlo method. The main key of the proposed method is that the noise level of the random search is adaptively controlled in order to exploring and exploiting the entire search space. In order to improve the solutions, we consider coupling a local search into random search process. Several test systems are presented to evaluate the performance of the proposed heuristic. We use a commercial optimizer to compare the quality of the solutions provided by the proposed method. The solution of the proposed algorithm showed a significant reduction in computational effort with respect to the full-scale outer approximation commercial solver. Numerical results show the potential and robustness of our approach.

Disease invasion risk in a growing population.

PubMed

Yuan, Sanling; van den Driessche, P; Willeboordse, Frederick H; Shuai, Zhisheng; Ma, Junling

2016-09-01

The spread of an infectious disease may depend on the population size. For simplicity, classic epidemic models assume homogeneous mixing, usually standard incidence or mass action. For standard incidence, the contact rate between any pair of individuals is inversely proportional to the population size, and so the basic reproduction number (and thus the initial exponential growth rate of the disease) is independent of the population size. For mass action, this contact rate remains constant, predicting that the basic reproduction number increases linearly with the population size, meaning that disease invasion is easiest when the population is largest. In this paper, we show that neither of these may be true on a slowly evolving contact network: the basic reproduction number of a short epidemic can reach its maximum while the population is still growing. The basic reproduction number is proportional to the spectral radius of a contact matrix, which is shown numerically to be well approximated by the average excess degree of the contact network. We base our analysis on modeling the dynamics of the average excess degree of a random contact network with constant population input, proportional deaths, and preferential attachment for contacts brought in by incoming individuals (i.e., individuals with more contacts attract more incoming contacts). In addition, we show that our result also holds for uniform attachment of incoming contacts (i.e., every individual has the same chance of attracting incoming contacts), and much more general population dynamics. Our results show that a disease spreading in a growing population may evade control if disease control planning is based on the basic reproduction number at maximum population size.

Randomized Trial of a Family-based, Automated, Conversational Obesity Treatment Program for Underserved Populations

PubMed Central

Wright, J. A.; Phillips, B.D.; Watson, B.L.; Newby, P.K.; Norman, G. J.; Adams, W.G.

2013-01-01

Objective To evaluate the acceptability and feasibility of a scalable obesity treatment program integrated with pediatric primary care and delivered using interactive voice technology (IVR) to families from underserved populations. Design and Methods Fifty parent-child dyads (child 9–12 yrs, BMI >95th percentile) were recruited from a pediatric primary care clinic and randomized to either an IVR or a wait-list control (WLC) group. The majority were lower-income, African-American (72%) families. Dyads received IVR calls for 12 weeks. Call content was informed by two evidenced-based interventions. Anthropometric and behavioral variables were assessed at baseline and 3 mo follow-up. Results Forty-three dyads completed the study. IVR parents ate 1 cup more fruit than WLC (p < .05). No other groups differences were found. Children classified as high users of the IVR decreased weight, BMI and BMI z-score compared to low users (p<.05). Mean number of calls for parents and children were 9.1 (5.2 SD) and 9.0 (5.7 SD), respectively. Of those who made calls, >75% agreed that the calls were useful, made for people like them, credible, and helped them eat healthy foods. Conclusion An obesity treatment program delivered via IVR may be an acceptable and feasible resource for families from underserved populations. PMID:23512915

First report of pyrethroid resistance in Rhipicephalus (Boophilus) annulatus larvae (Say, 1821) from Iran.

PubMed

Ziapour, Seyyed Payman; Kheiri, Sadegh; Asgarian, Fatemeh; Fazeli-Dinan, Mahmoud; Yazdi, Fariborz; Mohammadpour, Reza Ali; Aarabi, Mohsen; Enayati, Ahmadali

2016-04-01

Rhipicephalus (Boophilus) annulatus is one of the most important hard ticks parasitizing cattle in northern Iran. The aim of this study was to evaluate pyrethroid resistance levels of this species from Nur County, northern Iran. The hard ticks were collected through a multistage cluster randomized sampling method from the study area and fully engorged female R. (B.) annulatus were reared in a controlled insectary until they produced larvae for bioassay. Seventeen populations of the hard ticks were bioassayed with cypermethrin and 12 populations with lambda-cyhalothrin using a modified larval packet test (LPT). Biochemical assays to measure the contents/activity of different enzyme groups including mixed function oxidases (MFOs), glutathione S-transferases (GSTs) and general esterases were performed. Population 75 showed a resistance ratio of 4.05 with cypermethrin when compared with the most susceptible field population 66 at the LC50 level. With lambda-cyhalothrin the resistance ratio based on LC50 was 3.67 when compared with the susceptible population. The results of biochemical assays demonstrated significantly elevated levels of GSTs and esterases in populations tested compared with the heterozygous susceptible filed population and a correlation coefficient of these enzymes was found in association to lambda-cyhalothrin resistance. Based on the results, pyrethroid acaricides may operationally fail to control R. (B.) annulatus in North of Iran. This study is the first document of pyrethroid resistance in R. (B.) annulatus populations from Iran. Copyright © 2016 Elsevier B.V. All rights reserved.

Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial.

PubMed

Anema, Johannes R; Steenstra, Ivan A; Bongers, Paulien M; de Vet, Henrica C W; Knol, Dirk L; Loisel, Patrick; van Mechelen, Willem

2007-02-01

Population-based randomized controlled trial. To assess the effectiveness of workplace intervention and graded activity, separately and combined, for multidisciplinary rehabilitation of low back pain (LBP). Effective components for multidisciplinary rehabilitation of LBP are not yet established. Participants sick-listed 2 to 6 weeks due to nonspecific LBP were randomized to workplace intervention (n = 96) or usual care (n = 100). Workplace intervention consisted of workplace assessment, work modifications, and case management involving all stakeholders. Participants still sick-listed at 8 weeks were randomized for graded activity (n = 55) or usual care (n = 57). Graded activity comprised biweekly 1-hour exercise sessions based on operant-conditioning principles. Outcomes were lasting return to work, pain intensity and functional status, assessed at baseline, and at 12, 26, and 52 weeks after the start of sick leave. Time until return to work for workers with workplace intervention was 77 versus 104 days (median) for workers without this intervention (P = 0.02). Workplace intervention was effective on return to work (hazard ratio = 1.7; 95% CI, 1.2-2.3; P = 0.002). Graded activity had a negative effect on return to work (hazard ratio = 0.4; 95% CI, 0.3-0.6; P < 0.001) and functional status. Combined intervention had no effect. Workplace intervention is advised for multidisciplinary rehabilitation of subacute LBP. Graded activity or combined intervention is not advised.

Clinically observed chickenpox and the risk of childhood-onset multiple sclerosis.

PubMed

Mikaeloff, Yann; Caridade, Guillaume; Suissa, Samy; Tardieu, Marc

2009-05-15

The authors conducted a population-based case-control study to investigate whether clinically observed chickenpox, linked with a level of intensity for clinical expression, increases the risk of multiple sclerosis (MS) in childhood. The cases were MS patients whose disease onset occurred between 1994 and 2003, before age 16 years, in France. Each case was matched for age, sex, and geographic origin with as many as 12 controls randomly selected from the general population. Information about clinically observed chickenpox in cases and controls before the index date regarding onset of MS was collected with a standardized questionnaire and was checked against health certificates. Conditional logistic regression was used to estimate the odds ratio for an association between MS and chickenpox. The 137 MS cases were matched with 1,061 controls. Clinically observed chickenpox had occurred in 76.6% of the cases and 84.9% of their matched controls. The adjusted odds ratio of MS onset associated with chickenpox occurrence was 0.58 (95% confidence interval: 0.36, 0.92). The authors concluded that clinically observed chickenpox was associated with a lower risk of childhood-onset MS in a French population.

Haemorrhoids are associated with erectile dysfunction: a population-based study.

PubMed

Keller, J J; Lin, H-C

2012-12-01

Haemorrhoids are associated with regional vascular abnormalities and rectal pain, which are hypothesized to increase the risk of erectile dysfunction (ED); however, few studies have investigated the association between ED and haemorrhoids. This case-control study aimed to estimate the association between haemorrhoids and ED by using a population-based data in Taiwan. We identified 6,310 patients with ED as cases and randomly selected 31,550 controls. Conditional logistic regression was performed to compute the odds ratio (OR) for having been previously diagnosed with haemorrhoids between cases and controls. The results show that haemorrhoids were found to be present among 1,572 (24.9%) cases and 4,491 (14.20%) controls. The OR for prior haemorrhoids among cases was 1.90 (95% CI = 1.78-2.03) when compared with controls after adjusting for monthly income, geographical location, hypertension, diabetes, coronary heart disease, hyperlipidemia, obesity and alcohol abuse/alcohol dependence syndrome. Younger cases demonstrated a higher risk for prior haemorrhoids when compared with controls. In particular, the adjusted OR among cases <30 years old was 3.71 (95% CI = 2.74-5.02) when compared with controls. We concluded that there was an association between ED and a prior diagnosis of haemorrhoids. © 2012 The Authors. International Journal of Andrology © 2012 European Academy of Andrology.

The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders. Methods/design Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate. Discussion This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies. Systematic review registration PROSPERO CRD42014009506 PMID:25312992

Dissemination of the Look AHEAD Lifestyle Intervention in the United States Air Force: Study Rationale, Design and Methods

PubMed Central

Krukowski, Rebecca A.; Hare, Marion E.; Talcott, Gerald W.; Johnson, Karen C.; Richey, Phyllis A.; Kocak, Mehmet; Balderas, Jennifer; Colvin, Lauren; Keller, Patrick L.; Waters, Teresa M.; Klesges, Robert C.

2014-01-01

Despite an increase in overweight and obesity similar to the civilian population, there have been few randomized controlled trials examining behavioral weight management interventions in the military settings. This paper describes the design, intervention development and analysis plan of the Fit Blue study, a randomized controlled behavioral weight loss trial taking place in the United States Air Force. This study compares two adapted versions of the efficacious Look AHEAD Intensive Lifestyle Intervention (ILI), a counselor-initiated condition and a self-paced condition. Also described are the unique steps required when conducting military-based health promotion research and adaptations made to the Look AHEAD intervention to accommodate the military environment. To our knowledge, this is the first translation of the Look AHEAD ILI in the military setting and one of the first translations of the ILI in general. If successful, this intervention could be disseminated to the entire U.S. Military as this project is designed to overcome the barriers and utilize the facilitators for weight loss that are unique to a military population. Programs validated in military populations can have a major public health impact given that with 1.4 million active duty personnel, the Department of Defense is the nation’s largest employer. However, while this intervention is designed for a military population and there are unique aspects of the military that may enhance weight loss interventions, the diversity of the study population should help inform obesity efforts in both civilian and military settings. PMID:25545025

Dissemination of the Look AHEAD intensive lifestyle intervention in the United States Air Force: study rationale, design and methods.

PubMed

Krukowski, Rebecca A; Hare, Marion E; Talcott, Gerald W; Johnson, Karen C; Richey, Phyllis A; Kocak, Mehmet; Balderas, Jennifer; Colvin, Lauren; Keller, Patrick L; Waters, Teresa M; Klesges, Robert C

2015-01-01

Despite an increase in overweight and obesity similar to the civilian population, there have been few randomized controlled trials examining behavioral weight management interventions in the military settings. This paper describes the design, intervention development and analysis plan of the Fit Blue study, a randomized controlled behavioral weight loss trial taking place in the United States Air Force. This study compares two adapted versions of the efficacious Look AHEAD Intensive Lifestyle Intervention (ILI), a counselor-initiated condition and a self-paced condition. Also described are the unique steps required when conducting military-based health promotion research and adaptations made to the Look AHEAD intervention to accommodate the military environment. To our knowledge, this is the first translation of the Look AHEAD ILI in the military setting and one of the first translations of the ILI in general. If successful, this intervention could be disseminated to the entire U.S. Military as this project is designed to overcome the barriers and utilize the facilitators for weight loss that are unique to a military population. Programs validated in military populations can have a major public health impact given that with 1.4 million active duty personnel, the Department of Defense is the nation's largest employer. However, while this intervention is designed for a military population and there are unique aspects of the military that may enhance weight loss interventions, the diversity of the study population should help inform obesity efforts in both civilian and military settings. Copyright © 2014 Elsevier Inc. All rights reserved.

Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome: design and methods of a pilot randomized controlled trial.

PubMed

Raja-Khan, Nazia; Agito, Katrina; Shah, Julie; Stetter, Christy M; Gustafson, Theresa S; Socolow, Holly; Kunselman, Allen R; Reibel, Diane K; Legro, Richard S

2015-03-01

Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese (NCT01464398). Eighty six (86) women with body mass index ≥ 25 kg/m(2), including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. Copyright © 2015 Elsevier Inc. All rights reserved.

Mindfulness-Based Stress Reduction for Overweight/Obese Women With and Without Polycystic Ovary Syndrome: Design and Methods of a Pilot Randomized Controlled Trial

PubMed Central

Raja-Khan, Nazia; Agito, Katrina; Shah, Julie; Stetter, Christy M.; Gustafson, Theresa S.; Socolow, Holly; Kunselman, Allen R.; Reibel, Diane K.; Legro, Richard S.

2015-01-01

Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese. Eighty six (86) women with body mass index ≥25 kg/m2, including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. PMID:25662105

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia.

PubMed

Brown, Kirk Warren; Coogle, Constance L; Wegelin, Jacob

2016-11-01

The majority of care for those with Alzheimer's disease and other age-related dementias is provided in the home by family members. To date, there is no consistently effective intervention for reducing the significant stress burden of many family caregivers. The present pilot randomized controlled trial tested the efficacy of an adapted, eight-week mindfulness-based stress reduction (MBSR) program, relative to a near structurally equivalent, standard social support (SS) control condition for reducing caregiver stress and enhancing the care giver-recipient relationship. Thirty-eight family caregivers were randomized to MBSR or SS, with measures of diurnal salivary cortisol, and perceived stress, mental health, experiential avoidance, caregiver burden, and relationship quality collected pre- and post-intervention and at three-month follow-up. MBSR participants reported significantly lower levels of perceived stress and mood disturbance at post-intervention relative to SS participants. At three-month follow-up, participants in both treatment conditions reported improvements on several psychosocial outcomes. At follow-up, there were no condition differences on these outcomes, nor did MBSR and SS participants differ in diurnal cortisol response change over the course of the study. Both MBSR and SS showed stress reduction effects, and MBSR showed no sustained neuroendocrine and psychosocial advantages over SS. The lack of treatment condition differences could be attributable to active ingredients in both interventions, and to population-specific and design factors.

Recruiting and retaining low-income, multi-ethnic women into randomized controlled trials: Successful strategies and staffing

PubMed Central

Barnett, Josephine; Aguilar, Stephanie; Brittner, Mindy; Bonuck, Karen

2012-01-01

Developing effective recruitment and retention strategies in populations with traditionally high attrition rates is critical to the success of Randomized Controlled Trials (RCTs). Data on successful participation of women from low-income, minority populations in RCTs of behavioral interventions are limited. This is problematic given the multiplicity of Healthy People 2020 goals that target health disparities in these populations. This paper reports successful recruitment and retention methods from two separately funded NIH clinical trials of primary care-based prenatal interventions to increase breastfeeding among ethnically diverse, low-income women in urban medical centers in the Bronx, NY. It also presents the required staff effort necessary to conduct such a successful RCT, in terms of full-time equivalents (FTEs). Results include timely recruitment of 941 participants over 29 months, with 98.1% completing 1̄ follow-up interview. A recruitment and retention plan that maximized study staff access and availability to the participant, as well as strong study staff rapport with participants, addressed previously reported barriers in this population, optimizing follow-up rates. A qualitative assessment of the participants' study experience suggesting that high retention was due to strong rapport with participants, short interviews requiring little time commitment, and participants' perception of the study as informative, provides further evidence of our approach's effectiveness. Logistical protocol procedures and staff management strategies relating to successful recruitment/retention are provided to propose a practical, cost-effective and translational recruitment–retention plan for other researchers to adopt. PMID:22732312

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

PubMed

Borland, Ron; Balmford, James; Benda, Peter

2013-03-01

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

Cognitive Group Therapy Based on Schema-Focused Approach for Reducing Depression in Prisoners Living With HIV.

PubMed

Jalali, Farzad; Hasani, Alireza; Hashemi, Seyedeh Fatemeh; Kimiaei, Seyed Ali; Babaei, Ali

2018-06-01

Depression is one the most common mental disorders in prisons. People living with HIV are more likely to develop psychological difficulties when compared with the general population. This study aims to determine the efficacy of cognitive group therapy based on schema-focused approach in reducing depression in prisoners living with HIV. The design of this study was between-groups (or "independent measures"). It was conducted with pretest, posttest, and waiting list control group. The research population comprised all prisoners living with HIV in a men's prison in Iran. Based on voluntary desire, screening, and inclusion criteria, 42 prisoners living with HIV participated in this study. They were randomly assigned to an experimental group (21 prisoners) and waiting list control group (21 prisoners). The experimental group received 11 sessions of schema-focused cognitive group therapy, while the waiting list control group received the treatment after the completion of the study. The various groups were evaluated in terms of depression. ANCOVA models were employed to test the study hypotheses. Collated results indicated that depression was reduced among prisoners in the experimental group. Schema therapy (ST) could reduce depression among prisoners living with HIV/AIDS.

Estimation of the marginal effect of regular drug use on multiple sclerosis in the Iranian population.

PubMed

Abdollahpour, Ibrahim; Nedjat, Saharnaz; Mansournia, Mohammad Ali; Schuster, Tibor

2018-01-01

There are only few reports regarding the role of lifetime drug or substance use in multiple sclerosis (MS) etiology. In this study, we investigated the potential effect of drug or substance exposure on the onset of MS diagnosis. We conducted a population-based incident case control study in Tehran. Cases (n = 547) were 15-50 years old persons with MS identified from the Iranian Multiple Sclerosis Society (IMSS) register during August 7, 2013, and November 17, 2015. Population-based controls (n = 1057) were 15-50 years old and were recruited by random digit telephone dialing. Inverse-probability-of-treatment weighing (IPTW) using two sets of propensity scores (PSs) was used to estimate marginal incidence odds ratios (ORs) for MS contrasting pre-specified substance use. The estimated marginal OR was 6.03 (95% confidence interval: 3.54;10.3, using trimmed weights at the 95th percentile of the stabilized weight distribution) in both IPTW analyses comparing lifetime substance use (opioids, cannabis, inhalants, hallucinogens and stimulants) for at least one time monthly during a six-months or longer period vs. no such history of drug use. Subject to limitation of causal claims based on case-control studies, this study suggests that monthly drug or substance use for a period of at least six consecutive months, may increase the risk of MS by factor 3.5 or higher.

Practice facilitation for improving cardiovascular care: secondary evaluation of a stepped wedge cluster randomized controlled trial using population-based administrative data.

PubMed

Deri Armstrong, Catherine; Taljaard, Monica; Hogg, William; Mark, Amy E; Liddy, Clare

2016-09-05

Practice facilitation (PF), a multifaceted approach in which facilitators (external health care professionals) help family physicians to improve their adoption of best practices, has been highly successful. Improved Delivery of Cardiovascular Care (IDOCC) was an innovative PF trial designed to improve evidence-based care for people who have, or are at risk of, cardiovascular disease (CVD). The intervention was found to be ineffective as assessed by a patient-level composite score based on chart reviews from a subsample of patients (N = 5292). Here, we used population-based administrative data to examine IDOCC's effect on CVD-related hospitalizations. IDOCC used a pragmatic, stepped wedge cluster randomized controlled design involving primary care providers recruited across Eastern Ontario, Canada. IDOCC's effect on CVD-related hospitalizations was assessed in the 2 years of active intervention and post-intervention years. Marginal and mixed-effects regression analyses were used to account for the study design and to control for patient, physician, and practice characteristics. Secondary and subgroup analyses investigated robustness. Our sample included 262,996 patient/year observations representing 54,085 unique patients who had, or were at risk of, CVD, from 70 practices. There was a strong decreasing secular trend in CVD-related hospitalizations but no statistically significant effect of IDOCC. Relative to patients in the control condition, patients in the intervention condition were estimated to have 4 % lower odds of CVD-related hospitalizations (adjOR = 0.96, 99 % CI 0.83 to 1.11). The nonsignificant result persisted across robustness analyses. Clinical outcomes from administrative databases were examined to form a more complete picture of the (in)effectiveness of a large-scale quality improvement intervention. IDOCC did not have a significant effect on CVD hospitalizations, suggesting that the results from the primary composite adherence score analysis were neither due to choice of outcome nor relatively short follow-up period. ClinicalTrials.gov NCT00574808 , registered on 14 December 2007.

There is room for selection in a small local pig breed when using optimum contribution selection: a simulation study.

PubMed

Gourdine, J L; Sørensen, A C; Rydhmer, L

2012-01-01

Selection progress must be carefully balanced against the conservation of genetic variation in small populations of local breeds. Well-defined breeding programs with specified selection traits are rare in local pig breeds. Given the small population size, the focus is often on the management of genetic diversity. However, in local breeds, optimum contribution selection can be applied to control the rate of inbreeding and to avoid reduced performance in traits with high market value. The aim of this study was to assess the extent to which a breeding program aiming for improved product quality in a small local breed would be feasible. We used stochastic simulations to compare 25 scenarios. The scenarios differed in size of population, selection intensity of boars, type of selection (random selection, truncation selection based on BLUP breeding values, or optimum contribution selection based on BLUP breeding values), and heritability of the selection trait. It was assumed that the local breed is used in an extensive system for a high-meat-quality market. The simulations showed that in the smallest population (300 female reproducers), inbreeding increased by 0.8% when selection was performed at random. With optimum contribution selection, genetic progress can be achieved that is almost as great as that with truncation selection based on BLUP breeding values (0.2 to 0.5 vs. 0.3 to 0.5 genetic SD, P < 0.05), but at a considerably decreased rate of inbreeding (0.7 to 1.2 vs. 2.3 to 5.7%, P < 0.01). This confirmation of the potential utilization of OCS even in small populations is important in the context of sustainable management and the use of animal genetic resources.

Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness.

PubMed

Mashour, George A; Tremper, Kevin K; Avidan, Michael S

2009-11-05

The incidence of intraoperative awareness with explicit recall is 1-2/1000 cases in the United States. The Bispectral Index monitor is an electroencephalographic method of assessing anesthetic depth that has been shown in one prospective study to reduce the incidence of awareness in the high-risk population. In the B-Aware trial, the number needed to treat in order to prevent one case of awareness in the high-risk population was 138. Since the number needed to treat and the associated cost of treatment would be much higher in the general population, the efficacy of the Bispectral Index monitor in preventing awareness in all anesthetized patients needs to be clearly established. This is especially true given the findings of the B-Unaware trial, which demonstrated no significant difference between protocols based on the Bispectral Index monitor or minimum alveolar concentration for the reduction of awareness in high risk patients. To evaluate efficacy in the general population, we are conducting a prospective, randomized, controlled trial comparing the Bispectral Index monitor to a non-electroencephalographic gauge of anesthetic depth. The total recruitment for the study is targeted for 30,000 patients at both low and high risk for awareness. We have developed a novel algorithm that is capable of real-time analysis of our electronic perioperative information system. In one arm of the study, anesthesia providers will receive an electronic page if the Bispectral Index value is >60. In the other arm of the study, anesthesia providers will receive a page if the age-adjusted minimum alveolar concentration is <0.5. Our minimum alveolar concentration algorithm is sensitive to both inhalational anesthetics and intravenous sedative-hypnotic agents. Awareness during general anesthesia is a persistent problem and the role of the Bispectral Index monitor in its prevention is still unclear. The Michigan Awareness Control Study is the largest prospective trial of awareness prevention ever conducted. Clinical Trial NCT00689091.

A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial

PubMed Central

2013-01-01

Background Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men. Methods/design MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged ≥50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months. Discussion This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings. Trial registration ClinicalTrials.gov, NCT01092078 PMID:24011142

Dynamics and control of infections on social networks of population types.

PubMed

Williams, Brian G; Dye, Christopher

2018-06-01

Random mixing in host populations has been a convenient simplifying assumption in the study of epidemics, but neglects important differences in contact rates within and between population groups. For HIV/AIDS, the assumption of random mixing is inappropriate for epidemics that are concentrated in groups of people at high risk, including female sex workers (FSW) and their male clients (MCF), injecting drug users (IDU) and men who have sex with men (MSM). To find out who transmits infection to whom and how that affects the spread and containment of infection remains a major empirical challenge in the epidemiology of HIV/AIDS. Here we develop a technique, based on the routine sampling of infection in linked population groups (a social network of population types), which shows how an HIV/AIDS epidemic in Can Tho Province of Vietnam began in FSW, was propagated mainly by IDU, and ultimately generated most cases among the female partners of MCF (FPM). Calculation of the case reproduction numbers within and between groups, and for the whole network, provides insights into control that cannot be deduced simply from observations on the prevalence of infection. Specifically, the per capita rate of HIV transmission was highest from FSW to MCF, and most HIV infections occurred in FPM, but the number of infections in the whole network is best reduced by interrupting transmission to and from IDU. This analysis can be used to guide HIV/AIDS interventions using needle and syringe exchange, condom distribution and antiretroviral therapy. The method requires only routine data and could be applied to infections in other populations. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

A Randomized Trial of Yoga for Children Hospitalized With Sickle Cell Vaso-Occlusive Crisis.

PubMed

Moody, Karen; Abrahams, Bess; Baker, Rebecca; Santizo, Ruth; Manwani, Deepa; Carullo, Veronica; Eugenio, Doris; Carroll, Aaron

2017-06-01

Sickle cell disease (SCD) vaso-occlusive crisis (VOC) remains an important cause of acute pain in pediatrics and the most common SCD complication. Pain management recommendations in SCD include nonpharmacological interventions. Yoga is one nonpharmacological intervention that has been shown to reduce pain in some populations; however, evidence is lacking in children with VOC. The primary objective of this study was to compare the effect of yoga vs. an attention control on pain in children with VOC. The secondary objectives were to compare the effect of yoga vs. an attention control on anxiety, lengths of stay, and opioid use in this population. Patients were eligible if they had a diagnosis of SCD, were 5-21 years old, were hospitalized for uncomplicated VOC, and had an admission pain score of ≥7. Subjects were stratified based on disease severity and randomized to the yoga or control group. Eighty-three percent of patients approached (N = 73) enrolled on study. There were no significant differences in baseline clinical or demographic factors between groups. Compared with the control group, children randomized to yoga had a significantly greater reduction in mean pain score after one yoga session (-0.6 ± 0.96 vs. 0.0 ± 1.37; P = 0.029). There were no significant differences in anxiety, lengths of stay, or opioid use between the two groups. This study provides evidence that yoga is an acceptable, feasible, and helpful intervention for hospitalized children with VOC. Future research should further examine yoga for children with SCD pain in the inpatient and outpatient settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Motivating smokers to quit using computer-generated letters that target either reduction or cessation: A population-based randomized controlled trial among smokers who do not intend to quit.

PubMed

Meyer, Christian; Ulbricht, Sabina; Haug, Severin; Broda, Anja; Bischof, Gallus; Rumpf, Hans-Jürgen; John, Ulrich

2016-09-01

This study examined the long-term efficacy of individualized counseling letters that targeted either smoking abstinence or reducing the number of cigarettes smoked per day to promote future cessation. A nationwide random-digit-dialing telephone sample was used to identify smokers from the general adult population (participation proportion: 54.5%). In total, 1462 participants (48% female) who did not intend to quit within the next six months and who smoked ten or more cigarettes a day were randomized to one of two intervention groups or an assessment-only control condition. The interventions consisted of three tailored letters that were sent after baseline and follow-up assessments after three and six months. Follow-up data on smoking status were provided by 82% and 77% of the participants 12 and 24 months after study inclusion, respectively. Generalized estimation equation (GEE) models adjusted for potential baseline confounders and multiple imputation of missing follow-up data were used to estimate intervention effects. At 24-month follow-up prevalence of 7-day point abstinence was 8.4%, 12.9% and 14.7% in the control, abstinence intervention and reduction intervention condition, which corresponds to a number needed to treat of 22 (95%-CI: 11-707) and 16 (95%-CI: 9-53). Adjusted GEE analyses revealed that the smoking reduction intervention (ORadj=2.3, p<0.01) but not the abstinence intervention (ORadj=1.4, p=0.20) increased the odds of 6-month prolonged abstinence compared with the control condition. No significant differences appear when directly comparing both intervention groups. Smoking reduction should be considered as an alternative intervention goal for smokers who are unable or unwilling to quit. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results

PubMed Central

2012-01-01

Background The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here. Methods The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. Results There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys. Conclusions Randomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012. Trial registration Current Controlled Trials ISRCTN68175121 PMID:22769971

Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial.

PubMed

Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

2014-09-29

Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs).

Adherence and retention in clinical trials: a community-based approach.

PubMed

Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine; Person, Sharina D; Partridge, Edward E

2014-04-01

The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials. © 2014 American Cancer Society.

ProjectHeartforGirls.com: Development of a Web-Based HIV/STD Prevention Program for Adolescent Girls Emphasizing Sexual Communication Skills.

PubMed

Widman, Laura; Golin, Carol E; Noar, Seth M; Massey, Joy; Prinstein, Mitchell J

2016-10-01

This article describes the development of ProjectHeartforGirls.com , an interactive web-based program designed to improve sexual communication skills and reduce the risk of HIV/STDs among adolescent girls, a population at heightened risk for negative sexual health outcomes (Centers for Disease Control and Prevention, 2013). Although sexual communication is a critical predictor of safer sex among teens, there are few online interventions that target these skills as a central program component. We developed ProjectHeartforGirls.com to fill this gap. Program development involved (1) identifying the target population (ethnically diverse high school girls), (2) clarifying the theoretical foundation (Reasoned Action Model), (3) conducting formative qualitative research (n = 25 girls), (4) drafting initial program content, (5) receiving ongoing feedback from a teen advisory board (n = 5 girls), (6) programming online content, and (7) conducting usability testing (n = 6 girls). These steps are described along with the final intervention product, which is currently being evaluated in a randomized controlled trial.

Can evidence change the rate of back surgery? A randomized trial of community-based education.

PubMed

Goldberg, H I; Deyo, R A; Taylor, V M; Cheadle, A D; Conrad, D A; Loeser, J D; Heagerty, P J; Diehr, P

2001-01-01

Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences. To implement the conservative, evidence-based approach to low-back pain recommended in national guidelines, with the anticipated effect of reducing population-based rates of surgery. A randomized, controlled trial. Ten communities in western Washington State with annual rates of back surgery above the 1990 national average (158 operations per 100,000 adults). Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators. The five communities randomized to the intervention group received a package of six educational activities tailored to local needs by community planning groups. Surgeon study groups, primary care continuing medical education conferences, administrative consensus processes, videodisc-aided patient decision making, surgical outcomes management, and generalist academic detailing were serially implemented over a 30-month intervention period. Quarterly observations of surgical rates. After implementation of the intervention, surgery rates declined in the intervention communities but increased slightly in the control communities. The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000, a relative reduction of 8.9% (P = 0.01). We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities.

Dose-response association of physical activity with acute myocardial infarction: do amount and intensity matter?

PubMed

Elosua, Roberto; Redondo, Ana; Segura, Antonio; Fiol, Miquel; Aldasoro, Elena; Vega, Gema; Forteza, Jordi; Martí, Helena; Arteagoitia, José María; Marrugat, Jaume

2013-11-01

The aims of this study were to analyze the dose-response association between leisure time physical activity (PA) practice and myocardial infarction (MI), considering not only the total amount but also the amount of PA at different levels of intensity, and to determine whether these associations were modified by age. In a population-based age- and sex-matched case-control study, all first acute MI patients aged 25 to 74 years were prospectively registered in four Spanish hospitals between 2002 and 2004. Controls were randomly selected from population-based samples recruited during the same period of time. The Minnesota PA questionnaire was administered to assess total energy expenditure in PA and in light-, moderate-, and high-intensity PA. Finally, 1339 cases and 1339 controls were included. The association between PA and MI likelihood was non-linear, with significantly lower MI odds at low practice levels (≥ 500 MET·min/week), lowest odds around 1500 MET·min/week, and a plateau thereafter. Light- (in subjects older than 64 years), moderate-, and high-intensity PA produced similar benefits. Most of the population could reduce their likelihood of MI by engaging in PA at a moderate level of intensity or, in individuals older than 64 years, at a light level of intensity. © 2013.

Cluster-Randomized Trial to Increase Hepatitis B Testing among Koreans in Los Angeles

PubMed Central

Bastani, Roshan; Glenn, Beth A.; Maxwell, Annette E.; Jo, Angela M.; Herrmann, Alison K.; Crespi, Catherine M.; Wong, Weng K.; Chang, L. Cindy; Stewart, Susan L.; Nguyen, Tung T.; Chen, Moon S.; Taylor, Victoria M.

2015-01-01

Background In the United States, Korean immigrants experience a disproportionately high burden of chronic hepatitis B (HBV) viral infection and associated liver cancer compared to the general population. However, despite clear clinical guidelines, HBV serologic testing among Koreans remains persistently sub-optimal. Methods We conducted a cluster-randomized trial to evaluate a church-based small group intervention to improve HBV testing among Koreans in Los Angeles. Fifty-two Korean churches, stratified by size (small, medium, large) and location (Koreatown versus other), were randomized to intervention or control conditions. Intervention church participants attended a single-session small-group discussion on liver cancer and HBV testing and control church participants attended a similar session on physical activity and nutrition. Outcome data consisted of self-reported HBV testing obtained via 6-month telephone follow-up interviews. Results We recruited 1123 individuals, 18-64 years of age, across the 52 churches. Ninety-two percent of the sample attended the assigned intervention session and 86% completed the 6-month follow-up. Sample characteristics included: mean age 46 years, 65% female, 97% born in Korea, 69% completed some college, and 43% insured. In an intent-to-treat analysis, the intervention produced a statistically significant effect (OR = 4.9, p < .001), with 19% of intervention and 6% of control group participants reporting a HBV test. Conclusion Our intervention was successful in achieving a large and robust effect in a population at high risk of HBV infection and sequelae. Impact The intervention was fairly resource efficient and thus has high potential for replication in other high-risk Asian groups. PMID:26104909

Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

PubMed

González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

2015-10-31

Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed. ClinicalTrials.gov NCT02345668 . Registered 27 July 2015.

Nurse home visits with or without alert buttons versus usual care in the frail elderly: a randomized controlled trial

PubMed Central

Favela, Jesús; Castro, Luis A; Franco-Marina, Francisco; Sánchez-García, Sergio; Juárez-Cedillo, Teresa; Bermudez, Claudia Espinel; Mora-Altamirano, Julia; Rodriguez, Marcela D; García-Peña, Carmen

2013-01-01

Objective To assess whether an intervention based on nurse home visits including alert buttons (NV+AB) is effective in reducing frailty compared to nurse home visits alone (NV-only) and usual care (control group) for older adults. Design Unblinded, randomized, controlled trial. Setting Insured population covered by the Mexican Social Security Institute living in the city of Ensenada, Baja California, Mexico. Participants Patients were aged over 60 years with a frailty index score higher than 0.14. Intervention After screening and informed consent, participants were allocated randomly to the control, NV+AB, or NV-only groups. Measurements The primary outcome was the frailty score 9 months later. Quality of life, depression, comorbidities, health status, and health service utilization were also considered. Results The framing sample included 819 patients. Of those, 591 were not located because they did not have a landline/telephone (341 patients), they had died (107), they were ill (50), or they were not currently living in the city (28). A screening interview was applied to 228 participants, and 57 had a score ≤0.14, 171 had ≥0.14, and 16 refused to complete the baseline questionnaire. A home visit was scheduled for 155 patients. However, 22 did not complete the baseline questionnaire. The final 133 subjects were randomized into the NV+AB (n = 45), NV-only (n = 44), and control (n = 44) groups. There were no statistically significant differences in the baseline characteristics of the groups. The mean age overall was 76.3 years (standard deviation 4.7) and 45% were men. At the baseline, 61.65% were classified as frail. At end of follow-up the adjusted prevalence of frailty in NV+AB group was 23.3% versus 58.3% in the control group. Conclusion: An intervention based on NV+AB seems to have a positive effect on frailty scores. PMID:23378751

Impact of an Intervention Designed to Reduce Sexual Health Risk Behaviors of African American Adolescents: Results of a Randomized Controlled Trial

PubMed Central

Jenner, Lynne W.; Walsh, Sarah; Demby, Hilary; Gregory, Alethia; Davis, Erin

2016-01-01

Objectives. To replicate an evidence-based HIV risk reduction program and assess its impact on 2 behavioral outcomes—inconsistency of condom use and frequency of sex—6 months after the program. Methods. The study was an individual-level randomized controlled trial in which we randomly assigned 850 youths (aged 14–18 years) to 1 of 2 conditions. The treatment (Becoming a Responsible Teen) is a group-level sociocognitive and skills training sexual education course; the control is a general health intervention that includes the same initial informational component as the treatment. Participants were recruited over 3 summers (2012–2014) from a summer employment program in New Orleans, Louisiana, that serves primarily African American adolescents. Results. Six months after program exposure, we found no statistically significant difference between treatment and control group members’ self-reported inconsistency of condom use or frequency of sex (P > .05). Conclusions. Although previous evidence has indicated that this particular program can be effective, this study’s findings indicate that it was not effective in this setting with this specific population. Results should provide an incentive to learn why the intervention works in some cases and what conditions are necessary for causal impacts. PMID:27689499

Engagement practices that join scientific methods with community wisdom: Designing a patient-centered, randomized control trial with a Pacific Islander Community

PubMed Central

Goulden, Peter A.; Bursac, Zoran; Hudson, Jonell; Purvis, Rachel S.; Yeary, Karen H. Kim; Aitaoto, Nia; Kohler, Peter O.

2016-01-01

This article illustrates how a collaborative research process can successfully engage an underserved minority community to address health disparities. Pacific Islanders, including the Marshallese, are one of the fastest growing US populations. They face significant health disparities, including extremely high rates of type 2 diabetes. This article describes the engagement process of designing patient-centered outcomes research with Marshallese stakeholders, highlighting the specific influences of their input on a randomized control trial to address diabetes. Over 18 months, an interdisciplinary research team used community-based participatory principles to conduct patient-engaged outcomes research that involved 31 stakeholders in all aspects of research design, from defining the research question to making decisions about budgets and staffing. This required academic researcher flexibility, but yielded a design linking scientific methodology with community wisdom. PMID:27325179

Understanding the use of emergency department and urgent care services by diabetic patients of a Family Medicine Health Team: a retrospective observational study.

PubMed

Ward, Matthew

2017-03-01

Aim To understand the frequency, urgency, and rationale of emergency department and urgent care (ED/UC) use by diabetic patients of a Family Medicine Health Team (FHT). A retrospective, observational study with comparison control groups was conducted from 1 January 2013 to 31 December 2014. A total of 693 diabetic patients were compared with two, age-standardized non-diabetic groups: one with a higher disease burden based on International Classification of Diseases 9 diagnoses and the other from a randomized patient pool. Findings The diabetic group utilized ED/UC services 1.25 and 1.92 times more often than the two control populations, consistent with that observed in other studies. Canadian Triage and Acuity Scale scores were essentially the same for the diabetic population. Only 3.1% of visits were for diabetic related emergencies, in contrast to the expected 23% by surveyed physicians of the FHT. Diabetic patient's sought treatment for cellulitis, wounds, abscesses, and infections more often than the control populations.

Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial.

