Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial.

PubMed

Gæde, Peter; Oellgaard, Jens; Carstensen, Bendix; Rossing, Peter; Lund-Andersen, Henrik; Parving, Hans-Henrik; Pedersen, Oluf

2016-11-01

The aim of this work was to study the potential long-term impact of a 7.8 years intensified, multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria in terms of gained years of life and years free from incident cardiovascular disease. The original intervention (mean treatment duration 7.8 years) involved 160 patients with type 2 diabetes and microalbuminuria who were randomly assigned (using sealed envelopes) to receive either conventional therapy or intensified, multifactorial treatment including both behavioural and pharmacological approaches. After 7.8 years the study continued as an observational follow-up with all patients receiving treatment as for the original intensive-therapy group. The primary endpoint of this follow-up 21.2 years after intervention start was difference in median survival time between the original treatment groups with and without incident cardiovascular disease. Non-fatal endpoints and causes of death were adjudicated by an external endpoint committee blinded for treatment allocation. Thirty-eight intensive-therapy patients vs 55 conventional-therapy patients died during follow-up (HR 0.55 [95% CI 0.36, 0.83], p = 0.005). The patients in the intensive-therapy group survived for a median of 7.9 years longer than the conventional-therapy group patients. Median time before first cardiovascular event after randomisation was 8.1 years longer in the intensive-therapy group (p = 0.001). The hazard for all microvascular complications was decreased in the intensive-therapy group in the range 0.52 to 0.67, except for peripheral neuropathy (HR 1.12). At 21.2 years of follow-up of 7.8 years of intensified, multifactorial, target-driven treatment of type 2 diabetes with microalbuminuria, we demonstrate a median of 7.9 years of gain of life. The increase in lifespan is matched by time free from incident cardiovascular disease. ClinicalTrials.gov registration no. NCT00320008. The study was funded by an unrestricted grant from Novo Nordisk A/S.

Promoting Physical Activity Through a Manual Wheelchair Propulsion Intervention in Persons With Multiple Sclerosis.

PubMed

Rice, Ian M; Rice, Laura A; Motl, Robert W

2015-10-01

To examine the efficacy and feasibility of a multifactorial intervention to increase lifestyle physical activity in nonambulatory persons with multiple sclerosis (MS) based on wheelchair optimization, propulsion skill/technique training, and behavioral strategies based on social cognitive theory. Randomized controlled trial, 3-month postintervention follow-up. Home and general community, and university research laboratory. Nonambulatory individuals with MS (N=14; mean age ± SD, 53.6±8.7y) were randomly assigned to an intervention group (IG) or a control group (CG). After baseline testing, the IG participants received custom-fit, ultralightweight manual wheelchairs with propulsion/skills training, followed by 3 months of at-home use with the custom ultralightweight wheelchair and weekly phone calls to deliver support through a multifactorial intervention. The CG participants received no training and used their own wheelchairs at home during this time. All subjects were assessed at baseline and 3 months later for fatigue (Fatigue Severity Scale), upper extremity strength (digital handheld dynamometer), and propulsion technique (on a treadmill [0.5m/s] with instrumented wheels). Two 1-week bouts of physical activity were measured in both groups from home with wrist-worn accelerometry at the beginning (IG and CG in own wheelchairs) and end (IG in study wheelchair, CG in own) of the 3-month period of home use. The intervention was well tolerated, and no adverse events were reported. The IG demonstrated increased strength (P=.008) and a trend toward less fatigue (P=.068), both with large effect sizes (d>0.8), as well as reduced application of braking torque during propulsion (P=.003) with a moderate/large effect size (d=.73), compared with the CG. Findings suggest a 3-month physical activity intervention based on manual wheelchair propulsion and training is safe and feasible for some wheelchair users living with MS and may produce secondary benefits in strength, fatigue, and propulsion technique. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The effects of adding group-based lifestyle counselling to individual counselling on changes in plasma glucose levels in a randomized controlled trial: the Inter99 study.

PubMed

Lau, C; Vistisen, D; Toft, U; Tetens, I; Glümer, C; Pedersen, O; Jørgensen, T; Borch-Johnsen, K

2011-12-01

This study aimed to assess whether group-based lifestyle counselling offered to a high-risk population subgroup had any effect beyond individual multifactorial interventions on fasting plasma glucose (FPG) and 2-h plasma glucose (2hPG) changes. In a population-based study of 6784 participants, 4053 were determined to be at high risk based on a risk estimate of ischaemic heart disease or the presence of risk factors (smoking, hypertension, hypercholesterolaemia, obesity, impaired glucose tolerance). Of these subjects, 90% were randomized to high-intensity intervention (group A) and 10% to low-intensity intervention (group B). All participants went through health examinations, risk assessments and individual lifestyle counselling. Participants in group A were further offered group-based lifestyle counselling. The intervention was repeated after 1 and 3 years. A total of 2738 participants free of diabetes at baseline (1999-2001) and with at least one FPG and/or 2hPG measurement during 5 years of follow-up were included in the analyses. Differences in changes of plasma glucose between groups A and B were analyzed using multilevel linear regression. For FPG, crude 5-year changes were significantly different between the two groups (group A: -0.003 mmol/L vs group B: -0.079 mmol/L; P=0.0427). After adjusting for relevant confounders, no differences in FPG changes were observed (P=0.116). Also, no significant differences in the 5-year changes in 2hPG between the two groups were observed (group A: - 0.127 mmol/L vs group B: -0.201 mmol/L; P=0.546). Offering additional group-based intervention to a high-risk population subgroup had no clinical effects on changes in plasma glucose beyond those of individualized multifactorial interventions. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial

PubMed Central

Luck, Tobias; Motzek, Tom; Luppa, Melanie; Matschinger, Herbert; Fleischer, Steffen; Sesselmann, Yves; Roling, Gudrun; Beutner, Katrin; König, Hans-Helmut; Behrens, Johann; Riedel-Heller, Steffi G

2013-01-01

Background Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. Methods Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. Results Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. Conclusion Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people. PMID:23788832

Effectiveness and implementation aspects of interventions for preventing falls in elderly people in long-term care facilities: a systematic review of RCTs.

PubMed

Neyens, Jacques C; van Haastregt, Jolanda C; Dijcks, Béatrice P; Martens, Mark; van den Heuvel, Wim J; de Witte, Luc P; Schols, Jos M

2011-07-01

There is extensive literature on interventions to prevent or reduce falls in elderly people. These findings, however, were based mainly on studies of community-living persons. The primary aim of the present study was to report the effectiveness and implementation aspects of interventions aimed at reducing falls in elderly residents in long-term care facilities: a systematic review of randomized controlled trials (RCTs). MEDLINE, EMBASE, CINAHL, and hand searching of reference lists of included RCTs. RCTs that assessed fall incidents (falls, fallers, recurrent fallers, fall-related injuries) among elderly residents in long-term care facilities were included in this narrative review. Two independent reviewers abstracted data: general program characteristics (setting, population, intervention program) and outcomes, detailed program characteristics (assessment, intervention content, individually tailored, multidisciplinary), and implementation aspects (feasibility, implications for practice). The CONSORT Statement 2001 Checklist was used regarding the quality of reporting RCTs. Twenty trials met the inclusion criteria. Seven trials, 4 multifactorial and 3 monofactorial, showed a significant reduction in the fall rate, the percentage of recurrent fallers, or both the fall rate and the percentage of persons sustaining femoral fractures. The positive effective programs were as follows: a comprehensive structured individual assessment with specific safety recommendations; a multidisciplinary program including general strategies tailored to the setting and strategies tailored specifically to residents; a multifaceted intervention including education, environmental adaptation, balance, resistance training, and hip protector; calcium plus vitamin D supplementation; vitamin D supplementation; a clinical medication review; and a multifactorial intervention (fall risk evaluation, specific and general interventions). In general, because of the limited number of included trials, the evidence is inconclusive for multifaceted and single interventions in long-term care facilities. Most of the reviewed studies did not find a significant positive effect on fall incidents. However, our data support the conclusions of Gillespie et al. that multifactorial interventions in long-term care populations seem more likely to be beneficial. However, single interventions (eg, targeting vitamin D insufficiency) can be effective. Furthermore, a careful approach is needed as programs to prevent falls in these settings may be ineffective or even may have adverse effects. This may occur especially when a program is not feasible for the setting in which it is implemented. Copyright © 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.

Cost Effectiveness of Falls and Injury Prevention Strategies for Older Adults Living in Residential Aged Care Facilities.

PubMed

Church, Jody L; Haas, Marion R; Goodall, Stephen

2015-12-01

To evaluate the cost effectiveness of interventions designed to prevent falls and fall-related injuries among older people living in residential aged care facilities (RACFs) from an Australian health care perspective. A decision analytic Markov model was developed that stratified individuals according to their risk of falling and accounted for the risk of injury following a fall. The effectiveness of the interventions was derived from two Cochrane reviews of randomized controlled trials for falls/fall-related injury prevention in RACFs. Interventions were considered effective if they reduced the risk of falling or reduced the risk of injury following a fall. The interventions that were modelled included vitamin D supplementation, annual medication review, multifactorial intervention (a combination of risk assessment, medication review, vision assessment and exercise) and hip protectors. The cost effectiveness was calculated as the incremental cost relative to the incremental benefit, in which the benefit was estimated using quality-adjusted life-years (QALYs). Uncertainty was explored using univariate and probabilistic sensitivity analysis. Vitamin D supplementation and medication review both dominated 'no intervention', as these interventions were both more effective and cost saving (because of healthcare costs avoided). Hip protectors are dominated (less effective and more costly) by vitamin D and medication review. The incremental cost-effectiveness ratio (ICER) for medication review relative to vitamin D supplementation is AU$2442 per QALY gained, and the ICER for multifactorial intervention relative to medication review is AU$1,112,500 per QALY gained. The model is most sensitive to the fear of falling and the cost of the interventions. The model suggests that vitamin D supplementation and medication review are cost-effective interventions that reduce falls, provide health benefits and reduce health care costs in older adults living in RACFs.

Effectiveness of a multifactorial intervention to reduce physical restraints in nursing home residents.

PubMed

Koczy, Petra; Becker, Clemens; Rapp, Kilian; Klie, Thomas; Beische, Denis; Büchele, Gisela; Kleiner, Andrea; Guerra, Virginia; Rissmann, Ulrich; Kurrle, Susan; Bredthauer, Doris

2011-02-01

To evaluate the effectiveness of a multifactorial intervention to reduce the use of physical restraints in residents of nursing homes. Cluster-randomized controlled trial. Forty-five nursing homes in Germany. Three hundred thirty-three residents who were being restrained at the start of the intervention. Persons responsible for the intervention in the nursing homes attended a 6-hour training course that included education about the reasons restraints are used, the adverse effects, and alternatives to their use. Technical aids, such as hip protectors and sensor mats, were provided. The training was designed to give the change agents tools for problem-solving to prevent behavioral symptoms and injuries from falls without using physical restraints. The main outcome was the complete cessation of physical restraint use on 3 consecutive days 3 months after the start of the intervention. Secondary outcomes were partial reductions in restraint use, percentage of fallers, number of psychoactive drugs, and occurrence of behavioral symptoms. The probability of being unrestrained in the intervention group (IG) was more than twice that in the control group (CG) at the end of the study (odds ratio=2.16, 95% confidence interval=1.05-4.46). A partial reduction of restraint use was also about twice as often achieved in the IG as in the CG. No negative effect was observed regarding medication or behavioral symptoms. The percentage of fallers was higher in the IG. The intervention reduced restraint use without a significant increase in falling, behavioral symptoms, or medication. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

Effects of a two-school-year multifactorial back education program in elementary schoolchildren.

PubMed

Geldhof, Elisabeth; Cardon, Greet; De Bourdeaudhuij, Ilse; De Clercq, Dirk

2006-08-01

A quasi-experimental pre/post design. To investigate effects of a 2-school-year multifactorial back education program on back posture knowledge and postural behavior in elementary schoolchildren. Additionally, self-reported back or neck pain and fear-avoidance beliefs were evaluated. Epidemiologic studies report mounting nonspecific back pain prevalence among youngsters, characterized by multifactorial risk factors. Study findings of school-based interventions are promising. Furthermore, biomechanical discomfort is found in the school environment. The study sample included 193 intervention children and 172 controls (baseline, 9-to-11-year-olds). The multifactorial intervention consisted of a back education program and the stimulation of postural dynamism in the class through support and environmental changes. Evaluation consisted of a questionnaire, an observation of postural behavior in the classroom, and an observation of material handling during a movement session. The intervention resulted in increased back posture knowledge (P < 0.001), improved postural behavior during material handling (P < 0.001), and decreased duration of trunk flexion (P < 0.05) and neck torsion (P < 0.05) during lesson time. The intervention did not change fear-avoidance beliefs. There was a trend for decreased pain reports in boys of the intervention group (P < 0.09). The intervention resulted in improved postural aspects related to spinal loading. The long-term effect of improved postural behavior at young age on back pain prevalence later in life is of interest for future research.

Eating Patterns among Students with Intellectual Disabilities after a Multifactorial School Intervention Using the Plate Model

ERIC Educational Resources Information Center

Wallen, Eva Flygare; Mullerdorf, Maria; Christensson, Kyllike; Marcus, Claude

2013-01-01

Adolescents with intellectual disabilities (ID) have an increased prevalence of being overweight and having cardiometabolic diseases as adults, in part due to poor eating habits with an inadequate intake of vegetables. The aim of this study was to evaluate whether a multifactorial school intervention using the "Plate Model" results in…

Effect assessment in work environment interventions: a methodological reflection.

PubMed

Neumann, W P; Eklund, J; Hansson, B; Lindbeck, L

2010-01-01

This paper addresses a number of issues for work environment intervention (WEI) researchers in light of the mixed results reported in the literature. If researchers emphasise study quality over intervention quality, reviews that exclude case studies with high quality and multifactorial interventions may be vulnerable to 'quality criteria selection bias'. Learning from 'failed' interventions is inhibited by both publication bias and reporting lengths that limit information on relevant contextual and implementation factors. The authors argue for the need to develop evaluation approaches consistent with the complexity of multifactorial WEIs that: a) are owned by and aimed at the whole organisation; and b) include intervention in early design stages where potential impact is highest. Context variety, complexity and instability in and around organisations suggest that attention might usefully shift from generalisable 'proof of effectiveness' to a more nuanced identification of intervention elements and the situations in which they are more likely to work as intended. STATEMENT OF RELEVANCE: This paper considers ergonomics interventions from perspectives of what constitutes quality and 'proof". It points to limitations of traditional experimental intervention designs and argues that the complexity of organisational change, and the need for multifactorial interventions that reach deep into work processes for greater impact, should be recognised.

Cost-effectiveness of intensive multifactorial treatment compared with routine care for individuals with screen-detected Type 2 diabetes: analysis of the ADDITION-UK cluster-randomized controlled trial

PubMed Central

Tao, L; Wilson, E C F; Wareham, N J; Sandbæk, A; Rutten, G E H M; Lauritzen, T; Khunti, K; Davies, M J; Borch-Johnsen, K; Griffin, S J; Simmons, R K

2015-01-01

Aims To examine the short- and long-term cost-effectiveness of intensive multifactorial treatment compared with routine care among people with screen-detected Type 2 diabetes. Methods Cost–utility analysis in ADDITION-UK, a cluster-randomized controlled trial of early intensive treatment in people with screen-detected diabetes in 69 UK general practices. Unit treatment costs and utility decrement data were taken from published literature. Accumulated costs and quality-adjusted life years (QALYs) were calculated using ADDITION-UK data from 1 to 5 years (short-term analysis, n = 1024); trial data were extrapolated to 30 years using the UKPDS outcomes model (version 1.3) (long-term analysis; n = 999). All costs were transformed to the UK 2009/10 price level. Results Adjusted incremental costs to the NHS were £285, £935, £1190 and £1745 over a 1-, 5-, 10- and 30-year time horizon, respectively (discounted at 3.5%). Adjusted incremental QALYs were 0.0000, – 0.0040, 0.0140 and 0.0465 over the same time horizons. Point estimate incremental cost-effectiveness ratios (ICERs) suggested that the intervention was not cost-effective although the ratio improved over time: the ICER over 10 years was £82 250, falling to £37 500 over 30 years. The ICER fell below £30 000 only when the intervention cost was below £631 per patient: we estimated the cost at £981. Conclusion Given conventional thresholds of cost-effectiveness, the intensive treatment delivered in ADDITION was not cost-effective compared with routine care for individuals with screen-detected diabetes in the UK. The intervention may be cost-effective if it can be delivered at reduced cost. PMID:25661661

The effects of multifactorial fall prevention on depressive symptoms among the aged at increased risk of falling.

PubMed

Sjösten, Noora M; Vahlberg, Tero J; Kivelä, Sirkka-Liisa

2008-05-01

The aim was to determine the effects of multifactorial fall prevention on depressive symptoms among aged Finns at increased risk of falling. This study is part of a multifactorial fall prevention trial with a randomised controlled design implemented in the town of Pori, western Finland. The study population consisted of ambulatory, 65-year-old or older Finns, with moderate or high cognitive and physical abilities who had fallen at least once during the previous 12 months. The participants (n=591) were randomised into a risk-based multifactorial fall prevention programme (intervention group, IG) or into a one-time counselling group (control group, CG). The 1-year intervention included individual geriatric assessment followed by treatment recommendations, individual guidance regarding fall prevention, physical exercise in small groups twice a month, psychosocial group activities and lectures once a month, home-exercises and home hazard assessment. The outcome, depressive symptoms, was measured by the 30-item Geriatric Depression Scale (GDS). The full GDS data with no missing items were available for 464 persons. A significant decrease in depressive symptoms during the 12-month intervention was found both in IG and in CG, but the difference in change was not significant (p=0.110). However, a significant difference in change between the groups was found among men and older subjects (>or=75) in favour of the IG. Multifactorial fall prevention had no effects on depressive symptoms among the community-dwelling aged. However, men and older participants benefited from the intervention.

What works in falls prevention in Asia: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Hill, Keith D; Suttanon, Plaiwan; Lin, Sang-I; Tsang, William W N; Ashari, Asmidawati; Hamid, Tengku Aizan Abd; Farrier, Kaela; Burton, Elissa

2018-01-05

There is strong research evidence for falls prevention among older people in the community setting, although most is from Western countries. Differences between countries (eg sunlight exposure, diet, environment, exercise preferences) may influence the success of implementing falls prevention approaches in Asian countries that have been shown to be effective elsewhere in the world. The aim of this review is to evaluate the scope and effectiveness of falls prevention randomized controlled trials (RCTs) from the Asian region. RCTs investigating falls prevention interventions conducted in Asian countries from (i) the most recent (2012) Cochrane community setting falls prevention review, and (ii) subsequent published RCTs meeting the same criteria were identified, classified and grouped according to the ProFANE intervention classification. Characteristics of included trials were extracted from both the Cochrane review and original publications. Where ≥2 studies investigated an intervention type in the Asian region, a meta-analysis was performed. Fifteen of 159 RCTs in the Cochrane review were conducted in the Asian region (9%), and a further 11 recent RCTs conducted in Asia were identified (total 26 Asian studies: median 160 participants, mean age:75.1, female:71.9%). Exercise (15 RCTs) and home assessment/modification (n = 2) were the only single interventions with ≥2 RCTs. Intervention types with ≥1 effective RCT in reducing fall outcomes were exercise (6 effective), home modification (1 effective), and medication (vitamin D) (1 effective). One multiple and one multifactorial intervention also had positive falls outcomes. Meta-analysis of exercise interventions identified significant benefit (number of fallers: Odds Ratio 0.43 [0.34,0.53]; number of falls: 0.35 [0.21,0.57]; and number of fallers injured: 0.50 [0.35,0.71]); but multifactorial interventions did not reach significance (number of fallers OR = 0.57 [0.23,1.44]). There is a small but growing research base of falls prevention RCTs from Asian countries, with exercise approaches being most researched and effective. For other interventions shown to be effective elsewhere, consideration of local issues is required to ensure that research and programs implemented in these countries are effective, and relevant to the local context, people, and health system. There is also a need for further high quality, appropriately powered falls prevention trials in Asian countries.

The Influence of Cognitive Training on Older Adults’ Recall for Short Stories

PubMed Central

Sisco, S. M.; Marsiske, M; Gross, A. L.; Rebok, G. W.

2013-01-01

Objectives This paper investigated how a multi-component memory intervention affected memory for prose. We compared verbatim and paraphrased recall for short stories immediately and 1-, 2-, 3- and 5-years post-intervention in the ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly) sample. Methods We studied 1,912 ACTIVE participants aged 65–91. Participants were randomized into one of three training arms (Memory, Reasoning, Speed of Processing) or a no-contact Control group; about half of the trained participants received additional booster training 1 and 3 years post-intervention. Results Memory-trained participants showed higher verbatim recall than non-memory-trained participants. Booster memory training led to higher verbatim recall. Memory training effects were evident immediately following training and not after one year following training. Discussion Results suggest that multi-factorial memory training can improve verbatim recall for prose, but the effect does not last without continued intervention. PMID:24385636

The influence of cognitive training on older adults' recall for short stories.

PubMed

Sisco, Shannon M; Marsiske, Michael; Gross, Alden L; Rebok, George W

2013-12-01

This article investigated how a multicomponent memory intervention affected memory for prose. We compared verbatim and paraphrased recall for short stories immediately and 1, 2, 3, and 5 years post-intervention in the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) sample. We studied 1,912 ACTIVE participants aged 65 to 91. Participants were randomized into one of three training arms (Memory, Reasoning, Speed of Processing) or a no-contact Control group; about half of the trained participants received additional booster training 1 and 3 years post-intervention. Memory-trained participants showed higher verbatim recall than non-memory-trained participants. Booster-memory training led to higher verbatim recall. Memory training effects were evident immediately following training and not after 1 year following training. Results suggest that multifactorial memory training can improve verbatim recall for prose, but the effect does not last without continued intervention.

Promoting healthful diet and physical activity in the Mexican school system for the prevention of obesity in children.

PubMed

Safdie, Margarita; Lévesque, Lucie; González-Casanova, Inés; Salvo, Deborah; Islas, Ana; Hernández-Cordero, Sonia; Bonvecchio, Anabelle; Rivera, Juan A

2013-01-01

This paper describes the rationale, design, and methods of a two-year randomized controlled trial conducted to evaluate the effectiveness of an environmental intervention in 27 elementary schools in Mexico City. There were two units of analysis, school level addressing changes in elementary public part-time schools, and individual-level addressing behavioral changes in students 9 to 11 years of age. Two intensities of an intervention program were implemented (basic and plus), each containing two intervention components: physical activity and nutrition, supported by a communication/education component. Evaluation of the intervention was carried out during the school cycles 2006-2007 and 2007-2008. Primary outcomes were overweight and obesity prevalence and fitness; environmental and behavioural measures were also examined. This is the first institutional multilevel, multifactorial project, consistent with the best practices available in current literature, carried out in Mexico to prevent childhood obesity in schools.

Multifactorial causal model of brain (dis)organization and therapeutic intervention: Application to Alzheimer's disease.

PubMed

Iturria-Medina, Yasser; Carbonell, Félix M; Sotero, Roberto C; Chouinard-Decorte, Francois; Evans, Alan C

2017-05-15

Generative models focused on multifactorial causal mechanisms in brain disorders are scarce and generally based on limited data. Despite the biological importance of the multiple interacting processes, their effects remain poorly characterized from an integrative analytic perspective. Here, we propose a spatiotemporal multifactorial causal model (MCM) of brain (dis)organization and therapeutic intervention that accounts for local causal interactions, effects propagation via physical brain networks, cognitive alterations, and identification of optimum therapeutic interventions. In this article, we focus on describing the model and applying it at the population-based level for studying late onset Alzheimer's disease (LOAD). By interrelating six different neuroimaging modalities and cognitive measurements, this model accurately predicts spatiotemporal alterations in brain amyloid-β (Aβ) burden, glucose metabolism, vascular flow, resting state functional activity, structural properties, and cognitive integrity. The results suggest that a vascular dysregulation may be the most-likely initial pathologic event leading to LOAD. Nevertheless, they also suggest that LOAD it is not caused by a unique dominant biological factor (e.g. vascular or Aβ) but by the complex interplay among multiple relevant direct interactions. Furthermore, using theoretical control analysis of the identified population-based multifactorial causal network, we show the crucial advantage of using combinatorial over single-target treatments, explain why one-target Aβ based therapies might fail to improve clinical outcomes, and propose an efficiency ranking of possible LOAD interventions. Although still requiring further validation at the individual level, this work presents the first analytic framework for dynamic multifactorial brain (dis)organization that may explain both the pathologic evolution of progressive neurological disorders and operationalize the influence of multiple interventional strategies. Copyright © 2017 Elsevier Inc. All rights reserved.

Patients with recurrent falls attending Accident & Emergency benefit from multifactorial intervention--a randomised controlled trial.

PubMed

Davison, John; Bond, John; Dawson, Pamela; Steen, I Nicholas; Kenny, Rose Anne

2005-03-01

To determine the effectiveness of multifactorial intervention to prevent falls in cognitively intact older persons with recurrent falls. Randomised controlled trial of multifactorial (medical, physiotherapy and occupational therapy) post-fall assessment and intervention compared with conventional care. Accident & Emergency departments in a university teaching hospital and associated district general hospital. 313 cognitively intact men and women aged over 65 years presenting to Accident & Emergency with a fall or fall-related injury and at least one additional fall in the preceding year; 159 randomised to assessment and intervention and 154 to conventional care. primary outcome was the number of falls and fallers in 1 year after recruitment. Secondary outcomes included injury rates, fall-related hospital admissions, mortality and fear of falling. There were 36% fewer falls in the intervention group (relative risk 0.64, 95% confidence interval 0.46-0.90). The proportion of subjects continuing to fall (65% (94/144) compared with 68% (102/149) relative risk 0.95, 95% confidence interval 0.81-1.12), and the number of fall-related attendances and hospital admissions was not different between groups. Duration of hospital admission was reduced (mean difference admission duration 3.6 days, 95% confidence interval 0.1-7.6) and falls efficacy was better in the intervention group (mean difference in Activities Specific Balance Confidence Score of 7.5, 95% confidence interval 0.72-14.2). Multifactorial intervention is effective at reducing the fall burden in cognitively intact older persons with recurrent falls attending Accident & Emergency, but does not reduce the proportion of subjects still falling.

Prevention of falls in nursing homes: subgroup analyses of a randomized fall prevention trial.

PubMed

Rapp, Kilian; Lamb, Sarah E; Büchele, Gisela; Lall, Ranjit; Lindemann, Ulrich; Becker, Clemens

2008-06-01

To evaluate the effectiveness of a multifactorial fall prevention program in prespecified subgroups of nursing home residents. Secondary analysis of a cluster-randomized, controlled trial. Six nursing homes in Germany. Seven hundred twenty-five long-stay residents; median age 86; 80% female. Staff and resident education on fall prevention, advice on environmental adaptations, recommendation to wear hip protectors, and progressive balance and resistance training. Time to first fall and the number of falls. Falls were assessed during the 12-month intervention period. Univariate regression analyses were performed, including a confirmatory test of interaction. The intervention was more effective in people with cognitive impairment (hazard ratio (HR)=0.49, 95% confidence interval (CI)=0.35-0.69) than in those who were cognitively intact (HR=0.91, 95% CI=0.68-1.22), in people with a prior history of falls (HR=0.47, 95% CI=0.33-0.67) than in those with no prior fall history (HR=0.77, 95% CI=0.58-1.01), in people with urinary incontinence (HR=0.59, 95% CI=0.45-0.77) than in those with no urinary incontinence (HR=0.98, 95% CI=0.68-1.42), and in people with no mood problems (incidence rate ratio (IRR)=0.41, 95% CI=0.27-0.61) than in those with mood problems (IRR=0.74, 95% CI=0.51-1.09). The effectiveness of a multifactorial fall prevention program differed between subgroups of nursing home residents. Cognitive impairment, a history of falls, urinary incontinence, and depressed mood were important in determining response.

Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil).

PubMed

de Negreiros Cabral, Kelem; Perracini, Monica Rodrigues; Soares, Aline Thomaz; de Cristo Stein, Francine; Sera, Celisa Tiemi Nakagawa; Tiedemann, Anne; Sherrington, Cathie; Filho, Wilson Jacob; Paschoal, Sérgio Márcio Pacheco

2013-03-15

Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people. Multicentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis. This study is the first trial to be conducted in Brazil to evaluate the effectiveness of an intervention to prevent falls. If proven to reduce falls this study has the potential to benefit older adults and assist health care practitioners and policy makers to implement and promote effective falls prevention interventions. ClinicalTrials.gov (NCT01698580).

TROPHI: development of a tool to measure complex, multi-factorial patient handling interventions.

PubMed

Fray, Mike; Hignett, Sue

2013-01-01

Patient handling interventions are complex and multi-factorial. It has been difficult to make comparisons across different strategies due to the lack of a comprehensive outcome measurement method. The Tool for Risk Outstanding in Patient Handling Interventions (TROPHI) was developed to address this gap by measuring outcomes and comparing performance across interventions. Focus groups were held with expert patient handling practitioners (n = 36) in four European countries (Finland, Italy, Portugal and the UK) to identify preferred outcomes to be measured for interventions. A systematic literature review identified 598 outcome measures; these were critically appraised and the most appropriate measurement tool was selected for each outcome. TROPHI was evaluated in the four EU countries (eight sites) and by an expert panel (n = 16) from the European Panel of Patient Handling Ergonomics for usability and practical application. This final stage added external validity to the research by exploring transferability potential and presenting the data and analysis to allow respondent (participant) validation. Patient handling interventions are complex and multi-factorial and it has been difficult to make comparisons due to the lack of a comprehensive outcome measurement method. The Tool for Risk Outstanding in Patient Handling Interventions (TROPHI) was developed to address this gap by measuring outcomes to compare performance across interventions.

Educating medical students about anorexia nervosa: a potential method for reducing the volitional stigma associated with the disorder.

PubMed

Bannatyne, Amy; Stapleton, Peta

2015-01-01

It is frequently reported that clinicians across a range of professional disciplines experience strong negative reactions toward patients with anorexia nervosa (AN). The present study aimed to develop, evaluate, and compare the effectiveness of two different educational programs, based on an etiological framing model. Participants were medical students (N = 41) from an Australian University, who were randomly assigned to one of three conditions (biogenetic intervention vs. multifactorial intervention vs. control). Outcome attitudinal/stigma data were collected pre- and post-intervention, and at 8 weeks follow-up. Results indicated intervention participations exhibited significantly lower volitional stigma scores compared to the control group, who exhibited no change in attitudes or stigma. Specifically, intervention participants had significantly lower total ED stigma scores, levels of blame, perceptions of AN as a selfish/vain illness, and viewed sufferers as less responsible for their illness at post-intervention. These reductions were maintained at follow-up. Overall, the study provides preliminary evidence that brief targeted interventions can assist in reducing levels of volitional stigma toward AN.

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

PubMed Central

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016. Trial registration The study is registered as ISRCTN78113519. PMID:24261985

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.

A multifactorial intervention for the prevention of falls in psychogeriatric nursing home patients, a randomised controlled trial (RCT).

PubMed

Neyens, Jacques C L; Dijcks, Béatrice P J; Twisk, Jos; Schols, Jos M G A; van Haastregt, Jolanda C M; van den Heuvel, Wim J A; de Witte, Luc P

2009-03-01

to evaluate the effectiveness of a multifactorial intervention on incidence of falls in psychogeriatric nursing home patients. cluster-randomised controlled 12-month trial. psychogeriatric wards in 12 nursing homes in The Netherlands. psychogeriatric nursing home patients (n = 518). a general medical assessment and an additional specific fall risk evaluation tool, applied by a multidisciplinary fall prevention team, resulting in general and individual fall prevention activities. falls. there were 355 falls in 169.5 patient-years (2.09 falls per patient per year) in the intervention group and 422 falls in 166.3 patient-years (2.54 falls per patient per year) in the control group. Intention-to-treat analysis with adjustment for ward-related and patient-related parameters, and intra-cluster correlation, showed that the intervention group had a significantly lower mean fall incidence rate than the control group (rate ratio = 0.64, 95% CI = 0.43-0.96, P = 0.029). Subgroup analyses showed that fall risk declined further as patients participated longer in the intervention programme. the introduction of a structured multifactorial intervention to prevent falls in psychogeriatric nursing home patients significantly reduces the number of falls. This reduction is substantial and of high clinical relevance.

Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

PubMed

Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

2016-10-01

Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

Intensive multifactorial treatment modifies the effect of family history of diabetes on glycaemic control in people with Type 2 diabetes: a post hoc analysis of the ADDITION-Denmark randomized controlled trial.

PubMed

Eliraqi, G M; Vistisen, D; Lauritzen, T; Sandbaek, A; Jørgensen, M E; Faerch, K

2015-08-01

To investigate whether intensive multifactorial treatment can reverse the predisposed adverse phenotype of people with Type 2 diabetes who have a family history of diabetes. Data from the randomized controlled trial ADDITION-Denmark were used. A total of 1441 newly diagnosed patients with diabetes (598 with family history of diabetes) were randomized to intensive treatment or routine care. Family history of diabetes was defined as having one parent and/or sibling with diabetes. Linear mixed-effects models were used to assess the changes in risk factors (BMI, waist circumference, blood pressure, lipids and HbA1c ) after 5 years of follow-up in participants with and without a family history of diabetes. An interaction term between family history of diabetes and treatment group was included in the models to test for a modifying effect of the intervention. All analyses were adjusted for age, sex, baseline value of the risk factor and general practice (random effect). At baseline, participants with a family history of diabetes were younger and had a 1.1 mmol/mol (0.1%) higher HbA1c concentration at the time of diagnosis than those without a family history of diabetes. Family history of diabetes modified the effect of the intervention on changes in HbA1c levels. In the group receiving routine care, participants with a family history of diabetes experienced an improvement in HbA1c concentration that was 3.3 mmol/mol (0.3%) lower than the improvement found in those without a family history of diabetes after 5 years of follow-up. In the intensive treatment group, however, there was no difference in HbA1c concentrations between participants with and without a family history of diabetes after 5 years of treatment. Intensive treatment of diabetes may partly remove the adverse effects of family history of diabetes on glycaemic control. The effect of this improvement on long-term diabetic complications warrants further investigation. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

A randomized, controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home.

PubMed

Sandora, Thomas J; Taveras, Elsie M; Shih, Mei-Chiung; Resnick, Elissa A; Lee, Grace M; Ross-Degnan, Dennis; Goldmann, Donald A

2005-09-01

Good hand hygiene may reduce the spread of infections in families with children who are in out-of-home child care. Alcohol-based hand sanitizers rapidly kill viruses that are commonly associated with respiratory and gastrointestinal (GI) infections. The objective of this study was to determine whether a multifactorial campaign centered on increasing alcohol-based hand sanitizer use and hand-hygiene education reduces illness transmission in the home. A cluster randomized, controlled trial was conducted of homes of 292 families with children who were enrolled in out-of-home child care in 26 child care centers. Eligible families had > or =1 child who was 6 months to 5 years of age and in child care for > or =10 hours/week. Intervention families received a supply of hand sanitizer and biweekly hand-hygiene educational materials for 5 months; control families received only materials promoting good nutrition. Primary caregivers were phoned biweekly and reported respiratory and GI illnesses in family members. Respiratory and GI-illness-transmission rates (measured as secondary illnesses per susceptible person-month) were compared between groups, adjusting for demographic variables, hand-hygiene practices, and previous experience using hand sanitizers. Baseline demographics were similar in the 2 groups. A total of 1802 respiratory illnesses occurred during the study; 443 (25%) were secondary illnesses. A total of 252 GI illnesses occurred during the study; 28 (11%) were secondary illnesses. The secondary GI-illness rate was significantly lower in intervention families compared with control families (incidence rate ratio [IRR]: 0.41; 95% confidence interval [CI]: 0.19-0.90). The overall rate of secondary respiratory illness was not significantly different between groups (IRR: 0.97; 95% CI: 0.72-1.30). However, families with higher sanitizer usage had a marginally lower secondary respiratory illness rate than those with less usage (IRR: 0.81; 95% CI: 0.65-1.09). A multifactorial intervention emphasizing alcohol-based hand sanitizer use in the home reduced transmission of GI illnesses within families with children in child care. Hand sanitizers and multifaceted educational messages may have a role in improving hand-hygiene practices within the home setting.

Cost-effectiveness analysis of a multifactorial fall prevention intervention in older home care clients at risk for falling.

PubMed

Isaranuwatchai, Wanrudee; Perdrizet, Johnna; Markle-Reid, Maureen; Hoch, Jeffrey S

2017-09-01

Falls among older adults can cause serious morbidity and pose economic burdens on society. Older age is a known risk factor for falls and age has been shown to influence the effectiveness of fall prevention programs. To our knowledge, no studies have explicitly investigated whether cost-effectiveness of a multifactorial fall prevention intervention (the intervention) is influenced by age. This economic evaluation explores: 1) the cost-effectiveness of a multifactorial fall prevention intervention compared to usual care for community-dwelling adults ≥ 75 years at risk of falling in Canada; and 2) the influence of age on the cost-effectiveness of the intervention. Net benefit regression was used to examine the cost-effectiveness of the intervention with willingness-to-pay values ranging from $0-$50,000. Effects were measured as change in the number of falls, from baseline to 6-month follow-up. Costs were measured using a societal perspective. The cost-effectiveness analysis was conducted for both the total sample and by age subgroups (75-84 and 85+ years). For the total sample, the intervention was not economically attractive. However, the intervention was cost-effective at higher willingness-to-pay (WTP) (≥ $25,000) for adults 75-84 years and at lower WTP (< $5,000) for adults 85+ years. The cost-effectiveness of the intervention depends on age and decision makers' WTP to prevent falls. Understanding the influence of age on the cost-effectiveness of an intervention may help to target resources to those who benefit most. Retrospectively registered. Clinicaltrials.gov identifier: NCT00463658 (18 April 2007).

Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 study.

PubMed

Oellgaard, Jens; Gæde, Peter; Rossing, Peter; Rørth, Rasmus; Køber, Lars; Parving, Hans-Henrik; Pedersen, Oluf

2018-05-30

In type 2 diabetes mellitus, heart failure is a frequent, potentially fatal and often forgotten complication. Glucose-lowering agents and adjuvant therapies modify the risk of heart failure. We recently reported that 7.8 years of intensified compared with conventional multifactorial intervention in individuals with type 2 diabetes and microalbuminuria in the Steno-2 study reduced the risk of cardiovascular disease and prolonged life over 21.2 years of follow-up. In this post hoc analysis, we examine the impact of intensified multifactorial intervention on the risk of hospitalisation for heart failure. One hundred and sixty individuals were randomised to conventional or intensified multifactorial intervention, using sealed envelopes. The trial was conducted using the Prospective, Randomised, Open, Blinded Endpoints (PROBE) design. After 7.8 years, all individuals were offered intensified therapy and the study continued as an observational follow-up study for an additional 13.4 years. Heart-failure hospitalisations were adjudicated from patient records by an external expert committee blinded for treatment allocation. Event rates were compared using a Cox regression model adjusted for age and sex. Eighty patients were assigned to each treatment group. Ten patients undergoing intensive therapy vs 24 undergoing conventional therapy were hospitalised for heart failure during follow-up. The HR (95% CI) was 0.30 (0.14, 0.64), p = 0.002 in the intensive-therapy group compared with the conventional-therapy group. Including death in the endpoint did not lead to an alternate overall outcome; HR 0.51 (0.34, 0.76), p = 0.001. In a pooled cohort analysis, an increase in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the first two years of the trial was associated with incident heart failure. Intensified, multifactorial intervention for 7.8 years in type 2 diabetic individuals with microalbuminuria reduced the risk of hospitalisation for heart failure by 70% during a total of 21.2 years of observation. ClinicalTrials.gov NCT00320008.

Effect of a multifactorial fall-and-fracture risk assessment and management program on gait and balance performances and disability in hospitalized older adults: a controlled study.

PubMed

Trombetti, A; Hars, M; Herrmann, F; Rizzoli, R; Ferrari, S

2013-03-01

This controlled intervention study in hospitalized oldest old adults showed that a multifactorial fall-and-fracture risk assessment and management program, applied in a dedicated geriatric hospital unit, was effective in improving fall-related physical and functional performances and the level of independence in activities of daily living in high-risk patients. Hospitalization affords a major opportunity for interdisciplinary cooperation to manage fall-and-fracture risk factors in older adults. This study aimed at assessing the effects on physical performances and the level of independence in activities of daily living (ADL) of a multifactorial fall-and-fracture risk assessment and management program applied in a geriatric hospital setting. A controlled intervention study was conducted among 122 geriatric inpatients (mean ± SD age, 84 ± 7 years) admitted with a fall-related diagnosis. Among them, 92 were admitted to a dedicated unit and enrolled into a multifactorial intervention program, including intensive targeted exercise. Thirty patients who received standard usual care in a general geriatric unit formed the control group. Primary outcomes included gait and balance performances and the level of independence in ADL measured 12 ± 6 days apart. Secondary outcomes included length of stay, incidence of in-hospital falls, hospital readmission, and mortality rates. Compared to the usual care group, the intervention group had significant improvements in Timed Up and Go (adjusted mean difference [AMD] = -3.7s; 95 % CI = -6.8 to -0.7; P = 0.017), Tinetti (AMD = -1.4; 95 % CI = -2.1 to -0.8; P < 0.001), and Functional Independence Measure (AMD = 6.5; 95 %CI = 0.7-12.3; P = 0.027) test performances, as well as in several gait parameters (P < 0.05). Furthermore, this program favorably impacted adverse outcomes including hospital readmission (hazard ratio = 0.3; 95 % CI = 0.1-0.9; P = 0.02). A multifactorial fall-and-fracture risk-based intervention program, applied in a dedicated geriatric hospital unit, was effective and more beneficial than usual care in improving physical parameters related to the risk of fall and disability among high-risk oldest old patients.

Lipid Screening in Childhood and Adolescence for Detection of Multifactorial Dyslipidemia: Evidence Report and Systematic Review for the US Preventive Services Task Force.

PubMed

Lozano, Paula; Henrikson, Nora B; Morrison, Caitlin C; Dunn, John; Nguyen, Matt; Blasi, Paula R; Whitlock, Evelyn P

2016-08-09

Multifactorial dyslipidemia, characterized by elevated total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C), is associated with dyslipidemia and markers of atherosclerosis in young adulthood. Screening for dyslipidemia in childhood could delay or reduce cardiovascular events in adulthood. To systematically review the evidence on benefits and harms of screening adolescents and children for multifactorial dyslipidemia for the US Preventive Services Task Force (USPSTF). MEDLINE, Cochrane Central Register of Controlled Trials, and PubMed were searched for studies published between January 1, 2005, and June 2, 2015; studies included in a previous USPSTF evidence report and reference lists of relevant studies and ongoing trials were also searched. Surveillance was conducted through April 9, 2016. Fair- and good-quality studies in English with participants 0 to 20 years of age. Two investigators independently reviewed abstracts and full-text articles and extracted data into evidence tables. Results were qualitatively summarized. Outcomes included dyslipidemia (TC≥200 mg/dL or LDL-C≥130 mg/dL) and atherosclerosis in childhood; myocardial infarction and ischemic stroke in adulthood; diagnostic yield (number of confirmed cases per children screened); and harms of screening or treatment. Simulated diagnostic yield was calculated as initial screening yield × positive predictive value from a study with confirmatory testing. Screening of children for multifactorial dyslipidemia has not been evaluated in randomized clinical trials. Based on 1 observational study (n = 6500) and nationally representative prevalence estimates, the simulated diagnostic yield of screening for elevated TC varies between 4.8% and 12.3% (higher in obese children [12.3%] and at the ages when TC naturally peaks-7.2% at age 9-11 years and 7.2% at age 16-19 years). One good-quality randomized clinical trial (n = 663) found a modest effect of intensive dietary counseling for a low-fat, low-cholesterol diet on lipid levels at 1 year in children aged 8 to 10 years with mild to moderate dyslipidemia; mean between-group difference in TC change from baseline was -6.1 mg/dL (95% CI, -9.1 to -3.2 mg/dL; P < .001). Between-group differences dissipated by year 5. The intervention did not adversely affect nutritional status, growth, or development over the 18-year study period. One observational study (n = 9245) found that TC concentration at age 12 to 39 years was not associated with death before age 55 years. The diagnostic yield of lipid screening varies by age and body mass index. No direct evidence was identified for benefits or harms of childhood screening or treatment on outcomes in adulthood. Intensive dietary interventions may be safe, with modest short-term benefit of uncertain clinical significance.

Effect of animal-assisted activity on balance and quality of life in home-dwelling persons with dementia.

PubMed

Olsen, Christine; Pedersen, Ingeborg; Bergland, Astrid; Enders-Slegers, Marie-José; Ihlebæk, Camilla

2016-01-01

Purpose of the study was to examine if animal-assisted activity with a dog (AAA) in home-dwelling persons with dementia (PWDs) attending day-care centers would have an effect on factors related to risk of fall accidents, with balance (Berg balance scale) and quality of life (Quality of Life in Late-stage Dementia) as main outcome. The project was conducted as a prospective and cluster-randomized multicenter trial with a follow-up. 16 adapted day-care centers recruited respectively 42 (intervention group) and 38 (control group with treatment as usual) home-dwelling PWDs. The intervention consisted of 30 min sessions with AAA led by a qualified dog handler twice a week for 12 weeks in groups of 3-7 participants. The significant positive effect on balance indicates that AAA might work as a multifactorial intervention in dementia care and have useful clinical implication by affecting risk of fall. ClinicalTrial.gov; NCT02008630. Copyright © 2016 Elsevier Inc. All rights reserved.

The Impact of an Ergonomics Intervention on Psychosocial Factors and Musculoskeletal Symptoms among Thai Hospital Orderlies.

PubMed

Chanchai, Withaya; Songkham, Wanpen; Ketsomporn, Pranom; Sappakitchanchai, Punnarat; Siriwong, Wattasit; Robson, Mark Gregory

2016-05-03

(1) BACKGROUND: Musculoskeletal disorders have a multifactorial etiology that is not only associated with physical risk factors, but also psychosocial risk factors; (2) OBJECTIVE: This study evaluated the effects of an ergonomic intervention on musculoskeletal disorders and psychosocial risk factors; (3) MATERIAL AND METHODS: This study took a participatory ergonomic (PE) approach with a randomized controlled trial (RCT) conducted at tertiary care hospitals during July to December 2014. A group of hospital orderlies in Thailand were randomly selected for examination. Fifty orderlies were placed in a case group and another 50 orderlies were placed in the control group. The Nordic Musculoskeletal Disorders Questionnaire (NMQ) and the Copenhagen Psychosocial Questionnaire (COPSOQ) were used for data collection before and after the intervention program; (4) RESULTS: The most commonly reported problem among hospital orderlies was found to be lower back symptoms (82%). The study found significant differences in prevalence rates of reported musculoskeletal conditions in the arm, upper back, and lower back regions before and after intervention. Findings showed that psychosocial risk factors were affected by the intervention. COPSOQ psychosocial risk factors were significantly different pre/post intervention. These variables included: work pace, influence at work, meaning of work, predictability, rewards, role conflicts, and social support from supervisors. No other psychosocial risk factors were found to be significant; (5) CONCLUSIONS: Positive results were observed following the intervention in the work environment, particularly in terms of reducing physical work environment risk factors for musculoskeletal disorders and increasing promotion factors of the psychosocial work environment.

The Impact of an Ergonomics Intervention on Psychosocial Factors and Musculoskeletal Symptoms among Thai Hospital Orderlies

PubMed Central

Chanchai, Withaya; Songkham, Wanpen; Ketsomporn, Pranom; Sappakitchanchai, Punnarat; Siriwong, Wattasit; Robson, Mark Gregory

2016-01-01

(1) Background: Musculoskeletal disorders have a multifactorial etiology that is not only associated with physical risk factors, but also psychosocial risk factors; (2) Objective: This study evaluated the effects of an ergonomic intervention on musculoskeletal disorders and psychosocial risk factors; (3) Material and Methods: This study took a participatory ergonomic (PE) approach with a randomized controlled trial (RCT) conducted at tertiary care hospitals during July to December 2014. A group of hospital orderlies in Thailand were randomly selected for examination. Fifty orderlies were placed in a case group and another 50 orderlies were placed in the control group. The Nordic Musculoskeletal Disorders Questionnaire (NMQ) and the Copenhagen Psychosocial Questionnaire (COPSOQ) were used for data collection before and after the intervention program; (4) Results: The most commonly reported problem among hospital orderlies was found to be lower back symptoms (82%). The study found significant differences in prevalence rates of reported musculoskeletal conditions in the arm, upper back, and lower back regions before and after intervention. Findings showed that psychosocial risk factors were affected by the intervention. COPSOQ psychosocial risk factors were significantly different pre/post intervention. These variables included: work pace, influence at work, meaning of work, predictability, rewards, role conflicts, and social support from supervisors. No other psychosocial risk factors were found to be significant; (5) Conclusions: Positive results were observed following the intervention in the work environment, particularly in terms of reducing physical work environment risk factors for musculoskeletal disorders and increasing promotion factors of the psychosocial work environment. PMID:27153076

Effects of comprehensive geriatric intervention on physical performance among people aged 75 years and over.

PubMed

Lihavainen, Katri; Sipilä, Sarianna; Rantanen, Taina; Seppänen, Jarmo; Lavikainen, Piia; Sulkava, Raimo; Hartikainen, Sirpa

2012-08-01

We studied the effects of comprehensive geriatric assessment and multifactorial intervention on physical performance among older people. In a 3-year geriatric development project with an experimental design, 668 participants aged 75-98 were assigned to intervention (n=348) or control (n=320) groups. The intervention group received comprehensive geriatric assessment with an individually targeted intervention for 2 years. The outcome measures - performance in the Timed Up-and-Go (TUG), 10-meter walking and Berg Balance Scale tests - were gathered annually during the intervention and the 1-year follow-up after it. With linear mixed models, over the 2-year intervention period, the intervention group was found to be improved in the balance (p<0.001) and walking speed (p<0.001) tests, and maintained performance in the TUG test (p<0.001), compared with the control group. The results remained significant 1 year post-intervention. Comprehensive geriatric assessment and individually targeted multifactorial intervention had positive effects on physical performance, potentially helping to maintain mobility and prevent disability in old age.

Individualized home-based exercise programs for older people to reduce falls and improve physical performance: A systematic review and meta-analysis.

PubMed

Hill, Keith D; Hunter, Susan W; Batchelor, Frances A; Cavalheri, Vinicius; Burton, Elissa

2015-09-01

There is considerable diversity in the types of exercise programs investigated to reduce falls in older people. The purpose of this paper was to review the effectiveness of individualized (tailored) home-based exercise programs in reducing falls and improving physical performance among older people living in the community. A systematic review and meta-analysis was conducted of randomized or quasi-randomized trials that utilized an individualized home-based exercise program with at least one falls outcome measure reported. Single intervention exercise studies, and multifactorial interventions where results for an exercise intervention were reported independently were included. Two researchers independently rated the quality of each included study. Of 16,871 papers identified from six databases, 12 met all inclusion criteria (11 randomized trials and a pragmatic trial). Study quality overall was high. Sample sizes ranged from 40 to 981, participants had an average age 80.1 years, and although the majority of studies targeted the general older population, several studies included clinical groups as their target (Parkinson's disease, Alzheimer's disease, and hip fracture). The meta-analysis results for the five studies reporting number of fallers found no significant effect of the intervention (RR [95% CI]=0.93 [0.72-1.21]), although when a sensitivity analysis was performed with one study of participants recently discharged from hospital removed, this result was significant (RR [95% CI] = 0.84 [0.72-0.99]). The meta-analysis also found that intervention led to significant improvements in physical activity, balance, mobility and muscle strength. There were no significant differences for measures of injurious falls or fractures. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Interventions directed at eating habits and physical activity using the Transtheoretical Model: a systematic review.

PubMed

Carvalho de Menezes, Mariana; Bedeschi, Lydiane Bragunci; Santos, Luana Caroline Dos; Lopes, Aline Cristine Souza

2016-09-20

The multi-behavioral Transtheoretical Model (TTM) addresses multiple behaviors and it is a promising strategy to control multifactorial morbidities, such as chronic diseases. The results obtained using the TTM are positive, but are not consistently methodical. The aim of this study was to systematically review the effectiveness of the Transtheoretical Model in multi-behavioral interventions for changing eating habits and levels of physical activity. A search on PubMed and SciELO databases was performed with inclusion criteria set for intervention studies before 2016 using the Transtheoretical Model for more than one behavior, including eating habits and/or engaging in physical activity. Eighteen studies were identified; there was a predominance of randomized clinical trials, studies conducted in the United States, and the use of the Internet and/or telephone. The selected studies were aimed at changing eating behaviors; five of the studies did not address physical activity. The main results were reduction of fat consumption, an increase in the consumption of fruit and vegetables, and increases in physical activity, which are progressions in the stages of change and weight loss identified by the Transtheoretical Model. However, the studies showed methodological weaknesses, including high participant loss and the omission of information about randomization and blinding.

The interplay between gait, falls and cognition: can cognitive therapy reduce fall risk?

PubMed Central

Segev-Jacubovski, Orit; Herman, Talia; Yogev-Seligmann, Galit; Mirelman, Anat; Giladi, Nir; Hausdorff, Jeffrey M

2011-01-01

In this article, we briefly summarize the incidence and significant consequences of falls among older adults, the insufficient effectiveness of commonly used multifactorial interventions and the evidence linking falls and cognitive function. Recent pharmacologic and nonpharmacologic studies that evaluated the effects of cognitive therapy on fall risk are reviewed. The results of this article illustrate the potential utility of multiple, diverse forms of cognitive therapy for reducing fall risk. The article also indicates that large-scale, randomized controlled trials are warranted and that additional research is needed to better understand the pathophysiologic mechanisms underlying the interplay between human mobility, fall risk and cognitive function. Nonetheless, we suggest that multimodality interventions that combine motor and cognitive therapy should, eventually, be incorporated into clinical practice to enable older adults and patients to move safer and with a reduced fall risk. PMID:21721921

Preventing Falls in Older Persons.

PubMed

Moncada, Lainie Van Voast; Mire, L Glen

2017-08-15

The American Geriatrics Society and British Geriatrics Society recommend that all adults older than 65 years be screened annually for a history of falls or balance impairment. The U.S. Preventive Services Task Force and American Academy of Family Physicians recommend exercise or physical therapy and vitamin D supplementation to prevent falls in community-dwelling older adults who are at increased risk of falls. Although the U.S. Preventive Services Task Force and American Academy of Family Physicians do not recommend routine multifactorial intervention to prevent falls in all community-dwelling older adults, they state that it may be appropriate in individual cases. The Centers for Disease Control and Prevention developed an algorithm to aid in the implementation of the American Geriatrics Society/British Geriatrics Society guideline. The algorithm suggests assessment and multifactorial intervention for those who have had two or more falls or one fall-related injury. Multifactorial interventions should include exercise, particularly balance, strength, and gait training; vitamin D supplementation with or without calcium; management of medications, especially psychoactive medications; home environment modification; and management of postural hypotension, vision problems, foot problems, and footwear. These interventions effectively decrease falls in the community, hospital, and nursing home settings. Fall prevention is reimbursed as part of the Medicare Annual Wellness Visit.

Thrombus aspiration in acute myocardial infarction: concepts, clinical trials, and current guidelines.

PubMed

Vandermolen, Sebastian; Marciniak, Maciej; Byrne, Jonathan; De Silva, Kalpa

2016-05-01

The pathogenesis that underlies acute myocardial infarction is complex and multifactorial. One of the most important components, however, is the role of thrombus formation following atherosclerotic plaque rupture, leading to sudden coronary occlusion and subsequent ischemia and infarction. Thrombus aspiration provides the opportunity of intracoronary clot extraction with the aim to improve coronary and myocardial perfusion, by reducing the risk of no-reflow secondary to distal embolization of thrombus. The utility of thrombus aspiration during primary percutaneous coronary intervention has been assessed in an increasing number of observational and randomized studies. This article reviews the contemporary data and provides insights into the validity of thrombus aspiration in the setting of acute myocardial infarction.

Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol.

PubMed

Jay, Kenneth; Brandt, Mikkel; Sundstrup, Emil; Schraefel, Mc; Jakobsen, Markus D; Sjøgaard, Gisela; Andersen, Lars L

2014-12-18

Among laboratory technicians, the prevalence of neck and shoulder pain is widespread possibly due to typical daily work tasks such as pipetting, preparing vial samples for analysis, and data processing on a computer including mouse work - all tasks that require precision in motor control and may result in extended periods of time spent in static positions.In populations characterized by intense chronic musculoskeletal pain and diagnosed conditions in conjunction with psycho-physiological symptoms such as stress-related pain and soreness and other disabling conditions, multifactorial approaches applying a combination of individually tailored physical and cognitive strategies targeting the areas most needed, may be an effective solution to the physical and mental health challenges.The aim of this study is therefore to investigate the effect of an individually tailored biopsychosocial intervention strategy on musculoskeletal pain, stress and work disability in lab technicians with a history of musculoskeletal pain at a single worksite in Denmark. In this single-blind two-armed parallel-group randomized controlled trial with allocation concealment, participants receive either an individualized multifactorial intervention or "usual care" for 10 weeks at the worksite. 1) female laboratory technician (18-67 years of age) and 2) Pain intensity ≥ 3 (0-10 Visual Analogue Scale) lasting ≥3 months with a frequency of ≥ 3 days per week in one or more of the following regions: i) upper back i) low back iii) neck, iv) shoulder, v) elbow and/or vi) hand. 1) life-threatening disease and 2) pregnancy. Stress, as measured by Cohen´s perceived stress questionnaire is not an inclusion criteria, thus participants can participate regardless of their stress level.We will implement an individualized intervention addressing biopsychosocial elements of musculoskeletal pain with the following components; i) increasing physical capacity through strength- and motor control training; ii) lowering or preventing development of stress through mindfulness practice and learning de-catastrophizing pain management strategies through cognitive training.The primary outcome at 10-week follow-up is the between-group difference in intensity of perceived musculoskeletal pain during the last week (average value of back, neck, shoulder, elbow and hand) assessed by questionnaire (modified visual analogue scale 0-10). This study will provide experimental evidence to guide workplace initiatives designed towards reducing chronic musculoskeletal pain and stress. ClinicalTrials.gov NCT02047669.

Decreasing Uncorrected Refractive Error in the Classroom through a Multifactorial Pilot Intervention

ERIC Educational Resources Information Center

Kodjebacheva, Gergana; Maliski, Sally; Yu, Fei; Oelrich, Faye; Coleman, Anne L.

2014-01-01

The study assessed the effectiveness of a pilot intervention to promote the use of eyeglasses in one school in California. The intervention used a one-group pretest, posttest design. Between January and June 2011, during the intervention, all first- and second-grade children received eye evaluations and the children with refractive error received…

[The PROPRESE trial: results of a new health care organizational model in primary care for patients with chronic coronary heart disease based on a multifactorial intervention].