PubMed

Niederer, Iris; Kriemler, Susi; Zahner, Lukas; Bürgi, Flavia; Ebenegger, Vincent; Hartmann, Tim; Meyer, Ursina; Schindler, Christian; Nydegger, Andreas; Marques-Vidal, Pedro; Puder, Jardena J

2009-03-31

Childhood obesity and physical inactivity are increasing dramatically worldwide. Children of low socioeconomic status and/or children of migrant background are especially at risk. In general, the overall effectiveness of school-based programs on health-related outcomes has been disappointing. A special gap exists for younger children and in high risk groups. This paper describes the rationale, design, curriculum, and evaluation of a multicenter preschool randomized intervention study conducted in areas with a high migrant population in two out of 26 Swiss cantons. Twenty preschool classes in the German (canton St. Gallen) and another 20 in the French (canton Vaud) part of Switzerland were separately selected and randomized to an intervention and a control arm by the use of opaque envelopes. The multidisciplinary lifestyle intervention aimed to increase physical activity and sleep duration, to reinforce healthy nutrition and eating behaviour, and to reduce media use. According to the ecological model, it included children, their parents and the teachers. The regular teachers performed the majority of the intervention and were supported by a local health promoter. The intervention included physical activity lessons, adaptation of the built infrastructure; promotion of regional extracurricular physical activity; playful lessons about nutrition, media use and sleep, funny homework cards and information materials for teachers and parents. It lasted one school year. Baseline and post-intervention evaluations were performed in both arms. Primary outcome measures included BMI and aerobic fitness (20 m shuttle run test). Secondary outcomes included total (skinfolds, bioelectrical impedance) and central (waist circumference) body fat, motor abilities (obstacle course, static and dynamic balance), physical activity and sleep duration (accelerometry and questionnaires), nutritional behaviour and food intake, media use, quality of life and signs of hyperactivity (questionnaires), attention and spatial working memory ability (two validated tests). Researchers were blinded to group allocation. The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration: (clinicaltrials.gov) NCT00674544.

Risk factors for first trimester miscarriage--results from a UK-population-based case-control study.

PubMed

Maconochie, N; Doyle, P; Prior, S; Simmons, R

2007-02-01

The aim of this study was to examine the association between biological, behavioural and lifestyle risk factors and risk of miscarriage. Population-based case-control study. Case-control study nested within a population-based, two-stage postal survey of reproductive histories of women randomly sampled from the UK electoral register. Six hundred and three women aged 18-55 years whose most recent pregnancy had ended in first trimester miscarriage (<13 weeks of gestation; cases) and 6116 women aged 18-55 years whose most recent pregnancy had progressed beyond 12 weeks (controls). Women were questioned about socio-demographic, behavioural and other factors in their most recent pregnancy. First trimester miscarriage. After adjustment for confounding, the following were independently associated with increased risk: high maternal age; previous miscarriage, termination and infertility; assisted conception; low pre-pregnancy body mass index; regular or high alcohol consumption; feeling stressed (including trend with number of stressful or traumatic events); high paternal age and changing partner. Previous live birth, nausea, vitamin supplementation and eating fresh fruits and vegetables daily were associated with reduced risk, as were feeling well enough to fly or to have sex. After adjustment for nausea, we did not confirm an association with caffeine consumption, smoking or moderate or occasional alcohol consumption; nor did we find an association with educational level, socio-economic circumstances or working during pregnancy. The results confirm that advice to encourage a healthy diet, reduce stress and promote emotional wellbeing might help women in early pregnancy (or planning a pregnancy) reduce their risk of miscarriage. Findings of increased risk associated with previous termination, stress, change of partner and low pre-pregnancy weight are noteworthy, and we recommend further work to confirm these findings in other study populations.

Treatment intensification without improved HbA1c levels in children and adolescents with Type 1 diabetes mellitus.

PubMed

Sildorf, S M; Hertel, N T; Thomsen, J; Fredheim, S; Hastrup, H; Pipper, C; Hertz, B; Svensson, J

2016-04-01

To examine trends in diabetes treatment in Danish children and adolescents with Type 1 diabetes mellitus, comparing treatment intensity with metabolic outcomes in the population, and to describe the challenges of population-based registries in a clinical setting with rapidly changing treatment methods. This observational study is based on the Danish national population registry of childhood diabetes, which includes 99% of children diagnosed with Type 1 diabetes before the age of 15 years. We included 4527 people diagnosed between 2000 and 2012. Self-monitored blood glucose measurements, insulin injections/boluses, treatment method and metabolic control quantifications were analysed and adjusted for the effects of gender and ethnicity, the combined effect of age, visit year and duration, and for the random effects of individual and hospital settings. Treatment was intensified via an increasing number of self-monitored blood glucose measurements and injections/boluses. More than six injections/boluses and an increased number of self-monitored blood glucose measurements were significantly associated with lower metabolic control. No reduction, however, in the overall mean HbA1c concentration was observed between 2005 [66 mmol/mol (8.2%)] and 2012 [65 mmol/mol (8.1%)]. Changed registration practices in 2009 introduced artificial jumps in data. Intensifying treatment alone does not lead to improved metabolic control in the overall population despite the appearance of lower HbA1c in individuals with a greater number of self-monitored blood glucose measurements and injections/boluses. The contradictory results reflect difficulties in using observational studies to predict results of intervention in the individual. Data collected from population-based registries need to be adjusted continuously to reflect changes in care. © 2015 Diabetes UK.

Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial

PubMed Central

Peterson, Donna J.; Christiansen, Ann L.; Mahoney, Jane; Laud, Purushottam; Layde, Peter M.

2015-01-01

Objectives. We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. Methods. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Results. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007–2008) to follow-up (2010–2011). No significant difference was found between enhanced and standard support communities. Conclusions. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice. PMID:25602891

Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial.

PubMed

Guse, Clare E; Peterson, Donna J; Christiansen, Ann L; Mahoney, Jane; Laud, Purushottam; Layde, Peter M

2015-07-01

We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007-2008) to follow-up (2010-2011). No significant difference was found between enhanced and standard support communities. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice.

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial

PubMed Central

Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-01-01

Background Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. Objective The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. Methods The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List–Short Form, Maternal Support Scale, Ages and Stages Questionnaire–Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Results Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of inferiority (0.25 of a SD) on any outcome measure at any follow-up assessment, with the exception of MCDI scores assessing children’s language development at 21 months for randomized mothers, and PSI Isolation scores at 9 months for preference mothers. Conclusion Maternal and child outcomes from a clinic-based postnatal health check plus nurse-moderated Internet-based support were not inferior to those achieved by a universal home-based postnatal support program. Postnatal maternal and infant support using the Internet is a promising alternative to home-based universal support programs. Trial Registration Australian New Zealand Clinical Trials Registry Number (ANZCTR): ACTRN12613000204741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363712&isReview=true (Archived by WebCite at http://www.webcitation.org/6rZeCJ3k1) PMID:28739559

Effect of Deploying Trained Community Based Reproductive Health Nurses (CORN) on Long-Acting Reversible Contraception (LARC) Use in Rural Ethiopia: A Cluster Randomized Community Trial.

PubMed

Zerfu, Taddese Alemu; Ayele, Henok Taddese; Bogale, Tariku Nigatu

2018-06-01

To investigate the effect of innovative means to distribute LARC on contraceptive use, we implemented a three arm, parallel groups, cluster randomized community trial design. The intervention consisted of placing trained community-based reproductive health nurses (CORN) within health centers or health posts. The nurses provided counseling to encourage women to use LARC and distributed all contraceptive methods. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where the new service providers were deployed, health post or health center. We calculated difference-in-difference (DID) estimates to assess program impacts on LARC use. After nine months of intervention, the use of LARC methods increased significantly by 72.3 percent, while the use of short acting methods declined by 19.6 percent. The proportion of women using LARC methods increased by 45.9 percent and 45.7 percent in the health post and health center based intervention arms, respectively. Compared to the control group, the DID estimates indicate that the use of LARC methods increased by 11.3 and 12.3 percentage points in the health post and health center based intervention arms. Given the low use of LARC methods in similar settings, deployment of contextually trained nurses at the grassroots level could substantially increase utilization of these methods. © 2018 The Population Council, Inc.

Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial.

PubMed

Rosso, Isabelle M; Killgore, William D S; Olson, Elizabeth A; Webb, Christian A; Fukunaga, Rena; Auerbach, Randy P; Gogel, Hannah; Buchholz, Jennifer L; Rauch, Scott L

2017-03-01

Prior research has shown that the Sadness Program, a technician-assisted Internet-based cognitive behavioral therapy (iCBT) intervention developed in Australia, is effective for treating major depressive disorder (MDD). The current study aimed to expand this work by adapting the protocol for an American population and testing the Sadness Program with an attention control group. In this parallel-group, randomized controlled trial, adult MDD participants (18-45 years) were randomized to a 10-week period of iCBT (n = 37) or monitored attention control (MAC; n = 40). Participants in the iCBT group completed six online therapy lessons, which included access to content summaries and homework assignments. During the 10-week trial, iCBT and MAC participants logged into the web-based system six times to complete self-report symptom scales, and a nonclinician technician contacted participants weekly to provide encouragement and support. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), and the secondary outcomes were the Patient Health Questionnaire-9 and Kessler-10. Intent-to-treat analyses revealed significantly greater reductions in depressive symptoms in iCBT compared with MAC participants, using both the self-report measures and the clinician-rated HRSD (d = -0.80). Importantly, iCBT participants also showed significantly higher rates of clinical response and remission. Exploratory analyses did not support illness severity as a moderator of treatment outcome. The Sadness Program led to significant reductions in depression and distress symptoms. With its potential to be delivered in a scalable, cost-efficient manner, iCBT is a promising strategy to enhance access to effective care. © 2016 Wiley Periodicals, Inc.

Effects of Heart Rate Variability Biofeedback on EEG Alpha Asymmetry and Anxiety Symptoms in Male Athletes: A Pilot Study.

PubMed

Dziembowska, Inga; Izdebski, Paweł; Rasmus, Anna; Brudny, Janina; Grzelczak, Marta; Cysewski, Piotr

2016-06-01

Heart rate variability biofeedback (HRV-BFB) has been shown as useful tool to manage stress in various populations. The present study was designed to investigate whether the biofeedback-based stress management tool consisting of rhythmic breathing, actively self-generated positive emotions and a portable biofeedback device induce changes in athletes' HRV, EEG patterns, and self-reported anxiety and self-esteem. The study involved 41 healthy male athletes, aged 16-21 (mean 18.34 ± 1.36) years. Participants were randomly divided into two groups: biofeedback and control. Athletes in the biofeedback group received HRV biofeedback training, athletes in the control group didn't receive any intervention. During the randomized controlled trial (days 0-21), the mean anxiety score declined significantly for the intervention group (change-4 p < 0.001) but not for the control group (p = 0.817). In addition, as compared to the control, athletes in biofeedback group showed substantial and statistically significant improvement in heart rate variability indices and changes in power spectra of both theta and alpha brain waves, and alpha asymmetry. These changes suggest better self-control in the central nervous system and better flexibility of the autonomic nervous system in the group that received biofeedback training. A HRV biofeedback-based stress management tool may be beneficial for stress reduction for young male athletes.

Assessing the Generalizability of Randomized Trial Results to Target Populations

PubMed Central

Stuart, Elizabeth A.; Bradshaw, Catherine P.; Leaf, Philip J.

2014-01-01

Recent years have seen increasing interest in and attention to evidence-based practices, where the “evidence” generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as “internal validity”), they do not always yield relevant information about the effects in a particular target population (known as “external validity”). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a pre-specified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of School-wide Positive Behavioral Interventions and Supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless they are confident of the similarity between the trial sample and that target population. PMID:25307417

Assessing the generalizability of randomized trial results to target populations.

PubMed

Stuart, Elizabeth A; Bradshaw, Catherine P; Leaf, Philip J

2015-04-01

Recent years have seen increasing interest in and attention to evidence-based practices, where the "evidence" generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as "internal validity"), they do not always yield relevant information about the effects in a particular target population (known as "external validity"). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a prespecified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of school-wide positive behavioral interventions and supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless they are confident of the similarity between the trial sample and that target population.

Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial.

PubMed

Simon, Gregory E; Beck, Arne; Rossom, Rebecca; Richards, Julie; Kirlin, Beth; King, Deborah; Shulman, Lisa; Ludman, Evette J; Penfold, Robert; Shortreed, Susan M; Whiteside, Ursula

2016-09-15

Suicide remains the 10th-ranked most frequent cause of death in the United States, accounting for over 40,000 deaths per year. Nonfatal suicide attempts lead to over 200,000 hospitalizations and 600,000 emergency department visits annually. Recent evidence indicates that responses to the commonly used Patient Health Questionnaire (PHQ9) can identify outpatients who are at risk of suicide attempt and suicide death and that specific psychotherapy or Care Management programs can prevent suicide attempts in high-risk patients. Motivated by these developments, the NIMH-funded Mental Health Research Network has undertaken a multisite trial of two outreach programs to prevent suicide attempts among outpatients identified by routinely administered PHQ9 questionnaires. Outpatients who are at risk of suicide attempt are automatically identified using data from electronic health records (EHRs). Following a modified Zelen design, all those identified are assigned to continued usual care (i.e., no contact) or to be offered one of two population-based outreach programs. A Care Management intervention includes systematic outreach to assess suicide risk, EHR-based tools to implement risk-based care pathways, and care management to facilitate recommended follow-up. A Skills Training intervention includes interactive online training in Dialectical Behavior Therapy skills, supported by reminder and reinforcement messages from a skills coach. Each intervention supplements, rather than replaces, usual care; participants may receive any other services normally available. Interventions are delivered primarily by secure messaging through EHR patient portals. Suicide attempts and deaths following randomization are identified using state vital statistics data and health system EHR and insurance claim data. Primary evaluation will compare risk of suicide attempt or death over 18 months according to the initial assignment, regardless of intervention participation. Recruitment is underway in three health systems (Group Health Cooperative, HealthPartners, and Kaiser Permanente Colorado). Over 2500 participants have been randomized as of 1 March 2016, with enrollment averaging approximately 100 per week. Assessing the effectiveness of population-based suicide prevention requires adherence to the principles of pragmatic trials: population-based enrollment, accepting variable treatment participation, assessing outcomes using health record data, and analyses based on intent-to-treat. ClinicalTrials.gov registration # NCT02326883 , registered on 23 December 2014.

Comparison of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial.

PubMed

Champion, Jane Dimmitt; Collins, Jennifer L

2012-02-01

Ethnic minority adolescent women with a history of sexual or physical abuse and sexually transmitted infections represent a vulnerable population at risk for HIV. Community-based interventions for behavior modification and subsequent risk reduction have not been effective among these women. To evaluate the effects of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention model versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection at 6 and 12 months follow-up. Controlled randomized trial with longitudinal follow-up. Southwestern United States, Metropolitan community-based clinic. Mexican-and-African American adolescent women aged 14-18 years with a history of abuse or sexually transmitted infection seeking sexual health care. Extensive preliminary study for intervention development was conducted including individual interviews, focus groups, secondary data analysis, pre-testing and feasibility testing for modification of an evidence-based intervention prior to testing in the randomized controlled trial. Following informed consents for participation in the trial, detailed interviews concerning demographics, abuse history, sexual risk behavior, sexual health and physical exams were obtained. Randomization into either control or intervention groups was conducted. Intervention participants received workshop, support group and individual counseling sessions. Control participants received abuse and enhanced clinical counseling. Follow-up including detailed interview and physical exam was conducted at 6 and 12 months following study entry to assess for infection. Intention to treat analysis was conducted to assess intervention effects using chi-square and multiple regression models. 409 Mexican-(n=342) and African-(n=67) American adolescent women with abuse and sexually transmitted infection histories were enrolled; 90% intervention group attendance; longitudinal follow-up at 6 (93%) and 12 (94%) months. Intervention (n=199) versus control (n=210) group participants experienced fewer infections at 0-6 (0% versus 6.6%, p=.001), 6-12 (3.6% versus 7.8%, p=.005, CI 95% lower-upper .001-.386) and 0-12 (4.8% versus 13.2%, p=.002, CI 95% lower-upper, .002-.531) month intervals. A cognitive behavioral intervention specifically designed for ethnic minority adolescent women with a history of abuse and sexually transmitted infection was effective for prevention of infection. These results provide evidence for development of evidence-based interventions for sexually transmitted infection/HIV. Implications include translation to community-clinic-based settings for prevention of adverse outcomes regarding sexual health of adolescent women. Copyright © 2011 Elsevier Ltd. All rights reserved.

Evaluation of the Dogs, Physical Activity, and Walking (Dogs PAW) Intervention: A Randomized Controlled Trial.

PubMed

Richards, Elizabeth A; Ogata, Niwako; Cheng, Ching-Wei

2016-01-01

To facilitate physical activity (PA) adoption and maintenance, promotion of innovative population-level strategies that focus on incorporating moderate-intensity lifestyle PAs are needed. The purpose of this randomized controlled trial was to evaluate the Dogs, Physical Activity, and Walking intervention, a 3-month, social cognitive theory (SCT), e-mail-based PA intervention. In a longitudinal, repeated-measures design, 49 dog owners were randomly assigned to a control (n = 25) or intervention group (n = 24). The intervention group received e-mail messages (twice weekly for 4 weeks and weekly for 8 weeks) designed to influence SCT constructs of self-efficacy, self-regulation, outcome expectations and expectancies, and social support. At baseline and every 3 months through 1 year, participants completed self-reported questionnaires of individual, interpersonal, and PA variables. Linear mixed models were used to assess for significant differences in weekly minutes of dog walking and theoretical constructs between groups (intervention and control) across time. To test self-efficacy as a mediator of social support for dog walking, tests for mediation were conducted using the bootstrapping technique. With the exception of Month 9, participants in the intervention group accumulated significantly more weekly minutes of dog walking than the control group. On average, the intervention group accumulated 58.4 more minutes (SD = 18.1) of weekly dog walking than the control group (p < .05). Self-efficacy partially mediated the effect of social support variables on dog walking. Results indicate that a simple SCT-based e-mail intervention is effective in increasing and maintaining an increase in dog walking among dog owners at 12-month follow-up. In light of these findings, it may be advantageous to design dog walking interventions that focus on increasing self-efficacy for dog walking by fostering social support.

Does Internet-based cognitive behavioral therapy (iCBT) prevent major depressive episode for workers? A 12-month follow-up of a randomized controlled trial.

PubMed

Imamura, K; Kawakami, N; Furukawa, T A; Matsuyama, Y; Shimazu, A; Umanodan, R; Kawakami, S; Kasai, K

2015-07-01

In this study we investigated whether an Internet-based computerized cognitive behavioral therapy (iCBT) program can decrease the risk of DSM-IV-TR major depressive episodes (MDE) during a 12-month follow-up of a randomized controlled trial of Japanese workers. Participants were recruited from one company and three departments of another company. Those participants who did not experience MDE in the past month were randomly allocated to intervention or control groups (n = 381 for each). A 6-week, six-lesson iCBT program was provided to the intervention group. While the control group only received the usual preventive mental health service for the first 6 months, the control group was given a chance to undertake the iCBT program after a 6-month follow-up. The primary outcome was a new onset of DSM-IV-TR MDE during the 12-month follow-up, as assessed by means of the web version of the WHO Composite International Diagnostic Interview (CIDI), version 3.0 depression section. The intervention group had a significantly lower incidence of MDE at the 12-month follow-up than the control group (Log-rank χ2 = 7.04, p < 0.01). The hazard ratio for the intervention group was 0.22 (95% confidence interval 0.06-0.75), when estimated by the Cox proportional hazard model. The present study demonstrates that an iCBT program is effective in preventing MDE in the working population. However, it should be noted that MDE was measured by self-report, while the CIDI can measure the episodes more strictly following DSM-IV criteria.

Republic of Georgia estimates for prevalence of drug use: Randomized response techniques suggest under-estimation.

PubMed

Kirtadze, Irma; Otiashvili, David; Tabatadze, Mzia; Vardanashvili, Irina; Sturua, Lela; Zabransky, Tomas; Anthony, James C

2018-06-01

Validity of responses in surveys is an important research concern, especially in emerging market economies where surveys in the general population are a novelty, and the level of social control is traditionally higher. The Randomized Response Technique (RRT) can be used as a check on response validity when the study aim is to estimate population prevalence of drug experiences and other socially sensitive and/or illegal behaviors. To apply RRT and to study potential under-reporting of drug use in a nation-scale, population-based general population survey of alcohol and other drug use. For this first-ever household survey on addictive substances for the Country of Georgia, we used the multi-stage probability sampling of 18-to-64-year-old household residents of 111 urban and 49 rural areas. During the interviewer-administered assessments, RRT involved pairing of sensitive and non-sensitive questions about drug experiences. Based upon the standard household self-report survey estimate, an estimated 17.3% [95% confidence interval, CI: 15.5%, 19.1%] of Georgian household residents have tried cannabis. The corresponding RRT estimate was 29.9% [95% CI: 24.9%, 34.9%]. The RRT estimates for other drugs such as heroin also were larger than the standard self-report estimates. We remain unsure about what is the "true" value for prevalence of using illegal psychotropic drugs in the Republic of Georgia study population. Our RRT results suggest that standard non-RRT approaches might produce 'under-estimates' or at best, highly conservative, lower-end estimates. Copyright © 2018 Elsevier B.V. All rights reserved.

Efficacy of a Tailored Tobacco Control Program on Long-Term Use in a Population of U.S. Military Troops

ERIC Educational Resources Information Center

Klesges, Robert C.; DeBon, Margaret; Vander Weg, Mark W.; Haddock, C. Keith; Lando, Harry A.; Relyea, George E.; Peterson, Alan L.; Talcott, G. Wayne

2006-01-01

The authors evaluated the effect of a brief tailored smoking control intervention delivered during basic military training on tobacco use in a population of military personnel (N = 33,215). Participants were randomized to either a tobacco use intervention (smoking cessation, smokeless tobacco use cessation, or prevention depending on tobacco…

Effects of preventive online mindfulness interventions on stress and mindfulness: A meta-analysis of randomized controlled trials.

PubMed

Jayewardene, Wasantha P; Lohrmann, David K; Erbe, Ryan G; Torabi, Mohammad R

2017-03-01

Empirical evidence suggested that mind-body interventions can be effectively delivered online. This study aimed to examine whether preventive online mindfulness interventions (POMI) for non-clinical populations improve short- and long-term outcomes for perceived-stress (primary) and mindfulness (secondary). Systematic search of four electronic databases, manuscript reference lists, and journal content lists was conducted in 2016, using 21 search-terms. Eight randomized controlled trials (RCTs) evaluating effects of POMI in non-clinical populations with adequately reported perceived-stress and mindfulness measures pre- and post-intervention were included. Random-effects models utilized for all effect-size estimations with meta-regression performed for mean age and %females. Participants were volunteers (adults; predominantly female) from academic, workplace, or community settings. Most interventions utilized simplified Mindfulness-Based Stress Reduction protocols over 2-12 week periods. Post-intervention, significant medium effect found for perceived-stress (g = 0.432), with moderate heterogeneity and significant, but small, effect size for mindfulness (g = 0.275) with low heterogeneity; highest effects were for middle-aged individuals. At follow-up, significant large effect found for perceived-stress (g = 0.699) with low heterogeneity and significant medium effect (g = 0.466) for mindfulness with high heterogeneity. No publication bias was found for perceived-stress; publication bias found for mindfulness outcomes led to underestimation of effects, not overestimation. Number of eligible RCTs was low with inadequate data reporting in some studies. POMI had substantial stress reduction effects and some mindfulness improvement effects. POMI can be a more convenient and cost-effective strategy, compared to traditional face-to-face interventions, especially in the context of busy, hard-to-reach, but digitally-accessible populations.

The relationship of Asperger's syndrome to autism: a preliminary EEG coherence study.

PubMed

Duffy, Frank H; Shankardass, Aditi; McAnulty, Gloria B; Als, Heidelise

2013-07-31

It has long been debated whether Asperger's Syndrome (ASP) should be considered part of the Autism Spectrum Disorders (ASD) or whether it constitutes a unique entity. The Diagnostic and Statistical Manual, fourth edition (DSM-IV) differentiated ASP from high functioning autism. However, the new DSM-5 umbrellas ASP within ASD, thus eliminating the ASP diagnosis. To date, no clear biomarkers have reliably distinguished ASP and ASD populations. This study uses EEG coherence, a measure of brain connectivity, to explore possible neurophysiological differences between ASP and ASD. Voluminous coherence data derived from all possible electrode pairs and frequencies were previously reduced by principal components analysis (PCA) to produce a smaller number of unbiased, data-driven coherence factors. In a previous study, these factors significantly and reliably differentiated neurotypical controls from ASD subjects by discriminant function analysis (DFA). These previous DFA rules are now applied to an ASP population to determine if ASP subjects classify as control or ASD subjects. Additionally, a new set of coherence based DFA rules are used to determine whether ASP and ASD subjects can be differentiated from each other. Using prior EEG coherence based DFA rules that successfully classified subjects as either controls or ASD, 96.2% of ASP subjects are classified as ASD. However, when ASP subjects are directly compared to ASD subjects using new DFA rules, 92.3% ASP subjects are identified as separate from the ASD population. By contrast, five randomly selected subsamples of ASD subjects fail to reach significance when compared to the remaining ASD populations. When represented by the discriminant variable, both the ASD and ASD populations are normally distributed. Within a control-ASD dichotomy, an ASP population falls closer to ASD than controls. However, when compared directly with ASD, an ASP population is distinctly separate. The ASP population appears to constitute a neurophysiologically identifiable, normally distributed entity within the higher functioning tail of the ASD population distribution. These results must be replicated with a larger sample given their potentially immense clinical, emotional and financial implications for affected individuals, their families and their caregivers.

The relationship of Asperger’s syndrome to autism: a preliminary EEG coherence study

PubMed Central

2013-01-01

Background It has long been debated whether Asperger’s Syndrome (ASP) should be considered part of the Autism Spectrum Disorders (ASD) or whether it constitutes a unique entity. The Diagnostic and Statistical Manual, fourth edition (DSM-IV) differentiated ASP from high functioning autism. However, the new DSM-5 umbrellas ASP within ASD, thus eliminating the ASP diagnosis. To date, no clear biomarkers have reliably distinguished ASP and ASD populations. This study uses EEG coherence, a measure of brain connectivity, to explore possible neurophysiological differences between ASP and ASD. Methods Voluminous coherence data derived from all possible electrode pairs and frequencies were previously reduced by principal components analysis (PCA) to produce a smaller number of unbiased, data-driven coherence factors. In a previous study, these factors significantly and reliably differentiated neurotypical controls from ASD subjects by discriminant function analysis (DFA). These previous DFA rules are now applied to an ASP population to determine if ASP subjects classify as control or ASD subjects. Additionally, a new set of coherence based DFA rules are used to determine whether ASP and ASD subjects can be differentiated from each other. Results Using prior EEG coherence based DFA rules that successfully classified subjects as either controls or ASD, 96.2% of ASP subjects are classified as ASD. However, when ASP subjects are directly compared to ASD subjects using new DFA rules, 92.3% ASP subjects are identified as separate from the ASD population. By contrast, five randomly selected subsamples of ASD subjects fail to reach significance when compared to the remaining ASD populations. When represented by the discriminant variable, both the ASD and ASD populations are normally distributed. Conclusions Within a control-ASD dichotomy, an ASP population falls closer to ASD than controls. However, when compared directly with ASD, an ASP population is distinctly separate. The ASP population appears to constitute a neurophysiologically identifiable, normally distributed entity within the higher functioning tail of the ASD population distribution. These results must be replicated with a larger sample given their potentially immense clinical, emotional and financial implications for affected individuals, their families and their caregivers. PMID:23902729

Fibromyalgia: epidemiology and risk factors, a population-based case-control study in Lebanon.

PubMed

Moukaddem, Afaf; Chaaya, Monique; Slim, Zeinab F N; Jaffa, Miran; Sibai, Abla Mehio; Uthman, Imad

2017-02-01

To investigate the epidemiology of fibromyalgia (FM) and assess its risk factors. Using data from the 2009 Community Oriented Program for Control of Rheumatic Diseases (COPCORD) study conducted in Lebanon, a population-based case control study was performed. The sample included 34 FM patients, frequency matched with 136 controls free from any musculoskeletal complaints and randomly sampled from the population. The controls were frequency matched with cases by age and gender. The 34 female FM cases were prevalent cases which existed for a long period of time and all those who consulted a doctor were previously misdiagnosed. Family history of joint problems (OR = 4.93, 95% CI: 1.56-15.58) and working status (OR = 2.69, 95% CI: 1.04-6.93) were significant risk factors for FM, after adjusting for body mass index, distress level, smoking status and residence location. This was the first study to address the epidemiology of FM in Lebanon and the region. The chronic nature of FM that is characterized by frequent bouts of intense disabling pain and symptoms constitutes a significant health and economic burden. Clustering of cases in coastal areas was partially explained by other factors such as body mass index, distress level, smoking and work status. The high burden of FM found in our study calls for further investigation of potential risk factors of this condition. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Population-based assessment of vision-related quality of life in corneal disease: results from the CORE study.

PubMed

Vashist, Praveen; Gupta, Noopur; Tandon, Radhika; Gupta, Sanjeev K; Dwivedi, Sadanand; Mani, Kalaivani

2016-05-01

To assess the impact of corneal disease on vision-related quality of life (VR-QoL) in a rural North Indian population. Cross-sectional, population-based study. The Corneal Opacity Rural Epidemiological (CORE) study included 12 899 participants from 25 randomly selected clusters of rural Gurgaon, Haryana, India, with the primary objective of determining the prevalence of corneal disease in the general population during July 2011 to January 2013. VR-QoL was assessed through Indian Vision Function questionnaire (IND-VFQ-33) in adult participants (aged ≥18 years) detected with corneal opacity and equal number of healthy controls (no ocular pathology with visual acuity of 6/6 binocularly) selected from the same clusters. Scores of the three subscales of IND-VFQ-33 (vision-specific mobility, psychosocial impact and visual symptoms) were computed, analysed and compared separately across various groups. Overall, 12 113 participants of all ages underwent detailed ophthalmic examination and VR-QoL was assessed in 435 cases with corneal disease and 435 controls without any ophthalmic disease. The diseased population had significantly higher scores and hence poorer VR-QoL across all three domains of vision function (scores of 28 vs 22; 6 vs 5 and 14 vs 9, respectively; p<0.0001) and the scores were inversely related with the level of visual impairment in patients with corneal disease. Patients with unilateral corneal disease also had poorer VR-QoL scores as compared with healthy controls (p<0.0001). VR-QoL is impaired in patients with corneal disease, more so in patients with corneal blindness. This is the first population-based study to document VR-QoL through IND-VFQ-33 in the Indian population with corneal disease. 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/

Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population.

PubMed

Djoumessi, Romance Nguetse; Noubiap, Jean Jacques N; Kaze, Francois Folefack; Essouma, Mickael; Menanga, Alain Patrick; Kengne, Andre Pascal; Mbanya, Jean Claude; Sobngwi, Eugene

2016-03-23

Low-dose spironolactone has been proven to be effective for resistant hypertension in the general population, but this has yet to be confirmed in type 2 diabetic (T2DM) patients. We assessed the efficacy of a low-dose spironolactone on resistant hypertension in a sub-Saharan African population of T2DM patients from Cameroon. This was a four-week single blinded randomized controlled trial in 17 subjects presenting with resistant hypertension in specialized diabetes care units in Cameroon. They were randomly assigned to treatment with a daily 25 mg of spironolactone (n = 9) or to an alternative antihypertensive regimen (n = 8), on top of any ongoing regimen and prevailing lifestyle prescriptions. They were seen at the start of the treatment, then 2 and 4 weeks later. The primary outcome was change in office and self-measured blood pressure (BP) during follow-up, and secondary outcomes were changes in serum potassium, sodium, and creatinine levels. Compared with alternative treatment, low-dose spironolactone was associated with significant decrease in office systolic BP (-33 vs. -14 mmHg; p = 0.024), and in diastolic BP (-14 vs. -5 mmHg; p = 0.006). After 1 month of spironolactone, all the patients were controlled based on BP below 130/80 mmHg, with significant office BP reduction from 158 ± 17/86 ± 11 to 125 ± 11/72 ± 8, vs. 158 ± 8/94 ± 8 to 144 ± 17/89 ± 12 mmHg in the alternative treatment group. There was no significant variation in sodium and creatinine levels in both groups, but a mild increase of potassium levels in the spironolactone group. Add-on low-dose spironolactone was effective in reducing BP to optimal levels in T2DM Cameroonian patients despite mild increase in serum potassium. Trial registration ClinicalTrials.gov Identifier NCT02426099. Date of registration April 2015.

Assessing sample representativeness in randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

PubMed

Susukida, Ryoko; Crum, Rosa M; Stuart, Elizabeth A; Ebnesajjad, Cyrus; Mojtabai, Ramin

2016-07-01

To compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States. A total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P < 0.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P < 0.001. In the United States, individuals recruited into randomized controlled trials of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. © 2016 Society for the Study of Addiction.

Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials.

PubMed

Carter, Marissa J; Fife, Caroline E; Walker, David; Thomson, Brett

2009-07-01

To determine the percentage of individuals that would be excluded from wound care randomized controlled trials (RCTs) as a surrogate for applicability to general populations. A representative sample of wound-care RCTs was selected from the literature in the past 10 years. Exclusion criteria from the trials were evaluated, and prevalence values for each excluded condition were obtained from a large wound-care population, as well as from the literature. The percentage of patients excluded on this basis was calculated. Seventeen RCTs testing "high-technology" wound-care products were evaluated. : Patients in the trials were treated for ulcers (venous, diabetic foot, and pressure ulcers). A percentage of patients in the study population were excluded for each RCT. More than 50% of the study population would have been excluded in 15 of the 17 RCTs. When less clinically relevant exclusion criteria were removed, 14 of 17 RCTs would still have excluded between 25% and 50% of the study population. The results raise serious questions regarding the applicability of these RCTs to wound-care populations.

Rethinking sources of representative controls for the conduct of case-control studies in minority populations.

PubMed

Bandera, Elisa V; Chandran, Urmila; Zirpoli, Gary; McCann, Susan E; Ciupak, Gregory; Ambrosone, Christine B

2013-05-31

Recruitment of controls remains a challenge in case-control studies and particularly in studies involving minority populations. We compared characteristics of controls recruited through random digit dialing (RDD) to those of community controls enrolled through churches, health events and other outreach sources among women of African ancestry (AA) participating in the Women's Circle of Health Study, a case-control study of breast cancer. Odds ratios and 95% confidence intervals were also computed using unconditional logistic regression to evaluate the impact of including the community controls for selected variables relevant to breast cancer and for which there were significant differences in distribution between the two control groups. Compared to community controls (n=347), RDD controls (n=207) had more years of education and higher income, lower body mass index, were more likely to have private insurance, and less likely to be single. While the percentage of nulliparous women in the two groups was similar, community controls tended to have more children, have their first child at a younger age, and were less likely to breastfeed their children. Dietary intake was similar in the two groups. Compared to census data, the combination of RDD and community controls seems to be more representative of the general population than RDD controls alone. Furthermore, the inclusion of the community group had little impact on the magnitude of risk estimates for most variables, while enhancing statistical power. Community-based recruitment was found to be an efficient and feasible method to recruit AA controls.

Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs.

PubMed

Richardson, Lindsey; Laing, Allison; Milloy, M-J; Maynard, Russ; Nosyk, Bohdan; Marshall, Brandon; Grafstein, Eric; Daly, Patricia; Wood, Evan; Montaner, Julio; Kerr, Thomas

2016-07-29

Government social assistance payments seek to alleviate poverty and address survival needs, but their monthly disbursement may cue increases in illicit drug use. This cue may be magnified when assistance is disbursed simultaneously across the population. Synchronized payments have been linked to escalations in drug use and unintended but severe drug-related harms, including overdose, as well as spikes in demand for health, social, financial and police services. The TASA study examines whether changing payment timing and frequency can mitigate drug-related harm associated with synchronized social assistance disbursement. The study is a parallel arm multi-group randomized controlled trial in which 273 participants are randomly allocated for six assistance cycles to a control or one of two intervention arms on a 1:1:1 basis. Intervention arm participants receive their payments: (1) monthly; or (2) semi-monthly, in each case on days that are not during the week when cheques are normally issued. The study partners with a community-based credit union that has developed a system to vary social assistance payment timing. The primary outcome is a 40 % increase in drug use during the 3 days beginning with cheque issue day compared to other days of the month. Bi-weekly follow-up interviews collect participant information on this and secondary outcomes of interest, including drug-related harm (e.g. non-fatal overdose), exposure to violence and health service utilization. Self-reported data will be supplemented with participant information from health, financial, police and government administrative databases. A longitudinal, nested, qualitative parallel process evaluation explores participant experiences, and a cost-effectiveness evaluation of different disbursement scenarios will be undertaken. Outcomes will be compared between control and intervention arms to identify the impacts of alternative disbursement schedules on drug-related harm resulting from synchronized income assistance. This structural RCT benefits from strong community partnerships, highly detailed outcome measurement, robust methods of randomization and data triangulation with third party administrative databases. The study will provide evidence regarding the potential importance of social assistance program design as a lever to support population health outcomes and service provision for populations with a high prevalence of substance use. NCT02457949 Registered 13 May 2015.

Asthma control in Australia: a cross-sectional web-based survey in a nationally representative population.

PubMed

Reddel, Helen K; Sawyer, Susan M; Everett, Peter W; Flood, Paul V; Peters, Matthew J

2015-05-18

To identify patterns of asthma control and treatment in Australian adults with asthma. Cross-sectional web-based survey, conducted 1-27 November 2012. Adults with current asthma, at least 16 years of age, drawn randomly from a web-based panel and weighted to reflect national population proportions for people with asthma. Asthma Control Test (ACT) scores; health care utilisation; medication use. 2686 participants completed the survey (57.1% female; median age group, 40-49 years). Mean ACT score was 19.2 (95% CI, 18.9-19.3), with asthma classified as "well controlled" for 54.4% of participants, "not well controlled" for 22.7% and "very poorly controlled" for 23.0%. 60.8% reported using preventer medication (mostly combined inhaled corticosteroid/long-acting β2-agonist) during the previous year. 23.4% had made at least one urgent visit to a general practitioner concerning their asthma, 10.0% at least one emergency department visit. Urgent consultations were more common for "very poorly controlled" than "well controlled" asthma (adjusted odds ratio, urgent GP visits 5.98 [95% CI, 4.75-7.54] and emergency department visits 2.59 [95% CI, 1.91-3.53] respectively). Participants were classified according to asthma symptom control and frequency of preventer medication usage: Those with "well controlled" asthma included Group A (40.0% of participants) who used preventer medication infrequently (less than 5 days a week) or not at all, consistent with mild asthma, and Group B (14.7%), who used it at least 5 days a week. Uncontrolled asthma symptoms were reported by Group C (19.7%) despite regular preventer use, and by Group D (25.7%), who used none or little. This study provides the first data about asthma control and its relationship with treatment in a large representative Australian population. The findings highlight significant preventable asthma morbidity in Australia.

Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: A small randomized controlled trial

PubMed Central

Creswell, J. David; Myers, Hector F.; Cole, Steven W.; Irwin, Michael R.

2009-01-01

Mindfulness meditation training has stress reduction benefits in various patient populations, but its effects on biological markers of HIV-1 progression are unknown. The present study tested the efficacy of an 8-week Mindfulness-based stress reduction (MBSR) meditation program compared to a 1-day control seminar on CD4+ T lymphocyte counts in stressed HIV infected adults. A single-blind randomized controlled trial was conducted with enrollment and follow-up occurring between November 2005 and December 2007. A diverse community sample of 48 HIV-1 infected adults was randomized and entered treatment in either an 8-week MBSR or a 1-day control stress reduction education seminar. The primary outcome was circulating counts of CD4+ T lymphocytes. Participants in the 1-day control seminar showed declines in CD4+ T lymphocyte counts whereas counts among participants in the 8-week MBSR program were unchanged from baseline to post-intervention (time × treatment condition interaction, p = .02). This effect was independent of antiretroviral (ARV) medication use. Additional analyses indicated that treatment adherence to the mindfulness meditation program, as measured by class attendance, mediated the effects of mindfulness meditation training on buffering CD4+ T lymphocyte declines. These findings provide an initial indication that mindfulness meditation training can buffer CD4+ T lymphocyte declines in HIV-1 infected adults. PMID:18678242

A randomized trial to measure the impact of a community-based cognitive training intervention on balance and gait in cognitively intact Black older adults.

PubMed

Smith-Ray, Renae L; Makowski-Woidan, Beth; Hughes, Susan L

2014-10-01

Fall prevention is important for maintaining mobility and independence into old age. Approaches for reducing falls include exercise, tai chi, and home modifications; however, causes of falling are multifactorial and include not just physical but cognitive factors. Cognitive decline occurs with age, but older adults with the greatest declines in executive function experience more falls. The purpose of this study was twofold: to demonstrate the feasibility of a community-based cognitive training program for cognitively intact Black older adults and to analyze its impact on gait and balance in this population. This pilot study used a pretest/posttest randomized trial design with assignment to an intervention or control group. Participants assigned to the intervention completed a computer-based cognitive training class that met 2 days a week for 60 min over 10 weeks. Classes were held at senior/community centers. Primary outcomes included balance as measured by the Berg Balance Scale (BBS), 10-meter gait speed, and 10-meter gait speed under visuospatial dual-task condition. All measures were assessed at baseline and immediately post-intervention. Participants were community-dwelling Black adults with a mean age of 72.5 and history of falls (N = 45). Compared to controls, intervention participants experienced statistically significant improvements in BBS and gait speed. Mean performance on distracted gait speed also improved more for intervention participants compared to controls. Findings from this pilot randomized trial demonstrate the feasibility of a community-based cognitive training intervention. They provide initial evidence that cognitive training may be an efficacious approach toward improving balance and gait in older adults known to have a history of falls. © 2014 Society for Public Health Education.

Trauma and recent life events in individuals at ultra high risk for psychosis: review and meta-analysis.

PubMed

Kraan, Tamar; Velthorst, Eva; Smit, Filip; de Haan, Lieuwe; van der Gaag, Mark

2015-02-01

Childhood trauma and recent life-events have been related to psychotic disorders. The aim of the present study was to examine whether childhood trauma and recent life-events are significantly more prevalent in patients at Ultra High Risk (UHR) of developing a psychotic disorder compared to healthy controls. A search of PsychInfo and Embase was conducted, relevant papers were reviewed, and three random-effects meta-analyses were performed. One meta-analysis assessed the prevalence rate of childhood trauma in UHR subjects and two meta-analyses were conducted to compare UHR subjects and healthy control subjects on the experience of childhood trauma and recent life-events. We found 12 studies on the prevalence of (childhood) trauma in UHR populations and 4 studies on recent life-events in UHR populations. We performed a meta-analysis on 6 studies (of which trauma prevalence rates were available) on childhood trauma in UHR populations, yielding a mean prevalence rate of 86.8% (95% CI 77%-93%). Childhood trauma was significantly more prevalent in UHR subjects compared to healthy control groups (Random effects Hedges' g=1.09; Z=4.60, p<.001). In contrast to our hypothesis, life-event rates were significantly lower in UHR subjects compared to healthy controls (Random effects Hedges' g=-0.53; Z=-2.36, p<.02). Our meta-analytic results illustrate that childhood trauma is highly prevalent among UHR subjects and that childhood trauma is related to UHR status. These results are in line with studies on childhood trauma in psychotic populations. In contrast to studies on recent life-events in psychotic populations, our results show that recent life-events are not associated with UHR status. Copyright © 2014 Elsevier B.V. All rights reserved.

Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial.

PubMed

Merle, B; Chapurlat, R; Vignot, E; Thomas, T; Haesebaert, J; Schott, A-M

2017-05-01

We conducted a multicenter, randomized controlled trial to evaluate the impact of a population-based patient-centered post-fracture care program with a dedicated case manager, PREVention of OSTeoporosis (PREVOST), on appropriate post-fracture osteoporosis management. We showed that, compared to usual care, BMD investigation post-fracture was significantly improved (+20%) by our intervention program. Our study aims to evaluate the impact of a population-based patient-centered post-fracture care program, PREVOST, on appropriate post-fracture care. Multicenter, randomized controlled trial enrolling 436 women aged 50 to 85 years and attending a French hospital, for a low-energy fracture of the wrist or humerus. Randomization was stratified by age, hospital department, and site of fracture. The intervention was performed by a trained case manager who interacted only with the patients, with repeated oral and written information about fragility fractures and osteoporosis management, and prompting them to visit their primary care physicians. Control group received usual care. The primary outcome was the initiation of an appropriate post-fracture care defined by Bone Mineral Density (BMD) and/or anti-osteoporotic treatment prescription at 6 months. At 6 months, 53% of women in intervention group initiated a post-fracture care versus 33% for usual care (adjOR 2.35, 95%CI [1.58-3.50], p < 0.001). Post-fracture care was more frequent after wrist than humerus fracture (adjOR 1.93, 95%CI [1.14-3.30], p = 0.015) and decreased with age (adjOR for 10 years increase 0.76, 95%CI [0.61-0.96], p = 0.02). The intervention resulted in BMD prescription in 50% of patients (adjOR 2.10, 95%CI [1.41-3.11], p < 0.001) and in BMD performance in 41% of patients (adjOR 2.12, 95%CI [1.40-3.20], p < 0.001) versus 33 and 25% for usual care, respectively. Having performed a BMD increased treatment prescription; however, only 46% of women with a low BMD requiring a treatment according to the French guidelines received a prescription. A patient-centered care program with a dedicated case manager can significantly improve post-fracture BMD investigation.

Padres Trabajando por la Paz: a randomized trial of a parent education intervention to prevent violence among middle school children.

PubMed

Murray, N G; Kelder, S H; Parcel, G S; Frankowski, R; Orpinas, P

1999-06-01

This paper reports the results of a randomized trial to test the effectiveness of a theoretically derived intervention designed to increase parental monitoring among Hispanic parents of middle school students. Role model story newsletters developed through the process of Intervention Mapping were mailed to half of a subsample of parents whose children participated in Students for Peace, a comprehensive violence prevention program. The results indicated that parents in the experimental condition (N = 38) who had lower social norms for monitoring at baseline reported higher norms after the intervention than the parents in the control condition (N = 39) (P = 0.009). Children of parents in the experimental group reported slightly higher levels of monitoring at follow-up across baseline values, whereas control children who reported moderate to high levels of monitoring at pre-test reported lower levels at follow-up (P = 0.04). These newsletters are a population-based strategy for intervention with parents that show some promise for comprehensive school-based interventions for youth.

Decreasing harsh discipline in mothers at risk for maltreatment: a randomized control trial.

PubMed

Pereira, Mariana; Negrão, Mariana; Soares, Isabel; Mesman, Judi

2014-01-01

This study tested the effectiveness of the attachment-based program Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD; F. Juffer, M.J. Bakermans-Kranenburg, & M.H. van IJzendoorn, 2008) in decreasing harsh discipline of 43 mothers and their 1- to 4-year-old-children from severely deprived families. Based on previous studies, parenting stress was tested as a potential moderator of intervention effects on harsh discipline. Using a randomized control design, maternal harsh discipline was observed during home visits at the pretest and posttest, and mothers filled in questionnaires at both assessments. The VIPP-SD proved to be effective in decreasing maternal harsh discipline, but only for mothers who experienced higher levels of parenting stress at intake. These findings provide support for the program's ability to improve parenting in families who are most at risk for harsh parenting and for potentially maltreating child-parent interactions. The results are discussed in terms of the VIPP-SD elements most relevant to decreasing harsh discipline, and the challenges of parenting interventions in severely deprived populations. © 2014 Michigan Association for Infant Mental Health.

A randomized community trial of enhanced family planning outreach in Rakai, Uganda.

PubMed

Lutalo, Tom; Kigozi, Godfrey; Kimera, Edward; Serwadda, David; Wawer, Maria J; Zabin, Laurie Schwab; Gray, Ronald H

2010-03-01

A randomized community trial of a family planning outreach program was conducted in Rakai District, Uganda. Five communities received standard services; six intervention communities received additional family planning information, counseling, and contraceptive methods from government service providers and community-based volunteer agents using social marketing and other strategies. Condom use was promoted in all of the communities. The community-based family planning outreach program was implemented in two phases--1999-2000 (early) and 2001(late)--and its impact was evaluated by means of population surveys in 2002-03. At follow-up, hormonal contraceptive prevalence was 23 percent in the intervention communities, compared with 20 percent in the control communities. The differential was greater in the early-intervention communities than the late-intervention communities. Pregnancy rates at follow-up were 15 percent in the control and 13 percent in the intervention communities. No differentials in condom use were found between study arms. Family planning outreach via social marketing can significantly increase hormonal contraceptive use and decrease pregnancy rates, but the impact of this outreach program was modest.

Effects of a guided web-based smoking cessation program with telephone counseling: a cluster randomized controlled trial.

PubMed

Mehring, Michael; Haag, Max; Linde, Klaus; Wagenpfeil, Stefan; Schneider, Antonius

2014-09-24

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080). This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study's ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome. German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).

Fall Preventive Exercise With or Without Behavior Change Support for Community-Dwelling Older Adults: A Randomized Controlled Trial With Short-Term Follow-up.

PubMed

Arkkukangas, Marina; Söderlund, Anne; Eriksson, Staffan; Johansson, Ann-Christin

2017-02-27

In Western countries, falls and fall-related injuries are a well-known threat to health in the aging population. Studies indicate that regular exercise improves strength and balance and can therefore decrease the incidence of falls and fall-related injuries. The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population. The aim of this study was to investigate the short-term effect of a home-based exercise program with or without motivational interviewing (MI) compared with standard care on physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency. A total of 175 older adults participated in this randomized controlled study. They were randomly allocated for the Otago Exercise Program (OEP) (n = 61), OEP combined with MI (n = 58), or a control group (n = 56). The participants' mean age was 83 years. The recruitment period was from October 2012 to May 2015. Measurements of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency were done before and 12 weeks after randomization. A total of 161 participants were followed up, and there were no significant differences between groups after a period of 12 weeks of regular exercise. Within the OEP + MI group, physical performance, fall self-efficacy, physical activity level, and handgrip strength improved significantly; likewise, improved physical performance and fall self-efficacy were found in the control group. A corresponding difference did not occur in the OEP group. Adherence to the exercise was generally high in both exercise groups. In the short-term perspective, there were no benefits of an exercise program with or without MI regarding physical performance, fall self-efficacy, activity level, handgrip strength, adherence to the exercise, and fall frequency in comparison to a control group. However, some small effects occurred within the OEP + MI group, indicating that there may be some possible value in behavioral change support combined with exercise in older adults that requires further evaluation in both short- and long-term studies.

Case-based Learning Outperformed Simulation Exercises in Disaster Preparedness Education Among Nursing Trainees in India: A Randomized Controlled Trial.

PubMed

Aluisio, Adam R; Daniel, Pia; Grock, Andrew; Freedman, Joseph; Singh, Ajai; Papanagnou, Dimitrios; Arquilla, Bonnie

2016-10-01

In resource-constrained environments, appropriately employing triage in disaster situations is crucial. Although both case-based learning (CBL) and simulation exercises (SEs) commonly are utilized in teaching disaster preparedness to adult learners, there is no substantial evidence supporting one as a more efficacious methodology. This randomized controlled trial (RCT) evaluated the effectiveness of CBL versus SEs in addition to standard didactic instruction in knowledge attainment pertaining to disaster triage preparedness. This RCT was performed during a one-day disaster preparedness course in Lucknow, India during October 2014. Following provision of informed consent, nursing trainees were randomized to knowledge assessment after didactic teaching (control group); didactic plus CBL (Intervention Group 1); or didactic plus SE (Intervention Group 2). The educational curriculum used the topical focus of triage processes during disaster situations. Cases for the educational intervention sessions were scripted, identical between modalities, and employed structured debriefing. Trained live actors were used for SEs. After primary assessment, the groups underwent crossover to take part in the alternative educational modality and were re-assessed. Two standardized multiple-choice question batteries, encompassing key core content, were used for assessments. A sample size of 48 participants was calculated to detect a ≥20% change in mean knowledge score (α=0.05; power=80%). Robustness of randomization was evaluated using X 2, anova, and t-tests. Mean knowledge attainment scores were compared using one- and two-sample t-tests for intergroup and intragroup analyses, respectively. Among 60 enrolled participants, 88.3% completed follow-up. No significant differences in participant characteristics existed between randomization arms. Mean baseline knowledge score in the control group was 43.8% (standard deviation=11.0%). Case-based learning training resulted in a significant increase in relative knowledge scores at 20.8% (P=0.003) and 10.3% (P=.033) in intergroup and intragroup analyses, respectively. As compared to control, SEs did not significantly alter knowledge attainment scores with an average score increase of 6.6% (P=.396). In crossover intra-arm analysis, SEs were found to result in a 26.0% decrement in mean assessment score (P < .001). Among nursing trainees assessed in this RCT, the CBL modality was superior to SEs in short-term disaster preparedness educational translation. Simulation exercises resulted in no detectable improvement in knowledge attainment in this population, suggesting that CBL may be utilized preferentially for adult learners in similar disaster training settings. Aluisio AR , Daniel P , Grock A , Freedman J , Singh A , Papanagnou D , Arquilla B . Case-based learning outperformed simulation exercises in disaster preparedness education among nursing trainees in India: a randomized controlled trial. Prehosp Disaster Med. 2016;31(5):516-523.

Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial.

PubMed

Goldade, Kate; Whembolua, Guy-Lucien; Thomas, Janet; Eischen, Sara; Guo, Hongfei; Connett, John; Des Jarlais, Don; Resnicow, Ken; Gelberg, Lillian; Owen, Greg; Grant, Jon; Ahluwalia, Jasjit S; Okuyemi, Kolawole S

2011-12-01

Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers. To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes. Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders. Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication. The study's limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable. Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.

A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

ERIC Educational Resources Information Center

Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

2017-01-01

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

PubMed Central

Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

2015-01-01

Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). PMID:25608692

Rationale and methods of the iFightDepression study: A double-blind, randomized controlled trial evaluating the efficacy of an internet-based self-management tool for moderate to mild depression.

PubMed

Justicia, Azucena; Elices, Matilde; Cebria, Ana Isabel; Palao, Diego J; Gorosabel, Jesús; Puigdemont, Dolors; de Diego-Adeliño, Javier; Gabilondo, Andrea; Iruin, Alvaro; Hegerl, Ulrich; Pérez, Víctor

2017-04-19

During the last decade online interventions have emerged as a promising approach for patients with mild/moderate depressive symptoms, reaching at large populations and representing cost-effective alternatives. The main objective of this double-blind, randomized controlled trial is to examine the efficacy of an internet-based self-management tool (iFightDepression) for mild to moderate depression as an add-on to treatment as usual (TAU) versus internet-based psychoeducation plus TAU. A total of 310 participants with major depression disorder (MDD) will be recruited at four different mental-health facilities in Spain. Participants will be randomly allocated to one of two study arms: iFightDepression (iFD) tool + TAU vs. internet-based psychoeducation + TAU. Both interventions last for 8 weeks and there is a 12 weeks follow up. The primary outcome measure is changes in depressive symptoms assessed with the Hamilton Depression Rating Scale. Additionally, pre-post interventions assessments will include socio-demographic data, a brief medical and clinical history and self-reported measures of depressive symptoms, quality of life, functional impairments and satisfaction with the iFD tool. iFightDepression is an easy-prescribed tool that could increase the efficacy of conventional treatment and potentially reach untreated patients, shortening waiting lists to receive psychological treatment. Confirming the efficacy of the iFD internet-based self-management tool as an add-on treatment for individuals with mild to moderate depression will be clinically-relevant. Registration number NCT02312583 . Clinicaltrials.gov . December 4, 2014.

Peer mentor versus teacher delivery of a physical activity program on the effects of BMI and daily activity: protocol of a school-based group randomized controlled trial in Appalachia.

PubMed

Smith, Laureen H; Petosa, Rick L; Shoben, Abigail

2018-05-16

Rural Appalachian populations have poorer health and fewer positive health-related behaviors compared to other United States populations. Appalachians are the most sedentary U.S. population and teens are particularly sedentary. Obesity prevention through improving physical activity is a top priority in Rural Healthy People 2020. Obesity prevalence among Appalachian teens exceeds the national rates of 13.9% and has consistently been greater than 26%. Organized sports has not been effective at improving daily physical activity or health outcomes for Appalachian teens. The purpose of this study is to test the efficacy of a 10-week school-based intervention in promoting self-regulation of physical activity among adolescents not participating in organized sports. By using accelerometers, our study will measure both sedentary time and planned exercise during waking hours. The design for this four-year study is a group-randomized controlled trial (G-RCT). We will recruit high schools in 3 waves, with 4 in Wave 1, 8 in Wave 2, and 8 in Wave 3, for a total of 20 schools. For each wave of schools, we will randomly assign half of the schools to each condition--intervention (peer-to-peer mentoring [MBA]) and comparison (teacher-led [PBA])--for a total of 10 schools in each of the two conditions by study's end. We will collect data at baseline (T 1 ), 3 months post intervention (T 2 ), and 6 months post intervention (T 3 ). Linear Mixed Models (LMMs) and Generalized Linear Mixed Models (GLMMs) will be used to test the main hypotheses. Power for this study was based the primary analysis comparing BMI outcomes at T 2 between the groups, adjusting for baseline BMI values. This study provides age-appropriate lifestyle education and skill building. Peer-to-peer mentoring by local high school students and school-based tailored support strengthens sustainable behavioral change. Focusing on unique healthy-lifestyle challenges prevalent in low-resource areas such as Appalachia such as overcoming environmental, social, and psychological barriers may improve adherence to physical activity. Serving as role models, peer mentors may improve their own lifestyle behaviors, providing a dual intervention. NCT02329262 .

A model-based 'varimax' sampling strategy for a heterogeneous population.

PubMed

Akram, Nuzhat A; Farooqi, Shakeel R

2014-01-01

Sampling strategies are planned to enhance the homogeneity of a sample, hence to minimize confounding errors. A sampling strategy was developed to minimize the variation within population groups. Karachi, the largest urban agglomeration in Pakistan, was used as a model population. Blood groups ABO and Rh factor were determined for 3000 unrelated individuals selected through simple random sampling. Among them five population groups, namely Balochi, Muhajir, Pathan, Punjabi and Sindhi, based on paternal ethnicity were identified. An index was designed to measure the proportion of admixture at parental and grandparental levels. Population models based on index score were proposed. For validation, 175 individuals selected through stratified random sampling were genotyped for the three STR loci CSF1PO, TPOX and TH01. ANOVA showed significant differences across the population groups for blood groups and STR loci distribution. Gene diversity was higher across the sub-population model than in the agglomerated population. At parental level gene diversities are significantly higher across No admixture models than Admixture models. At grandparental level the difference was not significant. A sub-population model with no admixture at parental level was justified for sampling the heterogeneous population of Karachi.

Post-traumatic stress disorder in older adults: a systematic review of the psychotherapy treatment literature.

PubMed

Dinnen, Stephanie; Simiola, Vanessa; Cook, Joan M

2015-01-01

Older adults represent the fastest growing segment of the US and industrialized populations. However, older adults have generally not been included in randomized clinical trials of psychotherapy for post-traumatic stress disorder (PTSD). This review examined reports of psychological treatment for trauma-related problems, primarily PTSD, in studies with samples of at least 50% adults aged 55 and older using standardized measures. A systematic review of the literature was conducted on psychotherapy for PTSD with older adults using PubMed, Medline, PsychInfo, CINAHL, PILOTS, and Google Scholar. A total of 42 studies were retrieved for full review; 22 were excluded because they did not provide at least one outcome measure or results were not reported by age in the case of mixed-age samples. Of the 20 studies that met review criteria, there were: 13 case studies or series, three uncontrolled pilot studies, two randomized clinical trials, one non-randomized concurrent control study and one post hoc effectiveness study. Significant methodological limitations in the current older adult PTSD treatment outcome literature were found reducing its internal validity and generalizability, including non-randomized research designs, lack of comparison conditions and small sample sizes. Select evidence-based interventions validated in younger and middle-aged populations appear acceptable and efficacious with older adults. There are few treatment studies on subsets of the older adult population including cultural and ethnic minorities, women, the oldest old (over 85), and those who are cognitively impaired. Implications for clinical practice and future research directions are discussed.

Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain - study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs due to, for example, reduced productivity at the work place and absenteeism. Insomnia complaints by people experiencing work-related stress are correlated with a deficient cognitive detachment from work. Diffuse boundaries between work and private life can additionally complicate the use of recreational activities that facilitate cognitive detachment. Cognitive behavioral therapy for insomnia is effective but rarely implemented. Internet-based cognitive behavioral therapy for insomnia could potentially reduce this deficit given its demonstrated effectiveness. Less is known, however, about the efficacy of internet-based cognitive behavioral therapy for insomnia in populations affected by high work stress. Thus, the aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed, guided online training which is based on Cognitive Behavioral Therapy for insomnia and tailored to teachers affected by occupational stress. Methods/Design In a two-arm randomized controlled trial (N = 128), the effects of a guided online sleep training will be compared to a waitlist-control condition. German teachers with significant clinical insomnia complaints (Insomnia Severity Index ≥15) and work-related rumination (Irritation Scale, subscale Cognitive Irritation ≥15) will be included in the study. The primary outcome measure will be insomnia severity. Additionally, an economic evaluation from a societal perspective will be conducted. Data from the intention-to-treat sample will be analyzed two and six months after randomization. Discussion To the best of our knowledge, this is the first study to evaluate an online sleep training tailored to a specific population with work stress, that is, teachers. If this type of intervention is effective, it could reduce the paucity of cognitive behavioral therapy for insomnia and augment the support for teachers in coping with their insomnia problems. Trial registration German Clinical Trial Register (DRKS): DRKS00004700 PMID:23759035

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

PubMed

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

2018-01-01

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

The effect of increased coverage of participatory women's groups on neonatal mortality in Bangladesh: A cluster randomized trial.

PubMed

Fottrell, Edward; Azad, Kishwar; Kuddus, Abdul; Younes, Layla; Shaha, Sanjit; Nahar, Tasmin; Aumon, Bedowra Haq; Hossen, Munir; Beard, James; Hossain, Tanvir; Pulkki-Brannstrom, Anni-Maria; Skordis-Worrall, Jolene; Prost, Audrey; Costello, Anthony; Houweling, Tanja A J

2013-09-01

Community-based interventions can reduce neonatal mortality when health systems are weak. Population coverage of target groups may be an important determinant of their effect on behavior and mortality. A women's group trial at coverage of 1 group per 1414 population in rural Bangladesh showed no effect on neonatal mortality, despite a similar intervention having a significant effect on neonatal and maternal death in comparable settings. To assess the effect of a participatory women's group intervention with higher population coverage on neonatal mortality in Bangladesh. A cluster randomized controlled trial in 9 intervention and 9 control clusters. Rural Bangladesh. Women permanently residing in 18 unions in 3 districts and accounting for 19 301 births during the final 24 months of the intervention. Women's groups at a coverage of 1 per 309 population that proceed through a participatory learning and action cycle in which they prioritize issues that affected maternal and neonatal health and design and implement strategies to address these issues. Neonatal mortality rate. Analysis included 19 301 births during the final 24 months of the intervention. More than one-third of newly pregnant women joined the groups. The neonatal mortality rate was significantly lower in the intervention arm (21.3 neonatal deaths per 1000 live births vs 30.1 per 1000 in control areas), a reduction in neonatal mortality of 38% (risk ratio, 0.62 [95% CI, 0.43-0.89]) when adjusted for socioeconomic factors. The cost-effectiveness was US $220 to $393 per year of life lost averted. Cause-specific mortality rates suggest reduced deaths due to infections and those associated with prematurity/low birth weight. Improvements were seen in hygienic home delivery practices, newborn thermal care, and breastfeeding practices. Women's group community mobilization, delivered at adequate population coverage, is a highly cost-effective approach to improve newborn survival and health behavior indicators in rural Bangladesh. isrctn.org Identifier: ISRCTN01805825.

Self-efficacy as a predictor of dietary change in a low-socioeconomic-status southern adult population.

PubMed

Shannon, J; Kirkley, B; Ammerman, A; Keyserling, T; Kelsey, K; DeVellis, R; Simpson, R J

1997-06-01

There is an increasing emphasis on designing health promotion interventions for low-socioeconomic-status (SES) individuals. However, many previously developed behavior change tools have not been tested in this population. Self-efficacy was measured at pre- and postintervention as part of a randomized clinical trial to reduce cholesterol levels in rural low-SES Southern adults. A 22-item scale was designed and validated to measure subjects' confidence in their abilities to make dietary changes. High mean self-efficacy was noted in both control and intervention subjects at pre- and postintervention. Mean self-efficacy score was a significant predictor of dietary change at both preintervention and postintervention. This study demonstrates that self-efficacy is a predictor of ability to make dietary changes in a low-SES rural population. This finding is of significance to researchers and practitioners wishing to design theory-based health promotion interventions in this population.

A randomized controlled trial of a leg orthosis versus traditional treatment for soldiers with shin splints: a pilot study.

PubMed

Johnston, Ember; Flynn, Timothy; Bean, Michael; Breton, Matthew; Scherer, Matthew; Dreitzler, Gail; Thomas, Dennis

2006-01-01

Diagnosis and management strategies for shin splints in active duty military populations closely resemble those in civilian athletic populations. There is a paucity of evidence supporting the use of many of these interventions. The purpose of this study was to present data on the Shin Saver orthosis as a treatment for shin splints in an active duty military population and to review current condition management. Twenty-five subjects diagnosed with shin splints by a U.S. Army physical therapist were randomly assigned to a shin orthosis treatment group or a control group. There was no significant difference between treatment and control groups in days to finish a 0.5-mile run pain free. Visual analog scales for pain at intake versus after 1 week of relative rest revealed no significant improvement in symptoms in either group. Current best-practice guidelines support a treatment program of rest, cryotherapy, and a graduated walk-to-run program.

Self-blood pressure monitoring in an urban, ethnically diverse population: a randomized clinical trial utilizing the electronic health record.

PubMed

Yi, Stella S; Tabaei, Bahman P; Angell, Sonia Y; Rapin, Anne; Buck, Michael D; Pagano, William G; Maselli, Frank J; Simmons, Alvaro; Chamany, Shadi

2015-03-01

Hypertension is a leading risk factor for cardiovascular disease. Although control rates have improved over time, racial/ethnic disparities in hypertension control persist. Self-blood pressure monitoring, by itself, has been shown to be an effective tool in predominantly white populations, but less studied in minority, urban communities. These types of minimally intensive approaches are important to test in all populations, especially those experiencing related health disparities, for broad implementation with limited resources. The New York City Health Department in partnership with community clinic networks implemented a randomized clinical trial (n=900, 450 per arm) to investigate the effectiveness of self-blood pressure monitoring in medically underserved and largely black and Hispanic participants. Intervention participants received a home blood pressure monitor and training on use, whereas control participants received usual care. After 9 months, systolic blood pressure decreased (intervention, 14.7 mm Hg; control, 14.1 mm Hg; P=0.70). Similar results were observed when incorporating longitudinal data and calculating a mean slope over time. Control was achieved in 38.9% of intervention and 39.1% of control participants at the end of follow-up; the time-to-event experience of achieving blood pressure control in the intervention versus control groups were not different from each other (logrank P value =0.91). Self-blood pressure monitoring was not shown to improve control over usual care in this largely minority, urban population. The patient population in this study, which included a high proportion of Hispanics and uninsured persons, is understudied. Results indicate these groups may have additional meaningful barriers to achieving blood pressure control beyond access to the monitor itself. http://clinicaltrials.gov. Unique Identifier: NCT01123577. © 2015 American Heart Association, Inc.

Disparities in Hypertension Prevalence, Awareness, Treatment and Control between Bouyei and Han: Results from a Bi-Ethnic Health Survey in Developing Regions from South China.

PubMed

Dong, Fen; Wang, Dingming; Pan, Li; Yu, Yangwen; Wang, Ke; Li, Ling; Wang, Li; Liu, Tao; Zeng, Xianjia; Sun, Liangxian; Zhu, Guangjin; Feng, Kui; Zhang, Biao; Xu, Ke; Pang, Xinglong; Chen, Ting; Pan, Hui; Ma, Jin; Zhong, Yong; Ping, Bo; Shan, Guangliang

2016-02-19

Hypertension is highly prevalent in low-income population. This study aims to investigate ethnic disparities in hypertension and identify modifiable factors related to its occurrence and control in developing regions in South China. Blood pressure was measured in the Bouyei and Han populations during a community-based health survey in Guizhou, 2012. A multistage stratified sampling method was adopted to recruit Bouyei and Han aged from 20 to 80 years. Taking mixed effects into consideration, multilevel logistic models with random intercept were used for data analysis. The prevalence rates of hypertension were 35.3% for the Bouyei and 33.7% for the Han. Among the hypertensive participants, 30.1% of the Bouyei and 40.2% of the Han were aware of their hypertensive conditions, 19.7% of the Bouyei and 31.1% of the Han were receiving treatment, and only 3.6% of the Bouyei and 9.9% of the Han had their blood pressure under control. Age-sex standardized rates of awareness, treatment, and control were consistently lower in the Bouyei than the Han. Such ethnic disparities were more evident in the elderly population. Avoidance of excessive alcohol consumption and better education were favorable lifestyle for reduction in risk of hypertension. Moderate physical activity improved control of hypertension in Bouyei patients under treatment. Conclusively, hypertension awareness, treatment, and control were substantially lower in Bouyei than Han, particularly in the elderly population. Such ethnic disparities indicate that elderly Bouyei population should be targeted for tailored interventions in the future.

Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

PubMed Central

Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

2016-01-01

Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

Hospital-acquired complications in a randomized controlled clinical trial of a geriatric consultation team.

PubMed

Becker, P M; McVey, L J; Saltz, C C; Feussner, J R; Cohen, H J

1987-05-01

As part of a controlled clinical trial of a geriatric consultation team (GCT), we investigated whether a GCT could affect the incidence of hospital-acquired complications in elderly patients. One hundred eighty-five patients, aged 75 years and older, were randomized into an intervention (N = 92) and a control (N = 93) group. Members of the intervention group received a GCT consultation and were routinely followed up throughout their hospitalization. The incidence of hospital-acquired complications for the entire study population was 38%. The type and rate of hospital-acquired complications in the intervention and control groups were not significantly different. Functional status on admission and admission to the psychiatry service were predictive for the occurrence of a hospital-acquired complication. In a broadly selected population such as this, the intensity of care available through a GCT was unable to reduce the occurrence of hospital-acquired complications. However, since this is only one aspect of a GCT function, and others may be of great importance, such aspects, and more targeted populations, must be evaluated before final conclusions can be reached about GCT efficiency.

A pilot randomized controlled trial using EEG-based brain-computer interface training for a Chinese-speaking group of healthy elderly.

PubMed

Lee, Tih-Shih; Quek, Shin Yi; Goh, Siau Juinn Alexa; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Lee, Jimmy; Ng, Tze Pin; Krishnan, K Ranga Rama

2015-01-01

There is growing evidence that cognitive training (CT) can improve the cognitive functioning of the elderly. CT may be influenced by cultural and linguistic factors, but research examining CT programs has mostly been conducted on Western populations. We have developed an innovative electroencephalography (EEG)-based brain-computer interface (BCI) CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore. In this second pilot trial, we examine the acceptability, safety, and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly. Thirty-nine elderly participants were randomized into intervention (n=21) and wait-list control (n=18) arms. Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks; the control arm received the same intervention after an initial 8-week waiting period. At the end of the training, a usability and acceptability questionnaire was administered. Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which was translated and culturally adapted for the Chinese-speaking local population. Users were asked about any adverse events experienced after each session as a safety measure. The training was deemed easily usable and acceptable by senior users. The median difference in the change scores pre- and post-training of the modified RBANS total score was 8.0 (95% confidence interval [CI]: 0.0-16.0, P=0.042) higher in the intervention arm than waitlist control, while the mean difference was 9.0 (95% CI: 1.7-16.2, P=0.017). Ten (30.3%) participants reported a total of 16 adverse events - all of which were graded "mild" except for one graded "moderate". Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further evaluation in a Phase III trial. Overall, participants responded positively on the usability and acceptability questionnaire.

Education in cardiopulmonary resuscitation in Russia: A systematic review of the available evidence

PubMed Central

Birkun, Alexei; Glotov, Maksim

2017-01-01

BACKGROUND: To summarise and appraise cumulative published scientific evidence relevant to cardiopulmonary resuscitation (CPR) education in Russia. DATA RESOURCES: We searched Medline, Scopus, Science Direct and Russian Science Citation Index databases from December 1991 to December 2016 to identify studies pertaining to the field of CPR education that were carried out by Russian researchers and/or investigated the topic of interest for Russia/Russian population. Reference lists of eligible publications, contents pages of relevant Russian journals and Google Scholar were also searched. There was no limitation based on publication language or study design. RESULTS: Of 7 964 unique citations identified, 22 studies were included. All studies were published from 2009 to 2016, mainly in Russian. Only three studies were reported to be randomized controlled. Non-medical individuals constituted 17% of studied populations. Most of the studies aimed to assess effects of CPR educational interventions, generally suggesting positive influence of the training conducted. The studies were highly heterogeneous as for methodological approaches, structure and duration of educational interventions, evaluation methods and criteria being used. Methodological quality was generally poor, with >40% publications not passing quality screening and only 2 studies meeting the criteria of moderate high quality. CONCLUSION: The results suggest paucity, low population coverage, high thematic and methodological heterogeneity and low quality of the studies addressing CPR education, which were carried out in the Russian Federation. There is a critical need in conducting methodologically consistent, large-scale, randomized, controlled studies evaluating and comparing efficiency of educational interventions for teaching CPR in different population categories of Russia. PMID:29123601

Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial.

PubMed

Heber, Elena; Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

2016-01-27

Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus's transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F1,261=58.08, P<.001; Cohen's d=0.83) and at the 6-month follow-up (F1,261=80.17, P<.001; Cohen's d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl).

Effectiveness of a Dissonance-Based Eating Disorder Prevention Program for Ethnic Groups in Two Randomized Controlled Trials

PubMed Central

Stice, Eric; Marti, C. Nathan; Cheng, Zhen Hadassah

2014-01-01

Objective As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. Method In Study 1, 426 female undergraduates (M age = 21.6, SD = 5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Results Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Conclusions Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. PMID:24655465

Effectiveness of a dissonance-based eating disorder prevention program for ethnic groups in two randomized controlled trials.

PubMed

Stice, Eric; Marti, C Nathan; Cheng, Zhen Hadassah

2014-04-01

As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. In Study 1, 426 female undergraduates (M age=21.6, SD=5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Well London program--a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results.

PubMed

Phillips, Gemma; Renton, Adrian; Moore, Derek G; Bottomley, Christian; Schmidt, Elena; Lais, Shahana; Yu, Ge; Wall, Martin; Tobi, Patrick; Frostick, Caroline; Clow, Angela; Lock, Karen; Petticrew, Mark; Hayes, Richard

2012-07-06

The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here. The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys. Randomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012.

A randomized trial of tailoring and motivational interviewing to promote fruit and vegetable consumption for cancer prevention and control.

PubMed

Campbell, Marci Kramish; Carr, Carol; Devellis, Brenda; Switzer, Boyd; Biddle, Andrea; Amamoo, M Ahinee; Walsh, Joan; Zhou, Bingqing; Sandler, Robert

2009-10-01

Healthful dietary patterns, including eating fruits and vegetables (F&V) and avoiding obesity, may decrease the risk of cancer and other chronic diseases. In addition to promoting health for the general population, a cancer diagnosis may provide a "teachable moment," facilitating the adoption of more healthful eating habits and leading to lower risk of chronic disease and better overall health. This study was designed to test the effectiveness of two health communication interventions in increasing F&V consumption and physical activity in a sample of older adults (average age of 66 years), including both colorectal cancer (CRC) survivors and noncolorectal cancer-affected (N-CRC) individuals. CRC survivors and N-CRC individuals were recruited from a population-based case-control study and randomly assigned to four conditions using a 2 x 2 design. We tested two different methods of communicating and promoting health behavior change alone or in combination: tailored print communication (TPC) and brief telephone-based motivational interviewing (TMI). A significant increase in F&V consumption was found for the combined intervention group in the entire sample (p < 0.05). When stratified by cancer survivor status, the effect was concentrated in the N-CRC subset (p < 0.01) versus CRC survivors. The combined intervention was also found to be most cost-effective for the N-CRC group, with TPC more cost-effective than TMI. For physical activity, none of the interventions produced statistically significant improvements. This study indicates that combining tailoring and motivational interviewing may be an effective and cost-effective method for promoting dietary behavior change among older healthy adults. More research is needed to identify the optimal dose and timing for intervention strategies to promote dietary and physical activity change among both CRC survivors and the general population.

The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults.

PubMed

Barnes, Deborah E; Santos-Modesitt, Wendy; Poelke, Gina; Kramer, Arthur F; Castro, Cynthia; Middleton, Laura E; Yaffe, Kristine

2013-05-13

The prevalence of cognitive impairment and dementia are projected to rise dramatically during the next 40 years, and strategies for maintaining cognitive function with age are critically needed. Physical or mental activity alone result in relatively small, domain-specific improvements in cognitive function in older adults; combined interventions may have more global effects. To examine the combined effects of physical plus mental activity on cognitive function in older adults. Randomized controlled trial with a factorial design. San Francisco, California. A total of 126 inactive, community-residing older adults with cognitive complaints. All participants engaged in home-based mental activity (1 h/d, 3 d/wk) plus class-based physical activity (1 h/d, 3 d/wk) for 12 weeks and were randomized to either mental activity intervention (MA-I; intensive computer) or mental activity control (MA-C; educational DVDs) plus exercise intervention (EX-I; aerobic) or exercise control (EX-C; stretching and toning); a 2 × 2 factorial design was used so that there were 4 groups: MA-I/EX-I, MA-I/EX-C, MA-C/EX-1, and MA-C/EX-C. Global cognitive change based on a comprehensive neuropsychological test battery. Participants had a mean age of 73.4 years; 62.7% were women, and 34.9% were Hispanic or nonwhite. There were no significant differences between the groups at baseline. Global cognitive scores improved significantly over time (mean, 0.16 SD; P < .001) but did not differ between groups in the comparison between MA-I and MA-C (ignoring exercise, P = .17), the comparison between EX-I and EX-C (ignoring mental activity, P = .74), or across all 4 randomization groups (P = .26). In inactive older adults with cognitive complaints, 12 weeks of physical plus mental activity was associated with significant improvements in global cognitive function with no evidence of difference between intervention and active control groups. These findings may reflect practice effects or may suggest that the amount of activity is more important than the type in this subject population. clinicaltrials.gov Identifier: NCT00522899.

The Mortality Penalty of Incarceration: Evidence from a Population-based Case-control Study of Working-age Males.

PubMed

Pridemore, William Alex

2014-06-01

There is a growing body of research on the effects of incarceration on health, though there are few studies in the sociological literature of the association between incarceration and premature mortality. This study examined the risk of male premature mortality associated with incarceration. Data came from the Izhevsk (Russia) Family Study, a large-scale population-based case-control design. Cases (n = 1,750) were male deaths aged 25 to 54 in Izhevsk between October 2003 and October 2005. Controls (n = 1,750) were selected at random from a city population register. The key independent variable was lifetime prevalence of incarceration. I used logistic regression to estimate mortality odds ratios, controlling for age, hazardous drinking, smoking status, marital status, and education. Seventeen percent of cases and 5 percent of controls had been incarcerated. Men who had been incarcerated were more than twice as likely as those who had not to experience premature mortality (odds ratio = 2.2, 95 percent confidence interval: 1.6-3.0). Relative to cases with no prior incarceration, cases who had been incarcerated were more likely to die from infectious diseases, respiratory diseases, non-alcohol-related accidental poisonings, and homicide. Taken together with other recent research, these results from a rigorous case-control design reveal not only that incarceration has durable effects on illness, but that its consequences extend to a greater risk of early death. I draw on the sociology of health literature on exposure, stress, and social integration to speculate about the reasons for this mortality penalty of incarceration. © American Sociological Association 2014.

A novel image encryption algorithm based on synchronized random bit generated in cascade-coupled chaotic semiconductor ring lasers

NASA Astrophysics Data System (ADS)

Li, Jiafu; Xiang, Shuiying; Wang, Haoning; Gong, Junkai; Wen, Aijun

2018-03-01

In this paper, a novel image encryption algorithm based on synchronization of physical random bit generated in a cascade-coupled semiconductor ring lasers (CCSRL) system is proposed, and the security analysis is performed. In both transmitter and receiver parts, the CCSRL system is a master-slave configuration consisting of a master semiconductor ring laser (M-SRL) with cross-feedback and a solitary SRL (S-SRL). The proposed image encryption algorithm includes image preprocessing based on conventional chaotic maps, pixel confusion based on control matrix extracted from physical random bit, and pixel diffusion based on random bit stream extracted from physical random bit. Firstly, the preprocessing method is used to eliminate the correlation between adjacent pixels. Secondly, physical random bit with verified randomness is generated based on chaos in the CCSRL system, and is used to simultaneously generate the control matrix and random bit stream. Finally, the control matrix and random bit stream are used for the encryption algorithm in order to change the position and the values of pixels, respectively. Simulation results and security analysis demonstrate that the proposed algorithm is effective and able to resist various typical attacks, and thus is an excellent candidate for secure image communication application.