PubMed

Ruescas-Escolano, Esther; Orozco-Beltran, Domingo; Gaubert-Tortosa, María; Navarro-Palazón, Ana; Cordero-Fort, Alberto; Navarro-Pérez, Jorge; Carratalá-Munuera, Concepción; Pertusa-Martínez, Salvador; Soler-Bahilo, Enrique; Brotons-Muntó, Francisco; Bort-Cubero, Jose; Núñez-Martínez, Miguel A; Bertomeu-Martínez, Vicente; López-Pineda, Adriana; Gil-Guillén, Vicente F

2014-06-01

Comparison of the results from the EUROASPIRE I to the EUROASPIRE III, in patients with coronary heart disease, shows that the prevalence of uncontrolled risk factors remains high. The aim of the study was to evaluate the effectiveness of a new multifactorial intervention in order to improve health care for chronic coronary heart disease patients in primary care. In this randomized clinical trial with a 1-year follow-up period, we recruited patients with a diagnosis of coronary heart disease (145 for the intervention group and 1461 for the control group). An organizational intervention on the patient-professional relationship (centered on the Chronic Care Model, the Stanford Expert Patient Programme and the Kaiser Permanente model) and formative strategy for professionals were carried out. The main outcomes were smoking control, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP) and diastolic blood pressure (DBP). A multivariate analysis was performed. The characteristics of patients were: age (68.4±11.8 years), male (71.6%), having diabetes mellitus (51.3%), dyslipidemia (68.5%), arterial hypertension (76.7%), non-smokers (76.1%); LDL-C < 100mg/dL (46.9%); SBP < 140mmHg (64.5%); DBP < 90 (91.2%). The multivariable analysis showed the risk of good control for intervention group to be: smoking, adjusted relative risk (aRR): 15.70 (95% confidence interval [95%CI], 4.2-58.7); P < .001; LDL-C, aRR: 2.98 (95%CI, 1.48-6.02); P < .002; SPB, aRR: 1.97 (95%CI, 1.21-3.23); P < .007, and DBP: aRR: 1.51 (95%CI, 0.65-3.50); P < .342. An intervention based on models for chronic patients focused in primary care and involving patients in medical decision making improves cardiovascular risk factors control (smoking, LDL-C and SBP). Chronic care strategies may be an efficacy tool to help clinicians to involve the patients with a diagnosis of CHD to reach better outcomes. Copyright © 2014 Elsevier España, S.L. All rights reserved.

Interventions to Prevent Falls in Community-Dwelling Older Adults: US Preventive Services Task Force Recommendation Statement.

PubMed

Grossman, David C; Curry, Susan J; Owens, Douglas K; Barry, Michael J; Caughey, Aaron B; Davidson, Karina W; Doubeni, Chyke A; Epling, John W; Kemper, Alex R; Krist, Alex H; Kubik, Martha; Landefeld, Seth; Mangione, Carol M; Pignone, Michael; Silverstein, Michael; Simon, Melissa A; Tseng, Chien-Wen

2018-04-24

Falls are the leading cause of injury-related morbidity and mortality among older adults in the United States. In 2014, 28.7% of community-dwelling adults 65 years or older reported falling, resulting in 29 million falls (37.5% of which needed medical treatment or restricted activity for a day or longer) and an estimated 33 000 deaths in 2015. To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on the prevention of falls in community-dwelling older adults. The USPSTF reviewed the evidence on the effectiveness and harms of primary care-relevant interventions to prevent falls and fall-related morbidity and mortality in community-dwelling older adults 65 years or older who are not known to have osteoporosis or vitamin D deficiency. The USPSTF found adequate evidence that exercise interventions have a moderate benefit in preventing falls in older adults at increased risk for falls and that multifactorial interventions have a small benefit. The USPSTF found adequate evidence that vitamin D supplementation has no benefit in preventing falls in older adults. The USPSTF found adequate evidence to bound the harms of exercise and multifactorial interventions as no greater than small. The USPSTF found adequate evidence that the overall harms of vitamin D supplementation are small to moderate. The USPSTF recommends exercise interventions to prevent falls in community-dwelling adults 65 years or older who are at increased risk for falls. (B recommendation) The USPSTF recommends that clinicians selectively offer multifactorial interventions to prevent falls in community-dwelling adults 65 years or older who are at increased risk for falls. Existing evidence indicates that the overall net benefit of routinely offering multifactorial interventions to prevent falls is small. When determining whether this service is appropriate for an individual, patients and clinicians should consider the balance of benefits and harms based on the circumstances of prior falls, presence of comorbid medical conditions, and the patient's values and preferences. (C recommendation) The USPSTF recommends against vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older. (D recommendation) These recommendations apply to community-dwelling adults who are not known to have osteoporosis or vitamin D deficiency.

Evaluation of a fall-prevention program in older people after femoral neck fracture: a one-year follow-up.

PubMed

Berggren, M; Stenvall, M; Olofsson, B; Gustafson, Y

2008-06-01

A randomized, controlled fall-prevention study including 199 patients operated on for femoral neck fracture reduced inpatient falls and injuries. No statistically significant effects of the intervention program could be detected after discharge. It seems that fall-prevention must be part of everyday life in fall-prone old people. This study evaluates whether a postoperative multidisciplinary, multifactorial fall-prevention program performed by a geriatric team that reduced inpatient falls and injuries had any continuing effect after discharge. The intervention consisted of staff education, systematic assessment and treatment of fall risk factors and vitamin D and calcium supplementation. The randomized, controlled trial with a one-year follow-up at Umeå University Hospital, Sweden, included 199 patients operated on for femoral neck fracture, aged > or = 70 years. After one year 44 participants had fallen 138 times in the intervention group compared with 55 participants and 191 falls in the control group. The crude postoperative fall incidence was 4.16/1,000 days in the intervention group vs. 6.43/1,000 days in the control group. The incidence rate ratio was 0.64 (95% CI: 0.40-1.02, p = 0.063). Seven new fractures occurred in the intervention group and 11 in the control group. A team applying comprehensive geriatric assessment and rehabilitation, including prevention and treatment of fall-risk factors, reduced inpatient falls and injuries, but no statistically significant effects of the program could be detected after discharge. It seems that fall-prevention must be part of everyday life in fall-prone elderly.

Systematic Review of the Effect of Diet and Exercise Lifestyle Interventions in the Secondary Prevention of Coronary Heart Disease

PubMed Central

Cole, Judith A.; Smith, Susan M.; Hart, Nigel; Cupples, Margaret E.

2011-01-01

The effectiveness of lifestyle interventions within secondary prevention of coronary heart disease (CHD) remains unclear. This systematic review aimed to determine their effectiveness and included randomized controlled trials of lifestyle interventions, in primary care or community settings, with a minimum follow-up of three months, published since 1990. 21 trials with 10,799 patients were included; the interventions were multifactorial (10), educational (4), psychological (3), dietary (1), organisational (2), and exercise (1). The overall results for modifiable risk factors suggested improvements in dietary and exercise outcomes but no overall effect on smoking outcomes. In trials that examined mortality and morbidity, significant benefits were reported for total mortality (in 4 of 6 trials; overall risk ratio (RR) 0.75 (95% confidence intervals (CI) 0.65, 0.87)), cardiovascular mortality (3 of 8 trials; overall RR 0.63 (95% CI 0.47, 0.84)), and nonfatal cardiac events (5 of 9 trials; overall RR 0.68 (95% CI 0.55, 0.84)). The heterogeneity between trials and generally poor quality of trials make any concrete conclusions difficult. However, the beneficial effects observed in this review are encouraging and should stimulate further research. PMID:21197445

Commentary on "A roadmap for the prevention of dementia II. Leon Thal Symposium 2008." The Multidomain Alzheimer Preventive Trial (MAPT): a new approach to the prevention of Alzheimer's disease.

PubMed

Gillette-Guyonnet, Sophie; Andrieu, Sandrine; Dantoine, Thierry; Dartigues, Jean-François; Touchon, Jacques; Vellas, B

2009-03-01

Because no effective curative approaches are available, preventive approaches in the field of Alzheimer's disease (AD) are needed. We present the design of the ongoing Multidomain Alzheimer Preventive Trial (MAPT) Study. Several previous studies suggested that many factors may be involved in the occurrence of AD at late ages. Because of the probable multifactorial nature of AD, it seems logical to initiate multidomain interventions to examine their potential synergistic effects. The MAPT Study aims to evaluate the efficacy of a multidomain intervention (nutritional, physical, and cognitive training) and omega 3 treatment in the prevention of cognitive decline in frail elderly persons aged 70 years or over. The study also collects imaging and biological data that could be used in future AD prevention and treatment trials. The MAPT Study is a 3-year, randomized, controlled trial conducted by university hospital practitioners specializing in memory disorders in four French cities (Bordeaux, Limoges, Montpellier, and Toulouse). The study plans to enroll 1200 frail elderly subjects on the basis of at least one of the following criteria: subjective memory complaint spontaneously expressed to a general practitioner, limitation in one instrumental activity of daily living (IADL), and slow walking speed. To demonstrate the protective effect of interventions, subjects are randomized into one of the following four groups: omega 3 alone, multidomain intervention alone, omega 3 plus multidomain intervention, or placebo (n = 300 each). The principal outcome measure is a change in cognitive function at 3 years, as determined by the Grober and Buschke Test. The MAPT Study is the first preventive trial involving multidomain interventions. Final results should be available in 2013.

Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial

PubMed Central

Alonso-Domínguez, Rosario; Gómez-Marcos, Manuel A; Patino-Alonso, Maria C; Sánchez-Aguadero, Natalia; Agudo-Conde, Cristina; Castaño-Sánchez, Carmen; García-Ortiz, Luis; Recio-Rodríguez, José I

2017-01-01

Introduction New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. Methods and analysis Study scope and population: The study will be conducted at ‘La Alamedilla’ primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25–70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. Intervention Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. Variables and measurement instruments The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. Ethics and dissemination It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. Trial registration NCT02991079; Pre-results. PMID:28912193

Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

PubMed Central

Indahl, Aage; Andersen, Lars L.; Burton, Kim; Hertzum-Larsen, Rasmus

2017-01-01

Background Low back pain (LBP) is common in the population and multifactorial in nature, often involving negative consequences. Reassuring information to improve coping is recommended for reducing the negative consequences of LBP. Adding a simple non-threatening explanation for the pain (temporary muscular dysfunction) has been successful at altering beliefs and behavior when delivered with other intervention elements. This study investigates the isolated effect of this specific information on future occupational behavior outcomes when delivered to the workforce. Design A cluster-randomized controlled trial. Methods Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non-threatening explanation for LBP—the ‘functional-disturbance’-model. Data collections took place monthly over a 1-year period using text message tracking (SMS). Primary outcomes were self-reported days of cutting down usual activities and work participation. Secondary outcomes were self-reported back beliefs, work ability, number of healthcare visits, bothersomeness, restricted activity, use of pain medication, and sadness/depression. Results There was no between-group difference in the development of LBP during follow-up. Cumulative logistic regression analyses showed no between-group difference on days of cutting down activities, but increased odds for more days of work participation in the intervention group (OR = 1.83 95% CI: 1.08–3.12). Furthermore, the intervention group was more likely to report: higher work ability, reduced visits to healthcare professionals, lower bothersomeness, lower levels of sadness/depression, and positive back beliefs. Conclusion Reassuring information involving a simple non-threatening explanation for LBP significantly increased the odds for days of work participation and higher work ability among workers who went on to experience LBP during the 12-month follow-up. Our results confirm the potential for public-health education for LBP, and add to the discussion of simple versus multidisciplinary interventions. PMID:28346472

Multifactorial intervention for children with asthma and overweight (Mikado): study design of a randomised controlled trial.

PubMed

Willeboordse, Maartje; van de Kant, Kim D G; de Laat, Maroeska N; van Schayck, Onno C P; Mulkens, Sandra; Dompeling, Edward

2013-05-21

In children, the prevalence's of both obesity and asthma are disconcertingly high. Asthmatic children with obesity are characterised by less asthma control and a high need for asthma medication. As the obese asthmatic child is becoming more common in the clinical setting and the disease burden of the asthma-obesity phenotype is high, there is an increasing need for effective treatment in these children. In adults, weight reduction resulted in improved lung function, better asthma control and less need for asthma medication. In children this is hardly studied. The Mikado study aims to evaluate the effectiveness of a long term multifactorial weight reduction intervention, on asthma characteristics in children with asthma and a high body weight. The Mikado study is a two-armed, randomised controlled trial. In total, 104 participants will be recruited via online questionnaires, pulmonary paediatricians, the youth department of the Municipal Health Services and cohorts of existing studies. All participants will be aged 6-16 years, will have current asthma, a Body Mass Index in the overweight or obesity range, and no serious comorbidities (such as diabetes, heart diseases). Participants in the intervention arm will receive a multifactorial intervention of 18 months consisting of sessions concerning sports, parental involvement, individual counselling and lifestyle advices including dietary advices and cognitive behavioural therapy. The control group will receive usual care. The primary outcome variables will include Forced Expiratory Volume in one second and Body Mass Index - Standard Deviation Score. Secondary outcomes will include other lung function parameters (including dynamic and static lung function parameters), asthma control, asthma-specific quality of life, use of asthma medication and markers of systemic inflammation and airway inflammation. In this randomised controlled trial we will study the potential of a multifactorial weight reduction intervention to improve asthma-related outcome measures in asthmatic children with overweight. Moreover, it will provide information about the underlying mechanisms in the relationship between asthma and a high body weight in children. These findings can contribute to optimal management programs and better clinical guidelines for children with asthma and overweight. Clinicaltrial.gov NCT00998413.

Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis.

PubMed

Tricco, Andrea C; Thomas, Sonia M; Veroniki, Areti Angeliki; Hamid, Jemila S; Cogo, Elise; Strifler, Lisa; Khan, Paul A; Robson, Reid; Sibley, Kathryn M; MacDonald, Heather; Riva, John J; Thavorn, Kednapa; Wilson, Charlotte; Holroyd-Leduc, Jayna; Kerr, Gillian D; Feldman, Fabio; Majumdar, Sumit R; Jaglal, Susan B; Hui, Wing; Straus, Sharon E

2017-11-07

Falls result in substantial burden for patients and health care systems, and given the aging of the population worldwide, the incidence of falls continues to rise. To assess the potential effectiveness of interventions for preventing falls. MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Ageline databases from inception until April 2017. Reference lists of included studies were scanned. Randomized clinical trials (RCTs) of fall-prevention interventions for participants aged 65 years and older. Pairs of reviewers independently screened the studies, abstracted data, and appraised risk of bias. Pairwise meta-analysis and network meta-analysis were conducted. Injurious falls and fall-related hospitalizations. A total of 283 RCTs (159 910 participants; mean age, 78.1 years; 74% women) were included after screening of 10 650 titles and abstracts and 1210 full-text articles. Network meta-analysis (including 54 RCTs, 41 596 participants, 39 interventions plus usual care) suggested that the following interventions, when compared with usual care, were associated with reductions in injurious falls: exercise (odds ratio [OR], 0.51 [95% CI, 0.33 to 0.79]; absolute risk difference [ARD], -0.67 [95% CI, -1.10 to -0.24]); combined exercise and vision assessment and treatment (OR, 0.17 [95% CI, 0.07 to 0.38]; ARD, -1.79 [95% CI, -2.63 to -0.96]); combined exercise, vision assessment and treatment, and environmental assessment and modification (OR, 0.30 [95% CI, 0.13 to 0.70]; ARD, -1.19 [95% CI, -2.04 to -0.35]); and combined clinic-level quality improvement strategies (eg, case management), multifactorial assessment and treatment (eg, comprehensive geriatric assessment), calcium supplementation, and vitamin D supplementation (OR, 0.12 [95% CI, 0.03 to 0.55]; ARD, -2.08 [95% CI, -3.56 to -0.60]). Pairwise meta-analyses for fall-related hospitalizations (2 RCTs; 516 participants) showed no significant association between combined clinic- and patient-level quality improvement strategies and multifactorial assessment and treatment relative to usual care (OR, 0.78 [95% CI, 0.33 to 1.81]). Exercise alone and various combinations of interventions were associated with lower risk of injurious falls compared with usual care. Choice of fall-prevention intervention may depend on patient and caregiver values and preferences.

The role of exercise in fall prevention for older adults.

PubMed

Rose, Debra J; Hernandez, Danielle

2010-11-01

This article reviews the evidence for the effectiveness of stand-alone exercise interventions and multifactorial intervention strategies that include exercise in lowering fall incidence rates and/or fall risk among older adults residing in the community, acute, subacute, and long-term care settings. Stand-alone exercise programs that emphasize multiple exercise categories are effective in reducing fall rates and fall risk in community-residing older adults, and may also be effective when conducted for a sufficient duration with older adult patients in subacute settings. In contrast, multifactorial fall risk reduction programs that include exercise as a component and are delivered by a multidisciplinary team are more effective in lowering fall rates in long-term care settings. Copyright © 2010 Elsevier Inc. All rights reserved.

A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months). Methods/design This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up. Discussion Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed. Trial registration The trial is registered with the Dutch Trial Register (http://www.trialregister.nlNTR3816): (January 2013). The first participant was randomized in September 2012. PMID:23958154

Nurse Practitioner Care Improves Renal Outcome in Patients with CKD

PubMed Central

van Zuilen, Arjan D.; van den Brand, Jan A.J.G.; Bots, Michiel L.; van Buren, Marjolijn; ten Dam, Marc A.G.J.; Kaasjager, Karin A.H.; Ligtenberg, Gerry; Sijpkens, Yvo W.J.; Sluiter, Henk E.; van de Ven, Peter J.G.; Vervoort, Gerald; Vleming, Louis-Jean; Blankestijn, Peter J.; Wetzels, Jack F.M.

2014-01-01

Treatment goals for patients with CKD are often unrealized for many reasons, but support by nurse practitioners may improve risk factor levels in these patients. Here, we analyzed renal endpoints of the Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse Practitioners (MASTERPLAN) study after extended follow-up to determine whether strict implementation of current CKD guidelines through the aid of nurse practitioners improves renal outcome. In total, 788 patients with moderate to severe CKD were randomized to receive nurse practitioner support added to physician care (intervention group) or physician care alone (control group). Median follow-up was 5.7 years. Renal outcome was a secondary endpoint of the MASTERPLAN study. We used a composite renal endpoint of death, ESRD, and 50% increase in serum creatinine. Event rates were compared with adjustment for baseline serum creatinine concentration and changes in estimated GFR were determined. During the randomized phase, there were small but significant differences between the groups in BP, proteinuria, LDL cholesterol, and use of aspirin, statins, active vitamin D, and antihypertensive medications, in favor of the intervention group. The intervention reduced the incidence of the composite renal endpoint by 20% (hazard ratio, 0.80; 95% confidence interval, 0.66 to 0.98; P=0.03). In the intervention group, the decrease in estimated GFR was 0.45 ml/min per 1.73 m2 per year less than in the control group (P=0.01). In conclusion, additional support by nurse practitioners attenuated the decline of kidney function and improved renal outcome in patients with CKD. PMID:24158983

Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.

PubMed

Diamantidis, Clarissa J; Bosworth, Hayden B; Oakes, Megan M; Davenport, Clemontina A; Pendergast, Jane F; Patel, Sejal; Moaddeb, Jivan; Barnhart, Huiman X; Merrill, Peter D; Baloch, Khaula; Crowley, Matthew J; Patel, Uptal D

2018-06-01

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m 2 , mean eGFR was 80.7 ml/min/1.73 m 2 , and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided. NCT01829256. Copyright © 2018 Elsevier Inc. All rights reserved.

Complementary and Alternative Medicine in the Treatment of Chronic Pelvic Pain in Women: What Is the Evidence?

PubMed

Paiva, Sara; Carneiro, Márcia Mendonça

2013-01-01

Chronic pelvic pain (CPP) is defined as pain of at least 6 months' duration that occurs in the lower abdomen or below the umbilicus and has resulted in functional or psychological disability or required intervention and treatment. Therapeutic interventions center around the treatment of CPP as a diagnosis in and of itself, and treatment of specific disorders that may be related to CPP. A multidisciplinary approach for diagnosis and treatment seems to be most effective for symptomatic relief. This paper reviews the evidence for such interventions as psychological treatments including the use of complementary and alternative medicine techniques for CPP in women. Unfortunately, finding the best evidence in this setting is difficult as only very few randomized controlled trials are available. A combination of treatments is usually required over time for the treatment of refractory CPP. The multifactorial nature of CPP needs to be discussed with the patient and a good rapport as well as a partnership needs to be developed to plan a management program with regular followup. Promotion of a multidisciplinary approach which includes complementary and alternative medicine techniques in managing CPP in women seems to yield the best results.

Falls prevention in the elderly: translating evidence into practice.

PubMed

Luk, James K H; Chan, T Y; Chan, Daniel K Y

2015-04-01

Falls are a common problem in the elderly. A common error in their management is that injury from the fall is treated, without finding its cause. Thus a proactive approach is important to screen for the likelihood of fall in the elderly. Fall assessment usually includes a focused history and a targeted examination. Timed up-and-go test can be performed quickly and is able to predict the likelihood of fall. Evidence-based fall prevention interventions include multi-component group or home-based exercises, participation in Tai Chi, environmental modifications, medication review, management of foot and footwear problems, vitamin D supplementation, and management of cardiovascular problems. If possible, these are best implemented in the form of multifactorial intervention. Bone health enhancement for residential care home residents and appropriate community patients, and prescription of hip protectors for residential care home residents are also recommended. Multifactorial intervention may also be useful in a hospital and residential care home setting. Use of physical restraints is not recommended for fall prevention.

A School-Based Intervention Associated with Improvements in Cardiometabolic Risk Profiles in Young People with Intellectual Disabilities

ERIC Educational Resources Information Center

Wallén, Eva Flygare; Müllersdorf, Maria; Christensson, Kyllike; Marcus, Claude

2013-01-01

This study evaluates a multifactorial school-based intervention with the aim of decreasing cardiometabolic risk factors by means of a healthy lifestyle, primarily with daily physical activity and healthy food during school hours, at an upper secondary school for students with intellectual disabilities. The outcome is measured in terms of…

Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial.

PubMed

Aasmul, Irene; Husebo, Bettina Sandgathe; Flo, Elisabeth

2016-12-01

Most people with dementia develop neuropsychiatric symptoms (NPSs), which are distressing for their carers. Untreated pain may increase the prevalence and severity of NPSs and thereby staff burden. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n = 175) or control group (27 NH units; n = 177). Patients in the intervention group received individual pain treatment for eight weeks, followed by a four-week washout period; control groups received care as usual. Staff informants (n = 138) used the Neuropsychiatric Inventory-NH version (including caregiver distress) as primary outcome to assess their own distress. Other outcomes were pain (Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale) and cognitive functioning (Mini-Mental State Examination). Using hierarchical regression analysis, all NPS items at baseline were associated with staff distress (P < 0.01) apart from euphoria; agitation had the largest contribution (β = 0.24). Using mixed models, we found significantly lower staff distress in the intervention group compared to the control group. Moreover, we also found significantly reduced distress in the control group, and there were still effects in both groups throughout the washout period. Individual pain treatment reduced staff distress in the intervention group compared to control group especially in regard to agitation-related symptoms and apathy. Furthermore, our results indicated a multifactorial model of staff distress, in which enhanced knowledge and understanding of NPSs and pain in people with advanced dementia may play an important role. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Psychological Correlates of Sexual Dysfunction in Female Rectal and Anal Cancer Survivors: Analysis of Baseline Intervention Data

PubMed Central

Philip, Errol J.; Nelson, Christian; Temple, Larissa; Carter, Jeanne; Schover, Leslie; Jennings, Sabrina; Jandorf, Lina; Starr, Tatiana; Baser, Ray; DuHamel, Katherine

2013-01-01

Introduction Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported and undertreated issue in the field of cancer survivorship. Aim This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. Main Outcomes Measures Quality of life (EORTC-QLQ-C30 & QLQ-CR38), sexual functioning (FSFI) and psychological well-being (BSI Depression/Anxiety, IES-R, CR-38 Body Image). Methods There were 70 female post-treatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. Results Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%) and a median of 4 years post-primary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=−.45 to −.70, all p<.01). Body image, anxiety and cancer-specific post-traumatic distress were notable in their association with subscales of sexual functioning, while a global quality of life measure was largely unrelated. Conclusions For sexually-active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad quality of life assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients. PMID:23551928

Comparisons of Interventions for Preventing Falls in Older Adults

PubMed Central

Tricco, Andrea C.; Thomas, Sonia M.; Veroniki, Areti Angeliki; Hamid, Jemila S.; Cogo, Elise; Strifler, Lisa; Khan, Paul A.; Robson, Reid; Sibley, Kathryn M.; MacDonald, Heather; Riva, John J.; Thavorn, Kednapa; Wilson, Charlotte; Holroyd-Leduc, Jayna; Kerr, Gillian D.; Feldman, Fabio; Majumdar, Sumit R.; Jaglal, Susan B.; Hui, Wing

2017-01-01

Importance Falls result in substantial burden for patients and health care systems, and given the aging of the population worldwide, the incidence of falls continues to rise. Objective To assess the potential effectiveness of interventions for preventing falls. Data Sources MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Ageline databases from inception until April 2017. Reference lists of included studies were scanned. Study Selection Randomized clinical trials (RCTs) of fall-prevention interventions for participants aged 65 years and older. Data Extraction and Synthesis Pairs of reviewers independently screened the studies, abstracted data, and appraised risk of bias. Pairwise meta-analysis and network meta-analysis were conducted. Main Outcomes and Measures Injurious falls and fall-related hospitalizations. Results A total of 283 RCTs (159 910 participants; mean age, 78.1 years; 74% women) were included after screening of 10 650 titles and abstracts and 1210 full-text articles. Network meta-analysis (including 54 RCTs, 41 596 participants, 39 interventions plus usual care) suggested that the following interventions, when compared with usual care, were associated with reductions in injurious falls: exercise (odds ratio [OR], 0.51 [95% CI, 0.33 to 0.79]; absolute risk difference [ARD], −0.67 [95% CI, −1.10 to −0.24]); combined exercise and vision assessment and treatment (OR, 0.17 [95% CI, 0.07 to 0.38]; ARD, −1.79 [95% CI, −2.63 to −0.96]); combined exercise, vision assessment and treatment, and environmental assessment and modification (OR, 0.30 [95% CI, 0.13 to 0.70]; ARD, −1.19 [95% CI, −2.04 to −0.35]); and combined clinic-level quality improvement strategies (eg, case management), multifactorial assessment and treatment (eg, comprehensive geriatric assessment), calcium supplementation, and vitamin D supplementation (OR, 0.12 [95% CI, 0.03 to 0.55]; ARD, −2.08 [95% CI, −3.56 to −0.60]). Pairwise meta-analyses for fall-related hospitalizations (2 RCTs; 516 participants) showed no significant association between combined clinic- and patient-level quality improvement strategies and multifactorial assessment and treatment relative to usual care (OR, 0.78 [95% CI, 0.33 to 1.81]). Conclusions and Relevance Exercise alone and various combinations of interventions were associated with lower risk of injurious falls compared with usual care. Choice of fall-prevention intervention may depend on patient and caregiver values and preferences. PMID:29114830

Cognitive function, dementia and type 2 diabetes mellitus in the elderly.

PubMed

Strachan, Mark W J; Reynolds, Rebecca M; Marioni, Riccardo E; Price, Jacqueline F

2011-02-01

Increasing numbers of people are developing type 2 diabetes mellitus, but interventions to prevent and treat the classic microvascular and macrovascular complications have improved, so that people are living longer with the condition. This trend means that novel complications of type 2 diabetes mellitus, which are not targeted by current management strategies, could start to emerge. Cognitive impairment and dementia could come into this category. Type 2 diabetes mellitus is associated with a 1.5-2.5-fold increased risk of dementia. The etiology of dementia and cognitive impairment in people with type 2 diabetes mellitus is probably multifactorial. Chronic hyperglycemia is implicated, perhaps by promoting the development of cerebral microvascular disease. Data suggest that the brains of older people with type 2 diabetes mellitus might be vulnerable to the effects of recurrent, severe hypoglycemia. Other possible moderators of cognitive function include inflammatory mediators, rheological factors and dysregulation of the hypothalamic-pituitary-adrenal axis. Cognitive function should now be included as a standard end point in randomized trials of therapeutic interventions in patients with type 2 diabetes mellitus.

Simultaneous treatment to attain blood pressure and lipid goals and reduced CV risk burden using amlodipine/atorvastatin single-pill therapy in treated hypertensive participants in a randomized controlled trial

PubMed Central

Grimm, Richard; Malik, Mobin; Yunis, Carla; Sutradhar, Santosh; Kursun, Attila

2010-01-01

TOGETHER investigated whether targeting multiple cardiovascular (CV) risk factors using single-pill amlodipine/atorvastatin (AML/ATO) and therapeutic lifestyle changes (TLC) results in greater blood pressure (BP)/lipid control and additional reduction in estimated cardiovascular disease (CVD) risk compared with blood pressure intervention only using amlodipine (AML) + TLC. TOGETHER was a 6-week, randomized, double-blind, double-dummy trial using hypertensive participants with additional CV risk factors without CVD/diabetes. Participants were randomized to either AML/ATO (5 to 10/20 mg) + TLC or AML (5 to 10 mg) + TLC. The primary end point was the difference in proportion of participants attaining both BP (<140/90 mm Hg) and low-density lipoprotein cholesterol (LDL-C) (<100 mg/dL) goals at week 6. At week 6, 67.8% of participants receiving AML/ATO + TLC attained the combined BP/LDL-C goal versus 9.6% with AML + TLC (RD [A–B]: 58.2; 95% CI [48.1 to 68.4] P < 0.001; OR: 19.0; 95% CI 9.1 to 39.6; P < 0.001). Significant reductions from baseline in LDL-C, total cholesterol and triglycerides and estimated 10-year Framingham risk were also observed. Treatment with AML/ATO was well tolerated. In conclusion, a multifactorial CV management approach is more effective in achieving combined BP/LDL-C targets as well as CV risk reduction compared with BP intervention only in this patient population. PMID:20479948

Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial.

PubMed

Alonso-Domínguez, Rosario; Gómez-Marcos, Manuel A; Patino-Alonso, Maria C; Sánchez-Aguadero, Natalia; Agudo-Conde, Cristina; Castaño-Sánchez, Carmen; García-Ortiz, Luis; Recio-Rodríguez, José I

2017-09-14

New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. METHODS AND ANALYSIS: Study scope and population: The study will be conducted at 'La Alamedilla' primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25-70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. NCT02991079; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

How are information seeking, scanning, and processing related to beliefs about the roles of genetics and behavior in cancer causation?

PubMed Central

Waters, Erika A.; Wheeler, Courtney; Hamilton, Jada G.

2016-01-01

Background Understanding that cancer is caused by both genetic and behavioral risk factors is an important component of genomic literacy. However, a considerable percentage of people in the U.S. do not endorse such multifactorial beliefs. Methods Using nationally representative cross-sectional data from the U.S. Health Information National Trends Survey (N=2,529), we examined how information seeking, information scanning, and key information processing characteristics were associated with endorsing a multifactorial model of cancer causation. Results Multifactorial beliefs about cancer were more common among respondents who engaged in cancer information scanning (p=.001), were motivated to process health information (p=.005), and who reported a family history of cancer (p=.0002). Respondents who reported having previous negative information seeking experiences had lower odds of endorsing multifactorial beliefs (p=.01). Multifactorial beliefs were not associated with cancer information seeking, trusting cancer information obtained from the Internet, trusting cancer information from a physician, self-efficacy for obtaining cancer information, numeracy, or being aware of direct-to-consumer genetic testing (ps>.05). Conclusion Gaining additional understanding of how people access, process, and use health information will be critical for the continued development and dissemination of effective health communication interventions and for the further translation of genomics research to public health and clinical practice. PMID:27661291

How Are Information Seeking, Scanning, and Processing Related to Beliefs About the Roles of Genetics and Behavior in Cancer Causation?

PubMed

Waters, Erika A; Wheeler, Courtney; Hamilton, Jada G

2016-01-01

Understanding that cancer is caused by both genetic and behavioral risk factors is an important component of genomic literacy. However, a considerable percentage of people in the United States do not endorse such multifactorial beliefs. Using nationally representative cross-sectional data from the U.S. Health Information National Trends Survey (N = 2,529), we examined how information seeking, information scanning, and key information-processing characteristics were associated with endorsing a multifactorial model of cancer causation. Multifactorial beliefs about cancer were more common among respondents who engaged in cancer information scanning (p = .001), were motivated to process health information (p = .005), and reported a family history of cancer (p = .0002). Respondents who reported having previous negative information-seeking experiences had lower odds of endorsing multifactorial beliefs (p = .01). Multifactorial beliefs were not associated with cancer information seeking, trusting cancer information obtained from the Internet, trusting cancer information from a physician, self-efficacy for obtaining cancer information, numeracy, or being aware of direct-to-consumer genetic testing (ps > .05). Gaining additional understanding of how people access, process, and use health information will be critical for the continued development and dissemination of effective health communication interventions and for the further translation of genomics research to public health and clinical practice.

Vascular anomalies: classification, imaging characteristics and implications for interventional radiology treatment approaches

PubMed Central

Prajapati, H J S; Martin, L G; Patel, T H

2014-01-01

The term vascular anomaly represents a broad spectrum of vascular pathology, including proliferating vascular tumours and vascular malformations. While the treatment of most vascular anomalies is multifactorial, interventional radiology procedures, including embolic therapy, sclerotherapy and laser coagulation among others, are playing an increasingly important role in vascular anomaly management. This review discusses the diagnosis and treatment of common vascular malformations, with emphasis on the technique, efficacy and complications of different interventional radiology procedures. PMID:24588666

The aging musculoskeletal system and obesity-related considerations with exercise

PubMed Central

Vincent, Heather K.; Raiser, Sara N.; Vincent, Kevin R.

2012-01-01

Advancing age and adiposity contribute to musculoskeletal degenerative diseases and the development of sarcopenic obesity. The etiology of muscle loss is multifactorial, and includes inflammation, oxidative stress and hormonal changes, and is worsened by activity avoidance due to fear of pain. The risk for mobility disability and functional impairment rises with severity of obesity in the older adult. Performance measures of walking distance, walking speed, chair rise, stair climb, body transfers and ability to navigate obstacles on a course are adversely affected in this population, and this reflects decline in daily physical functioning. Exercise training is an ideal intervention to counteract the effects of aging and obesity. The 18 randomized controlled trials of exercise studies with or without diet components reviewed here indicate that 3–18 month programs that included aerobic and strengthening exercise (2–3 days per week) with caloric restriction (typically 750 kcal deficit/day), induced the greatest change in functional performance measures compared with exercise or diet alone. Importantly, resistance exercise attenuates muscle mass loss with the interventions. These interventions can also combat factors that invoke sarcopenia, including inflammation, oxidative stress and insulin resistance. Therefore, regular multimodal exercise coupled with diet appears to be very effective for counteracting sarocpenic obesity and improving mobility and function in the older, obese adult. PMID:22440321

Role of Microbial Modulation in Management of Atopic Dermatitis in Children

PubMed Central

van’t Land, Belinda; Sprikkelman, Aline B.; Garssen, Johan

2017-01-01

The pathophysiology of atopic dermatitis (AD) is multifactorial and is a complex interrelationship between skin barrier, genetic predisposition, immunologic development, skin microbiome, environmental, nutritional, pharmacological, and psychological factors. Several microbial modulations of the intestinal microbiome with pre- and/or probiotics have been used in AD management, with different clinical out-come (both positive, as well as null findings). This review provides an overview of the clinical evidence from trials in children from 2008 to 2017, aiming to evaluate the effect of dietary interventions with pre- and/or pro-biotics for the treatment of AD. By searching the PUBMED/MEDLINE, EMBADE, and COCHRANE databases 14 clinical studies were selected and included within this review. Data extraction was independently conducted by two authors. The primary outcome was an improvement in the clinical score of AD severity. Changes of serum immunological markers and/or gastrointestinal symptoms were explored if available. In these studies some dietary interventions with pre- and/or pro-biotics were beneficial compared to control diets in the management of AD in children, next to treatment with emollients, and/or local corticosteroids. However, heterogeneity between studies was high, making it clear that focused clinical randomized controlled trials are needed to understand the potential role and underlying mechanism of dietary interventions in children with AD. PMID:28792444

Role of Microbial Modulation in Management of Atopic Dermatitis in Children.

PubMed

Hulshof, Lies; Van't Land, Belinda; Sprikkelman, Aline B; Garssen, Johan

2017-08-09

The pathophysiology of atopic dermatitis (AD) is multifactorial and is a complex interrelationship between skin barrier, genetic predisposition, immunologic development, skin microbiome, environmental, nutritional, pharmacological, and psychological factors. Several microbial modulations of the intestinal microbiome with pre- and/or probiotics have been used in AD management, with different clinical out-come (both positive, as well as null findings). This review provides an overview of the clinical evidence from trials in children from 2008 to 2017, aiming to evaluate the effect of dietary interventions with pre- and/or pro-biotics for the treatment of AD. By searching the PUBMED/MEDLINE, EMBADE, and COCHRANE databases 14 clinical studies were selected and included within this review. Data extraction was independently conducted by two authors. The primary outcome was an improvement in the clinical score of AD severity. Changes of serum immunological markers and/or gastrointestinal symptoms were explored if available. In these studies some dietary interventions with pre- and/or pro-biotics were beneficial compared to control diets in the management of AD in children, next to treatment with emollients, and/or local corticosteroids. However, heterogeneity between studies was high, making it clear that focused clinical randomized controlled trials are needed to understand the potential role and underlying mechanism of dietary interventions in children with AD.

Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

PubMed Central

2010-01-01

Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester). Design A single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care. Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment groups at one year. Randomisation will occur at practice-level with newly diagnosed T2DM cases receiving either conventional (according to current national guidelines) or intensive (algorithmic target-driven multi-factorial cardiovascular risk intervention) treatments. Discussion ADDITION-Leicester is the largest multiethnic (targeting >30% South Asian recruitment) community T2DM and vascular risk screening programme in the UK. By assessing feasibility and efficacy of T2DM screening, it will inform national disease prevention policy and contribute significantly to our understanding of the health care needs of UK South Asians. Trial registration Clinicaltrial.gov (NCT00318032). PMID:20170482

Does disinfection of environmental surfaces influence nosocomial infection rates? A systematic review.

PubMed

Dettenkofer, Markus; Wenzler, Sibylle; Amthor, Susanne; Antes, Gerd; Motschall, Edith; Daschner, Franz D

2004-04-01

To review the evidence on the effects of disinfection of environmental surfaces in hospitals (as compared with cleaning without use of disinfectants) on the occurrence of nosocomial infections. Systematic review of experimental and nonexperimental intervention studies dealing with environmental disinfection or cleaning in different health care settings. A total of 236 scientific articles were identified. None described a meta-analysis, systematic review, or randomized controlled trial. Only 4 articles described completed cohort studies matching the inclusion criteria. None of these studies showed lower infection rates associated with routine disinfection of surfaces (mainly floors) versus cleaning with detergent only. Disinfectants may pose a danger to staff, patients, and the environment and require special safety precautions. However, targeted disinfection of certain environmental surfaces is in certain instances an established component of hospital infection control. Given the complex, multifactorial nature of nosocomial infections, well-designed studies that systematically investigate the role of surface disinfection are required.

Effect of Modified Otago Exercises on Postural Balance, Fear of Falling, and Fall Risk in Older Fallers With Knee Osteoarthritis and Impaired Gait and Balance: A Secondary Analysis.

PubMed

Mat, Sumaiyah; Ng, Chin Teck; Tan, Pey June; Ramli, Norlisah; Fadzli, Farhana; Rozalli, Faizatul Izza; Mazlan, Mazlina; Hill, Keith D; Tan, Maw Pin

2018-03-01

Osteoarthritis (OA) is considered an established risk factor for falls. Published studies evaluating secondary falls prevention strategies among individuals with OA are limited. To evaluate the effect of a personalized home-based exercise program to improve postural balance, fear of falling, and falls risk in older fallers with knee OA and gait and balance problems. Randomized controlled trial. University of Malaya Medical Centre. Fallers who had both radiological OA and a Timed Up and Go (TUG) score of over 13.5 seconds. Postural sway (composite sway) was quantified with the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) under 4 different sensory conditions: eyes open on firm surface, eyes closed on firm surface, eyes open on unstable foam surface, and eyes closed on unstable foam surface. Participants were asked to stand upright and to attempt to hold their position for 10 seconds for each test condition. The average reading for all conditions were calculated. Participants randomized to the intervention arm received a home-based modified Otago Exercise Program (OEP) as part of a multifactorial intervention, whereas control participants received general health advice and conventional treatment. This was a secondary subgroup analysis from an original randomized controlled trial, the Malaysian Falls Assessment and Intervention Trial (MyFAIT) (trial registration number: ISRCTN11674947). Posturography using a long force plate balance platform (Balancemaster, NeuroCom, USA), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the short-form Falls Efficacy Scale-International (short FES-I) were assessed at baseline and 6 months. Results of 41 fallers with radiological evidence of OA and impaired TUG (intervention, 17; control, 24) were available for the final analysis. Between-group analysis revealed significant improvements in the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), Limits of Stability (LOS), and short FES-I scores by the intervention group compared to the control group at 6 months. No significant difference in time to first fall or in fall-free survival between the intervention and control groups was found. Home-based balance and strength exercises benefited older fallers with OA and gait and balance disorders by improving postural control, with no observable trend in reduction of fall recurrence. Our findings will now inform a future, adequately powered, randomized controlled study using fall events as definitive outcomes. I. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2): study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression.

PubMed

Watkins, Edward; Newbold, Alexandra; Tester-Jones, Michelle; Javaid, Mahmood; Cadman, Jennifer; Collins, Linda M; Graham, John; Mostazir, Mohammod

2016-10-06

Depression is a global health challenge. Although there are effective psychological and pharmaceutical interventions, our best treatments achieve remission rates less than 1/3 and limited sustained recovery. Underpinning this efficacy gap is limited understanding of how complex psychological interventions for depression work. Recent reviews have argued that the active ingredients of therapy need to be identified so that therapy can be made briefer, more potent, and to improve scalability. This in turn requires the use of rigorous study designs that test the presence or absence of individual therapeutic elements, rather than standard comparative randomised controlled trials. One such approach is the Multiphase Optimization Strategy, which uses efficient experimentation such as factorial designs to identify active factors in complex interventions. This approach has been successfully applied to behavioural health but not yet to mental health interventions. A Phase III randomised, single-blind balanced fractional factorial trial, based in England and conducted on the internet, randomized at the level of the patient, will investigate the active ingredients of internet cognitive-behavioural therapy (CBT) for depression. Adults with depression (operationalized as PHQ-9 score ≥ 10), recruited directly from the internet and from an UK National Health Service Improving Access to Psychological Therapies service, will be randomized across seven experimental factors, each reflecting the presence versus absence of specific treatment components (activity scheduling, functional analysis, thought challenging, relaxation, concreteness training, absorption, self-compassion training) using a 32-condition balanced fractional factorial design (2 IV 7-2 ). The primary outcome is symptoms of depression (PHQ-9) at 12 weeks. Secondary outcomes include symptoms of anxiety and process measures related to hypothesized mechanisms. Better understanding of the active ingredients of efficacious therapies, such as CBT, is necessary in order to improve and further disseminate these interventions. This study is the first application of a component selection experiment to psychological interventions in depression and will enable us to determine the main effect of each treatment component and its relative efficacy, and cast light on underlying mechanisms, so that we can systematically enhance internet CBT. Current Controlled Trials ISRCTN24117387 . Registered 26 August 2014.

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

PubMed Central

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model.

PubMed

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Our results suggest that RJ improves tear volume in patients with dry eye. Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).

Cancer-related fatigue: Mechanisms, risk factors, and treatments

PubMed Central

Bower, Julienne E.

2015-01-01

Fatigue is one of the most common and distressing side effects of cancer and its treatment, and may persist for years after treatment completion in otherwise healthy survivors. Cancer-related fatigue causes disruption in all aspects of quality of life and may be a risk factor for reduced survival. The prevalence and course of fatigue in cancer patients has been well characterized, and there is growing understanding of underlying biological mechanisms. Inflammation has emerged as a key biological pathway for cancer-related fatigue, with studies documenting links between markers of inflammation and fatigue before, during, and particularly after treatment. There is considerable variability in the experience of cancer-related fatigue that is not explained by disease- or treatment-related characteristics, suggesting that host factors may play an important role in the development and persistence of this symptom. Indeed, longitudinal studies have begun to identify genetic, biological, psychosocial, and behavioral risk factors for cancer-related fatigue. Given the multi-factorial nature of cancer-related fatigue, a variety of intervention approaches have been examined in randomized controlled trials, including physical activity, psychosocial, mind-body, and pharmacological treatments. Although there is currently no gold standard for treating fatigue, several of these approaches have shown beneficial effects and can be recommended to patients. This report provides a state of the science review of mechanisms, risk factors, and interventions for cancer-related fatigue, with a focus on recent longitudinal studies and randomized trials that have targeted fatigued patients. PMID:25113839

Effectiveness of treat-to-target strategy for LDL-cholesterol control in type 2 diabetes: post-hoc analysis of data from the MIND.IT study.

PubMed

Ardigò, Diego; Vaccaro, Olga; Cavalot, Franco; Rivellese, Albarosa Angela; Franzini, Laura; Miccoli, Roberto; Patti, Lidia; Boemi, Massimo; Trovati, Mariella; Zavaroni, Ivana

2014-04-01

The paper presents a post-hoc analysis of the intensity of dyslipidaemia care operated in the first 2 years of Multiple-Intervention-in-type-2-Diabetes.ITaly (MIND.IT) study. MIND.IT is a multicentric, randomized, two-parallel arm trial involving 1461 type 2 diabetic patients at high cardiovascular (CV) risk. The study compares the usual care (UC) of CV prevention with a multifactorial intensive care (IC) approach aiming at achieving target values for the main CV risk factors according to a step-wise treat-to-target approach. Proportion of patients on target for low-density lipoprotein cholesterol (LDL-C) was about 10% at baseline and increased significantly more with IC than UC (43 vs. 27%; p < 0.001). However, the majority (57%) of patients, in this intended intensively treated cohort, failed to achieve the proposed target. Average LDL-C decreased from 144 ± 35 to 108 ± 31 mg/dl with IC and from 142 ± 28 to 118 ± 32 with UC (p-for-interaction <0.0001). IC was associated with a significantly greater increase in statin prescription and lower withdrawal from treatment than UC (43 vs. 11% and 28 vs. 61%, respectively; both p < 0.001). However, the new treatments were characterized in both groups by the use of low starting doses (≤ 10 mg of atorvastatin, equivalent dose in more than 90% of patients) without increase in case of missed target. The application of a multifactorial treat-to-target intervention is associated with a significant improvement in LDL-C beyond usual practice. However, the change in LDL-C appears to be more related to an increased number of treated patients and a decreased treatment withdrawal than to a true treat-to-target approach.

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT)

PubMed Central

Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-01

Introduction Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. Methods and analysis A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver ‘active’ interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to ‘active’ intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. Ethics and dissemination The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties. Trial registration number ISRCTN 71002650; Pre-results. PMID:26781504

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

PubMed

Bruce, Julie; Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-18

Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties. ISRCTN 71002650; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A multifactorial intervention for frail older people is more than twice as effective among those who are compliant: complier average causal effect analysis of a randomised trial.

PubMed

Fairhall, Nicola; Sherrington, Catherine; Cameron, Ian D; Kurrle, Susan E; Lord, Stephen R; Lockwood, Keri; Herbert, Robert D

2017-01-01

What is the effect of a multifactorial intervention on frailty and mobility in frail older people who comply with their allocated treatment? Secondary analysis of a randomised, controlled trial to derive an estimate of complier average causal effect (CACE) of treatment. A total of 241 frail community-dwelling people aged ≥ 70 years. Intervention participants received a 12-month multidisciplinary intervention targeting frailty, with home exercise as an important component. Control participants received usual care. Primary outcomes were frailty, assessed using the Cardiovascular Health Study criteria (range 0 to 5 criteria), and mobility measured using the 12-point Short Physical Performance Battery. Outcomes were assessed 12 months after randomisation. The treating physiotherapist evaluated the amount of treatment received on a 5-point scale. 216 participants (90%) completed the study. The median amount of treatment received was 25 to 50% (range 0 to 100). The CACE (ie, the effect of treatment in participants compliant with allocation) was to reduce frailty by 1.0 frailty criterion (95% CI 0.4 to 1.5) and increase mobility by 3.2 points (95% CI 1.8 to 4.6) at 12 months. The mean CACE was substantially larger than the intention-to-treat effect, which was to reduce frailty by 0.4 frailty criteria (95% CI 0.1 to 0.7) and increase mobility by 1.4 points (95% CI 0.8 to 2.1) at 12 months. Overall, compliance was low in this group of frail people. The effect of the treatment on participants who comply with allocated treatment was substantially greater than the effect of allocation on all trial participants. Australian and New Zealand Trial Registry ANZCTRN12608000250336. [Fairhall N, Sherrington C, Cameron ID, Kurrle SE, Lord SR, Lockwood K, Herbert RD (2016) A multifactorial intervention for frail older people is more than twice as effective among those who are compliant: complier average causal effect analysis of a randomised trial.Journal of Physiotherapy63: 40-44]. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: analysis of baseline intervention data.

PubMed

Philip, Errol J; Nelson, Christian; Temple, Larissa; Carter, Jeanne; Schover, Leslie; Jennings, Sabrina; Jandorf, Lina; Starr, Tatiana; Baser, Ray; DuHamel, Katherine

2013-10-01

Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship. This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30] and Colorectal Cancer-Specific Module [QLQ-CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well-being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale-Revised, CR-38 Body Image). Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=-0.45 to -0.70, all P<0.01). Body image, anxiety, and cancer-specific posttraumatic distress were notable in their association with subscales of sexual functioning, while a global QOL measure was largely unrelated. For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad QOL assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients. © 2013 International Society for Sexual Medicine.

Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial.

PubMed

Anderson, Cheryl A M; Cobb, Laura K; Miller, Edgar R; Woodward, Mark; Hottenstein, Annette; Chang, Alex R; Mongraw-Chaffin, Morgana; White, Karen; Charleston, Jeanne; Tanaka, Toshiko; Thomas, Letitia; Appel, Lawrence J

2015-09-01

For decades, dietary sodium intake in the United States has remained high, and few studies have examined strategies for maintaining recommended intakes. We examined the effects of a behavioral intervention, which emphasized spices and herbs, on the maintenance of sodium intake at the recommended intake of 1500 mg/d in individuals to whom the US Dietary Guidelines for Americans apply. We conducted a 2-phase study that included adults ≥18 y of age for whom Dietary Guidelines for Americans recommends 1500 mg Na/d. The study was conducted in Baltimore, Maryland, from 2012 to 2014. In phase 1, 55 individuals consumed a low-sodium diet for 4 wk. Participants were provided all foods, snacks, and calorie-containing drinks. In phase 2, 40 participants from phase 1 were randomly assigned to either a behavioral intervention to reduce sodium intake (n = 20) or a self-directed control group (n = 20) for 20 wk. The primary study outcome was the change in mean 24-h urinary sodium excretion during phase 2. Linear regression analyses were used to determine intervention effects on urinary sodium excretion. Participant characteristics were as follows: women: 65%; African American: 88%; hypertension: 63%; diabetes: 18%; mean age: 61 y; and mean body mass index (in kg/m(2)): 30. At the end of phase 2, mean 24-h sodium excretion was lower in the behavioral intervention than in the self-directed group (mean difference: -956.8 mg/d; 95% CI: -1538.7, -374.9 mg/d) after sodium intake at screening was controlled for (P = 0.002). These findings persisted in sensitivity analyses that excluded potentially incomplete urine collections [Mage's equation mean difference: -1090 mg/d (P = 0.001); Joosens' equation mean difference: -796 mg/d (P = 0.04)]. A multifactorial behavioral intervention emphasizing spices and herbs significantly reduced sodium intake. Because of the ubiquity of sodium in the US food supply, multilevel strategies addressing individual behaviors and the food supply are needed to improve adherence to recommendations. This trial was registered at clinicaltrials.gov as NCT01615159. © 2015 American Society for Nutrition.

Age-related macular degeneration: Effects of a short-term intervention with an oleaginous kale extract--a pilot study.

PubMed

Arnold, Christin; Jentsch, Susanne; Dawczynski, Jens; Böhm, Volker

2013-01-01

Age-related macular degeneration (AMD) is a multifactorial degenerative disease of the retina, which accounts for slowly progressive visual impairment in the elderly. An increased dietary intake of xanthophylls is suggested to be inversely related to the risk of macular disease. The present study was designed as a randomized, double-blind, placebo-controlled, parallel trial examining the influence of a short-term intervention with an oleaginous extract of Brassica oleracea var. sabellica L. (kale) on plasma xanthophyll concentrations and the optical density of the macular pigment xanthophylls (MPOD). Twenty patients with non-exudative AMD were recruited for a 10-wk study period (2-wk run-in, 4-wk intervention, 4-wk washout). All participants received 50 mL of a beverage containing either an oleaginous extract of kale (kale) or refined rapeseed oil (placebo). The verum product provides 10 mg lutein and 3 mg zeaxanthin per day. The concentrations of the xanthophylls in plasma and the MPOD increased significantly in the kale group after 4 wk of intervention. The successive washout period resulted in a significant decline of the values in plasma and macula. The values at the end of the study were still significantly higher than the initial values. Nevertheless, the improvements did not persist over 4 wk of washout. The distribution of the xanthophylls in the macula seems to be more dynamic than originally assumed. Copyright © 2013 Elsevier Inc. All rights reserved.

Multifactorial intervention for diabetes control among older users of insulin

PubMed Central

Machry, Rafael Vaz; Pedroso, Henrique Umpierre; Vasconcellos, Luthiele Silva; Nunes, Rafaela Ramos; Evaldt, Cibelle de Abreu; Yunes, Eduardo Bardou; Rodrigues, Ticiana da Costa

2018-01-01

ABSTRACT OBJECTIVE: To evaluate if the closer follow-up with the supply of insulin pens and the measurement of capillary blood glucose improve the management of older patients with type 2 diabetes without adequate glycemic control despite extensive therapy. METHODS: This is a prospective, non-randomized, quasi-experimental study. We have included 45 patients over 60 years old, from both sexes, with glycated hemoglobin (HbA1c) > 8.5% using oral hypoglycemic agents and insulin. The intervention consisted of monthly medical visits, with the provision of insulin pens and strips for blood glucose measurement. All patients received insulin pen, refills of Neutral Protamine Hagedorn and regular insulin, needles for the pen, blood glucose meter, and capillary blood glucose tests (three tests/day). Treatment was adjusted with the same endocrinologist monthly for six months. Glycated hemoglobin was measured at baseline and 12 and 24 weeks after intervention. RESULTS: Glycated hemoglobin at baseline was 10.34% (SE = 0.22%) and 8.54% (SE = 0.24%, p < 0.001) and 8.09% (SE = 0.21%, p < 0.001) at 12 and 24 weeks after intervention, respectively, with a significant reduction from baseline. CONCLUSIONS: More frequent medical visits, with treatment inputs including the use of insulin pens and self-monitoring, have improved glycemic control (reduction of 2.25% in HbA1C, on average, at 24 weeks of follow-up). Our data support a change in the management and medical behavior of older patients with chronically decompensated diabetes. PMID:29791677

The effects of a single session of spinal manipulation on strength and cortical drive in athletes.

PubMed

Christiansen, Thomas Lykke; Niazi, Imran Khan; Holt, Kelly; Nedergaard, Rasmus Wiberg; Duehr, Jens; Allen, Kathryn; Marshall, Paul; Türker, Kemal S; Hartvigsen, Jan; Haavik, Heidi

2018-04-01

The primary purpose of this study was to investigate whether a single session of spinal manipulation (SM) increases strength and cortical drive in the lower limb (soleus muscle) of elite Taekwondo athletes. Soleus-evoked V-waves, H-reflex and maximum voluntary contraction (MVC) of the plantar flexors were recorded from 11 elite Taekwondo athletes using a randomized controlled crossover design. Interventions were either SM or passive movement control. Outcomes were assessed at pre-intervention and at three post-intervention time periods (immediate post, post 30 min and post 60 min). A multifactorial repeated measures ANOVA was conducted to assess within and between group differences. Time and session were used as factors. A post hoc analysis was carried out, when an interactive effect was present. Significance was set at p ≤ 0.05. SM increased MVC force [F(3,30) = 5.95, p < 0.01], and V-waves [F(3,30) = 4.25, p = 0.01] over time compared to the control intervention. Between group differences were significant for all time periods (p < 0.05) except for the post60 force measurements (p = 0.07). A single session of SM increased muscle strength and corticospinal excitability to ankle plantar flexor muscles in elite Taekwondo athletes. The increased MVC force lasted for 30 min and the corticospinal excitability increase persisted for at least 60 min.