Environment And Genetics in Lung cancer Etiology (EAGLE) study: an integrative population-based case-control study of lung cancer.

PubMed

Landi, Maria Teresa; Consonni, Dario; Rotunno, Melissa; Bergen, Andrew W; Goldstein, Alisa M; Lubin, Jay H; Goldin, Lynn; Alavanja, Michael; Morgan, Glen; Subar, Amy F; Linnoila, Ilona; Previdi, Fabrizio; Corno, Massimo; Rubagotti, Maurizia; Marinelli, Barbara; Albetti, Benedetta; Colombi, Antonio; Tucker, Margaret; Wacholder, Sholom; Pesatori, Angela C; Caporaso, Neil E; Bertazzi, Pier Alberto

2008-06-06

Lung cancer is the leading cause of cancer mortality worldwide. Tobacco smoking is its primary cause, and yet the precise molecular alterations induced by smoking in lung tissue that lead to lung cancer and impact survival have remained obscure. A new framework of research is needed to address the challenges offered by this complex disease. We designed a large population-based case-control study that combines a traditional molecular epidemiology design with a more integrative approach to investigate the dynamic process that begins with smoking initiation, proceeds through dependency/smoking persistence, continues with lung cancer development and ends with progression to disseminated disease or response to therapy and survival. The study allows the integration of data from multiple sources in the same subjects (risk factors, germline variation, genomic alterations in tumors, and clinical endpoints) to tackle the disease etiology from different angles. Before beginning the study, we conducted a phone survey and pilot investigations to identify the best approach to ensure an acceptable participation in the study from cases and controls. Between 2002 and 2005, we enrolled 2101 incident primary lung cancer cases and 2120 population controls, with 86.6% and 72.4% participation rate, respectively, from a catchment area including 216 municipalities in the Lombardy region of Italy. Lung cancer cases were enrolled in 13 hospitals and population controls were randomly sampled from the area to match the cases by age, gender and residence. Detailed epidemiological information and biospecimens were collected from each participant, and clinical data and tissue specimens from the cases. Collection of follow-up data on treatment and survival is ongoing. EAGLE is a new population-based case-control study that explores the full spectrum of lung cancer etiology, from smoking addiction to lung cancer outcome, through examination of epidemiological, molecular, and clinical data. We have provided a detailed description of the study design, field activities, management, and opportunities for research following this integrative approach, which allows a sharper and more comprehensive vision of the complex nature of this disease. The study is poised to accelerate the emergence of new preventive and therapeutic strategies with potentially enormous impact on public health.

A study of renal function influence by integrating cloud-based manometers and physician order entry systems.

PubMed

Lin, Yuh-Feng; Sheng, Li-Huei; Wu, Mei-Yi; Zheng, Cai-Mei; Chang, Tian-Jong; Li, Yu-Chuan; Huang, Yu-Hui; Lu, Hsi-Peng

2014-12-01

No evidence exists from randomized trials to support using cloud-based manometers integrated with available physician order entry systems for tracking patient blood pressure (BP) to assist in the control of renal function deterioration. We investigated how integrating cloud-based manometers with physician order entry systems benefits our outpatient chronic kidney disease patients compared with typical BP tracking systems. We randomly assigned 36 chronic kidney disease patients to use cloud-based manometers integrated with physician order entry systems or typical BP recording sheets, and followed the patients for 6 months. The composite outcome was that the patients saw improvement both in BP and renal function. We compared the systolic and diastolic BP (SBP and DBP), and renal function of our patients at 0 months, 3 months, and 6 months after using the integrated manometers and typical BP monitoring sheets. Nighttime SBP and DBP were significantly lower in the study group compared with the control group. Serum creatinine level in the study group improved significantly compared with the control group after the end of Month 6 (2.83 ± 2.0 vs. 4.38 ± 3.0, p = 0.018). Proteinuria improved nonsignificantly in Month 6 in the study group compared with the control group (1.05 ± 0.9 vs. 1.90 ± 1.3, p = 0.09). Both SBP and DBP during the nighttime hours improved significantly in the study group compared with the baseline. In pre-end-stage renal disease patients, regularly monitoring BP by integrating cloud-based manometers appears to result in a significant decrease in creatinine and improvement in nighttime BP control. Estimated glomerular filtration rate and proteinuria were found to be improved nonsignificantly, and thus, larger population and longer follow-up studies may be needed.

A public health initiative to increase annual influenza immunization among hospital health care personnel: the San Diego Hospital Influenza Immunization Partnership.

PubMed

Sawyer, Mark H; Peddecord, K Michael; Wang, Wendy; Deguire, Michelle; Miskewitch-Dzulynsky, Michelle; Vuong, David D

2012-09-01

A public health department-supported intervention to increase influenza immunization among hospital-based health care practitioners (HCPs) in San Diego County took place between 2005 and 2008. The study included all major hospitals in the county, with a population of approximately 3.5 million. Information on hospital activities was collected from before, during and after initiative activities. Vaccination status and demographics were collected directly from HCP using hospital-based and random-dialed telephone surveys. Between 2006 and 2008, hospitals increased promotion activities and reported increases in vaccination rates. Based on the random-dialed surveys, HCP influenza vaccination coverage rates did not increase significantly. Vaccination rates were significantly higher in HCPs who reported that employers provided free vaccination and those who believed that their employers mandated influenza vaccination. This local public health initiative and concurrent state legislation were effective in increasing employer efforts to promote influenza vaccination; however, population-based surveys of HCPs did not show significant increases in influenza vaccination. Overall, this study suggests that public health leadership, intensive employer promotion activities, and state-required declinations alone were not sufficient to significantly increase HCP influenza vaccination. Policymakers and employers should consider mandates to achieve optimal influenza vaccination among HCPs. Copyright © 2012 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Prevention of depression and anxiety in adolescents: a randomized controlled trial testing the efficacy and mechanisms of Internet-based self-help problem-solving therapy.

PubMed

Hoek, Willemijn; Schuurmans, Josien; Koot, Hans M; Cuijpers, Pim

2009-10-12

Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best. This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted. This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet-based problem-solving therapy is shown to reduce depressive and anxiety symptoms in adolescents, the implication is to implement the intervention in clinical practice. Strengths and limitations of the study are discussed. Netherlands Trial Register NTR1322.

Effects of education based on the health belief model on screening behavior in high risk women for breast cancer, Tehran, Iran.

PubMed

Hajian, Sepideh; Vakilian, Katayon; Najabadi, Khadijeh Mirzaii; Hosseini, Jalil; Mirzaei, Hamid Reza

2011-01-01

Breast cancer is the most common malignancy in women. Early diagnosis allows efficient treatment and increases survival, but the efficacy of breast self examination (BSE) is not sufficiently well established. The American Cancer Society aims to give women the opportunity to recognize the utility, limitations and adverse effects of breast cancer screening through education models based on psychological theories. With the Health Belief Model, people's health perceptions and attitudes influence their practices, for example with screening. The purpose of this randomized controlled clinical trial was to determine the effect of education based on this model on breast cancer screening in high risk Iranian women. Participants were women with a family history of breast cancer (mother, sister, and daughter). After explanation of the study objectives to participants, they were recruited on obtaining oral consent and each filled out the study questionnaire based on the Health Belief Model. Allocation was into two groups by computerized randomization, control and intervention, receiving education on breast cancer screening. Perceived susceptibility to and seriousness of breast cancer, perceived usefulness of and barriers to BSE, clinical breast examination, and mammography, and self-efficacy in the ability to perform these, were assessed, with comparison of scores for BSE practice before and after education and doing mammography and clinical examination by a physician in intervention and control group. The mean age was 37.8 ± 11.7 (range 19-60). The mean rank in the intervention group significantly differed before and after the education, but except for " perceived threat" and "perceived usefulness of breast self examination", we did not find any significant differences from the control group. After educational sessions, breast self examination and clinical examination practice rates were elevated. Health education based on well known psychological theories for breast cancer screening should be extended to the entire populations in developing countries. In addition, we should pay attention to barriers to women undergoing mammography, such as costs, shame and accessibility, and increase the target population awareness and positive attitudes towards benefits of early breast cancer screening.

A randomized comparison of print and web communication on colorectal cancer screening.

PubMed

Weinberg, David S; Keenan, Eileen; Ruth, Karen; Devarajan, Karthik; Rodoletz, Michelle; Bieber, Eric J

2013-01-28

New methods to enhance colorectal cancer (CRC) screening rates are needed. The web offers novel possibilities to educate patients and to improve health behaviors, such as cancer screening. Evidence supports the efficacy of health communications that are targeted and tailored to improve the uptake of recommendations. We identified unscreened women at average risk for CRC from the scheduling databases of obstetrics and gynecology practices in 2 large health care systems. Participants consented to a randomized controlled trial that compared CRC screening uptake after receipt of CRC screening information delivered via the web or in print form. Participants could also be assigned to a control (usual care) group. Women in the interventional arms received tailored information in a high- or low-monitoring Cognitive Social Information Processing model-defined attentional style. The primary outcome was CRC screening participation at 4 months. A total of 904 women were randomized to the interventional or control group. At 4 months, CRC screening uptake was not significantly different in the web (12.2%), print (12.0%), or control (12.9%) group. Attentional style had no effect on screening uptake for any group. Some baseline participant factors were associated with greater screening, including higher income (P = .03), stage of change (P < .001), and physician recommendation to screen (P < .001). A web-based educational intervention was no more effective than a print-based one or control (no educational intervention) in increasing CRC screening rates in women at average risk of CRC. Risk messages tailored to attentional style had no effect on screening uptake. In average-risk populations, use of the Internet for health communication without additional enhancement is unlikely to improve screening participation. clinicaltrials.gov Identifier: NCT00459030.

Effectiveness of the bucco-lingual technique within a school-based supervised toothbrushing program on preventing caries: a randomized controlled trial

PubMed Central

2011-01-01

Background Supervised toothbrushing programs using fluoride dentifrice have reduced caries increment. However there is no information about the effectiveness of the professional cross-brushing technique within a community intervention. The aim was to assess if the bucco-lingual technique can increase the effectiveness of a school-based supervised toothbrushing program on preventing caries. Methods A randomized double-blinded controlled community intervention trial to be analyzed at an individual level was conducted in a Brazilian low-income fluoridated area. Six preschools were randomly assigned to the test and control groups and 284 five-year-old children presenting at least one permanent molar with emerged/sound occlusal surface participated. In control group, oral health education and dental plaque dying followed by toothbrushing with fluoride dentifrice supervised directly by a dental assistant, was developed four times per year. At the remaining school days the children brushed their teeth under indirect supervising of the teachers. In test group, children also underwent a professional cross-brushing on surfaces of first permanent molar rendered by a specially trained dental assistant five times per year. Enamel and dentin caries were recorded on buccal, occlusal and lingual surfaces of permanent molars during 18-month follow-up. Exposure time of surfaces was calculated and incidence density ratio was estimated using Poisson regression model. Results Difference of 21.6 lesions per 1,000 children between control and test groups was observed. Among boys whose caries risk was higher compared to girls, incidence density was 50% lower in test group (p = 0.016). Conclusion Modified program was effective among the boys. It is licit to project a relevant effect in a larger period suggesting in a broader population substantial reduction of dental care needs. Trial registration ISRCTN18548869. PMID:21426572

Physical Activity Outcomes of Nurse-Delivered Lifestyle Interventions.

PubMed

Richards, Elizabeth A; Cai, Yun

2016-02-01

Promotion of physical activity has been a public health priority for decades. Over two million home healthcare nurses are at the front line to deliver effective health education and health promotion interventions in the United States. The purpose of this systematic review is to examine the effectiveness of nurse-delivered lifestyle physical interventions on physical activity outcomes conducted in home settings. Computerized database and ancestry search strategies located distinct intervention trials between 1990 and 2015. A total of eight quantitative studies were reviewed. Four of the eight studies were randomized control trials and four studies used an uncontrolled pretest-posttest design. The eight studies represented a total of 1,221 participants with mean ages from 43 to 81. Study sample sizes ranged from 16 to 504. Seven of the eight studies demonstrated modest effect of nurse-delivered home-based interventions on physical activity behaviors. Home-based physical activity promotion was most often incorporated into secondary prevention of postacute diseases, chronic disease management, or disease prevention/health promotion. Findings indicate that nurse-delivered home-based physical activity promotion show overall effectiveness in general adult populations. Possible effective intervention domains were also discussed in this review to guide future home-based health promotion. More large randomized controlled trials with longer study/follow-up periods and studies with cost-effectiveness data are warranted in future research.

Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial.

PubMed

Lappe, Joan M; Travers-Gustafson, Dianne; Davies, K Michael; Recker, Robert R; Heaney, Robert P

2007-06-01

Numerous observational studies have found supplemental calcium and vitamin D to be associated with reduced risk of common cancers. However, interventional studies to test this effect are lacking. The purpose of this analysis was to determine the efficacy of calcium alone and calcium plus vitamin D in reducing incident cancer risk of all types. This was a 4-y, population-based, double-blind, randomized placebo-controlled trial. The primary outcome was fracture incidence, and the principal secondary outcome was cancer incidence. The subjects were 1179 community-dwelling women randomly selected from the population of healthy postmenopausal women aged >55 y in a 9-county rural area of Nebraska centered at latitude 41.4 degrees N. Subjects were randomly assigned to receive 1400-1500 mg supplemental calcium/d alone (Ca-only), supplemental calcium plus 1100 IU vitamin D3/d (Ca + D), or placebo. When analyzed by intention to treat, cancer incidence was lower in the Ca + D women than in the placebo control subjects (P < 0.03). With the use of logistic regression, the unadjusted relative risks (RR) of incident cancer in the Ca + D and Ca-only groups were 0.402 (P = 0.01) and 0.532 (P = 0.06), respectively. When analysis was confined to cancers diagnosed after the first 12 mo, RR for the Ca + D group fell to 0.232 (CI: 0.09, 0.60; P < 0.005) but did not change significantly for the Ca-only group. In multiple logistic regression models, both treatment and serum 25-hydroxyvitamin D concentrations were significant, independent predictors of cancer risk. Improving calcium and vitamin D nutritional status substantially reduces all-cancer risk in postmenopausal women. This trial was registered at clinicaltrials.gov as NCT00352170.

A randomized controlled trial evaluating the erythropoiesis stimulating agent sparing potential of a vitamin E-bonded polysulfone dialysis membrane

PubMed Central

Lines, Simon W.; Carter, Angela M.; Dunn, Emma J.; Lindley, Elizabeth J.; Tattersall, James E.; Wright, Mark J.

2014-01-01

Background Vitamin E (VE) bonded polysulfone dialysis membranes have putative erythropoiesis stimulating agent (ESA)-sparing and anti-inflammatory properties based on data from a small number of studies. We sought to investigate this in a large, prospective 12-month randomized controlled trial. Methods Two-hundred and sixty prevalent haemodialysis (HD) patients were randomized to dialysis with VE-bonded polysulfone membranes or non-VE-bonded equivalents. All ESA-dosing was performed by means of a computer-based anaemia management decision support system. Monthly data were used to calculate the ESA resistance index (ERI) and blood tests were performed at baseline, 6 and 12 months for measurement of C-reactive protein (CRP) levels. Results Of the 260 patients, 123 were randomized to dialysis with the VE-membrane and 12-month data was available for 220 patients. At the study population level, no beneficial effect of the VE membranes on the ERI or CRP levels was observed. Post hoc analyses indicated that there was a significant fall in ERI for patients with the highest baseline ESA resistance dialysed with the VE (9.28 [7.70–12.5] versus 7.70 [5.34–12.7] IU/week/kg/g/dL Hb, P = 0.01) but not the control membranes (9.45 [7.62–12.3] versus 8.14 [4.44–15.6] IU/week/kg/g/dL Hb, P = 0.41); this was not attributable to changes in CRP levels. Conclusions Wholesale switching of all chronic HD patients to dialysis with VE-bonded polysulfone membranes appears not to be associated with improvements in ESA-responsiveness or CRP. These membranes may have utility in patients with heightened ESA resistance. PMID:24293660

Association of bladder pain syndrome/interstitial cystitis with urinary calculus: a nationwide population-based study.

PubMed

Keller, Joseph; Chen, Yi-Kuang; Lin, Herng-Ching

2013-04-01

Although one prior study reported an association between bladder pain syndrome/interstitial cystitis (BPS/IC) and urinary calculi (UC), no population-based study to date has been conducted to explore this relationship. Therefore, using a population-based data set in Taiwan, this study set out to investigate the association between BPS/IC and a prior diagnosis of UC. This study included 9,269 cases who had received their first-time diagnosis of BPS/IC between 2006 and 2007 and 46,345 randomly selected controls. We used conditional logistic regression analysis to compute the odds ratio (OR) and its corresponding 95 % confidence interval (CI) for having been previously diagnosed with UC between cases and controls. There was a significant difference in the prevalence of prior UC between cases and controls (8.1 vs 4.3 %, p < 0.001). Conditional logistic regression analysis revealed that cases were more likely to have been previously diagnosed with UC than controls (OR = 1.70; 95 % CI = 1.56-1.84) after adjusting for chronic pelvic pain, irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, depression, panic disorder, migraine, sicca syndrome, allergy, endometriosis, and asthma. BPS/IC was found to be significantly associated with prior UC regardless of stone location; the adjusted ORs of kidney calculus, ureter calculus, bladder calculus, and unspecified calculus when compared to controls were 1.58 (95 % CI = 1.38-1.81), 1.73 (95 % CI = 1.45-2.05), 3.80 (95 % CI = 2.18-6.62), and 1.83 (95 % CI = 1.59-2.11), respectively. This work generates the hypothesis that UC may be associated with BPS/IC.

Vegetarian Diets and Weight Reduction: a Meta-Analysis of Randomized Controlled Trials.

PubMed

Huang, Ru-Yi; Huang, Chuan-Chin; Hu, Frank B; Chavarro, Jorge E

2016-01-01

Vegetarian diets may promote weight loss, but evidence remains inconclusive. PubMed, EMBASE and UpToDate databases were searched through September 22, 2014, and investigators extracted data regarding study characteristics and assessed study quality among selected randomized clinical trials. Population size, demographic (i.e., gender and age) and anthropometric (i.e., body mass index) characteristics, types of interventions, follow-up periods, and trial quality (Jadad score) were recorded. The net changes in body weight of subjects were analyzed and pooled after assessing heterogeneity with a random effects model. Subgroup analysis was performed based on type of vegetarian diet, type of energy restriction, study population, and follow-up period. Twelve randomized controlled trials were included, involving a total of 1151 subjects who received the intervention over a median duration of 18 weeks. Overall, individuals assigned to the vegetarian diet groups lost significantly more weight than those assigned to the non-vegetarian diet groups (weighted mean difference, -2.02 kg; 95 % confidence interval [CI]: -2.80 to -1.23). Subgroup analysis detected significant weight reduction in subjects consuming a vegan diet (-2.52 kg; 95 % CI: -3.02 to -1.98) and, to a lesser extent, in those given lacto-ovo-vegetarian diets (-1.48 kg; 95 % CI: -3.43 to 0.47). Studies on subjects consuming vegetarian diets with energy restriction (ER) revealed a significantly greater weight reduction (-2.21 kg; 95 % CI: -3.31 to -1.12) than those without ER (-1.66 kg; 95 % CI: -2.85 to -0.48). The weight loss for subjects with follow-up of <1 year was greater (-2.05 kg; 95 % CI: -2.85 to -1.25) than those with follow-up of ≥1 year (-1.13 kg; 95 % CI: -2.04 to -0.21). Vegetarian diets appeared to have significant benefits on weight reduction compared to non-vegetarian diets. Further long-term trials are needed to investigate the effects of vegetarian diets on body weight control.

APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

PubMed Central

Schnadig, Ian D; Agajanian, Richy; Dakhil, Christopher; Gabrail, Nashat; Vacirca, Jeffrey; Taylor, Charles; Wilks, Sharon; Braun, Eduardo; Mosier, Michael C; Geller, Robert B; Schwartzberg, Lee; Vogelzang, Nicholas

2017-01-01

Background APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC) trial. Patients and methods This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC) regimen. Patients were randomized 1:1 to APF530 500 mg subcutaneously (granisetron 10 mg) or ondansetron 0.15 mg/kg intravenously (IV) (≤16 mg); stratification was by planned cisplatin ≥50 mg/m2 (yes/no). Patients were to receive fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1, then dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1 years, female, 99.3%; ondansetron arm, 53.8 years, female 98.3%). The primary end point was delayed-phase (>24–120 hours) complete response (CR). Results APF530 versus ondansetron regimens achieved numerically better CINV control in delayed and overall (0–120 hours) phases for CR, complete control, total response, rescue medication use, and proportion with no nausea. APF530 trends are consistent with the overall population, although not statistically superior given the underpowered AC subgroup analysis. The APF530 regimen in this population was generally well tolerated, with safety comparable to that of the overall population. Conclusion APF530 plus fosaprepitant and dexamethasone effectively prevented CINV among patients receiving AC-based HEC, a large subgroup in whom CINV control has traditionally been challenging. PMID:28579832

Ethnicity, social disadvantage and psychotic-like experiences in a healthy population based sample.

PubMed

Morgan, C; Fisher, H; Hutchinson, G; Kirkbride, J; Craig, T K; Morgan, K; Dazzan, P; Boydell, J; Doody, G A; Jones, P B; Murray, R M; Leff, J; Fearon, P

2009-03-01

We sought to investigate the prevalence and social correlates of psychotic-like experiences in a general population sample of Black and White British subjects. Data were collected from randomly selected community control subjects, recruited as part of the AESOP study, a three-centre population based study of first-episode psychosis. The proportion of subjects reporting one or more psychotic-like experience was 19% (n = 72/372). These were more common in Black Caribbean (OR 2.08) and Black African subjects (OR 4.59), compared with White British. In addition, a number of indicators of childhood and adult disadvantage were associated with psychotic-like experiences. When these variables were simultaneously entered into a regression model, Black African ethnicity, concentrated adult disadvantage, and separation from parents retained a significant effect. The higher prevalence of psychotic-like experiences in the Black Caribbean, but not Black African, group was explained by high levels of social disadvantage over the life course.

Neutral aggregation in finite-length genotype space

NASA Astrophysics Data System (ADS)

Houchmandzadeh, Bahram

2017-01-01

The advent of modern genome sequencing techniques allows for a more stringent test of the neutrality hypothesis of Darwinian evolution, where all individuals have the same fitness. Using the individual-based model of Wright and Fisher, we compute the amplitude of neutral aggregation in the genome space, i.e., the probability of finding two individuals at genetic (Hamming) distance k as a function of the genome size L , population size N , and mutation probability per base ν . In well-mixed populations, we show that for N ν <1 /L , neutral aggregation is the dominant force and most individuals are found at short genetic distances from each other. For N ν >1 , on the contrary, individuals are randomly dispersed in genome space. The results are extended to a geographically dispersed population, where the controlling parameter is shown to be a combination of mutation and migration probability. The theory we develop can be used to test the neutrality hypothesis in various ecological and evolutionary systems.

Emergency Department Use for Dental Problems among Homeless Individuals: A Population-Based Cohort Study.

PubMed

Figueiredo, Rafael; Dempster, Laura; Quiñonez, Carlos; Hwang, Stephen W

2016-01-01

To evaluate emergency department (ED) visits for dental problems among Toronto's homeless population (Ontario, Canada). A random sample of 1,189 homeless was recruited from shelters and meal programs. Emergency department visits for non-traumatic dental problems (ICD-10-CA codes K00-K14) were identified using participants' health insurance number, during 2005-2009. Age- and sex-matched controls were selected from low-income neighborhoods. Homeless and matched controls had 182 and 10 ED visits for dental problems, respectively. Homeless people were more significantly more likely (OR=2.27, p=.007) to make ED visit for dental problems compared with controls. Over 80% of the ED visits by homeless people were for odontogenic infections, and 46% of homeless people had more than one such visit. The high rate of ED visits for dental problems by people who are homeless suggests that access to dental care is inadequate. The large number of repeat visits indicates that ED settings are ineffective for treatment of dental problems.

Childhood obesity prevention through a community-based cluster randomized controlled physical activity intervention among schools in china: the health legacy project of the 2nd world summer youth olympic Games (YOG-Obesity study)

PubMed Central

Wang, Z; Xu, F; Ye, Q; Tse, L A; Xue, H; Tan, Z; Leslie, E; Owen, N; Wang, Y

2018-01-01

Background: Childhood obesity has been becoming a worldwide public health problem. We conducted a community-based physical activity (PA) intervention program aiming at childhood obesity prevention in general student population in Nanjing of China, the host city of the 2nd World Summer Youth Olympic Games (YOG-Obesity study). Methods: This was a cluster randomized controlled intervention study. Participants were the 4th (mean age±s.e.: 9.0±0.01) and 7th (mean age±s.e.: 12.0±0.01) grade students (mean age±s.e.: 10.5±0.02) from 48 schools and randomly allocated (1:1) to intervention or control groups at school level. Routine health education was provided to all schools, whereas the intervention schools additionally received an 1-year tailored multi-component PA intervention program, including classroom curricula, school environment support, family involvement and fun programs/events. The primary outcome measures were changes in body mass index, obesity occurrence and PA. Results: Overall, 9858 (97.7%) of the 10091 enrolled students completed the follow-up survey. Compared with the baseline, PA level increased by 33.13 min per week (s.e. 10.86) in the intervention group but decreased by 1.76 min per week (s.e. 11.53) in the control group (P=0.028). After adjustment for potential confounders, compared with the control group, the intervention group were more likely to have increased time of PA (adj. Odds ratio=1.15, 95% confidence interval=1.06–1.25), but had a smaller increase in mean body mass index (BMI) (0.22 (s.e. 0.02) vs 0.46 (0.02), P=0.01) and BMI z-score (0.07 (0.01) vs 0.16 (0.01), P=0.01), and were less likely to be obese (adj. Odds ratio=0.7, 95% confidence interval=0.6, 0.9) at study end. The intervention group had fewer new events of obesity/overweight but a larger proportion of formerly overweight/obese students having normal weight by study end. Conclusions: This large community-based PA intervention was feasible and effective in promoting PA and preventing obesity among the general student population in a large city in China. Experiences from this study are the lessons for China to control the childhood obesity epidemic. PMID:28978975

Childhood obesity prevention through a community-based cluster randomized controlled physical activity intervention among schools in china: the health legacy project of the 2nd world summer youth olympic Games (YOG-Obesity study).

PubMed

Wang, Z; Xu, F; Ye, Q; Tse, L A; Xue, H; Tan, Z; Leslie, E; Owen, N; Wang, Y

2018-04-01

Childhood obesity has been becoming a worldwide public health problem. We conducted a community-based physical activity (PA) intervention program aiming at childhood obesity prevention in general student population in Nanjing of China, the host city of the 2nd World Summer Youth Olympic Games (YOG-Obesity study). This was a cluster randomized controlled intervention study. Participants were the 4th (mean age±s.e.: 9.0±0.01) and 7th (mean age±s.e.: 12.0±0.01) grade students (mean age±s.e.: 10.5±0.02) from 48 schools and randomly allocated (1:1) to intervention or control groups at school level. Routine health education was provided to all schools, whereas the intervention schools additionally received an 1-year tailored multi-component PA intervention program, including classroom curricula, school environment support, family involvement and fun programs/events. The primary outcome measures were changes in body mass index, obesity occurrence and PA. Overall, 9858 (97.7%) of the 10091 enrolled students completed the follow-up survey. Compared with the baseline, PA level increased by 33.13 min per week (s.e. 10.86) in the intervention group but decreased by 1.76 min per week (s.e. 11.53) in the control group (P=0.028). After adjustment for potential confounders, compared with the control group, the intervention group were more likely to have increased time of PA (adj. Odds ratio=1.15, 95% confidence interval=1.06-1.25), but had a smaller increase in mean body mass index (BMI) (0.22 (s.e. 0.02) vs 0.46 (0.02), P=0.01) and BMI z-score (0.07 (0.01) vs 0.16 (0.01), P=0.01), and were less likely to be obese (adj. Odds ratio=0.7, 95% confidence interval=0.6, 0.9) at study end. The intervention group had fewer new events of obesity/overweight but a larger proportion of formerly overweight/obese students having normal weight by study end. This large community-based PA intervention was feasible and effective in promoting PA and preventing obesity among the general student population in a large city in China. Experiences from this study are the lessons for China to control the childhood obesity epidemic.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial.

PubMed

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

2018-04-01

Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40-79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78-83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3-3.4%, P ≥ 0.138). Linear dose-response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. The 5-year CWI using the focused social marketing strategy increased the population-level of PA.

Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial

PubMed Central

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

2018-01-01

Abstract Background Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. Methods We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40–79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78–83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3–3.4%, P ≥ 0.138). Linear dose–response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. Conclusions The 5-year CWI using the focused social marketing strategy increased the population-level of PA. PMID:29228255

Cluster-Randomized Trial to Increase Hepatitis B Testing among Koreans in Los Angeles.

PubMed

Bastani, Roshan; Glenn, Beth A; Maxwell, Annette E; Jo, Angela M; Herrmann, Alison K; Crespi, Catherine M; Wong, Weng K; Chang, L Cindy; Stewart, Susan L; Nguyen, Tung T; Chen, Moon S; Taylor, Victoria M

2015-09-01

In the United States, Korean immigrants experience a disproportionately high burden of chronic hepatitis B (HBV) viral infection and associated liver cancer compared with the general population. However, despite clear clinical guidelines, HBV serologic testing among Koreans remains persistently suboptimal. We conducted a cluster-randomized trial to evaluate a church-based small group intervention to improve HBV testing among Koreans in Los Angeles. Fifty-two Korean churches, stratified by size (small, medium, large) and location (Koreatown versus other), were randomized to intervention or control conditions. Intervention church participants attended a single-session small-group discussion on liver cancer and HBV testing, and control church participants attended a similar session on physical activity and nutrition. Outcome data consisted of self-reported HBV testing obtained via 6-month telephone follow-up interviews. We recruited 1,123 individuals, 18 to 64 years of age, across the 52 churches. Ninety-two percent of the sample attended the assigned intervention session and 86% completed the 6-month follow-up. Sample characteristics included were as follows: mean age 46 years, 65% female, 97% born in Korea, 69% completed some college, and 43% insured. In an intent-to-treat analysis, the intervention produced a statistically significant effect (OR = 4.9, P < 0.001), with 19% of intervention and 6% of control group participants reporting a HBV test. Our intervention was successful in achieving a large and robust effect in a population at high risk of HBV infection and sequelae. The intervention was fairly resource efficient and thus has high potential for replication in other high-risk Asian groups. ©2015 American Association for Cancer Research.

A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

PubMed

Huberty, Jennifer; Matthews, Jeni; Leiferman, Jenn; Cacciatore, Joanne; Gold, Katherine J

2018-01-01

In the USA, stillbirth (in utero fetal death ≥20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a positive screen for post-traumatic stress disorder (PTSD) and a fourfold increased risk of depressive symptoms. Because the majority of women who have experienced the death of their baby become pregnant within 12-18 months and the lack of intervention studies conducted within this population, novel approaches targeting physical and mental health, specific to the needs of this population, are critical. Evidence suggests that yoga is efficacious, safe, acceptable, and cost-effective for improving mental health in a variety of populations, including pregnant and postpartum women. To date, there are no known studies examining online-streaming yoga as a strategy to help mothers cope with PTSD symptoms after stillbirth. The present study is a two-phase randomized controlled trial. Phase 1 will involve (1) an iterative design process to develop the online yoga prescription for phase 2 and (2) qualitative interviews to identify cultural barriers to recruitment in non-Caucasian women (i.e., predominately Hispanic and/or African American) who have experienced stillbirth ( N  = 5). Phase 2 is a three-group randomized feasibility trial with assessments at baseline, and at 12 and 20 weeks post-intervention. Ninety women who have experienced a stillbirth within 6 weeks to 24 months will be randomized into one of the following three arms for 12 weeks: (1) intervention low dose (LD) = 60 min/week online-streaming yoga ( n  = 30), (2) intervention moderate dose (MD) = 150 min/week online-streaming yoga ( n  = 30), or (3) stretch and tone control (STC) group = 60 min/week of stretching/toning exercises ( n  = 30). This study will explore the feasibility and acceptability of a 12-week, home-based, online-streamed yoga intervention, with varying doses among mothers after a stillbirth. If feasible, the findings from this study will inform a full-scale trial to determine the effectiveness of home-based online-streamed yoga to improve PTSD. Long-term, health care providers could use online yoga as a non-pharmaceutical, inexpensive resource for stillbirth aftercare. NCT02925481.

Attitudes and Perception Towards Eye Donation in Patients with Corneal Disease: A Case-controlled Population-based Study.

PubMed

Noopur, Gupta; Praveen, Vashist; Radhika, Tandon; Sanjeev K, Gupta; Mani, Kalaivani; Deepak, Kumar

2018-06-01

To assess awareness, barriers, and misconceptions related to eye donation in people with corneal disease as compared to controls in a population setting. A population-based study was conducted in 25 randomly selected clusters of Rural Gurgaon, Haryana, India, as part of the CORE (Cornea Opacity Rural Epidemiological) study. In addition to ophthalmic examination, knowledge and perceptions regarding eye donation were assessed through a validated questionnaire. The questionnaire captured the sociodemographic factors influencing awareness regarding eye donation in participants with corneal disease and twice the number of age- and gender-matched controls recruited from the same study clusters. Descriptive statistics were computed along with multivariable logistic regression analysis to determine associated factors for awareness of eye donation. In the CORE study, 452 participants had corneal opacities on ocular examination. Of these, 442 were assessed for eye donation awareness. Additionally, 884 age- and gender-matched controls were recruited. The mean age of cases and controls was 60.9 ± 15.5 and 59.6 ± 14.3 years, respectively. Awareness of eye donation in cases and controls was 46.4% (n = 205 of 442) and 52.3% (n = 462 of 884), respectively (P = 0.044). Educational status was an important factor determining knowledge about eye donation in both cases and controls (P = < 0.001). Major barriers reported for not pledging eyes were lack of willingness (36.7%) and ignorance (15.3%). Common misconceptions like eyes could be donated before death or even after 24 h of death and that any type of blindness could be treated with corneal transplantation were prevalent. The study demonstrated that although there is substantial awareness about eye donation, there are numerous barriers in this population that need to be resolved to improve donation rates. Additional efforts are needed to translate this awareness into actual eye donation in both cases with corneal disease and controls.

Development and Assessment of Plant-Based Synthetic Odor Baits for Surveillance and Control of Malaria Vectors

PubMed Central

Nyasembe, Vincent O.; Tchouassi, David P.; Kirwa, Hillary K.; Foster, Woodbridge A.; Teal, Peter E. A.; Borgemeister, Christian; Torto, Baldwyn

2014-01-01

Background Recent malaria vector control measures have considerably reduced indoor biting mosquito populations. However, reducing the outdoor biting populations remains a challenge because of the unavailability of appropriate lures to achieve this. This study sought to test the efficacy of plant-based synthetic odor baits in trapping outdoor populations of malaria vectors. Methodology and Principal Finding Three plant-based lures ((E)-linalool oxide [LO], (E)-linalool oxide and (E)-β-ocimene [LO + OC], and a six-component blend comprising (E)-linalool oxide, (E)-β-ocimene, hexanal, β-pinene, limonene, and (E)-β-farnesene [Blend C]), were tested alongside an animal/human-based synthetic lure (comprising heptanal, octanal, nonanal, and decanal [Blend F]) and worn socks in a malaria endemic zone in the western part of Kenya. Mosquito Magnet-X (MM-X) and lightless Centre for Disease Control (CDC) light traps were used. Odor-baited traps were compared with traps baited with either solvent alone or solvent + carbon dioxide (controls) for 18 days in a series of randomized incomplete-block designs of days × sites × treatments. The interactive effect of plant and animal/human odor was also tested by combining LO with either Blend F or worn socks. Our results show that irrespective of trap type, traps baited with synthetic plant odors compared favorably to the same traps baited with synthetic animal odors and worn socks in trapping malaria vectors, relative to the controls. Combining LO and worn socks enhanced trap captures of Anopheles species while LO + Blend F recorded reduced trap capture. Carbon dioxide enhanced total trap capture of both plant- and animal/human-derived odors. However, significantly higher proportions of male and engorged female Anopheles gambiae s.l. were caught when the odor treatments did not include carbon dioxide. Conclusion and Significance The results highlight the potential of plant-based odors and specifically linalool oxide, with or without carbon dioxide, for surveillance and mass trapping of malaria vectors. PMID:24587059

Development and assessment of plant-based synthetic odor baits for surveillance and control of malaria vectors.

PubMed

Nyasembe, Vincent O; Tchouassi, David P; Kirwa, Hillary K; Foster, Woodbridge A; Teal, Peter E A; Borgemeister, Christian; Torto, Baldwyn

2014-01-01

Recent malaria vector control measures have considerably reduced indoor biting mosquito populations. However, reducing the outdoor biting populations remains a challenge because of the unavailability of appropriate lures to achieve this. This study sought to test the efficacy of plant-based synthetic odor baits in trapping outdoor populations of malaria vectors. Three plant-based lures ((E)-linalool oxide [LO], (E)-linalool oxide and (E)-β-ocimene [LO + OC], and a six-component blend comprising (E)-linalool oxide, (E)-β-ocimene, hexanal, β-pinene, limonene, and (E)-β-farnesene [Blend C]), were tested alongside an animal/human-based synthetic lure (comprising heptanal, octanal, nonanal, and decanal [Blend F]) and worn socks in a malaria endemic zone in the western part of Kenya. Mosquito Magnet-X (MM-X) and lightless Centre for Disease Control (CDC) light traps were used. Odor-baited traps were compared with traps baited with either solvent alone or solvent + carbon dioxide (controls) for 18 days in a series of randomized incomplete-block designs of days × sites × treatments. The interactive effect of plant and animal/human odor was also tested by combining LO with either Blend F or worn socks. Our results show that irrespective of trap type, traps baited with synthetic plant odors compared favorably to the same traps baited with synthetic animal odors and worn socks in trapping malaria vectors, relative to the controls. Combining LO and worn socks enhanced trap captures of Anopheles species while LO + Blend F recorded reduced trap capture. Carbon dioxide enhanced total trap capture of both plant- and animal/human-derived odors. However, significantly higher proportions of male and engorged female Anopheles gambiae s.l. were caught when the odor treatments did not include carbon dioxide. The results highlight the potential of plant-based odors and specifically linalool oxide, with or without carbon dioxide, for surveillance and mass trapping of malaria vectors.

The Detroit Young Adult Asthma Project: Proposal for a Multicomponent Technology Intervention for African American Emerging Adults With Asthma.

PubMed

MacDonell, Karen; Naar, Sylvie; Gibson-Scipio, Wanda; Bruzzese, Jean-Marie; Wang, Bo; Brody, Aaron

2018-05-07

Racial and ethnic minority youth have poorer asthma status than white youth, even after controlling for socioeconomic variables. Proper use of asthma controller medications is critical in reducing asthma mortality and morbidity. The clinical consequences of poor asthma management include increased illness complications, excessive functional morbidity, and fatal asthma attacks. There are significant limitations in research on interventions to improve asthma management in racial minority populations, particularly minority adolescents and young adults, although illness management tends to deteriorate after adolescence during emerging adulthood, the unique developmental period beyond adolescence but before adulthood. The objective of the pilot study was to test the feasibility, acceptability, and signals of efficacy of an intervention targeting adherence to controller medication in African American youth (ages 18-29) with asthma. All elements of the protocol were piloted in a National Heart, Lung, and Blood Institute (NHLBI)-funded pilot study (1R34HL107664 MacDonell). Results suggested feasibility and acceptability of the protocol as well as proof of concept. We are now ready to test the intervention in a larger randomized clinical trial. The proposed study will include 192 African American emerging adults with moderate to severe persistent asthma and low controller medication adherence recruited from clinic, emergency department, and community settings. Half of the sample will be randomized to receive a multicomponent technology-based intervention targeting adherence to daily controller medication. The multicomponent technology-based intervention consists of 2 components: (1) 2 sessions of computer-delivered motivational interviewing targeting medication adherence and (2) individualized text messaging focused on medication adherence between the sessions. Text messages will be individualized based on ecological momentary assessment. The remaining participants will complete a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants will also receive text messages between intervention sessions. Message content will be the same for all control participants and contain general facts about asthma (not tailored). It is hypothesized that youth randomized to multicomponent technology-based intervention will show improvements in medication adherence (primary outcome) and asthma control (secondary outcome) compared with comparison condition at all postintervention follow-ups (3, 6, 9, and 12 months). The proposed study was funded by NHLBI from September 1, 2016 through August 31, 2021. This project will test a brief, technology-based intervention specifically targeting adherence to asthma controller medications in an under-researched population, African American emerging adults. If successful, our multicomponent technology-based intervention aimed at improving adherence to asthma medications has the potential to improve quality of life of minority emerging adults with asthma at relatively low cost. It could eventually be integrated into clinical settings and practice to reach a large number of emerging adults with asthma. ClinicalTrials.gov NCT03121157; https://clinicaltrials.gov/ct2/show/NCT03121157 (Archived by WebCite at http://www.webcitation.org/6wq4yWHPv). ©Karen MacDonell, Sylvie Naar, Wanda Gibson-Scipio, Jean-Marie Bruzzese, Bo Wang, Aaron Brody. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.05.2018.