Effectiveness of Non-Pharmacological Interventions to Prevent Falls in Older People: A Systematic Overview. The SENATOR Project ONTOP Series

PubMed Central

Rimland, Joseph M.; Abraha, Iosief; Dell’Aquila, Giuseppina; Cruz-Jentoft, Alfonso; Soiza, Roy; Gudmusson, Adalsteinn; Petrovic, Mirko; O’Mahony, Denis; Todd, Chris; Cherubini, Antonio

2016-01-01

Background Falls are common events in older people, which cause considerable morbidity and mortality. Non-pharmacological interventions are an important approach to prevent falls. There are a large number of systematic reviews of non-pharmacological interventions, whose evidence needs to be synthesized in order to facilitate evidence-based clinical decision making. Objectives To systematically examine reviews and meta-analyses that evaluated non-pharmacological interventions to prevent falls in older adults in the community, care facilities and hospitals. Methods We searched the electronic databases Pubmed, the Cochrane Database of Systematic Reviews, EMBASE, CINAHL, PsycINFO, PEDRO and TRIP from January 2009 to March 2015, for systematic reviews that included at least one comparative study, evaluating any non-pharmacological intervention, to prevent falls amongst older adults. The quality of the reviews was assessed using AMSTAR and ProFaNE taxonomy was used to organize the interventions. Results Fifty-nine systematic reviews were identified which consisted of single, multiple and multifactorial non-pharmacological interventions to prevent falls in older people. The most frequent ProFaNE defined interventions were exercises either alone or combined with other interventions, followed by environment/assistive technology interventions comprising environmental modifications, assistive and protective aids, staff education and vision assessment/correction. Knowledge was the third principle class of interventions as patient education. Exercise and multifactorial interventions were the most effective treatments to reduce falls in older adults, although not all types of exercise were equally effective in all subjects and in all settings. Effective exercise programs combined balance and strength training. Reviews with a higher AMSTAR score were more likely to contain more primary studies, to be updated and to perform meta-analysis. Conclusions The aim of this overview of reviews of non-pharmacological interventions to prevent falls in older people in different settings, is to support clinicians and other healthcare workers with clinical decision-making by providing a comprehensive perspective of findings. PMID:27559744

Rapid Improvement of Glycemic Control in Type 2 Diabetes Using Weekly Intensive Multifactorial Interventions: Structured Glucose Monitoring, Patient Education, and Adjustment of Therapy—A Randomized Controlled Trial

PubMed Central

Rodbard, David; Zanella, Maria Teresa

2011-01-01

Abstract Background We evaluated intensive intervention in poorly controlled patients with type 2 diabetes mellitus involving weekly clinic visits and adjustment of therapy with analysis of three seven-point glucose profiles and intervention from an interdisciplinary staff. Methods Sixty-three patients were randomized to an intensive treatment group that obtained self-monitoring of blood glucose (SMBG) profiles (six or seven values per day, 3 days/week) and were seen in the clinic at Weeks 1–6 and 12. SMBG results were downloaded, analyzed using Accu-Chek® 360° software (Roche Diagnostics, Indianapolis, IN), and used to adjust therapy. Control group subjects obtained glucose profiles and had clinic visits only at Weeks 0, 6, and 12. Results There were highly statistically significant improvements in the intensive treatment group compared with the control group between Weeks 0 and 6 with greater reductions in weekly mean glycemia (WMG) (−76.7±8.9 mg/dL vs. −20.5±8.1 mg/dL), glycemic variability (SD) (−16.3±3.1 mg/dL vs. −5.0±3.1 mg/dL), and glycated hemoglobin (−1.82±0.16% vs. −0.66±0.22%) without significant changes in frequency of hypoglycemia or weight. Improvements were sustained in the intensive treatment group through Week 12. A minimal but statistically significant degree of improvement was seen in the control group at Week 12. Conclusions This short-term pilot study of an intensive monitoring, educational, and pharmacological interventions program resulted in dramatic improvement of glycemic control within 6 weeks, and these effects are sustained through Week 12. SMBG glucose profiles, calculation of WMG and SD, and graphical displays of glucose data can improve the effectiveness of adjustment of therapy at weekly clinic visits when combined with intensive support from a multidisciplinary team. PMID:21751888

Spirituality, religiosity and addiction recovery: current perspectives.

PubMed

Castaldelli-Maia, Joao Mauricio; Beraldo, Livia; Ventriglio, Antonio; de Andrade, Arthur Guerra; da Silva, Antonio Geraldo; Torales, Julio; Goncalves, Priscila Dib; Bhugra, Dinesh

2018-06-11

Substance use disorders are an important public health problem with a multifactorial etiology and limited effective treatment options. Within this context, spirituality-based approaches may provide interesting and useful options in managing substance use disorders. This kind of intervention can have positive effects in alleviating some core symptoms associated with substance use, such as aggressiveness. Improvement in cessation rates for alcohol, cocaine and opioid use disorders have also been described in some clinical studies. However, spirituality may not play a beneficial role in some subgroups, such as among individuals with crack cocaine and cannabis use disorders. A widely available intervention for alcohol use disorders is Alcoholics Anonymous (AA), which can be seen as a spirituality-based intervention. Spirituality also seems to be especially beneficial for minorities such as Latinos, African-Americans and Native-Americans. Moreover, spiritual-based interventions are also helpful alternatives in many rural environments where conventional healthcare for substance use disorders may not be easily available. However, spiritual-based interventions may be considered as a possible adjunctive therapeutic option to conventional treatments. There is a need for prospective studies outside U.S., especially where spiritual-based approaches are available. It may be difficult to carry out randomized controlled trials because of the nature of the spiritual/religious dimensions. However, prospective studies that evaluate mediation effect of spirituality and religiosity on recovery would be helpful. Qualitative studies combined with quantitative design offer excellent options to evaluate the recovery process, especially among special populations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The aging musculoskeletal system and obesity-related considerations with exercise.

PubMed

Vincent, Heather K; Raiser, Sara N; Vincent, Kevin R

2012-07-01

Advancing age and adiposity contribute to musculoskeletal degenerative diseases and the development of sarcopenic obesity. The etiology of muscle loss is multifactorial, and includes inflammation, oxidative stress and hormonal changes, and is worsened by activity avoidance due to fear of pain. The risk for mobility disability and functional impairment rises with severity of obesity in the older adult. Performance measures of walking distance, walking speed, chair rise, stair climb, body transfers and ability to navigate obstacles on a course are adversely affected in this population, and this reflects decline in daily physical functioning. Exercise training is an ideal intervention to counteract the effects of aging and obesity. The 18 randomized controlled trials of exercise studies with or without diet components reviewed here indicate that 3-18 month programs that included aerobic and strengthening exercise (2-3 days per week) with caloric restriction (typically 750 kcal deficit/day), induced the greatest change in functional performance measures compared with exercise or diet alone. Importantly, resistance exercise attenuates muscle mass loss with the interventions. These interventions can also combat factors that invoke sarcopenia, including inflammation, oxidative stress and insulin resistance. Therefore, regular multimodal exercise coupled with diet appears to be very effective for counteracting sarocpenic obesity and improving mobility and function in the older, obese adult. Copyright © 2012 Elsevier B.V. All rights reserved.

The Strategies to Reduce Injuries and Develop Confidence in Elders Intervention: Falls Risk Factor Assessment and Management, Patient Engagement, and Nurse Co-management.

PubMed

Reuben, David B; Gazarian, Priscilla; Alexander, Neil; Araujo, Katy; Baker, Dorothy; Bean, Jonathan F; Boult, Chad; Charpentier, Peter; Duncan, Pamela; Latham, Nancy; Leipzig, Rosanne M; Quintiliani, Lisa M; Storer, Thomas; McMahon, Siobhan

2017-12-01

In response to the epidemic of falls and serious falls-related injuries in older persons, in 2014, the Patient Centered Outcomes Research Institute (PCORI) and the National Institute on Aging funded a pragmatic trial, Strategies to Reduce Injuries and Develop confidence in Elders (STRIDE) to compare the effects of a multifactorial intervention with those of an enhanced usual care intervention. The STRIDE multifactorial intervention consists of five major components that registered nurses deliver in the role of falls care managers, co-managing fall risk in partnership with patients and their primary care providers (PCPs). The components include a standardized assessment of eight modifiable risk factors (medications; postural hypotension; feet and footwear; vision; vitamin D; osteoporosis; home safety; strength, gait, and balance impairment) and the use of protocols and algorithms to generate recommended management of risk factors; explanation of assessment results to the patient (and caregiver when appropriate) using basic motivational interviewing techniques to elicit patient priorities, preferences, and readiness to participate in treatments; co-creation of individualized falls care plans that patients' PCPs review, modify, and approve; implementation of the falls care plan; and ongoing monitoring of response, regularly scheduled re-assessments of fall risk, and revisions of the falls care plan. Custom-designed falls care management software facilitates risk factor assessment, the identification of recommended interventions, clinic note generation, and longitudinal care management. The trial testing the effectiveness of the STRIDE intervention is in progress, with results expected in late 2019. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Malnutrition in hip fracture patients: an intervention study.

PubMed

Olofsson, Birgitta; Stenvall, Michael; Lundström, Maria; Svensson, Olle; Gustafson, Yngve

2007-11-01

To investigate whether a nutritional intervention in older women and men with femoral neck fracture had an effect on postoperative complications during hospitalization and on nutritional status at a four-month follow-up. The design was a randomized controlled trial. The present study sample consisted of 157 patients aged 70 years and above with femoral neck fracture. The nutritional intervention included, among other things, a nutritional journal to detect nutrition deficiencies and protein-enriched meals for at least four days postoperatively. Further, at least two nutritional and protein drinks were served each day during the whole hospitalization and other factors that would influence the patient's nutrition were also considered and dealt with. Postoperative complications were registered and patients were assessed using the Mini Nutritional Assessment (MNA) scale, including body mass index (BMI), on admission and at a four-month follow-up. Malnutrition was common and low MNA scores were associated with postoperative complications such as delirium and decubitus ulcers. There were significantly fewer days of delirium in the intervention group, seven patients in the intervention group developed decubitus ulcers vs. 14 patients in the control group and the total length of hospitalization was shorter. There were no detectable significant improvements regarding nutritional parameters between the intervention and the control group at the four-month follow-up but men improved their mean BMI, body weight and MNA scores in both the intervention and the control groups while women deteriorated in both groups. Malnutrition was common among older people with hip fractures admitted to hospital. The nutritional intervention might have contributed to the patients suffering fewer days with delirium, fewer decubitus ulcers and shorter hospitalization but did not improve the long-term nutritional status, at least not in women. This nutritional intervention, which was included in a multifactorial multidisciplinary intervention, is inexpensive and relatively easy to implement. It has significant effects on complications but no long-term effect on nutritional parameters, at least not in women.

The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT).

PubMed

Bruce, Julie; Ralhan, Shvaita; Sheridan, Ray; Westacott, Katharine; Withers, Emma; Finnegan, Susanne; Davison, John; Martin, Finbarr C; Lamb, Sarah E

2017-06-01

This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and fractures, will be reported at the conclusion of the trial.

Falls Assessment Clinical Trial (FACT): design, interventions, recruitment strategies and participant characteristics.

PubMed

Elley, C Raina; Robertson, M Clare; Kerse, Ngaire M; Garrett, Sue; McKinlay, Eileen; Lawton, Beverley; Moriarty, Helen; Campbell, A John

2007-07-29

Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used - waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. 312 participants were recruited (69% women). Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05). Mean age of all participants was 81 years (SD 5). On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics) with a median of 2 falls (interquartile range 1, 3) in the previous year. The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a 'real life' setting is important.

Interventions to Improve Patient Education Regarding Multifactorial Genetic Conditions: A Systematic Review

PubMed Central

Meilleur, Katherine G.; Littleton-Kearney, Marguerite T.

2009-01-01

The careful education of patients with complex genetic disease is essential. However, healthcare providers often have limited time to spend providing thorough genetic education. Furthermore, the number of healthcare professionals possessing strong genetics training may be inadequate to meet increasing patient demands. Due to such constraints, several interventions have been investigated over the past decade to identify potential resources for the facilitation of this specific type of patient education. This systematic literature review of these interventions for patient education attempts to elucidate the answer to the question: is there sufficient evidence for best practice for delivering genetic information to patients with multifactorial conditions? The various interventions (CD-ROM, group counseling, video/decision aid, and miscellaneous) were analyzed in terms of quality criteria and achievement of specific outcomes and were rated according to the Stetler model for evidence based practice. Seven main outcomes were evaluated: 1. objective and subjective knowledge assessment 2. psychological measures (general anxiety, depression, stress, cancer worry) 3. satisfaction/effectiveness of intervention 4. time spent in counseling (time spent on basic genetic information vs. specific concerns) 5. decision making/intent to undergo genetic testing 6. treatment choice and value of that choice, and, finally 7. risk perception. Overall, the computer interventions resulted in more significant findings that were beneficial than any other category followed by the video category, although the group and miscellaneous categories did not measure all of the outcomes reported by the other two categories. Nevertheless, while these groups had neutral or negative findings in some of the outcomes, the computer intervention group showed significant improvement in genetics knowledge, psychological measures, satisfaction/effectiveness, time spent with counselor, and decision/intent to undergo testing. PMID:19291763

Can We Modify the Intrauterine Environment to Halt the Intergenerational Cycle of Obesity?

PubMed Central

Adamo, Kristi B.; Ferraro, Zachary M.; Brett, Kendra E.

2012-01-01

Child obesity is a global epidemic whose development is rooted in complex and multi-factorial interactions. Once established, obesity is difficult to reverse and epidemiological, animal model, and experimental studies have provided strong evidence implicating the intrauterine environment in downstream obesity. This review focuses on the interplay between maternal obesity, gestational weight gain and lifestyle behaviours, which may act independently or in combination, to perpetuate the intergenerational cycle of obesity. The gestational period, is a crucial time of growth, development and physiological change in mother and child. This provides a window of opportunity for intervention via maternal nutrition and/or physical activity that may induce beneficial physiological alternations in the fetus that are mediated through favourable adaptations to in utero environmental stimuli. Evidence in the emerging field of epigenetics suggests that chronic, sub-clinical perturbations during pregnancy may affect fetal phenotype and long-term human data from ongoing randomized controlled trials will further aid in establishing the science behind ones predisposition to positive energy balance. PMID:22690193

Effects on leisure activities and social participation of a case management intervention for frail older people living at home: a randomised controlled trial.

PubMed

Granbom, Marianne; Kristensson, Jimmie; Sandberg, Magnus

2017-07-01

Frailty causes disability and restrictions on older people's ability to engage in leisure activities and for social participation. The objective of this study was to evaluate the effects of a 1-year case management intervention for frail older people living at home in Sweden in terms of social participation and leisure activities. The study was a randomised controlled trial with repeated follow-ups. The sample (n = 153) was consecutively and randomly assigned to intervention (n = 80) or control groups (n = 73). The intervention group received monthly home visits over the course of a year by nurses and physiotherapists working as case managers, using a multifactorial preventive approach. Data collections on social participation, leisure activities and rating of important leisure activities were performed at baseline, 3, 6, 9 and 12 months, with recruitment between October 2006 and April 2011. The results did not show any differences in favour of the intervention on social participation. However, the intervention group performed leisure activities in general, and important physical leisure activities, to a greater extent than the control group at the 3-month follow-up (median 13 vs. 11, P = 0.034 and median 3 vs. 3, P = 0.031 respectively). A statistically significantly greater proportion of participants from the intervention group had an increased or unchanged number of important social leisure activities that they performed for the periods from baseline to 3 months (93.2% vs. 75.4%, OR = 4.48, 95% CI: 1.37-14.58). Even though statistically significant findings in favour of the intervention were found, more research on activity-focused case management interventions is needed to achieve clear effects on social participation and leisure activities. © 2017 John Wiley & Sons Ltd.

Cancer wasting and quality of life react to early individualized nutritional counselling!

PubMed

Ravasco, Paula; Monteiro Grillo, Isabel; Camilo, Maria

2007-02-01

To devise a meaningful nutritional therapy in cancer, a greater understanding of nutritional dimensions as well as patients' expectations and disease impact is essential. We have shown that nutritional deterioration in patients with gastrointestinal and head and neck cancer was multifactorial and mainly determined by the tumour burden and location. In a larger cohort, stage and location were yet again the major determinants of patients' quality of life (QoL), despite the fact that nutritional deterioration combined with intake deficits were functionally more relevant than cancer stage. Based on this framework, the potential role of integrated oral nutritional support on outcomes was investigated. In a pilot study using individualized nutritional counselling on a heterogeneous patient population, the achieved improvement of nutritional intake was proportional to a better QoL. The role of early nutritional support was further analysed in a prospective randomized controlled trial in head and neck cancer patients stratified by stage undergoing radiotherapy. Pre-defined outcomes were: nutritional status and intake, morbidity and QoL, at the end and 3 months after radiotherapy. Nutritional interventions, only given during radiotherapy, consisted of three randomization arms: (1) individualized nutritional counselling vs. (2) ad libitum diet+high protein supplements vs. (3) ad libitum diet. Nutritional interventions 1 and 2 positively influenced outcomes during radiotherapy; however, 3 months after its completion individualized nutritional counselling was the single method capable of sustaining a significant impact on patients' outcomes. The early provision of the appropriate mixture of foods and textures using regular foods may modulate outcomes in cancer patients.

Longitudinal comparison of low- and high-velocity resistance training in relation to body composition and functional fitness of older adults.

PubMed

Gray, Michelle; Powers, Melissa; Boyd, Larissa; Garver, Kayla

2018-03-22

Functional mobility disability affects more than one in five adults over 70 years and increases to 80% by 90 years. While negative changes in mobility are multifactorial, deleterious body composition changes contribute significantly. Resistance training alters the negative trajectory of physical function as well as increases lean mass among older adults. Recently, high-velocity (HV) resistance training has been indicated as an effective intervention to increase lean mass and functional performance. The present investigation compared body composition, physical function, and muscular strength changes between HV and LV resistance training programs. Participants > 65 years (n = 53) were randomly assigned to LV, HV, or active control (AC) group and participated in their respective intervention for 48 weeks. Analysis of covariance revealed no significant body composition changes over time between groups (p > 0.05). Eight-foot up-and-go performance improved in the HV and AC groups (p < 0.05) with no change in the LV group (p > 0.05) over time. Muscular strength increased in both the LV and HV groups within the first 24 weeks, while only in the LV group, muscular strength continued to increase from 24 to 48 weeks (p < 0.05). Resistance training appears to be an effective intervention for improving aspects of physical function and muscular strength; however, no significant changes in body composition were observed over the 48-week intervention. Findings from the current investigation support use of resistance training for improving physical function among community-dwelling older adults.

Theories of Memory and Aging: A Look at the Past and a Glimpse of the Future

PubMed Central

Festini, Sara B.

2017-01-01

The present article reviews theories of memory and aging over the past 50 years. Particularly notable is a progression from early single-mechanism perspectives to complex multifactorial models proposed to account for commonly observed age deficits in memory function. The seminal mechanistic theories of processing speed, limited resources, and inhibitory deficits are discussed and viewed as especially important theories for understanding age-related memory decline. Additionally, advances in multivariate techniques including structural equation modeling provided new tools that led to the development of more complex multifactorial theories than existed earlier. The important role of neuroimaging is considered, along with the current prevalence of intervention studies. We close with predictions about new directions that future research on memory and aging will take. PMID:27257229

Surgical Intervention for Medically Refractory Hyperthyroidism.

PubMed

Knollman, Philip D; Giese, Ann; Bhayani, Mihir K

2016-05-01

Pediatric hyperthyroidism can be multifactorial, with Graves' disease (GD) being the most common etiology. Treatment focuses on identification of the cause of the hyperthyroidism and achieving a biochemical cure with symptom resolution. This article highlights the clinical presentation, diagnosis, and treatment of a pediatric patient with GD. [Pediatr Ann. 2016;45(5):e171-e175.]. Copyright 2016, SLACK Incorporated.

Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial12

PubMed Central

Anderson, Cheryl AM; Cobb, Laura K; Miller, Edgar R; Woodward, Mark; Hottenstein, Annette; Chang, Alex R; Mongraw-Chaffin, Morgana; White, Karen; Charleston, Jeanne; Tanaka, Toshiko; Thomas, Letitia; Appel, Lawrence J

2015-01-01

Background: For decades, dietary sodium intake in the United States has remained high, and few studies have examined strategies for maintaining recommended intakes. Objective: We examined the effects of a behavioral intervention, which emphasized spices and herbs, on the maintenance of sodium intake at the recommended intake of 1500 mg/d in individuals to whom the US Dietary Guidelines for Americans apply. Design: We conducted a 2-phase study that included adults ≥18 y of age for whom Dietary Guidelines for Americans recommends 1500 mg Na/d. The study was conducted in Baltimore, Maryland, from 2012 to 2014. In phase 1, 55 individuals consumed a low-sodium diet for 4 wk. Participants were provided all foods, snacks, and calorie-containing drinks. In phase 2, 40 participants from phase 1 were randomly assigned to either a behavioral intervention to reduce sodium intake (n = 20) or a self-directed control group (n = 20) for 20 wk. The primary study outcome was the change in mean 24-h urinary sodium excretion during phase 2. Linear regression analyses were used to determine intervention effects on urinary sodium excretion. Results: Participant characteristics were as follows: women: 65%; African American: 88%; hypertension: 63%; diabetes: 18%; mean age: 61 y; and mean body mass index (in kg/m2): 30. At the end of phase 2, mean 24-h sodium excretion was lower in the behavioral intervention than in the self-directed group (mean difference: −956.8 mg/d; 95% CI: −1538.7, −374.9 mg/d) after sodium intake at screening was controlled for (P = 0.002). These findings persisted in sensitivity analyses that excluded potentially incomplete urine collections [Mage’s equation mean difference: −1090 mg/d (P = 0.001); Joosens’ equation mean difference: −796 mg/d (P = 0.04)]. Conclusions: A multifactorial behavioral intervention emphasizing spices and herbs significantly reduced sodium intake. Because of the ubiquity of sodium in the US food supply, multilevel strategies addressing individual behaviors and the food supply are needed to improve adherence to recommendations. This trial was registered at clinicaltrials.gov as NCT01615159. PMID:26269371

Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study.

PubMed

Matchar, David B; Duncan, Pamela W; Lien, Christopher T; Ong, Marcus Eng Hock; Lee, Mina; Gao, Fei; Sim, Rita; Eom, Kirsten

2017-06-01

To evaluate the effectiveness of a multifactorial, tailored program of physical therapy to reduce the occurrence of falls among a heterogeneous group of high-risk elderly Singaporeans recently discharged from the emergency department (ED). Randomized controlled trial. Communities. Adults (N=354) aged ≥65 years who were seen in the ED for a fall or fall-related injuries and discharged home. The intervention primarily consisted of a tailored program of physical therapy focused on progressive training in strength, balance, and gait for a period of 3 months. Participants in the intervention group also received screening and follow-up for vision, polypharmacy, and environmental hazards. Participants in the control group received usual care prescribed by a physician and educational materials on falls prevention. The primary outcome measure was experiencing at least 1 fall during the 9-month study period (a 3-mo active intervention phase and a 6-mo maintenance phase). Secondary outcome measures were the occurrence of at least 1 injurious fall during the study period and a change in the Short Physical Performance Battery (SPPB) score. Participants were assessed both after 3 and 9 months. During the 9-month study period, 37.8% of the control group and 30.5% of the intervention group fell at least once, which was not statistically significantly different (odds ratio [OR]=.72; 95% confidence interval [CI], .46-1.12; P=.146). The intervention group had statistically significantly fewer individuals with injurious falls (OR=.56; 95% CI, .32-.98; P=.041) and less deterioration in physical performance, reflected by a mean difference of 0.6 in SPPB scores (P=.029). Multivariate analyses indicated a strong interaction effect between the intervention and the presence of 2 or more major comorbidities; after accounting for this effect, the intervention program reduced the number of people experiencing at least 1 fall (OR=.34; 95% CI, .17-.67; P=.002). We observed that in this heterogeneous population, the proportion of participants experiencing at least 1 fall during the study period was not statistically significantly lower in the intervention group compared with the control group. Secondary analyses strongly suggest that individuals with 2 or more major comorbidities do not benefit from a tailored physical therapy program; however, individuals with less comorbidity may substantially benefit. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A multifactorial obesity model developed from nationwide public health exposome data and modern computational analyses.

PubMed

Gittner, LisaAnn S; Kilbourne, Barbara J; Vadapalli, Ravi; Khan, Hafiz M K; Langston, Michael A

Obesity is both multifactorial and multimodal, making it difficult to identify, unravel and distinguish causative and contributing factors. The lack of a clear model of aetiology hampers the design and evaluation of interventions to prevent and reduce obesity. Using modern graph-theoretical algorithms, we are able to coalesce and analyse thousands of inter-dependent variables and interpret their putative relationships to obesity. Our modelling is different from traditional approaches; we make no a priori assumptions about the population, and model instead based on the actual characteristics of a population. Paracliques, noise-resistant collections of highly-correlated variables, are differentially distilled from data taken over counties associated with low versus high obesity rates. Factor analysis is then applied and a model is developed. Latent variables concentrated around social deprivation, community infrastructure and climate, and especially heat stress were connected to obesity. Infrastructure, environment and community organisation differed in counties with low versus high obesity rates. Clear connections of community infrastructure with obesity in our results lead us to conclude that community level interventions are critical. This effort suggests that it might be useful to study and plan interventions around community organisation and structure, rather than just the individual, to combat the nation's obesity epidemic. Copyright © 2017 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Interventions to reduce racial and ethnic disparities in health care.

PubMed

Chin, Marshall H; Walters, Amy E; Cook, Scott C; Huang, Elbert S

2007-10-01

In 2005, the Robert Wood Johnson Foundation created Finding Answers: Disparities Research for Change, a program to identify, evaluate, and disseminate interventions to reduce racial and ethnic disparities in the care and outcomes of patients with cardiovascular disease, depression, and diabetes. In this introductory paper, we present a conceptual model for interventions that aim to reduce disparities. With this model as a framework, we summarize the key findings from the six other papers in this supplement on cardiovascular disease, diabetes, depression, breast cancer, interventions using cultural leverage, and pay-for-performance and public reporting of performance measures. Based on these findings, we present global conclusions regarding the current state of health disparities interventions and make recommendations for future interventions to reduce disparities. Multifactorial, culturally tailored interventions that target different causes of disparities hold the most promise, but much more research is needed to investigate potential solutions and their implementation.

Effects of a high-intensity functional exercise programme on depressive symptoms and psychological well-being among older people living in residential care facilities: A cluster-randomized controlled trial.

PubMed

Conradsson, Mia; Littbrand, Håkan; Lindelof, Nina; Gustafson, Yngve; Rosendahl, Erik

2010-07-01

To evaluate the effects of a high-intensity functional exercise programme on depressive symptoms and psychological well-being among older people dependent in activities of daily living (ADL) and living in residential care facilities. Cluster-randomized controlled study. Participants were 191 older people, aged 65-100, dependent in ADL and with Mini Mental State Examination scores between 10 and 30. One-hundred (52%) of the participants had a diagnosed dementia disorder. A high-intensity functional weight-bearing exercise programme and a control activity were performed in groups. Sessions were held five times over each two week period for three months, a total of 29 times. The outcome measures, Geriatric Depression Scale (GDS-15) and Philadelphia Geriatric Center Morale Scale (PGCMS) were blindly assessed at baseline, three and six months. At baseline, mean +/- SD (range) for GDS was 4.4 +/- 3.2 (0-14), and for PGCMS 11.0 +/- 3.5 (2-17). There were no significant differences in GDS or PGCMS between the exercise and the control group at the three and six month follow-ups in the total sample. Among people with dementia, there was a between-group difference at three months in PGCMS scores in favour of the exercise group. A high-intensity functional exercise programme seems generally not to influence depressive symptoms or psychological well-being among older people dependent in ADL and living in residential care facilities. An individualized and multifactorial intervention may be needed in this group. However, an exercise programme as a single intervention may have a short-term effect on well-being among people with dementia.

Back posture education in elementary schoolchildren: stability of two-year intervention effects.

PubMed

Geldhof, E; Cardon, G; De Bourdeaudhuij, I; De Clercq, D

2007-09-01

The study's first objective was to evaluate class teachers' efforts to promote good body mechanics after a structured back education program was finished and to evaluate whether their support during follow-up resulted in better intervention effects at 1-year follow-up. Secondary, the stability of intervention effects on children's back posture knowledge, fear-avoidance beliefs and back pain reports following a 2-school-year multi-factorial back education program was evaluated at 1-year follow-up. An additional focus was put on what young children learned about good body mechanics in the obligatory school curriculum compared to intensive back posture promotion. The quasi-experimental study included at baseline 398 elementary schoolchildren aged 8-11 years. The back education program consisted of 13 h back education and the stimulation of postural dynamism in the class through support and environmental changes lasting 2 school-years. Controls received the obligatory curriculum, not including back education. Evaluation consisted of a questionnaire, which was filled out by 121 intervention children and 124 controls at baseline, post-test and follow-up. Teachers were interviewed at the end of the follow-up school-year. Teachers continued with initiatives to increase postural dynamism in the class when they had been instructed about that matter. However, teachers' efforts to continue the promotion of good body mechanics showed no additional effect on children's knowledge. Improved back posture knowledge demonstrated stability at 1-year follow-up. Whereas the obligatory curriculum provided children with fundamental postural knowledge, the back posture program added important aspects. Fear-avoidance beliefs and self-reported pain were not increased at 1-year follow-up. The stable intervention effects point out that intensive implementation of a structured multifactorial back education program in the elementary school curriculum is effective.

The effectiveness of a multidisciplinary QI activity for accidental fall prevention: Staff compliance is critical

PubMed Central

2012-01-01

Background Accidental falls among inpatients are a substantial cause of hospital injury. A number of successful experimental studies on fall prevention have shown the importance and efficacy of multifactorial intervention, though success rates vary. However, the importance of staff compliance with these effective, but often time-consuming, multifactorial interventions has not been fully investigated in a routine clinical setting. The purpose of this observational study was to describe the effectiveness of a multidisciplinary quality improvement (QI) activity for accidental fall prevention, with particular focus on staff compliance in a non-experimental clinical setting. Methods This observational study was conducted from July 2004 through December 2010 at St. Luke’s International Hospital in Tokyo, Japan. The QI activity for in-patient falls prevention consisted of: 1) the fall risk assessment tool, 2) an intervention protocol to prevent in-patient falls, 3) specific environmental safety interventions, 4) staff education, and 5) multidisciplinary healthcare staff compliance monitoring and feedback mechanisms. Results The overall fall rate was 2.13 falls per 1000 patient days (350/164331) in 2004 versus 1.53 falls per 1000 patient days (263/172325) in 2010, representing a significant decrease (p = 0.039). In the first 6 months, compliance with use of the falling risk assessment tool at admission was 91.5% in 2007 (3998/4368), increasing to 97.6% in 2010 (10564/10828). The staff compliance rate of implementing an appropriate intervention plan was 85.9% in 2007, increasing to 95.3% in 2010. Conclusion In our study we observed a substantial decrease in patient fall rates and an increase of staff compliance with a newly implemented falls prevention program. A systematized QI approach that closely involves, encourages, and educates healthcare staff at multiple levels is effective. PMID:22788785

Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial.

PubMed

Ueki, Kohjiro; Sasako, Takayoshi; Okazaki, Yukiko; Kato, Masayuki; Okahata, Sumie; Katsuyama, Hisayuki; Haraguchi, Mikiko; Morita, Ai; Ohashi, Ken; Hara, Kazuo; Morise, Atsushi; Izumi, Kazuo; Ishizuka, Naoki; Ohashi, Yasuo; Noda, Mitsuhiko; Kadowaki, Takashi

2017-12-01

Limited evidence suggests that multifactorial interventions for control of glucose, blood pressure, and lipids reduce macrovascular complications and mortality in patients with type 2 diabetes. However, safe and effective treatment targets for these risk factors have not been determined for such interventions. In this multicentre, open-label, randomised, parallel-group trial, undertaken at 81 clinical sites in Japan, we randomly assigned (1:1) patients with type 2 diabetes aged 45-69 years with hypertension, dyslipidaemia, or both, and an HbA 1c of 6·9% (52·0 mmol/mol) or higher, to receive conventional therapy for glucose, blood pressure, and lipid control (targets: HbA 1c <6·9% [52·0 mmol/mol], blood pressure <130/80 mm Hg, LDL cholesterol <120 mg/dL [or 100 mg/dL in patients with a history of coronary artery disease]) or intensive therapy (HbA 1c <6·2% [44·3 mmol/mol], blood pressure <120/75 mm Hg, LDL cholesterol <80 mg/dL [or 70 mg/dL in patients with a history of coronary artery disease]). Randomisation was done using a computer-generated, dynamic balancing method, stratified by sex, age, HbA 1c , and history of cardiovascular disease. Neither patients nor investigators were masked to group assignment. The primary outcome was occurrence of any of a composite of myocardial infarction, stroke, revascularisation (coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, and carotid artery stenting), and all-cause mortality. The primary analysis was done in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00300976. Between June 16, 2006, and March 31, 2009, 2542 eligible patients were randomly assigned to intensive therapy or conventional therapy (1271 in each group) and followed up for a median of 8·5 years (IQR 7·3-9·0). Two patients in the intensive therapy group were found to be ineligible after randomisation and were excluded from the analyses. During the intervention period, mean HbA 1c , systolic blood pressure, diastolic blood pressure, and LDL cholesterol concentrations were significantly lower in the intensive therapy group than in the conventional therapy group (6·8% [51·0 mmol/mol] vs 7·2% [55·2 mmol/mol]; 123 mm Hg vs 129 mm Hg; 71 mm Hg vs 74 mm Hg; and 85 mg/dL vs 104 mg/dL, respectively; all p<0·0001). The primary outcome occurred in 109 patients in the intensive therapy group and in 133 patients in the conventional therapy group (hazard ratio [HR] 0·81, 95% CI 0·63-1·04; p=0·094). In a post-hoc breakdown of the composite outcome, frequencies of all-cause mortality (HR 1·01, 95% CI 0·68-1·51; p=0·95) and coronary events (myocardial infarction, coronary artery bypass surgery, and percutaneous transluminal coronary angioplasty; HR 0·86, 0·58-1·27; p=0·44) did not differ between groups, but cerebrovascular events (stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, and carotid artery stenting) were significantly less frequent in the intensive therapy group (HR 0·42, 0·24-0·74; p=0·002). Apart from non-severe hypoglycaemia (521 [41%] patients in the intensive therapy group vs 283 [22%] in the conventional therapy group, p<0·0001) and oedema (193 [15%] vs 129 [10%], p=0·0001), the frequencies of major adverse events did not differ between groups. Our results do not fully support the efficacy of further intensified multifactorial intervention compared with current standard care for the prevention of a composite of coronary events, cerebrovascular events, and all-cause mortality. Nevertheless, our findings suggest a potential benefit of an intensified intervention for the prevention of cerebrovascular events in patients with type 2 diabetes. Ministry of Health, Labour and Welfare of Japan, Asahi Kasei Pharma, Astellas Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Kissei Pharmaceutical, Kowa Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, MSD, Novartis Pharma, Novo Nordisk, Ono Pharmaceutical, Pfizer, Sanwa Kagaku Kenkyusho, Shionogi, Sumitomo Dainippon Pharma, Taisho Toyama Pharmaceutical, and Takeda. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving the appropriateness of antimicrobial use in primary care after implementation of a local antimicrobial guide in both levels of care.

PubMed

Fernández Urrusuno, Rocío; Flores Dorado, Macarena; Vilches Arenas, Angel; Serrano Martino, Carmen; Corral Baena, Susana; Montero Balosa, Ma Carmen

2014-08-01

This study aims to assess the effectiveness of multiple interventions carried out during the implementation of a guide, on the improvement of the appropriateness of antimicrobial prescribing in primary care. This is a cross-sectional before/after study carried out in Aljarafe Health Care Area (Andalusia, Spain), with a population of 368,728 inhabitants assisted in 37 health centers. Subjects include patients with antibiotic prescriptions during 2009 (pre-intervention phase) or 2012 (postintervention phase) selected by simple random sampling (confidence level, 95%; accuracy, 5%), with infections registered in the electronic clinical history. This study involve training sessions in primary care centers and hospital services, incorporation of the electronic guide to the Health Care Service Websites, and incorporation of the guide to the Digital Health History as a tool to support decision making. Difference on appropriate antibiotic prescribing before and after interventions resulted from the study. Other variables also include age, gender, type of pharmacy, antibiotic prescribed, number of treatments per year, infection site, and main comorbidities In addition, this study uses computerized pharmacy records of reimbursed and dispensed drugs and electronic medical histories. The percentage of appropriate antibiotic prescribing increased from 36% in 2009 to 57% in 2012 (p < 0.001) is shown. The improvement was observed in all age patients of any sex and was higher among working-age patients and patients with comorbidities. The best results were observed in the group of beta-lactams and in the treatment of respiratory and skin infections. The realization of multifactorial interventions involving professionals from both levels of care could be an effective strategy to improve the use of antimicrobials in primary care.

Multifactorial screening for fall risk in community-dwelling older adults in the primary care office: development of the fall risk assessment & screening tool.

PubMed

Renfro, Mindy Oxman; Fehrer, Steven

2011-01-01

Unintentional falls is an increasing public health problem as incidence of falls rises and the population ages. The Centers for Disease Control and Prevention reports that 1 in 3 adults aged 65 years and older will experience a fall this year; 20% to 30% of those who fall will sustain a moderate to severe injury. Physical therapists caring for older adults are usually engaged with these patients after the first injury fall and may have little opportunity to abate fall risk before the injuries occur. This article describes the content selection and development of a simple-to-administer, multifactorial, Fall Risk Assessment & Screening Tool (FRAST), designed specifically for use in primary care settings to identify those older adults with high fall risk. Fall Risk Assessment & Screening Tool incorporates previously validated measures within a new multifactorial tool and includes targeted recommendations for intervention. Development of the multifactorial FRAST used a 5-part process: identification of significant fall risk factors, review of best evidence, selection of items, creation of the scoring grid, and development of a recommended action plan. Fall Risk Assessment & Screening Tool has been developed to assess fall risk in the target population of older adults (older than 65 years) living and ambulating independently in the community. Many fall risk factors have been considered and 15 items selected for inclusion. Fall Risk Assessment & Screening Tool includes 4 previously validated measures to assess balance, depression, falls efficacy, and home safety. Reliability and validity studies of FRAST are under way. Fall risk for community-dwelling older adults is an urgent, multifactorial, public health problem. Providing primary care practitioners (PCPs) with a very simple screening tool is imperative. Fall Risk Assessment & Screening Tool was created to allow for safe, quick, and low-cost administration by minimally trained office staff with interpretation and follow-up provided by the PCP.

The effects of cognitive intervention on cognitive impairments after intensive care unit admission.

PubMed

Zhao, Jingjing; Yao, Li; Wang, Changqing; Sun, Yun; Sun, Zhongwu

2017-04-01

Patients who survive critical illness commonly suffer cognitive impairments. We aimed to study the effects of cognitive intervention to treat the long-term impairments observed among different populations of intensive care unit (ICU) survivors. The results showed that the intervention significantly suppressed the deterioration of cognitive function in these patients. Medical and neurological ICU survivors were more susceptible than post-anaesthesia ICU patients to severe cognitive damage. In the former, the deterioration of impairments can be slowed by cognitive intervention. In comparison, intervention exerted significantly positive effects on the recovery of the cognitive functions of post-anaesthesia care unit patients. Furthermore, young populations were more likely than older populations to recover from acute cognitive impairments, and the impairment observed among the older population seemed to be multi-factorial and irreversible.

Association of lay beliefs about causes of depression with social distance.

PubMed

Cleveland, H-R; Baumann, A; Zäske, H; Jänner, M; Icks, A; Gaebel, W

2013-11-01

The aim of this study was to examine the association of lay attributions about causes of depression with attitudes and prejudiced behaviour towards people with depression. Subjects (1631 German-speakers aged 18 and over, randomly selected) were interviewed in two German cities by telephone using a standardized questionnaire. The survey assessed knowledge about depression, stereotypical attitudes and social distance towards persons with depression. The results indicate that a majority of the respondents holds predominantly non-pejorative attitudes towards persons with depression. The majority estimated psychosocial causes as being most important for the genesis of depression. Stronger social distance was linked to an estimation of personal causes as relevant. Subgroup differences were apparent with respect to age, sex and reported contact to people with depression. Improvements in the education of the public about depression should be based on a multifactorial model. Future interventions should promote contact with people with depression and place special emphasis on conveying information in a suitable manner depending on the needs of different target groups. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Economic modeling of surgical disease: a measure of public health interventions.

PubMed

Corlew, D Scott

2013-07-01

The measurement of the burden of disease and the interventions that address that burden can be done in various units. Reducing these measures to the common denominator of economic units (i.e., currency) enables comparison with other health entities, interventions, and even other fields. Economic assessment is complex, however, because of the multifactorial components of what constitutes health and what constitutes health interventions, as well as the coupling of those data to economic means. To perform economic modeling in a meaningful manner, it is necessary to: (1) define the health problem to be addressed; (2) define the intervention to be assessed; (3) define a measure of the effect of the health entity with and without the intervention (which includes defining the counterfactual); and (4) determine the appropriate method of converting the health effect to economics. This paper discusses technical aspects of how economic modeling can be done both of disease entities and of interventions. Two examples of economic modeling applied to surgical problems are then given.

Protocol for the specialist supervised individualised multifactorial treatment of new clinically diagnosed type 2 diabetes in general practice (IDA): a prospective controlled multicentre open-label intervention study

PubMed Central

Stidsen, Jacob Volmer; Nielsen, Jens Steen; Henriksen, Jan Erik; Friborg, Søren Gunnar; Olesen, Thomas Bastholm; Olsen, Michael Hecht; Beck-Nielsen, Henning

2017-01-01

Introduction We present the protocol for a multifactorial intervention study designed to test whether individualised treatment, based on pathophysiological phenotyping and individualised treatment goals, improves type 2 diabetes (T2D) outcomes. Methods and analysis We will conduct a prospective controlled multicentre open-label intervention study, drawing on the longitudinal cohort of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2). New clinically diagnosed patients with T2D in the intervention group will be assigned to receive individualised treatment by their general practitioner. Intervention patients will be compared with a matched control cohort of DD2 patients receiving routine clinical care. Among intervention patients, we will first do pathophysiological phenotyping to classify patients into WHO-defined T2D or other specific types of diabetes (monogenic diabetes, secondary diabetes etc). Patients with WHO-defined T2D will then be further subcharacterised by their beta-cell function (BCF) and insulin sensitivity (IS), using the revised homeostatic assessment model, as having either insulinopaenic T2D (high IS and low BCF), classical T2D (low IS and low BCF) or hyperinsulinaemic T2D (low IS and high BCF). For each subtype, a specific treatment algorithm will target the primary pathophysiological defect. Similarly, antihypertensive treatment will be targeted at the specific underlying pathophysiology, characterised by impedance cardiography (relative importance of vascular resistance, intravascular volume and cardiac inotropy). All treatment goals will be based on individual patient assessment of expected positive versus adverse effects. Web-based and face-to-face individualised lifestyle intervention will also be implemented to empower patients to make a sustainable improvement in daily physical activity and to change to a low-carbohydrate diet. Ethics and dissemination The study will use well-known pharmacological agents according to their labels; patient safety is therefore considered high. Study results will be published in international peer-reviewed journals. Trial registration number NCT02015130; Pre-results. PMID:29229652

Rehabilitation Interventions for Older Individuals with Cognitive Impairment Post Hip Fracture: A Systematic Review

PubMed Central

Resnick, Barbara; Beaupre, Lauren; McGilton, Katherine S; Galik, Elizabeth; Liu, Wen; Neuman, Mark D.; Gruber-Baldini, Ann L.; Orwig, Denise; Magaziner, Jay

2015-01-01

Purpose Currently, most rehabilitation services for individuals who sustain a hip fracture are not designed to meet the complex needs of those who also have cognitive impairment. The goal of this review was to identify current best practices for rehabilitation in long term care settings and approaches to optimize outcomes among individuals with dementia and other cognitive impairments post hip fracture. Procedures The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (the PRISMA Statement) was used to guide the review. Five electronic databases, including Pubmed, EMBASE, CINAHL (EBSCO), Medline (EBSCO) and PsycINFO (EBSCO), were searched for intervention studies published in English language journals. Studies were eligible if they focused on rehabilitation interventions post hip fracture among older individuals (≥ 65 years) with cognitive impairment who were living in or transferred to long-term care or post-acute/rehabilitation settings post hip fracture. Studies were excluded if they did not enroll individuals with cognitive impairment, the study was descriptive without any intervention content, or the intervention components were only medication, surgical approach or medical treatment. Main Findings A total of 4,478 records were identified, 1915 of which were duplicative, 2,563 were relevant based on title and after careful review seven studies were included. Two included studies were randomized controlled trials, one was a single group pre- and post-test, one a descriptive comparison between those with and without cognitive impairment, one a case controlled matched trial, one a nonequivalent groups trial, and one a case report. The interventions varied between manipulating the type and amount of exercise or testing multifactorial issues including environmental interventions and the use of an interdisciplinary team to address psychosocial factors, medication management, use of assistive devices, and specific preferences or concerns of the individuals. Conclusions The evidence summarized in this review suggests that it is feasible to implement rehabilitation programs focused on individuals with cognitive impairment in post-acute care settings. Moreover, there was evidence to suggest that intensive rehabilitation and exercise activities are beneficial, although innovative approaches may be needed to engage individuals with cognitive impairment. PMID:26612482

Rehabilitation Interventions for Older Individuals With Cognitive Impairment Post-Hip Fracture: A Systematic Review.

PubMed

Resnick, Barbara; Beaupre, Lauren; McGilton, Katherine S; Galik, Elizabeth; Liu, Wen; Neuman, Mark D; Gruber-Baldini, Ann L; Orwig, Denise; Magaziner, Jay

2016-03-01

Currently, most rehabilitation services for individuals who sustain a hip fracture are not designed to meet the complex needs of those who also have cognitive impairment. The goal of this review was to identify current best practices for rehabilitation in long-term care settings and approaches to optimize outcomes among individuals with dementia and other cognitive impairments post-hip fracture. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement was used to guide the review. Five electronic databases, including PubMed, EMBASE, CINAHL (EBSCO), Medline (EBSCO), and PsycINFO (EBSCO), were searched for intervention studies published in English language journals. Studies were eligible if they focused on rehabilitation interventions post-hip fracture among older individuals (≥ 65 years) with cognitive impairment who were living in or transferred to long-term care or postacute/rehabilitation settings post-hip fracture. Studies were excluded if they did not enroll individuals with cognitive impairment, the study was descriptive without any intervention content, or the intervention components were only medication, surgical approach or medical treatment. A total of 4478 records were identified, 1915 of which were duplicative, 2563 were relevant based on title, and after careful review 7 studies were included. Two included studies were randomized controlled trials, one was a single group pre- and post-test, one a descriptive comparison between those with and without cognitive impairment, one a case controlled matched trial, one a nonequivalent groups trial, and one a case report. The interventions varied between manipulating the type and amount of exercise or testing multifactorial issues including environmental interventions and the use of an interdisciplinary team to address psychosocial factors, medication management, use of assistive devices, and specific preferences or concerns of the individuals. The evidence summarized in this review suggests that it is feasible to implement rehabilitation programs focused on individuals with cognitive impairment in postacute care settings. Moreover, there was evidence to suggest that intensive rehabilitation and exercise activities are beneficial, although innovative approaches may be needed to engage individuals with cognitive impairment. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Attention Deficit Hyperactivity Disorder in Preschool-Age Children.

PubMed

Tandon, Mini; Pergjika, Alba

2017-07-01

Attention deficit hyperactivity disorder is a neurodevelopmental disorder marked by age-inappropriate deficits in attention or hyperactivity/impulsivity that interfere with functioning or development. It is highly correlated with other disorders, such as oppositional defiant disorder, conduct disorder, and mood symptoms. The etiology is multifactorial, and neuroimaging findings are nonspecific. Although assessment tools exist, there is variability among them, and historically, parent-teacher agreement has not been consistent. Treatment algorithm for attention deficit hyperactivity disorder in preschoolers includes behavioral interventions first followed by psychopharmacologic treatment when behavioral therapies fail. Other nonpharmacologic and nonbehavioral interventions are discussed including the role of exercise and nutrition. Copyright © 2017 Elsevier Inc. All rights reserved.

Technologies for participatory medicine and health promotion in the elderly population

PubMed Central

Nieto-Riveiro, Laura; Groba, Betania; Miranda, M. Carmen; Concheiro, Patricia; Pazos, Alejandro; Pousada, Thais; Pereira, Javier

2018-01-01

Abstract Introduction: The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called “geriatric syndromes” frequently occur. The focus of this study is the quality of life of the elderly in relation to these 3 factors: risk of falls, urinary incontinence, and insomnia. Objective: The main purpose is to determine the impact of a multifactorial intervention program implemented with institutionalized elderly people. The program is focused on the treatment of the aforementioned factors. Methods and Analysis: The study will be carried out with elderly people living in three residences for the elderly in A Coruña Province (Galicia, Spain).It is a prospective and longitudinal study, with a temporary series design of a “quasi-experimental” type that evaluates the effect of an intervention in 1 given population by doing assessments pre- and post-intervention, but there is no comparison with a control group. The intervention will be based on a multifactorial program, including the following phases: the use of wearable devices (wearable fitness trackers to register physical activity and sleep), the use of an App on a Tablet to record the participants’ occupations and activities, counseling about performance in activities of daily living, the implementation of a physical activity program, and the treatment of the pelvic floor (according to each research line). The Quality of Life (QoL) will be assessed before and after the intervention, with the use of the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables through a quantitative perspective. Ethics and Dissemination: The protocol has been approved by the host institution's ethics committee (Research Ethics Committee of Galicia) under the number 2017/106. Results will be disseminated via peer-reviewed journal articles and conferences. This clinical trial is registered at ClinicalTrials.gov identifier: NCT03504813. PMID:29768372

Technologies for participatory medicine and health promotion in the elderly population.

PubMed

Nieto-Riveiro, Laura; Groba, Betania; Miranda, M Carmen; Concheiro, Patricia; Pazos, Alejandro; Pousada, Thais; Pereira, Javier

2018-05-01

The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called "geriatric syndromes" frequently occur. The focus of this study is the quality of life of the elderly in relation to these 3 factors: risk of falls, urinary incontinence, and insomnia. The main purpose is to determine the impact of a multifactorial intervention program implemented with institutionalized elderly people. The program is focused on the treatment of the aforementioned factors. The study will be carried out with elderly people living in three residences for the elderly in A Coruña Province (Galicia, Spain).It is a prospective and longitudinal study, with a temporary series design of a "quasi-experimental" type that evaluates the effect of an intervention in 1 given population by doing assessments pre- and post-intervention, but there is no comparison with a control group.The intervention will be based on a multifactorial program, including the following phases: the use of wearable devices (wearable fitness trackers to register physical activity and sleep), the use of an App on a Tablet to record the participants' occupations and activities, counseling about performance in activities of daily living, the implementation of a physical activity program, and the treatment of the pelvic floor (according to each research line). The Quality of Life (QoL) will be assessed before and after the intervention, with the use of the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables through a quantitative perspective. The protocol has been approved by the host institution's ethics committee (Research Ethics Committee of Galicia) under the number 2017/106. Results will be disseminated via peer-reviewed journal articles and conferences. This clinical trial is registered at ClinicalTrials.gov identifier: NCT03504813.

[Some reflections on evidenced-based medicine, precision medicine, and big data-based research].

PubMed

Tang, J L; Li, L M

2018-01-10

Evidence-based medicine remains the best paradigm for medical practice. However, evidence alone is not decisions; decisions must also consider resources available and the values of people. Evidence shows that most of those treated with blood pressure-lowering, cholesterol-lowering, glucose-lowering and anti-cancer drugs do not benefit from preventing severe complications such as cardiovascular events and deaths. This implies that diagnosis and treatment in modern medicine in many circumstances is imprecise. It has become a dream to identify and treat only those few who can respond to the treatment. Precision medicine has thus come into being. Precision medicine is however not a new idea and cannot rely solely on gene sequencing as it was initially proposed. Neither is the large cohort and multi-factorial approach a new idea; in fact it has been used widely since 1950s. Since its very beginning, medicine has never stopped in searching for more precise diagnostic and therapeutic methods and already made achievements at various levels of our understanding and knowledge, such as vaccine, blood transfusion, imaging, and cataract surgery. Genetic biotechnology is not the only path to precision but merely a new method. Most genes are found only weakly associated with disease and are thus unlikely to lead to great improvement in diagnostic and therapeutic precision. The traditional multi-factorial approach by embracing big data and incorporating genetic factors is probably the most realistic way ahead for precision medicine. Big data boasts of possession of the total population and large sample size and claims correlation can displace causation. They are serious misleading concepts. Science has never had to observe the totality in order to draw a valid conclusion; a large sample size is required only when the anticipated effect is small and clinically less meaningful; emphasis on correlation over causation is equivalent to rejection of the scientific principles and methods in epidemiology and a call to give up the assurance for validity in scientific research, which will inevitably lead to futile interventions. Furthermore, in proving the effectiveness of intervention, analyses of real-world big data cannot displace the role of randomized controlled trial. We expressed doubts and critiques in this article on precision medicine and big data, merely hoping to stimulate discussing on the true potentials of precision medicine and big data.

Nutrition and physical activity programs for obesity treatment (PRONAF study): methodological approach of the project

PubMed Central

2012-01-01

Background At present, scientific consensus exists on the multifactorial etiopatogenia of obesity. Both professionals and researchers agree that treatment must also have a multifactorial approach, including diet, physical activity, pharmacology and/or surgical treatment. These two last ones should be reserved for those cases of morbid obesities or in case of failure of the previous ones. The aim of the PRONAF study is to determine what type of exercise combined with caloric restriction is the most appropriate to be included in overweigth and obesity intervention programs, and the aim of this paper is to describe the design and the evaluation methods used to carry out the PRONAF study. Methods/design One-hundred nineteen overweight (46 males) and 120 obese (61 males) subjects aged 18–50 years were randomly assigned to a strength training group, an endurance training group, a combined strength + endurance training group or a diet and physical activity recommendations group. The intervention period was 22 weeks (in all cases 3 times/wk of training for 22 weeks and 2 weeks for pre and post evaluation). All subjects followed a hypocaloric diet (25-30% less energy intake than the daily energy expenditure estimated by accelerometry). 29–34% of the total energy intake came from fat, 14–20% from protein, and 50–55% from carbohydrates. The mayor outcome variables assesed were, biochemical and inflamatory markers, body composition, energy balance, physical fitness, nutritional habits, genetic profile and quality of life. 180 (75.3%) subjects finished the study, with a dropout rate of 24.7%. Dropout reasons included: personal reasons 17 (28.8%), low adherence to exercise 3 (5.1%), low adherence to diet 6 (10.2%), job change 6 (10.2%), and lost interest 27 (45.8%). Discussion Feasibility of the study has been proven, with a low dropout rate which corresponds to the estimated sample size. Transfer of knowledge is foreseen as a spin-off, in order that overweight and obese subjects can benefit from the results. The aim is to transfer it to sports centres. Effectiveness on individual health-related parameter in order to determine the most effective training programme will be analysed in forthcoming publications. Trial registration ClinicalTrials.gov NCT01116856 PMID:23259716

Adoption of Evidence-Based Fall Prevention Practices in Primary Care for Older Adults with a History of Falls.

PubMed

Phelan, Elizabeth A; Aerts, Sally; Dowler, David; Eckstrom, Elizabeth; Casey, Colleen M

2016-01-01

A multifactorial approach to assess and manage modifiable risk factors is recommended for older adults with a history of falls. Limited research suggests that this approach does not routinely occur in clinical practice, but most related studies are based on provider self-report, with the last chart audit of United States practice published over a decade ago. We conducted a retrospective chart review to assess the extent to which patients aged 65+ years with a history of repeated falls or fall-related health-care use received multifactorial risk assessment and interventions. The setting was an academic primary care clinic in the Pacific Northwest. Among the 116 patients meeting our inclusion criteria, 48% had some type of documented assessment. Their mean age was 79 ± 8 years; 68% were female, and 10% were non-white. They averaged six primary care visits over a 12-month period subsequent to their index fall. Frequency of assessment of fall-risk factors varied from 24% (for home safety) to 78% (for vitamin D). An evidence-based intervention was recommended for identified risk factors 73% of the time, on average. Two risk factors were addressed infrequently: medications (21%) and home safety (24%). Use of a structured visit note template independently predicted assessment of fall-risk factors (p = 0.003). Geriatrics specialists were more likely to use a structured note template (p = 0.04) and perform more fall-risk factor assessments (4.6 vs. 3.6, p = 0.007) than general internists. These results suggest opportunities for improving multifactorial fall-risk assessment and management of older adults at high fall risk in primary care. A structured visit note template facilitates assessment. Given that high-risk medications have been found to be independent risk factors for falls, increasing attention to medications should become a key focus of both public health educational efforts and fall prevention in primary care practice.

Adoption of Evidence-Based Fall Prevention Practices in Primary Care for Older Adults with a History of Falls

PubMed Central

Phelan, Elizabeth A.; Aerts, Sally; Dowler, David; Eckstrom, Elizabeth; Casey, Colleen M.

2016-01-01

A multifactorial approach to assess and manage modifiable risk factors is recommended for older adults with a history of falls. Limited research suggests that this approach does not routinely occur in clinical practice, but most related studies are based on provider self-report, with the last chart audit of United States practice published over a decade ago. We conducted a retrospective chart review to assess the extent to which patients aged 65+ years with a history of repeated falls or fall-related health-care use received multifactorial risk assessment and interventions. The setting was an academic primary care clinic in the Pacific Northwest. Among the 116 patients meeting our inclusion criteria, 48% had some type of documented assessment. Their mean age was 79 ± 8 years; 68% were female, and 10% were non-white. They averaged six primary care visits over a 12-month period subsequent to their index fall. Frequency of assessment of fall-risk factors varied from 24% (for home safety) to 78% (for vitamin D). An evidence-based intervention was recommended for identified risk factors 73% of the time, on average. Two risk factors were addressed infrequently: medications (21%) and home safety (24%). Use of a structured visit note template independently predicted assessment of fall-risk factors (p = 0.003). Geriatrics specialists were more likely to use a structured note template (p = 0.04) and perform more fall-risk factor assessments (4.6 vs. 3.6, p = 0.007) than general internists. These results suggest opportunities for improving multifactorial fall-risk assessment and management of older adults at high fall risk in primary care. A structured visit note template facilitates assessment. Given that high-risk medications have been found to be independent risk factors for falls, increasing attention to medications should become a key focus of both public health educational efforts and fall prevention in primary care practice. PMID:27660753

Prophylactic Acetaminophen or Ibuprofen Results in Equivalent Acute Mountain Sickness Incidence at High Altitude: A Prospective Randomized Trial.

PubMed

Kanaan, Nicholas C; Peterson, Alicia L; Pun, Matiram; Holck, Peter S; Starling, Jennifer; Basyal, Bikash; Freeman, Thomas F; Gehner, Jessica R; Keyes, Linda; Levin, Dana R; O'Leary, Catherine J; Stuart, Katherine E; Thapa, Ghan B; Tiwari, Aditya; Velgersdyk, Jared L; Zafren, Ken; Basnyat, Buddha

2017-06-01

Recent trials have demonstrated the usefulness of ibuprofen in the prevention of acute mountain sickness (AMS), yet the proposed anti-inflammatory mechanism remains unconfirmed. Acetaminophen and ibuprofen were tested for AMS prevention. We hypothesized that a greater clinical effect would be seen from ibuprofen due to its anti-inflammatory effects compared with acetaminophen's mechanism of possible symptom reduction by predominantly mediating nociception in the brain. A double-blind, randomized trial was conducted testing acetaminophen vs ibuprofen for the prevention of AMS. A total of 332 non-Nepali participants were recruited at Pheriche (4371 m) and Dingboche (4410 m) on the Everest Base Camp trek. The participants were randomized to either acetaminophen 1000 mg or ibuprofen 600 mg 3 times a day until they reached Lobuche (4940 m), where they were reassessed. The primary outcome was AMS incidence measured by the Lake Louise Questionnaire score. Data from 225 participants who met inclusion criteria were analyzed. Twenty-five participants (22.1%) in the acetaminophen group and 18 (16.1%) in the ibuprofen group developed AMS (P = .235). The combined AMS incidence was 19.1% (43 participants), 14 percentage points lower than the expected AMS incidence of untreated trekkers in prior studies at this location, suggesting that both interventions reduced the incidence of AMS. We found little evidence of any difference between acetaminophen and ibuprofen groups in AMS incidence. This suggests that AMS prevention may be multifactorial, affected by anti-inflammatory inhibition of the arachidonic-acid pathway as well as other analgesic mechanisms that mediate nociception. Additional study is needed. Copyright © 2017 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

The effect of simethicone on postoperative ileus in patients undergoing colorectal surgery (SPOT), a randomized controlled trial.

PubMed

Springer, Jeremy E; Elkheir, Shiraz; Eskicioglu, Cagla; Doumouras, Aristithes G; Kelly, Stephen; Yang, Ilun; Forbes, Shawn

2018-06-12

Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and healthcare cost. To date, there are few pharmacological interventions that shorten the duration of postoperative ileus. This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery. A multicenter, double-blinded, placebo controlled randomized controlled trial. This trial was conducted at two academic tertiary care centres in Ontario, Canada. 118 patients undergoing colorectal surgery. Patients were randomized to receive either a five-day course of oral simethicone (n = 58) or a placebo (n = 60). The primary outcome was time to first passage of flatus. Secondary outcomes included time to first bowel movement, postoperative length of stay, and postoperative pain. Statistical analyses were performed on an intention-to-treat basis. Statistical significance set at p = 0.05. The median time to first passage of flatus in simethicone arm was 25.2 h and 26.7 h in controls (P = 0.98). There were no significant differences in the median time to first bowel movement (simethicone = 41.1 h vs. control = 42.9 h, P = 0.91) or median length of hospital stay (simethicone = 4.5 days vs. control = 4.0 days, P = 0.63). This study failed to show a difference in return of gastrointestinal motility in patients receiving simethicone following colorectal surgery. Postoperative ileus remains a significant clinical and economic burden to the healthcare system and further research is needed to identify a reliable and effective method of treatment. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Biopsychosocial influence on shoulder pain: rationale and protocol for a pre-clinical trial

PubMed Central

George, Steven Z.; Staud, Roland; Borsa, Paul A.; Wu, Samuel S.; Wallace, Margaret R.; Greenfield, Warren. H.; Mackie, Lauren N.; Fillingim, Roger B.

2017-01-01

Background Chronic musculoskeletal pain conditions are a prevalent and disabling problem. Preventing chronic musculoskeletal pain requires multifactorial treatment approaches that address its complex etiology. Prior cohort studies identified a high risk subgroup comprised of variation in COMT genotype and pain catastrophizing. This subgroup had increased chance of heightened pain responses (in a pre-clinical model) and higher 12 month post-operatives pain intensity ratings (in a clinical model). This pre-clinical trial will test mechanisms and efficacy of personalized pain interventions matched to the genetic and psychological characteristics of the high-risk subgroup. Methods Potential participants will be screened for high risk subgroup membership, appropriateness for exercise-induced muscle injury protocol, and appropriateness for propranolol administration. Eligible participants that consent to the study will then be randomized into one of four treatment groups; 1) personalized pharmaceutical and psychological education; 2) personalized pharmaceutical and general education; 3) placebo pharmaceutical and psychological education; 4) placebo pharmaceutical and psychological education. Over the 5-day study period participants will complete an exercise-induced muscle injury protocol and receive study interventions. Pain and disability assessments will be completed daily, with primary outcomes being duration of shoulder pain (number of days until recovery), peak shoulder pain intensity, and peak shoulder disability. Secondary outcomes include inflammatory markers, psychological mediators, and measures of pain sensitivity regulation. Conclusion This pre-clinical trial builds on prior cohort studies and its completion will provide foundational data supporting efficacy and mechanisms of personalized interventions for individuals that may be at increased risk for developing chronic shoulder pain. Trial Registration ClinicalTrials.gov registry, NCT02620579 (Registered on November 13, 2015) PMID:28315479

Fall Prevention in a Primary Care Setting.

PubMed

Siegrist, Monika; Freiberger, Ellen; Geilhof, Barbara; Salb, Johannes; Hentschke, Christian; Landendoerfer, Peter; Linde, Klause; Halle, Martin; Blank, Wolfgang A

2016-05-27

Falls and fall-related injuries are common in community-dwelling elderly people. Effective multifactorial fall prevention programs in the primary care setting may be a promising approach to reduce the incidence rate of falls. In a cluster randomized trial in 33 general practices 378 people living independently and at high risk of falling (65 to 94 years old; 285 women) were allocated to either a 16 week exercise-based fall prevention program including muscle strengthening and challenging balance training exercises, combined with a 12 week home-based exercise program (222 participants), or to usual care (156 participants). The main outcome was number of falls over a period of 12 months. Secondary outcomes were the number of fall-related injuries, physical function (Timed-Up-and-Go-Test, TUG, Chair-Stand-Test, CST, modified Romberg Test), and fear of falling. In the intervention group (n=222 patients in 17 general practices) 291 falls occurred, compared to 367 falls in the usual care group (n=156 patients in 16 general practices). We observed a lower incidence rate for falls in the intervention group (incidence rate ratio/IRR: 0.54; 95% confidence interval (CI): [0.35; 0.84], p=0.007) and for fall-related injuries (IRR: 0.66; [0.42; 0.94], p=0.033). Additionally, patients in the intervention group showed significant improvements in secondary endpoints (TUG: -2.39 s, [-3.91; -0.87], p=0.014; mRomberg: 1.70 s, [0.35; 3.04], p=0.037; fear of falling: -2.28 points, [-3.87; -0.69], p=0.022) compared to usual care. A complex falls prevention program in a primary care setting was effective in reducing falls and fall-related injuries in community dwelling older adults at risk.

Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.

PubMed

George, Steven Z; Staud, Roland; Borsa, Paul A; Wu, Samuel S; Wallace, Margaret R; Greenfield, Warren H; Mackie, Lauren N; Fillingim, Roger B

2017-05-01

Chronic musculoskeletal pain conditions are a prevalent and disabling problem. Preventing chronic musculoskeletal pain requires multifactorial treatment approaches that address its complex etiology. Prior cohort studies identified a high risk subgroup comprised of variation in COMT genotype and pain catastrophizing. This subgroup had increased chance of heightened pain responses (in a pre-clinical model) and higher 12month post-operatives pain intensity ratings (in a clinical model). This pre-clinical trial will test mechanisms and efficacy of personalized pain interventions matched to the genetic and psychological characteristics of the high-risk subgroup. Potential participants will be screened for high risk subgroup membership, appropriateness for exercise-induced muscle injury protocol, and appropriateness for propranolol administration. Eligible participants that consent to the study will then be randomized into one of four treatment groups; 1) personalized pharmaceutical and psychological education; 2) personalized pharmaceutical and general education; 3) placebo pharmaceutical and psychological education; 4) placebo pharmaceutical and psychological education. Over the 5-day study period participants will complete an exercise-induced muscle injury protocol and receive study interventions. Pain and disability assessments will be completed daily, with primary outcomes being duration of shoulder pain (number of days until recovery), peak shoulder pain intensity, and peak shoulder disability. Secondary outcomes include inflammatory markers, psychological mediators, and measures of pain sensitivity regulation. This pre-clinical trial builds on prior cohort studies and its completion will provide foundational data supporting efficacy and mechanisms of personalized interventions for individuals that may be at increased risk for developing chronic shoulder pain. ClinicalTrials.gov registry, NCT02620579 (Registered on November 13, 2015). Copyright © 2017 Elsevier Inc. All rights reserved.

Prolotherapy for Osteoarthritis and Tendinopathy: a Descriptive Review.

PubMed

Rabago, David; Nourani, Bobby

2017-06-01

Osteoarthritis and overuse tendinopathy are common chronic conditions of high societal and patient burden. The precise etiology of pain and disability in both conditions is multifactorial and not well understood. Patients are often refractory to conservative therapy. The development of new therapeutic options in both conditions is a public health priority. Prolotherapy is an injection-based outpatient regenerative therapy for chronic musculoskeletal conditions, including osteoarthritis and tendinopathy. The authors reviewed the basic science and clinical literature associated with prolotherapy for these conditions. Systematic review, including meta-analysis, and randomized controlled trials suggest that prolotherapy may be associated with symptom improvement in mild to moderate symptomatic knee osteoarthritis and overuse tendinopathy. Although the mechanism of action is not well understood and is likely multifactorial, a growing body of literature suggests that prolotherapy for knee osteoarthritis may be appropriate for the treatment of symptoms associated with knee osteoarthritis in carefully selected patients who are refractory to conservative therapy and deserves further basic and clinical science investigation for the treatment of osteoarthritis and tendinopathy.

Marginal socio-economic effects of an employer's efforts to improve the work environment.

PubMed

Rezagholi, Mahmoud

2018-01-01

Workplace health promotion (WHP) strongly requires the employer's efforts to improve the psychosocial, ergonomic, and physical environments of the workplace. There are many studies discussing the socio-economic advantage of WHP intervention programmes and thus the internal and external factors motivating employers to implement and integrate such programmes. However, the socio-economic impacts of the employer's multifactorial efforts to improve the work environment need to be adequately assessed. Data were collected from Swedish company Sandvik Materials Technology (SMT) through a work environment survey in April 2014. Different regression equations were analysed to assess marginal effects of the employer's efforts on overall labour effectiveness (OLE), informal work impairments (IWI), lost working hours (LWH), and labour productivity loss (LPL) in terms of money. The employer's multifactorial efforts resulted in increasing OLE, decreasing IWI and illness-related LWH, and cost savings in terms of decreasing LPL. Environmental factors at the workplace are the important determinant factor for OLE, and the latter is where socio-economic impacts of the employer's efforts primarily manifest.

Mindfulness-based stress reduction (MBSR) as sole intervention for non-somatisation chronic non-cancer pain (CNCP): protocol for a systematic review and meta-analysis of randomised controlled trials.

PubMed

Leung, Lawrence; Han, Han; Martin, Mary; Kotecha, Jyoti

2015-05-18

Chronic non-cancer pain (CNCP) affects up to 50% of the world's population. It impacts negatively on quality of life; entailing high costs on our medical systems, and translates to economic burden due to work loss. Aetiology of CNCP is complex and multifactorial, embracing the somatosensory, cognitive and affective domains. Opioid analgesia and other invasive interventions are often inadequate for clinical management of CNCP. Recently, mindfulness-based stress reduction (MBSR) has become a popular therapy for various medical conditions, including CNCP. However, studies reported varying efficacies, and relevant systematic reviews have included clinical trials with inherent heterogeneity either in study conditions or types of interventions used. Our study aims to provide an updated and more critical evaluation of the efficacy of MBSR as the intervention for non-somatisation CNCP. A systematic review with meta-analysis of randomised controlled trials published in English will be performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines and the Cochrane Collaboration format. MEDLINE, EMBASE, PsychINFO, and the Cochrane Central Register of Controlled Trials Intervention, will be searched independently by reviewers using defined MeSH terms. Studies with full texts using MBSR as the main intervention on patients with non-somatising CNCP will be included. Outcome measures include pain scores and disability assessment scales. Continuous data will be meta-analysed using the RevMan 5 Review Manager programme. Primary analysis will adopt the random effects model in view of heterogeneity between trials. The standardised mean difference will be expressed as the effect size with 95% CIs. Forest plots, funnel plots, the I(2) statistic and the Cochrane Risks of Bias Assessment table will be included. No ethics approval is deemed necessary. Results of this study will be disseminated via peer-reviewed publications and scientific meetings. PROSPERO CRD42014015568. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Systematic Review of CPAP Adherence Across Age Groups: Clinical and Empiric Insights for Developing CPAP Adherence Interventions

PubMed Central

Sawyer, A.M.; Gooneratne, N.; Marcus, C.L.; Ofer, D.; Richards, K.C.; Weaver, T.E.

2011-01-01

Continuous positive airway pressure (CPAP) is a highly efficacious treatment for obstructive sleep apnea (OSA) but adherence to the treatment limits its overall effectiveness across all age groups of patients. Factors that influence adherence to CPAP include disease and patient characteristics, treatment titration procedures, technological device factors and side effects, and psychological and social factors. These influential factors have guided the development of interventions to promote CPAP adherence. Various intervention strategies have been described and include educational, technological, psychosocial, pharmacological, and multi-dimensional approaches. Though evidence to date has led to innovative strategies that address adherence in CPAP-treated children, adults, and older adults, significant opportunities exist to develop and test interventions that are clinically applicable, specific to subgroups of patients likely to demonstrate poor adherence, and address the multifactorial nature of CPAP adherence. The translation of CPAP adherence promotion interventions to clinical practice is imperative to improve health and functional outcomes in all persons with CPAP-treated OSA. PMID:21652236

[Transdisciplinary Approach for Sarcopenia. Effect of nutritional support for the prevention of sarcopenia].

PubMed

Nishioka, Hiroaki

2014-10-01

Sarcopenia is defined as the age-related loss of muscle mass and function. Sarcopenia is closely related with decreased physical function, fall, bone fracture, osteoporosis, and insulin resistance, which lead to increased morbidity and mortality in elderly people. The pathogenesis of sarcopenia is complex and multifactorial, which remains not to be fully understood. Inappropriate food intake and reduced physical activity are known to increase the risk of developing sarcopenia. Resistance training and nutritional support have been shown to be an effective intervention for prevention of sarcopenia. Protein, especially branched chain amino acid, and vitamin D have been reported to improve sarcopenia. The intervention together with nutrition and exercise are more effective.

The impact of intensive multifactorial treatment on perceptions of chronic care among individuals with screen-detected diabetes: results from the ADDITION-Denmark trial.

PubMed

Kuznetsov, L; Simmons, R K; Sandbaek, A; Maindal, H T

2015-04-01

To describe perceptions of chronic care among diabetes patients 6 years after diagnosis by screening and to examine the impact of intensive treatment on patients' perceptions of chronic care. The ADDITION-Denmark (2001-2006) trial compared the effects of intensive multifactorial therapy (IT) with routine care (RC) among individuals with screen-detected diabetes. Perceptions of chronic care were assessed using the Patient Assessment of Chronic Illness Care (PACIC) measure after 6-year follow-up (n = 937). Analysis was by intention-to-treat, accounting for clustering by general practice. The mean (SD) summary PACIC score was 2.4 (0.79) in the RC and 2.4 (0.82) in the IT group. The highest mean (SD) PACIC subscale score was for Delivery System Design/Decision Support [RC: 3.2 (0.95), IT: 3.3 (0.91)] and the lowest was for Follow-up/Coordination [RC: 2.1 (0.84), IT: 2.1 (0.87)]. Perceptions of chronic care did not differ between trial groups. Compared to RC, an intensive multifactorial intervention was not associated with differences in perceptions of chronic care among patients with screen-detected diabetes after 6 years. Intensive treatment does not adversely affect perceptions of chronic care early in the course of the disease. However, there is potentially room for improvement in some aspects of chronic care. © 2014 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Kennedy Space Center Coronary Heart Disease Risk Screening Program

NASA Technical Reports Server (NTRS)

Tipton, David A.; Scarpa, Philip J.

1999-01-01

Coronary heart disease (CHD) is the number one cause of death in the U.S. It is a likely cause of death and disability in the lives of employees at Kennedy Space Center (KSC) as well. The KSC Biomedical Office used a multifactorial formula developed by the Framingham Heart Study to calculate CHD risk probabilities for individuals in a segment of the KSC population who require medical evaluation for job certification. Those individuals assessed to have a high risk probability will be targeted for intervention.

Nutritional assessment and intervention in a pediatric oncology unit.

PubMed

Schoeman, J

2015-01-01

Nutritional status in children with cancer is an important prognostic factor. Assessment consisting of anthropometry, biochemistry, clinical, and diet that needs to be done on diagnosis and regularly to ensure that patient's nutritional status does not deteriorate. In developing countries, assessment will depend on the availability of all resources, but monitoring is essential. The development of malnutrition during treatment is possible and the reasons are multifactorial. Nutrition plays a deciding role and a key factor in children with cancer and can influence their outcome.

Diabetes prevention program in a Mediterranean environment: individual or group therapy? An effectiveness evaluation.

PubMed

Endevelt, R; Peled, R; Azrad, A; Kowen, G; Valinsky, L; Heymann, A D

2015-04-01

Diabetes as a multifactorial disorder requires prevention measures based upon the modification of several risk factors simultaneously; otherwise, there is insufficient potential for prevention. Following the success of the American Diabetes Prevention Program (DPP), we implemented an intervention program in a large Israeli healthcare organization with an emphasize on Mediterranean Diet (MedDiet) and physical activity. The objective was to evaluate the effectiveness of two types of intervention, individual and group therapies, in reducing risk factors and in preventing or delaying the development of type 2 diabetes. Out of 180 primary care physicians, 85 who agreed to participate, were randomly assigned, between the years 2005 and 2006, into two groups: those who would refer pre-diabetes adult patients for individual therapy and those who would refer for group therapy. The two groups of patients consisted of 111 and 112 in each group. The intervention lasted for 6 months and discussed: the benefits of MedDiet, planning nutritional behavior and mindful eating, and the importance of physical activity. All patients were invited to participate in walking groups. Follow up lasted for 24 months and logistic, mixed models, and Cox regressions were employed. No statistically significant differences were detected between the two intervention groups in age; gender and clinical measurements at recruitment. Thirty nine percent of both groups developed diabetes (entered the DR by 2012), including 38.7% from the individual therapy and 39.3% from the group therapy (P=0.933). The mean time from 2005 until entry to the Diabetes Registry (DR) was 2.9 and 2.5 years for the individual and group therapy respectively (P=0.542). Both interventions were equally effective in achieving the desired outcomes and time until entry to the DR. For large health organizations with a high number of pre-diabetes patients and scarce resources, group therapy, where 12 people are reached out by one team member are preferable and more costly effective, than a one on one therapy. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Interaction of Occupational and Personal Risk Factors in Workforce Health and Safety

PubMed Central

Pandalai, Sudha; Wulsin, Victoria; Chun, HeeKyoung

2012-01-01

Most diseases, injuries, and other health conditions experienced by working people are multifactorial, especially as the workforce ages. Evidence supporting the role of work and personal risk factors in the health of working people is frequently underused in developing interventions. Achieving a longer, healthy working life requires a comprehensive preventive approach. To help develop such an approach, we evaluated the influence of both occupational and personal risk factors on workforce health. We present 32 examples illustrating 4 combinatorial models of occupational hazards and personal risk factors (genetics, age, gender, chronic disease, obesity, smoking, alcohol use, prescription drug use). Models that address occupational and personal risk factors and their interactions can improve our understanding of health hazards and guide research and interventions. PMID:22021293

Cancer Cachexia: Beyond Weight Loss.

PubMed

Bruggeman, Andrew R; Kamal, Arif H; LeBlanc, Thomas W; Ma, Joseph D; Baracos, Vickie E; Roeland, Eric J

2016-11-01

Cancer cachexia is a multifactorial syndrome characterized by skeletal muscle loss leading to progressive functional impairment. Despite the ubiquity of cachexia in clinical practice, prevention, early identification, and intervention remain challenging. The impact of cancer cachexia on quality of life, treatment-related toxicity, physical function, and mortality are well established; however, establishing a clinically meaningful definition has proven challenging because of the focus on weight loss alone. Attempts to more comprehensively define cachexia through body composition, physical functioning, and molecular biomarkers, while promising, are yet to be routinely incorporated into clinical practice. Pharmacologic agents that have not been approved by the US Food and Drug Administration but that are currently used in cancer cachexia (ie, megestrol, dronabinol) may improve weight but not outcomes of interest such as muscle mass, physical activity, or mortality. Their routine use is limited by adverse effects. For the practicing oncologist, early identification and management of cachexia is critical. Oncologists must recognize cachexia beyond weight loss alone, focusing instead on body composition and physical functioning. In fact, becoming emaciated is a late sign of cachexia that characterizes its refractory stage. Given that cachexia is a multifactorial syndrome, it requires early identification and polymodal intervention, including optimal cancer therapy, symptom management, nutrition, exercise, and psychosocial support. Consequently, oncologists have a role in ensuring that these resources are available to their patients. In addition, in light of the promising investigational agents, it remains imperative to refer patients with cachexia to clinical trials so that available options can be expanded to effectively treat this pervasive problem.

Systems Biology Methods for Alzheimer's Disease Research Toward Molecular Signatures, Subtypes, and Stages and Precision Medicine: Application in Cohort Studies and Trials.

PubMed

Castrillo, Juan I; Lista, Simone; Hampel, Harald; Ritchie, Craig W

2018-01-01

Alzheimer's disease (AD) is a complex multifactorial disease, involving a combination of genomic, interactome, and environmental factors, with essential participation of (a) intrinsic genomic susceptibility and (b) a constant dynamic interplay between impaired pathways and central homeostatic networks of nerve cells. The proper investigation of the complexity of AD requires new holistic systems-level approaches, at both the experimental and computational level. Systems biology methods offer the potential to unveil new fundamental insights, basic mechanisms, and networks and their interplay. These may lead to the characterization of mechanism-based molecular signatures, and AD hallmarks at the earliest molecular and cellular levels (and beyond), for characterization of AD subtypes and stages, toward targeted interventions according to the evolving precision medicine paradigm. In this work, an update on advanced systems biology methods and strategies for holistic studies of multifactorial diseases-particularly AD-is presented. This includes next-generation genomics, neuroimaging and multi-omics methods, experimental and computational approaches, relevant disease models, and latest genome editing and single-cell technologies. Their progressive incorporation into basic research, cohort studies, and trials is beginning to provide novel insights into AD essential mechanisms, molecular signatures, and markers toward mechanism-based classification and staging, and tailored interventions. Selected methods which can be applied in cohort studies and trials, with the European Prevention of Alzheimer's Dementia (EPAD) project as a reference example, are presented and discussed.

Agency for Healthcare Research and Quality Evidence-based Practice Center methods for systematically reviewing complex multicomponent health care interventions.

PubMed

Guise, Jeanne-Marie; Chang, Christine; Viswanathan, Meera; Glick, Susan; Treadwell, Jonathan; Umscheid, Craig A; Whitlock, Evelyn; Fu, Rongwei; Berliner, Elise; Paynter, Robin; Anderson, Johanna; Motu'apuaka, Pua; Trikalinos, Tom

2014-11-01

The purpose of this Agency for Healthcare Research and Quality Evidence-based Practice Center methods white paper was to outline approaches to conducting systematic reviews of complex multicomponent health care interventions. We performed a literature scan and conducted semistructured interviews with international experts who conduct research or systematic reviews of complex multicomponent interventions (CMCIs) or organizational leaders who implement CMCIs in health care. Challenges identified include lack of consistent terminology for such interventions (eg, complex, multicomponent, multidimensional, multifactorial); a wide range of approaches used to frame the review, from grouping interventions by common features to using more theoretical approaches; decisions regarding whether and how to quantitatively analyze the interventions, from holistic to individual component analytic approaches; and incomplete and inconsistent reporting of elements critical to understanding the success and impact of multicomponent interventions, such as methods used for implementation the context in which interventions are implemented. We provide a framework for the spectrum of conceptual and analytic approaches to synthesizing studies of multicomponent interventions and an initial list of critical reporting elements for such studies. This information is intended to help systematic reviewers understand the options and tradeoffs available for such reviews. Copyright © 2014 Elsevier Inc. All rights reserved.

Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial.

PubMed

Santos, Hélio Gustavo; Chiavegato, Luciana Dias; Valentim, Daniela Pereira; da Silva, Patricia Rodrigues; Padula, Rosimeire Simprini

2016-12-22

Fatigue is a multifactorial condition that leads to disease and loss in production, and it affects a large number of workers worldwide. This study aims to demonstrate a resistance exercise protocol that individuals will perform during the work schedule, and to evaluate the effectiveness of this exercises program for fatigue control. This is a cluster randomized controlled trial with two arms and is assessor blinded. A total of 352 workers of both sexes, aged 18-65 years, from a medium-sized dairy plant were enrolled in this study. Participants will be recruited from 13 production sectors according to the eligibility criteria and will be randomized by clusters to either the Progressive Resistance Exercise (PRE) intervention group or the Compensatory Workplace Exercise (CWE) comparative group. A resistance exercise program will be implemented for both groups. The groups will receive instructions on self-management, breaks, adjustments to workstations, and the benefits of physical exercise. The PRE group will perform resistance exercises with gradual loads in an exercise room, and the CWE group will perform exercise at their workstations using elastic bands. The exercise sessions will be held 3 times a week for 20 min. The primary outcome measures will be symptoms of physical and mental fatigue, and muscular fatigue based on a one-repetition maximum (1RM). The secondary outcome measures will be level of physical activity, musculoskeletal symptoms, physical condition, perceived exposure, and productivity. The workers will be assessed at baseline and after a 4-month program. A linear mixed model will be applied on an intention-to-treat basis. This intervention is expected to reduce symptoms of fatigue in the workers. The exercise program is indicating in the workplace, although there are few studies describing the effects of exercise on the control of fatigue in the workplace. Emphasis will be placed on adherence to the program, which may result in significant and clinically important reductions in fatigue. It is also expected that the findings of this study will contribute significantly to the decision-making capacity of professionals working in the field of occupational health. U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT02172053 . Date registered 19 June 2014.

[Multifactorial ergonomic evaluation of the hospital nursing activity in assisting not self-sufficient patients].

PubMed

Capodaglio, E M; Capodaglio, P; Bazzini, G

1999-01-01

8 Institutes of Health Care and Research of Northern-Central Italy participated in the study, which consisted of on-site investigations, interviews with the chief-nurse, and monitoring of physiological and subjective variables. We studied the most critical phases in the laboratory, by means of video-graphical systems for biomechanical and postural analysis. The outlined profile shows a demanding activity, yielding important risk factors relative to musculoskeletal lesions. The preventive attitude (education, training) must be implemented by ergonomic interventions, aimed to minimize the risk related to manual handling.

Transgender populations and HIV: unique risks, challenges and opportunities.

PubMed

Wansom, Tanyaporn; Guadamuz, Thomas E; Vasan, Sandhya

2016-04-01

Due to unique social, behavioural, structural and biological issues, transgender (TG) populations, especially TG women, are at high risk for HIV acquisition. This increased risk is multifactorial, due to differing psychosocial risk factors, poorer access to TG-specific healthcare, a higher likelihood of using exogenous hormones or fillers without direct medical supervision, interactions between hormonal therapy and antiretroviral therapy, and direct effects of hormonal therapy on HIV acquisition and immune control. Further research is needed to elucidate these mechanisms of risk and to help design interventions to reduce HIV risk among transgender populations.

Fibromyalgia in Primary Care.

PubMed

Higgs, Jay B

2018-06-01

Fibromyalgia is a common disorder and has substantial impact on quality of life. The cause remains unknown, but current evidence points to multifactorial involvement of pain processing. Clinical diagnosis is aided by evidence-based diagnostic criteria with subscores for widespread pain and symptom severity. Nonpharmacologic treatments, including cognitive behavioral therapy, sleep hygiene, and regular aerobic exercise, form the cornerstone of management. Pharmacologic intervention is an important adjunct, but benefit is variable. There is no cure for fibromyalgia at this time, but persistence and patience in management may lead to a satisfactory lifestyle. Published by Elsevier Inc.

Patellofemoral pain in athletes: clinical perspectives

PubMed Central

Halabchi, Farzin; Abolhasani, Maryam; Mirshahi, Maryam; Alizadeh, Zahra

2017-01-01

Patellofemoral pain (PFP) is a very common problem in athletes who participate in jumping, cutting and pivoting sports. Several risk factors may play a part in the pathogenesis of PFP. Overuse, trauma and intrinsic risk factors are particularly important among athletes. Physical examination has a key role in PFP diagnosis. Furthermore, common risk factors should be investigated, such as hip muscle dysfunction, poor core muscle endurance, muscular tightness, excessive foot pronation and patellar malalignment. Imaging is seldom needed in special cases. Many possible interventions are recommended for PFP management. Due to the multifactorial nature of PFP, the clinical approach should be individualized, and the contribution of different factors should be considered and managed accordingly. In most cases, activity modification and rehabilitation should be tried before any surgical interventions. PMID:29070955

Light-Induced Changes of the Circadian Clock of Humans: Increasing Duration is More Effective than Increasing Light Intensity

PubMed Central

Dewan, Karuna; Benloucif, Susan; Reid, Kathryn; Wolfe, Lisa F.; Zee, Phyllis C.

2011-01-01

Study Objectives: To evaluate the effect of increasing the intensity and/or duration of exposure on light-induced changes in the timing of the circadian clock of humans. Design: Multifactorial randomized controlled trial, between and within subject design Setting: General Clinical Research Center (GCRC) of an academic medical center Participants: 56 healthy young subjects (20-40 years of age) Interventions: Research subjects were admitted for 2 independent stays of 4 nights/3 days for treatment with bright or dim-light (randomized order) at a time known to induce phase delays in circadian timing. The intensity and duration of the bright light were determined by random assignment to one of 9 treatment conditions (duration of 1, 2, or 3 hours at 2000, 4000, or 8000 lux). Measurements and Results: Treatment-induced changes in the dim light melatonin onset (DLMO) and dim light melatonin offset (DLMOff) were measured from blood samples collected every 20-30 min throughout baseline and post-treatment nights. Comparison by multi-factor analysis of variance (ANOVA) of light-induced changes in the time of the circadian melatonin rhythm for the 9 conditions revealed that changing the duration of the light exposure from 1 to 3 h increased the magnitude of light-induced delays. In contrast, increasing from moderate (2,000 lux) to high (8,000 lux) intensity light did not alter the magnitude of phase delays of the circadian melatonin rhythm. Conclusions: Results from the present study suggest that for phototherapy of circadian rhythm sleep disorders in humans, a longer period of moderate intensity light may be more effective than a shorter exposure period of high intensity light. Citation: Dewan K; Benloucif S; Reid K; Wolfe LF; Zee PC. Light-induced changes of the circadian clock of humans: increasing duration is more effective than increasing light intensity. SLEEP 2011;34(5):593-599. PMID:21532952

Smoking Initiation and Cessation among Youths in Vietnam: A Longitudinal Study Using the Chi Linh Demographic—Epidemiological Surveillance System (CHILILAB DESS)

PubMed Central

Duc, Duong Minh; Vui, Le Thi; Son, Hoang Ngoc; Minh, Hoang Van

2016-01-01

Study of smoking initiation and cessation is particularly important in adolescent population because smoking prevention and cessation at this time may prevent several health consequences later in life. There is a very limited knowledge about the determinants of smoking initiation and cessation among youths in Vietnam. This limits the development and implementation of appropriately targeted anti-smoking prevention interventions. This study applied pooled data from 3 rounds of a longitudinal survey in the Chi Linh Demographic—Epidemiological Surveillance System (CHILILAB DESS) in a northern province in Vietnam to analyse the determinants of smoking initiation and cessation among youths. The total of youths in the first round, second, and third rounds was 12,406, 10,211, and 7,654, respectively. The random-effects logit model controlling for both time-variant and time-invariant variables was conducted to explore the associated factors with new smokers and quitters. We found an increase trend of new smokers (7.0% to 9.6%) and quitters (27.5% to 31.4%) during 2009–2013. Smoking initiation and cessation are the result of multifactorial influences of demographic and health behaviours and status. Demographic background (older youths, male, unmarried youths, and youths having informal work) and health behaviours and status (youths who had smoking family members and/or smoking close friends, and had harmful drinking) were more likely to initiate smoking and more difficult to quit smoking. Among these variables, youths who had smoking close-friends had the highest likelihood of both initiating smoking and failed quitting. Our results could represent the similar health problems among youths in peri-urban areas in Vietnam. Further, our findings suggested that anti-smoking interventions should involve peer intervention, integrated with the reduction of other unhealthy behaviours such as alcohol consumption, and to focus on adolescents in their very early age (10–14 years old). PMID:29546208

Factors associated with recognition and prioritization for falling, and the effect on fall incidence in community dwelling older adults.

PubMed

Jansen, Sofie; Schoe, Jolanda; van Rijn, Marjon; Abu-Hanna, Ameen; Moll van Charante, Eric P; van der Velde, Nathalie; de Rooij, Sophia E

2015-12-17

Recent trials have shown that multifactorial fall interventions vary in effectiveness, possibly due to lack of adherence to the interventions. The aim of this study was to examine what proportion of older adults recognize their falls risk and prioritize for fall-preventive care, and which factors are associated with this prioritization. Observational study within the intervention arm of a cluster randomized controlled trial (RCT) on the effect of preventive interventions for geriatric problems in older community-dwellers at risk of functional decline.  general practices in the Netherlands. Participants were community dwellers (70+) in whom falling was identified as a condition. A comprehensive geriatric assessment (CGA) was performed by a registered community care nurse. Participants were asked which of the identified conditions they recognized and prioritized for in a preventive care plan, and subsequent interventions were started. Multivariable logistic regression was performed to identify which factors were associated with this prioritization. Fall-incidence was measured during one-year follow-up. The RCT included 6668 participants, 3430 were in the intervention arm. Of those, 1209 were at risk of functional decline, of whom 936 underwent CGA. In 380 participants (41 %), falling was identified as a condition; 62 (16 %) recognized this and 37 (10 %) prioritized for it. Factors associated with prioritization for falls-prevention were: recurrent falls in the past year (OR 2.2 [95 % CI 1.1-4.4]), severe fear-of-falling (OR 2.7 [1.2-6.0]) and use of a walking aid (2.3 [1.1-5.0]). Sixty participants received a preventive intervention for falling; 29 had prioritized for falling. Incidence of falls was higher in the priority group than the non-priority group (67 % vs. 37 % respectively) during first six months of follow-up, but similar between groups after 12 months (40.7 % vs. 44.4 %). The proportion of community-dwellers at risk of falls that recognizes this risk and prioritizes for preventive care is small. Recurrent falls in the past year, severe fear-of-falling and use of a walking aid were associated with prioritization. Prioritization was associated with a greater fall-risk during first six months, which appeared to level out at one-year follow-up. These results could aid in the identification of community-dwellings likely to benefit from fall-preventive interventions. NTR2653 , 17 December 2010.

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

PubMed Central

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

How Stuttering Develops: The Multifactorial Dynamic Pathways Theory

ERIC Educational Resources Information Center

Smith, Anne; Weber, Christine

2017-01-01

Purpose: We advanced a multifactorial, dynamic account of the complex, nonlinear interactions of motor, linguistic, and emotional factors contributing to the development of stuttering. Our purpose here is to update our account as the multifactorial dynamic pathways theory. Method: We review evidence related to how stuttering develops, including…

Preventing falls among older people with mental health problems: a systematic review

PubMed Central

2014-01-01

Background Falls are a leading cause of mortality and morbidity in older people and the risk of falling is exacerbated by mental health conditions. Existing reviews have focused on people with dementia and cognitive impairment, but not those with other mental health conditions or in mental health settings. The objective of this review is to evaluate the effectiveness of fall prevention interventions for older people with mental health problems being cared for across all settings. Methods A systematic review of fall prevention interventions for older people with mental health conditions. We undertook electronic database and lateral searches to identify studies reporting data on falls or fall related injuries. Searches were initially conducted in February 2011 and updated in November 2012 and October 2013; no date restrictions were applied. Studies were assessed for risk of bias. Due to heterogeneity results were not pooled but are reported narratively. Results Seventeen RCTs and four uncontrolled studies met the inclusion criteria; 11 involved single interventions and ten multifactorial. Evidence relating to fall reduction was inconsistent. Eight of 14 studies found a reduction in fallers (statistically significant in five), and nine of 14 reported a significant reduction in rate or number of falls. Four studies found a non-significant increase in falls. Multifactorial, multi-disciplinary interventions and those involving exercise, medication review and increasing staff awareness appear to reduce the risk of falls but evidence is mixed and study quality varied. Changes to the environment such as increased supervision or sensory stimulation to reduce agitation may be promising for people with dementia but further evaluation is needed. Most of the studies were undertaken in nursing and residential homes, and none in mental health hospital settings. Conclusions There is a dearth of falls research in mental health settings or which focus on patients with mental health problems despite the high number of falls experienced by this population group. This review highlights the lack of robust evidence to support practitioners to implement practices that prevent people with mental health problems from falling. PMID:24552165

The application of participatory ergonomics in a healthcare setting in Hong Kong.

PubMed

Lee, Edwin W C; Fok, Joan P C; Lam, Augustine T; Law, Rainbow K Y; Szeto, Grace P Y; Li, Philip P K

2014-01-01

Work-related musculoskeletal disorders (WRMDs) are recognized as a major source of significant pain and disability in the healthcare sector. However, they are preventable if appropriate surveillance and intervention programs are implemented. The purpose of this paper is to describe the holistic ergonomic approach that was used to address the multifactorial problems encountered by healthcare workers in their daily work. Using participatory ergonomics, healthcare workers in this study teamed up with management and staff with expertise in ergonomic analysis, design, and implementation of remedies. Selected participatory ergonomic intervention programs targeted at an organizational level are elaborated. Interventions included pre-work stretching, workplace surveillance at a psychiatric department, on-site ergonomic teaching for community nurses, and display screen equipment consultancy. Changes in workplace design, equipment re-arrangement, awareness of proper posture, and adoption of good work practices all play important roles in reducing musculoskeletal disorders among healthcare workers. Prompt occupational medicine and rehabilitation services were also provided to complement the work disability prevention process. The impact of the various intervention programs on staff health, costs and productivity of the organization are simultaneously discussed.

Increased alcohol consumption as a cause of alcoholism, without similar evidence for depression: a Mendelian randomization study.

PubMed

Wium-Andersen, Marie Kim; Ørsted, David Dynnes; Tolstrup, Janne Schurmann; Nordestgaard, Børge Grønne

2015-04-01

Increased alcohol consumption has been associated with depression and alcoholism, but whether these associations are causal remains unclear. We tested whether alcohol consumption is causally associated with depression and alcoholism. We included 78,154 men and women aged 20-100 years randomly selected in 1991-2010 from the general population of Copenhagen, Denmark, and genotyped 68,486 participants for two genetic variants in two alcohol dehydrogenase (ADH) genes, ADH-1B (rs1229984) and ADH-1C (rs698). We performed observational and causal analyses using a Mendelian randomization design with antidepressant medication use and hospitalization/death, with depression and alcoholism as outcomes. In prospective analyses, the multifactorially adjusted hazard ratio for participants reporting >6 drinks/day vs participants reporting 0.1-1 drinks/day was 1.28 (95% confidence interval, 1.00-1.65) for prescription antidepressant use, with a corresponding hazard ratio of 0.80 (0.45-1.45) for hospitalization/death with depression and of 11.7 (8.77-15.6) for hospitalization/death with alcoholism. For hospitalization/death with alcoholism, instrumental variable analysis yielded a causal odds ratio of 28.6 (95 % confidence interval 6.47-126) for an increase of 1 drink/day estimated from the combined genotype combination, whereas the corresponding multifactorially adjusted observational odds ratio was 1.28 (1.25-1.31). Corresponding odds ratios were 1.11 (0.67-1.83) causal and 1.04 (1.03-1.06) observational for prescription antidepressant use, and 4.52 (0.99-20.5) causal and 0.98 (0.94-1.03) observational for hospitalization/death with depression. These data indicate that the association between increased alcohol consumption and alcoholism is causal, without similar strong evidence for depression. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

A Multifactorial, Criteria-based Progressive Algorithm for Hamstring Injury Treatment.

PubMed

Mendiguchia, Jurdan; Martinez-Ruiz, Enrique; Edouard, Pascal; Morin, Jean-Benoît; Martinez-Martinez, Francisco; Idoate, Fernando; Mendez-Villanueva, Alberto

2017-07-01

Given the prevalence of hamstring injuries in football, a rehabilitation program that effectively promotes muscle tissue repair and functional recovery is paramount to minimize reinjury risk and optimize player performance and availability. This study aimed to assess the concurrent effectiveness of administering an individualized and multifactorial criteria-based algorithm (rehabilitation algorithm [RA]) on hamstring injury rehabilitation in comparison with using a general rehabilitation protocol (RP). Implementing a double-blind randomized controlled trial approach, two equal groups of 24 football players (48 total) completed either an RA group or a validated RP group 5 d after an acute hamstring injury. Within 6 months after return to sport, six hamstring reinjuries occurred in RP versus one injury in RA (relative risk = 6, 90% confidence interval = 1-35; clinical inference: very likely beneficial effect). The average duration of return to sport was possibly quicker (effect size = 0.34 ± 0.42) in RP (23.2 ± 11.7 d) compared with RA (25.5 ± 7.8 d) (-13.8%, 90% confidence interval = -34.0% to 3.4%; clinical inference: possibly small effect). At the time to return to sport, RA players showed substantially better 10-m time, maximal sprinting speed, and greater mechanical variables related to speed (i.e., maximum theoretical speed and maximal horizontal power) than the RP. Although return to sport was slower, male football players who underwent an individualized, multifactorial, criteria-based algorithm with a performance- and primary risk factor-oriented training program from the early stages of the process markedly decreased the risk of reinjury compared with a general protocol where long-length strength training exercises were prioritized.

Exploring Older Adult ED Fall Patients' Understanding of Their Fall: A Qualitative Study.

PubMed

Shankar, Kalpana N; Taylor, Devon; Rizzo, Caroline T; Liu, Shan W

2017-12-01

We sought to understand older patients' perspectives about their fall, fall risk factors, and attitude toward emergency department (ED) fall-prevention interventions. We conducted semistructured interviews between July 2015 and January 2016 of community-dwelling, nondemented patients in the ED, who presented with a fall to an urban, teaching hospital. Interviews were halted once we achieve thematic saturation with the data coded and categorized into themes. Of the 63 patients interviewed, patients blamed falls on the environment, accidents, a medical condition, or themselves. Three major themes were generated: (1) patients blamed falls on a multitude of things but never acknowledged a possible multifactorial rationale, (2) patients have variable level of concerns regarding their current fall and future fall risk, and (3) patients demonstrated a range of receptiveness to ED interventions aimed at preventing falls but provided little input as to what those interventions should be. Many older patients who fall do not understand their fall risk. However, based on the responses provided, older adults tend to be more receptive to intervention and more concerned about their future fall risk, making the ED an appropriate setting for intervention.

Design and statistical problems in prevention.

PubMed

Gullberg, B

1996-01-01

Clinical and epidemiological research in osteoporosis can benefit from using the methods and techniques established in the area of chronic disease epidemiology. However, attention has to be given to the special characteristics such as the multifactorial nature and the fact that the subjects usually are of high ages. In order to evaluate prevention it is of course first necessary to detect and confirm reversible risk factors. The advantage and disadvantage of different design (cross-sectional, cohort and case-control) are well known. The effects of avoidable biases, e.g. selection, observation and confounding have to be balanced against practical conveniences like time, expenses, recruitment etc. The translation of relative risks into population attributable risks (etiologic fractions, prevented fractions) are complex and are usually performed under unrealistic, simplified assumptions. The consequences of interactions (synergy) between risk factors are often neglected. The multifactorial structure requires application of more advanced multi-level statistical techniques. The common strategy in prevention to target a cluster of risk factors in order to avoid the multifactorial nature implies that in the end it is impossible to separate each unique factor. Experimental designs for evaluating prevention like clinical trials and intervention have to take into account the distinction between explanatory and pragmatic studies. An explanatory approach is similar to an idealized laboratory trial while the pragmatic design is more realistic, practical and has a general public health perspective. The statistical techniques to be used in osteoporosis research are implemented in easy available computer-packages like SAS, SPSS, BMDP and GLIM. In addition to the traditional logistic regression methods like Cox analysis and Poisson regression also analysis of repeated measurement and cluster analysis are relevant.

Falls and Fall Prevention in Older Adults With Early-Stage Dementia: An Integrative Review.

PubMed

Lach, Helen W; Harrison, Barbara E; Phongphanngam, Sutthida

2017-05-01

Older adults with mild cognitive impairment (MCI) and early-stage dementia have an increased risk of falling, with risks to their health and quality of life. The purpose of the current integrative review was to evaluate evidence on fall risk and fall prevention in this population. Studies were included if they examined falls or fall risk factors in older adults with MCI or early-stage dementia, or reported interventions in this population; 40 studies met criteria. Evidence supports the increased risk of falls in individuals even in the early stages of dementia or MCI, and changes in gait, balance, and fear of falling that may be related to this increased fall risk. Interventions included exercise and multifactorial interventions that demonstrated some potential to reduce falls in this population. Few studies had strong designs to provide evidence for recommendations. Further study in this area is warranted. [Res Gerontol Nurs. 2017; 10(03):139-148.]. Copyright 2016, SLACK Incorporated.

Genetic Associations with Intimate Partner Violence in a Sample of Hazardous Drinking Men in Batterer Intervention Programs

PubMed Central

Stuart, Gregory L.; McGeary, John; Shorey, Ryan C.; Knopik, Valerie; Beaucage, Kayla; Temple, Jeff R.

2014-01-01

The etiology of intimate partner violence (IPV) is multifactorial. However, etiological theories of IPV have rarely included potential genetic factors. The purpose of the present study was to examine whether a cumulative genetic score (CGS) containing the MAOA and 5-HTTLPR polymorphisms was associated with IPV perpetration after accounting for the effects of alcohol problems, drug problems, age, and length of relationship. We obtained DNA from 97 men in batterer intervention programs in the state of Rhode Island. In the full sample, the CGS was significantly associated with physical and psychological aggression and injuries caused to one's partner, even after controlling for the effects of alcohol problems, drug problems, age, and length of relationship. Two of the men in the sample likely had Klinefelter's syndrome and analyses were repeated excluding these two individuals, leading to similar results. The implications of the genetics findings for the etiology and treatment of IPV among men in batter intervention programs are briefly discussed. PMID:24759925

THAO-CHILD HEALTH PROGRAMME: COMMUNITY BASED INTERVENTION FOR HEALTHY LIFESTYLES PROMOTION TO CHILDREN AND FAMILIES: RESULTS OF A COHORT STUDY.

PubMed

Gómez Santos, Santiago Felipe; Estévez Santiago, Rocío; Palacios Gil-Antuñano, Nieves; Leis Trabazo, Maria Rosaura; Tojo Sierra, Rafael; Cuadrado Vives, Carmen; Beltrán de Miguel, Beatriz; Ávila Torres, José Manuel; Varela Moreiras, Gregorio; Casas Esteve, Rafael

2015-12-01

childhood obesity is one of the main public health concerns. The multifactorial and multilevel causes require complex interventions such the community based interventions (CBI). Thao-Child Health Programme is a CBI implemented in Spain since 2007. show the Thao methodology and the latest cross-sectional and longitudinal results. longitudinal cohort study (4 years of follow- up) and cross sectional study. the longitudinal study found an increase of 1% in the overweight prevalence after a follow-up of 4 years of Thao-Programme implementation in 10 municipalities with 6 697 children involved. The cross-sectional study carried out with 20 636 children from 22 municipalities found a childhood overweight prevalence of 26.6%. currently a brake in the increase of childhood overweight prevalence is considered a success due to the high prevalence worldwide. More studies well methodologically performed are needed to know the efficacy of the CBI's in this field. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Sex hormones and sarcopenia in older persons.

PubMed

Maggio, Marcello; Lauretani, Fulvio; Ceda, Gian Paolo

2013-01-01

Sarcopenia is a geriatric syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. Sarcopenia is a multifactorial process involving the decline of androgens, including dehydroepiandrosterone sulphate (DHEAS) and testosterone. The aim of this review is to highlight the effects of DHEAS and testosterone treatment to counteract sarcopenia, especially in older men. DHEAS and, more importantly, testosterone treatment are associated with increased muscle mass, whereas the effects on muscle function and physical performance are less clear. The results of recent randomized placebo controlled trials with DHEAS in older men and women and testosterone in men with mobility limitation are discussed. The novel current and future scenarios to attenuate the detrimental effects and to optimize the efficacy of sex hormone treatment are also addressed. DHEAS and testosterone are important options in the armamentarium of sarcopenia treatment in older men. Future studies are needed to address new approaches by using selective compounds, targeting the correct form and dosage, tailoring the correct patient to treat, and taking into account the multifactorial origin and the new definition of sarcopenia.

Neighborhood, Socioeconomic, and Racial Influence on Chronic Pain.

PubMed

Maly, Angelika; Vallerand, April Hazard

2018-02-01

The purpose of this review is to highlight the neighborhood, socioeconomic, and racial influences on chronic pain. Negative influences on the experience of chronic pain are explored and defined as any adverse stressor common in low socioeconomic, urban neighborhoods that potentially contributes to health disparity in African Americans experiencing chronic pain. The multifactorial influences on chronic pain disparity in African Americans are explored and expounded upon in this review of existing evidence. Databases used for the search included CINAHL, PubMed, and PsycArticles. The experience of chronic pain is multifaceted, existing with multiple comorbidities and lasting consequences. To improve the burden of chronic pain requires a multifactorial assessment that considers neighborhood risk factors, emphasis on environmental stressors, limitations to support networks, barriers to physical activity, and access to primary care providers with whom communication is open and without bias. A comprehensive assessment of barriers will aid in the development of interventions that reach beyond the physical factors of chronic pain, also considering the psychosocial barriers to improving the burden of chronic pain in African Americans living in impoverished urban neighborhoods. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Interventions incorporating physical and cognitive elements to reduce falls risk in cognitively impaired older adults: a systematic review.

PubMed

Booth, Vicky; Hood, Victoria; Kearney, Fiona

2016-05-01

Cognitive impairment is a risk factor for falls. Older adults with cognitive impairment (such as dementia) have an increased risk of falling compared with age-matched individuals without a cognitive impairment. To reduce falls in this population, interventions could theoretically target and train both physical and cognitive abilities. Combining and addressing cognitive components in falls rehabilitation is a novel and emerging area of healthcare. The objective of this review was to identify the effectiveness of combined cognitive and physical interventions on the risk of falls in cognitively impaired older adults. Older persons who were 65 years or older and identified as having a cognitive impairment either through diagnosis or assessment of global cognition. Multifactorial or multiple interventions where physical and cognitive elements were combined was compared against standard care or a single element intervention. Randomized controlled trials (RCTs), controlled clinical trials and experimental studies in which randomization was used. Outcomes related to falls, including falls rate, specific falls risk measures (i.e. Physiological Profile Assessment) or related clinical outcome measures (i.e. Timed Up and Go test, Tinetti and gait speed). A three-step search strategy was utilized in this review, including search of electronic databases: CENTRAL, JBISRIR, MEDLINE, EMBASE, AMED, CINAHL and PsychINFO. Initial keywords used were dementia, cognitive impairment, memory loss, exercise, rehabilitation and accidental falls. Grey literature (Google Scholar) and trials registers (Current Controlled Trials) searches were also completed. The methodological quality of included studies was assessed using Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) software. Data was extracted from articles included in the review using the standardized data extraction tool from JBI-MAStARI. A quantitative meta-analysis was performed where possible. Otherwise, data synthesis was in the form of narrative review. Sub-group analysis according to level of cognitive impairment was completed where possible. Eight RCTs were included in this review; they evaluated the effectiveness of multicomponent exercise programs, including physical and cognitive activities, music-based group exercise and mind-body tai chi on falls related outcomes. Most of the studies were of good quality with an average quality score of 7.5. Four studies reported effectiveness based on the number of falls, half of which reported a significant difference between the groups, but pooling of results into meta-analysis was not possible because of differences in reporting of the outcome. Falls related outcomes that were combined in meta-analysis included balance (Berg balance scale), functional mobility (Timed Up and Go) and gait speed (m/s). There was a statistically significant improvement in balance and gait speed following the intervention; however, the studies were too heterogeneous to be included in the analysis from the functional mobility results. Overall, multicomponent interventions incorporating both physical and cognitive components demonstrated positive effects on balance, functional mobility and gait speed when compared with a control and had significantly better effect on balance and gait speed within mild cognitive impairment populations.

[Impaired hypoglycemia awareness in diabetes mellitus].

PubMed

Brož, Jan; Piťhová, Pavlína; Janíčková Žďárská, Denisa

Impaired hypoglycemia awareness is defined at the onset of neuroglycopenia without the appearance of autonomic warning symptoms. Impaired hypoglycemia awareness is disorder which affects aprox. one third of patients with type 1 diabetes mellitus and 8-10 % of patients with type 2 diabetes mellitus who are treated with insulin. The most dangerous consequence is 6 times higher frequency of severe hypoglycemia in patients with Type 1 diabetes mellitus and 17 times higher in Type 2 diabetic patients treated with insulin. Treatment of impaired hypoglycemia awareness is complex, based on a multifactorial intervention of clinical care and structured patient education. diabetes mellitus - hypoglycemia- impaired hypoglycemia awareness.

Dental ergonomics to combat musculoskeletal disorders: a review.

PubMed

Gupta, Arpit; Ankola, Anil V; Hebbal, Mamata

2013-01-01

Musculoskeletal disorders (MSDs) are significant workplace problems affecting occupational health, productivity and the careers of dental professionals. The prevalence of MSDs is on the rise for all types of dental workers. In spite of different patterns of work culture, there are parallel levels of symptoms in dentists across nations. Risk factors for MSDs are multifactorial. Symptoms appear very early in careers, with higher prevalence of MSDs even during educational training. Ergonomics improvements, health promotion and organizational interventions are necessary to reduce the risk. An interdisciplinary approach with progressive efforts should be taken to address MSDs in dental professionals.

Prevention of Youth Violence: A Public Health Approach.

PubMed

Sood, Aradhana Bela; Berkowitz, Steven J

2016-04-01

The causes of youth violence are multifactorial and include biological, individual, familial, social, and economic factors. The influence of parents, family members, and important adults can shape the beliefs of the child toward violence in a significant manner. However, the influence of school and the neighborhood also have an important role in attitudes and behaviors of children toward violence. The complexity of factors related to violence requires a comprehensive public health approach. This article focuses on evidence-based models of intervention to reduce violence while emphasizing collective impact as a guiding principle. Copyright © 2016 Elsevier Inc. All rights reserved.

A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD.

PubMed

Cheung, Elaine O; Addington, Elizabeth L; Bassett, Sarah M; Schuette, Stephanie A; Shiu, Eva W; Cohn, Michael A; Leykin, Yan; Saslow, Laura R; Moskowitz, Judith T

2018-06-05

Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). RR1-10.2196/10494. ©Elaine O Cheung, Elizabeth L Addington, Sarah M Bassett, Stephanie A Schuette, Eva W Shiu, Michael A Cohn, Yan Leykin, Laura R Saslow, Judith T Moskowitz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.06.2018.

Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial.

PubMed

Giordano, Alessandro; Bonometti, Gian Pietro; Vanoglio, Fabio; Paneroni, Mara; Bernocchi, Palmira; Comini, Laura; Giordano, Amerigo

2016-12-07

Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programmes are effective in all older population studied. However, the application of these programmes may not be the same in all National health care setting and, consequently, needs to be evaluated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention programme at home has never been explored. This will be a two-group randomised controlled trial aiming to evaluate the effects of a home-based intervention programme delivered by a multidisciplinary health team. The home tele-management programme, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at hospital discharge. The programme will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed for 6 months after hospital discharge. A nurse-tutor telephone support and tele-exercise will characterize the intervention programme. People in the control group will receive usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios. To date, no adequately powered studies have investigated the effect of the Information and Communication Technologies (ICT) in a home fall prevention program. We aim the program will be feasible in terms of intensity and characteristics, but particularly in terms of patient and provider compliance. The results of the economic evaluation could provide information about the cost-effectiveness of the intervention and the effects on quality of life. In case of shown effectiveness and cost effectiveness, the program could be implemented into health services settings. ClinicalTrials.gov ( NCT02487589 ).

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Olfactory identification and Stroop interference converge in schizophrenia.

PubMed Central

Purdon, S E

1998-01-01

OBJECTIVE: To test the discriminant validity of a model predicting a dissociation between measures of right and left frontal lobe function in people with schizophrenia. PARTICIPANTS: Twenty-one clinically stable outpatients with schizophrenia. INTERVENTIONS: Patients were administered the University of Pennsylvania Smell Identification Test (UPSIT), the Stroop Color-Word Test (Stroop), and the Positive and Negative Syndrome Scale (PANSS). OUTCOME MEASURES: Scores on these tests and relation among scores. RESULTS: There was a convergence of UPSII and Stroop interference scores consistent with a common cerebral basis for limitations in olfactory identification and inhibition of distraction. There was also a divergence of UPSIT and Stroop reading scores suggesting that the olfactory identification limitation is distinct from a general limitation of attention or a dysfunction of the left dorsolateral prefrontal cortex. Most notable was the 81% classification convergence between the UPSIT and Stroop incongruous colour naming scores compared with the near-random 57% classification convergence of the UPSIT and Stroop reading scores. CONCLUSIONS: These data are consistent with a right orbitofrontal dysfunction in a subgroup of patients with schizophrenia, although the involvement of mesial temporal structures in both tasks must be ruled out with further study. A multifactorial model depicting contributions from diverse cerebral structures is required to describe the pathophysiology of schizophrenia. Valid behavioural methods for classifying suspected subgroups of patients with particular cerebral dysfunction would be of value in the construction of this model. PMID:9595890

Current Diagnosis and Management of Cervical Spondylotic Myelopathy.

PubMed

Bakhsheshian, Joshua; Mehta, Vivek A; Liu, John C

2017-09-01

Review. Cervical spondylotic myelopathy (CSM) is a major cause of disability, particular in elderly patients. Awareness and understanding of CSM is imperative to facilitate early diagnosis and management. This review article addresses CSM with regard to its epidemiology, anatomical considerations, pathophysiology, clinical manifestations, imaging characteristics, treatment approaches and outcomes, and the cost-effectiveness of surgical options. The authors performed an extensive review of the peer-reviewed literature addressing the aforementioned objectives. The clinical presentation and natural history of CSM is variable, alternating between quiescent and insidious to stepwise decline or rapid neurological deterioration. For mild CSM, conservative options could be employed with careful observation. However, surgical intervention has shown to be superior for moderate to severe CSM. The success of operative or conservative management of CSM is multifactorial and high-quality studies are lacking. The optimal surgical approach is still under debate, and can vary depending on the number of levels involved, location of the pathology and baseline cervical sagittal alignment. Early recognition and treatment of CSM, before the onset of spinal cord damage, is essential for optimal outcomes. The goal of surgery is to decompress the cord with expansion of the spinal canal, while restoring cervical lordosis, and stabilizing when the risk of cervical kyphosis is high. Further high-quality randomized clinical studies with long-term follow up are still needed to further define the natural history and help predict the ideal surgical strategy.

Incidence and multivariable correlates of long-term mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial.