Can a print-based intervention increase screening for first degree relatives of people with colorectal cancer? A randomised controlled trial.

PubMed

Carey, Mariko; Sanson-Fisher, Robert; Macrae, Finlay; Cameron, Emilie; Hill, David; D'Este, Catherine; Simmons, Jody; Doran, Christopher

2016-12-01

To test the effectiveness of a targeted print-based intervention to improve screening adherence in first degree relatives of people with colorectal cancer (CRC). People with CRC and their adult first degree relatives were identified through a population-based cancer registry and randomly allocated as a family unit to the intervention or control condition. The control group received general information about CRC screening. The intervention group received printed advice regarding screening that was targeted to their risk level. Screening adherence was assessed at baseline and at 12 months via self report. 752 (25%) index cases and 574 (34%) eligible first degree relatives consented to take part in the trial and completed baseline interviews. At 12 months, 58% of first degree relatives in the control group and 61% in the intervention group were adherent to screening guidelines (mixed effects logistic regression group by time interaction effect =2.7; 95%CI=1.2-5.9; P=0.013). Subgroup analysis indicated that the intervention was only effective for those with the lowest risk. Provision of personalised risk information may have a modest effect on adherence to CRC screening recommendations among first degree relatives of people diagnosed with CRC. Improved strategies for identifying and engaging first degree relatives are needed to maximise the population impact of the intervention. © 2016 The Authors.

Consequences of harvesting for genetic diversity in American ginseng (Panax quinquefolius L.): A simulation study

USGS Publications Warehouse

Cruse-Sanders, J. M.; Hamrick, J.L.; Ahumada, J.A.

2005-01-01

American ginseng, Panax quinquefolius L., is one of the most heavily traded medicinal plants in North America. The effect of harvest on genetic diversity in ginseng was measured with a single generation culling simulation program. Culling scenarios included random harvest at varying levels, legal limit random harvest and legal limit mature plant harvest. The legal limit was determined by the proportion of legally harvestable plants per population (% mature plants per population). Random harvest at varying levels resulted in significant loss of genetic diversity, especially allelic richness. Relative to initial levels, average within-population genetic diversity (H e) was significantly lower when plants were culled randomly at the legal limit (Mann-Whitney U = 430, p < 0.001) or when only mature plants were culled (Mann-Whitney U = 394, p < 0.01). Within-population genetic diversity was significantly higher with legal limit mature plant harvest (H e = 0.068) than when plants were culled randomly at the legal limit (H e = 0.064; U = 202, p < 0.01). Based on these simulations of harvest over one generation, we recommend that harvesting fewer than the proportion of mature plants could reduce the negative genetic effects of harvest on ginseng populations. ?? Springer 2005.

The effect of cognitive-based training for the healthy older people: A meta-analysis of randomized controlled trials

PubMed Central

Chiu, Huei-Ling; Chu, Hsin; Tsai, Jui-Chen; Liu, Doresses; Chen, Ying-Ren; Yang, Hui-Ling

2017-01-01

Background From the perspective of disease prevention, the enhancement of cognitive function among the healthy older people has become an important issue in many countries lately. This study aim to investigate the effect of cognitive-based training on the overall cognitive function, memory, attention, executive function, and visual-spatial ability of the healthy older people. Methods Cochrane, PubMed, EMBASE, MEDLINE, PsycINFO, and CINAHL of selected randomized controlled trials (RCTs), and previous systematic reviews were searched for eligible studies. The population focused on this study were healthy older people who participated in randomized controlled trials that investigated the effectiveness of cognitive-based training. The outcomes including change in overall cognitive function, memory, attention, executive function, and visual-spatial ability. Results We collected a total of 31 RCTs, the results showed that cognitive-based training has a moderate effect on overall cognitive function (g = 0.419; 95%CI = 0.205–0.634) and executive function (g = 0.420; 95%CI = 0.239–0.602), and a small effect on the memory (g = 0.354; 95%CI = 0.244–0.465), attention (g = 0.218; 95%CI = 0.125–0.311), and visual-spatial ability (g = 0.183;95%CI = 0.015–0.352) in healthy older people. Subgroup analysis indicated the intervention characteristics of ≧3 times each week (p = 0.042), ≧8 total training weeks (p = 0.003) and ≧24 total training sessions (p = 0.040) yields a greater effect size. Conclusions Cognitive-based training is effective for the healthy older people. This improvement can represent a clinically important benefit, provide information about the use of cognitive-based training in healthy older people, and help the healthy older people obtain the greatest possible benefit in health promotion and disease prevention. PMID:28459873

Pilot Study of Treatment for Major Depression Among Women Prisoners with Substance Use Disorder

PubMed Central

Johnson, Jennifer E.; Zlotnick, Caron

2012-01-01

This study, the largest randomized controlled trial of treatment for major depressive disorder (MDD) in an incarcerated population to date, wave-randomized 38 incarcerated women (6 waves) in prison substance use treatment with MDD to group interpersonal psychotherapy (IPT) or to an attention-matched control. Intent-to-treat analyses found that IPT participants had significantly lower depressive symptoms at the end of 8 weeks of in-prison treatment than did control participants. Control participants improved later, after prison release. IPT's rapid effect on MDD within prison may reduce serious in-prison consequences of MDD. PMID:22694906

The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

PubMed Central

2013-01-01

Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

PubMed

Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

2013-07-29

In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

Learning From Past Failures of Oral Insulin Trials.

PubMed

Michels, Aaron W; Gottlieb, Peter A

2018-07-01

Very recently one of the largest type 1 diabetes prevention trials using daily administration of oral insulin or placebo was completed. After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point. The unfortunate outcome follows the previous large-scale trial, the Diabetes Prevention Trial-Type 1 (DPT-1), which again failed to delay diabetes onset with oral insulin or low-dose subcutaneous insulin injections in a randomized controlled trial with relatives at risk for type 1 diabetes. These sobering results raise the important question, "Where does the type 1 diabetes prevention field move next?" In this Perspective, we advocate for a paradigm shift in which smaller mechanistic trials are conducted to define immune mechanisms and potentially identify treatment responders. The stage is set for these interventions in individuals at risk for type 1 diabetes as Type 1 Diabetes TrialNet has identified thousands of relatives with islet autoantibodies and general population screening for type 1 diabetes risk is under way. Mechanistic trials will allow for better trial design and patient selection based upon molecular markers prior to large randomized controlled trials, moving toward a personalized medicine approach for the prevention of type 1 diabetes. © 2018 by the American Diabetes Association.

Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects.

PubMed

Ogedegbe, Gbenga; Tobin, Jonathan N; Fernandez, Senaida; Cassells, Andrea; Diaz-Gloster, Marleny; Khalida, Chamanara; Pickering, Thomas; Schwartz, Joseph E

2014-05-20

Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. http://www.clinicaltrials.gov. Unique identifier: NCT00233220. © 2014 American Heart Association, Inc.

Survival in individuals with severe alpha 1-antitrypsin deficiency (PiZZ) in comparison to a general population with known smoking habits.

PubMed

Tanash, Hanan A; Ekström, Magnus; Rönmark, Eva; Lindberg, Anne; Piitulainen, Eeva

2017-09-01

Knowledge about the natural history of severe alpha 1-antitrypsin (AAT) deficiency (PiZZ) is limited. Our aim was to compare the survival of PiZZ individuals with randomly selected controls from the Swedish general population.The PiZZ subjects (n=1585) were selected from the Swedish National AATD Register. The controls (n=5999) were randomly selected from the Swedish population register. Smoking habits were known for all subjects.Median follow-up times for the PiZZ subjects (731 never-smokers) and controls (3179 never-smokers) were 12 and 17 years, respectively (p<0.001). During follow-up, 473 PiZZ subjects (30%), and 747 controls (12%) died. The PiZZ subjects had a significantly shorter survival time than the controls, p<0.001. After adjustment for gender, age, smoking habits and presence of respiratory symptoms, the risk of death was still significantly higher for the PiZZ individuals than for the controls, hazard ratio (HR) 3.2 (95% CI 2.8-3.6; p<0.001). By contrast, the risk of death was not increased in never-smoking PiZZ individuals identified by screening, compared to never-smoking controls, HR 1.2 (95% CI 0.6-2.2).The never-smoking PiZZ individuals identified by screening had a similar life expectancy to the never-smokers in the Swedish general population. Early diagnosis of AAT deficiency is of utmost importance. Copyright ©ERS 2017.

A randomized controlled trial of a peer co-led dissonance-based eating disorder prevention program for gay men.

PubMed

Brown, Tiffany A; Keel, Pamela K

2015-11-01

Gay males have increased risk for eating disorders compared to heterosexual males, establishing a need to develop and empirically evaluate programs to reduce risk for this population. The present study investigated the acceptability and efficacy of a cognitive dissonance-based (DB) intervention (The PRIDE Body Project(©)) in reducing eating disorder risk factors among gay males in a university-based setting. Eighty-seven gay males were randomized to either a 2-session DB intervention (n = 47) or a waitlist control condition (n = 40). Participants completed eating disorder risk factor assessments pre-intervention, post-intervention, and at 4-week follow-up, and those receiving the intervention completed post-treatment acceptability measures. Acceptability ratings were highly favorable. Regarding efficacy, the DB condition was associated with significantly greater decreases in body dissatisfaction, drive for muscularity, self-objectification, partner-objectification, body-ideal internalization, dietary restraint, and bulimic symptoms compared to waitlist control from pre- to post-intervention. Improvements in the DB group were maintained at 4-week follow-up, with the exception of body-ideal internalization. Body-ideal internalization mediated treatment effects on bulimic symptoms. Results support the acceptability and efficacy of The PRIDE Body Project(©) and provide support for theoretical models of eating pathology in gay men. Copyright © 2015 Elsevier Ltd. All rights reserved.

Measuring self-management of patients' and employees' health: further validation of the Patient Activation Measure (PAM) based on its relation to employee characteristics.

PubMed

Fowles, Jinnet Briggs; Terry, Paul; Xi, Min; Hibbard, Judith; Bloom, Christine Taddy; Harvey, Lisa

2009-10-01

Evaluate the Patient Activation Measure (PAM) in relation to personal characteristics in employed populations. Further validate the PAM for use in improving clinical or employer-based health-intervention programs. Data for analysis were taken from baseline survey information and health screenings collected during a randomized, controlled trial testing two different health promotion programs. Study population included 625 employees (predominantly white collar) from two companies in the northern Midwest of the United States: a large, integrated health care system and a national airline. PAM's psychometric properties are robust in two employed populations. Activation is directly related not only to health status, but also to job performance measures. The strong positive relationship of PAM to measures of healthy behavior, health information-seeking and readiness-to-change further validate the measure. Commonly, a difference of 5 points on the PAM separated healthy from less healthy behaviors. Activation can be understood in a broader population health context and need not be restricted to people with chronic illnesses. The study provides guidance on how to interpret PAM scores. The PAM can be used as part of any health-intervention program designed to improve patients' or employees' self-management skills, whether the program is clinic-based or employer-based. 2009 Elsevier Ireland Ltd.

A community-based Argentine tango dance program is associated with increased activity participation among individuals with Parkinson disease

PubMed Central

Foster, Erin R.; Golden, Laura; Duncan, Ryan P.; Earhart, Gammon M.

2012-01-01

Objective To determine the effect of a 12-month community-based tango dance program on activity participation among individuals with Parkinson disease (PD). Design Randomized controlled trial with assessment at baseline, 3, 6, and 12 months. Setting The intervention was administered in the community; assessments were completed in a university laboratory. Participants Sixty-two volunteers with PD enrolled in the study and were randomized to treatment group. Ten participants did not receive the allocated intervention, so the final analyzed sample included 52 participants. Intervention Participants were randomly assigned to the Tango group, which involved 12 months of twice weekly Argentine tango dance classes, or to the no intervention Control group (n = 26 per group). Main Outcome Measures Current, new and retained participation in instrumental, leisure and social activities as measured by the Activity Card Sort (with the “dance” activity removed). Results Total Current participation in the Tango group was higher at 3, 6, and 12 months compared to baseline (ps ≤ 0.008), while the Control group did not change (ps ≥ 0.11). Total Activity Retention (since onset of PD) in the Tango group increased from 77% to 90% (p = 0.006) over the course of the study, whereas the Control group remained around 80% (p = 0.60). These patterns were similar in the separate activity domains. The Tango group gained a significant number of New Social activities (p = 0.003), but the Control group did not (p = 0.71). Conclusions Individuals with PD who participated in a community-based Argentine tango class reported increased participation in complex daily activities, recovery of activities lost since the onset of PD, and engagement in new activities. Incorporating dance into the clinical management of PD may benefit participation and subsequently quality of life for this population. PMID:22902795

Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

PubMed Central

2014-01-01

Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons. Methods We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model. Results Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants’ diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups. Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control. Trial registration Clinicaltrials.gov Identifier: NCT01221090. PMID:24450992

Iterative usage of fixed and random effect models for powerful and efficient genome-wide association studies

USDA-ARS?s Scientific Manuscript database

False positives in a Genome-Wide Association Study (GWAS) can be effectively controlled by a fixed effect and random effect Mixed Linear Model (MLM) that incorporates population structure and kinship among individuals to adjust association tests on markers; however, the adjustment also compromises t...

A Randomized Phase II Dose-Response Exercise Trial among Colon Cancer Survivors: Purpose, Study Design, Methods, and Recruitment Results

PubMed Central

Brown, Justin C.; Troxel, Andrea B.; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S.; Rickels, Michael R.; Rhim, Andrew D.; Rustgi, Anil K.; Courneya, Kerry S.; Schmitz, Kathryn H.

2016-01-01

Background Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the COURAGE trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. Methods/Results The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·wk−1) and high-dose (300 min·wk−1) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1,433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (P<0.001) and randomization onto the study protocol (P<0.001). No other demographic, clinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. Discussion The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. PMID:26970181

Enhancing medication adherence: in older adults with bipolar disorder.

PubMed

Depp, Colin A; Lebowitz, Barry D

2007-06-01

The number of older adults with bipolar disorder is increasing, yet little is known about the optimal clinical management of these patients. Medication adherence is a vital to effective long-term treatment of these patients; thus enhancement of adherence is often an important clinical goal. We reviewed available evidence about the characteristics of later-life bipolar disorder along with behavioral and organizational strategies to enhance adherence in this population. Based on available data, cognitive impairment, medical comorbidity, and functional limitations are frequent and are likely to impact treatment adherence in this population. In terms of treatment, there have been no placebo-controlled randomized clinical trials of medications or psychosocial interventions for this population. Based on extrapolation from intervention research on younger adults with bipolar disorder and older adults with other chronic illness, psychosocial interventions that reduce effortful cognitive processing in managing medications and reduce organizational barriers to adherence may be beneficial in enhancing adherence in this population. Much more research needs to be done to understand the impact of aging on bipolar disorder, along with optimization of treatment. Interventions to enhance adherence in this population need to be adapted to fit with the unique needs of older adults with bipolar disorder.

Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial.

PubMed

Hirshfield, Sabina; Downing, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

2016-06-17

Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Sex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Participant recruitment began in June 2015 and ended in December 2015. This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive!([+]) intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG).

Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

PubMed Central

Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

2016-01-01

Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive![+] intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrial ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG) PMID:27315764

A randomized-controlled trial focusing on socio-economic status for promoting vegetable intake among adults using a web-based nutrition intervention programme: study protocol.

PubMed

Nakamura, Saki; Inayama, Takayo; Arao, Takashi

2017-01-13

Web-based nutritional education programmes appear to be comparable to those delivered face-to-face. However, no existing web-based nutrition education or similar programme has yet been evaluated with consideration of socio-economic status. The objective of a nutritional education programme of promoting vegetable intake designed a randomized controlled trial (RCT) is to evaluate the results of intervention and to determine how socio-economic status influences the programme effects. Participants will be randomly sampled individuals (aged 30-59) stratified according national population statistics for sex, age, and household income. Participants were consented to survey participation (n = 1500), and will be randomly divided into intervention and control groups. The intervention period is 5 weeks with one step of diet-related education per week. The main outcome of the programme is dietary behaviour as eating vegetable (350 g per day, five small bowl). To encourage behavioural changes, the programme contents are prepared using behavioural theories and techniques tailored to the assumed group stages of behavioural change. In the first step, we employ the health belief model to encourage a shift from the pre-contemplative to the contemplative phase; in the second and third steps, social cognitive theory is used to encourage transition to the preparatory phase; in the fourth step, social cognitive theory and strengthening social support are used to promote progression to the execution phase; finally, in the fifth step, strengthening social capital and social support are used to promote the shift to the maintenance phase. The baseline, post intervention and follow-up survey was assessed using a self-administered questionnaire. For process evaluation, we use five items relating to programme participation and satisfaction. A follow-up survey of participants will be carried out 3 months after intervention completion. The fact that this study is an RCT with an established control group is a strong advantage. Information and communications technology is not limited by time or place. If we could show this web-based nutrition education programmes has a positive effect, it may be an appropriate tool for reaching individuals in lower socio-economic state. Current Controlled Trials UMIN-ICDR UMIN 000019376 (Registered October 16, 2015).

Case-control study of urinary bladder cancer in metropolitan Nagoya.

PubMed

Ohno, Y; Aoki, K; Obata, K; Morrison, A S

1985-12-01

We conducted a population-based case-control study of patients with bladder cancer and of controls drawn randomly from the general population of Metropolitan Nagoya and interviewed both groups. The incidence rates of bladder cancer were 2.42 and 7.05/100,000 for females and males, respectively. The analysis, based on 293 patients and 589 controls who were frequency matched for age, sex, and residence, provided the following major findings. Age-adjusted relative risks of 1.89 (1.15-3.10) and 3.53 (1.71-7.27) were found in male and female cigarette smokers, respectively. Significant relative risk was also found in males who drank cocoa. Elevated risk with a dose-response relationship was observed among women who used hair dye and who smoke, but this risk was insignificant, with the disappearance of a dose-response relationship, when it was adjusted for smoking. Age- and smoking-adjusted relative risk of coffee drinking was insignificant with no dose-response relationship. Relative risk of artificial sweetener use was below 1 with adjustment for age and smoking. Intake of alcoholic beverages and cola was insignificantly associated. Reduced risk of significance was suggested for the intake of black tea and matcha (powdered green tea) in females and of fruit juice in males.

The effectiveness of critical time intervention for abused women leaving women's shelters: a randomized controlled trial.

PubMed

Lako, Danielle A M; Beijersbergen, Mariëlle D; Jonker, Irene E; de Vet, Renée; Herman, Daniel B; van Hemert, Albert M; Wolf, Judith R L M

2018-05-01

To examine the effectiveness of critical time intervention (CTI)-an evidence-based intervention-for abused women transitioning from women's shelters to community living. A randomized controlled trial was conducted in nine women's shelters across the Netherlands. 136 women were assigned to CTI (n = 70) or care-as-usual (n = 66). Data were analyzed using intention-to-treat three-level mixed-effects models. Women in the CTI group had significant fewer symptoms of post-traumatic stress (secondary outcome) (adjusted mean difference - 7.27, 95% CI - 14.31 to - 0.22) and a significant fourfold reduction in unmet care needs (intermediate outcome) (95% CI 0.06-0.94) compared to women in the care-as-usual group. No differences were found for quality of life (primary outcome), re-abuse, symptoms of depression, psychological distress, self-esteem (secondary outcomes), family support, and social support (intermediate outcomes). This study shows that CTI is effective in a population of abused women in terms of a reduction of post-traumatic stress symptoms and unmet care needs. Because follow-up ended after the prescribed intervention period, further research is needed to determine the full long-term effects of CTI in this population.

Rethinking sources of representative controls for the conduct of case–control studies in minority populations

PubMed Central

2013-01-01

Background Recruitment of controls remains a challenge in case–control studies and particularly in studies involving minority populations. Methods We compared characteristics of controls recruited through random digit dialing (RDD) to those of community controls enrolled through churches, health events and other outreach sources among women of African ancestry (AA) participating in the Women’s Circle of Health Study, a case–control study of breast cancer. Odds ratios and 95% confidence intervals were also computed using unconditional logistic regression to evaluate the impact of including the community controls for selected variables relevant to breast cancer and for which there were significant differences in distribution between the two control groups. Results Compared to community controls (n=347), RDD controls (n=207) had more years of education and higher income, lower body mass index, were more likely to have private insurance, and less likely to be single. While the percentage of nulliparous women in the two groups was similar, community controls tended to have more children, have their first child at a younger age, and were less likely to breastfeed their children. Dietary intake was similar in the two groups. Compared to census data, the combination of RDD and community controls seems to be more representative of the general population than RDD controls alone. Furthermore, the inclusion of the community group had little impact on the magnitude of risk estimates for most variables, while enhancing statistical power. Conclusions Community-based recruitment was found to be an efficient and feasible method to recruit AA controls. PMID:23721229

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

PubMed

Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-07-24

Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of inferiority (0.25 of a SD) on any outcome measure at any follow-up assessment, with the exception of MCDI scores assessing children's language development at 21 months for randomized mothers, and PSI Isolation scores at 9 months for preference mothers. Maternal and child outcomes from a clinic-based postnatal health check plus nurse-moderated Internet-based support were not inferior to those achieved by a universal home-based postnatal support program. Postnatal maternal and infant support using the Internet is a promising alternative to home-based universal support programs. Australian New Zealand Clinical Trials Registry Number (ANZCTR): ACTRN12613000204741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363712&isReview=true (Archived by WebCite at http://www.webcitation.org/6rZeCJ3k1). ©Michael G Sawyer, Christy E Reece, Kerrie Bowering, Debra Jeffs, Alyssa C P Sawyer, Murthy Mittinty, John W Lynch. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.07.2017.

The effect of periodontal therapy on glycaemic control in a Hispanic population with type 2 diabetes: a randomized controlled trial.

PubMed

Gay, Isabel C; Tran, Duong T; Cavender, Adriana C; Weltman, Robin; Chang, Jennifer; Luckenbach, Estelle; Tribble, Gena D

2014-07-01

In the Mexican-American population, the prevalence of Type 2 diabetes mellitus (T2DM) is as high as 50% of the population. This randomized controlled clinical trial was designed to elucidate how treatment of periodontal disease affects HbA1c values in this population. One hundred and fifty-four T2DM patients with periodontal disease were enrolled in the study. The test group was treated with scaling and root planing (SRP); the control group received oral hygiene instructions. At baseline and 4-6 weeks after therapy, a complete periodontal examination was performed. Blood was collected at baseline and 4 months later for HbA1c levels. One hundred and twenty-six individuals completed the study. Baseline mean ± SD HbA1c for the test and control groups were 9.0 ± 2.3% and 8.4 ± 2.0% respectively. Non-significant difference in HbA1c reductions (0.6 ± 2.1% and 0.3 ± 1.7%) was found between test and control groups at 4 months. Comparisons of the periodontal clinical parameters between the test and control groups found significant differences with improved results in the test subjects. No statistically significant differences were found in the changes of HbA1c levels between test and control groups. Non-surgical periodontal therapy improved the magnitude of change in periodontal parameters as compared to the control subjects. ClinicalTrials.gov Identifier: NCT01128374. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Efficacy of Web-Based Collection of Strength-Based Testimonials for Text Message Extension of Youth Suicide Prevention Program: Randomized Controlled Experiment.

PubMed

Thiha, Phyo; Pisani, Anthony R; Gurditta, Kunali; Cherry, Erin; Peterson, Derick R; Kautz, Henry; Wyman, Peter A

2016-11-09

Equipping members of a target population to deliver effective public health messaging to peers is an established approach in health promotion. The Sources of Strength program has demonstrated the promise of this approach for "upstream" youth suicide prevention. Text messaging is a well-established medium for promoting behavior change and is the dominant communication medium for youth. In order for peer 'opinion leader' programs like Sources of Strength to use scalable, wide-reaching media such as text messaging to spread peer-to-peer messages, they need techniques for assisting peer opinion leaders in creating effective testimonials to engage peers and match program goals. We developed a Web interface, called Stories of Personal Resilience in Managing Emotions (StoryPRIME), which helps peer opinion leaders write effective, short-form messages that can be delivered to the target population in youth suicide prevention program like Sources of Strength. To determine the efficacy of StoryPRIME, a Web-based interface for remotely eliciting high school peer leaders, and helping them produce high-quality, personal testimonials for use in a text messaging extension of an evidence-based, peer-led suicide prevention program. In a double-blind randomized controlled experiment, 36 high school students wrote testimonials with or without eliciting from the StoryPRIME interface. The interface was created in the context of Sources of Strength-an evidence-based youth suicide prevention program-and 24 ninth graders rated these testimonials on relatability, usefulness/relevance, intrigue, and likability. Testimonials written with the StoryPRIME interface were rated as more relatable, useful/relevant, intriguing, and likable than testimonials written without StoryPRIME, P=.054. StoryPRIME is a promising way to elicit high-quality, personal testimonials from youth for prevention programs that draw on members of a target population to spread public health messages. ©Phyo Thiha, Anthony R Pisani, Kunali Gurditta, Erin Cherry, Derick R Peterson, Henry Kautz, Peter A Wyman. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 09.11.2016.

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review.

PubMed

Demarzo, Marcelo M P; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-11-01

Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I(2) = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I(2) = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I(2) = 0; P >.05). Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. © 2015 Annals of Family Medicine, Inc.

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review

PubMed Central

Demarzo, Marcelo M.P.; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R.; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-01-01

PURPOSE Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. METHODS We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. RESULTS The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I2 = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I2 = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I2 = 0; P >.05). CONCLUSIONS Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. PMID:26553897

Randomized Controlled Trial of Nuevo Amanecer: A Peer-delivered Stress Management Intervention for Spanish-speaking Latinas with Breast Cancer

PubMed Central

Nápoles, Anna María; Santoyo-Olsson, Jasmine; Ortiz, Carmen; Gregorich, Steven; Lee, Howard E.; Duron, Ysabel; Graves, Kristi; Luce, Judith A.; McGuire, Peggy; Díaz-Méndez, Marynieves; Stewart, Anita L.

2014-01-01

Background Latinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population. Purpose We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomized controlled trial to test the program in community settings. Methods We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial, emphasizing community engagement processes. Results In phase 1, we established project infrastructure: academic and community Co-Principal Investigators, community partners, community advisory board, steering committee, and funding. In phase 2, we identified three program inputs: formative research, a community best practices model, and an evidence-based intervention tested in non-Latinas. In phase 3, we created the new program by integrating and adapting intervention components from the three sources, making adaptations to accommodate low-literacy, Spanish language, cultural factors, community context, and population needs. In phase 4, we built community capacity for the program and trial by training field staff (recruiters and interventionists embedded in community sites), compensating field staff, and creating a system for identifying potential participants. In phase 5, we implemented and monitored the program and trial. Engaging community partners in all phases has resulted in a new, culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners. Lessons Learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings. Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation. Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues. Randomization was challenging due to community concerns about assigning women to a control group. Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment. Limitations These were resource-intensive processes to develop and implement the program that need to be compared to less intensive alternatives. Conclusions Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context. If the randomized trial demonstrates that the intervention is effective, it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer. PMID:24577971

Indoor pollution as an occupational risk factor for tuberculosis among women: a population-based, gender oriented, case-control study in Southern Mexico.

PubMed

García-Sancho, Ma Cecilia; García-García, Lourdes; Báez-Saldaña, Renata; Ponce-De-León, Alfredo; Sifuentes-Osornio, José; Bobadilla-Del-valle, Miriam; Ferreyra-Reyes, Leticia; Cano-Arellano, Bulmaro; Canizales-Quintero, Sergio; Palacios-Merino, Luz del Carmen; Juárez-Sandino, Luis; Ferreira-Guerrero, Elizabeth; Cruz-Hervert, Luis Pablo; Small, Peter M; Pérez-Padilla, José Rogelio

2009-01-01

Indoor air pollution produced by biomass cooking fuels in developing countries has been associated with acute and chronic lower respiratory diseases, but has not been identified as an occupational exposure among women. To examine the relationship between the use of biomass cooking fuels (mainly wood) and tuberculosis (TB) among women living in rural areas in Southern Mexico. We conducted a population based case-control study in the health jurisdiction of Orizaba, Mexico. Cases were all incident female pulmonary TB patients, with Mycobacterium tuberculosis in sputum, living in communities with fewer than 15,000 inhabitants, diagnosed between March 1995 and April 2003. Woodsmoke exposure was assessed by applying a standardized questionnaire (ATS-DLD-78 questionnaire). Controls were randomly selected from sex-matched neighbors. Appropriate IRB approval was obtained. 42 TB cases and 84 community controls were recruited. Multivariate assessment showed that more than 20 years of exposure to smoke from biomass fuels was three times more frequent among cases than among controls [Odds ratio (OR): 3.3, 95% confidence interval (CI):1.06-10.30, p = 0.03], after controlling for age, body mass, household crowding, years of formal education and tobacco use. We found a strong association between the use of biomass cooking fuels and tuberculosis among women in a community-based, case-control study. Results of this study are intended to provide evidence to policy makers, community leaders and the general public on the importance of implementing gender oriented interventions that decrease the use of biomass fuels in poor communities in developing countries.

The association between the SLC6A3 VNTR 9-repeat allele and alcoholism-a meta-analysis.

PubMed

Du, Yanlei; Nie, Yuqiang; Li, Yuyuan; Wan, Yu-Jui Y

2011-09-01

Dopamine transporter gene (SLC6A3) represents a promising candidate involved in the development of alcoholism. This study aimed to explore the association between the 9-repeat allele (A9) of a 40-bp variable number tandem repeat (VNTR) polymorphism in the 3' un-translated region (3' UTR) of the SLC6A3 gene and alcoholism. The SLC6A3 VNTR was genotyped by PCR in unrelated Mexican Americans including 337 controls and 365 alcoholics. Pearson's chi-square test or Fisher's exact test was used to compare the genotype and allele distribution. Meta-analyses were performed for population-based case-control association studies of the SLC6A3 VNTR polymorphism with alcoholism. Data were analyzed under random effect models with the Comprehensive Meta-analysis (v.2) statistical software package. In Mexican Americans, no significant difference was found in allele and genotype distribution between controls and alcoholics or between controls and alcoholics with alcohol withdrawal seizure (AWS) or delirium tremens (DT) (unadjusted p > 0.05). A total of 13 research articles were included in the meta-analyses. No significant difference of the SLC6A3 VNTR A9 was noted between controls and alcoholics at the genotypic and allelic level when all ethnic populations, only Caucasian populations, or only Asian populations were considered (p > 0.05). Significant associations were observed between SLC6A3 VNTR A9 and alcoholics with AWS or DT at the genotypic as well as allelic level when all ethnic populations or only Caucasian populations were considered (p < 0.05, OR 1.5-2.1). Meta-analyses suggest a possible association between the SLC6A3 VNTR A9 and alcoholic subgroup with AWS or DT. 2011 by the Research Society on Alcoholism.

Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial.

PubMed

Niederer, Daniel; Vogt, Lutz; Wippert, Pia-Maria; Puschmann, Anne-Katrin; Pfeifer, Ann-Christin; Schiltenwolf, Marcus; Banzer, Winfried; Mayer, Frank

2016-10-20

Arising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain. A multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed. The control group stays inactive during this period. Outcomes are pain, and pain-associated function as well as motor function in adults with nonspecific low back pain. Each participant is scheduled to five measurement dates: baseline (M1), following centre-based training (M2), following home-based training (M3) and at two follow-up time points 6 months (M4) and 12 months (M5) after M1. All investigations and the assessment of the primary and secondary outcomes are performed in a standardized order: questionnaires - clinical examination - biomechanics (motor function). Subsequent statistical procedures are executed after the examination of underlying assumptions for parametric or rather non-parametric testing. The results and practical relevance of the study will be of clinical and practical relevance not only for researchers and policy makers but also for the general population suffering from nonspecific low back pain. Identification number DRKS00010129. German Clinical Trial registered on 3 March 2016.

Comprehensive geriatric intervention program with and without weekly class-style exercise: research protocol of a cluster randomized controlled trial in Kyoto-Kameoka Study

PubMed Central

Yoshida, Tsukasa; Yoshinaka, Yasuko; Yoshimoto, Mie; Tanaka, Yoko; Itoi, Aya; Yamagata, Emi; Ebine, Naoyuki; Ishikawa-Takata, Kazuko; Kimura, Misaka

2018-01-01

Objective The number of long-term care (LTC) users and the associated expenditures in Japan are increasing dramatically. The national government recommends LTC prevention through activation of communities. However, there is no clear evidence of the effect of population-based comprehensive geriatric intervention program (CGIP) for restraints of LTC users and the associated expenditures in the future. The aims of the current paper are to describe the study protocol and progress of a cluster randomized controlled trial (RCT) with a CGIP in Kameoka City. Methods The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged ≥65 years without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality. Results and discussion The study was launched with good response rates in each phase. Participants of both groups significantly increased their step counts by ~1,000 per day from the baseline during the CGIP. This RCT will provide valuable information and evidence about effectiveness of a community-based CGIP. PMID:29872280

Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).

PubMed

Kamal, Ayeesha Kamran; Khoja, Adeel; Usmani, Bushra; Muqeet, Abdul; Zaidi, Fabiha; Ahmed, Masood; Shakeel, Saadia; Soomro, Nabila; Gowani, Ambreen; Asad, Nargis; Ahmed, Asma; Sayani, Saleem; Azam, Iqbal; Saleem, Sarah

2016-01-27

Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle. Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems. NCT02202330 (28 January 2015).

Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial.

PubMed

Lewandowski, Kathryn Eve; Sperry, Sarah H; Ongur, Dost; Cohen, Bruce M; Norris, Lesley A; Keshavan, Matcheri S

2016-03-12

Cognitive dysfunction is a major feature of bipolar disorder with psychosis and is strongly associated with functional outcomes. Computer-based cognitive remediation has shown promise in improving cognition in patients with schizophrenia. However, despite similar neurocognitive deficits between patients with schizophrenia and bipolar disorder, few studies have extended neuroscience-based cognitive remediation programs to this population. The Treatment to Enhance Cognition in Bipolar Disorder study is an investigator-initiated, parallel group, randomized, blinded clinical trial of an Internet-based cognitive remediation protocol for patients with bipolar disorder I with psychosis (n = 100). We also describe the development of our dose-matched active control paradigm. Both conditions involve 70 sessions of computer-based activities over 24 weeks. The control intervention was developed to mirror the treatment condition in dose and format but without the neuroplasticity-based task design and structure. All participants undergo neuropsychological and clinical assessment at baseline, after approximately 25 hours of study activities, post treatment, and after 6 months of no study contact to assess durability. Neuroimaging at baseline and post treatment are offered in an "opt-in" format. The primary outcomes are scores on the MATRICS battery; secondary and exploratory outcomes include measures of clinical symptoms, community functioning, and neuroimaging changes. Associations between change in cognitive measures and change in community functioning will be assessed. Baseline predictors of treatment response will be examined. The present study is the first we are aware of to implement an Internet-based cognitive remediation program in patients with bipolar disorder with psychosis and to develop a comparable web-based control paradigm. The mixed online and study-site format allows accessible treatment while providing weekly staff contact and bridging. Based on user-provided feedback, participant blinding is feasible. ClinicalTrials.gov NCT01470781 ; 11 July 2011.

Improvement of continence rate with pelvic floor muscle training post-prostatectomy: a meta-analysis of randomized controlled trials.

PubMed

Fernández, Rubén Arroyo; García-Hermoso, Antonio; Solera-Martínez, Montserrat; Correa, Ma Teresa Martín; Morales, Asunción Ferri; Martínez-Vizcaíno, Vicente

2015-01-01

The aim of this meta-analysis was to evaluate the evidence of the effect of pelvic floor muscle training on urinary incontinence after radical prostatectomy. A bibliographic search was conducted in four databases. Studies were grouped according to the intervention program(muscle training versus control and individual home-based versus physiotherapist-guided muscle training). Eight studies were selected for meta-analysis after satisfying the selection criteria. The data show that pelvic floor muscle training improves continence rate in the short (RR=2.16; p<0.001), medium (RR=1.45; p=0.001) and long term (RR=1.23; p=0.019) after surgery. The number of randomized controlled trials and the heterogeneity in the study population and type of pelvic floor muscle training were the main limitations. Programs including at least three sets of 10 repetitions of muscle training daily appear to improve continence rate after radical prostatectomy. Our meta-analysis shows that muscle training programs for urinary incontinence provide similar results to those of physiotherapist-guided programs, therefore being more cost-effective. © 2014 S. Karger AG, Basel.

Efficacy of a DVD-Based Smoking Cessation Intervention for African Americans

PubMed Central

Baker, Elizabeth A.; Robinson, Robert G.

2014-01-01

Introduction: Previous research suggests that African American smokers may have improved outcomes if interventions are culturally specific. However, few interventions sufficiently address the unique needs of this population in a format with large reach potential. The purpose of this study was to test the efficacy of a newly developed digital video disc (DVD)-based cessation intervention targeting African Americans. Methods: In a 2-arm randomized trial, smokers (N = 140) were randomly assigned to view either the new Pathways to Freedom (PTF) DVD or a standard control DVD. Participants were assessed at baseline, immediately postviewing the DVD, and at a 1-month follow-up. The primary outcomes were feasibility and process variables, including intervention evaluations, readiness to quit, and risk perceptions, and smoking-related behavior changes were examined as secondary outcomes. Results: Findings demonstrated the hypothesized positive effects of the PTF DVD compared with the control DVD on content evaluations, risk perceptions, and readiness to quit at follow-up. Conclusions: We found initial evidence for the efficacy of the PTF DVD as a stand-alone intervention. Future research will test the efficacy of the DVD for smoking cessation in a larger randomized trial. The ultimate goal of this research is to validate a new intervention for an underserved community of smokers that can be used in multiple settings, such as community health clinics, primary care, quitlines, cessation clinics, and seminars/workshops. PMID:24838844

Web-Based Positive Psychology Interventions: A Reexamination of Effectiveness.

PubMed

Woodworth, Rosalind J; O'Brien-Malone, Angela; Diamond, Mark R; Schüz, Benjamin

2017-03-01

Seligman, Steen, Park, and Peterson (2005) suggested that positive psychology interventions (PPIs) contain specific, powerful, therapeutic ingredients that effect greater increases in happiness and reductions in depression than a placebo control. This study reexamined the three PPIs that Seligman et al. found to be most effective when delivered over the internet. Three PPIs and a placebo control, identical with the interventions used by Seligman et al., were examined in a web-based, randomized assignment design. Mixed-design analysis of variance and multilevel modeling showed that all interventions, including the placebo, led to significant increases in happiness and reductions in depression. The effects of PPIs were indistinguishable from those of the placebo control. Using web-based delivery, both PPIs and theoretically neutral placebos can increase happiness and reduce depression in self-selected populations. Possible explanations include that non-specific factors common to most therapeutic treatments are responsible for the observed changes, or that cultural or other context-related variables operate to account for the divergent findings. © 2016 Wiley Periodicals, Inc.

Game-based digital interventions for depression therapy: a systematic review and meta-analysis.