PubMed

Farooq, Vasim; Serruys, Patrick W; Bourantas, Christos; Vranckx, Pascal; Diletti, Roberto; Garcia Garcia, Hector M; Holmes, David R; Kappetein, Arie-Pieter; Mack, Michael; Feldman, Ted; Morice, Marie Claude; Colombo, Antonio; Morel, Marie-angèle; de Vries, Ton; van Es, Gerrit Anne; Steyerberg, Ewout W; Dawkins, Keith D; Mohr, Friedrich W; James, Stefan; Ståhle, Elisabeth

2012-12-01

The aim of this investigation was to determine the incidence and multivariable correlates of long-term (4-year) mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention (PCI) with TAXUS Express and Cardiac Surgery (SYNTAX) trial. A total of 1800 patients were randomized to undergo coronary artery bypass graft (CABG) surgery (n = 897) or PCI (n = 903). Prospectively collected baseline and peri- and post-procedural data were used to determine independent correlates of 4-year all-cause death in the CABG and the PCI arms (Cox proportional hazards model). Four-year mortality rates in the CABG and the PCI arms were 9.0% [74 deaths (12 in-hospital)] and 11.8% [104 deaths (16 in-hospital)], respectively (log-rank P-value = 0.063). Censored data comprised 78 patients (8.7%) in the CABG arm, and 24 patients (2.7%) in the PCI arm (log-rank P-value < 0.001). Within the CABG arm, the strongest independent correlates of 4-year mortality were lack of discharge aspirin [hazard ratio (HR) 3.56; 95% CI: 2.04, 6.21; P < 0.001], peripheral vascular disease (PVD) (HR: 2.65; 95% CI: 1.49, 4.72; P = 0.001), chronic obstructive pulmonary disease, age, and serum creatinine. Within the PCI arm, the strongest independent correlate of 4-year mortality was lack of post-procedural anti-platelet therapy (HR: 152.16; 95% CI: 53.57, 432.22; P < 0.001), with 10 reported early (within 45 days) in-hospital deaths secondary to multifactorial causes precluding administration of anti-platelet therapy. Other independent correlates of mortality in the PCI arm included amiodarone therapy on discharge, pre-procedural poor left ventricular ejection fraction, a 'history of gastrointestinal bleeding or peptic ulcer disease', PVD (HR: 2.13; 95% CI: 1.26, 3.60; P = 0.005), age, female gender (HR: 1.60; 95% CI: 1.01, 2.56; P = 0.048), and the SYNTAX score (Per increase in 10 points: HR: 1.25; 95% CI: 1.06, 1.47; P = 0.007). Independent correlates of 4-year mortality in the SYNTAX trial were multifactorial. Lack of discharge aspirin and lack of post-procedural anti-platelet therapy were the strongest independent correlates of mortality in the CABG and the PCI arms, respectively. Peripheral vascular disease is a common independent correlate of 4-year mortality and may be a marker of the severity of baseline coronary disease and risk of future native coronary disease (and extra-cardiac disease) progression.

Effectiveness of an HIV/STD risk-reduction intervention for adolescents when implemented by community-based organizations: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Fong, Geoffrey T; Morales, Knashawn H

2010-04-01

We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (beta = 0.06; 95% CI = 0.00, 0.12) than did the control group. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established.

Effectiveness of an HIV/STD Risk-Reduction Intervention for Adolescents When Implemented by Community-Based Organizations: A Cluster-Randomized Controlled Trial

PubMed Central

Jemmott, Loretta S.; Fong, Geoffrey T.; Morales, Knashawn H.

2010-01-01

Objectives. We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). Methods. In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Results. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (β = 0.06; 95% CI = 0.00, 0.12) than did the control group. Conclusions. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established. PMID:20167903

Randomized controlled trial of a cognitive-behavioral intervention for HIV-positive persons: an investigation of treatment effects on psychosocial adjustment.

PubMed

Carrico, Adam W; Chesney, Margaret A; Johnson, Mallory O; Morin, Stephen F; Neilands, Torsten B; Remien, Robert H; Rotheram-Borus, Mary Jane; Lennie Wong, F

2009-06-01

Questions remain regarding the clinical utility of psychological interventions for HIV-positive persons because randomized controlled trials have utilized stringent inclusion criteria and focused extensively on gay men. The present randomized controlled trial examined the efficacy of a 15-session, individually delivered cognitive-behavioral intervention (n = 467) compared to a wait-list control (n = 469) in a diverse sample of HIV-positive persons who reported HIV transmission risk behavior. Five intervention sessions that dealt with executing effective coping responses were delivered between baseline and the 5 months post-randomization. Additional assessments were completed through 25 months post-randomization. Despite previously documented reductions in HIV transmission risk, no intervention-related changes in psychosocial adjustment were observed across the 25-month investigation period. In addition, there were no intervention effects on psychosocial adjustment among individuals who presented with mild to moderate depressive symptoms. More intensive mental health interventions may be necessary to improve psychosocial adjustment among HIV-positive individuals.

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

Hyperbaric oxygen therapy for children with autism spectrum disorder.

PubMed

Sakulchit, Teeranai; Ladish, Chris; Goldman, Ran D

2017-06-01

Question As autism spectrum disorder (ASD) is a multifactorial condition, with genetic and environmental risk factors contributing to children's unique presentation and symptom severity, a range of treatments have been suggested. Parents of children with ASD in my clinic are asking me about alternative therapies to improve their children's condition. One of those therapies is hyperbaric oxygen therapy (HBOT); commercial advertisement in the past has suggested good results with this approach. Should I recommend the use of HBOT for children with ASD? Answer Hyperbaric oxygen therapy provides a higher concentration of oxygen delivered in a chamber or tube containing higher than sea level atmospheric pressure. Case series and randomized controlled trials show no evidence to support the benefit of HBOT for children with ASD. Only 1 randomized controlled trial reported effectiveness of this treatment, and those results have yet to be repeated. Copyright© the College of Family Physicians of Canada.

How are multifactorial beliefs about the role of genetics and behavior in cancer causation associated with cancer risk cognitions and emotions in the US population?

PubMed

Hamilton, Jada G; Waters, Erika A

2018-02-01

People who believe that cancer has both genetic and behavioral risk factors have more accurate mental models of cancer causation and may be more likely to engage in cancer screening behaviors than people who do not hold such multifactorial causal beliefs. This research explored possible health cognitions and emotions that might produce such differences. Using nationally representative cross-sectional data from the US Health Information National Trends Survey (N = 2719), we examined whether endorsing a multifactorial model of cancer causation was associated with perceptions of risk and other cancer-related cognitions and affect. Data were analyzed using linear regression with jackknife variance estimation and procedures to account for the complex survey design and weightings. Bivariate and multivariable analyses indicated that people who endorsed multifactorial beliefs about cancer had higher absolute risk perceptions, lower pessimism about cancer prevention, and higher worry about harm from environmental toxins that could be ingested or that emanate from consumer products (Ps < .05). Bivariate analyses indicated that multifactorial beliefs were also associated with higher feelings of risk, but multivariable analyses suggested that this effect was accounted for by the negative affect associated with reporting a family history of cancer. Multifactorial beliefs were not associated with believing that everything causes cancer or that there are too many cancer recommendations to follow (Ps > .05). Holding multifactorial causal beliefs about cancer are associated with a constellation of risk perceptions, health cognitions, and affect that may motivate cancer prevention and detection behavior. Copyright © 2017 John Wiley & Sons, Ltd.

Interventions for preventing falls in older people living in the community.

PubMed

Gillespie, Lesley D; Robertson, M Clare; Gillespie, William J; Sherrington, Catherine; Gates, Simon; Clemson, Lindy M; Lamb, Sarah E

2012-09-12

Approximately 30% of people over 65 years of age living in the community fall each year. This is an update of a Cochrane review first published in 2009. To assess the effects of interventions designed to reduce the incidence of falls in older people living in the community. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (February 2012), CENTRAL (The Cochrane Library 2012, Issue 3), MEDLINE (1946 to March 2012), EMBASE (1947 to March 2012), CINAHL (1982 to February 2012), and online trial registers. Randomised trials of interventions to reduce falls in community-dwelling older people. Two review authors independently assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person year) between intervention and control groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of people falling (fallers) in each group. We pooled data where appropriate. We included 159 trials with 79,193 participants. Most trials compared a fall prevention intervention with no intervention or an intervention not expected to reduce falls. The most common interventions tested were exercise as a single intervention (59 trials) and multifactorial programmes (40 trials). Sixty-two per cent (99/159) of trials were at low risk of bias for sequence generation, 60% for attrition bias for falls (66/110), 73% for attrition bias for fallers (96/131), and only 38% (60/159) for allocation concealment.Multiple-component group exercise significantly reduced rate of falls (RaR 0.71, 95% CI 0.63 to 0.82; 16 trials; 3622 participants) and risk of falling (RR 0.85, 95% CI 0.76 to 0.96; 22 trials; 5333 participants), as did multiple-component home-based exercise (RaR 0.68, 95% CI 0.58 to 0.80; seven trials; 951 participants and RR 0.78, 95% CI 0.64 to 0.94; six trials; 714 participants). For Tai Chi, the reduction in rate of falls bordered on statistical significance (RaR 0.72, 95% CI 0.52 to 1.00; five trials; 1563 participants) but Tai Chi did significantly reduce risk of falling (RR 0.71, 95% CI 0.57 to 0.87; six trials; 1625 participants).Multifactorial interventions, which include individual risk assessment, reduced rate of falls (RaR 0.76, 95% CI 0.67 to 0.86; 19 trials; 9503 participants), but not risk of falling (RR 0.93, 95% CI 0.86 to 1.02; 34 trials; 13,617 participants).Overall, vitamin D did not reduce rate of falls (RaR 1.00, 95% CI 0.90 to 1.11; seven trials; 9324 participants) or risk of falling (RR 0.96, 95% CI 0.89 to 1.03; 13 trials; 26,747 participants), but may do so in people with lower vitamin D levels before treatment.Home safety assessment and modification interventions were effective in reducing rate of falls (RR 0.81, 95% CI 0.68 to 0.97; six trials; 4208 participants) and risk of falling (RR 0.88, 95% CI 0.80 to 0.96; seven trials; 4051 participants). These interventions were more effective in people at higher risk of falling, including those with severe visual impairment. Home safety interventions appear to be more effective when delivered by an occupational therapist.An intervention to treat vision problems (616 participants) resulted in a significant increase in the rate of falls (RaR 1.57, 95% CI 1.19 to 2.06) and risk of falling (RR 1.54, 95% CI 1.24 to 1.91). When regular wearers of multifocal glasses (597 participants) were given single lens glasses, all falls and outside falls were significantly reduced in the subgroup that regularly took part in outside activities. Conversely, there was a significant increase in outside falls in intervention group participants who took part in little outside activity.Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity (RaR 0.73, 95% CI 0.57 to 0.93; three trials; 349 participants) but not risk of falling. First eye cataract surgery in women reduced rate of falls (RaR 0.66, 95% CI 0.45 to 0.95; one trial; 306 participants), but second eye cataract surgery did not.Gradual withdrawal of psychotropic medication reduced rate of falls (RaR 0.34, 95% CI 0.16 to 0.73; one trial; 93 participants), but not risk of falling. A prescribing modification programme for primary care physicians significantly reduced risk of falling (RR 0.61, 95% CI 0.41 to 0.91; one trial; 659 participants).An anti-slip shoe device reduced rate of falls in icy conditions (RaR 0.42, 95% CI 0.22 to 0.78; one trial; 109 participants). One trial (305 participants) comparing multifaceted podiatry including foot and ankle exercises with standard podiatry in people with disabling foot pain significantly reduced the rate of falls (RaR 0.64, 95% CI 0.45 to 0.91) but not the risk of falling.There is no evidence of effect for cognitive behavioural interventions on rate of falls (RaR 1.00, 95% CI 0.37 to 2.72; one trial; 120 participants) or risk of falling (RR 1.11, 95% CI 0.80 to 1.54; two trials; 350 participants).Trials testing interventions to increase knowledge/educate about fall prevention alone did not significantly reduce the rate of falls (RaR 0.33, 95% CI 0.09 to 1.20; one trial; 45 participants) or risk of falling (RR 0.88, 95% CI 0.75 to 1.03; four trials; 2555 participants).No conclusions can be drawn from the 47 trials reporting fall-related fractures.Thirteen trials provided a comprehensive economic evaluation. Three of these indicated cost savings for their interventions during the trial period: home-based exercise in over 80-year-olds, home safety assessment and modification in those with a previous fall, and one multifactorial programme targeting eight specific risk factors. Group and home-based exercise programmes, and home safety interventions reduce rate of falls and risk of falling.Multifactorial assessment and intervention programmes reduce rate of falls but not risk of falling; Tai Chi reduces risk of falling.Overall, vitamin D supplementation does not appear to reduce falls but may be effective in people who have lower vitamin D levels before treatment.

An overview of calf diarrhea - infectious etiology, diagnosis, and intervention

PubMed Central

Cho, Yong-il

2014-01-01

Calf diarrhea is a commonly reported disease in young animals, and still a major cause of productivity and economic loss to cattle producers worldwide. In the report of the 2007 National Animal Health Monitoring System for U.S. dairy, half of the deaths among unweaned calves was attributed to diarrhea. Multiple pathogens are known or postulated to cause or contribute to calf diarrhea development. Other factors including both the environment and management practices influence disease severity or outcomes. The multifactorial nature of calf diarrhea makes this disease hard to control effectively in modern cow-calf operations. The purpose of this review is to provide a better understanding of a) the ecology and pathogenesis of well-known and potential bovine enteric pathogens implicated in calf diarrhea, b) describe diagnostic tests used to detect various enteric pathogens along with their pros and cons, and c) propose improved intervention strategies for treating calf diarrhea. PMID:24378583

Law enforcement-applied tourniquets: a case series of life-saving interventions.

PubMed

Callaway, David W; Robertson, Joshua; Sztajnkrycer, Matthew D

2015-01-01

Although the epidemiology of civilian trauma is distinct from that encountered in combat, in both settings, extremity hemorrhage remains a major preventable cause of potential mortality. The current paper describes the largest case series in the literature in which police officers arriving prior to emergency medical services applied commercially available field tourniquets to civilian victims of violent trauma. Although all 3 patients with vascular injury arrived at the receiving emergency department in extremis, they were successfully resuscitated and survived to discharge without major morbidity. While this outcome is likely multifactorial and highlights the exceptional care delivered by the modern trauma system, tourniquet application appears to have kept critically injured patients alive long enough to reach definitive trauma care. No patient had a tourniquet-related complication. This case series suggests that law enforcement officers can effectively identify indications for tourniquets and rapidly apply such life-saving interventions.

Amplifying Health Through Community Gardens: A Framework for Advancing Multicomponent, Behaviorally Based Neighborhood Interventions.

PubMed

Alaimo, Katherine; Beavers, Alyssa W; Crawford, Caroline; Snyder, Elizabeth Hodges; Litt, Jill S

2016-09-01

The article presents a framework for understanding the relationship between community garden participation, and the myriad ways gardens and participation lead to emotional, social, and health impacts. Existing empirical research relating community gardens to health behaviors, such as physical activity and diet, and longer-term chronic disease-related outcomes is summarized. The research areas discussed include the effects of community garden participation on individual, social, emotional, and environmental processes; health behaviors including diet and physical activity; and health outcomes such as self-rated health, obesity, and mental health. Other mechanisms through which community gardens may affect population health are described. Applying a multitheoretical lens to explore associations between community garden participation and health enables us to delineate key aspects of gardening that elicit positive health behaviors and multifactorial health assets that could be applied to designing other types of health interventions.

International collaboration in health promotion and disease management: implications of U.S. health promotion efforts on Japan's health care system.

PubMed

Pelletier, Kenneth R

2005-01-01

For more than 25 years, health promotion and disease management interventions have been conducted by large employers in the United States. Today there are more than 100 studies of such multifactorial, comprehensive interventions that all demonstrate positive clinical outcomes. For those interventions that have also been evaluated for return on investment, all but one have demonstrated cost-effectiveness. This article is an evidence-based overview of the clinical and cost outcomes research to elaborate on the insights gained from this research in the areas of implementation and evaluation of such programs; integration of health promotion and disease management programs into conventional, occupational medicine; accessing difficult to reach populations, such as mobile workers, retirees, and/or dependents; areas of potential conflict of interest and privacy/confidentiality issues; health consequences of downsizing and job strain; and, finally, recommendations for improved integration and evaluation of such programs for both clinical and cost outcomes. With medical costs rapidly escalating again on a global scale, these interventions with evidence of both clinical and cost outcomes can provide the foundation to improve the health, performance, and productivity of both individuals and their corporations.

Modifiable Risk Factors and Interventions for Childhood Obesity Prevention within the First 1,000 Days.

PubMed

Dattilo, Anne M

2017-01-01

Worldwide, the prevalence of childhood obesity has increased, amounting to 42 million overweight or obese children, and there is increasing evidence that the origins are within the first 1,000 days: the period of conception through 2 years. Antecedents of early childhood obesity are multifactorial, and associations of varying strength have been documented for genetic/epigenetic, biologic, dietary, environmental, social, and behavioral influences. Modifiable factors in pregnancy and early infancy associated with childhood obesity include maternal overweight/obesity, maternal smoking, gestational weight gain, infant and young child feeding, caregiver responsive feeding practices, as well as sleep duration, and physical activity. Promising obesity prevention interventions include those beginning during the first 1,000 days, using a multicomponent approach, with roots in nutrition education theories or behavior change communication that can continue over time. However, the limited number of completed interventions to date (within pediatric clinics or in home-based or community settings) may not be scalable to the magnitude needed for sustainable obesity prevention. Scale-up interventions that can be maintained for the durations needed, addressing infant and young child feeding and other modifiable risk factors associated with childhood obesity are needed. © 2017 Nestec Ltd., Vevey/S. Karger AG, Basel.

Primary Care Interventions to Reduce Childhood Obesity in Latino Families.

PubMed

Gonzalez, Giulliana

2016-01-01

Increasing rates of obesity in Latino children call for culturally sensitive primary care interventions. Despite recent efforts to address this growing disparity, little is known about cultural variables that influence obesity management programs in Latino children. A literature search was conducted using CINHAL, Scopus, PubMed, and PsycINFO to review the state of the science regarding primary care interventions to decrease obesity in Latino children. The author analyzed the effects of several cultural practices on obesity and made recommendations based on their clinical implications for weight reduction management programs. Obesity in Latino children is a multifactorial problem influenced by family behaviors, cultural perceptions of weight and health, traditional dietary norms, and socioeconomic status. Current practice lags behind national obesity management recommendations and is further hindered by a lack of consideration of the roles of key cultural differences in Latino families. It is imperative to recognize the importance of family preferences and culture when developing weight reduction programs so as to foster long-term behavior changes. More research assessing the efficacy of culturally competent interventions is necessary to guide national efforts to address this increasing disparity. Copyright © 2015 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

A Narrative Review of Diabetes Intervention Studies to Explore Diabetes Care Opportunities for Pharmacists.

PubMed

Ayadurai, Shamala; Hattingh, H Laetitia; Tee, Lisa B G; Md Said, Siti Norlina

2016-01-01

Background. We conducted a review of current diabetes intervention studies in type 2 diabetes and identified opportunities for pharmacists to deliver quality diabetes care. Methods. A search on randomised controlled trials (RCT) on diabetes management by healthcare professionals including pharmacists published between 2010 and 2015 was conducted. Results and Discussion. Diabetes management includes multifactorial intervention which includes seven factors as outlined in diabetes guidelines, namely, glycaemic, cholesterol and blood pressure control, medication, lifestyle, education, and cardiovascular risk factors. Most studies do not provide evidence that the intervention methods used included all seven factors with exception of three RCT which indicated HbA1c (glycated hemoglobin) reduction range of 0.5% to 1.8%. The varied HbA1C reduction suggests a lack of standardised and consistent approach to diabetes care. Furthermore, the duration of most studies was from one month to two years; therefore long term outcomes could not be established. Conclusion. Although pharmacists' contribution towards improving clinical outcomes of diabetes patients was well documented, the methods used to deliver structured, consistent evidence-based care were not clearly stipulated. Therefore, approaches to achieving long term continuity of care are uncertain. An intervention strategy that encompass all seven evidence-based factors will be useful.

Addressing weight stigma in physiotherapy: Development of a theory-driven approach to (re)thinking weight-related interactions.

PubMed

Setchell, J; Gard, M; Jones, L; Watson, B M

2017-08-01

In this article, we propose a theory-driven approach to developing interventions for reducing weight stigma in physiotherapy and discuss the design and exploratory trial of such an intervention. Weight stigma has been identified in physiotherapists in empirical investigations. However, there has been little consideration of how this stigma might be addressed. We highlight Goffman's work on stigma that provides social and embodied understandings of stigma. Goffman's approach, however, is notably apolitical, ahistorical and lacks mechanisms for understanding power. We suggest that post-structuralist perspectives can provide insight into these areas. Drawing on these theories, we critically examine the literature on weight stigma reduction, finding that trials have largely been unsuccessful. We argue that this may be due to overly passive and simplistic intervention designs. As context-specific understandings are desirable, we examine the nature of physiotherapy to determine what might be relevant to (re)thinking weight in this profession. We then discuss the development of a multifactorial, active weight stigma intervention we trialed with eight physiotherapists. Supported by theory, the outcomes of the exploratory study suggest that physiotherapy-specific factors such as fostering professional reflexivity and improving understandings of stigma need to be incorporated into an active intervention that considers the complex determinants of weight stigma.

Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

2005-01-01

This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

Randomization at the level of primary care practice: use of pre-intervention data and random effects models.

PubMed

Nixon, R M; Duffy, S W; Fender, G R; Day, N E; Prevost, T C

2001-06-30

The Anglia menorrhagia education study tests the effectiveness of an education package for the treatment of menorrhagia given to doctors at a primary care level. General practices were randomized to receive or not receive the package. It is hoped that this intervention will reduce the proportion of women suffering from menorrhagia that are referred to hospital. Data are available on the treatment and referral of women in the practices in the education and control groups, both pre- and post-intervention. We define and demonstrate a random effects logistic regression model that includes pre-intervention data for calculating the effectiveness of the intervention. Copyright 2001 John Wiley & Sons, Ltd.

Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

PubMed

Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

2017-01-01

Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.

Knowledge, Attitude, and Barriers to Fluoride Application as a Preventive Measure among Oral Health Care Providers

PubMed Central

Al-Sumait, Noura; Al-Yahya, Hanan

2018-01-01

Objective To investigate the knowledge, attitude, and possible barriers to fluoride application among oral health-care providers in Kuwait. Methods A validated self-administered questionnaire was distributed to a random sample of 291 dentists. The questionnaire included four categories: dentists' characteristics, knowledge of and attitude towards fluoride application, factors influencing decision-making on prescription of fluoride, and the clinician's perception of own knowledge. Means, group differences, and logistic regression were calculated. Results 262 completed the questionnaire (response rate of 90%). Half of the participants (49%) reported that water fluoridation is the best method for caries prevention in children. Majority of the participants (80%) acknowledged that topical fluoride prevents dental caries, but only 40% frequently use it in their practices. Fear of overdose was a concern in 57% of the participants. About 31% believed that caries is a multifactorial disease and cannot be prevented. In addition, 32% of the dentists who thought caries is multifactorial and cannot be prevented stated that restorations take precedence over preventive therapy. Conclusion Despite the participants being in favor of topical fluoride application and believing in its effectiveness, certain barriers were apparent such as knowledge deficiencies, products labelling flaw, and lack of participation in effective continuing educational activities. PMID:29849638

From Genes to Environment: Using integrative genomics to build a “systems level” understanding of autism spectrum disorders

PubMed Central

Hu, Valerie W.

2012-01-01

Autism spectrum disorders (ASD) are pervasive neurodevelopmental disorders that affect an estimated 1 in 110 individuals. Although there is a strong genetic component associated with these disorders, this review focuses on the multi-factorial nature of ASD and how different genome-wide (genomic) approaches contribute to our understanding of autism. Emphasis is placed on the need to study defined ASD phenotypes as well as to integrate large-scale ‘omics’ data in order to develop a “systems level” perspective of ASD which, in turn, is necessary to allow predictions regarding responses to specific perturbations and interventions. PMID:22497667

PREVENTION AND MANAGEMENT OF LIMB CONTRACTURES IN NEUROMUSCULAR DISEASES

PubMed Central

Skalsky, Andrew J.; McDonald, Craig M.

2012-01-01

Synopsis Limb contractures are a common impairment in neuromuscular diseases (NMD). They contribute to increased disability due to decreased motor performance, mobility limitations, reduced functional range of motion, loss of function for activities of daily living (ADL), and increased pain. The pathogenesis of contractures is multifactorial. Myopathic conditions are associated with more severe limb contractures in comparison to neuropathic disorders. Although the evidence supporting the efficacy of multiple interventions to improve ROM in NMD in a sustained manner is lacking, there are generally accepted principles with regard to splinting, bracing, stretching, and surgery that help minimize the impact or disability from the contractures. PMID:22938881

An Integrative Review of Factors Associated with Patient Attrition from Community Health Worker Programs that Support Diabetes Self-Care.

PubMed

Merius, Heidy N; Rohan, Annie J

2017-01-01

An integrative review was conducted using PubMed and CINAHL databases to answer: What is known about adult attrition from community health worker (CHW) programs on diabetes self-care? The 14 articles described patients of multiple races who were mainly of lower socioeconomic status. CHW interventions were given in individual meetings and/or group sessions. Incentives to reduce attrition came in different forms. Barriers involved transportation, family obligations, and scheduling conflicts. Attrition from these programs is a multifactorial problem. Alleviating transportation barrier appears to be protective. Program planners should consider these barriers when planning CHW programs.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Comparative Effectiveness of Published Interventions for Elderly Fall Prevention: A Systematic Review and Network Meta-Analysis.

PubMed

Cheng, Peixia; Tan, Liheng; Ning, Peishan; Li, Li; Gao, Yuyan; Wu, Yue; Schwebel, David C; Chu, Haitao; Yin, Huaiqiong; Hu, Guoqing

2018-03-12

Falls are a major threat to older adults worldwide. Although various effective interventions have been developed, their comparative effectiveness remains unreported. A systematic review and network meta-analysis was conducted to determine the most effective interventions to prevent falls in community-dwelling adults aged 60 and over. Combined odds ratio (OR) and 95% credible interval (95% CrI) were calculated. A total of 49 trials involving 27,740 participants and 9271 fallers were included. Compared to usual care, multifactorial interventions (MFI) demonstrated the greatest efficacy (OR: 0.64, 95% CrI: 0.53 to 0.77) followed by interventions combining education and exercise (EDU + EXC) (OR: 0.65, 95% CrI: 0.38 to 1.00) and interventions combining exercise and hazard assessment and modification (EXC + HAM) (OR: 0.66, 95% CrI: 0.40 to 1.04). The effect of medical care performed the worst (OR: 1.02, 95% CrI: 0.78 to 1.34). Model fit was good, inconsistency was low, and publication bias was considered absent. The overall quality of included trials was high. The pooled odds ratios and ranking probabilities remained relatively stable across all sensitivity analyses. MFI and exercise appear to be effective to reduce falls among older adults, and should be considered first as service delivery options. Further investigation is necessary to verify effectiveness and suitableness of the strategies to at-risk populations.

Some design issues of strata-matched non-randomized studies with survival outcomes.

PubMed

Mazumdar, Madhu; Tu, Donsheng; Zhou, Xi Kathy

2006-12-15

Non-randomized studies for the evaluation of a medical intervention are useful for quantitative hypothesis generation before the initiation of a randomized trial and also when randomized clinical trials are difficult to conduct. A strata-matched non-randomized design is often utilized where subjects treated by a test intervention are matched to a fixed number of subjects treated by a standard intervention within covariate based strata. In this paper, we consider the issue of sample size calculation for this design. Based on the asymptotic formula for the power of a stratified log-rank test, we derive a formula to calculate the minimum number of subjects in the test intervention group that is required to detect a given relative risk between the test and standard interventions. When this minimum number of subjects in the test intervention group is available, an equation is also derived to find the multiple that determines the number of subjects in the standard intervention group within each stratum. The methodology developed is applied to two illustrative examples in gastric cancer and sarcoma.

Current Perspectives on Physical Activity and Exercise Recommendations for Children and Adolescents With Autism Spectrum Disorders

PubMed Central

Srinivasan, Sudha M.; Pescatello, Linda S.

2014-01-01

Recent evidence suggests that childhood obesity is increasing in children who are developing typically as well as in children with developmental disabilities such as autism spectrum disorders (ASDs). Impairments specific to autism as well as general environmental factors could lead to an imbalance between the intake and expenditure of energy, leading to obesity. In this article, we describe the mechanisms by which autism-specific impairments contribute to obesity. The evidence on exercise interventions to improve physical fitness, address obesity, and reduce autism-specific impairments in children and adolescents with ASDs is discussed. Limited evidence is currently available for exercise interventions in individuals with ASDs. Therefore, literature on other pediatric developmental disabilities and children who are developing typically was reviewed to provide recommendations for clinicians to assess physical activity levels, to promote physical fitness, and to reduce obesity in children and adolescents with ASDs. There is a clear need for further systematic research to develop sensitive assessment tools and holistic multisystem and multifactorial obesity interventions that accommodate the social communication, motor, and behavioral impairments of individuals with ASDs. PMID:24525861

A framework for learning about improvement: embedded implementation and evaluation design to optimize learning

PubMed Central

Barry, Danika; Kimble, Leighann E; Nambiar, Bejoy; Parry, Gareth; Jha, Ashish; Chattu, Vijay Kumar; Massoud, M Rashad; Goldmann, Don

2018-01-01

Abstract Improving health care involves many actors, often working in complex adaptive systems. Interventions tend to be multi-factorial, implementation activities diverse, and contexts dynamic and complicated. This makes improvement initiatives challenging to describe and evaluate as matching evaluation and program designs can be difficult, requiring collaboration, trust and transparency. Collaboration is required to address important epidemiological principles of bias and confounding. If this does not take place, results may lack credibility because the association between interventions implemented and outcomes achieved is obscure and attribution uncertain. Moreover, lack of clarity about what was implemented, how it was implemented, and the context in which it was implemented often lead to disappointment or outright failure of spread and scale-up efforts. The input of skilled evaluators into the design and conduct of improvement initiatives can be helpful in mitigating these potential problems. While evaluation must be rigorous, if it is too rigid necessary adaptation and learning may be compromised. This article provides a framework and guidance on how improvers and evaluators can work together to design, implement and learn about improvement interventions more effectively. PMID:29873794

Multifactorial discrimination as a fundamental cause of mental health inequities.

PubMed

Khan, Mariam; Ilcisin, Misja; Saxton, Katherine

2017-03-04

The theory of fundamental causes explains why health disparities persist over time, even as risk factors, mechanisms, and diseases change. Using an intersectional framework, we evaluated multifactorial discrimination as a fundamental cause of mental health disparities. Using baseline data from the Project STRIDE: Stress, Identity, and Mental Health study, we examined the health effects of discrimination among individuals who self-identified as lesbian, gay, or bisexual. We used logistic and linear regression to assess whether multifactorial discrimination met the four criteria designating a fundamental cause, namely that the cause: 1) influences multiple health outcomes, 2) affects multiple risk factors, 3) involves access to resources that can be leveraged to reduce consequences of disease, and 4) reproduces itself in varied contexts through changing mechanisms. Multifactorial discrimination predicted high depression scores, psychological well-being, and substance use disorder diagnosis. Discrimination was positively associated with risk factors for high depression scores: chronic strain and total number of stressful life events. Discrimination was associated with significantly lower levels of mastery and self-esteem, protective factors for depressive symptomatology. Even after controlling for risk factors, discrimination remained a significant predictor for high depression scores. Among subjects with low depression scores, multifactorial discrimination also predicted anxiety and aggregate mental health scores. Multifactorial discrimination should be considered a fundamental cause of mental health inequities and may be an important cause of broad health disparities among populations with intersecting social identities.

Effects of a lifestyle programme on ambulatory blood pressure and drug dosage in treated hypertensive patients: a randomized controlled trial.

PubMed

Burke, Valerie; Beilin, Lawrie J; Cutt, Hayley E; Mansour, Jacqueline; Wilson, Amy; Mori, Trevor A

2005-06-01

To assess effects of multifactorial lifestyle modification on antihypertensive drug needs in treated hypertensive individuals. Randomized controlled trial. Research studies unit. Overweight hypertensive patients, receiving one or two antihypertensive drugs, were recruited by advertising, and allocated randomly to a usual care group (controls; n = 118) or a lifestyle modification group (programme group; n = 123). A 4-month programme of weight loss, a low-sodium 'Dietary Approaches to Stop Hypertension'-type diet with added fish, physical activity and moderation of alcohol intake. After 4 months, if mean 24-h ambulatory blood pressure (ABP) was less than 135/85 mmHg, antihypertensive drugs were withdrawn over 4 weeks and long-term home blood pressure monitoring was begun. Antihypertensive drug requirements, ABP, weight, waist girth at 4 months and 1-year follow-up. Ninety control group and 102 programme group participants completed the study. Mean 24-h ABP changed after 4 months by -1.0/-0.3 +/- 0.5/0.4 mmHg in controls and -4.1/-2.1 +/- 0.7/0.5 mmHg with the lifestyle programme (P < 0.01). At follow-up, changes in the two groups were not significantly different (4.1/1.3 +/- 1.1/1.0 mmHg in controls; 2.5/-0.1 +/- 1.1/0.8 mmHg in the programme group; P = 0.73). At 4 months, drug withdrawal differed significantly between the groups (P = 0.038) in men (control 44%; programme 66%) but not in women (65 and 64%, respectively; P = 0.964). At follow-up, sex-related differences were not significant, and 41% in the control group and 43% in the programme group maintained drug-withdrawal status. With the programme, net weight loss was 3.3 kg (P < 0.001) at 4 months and 3.0 kg (P < 0.001) at follow-up; respective net decreases in waist girth were 3.3 cm (P < 0.001) and 3.5 cm (P < 0.001). A 4-month multifactorial lifestyle modification in patients with treated hypertension reduced blood pressure in the short-term. Decreased central obesity persisted 1 year later and could reduce overall cardiovascular risk.

Rationale and design of a multicenter randomized controlled study to evaluate the preventive effect of ipragliflozin on carotid atherosclerosis: the PROTECT study.

PubMed

Tanaka, Atsushi; Murohara, Toyoaki; Taguchi, Isao; Eguchi, Kazuo; Suzuki, Makoto; Kitakaze, Masafumi; Sato, Yasunori; Ishizu, Tomoko; Higashi, Yukihito; Yamada, Hirotsugu; Nanasato, Mamoru; Shimabukuro, Michio; Teragawa, Hiroki; Ueda, Shinichiro; Kodera, Satoshi; Matsuhisa, Munehide; Kadokami, Toshiaki; Kario, Kazuomi; Nishio, Yoshihiko; Inoue, Teruo; Maemura, Koji; Oyama, Jun-Ichi; Ohishi, Mitsuru; Sata, Masataka; Tomiyama, Hirofumi; Node, Koichi

2016-09-13

Type 2 diabetes mellitus is associated strongly with an increased risk of micro- and macro-vascular complications, leading to impaired quality of life and shortened life expectancy. In addition to appropriate glycemic control, multi-factorial intervention for a wide range of risk factors, such as hypertension and dyslipidemia, is crucial for management of diabetes. A recent cardiovascular outcome trial in diabetes patients with higher cardiovascular risk demonstrated that a SGLT2 inhibitor markedly reduced mortality, but not macro-vascular events. However, to date there is no clinical evidence regarding the therapeutic effects of SGLT2 inhibitors on arteriosclerosis. The ongoing PROTECT trial was designed to assess whether the SGLT2 inhibitors, ipragliflozin, prevented progression of carotid intima-media thickness in Japanese patients with type 2 diabetes mellitus. A total of 480 participants with type 2 diabetes mellitus with a HbA1c between 6 and 10 % despite receiving diet/exercise therapy and/or standard anti-diabetic agents for at least 3 months, will be randomized systematically (1:1) into either ipragliflozin or control (continuation of conventional therapy) groups. After randomization, ipragliflozin (50-100 mg once daily) will be added on to the background therapy in participants assigned to the ipragliflozin group. The primary endpoint of the study is the change in mean intima-media thickness of the common carotid artery from baseline to 24 months. Images of carotid intima-media thickness will be analyzed at a central core laboratory in a blinded manner. The key secondary endpoints include the change from baseline in other parameters of carotid intima-media thickness, various metabolic parameters, and renal function. Other cardiovascular functional tests are also planned for several sub-studies. The PROTECT study is the first to assess the preventive effect of ipragliflozin on progression of carotid atherosclerosis using carotid intima-media thickness as a surrogate marker. The study has potential to clarify the protective effects of ipragliflozin on atherosclerosis. Trial registration Unique Trial Number, JPRN/UMIN000018440 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021348 ).

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.…

The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

ERIC Educational Resources Information Center

Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

2015-01-01

This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

ERIC Educational Resources Information Center

Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

2016-01-01

Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

ERIC Educational Resources Information Center

Schroder, Kerstin E. E.

2011-01-01

Objectives: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. Methods: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CADG). Dependent variables were…

Effectiveness of postoperative physical therapy for upper-limb impairments after breast cancer treatment: a systematic review.

PubMed

De Groef, An; Van Kampen, Marijke; Dieltjens, Evi; Christiaens, Marie-Rose; Neven, Patrick; Geraerts, Inge; Devoogdt, Nele

2015-06-01

To systematically review the effectiveness of various postoperative physical therapy modalities and timing of physical therapy after treatment of breast cancer on pain and impaired range of motion (ROM) of the upper limb. We searched the following databases: PubMed/MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, Physiotherapy Evidence Database, and Cochrane. Articles published until October 2012 were included. Only (pseudo) randomized controlled trials and nonrandomized experimental trials investigating the effectiveness of passive mobilization, manual stretching, myofascial therapy, and/or exercise therapy and timing of physical therapy after treatment for breast cancer are reviewed. Primary outcomes are pain of the upper limb and/or ROM of the shoulder. Secondary outcomes are decreased shoulder strength, arm lymphedema, limitations in activities of daily living, decreased quality of life, and wound drainage volume. Physical therapy modalities had to be started in the first 6 weeks after surgery. Articles were selected by 2 independent researchers in 3 phases and compared for consensus. First the titles were analyzed, and then the selected abstracts and finally the full texts were reviewed. Eighteen randomized controlled trials were included in the review. Three studies investigated the effect of multifactorial therapy: 2 studies confirmed that the combination of general exercises and stretching is effective for the treatment of impaired ROM another study showed that passive mobilization combined with massage had no beneficial effects on pain and impaired ROM. Fifteen studies investigated the effectiveness of a single physical therapy modality. One study of poor quality found evidence supporting the beneficial effects of passive mobilization. The only study investigating the effect of stretching did not find any beneficial effects. No studies were found about the effectiveness of myofascial therapy in the postoperative phase. Five studies found that active exercises were more effective than no therapy or information on the treatment of impairments of the upper limb. Three studies supported the early start of exercises for recovery of shoulder ROM, whereas 4 studies supported the delay of exercises to avoid prolonged wound healing. Multifactorial physical therapy (ie, stretching, exercises) and active exercises were effective to treat postoperative pain and impaired ROM after treatment for breast cancer. High-quality studies are necessary to determine the effectiveness of passive mobilization, stretching, and myofascial therapy as part of the multifactorial treatment. In addition, the appropriate timing and content of the exercise programs need to be further investigated. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Falls in elderly people: a multifactorial analysis of risk markers using data from the Swedish general population study 'Good ageing in Skåne'.

PubMed

Stenhagen, Magnus; Nordell, Eva; Elmståhl, Sölve

2013-04-01

The aim of this study was to describe the prevalence of falls in a general older population, especially among the most elderly, and the risk markers associated with falls. This is a cross-sectional study in which 38 fall risk markers were analysed in non-, occasional- and frequent-fallers. The population was 2,865 individuals (aged 60-93), randomly selected from the general population register. The risk of falling was calculated as age-adjusted odds ratios. The relation between the number of risk markers for an individual and falls was also analysed. About one in ten reported falling during the past 6 months, 35% of which were over 90 years old. Twenty-one risk markers were significantly related to falls confirming falling as a multifactorial problem. These included a variety of diseases, symptoms, medical and physical functions, life-style factors and the taking of certain drugs. The five risk markers with the highest odds ratio in frequent fallers were 'tendency to fall' (37.9), 'low walking speed' (12.8), consumption of 'neuroleptics' (10.9), 'impaired mobility' (10.0) and 'dementia' (5.4). Subjects with more than four and seven risk markers showed a 9- respectively 28-fold increase in the risk of falling, especially among frequent fallers and those aged over 90 years. Falls are common in the elderly population and the risk is multifactorial. The results imply that there is an overrepresentation of fallers in a distinct subgroup of the very elderly and those with multiple risk markers. The self-perceived clinical sign 'tendency to fall' seems highly sensitive as indicator of individuals at risk. Several risk markers may be treatable. Fall risk seems to increase in a non-linear, almost exponential way with increasing number of risk markers.

Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

ERIC Educational Resources Information Center

Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

2012-01-01

Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

Randomized controlled trial of a web-based indoor tanning intervention: Acceptability and preliminary outcomes.

PubMed

Stapleton, Jerod L; Manne, Sharon L; Darabos, Katie; Greene, Kathryn; Ray, Anne E; Turner, Amber L; Coups, Elliot J

2015-12-01

This article describes the acceptability and preliminary behavioral outcomes of a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning users' perceptions of the benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre- and postintervention assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants' evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6 weeks postintervention. Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared with control participants on the postintervention assessment. No differences were found for sunburns. The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Universal etiology, multifactorial diseases and the constitutive model of disease classification.

PubMed

Fuller, Jonathan

2018-02-01

Infectious diseases are often said to have a universal etiology, while chronic and noncommunicable diseases are said to be multifactorial in their etiology. It has been argued that the universal etiology of an infectious disease results from its classification using a monocausal disease model. In this article, I will reconstruct the monocausal model and argue that modern 'multifactorial diseases' are not monocausal by definition. 'Multifactorial diseases' are instead defined according to a constitutive disease model. On closer analysis, infectious diseases are also defined using the constitutive model rather than the monocausal model. As a result, our classification models alone cannot explain why infectious diseases have a universal etiology while chronic and noncommunicable diseases lack one. The explanation is instead provided by the Nineteenth Century germ theorists. Copyright © 2017 Elsevier Ltd. All rights reserved.

Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

ERIC Educational Resources Information Center

Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

2012-01-01

The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

Family history in primary care: understanding GPs' resistance to clinical genetics--qualitative study.

PubMed

Mathers, Jonathan; Greenfield, Sheila; Metcalfe, Alison; Cole, Trevor; Flanagan, Sarah; Wilson, Sue

2010-05-01

National and local evaluations of clinical genetics service pilots have experienced difficulty in engaging with GPs. To understand GPs' reluctance to engage with clinical genetics service developments, via an examination of the role of family history in general practice. Qualitative study using semi-structured one-to-one interviews. The West Midlands, UK. Interviews with 21 GPs working in 15 practices, based on a stratified random sample from the Midlands Research Practices Consortium database. Thematic analysis proceeded alongside data generation. Framework grids were constructed for comparative analytical questioning. Interpretation was framed by two explanatory models: a knowledge deficit model, and practice and professional identity model. There is a clear distinction between the routine use and function of family history in GPs' clinical decision making, and contrasting conceptualisations of genetics and 'genetic conditions'. Although genetics is clearly a part of current GP practice, with acknowledgement of genetic components to multifactorial disease, this is distinguished from 'genetic conditions' which are seen as rare, complex single-gene disorders. Importantly, family history takes its place within a broader notion of the 'family doctor' that interviewees identified as a key aspect of their role. In contrast, clinical genetics was not identified as a core component of generalist practice. The likely effectiveness of educational policy interventions aimed at GPs that focus solely on knowledge deficit models, is questionable. There is a need to acknowledge how appropriate practice is constructed by GPs, within the context of accepted generalist roles and related identities.

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

Lifestyle genomics and the metabolic syndrome: A review of genetic variants that influence response to diet and exercise interventions.

PubMed

Fenwick, Peri H; Jeejeebhoy, Khursheed; Dhaliwal, Rupinder; Royall, Dawna; Brauer, Paula; Tremblay, Angelo; Klein, Doug; Mutch, David M

2018-02-05

Metabolic syndrome (MetS) comprises a cluster of risk factors that includes central obesity, dyslipidemia, impaired glucose homeostasis and hypertension. Individuals with MetS have elevated risk of type 2 diabetes and cardiovascular disease; thus placing significant burdens on social and healthcare systems. Lifestyle interventions (comprised of diet, exercise or a combination of both) are routinely recommended as the first line of treatment for MetS. Only a proportion of people respond, and it has been assumed that psychological and social aspects primarily account for these differences. However, the etiology of MetS is multifactorial and stems, in part, on a person's genetic make-up. Numerous single nucleotide polymorphisms (SNPs) are associated with the various components of MetS, and several of these SNPs have been shown to modify a person's response to lifestyle interventions. Consequently, genetic variants can influence the extent to which a person responds to changes in diet and/or exercise. The goal of this review is to highlight SNPs reported to influence the magnitude of change in body weight, dyslipidemia, glucose homeostasis and blood pressure during lifestyle interventions aimed at improving MetS components. Knowledge regarding these genetic variants and their ability to modulate a person's response will provide additional context for improving the effectiveness of personalized lifestyle interventions that aim to reduce the risks associated with MetS.

Falls amongst older people in Southeast Asia: a scoping review.

PubMed

Romli, M H; Tan, M P; Mackenzie, L; Lovarini, M; Suttanon, P; Clemson, L

2017-04-01

The older population in the Southeast Asian region is accelerating and is expected to surpass the proportion of the ageing population in North America and Europe in the future. This study aims to identify the research literature related to falls among older people in Southeast Asia, to examine current practice and discuss the future direction on falls prevention and interventions in the region. A scoping review design was used. A systematic literature search was conducted using the Medline, CINAHL, AMED, Ageline, PsycINFO, Web of Sciences, Scopus, Thai-Journal Citation Index, MyCite and trial registries databases. Thirty-seven studies and six study protocols were included, from Thailand, Malaysia, Singapore, Vietnam, Indonesia and the Philippines. One-sixth of the studies involved interventions, while the remainder were observational studies. The observational studies mainly determined the falls risk factors. The intervention studies comprised multifactorial interventions and single interventions such as exercises, educational materials and visual correction. Many of the studies replicated international studies and may not have taken into account features unique to Southeast Asia. Our review has revealed studies evaluating falls and management of falls in the Southeast Asian context. More research is required from all Southeast Asian countries to prepare for the future challenges of managing falls as the population ages. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

PubMed Central

2014-01-01

Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed wrist interventions has been studied in only 4 randomized studies compared to 50 randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy. PMID:25059881

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Multiplex Biomarker Approaches in Type 2 Diabetes Mellitus Research.

PubMed

Ozanne, Susan E; Rahmoune, Hassan; Guest, Paul C

2017-01-01

Type 2 diabetes mellitus is a multifactorial condition resulting in high fasting blood glucose levels. Although its diagnosis is straightforward, there is not one set of biomarkers or drug targets that can be used for classification or personalized treatment of individuals who suffer from this condition. Instead, the application of multiplex methods incorporating a systems biology approach is essential in order to increase our understanding of this disease. This chapter reviews the state of the art in biomarker studies of human type 2 diabetes from a proteomic and metabolomic perspective. Our main focus was on biomarkers for disease prediction as these could lead to early intervention strategies for the best possible patient outcomes.

Clinical and Community Strategies to Prevent Falls and Fall-Related Injuries Among Community-Dwelling Older Adults.

PubMed

Taylor-Piliae, Ruth E; Peterson, Rachel; Mohler, Martha Jane

2017-09-01

Falls in older adults are the result of several risk factors across biological and behavioral aspects of the person, along with environmental factors. Falls can trigger a downward spiral in activities of daily living, independence, and overall health outcomes. Clinicians who care for older adults should screen them annually for falls. A multifactorial comprehensive clinical fall assessment coupled with tailored interventions can result in a dramatic public health impact, while improving older adult quality of life. For community-dwelling older adults, effective fall prevention has the potential to reduce serious fall-related injuries, emergency room visits, hospitalizations, institutionalization, and functional decline. Copyright © 2017 Elsevier Inc. All rights reserved.

[The nature, diagnosis and treatment of post-concussion syndrome].

PubMed

Muñoz-Céspedes, J M; Pelegrín-Valero, C; Tirapu-Ustarroz, J; Fernández-Guinea, S

1998-11-01

The relationship between brief loss of consciousness, subsequent cognitive and emotional complaints, and impact on daily functioning continues to be hotly debated. In this paper the strong variability about prevalence of the postconcussional syndrome found in several studies is outstanding and the main issues of this disagreement are suggested. Recent neuroimaging techniques are discussed and some neuropsychological measures are suggested. Currents models (organic/psychogenic) of postconcussional symptoms are reviewed, and a multifactorial model which integrates biological factors with the relevance of neuropsychological deficits--attention, memory, speed of information processing--and coping process is proposed. Finally, according with this model, we conclude with some suggestions to improve neuropsychological intervention and medical treatment of these patients.

Comparative Effectiveness of Published Interventions for Elderly Fall Prevention: A Systematic Review and Network Meta-Analysis

PubMed Central

Cheng, Peixia; Tan, Liheng; Ning, Peishan; Li, Li; Gao, Yuyan; Chu, Haitao; Yin, Huaiqiong

2018-01-01

Background: Falls are a major threat to older adults worldwide. Although various effective interventions have been developed, their comparative effectiveness remains unreported. Methods: A systematic review and network meta-analysis was conducted to determine the most effective interventions to prevent falls in community-dwelling adults aged 60 and over. Combined odds ratio (OR) and 95% credible interval (95% CrI) were calculated. Results: A total of 49 trials involving 27,740 participants and 9271 fallers were included. Compared to usual care, multifactorial interventions (MFI) demonstrated the greatest efficacy (OR: 0.64, 95% CrI: 0.53 to 0.77) followed by interventions combining education and exercise (EDU + EXC) (OR: 0.65, 95% CrI: 0.38 to 1.00) and interventions combining exercise and hazard assessment and modification (EXC + HAM) (OR: 0.66, 95% CrI: 0.40 to 1.04). The effect of medical care performed the worst (OR: 1.02, 95% CrI: 0.78 to 1.34). Model fit was good, inconsistency was low, and publication bias was considered absent. The overall quality of included trials was high. The pooled odds ratios and ranking probabilities remained relatively stable across all sensitivity analyses. Conclusions: MFI and exercise appear to be effective to reduce falls among older adults, and should be considered first as service delivery options. Further investigation is necessary to verify effectiveness and suitableness of the strategies to at-risk populations. PMID:29534531

Electronic and postal reminders for improving immunisation coverage in children: protocol for a systematic review and meta-analysis.

PubMed

Chachou, Martel J; Mukinda, Fidele K; Motaze, Villyen; Wiysonge, Charles S

2015-10-15

Worldwide, suboptimal immunisation coverage causes the deaths of more than one million children under five from vaccine-preventable diseases every year. Reasons for suboptimal coverage are multifactorial, and a combination of interventions is needed to improve compliance with immunisation schedules. One intervention relies on reminders, where the health system prompts caregivers to attend immunisation appointments on time or re-engages caregivers who have defaulted on scheduled appointments. We undertake this systematic review to investigate the potential of reminders using emails, phone calls, social media, letters or postcards to improve immunisation coverage in children under five. We will search for published and unpublished randomised controlled trials and non-randomised controlled trials in PubMed, Scopus, CINAHL, CENTRAL, Science Citation Index, WHOLIS, Clinicaltrials.gov and the WHO International Clinical Trials Platform. We will conduct screening of search results, study selection, data extraction and risk-of-bias assessment in duplicate, resolving disagreements by consensus. In addition, we will pool data from clinically homogeneous studies using random-effects meta-analysis; assess heterogeneity of effects using the χ(2) test of homogeneity; and quantify any observed heterogeneity using the I(2) statistic. This protocol does not need approval by an ethics committee because we will use publicly available data, without directly involving human participants. The results will provide updated evidence on the effects of electronic and postal reminders on immunisation coverage, and we will discuss the applicability of the findings to low and middle-income countries. We plan to disseminate review findings through publication in a peer-reviewed journal and presentation at relevant conferences. In addition, we will prepare a policymaker-friendly summary using a validated format (eg, SUPPORT Summary) and disseminate this through social media and email discussion groups. PROSPERO registration number CRD42014012888. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Comparison of energy expenditure, body composition, metabolic disorders, and energy intake between obese children with a history of craniopharyngioma and children with multifactorial obesity.

PubMed

Bomer, Ilanit; Saure, Carola; Caminiti, Carolina; Ramos, Javier Gonzales; Zuccaro, Graciela; Brea, Mercedes; Bravo, Mónica; Maza, Carmen

2015-11-01

Craniopharyngioma is a histologically benign brain malformation with a fundamental role in satiety modulation, causing obesity in up to 52% of patients. To evaluate cardiovascular risk factors, body composition, resting energy expenditure (REE), and energy intake in craniopharyngioma patients and to compare the data with those from children with multifactorial obesity. All obese children and adolescents who underwent craniopharyngioma resection and a control group of children with multifactorial obesity in follow-up between May 2012 and April 2013. Anthropometric measurements, bioelectrical impedance, indirect calorimetry, energy intake, homeostatic model assessment insulin resistance (HOMA-IR), and dyslipidemia were evaluated. Twenty-three patients with craniopharyngioma and 43 controls were included. Children with craniopharyngioma-related obesity had a lower fat-free mass percentage (62.4 vs. 67.5; p=0.01) and a higher fat mass percentage (37.5 vs. 32.5; p=0.01) compared to those with multifactorial obesity. A positive association was found between %REE and %fat-free mass in subjects with multifactorial obesity (68±1% in normal REE vs. 62.6±1% in low REE; p=0.04), but not in craniopharyngioma patients (62±2.7 in normal REE vs. 61.2±1.8% in low REE; p=0.8). No differences were found in metabolic involvement or energy intake. REE was lower in craniopharyngioma patients compared to children with multifactorial obesity regardless of the amount of fat-free mass, suggesting that other factors may be responsible for the lower REE.

Evaluating an Organizational-Level Occupational Health Intervention in a Combined Regression Discontinuity and Randomized Control Design.

PubMed

Sørensen, By Ole H

2016-10-01

Organizational-level occupational health interventions have great potential to improve employees' health and well-being. However, they often compare unfavourably to individual-level interventions. This calls for improving methods for designing, implementing and evaluating organizational interventions. This paper presents and discusses the regression discontinuity design because, like the randomized control trial, it is a strong summative experimental design, but it typically fits organizational-level interventions better. The paper explores advantages and disadvantages of a regression discontinuity design with an embedded randomized control trial. It provides an example from an intervention study focusing on reducing sickness absence in 196 preschools. The paper demonstrates that such a design fits the organizational context, because it allows management to focus on organizations or workgroups with the most salient problems. In addition, organizations may accept an embedded randomized design because the organizations or groups with most salient needs receive obligatory treatment as part of the regression discontinuity design. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Risk Assessment and Communication Tools for Genotype Associations with Multifactorial Phenotypes: The Concept of “Edge Effect” and Cultivating an Ethical Bridge between Omics Innovations and Society

PubMed Central

Suarez-Kurtz, Guilherme; Stenne, Raphaëlle; Somogyi, Andrew A.; Someya, Toshiyuki; Kayaalp, S. Oğuz; Kolker, Eugene

2009-01-01

Abstract Applications of omics technologies in the postgenomics era swiftly expanded from rare monogenic disorders to multifactorial common complex diseases, pharmacogenomics, and personalized medicine. Already, there are signposts indicative of further omics technology investment in nutritional sciences (nutrigenomics), environmental health/ecology (ecogenomics), and agriculture (agrigenomics). Genotype–phenotype association studies are a centerpiece of translational research in omics science. Yet scientific and ethical standards and ways to assess and communicate risk information obtained from association studies have been neglected to date. This is a significant gap because association studies decisively influence which genetic loci become genetic tests in the clinic or products in the genetic test marketplace. A growing challenge concerns the interpretation of large overlap typically observed in distribution of quantitative traits in a genetic association study with a polygenic/multifactorial phenotype. To remedy the shortage of risk assessment and communication tools for association studies, this paper presents the concept of edge effect. That is, the shift in population edges of a multifactorial quantitative phenotype is a more sensitive measure (than population averages) to gauge the population level impact and by extension, policy significance of an omics marker. Empirical application of the edge effect concept is illustrated using an original analysis of warfarin pharmacogenomics and the VKORC1 genetic variation in a Brazilian population sample. These edge effect analyses are examined in relation to regulatory guidance development for association studies. We explain that omics science transcends the conventional laboratory bench space and includes a highly heterogeneous cast of stakeholders in society who have a plurality of interests that are often in conflict. Hence, communication of risk information in diagnostic medicine also demands attention to processes involved in production of knowledge and human values embedded in scientific practice, for example, why, how, by whom, and to what ends association studies are conducted, and standards are developed (or not). To ensure sustainability of omics innovations and forecast their trajectory, we need interventions to bridge the gap between omics laboratory and society. Appreciation of scholarship in history of omics science is one remedy to responsibly learn from the past to ensure a sustainable future in omics fields, both emerging (nutrigenomics, ecogenomics), and those that are more established (pharmacogenomics). Another measure to build public trust and sustainability of omics fields could be legislative initiatives to create a multidisciplinary oversight body, at arm's length from conflict of interests, to carry out independent, impartial, and transparent innovation analyses and prospective technology assessment. PMID:19290811

Risk assessment and communication tools for genotype associations with multifactorial phenotypes: the concept of "edge effect" and cultivating an ethical bridge between omics innovations and society.

PubMed

Ozdemir, Vural; Suarez-Kurtz, Guilherme; Stenne, Raphaëlle; Somogyi, Andrew A; Someya, Toshiyuki; Kayaalp, S Oğuz; Kolker, Eugene

2009-02-01

Applications of omics technologies in the postgenomics era swiftly expanded from rare monogenic disorders to multifactorial common complex diseases, pharmacogenomics, and personalized medicine. Already, there are signposts indicative of further omics technology investment in nutritional sciences (nutrigenomics), environmental health/ecology (ecogenomics), and agriculture (agrigenomics). Genotype-phenotype association studies are a centerpiece of translational research in omics science. Yet scientific and ethical standards and ways to assess and communicate risk information obtained from association studies have been neglected to date. This is a significant gap because association studies decisively influence which genetic loci become genetic tests in the clinic or products in the genetic test marketplace. A growing challenge concerns the interpretation of large overlap typically observed in distribution of quantitative traits in a genetic association study with a polygenic/multifactorial phenotype. To remedy the shortage of risk assessment and communication tools for association studies, this paper presents the concept of edge effect. That is, the shift in population edges of a multifactorial quantitative phenotype is a more sensitive measure (than population averages) to gauge the population level impact and by extension, policy significance of an omics marker. Empirical application of the edge effect concept is illustrated using an original analysis of warfarin pharmacogenomics and the VKORC1 genetic variation in a Brazilian population sample. These edge effect analyses are examined in relation to regulatory guidance development for association studies. We explain that omics science transcends the conventional laboratory bench space and includes a highly heterogeneous cast of stakeholders in society who have a plurality of interests that are often in conflict. Hence, communication of risk information in diagnostic medicine also demands attention to processes involved in production of knowledge and human values embedded in scientific practice, for example, why, how, by whom, and to what ends association studies are conducted, and standards are developed (or not). To ensure sustainability of omics innovations and forecast their trajectory, we need interventions to bridge the gap between omics laboratory and society. Appreciation of scholarship in history of omics science is one remedy to responsibly learn from the past to ensure a sustainable future in omics fields, both emerging (nutrigenomics, ecogenomics), and those that are more established (pharmacogenomics). Another measure to build public trust and sustainability of omics fields could be legislative initiatives to create a multidisciplinary oversight body, at arm's length from conflict of interests, to carry out independent, impartial, and transparent innovation analyses and prospective technology assessment.

The efficacy of a multifactorial memory training in older adults living in residential care settings.

PubMed

Vranić, Andrea; Španić, Ana Marija; Carretti, Barbara; Borella, Erika

2013-11-01

Several studies have shown an increase in memory performance after teaching mnemonic techniques to older participants. However, transfer effects to non-trained tasks are generally either very small, or not found. The present study investigates the efficacy of a multifactorial memory training program for older adults living in a residential care center. The program combines teaching of memory strategies with activities based on metacognitive (metamemory) and motivational aspects. Specific training-related gains in the Immediate list recall task (criterion task), as well as transfer effects on measures of short-term memory, long-term memory, working memory, motivational (need for cognition), and metacognitive aspects (subjective measure of one's memory) were examined. Maintenance of training benefits was assessed after seven months. Fifty-one older adults living in a residential care center, with no cognitive impairments, participated in the study. Participants were randomly assigned to two programs: the experimental group attended the training program, while the active control group was involved in a program in which different psychological issues were discussed. A benefit in the criterion task and substantial general transfer effects were found for the trained group, but not for the active control, and they were maintained at the seven months follow-up. Our results suggest that training procedures, which combine teaching of strategies with metacognitive-motivational aspects, can improve cognitive functioning and attitude toward cognitive activities in older adults.

Management of Dyslipidemia in Patients with Hypertension, Diabetes, and Metabolic Syndrome.

PubMed

Srikanth, Sundararajan; Deedwania, Prakash

2016-10-01

The purpose of this review is to discuss dyslipidemia in the various common clinical conditions including hypertension, diabetes mellitus, and metabolic syndrome and review the current therapeutic strategy in these settings. Dyslipidemias are common in patients with hypertension, diabetes mellitus, and metabolic syndrome. Epidemiologic studies have shown a strong correlation between serum lipid levels and risk of atherosclerotic cardiovascular disease. Multifactorial intervention strategies aimed at controlling lipids, blood pressure, and blood glucose simultaneously achieve maximal reductions in cardiovascular risk. Dyslipidemia and metabolic abnormalities are strongly associated with atherosclerosis and worse cardiovascular outcomes. While pharmacotherapy with statins has been proven to be beneficial for dyslipidemia, lifestyle modification emphasizing weight loss and regular exercise is an essential component of the interventional strategy. The common thread underlying atherosclerosis and metabolic abnormalities is endothelial dysfunction. Improved understanding of the role of endothelium in health and disease can potentially lead to novel therapies that may preempt development of atherosclerosis and its complications.

Why invest, and what it will take to improve breastfeeding practices?

PubMed

Rollins, Nigel C; Bhandari, Nita; Hajeebhoy, Nemat; Horton, Susan; Lutter, Chessa K; Martines, Jose C; Piwoz, Ellen G; Richter, Linda M; Victora, Cesar G

2016-01-30

Despite its established benefits, breastfeeding is no longer a norm in many communities. Multifactorial determinants of breastfeeding need supportive measures at many levels, from legal and policy directives to social attitudes and values, women's work and employment conditions, and health-care services to enable women to breastfeed. When relevant interventions are delivered adequately, breastfeeding practices are responsive and can improve rapidly. The best outcomes are achieved when interventions are implemented concurrently through several channels. The marketing of breastmilk substitutes negatively affects breastfeeding: global sales in 2014 of US$44·8 billion show the industry's large, competitive claim on infant feeding. Not breastfeeding is associated with lower intelligence and economic losses of about $302 billion annually or 0·49% of world gross national income. Breastfeeding provides short-term and long-term health and economic and environmental advantages to children, women, and society. To realise these gains, political support and financial investment are needed to protect, promote, and support breastfeeding. Copyright © 2016 Elsevier Ltd. All rights reserved.

Neighborhood-Level Interventions to Improve Childhood Opportunity and Lift Children Out of Poverty.

PubMed

Sandel, Megan; Faugno, Elena; Mingo, Angela; Cannon, Jessie; Byrd, Kymberly; Garcia, Dolores Acevedo; Collier, Sheena; McClure, Elizabeth; Boynton-Jarrett, Renée

2016-04-01

Population health is associated with the socioeconomic characteristics of neighborhoods. There is considerable scientific and policy interest in community-level interventions to alleviate child poverty. Intergenerational poverty is associated with inequitable access to opportunities. Improving opportunity structures within neighborhoods may contribute to improved child health and development. Neighborhood-level efforts to alleviate poverty for all children require alignment of cross-sector efforts, community engagement, and multifactorial approaches that consider the role of people as well as place. We highlight several accessible tools and strategies that health practitioners can engage to improve regional and local systems that influence child opportunity. The Child Opportunity Index is a population-level surveillance tool to describe community-level resources and inequities in US metropolitan areas. The case studies reviewed outline strategies for creating higher opportunity neighborhoods for pediatricians interested in working across sectors to address the impact of neighborhood opportunity on child health and well-being. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

[Violence against women in the perspective of community health agents].

PubMed

Hesler, Lilian Zielke; da Costa, Marta Cocco; Resta, Darielli Gindri; Colomé, Isabel Cristina dos Santos

2013-03-01

The current study has the objective of learning and understanding how Community Health Agents conceptualize, develop and perform strategies to counter violence against women attending the Family Health Strategies in a northeastern municipality of Rio Grande do Sul. It is an exploratory research, utilizing a descriptive and qualitative approach, carried out with 35 Community Health Agents. Semi-structured interviews were performed to collect the data, which were analyzed using the thematic model. Conceptions of violence against women are centered around violence as a social construction based on gender inequalities and on violence as having a multifactorial construction. Regarding care practices and interventions to counter violence, the following tools are highlighted construction of intervention strategies within the staff forming bonds, listening and dialogue with the women victims of violence; and directing victims to support services. We believe that this study contributes to the visibility of this theme as a need in health care, as well as for the construction of strategies to counter it.

Self-management and psychological-sexological interventions in patients with endometriosis: strategies, outcomes, and integration into clinical care

PubMed Central

Buggio, Laura; Barbara, Giussy; Facchin, Federica; Frattaruolo, Maria Pina; Aimi, Giorgio; Berlanda, Nicola

2017-01-01

Endometriosis has a multifactorial etiology. The onset and progression of the disease are believed to be related to different pathogenic mechanisms. Among them, the environment and lifestyle may play significant roles. Diet, dietary supplements, physical exercise, osteopathy, massage, acupuncture, transcutaneous electrical nerve stimulation, and Chinese herbal medicine may represent a complementary and feasible approach in the treatment of symptoms related to the disease. In this narrative review, we aimed to examine the most updated evidence on these alternative approaches implicated in the self-management of the disease. In addition, several studies have demonstrated that endometriosis may negatively impact mental health and quality of life, suggesting that affected women may have an increased risk of developing psychological suffering as well as sexual problems due to the presence of pain. In light of these findings, we discuss the importance of integrating psychological interventions (including psychotherapy) and sexual therapy in endometriosis treatment. PMID:28496368

A Body Image and Disordered Eating Intervention for Women in Midlife: A Randomized Controlled Trial

ERIC Educational Resources Information Center

McLean, Sian A.; Paxton, Susan J.; Wertheim, Eleanor H.

2011-01-01

Objective: This study examined the outcome of a body image and disordered eating intervention for midlife women. The intervention was specifically designed to address risk factors that are pertinent in midlife. Method: Participants were 61 women aged 30 to 60 years (M = 43.92, SD = 8.22) randomly assigned to intervention (n = 32) or (delayed…

Mechanisms of hypoglycemia unawareness and implications in diabetic patients

PubMed Central

Martín-Timón, Iciar; del Cañizo-Gómez, Francisco Javier

2015-01-01

Hypoglycemia unawareness (HU) is defined at the onset of neuroglycopenia before the appearance of autonomic warning symptoms. It is a major limitation to achieving tight diabetes and reduced quality of life. HU occurs in approximately 40% of people with type 1 diabetes mellitus (T1DM) and with less frequency in T2DM. Though the aetiology of HU is multifactorial, possible mechanisms include chronic exposure to low blood glucose, antecedent hypoglycaemia, recurrent severe hypoglycaemia and the failure of counter-regulatory hormones. Clinically it manifests as the inability to recognise impeding hypoglycaemia by symptoms, but the mechanisms and mediators remain largely unknown. Prevention and management of HU is complex, and can only be achieved by a multifactorial intervention of clinical care and structured patient education by the diabetes team. Less know regarding the impact of medications on the development or recognition of this condition in patients with diabetes. Several medications are thought to worsen or promote HU, whereas others may have an attenuating effect on the problem. This article reviews recent advances in how the brain senses and responds to hypoglycaemia, novel mechanisms by which people with insulin-treated diabetes develop HU and impaired counter-regulatory responses. The consequences that HU has on the person with diabetes and their family are also described. Finally, it examines the evidence for prevention and treatment of HU, and summarizes the effects of medications that may influence it. PMID:26185599

A managed care organization's use of integrated health management to improve secondary prevention of coronary artery disease.

PubMed

Berthiaume, John T; Davis, Jim; Taira, Deborah A; Thein, Ko Ko

2007-03-01

To evaluate the effect of a managed care organization's multifactorial intervention program in optimizing secondary prevention of coronary artery disease (CAD). Retrospective observational analysis of claims-based data of health plan members with CAD receiving 1 or more prescriptions per year of any of the following classes of medications used for secondary prevention of CAD: lipid-lowering agents, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs) and beta-blockers. Claims-based data of members from 2000 to 2004 were analyzed to discover trends in the use of medications for secondary prevention of CAD. chi(2) Test of proportion was used to determine whether the changes in the annual medication use rates were statistically significant. The annual medication use rates improved consistently throughout each year of the study period. From 2000 to 2004, the medication use rates increased for lipid-lowering agents (from 55% to 71%), ACE inhibitors or ARBs (from 44% to 55%), and beta-blockers (from 36% to 47%). Changes in all 3 indicators were statistically significant at P < .001. An integrated multifactorial approach is essential in addressing the underutilization of therapies available for secondary prevention of CAD. Managed care organizations are in a unique position to optimize the use of evidence-based pharmacological and behavioral therapies to effectively prevent and treat the underlying pathophysiology of CAD in member populations.

The Impact of a Multi-Level Multi-Component Childhood Obesity Prevention Intervention on Healthy Food Availability, Sales, and Purchasing in a Low-Income Urban Area.

PubMed

Gittelsohn, Joel; Trude, Angela C; Poirier, Lisa; Ross, Alexandra; Ruggiero, Cara; Schwendler, Teresa; Anderson Steeves, Elizabeth

2017-11-10

The multifactorial causes of obesity require multilevel and multicomponent solutions, but such combined strategies have not been tested to improve the community food environment. We evaluated the impact of a multilevel (operating at different levels of the food environment) multicomponent (interventions occurring at the same level) community intervention. The B'more Healthy Communities for Kids (BHCK) intervention worked at the wholesaler ( n = 3), corner store ( n = 50), carryout ( n = 30), recreation center ( n = 28), household ( n = 365) levels to improve availability, purchasing, and consumption of healthier foods and beverages (low-sugar, low-fat) in low-income food desert predominantly African American zones in the city of Baltimore (MD, USA), ultimately intending to lead to decreased weight gain in children (not reported in this manuscript). For this paper, we focus on more proximal impacts on the food environment, and measure change in stocking, sales and purchase of promoted foods at the different levels of the food system in 14 intervention neighborhoods, as compared to 14 comparison neighborhoods. Sales of promoted products increased in wholesalers. Stocking of these products improved in corner stores, but not in carryouts, and we did not find any change in total sales. Children more exposed to the intervention increased their frequency of purchase of promoted products, although improvement was not seen for adult caregivers. A multilevel food environment intervention in a low-income urban setting improved aspects of the food system, leading to increased healthy food purchasing behavior in children.

The Impact of a Multi-Level Multi-Component Childhood Obesity Prevention Intervention on Healthy Food Availability, Sales, and Purchasing in a Low-Income Urban Area

PubMed Central

Gittelsohn, Joel; Trude, Angela C.; Poirier, Lisa; Ross, Alexandra; Ruggiero, Cara; Schwendler, Teresa; Anderson Steeves, Elizabeth

2017-01-01

The multifactorial causes of obesity require multilevel and multicomponent solutions, but such combined strategies have not been tested to improve the community food environment. We evaluated the impact of a multilevel (operating at different levels of the food environment) multicomponent (interventions occurring at the same level) community intervention. The B’more Healthy Communities for Kids (BHCK) intervention worked at the wholesaler (n = 3), corner store (n = 50), carryout (n = 30), recreation center (n = 28), household (n = 365) levels to improve availability, purchasing, and consumption of healthier foods and beverages (low-sugar, low-fat) in low-income food desert predominantly African American zones in the city of Baltimore (MD, USA), ultimately intending to lead to decreased weight gain in children (not reported in this manuscript). For this paper, we focus on more proximal impacts on the food environment, and measure change in stocking, sales and purchase of promoted foods at the different levels of the food system in 14 intervention neighborhoods, as compared to 14 comparison neighborhoods. Sales of promoted products increased in wholesalers. Stocking of these products improved in corner stores, but not in carryouts, and we did not find any change in total sales. Children more exposed to the intervention increased their frequency of purchase of promoted products, although improvement was not seen for adult caregivers. A multilevel food environment intervention in a low-income urban setting improved aspects of the food system, leading to increased healthy food purchasing behavior in children. PMID:29125558

Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial.

PubMed

Diener, Markus K; Knebel, Phillip; Kieser, Meinhard; Schüler, Philipp; Schiergens, Tobias S; Atanassov, Vladimir; Neudecker, Jens; Stein, Erwin; Thielemann, Henryk; Kunz, Reiner; von Frankenberg, Moritz; Schernikau, Utz; Bunse, Jörg; Jansen-Winkeln, Boris; Partecke, Lars I; Prechtl, Gerald; Pochhammer, Julius; Bouchard, Ralf; Hodina, René; Beckurts, K Tobias E; Leißner, Lothar; Lemmens, Hans-Peter; Kallinowski, Friedrich; Thomusch, Oliver; Seehofer, Daniel; Simon, Thomas; Hyhlik-Dürr, Alexander; Seiler, Christoph M; Hackert, Thilo; Reissfelder, Christoph; Hennig, René; Doerr-Harim, Colette; Klose, Christina; Ulrich, Alexis; Büchler, Markus W

2014-07-12

Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598; OR 0·91, 95% CI 0·66-1·25; p=0·64). Serious adverse events also did not differ between the groups-146 of 583 (25·0%) patients treated with PDS Plus had at least one serious adverse event, compared with 138 of 602 (22·9%) patients treated with PDS II; p=0·39). Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy. Innovative, multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections. Johnson & Johnson Medical Limited. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of a tobacco control intervention for teachers in India: results of the Bihar school teachers study.

PubMed

Sorensen, Glorian; Pednekar, Mangesh S; Sinha, Dhirendra N; Stoddard, Anne M; Nagler, Eve; Aghi, Mira B; Lando, Harry A; Viswanath, Kasisomayajula; Pawar, Pratibha; Gupta, Prakash C

2013-11-01

We assessed a school-based intervention designed to promote tobacco control among teachers in the Indian state of Bihar. We used a cluster-randomized design to test the intervention, which comprised educational efforts, tobacco control policies, and cessation support and was tailored to the local social context. In 2009 to 2011, we randomly selected 72 schools from participating school districts and randomly assigned them in blocks (rural or urban) to intervention or delayed-intervention control conditions. Immediately after the intervention, the 30-day quit rate was 50% in the intervention and 15% in the control group (P = .001). At the 9-month postintervention survey, the adjusted 6-month quit rate was 19% in the intervention and 7% in the control group (P = .06). Among teachers employed for the entire academic year of the intervention, the adjusted 6-month abstinence rates were 20% and 5%, respectively, for the intervention and control groups (P = .04). These findings demonstrate the potent impact of an intervention that took advantage of social resources among teachers, who can serve as role models for tobacco control in their communities.

Prebiotics as a modulator of gut microbiota in paediatric obesity.

PubMed

Nicolucci, A C; Reimer, R A

2017-08-01

This review highlights our current understanding of the role of gut microbiota in paediatric obesity and the potential role for dietary manipulation of the gut microbiota with prebiotics in managing paediatric obesity. The aetiology of obesity is multifactorial and is now known to include microbial dysbiosis in the gut. Prebiotics are non-digestible carbohydrates which selectively modulate the number and/or composition of gut microbes. The goal of prebiotic consumption is to restore symbiosis and thereby confer health benefits to the host. There is convincing evidence that prebiotics can reduce adiposity and improve metabolic health in preclinical rodent models. Furthermore, there are several clinical trials in adult humans highlighting metabolic and appetite-regulating benefits of prebiotics. In paediatric obesity, however, there are very limited data regarding the potential role of prebiotics as a dietary intervention for obesity management. As the prevalence of paediatric obesity and obesity-associated comorbidities increases globally, interventions that target the progression of obesity from an early age are essential in slowing the obesity epidemic. This review emphasizes the need for further research assessing the role of prebiotics, particularly as an intervention in effectively managing paediatric obesity. © 2016 World Obesity Federation.

Overweight and obesity in children and adolescents with Down syndrome-prevalence, determinants, consequences, and interventions: A literature review.

PubMed

Bertapelli, Fabio; Pitetti, Ken; Agiovlasitis, Stamatis; Guerra-Junior, Gil

2016-10-01

Children with Down syndrome (DS) are more likely to be overweight or obese than the general population of youth without DS. To review the prevalence of overweight and obesity and their determinants in youth with DS. The health consequences and the effectiveness of interventions were also examined. A search using MEDLINE, Embase, Web of Science, Scopus, CINAHL, PsycINFO, SPORTDiscus, LILACS, and COCHRANE was conducted. From a total of 4280 studies, we included 45 original research articles published between 1988 and 2015. The combined prevalence of overweight and obesity varied between studies from 23% to 70%. Youth with DS had higher rates of overweight and obesity than youths without DS. Likely determinants of obesity included increased leptin, decreased resting energy expenditure, comorbidities, unfavorable diet, and low physical activity levels. Obesity was positively associated with obstructive sleep apnea, dyslipidemia, hyperinsulinemia, and gait disorder. Interventions for obesity prevention and control were primarily based on exercise-based programs, and were insufficient to achieve weight or fat loss. Population-based research is needed to identify risk factors and support multi-factorial strategies for reducing overweight and obesity in children and adolescents with DS. Copyright © 2016 Elsevier Ltd. All rights reserved.

Analyzing Randomized Controlled Interventions: Three Notes for Applied Linguists

ERIC Educational Resources Information Center

Vanhove, Jan

2015-01-01

I discuss three common practices that obfuscate or invalidate the statistical analysis of randomized controlled interventions in applied linguistics. These are (a) checking whether randomization produced groups that are balanced on a number of possibly relevant covariates, (b) using repeated measures ANOVA to analyze pretest-posttest designs, and…

Social marketing-based communications to integrate and support the HEALTHY study intervention

USDA-ARS?s Scientific Manuscript database

The HEALTHY study was a randomized, controlled, multicenter, middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth gr...

Randomized Study of a Prebirth Coparenting Intervention with Adolescent and Young Fathers

ERIC Educational Resources Information Center

Fagan, Jay

2008-01-01

This randomized study tested the effects of 2 prebirth interventions, Minnesota Early Learning Design coparenting and childbirth curricula, on young African American and Hispanic fathers and their adolescent partners (N = 154). The coparenting intervention (n = 44) was associated with changing fathers' perceptions of their coparenting behavior…

Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

ERIC Educational Resources Information Center

Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L.; Baca, Brandon; Ndayisenga, Martin; Greene, R. Neil; Shantzek, Cece

2017-01-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their…

A PARENT–ADOLESCENT INTERVENTION TO INCREASE SEXUAL RISK COMMUNICATION: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

PubMed Central

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

2009-01-01

This article reports results of a randomized controlled trial designed to test an intervention to increase parent–adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HTV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6– and 12–month follow–ups. Generalized estimation equation (GEE) analysis indicates parents in the HIV risk reduction intervention reported significantly more general communication (p < .005), more sexual risk communication (p < .001) and more comfort with communication (p < .001) than parents in the control intervention. Behavioral, normative, and control beliefs significantly mediated the effect of the intervention on all communication outcomes. This study demonstrates the efficacy of an intervention to increase the quality and quantity of parent–adolescent communication related to general and sex–specific communication. PMID:18956979

Physical Activity Self-Management and Coaching Compared to Social Interaction in Huntington Disease: Results From the ENGAGE-HD Randomized, Controlled Pilot Feasibility Trial

PubMed Central

Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; Rosser, Anne; Hood, Kerenza

2017-01-01

Abstract Background. Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective. This study assessed feasibility and outcomes of a 14-week physical activity self-management and coaching intervention compared with social contact in Huntington disease (HD) to inform the design of a future full-scale trial. Design. Assessor blind, multisite, randomized pilot feasibility trial. Setting. Participants were recruited and assessed at baseline, 16 weeks following randomization, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention. People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements. Eligibility, recruitment, retention, and intervention participation were determined at 16 weeks. Other outcomes of interest included measures of mobility, self-efficacy, physical activity, and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results. Forty percent (n = 46) of eligible patients were enrolled; 22 were randomized to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92%, respectively. Minimum participation criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between-group treatment effects on function; however, increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lend support to our predefined intervention logic model. Limitations. The use of self-report measures may have introduced bias. Conclusions. An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation. PMID:28371942

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.

Does the Use of Multifactorial Training Methods Increase Practitioners' Competence?

ERIC Educational Resources Information Center

Pittman, Corinthus Omari; Lawdis, Katina

2017-01-01

Skilled therapy practitioners are required by their governing associations to seek professional development per licensure requirements. These requirements facilitate clinical reasoning and confidence during patient care. There are limited online professional development workshops, especially ones that offer multifactorial training as an…

Assessing first-stage labor progression and its relationship to complications.

PubMed

Hamilton, Emily F; Warrick, Philip A; Collins, Kathleen; Smith, Samuel; Garite, Thomas J

2016-03-01

New labor curves have challenged the traditional understanding of the general pattern of dilation and descent in labor. They also revealed wide variation in the time to advance in dilation. An interval of arrest such as 4 hours did not fall beyond normal limits until dilation had reached 6 cm. Thus, the American College of Obstetricians and Gynecologists/Society for Maternal-Fetal Medicine first-stage arrest criteria, based in part on these findings, are applicable only in late labor. The wide range of time to dilate is unavoidable because cervical dilation has neither a precise nor direct relationship to time. Newer statistical techniques (multifactorial models) can improve precision by incorporating several factors that are related directly to labor progress. At each examination, the calculations adapt to the mother's current labor conditions. They produce a quantitative assessment that is expressed in percentiles. Low percentiles indicate potentially problematic labor progression. The purpose of this study was to assess the relationship between first-stage labor progress- and labor-related complications with the use of 2 different assessment methods. The first method was based on arrest of dilation definitions. The other method used percentile rankings of dilation or station based on adaptive multifactorial models. We included all 4703 cephalic-presenting, term, singleton births with electronic fetal monitoring and cord gases at 2 academic community referral hospitals in 2012 and 2013. We assessed electronic data for route of delivery, all dilation and station examinations, newborn infant status, electronic fetal monitoring tracings, and cord blood gases. The labor-related complication groups included 272 women with cesarean delivery for first-stage arrest, 558 with cesarean delivery for fetal heart rate concerns, 178 with obstetric hemorrhage, and 237 with neonatal depression, which left 3004 women in the spontaneous vaginal birth group. Receiver operating characteristic curves were constructed for each assessment method by measurement of the sensitivity for each complication vs the false-positive rate in the normal reference group. The duration of arrest at ≥6 cm dilation showed poor levels of discrimination for the cesarean delivery interventions (area under the curve, 0.55-0.65; P < .01) and no significant relationship to hemorrhage or neonatal depression. The dilation and station percentiles showed high discrimination for the cesarean delivery-related outcomes (area under the curve, 0.78-0.93; P < .01) and low discrimination for the clinical outcomes of hemorrhage and neonatal depression (area under the curve, 0.58-0.61; P < .01). Duration of arrest of dilation at ≥6 cm showed little or no discrimination for any of the complications. In comparison, percentile rankings that were based on the adaptive multifactorial models showed much higher discrimination for cesarean delivery interventions and better, but low discrimination for hemorrhage. Adaptive multifactorial models present a different method to assess labor progress. Rather than "pass/fail" criteria that are applicable only to dilation in late labor, they produce percentile rankings, assess 2 essential processes for vaginal birth (dilation and descent), and can be applied from 3 cm onward. Given the limitations of labor-progress assessment based solely on the passage of time and because of the extreme variation in decision-making for cesarean delivery for labor disorders, the types of mathematic analyses that are described in this article are logical and promising steps to help standardize labor assessment. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

PubMed

Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

2017-05-01

To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

A Written Language Intervention for At-Risk Second Grade Students: A Randomized Controlled Trial of the Process Assessment of the Learner Lesson Plans in a Tier 2 Response-to-Intervention (RtI) Model

ERIC Educational Resources Information Center

Hooper, Stephen R.; Costa, Lara-Jeane C.; McBee, Matthew; Anderson, Kathleen L.; Yerby, Donna Carlson; Childress, Amy; Knuth, Sean B.

2013-01-01

In a randomized controlled trial, 205 students were followed from grades 1 to 3 with a focus on changes in their writing trajectories following an evidence-based intervention during the spring of second grade. Students were identified as being at-risk (n = 138), and then randomized into treatment (n = 68) versus business-as-usual conditions (n =…

Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial

PubMed Central

Vesco, Kimberly K.; Karanja, Njeri; King, Janet C.; Gillman, Matthew W.; Leo, Michael C.; Perrin, Nancy; McEvoy, Cindy T.; Eckhardt, Cara L.; Smith, K. Sabina; Stevens, Victor J.

2014-01-01

Objective Observational studies suggest that minimal gestational weight gain (GWG) may optimize pregnancy outcomes for obese women. This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women. Methods We randomized 114 obese women (BMI [mean±SD] 36.7±4.9 kg/m2) between 7–21 weeks’ (14.9±2.6) gestation to intervention (n=56) or usual care control conditions (n=58). The intervention included individualized calorie goals, advice to maintain weight within 3% of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction, and attendance at weekly group meetings until delivery. Control participants received one-time dietary advice. Our three main outcomes were maternal weight change from randomization to 2 weeks postpartum and from randomization to 34 weeks gestation, and newborn large-for-gestational age (birth weight >90th percentile, LGA). Results Intervention participants gained less weight from randomization to 34 weeks gestation (5.0 vs 8.4 kg, mean difference=−3.4 kg, 95% CI [−5.1, −1.8]), and from randomization to 2 weeks postpartum (−2.6 vs +1.2 kg, mean difference=−3.8 kg, 95% CI [−5.9, −1.7]). They also had a lower proportion of LGA babies (9% vs. 26%, odds ratio=0.28, 95% CI [0.09, 0.84]). Conclusions The intervention resulted in lower GWG and lower prevalence of LGA newborns. PMID:25164259

Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults. Results from the arthritis, diet, and activity promotion trial.

PubMed

van Gool, Coen H; Penninx, Brenda W J H; Kempen, Gertrudis I J M; Miller, Gary D; van Eijk, Jacques Th M; Pahor, Marco; Messier, Stephen P

2006-06-01

Determinants of adherence to lifestyle regimens are ill understood. Attendance to intervention sessions is crucial for patients to acquire knowledge and skills regarding the core elements of an intervention. Therefore, we explored demographic, health-related, and social determinants of high and low attendance to diet and exercise sessions among overweight and obese patients with knee osteoarthritis (> or = 60 years; N = 206). The Arthritis, Diet, and Activity Promotion Trial was an 18-month randomized controlled trial on the effectiveness of dietary weight loss and exercise interventions. We conducted chi-square and t-tests, and logistic regression analyses on categories of short- and long-term attendance to intervention sessions. Over the 18-month duration of the study, 60.7% (+/- 28.5) of diet sessions, and 53.2% (+/- 29.0) of exercise sessions were attended. Not being married, low social participation, and single intervention randomization predicted high attendance to diet sessions during months 1-4. Exercising at home, and single intervention randomization predicted high attendance to exercise sessions during months 5-18. High attendance to sessions early in the intervention was a significant determinant of high session attendance thereafter. Offering people a choice where to exercise, and stimulating early intervention session attendance can be effective in improving long-term attendance to both interventions. Several determinants we found may be amenable to change to enhance intervention adherence of future randomized controlled trials involving dietary weight loss and/or physical exercise.

A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer.

PubMed

Porter, Laura S; Keefe, Francis J; Baucom, Donald H; Olsen, Maren; Zafar, S Yousuf; Uronis, Hope

2017-07-01

This study aims to test the feasibility and preliminary efficacy of a couple-based communication intervention for advanced GI cancer delivered via videoconference. Thirty-two couples were randomly assigned to either couples communication skills training (CCST) or an education comparison intervention, both delivered via videoconference. Participation was limited to couples who reported communication difficulties at screening. Patients and partners completed measures of relationship functioning and individual functioning at baseline and post-intervention. Eighty-eight percent of randomized dyads completed all six sessions and reported high levels of satisfaction with the intervention. Between-group effect sizes suggested that the CCST intervention led to improvements in relationship satisfaction for patients and partners and to improvements in intimacy and communication for patients. A couples-based communication intervention delivered via videoconference is feasible and acceptable in the context of advanced cancer. Preliminary findings suggest that the intervention shows promise in contributing to enhanced relationship functioning. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

PubMed Central

Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

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

ERIC Educational Resources Information Center

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

2011-01-01

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

Literate Language Intervention with High-Need Prekindergarten Children: A Randomized Trial

ERIC Educational Resources Information Center

Phillips, Beth M.; Tabulda, Galiya; Ingrole, Smriti A.; Webb Burris, Pam; Sedgwick, T. Kayla; Chen, Shiyi

2016-01-01

Purpose: The present article reports on the implementation and results of a randomized intervention trial targeting the literate language skills of prekindergarten children without identified language disorders but with low oral language skills. Method: Children (N = 82; 45 boys and 37 girls) were screened-in and randomized to a business-as-usual…

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

ERIC Educational Resources Information Center

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

2010-01-01

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

Behavioral Family Intervention for Children with Developmental Disabilities and Behavioral Problems

ERIC Educational Resources Information Center

Roberts, Clare; Mazzucchelli, Trevor; Studman, Lisa; Sanders, Matthew R.

2006-01-01

The outcomes of a randomized clinical trial of a new behavioral family intervention, Stepping Stones Triple P, for preschoolers with developmental and behavior problems are presented. Forty-eight children with developmental disabilities participated, 27 randomly allocated to an intervention group and 20 to a wait-list control group. Parents…

Hybrid Implementation Model of Community-Partnered Early Intervention for Toddlers with Autism: A Randomized Trial

ERIC Educational Resources Information Center

Shire, Stephanie Y.; Chang, Ya-Chih; Shih, Wendy; Bracaglia, Suzanne; Kodjoe, Maria; Kasari, Connie

2017-01-01

Background: Interventions found to be effective in research settings are often not as effective when implemented in community settings. Considering children with autism, studies have rarely examined the efficacy of laboratory-tested interventions on child outcomes in community settings using randomized controlled designs. Methods: One hundred and…

A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

2016-01-01

We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

A Meta-Analysis of Smoking Cessation Interventions With Individuals in Substance Abuse Treatment or Recovery

ERIC Educational Resources Information Center

Prochaska, Judith J.; Delucchi, Kevin; Hall, Sharon M.

2004-01-01

This meta-analysis examined outcomes of smoking cessation interventions evaluated in 19 randomized controlled trials with individuals in current addictions treatment or recovery. Smoking and substance use outcomes at posttreatment and long-term follow-up (? 6 months) were summarized with random effects models. Intervention effects for smoking…

Testing the Intervention Effect in Single-Case Experiments: A Monte Carlo Simulation Study

ERIC Educational Resources Information Center

Heyvaert, Mieke; Moeyaert, Mariola; Verkempynck, Paul; Van den Noortgate, Wim; Vervloet, Marlies; Ugille, Maaike; Onghena, Patrick

2017-01-01

This article reports on a Monte Carlo simulation study, evaluating two approaches for testing the intervention effect in replicated randomized AB designs: two-level hierarchical linear modeling (HLM) and using the additive method to combine randomization test "p" values (RTcombiP). Four factors were manipulated: mean intervention effect,…

Comparing Intervention Strategies among Rural, Low SES, Young Adult Tobacco Users

ERIC Educational Resources Information Center

Zanis, David A.; Hollm, Ronald E.; Derr, Daniel; Ibrahim, Jennifer K.; Collins, Bradley N.; Coviello, Donna; Melochick, Jennifer Ryan

2011-01-01

Objective: To evaluate 3-month tobacco quit rates of young adult tobacco users randomized to 2 intervention conditions. Methods: Overall 192 non-treatment-seeking 18-to-24-year-old tobacco users received educational information and advice to quit smoking. Participants were then block randomized to 2 brief intervention conditions: (1) a telephone…

Effects of an Early Numeracy Intervention on Struggling Kindergarteners' Mathematics Performance

ERIC Educational Resources Information Center

Bryant, Brian R.; Bryant, Diane Pedrotty; Roberts, Greg; Fall, Anna-Maria

2016-01-01

The purpose of this study was to investigate the effects of an early numeracy intervention delivered by kindergarten teachers to students identified as having mathematics difficulties. A multigroup growth-modeling-with-random-assignment-to-intervention-condition design was employed. Thirty-two teachers were randomly assigned to the treatment or…

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…

Systematic Review of Interventions to Improve the Provision of Information for Adults with Primary Brain Tumors and Their Caregivers

PubMed Central

Langbecker, Danette; Janda, Monika

2014-01-01

Background: Adults with primary brain tumors and their caregivers have significant information needs. This review assessed the effect of interventions to improve information provision for adult primary brain tumor patients and/or their caregivers. Methods: We included randomized or non-randomized trials testing educational interventions that had outcomes of information provision, knowledge, understanding, recall, or satisfaction with the intervention, for adults diagnosed with primary brain tumors and/or their family or caregivers. PubMed, MEDLINE, EMBASE, and Cochrane Reviews databases were searched for studies published between 1980 and June 2014. Results: Two randomized controlled, 1 non-randomized controlled, and 10 single group pre–post trials enrolled more than 411 participants. Five group, four practice/process change, and four individual interventions assessed satisfaction (12 studies), knowledge (4 studies), and information provision (2 studies). Nine studies reported high rates of satisfaction. Three studies showed statistically significant improvements over time in knowledge and two showed greater information was provided to intervention than control group participants, although statistical testing was not performed. Discussion: The trials assessed intermediate outcomes such as satisfaction, and only 4/13 reported on knowledge improvements. Few trials had a randomized controlled design and risk of bias was either evident or could not be assessed in most domains. PMID:25667919

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

PubMed Central

Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

2016-01-01

Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States.

PubMed

Olson, Ryan; Wipfli, Brad; Thompson, Sharon V; Elliot, Diane L; Anger, W Kent; Bodner, Todd; Hammer, Leslie B; Perrin, Nancy A

2016-09-01

To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = -0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers.

The effectiveness of an intervention to reduce alcohol‐related violence in premises licensed for the sale and on‐site consumption of alcohol: a randomized controlled trial

PubMed Central

Alam, M. Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

2017-01-01

Abstract Background and Aims Premises licensed for the sale and consumption of alcohol can contribute to levels of assault‐related injury through poor operational practices that, if addressed, could reduce violence. We tested the real‐world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. Design A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. Setting All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. Participants A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police‐recorded crime data; n = 837) were randomized into control and intervention groups. Intervention and comparator Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow‐up visits) on how risks could be addressed. Control premises received usual practice. Measurements Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455‐day period following randomization. Findings Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention‐to‐treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20–1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow‐up visits). Conclusion An Environmental Health Practitioner‐led intervention in premises licensed for the sale and on‐site consumption of alcohol resulted in an increase in police recorded violence. PMID:28543914

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

PubMed

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

PubMed

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

RNAi control of aflatoxins in peanut plants, a multifactorial system

USDA-ARS?s Scientific Manuscript database

RNA-interference (RNAi)-mediated control of aflatoxin contamination in peanut plants is a multifactorial and hyper variable system. The use of RNAi biotechnology to silence single genes in plants has inherently high-variability among transgenic events. Also the level of expression of small interfe...

Effect of intervention programs in schools to reduce screen time: a meta-analysis.

PubMed

Friedrich, Roberta Roggia; Polet, Jéssica Pinto; Schuch, Ilaine; Wagner, Mário Bernardes

2014-01-01

to evaluate the effects of intervention program strategies on the time spent on activities such as watching television, playing videogames, and using the computer among schoolchildren. a search for randomized controlled trials available in the literature was performed in the following electronic databases: PubMed, Lilacs, Embase, Scopus, Web of Science, and Cochrane Library using the following Keywords randomized controlled trial, intervention studies, sedentary lifestyle, screen time, and school. A summary measure based on the standardized mean difference was used with a 95% confidence interval. a total of 1,552 studies were identified, of which 16 were included in the meta-analysis. The interventions in the randomized controlled trials (n=8,785) showed a significant effect in reducing screen time, with a standardized mean difference (random effect) of: -0.25 (-0.37, -0.13), p<0.01. interventions have demonstrated the positive effects of the decrease of screen time among schoolchildren. Copyright © 2014 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

A brief randomized controlled intervention targeting parents improves grades during middle school.

PubMed

Destin, Mesmin; Svoboda, Ryan C

2017-04-01

Despite a growing number of brief, psychosocial interventions that improve academic achievement, little research investigates how to leverage parents during such efforts. We designed and tested a randomized controlled intervention targeting parents to influence important discussions about the future and responses to academic difficulty experienced by their adolescent during eighth grade in the United States. We recruited experienced parents to convey the main messages of the intervention in a parent panel format. As expected, current parents who were randomly assigned to observe the parent panel subsequently planned to talk with their adolescents sooner about future opportunities and to respond more positively to experiences of academic difficulty than parents who were randomly assigned to a control group. The intervention also led to a significant increase in student grades, which was mediated by parents' responses to academic difficulty. We suggest an increase in experimental research that utilizes parents to influence student achievement. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Update on the therapy of Behçet disease

PubMed Central

Saleh, Zeinab

2014-01-01

Behçet disease is a chronic inflammatory systemic disorder, characterized by a relapsing and remitting course. It manifests with oral and genital ulcerations, skin lesions, uveitis, and vascular, central nervous system and gastrointestinal involvement. The main histopathological finding is a widespread vasculitis of the arteries and veins of any size. The cause of this disease is presumed to be multifactorial involving infectious triggers, genetic predisposition, and dysregulation of the immune system. As the clinical expression of Behçet disease is heterogeneous, pharmacological therapy is variable and depends largely on the severity of the disease and organ involvement. Treatment of Behçet disease continues to be based largely on anecdotal case reports, case series, and a few randomized clinical trials. PMID:24790727

Energy-Based Devices in Treatment of Acne Vulgaris.

PubMed

Handler, Marc Z; Bloom, Bradley S; Goldberg, David J

2016-05-01

Acne vulgaris is a chronic dermatologic complaint with a multifactorial cause. Traditionally, antibiotics and retinoids have been used to manage the condition; patient compliance has been an ongoing issue. A variety of energy-based devices have been reported to be effective in the treatment of acne vulgaris. To review and summarize the current literature specific to treatment of acne vulgaris with energy-based devices. A review of the current literature of energy-based devices used for the treatment of acne vulgaris. Although limited randomized controlled trials for the treatment of acne have been performed, significant clinical improvement of acne vulgaris, especially of inflammatory lesions, has been demonstrated with a variety of energy-based devices. Newer approaches may lead to even better results.

Effects of a Tobacco Control Intervention for Teachers in India: Results of the Bihar School Teachers Study

PubMed Central

Sorensen, Glorian; Pednekar, Mangesh S.; Sinha, Dhirendra N.; Stoddard, Anne M.; Nagler, Eve; Aghi, Mira B.; Lando, Harry A.; Viswanath, Kasisomayajula; Pawar, Pratibha; Gupta, Prakash C.

2013-01-01

Objectives. We assessed a school-based intervention designed to promote tobacco control among teachers in the Indian state of Bihar. Methods. We used a cluster-randomized design to test the intervention, which comprised educational efforts, tobacco control policies, and cessation support and was tailored to the local social context. In 2009 to 2011, we randomly selected 72 schools from participating school districts and randomly assigned them in blocks (rural or urban) to intervention or delayed-intervention control conditions. Results. Immediately after the intervention, the 30-day quit rate was 50% in the intervention and 15% in the control group (P = .001). At the 9-month postintervention survey, the adjusted 6-month quit rate was 19% in the intervention and 7% in the control group (P = .06). Among teachers employed for the entire academic year of the intervention, the adjusted 6-month abstinence rates were 20% and 5%, respectively, for the intervention and control groups (P = .04). Conclusions. These findings demonstrate the potent impact of an intervention that took advantage of social resources among teachers, who can serve as role models for tobacco control in their communities. PMID:24028234

Cost-effectiveness of a day hospital falls prevention programme for screened community-dwelling older people at high risk of falls.

PubMed

Irvine, Lisa; Conroy, Simon P; Sach, Tracey; Gladman, John R F; Harwood, Rowan H; Kendrick, Denise; Coupland, Carol; Drummond, Avril; Barton, Garry; Masud, Tahir

2010-11-01

multifactorial falls prevention programmes for older people have been proved to reduce falls. However, evidence of their cost-effectiveness is mixed. economic evaluation alongside pragmatic randomised controlled trial. randomised trial of 364 people aged ≥70, living in the community, recruited via GP and identified as high risk of falling. Both arms received a falls prevention information leaflet. The intervention arm were also offered a (day hospital) multidisciplinary falls prevention programme, including physiotherapy, occupational therapy, nurse, medical review and referral to other specialists. self-reported falls, as collected in 12 monthly diaries. Levels of health resource use associated with the falls prevention programme, screening (both attributed to intervention arm only) and other health-care contacts were monitored. Mean NHS costs and falls per person per year were estimated for both arms, along with the incremental cost-effectiveness ratio (ICER) and cost effectiveness acceptability curve. in the base-case analysis, the mean falls programme cost was £349 per person. This, coupled with higher screening and other health-care costs, resulted in a mean incremental cost of £578 for the intervention arm. The mean falls rate was lower in the intervention arm (2.07 per person/year), compared with the control arm (2.24). The estimated ICER was £3,320 per fall averted. the estimated ICER was £3,320 per fall averted. Future research should focus on adherence to the intervention and an assessment of impact on quality of life.

Interdisciplinary Medication Adherence Program: The Example of a University Community Pharmacy in Switzerland

PubMed Central

Lelubre, Mélanie; Kamal, Susan; Genre, Noëllie; Celio, Jennifer; Gorgerat, Séverine; Hugentobler Hampai, Denise; Bourdin, Aline; Berger, Jerôme; Bugnon, Olivier; Schneider, Marie

2015-01-01

The Community Pharmacy of the Department of Ambulatory Care and Community Medicine (Policlinique Médicale Universitaire, PMU), University of Lausanne, developed and implemented an interdisciplinary medication adherence program. The program aims to support and reinforce medication adherence through a multifactorial and interdisciplinary intervention. Motivational interviewing is combined with medication adherence electronic monitors (MEMS, Aardex MWV) and a report to patient, physician, nurse, and other pharmacists. This program has become a routine activity and was extended for use with all chronic diseases. From 2004 to 2014, there were 819 patient inclusions, and 268 patients were in follow-up in 2014. This paper aims to present the organization and program's context, statistical data, published research, and future perspectives. PMID:26839879

[From aviation to surgery: the challenge of safety].

PubMed

Suva, D; Haller, G; Lübbeke-Wolff, A; Macheret, F; Kindler, V; Hoffmeyer, P

2011-03-23

Medical errors result in 44,000 to 98,000 deaths per year in the United States of America. Within the surgical specialties, half of these errors occur in the operating room. The origin of these errors is multifactorial, and is generally associated with problems in communication and teamwork. In order to improve safety in the operating room, many hospitals now propose to the medical staff "crew resource management" (CRM) training programs inspired by the aviation industry. This approach favors a better utilization of surgical checklists, improves efficiency during chirurgical interventions, and reduces patient mortality. In October 2009 we introduced a CRM course within the department of surgery at the Geneva University Hospitals. We are presenting this program as well as the first results following its application.

Interdisciplinary Medication Adherence Program: The Example of a University Community Pharmacy in Switzerland.

PubMed

Lelubre, Mélanie; Kamal, Susan; Genre, Noëllie; Celio, Jennifer; Gorgerat, Séverine; Hugentobler Hampai, Denise; Bourdin, Aline; Berger, Jerôme; Bugnon, Olivier; Schneider, Marie

2015-01-01

The Community Pharmacy of the Department of Ambulatory Care and Community Medicine (Policlinique Médicale Universitaire, PMU), University of Lausanne, developed and implemented an interdisciplinary medication adherence program. The program aims to support and reinforce medication adherence through a multifactorial and interdisciplinary intervention. Motivational interviewing is combined with medication adherence electronic monitors (MEMS, Aardex MWV) and a report to patient, physician, nurse, and other pharmacists. This program has become a routine activity and was extended for use with all chronic diseases. From 2004 to 2014, there were 819 patient inclusions, and 268 patients were in follow-up in 2014. This paper aims to present the organization and program's context, statistical data, published research, and future perspectives.

Cachexia.

PubMed

Graul, A I; Stringer, M; Sorbera, L

2016-09-01

Cachexia is a multiorgan, multifactorial and often irreversible wasting syndrome associated with cancer and other serious, chronic illnesses including AIDS, chronic heart failure, chronic kidney disease and chronic obstructive pulmonary disease. Treatment of the patient with cachexia is currently targeted to correcting the two underlying features of the condition: anorexia and metabolic disturbances. Greater understanding of the mechanisms behind cachexia and muscle wasting have led to new therapeutic possibilities, however. Several classes of drugs are under active development for cachexia including drugs acting on hormone receptors or cytokine receptors, myostatin/activin pathway antagonists, beta-adrenoceptor agonists and cannabinoids. This review will cover the pathophysiology, epidemiology, diagnosis, treatment, drug candidates under active development and targets for therapeutic intervention of cachexia. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

The Genetic Basis of Psoriasis

PubMed Central

Capon, Francesca

2017-01-01

Psoriasis is widely regarded as a multifactorial condition which is caused by the interaction between inherited susceptibility alleles and environmental triggers. In the last decade, technological advances have enabled substantial progress in the understanding of disease genetics. Genome-wide association studies have identified more than 60 disease susceptibility regions, highlighting the pathogenic involvement of genes related to Th17 cell activation. This pathway has now been targeted by a new generation of biologics that have shown great efficacy in clinical trials. At the same time, the study of rare variants of psoriasis has identified interleukin (IL)-36 cytokines as important amplifiers of Th17 signaling and promising targets for therapeutic intervention. Here, we review these exciting discoveries, which highlight the translational potential of genetic studies. PMID:29186830

The advocacy in action study a cluster randomized controlled trial to reduce pedestrian injuries in deprived communities.

PubMed

Lyons, R A; Towner, E; Christie, N; Kendrick, D; Jones, S J; Hayes, M; Kimberlee, R; Sarvotham, T; Macey, S; Brussoni, M; Sleney, J; Coupland, C; Phillips, C

2008-04-01

Road traffic-related injury is a major global public health problem. In most countries, pedestrian injuries occur predominantly to the poorest in society. A number of evaluated interventions are effective in reducing these injuries. Very little research has been carried out into the distribution and determinants of the uptake of these interventions. Previous research has shown an association between local political influence and the distribution of traffic calming after adjustment for historical crash patterns. This led to the hypothesis that advocacy could be used to increase local politicians knowledge of pedestrian injury risk and effective interventions, ultimately resulting in improved pedestrian safety. To design an intervention to improve the uptake of pedestrian safety measures in deprived communities. Electoral wards in deprived areas of England and Wales with a poor record of pedestrian safety for children and older adults. Design mixedmethods study, incorporating a cluster randomized controlled trial. Data mixture of Geographical Information Systems data collision locations, road safety interventions, telephone interviews, and questionnaires. Randomization 239 electoral wards clustered within 57 local authorities. Participants 615 politicians representing intervention and control wards. Intervention a package of tailored information including maps of pedestrian injuries was designed for intervention politicians, and a general information pack for controls. Primary outcome number of road safety interventions 25 months after randomization. Secondary outcomes politicians interest and involvement in injury prevention cost of interventions. Process evaluation use of advocacy pack, facilitators and barriers to involvement, and success.

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

Prevention of overweight and obesity in early life.

PubMed

Lanigan, Julie

2018-05-29

Childhood obesity is a serious challenge for public health. The problem begins early with most excess childhood weight gained before starting school. In 2016, the WHO estimated that 41 million children under 5 were overweight or obese. Once established, obesity is difficult to reverse, likely to persist into adult life and is associated with increased risk of CVD, type 2 diabetes and certain cancers. Preventing obesity is therefore of high importance. However, its development is multi-factorial and prevention is a complex challenge. Modifiable lifestyle behaviours such as diet and physical activity are the most well-known determinants of obesity. More recently, early-life factors have emerged as key influencers of obesity in childhood. Understanding risk factors and how they interact is important to inform interventions that aim to prevent obesity in early childhood. Available evidence supports multi-component interventions as effective in obesity prevention. However, relatively few interventions are available in the UK and only one, TrimTots, has been evaluated in randomised controlled trials and shown to be effective at reducing obesity risk in preschool children (age 1-5 years). BMI was lower in children immediately after completing TrimTots compared with waiting list controls and this effect was sustained at long-term follow-up, 2 years after completion. Developing and evaluating complex interventions for obesity prevention is a challenge for clinicians and researchers. In addition, parents encounter barriers engaging with interventions. This review considers early-life risk factors for obesity, highlights evidence for preventative interventions and discusses barriers and facilitators to their success.

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

PubMed

Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

ERIC Educational Resources Information Center

Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

2009-01-01

Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

ERIC Educational Resources Information Center

Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

2017-01-01

Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

ERIC Educational Resources Information Center

Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

2009-01-01

When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

Mediating Parent Learning to Promote Social Communication for Toddlers with Autism: Effects from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Schertz, Hannah H.; Odom, Samuel L.; Baggett, Kathleen M.; Sideris, John H.

2018-01-01

A randomized controlled trial was conducted to evaluate effects of the Joint Attention Mediated Learning (JAML) intervention. Toddlers with autism spectrum disorders (ASD) aged 16-30 months (n = 144) were randomized to intervention and community control conditions. Parents, who participated in 32 weekly home-based sessions, followed a mediated…

Impact of Patient Education on Influenza Vaccine Uptake among Community-Dwelling Elderly: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Ka Chun; Mui, Carlo; Chiu, Wing Yan; Ng, Yuk Yiu; Chen, Matthew H. Y.; Ho, Pui Hung; Kwok, Chun Pong; Lam, Suki S. M.; Wong, Chun Yip; Wong, Kit Yee; Pang, Herbert H.

2017-01-01

This randomized controlled trial aimed to test the effectiveness of brief face-to-face patient education in increasing influenza vaccination rate among elderly in the community. Recruitment and intervention were conducted at two general outpatient clinics in Hong Kong. 529 eligible patients were randomly assigned to intervention or control group…

Factors Associated with Use of Automated Smoking Cessation Interventions: Findings from the eQuit Study

ERIC Educational Resources Information Center

Balmford, James; Borland, Ron; Benda, Peter; Howard, Steve

2013-01-01

The aim was to better understand structural factors associated with uptake of automated tailored interventions for smoking cessation. In a prospective randomized controlled trial with interventions only offered, not mandated, participants were randomized based on the following: web-based expert system (QuitCoach); text messaging program (onQ);…

Randomized Controlled Trial of Abstinence and Safer Sex Intervention for Adolescents in Singapore: 6-Month Follow-Up

ERIC Educational Resources Information Center

Wong, Mee Lian; Ng, Junice Y. S.; Chan, Roy K. W.; Chio, Martin T. W.; Lim, Raymond B. T.; Koh, David

2017-01-01

We assessed the efficacy of an individual-based behavioral intervention on sexually transmitted infections' (STI) risk-reduction behaviors in Singapore. A randomized controlled trial of a behavioral intervention compared to usual care was conducted on sexually active heterosexual adolescents aged 16-19 years attending the only public STI clinic.…

Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

ERIC Educational Resources Information Center

Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

2014-01-01

Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

A Preliminary Randomized Controlled Trial of Two Social Skills Interventions for Youth with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Lerner, Matthew D.; Mikami, Amori Y.

2012-01-01

This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or…

An Intervention for Sensory Difficulties in Children with Autism: A Randomized Trial

ERIC Educational Resources Information Center

Schaaf, Roseann C.; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna

2014-01-01

This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored…

Outcomes of an HIV Prevention Peer Group Intervention for Rural Adults in Malawi

ERIC Educational Resources Information Center

Kaponda, Chrissie P. N.; Norr, Kathleen F.; Crittenden, Kathleen S.; Norr, James L.; McCreary, Linda L.; Kachingwe, Sitingawawo I.; Mbeba, Mary M.; Jere, Diana L. N.; Dancy, Barbara L.

2011-01-01

This study used a quasi-experimental design to evaluate a six-session peer group intervention for HIV prevention among rural adults in Malawi. Two rural districts were randomly assigned to intervention and control conditions. Independent random samples of community adults compared the districts at baseline and at 6 and 18 months postintervention.…

Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

ERIC Educational Resources Information Center

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

2008-01-01

In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

Effectiveness of a Web-Based Intervention to Reduce Alcohol Consumption among French Hazardous Drinkers: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Guillemont, Juliette; Cogordan, Chloé; Nalpas, Bertrand; Nguyen-Thanh, Vi?t; Richard, Jean-Baptiste; Arwidson, Pierre

2017-01-01

This study aims to evaluate the effectiveness of a web-based intervention to reduce alcohol consumption among hazardous drinkers. A two-group parallel randomized controlled trial was conducted among adults identified as hazardous drinkers according to the Alcohol Use Disorders Identification Test. The intervention delivers personalized normative…

Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Two Eating Disorder Prevention Programs

ERIC Educational Resources Information Center

Stice, Eric; Presnell, Katherine; Gau, Jeff; Shaw, Heather

2007-01-01

The authors investigated mediators hypothesized to account for the effects of 2 eating disorder prevention programs using data from 355 adolescent girls who were randomized to a dissonance or a healthy weight intervention or an active control condition. The dissonance intervention produced significant reductions in outcomes (body…

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.

The effectiveness of an intervention to reduce alcohol-related violence in premises licensed for the sale and on-site consumption of alcohol: a randomized controlled trial.

PubMed

Moore, Simon C; Alam, M Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

2017-11-01

Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

A systematic approach for the development of a kindergarten-based intervention for the prevention of obesity in preschool age children: the ToyBox-study.

PubMed

Manios, Y; Grammatikaki, E; Androutsos, O; Chinapaw, M J M; Gibson, E L; Buijs, G; Iotova, V; Socha, P; Annemans, L; Wildgruber, A; Mouratidou, T; Yngve, A; Duvinage, K; de Bourdeaudhuij, I

2012-03-01

The increasing childhood obesity epidemic calls for appropriate measures and effective policies to be applied early in life. Large-scale socioecological frameworks providing a holistic multifactorial and cost-effective approach necessary to support obesity prevention initiatives in this age are however currently missing. To address this missing link, ToyBox-study aims to build and evaluate a cost-effective kindergarten-based, family-involved intervention scheme to prevent obesity in early childhood, which could potentially be expanded on a pan-European scale. A multidisciplinary team of researchers from 10 countries have joined forces and will work to realize this according to a systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and intervention mapping protocol. ToyBox-study will conduct systematic and narrative reviews, secondary data analyses, focus group research and societal assessment to design, implement and evaluate outcome, impact, process and cost effectiveness of the intervention. This is the first time that such a holistic approach has been used on a pan-European scale to promote healthy weight and healthy energy balance-related behaviours for the prevention of early childhood obesity. The results of ToyBox-study will be disseminated among key stakeholders including researchers, policy makers, practitioners and the general population. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

Efficacy of a Social Self-Value Empowerment Intervention to Improve Quality of Life of HIV Infected People Receiving Antiretroviral Treatment in Nepal: A Randomized Controlled Trial.

PubMed

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

2017-06-01

We developed a comprehensive and culturally applicable empowerment intervention social self-value package with an aim to assess its efficacy in order to improve the quality of life (QoL) of HIV infected people receiving antiretroviral treatment. Participants were randomly allocated to receive either six weekly intervention sessions or standard care. Nonlinear mixed-effects models were performed to compare changes in empowerment scores over time. Between September and November 2014, 1447 individuals were screened, of whom 132 were randomly assigned to either the intervention or control group. The mean scores of empowerment, social support and quality of life increased and stigma scores were reduced in the intervention group at 3- and 6-months. An intervention effect on social support, stigma and QoL was significantly increased by time and group with low and high empowerment. No adverse events were reported. The empowerment intervention was efficacious in improving QoL of HIV infected people.

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

PubMed

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016. ISRCTN61538090 Registered 20 April 2015.

Multimodal imaging-based therapeutic fingerprints for optimizing personalized interventions: Application to neurodegeneration.

PubMed

Iturria-Medina, Yasser; Carbonell, Félix M; Evans, Alan C

2018-06-14

Personalized Medicine (PM) seeks to assist the patients according to their specific treatment needs and potential intervention responses. However, in the neurological context, this approach is limited by crucial methodological challenges, such as the requirement for an understanding of the causal disease mechanisms and the inability to predict the brain's response to therapeutic interventions. Here, we introduce and validate the concept of the personalized Therapeutic Intervention Fingerprint (pTIF), which predicts the effectiveness of potential interventions for controlling a patient's disease evolution. Each subject's pTIF can be inferred from multimodal longitudinal imaging (e.g. amyloid-β, metabolic and tau PET; vascular, functional and structural MRI). We studied an aging population (N = 331) comprising cognitively normal and neurodegenerative patients, longitudinally scanned using six different neuroimaging modalities. We found that the resulting pTIF vastly outperforms cognitive and clinical evaluations on predicting individual variability in gene expression (GE) profiles. Furthermore, after regrouping the patients according to their predicted primary single-target interventions, we observed that these pTIF-based subgroups present distinctively altered molecular pathway signatures, supporting the across-population identification of dissimilar pathological stages, in active correspondence with different therapeutic needs. The results further evidence the imprecision of using broad clinical categories for understanding individual molecular alterations and selecting appropriate therapeutic needs. To our knowledge, this is the first study highlighting the direct link between multifactorial brain dynamics, predicted treatment responses, and molecular alterations at the patient level. Inspired by the principles of PM, the proposed pTIF framework is a promising step towards biomarker-driven assisted therapeutic interventions, with additional important implications for selective enrollment of patients in clinical trials. Copyright © 2018 Elsevier Inc. All rights reserved.