PubMed

Li, Jinhui; Theng, Yin-Leng; Foo, Schubert

2014-08-01

The aim of this study was to review the existing literature on game-based digital interventions for depression systematically and examine their effectiveness through a meta-analysis of randomized controlled trials (RCTs). Database searching was conducted using specific search terms and inclusion criteria. A standard meta-analysis was also conducted of available RCT studies with a random effects model. The standard mean difference (Cohen's d) was used to calculate the effect size of each study. Nineteen studies were included in the review, and 10 RCTs (eight studies) were included in the meta-analysis. Four types of game interventions-psycho-education and training, virtual reality exposure therapy, exercising, and entertainment-were identified, with various types of support delivered and populations targeted. The meta-analysis revealed a moderate effect size of the game interventions for depression therapy at posttreatment (d=-0.47 [95% CI -0.69 to -0.24]). A subgroup analysis showed that interventions based on psycho-education and training had a smaller effect than those based on the other forms, and that self-help interventions yielded better outcomes than supported interventions. A higher effect was achieved when a waiting list was used as the control. The review and meta-analysis support the effectiveness of game-based digital interventions for depression. More large-scale, high-quality RCT studies with sufficient long-term data for treatment evaluation are needed.

Game-Based Digital Interventions for Depression Therapy: A Systematic Review and Meta-Analysis

PubMed Central

Theng, Yin-Leng; Foo, Schubert

2014-01-01

Abstract The aim of this study was to review the existing literature on game-based digital interventions for depression systematically and examine their effectiveness through a meta-analysis of randomized controlled trials (RCTs). Database searching was conducted using specific search terms and inclusion criteria. A standard meta-analysis was also conducted of available RCT studies with a random effects model. The standard mean difference (Cohen's d) was used to calculate the effect size of each study. Nineteen studies were included in the review, and 10 RCTs (eight studies) were included in the meta-analysis. Four types of game interventions—psycho-education and training, virtual reality exposure therapy, exercising, and entertainment—were identified, with various types of support delivered and populations targeted. The meta-analysis revealed a moderate effect size of the game interventions for depression therapy at posttreatment (d=−0.47 [95% CI −0.69 to −0.24]). A subgroup analysis showed that interventions based on psycho-education and training had a smaller effect than those based on the other forms, and that self-help interventions yielded better outcomes than supported interventions. A higher effect was achieved when a waiting list was used as the control. The review and meta-analysis support the effectiveness of game-based digital interventions for depression. More large-scale, high-quality RCT studies with sufficient long-term data for treatment evaluation are needed. PMID:24810933

Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial

PubMed Central

van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

2014-01-01

Background Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. Objective The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. Methods We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. Results At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Conclusions Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Trial Registration Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs). PMID:25266929

Effectiveness of Evidence-Based Asthma Interventions.

PubMed

Kennedy, Suzanne; Bailey, Ryan; Jaffee, Katy; Markus, Anne; Gerstein, Maya; Stevens, David M; Lesch, Julie Kennedy; Malveaux, Floyd J; Mitchell, Herman

2017-06-01

Researchers often struggle with the gap between efficacy and effectiveness in clinical research. To bridge this gap, the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) study adapted an efficacious, randomized controlled trial that resulted in evidence-based asthma interventions in community health centers. Children (aged 5-12 years; N = 590) with moderate to severe asthma were enrolled from 3 intervention and 3 geographically/capacity-matched control sites in high-risk, low-income communities located in Arizona, Michigan, and Puerto Rico. The asthma intervention was tailored to the participant's allergen sensitivity and exposure, and it comprised 4 visits over the course of 1 year. Study visits were documented and monitored prospectively via electronic data capture. Asthma symptoms and health care utilization were evaluated at baseline, and at 6 and 12 months. A total of 314 intervention children and 276 control children were enrolled in the study. Allergen sensitivity testing (96%) and home environmental assessments (89%) were performed on the majority of intervention children. Overall study activity completion (eg, intervention visits, clinical assessments) was 70%. Overall and individual site participant symptom days in the previous 4 weeks were significantly reduced compared with control findings (control, change of -2.28; intervention, change of -3.27; difference, -0.99; P < .001), and this result was consistent with changes found in the rigorous evidence-based interventions. Evidence-based interventions can be successfully adapted into primary care settings that serve impoverished, high-risk populations, reducing the morbidity of asthma in these high-need populations. Copyright © 2017 by the American Academy of Pediatrics.

Socioeconomic Status and Childhood Leukemia Incidence in Switzerland

PubMed Central

Adam, Martin; Kuehni, Claudia E.; Spoerri, Adrian; Schmidlin, Kurt; Gumy-Pause, Fabienne; Brazzola, Pierluigi; Probst-Hensch, Nicole; Zwahlen, Marcel

2015-01-01

Socioeconomic status (SES) discrepancies exist for child and adult cancer morbidity and are a major public health concern. In this Swiss population-based matched case–control study on the etiology of childhood leukemia, we selected the cases from the Swiss Childhood Cancer Registry diagnosed since 1991 and the controls randomly from census. We assigned eight controls per case from the 1990 and 2000 census and matched them by the year of birth and gender. SES information for both cases and controls was obtained from census records by probabilistic record linkage. We investigated the association of SES with childhood leukemia in Switzerland, and explored whether it varied with different definitions of socioeconomic status (parental education, living condition, area-based SES), time period, and age. In conditional logistic regression analyses of 565 leukemia cases and 4433 controls, we found no consistent evidence for an association between SES and childhood leukemia. The odds ratio comparing the highest with the lowest SES category ranged from 0.95 (95% CI: 0.71–1.26; Ptrend = 0.73) for paternal education to 1.37 (1.00–1.89; Ptrend = 0.064) for maternal education. No effect modification was found for time period and age at diagnosis. Based on this population-based study, which avoided participation and reporting bias, we assume the potential association of socioeconomic status and childhood leukemia if existing to be small. This study did not find evidence that socioeconomic status, of Switzerland or comparable countries, is a relevant risk factor or strong confounder in etiological investigations on childhood leukemia. PMID:26175964

Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial

USDA-ARS?s Scientific Manuscript database

As populations shift to include a larger proportion of older adults, the necessity of research targeting older populations is becoming increasingly apparent. Changes in motor coordination during ‘normal’ aging, in animals and humans, include decrements in balance and locomotion. Parallel to alterati...

Randomized controlled trial of oatmeal consumption versus noodle consumption on blood lipids of urban Chinese adults with hypercholesterolemia

PubMed Central

2012-01-01

Background Cardiovascular disease (CVD) is the leading cause of death in China and worldwide. Whole grain oats can reduce risk of CVD by reducing total and LDL-cholesterol, major risk factors for CVD. While this association has been established in many populations, data from Asian populations is limited. Thus, this study investigated the impact of oat consumption on cholesterol levels in Chinese adults. Male and female data from this work were previously published separately in mandarin in two Chinese journals. The combined male and female data were reanalyzed and are presented here. Methods A randomized, controlled, parallel-arm study was conducted at Beijing Hospital, Beijing china. Subjects were adults (men and women) with mild to moderate hypercholesterolemia. The oat group (n=85) consumed 100grams of instant oat cereal versus the control group (n=81) who consumed 100grams of wheat flour-based noodles daily for 6weeks. Laboratory and anthropometric measurements were conducted at baseline and at the end of the 6-week intervention. Results Dietary fiber intake increased significantly in the oat group compared to the control group at the end of the 6-week intervention. Total-, LDL-cholesterol and waist circumference decreased significantly in the oat group compared to the control. HDL-cholesterol decreased significantly in the control group versus the oat group. There were no significant changes in blood pressure, other anthropometric or laboratory measures between the two groups at the end of the intervention. Conclusions Instant oatmeal consumed daily for 6 weeks significantly increased fiber intake and decreased major risk factors for CVD in Chinese adults with hypercholesterolemia. Increased consumption of whole grains, including oats, should continue to be encouraged. PMID:22866937

Randomized controlled trial of oatmeal consumption versus noodle consumption on blood lipids of urban Chinese adults with hypercholesterolemia.

PubMed

Zhang, Jian; Li, Lixiang; Song, Pengkun; Wang, Chunrong; Man, Qingqing; Meng, Liping; Cai, Jenny; Kurilich, Anne

2012-08-06

Cardiovascular disease (CVD) is the leading cause of death in China and worldwide. Whole grain oats can reduce risk of CVD by reducing total and LDL-cholesterol, major risk factors for CVD. While this association has been established in many populations, data from Asian populations is limited. Thus, this study investigated the impact of oat consumption on cholesterol levels in Chinese adults. Male and female data from this work were previously published separately in mandarin in two Chinese journals. The combined male and female data were reanalyzed and are presented here. A randomized, controlled, parallel-arm study was conducted at Beijing Hospital, Beijing china. Subjects were adults (men and women) with mild to moderate hypercholesterolemia. The oat group (n=85) consumed 100 grams of instant oat cereal versus the control group (n=81) who consumed 100 grams of wheat flour-based noodles daily for 6 weeks. Laboratory and anthropometric measurements were conducted at baseline and at the end of the 6-week intervention. Dietary fiber intake increased significantly in the oat group compared to the control group at the end of the 6-week intervention. Total-, LDL-cholesterol and waist circumference decreased significantly in the oat group compared to the control. HDL-cholesterol decreased significantly in the control group versus the oat group. There were no significant changes in blood pressure, other anthropometric or laboratory measures between the two groups at the end of the intervention. Instant oatmeal consumed daily for 6 weeks significantly increased fiber intake and decreased major risk factors for CVD in Chinese adults with hypercholesterolemia. Increased consumption of whole grains, including oats, should continue to be encouraged.

A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions

PubMed Central

Farmer, Sybil; Pandyan, Anand; Chockalingam, Nachiappan

2018-01-01

Background Assistive products are items which allow older people and people with disabilities to be able to live a healthy, productive and dignified life. It has been estimated that approximately 1.5% of the world’s population need a prosthesis or orthosis. Objective The objective of this study was to systematically identify and review the evidence from randomized controlled trials assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions. Methods Literature searches, completed in September 2015, were carried out in fourteen databases between years 1995 and 2015. The search results were independently screened by two reviewers. For the purpose of this manuscript, only randomized controlled trials which examined interventions using orthotic or prosthetic devices were selected for data extraction and synthesis. Results A total of 342 randomised controlled trials were identified (319 English language and 23 non-English language). Only 4 of these randomised controlled trials examined prosthetic interventions and the rest examined orthotic interventions. These orthotic interventions were categorised based on the medical conditions/injuries of the participants. From these studies, this review focused on the medical condition/injuries with the highest number of randomised controlled trials (osteoarthritis, fracture, stroke, carpal tunnel syndrome, plantar fasciitis, anterior cruciate ligament, diabetic foot, rheumatoid and juvenile idiopathic arthritis, ankle sprain, cerebral palsy, lateral epicondylitis and low back pain). The included articles were assessed for risk of bias using the Cochrane Risk of Bias tool. Details of the clinical population examined, the type of orthotic/prosthetic intervention, the comparator/s and the outcome measures were extracted. Effect sizes and odds ratios were calculated for all outcome measures, where possible. Conclusions At present, for prosthetic and orthotic interventions, the scientific literature does not provide sufficient high quality research to allow strong conclusions on their effectiveness and cost-effectiveness. PMID:29538382

Screening for asymptomatic bacteriuria in adults: evidence for the U.S. Preventive Services Task Force reaffirmation recommendation statement.

PubMed

Lin, Kenneth; Fajardo, Kevin

2008-07-01

Asymptomatic bacteriuria is common, and screening for this condition in pregnant women is a well-established, evidence-based standard of current medical practice. Screening other groups of adults has not been shown to improve outcomes. To review new and substantial evidence on screening for asymptomatic bacteriuria, to support the work of the U.S. Preventive Services Task Force. English-language studies of adults (age >18 years) indexed in PubMed and the Cochrane Library and published from 1 January 2002 through 30 April 2007. For benefits of screening or treatment for screened populations, systematic reviews; meta-analyses; and randomized, controlled trials were included. For harms of screening, systematic reviews; meta-analyses; randomized, controlled trials; cohort studies; case-control studies; and case series of large multisite databases were included. Two reviewers independently reviewed titles, abstracts, and full articles for inclusion. Two reviewers extracted data from studies on benefits of screening and treatment (including decreases in the incidence of adverse maternal and fetal outcomes, symptomatic urinary tract infections, hypertension, and renal function decline). An updated Cochrane systematic review of 14 randomized, controlled trials of treatment supports screening for asymptomatic bacteriuria in pregnant women. A randomized, controlled trial and a prospective cohort study show that screening nonpregnant women with diabetes for asymptomatic bacteriuria is unlikely to produce benefits. No new evidence on screening men for asymptomatic bacteriuria or on harms of screening was found. The focused search strategy may have missed some smaller studies on the benefits and harms of screening for asymptomatic bacteriuria. The available evidence continues to support screening for asymptomatic bacteriuria in pregnant women, but not in other groups of adults.

The effectiveness of a Web-based personalized feedback and social norms alcohol intervention on United Kingdom university students: randomized controlled trial.

PubMed

Bewick, Bridgette M; West, Robert M; Barkham, Michael; Mulhern, Brendan; Marlow, Robert; Traviss, Gemma; Hill, Andrew J

2013-07-24

Alcohol consumption in the student population continues to be cause for concern. Building on the established evidence base for traditional brief interventions, interventions using the Internet as a mode of delivery are being developed. Published evidence of replication of initial findings and ongoing development and modification of Web-based personalized feedback interventions for student alcohol use is relatively rare. The current paper reports on the replication of the initial Unitcheck feasibility trial. To evaluate the effectiveness of Unitcheck, a Web-based intervention that provides instant personalized feedback on alcohol consumption. It was hypothesized that use of Unitcheck would be associated with a reduction in alcohol consumption. A randomized control trial with two arms (control=assessment only; intervention=fully automated personalized feedback delivered using a Web-based intervention). The intervention was available week 1 through to week 15. Students at a UK university who were completing a university-wide annual student union electronic survey were invited to participate in the current study. Participants (n=1618) were stratified by sex, age group, year of study, self-reported alcohol consumption, then randomly assigned to one of the two arms, and invited to participate in the current trial. Participants were not blind to allocation. In total, n=1478 (n=723 intervention, n=755 control) participants accepted the invitation. Of these, 70% were female, the age ranged from 17-50 years old, and 88% were white/white British. Data were collected electronically via two websites: one for each treatment arm. Participants completed assessments at weeks 1, 16, and 34. Assessment included CAGE, a 7-day retrospective drinking diary, and drinks consumed per drinking occasion. The regression model predicted a monitoring effect, with participants who completed assessments reducing alcohol consumption over the final week. Further reductions were predicted for those allocated to receive the intervention, and additional reductions were predicted as the number of visits to the intervention website increased. Unitcheck can reduce the amount of alcohol consumed, and the reduction can be sustained in the medium term (ie, 19 weeks after intervention was withdrawn). The findings suggest self-monitoring is an active ingredient to Web-based personalized feedback.

Effect of an Online Video-Based Intervention to Increase HIV Testing in Men Who Have Sex with Men in Peru

PubMed Central

Blas, Magaly M.; Alva, Isaac E.; Carcamo, Cesar P.; Cabello, Robinson; Goodreau, Steven M.; Kimball, Ann M.; Kurth, Ann E.

2010-01-01

Background Although many men who have sex with men (MSM) in Peru are unaware of their HIV status, they are frequent users of the Internet, and can be approached by that medium for promotion of HIV testing. Methods We conducted an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through a gay website. The videos were customized for two audiences based on self-identification: either gay or non-gay men. The outcomes evaluated were ‘intention to get tested’ and ‘HIV testing at the clinic.’ Findings In the non-gay identified group, 97 men were randomly assigned to the video-based intervention and 90 to the text-based intervention. Non-gay identified participants randomized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days (62.5% vs. 15.4%, Relative Risk (RR): 2.77, 95% Confidence Interval (CI): 1.42–5.39). After a mean of 125.5 days of observation (range 42–209 days), 11 participants randomized to the video and none of the participants randomized to text attended our clinic requesting HIV testing (p = 0.001). In the gay-identified group, 142 men were randomized to the video-based intervention and 130 to the text-based intervention. Gay-identified participants randomized to the video were more likely to report intentions of getting an HIV test within 30 days, although not significantly (50% vs. 21.6%, RR: 1.54, 95% CI: 0.74–3.20). At the end of follow up, 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing (Hazard Ratio: 1.07, 95% CI: 0.40–2.85). Conclusion This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru. This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM populations. Trial registration Clinicaltrials.gov NCT00751192 PMID:20454667

Effect of an online video-based intervention to increase HIV testing in men who have sex with men in Peru.

PubMed

Blas, Magaly M; Alva, Isaac E; Carcamo, Cesar P; Cabello, Robinson; Goodreau, Steven M; Kimball, Ann M; Kurth, Ann E

2010-05-03

Although many men who have sex with men (MSM) in Peru are unaware of their HIV status, they are frequent users of the Internet, and can be approached by that medium for promotion of HIV testing. We conducted an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through a gay website. The videos were customized for two audiences based on self-identification: either gay or non-gay men. The outcomes evaluated were 'intention to get tested' and 'HIV testing at the clinic.' In the non-gay identified group, 97 men were randomly assigned to the video-based intervention and 90 to the text-based intervention. Non-gay identified participants randomized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days (62.5% vs. 15.4%, Relative Risk (RR): 2.77, 95% Confidence Interval (CI): 1.42-5.39). After a mean of 125.5 days of observation (range 42-209 days), 11 participants randomized to the video and none of the participants randomized to text attended our clinic requesting HIV testing (p = 0.001). In the gay-identified group, 142 men were randomized to the video-based intervention and 130 to the text-based intervention. Gay-identified participants randomized to the video were more likely to report intentions of getting an HIV test within 30 days, although not significantly (50% vs. 21.6%, RR: 1.54, 95% CI: 0.74-3.20). At the end of follow up, 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing (Hazard Ratio: 1.07, 95% CI: 0.40-2.85). This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru. This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM populations. Clinicaltrials.gov NCT00751192.

A cluster randomized-controlled trial of a classroom-based drama workshop program to improve mental health outcomes among immigrant and refugee youth in special classes.

PubMed

Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention. ClinicalTrials.gov NCT01426451.

A Cluster Randomized-Controlled Trial of a Classroom-Based Drama Workshop Program to Improve Mental Health Outcomes among Immigrant and Refugee Youth in Special Classes

PubMed Central

Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. Results The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. Conclusion The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention. Trial Registration ClinicalTrials.gov NCT01426451 PMID:25127251

Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial.

PubMed

Dixit, Snehil; Maiya, Arun G; Shastry, B A

2014-01-01

To evaluate the effect of moderate intensity aerobic exercise (40%-60% of Heart Rate Reserve (HRR)) on diabetic peripheral neuropathy. A parallel-group, randomized controlled trial was carried out in a tertiary health care setting, India. The study comprised of experimental (moderate intensity aerobic exercise and standard care) and control groups (standard care). Population with type 2 diabetes with clinical neuropathy, defined as a minimum score of seven on the Michigan Diabetic Neuropathy Score (MDNS), was randomly assigned to experimental and control groups by computer generated random number tables. RANOVA was used for data analysis (p<0.05 was significant). A total of 87 patients with DPN were evaluated in the study. After randomization there were 47 patients in the control group and 40 patients in the experimental group. A comparison of two groups using RANOVA for anthropometric measures showed an insignificant change at eight weeks. For distal peroneal nerve's conduction velocity there was a significant difference in two groups at eight weeks (p<0.05), Degrees of freedom (Df)=1, 62, F=5.14, and p=0.03. Sural sensory nerve at eight weeks showed a significant difference in two groups for conduction velocity, Df =1, 60, F=10.16, and p=0.00. Significant differences in mean scores of MDNS were also observed in the two groups at eight weeks (p value significant<0.05). Moderate intensity aerobic exercises can play a valuable role to disrupt the normal progression of DPN in type 2 diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

Population and forensic genetic analyses of mitochondrial DNA control region variation from six major provinces in the Korean population.

PubMed

Hong, Seung Beom; Kim, Ki Cheol; Kim, Wook

2015-07-01

We generated complete mitochondrial DNA (mtDNA) control region sequences from 704 unrelated individuals residing in six major provinces in Korea. In addition to our earlier survey of the distribution of mtDNA haplogroup variation, a total of 560 different haplotypes characterized by 271 polymorphic sites were identified, of which 473 haplotypes were unique. The gene diversity and random match probability were 0.9989 and 0.0025, respectively. According to the pairwise comparison of the 704 control region sequences, the mean number of pairwise differences between individuals was 13.47±6.06. Based on the result of mtDNA control region sequences, pairwise FST genetic distances revealed genetic homogeneity of the Korean provinces on a peninsular level, except in samples from Jeju Island. This result indicates there may be a need to formulate a local mtDNA database for Jeju Island, to avoid bias in forensic parameter estimates caused by genetic heterogeneity of the population. Thus, the present data may help not only in personal identification but also in determining maternal lineages to provide an expanded and reliable Korean mtDNA database. These data will be available on the EMPOP database via accession number EMP00661. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The mCME Project: A Randomized Controlled Trial of an SMS-Based Continuing Medical Education Intervention for Improving Medical Knowledge among Vietnamese Community Based Physicians' Assistants.

PubMed

Gill, Christopher J; Le Ngoc, Bao; Halim, Nafisa; Nguyen Viet, Ha; Larson Williams, Anna; Nguyen Van, Tan; McNabb, Marion; Tran Thi Ngoc, Lien; Falconer, Ariel; An Phan Ha, Hai; Rohr, Julia; Hoang, Hai; Michiel, James; Nguyen Thi Thanh, Tam; Bird, Liat; Pham Vu, Hoang; Yeshitla, Mahlet; Ha Van, Nhu; Sabin, Lora

2016-01-01

Community health workers (CHWs) provide critical services to underserved populations in low and middle-income countries, but maintaining CHW's clinical knowledge through formal continuing medical education (CME) activities is challenging and rarely occurs. We tested whether a Short Message Service (SMS)-based mobile CME (mCME) intervention could improve medical knowledge among a cadre of Vietnamese CHWs (Community Based Physician's Assistants-CBPAs) who are the leading providers of primary medical care for rural underserved populations. The mCME Project was a three arm randomized controlled trial. Group 1 served as controls while Groups 2 and 3 experienced two models of the mCME intervention. Group 2 (passive model) participants received a daily SMS bullet point, and were required to reply to the text to acknowledge receipt; Group 3 (interactive model) participants received an SMS in multiple choice question format addressing the same thematic area as Group 2, entering an answer (A, B, C or D) in their response. The server provided feedback immediately informing the participant whether the answer was correct. Effectiveness was based on standardized examination scores measured at baseline and endline (six months later). Secondary outcomes included job satisfaction and self-efficacy. 638 CBPAs were enrolled, randomized, and tested at baseline, with 592 returning at endline (93.7%). Baseline scores were similar across all three groups. Over the next six months, participation of Groups 2 and 3 remained high; they responded to >75% of messages. Group 3 participants answered 43% of the daily SMS questions correctly, but their performance did not improve over time. At endline, the CBPAs reported high satisfaction with the mCME intervention, and deemed the SMS messages highly relevant. However, endline exam scores did not increase over baseline, and did not differ between the three groups. Job satisfaction and self-efficacy scores also did not improve. Average times spent on self-study per week did not increase, and the kinds of knowledge resources used by the CBPAs did not differ between the three groups; textbooks, while widely available, were seldom used. The SMS-based mCME intervention, while feasible and acceptable, did not result in increased medical knowledge. We hypothesize that this was because the intervention failed to stimulate lateral learning. For an intervention of this kind to be effective, it will be essential to find more effective ways to couple SMS as a stimulus to promote increased self-study behaviors. ClinicalTrials.gov NCT02381743.

A new logistic dynamic particle swarm optimization algorithm based on random topology.

PubMed

Ni, Qingjian; Deng, Jianming

2013-01-01

Population topology of particle swarm optimization (PSO) will directly affect the dissemination of optimal information during the evolutionary process and will have a significant impact on the performance of PSO. Classic static population topologies are usually used in PSO, such as fully connected topology, ring topology, star topology, and square topology. In this paper, the performance of PSO with the proposed random topologies is analyzed, and the relationship between population topology and the performance of PSO is also explored from the perspective of graph theory characteristics in population topologies. Further, in a relatively new PSO variant which named logistic dynamic particle optimization, an extensive simulation study is presented to discuss the effectiveness of the random topology and the design strategies of population topology. Finally, the experimental data are analyzed and discussed. And about the design and use of population topology on PSO, some useful conclusions are proposed which can provide a basis for further discussion and research.

The c.553G>T Genetic Variant of the APOA5 Gene and Altered Triglyceride Levels in the Asian Population: A Meta-Analysis of Case-Control Studies.

PubMed

He, Hongjuan; Lei, Lei; Chen, Erfei; Dong, Jing; Zhang, Kejin; Yang, Jin

2016-12-01

To explore the association of the APOA5 gene c.553G>T polymorphism with hypertriglyceridemia (HTG) susceptibility and altered triglyceride levels. We searched the PubMed, Google Scholar, and CNKI databases for published studies relating to analyses of these associations. Case-control and comparative studies of the association between the APOA5 c.553G>T variant and altered triglyceride levels were included. In total, the meta-analysis involved 10 studies on HTG, which provided 2219 cases and 3401 controls. To measure the correlation between the c.553G>T polymorphism and HTG susceptibility, odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. The overall OR was calculated using a random-effects model. Compared with APOA5 c.553 GG carriers, c.553T carriers displayed an increased risk of HTG in the Asian population, with an overall random effects OR of 3.55 (95% CI: 2.46-5.13) in the dominant model. There was significant heterogeneity among the studies (P heterogeneity : Chi 2  = 45.80, I 2  = 75.98%), which may be largely explained by certain patient types. Both the sensitivity analysis and publication bias suggested that the overall result was acceptable. Subgroup analysis showed a large difference in serum triglyceride levels based on the c.553 G > T polymorphism in healthy individuals and HTG patients. APOA5 c.553T carriers exhibit higher triglyceride levels than GG carriers. Our results suggest that APOA5 c. 553T is an independent risk factor for HTG and increased triglyceride levels in the Asian population. APOA5 c. 553T could be employed as a genetic risk marker for HTG and increased triglyceride levels.

Polypharmacy correlates with increased risk for hip fracture in the elderly: a population-based study.

PubMed

Lai, Shih-Wei; Liao, Kuan-Fu; Liao, Chien-Chang; Muo, Chih-Hsin; Liu, Chiu-Shong; Sung, Fung-Chang

2010-09-01

Few studies have addressed the association between polypharmacy and hip fracture using population data. We conducted a population-based case-control study to investigate whether polypharmacy increases the risk for hip fracture in the elderly. We used insurance claims data from the Taiwan Bureau of National Health Insurance, a universal insurance program with a coverage rate of more than 98% of the population in Taiwan. We identified 2328 elderly patients with newly diagnosed hip fracture during the period 2005-2007. We randomly selected 9312 individuals without hip fracture to serve as the control group. Patient characteristics, drugs prescribed by physicians, and all types of hip fracture were ascertained. The odds ratio (OR) of hip fracture in association with the number of medications used per day in previous years was assessed.We found that patients were older than controls, predominantly female, and more likely to use 5 or more drugs (22.2% vs. 9.3%, p < 0.0001). The OR of hip fracture increased with the number of medications used per day and with age. Multivariate logistic regression analysis revealed that the overall OR for patients using 10 or more drugs was 8.42 (95% confidence interval [CI], 4.73-15.0) compared with patients who used 0-1 drug per day. However, age-specific analysis revealed that the risk for hip fracture was 23 times greater for patients aged > or = 85 years who used 10 or more drugs than for those aged 65-74 years who used 0-1 drug after controlling for covariates (OR, 23.0; 95% CI, 3.77-140).We conclude that the risk of hip fracture in older people increases with the number of medications used, especially in women. Age interacts with the daily medications for the risk of hip fracture.

Telegerontology as a Novel Approach to Address Health and Safety by Supporting Community-Based Rural Dementia Care Triads: Randomized Controlled Trial Protocol.

PubMed

Wallack, Elizabeth M; Harris, Chelsea; Ploughman, Michelle; Butler, Roger

2018-02-22

Telegerontology is an approach using videoconferencing to connect an interdisciplinary team in a regional specialty center to patients in rural communities, which is becoming increasingly practical for addressing current limitations in rural community-based dementia care. Using the remotely-delivered expertise of the Telegerontology dementia care team, we aim to enhance the caregiver/patient/physician triad and thereby provide the necessary support for the person with dementia to "age in place." This is a cluster randomized feasibility trial with four rural regions in the province of Newfoundland and Labrador, Canada (2 regions randomly assigned to "intervention" and 2 to "control"). The study population includes 22 "dementia triads" that consist of a community-dwelling older Canadian with moderate to late dementia, their family caregivers, and their Primary Care Physician (PCP). Over the 6-month active study period, all participants will be provided an iPad. The intervention is intended as an adjunct to existing PCP care, consisting of weekly Skype-based videoconferencing calls with the Telegerontology physician, and other team members as needed (occupational therapist, physical therapist etc). Control participants receive usual community-based dementia care with their PCP. A baseline (pre-) assessment will be performed during a home visit with the study team. Post intervention, 6- and 12-month follow-up assessments will be collected remotely using specialized dementia monitoring applications and Skype calls. Primary outcomes include admission to long-term care, falls, emergency room visits, hospital stays, and caregiver burden. Results will be available in March of 2018. Results from this study will demonstrate a novel approach to dementia care that has the potential to impact both rural PCPs, family caregivers, and people with dementia, as well as provide evidence for the utility of Telegerontology in models of eHealth-based care. ©Elizabeth M. Wallack, Chelsea Harris, Michelle Ploughman, Roger Butler. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2018.

Effects of Action Observational Training Plus Brain-Computer Interface-Based Functional Electrical Stimulation on Paretic Arm Motor Recovery in Patient with Stroke: A Randomized Controlled Trial.

PubMed

Kim, TaeHoon; Kim, SeongSik; Lee, ByoungHee

2016-03-01

The purpose of this study was to investigate whether action observational training (AOT) plus brain-computer interface-based functional electrical stimulation (BCI-FES) has a positive influence on motor recovery of paretic upper extremity in patients with stroke. This was a hospital-based, randomized controlled trial with a blinded assessor. Thirty patients with a first-time stroke were randomly allocated to one of two groups: the BCI-FES group (n = 15) and the control group (n = 15). The BCI-FES group administered to AOT plus BCI-FES on the paretic upper extremity five times per week during 4 weeks while both groups received conventional therapy. The primary outcomes were the Fugl-Meyer Assessment of the Upper Extremity, Motor Activity Log (MAL), Modified Barthel Index and range of motion of paretic arm. A blinded assessor evaluated the outcomes at baseline and 4 weeks. All baseline outcomes did not differ significantly between the two groups. After 4 weeks, the Fugl-Meyer Assessment of the Upper Extremity sub-items (total, shoulder and wrist), MAL (MAL-Activity of Use and Quality of Movement), Modified Barthel Index and wrist flexion range of motion were significantly higher in the BCI-FES group (p < 0.05). AOT plus BCI-based FES is effective in paretic arm rehabilitation by improving the upper extremity performance. The motor improvements suggest that AOT plus BCI-based FES can be used as a therapeutic tool for stroke rehabilitation. The limitations of the study are that subjects had a certain limited level of upper arm function, and the sample size was comparatively small; hence, it is recommended that future large-scale trials should consider stratified and lager populations according to upper arm function. Copyright © 2015 John Wiley & Sons, Ltd.

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

PubMed

Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

2017-04-01

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

PubMed Central

Matsui, Kenji; Lie, Reidar K.; Turin, Tanvir C.; Kita, Yoshikuni

2012-01-01

Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Methods Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Results Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. Conclusions A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research. PMID:22447213

Physical Activity Promotion in the Preschool Years: A Critical Period to Intervene

PubMed Central

Goldfield, Gary S.; Harvey, Alysha; Grattan, Kimberly; Adamo, Kristi B.

2012-01-01

The primary aim of this paper is to provide a rationale for the necessity of intervening with a physical activity intervention in the preschool years and why the daycare environment is amenable to such intervention. We also review the prevalence of physical activity, sedentary behaviour and obesity in the preschool population and the impact that these lifestyle behaviours and conditions have on the health of preschool aged children, as secondary objectives. Moreover we discuss implications for intervention and research using a “lessons learned” model based on our research team’s experience of conducting a randomized controlled trial aimed at increasing physical activity, reducing sedentary behaviour and improving motor skill development and body composition in preschoolers. Lastly, we make conclusions based on the literature and highlight issues and directions that need to be addressed in future research in order to maximize health promotion and chronic disease prevention in the pediatric population. PMID:22690196

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

PubMed Central

LOCHER, JULIE L.; BALES, CONNIE W.; ELLIS, AMY C.; LAWRENCE, JEANNINE C.; NEWTON, LAURA; RITCHIE, CHRISTINE S.; ROTH, DAVID L.; BUYS, DAVID L.; VICKERS, KRISTIN S.

2012-01-01

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article. PMID:22098180

Folic acid supplements and colorectal cancer risk: meta-analysis of randomized controlled trials

NASA Astrophysics Data System (ADS)

Qin, Tingting; Du, Mulong; Du, Haina; Shu, Yongqian; Wang, Meilin; Zhu, Lingjun

2015-07-01

Numerous studies have investigated the effects of folic acid supplementation on colorectal cancer risk, but conflicting results were reported. We herein performed a meta-analysis based on relevant studies to reach a more definitive conclusion. The PubMed and Embase databases were searched for quality randomized controlled trials (RCTs) published before October 2014. Eight articles met the inclusion criteria and were subsequently analyzed. The results suggested that folic acid treatment was not associated with colorectal cancer risk in the total population (relative risk [RR] = 1.00, 95% confidence interval [CI] = 0.82-1.22, P = 0.974). Moreover, no statistical effect was identified in further subgroup analyses stratified by ethnicity, gender, body mass index (BMI) and potential confounding factors. No significant heterogeneity or publication bias was observed. In conclusion, our meta-analysis demonstrated that folic acid supplementation had no effect on colorectal cancer risk. However, this finding must be validated by further large studies.

Solution-Focused Wellness: A Randomized Controlled Trial of College Students.

PubMed

Beauchemin, James D

2018-05-01

Heightened stress levels and compromised well-being are common among college students. Current trends on college campuses include an increase in the number of students experiencing mental health issues and an increase in students seeking help, illustrating a need for evidence-based brief interventions that improve student wellness. This research study used a randomized controlled study design to examine the effects of a short-term (seven-week), solution-focused wellness intervention on perceived stress and wellness of college students. Repeated measures analysis of variance results demonstrated that the effect of group membership across time was significant for both perceived wellness and stress (p < .01). Effect sizes using partial eta2 statistics were large for both outcome variables. Findings indicate that a brief solution-focused wellness intervention can significantly improve perceptions of wellness and reduce stress among college students and is more effective than treatment as usual. Intervention replicability allows for dissemination across varied academic groups and locations, and potential generalization across populations.

Effects of a behavioral intervention to reduce serodiscordant unsafe sex among HIV positive men who have sex with men: the Positive Connections randomized controlled trial study.

PubMed

Rosser, B R Simon; Hatfield, Laura A; Miner, Michael H; Ghiselli, Margherita E; Lee, Brian R; Welles, Seth L

2010-04-01

Few behavioral interventions have been conducted to reduce high-risk sexual behavior among HIV-positive Men who have Sex with Men (HIV+ MSM). Hence, we lack well-proven interventions for this population. Positive Connections is a randomized controlled trial (n = 675 HIV+ MSM) comparing the effects of two sexual health seminars--for HIV+ MSM and all MSM--with a contrast prevention video arm. Baseline, 6-, 12- and 18-month follow-up surveys assessed psychosexual variables and frequency of serodiscordant unprotected anal intercourse (SDUAI). At post-test, intentions to avoid transmission were significantly higher in the sexual health arms. However, SDUAI frequency decreased equally across arms. HIV+ MSM engaging in SDUAI at baseline were more likely to leave the study. Tailoring interventions to HIV+ MSM did not increase their effectiveness in this study. A sexual health approach appeared as effective as an untailored video-based HIV prevention intervention in reducing SDUAI among HIV+ MSM.

The effects of water-based exercise in combination with blood flow restriction on strength and functional capacity in post-menopausal women.

PubMed

Araújo, Joamira P; Neto, Gabriel R; Loenneke, Jeremy P; Bemben, Michael G; Laurentino, Gilberto C; Batista, Gilmário; Silva, Júlio C G; Freitas, Eduardo D S; Sousa, Maria S C

2015-12-01

Water-based exercise and low-intensity exercise in combination with blood flow restriction (BFR) are two methods that have independently been shown to improve muscle strength in those of advancing age. The objective of this study was to assess the long-term effect of water-based exercise in combination with BFR on maximum dynamic strength and functional capacity in post-menopausal women. Twenty-eight women underwent an 8-week water-based exercise program. The participants were randomly allocated to one of the three groups: (a) water exercise only, (b) water exercise + BFR, or (c) a non-exercise control group. Functional capacity (chair stand test, timed up and go test, gait speed, and dynamic balance) and strength testing were tested before and after the 8-week aquatic exercise program. The main findings were as follows: (1) water-based exercise in combination with BFR significantly increased the lower limb maximum strength which was not observed with water-based exercise alone and (2) water-based exercise, regardless of the application of BFR, increased functional performance measured by the timed up and go test over a control group. Although we used a healthy population in the current study, these findings may have important implications for those who may be contraindicated to using traditional resistance exercise. Future research should explore this promising modality in these clinical populations.

Internet-based implementation of non-pharmacological interventions of the "people getting a grip on arthritis" educational program: an international online knowledge translation randomized controlled trial design protocol.

PubMed

Brosseau, Lucie; Wells, George; Brooks-Lineker, Sydney; Bennell, Kim; Sherrington, Cathie; Briggs, Andrew; Sturnieks, Daina; King, Judy; Thomas, Roanne; Egan, Mary; Loew, Laurianne; De Angelis, Gino; Casimiro, Lynn; Toupin April, Karine; Cavallo, Sabrina; Bell, Mary; Ahmed, Rukhsana; Coyle, Doug; Poitras, Stéphane; Smith, Christine; Pugh, Arlanna; Rahman, Prinon

2015-02-03

Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers' Associations to participate using online recruitment. This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to "closed", thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8).

Internet-Based Implementation of Non-Pharmacological Interventions of the "People Getting a Grip on Arthritis" Educational Program: An International Online Knowledge Translation Randomized Controlled Trial Design Protocol

PubMed Central

Thomas, Roanne; De Angelis, Gino

2015-01-01

Background Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. Objective The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). Methods This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers’ Associations to participate using online recruitment. Results This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. Conclusions The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to “closed”, thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8). PMID:25648515

A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

PubMed Central

2011-01-01

Background We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. Methods This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. Results The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age. Conclusion Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822. PMID:21510905

A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods.

PubMed

Labrique, Alain B; Christian, Parul; Klemm, Rolf D W; Rashid, Mahbubur; Shamim, Abu Ahmed; Massie, Allan; Schulze, Kerry; Hackman, Andre; West, Keith P

2011-04-21

We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age. Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822.

Selection of population controls for a Salmonella case-control study in the UK using a market research panel and web-survey provides time and resource savings.

PubMed

Mook, P; Kanagarajah, S; Maguire, H; Adak, G K; Dabrera, G; Waldram, A; Freeman, R; Charlett, A; Oliver, I

2016-04-01

Timely recruitment of population controls in infectious disease outbreak investigations is challenging. We evaluated the timeliness and cost of using a market research panel as a sampling frame for recruiting controls in a case-control study during an outbreak of Salmonella Mikawasima in the UK in 2013. We deployed a web-survey by email to targeted members of a market research panel (panel controls) in parallel to the outbreak control team interviewing randomly selected public health staff by telephone and completing paper-based questionnaires (staff controls). Recruitment and completion of exposure history web-surveys for panel controls (n = 123) took 14 h compared to 15 days for staff controls (n = 82). The average staff-time cost per questionnaire for staff controls was £13·13 compared to an invoiced cost of £3·60 per panel control. Differences in the distribution of some exposures existed between these control groups but case-control studies using each group found that illness was associated with consumption of chicken outside of the home and chicken from local butchers. Recruiting market research panel controls offers time and resource savings. More rapid investigations would enable more prompt implementation of control measures. We recommend that this method of recruiting controls is considered in future investigations and assessed further to better understand strengths and limitations.

Effects of a tailored lifestyle self-management intervention (TALENT) study on weight reduction: a randomized controlled trial.