The Unhealthy Lifestyle Factors Associated with an Increased Risk of Poor Nutrition among the Elderly Population in China.

PubMed

Lin, W-Q; Wang, H H X; Yuan, L-X; Li, B; Jing, M-J; Luo, J-L; Tang, J; Ye, B-K; Wang, P-X

2017-01-01

The associations between nutritional status and lifestyle factors have not been well established. This study aimed to investigate the prevalence of poor nutrition and to examine the relationships between nutritional status and unhealthy lifestyle and other related factors among the elderly. This cross-sectional study was conducted in Liaobu Town, Dongguan city, China. A total of 708 community-dwelling older adults aged ≥60 years were recruited by stratified random sampling. Data on sociodemographic characteristics, health and lifestyle factors, and the Mini Nutritional Assessment (MNA) scores were collected using structured questionnaires via face-to-face interviews. A multivariate logistic regression model was constructed to identify the risk factors of poor nutrition. The prevalence of malnutrition among the elderly adults in this study was 1.3%, and 24.4% were at risk of malnutrition (RM). Poor nutrition was significantly associated with female gender, older age, lower education, a high number of self-reported chronic diseases, and hospitalization in the last year. Unhealthy lifestyle factors associated with poor nutrition included current smoking status, higher alcohol consumption, lack of physical activity, longer duration of sitting, negative attitude towards life, and a poor family relationship. While the prevalence of malnutrition was low, RM was high in the elderly population in China. The determinants of malnutrition were explored and the relationships between nutritional status and unhealthy lifestyle factors were examined. The results of this study provide information for future longitudinal studies with multi-factorial interventional design in order to determine the effects of the causal relationships.

Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial

PubMed Central

Griffin, Simon J; Borch-Johnsen, Knut; Davies, Melanie J; Khunti, Kamlesh; Rutten, Guy EHM; Sandbæk, Annelli; Sharp, Stephen J; Simmons, Rebecca K; van den Donk, Maureen; Wareham, Nicholas J; Lauritzen, Torsten

2011-01-01

Summary Background Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening. Methods In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40–69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice's study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549. Findings Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA1c and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65–1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69–1·21), respectively. Interpretation An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death. Funding National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck. PMID:21705063

Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

PubMed Central

Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

Assessing a change mechanism in a randomized home-visiting trial: Reducing disrupted maternal communication decreases infant disorganization.

PubMed

Tereno, Susana; Madigan, Sheri; Lyons-Ruth, Karlen; Plamondon, Andre; Atkinson, Leslie; Guedeney, Nicole; Greacen, Tim; Dugravier, Romain; Saias, Thomas; Guedeney, Antoine

2017-05-01

Although randomized interventions trials have been shown to reduce the incidence of disorganized attachment, no studies to date have identified the mechanisms of change responsible for such reductions. Maternal sensitivity has been assessed in various studies and shown to change with intervention, but in the only study to formally assess mediation, changes in maternal sensitivity did not mediate changes in infant security of attachment (Cicchetti, Rogosch, & Toth, 2006). Primary aims of the current randomized controlled intervention trial in a high-risk population were to fill gaps in the literature by assessing whether the intervention (a) reduced disorganization, (b) reduced disrupted maternal communication, and (c) whether reductions in disrupted maternal communication mediated changes in infant disorganization. The results indicated that, compared to controls (n = 52), both infant disorganization and disrupted maternal communication were significantly reduced in the intervention group (n = 65) that received regular home-visiting during pregnancy and the first year of life. Furthermore, reductions in disrupted maternal communication partially accounted for the observed reductions in infant disorganization compared to randomized controls. The results are discussed in relation to the societal cost effectiveness of early attachment-informed interventions for mothers and infants, as well as the importance of formally assessing underlying mechanisms of change in order to improve and appropriately target preventive interventions.

Child language interventions in public health: a systematic literature review.

PubMed

De Cesaro, Bruna Campos; Gurgel, Léia Gonçalves; Nunes, Gabriela Pisoni Canedo; Reppold, Caroline Tozzi

2013-01-01

Systematically review the literature on interventions in children's language in primary health care. One searched the electronic databases (January 1980 to March 2013) MEDLINE (accessed by PubMed), Scopus, Lilacs and Scielo. The search terms used were "child language", "primary health care", "randomized controlled trial" and "intervention studies" (in English, Portuguese and Spanish). There were included any randomized controlled trials that addressed the issues child language and primary health care. The analysis was based on the type of language intervention conducted in primary health care. Seven studies were included and used intervention strategies such as interactive video, guidance for parents and group therapy. Individuals of both genders were included in the seven studies. The age of the children participant in the samples of the articles included in this review ranged from zero to 11 years. These seven studies used approaches that included only parents, parents and children or just children. The mainly intervention in language on primary health care, used in randomized controlled trials, involved the use of interactional video. Several professionals, beyond speech and language therapist, been inserted in the language interventions on primary health care, demonstrating the importance of interdisciplinary work. None of the articles mentioned aspects related to hearing. There was scarcity of randomized controlled trials that address on language and public health, either in Brazil or internationally.

Evaluation of physical activity interventions in children via the reach, efficacy/effectiveness, adoption, implementation, and maintenance (RE-AIM) framework: A systematic review of randomized and non-randomized trials.

PubMed

McGoey, Tara; Root, Zach; Bruner, Mark W; Law, Barbi

2016-01-01

Existing reviews of physical activity (PA) interventions designed to increase PA behavior exclusively in children (ages 5 to 11years) focus primarily on the efficacy (e.g., internal validity) of the interventions without addressing the applicability of the results in terms of generalizability and translatability (e.g., external validity). This review used the RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, Maintenance) framework to measure the degree to which randomized and non-randomized PA interventions in children report on internal and external validity factors. A systematic search for controlled interventions conducted within the past 12years identified 78 studies that met the inclusion criteria. Based on the RE-AIM criteria, most of the studies focused on elements of internal validity (e.g., sample size, intervention location and efficacy/effectiveness) with minimal reporting of external validity indicators (e.g., representativeness of participants, start-up costs, protocol fidelity and sustainability). Results of this RE-AIM review emphasize the need for future PA interventions in children to report on real-world challenges and limitations, and to highlight considerations for translating evidence-based results into health promotion practice. Copyright © 2015 Elsevier Inc. All rights reserved.

Changing friend selection in middle school: A social network analysis of a randomized intervention study designed to prevent adolescent problem behavior

PubMed Central

DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J.

2015-01-01

Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends five years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum—one level of the Family Check-up model—on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n=500) was randomly assigned to the intervention and the other half (n=498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within School 1, but not within Schools 2 or 3. The effects of friend selection in School 1 translated into reductions in observed deviancy training five years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance five years later. PMID:26377235

Sun protection at elementary schools: a cluster randomized trial.

PubMed

Hunter, Seft; Love-Jackson, Kymia; Abdulla, Rania; Zhu, Weiwei; Lee, Ji-Hyun; Wells, Kristen J; Roetzheim, Richard

2010-04-07

Elementary schools represent both a source of childhood sun exposure and a setting for educational interventions. Sun Protection of Florida's Children was a cluster randomized trial promoting hat use at (primary outcome) and outside of schools among fourth-grade students during August 8, 2006, through May 22, 2007. Twenty-two schools were randomly assigned to the intervention (1115 students) or control group (1376 students). Intervention schools received classroom sessions targeting sun protection attitudes and social norms. Each student attending an intervention school received two free wide-brimmed hats. Hat use at school was measured by direct observation and hat use outside of school was measured by self-report. A subgroup of 378 students (178 in the intervention group and 200 in the control group) underwent serial measurements of skin pigmentation to explore potential physiological effects of the intervention. Generalized linear mixed models were used to evaluate the intervention effect by accounting for the cluster randomized trial design. All P values were two-sided and were claimed as statistically significant at a level of .05. The percentage of students observed wearing hats at control schools remained essentially unchanged during the school year (baseline = 2%, fall = 0%, and spring = 1%) but increased statistically significantly at intervention schools (baseline = 2%, fall = 30%, and spring = 41%) (P < .001 for intervention effect comparing the change in rate of hat use over time at intervention vs control schools). Self-reported use of hats outside of school did not change statistically significantly during the study (control: baseline = 14%, fall = 14%, and spring = 11%; intervention: baseline = 24%, fall = 24%, and spring = 23%) nor did measures of skin pigmentation. The intervention increased use of hats among fourth-grade students at school but had no effect on self-reported wide-brimmed hat use outside of school or on measures of skin pigmentation.

HYPERTENSION IMPROVEMENT PROJECT (HIP): RANDOMIZED TRIAL OF QUALITY IMPROVEMENT FOR PHYSICIANS AND LIFESTYLE MODIFICATION FOR PATIENTS

PubMed Central

Svetkey, Laura P.; Pollak, Kathryn I.; Yancy, William S.; Dolor, Rowena J.; Batch, Bryan C.; Samsa, Greg; Matchar, David B.; Lin, Pao-Hwa

2009-01-01

Despite widely publicized hypertension treatment guidelines for physicians and lifestyle recommendations for patients, blood pressure control rates remain low. In community-based primary care clinics, we performed a nested, 2×2 randomized, controlled trial of physician intervention vs. control and/or patient intervention vs. control. Physician Intervention included internet-based training, self-monitoring, and quarterly feedback reports. Patient Intervention included 20 weekly group sessions followed by 12 monthly phone counseling contacts, and focused on weight loss, DASH dietary pattern, exercise, and reduced sodium intake. The primary outcome was change in systolic blood pressure at 6 months. Eight primary care practices (32 physicians) were randomized to Physician Intervention or Control. Within those practices, 574 patients were randomized to Patient Intervention or Control. Patients’ mean age was 60 years, 61% female, 37% African American. BP data were available for 91% of patients at 6 months. The main effect of Physician Intervention on systolic blood pressure at 6 months, adjusted for baseline pressure, was 0.3 mmHg (95% CI −1.5 to 2.2; p = 0.72). The main effect of the Patient Intervention was −2.6 mmHg (95% CI −4.4, −0.7; p = 0.01). The interaction of the 2 interventions was significant (p = 0.03); the largest impact was observed with the combination of Physician and Patient Intervention (−9.7 ± 12.7 mmHg). Differences between treatment groups did not persist at 18 months. Combined physician and patient intervention lowers blood pressure; future research should focus on enhancing effectiveness and sustainability of these interventions. PMID:19920081

Effects of a behaviour change intervention for Girl Scouts on child and parent energy-saving behaviours

NASA Astrophysics Data System (ADS)

Boudet, Hilary; Ardoin, Nicole M.; Flora, June; Armel, K. Carrie; Desai, Manisha; Robinson, Thomas N.

2016-08-01

Energy education programmes for children are hypothesized to have great potential to save energy. Such interventions are often assumed to impact child and family behaviours. Here, using a cluster-randomized controlled trial with 30 Girl Scout troops in Northern California, we assess the efficacy of two social cognitive theory-based interventions focused on residential and food-and-transportation energy-related behaviours of Girl Scouts and their families. We show that Girl Scouts and parents in troops randomly assigned to the residential energy intervention significantly increased their self-reported residential energy-saving behaviours immediately following the intervention and after more than seven months of follow-up, compared with controls. Girl Scouts in troops randomly assigned to the food-and-transportation energy intervention significantly increased their self-reported food-and-transportation energy-saving behaviours immediately following the intervention, compared with controls, but not at follow-up. The results demonstrate that theory-based, child-focused energy interventions have the potential to increase energy-saving behaviours among both children and their parents.

A Randomized Controlled Trial of a Tailored Interactive Computer-Delivered Intervention to Promote Colorectal Cancer Screening: Sometimes More is Just the Same

PubMed Central

Bartholomew, Leona K.; McQueen, Amy; Bettencourt, Judy L.; Greisinger, Anthony; Coan, Sharon P.; Lairson, David; Chan, Wenyaw; Hawley, S. T.; Myers, R. E.

2012-01-01

Background There have been few studies of tailored interventions to promote colorectal cancer (CRC) screening. Purpose We conducted a randomized trial of a tailored, interactive intervention to increase CRC screening. Methods Patients 50–70 years completed a baseline survey, were randomized to one of three groups, and attended a wellness exam after being exposed to a tailored intervention about CRC screening (tailored group), a public web site about CRC screening (web site group), or no intervention (survey-only group). The primary outcome was completion of any recommended CRC screening by 6 months. Results There was no statistically significant difference in screening by 6 months: 30%, 31%, and 28% of the survey-only, web site, and tailored groups were screened. Exposure to the tailored intervention was associated with increased knowledge and CRC screening self-efficacy at 2 weeks and 6 months. Family history, prior screening, stage of change, and physician recommendation moderated the intervention effects. Conclusions A tailored intervention was not more effective at increasing screening than a public web site or only being surveyed. PMID:21271365

A Randomized Controlled Trial of Two Syntactic Treatment Procedures with Cantonese-Speaking, School-Age Children with Language Disorders

ERIC Educational Resources Information Center

To, Carol K. S.; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y. H

2015-01-01

Purpose: In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Method: Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment…

Parent-Mediated Intervention for One-Year-Olds Screened as At-Risk for Autism Spectrum Disorder: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Watson, Linda R.; Crais, Elizabeth R.; Baranek, Grace T.; Turner-Brown, Lauren; Sideris, John; Wakeford, Linn; Kinard, Jessica; Reznick, J. Steven; Martin, Katrina L.; Nowell, Sallie W.

2017-01-01

Theoretically, interventions initiated with at-risk infants prior to the point in time a definitive autism spectrum disorder (ASD) diagnosis can be made will improve outcomes. Pursuing this idea, we tested the efficacy of a parent-mediated early intervention called Adapted Responsive Teaching (ART) via a randomized controlled trial with 87…

Evaluation of a Randomized Intervention to Delay Sexual Initiation among Fifth-Graders Followed through the Sixth Grade

ERIC Educational Resources Information Center

Koo, Helen P.; Rose, Allison; El-Khorazaty, M. Nabil; Yao, Qing; Jenkins, Renee R.; Anderson, Karen M.; Davis, Maurice; Walker, Leslie R.

2011-01-01

US adolescents initiate sex at increasingly younger ages, yet few pregnancy prevention interventions for children as young as 10-12 years old have been evaluated. Sixteen Washington, DC schools were randomly assigned to intervention versus control conditions. Beginning in 2001/02 with fifth-grade students and continuing during the sixth grade,…

Evaluation of a Brief Parent Intervention Teaching Coping-Promoting Behavior for the Infant Immunization Context: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bustos, Theona; Jaaniste, Tiina; Salmon, Karen; Champion, G. David

2008-01-01

This study was designed to investigate whether a brief intervention encouraging parental coping-promoting talk within the treatment room would have beneficial effects on infant pain responses to an immunization injection. Infant-parent dyads were recruited from a 6-month immunization clinic and randomized to an intervention group (n = 25) or…

The Efficacy of Fast ForWord Language Intervention in School-Age Children with Language Impairment: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Gillam, Ronald B.; Loeb, Diane Frome; Hoffman, LaVae M.; Bohman, Thomas; Champlin, Craig A.; Thibodeau, Linda; Widen, Judith; Brandel, Jayne; Friel-Patti, Sandy

2008-01-01

Purpose: A randomized controlled trial was conducted to compare the language and auditory processing outcomes of children assigned to receive the Fast ForWord Language intervention (FFW-L) with the outcomes of children assigned to nonspecific or specific language intervention comparison treatments that did not contain modified speech. Method: Two…

Personality-Targeted Interventions Delay Uptake of Drinking and Decrease Risk of Alcohol-Related Problems when Delivered by Teachers

ERIC Educational Resources Information Center

O'Leary-Barrett, Maeve; Mackie, Clare J.; Castellanos-Ryan, Natalie; Al-Khudhairy, Nadia; Conrod, Patricia J.

2010-01-01

Objective: This trial examined the efficacy of teacher-delivered personality-targeted interventions for alcohol-misuse over a 6-month period. Method: This randomized controlled trial randomly allocated participating schools to intervention (n = 11) or control (n = 7) conditions. A total of 2,506 (mean age, 13.7 years) were assessed for elevated…

A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

ERIC Educational Resources Information Center

Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

2014-01-01

The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…

Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

ERIC Educational Resources Information Center

Wong, Virginia C. N.; Kwan, Queenie K.

2010-01-01

We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

"Right from the Start": Randomized Trial Comparing an Attachment Group Intervention to Supportive Home Visiting

ERIC Educational Resources Information Center

Niccols, Alison

2008-01-01

Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…

A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

ERIC Educational Resources Information Center

Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

2010-01-01

Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

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.

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

PubMed

Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

2015-11-01

To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse with Injured Emergency Department Patients

PubMed Central

Mello, Michael J.; Baird, Janette; Lee, Christina; Strezsak, Valerie; French, Michael T.; Longabaugh, Richard

2015-01-01

Objective This was a randomized controlled trial to test efficacy of a telephone intervention (TBMI) for injured ED patients with alcohol misuse to decrease alcohol use, impaired driving, alcohol-related injuries and alcohol-related negative consequences. Methods ED patients screening positive for alcohol misuse were randomized to a three-session telephone brief motivational intervention on alcohol (TBMI) delivered by a counselor trained in motivational interviewing over 6 weeks or a control intervention of a scripted home fire and burn safety education delivered in three calls. Patients were followed for 12 months and assessed for changes in alcohol use, impaired driving, alcohol-related injuries and alcohol-related negative consequences. Results 730 ED patients were randomized; 78% received their assigned intervention by telephone and of those, 72% completed 12 months assessments. There were no differential benefits of TBMI intervention versus assessment and a control intervention in all three variables of alcohol use (frequency of binge alcohol use over the prior 30 days, maximum number of drinks at one time in past 30 days, typical alcohol use in past 30 days), alcohol impaired driving, alcohol related injuries and alcohol-related negative consequences. Conclusions Despite the potential advantage of delivering a TBMI in not disrupting ED clinical care, our study found no efficacy for it over an assessment and control intervention. Potential etiologies for our finding include that injury itself or alcohol assessments, or the control intervention had active ingredients for alcohol change. PMID:26585044

Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Ngwane, Zolani; Zhang, Jingwen; Heeren, G Anita; Icard, Larry D; O'Leary, Ann; Mtose, Xoliswa; Teitelman, Anne; Carty, Craig

2014-07-01

To determine whether a health-promotion intervention increases South African men's adherence to physical-activity guidelines. We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007-2010. Data collectors, but not facilitators or participants, were blind to group assignment. Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR=1.34; 95% CI, 1.09-1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. A theory-based culturally congruent intervention increased South African men's self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. ClinicalTrials.gov Identifier: NCT01490359. Copyright © 2014 Elsevier Inc. All rights reserved.

Models of comorbidity for multifactorial disorders.

PubMed Central

Neale, M C; Kendler, K S

1995-01-01

We develop several formal models for comorbidity between multifactorial disorders. Based on the work of D. N. Klein and L. P. Riso, the models include (i) alternate forms, where the two disorders have the same underlying continuum of liability; (ii) random multiformity, in which affection status on one disorder abruptly increases risk for the second; (iii) extreme multiformity, where only extreme cases have an abruptly increased risk for the second disorder; (iv) three independent disorders, in which excess comorbid cases are due to a separate, third disorder; (v) correlated liabilities, where the risk factors for the two disorders correlate; and (vi) direct causal models, where the liability for one disorder is a cause of the other disorder. These models are used to make quantitative predictions about the relative proportions of pairs of relatives who are classified according to whether each relative has neither disorder, disorder A but not B, disorder B but not A, or both A and B. For illustration, we analyze data on major depression (MD) and generalized anxiety disorder (GAD) assessed in adult female MZ and DZ twins, which enable estimation of the relative impact of genetic and environmental factors. Several models are rejected--that comorbid cases are due to chance; multiformity of GAD; a third independent disorder; and GAD being a cause of MD. Of the models that fit the data, correlated liabilities, MD causes GAD, and reciprocal causation seem best. MD appears to be a source of liability for GAD. Possible extensions to the models are discussed. PMID:7573055

Development and Validation of a Multifactorial Treatment Outcome Measure for Eating Disorders.

ERIC Educational Resources Information Center

Anderson, Drew A.; Williamson, Donald A.; Duchmann, Erich G.; Gleaves, David H.; Barbin, Jane M.

1999-01-01

Developed a brief self-report inventory to evaluate treatment outcome for anorexia and bulimia nervosa, the Multifactorial Assessment of Eating Disorders, and evaluated the instrument in a series of studies involving 1,054 women. Results support a stable factor structure and satisfactory reliability and validity, and establish normative data. (SLD)

Functional disorders of the temporomandibular joints: Internal derangement of the temporomandibular joint.

PubMed

Chang, Chih-Ling; Wang, Ding-Han; Yang, Mu-Chen; Hsu, Wun-Eng; Hsu, Ming-Lun

2018-04-01

Temporomandibular joint (TMJ) is one of the most complex joints of the human body. Due to its unique movement, in terms of combination of rotation and translator movement, disc of the joint plays an important role to maintain its normal function. In order to sustain the normal function of the TMJ, disc must be kept in proper position as well as maintain normal shape in all circumstances. Once the disc is not any more in its normal position during function of the joint, disturbance of the joint can be occurred which will lead to subsequent distortion of the disc. Shape of the disc can be influenced by many factors i.e.: abnormal function or composition of the disc itself. Etiology of the internal derangement of the disc remains controversial. Multifactorial theory has been postulated in most of previous manuscripts. Disc is composed of mainly extracellular matrix. Abnormal proportion of collagen type I & III may also leads to joint hypermobility which may be also a predisposing factor of this disorder. Thus it can be recognized as local manifestation of a systemic disorder. Different treatment modalities with from conservative treatment to surgical intervention distinct success rate have been reported. Recently treatment with extracellular matrix injection becomes more and more popular to strengthen the joint itself. Since multifactorial in character, the best solution of the treatment modalities should be aimed to resolve possible etiology from different aspects. Team work may be indication to reach satisfied results. Copyright © 2018. Published by Elsevier Taiwan.

A Novel Approach to Proactive Primary Care-Based Case Finding and Multidisciplinary Management of Falls, Syncope, and Dizziness in a One-Stop Service: Preliminary Results.

PubMed

Parry, Steve W; Hill, Harry; Lawson, Joanna; Lawson, Nick; Green, David; Trundle, Heidi; McNaught, Judith; Strassheim, Victoria; Caldwell, Alma; Mayland, Richard; Earley, Phillip; McMeekin, Peter

2016-11-01

National and international evidence and guidelines on falls prevention and management in community-dwelling elderly adults recommend that falls services should be multifactorial and their interventions multicomponent. The way that individuals are identified as having had or being at risk of falls in order to take advantage of such services is far less clear. A novel multidisciplinary, multifactorial falls, syncope, and dizziness service model was designed with enhanced case ascertainment through proactive, primary care-based screening (of individual case notes of individuals aged ≥60) for individual fall risk factors. The service model identified 4,039 individuals, of whom 2,232 had significant gait and balance abnormalities according to senior physiotherapist assessment. Significant numbers of individuals with new diagnoses ranging from cognitive impairment to Parkinson's disease to urgent indications for a pacemaker were discovered. More than 600 individuals were found who were at high risk of osteoporosis according to World Health Association Fracture Risk Assessment Tool score, 179 with benign positional paroxysmal vertigo and 50 with atrial fibrillation. Through such screening and this approach, Comprehensive Geriatric Assessment Plus (Plus falls, syncope and dizziness expertise), unmet need was targeted on a scale far outside the numbers seen in clinical trials. Further work is needed to determine whether this approach translates into fewer falls and decreases in syncope and dizziness. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Baseline Telomere Length and Effects of a Multidomain Lifestyle Intervention on Cognition: The FINGER Randomized Controlled Trial

PubMed Central

Sindi, Shireen; Ngandu, Tiia; Hovatta, Iiris; Kåreholt, Ingemar; Antikainen, Riitta; Hänninen, Tuomo; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Paajanen, Teemu; Peltonen, Markku; Khalsa, Dharma Singh; Wolozin, Benjamin; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia; Solomon, Alina

2017-01-01

Leukocyte telomere length (LTL) is a biomarker of aging, and it is associated with lifestyle. It is currently unknown whether LTL is associated with the response to lifestyle interventions. The goal is to assess whether baseline LTL modified the cognitive benefits of a 2-year multidomain lifestyle intervention (exploratory analyses). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a 2-year randomized controlled trial including 1,260 people at risk of cognitive decline, aged 60–77 years identified from the general population. Participants were randomly assigned to the lifestyle intervention (diet, exercise, cognitive training, and vascular risk management) and control (general health advice) groups. Primary outcome was change in cognition (comprehensive neuropsychological test battery). Secondary outcomes were changes in cognitive domains: memory, executive functioning, and processing speed. 775 participants (392 control, 383 intervention) had baseline LTL (peripheral blood DNA). Mixed effects regression models with maximum likelihood estimation were used to analyze change in cognition as a function of randomization group, time, baseline LTL, and their interaction. Intervention and control groups did not significantly differ at baseline. Shorter LTL was related to less healthy baseline lifestyle. Intervention benefits on executive functioning were more pronounced among those with shorter baseline LTL (p-value for interaction was 0.010 adjusted for age and sex, and 0.007 additionally adjusted for baseline lifestyle factors). The FINGER intervention cognitive benefits were more pronounced with shorter baseline LTL, particularly for executive functioning, indicating that the multidomain lifestyle intervention was especially beneficial among higher-risk individuals. PMID:28777749

Cell phone Intervention for You (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology

PubMed Central

Svetkey, LP; Batch, BC; Lin, P-H; Intille, SS; Corsino, L; Tyson, CC; Bosworth, HB; Grambow, SC; Voils, C; Loria, C; Gallis, JA; Schwager, J; Bennett, GB

2015-01-01

Objectives To determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Methods Randomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. Results The 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months. Conclusions Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. Trial Registration ClinicalTrials.gov Identifier NCT01092364. https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3 PMID:26530929

Baseline Telomere Length and Effects of a Multidomain Lifestyle Intervention on Cognition: The FINGER Randomized Controlled Trial.

PubMed

Sindi, Shireen; Ngandu, Tiia; Hovatta, Iiris; Kåreholt, Ingemar; Antikainen, Riitta; Hänninen, Tuomo; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Paajanen, Teemu; Peltonen, Markku; Khalsa, Dharma Singh; Wolozin, Benjamin; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia; Solomon, Alina

2017-01-01

Leukocyte telomere length (LTL) is a biomarker of aging, and it is associated with lifestyle. It is currently unknown whether LTL is associated with the response to lifestyle interventions. The goal is to assess whether baseline LTL modified the cognitive benefits of a 2-year multidomain lifestyle intervention (exploratory analyses). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a 2-year randomized controlled trial including 1,260 people at risk of cognitive decline, aged 60-77 years identified from the general population. Participants were randomly assigned to the lifestyle intervention (diet, exercise, cognitive training, and vascular risk management) and control (general health advice) groups. Primary outcome was change in cognition (comprehensive neuropsychological test battery). Secondary outcomes were changes in cognitive domains: memory, executive functioning, and processing speed. 775 participants (392 control, 383 intervention) had baseline LTL (peripheral blood DNA). Mixed effects regression models with maximum likelihood estimation were used to analyze change in cognition as a function of randomization group, time, baseline LTL, and their interaction. Intervention and control groups did not significantly differ at baseline. Shorter LTL was related to less healthy baseline lifestyle. Intervention benefits on executive functioning were more pronounced among those with shorter baseline LTL (p-value for interaction was 0.010 adjusted for age and sex, and 0.007 additionally adjusted for baseline lifestyle factors). The FINGER intervention cognitive benefits were more pronounced with shorter baseline LTL, particularly for executive functioning, indicating that the multidomain lifestyle intervention was especially beneficial among higher-risk individuals.

Assessing the effectiveness and cost-effectiveness of audit and feedback on physician’s prescribing indicators: study protocol of a randomized controlled trial with economic evaluation

PubMed Central

2012-01-01

Background Physician prescribing is the most frequent medical intervention with a highest impact on healthcare costs and outcomes. Therefore improving and promoting rational drug use is a great interest. We aimed to assess the effectiveness and cost-effectiveness of two forms of conducting prescribing audit and feedback interventions and a printed educational material intervention in improving physician prescribing. Method/design A four-arm randomized trial with economic evaluation will be conducted in Tehran. Three interventions (routine feedback, revised feedback, and printed educational material) and a no intervention control arm will be compared. Physicians working in outpatient practices are randomly allocated to one of the four arms using stratified randomized sampling. The interventions are developed based on a review of literature, physician interviews, current experiences in Iran and with theoretical insights from the Theory of Planned Behavior. Effects of the interventions on improving antibiotics and corticosteroids prescribing will be assessed in regression analyses. Cost data will be assessed from a health care provider’s perspective and incremental cost-effectiveness ratios will be calculated. Discussion This study will determine the effectiveness and cost-effectiveness of three interventions and allow us to determine the most effective interventions in improving prescribing pattern. If the interventions are cost-effective, they will likely be applied nationwide. Trial registration Iranian Registry of Clinical Trials Registration Number: IRCT201106086740N1Pharmaceutical Sciences Research Center of TUMS Ethics Committee Registration Number: 90-02-27-07 PMID:23351564

A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students.

PubMed

Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi

2009-07-01

The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.

A Randomized Clinical Trial Evaluating a Combined Alcohol Intervention for High-Risk College Students*

PubMed Central

Turrisi, Rob; Larimer, Mary E.; Mallett, Kimberly A.; Kilmer, Jason R.; Ray, Anne E.; Mastroleo, Nadine R.; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W.; Montoya, Heidi

2009-01-01

Objective: The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Method: Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. Results: The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. Conclusions: The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session. PMID:19515296

Multifactorial disease risk calculator: Risk prediction for multifactorial disease pedigrees.

PubMed

Campbell, Desmond D; Li, Yiming; Sham, Pak C

2018-03-01

Construction of multifactorial disease models from epidemiological findings and their application to disease pedigrees for risk prediction is nontrivial for all but the simplest of cases. Multifactorial Disease Risk Calculator is a web tool facilitating this. It provides a user-friendly interface, extending a reported methodology based on a liability-threshold model. Multifactorial disease models incorporating all the following features in combination are handled: quantitative risk factors (including polygenic scores), categorical risk factors (including major genetic risk loci), stratified age of onset curves, and the partition of the population variance in disease liability into genetic, shared, and unique environment effects. It allows the application of such models to disease pedigrees. Pedigree-related outputs are (i) individual disease risk for pedigree members, (ii) n year risk for unaffected pedigree members, and (iii) the disease pedigree's joint liability distribution. Risk prediction for each pedigree member is based on using the constructed disease model to appropriately weigh evidence on disease risk available from personal attributes and family history. Evidence is used to construct the disease pedigree's joint liability distribution. From this, lifetime and n year risk can be predicted. Example disease models and pedigrees are provided at the website and are used in accompanying tutorials to illustrate the features available. The website is built on an R package which provides the functionality for pedigree validation, disease model construction, and risk prediction. Website: http://grass.cgs.hku.hk:3838/mdrc/current. © 2017 WILEY PERIODICALS, INC.

The effect of a health promotion intervention for construction workers on work-related outcomes: results from a randomized controlled trial.

PubMed

Viester, Laura; Verhagen, Evert A L M; Bongers, Paulien M; van der Beek, Allard J

2015-08-01

The objective of the present study is to investigate the effects of a worksite health promotion intervention on musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence. In a randomized controlled design, 314 construction workers were randomized into an intervention group (n = 162) receiving personal coaching, tailored information, and materials, and a control group (n = 152) receiving usual care. Sickness absence was recorded continuously in company records, and questionnaires were completed before, directly after the 6-month intervention period, and 12 months after baseline measurements. Linear and logistic regression analyses were performed to determine intervention effects. No significant changes at 6 or 12 months of follow-up were observed in musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence as a result of the intervention. This study shows that the intervention was not statistically significantly effective on secondary outcomes. Although the intervention improved physical activity, dietary, and weight-related outcomes, it was not successful in decreasing musculoskeletal symptoms and improving other work-related measures. Presumably, more multifaceted interventions are required to establish significant change in these outcomes.

Effects of a Worksite Tobacco Control Intervention in India: The Mumbai Worksite Tobacco Control Study, a Cluster Randomized Trial

PubMed Central

Sorensen, Glorian; Pednekar, Mangesh; Cordeira, Laura Shulman; Pawar, Pratibha; Nagler, Eve; Stoddard, Anne M.; Kim, Hae-Young; Gupta, Prakash C.

2016-01-01

Objectives We assessed a worksite intervention designed to promote tobacco control among manufacturing workers in Greater Mumbai, India. Methods We used a cluster-randomized design to test an integrated health promotion/health protection intervention, which addressed changes at the management and worker levels. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014. Results The difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, P=0.03), although not for the overall sample (OR=1.70; P=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; P=0.07) and for the overall sample (OR=1.81; P=0.13), but the difference did not reach statistical significance. Conclusions These findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites. PMID:26883793

Intervention-Based Stochastic Disease Eradication

NASA Astrophysics Data System (ADS)

Billings, Lora; Mier-Y-Teran-Romero, Luis; Lindley, Brandon; Schwartz, Ira

2013-03-01

Disease control is of paramount importance in public health with infectious disease extinction as the ultimate goal. Intervention controls, such as vaccination of susceptible individuals and/or treatment of infectives, are typically based on a deterministic schedule, such as periodically vaccinating susceptible children based on school calendars. In reality, however, such policies are administered as a random process, while still possessing a mean period. Here, we consider the effect of randomly distributed intervention as disease control on large finite populations. We show explicitly how intervention control, based on mean period and treatment fraction, modulates the average extinction times as a function of population size and the speed of infection. In particular, our results show an exponential improvement in extinction times even though the controls are implemented using a random Poisson distribution. Finally, we discover those parameter regimes where random treatment yields an exponential improvement in extinction times over the application of strictly periodic intervention. The implication of our results is discussed in light of the availability of limited resources for control. Supported by the National Institute of General Medical Sciences Award No. R01GM090204

Segregation analysis of apolipoproteins A-1 and B-100 measured before and after an exercise training program: the HERITAGE Family Study.

PubMed

An, P; Rice, T; Gagnon, J; Borecki, I B; Bergeron, J; Després, J P; Leon, A S; Skinner, J S; Wilmore, J H; Bouchard, C; Rao, D C

2000-03-01

Complex segregation analyses of apolipoproteins (apo) A-1 and B-100 were performed in a sample of 520 individuals from 99 white families who participated in the HERITAGE Family Study. In these sedentary families, plasma apo A-1 and B-100 concentrations were measured before and after a 20-week endurance exercise training program. Baseline apo A-1 and B-100 were adjusted for the effects of age (age-adjusted baseline apo A-1 and B-100) and for the effects of age and BMI (age-BMI-adjusted baseline apo A-1 and B-100). The change in response to training was computed as a simple Delta (posttraining minus baseline) and was adjusted for age and the baseline (age-baseline-adjusted apo A-1 and B-100 responses to training). In the present study, a major gene could not be inferred for baseline apo A-1. Rather, we found a major effect along with a multifactorial effect accounting for 8% to 9% and 51% to 56% of the variance, respectively. In addition, no clear evidence supported a major-gene effect for its response to training, whereas the transmission of a major effect from parents to offspring was ambiguous, ie, genetic in nature or familial environmental in origin. The major effect accounted for 15% of the variance, with an additional 21% and 58% of the variance being accounted for by a multifactorial effect in parents and offspring, respectively. It is interesting to have obtained evidence of a putative recessive major locus for baseline apo B-100, which accounted for 50% to 56% of the variance, with an additional 25% to 29% of the variance due to a multifactorial effect. In contrast, no major effect for its response to training was identified, although a multifactorial effect was found that accounted for 27% of the variance. The novel findings arising from the present study are summarized as follows. Baseline apo A-1 and its response to training were influenced by a major effect and a multifactorial effect. Baseline apo B-100 was influenced by a putative major recessive gene with a multifactorial component, but its response to training was influenced solely by a multifactorial component in these sedentary families.

Effects of web-based instruction and patient preferences on patient-reported outcomes and learning for women with advanced ovarian cancer: A randomized controlled trial.

PubMed

Petzel, Sue V; Isaksson Vogel, Rachel; Cragg, Julie; McClellan, Molly; Chan, Daniel; Jacko, Julie A; Sainfort, François; Geller, Melissa A

2018-05-23

A randomized controlled trial was conducted of a web-based intervention to improve advanced care planning in women with ovarian cancer. A secondary analysis of 35 randomized women focused on changes in distress and knowledge about ovarian cancer through distress monitoring and information tailored to patients' cognitive coping style (monitoring, blunting). Pre-/postresults indicated the Intervention group demonstrated lower distress (p = 0.06); blunting was associated with lower depression (p = 0.04); knowledge in both groups was unchanged. Women in the Intervention vs. Control group reported their family was less likely to be upset by cancer information (p = 0.0004). This intervention reduced distress while incorporating patient preferences.

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

Systematic review and meta-analysis of music interventions in hypertension treatment: a quest for answers.

PubMed

Kühlmann, Anne Y R; Etnel, Jonathan R G; Roos-Hesselink, Jolien W; Jeekel, Johannes; Bogers, Ad J J C; Takkenberg, Johanna J M

2016-04-19

Adverse effects, treatment resistance and high costs associated with pharmacological treatment of hypertension have led to growing interest in non-pharmacological complementary therapies such as music interventions. This meta-analysis aims to provide an overview of reported evidence on the efficacy of music interventions in the treatment of hypertension. A systematic literature search was conducted for publications on the effect of music interventions on blood pressure in adult hypertensive subjects published between January 1990-June 2014. Randomized controlled trials with a follow-up duration ≥28 days were included. Blood pressure measures were pooled using inverse variance weighting. Of the 1689 abstracts reviewed, 10 randomized controlled trials were included. Random-effects pooling of the music intervention groups showed a trend toward a decrease in mean systolic blood pressure (SBP) from 144 mmHg(95 % CI:137-152) to 134 mmHg(95 % CI:124-144), and in mean diastolic blood pressure (DBP) from 84 mmHg(95 % CI:78-89) to 78 mmHg(95 % CI:73-84). Fixed-effect analysis of a subgroup of 3 trials with valid control groups showed a significant decrease in pooled mean SBP and DBP in both intervention and control groups. A comparison between music intervention groups and control groups was not possible due to unavailable measures of dispersion. This systematic review and meta-analysis revealed a trend towards a decrease in blood pressure in hypertensive patients who received music interventions, but failed to establish a cause-effect relationship between music interventions and blood pressure reduction. Considering the potential value of this safe, low-cost intervention, well-designed, high quality and sufficiently powered randomized studies assessing the efficacy of music interventions in the treatment of hypertension are warranted.

[Non-randomized evaluation studies (TREND)].

PubMed

Vallvé, Carles; Artés, Maite; Cobo, Erik

2005-12-01

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

Examining the Minimal Required Elements of a Computer-Tailored Intervention Aimed at Dietary Fat Reduction: Results of a Randomized Controlled Dismantling Study

ERIC Educational Resources Information Center

Kroeze, Willemieke; Oenema, Anke; Dagnelie, Pieter C.; Brug, Johannes

2008-01-01

This study investigated the minimally required feedback elements of a computer-tailored dietary fat reduction intervention to be effective in improving fat intake. In all 588 Healthy Dutch adults were randomly allocated to one of four conditions in an randomized controlled trial: (i) feedback on dietary fat intake [personal feedback (P feedback)],…

Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

ERIC Educational Resources Information Center

Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

2010-01-01

The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

A Comprehensive Peer Network Intervention to Improve Social Communication of Children with Autism Spectrum Disorders: A Randomized Trial in Kindergarten and First Grade

ERIC Educational Resources Information Center

Kamps, Debra; Thiemann-Bourque, Kathy; Heitzman-Powell, Linda; Schwartz, Ilene; Rosenberg, Nancy; Mason, Rose; Cox, Suzanne

2015-01-01

The purpose of this randomized control group study was to examine the effects of a peer network intervention that included peer mediation and direct instruction for Kindergarten and First-grade children with autism spectrum disorders. Trained school staff members provided direct instruction for 56 children in the intervention group, and 39…

A Randomized Controlled Trial of the Social Tools and Rules for Teens (START) Program: An Immersive Socialization Intervention for Adolescents with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Vernon, Ty W.; Miller, Amber R.; Ko, Jordan A.; Barrett, Amy C.; McGarry, Elizabeth S.

2018-01-01

Adolescents with ASD face numerous personal and contextual barriers that impede the development of social motivation and core competencies, warranting the need for targeted intervention. A randomized controlled trial was conducted with 40 adolescents to evaluate the merits of a multi-component socialization intervention that places emphasis on…

A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

ERIC Educational Resources Information Center

Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

2016-01-01

Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

A Randomized Controlled Trial of a Home-Visiting Intervention Aimed at Preventing Relationship Problems in Depressed Mothers and Their Infants

ERIC Educational Resources Information Center

van Doesum, Karin T. M.; Riksen-Walraven, J. Marianne; Hosman, Clemens M. H.; Hoefnagels, Cees

2008-01-01

This study examined the effect of a mother-baby intervention on the quality of mother-child interaction, infant-mother attachment security, and infant socioemotional functioning in a group of depressed mothers with infants aged 1-12 months. A randomized controlled trial compared an experimental group (n = 35) receiving the intervention (8-10 home…

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.

The effect of a knowledge-based ergonomic intervention amongst administrators at Aga Khan University Hospital, Nairobi.

PubMed

Wanyonyi, Nancy; Frantz, Jose; Saidi, Hassan

2015-01-01

Low back pain (LBP) and neck pain are part of the common work-related musculoskeletal disorders with a large impact on the affected person. Despite having a multifactorial aetiology, ergonomic factors play a major role thus necessitating workers' education. To determine the prevalence of ergonomic-related LBP and neck pain, and describe the effect of a knowledge-based ergonomic intervention amongst administrators in Aga Khan University Hospital, Nairobi. This study applied a mixed method design utilizing a survey and two focus group discussions (FGD). A self-administered questionnaire was distributed to 208 participants through systematic sampling. A one hour knowledge-based ergonomic session founded on the survey results was thereafter administered to interested participants, followed by two FGDs a month later with purposive selection of eight participants to explore their experience of the ergonomic intervention. Quantitative data was captured and analyzed using SPSS by means of descriptive and inferential statistics, whereas thematic content analysis was used for qualitative data. Most participants were knowledgeable about ergonomic-related LBP and neck pain with a twelve month prevalence of 75.5% and 67.8% respectively. Continual ergonomic education is necessary for adherence to health-related behaviours that will preventwork-related LBP and neck pain.

Evidence-based exercise prescription for balance and falls prevention: a current review of the literature.

PubMed

Shubert, Tiffany E

2011-01-01

Falls are the leading cause of emergency department visits, hospital admissions, and unintentional death for older adults. Balance and strength impairments are common falls risk factors for community-dwelling older adults. Though physical therapists commonly treat balance and strength, standardized falls screening has not been fully incorporated into physical therapy practice and there is much variation in the frequency, intensity, and duration of therapy prescribed to achieve optimal results. For community-dwelling older adults, a progressive exercise program that focuses on moderate to high-intensity balance exercises appears to be one of the most effective interventions to prevent falls. For more frail older adults in institutional settings, exercise programs in addition to multifactorial interventions appear to show promise as effective falls prevention interventions. The minimum dose of exercise to protect an older adult against falls is 50 hours. This article describes the current best practices for physical therapists to effectively improve balance and manage falls risk in patients. The unique challenges and opportunities for physical therapists to incorporate evidence-based fall-prevention strategies are discussed. Innovative practice models incorporating evidence-based fall-prevention programs and partnerships with public health and aging service providers to create a continuum of care and achieve the optimal dose of balance training are presented.

Relapse prevention interventions for smoking cessation.

PubMed

Hajek, Peter; Stead, Lindsay F; West, Robert; Jarvis, Martin; Hartmann-Boyce, Jamie; Lancaster, Tim

2013-08-20

A number of treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. Several interventions have been proposed to help prevent relapse. To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking. We searched the Cochrane Tobacco Addiction Group trials register in May 2013 for studies mentioning relapse prevention or maintenance in title, abstracts or keywords. Randomized or quasi-randomized controlled trials of relapse prevention interventions with a minimum follow-up of six months. We included smokers who quit on their own, were undergoing enforced abstinence, or were participating in treatment programmes. We included trials that compared relapse prevention interventions with a no intervention control, or that compared a cessation programme with additional relapse prevention components with a cessation programme alone. Studies were screened and data extracted by one review author, and checked by a second. Disagreements were resolved by discussion or by referral to a third review author. Sixty-three studies met inclusion criteria but were heterogeneous in terms of populations and interventions. We considered 41 studies that randomly assigned abstainers separately from studies that randomly assigned participants before their quit date.Upon looking at studies of behavioural interventions that randomly assigned abstainers, we detected no benefit of brief and 'skills-based' relapse prevention methods for women who had quit smoking because of pregnancy, or for smokers undergoing a period of enforced abstinence during hospitalisation or military training. We also failed to detect significant effects of behavioural interventions in trials in unselected groups of smokers who had quit on their own or through a formal programme. Amongst trials randomly assigning smokers before their quit date and evaluating the effects of additional relapse prevention components, we found no evidence of benefit of behavioural interventions or combined behavioural and pharmacotherapeutic interventions in any subgroup. Overall, providing training in skills thought to be needed for relapse avoidance did not reduce relapse, but most studies did not use experimental designs best suited to the task and had limited power to detect expected small differences between interventions. For pharmacological interventions, extended treatment with varenicline significantly reduced relapse in one trial (risk ratio (RR) 1.18, 95% confidence interval (CI) 1.03 to 1.36). Pooling of six studies of extended treatment with bupropion failed to detect a significant effect (RR 1.15, 95% CI 0.98 to 1.35). Two small trials of oral nicotine replacement treatment (NRT) failed to detect an effect, but treatment compliance was low, and in two other trials of oral NRT in which short-term abstainers were randomly assigned, a significant effect of intervention was noted. At the moment, there is insufficient evidence to support the use of any specific behavioural intervention to help smokers who have successfully quit for a short time to avoid relapse. The verdict is strongest for interventions focused on identifying and resolving tempting situations, as most studies were concerned with these. Little research is available regarding other behavioural approaches.Extended treatment with varenicline may prevent relapse. Extended treatment with bupropion is unlikely to have a clinically important effect. Studies of extended treatment with nicotine replacement are needed.

Lifestyle interventions to reduce risk of diabetes among women with prior gestational diabetes mellitus.

PubMed

Chasan-Taber, Lisa

2015-01-01

While lifestyle interventions involving exercise and a healthy diet in high-risk adults have been found to reduce progression to type 2 diabetes by >50%, little attention has been given to the potential benefits of such strategies in women with a history of gestational diabetes mellitus (GDM). We conducted a literature search of PubMed for English language studies of randomized controlled trials of lifestyle interventions among women with a history of GDM. In total, nine studies were identified which fulfilled the eligibility criteria. The majority of randomized trials of lifestyle interventions in women with GDM have been limited to pilot or feasibility studies. However, preliminary findings suggest that such interventions can improve diabetes risk factors in women with a history of GDM. Larger, well-designed controlled randomized trials are needed to assess the effects of lifestyle interventions on preventing subsequent progression to type 2 diabetes among women with GDM. Copyright © 2014 Elsevier Ltd. All rights reserved.

Regulatory competence and social communication in term and preterm infants at 12 months corrected age. Results from a randomized controlled trial.

PubMed

Olafsen, Kåre S; Rønning, John A; Handegård, Bjørn Helge; Ulvund, Stein Erik; Dahl, Lauritz Bredrup; Kaaresen, Per Ivar

2012-02-01

Temperamental regulatory competence and social communication in term and preterm infants at 12 months corrected age was studied in a randomized controlled intervention trial aimed at enhancing maternal sensitive responsiveness. Surviving infants <2000 g from a geographically defined area were randomized to an intervention (71) or a control group (69), and compared with term infants (74). The intervention was a modified version of the "Mother-Infant Transaction Program". Regulatory competence was measured with the Infant Behavior Questionnaire, and social communication with the Early Social Communication Scales. Preterm intervention infants with low regulatory competence had higher responding to joint attention than preterm control infants. A sensitizing intervention may moderate the association between temperament and social communication, and thus allow an alternative functional outlet for preterm infants low in regulatory competence. The finding may have implications for conceptualizations of the role of early sensitizing interventions in promoting important developmental outcomes for premature infants. Copyright © 2011 Elsevier Inc. All rights reserved.

The effect of obesity, weight gain, and weight loss on asthma inception and control.

PubMed

Forno, Erick; Celedón, Juan C

2017-04-01

There is ample and growing evidence that obesity increases the risk of asthma and morbidity from asthma. Here, we review recent clinical evidence supporting a causal link between obesity and asthma, and the mechanisms that may lead to 'obese asthma'. Although in some children obesity and asthma simply co-occur, those with 'obese asthma' have increased asthma severity, lower quality of life, and reduced medication response. Underlying mechanistic pathways may include anatomical changes of the airways such as obstruction and dysanapsis, systemic inflammation, production of adipokines, impaired glucose-insulin metabolism, altered nutrient levels, genetic and epigenetic changes, and alterations in the airway and/or gut microbiome. A few small studies have shown that weight loss interventions may lead to improvements in asthma outcomes, but thus far research on therapeutic interventions for these children has been limited. Obesity increases the risk of asthma - and worsens asthma severity or control - via multiple mechanisms. 'Obese asthma' is a complex, multifactorial phenotype in children. Obesity and its complications must be managed as part of the treatment of asthma in obese children.

Aging, neurogenesis, and caloric restriction in different model organisms.

PubMed

Arslan-Ergul, Ayca; Ozdemir, A Tugrul; Adams, Michelle M

2013-08-01

Brain aging is a multifactorial process that is occurring across multiple cognitive domains. A significant complaint that occurs in the elderly is a decrement in learning and memory ability. Both rodents and zebrafish exhibit a similar problem with memory during aging. The neurobiological changes that underlie this cognitive decline are complex and undoubtedly influenced by many factors. Alterations in the birth of new neurons and neuron turnover may contribute to age-related cognitive problems. Caloric restriction is the only non-genetic intervention that reliably increases life span and healthspan across multiple organisms although the molecular mechanisms are not well-understood. Recently the zebrafish has become a popular model organism for understanding the neurobiological consequences but to date very little work has been performed. Similarly, few studies have examined the effects of dietary restriction in zebrafish. Here we review the literature related to memory decline, neurogenesis, and caloric restriction across model organisms and suggest that zebrafish has the potential to be an important animal model for understanding the complex interactions between age, neurobiological changes in the brain, and dietary regimens or their mimetics as interventions.

Mediterranean Diet and Multi-Ingredient-Based Interventions for the Management of Non-Alcoholic Fatty Liver Disease

PubMed Central

Suárez, Manuel; Boqué, Noemí; del Bas, Josep M.; Arola, Lluís; Caimari, Antoni

2017-01-01

Non-alcoholic fatty liver disease (NAFLD) comprises a wide spectrum of hepatic disorders, from simple steatosis to hepatic necro-inflammation leading to non-alcoholic steatohepatitis (NASH). Although the prevalence of these multifactorial pathologies is continuously increasing in the population, there is still not an established methodology for their treatment other than weight loss and a change in lifestyle habits, such as a hypocaloric diet and physical exercise. In this framework, there is increasing evidence that several food bioactives and dietary patterns are effective for reversing and preventing the onset of these pathologies. Some studies have claimed that better responses are obtained when treatments are performed under a multifaceted approach, using different bioactive compounds that act against complementary targets. Thus, in this work, current strategies for treating NAFLD and NASH based on multi-ingredient-based supplements or the Mediterranean diet, a dietary pattern rich in bioactive compounds, are reviewed. Furthermore, the usefulness of omics techniques to design effective multi-ingredient nutritional interventions and to predict and monitor their response against these disorders is also discussed. PMID:28937599

Effect of a social intervention of choice vs. control on depressive symptoms, melancholy, feeling of loneliness, and perceived togetherness in older Finnish people: a randomized controlled trial.

PubMed

Pynnönen, Katja; Törmäkangas, Timo; Rantanen, Taina; Tiikkainen, Pirjo; Kallinen, Mauri

2018-01-01

This study examined effects of a social intervention on depressive symptoms, melancholy, loneliness, and perceived togetherness in community-dwelling Finnish older people. Promotion of mental well-being in older people (GoodMood; ISRCTN78426775) was a single-blinded randomized control trial lasting 1.5 years. Two hundred and twenty-three persons aged 75-79 years reporting symptoms of loneliness or melancholy were randomized into intervention and control groups. The intervention group was allowed to choose among supervised exercise, social activity, or personal counseling. Follow-up measurements were conducted at the end of 6-month intervention, and at 3, 6, and 12 months post intervention. Number of depressive symptoms remained unchanged, while loneliness and melancholy decreased in both the intervention and control groups during the study (p < 0.001). Social integration increased in the intervention group but not in controls (p = 0.041). Attachment and guidance increased in both groups (p < 0.001). The intervention did not alleviate depressed mood. Positive changes over time were observed in loneliness, feelings of melancholy, attachment, and guidance but these occurred independently of the intervention. Our secondary analysis suggests that the intervention increased perceived social integration. In sum, the effects of the intervention were moderate only and did not expedite further overcoming depressive mood or loneliness.

Zero-inflated count models for longitudinal measurements with heterogeneous random effects.

PubMed

Zhu, Huirong; Luo, Sheng; DeSantis, Stacia M

2017-08-01

Longitudinal zero-inflated count data arise frequently in substance use research when assessing the effects of behavioral and pharmacological interventions. Zero-inflated count models (e.g. zero-inflated Poisson or zero-inflated negative binomial) with random effects have been developed to analyze this type of data. In random effects zero-inflated count models, the random effects covariance matrix is typically assumed to be homogeneous (constant across subjects). However, in many situations this matrix may be heterogeneous (differ by measured covariates). In this paper, we extend zero-inflated count models to account for random effects heterogeneity by modeling their variance as a function of covariates. We show via simulation that ignoring intervention and covariate-specific heterogeneity can produce biased estimates of covariate and random effect estimates. Moreover, those biased estimates can be rectified by correctly modeling the random effects covariance structure. The methodological development is motivated by and applied to the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study, the largest clinical trial of alcohol dependence performed in United States with 1383 individuals.

A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students.

PubMed

Saravanan, Coumaravelou; Kingston, Rajiah

2014-05-01

Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1(st) year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P < 0.01) and high intrinsic and extrinsic motivation (P < 0.01) in the postassessment compared with their preassessment scores. Overall psychological intervention is effective to reduce anxiety scores and its related variables.

Telehealth methods to deliver multifactorial dietary interventions in adults with chronic disease: a systematic review protocol.

PubMed

Kelly, Jaimon T; Reidlinger, Dianne P; Hoffmann, Tammy C; Campbell, Katrina L

2015-12-22

The long-term management of chronic diseases requires adoption of complex dietary recommendations, which can be facilitated by regular coaching to support sustained behaviour change. Telehealth interventions can overcome patient-centred barriers to accessing face-to-face programs and provide feasible delivery methods, ubiquitous and accessible regardless of geographic location. The protocol for this systematic review explains the methods that will be utilised to answer the review question of whether telehealth interventions are effective at promoting change in dietary intake and improving diet quality in people with chronic disease. A structured search of Medline, EMBASE, CINAHL, and PsychINFO, from their inception, will be conducted. We will consider randomised controlled trials which evaluate complex dietary interventions in adults with chronic disease. Studies must provide diet education in an intervention longer than 4 weeks in duration, and at least half of the intervention contact must be delivered via telehealth. Comparisons will be made against usual care or a non-telehealth intervention. The primary outcome of interest is dietary change with secondary outcomes relating to clinical markers pre-specified in the methodology. The process for selecting studies, extracting data, and resolving conflicts will follow a set protocol. Two authors will independently appraise the studies and extract the data, using specified methods. Meta-analyses will be conducted where appropriate, with parameters for determining statistical heterogeneity pre-specified. The GRADE tool will be used for determining the quality of evidence for analysed outcomes. To date, there has been a considerable variability in the strategies used to deliver dietary education, and the overall effectiveness of telehealth dietary interventions for facilitating dietary change has not been reviewed systematically in adults with chronic disease. A systematic synthesis of telehealth strategies will inform the development of evidence-based telehealth programs that can be tailored to deliver dietary interventions specific to chronic disease conditions. PROSPERO CRD42015026398.

Interventions to reduce medication errors in neonatal care: a systematic review

PubMed Central

Nguyen, Minh-Nha Rhylie; Mosel, Cassandra

2017-01-01

Background: Medication errors represent a significant but often preventable cause of morbidity and mortality in neonates. The objective of this systematic review was to determine the effectiveness of interventions to reduce neonatal medication errors. Methods: A systematic review was undertaken of all comparative and noncomparative studies published in any language, identified from searches of PubMed and EMBASE and reference-list checking. Eligible studies were those investigating the impact of any medication safety interventions aimed at reducing medication errors in neonates in the hospital setting. Results: A total of 102 studies were identified that met the inclusion criteria, including 86 comparative and 16 noncomparative studies. Medication safety interventions were classified into six themes: technology (n = 38; e.g. electronic prescribing), organizational (n = 16; e.g. guidelines, policies, and procedures), personnel (n = 13; e.g. staff education), pharmacy (n = 9; e.g. clinical pharmacy service), hazard and risk analysis (n = 8; e.g. error detection tools), and multifactorial (n = 18; e.g. any combination of previous interventions). Significant variability was evident across all included studies, with differences in intervention strategies, trial methods, types of medication errors evaluated, and how medication errors were identified and evaluated. Most studies demonstrated an appreciable risk of bias. The vast majority of studies (>90%) demonstrated a reduction in medication errors. A similar median reduction of 50–70% in medication errors was evident across studies included within each of the identified themes, but findings varied considerably from a 16% increase in medication errors to a 100% reduction in medication errors. Conclusion: While neonatal medication errors can be reduced through multiple interventions aimed at improving the medication use process, no single intervention appeared clearly superior. Further research is required to evaluate the relative cost-effectiveness of the various medication safety interventions to facilitate decisions regarding uptake and implementation into clinical practice. PMID:29387337

Using Behavioral Analytics to Increase Exercise: A Randomized N-of-1 Study.