PubMed

Melchart, Dieter; Löw, Peter; Wühr, Erich; Kehl, Victoria; Weidenhammer, Wolfgang

2017-01-01

Overweight and obesity are globally increasing risk factors for diseases in the context of metabolic syndrome. A randomized controlled trial was conducted to investigate whether there are any existing differences between two lifestyle intervention strategies with respect to weight reduction after 1 year. A total of 166 subjects with a body mass index of 28-35 kg/m 2 were enrolled in this trial at seven study centers; 109 were randomly allocated to the intervention group (comprehensive lifestyle modification program: web-based Individual Health Management [IHM]) with 3-month reduction phase plus 9-month maintenance phase, and 57 were allocated to the control group (written information with advice for healthy food habits: usual care [UC]). Body weight, waist circumference, blood pressure, laboratory findings, and bioimpedance analysis used to determine body composition were measured at baseline and after 3, 6, 9, and 12 months. The primary outcome parameter was body weight at month 12 compared to baseline. With respect to baseline status there were no statistically significant differences between the groups. Based on the intent-to-treat population, body weight showed a mean decrease of 8.7 kg (SD 6.1) in the intervention group (IHM) and 4.2 kg (SD 5) in the control group (UC) at month 12. This statistically significant difference ( P <0.001) was confirmed by various sensitivity analyses. Body mass index, waist circumference, high-density lipid cholesterol, body fat, and the ratio of fat and body cell mass improved to a significantly higher degree in the IHM group. IHM proved to be superior to UC in weight reduction after 1 year. With a mean loss of about 10% of the baseline weight, a clinically high relevant risk reduction for cardio-metabolic diseases is achievable.

Effect of patient navigation on colorectal cancer screening in a community-based randomized controlled trial of urban African American adults

PubMed Central

Phelan-Emrick, Darcy F.; Pollack, Craig E.; Markakis, Diane; Wenzel, Jennifer; Ahmed, Saifuddin; Garza, Mary A.; Shapiro, Gary R.; Bone, Lee R.; Johnson, Lawrence B.; Ford, Jean G.

2015-01-01

Purpose In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Methods Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Results Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07–2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07–2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65–69 years and those with an adequate health literacy level. Conclusions In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels. PMID:25516073

Effect of patient navigation on colorectal cancer screening in a community-based randomized controlled trial of urban African American adults.

PubMed

Horne, Hisani N; Phelan-Emrick, Darcy F; Pollack, Craig E; Markakis, Diane; Wenzel, Jennifer; Ahmed, Saifuddin; Garza, Mary A; Shapiro, Gary R; Bone, Lee R; Johnson, Lawrence B; Ford, Jean G

2015-02-01

In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07-2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07-2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65-69 years and those with an adequate health literacy level. In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels.

Effects of an Internet-based cognitive behavioral therapy (iCBT) program in Manga format on improving subthreshold depressive symptoms among healthy workers: a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A; Matsuyama, Yutaka; Shimazu, Akihito; Umanodan, Rino; Kawakami, Sonoko; Kasai, Kiyoto

2014-01-01

The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy (iCBT) program in Manga format, the Japanese cartoon, for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial (RCT) design among workers employed in private companies in Japan. All workers in a company (n = 290) and all workers in three departments (n = 1,500) at the headquarters of another large company were recruited by an invitation e-mail. Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups (N = 381 for each group). A six-week, six-lesson iCBT program using Manga (Japanese comic) story was developed. The program included several CBT skills: self-monitoring, cognitive restructuring, assertiveness, problem solving, and relaxation. The intervention group studied the iCBT program at a frequency of one lesson per week. Depression (Beck Depression Inventory II; BDI-II) was assessed as a primary outcome at baseline, and three- and six-month follow-ups for both intervention and control groups were performed. The iCBT program showed a significant intervention effect on BDI-II (t = -1.99, p<0.05) with small effect sizes (Cohen's d: -0.16, 95% Confidence Interval: -0.32 to 0.00, at six-month follow-up). The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population. It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program. UMIN Clinical Trials Registry UMIN000006210.

Mind-Body Training for At-Risk Populations: Preventive Medicine at its Best.

PubMed

Elder, Charles

2017-01-01

This article is a companion to "Transcendental meditation and reduced trauma symptoms in female inmates: A randomized controlled pilot study," available at: www.thepermanentejournal.org/issues/2017/6290-meditation.html, and on page 39 and to "Reduced trauma symptoms and perceived stress in male prison inmates through the Transcendental Meditation program: A randomized controlled trial," available at: www.thepermanentejournal.org/issues/2016/fall/6227-incarcerated-healthcare.html and in the Fall 2016 issue of The Permanente Journal.

Early Statin Use and the Progression of Alzheimer Disease: A Total Population-Based Case-Control Study.

PubMed

Lin, Feng-Cheng; Chuang, Yun-Shiuan; Hsieh, Hui-Min; Lee, Tzu-Chi; Chiu, Kuei-Fen; Liu, Ching-Kuan; Wu, Ming-Tsang

2015-11-01

The protective effect of statin on Alzheimer disease (AD) is still controversial, probably due to the debate about when to start the use of statin and the lack of any large-scale randomized evidence that actually supports the hypothesis. The purpose of this study was to examine the protective effect of early statin use on mild-to-moderate AD in the total Taiwanese population.This was a total population-based case-control study, using the total population of Taiwanese citizens seen in general medical practice; therefore, the findings can be applied to the general population. The study patients were those with newly diagnosed dementia (ICD-9 290.x) and prescribed any acetylcholinesterase inhibitors (AChEI) from the Taiwan National Health Insurance dataset in 1997 to 2008. The newly diagnosed eligible mild-to-moderate AD patients were traced from the dates of their index dates, which was defined as the first day to receive any AChEI treatment, back to 1 year (exposure period) to categorize them into AD with early statin use and without early statin use. Early statin use was defined as patients using statin before AChEI treatment. Alzheimer disease patients with early statin use were those receiving any statin treatment during the exposure period. Then, we used propensity-score-matched strategy to match these 2 groups as 1:1. The matched study patients were followed-up from their index dates. The primary outcome was the discontinuation of AChEI treatment, indicating AD progression.There were 719 mild-to-moderate AD-paired patients with early statin use and without early statin use for analyses. Alzheimer disease progression was statistically lower in AD patients with early statin use than those without (P = 0.00054). After adjusting for other covariates, mild-to-moderate AD patients with early stain use exhibited a 0.85-risk (95% CI = 0.76-0.95, P = 0.0066) to have AD progression than those without.Early statin use was significantly associated with a reduction in AD progression in mild-to-moderate AD patients. The future randomized trial studies can confirm our findings.

Limitations of basing screening policies on screening trials: The US Preventive Services Task Force and Prostate Cancer Screening.

PubMed

Etzioni, Ruth; Gulati, Roman; Cooperberg, Matt R; Penson, David M; Weiss, Noel S; Thompson, Ian M

2013-04-01

The US Preventive Services Task Force recently recommended against prostate-specific antigen screening for prostate cancer based primarily on evidence from the European Randomized Study of Screening for Prostate Cancer (ERSPC) and the US Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial. : To examine limitations of basing screening policy on evidence from screening trials. We reviewed published modeling studies that examined population and trial data. The studies (1) project the roles of screening and changes in primary treatment in the US mortality decline; (2) extrapolate the ERSPC mortality reduction to the long-term US setting; (3) estimate overdiagnosis based on US incidence trends; and (4) quantify the impact of control arm screening on PLCO mortality results. Screening plausibly explains 45% and changes in primary treatment can explain 33% of the US prostate cancer mortality decline. Extrapolating the ERSPC results to the long-term US setting implies an absolute mortality reduction at least 5 times greater than that observed in the trial. Approximately 28% of screen-detected cases are overdiagnosed in the United States versus 58% of screen-detected cases suggested by the ERSPC results. Control arm screening can explain the null result in the PLCO trial. Modeling studies indicate that population trends and trial results extended to the long-term population setting are consistent with greater benefit of prostate-specific antigen screening-and more favorable harm-benefit tradeoffs-than has been suggested by empirical trial evidence.

The effect of reminder systems on patients’ adherence to treatment

PubMed Central

Fenerty, Sarah D; West, Cameron; Davis, Scott A; Kaplan, Sebastian G; Feldman, Steven R

2012-01-01

Background Patient adherence is an important component of the treatment of chronic disease. An understanding of patient adherence and its modulating factors is necessary to correctly interpret treatment efficacy and barriers to therapeutic success. Purpose This meta-analysis aims to systematically review published randomized controlled trials of reminder interventions to assist patient adherence to prescribed medications. Methods A Medline search was performed for randomized controlled trials published between 1968 and June 2011, which studied the effect of reminder-based interventions on adherence to self-administered daily medications. Results Eleven published randomized controlled trials were found between 1999 and 2009 which measured adherence to a daily medication in a group receiving reminder interventions compared to controls receiving no reminders. Medication adherence was measured as the number of doses taken compared to the number prescribed within a set period of time. Meta- analysis showed a statistically significant increase in adherence in groups receiving a reminder intervention compared to controls (66.61% versus 54.71%, 95% CI for mean: 0.8% to 22.4%). Self-reported and electronically monitored adherence rates did not significantly differ (68.04% versus 63.67%, P = 1.0). Eight of eleven studies showed a statistically significant increase in adherence for at least one of the reminder group arms compared to the control groups receiving no reminder intervention. Limitations The data are limited by imperfect measures of adherence due to variability in data collection methods. It is also likely that concomitant educational efforts in the study populations, such as instructions regarding proper administration and importance of correct dosing schedules, contributed to improved patient adherence, both in reminder and control arms. The search strategy could have missed relevant studies which were categorized by disease rather than adherence. Conclusions Reminder-based interventions may improve adherence to daily medications. However, the interventions used in these studies, which included reminder phone calls, text messages, pagers, interactive voice response systems, videotelephone calls, and programmed electronic audiovisual reminder devices, are impractical for widespread implementation, and their efficacy may be optimized when combined with alternative adherence-modifying strategies. More practical reminder-based interventions should be assessed to determine their value in improving patient adherence and treatment outcomes. PMID:22379363

Smoking and adult glioma: a population-based case-control study in China.

PubMed

Hou, Lei; Jiang, Jingmei; Liu, Boqi; Han, Wei; Wu, Yanping; Zou, Xiaonong; Nasca, Philip C; Xue, Fang; Chen, Yuanli; Zhang, Biao; Pang, Haiyu; Wang, Yuyan; Wang, Zixing; Li, Junyao

2016-01-01

Smoking increases the risk of numerous cancers; however, an association of smoking with adult gliomas has not been found in a population. This case-control study included 4556 glioma cases (ICD-9 code 191.0-191.9) aged ≥ 30 years and 9112 controls from a national survey of smoking and mortality in China in 1989-1991. Controls from 325 255 surviving spouses of all-cause deaths were randomly assigned to cases in each of 103 areas according to sex and age groups at a ratio of 2:1. Smoking information was ascertained retrospectively by interviewing surviving spouses. After adjustment for confounders, smoking increased the risk of glioma deaths by 11% (odds ratio [OR] = 1.11; 95% confidence interval [CI]: 1.03-1.21). Compared with non-smokers; the increased risk was 9% (OR = 1.09; 95% CI: 0.99-1.20) in men and 16% (OR = 1.16; 95% CI: 1.00-1.36) in women. The risk increased with age and doses. For individuals aged ≥ 50 years, smoking was associated with higher risk of glioma death by 25% (OR = 1.25; 95% CI: 1.15-1.38); this increased risk for smokers who smoked ≥ 20 cigarettes daily for ≥ 30 years was 53% (OR = 1.53; 95% CI: 1.34-1.74). There were similar findings in both men and women and with either pathology-based or non-pathology-based comparisons. This study indicates that smoking is associated with glioma deaths in the Chinese population. Long-term heavy smoking could be a factor for risk stratification in individuals attending brain tumor clinics. © The Author(s) 2015. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A standardized crisis management model for self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder: The Brief Admission Skåne randomized controlled trial protocol (BASRCT).

PubMed

Liljedahl, Sophie I; Helleman, Marjolein; Daukantaité, Daiva; Westrin, Åsa; Westling, Sofie

2017-06-15

Brief Admission is a crisis and risk management strategy in which self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder self-admit to hospital at times of increasing risk when other efforts to stay safe are failing. Standardized in the current randomized controlled trial, the intensity of Brief Admission Skåne is implemented in durations of three days, with a maximum frequency of three times a month. Brief Admission is integrated into existing treatment plans in advance of crises to prevent reliance on general psychiatric admissions for risk management, as these may be lengthy, unstructured, and of uncertain therapeutic value. The overall objective of the Brief Admission Skåne randomized controlled trial is to determine if Brief Admission can replace general psychiatric admission for self-harming and suicidal individuals with complex mental illness at times of escalating risk. Other objectives of the study are to evaluate whether Brief Admission increases daily functioning and enhances coping, reduces psychiatric symptoms including frequency and severity of self-harm and suicidal behaviours. A final objective is to determine if Brief Admission is an effective crisis management model for this population. Participants are randomized at an individual level to either Brief Admission Skåne plus Treatment as Usual or Treatment As Usual. Based on a priori power analyses, N = 124 participants will be recruited to the study. Data collection is in progress, and will continue until June 2018. All participant data are single-blinded and will be handled with intention-to-treat analysis. Based on the combined clinical experience of our international research group, the Brief Admission Skåne randomized controlled trial upon which the current protocol is based represents the first initiative to standardize, implement and evaluate Brief Admission amongst self-harming and suicidal individuals, including those with borderline traits. Objectively measuring protocol fidelity and developing English-language Brief Admission study protocols and training materials are implementation and dissemination targets developed in order to facilitate adherent international export of Brief Admission Skåne. NCT02985047 . Registered November 25, 2016. Retrospectively registered.

Randomized Trial of Internet-Delivered Self-Help with Telephone Support for Pathological Gamblers

ERIC Educational Resources Information Center

Carlbring, Per; Smit, Filip

2008-01-01

Although effective therapies for pathological gambling exist, their uptake is limited to 10% of the target population. To lower the barriers for help seeking, the authors tested an online alternative in a randomized trial (N = 66). The participants were pathological gamblers not presenting with severe comorbid depression. A wait-list control was…

Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

Weight Management in Adults with Intellectual and Developmental Disabilities: A Randomized Controlled Trial of Two Dietary Approaches

ERIC Educational Resources Information Center

Ptomey, Lauren T.; Saunders, Richard R.; Saunders, Muriel; Washburn, Richard A.; Mayo, Matthew S.; Sullivan, Debra K.; Gibson, Cheryl A.; Goetz, Jeannine R.; Honas, Jeff J.; Willis, Erik A.; Danon, Jessica C.; Krebill, Ron; Donnelly, Joseph E.

2018-01-01

Background: The prevalence of obesity among individuals with intellectual and developmental disabilities (IDD) is equal to or greater than the general population. Methods: Overweight/obese adults (BMI =25 kg/m2) with mild-to-moderate intellectual and developmental disabilities were randomized to an enhanced stop light diet…

An evaluation of the genetic-matched pair study design using genome-wide SNP data from the European population.

PubMed

Lu, Timothy Tehua; Lao, Oscar; Nothnagel, Michael; Junge, Olaf; Freitag-Wolf, Sandra; Caliebe, Amke; Balascakova, Miroslava; Bertranpetit, Jaume; Bindoff, Laurence Albert; Comas, David; Holmlund, Gunilla; Kouvatsi, Anastasia; Macek, Milan; Mollet, Isabelle; Nielsen, Finn; Parson, Walther; Palo, Jukka; Ploski, Rafal; Sajantila, Antti; Tagliabracci, Adriano; Gether, Ulrik; Werge, Thomas; Rivadeneira, Fernando; Hofman, Albert; Uitterlinden, André Gerardus; Gieger, Christian; Wichmann, Heinz-Erich; Ruether, Andreas; Schreiber, Stefan; Becker, Christian; Nürnberg, Peter; Nelson, Matthew Roberts; Kayser, Manfred; Krawczak, Michael

2009-07-01

Genetic matching potentially provides a means to alleviate the effects of incomplete Mendelian randomization in population-based gene-disease association studies. We therefore evaluated the genetic-matched pair study design on the basis of genome-wide SNP data (309,790 markers; Affymetrix GeneChip Human Mapping 500K Array) from 2457 individuals, sampled at 23 different recruitment sites across Europe. Using pair-wise identity-by-state (IBS) as a matching criterion, we tried to derive a subset of markers that would allow identification of the best overall matching (BOM) partner for a given individual, based on the IBS status for the subset alone. However, our results suggest that, by following this approach, the prediction accuracy is only notably improved by the first 20 markers selected, and increases proportionally to the marker number thereafter. Furthermore, in a considerable proportion of cases (76.0%), the BOM of a given individual, based on the complete marker set, came from a different recruitment site than the individual itself. A second marker set, specifically selected for ancestry sensitivity using singular value decomposition, performed even more poorly and was no more capable of predicting the BOM than randomly chosen subsets. This leads us to conclude that, at least in Europe, the utility of the genetic-matched pair study design depends critically on the availability of comprehensive genotype information for both cases and controls.

A population 'consensus', partial linkage map of Picea abies Karst. based on RAPD markers

Treesearch

G. Bucci; Thomas L. Kubisiak; W.L. Nance; P. Menozzi

1997-01-01

The authors built a "consensus" partial linkage map based on RAPD markers using 48 sibships of eight megagametophytes each from a natural population of Norway spruce. A RAPD linkage map for a single individual from the same population had previously been constructed. Using 30 random decamers that had yielded 83 RAPD markers in the single-tree map, eight...

Efficacy of Peer Education for Adopting Preventive Behaviors against Head Lice Infestation in Female Elementary School Students: A Randomised Controlled Trial

PubMed Central

Zamani-Alavijeh, Fereshteh; Mojadam, Mehdi

2017-01-01

Background Pediculosis is a common parasitic infestation in students worldwide, including Iran. This condition is more prevalent in populous and deprived communities with poor personal hygiene. This study sought to assess the efficacy of peer education for adopting preventive behaviors against pediculosis in female elementary school students based on the Health Belief Model (HBM). Methods A total of 179 female fifth grade students were selected using multistage random sampling and were randomly allocated to control and intervention groups. A standard questionnaire was designed and administered to collect baseline information. An educational intervention was then designed based on the conducted needs assessment. The educational program consisted of three sessions, held by peers for the intervention group. The questionnaire was re-administered one month after the intervention. Independent and paired t-test, Pearson’s correlation coefficient, and regression analysis were applied as appropriate. Results The two groups had no significant differences in the scores of knowledge, HBM constructs, or behavior before the intervention. After the intervention, however, the mean scores of all parameters significantly improved in the intervention group. Conclusion Peer education based on HBM is an effective strategy to promote preventive behaviors against pediculosis in among fifth grade female elementary school students in Iran. PMID:28072852

Mindfulness-Based Stress Reduction for the Treatment of Adolescent Psychiatric Outpatients: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.

2009-01-01

Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…

Speckle lithography for fabricating Gaussian, quasi-random 2D structures and black silicon structures.

PubMed

Bingi, Jayachandra; Murukeshan, Vadakke Matham

2015-12-18

Laser speckle pattern is a granular structure formed due to random coherent wavelet interference and generally considered as noise in optical systems including photolithography. Contrary to this, in this paper, we use the speckle pattern to generate predictable and controlled Gaussian random structures and quasi-random structures photo-lithographically. The random structures made using this proposed speckle lithography technique are quantified based on speckle statistics, radial distribution function (RDF) and fast Fourier transform (FFT). The control over the speckle size, density and speckle clustering facilitates the successful fabrication of black silicon with different surface structures. The controllability and tunability of randomness makes this technique a robust method for fabricating predictable 2D Gaussian random structures and black silicon structures. These structures can enhance the light trapping significantly in solar cells and hence enable improved energy harvesting. Further, this technique can enable efficient fabrication of disordered photonic structures and random media based devices.

Control of diabetes and fibrinogen levels as well as improvement in health care might delay low cognitive performance in societies aging progressively.

PubMed

Lopes, Daniele Almeida; Moraes, Suzana Alves de; Freitas, Isabel Cristina Martins de

2015-01-01

To know the prevalence and factors associated to low cognitive performance in a representative sample of the adult population in a society aging progressively. Cross-sectional population-based study carried out in a three-stage sampling: 81 census tracts (primary sampling unity) were randomly selected, followed by 1,672 households and 2,471 participants (weighted sample) corresponding to the second and third stages, respectively. The outcome prevalence was calculated according sociodemographic, behavioral and health related variables. Crude and adjusted prevalence ratios were estimated using Poisson regression. The prevalence of low cognitive performance was high, mainly among females, and indicated linear trends into categories of age, schooling, income, plasma fibrinogen and self-reported health status. In multivariate models, gender, diabetes, fibrinogen and self-reported health status presented positive associations, while schooling, employment and sitting time presented negative associations with the outcome. Interventions related to diabetes and fibrinogen levels control as well as improvement in health care might delay low cognitive performance in societies aging progressively as such the study population.

Artificial sweeteners and absence of bladder cancer risk in Copenhagen.

PubMed

Møller-Jensen, O; Knudsen, J B; Sørensen, B L; Clemmesen, J

1983-11-15

During the years 1979 to 1981 a population-based case-control study of bladder cancer including papillomas was performed in Greater Copenhagen. After exclusions some 388 patients (290 males; 98 females) and an age- and sex-matched group of 787 controls (592 males; 195 females) remained for analysis. Controls were selected at random from the general population of the study area. All persons were interviewed concerning use of artificial sweeteners in addition to their exposure to a number of other known or suspected risk factors for bladder cancer. Fifty-five male bladder cancer patients (19.4%) and 150 controls (25.7%) had at some time used artificial sweeteners regularly. Among females 27.1% of cases and 25.9% of controls regularly used sweeteners. In neither sex was the relative risk significantly increased in users compared with non-users of artificial sweeteners. The relative risk of 0.78 in the two sexes combined was not significantly different from 1.0 (95% C.I.: 0.58-1.05). There was no indication of a regular increase in risk with increasing daily consumption of table-top sweeteners nor was there any indication of an increase in risk with a duration of regular use of artificial sweeteners. Taking into account a possible latency period between first regular use and bladder cancer development did not change the finding of an absence of association between use of artificial sweeteners and the risk of bladder cancer. Neither saccharine nor cyclamate users had an increased risk of bladder cancer. This population-based case-control investigation provides further evidence that it is highly unlikely that the consumption of artificial sweeteners has contributed to current bladder cancer rates in man.

[Sociodemographic characteristics, risk factors and reproductive history in subjects with fibromyalgia--results of a population-based case-control study].

PubMed

Schochat, T; Beckmann, C

2003-02-01

According to recent studies, 1.3 to 4.8% of the population of Western industrialized nations suffer from fibromyalgia, with 80 to 90% of the affected persons being women. This preponderance of women, mostly in their reproductive years, suggests an association between fibromyalgia and sex hormones. Within the framework of a population-based cross-sectional study of 3174 female residents of Bad Säckingen aged 35 to 74 years a stratified random sample of 653 women was clinically examined and surveyed. Thirty-six of these women fulfilled the ACR criteria of fibromyalgia. Forty-four women suffered from chronic widespread pain without having fibromyalgia (chronic pain group); 408 had no chronic pain (controls). Compared to the control group, subjects with fibromyalgia have a 3.6-fold risk, while compared to the chronic pain group, there is a 3.9-fold risk of having a lower social level. Subjects with fibromyalgia drink less alcohol than subjects from the chronic pain group and the control group. After adjusting for age, multivariate analyses demonstrated that, in comparison to controls, subjects with fibromyalgia have a significantly later menarche (OR=2.2 for >14 years) and had never been pregnant (OR=0.3). The comparison of the chronic pain group and controls did not demonstrate these associations. The associations with a low social level, low alcohol intake, late menarche and rare pregnancies are specific for subjects with fibromyalgia. These factors distinguish subjects with fibromyalgia from subjects with other chronic pain conditions as well as from subjects with no chronic pain. The same hormonal factors responsible for a delayed menarche and a reduced fertility may be relevant in the development of fibromyalgia.

Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial.

PubMed

Nicklas, Jacinda M; Skurnik, Geraldine; Zera, Chloe A; Reforma, Liberty G; Levkoff, Sue E; Seely, Ellen W

2016-02-01

The postpartum period is a window of opportunity for diabetes prevention in women with recent gestational diabetes (GDM), but recruitment for clinical trials during this period of life is a major challenge. We adapted a social-ecologic model to develop a multi-level recruitment strategy at the macro (high or institutional level), meso (mid or provider level), and micro (individual) levels. Our goal was to recruit 100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period. Participants were asked to attend three in-person study visits at 6 weeks, 6, and 12 months postpartum. They were randomized into a control arm or a web-based intervention arm at the end of the baseline visit at six weeks postpartum. At the end of the recruitment period, we compared population characteristics of our enrolled subjects to the entire population of women with GDM delivering at Brigham and Women's Hospital (BWH). We successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum. 78 subjects attended the initial baseline visit, and 75 subjects were randomized into the trial at a mean 7 (SD ± 2) weeks postpartum. The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period. Our multilevel approach allowed us to successfully meet our recruitment goal and recruit a representative sample of women with recent GDM. We believe that our most successful strategies included using a dedicated in-person recruiter, integrating recruitment into clinical flow, allowing for flexibility in recruitment, minimizing barriers to participation, and using an opt-out strategy with providers. Although the majority of women were recruited while pregnant, women recruited in the early postpartum period were more likely to present for the first study visit. Given the increased challenges of recruiting postpartum women with GDM into research studies, we believe our findings will be useful to other investigators seeking to study this population.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

PubMed

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Efficacy of a store-based environmental change intervention compared with a delayed treatment control condition on store customers’ intake of fruits and vegetables

PubMed Central

Ayala, Guadalupe X; Baquero, Barbara; Laraia, Barbara A; Ji, Ming; Linnan, Laura

2013-01-01

Objective The present store-based intervention was designed to promote sales of fruits and vegetables (F&V) to increase intake among store customers – specifically customers of tiendas, small-to-medium-sized Latino food stores. Design Four tiendas were randomized to a 2-month environmental change intervention or a delayed treatment control condition. Employees and managers were trained to promote F&V sales, including how to implement a food marketing campaign and installing store equipment to promote fresh fruits and vegetables. The primary outcome was self-reported daily intake of F&V among a convenience sample of customers (at least forty per store) collected at baseline prior to randomization and then 4 months later. In addition, changes in availability of F&V in the tiendas, using unobtrusive observational methods, provided evidence of intervention fidelity. Setting Tiendas in central North Carolina. Subjects Participants included 179 customers who were recent immigrants from Mexico and Central America. Results A group-by-time interaction approached significance on daily servings of F&V; intervention customers reported an increase in F&V intake over time and as a function of the intervention (P≤0·06). Unexpectedly, self-efficacy for consuming more fruits (P≤0·01) and more vegetables (P≤0·06) decreased. In our store-level analyses, a group-by-time interaction was observed for availability of fresh and canned vegetables; the intervention increased availability of vegetables but not fruit. Conclusions Environmental change strategies to promote healthy eating are needed given the rates of obesity and diabetes in the Latino population. A store-based intervention was moderately effective at increasing customers’ reported F&V intake. Such strategies can have a public health impact on underserved populations. PMID:23561842

Efficacy of a store-based environmental change intervention compared with a delayed treatment control condition on store customers' intake of fruits and vegetables.

PubMed

Ayala, Guadalupe X; Baquero, Barbara; Laraia, Barbara A; Ji, Ming; Linnan, Laura

2013-11-01

The present store-based intervention was designed to promote sales of fruits and vegetables (F&V) to increase intake among store customers--specifically customers of tiendas, small-to-medium-sized Latino food stores. Four tiendas were randomized to a 2-month environmental change intervention or a delayed treatment control condition. Employees and managers were trained to promote F&V sales, including how to implement a food marketing campaign and installing store equipment to promote fresh fruits and vegetables. The primary outcome was self-reported daily intake of F&V among a convenience sample of customers (at least forty per store) collected at baseline prior to randomization and then 4 months later. In addition, changes in availability of F&V in the tiendas, using unobtrusive observational methods, provided evidence of intervention fidelity. Tiendas in central North Carolina. Participants included 179 customers who were recent immigrants from Mexico and Central America. A group-by-time interaction approached significance on daily servings of F&V; intervention customers reported an increase in F&V intake over time and as a function of the intervention (P < or = 0.06). Unexpectedly, self-efficacy for consuming more fruits (P < or = 0.01) and more vegetables (P < or = 0.06) decreased. In our store-level analyses, a group-by-time interaction was observed for availability of fresh and canned vegetables; the intervention increased availability of vegetables but not fruit. Environmental change strategies to promote healthy eating are needed given the rates of obesity and diabetes in the Latino population. A store-based intervention was moderately effective at increasing customers’ reported F&V intake. Such strategies can have a public health impact on underserved populations.

Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560].

PubMed

Steenstra, Ivan A; Anema, Johannes R; Bongers, Paulien M; de Vet, Henrica C W; van Mechelen, Willem

2003-11-21

To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2-8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back pain management. An RCT and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain. Interventions used are 1. Communication between general practitioner and occupational physician plus Participative Ergonomics protocol performed by an ergonomist. 2. Graded Activity based on cognitive behavioural principles by a physiotherapist. 3. Usual care, provided by an occupational physician according to the Dutch guidelines for the occupational health management of workers with low back pain. The primary outcome measure is return to work. Secondary outcome measures are pain intensity, functional status and general improvement. Intermediate variables are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs due to low back pain. The outcome measures are assessed before randomization (after 2-6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave. The combination of these interventions has been subject of earlier research in Canada. The results of the current RCT will: 1. crossvalidate the Canadian findings in an different sociocultural environment; 2. add to the cost-effectiveness on treatment options for workers in the sub acute phase of low back pain. Results might lead to alterations of existing (inter)national guidelines.

A process of rumour scotching on finite populations.

PubMed

de Arruda, Guilherme Ferraz; Lebensztayn, Elcio; Rodrigues, Francisco A; Rodríguez, Pablo Martín

2015-09-01

Rumour spreading is a ubiquitous phenomenon in social and technological networks. Traditional models consider that the rumour is propagated by pairwise interactions between spreaders and ignorants. Only spreaders are active and may become stiflers after contacting spreaders or stiflers. Here we propose a competition-like model in which spreaders try to transmit an information, while stiflers are also active and try to scotch it. We study the influence of transmission/scotching rates and initial conditions on the qualitative behaviour of the process. An analytical treatment based on the theory of convergence of density-dependent Markov chains is developed to analyse how the final proportion of ignorants behaves asymptotically in a finite homogeneously mixing population. We perform Monte Carlo simulations in random graphs and scale-free networks and verify that the results obtained for homogeneously mixing populations can be approximated for random graphs, but are not suitable for scale-free networks. Furthermore, regarding the process on a heterogeneous mixing population, we obtain a set of differential equations that describes the time evolution of the probability that an individual is in each state. Our model can also be applied for studying systems in which informed agents try to stop the rumour propagation, or for describing related susceptible-infected-recovered systems. In addition, our results can be considered to develop optimal information dissemination strategies and approaches to control rumour propagation.

A process of rumour scotching on finite populations

PubMed Central

de Arruda, Guilherme Ferraz; Lebensztayn, Elcio; Rodrigues, Francisco A.; Rodríguez, Pablo Martín

2015-01-01

Rumour spreading is a ubiquitous phenomenon in social and technological networks. Traditional models consider that the rumour is propagated by pairwise interactions between spreaders and ignorants. Only spreaders are active and may become stiflers after contacting spreaders or stiflers. Here we propose a competition-like model in which spreaders try to transmit an information, while stiflers are also active and try to scotch it. We study the influence of transmission/scotching rates and initial conditions on the qualitative behaviour of the process. An analytical treatment based on the theory of convergence of density-dependent Markov chains is developed to analyse how the final proportion of ignorants behaves asymptotically in a finite homogeneously mixing population. We perform Monte Carlo simulations in random graphs and scale-free networks and verify that the results obtained for homogeneously mixing populations can be approximated for random graphs, but are not suitable for scale-free networks. Furthermore, regarding the process on a heterogeneous mixing population, we obtain a set of differential equations that describes the time evolution of the probability that an individual is in each state. Our model can also be applied for studying systems in which informed agents try to stop the rumour propagation, or for describing related susceptible–infected–recovered systems. In addition, our results can be considered to develop optimal information dissemination strategies and approaches to control rumour propagation. PMID:26473048

Specific Safety Profile of Bevacizumab in Asian Patients With Advanced NSCLC

PubMed Central

Chen, Zhenguang; Zhong, Beilong; Lun, Xueping; Lai, Yingrong; Bella, Amos Ela; Yang, Weilin; Wu, Jiabin

2015-01-01

Abstract Randomized studies have obtained varying findings regarding the benefits and toxicities of bevacizumab in the treatment of nonsmall cell lung cancer (NSCLC). It is unclear whether the discrepancies among trials are due to ethnic/racial differences. We therefore performed a meta-analysis of all published, randomized, controlled clinical trials involving bevacizumab in patients with NSCLC to assess its effectiveness and safety in Asian and non-Asian populations. Results from the phase II JO19907 trial, the phase III AVAiL and ECOG 4599 trials, and the phase IV SAiL trials were used to calculate the benefits and toxicities of bevacizumab in Asian and non-Asian patients. Combined statistical estimates, including hazard ratios and odds ratios, were calculated using fixed-effects and random-effects models. A total of 4308 patients were evaluated. Combining bevacizumab with different chemotherapy regimens resulted in similar objective response rates, overall survival, and progression-free survival in Asian and non-Asian populations. Disease control rates, however, were only reported in Asian populations. The rates of severe bleeding (relative risk [RR], 2.17; P = 0.02) and thromboembolism (RR, 3.65; P < 0.0001) were significantly higher, while the rate of severe proteinuria was significantly lower (RR, 0.43; P < 0.0001), in non-Asian than in Asian populations. The rates of severe hypertension (P = 0.71) and hemoptysis (P = 0.66) were similar in Asian and non-Asian populations. Bevacizumab combined with chemotherapy for first-line NSCLC treatment showed similar benefits in Asian and non-Asian populations, but had specific safety profiles in each. PMID:26091469

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children.

PubMed

Lepore, Stephen J; Winickoff, Jonathan P; Moughan, Beth; Bryant-Stephens, Tyra C; Taylor, Daniel R; Fleece, David; Davey, Adam; Nair, Uma S; Godfrey, Melissa; Collins, Bradley N

2013-08-30

Secondhand smoke exposure (SHSe) harms children's health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers' advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to "ask, advise, and refer" guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. NCT01745393 (clinicaltrials.gov).

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children

PubMed Central

2013-01-01

Background Secondhand smoke exposure (SHSe) harms children’s health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers’ advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. Methods/design This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. Discussion This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to “ask, advise, and refer” guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. Trial registration NCT01745393 (clinicaltrials.gov). PMID:23987302

Randomized Clinical Trial of Clinic-Integrated, Low-Intensity Treatment to Prevent Deterioration of Disease Care in Adolescents With Type 1 Diabetes

PubMed Central

Holmes, Clarissa S.; Chen, Rusan; Mackey, Eleanor; Grey, Margaret; Streisand, Randi

2014-01-01

OBJECTIVE To evaluate the efficacy of two office-based treatments designed to prevent deterioration in glycemic control in young adolescents with type 1 diabetes in a randomized clinical trial. An individualized, more intensive family teamwork Coping skills program was compared with a diabetes Education treatment. RESEARCH DESIGN AND METHODS A baseline assessment was followed by four brief treatment sessions and immediate posttesting over the course of 1.5 years. Families of 226 early adolescents (ages 11–14) were randomized to receive either individualized coping skills education or diabetes education as adjunctive treatment to quarterly medical appointments. Continued follow-up occurred at 3.5-month intervals for a long-term follow-up of up to 3 years. A post hoc Usual Care group facilitated comparisons of glycemic control. RESULTS Growth curve analysis showed that both treatment groups successfully prevented deterioration in adolescent disease care and simultaneously improved adolescent and parent quality of life that included indicators of more effective communication and reduced adherence barriers—without a concomitant increase in diabetes-related or general family conflict. However, contrary to expectation, the Education group was more efficacious than the Coping group in improvement of disease adherence and glycemic control over a 3-year follow-up. CONCLUSIONS Low-intensity office-based quarterly treatment can maintain or improve disease care adherence in early adolescence when provided to adolescent/parent dyads. Better outcomes are achieved when treatment goals and techniques match the needs of the targeted population. PMID:24623027

Mapping the receptivity of malaria risk to plan the future of control in Somalia

PubMed Central

Alegana, Victor Adagi; Patil, Anand Prabhakar; Moloney, Grainne; Borle, Mohammed; Yusuf, Fahmi; Amran, Jamal; Snow, Robert William

2012-01-01

Objectives To measure the receptive risks of malaria in Somalia and compare decisions on intervention scale-up based on this map and the more widely used contemporary risk maps. Design Cross-sectional community Plasmodium falciparum parasite rate (PfPR) data for the period 2007–2010 corrected to a standard age range of 2 to <10 years (PfPR2–10) and used within a Bayesian space–time geostatistical framework to predict the contemporary (2010) mean PfPR2–10 and the maximum annual mean PfPR2–10 (receptive) from the highest predicted PfPR2–10 value over the study period as an estimate of receptivity. Setting Randomly sampled communities in Somalia. Participants Randomly sampled individuals of all ages. Main outcome measure Cartographic descriptions of malaria receptivity and contemporary risks in Somalia at the district level. Results The contemporary annual PfPR2–10 map estimated that all districts (n=74) and population (n=8.4 million) in Somalia were under hypoendemic transmission (≤10% PfPR2–10). Of these, 23% of the districts, home to 13% of the population, were under transmission of <1% PfPR2–10. About 58% of the districts and 55% of the population were in the risk class of 1% to <5% PfPR2–10. In contrast, the receptivity map estimated 65% of the districts and 69% of the population were under mesoendemic transmission (>10%–50% PfPR2–10) and the rest as hypoendemic. Conclusion Compared with maps of receptive risks, contemporary maps of transmission mask disparities of malaria risk necessary to prioritise and sustain future control. As malaria risk declines across Africa, efforts must be invested in measuring receptivity for efficient control planning. PMID:22855625

Overall mortality among patients surviving an episode of peptic ulcer bleeding

PubMed Central

Ruigomez, A.; Rodriguez, L. A.; Hasselgren, G.; Johansson, S.; Wallander, M.

2000-01-01

STUDY OBJECTIVE—The authors investigated whether patients who have survived an acute episode of peptic ulcer bleeding (PUB) have an excess long term all cause mortality compared with the general population free of PUB.
DESIGN—Follow up study of previously identified cohort of patients with a PUB episode and a general population cohort.
SETTING—The source population included all people aged 30 to 89 years, registered with general practitioners in the United Kingdom.
PATIENTS—All patients alive one month after the PUB episode constituted the cohort of PUB patients (n=978). A control group of 5000 people was randomly sampled from the source population. The same eligibility criteria as for patients with PUB were applied to the control series. Also, controls had to be free of PUB before start date.
MAIN RESULTS—Relative risk of mortality among PUB patients was 2.1, 95%CI: 1.7, 2.6) compared with the general population. This increased mortality risk occurred mainly in the patients less than 60 years old. No difference was observed between men and women. The excess mortality was not only circumscribed to deaths attributable to recurrent gastrointestinal bleed, but also cardiovascular, cancer and other causes.
CONCLUSIONS—People who have survived an acute episode of PUB have a reduced long term survival compared with the general population.This reduction was stronger among middle age patients than in the elderly.


Keywords: cohort study; mortality; peptic ulcer; bleeding; population-based study PMID:10715746

Assessing Health Promotion Interventions: Limitations of Traditional Research Methods in Community-Based Studies.

PubMed

Dressel, Anne; Schneider, Robert; DeNomie, Melissa; Kusch, Jennifer; Welch, Whitney; Sosa, Mirtha; Yeldell, Sally; Maida, Tatiana; Wineberg, Jessica; Holt, Keith; Bernstein, Rebecca

2017-09-01

Most low-income Americans fail to meet physical activity recommendations. Inactivity and poor diet contribute to obesity, a risk factor for multiple chronic diseases. Health promotion activities have the potential to improve health outcomes for low-income populations. Measuring the effectiveness of these activities, however, can be challenging in community settings. A "Biking for Health" study tested the impact of a bicycling intervention on overweight or obese low-income Latino and African American adults to reduce barriers to cycling and increase physical activity and fitness. A randomized controlled trial was conducted in Milwaukee, Wisconsin, in summer 2015. A 12-week bicycling intervention was implemented at two sites with low-income, overweight, or obese Latino and African American adults. We found that randomized controlled trial methodology was suboptimal for use in this small pilot study and that it negatively affected participation. More discussion is needed about the effectiveness of using traditional research methods in community settings to assess the effectiveness of health promotion interventions. Modifications or alternative methods may yield better results. The aim of this article is to discuss the effectiveness and feasibility of using traditional research methods to assess health promotion interventions in community-based settings.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

PubMed

Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

2014-02-26

Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927. PMID:24568299

Selecting at-risk populations for sexually transmitted disease/HIV intervention studies.

PubMed

Wu, Zunyou; Rotheram-Borus, Mary Jane; Detels, Roger; Li, Li; Guan, Jihui; Liang, Guojun; Yap, Lorraine

2007-12-01

This paper describes one option to select populations for randomized, controlled trials (RCT). We used a popular opinion leader intervention in Fuzhou, China, to: (1) identify population selection criteria; (2) systematically examine the suitability of potential target populations and settings; (3) briefly evaluate risk and stability in the population; and (4) evaluate regional and organizational support among administrators and government officials. After comparing migrant villagers, truck drivers, factory workers, construction workers, and market employees in five regions of China, market employees in Fuzhou were identified as the optimal target population. Markets were the optimal sites for several reasons: (1) the population demonstrated a sufficient base rate of sexually transmitted diseases; (2) the population was stable over time; (3) a sufficient number of sites of manageable sizes were available; (4) stable networks existed; (5) local gatekeepers/stakeholders supported the intervention; (6) there was organizational capacity in the local health department to mount the intervention; (7) the demographic profile was similar across potential sites; and (8) the sites were sufficiently distanced to minimize contamination. Evaluating intervention efficacy in an RCT requires a time-consuming and rigorous process that systematically and routinely documents selection criteria, evaluates multiple populations, sites, and organizations for their appropriateness.

Vernal keratoconjunctivitis in school children in Rwanda and its association with socio-economic status: a population-based survey.

PubMed

Smedt, Stefan De; Nkurikiye, John; Fonteyne, Yannick; Hogewoning, Arjan; Esbroeck, Marjan Van; Bacquer, Dirk De; Tuft, Stephen; Gilbert, Clare; Delanghe, Joris; Kestelyn, Philippe

2011-10-01

Vernal keratoconjunctivitis (VKC) is an allergic eye disease and an important cause of hospital referral among children in Africa and Asia. Hospital-based studies have suggested a role for parasites in its pathogenesis. To determine the prevalence and risk factors for VKC in Central Africa, we conducted a nested population-based case control study in Rwanda, involving randomly selected primary schools from different environments (rural/urban) and climate. A prevalence of VKC of 4.0% (95% confidence interval 3.3-4.7%) was found among 3,041 children studied (participation rate 94.7%). The intestinal parasitic burden was not related to VKC. Besides hot dry climate (odds ratio [OR] = 1.5, P = 0.05) and male gender (OR = 1.7, P = 0.005), multivariate analysis identified higher economic status as a risk for VKC (OR = 1.4, P = 0.005). The effect on VKC of higher economic status appears not to act through differences in parasitic intestinal load.

Vernal Keratoconjunctivitis in School Children in Rwanda and Its Association with Socio-Economic Status: A Population-Based Survey

PubMed Central

Smedt, Stefan De; Nkurikiye, John; Fonteyne, Yannick; Hogewoning, Arjan; Esbroeck, Marjan Van; Bacquer, Dirk De; Tuft, Stephen; Gilbert, Clare; Delanghe, Joris; Kestelyn, Philippe

2011-01-01

Vernal keratoconjunctivitis (VKC) is an allergic eye disease and an important cause of hospital referral among children in Africa and Asia. Hospital-based studies have suggested a role for parasites in its pathogenesis. To determine the prevalence and risk factors for VKC in Central Africa, we conducted a nested population-based case control study in Rwanda, involving randomly selected primary schools from different environments (rural/urban) and climate. A prevalence of VKC of 4.0% (95% confidence interval 3.3–4.7%) was found among 3,041 children studied (participation rate 94.7%). The intestinal parasitic burden was not related to VKC. Besides hot dry climate (odds ratio [OR] = 1.5, P = 0.05) and male gender (OR = 1.7, P = 0.005), multivariate analysis identified higher economic status as a risk for VKC (OR = 1.4, P = 0.005). The effect on VKC of higher economic status appears not to act through differences in parasitic intestinal load. PMID:21976577

Peer education for secondary stroke prevention in inner-city minorities: design and methods of the prevent recurrence of all inner-city strokes through education randomized controlled trial.

PubMed

Goldfinger, Judith Z; Kronish, Ian M; Fei, Kezhen; Graciani, Albert; Rosenfeld, Peri; Lorig, Kate; Horowitz, Carol R

2012-09-01

The highest risk for stroke is among survivors of strokes or transient ischemic attacks (TIA). However, use of proven-effective cardiovascular medications to control stroke risk is suboptimal, particularly among the Black and Latino populations disproportionately impacted by stroke. A partnership of Harlem and Bronx community representatives, stroke survivors, researchers, clinicians, outreach workers and patient educators used community-based participatory research to conceive and develop the Prevent Recurrence of All Inner-city Strokes through Education (PRAISE) trial. Using data from focus groups with stroke survivors, they tailored a peer-led, community-based chronic disease self-management program to address stroke risk factors. PRAISE will test, in a randomized controlled trial, whether this stroke education intervention improves blood pressure control and a composite outcome of blood pressure control, lipid control, and use of antithrombotic medications. Of the 582 survivors of stroke and TIA enrolled thus far, 81% are Black or Latino and 56% have an annual income less than $15,000. Many (33%) do not have blood pressures in the target range, and most (66%) do not have control of all three major stroke risk factors. Rates of stroke recurrence risk factors remain suboptimal in the high risk, urban, predominantly minority communities studied. With a community-partnered approach, PRAISE has recruited a large number of stroke and TIA survivors to date, and may prove successful in engaging those at highest risk for stroke and reducing disparities in stroke outcomes in inner-city communities. Copyright © 2012 Elsevier Inc. All rights reserved.

Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

PubMed Central

Hund, Lauren; Pagano, Marcello

2014-01-01

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible non-parametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. PMID:24633656

Financial incentives for smoking cessation in low-income smokers: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Tobacco smoking is the leading avoidable cause of death in high-income countries. The smoking-related disease burden is borne primarily by the least educated and least affluent groups. Thus, there is a need for effective smoking cessation interventions that reach to, and are effective in this group. Research suggests that modest financial incentives are not very effective in helping smokers quit. What is not known is whether large financial incentives can enhance longer-term (1 year) smoking cessation rates, outside clinical and workplace settings. Trial design A randomized, parallel groups, controlled trial. Methods Participants: Eight hundred low-income smokers in Switzerland (the less affluent third of the population, based on fiscal taxation). Intervention: A smoking cessation program including: (a) financial incentives given during 6 months; and (b) Internet-based counseling. Financial rewards will be offered for biochemically verified smoking abstinence after 1, 2, and 3 weeks and 1, 3, and 6 months, for a maximum of 1,500 CHF (1,250 EUR, 1,500 USD) for those abstinent at all time-points. All participants, including controls, will receive Internet-based, individually-tailored, smoking cessation counseling and self-help booklets, but there will be no in-person or telephone counseling, and participants will not receive medications. The control group will not receive financial incentives. Objective: To increase smoking cessation rates. Outcome: Smoking abstinence after 6 and 18 months, not contradicted by biochemical tests. We will assess relapse after the end of the intervention, to test whether 6-month effects translate into sustained abstinence 12 months after the incentives are withdrawn. Randomization: Will be done using sealed envelopes drawn by participants. Blinding: Is not possible in this context. Discussion Smoking prevention policies and interventions have been least effective in the least educated, low-income groups. Combining financial incentives and Internet-based counseling is an innovative approach that, if proven acceptable and effective, could be later implemented on a large scale at a reasonable cost, decrease health disparities, and save many lives. Trial registration Current Controlled Trials ISRCTN04019434. PMID:22721577

Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

PubMed

Ebenfeld, Lara; Kleine Stegemann, Stefan; Lehr, Dirk; Ebert, David Daniel; Jazaieri, Hooria; van Ballegooijen, Wouter; Funk, Burkhardt; Riper, Heleen; Berking, Matthias

2014-11-04

Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks. A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol. To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults. German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

PubMed Central

Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user’s daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology. PMID:28983477

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial.

PubMed

Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N  = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user's daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology.

Generalizability of findings from randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

PubMed

Susukida, Ryoko; Crum, Rosa M; Ebnesajjad, Cyrus; Stuart, Elizabeth A; Mojtabai, Ramin

2017-07-01

To compare randomized controlled trial (RCT) sample treatment effects with the population effects of substance use disorder (SUD) treatment. Statistical weighting was used to re-compute the effects from 10 RCTs such that the participants in the trials had characteristics that resembled those of patients in the target populations. Multi-site RCTs and usual SUD treatment settings in the United States. A total of 3592 patients in 10 RCTs and 1 602 226 patients from usual SUD treatment settings between 2001 and 2009. Three outcomes of SUD treatment were examined: retention, urine toxicology and abstinence. We weighted the RCT sample treatment effects using propensity scores representing the conditional probability of participating in RCTs. Weighting the samples changed the significance of estimated sample treatment effects. Most commonly, positive effects of trials became statistically non-significant after weighting (three trials for retention and urine toxicology and one trial for abstinence); also, non-significant effects became significantly positive (one trial for abstinence) and significantly negative effects became non-significant (two trials for abstinence). There was suggestive evidence of treatment effect heterogeneity in subgroups that are under- or over-represented in the trials, some of which were consistent with the differences in average treatment effects between weighted and unweighted results. The findings of randomized controlled trials (RCTs) for substance use disorder treatment do not appear to be directly generalizable to target populations when the RCT samples do not reflect adequately the target populations and there is treatment effect heterogeneity across patient subgroups. © 2017 Society for the Study of Addiction.

Effectiveness of active-online, an individually tailored physical activity intervention, in a real-life setting: randomized controlled trial.

PubMed

Wanner, Miriam; Martin-Diener, Eva; Braun-Fahrländer, Charlotte; Bauer, Georg; Martin, Brian W

2009-07-28

Effective interventions are needed to reduce the chronic disease epidemic. The Internet has the potential to provide large populations with individual advice at relatively low cost. The focus of the study was the Web-based tailored physical activity intervention Active-online. The main research questions were (1) How effective is Active-online, compared to a nontailored website, in increasing self-reported and objectively measured physical activity levels in the general population when delivered in a real-life setting? (2) Do respondents recruited for the randomized study differ from spontaneous users of Active-online, and how does effectiveness differ between these groups? (3) What is the impact of frequency and duration of use of Active-online on changes in physical activity behavior? Volunteers recruited via different media channels completed a Web-based baseline survey and were randomized to Active-online (intervention group) or a nontailored website (control group). In addition, spontaneous users were recruited directly from the Active-online website. In a subgroup of participants, physical activity was measured objectively using accelerometers. Follow-up assessments took place 6 weeks (FU1), 6 months (FU2), and 13 months (FU3) after baseline. A total of 1531 respondents completed the baseline questionnaire (intervention group n = 681, control group n = 688, spontaneous users n = 162); 133 individuals had valid accelerometer data at baseline. Mean age of the total sample was 43.7 years, and 1146 (74.9%) were women. Mixed linear models (adjusted for sex, age, BMI category, and stage of change) showed a significant increase in self-reported mean minutes spent in moderate- and vigorous-intensity activity from baseline to FU1 (coefficient = 0.14, P = .001) and to FU3 (coefficient = 0.19, P < .001) in all participants with no significant differences between groups. A significant increase in the proportion of individuals meeting the HEPA recommendations (self-reported) was observed in all participants between baseline and FU3 (OR = 1.47, P = .03), with a higher increase in spontaneous users compared to the randomized groups (interaction between FU3 and spontaneous users, OR = 2.95, P = .02). There were no increases in physical activity over time in any group for objectively measured physical activity. A significant relation was found between time spent on the tailored intervention and changes in self-reported physical activity between baseline and FU3 (coefficient = 1.13, P = .03, intervention group and spontaneous users combined). However, this association was no longer significant when adjusting for stage of change. In a real-life setting, Active-online was not more effective than a nontailored website in increasing physical activity levels in volunteers from the general population. Further research may investigate ways of integrating Web-based physical activity interventions in a wider context, for example, primary care or workplace health promotion.

Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study)

PubMed Central

2013-01-01

Background Colorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening. Methods/Design A total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC. Discussion This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC. Trial registration ClinicalTrials.gov Identifier: NCT01651624. PMID:23497601

Cervical cancer patterns with automation-assisted and conventional cytological screening: a randomized study.

PubMed

Anttila, Ahti; Pokhrel, Arun; Kotaniemi-Talonen, Laura; Hakama, Matti; Malila, Nea; Nieminen, Pekka

2011-03-01

The purpose was to evaluate alternative cytological screening methods in population-based screening for cervical cancer up to cancer incidence and mortality outcome. Automation-assisted screening was compared to conventional cytological screening in a randomized design. The study was based on follow-up of 503,391 women invited in the Finnish cervical cancer screening program during 1999-2003. The endpoints were incident cervical cancer, severe intraepithelial neoplasia and deaths from cervical cancer. One third of the women had been randomly allocated to automation-assisted screening and two thirds to conventional cytology. Information on cervical cancer and severe neoplasia were obtained through 1999-2007 from a linkage between screening and cancer registry files. There were altogether 3.2 million woman-years at risk, and the average follow-up time was 6.3 years. There was no difference in the risk of cervical cancer between the automation-assisted and conventional screening methods; the relative risk (RR) of cervical cancer between the study and control arm was 1.00 (95% confidence interval [CI] = 0.76-1.29) among all invited and 1.08 (95% CI = 0.76-1.51) among women who were test negative at entry. Comparing women who were test negative with nonscreened, RR of cervical cancer incidence was 0.26, 95% CI = 0.19-0.36 and of mortality 0.24 (0.13-0.43). Both methods were valid for screening. Because cervical cancer is rare in our country, we cannot rule out small differences between methods. Evidence on alternative methods for cervical cancer screening is increasing and it is thus feasible to evaluate new methods in large-scale population-based screening programs up to cancer outcome. Copyright © 2010 UICC.

Adaptive adjustment of the randomization ratio using historical control data

PubMed Central

Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

2013-01-01

Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on pre-existing information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare. PMID:23690095

Adaptive adjustment of the randomization ratio using historical control data.

PubMed

Hobbs, Brian P; Carlin, Bradley P; Sargent, Daniel J

2013-01-01

Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare.

Virtual reality measures in neuropsychological assessment: a meta-analytic review.

PubMed

Neguț, Alexandra; Matu, Silviu-Andrei; Sava, Florin Alin; David, Daniel

2016-02-01

Virtual reality-based assessment is a new paradigm for neuropsychological evaluation, that might provide an ecological assessment, compared to paper-and-pencil or computerized neuropsychological assessment. Previous research has focused on the use of virtual reality in neuropsychological assessment, but no meta-analysis focused on the sensitivity of virtual reality-based measures of cognitive processes in measuring cognitive processes in various populations. We found eighteen studies that compared the cognitive performance between clinical and healthy controls on virtual reality measures. Based on a random effects model, the results indicated a large effect size in favor of healthy controls (g = .95). For executive functions, memory and visuospatial analysis, subgroup analysis revealed moderate to large effect sizes, with superior performance in the case of healthy controls. Participants' mean age, type of clinical condition, type of exploration within virtual reality environments, and the presence of distractors were significant moderators. Our findings support the sensitivity of virtual reality-based measures in detecting cognitive impairment. They highlight the possibility of using virtual reality measures for neuropsychological assessment in research applications, as well as in clinical practice.

Use of medications by people with chronic fatigue syndrome and healthy persons: a population-based study of fatiguing illness in Georgia.

PubMed

Boneva, Roumiana S; Lin, Jin-Mann S; Maloney, Elizabeth M; Jones, James F; Reeves, William C

2009-07-20

Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology and no definitive pharmacotherapy. Patients are usually prescribed symptomatic treatment or self-medicate. We evaluated prescription and non-prescription drug use among persons with CFS in Georgia and compared it to that in non-fatigued Well controls and also to chronically Unwell individuals not fully meeting criteria for CFS. A population-based, case-control study. To identify persons with possible CFS-like illness and controls, we conducted a random-digit dialing telephone screening of 19,807 Georgia residents, followed by a detailed telephone interview of 5,630 to identify subjects with CFS-like illness, other chronically Unwell, and Well subjects. All those with CFS-like illness (n = 469), a random sample of chronically Unwell subjects (n = 505), and Well individuals (n = 641) who were age-, sex-, race-, and geographically matched to those with CFS-like illness were invited for a clinical evaluation and 783 participated (48% overall response rate). Clinical evaluation identified 113 persons with CFS, 264 Unwell subjects with insufficient symptoms for CFS (named ISF), and 124 Well controls; the remaining 280 subjects had exclusionary medical or psychiatric conditions, and 2 subjects could not be classified. Subjects were asked to bring all medications taken in the past 2 weeks to the clinic where a research nurse viewed and recorded the name and the dose of each medication. More than 90% of persons with CFS used at least one drug or supplement within the preceding two weeks. Among users, people with CFS used an average of 5.8 drugs or supplements, compared to 4.1 by ISF and 3.7 by Well controls. Persons with CFS were significantly more likely to use antidepressants, sedatives, muscle relaxants, and anti-acids than either Well controls or the ISF group. In addition, persons with CFS were significantly more likely to use pain-relievers, anti-histamines and cold/sinus medications than were Well controls. Medical care providers of patients with chronic fatigue syndrome should be aware of polypharmacy as a problem in such patients, and the related potential iatrogenic effects and drug interactions.

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial.

PubMed

Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

2017-08-04

Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. This will be analyzed by negative binomial regression, yielding density ratios. This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources. Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial.

PubMed

Rachyla, Iryna; Pérez-Ara, Marian; Molés, Mar; Campos, Daniel; Mira, Adriana; Botella, Cristina; Quero, Soledad

2018-05-31

Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet-based intervention for AjD in the Spanish population. ClinicalTrial.gov: NCT02758418 . Trial registration date 2 May 2016.

Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial.

PubMed

Fowler, Eileen G; Knutson, Loretta M; Demuth, Sharon K; Siebert, Kara L; Simms, Victoria D; Sugi, Mia H; Souza, Richard B; Karim, Roksana; Azen, Stanley P

2010-03-01

Effective interventions to improve and maintain strength (force-generating capacity) and endurance are needed for children with cerebral palsy (CP). This study was performed to examine the effects of a stationary cycling intervention on muscle strength, locomotor endurance, preferred walking speed, and gross motor function in children with spastic diplegic CP. This was a phase I randomized controlled trial with single blinding. The interventions were performed in community-based outpatient physical therapy clinics. Outcome assessments were performed in university laboratories. Sixty-two ambulatory children aged 7 to 18 years with spastic diplegic CP and Gross Motor Function Classification System levels I to III participated in this study. Participants were randomly assigned to cycling or control (no-intervention) groups. Thirty intervention sessions occurred over 12 weeks. Primary outcomes were peak knee extensor and flexor moments, the 600-Yard Walk-Run Test, the Thirty-Second Walk Test, and the Gross Motor Function Measure sections D and E (GMFM-66). Significant baseline-postintervention improvements were found for the 600-Yard Walk-Run Test, the GMFM-66, peak knee extensor moments at 120 degrees /s, and peak knee flexor moments at 30 degrees /s for the cycling group. Improved peak knee flexor moments at 120 degrees/s were found for the control group only, although not all participants could complete this speed of testing. Significant differences between the cycling and control groups based on change scores were not found for any outcomes. Limitations Heterogeneity of the patient population and intrasubject variability were limitations of the study. Significant improvements in locomotor endurance, gross motor function, and some measures of strength were found for the cycling group but not the control group, providing preliminary support for this intervention. As statistical differences were not found in baseline-postintervention change scores between the 2 groups; the results did not demonstrate that stationary cycling was more effective than no intervention. The results of this phase I study provide guidance for future research.

The effect of newly induced mutations on the fitness of genotypes and populations of yeast (Saccharomyces cerevisiae).

PubMed

Orthen, E; Lange, P; Wöhrmann, K

1984-12-01

This paper analyses the fate of artificially induced mutations and their importance to the fitness of populations of the yeast, Saccharomyces cerevisiae, an increasingly important model organism in population genetics. Diploid strains, treated with UV and EMS, were cultured asexually for approximately 540 generations and under conditions where the asexual growth was interrupted by a sexual phase. Growth rates of 100 randomly sampled diploid clones were estimated at the beginning and at the end of the experiment. After the induction of sporulation the growth rates of 100 randomly sampled spores were measured. UV and EMS treatment decreases the average growth rate of the clones significantly but increases the variability in comparison to the untreated control. After selection over approximately 540 generations, variability in growth rates was reduced to that of the untreated control. No increase in mean population fitness was observed. However, the results show that after selection there still exists a large amount of hidden genetic variability in the populations which is revealed when the clones are cultivated in environments other than those in which selection took place. A sexual phase increased the reduction of the induced variability.

Association between osteoporosis and urinary calculus: evidence from a population-based study.

PubMed

Keller, J J; Lin, C-C; Kang, J-H; Lin, H-C

2013-02-01

This population-based case-control analysis investigated the association between osteoporosis and prior urinary calculus (UC) in Taiwan. We succeeded in detecting an association between osteoporosis and prior UC (adjusted odds ratio = 1.66). This association was consistent and significant regardless of stone location. UC has been demonstrated to be a risk factor for osteoporotic fractures, but no studies to date have directly investigated the association between UC and osteoporosis. This case-control analysis aimed to investigate the association of osteoporosis with prior UC using a population-based dataset in Taiwan. We first identified 39,840 cases ≥40 years who received their first-time diagnosis of osteoporosis between 2002 and 2009 and then randomly selected 79,680 controls. We used conditional logistic regression analyses to compute the odds ratio (OR) and the corresponding 95 % confidence interval (CI) for having been previously diagnosed with UC between cases and controls. The OR of having been previously diagnosed with UC for patients with osteoporosis was 1.66 (95 % CI = 1.59-1.73) when compared to controls after adjusting for geographic location, urbanization level, type I diabetes mellitus, coronary heart disease, hyperlipidemia, rheumatoid arthritis, stroke, renal disease, Parkinson's disease, hyperthyroidism, chronic hepatopathy, Cushing's syndrome, malabsorption, gastrectomy, obesity, and alcohol abuse/alcohol dependence syndrome. The results consistently showed that osteoporosis was significantly associated with a previous diagnosis of UC regardless of stone location; the adjusted ORs of prior kidney calculus, ureter calculus, bladder calculus, and unspecified calculus when compared to controls were 1.71 (95 % CI = 1.61-1.81), 1.60 (95 % CI = 1.47-1.74), 1.59 (95 % CI = 1.23-2.04), and 1.69 (95 % CI = 1.59-1.80), respectively. This study succeeded in detecting an association between osteoporosis and prior UC. In addition, our findings were consistent and significant regardless of stone location.

An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

PubMed

Miranda, Joyal; Côté, José; Godin, Gaston; Blais, Martin; Otis, Joanne; Guéhéneuc, Yann-Gaël; Fadel, Ghayas; Barton, Luisa; Fowler, Shawn

2013-10-16

In the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue. Condom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study. We will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant's group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test). The study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost-effective and widely accessible approach to HIV prevention for HIV-positive MSM. Internet-based interventions for HIV-positive MSM, a population that has been under-represented in the efforts for positive prevention of HIV within Canada, have the potential to provide a cost-effective strategy, which influences the way in which information is accessed and provided to high-risk individuals. The advantages of an Internet-based intervention include the potential to provide consistency in the delivery of an intervention and the ability to disseminate the intervention to a wider population. Internet-based interventions are perceived as vital tools in combating HIV infection within the realm of social media. Therefore, it is important to determine the feasibility and acceptability of these interventions before implementing them. Clinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).

Effectiveness of music-based interventions on motricity or cognitive functioning in neurological populations: a systematic review.

PubMed

Moumdjian, Lousin; Sarkamo, Teppo; Leone, Carmela; Leman, Marc; Feys, Peter

2017-06-01

Motor and cognitive symptoms are frequent in persons with neurological disorders and often require extensive long-term rehabilitation. Recently, a variety of music-based interventions have been introduced into neurological rehabilitation as training tools. This review aims to 1) describe and define music-based intervention modalities and content which are applied in experimental studies; and 2) describe the effects of these interventions on motor and/or cognitive symptoms in the neurological population. The databases PubMed and Web of Science were searched. Cited references of included articles where screened for potential inclusion. A systematic literature search up to 20th of June 2016 was conducted to include controlled trials and cohort studies that have used music-based interventions for ≥3 weeks in the neurological population (in- and outpatients) targeting motor and/or cognitive symptoms. No limitations to publication date was set. EVIDENCE SYNTHESISː Nineteen articles comprising thirteen randomized controlled trials (total participants Nexp=241, Nctrl=269), four controlled trials (Nexp=59, Nctrl=53) and two cohort studies (N.=27) were included. Fourteen studies were conducted in stroke, three in Parkinson's disease, and two in multiple sclerosis population. Modalities of music-based interventions were clustered into four groups: instrument-based, listening-based, rhythm-based, and multicomponent-based music interventions. Overall, studies consistently showed that music-based interventions had similar or larger effects than conventional rehabilitation on upper limb function (N.=16; fine motricity, hand and arm capacity, finger and hand tapping velocity/variability), mobility (N.=7; gait parameters), and cognition (N.=4; verbal memory and focused attention). CONCLUSIONSː Variety of modalities using music-based interventions has been identified and grouped into four clusters. Effects of interventions demonstrate an improvement in the domains assessed. Evidence is most available for improving motricity in stroke. More studies are warranted to investigate cognition as well as motor and cognition dysfunctions in combination. Instrument-based music interventions can improve fine motor dexterity and gross motor functions in stroke. Rhythm-based music interventions can improve gait parameters of velocity and cadence in stroke, Parkinson's disease and multiple sclerosis. Cognition in the domains of verbal memory and focused attention can improve after listening-based music interventions in stroke.

Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials

ERIC Educational Resources Information Center

Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

2017-01-01

A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating…

1/f oscillations in a model of moth populations oriented by diffusive pheromones

NASA Astrophysics Data System (ADS)

Barbosa, L. A.; Martins, M. L.; Lima, E. R.

2005-01-01

An individual-based model for the population dynamics of Spodoptera frugiperda in a homogeneous environment is proposed. The model involves moths feeding plants, mating through an anemotaxis search (i.e., oriented by odor dispersed in a current of air), and dying due to resource competition or at a maximum age. As observed in the laboratory, the females release pheromones at exponentially distributed time intervals, and it is assumed that the ranges of the male flights follow a power-law distribution. Computer simulations of the model reveal the central role of anemotaxis search for the persistence of moth population. Such stationary populations are exponentially distributed in age, exhibit random temporal fluctuations with 1/f spectrum, and self-organize in disordered spatial patterns with long-range correlations. In addition, the model results demonstrate that pest control through pheromone mass trapping is effective only if the amounts of pheromone released by the traps decay much slower than the exponential distribution for calling female.

Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial.

PubMed

Coscia, Alessandra; Bertino, Enrico; Tonetto, Paola; Peila, Chiara; Cresi, Francesco; Arslanoglu, Sertac; Moro, Guido E; Spada, Elena; Milani, Silvano; Giribaldi, Marzia; Antoniazzi, Sara; Conti, Amedeo; Cavallarin, Laura

2018-01-09

Fortification of human milk is a standard practice for feeding very low birth weight infants. However, preterm infants often still experience suboptimal growth and feeding intolerance. New fortification strategies and different commercially available fortifiers have been developed. Commercially available fortifiers are constituted by a blend of ingredients from different sources, including plant oils and bovine milk proteins, thus presenting remarkable differences in the quality of macronutrients with respect to human milk. Based on the consideration that donkey milk has been suggested as a valid alternative for children allergic to cow's milk proteins, due to its biochemical similarity to human milk, we hypothesized that donkey milk could be a suitable ingredient for developing an innovative human milk fortifier. The aim of the study is to evaluate feeding tolerance, growth and clinical short and long-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk, in comparison to an analogous population fed with traditional fortifier and protein supplement containing bovine milk proteins. The study has been designed as a randomized, controlled, single-blind clinical trial. Infants born <1500 g and <32 weeks of gestational age were randomized to receive for 21 days either a combination of control bovine milk-based multicomponent fortifier and protein supplement, or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The fortification protocol followed is the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. Weight, length and head circumference are measured; feeding tolerance is assessed by a standardized protocol. The occurrence of sepsis, necrotizing enterocolitis and adverse effects are monitored. This is the first clinical study investigating the use of a human milk fortifier derived from donkey milk for the nutrition of preterm infants. If donkey milk derived products will be shown to improve the feeding tolerance or either of the clinical, metabolic, neurological or auxological outcomes of preterm infants, it would be an absolute innovation in the field of feeding practices for preterm infants. ISRCTN - ISRCTN70022881 .

Improving prospective memory in persons with Parkinson disease: A randomized controlled trial

PubMed Central

Foster, Erin R.; McDaniel, Mark A.; Rendell, Peter G.

2017-01-01

Background Prospective memory is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause prospective memory deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions is an encoding strategy that may improve prospective memory in this population. Objective To determine the effect of implementation intentions on prospective memory performance in PD. Methods This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (N = 62) performed a computerized prospective memory test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either implementation intentions or a rehearsal encoding strategy. Results Prospective memory performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared to time-based cues. In addition, implementation intentions resulted in a larger effect than rehearsal for the non-repeated tasks. Conclusions Strategies that support full encoding of prospective memory cues and actions can improve prospective memory performance among people with PD, particularly for tasks with cues that are readily available in the environment. Implementation intentions may be more effective than rehearsal for non-repeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage prospective memory impairment could improve function and quality of life and significantly impact clinical care for people with PD. (NCT01469741) PMID:28176547

Learning to dislike safe water products: results from a randomized controlled trial of the effects of direct and peer experience on willingness to pay.

PubMed

Luoto, Jill; Mahmud, Minhaj; Albert, Jeff; Luby, Stephen; Najnin, Nusrat; Unicomb, Leanne; Levine, David I

2012-06-05

Low-cost point-of-use (POU) safe water products have the potential to reduce waterborne illness, but adoption by the global poor remains low. We performed an eight-month randomized trial of four low-cost household water treatment products in Dhaka, Bangladesh. Intervention households (n = 600) received repeated educational messages about the importance of drinking safe water along with consecutive two-month free trials with each of four POU products in random order. Households randomly assigned to the control group (n = 200) did not receive free products or repeated educational messages. Households' willingness to pay for these products was quite low on average (as measured by bids in an incentive-compatible real-money auction), although a modest share was willing to pay the actual or expected retail price for low-cost chlorine-based products. Furthermore, contrary to our hypotheses that both one's own personal experience and the influence of one's peers would increase consumers' willingness to pay, direct experience significantly decreased mean bids by 18-55% for three of the four products and had no discernible effect on the fourth. Neighbor experience also did not increase bids. Widespread dissemination of safe water products is unlikely until we better understand the preferences and aspirations of these at-risk populations.

Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial.

PubMed

Buntrock, Claudia; Ebert, David Daniel; Lehr, Dirk; Smit, Filip; Riper, Heleen; Berking, Matthias; Cuijpers, Pim

2016-05-03

Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD. To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD. Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204). The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6). Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer. German Clinical Trial Registry Identifier: DRKS00004709.

An Innovative Multiphased Strategy to Recruit Underserved Adults into a Randomized Trial of a Community-Based Diabetes Risk Reduction Program

ERIC Educational Resources Information Center

Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.

2011-01-01

Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4…

Meditation and Yoga for Posttraumatic Stress Disorder: A Meta-Analytic Review of Randomized Controlled Trials

PubMed Central

Gallegos, Autumn M.; Crean, Hugh F.; Pigeon, Wilfred R.; Heffner, Kathi L.

2018-01-01

Posttraumatic stress disorder (PTSD) is a chronic and debilitating disorder that affects the lives of 7-8% of adults in the U.S. Although several interventions demonstrate clinical effectiveness for treating PTSD, many patients continue to have residual symptoms and ask for a variety of treatment options. Complementary health approaches, such as meditation and yoga, hold promise for treating symptoms of PTSD. This meta-analysis evaluates the effect size (ES) of yoga and meditation on PTSD outcomes in adult patients. We also examined whether the intervention type, PTSD outcome measure, study population, sample size, or control condition moderated the effects of complementary approaches on PTSD outcomes. The studies included were 19 randomized control trials with data on 1,173 participants. A random effects model yielded a statistically significant ES in the small to medium range (ES = −.39, p < .001, 95% CI [−.57, −.22]). There were no appreciable differences between intervention types, study population, outcome measures, or control condition. There was, however, a marginally significant higher ES for sample size ≤ 30 (ES = −.78, k = 5). These findings suggest that meditation and yoga are promising complementary approaches in the treatment of PTSD among adults and warrant further study. PMID:29100863

Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis.

PubMed

Anheyer, Dennis; Leach, Matthew J; Klose, Petra; Dobos, Gustav; Cramer, Holger

2018-01-01

Background Mindfulness-based stress reduction/cognitive therapy are frequently used for pain-related conditions, but their effects on headache remain uncertain. This review aimed to assess the efficacy and safety of mindfulness-based stress reduction/cognitive therapy in reducing the symptoms of chronic headache. Data sources and study selection MEDLINE/PubMed, Scopus, CENTRAL, and PsychINFO were searched to 16 June 2017. Randomized controlled trials comparing mindfulness-based stress reduction/cognitive therapy with usual care or active comparators for migraine and/or tension-type headache, which assessed headache frequency, duration or intensity as a primary outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Tool. Results Five randomized controlled trials (two on tension-type headache; one on migraine; two with mixed samples) with a total of 185 participants were included. Compared to usual care, mindfulness-based stress reduction/cognitive therapy did not improve headache frequency (three randomized controlled trials; standardized mean difference = 0.00; 95% confidence interval = -0.33,0.32) or headache duration (three randomized controlled trials; standardized mean difference = -0.08; 95% confidence interval = -1.03,0.87). Similarly, no significant difference between groups was found for pain intensity (five randomized controlled trials; standardized mean difference = -0.78; 95% confidence interval = -1.72,0.16). Conclusions Due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.

Asthma control and productivity loss in those with work-related asthma: A population-based study.

PubMed

Wong, Alyson; Tavakoli, Hamid; Sadatsafavi, Mohsen; Carlsten, Chris; FitzGerald, J Mark

2017-06-01

In Canada, asthma is the third leading cause of work loss, yet little is known about the associated productivity loss. The goal of this study was to look at the relationship between asthma control and productivity loss, particularly contrasting those with work-related asthma (WRA) and non-work-related asthma (NWRA). A population-based random sample of adults with asthma in British Columbia, Canada, was prospectively recruited. Asthma control was graded according to Global Initiative for Asthma classification, while productivity loss and presence of WRA was assessed using questionnaires. Ordinal regression models were then used to associate WRA with asthma control. Generalized linear models were applied to estimate the average productivity loss associated with different levels of asthma control among those with WRA and NWRA. The study included 300 employed adults. Sixty (20%) had WRA. The odds of being controlled were significantly lower in those with WRA (OR = 0.23, 95% CI: 0.09, 0.56; P < 0.01). Those with WRA and uncontrolled asthma had a significant difference in productivity loss due to presenteeism ($659.1 [95% CI: 12.9, 1581.5; P = 0.04]), but not absenteeism ($88.7 [95% CI: -86.5, 279.6; P = 0.35]), when compared to those with NWRA and uncontrolled asthma. There was no significant difference when a similar comparison was made for those with controlled or partially controlled asthma. WRA is associated with worse asthma control and increased productivity loss. Presenteeism makes a significant contribution to productivity loss and should be considered when evaluating the overall economic burden of asthma, particularly WRA.

Effect of family presence on pain and anxiety during invasive nursing procedures in an emergency department: A randomized controlled experimental study.

PubMed

İşlekdemir, Burcu; Kaya, Nurten

2016-01-01

Patients generally prefer to have their family present during medical or nursing interventions. Family presence is assumed to reduce anxiety, especially during painful interventions. This study employed a randomized controlled experimental design to determine the effects of family presence on pain and anxiety during invasive nursing procedures. The study population consisted of patients hospitalized in the observation unit of the internal medicine section in the emergency department of a university hospital. The sample comprised 138 patients assigned into the experimental and control groups by drawing lots. The invasive nursing procedure was carried out in the presence of family members, for members of the experimental group, and without family members, for members of the control group. Thus, the effects of family presence on pain and anxiety during the administration of an invasive nursing procedure to patients were analyzed. The results showed that members of the experimental and control groups did not differ with respect to the pain and state anxiety scores during the intervention. Family presence does not influence the participants' pain and anxiety during an invasive nursing procedure. Thus, the decision regarding family presence during such procedures should be based on patient preference. Copyright © 2015 Elsevier Ltd. All rights reserved.

The talent study: a multicentre randomized controlled trial assessing the impact of a 'tailored lifestyle self-management intervention' (talent) on weight reduction.

PubMed

Melchart, Dieter; Doerfler, Wolfgang; Eustachi, Axel; Wellenhofer-Li, Yanqing; Weidenhammer, Wolfgang

2015-01-01

Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a Body Mass Index of 28 to 35. The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons. The study is a multicentre randomized controlled trial with observation duration of 12 months. Eight study centres are involved to include a minimal sample size of 150 participants. Randomization ratio is 2:1. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A) intervention group: comprehensive lifestyle modification program (Individual Health Management IHM) with 3 months reduction phase plus 9 months maintaining phase, B) control group: written information with advice for healthy food habits (Usual care UC). Participants of the IHM group have access to a web-based health portal and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months four refresh trainings will be performed. There are 3 different diet strategies (fasting, two-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according to the German Nutrition Society (DGE). Examinations are conducted at baseline, after 3, 6, 9 and 12 months. They include body weight, waist circumference, blood pressure, laboratory findings and a bio-impedance analysis to measure body composition. Statistical analysis of the primary outcome 'change of body weight after 12 months' is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors 'group', 'baseline value' and 'study centre'. Secondary outcomes will be analyzed exploratively. The monitoring of the study will implement different measures to enhance compliance, avoid attrition and ensure data quality. Based on a blended learning concept and using web-based e-health tools the program promises to achieve sustainable effects in weight reduction. German Clinical Trials Register Freiburg (DRKS): DRKS00006736 (date registered 20/09/2014).

The impact of hotspot-targeted interventions on malaria transmission: study protocol for a cluster-randomized controlled trial

PubMed Central

2013-01-01

Background Malaria transmission is highly heterogeneous in most settings, resulting in the formation of recognizable malaria hotspots. Targeting these hotspots might represent a highly efficacious way of controlling or eliminating malaria if the hotspots fuel malaria transmission to the wider community. Methods/design Hotspots of malaria will be determined based on spatial patterns in age-adjusted prevalence and density of antibodies against malaria antigens apical membrane antigen-1 and merozoite surface protein-1. The community effect of interventions targeted at these hotspots will be determined. The intervention will comprise larviciding, focal screening and treatment of the human population, distribution of long-lasting insecticide-treated nets and indoor residual spraying. The impact of the intervention will be determined inside and up to 500 m outside the targeted hotspots by PCR-based parasite prevalence in cross-sectional surveys, malaria morbidity by passive case detection in selected facilities and entomological monitoring of larval and adult Anopheles populations. Discussion This study aims to provide direct evidence for a community effect of hotspot-targeted interventions. The trial is powered to detect large effects on malaria transmission in the context of ongoing malaria interventions. Follow-up studies will be needed to determine the effect of individual components of the interventions and the cost-effectiveness of a hotspot-targeted approach, where savings made by reducing the number of compounds that need to receive interventions should outweigh the costs of hotspot-detection. Trial registration NCT01575613. The protocol was registered online on 20 March 2012; the first community was randomized on 26 March 2012. PMID:23374910