PubMed

Yoon, Sunmoo; Schwartz, Joseph E; Burg, Matthew M; Kronish, Ian M; Alcantara, Carmela; Julian, Jacob; Parsons, Faith; Davidson, Karina W; Diaz, Keith M

2018-04-01

This intervention study used mobile technologies to investigate whether those randomized to receive a personalized "activity fingerprint" (i.e., a one-time tailored message about personal predictors of exercise developed from 6 months of observational data) increased their physical activity levels relative to those not receiving the fingerprint. A 12-month randomized intervention study. From 2014 to 2015, 79 intermittent exercisers had their daily physical activity assessed by accelerometry (Fitbit Flex) and daily stress experience, a potential predictor of exercise behavior, was assessed by smartphone. Data collected during the first 6 months of observation were used to develop a person-specific "activity fingerprint" (i.e., N-of-1) that was subsequently sent via email on a single occasion to randomized participants. Pre-post changes in the percentage of days exercised were analyzed within and between control and intervention groups. The control group significantly decreased their proportion of days exercised (10.5% decrease, p<0.0001) following randomization. By contrast, the intervention group showed a nonsignificant decrease in the proportion of days exercised (4.0% decrease, p=0.14). Relative to the decrease observed in the control group, receipt of the activity fingerprint significantly increased the likelihood of exercising in the intervention group (6.5%, p=0.04). This N-of-1 intervention study demonstrates that a one-time brief message conveying personalized exercise predictors had a beneficial effect on exercise behavior among urban adults. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Changing Friend Selection in Middle School: A Social Network Analysis of a Randomized Intervention Study Designed to Prevent Adolescent Problem Behavior.

PubMed

DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J

2016-04-01

Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school-based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends 5 years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum-one level of the Family Check-up model-on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n = 500) was randomly assigned to the intervention, and the other half (n = 498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within school 1 but not within schools 2 or 3. The effects of friend selection in school 1 translated into reductions in observed deviancy training 5 years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study, the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance 5 years later.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

A Pilot Study of Parent Mentors for Early Childhood Obesity.

PubMed

Foster, Byron A; Aquino, Christian A; Gil, Mario; Gelfond, Jonathan A L; Hale, Daniel E

2016-01-01

Objective. To assess the feasibility of a parent mentor model of intervention for early childhood obesity using positive deviance-based methods to inform the intervention. Methods. In this pilot, randomized clinical trial, parent-child dyads (age: 2-5) with children whose body mass index (BMI) was ≥95th percentile were randomized to parent mentor intervention or community health worker comparison. The child's height and weight were measured at baseline, after the six-month intervention, and six months after the intervention. Feasibility outcomes were recruitment, participation, and retention. The primary clinical outcome was BMI z-score change. Results. Sixty participants were enrolled, and forty-eight completed the six-month intervention. At baseline, the BMI z-score in the parent mentor group was 2.63 (SD = 0.65) and in the community health worker group it was 2.61 (SD = 0.89). For change in BMI z-score over time, there was no difference by randomization group at the end of the intervention: -0.02 (95% CI: -0.26, 0.22). At the end of the intervention, the BMI z-score for the parent mentor group was 2.48 (SD = 0.58) and for the community health worker group it was 2.45 (SD = 0.91), both reduced from baseline, p < 0.001. Conclusion. The model of a parent mentor clinical trial is feasible, and both randomized groups experienced small, sustained effects on adiposity in an obese, Hispanic population.

Interventions for reducing fear of childbirth: A systematic review and meta-analysis of clinical trials.

PubMed

MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh

2017-11-07

Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I 2 index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

The Family Navigator: A Pilot Intervention to Support Intensive Care Unit Family Surrogates.

PubMed

Torke, Alexia M; Wocial, Lucia D; Johns, Shelley A; Sachs, Greg A; Callahan, Christopher M; Bosslet, Gabriel T; Slaven, James E; Perkins, Susan M; Hickman, Susan E; Montz, Kianna; Burke, Emily S

2016-11-01

Communication problems between family surrogates and intensive care unit (ICU) clinicians have been documented, but few interventions are effective. Nurses have the potential to play an expanded role in ICU communication and decision making. To conduct a pilot randomized controlled trial of the family navigator (FN), a distinct nursing role to address family members' unmet communication needs early in an ICU stay. An interprofessional team developed the FN protocol. A randomized controlled pilot intervention trial of the FN was performed in a tertiary referral hospital's ICU to test the feasibility and acceptability of the intervention. The intervention addressed informational and emotional communication needs through daily contact by using structured clinical updates, emotional and informational support modules, family meeting support, and follow-up phone calls. Twenty-six surrogate/patient pairs (13 per study arm) were enrolled. Surrogates randomized to the intervention had contact with the FN on 90% or more of eligible patient days. All surrogates agreed that they would recom mend the FN to other families. Open-ended comments from both surrogates and clinicians were uniformly positive. Having a fully integrated nurse empowered to facilitate decision making is a feasible intervention in an ICU and is well-received by ICU families and staff. A larger randomized controlled trial is needed to demonstrate impact on important outcomes, such as surrogates' well-being and decision quality. ©2016 American Association of Critical-Care Nurses.

Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial

PubMed Central

Ephraim, Patti L.; Hill-Briggs, Felicia; Roter, Debra; Bone, Lee; Wolff, Jennifer; Lewis-Boyer, LaPricia; Levine, David; Aboumatar, Hanan; Cooper, Lisa A; Fitzpatrick, Stephanie; Gudzune, Kimberly; Albert, Michael; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary; Fagan, Peter; Ramamurthi, Hema; Ameling, Jessica; Charlston, Jeanne; Sam, Tanyka; Carson, Kathryn A.; Wang, Nae-Yuh; Crews, Deidra; Greer, Raquel; Sneed, Valerie; Flynn, Sarah J.; DePasquale, Nicole; Boulware, L. Ebony

2014-01-01

Background Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. Methods/Design We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months. Discussion Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control. PMID:24956323

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

PubMed

Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

2014-07-01

Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

Learning Petri net models of non-linear gene interactions.

PubMed

Mayo, Michael

2005-10-01

Understanding how an individual's genetic make-up influences their risk of disease is a problem of paramount importance. Although machine-learning techniques are able to uncover the relationships between genotype and disease, the problem of automatically building the best biochemical model or "explanation" of the relationship has received less attention. In this paper, I describe a method based on random hill climbing that automatically builds Petri net models of non-linear (or multi-factorial) disease-causing gene-gene interactions. Petri nets are a suitable formalism for this problem, because they are used to model concurrent, dynamic processes analogous to biochemical reaction networks. I show that this method is routinely able to identify perfect Petri net models for three disease-causing gene-gene interactions recently reported in the literature.

Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial.

PubMed

Jakicic, John M; Davis, Kelliann K; Rogers, Renee J; King, Wendy C; Marcus, Marsha D; Helsel, Diane; Rickman, Amy D; Wahed, Abdus S; Belle, Steven H

2016-09-20

Effective long-term treatments are needed to address the obesity epidemic. Numerous wearable technologies specific to physical activity and diet are available, but it is unclear if these are effective at improving weight loss. To test the hypothesis that, compared with a standard behavioral weight loss intervention (standard intervention), a technology-enhanced weight loss intervention (enhanced intervention) would result in greater weight loss. Randomized clinical trial conducted at the University of Pittsburgh and enrolling 471 adult participants between October 2010 and October 2012, with data collection completed by December 2014. Participants were placed on a low-calorie diet, prescribed increases in physical activity, and had group counseling sessions. At 6 months, the interventions added telephone counseling sessions, text message prompts, and access to study materials on a website. At 6 months, participants randomized to the standard intervention group initiated self-monitoring of diet and physical activity using a website, and those randomized to the enhanced intervention group were provided with a wearable device and accompanying web interface to monitor diet and physical activity. The primary outcome of weight was measured over 24 months at 6-month intervals, and the primary hypothesis tested the change in weight between 2 groups at 24 months. Secondary outcomes included body composition, fitness, physical activity, and dietary intake. Among the 471 participants randomized (body mass index [BMI], 25 to <40; age range, 18-35 years; 28.9% nonwhite, 77.2% women), 470 (233 in the standard intervention group, 237 in the enhanced intervention group) initiated the interventions as randomized, and 74.5% completed the study. For the enhanced intervention group, mean base line weight was 96.3 kg (95% CI, 94.2-98.5) and 24-month weight 92.8 kg (95% CI, 90.6- 95.0) [corrected]. For the standard intervention group, mean baseline weight was 95.2kg (95%CI,93.0-97.3)and24-month weight was 89.3 kg (95%CI, 87.1-91.5) [corrected]. Weight change at 24 months differed significantly by intervention group (estimated mean weight loss, 3.5 kg [95% CI, 2.6-4.5} in the enhanced intervention group and 5.9 kg [95% CI, 5.0-6.8] in the standard intervention group; difference, 2.4 kg [95% CI, 1.0-3.7]; P = .002). Both groups had significant improvements in body composition, fitness, physical activity, and diet, with no significant difference between groups. Among young adults with a BMI between 25 and less than 40, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months. Devices that monitor and provide feedback on physical activity may not offer an advantage over standard behavioral weight loss approaches. clinicaltrials.gov Identifier: NCT01131871.

The epidemiology of bovine respiratory disease: What is the evidence for preventive measures?

PubMed Central

Taylor, Jared D.; Fulton, Robert W.; Lehenbauer, Terry W.; Step, Douglas L.; Confer, Anthony W.

2010-01-01

Bovine respiratory disease (BRD) is the most common and costly disease of beef cattle in North America. Despite extensive research, industry practices are often more informed by dogma than by fact. Frequently advocated interventions, including vaccination, various processing procedures, and nutritional manipulation, have limited impact on morbidity and mortality. Evidence for use of oral antimicrobials, either in feed or water, appears to be equivocal. In contrast, preconditioning and metaphylaxis have significant scientific evidence of efficacy, with weaning prior to sale potentially being the most important component of preconditioning. The inability to reach more definitive conclusions in preventing BRD may be attributable to difficulties in investigating the disease. Study challenges include potential for extensive confounding, tremendous variability, the multi-factorial nature of the disease, and inadequate methods for diagnosis. PMID:21358927

Peripheral subcutaneous vulvar stimulation in the management of severe and refractory vulvodynia.

PubMed

De Andres, Jose; Sanchis-Lopez, Nerea; Asensio-Samper, Juan Marcos; Fabregat-Cid, Gustavo; Dolz, Vicente Molsalve

2013-02-01

Vulvodynia is a complex and multifactorial clinical condition with severe pain that occurs in the absence of visible infectious, inflammatory, neoplastic, or neurological findings. A 35-year-old woman with 3 years of dysesthetic vulvodynia tried conventional and interventional medical treatment with inadequate relief. She was offered peripheral subcutaneous vulvar field stimulation and underwent implantation of two vulvar subcutaneous electrodes. At 15 days after treatment and during 1-year follow-up, the patient scored 1 out of 15 on Friedrich scale, 1 out of 10 on the visual analog scale, and 1 out of 10 on the tampon test. The patient no longer requires oral medication. Stimulation with subcutaneous electrodes provided relief from vulvodynia to a patient in whom all previous therapeutic approaches had failed.

New concept in natural history and management of diabetes mellitus in thalassemia major.

PubMed

Chatterjee, Ratna; Bajoria, Rekha

2009-01-01

Diabetes Mellitus is a major endocrinopathy, which occurs due transfusional haemosiderosis and is found in 20-30% of adult patients with beta-thalassaemia worldwide, accounting for significant morbidity. It is multifactorial with iron loading being the dominant cause and its management poses a clinical challenge. Diabetes in thalassaemia patients is distinct from type 2 diabetes. It is peculiar in many aspects including its pathophysiology and occurs due to insulin resistance as well as islet cell insufficiency. This article reviews the natural history of diabetes in this presentation with emphasis on prevention monitoring and management. Use of MRI techniques may be useful for future monitoring as well as biochemical monitoring to prevent complications of diabetes. Early intervention with intensified chelation may reverse pancreatic function and structural changes as evident from MRI.

Water Buffalo (Bubalus bubalis) as a spontaneous animal model of Vitiligo.

PubMed

Singh, Vijay Pal; Motiani, Rajender K; Singh, Archana; Malik, Garima; Aggarwal, Rangoli; Pratap, Kunal; Wani, Mohan R; Gokhale, Suresh B; Natarajan, Vivek T; Gokhale, Rajesh S

2016-07-01

Vitiligo is a multifactorial acquired depigmenting disorder. Recent insights into the molecular mechanisms driving the gradual destruction of melanocytes in vitiligo will likely lead to the discovery of novel therapies, which need to be evaluated in animal models that closely recapitulate the pathogenesis of human vitiligo. In humans, vitiligo is characterized by a spontaneous loss of functional melanocytes from the epidermis, but most animal models of vitiligo are either inducible or genetically programmed. Here, we report that acquired depigmentation in water buffalo recapitulates molecular, histological, immunohistochemical, and ultrastructural changes observed in human vitiligo and hence could be used as a model to study vitiligo pathogenesis and facilitate the discovery and evaluation of therapeutic interventions for vitiligo. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies

PubMed Central

Papanikolaou, Panagiotis N.; Christidi, Georgia D.; Ioannidis, John P.A.

2006-01-01

Background Information on major harms of medical interventions comes primarily from epidemiologic studies performed after licensing and marketing. Comparison with data from large-scale randomized trials is occasionally feasible. We compared evidence from randomized trials with that from epidemiologic studies to determine whether they give different estimates of risk for important harms of medical interventions. Methods We targeted well-defined, specific harms of various medical interventions for which data were already available from large-scale randomized trials (> 4000 subjects). Nonrandomized studies involving at least 4000 subjects addressing these same harms were retrieved through a search of MEDLINE. We compared the relative risks and absolute risk differences for specific harms in the randomized and nonrandomized studies. Results Eligible nonrandomized studies were found for 15 harms for which data were available from randomized trials addressing the same harms. Comparisons of relative risks between the study types were feasible for 13 of the 15 topics, and of absolute risk differences for 8 topics. The estimated increase in relative risk differed more than 2-fold between the randomized and nonrandomized studies for 7 (54%) of the 13 topics; the estimated increase in absolute risk differed more than 2-fold for 5 (62%) of the 8 topics. There was no clear predilection for randomized or nonrandomized studies to estimate greater relative risks, but usually (75% [6/8]) the randomized trials estimated larger absolute excess risks of harm than the nonrandomized studies did. Interpretation Nonrandomized studies are often conservative in estimating absolute risks of harms. It would be useful to compare and scrutinize the evidence on harms obtained from both randomized and nonrandomized studies. PMID:16505459

Cluster Randomized Trial of a Church-Based Peer Counselor and Tailored Newsletter Intervention to Promote Colorectal Cancer Screening and Physical Activity among Older African Americans

ERIC Educational Resources Information Center

Leone, Lucia A.; Allicock, Marlyn; Pignone, Michael P.; Walsh, Joan F.; Johnson, La-Shell; Armstrong-Brown, Janelle; Carr, Carol C.; Langford, Aisha; Ni, Andy; Resnicow, Ken; Campbell, Marci K.

2016-01-01

Action Through Churches in Time to Save Lives (ACTS) of Wellness was a cluster randomized controlled trial developed to promote colorectal cancer screening and physical activity (PA) within urban African American churches. Churches were recruited from North Carolina (n = 12) and Michigan (n = 7) and were randomized to intervention (n = 10) or…

Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

PubMed Central

Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

2013-01-01

Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. PMID:24028942

Effectiveness of Healthy Relationships Video-Group—A Videoconferencing Group Intervention for Women Living with HIV: Preliminary Findings from a Randomized Controlled Trial

PubMed Central

Buhi, Eric R.; Baldwin, Julie; Chen, Henian; Johnson, Ayesha; Lynn, Vickie; Glueckauf, Robert

2014-01-01

Abstract Introduction: Expanded access to efficacious interventions is needed for women living with human immunodeficiency virus (WLH) in the United States. Availability of “prevention with (human immunodeficiency virus [HIV)] positives” interventions in rural/remote and low HIV prevalence areas remains limited, leaving WLH in these communities few options for receiving effective behavioral interventions such as Healthy Relationships (HR). Offering such programs via videoconferencing groups (VGs) may expand access. This analysis tests the effectiveness of HR-VG (versus wait-list control) for reducing sexual risk behavior among WLH and explores intervention satisfaction. Subjects and Methods: In this randomized controlled trial unprotected vaginal/anal sex occasions over the prior 3 months reported at the 6-month follow-up were compared across randomization groups through zero-inflated Poisson regression modeling, controlling for unprotected sex at baseline. Seventy-one WLH were randomized and completed the baseline assessment (n=36 intervention and n=35 control); 59 (83% in each group) had follow-up data. Results: Among those who engaged in unprotected sex at 6-month follow-up, intervention participants had approximately seven fewer unprotected occasions than control participants (95% confidence interval 5.43–7.43). Intervention participants reported high levels of satisfaction with HR-VG; 84% reported being “very satisfied” overall. Conclusions: This study found promising evidence for effective dissemination of HIV risk reduction interventions via VGs. Important next steps will be to determine whether VGs are effective with other subpopulations of people living with HIV (i.e., men and non-English speakers) and to assess cost-effectiveness. Possibilities for using VGs to expand access to other psychosocial and behavioral interventions and reduce stigma are discussed. PMID:24237482

Testing a workplace physical activity intervention: a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

A Randomized Controlled Trial of the First Step to Success Early Intervention: Demonstration of Program Efficacy Outcomes in a Diverse, Urban School District

ERIC Educational Resources Information Center

Walker, Hill M.; Seeley, John R.; Small, Jason; Severson, Herbert H.; Graham, Bethany A.; Feil, Edward G.; Serna, Loretta; Golly, Annemieke M.; Forness, Steven R.

2009-01-01

This article reports on a randomized controlled trial of the First Step to Success early intervention that was conducted over a 4-year period in Albuquerque Public Schools. First Step is a selected intervention for students in Grades 1 through 3 with externalizing behavior problems, and it addresses secondary prevention goals and objectives. It…

Process Evaluation of a Multi-Component Intervention to Reduce Infectious Diseases and Improve Hygiene and Well-Being among School Children: The Hi Five Study

ERIC Educational Resources Information Center

Bonnesen, C. T.; Plauborg, R.; Denbaek, A. M.; Due, P.; Johansen, A.

2015-01-01

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n = 43) were randomized into either control (n = 15) or one of two intervention groups (n = 28). The intervention consisted of three components: (i) a curriculum (ii)…

The Role of Critical Self-Reflection of Assumptions in an Online HIV Intervention for Men Who Have Sex with Men

ERIC Educational Resources Information Center

Wilkerson, J. Michael; Danilenko, Gene P.; Smolenski, Derek J.; Myer, Bryn B.; Rosser, B. R. Simon

2011-01-01

The Men's INTernet Study II included a randomized controlled trial to develop and test an Internet-based HIV prevention intervention for U.S men who use the Internet to seek sex with men. In 2008, participants (n = 560) were randomized to an online, interactive, sexual risk-reduction intervention or to a wait list null control. After 3 months,…

To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First Grade Response to Intervention (RTI) in Reading

ERIC Educational Resources Information Center

Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

2015-01-01

This randomized control study compares the efficacy of two response-to-intervention (RTI) models: (1) Dynamic RTI, which immediately refers grade 1 students with the weakest skills to the most intensive intervention supports (Tier 2 or Tier 3); and (2) Typical RTI, which starts all students in Tier 1 and after 8 weeks, decides whether students who…

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

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.

Incidence of in-hospital falls in geriatric patients before and after the introduction of an interdisciplinary team-based fall-prevention intervention.

PubMed

von Renteln-Kruse, Wolfgang; Krause, Tom

2007-12-01

Falls are among the most common unwanted events in older hospital inpatients, but evidence of effective prevention is still limited compared with that in the community and in long-term care facilities. This article describes a prevention program and its effects on the incidence of falls in geriatric hospital wards. It was a prospective cohort study with historical control including all 4,272 patients (mean age 80, 69% female) before and 2,982 (mean age 81, 69% female) after introduction of the intervention. The intervention included fall-risk assessment on admission and reassessment after a fall; risk alert; additional supervision and assistance with the patients' transfer and use of the toilet; provision of an information leaflet; individual patient and caregiver counseling; encouragement of appropriate use of eyeglasses, hearing aids, footwear, and mobility devices; and staff education. Measurements included standardized fall-incidence reporting, activity of daily living and mobility status, number of falls and injurious falls, and number of patients who fell. Before the intervention was introduced, 893 falls were recorded. After the intervention was implemented, only 468 falls were recorded (incidence rate ratio (IRR)=0.82, 95% confidence interval (CI)=0.73-0.92), 240 versus 129 total injurious falls (IRR=0.84, 95% CI=0.67-1.04), 10 versus nine falls with fracture (IRR=1.40, 95% CI=0.51-3.85) and 611 versus 330 fallers. The relative risk of falling was significantly reduced (0.77, 95% CI=0.68-0.88). A structured multifactorial intervention reduced the incidence of falls, but not injurious falls, in a hospital ward setting with existing geriatric multidisciplinary care. Improvement of functional competence and mobility may be relevant to fall prevention in older hospital inpatients.

Associations between perinatal interventions and hospital stillbirth rates and neonatal mortality.

PubMed

Joyce, R; Webb, R; Peacock, J L

2004-01-01

Previous studies suggest that high risk and low birthweight babies have better outcomes if born in hospitals with level III neonatal intensive care units. Relations between obstetric care, particularly intrapartum interventions and perinatal outcomes, are less well understood, however. To investigate effects of obstetric, paediatric, and demographic factors on rates of hospital stillbirths and neonatal mortality. Cross sectional data on all 65 maternity units in all Thames Regions, 1994-1996, covering 540 834 live births and stillbirths. Hospital level analyses investigated associations between staffing rates (consultant/junior paediatricians, consultant/junior obstetricians, midwives), facilities (consultant obstetrician/anaesthetist sessions, delivery beds, special care baby unit, neonatal intensive care unit cots, etc), interventions (vaginal births, caesarean sections, forceps, epidurals, inductions, general anaesthetic), parental data (parity, maternal age, social class, deprivation, multiple births), and birthweight standardised stillbirth rates and neonatal mortality. Unifactorial analyses showed consistent negative associations between measures of obstetric intervention and stillbirth rates. Some measures of staffing, facilities, and parental data also showed significant associations. Scores for interventional, organisational, and parental variables were derived for multifactorial analysis to overcome the statistical problems caused by high intercorrelations between variables. A higher intervention score and higher number of consultant obstetricians per 1000 births were both independently and significantly associated with lower stillbirth rates. Organisational and parental factors were not significant after adjustment. Only Townsend deprivation score was significantly associated with neonatal mortality (positive correlation). Birthweight adjusted stillbirth rates were significantly lower in units that took a more interventionalist approach and in those with higher levels of consultant obstetric staffing. There were no apparent associations between neonatal death rates and the hospital factors measured here.

Nutrition in cachexia: from bench to bedside.

PubMed

Konishi, Masaaki; Ishida, Junichi; von Haehling, Stephan; Anker, Stefan D; Springer, Jochen

2016-05-01

As malnutrition is often present in cachexia, nutritional intervention has been one of the widely accepted strategies. A literature review of cachexia models with dietary interventions in the present issue of this journal pointed out that the majority of nutrient intervention studies were of n-3 fatty acid, mainly eicosapentaenoic acid and docosahexaenoic acid. Effect on protein catabolism and anti-inflammation are most pronounced benefits of n-3 fatty acid. The effectiveness of n-3 fatty acid may depend on control diet or even be attributed to the polyunsaturated fatty acid deficiency inadvertently produced in control group. However, there is not enough clinical evidence to support a benefit of n-3 fatty acid substitution in patients with cachexia. The second important result from this review is that the majority of studies did not provide information about dietary design or did not standardize design, content, source, and overall composition. To guide dietary design for researchers in preclinical studies, a model has been proposed in this review, which may be useful to predict the efficacy of new dietary intervention in cachexia science. From a clinical point of view, the limited effectiveness of nutritional support in cachexia may partly be explained by the multifactorial nature of this condition. Cachexia differs from malnutrition inasmuch as malnutrition can be reversed by adequate nutrition and/or by overcoming problems of absorption or utilization of nutrients, but cachexia cannot be successfully treated by nutrition alone. Multidisciplinary approach including the assessment and intervention in feeding, appetite, swallowing, exercise, psychosocial, and psychological issue may be needed to improve nutrition in patients with cachexia.

Effect of nocturnal sound reduction on the incidence of delirium in intensive care unit patients: An interrupted time series analysis.

PubMed

van de Pol, Ineke; van Iterson, Mat; Maaskant, Jolanda

2017-08-01

Delirium in critically-ill patients is a common multifactorial disorder that is associated with various negative outcomes. It is assumed that sleep disturbances can result in an increased risk of delirium. This study hypothesized that implementing a protocol that reduces overall nocturnal sound levels improves quality of sleep and reduces the incidence of delirium in Intensive Care Unit (ICU) patients. This interrupted time series study was performed in an adult mixed medical and surgical 24-bed ICU. A pre-intervention group of 211 patients was compared with a post-intervention group of 210 patients after implementation of a nocturnal sound-reduction protocol. Primary outcome measures were incidence of delirium, measured by the Intensive Care Delirium Screening Checklist (ICDSC) and quality of sleep, measured by the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcome measures were use of sleep-inducing medication, delirium treatment medication, and patient-perceived nocturnal noise. A significant difference in slope in the percentage of delirium was observed between the pre- and post-intervention periods (-3.7% per time period, p=0.02). Quality of sleep was unaffected (0.3 per time period, p=0.85). The post-intervention group used significantly less sleep-inducing medication (p<0.001). Nocturnal noise rating improved after intervention (median: 65, IQR: 50-80 versus 70, IQR: 60-80, p=0.02). The incidence of delirium in ICU patients was significantly reduced after implementation of a nocturnal sound-reduction protocol. However, reported sleep quality did not improve. Copyright © 2017. Published by Elsevier Ltd.

A combination of supplements may reduce the risk of Alzheimer's disease in elderly Japanese with normal cognition.

PubMed

Bun, Shogyoku; Ikejima, Chiaki; Kida, Jiro; Yoshimura, Atsuko; Lebowitz, Adam Jon; Kakuma, Tatsuyuki; Asada, Takashi

2015-01-01

A number of studies have examined the effect of a single supplement against Alzheimer's disease (AD) with conflicting results. Taking into account the complex and multifactorial nature of AD pathogenesis, multiple supplements may be more effective. Physical activity is another prospect against AD. An open-label intervention study was conducted to explore a potential protective effect of multiple supplements and physical activity. Their interaction was also examined. Participants were community-dwelling volunteers aged 65 or older as of May 2001 in a rural area of Japan. Among 918 cognitively normal participants included in the analyses, 171 took capsules daily for three years that contained n-3 polyunsaturated fatty acid, Ginkgo biloba leaf dry extracts, and lycopene. Two hundred and forty one participants joined the two-year exercise intervention that included a community center-based and a home-based exercise program. One-hundred and forty eight participated in both interventions. A standardized neuropsychological battery was administered at baseline in 2001, the first follow-up in 2004-2005, and the second in 2008-2009. The primary outcome was AD diagnosis at follow-ups. A complementary log-log model was used for survival analysis. A total of 76 participants were diagnosed with AD during follow-up periods. Higher adherence to supplementation intervention was associated with lower AD incidence in both unadjusted and adjusted models. Exercise intervention was also associated with lower AD incidence in the unadjusted model, but not in the adjusted model. We hypothesized that the combination of supplements acted in a complementary and synergistic fashion to bring significant effects against AD occurrence.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

An Evaluation of a Behaviorally Based Social Skills Group for Individuals Diagnosed with Autism Spectrum Disorder.

PubMed

Leaf, Justin B; Leaf, Jeremy A; Milne, Christine; Taubman, Mitchell; Oppenheim-Leaf, Misty; Torres, Norma; Townley-Cochran, Donna; Leaf, Ronald; McEachin, John; Yoder, Paul

2017-02-01

In this study we evaluated a social skills group which employed a progressive applied behavior analysis model for individuals diagnosed with autism spectrum disorder. A randomized control trial was utilized; eight participants were randomly assigned to a treatment group and seven participants were randomly assigned to a waitlist control group. The social skills group consisted of 32, 2 h sessions. Teachers implemented a variety of behaviorally based procedures. A blind evaluator measured participants' behavior immediately prior to intervention, immediately following intervention, and during 16 and 32-week maintenance probes. Results of the study demonstrated that participants made significant improvements with their social behavior (p < .001) following intervention, and the results were maintained up to 32 weeks after intervention had concluded.

The effects of educating mothers and girls on the girls' attitudes toward puberty health: a randomized controlled trial.

PubMed

Afsari, Atousa; Mirghafourvand, Mojgan; Valizadeh, Sousan; Abbasnezhadeh, Massomeh; Galshi, Mina; Fatahi, Samira

2017-04-01

The attitude of a girl toward her menstruation and puberty has a considerable impact on her role during motherhood, social adjustment, and future marital life. This study was conducted in 2014 with the aim of comparing the effects of educating mothers and girls on the attitudes of adolescent girls of Tabriz City, Iran, towards puberty health. This randomized control clinical trial was conducted on 364 adolescent girls who experienced menstruation. Twelve schools were selected randomly among 107 secondary schools for girls. One-third of the students of each school were selected randomly using a table of random numbers and socio-demographic and each participant was asked to answer the attitude questionnaires. The schools were randomly allocated to the groups of mother's education, girl's education, and no-intervention. The attitude questionnaire was filled out by the participants again 2 months after intervention. The general linear model, in which the baseline values were controlled, was employed to compare the scores of the three groups after the intervention. No significant differences were observed among the three groups in terms of the attitude score before intervention (p>0.05). Attitude score improvement after intervention in the girl's education group was significantly higher than the one of both mother's education (adjusted mean difference [AMD]: 1.8; [95% confidence interval (CI): 0.4-1.3]) and no-intervention groups (AMD: 1.3; [95% CI: 0.0-2.6]) by controlling the attitude score before intervention. Based on the findings, it is more effective to educate girls directly about puberty health to improve adolescent girls' attitudes than educating mothers and asking them to transfer information to the girls. Nevertheless, studies with longer training period and follow-up are proposed to determine the effects of educating girls (through their mothers) on their attitudes about puberty health.

Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials.

PubMed

Ewald, H; Kirby, J; Rees, K; Robertson, W

2014-09-01

An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong

PubMed Central

Ho, Henry C. Y.; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M.; Yew, Carol; Lam, Tai Hing; Chan, Sophia S.

2016-01-01

Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial.

PubMed

Pérez-Balbuena, Ana L; Ochoa-Tabares, Juan C; Belalcazar-Rey, Sandra; Urzúa-Salinas, Cristian; Saucedo-Rodríguez, Laura R; Velasco-Ramos, Regina; Suárez-Sánchez, Raúl G; Rodríguez-Carrizalez, Adolfo D; Oregón-Miranda, Aldo A

2016-09-20

Dry eye disease (DED) is multifactorial, affecting 5-34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention. A phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n = 76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n = 72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains. The primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4 ± 2.2 vs 11.0 ± 6.6; p = 0.002) and PEG/PG (6.5 ± 2.5 vs 10.5 ± 5.6; p = 0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5 ± 2.1 vs 7.4 ± 2.9; p = 0.027) and PEG/PG (5.2 ± 2.0 vs 7.4 ± 2.7; p = 0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3 ± 7.4 vs 7.3 ± 5.9; p = 0.001) and PEG/PG (19.3 ± 7.5 vs 7.9 ± 8.2; p = 0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions. Xanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease. ClinicalTrials.gov: NCT01657253 . Date of registration May 19, 2014.

Randomized, community-based pharmacy intervention to expand services beyond sale of sterile syringes to injection drug users in pharmacies in New York City.

PubMed

Crawford, Natalie D; Amesty, Silvia; Rivera, Alexis V; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M

2013-09-01

Structural interventions may help reduce racial/ethnic disparities in HIV. In 2009 to 2011, we randomized pharmacies participating in a nonprescription syringe access program in minority communities to intervention (pharmacy enrolled and delivered HIV risk reduction information to injection drug users [IDUs]), primary control (pharmacy only enrolled IDUs), and secondary control (pharmacy did not engage IDUs). Intervention pharmacy staff reported more support for syringe sales than did control staff. An expanded pharmacy role in HIV risk reduction may be helpful.

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

PubMed Central

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

2016-01-01

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

An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families.

PubMed

Wilson, Dawn K; Kitzman-Ulrich, Heather; Resnicow, Ken; Van Horn, M Lee; St George, Sara M; Siceloff, E Rebekah; Alia, Kassandra A; McDaniel, Tyler; Heatley, VaShawn; Huffman, Lauren; Coulon, Sandra; Prinz, Ron

2015-05-01

The Families Improving Together (FIT) randomized controlled trial tests the efficacy of integrating cultural tailoring, positive parenting, and motivational strategies into a comprehensive curriculum for weight loss in African American adolescents. The overall goal of the FIT trial is to test the effects of an integrated intervention curriculum and the added effects of a tailored web-based intervention on reducing z-BMI in overweight African American adolescents. The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11-16 years. The trial tests the efficacy of an 8-week face-to-face group randomized program comparing M + FWL (Motivational Plus Family Weight Loss) to a comprehensive health education program (CHE) and re-randomizes participants to either an 8-week on-line tailored intervention or control on-line program resulting in a 2 (M + FWL vs. CHE group) × 2 (on-line intervention vs. control on-line program) factorial design to test the effects of the intervention on reducing z-BMI at post-treatment and at 6-month follow-up. The interventions for this trial are based on a theoretical framework that is novel and integrates elements from cultural tailoring, Family Systems Theory, Self-Determination Theory and Social Cognitive Theory. The intervention targets positive parenting skills (parenting style, monitoring, communication); cultural values; teaching parents to increase youth motivation by encouraging youth to have input and choice (autonomy-support); and provides a framework for building skills and self-efficacy through developing weight loss action plans that target goal setting, monitoring, and positive feedback. Copyright © 2015. Published by Elsevier Inc.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

A randomized controlled trial of a pharmacist consultation program for family physicians and their elderly patients

PubMed Central

Sellors, John; Kaczorowski, Janusz; Sellors, Connie; Dolovich, Lisa; Woodward, Christel; Willan, Andrew; Goeree, Ron; Cosby, Roxanne; Trim, Kristina; Sebaldt, Rolf; Howard, Michelle; Hardcastle, Linda; Poston, Jeff

2003-01-01

Background Pharmacists can improve patient outcomes in institutional and pharmacy settings, but little is known about their effectiveness as consultants to primary care physicians. We examined whether an intervention by a specially trained pharmacist could reduce the number of daily medication units taken by elderly patients, as well as costs and health care use. Methods We conducted a randomized controlled trial in family practices in 24 sites in Ontario. We randomly allocated 48 randomly selected family physicians (69.6% participation rate) to the intervention or the control arm, along with 889 (69.5% participation rate) of their randomly selected community-dwelling, elderly patients who were taking 5 or more medications daily. In the intervention group, pharmacists conducted face-to-face medication reviews with the patients and then gave written recommendations to the physicians to resolve any drug-related problems. Process outcomes included the number of drug-related problems identified among the senior citizens in the intervention arm and the proportion of recommendations implemented by the physicians. Results After 5 months, seniors in the intervention and control groups were taking a mean of 12.4 and 12.2 medication units per day respectively (p = 0.50). There were no statistically significant differences in health care use or costs between groups. A mean of 2.5 drug-related problems per senior was identified in the intervention arm. Physicians implemented or attempted to implement 72.3% (790/1093) of the recommendations. Interpretation The intervention did not have a significant effect on patient outcomes. However, physicians were receptive to the recommendations to resolve drug-related problems, suggesting that collaboration between physicians and pharmacists is feasible. PMID:12847034

Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors: a cluster randomized trial.

PubMed

Verdurmen, Jacqueline E E; Koning, Ina M; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E

2014-03-01

To examine risk moderation of an alcohol intervention targeting parents and adolescents. A cluster randomized trial including 2937 Dutch early adolescents (m=12.68years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combined parent-student intervention, and control group. 152 classes of 19 high schools in The Netherlands (2006). Moderators at baseline (adolescent: gender, educational level and externalizing behavior; parent: educational level and heavy alcohol use) were used to examine the differential effects of the interventions on onset of (heavy) weekly drinking at 22-month follow-up. The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents, and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents (i.e. those attending lower levels of education and reporting higher levels of externalizing behavior). Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents, with an added effect on postponing heavy weekly drinking in high risk subgroups. Therefore, implementation of this intervention in the general population of schools in The Netherlands is advised. NTR649. Copyright © 2013 Elsevier Inc. All rights reserved.

Effect on mental health of a participatory intervention to improve psychosocial work environment: a cluster randomized controlled trial among nurses.

PubMed

Uchiyama, Ayako; Odagiri, Yuko; Ohya, Yumiko; Takamiya, Tomoko; Inoue, Shigeru; Shimomitsu, Teruichi

2013-01-01

Improvement of psychosocial work environment has proved to be valuable for workers' mental health. However, limited evidence is available for the effectiveness of participatory interventions. The purpose of this study was to investigate the effect on mental health among nurses of a participatory intervention to improve the psychosocial work environment. A cluster randomized controlled trial was conducted in hospital settings. A total of 434 nurses in 24 units were randomly allocated to 11 intervention units (n=183) and 13 control units (n=218). A participatory program was provided to the intervention units for 6 months. Depressive symptoms as mental health status and psychosocial work environment, assessed by the Job Content Questionnaire, the Effort-Reward Imbalance Questionnaire, and the Quality Work Competence questionnaire, were measured before and immediately after the 6-month intervention by a self-administered questionnaire. No significant intervention effect was observed for mental health status. However, significant intervention effects were observed in psychosocial work environment aspects, such as Coworker Support (p<0.01) and Goals (p<0.01), and borderline significance was observed for Job Control (p<0.10). It is suggested that a 6-month participatory intervention is effective in improving psychosocial work environment, but not mental health, among Japanese nurses.

Individual differences in the efficacy of a short theory of mind intervention for children with autism spectrum disorder: a randomized controlled trial.

PubMed

Hoddenbach, Elske; Koot, Hans M; Clifford, Pamela; Gevers, Carolien; Clauser, Cassandra; Boer, Frits; Begeer, Sander

2012-11-09

Having a 'theory of mind', or having the ability to attribute mental states to oneself or others, is considered one of the most central domains of impairment among children with an autism spectrum disorder (ASD). Many interventions focus on improving theory of mind skills in children with ASD. Nonetheless, the empirical evidence for the effect of these interventions is limited. The main goal of this study is to examine the effectiveness of a short theory of mind intervention for children with ASD. A second objective is to determine which subgroups within the autism spectrum profit most from the intervention. This study is a randomized controlled trial. One hundred children with ASD, aged 7 to 12 years will be randomly assigned to an intervention or a waiting list control group. Outcome measures include the completion of theory of mind and emotion understanding tasks, and parent and teacher questionnaires on children's social skills. Follow-up data for the intervention group will be collected 6 months after the interventions. This study evaluates the efficacy of a theory of mind intervention for children with ASD. Hypotheses, strengths, and limitations of the study are discussed. Netherlands Trial Register NTR2327.

Attitudes and Lifestyle Changes Following Jog Your Mind: Results from a Multi-Factorial Community-Based Program Promoting Cognitive Vitality among Seniors

ERIC Educational Resources Information Center

Laforest, Sophie; Lorthios-Guilledroit, Agathe; Nour, Kareen; Parisien, Manon; Fournier, Michel; Ellemberg, Dave; Guay, Danielle; Desgagnés-Cyr, Charles-Émile; Bier, Nathalie

2017-01-01

This study examined the effects on attitudes and lifestyle behavior of "Jog your Mind," a multi-factorial community-based program promoting cognitive vitality among seniors with no known cognitive impairment. A quasi-experimental study was conducted. Twenty-three community organizations were assigned either to the experimental group…

Facilitating sunscreen use in women by a theory-based online intervention: a randomized controlled trial.

PubMed

Craciun, Catrinel; Schüz, Natalie; Lippke, Sonia; Schwarzer, Ralf

2012-03-01

This study compares a motivational skin cancer prevention approach with a volitional planning and self-efficacy intervention to enhance regular sunscreen use. A randomized controlled trial (RCT) was conducted with 205 women (mean age 25 years) in three groups: motivational; volitional; and control. Sunscreen use, action planning, coping planning and coping self-efficacy were assessed at three points in time. The volitional intervention improved sunscreen use. Coping planning emerged as the only mediator between the intervention and sunscreen use at Time 3. Findings point to the role played by coping planning as an ingredient of sun protection interventions.

A Long-Term Intensive Lifestyle Intervention and Physical Function: the Look AHEAD Movement and Memory Study

PubMed Central

Houston, Denise K.; Leng, Xiaoyan; Bray, George A.; Hergenroeder, Andrea L.; Hill, James O.; Jakicic, John M.; Johnson, Karen C.; Neiberg, Rebecca H.; Marsh, Anthony P.; Rejeski, W. Jack; Kritchevsky, Stephen B.

2014-01-01

OBJECTIVE To assess the long-term effects of an intensive lifestyle intervention on physical function using a randomized post-test design in the Look AHEAD trial. METHODS Overweight and obese (BMI ≥25 kg/m2) middle-aged and older adults (aged 45–76 years at enrollment) with type 2 diabetes (n=964) at four clinics in Look AHEAD, a trial evaluating an intensive lifestyle intervention (ILI) designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including an expanded short physical performance battery (SPPBexp), 20-m and 400-m walk, and grip and knee extensor strength 8 years post-randomization, during the trial’s weight maintenance phase. RESULTS Eight years post-randomization, individuals randomized to ILI had better SPPBexp scores (adjusted mean (SE) difference: 0.055 (0.022), p=0.01) and faster 20-m and 400-m walk speeds (0.032 (0.012) m/sec, p=0.01, and 0.025 (0.011) m/sec, p=0.02, respectively) compared to those randomized to DSE. Achieved weight loss greatly attenuated the group differences in physical function and the intervention effect was no longer significant. CONCLUSIONS An intensive lifestyle intervention has long-term benefits for mobility function in overweight and obese middle-aged and older individuals with type 2 diabetes. PMID:25452229

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

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

Increasing Efficiency in Evaluation of Chronic Cough: A Multidisciplinary, Collaborative Approach.

PubMed

Patton, Cynthia M; Lim, Kaiser G; Ramlow, Luke W; White, Kathleen M

2015-01-01

Chronic cough is the most common reason for medical office visits in the United States. The typical patient has coughed more than 8 years and seen many specialists. This quality improvement project is an ambulatory clinic redesign to deliver efficient, patient-centered care with interspecialty collaboration. Methodology included the Institute for Healthcare Improvement collaborative model focused on Lean/Six Sigma and ADKAR (Awareness, Desire, Knowledge, Ability, Reinforcement) Change Management. Interventions targeted education to referring providers, implementation of software changes, building a collaborative interdepartmental scheduling decision tree, and an interclinic dashboard enhancing communication and decision support. Outcome measures compare group resource utilization, evidenced by the total number of specialist referrals for same indication of chronic cough (International Classification of Diseases, Ninth Revision: 786.2), and length of time to complete evaluation. A retrospective review of 165 medical records yielded 2 groups, "current care" (n = 67) and "intervention" (n = 68). The number of specialist referrals per patient was reduced in the intervention group (M = 1.22, SD = 0.48) compared with the current care group (M = 3.33, SD = 1.02). Length of itinerary was reduced in the intervention group (M = 11.90, SD = 12.13, GM = 6.82) compared with the current care group (M = 126.93, SD = 158.13, GM = 54.8). Multidisciplinary collaboration, communication, coordinating diagnosis, and management of multifactorial conditions, such as chronic cough, are associated with lower costs and decreased utilization of health care resources.

Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of DESTRESS-PC

DTIC Science & Technology

2009-08-01

Bryant, R, Engel, CC (2004). A therapist-assisted internet self-help program for traumatic stress . Professional Psychology: Research and Practice, 35...Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of “DESTRESS-PC” PRINCIPAL INVESTIGATOR: Charles Engel...Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of DESTRESS-PC 5b. GRANT NUMBER

Unity in Diversity: Results of a Randomized Clinical Culturally Tailored Pilot HIV Prevention Intervention Trial in Baltimore, Maryland, for African American Men Who Have Sex with Men

ERIC Educational Resources Information Center

Tobin, Karin; Kuramoto, Satoko J.; German, Danielle; Fields, Errol; Spikes, Pilgrim S.; Patterson, Jocelyn; Latkin, Carl

2013-01-01

Unity in Diversity was a randomized controlled trial of a culturally tailored HIV prevention intervention for African American men who have sex with men. The intervention condition was six group-based sessions and one individual session. The control condition was a single-session HIV prevention review. Participants were aged 18 years or older,…

Mediating Effects of Home-Related Factors on Fat Intake from Snacks in a School-Based Nutrition Intervention among Adolescents

ERIC Educational Resources Information Center

Van Lippevelde, Wendy; van Stralen, Maartje; Verloigne, Maite; De Bourdeaudhuij, Ilse; Deforche, Benedicte; Brug, Johannes; Maes, Lea; Haerens, Leen

2012-01-01

The purpose of the present study was to investigate if the effects of the parental component of a school-based intervention on dietary fat intake from snacking were mediated by changes in home-related factors. A random sample of 10 schools with 2232 pupils aged 11-15 years was randomly assigned to one of two intervention groups [one with (n =…

Web-Based Intervention for Women With Type 1 Diabetes in Pregnancy and Early Motherhood: Critical Analysis of Adherence to Technological Elements and Study Design.

PubMed

Berg, Marie; Linden, Karolina; Adolfsson, Annsofie; Sparud Lundin, Carina; Ranerup, Agneta

2018-05-02

Numerous Web-based interventions have been implemented to promote health and health-related behaviors in persons with chronic conditions. Using randomized controlled trials to evaluate such interventions creates a range of challenges, which in turn can influence the study outcome. Applying a critical perspective when evaluating Web-based health interventions is important. The objective of this study was to critically analyze and discuss the challenges of conducting a Web-based health intervention as a randomized controlled trial. The MODIAB-Web study was critically examined using an exploratory case study methodology and the framework for analysis offered through the Persuasive Systems Design model. Focus was on technology, study design, and Web-based support usage, with special focus on the forum for peer support. Descriptive statistics and qualitative content analysis were used. The persuasive content and technological elements in the design of the randomized controlled trial included all four categories of the Persuasive Systems Design model, but not all design principles were implemented. The study duration was extended to a period of four and a half years. Of 81 active participants in the intervention group, a maximum of 36 women were simultaneously active. User adherence varied greatly with a median of 91 individual log-ins. The forum for peer support was used by 63 participants. Although only about one-third of the participants interacted in the forum, there was a fairly rich exchange of experiences and advice between them. Thus, adherence in terms of social interactions was negatively affected by limited active participation due to prolonged recruitment process and randomization effects. Lessons learned from this critical analysis are that technology and study design matter and might mutually influence each other. In Web-based interventions, the use of design theories enables utilization of the full potential of technology and promotes adherence. The randomization element in a randomized controlled trial design can become a barrier to achieving a critical mass of user interactions in Web-based interventions, especially when social support is included. For extended study periods, the technology used may need to be adapted in line with newly available technical options to avoid the risk of becoming outdated in the user realm, which in turn might jeopardize study validity in terms of randomized controlled trial designs. On the basis of lessons learned in this randomized controlled trial, we give recommendations to consider when designing and evaluating Web-based health interventions. ©Marie Berg, Karolina Linden, Annsofie Adolfsson, Carina Sparud Lundin, Agneta Ranerup. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.05.2018.

Social network targeting to maximise population behaviour change: a cluster randomised controlled trial.

PubMed

Kim, David A; Hwong, Alison R; Stafford, Derek; Hughes, D Alex; O'Malley, A James; Fowler, James H; Christakis, Nicholas A

2015-07-11

Information and behaviour can spread through interpersonal ties. By targeting influential individuals, health interventions that harness the distributive properties of social networks could be made more effective and efficient than those that do not. Our aim was to assess which targeting methods produce the greatest cascades or spillover effects and hence maximise population-level behaviour change. In this cluster randomised trial, participants were recruited from villages of the Department of Lempira, Honduras. We blocked villages on the basis of network size, socioeconomic status, and baseline rates of water purification, for delivery of two public health interventions: chlorine for water purification and multivitamins for micronutrient deficiencies. We then randomised villages, separately for each intervention, to one of three targeting methods, introducing the interventions to 5% samples composed of either: randomly selected villagers (n=9 villages for each intervention); villagers with the most social ties (n=9); or nominated friends of random villagers (n=9; the last strategy exploiting the so-called friendship paradox of social networks). Participants and data collectors were not aware of the targeting methods. Primary endpoints were the proportions of available products redeemed by the entire population under each targeting method. This trial is registered with ClinicalTrials.gov, number NCT01672580. Between Aug 4, and Aug 14, 2012, 32 villages in rural Honduras (25-541 participants each; total study population of 5773) received public health interventions. For each intervention, nine villages (each with 1-20 initial target individuals) were randomised, using a blocked design, to each of the three targeting methods. In nomination-targeted villages, 951 (74·3%) of 1280 available multivitamin tickets were redeemed compared with 940 (66·2%) of 1420 in randomly targeted villages and 744 (61·0%) of 1220 in indegree-targeted villages. All pairwise differences in redemption rates were significant (p<0·01) after correction for multiple comparisons. Targeting nominated friends increased adoption of the nutritional intervention by 12·2% compared with random targeting (95% CI 6·9-17·9). Targeting the most highly connected individuals, by contrast, produced no greater adoption of either intervention, compared with random targeting. Introduction of a health intervention to the nominated friends of random individuals can enhance that intervention's diffusion by exploiting intrinsic properties of human social networks. This method has the additional advantage of scalability because it can be implemented without mapping the network. Deployment of certain types of health interventions via network targeting, without increasing the number of individuals targeted or the resources used, could enhance the adoption and efficiency of those interventions, thereby improving population health. National Institutes of Health, The Bill & Melinda Gates Foundation, Star Family Foundation, and the Canadian Institutes of Health Research. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Randomized Controlled Trial of Brief Coparenting and Relationship Interventions During the Transition to Parenthood

PubMed Central

Doss, Brian D.; Cicila, Larisa N.; Hsueh, Annie C.; Morrison, Kristen R.; Carhart, Kathryn

2014-01-01

The transition to parenthood has been repeatedly identified as a stressful period, with couples reporting difficulties in domains of individual, coparenting, and relationship functioning. Moreover, these difficulties have been shown to impact children’s development. To buffer against these difficulties, numerous effective parenting, couple, and combined interventions have been developed; however, these interventions are typically lengthy, which limits their potential for dissemination. Therefore, in the present study, we developed and tested separate six-hour interventions that focused exclusively on improving either coparenting or relationship functioning. In a randomized control trial, 90 heterosexual couples (180 individuals) were randomly assigned to an information control group, a coparenting intervention, or a relationship intervention and assessed on seven occasions during the two years following birth. Results revealed that women and high-risk men in both the couple and coparenting interventions showed fewer declines in relationship satisfaction (Cohen’s d = 0.53–0.99) and other areas of relationship functioning. Women also reported improved coparenting in both intervention groups (Cohen’s d = 0.47–1.06). Additionally, women in both interventions experienced less perceived stress during the first year after birth. Given similar effects of the two interventions on coparenting and relationship functioning, future dissemination may be enhanced by delivery of coparenting interventions, as coparenting (compared to relationship) interventions seem to attract more interest from couples and are likely easier to integrate into existing services. PMID:25090255

Low-fat dietary pattern intervention and health-related quality of life: The WHI randomized controlled Dietary Modification trial

PubMed Central

Assaf, Annlouise R.; Beresford, Shirley A.A.; Risica, Patricia Markham; Aragaki, Aaron; Brunner, Robert L.; Bowen, Deborah J.; Naughton, Michelle; Rosal, Milagros C.; Snetselaar, Linda; Wenger, Nanette

2015-01-01

Background Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women’s Health Initiative (WHI) Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. Objective To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depressive symptoms, cognitive functioning, and sleep quality. Design Randomized controlled trial was analyzed as intent to treat. Participants Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type-1 diabetes, medical conditions with predicted survival less than three years. Intervention Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. Main Outcome Measures RAND 36-Item Health Survey was used to assess HRQoL at baseline, year 1, and close-out (about 8 years post randomization), and estimate differential HRQoL subscale change scores. Statistical analysis performed Mean change in HRQoL scores (year 1 minus baseline) were compared by randomization group using linear models. Results At one year, there was a differential change between intervention and comparison group of 1.7 units (1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (1.7, 2.3), vitality by 1.9 units (1.6, 2.2), and global QOL by 0.09 units (0.07, 0.12). With the exception of global QOL, these effects were significantly modified by BMI at baseline. Conclusions DM intervention was associated with small, but significant improvements in three health related quality of life subscales: general health, physical functioning, and vitality at one year follow-up, with the largest improvements seen in the women with the greatest baseline BMI. PMID:26384466

Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS).

PubMed

Larsen, Kristian Traberg; Huang, Tao; Møller, Niels Christian; Andersen, Lars Bo; Ried-Larsen, Mathias

2014-04-05

Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children. The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm. This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children. NCT01574352 at http://clinicaltrials.gov on the 8th of March 2012.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

PubMed

Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-04-01

Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

The Effects of Mindfulness-Based Intervention on Children's Attention Regulation.

PubMed

Felver, Joshua C; Tipsord, Jessica M; Morris, Maxwell J; Racer, Kristina Hiatt; Dishion, Thomas J

2017-08-01

This article describes results from a randomized clinical trial of a mindfulness-based intervention for parents and children, Mindful Family Stress Reduction, on a behavioral measure of attention in youths, the Attention Network Task (ANT). Forty-one parent-child dyads were randomly assigned to either the mindfulness-based intervention condition or a wait-list control. School-age youths completed the ANT before and after the intervention. Results demonstrate significant, medium-size ( f 2 = -.16) intervention effects to the conflict monitoring subsystem of the ANT such that those in the intervention condition decreased in conflict monitoring more than those in the wait-list control. Youths in the intervention condition also showed improvements in their orienting subsystem scores, compared with controls. Mindfulness-based interventions for youths have potential utility to improve attentional self-regulation, and future research should consider incorporating measures of attention into interventions that use mindfulness training.

Online interventions for problem gamblers with and without co-occurring problem drinking: study protocol of a randomized controlled trial.

PubMed

Cunningham, John A; Hodgins, David C; Keough, Matthew; Hendershot, Christian S; Bennett, Kylie; Bennett, Anthony; Godinho, Alexandra

2018-05-25

The current randomized controlled trial seeks to evaluate whether providing access to an Internet intervention for problem drinking in addition to an Internet intervention for problem gambling is beneficial for participants with gambling problems who do or do not have co-occurring problem drinking. Potential participants will be recruited online via a comprehensive advertisement strategy, if they meet the criteria for problem gambling. As part of the baseline measures, problem drinking will also be assessed. Eligible participants (N = 280) who agree to partake in the study and to be followed up for 6 months will be randomized into one of two versions of an Internet intervention for gamblers: an intervention that targets only gambling issues (G-only) and one that combines a gambling intervention with an intervention for problem drinking (G + A). For problem gamblers who exhibit co-occurring problem drinking, it is predicted that participants who are provided access to the G + A intervention will demonstrate a significantly greater level of reduction in gambling outcomes at 6 months compared to those provided access to the G-only intervention. This trial will expand upon the current research on Internet interventions for addictions and inform the development of treatments for those with co-occurring problem drinking and gambling. ClinicalTrials.gov, NCT03323606 . Registered on 24 October 2017.

Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study

ERIC Educational Resources Information Center

Byun, Tara McAllister

2017-01-01

Purpose: This study documented the efficacy of visual-acoustic biofeedback intervention for residual rhotic errors, relative to a comparison condition involving traditional articulatory treatment. All participants received both treatments in a single-subject experimental design featuring alternating treatments with blocked randomization of…

Investigating a Tier 1 Intervention Focused on Proportional Reasoning: A Follow-Up Study

ERIC Educational Resources Information Center

Jitendra, Asha K.; Harwell, Michael R.; Karl, Stacy R.; Simonson, Gregory R.; Slater, Susan C.

2017-01-01

This randomized controlled study investigated the efficacy of a Tier 1 intervention--schema-based instruction--designed to help students with and without mathematics difficulties (MD) develop proportional reasoning. Twenty seventh-grade teachers/classrooms were randomly assigned to a treatment condition (schema-based instruction) or control…

A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

ERIC Educational Resources Information Center

McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

2008-01-01

Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

Evaluation of a School-Based Teen Obesity Prevention Minimal Intervention

ERIC Educational Resources Information Center

Abood, Doris A.; Black, David R.; Coster, Daniel C.

2008-01-01

Objective: A school-based nutrition education minimal intervention (MI) was evaluated. Design: The design was experimental, with random assignment at the school level. Setting: Seven schools were randomly assigned as experimental, and 7 as delayed-treatment. Participants: The experimental group included 551 teens, and the delayed treatment group…

Reporting Randomized Controlled Trials in Education

ERIC Educational Resources Information Center

Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

2014-01-01

Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

Educational and Skills-Based Interventions to Prevent Relationship Violence in Young People

ERIC Educational Resources Information Center

Fellmeth, Gracia; Heffernan, Catherine; Nurse, Joanna; Habibula, Shakiba; Sethi, Dinesh

2015-01-01

Objectives: To assess the efficacy of educational and skills-based interventions to prevent relationship and dating violence in adolescents and young adults. Methods: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, and other databases for randomized, cluster-randomized, and quasi-randomized…

A Randomized Violence Prevention Trial with Comparison: Responses by Gender

ERIC Educational Resources Information Center

Griffin, James P., Jr.; Chen, Dungtsa; Eubanks, Adriane; Brantley, Katrina M.; Willis, Leigh A.

2007-01-01

Using random assignment of students to two intervention groups and a comparison school sample, the researchers evaluated a three-group school-based violence prevention program. The three groups were (1) a whole-school intervention, (2) whole-school, cognitive-behavioral and cultural enrichment training, and (3) no violence prevention. The…

Improving psychosocial outcomes for caregivers of people with poor prognosis gastrointestinal cancers: a randomized controlled trial (Family Connect).

PubMed

Shaw, Joanne M; Young, Jane M; Butow, Phyllis N; Badgery-Parker, Tim; Durcinoska, Ivana; Harrison, James D; Davidson, Patricia M; Martin, David; Sandroussi, Charbel; Hollands, Michael; Joseph, David; Das, Amitabha; Lam, Vincent; Johnston, Emma; Solomon, Michael J

2016-02-01

This study investigated the effectiveness of a structured telephone intervention for caregivers of people diagnosed with poor prognosis gastrointestinal cancer to improve psychosocial outcomes for both caregivers and patients. Caregivers of patients starting treatment for upper gastrointestinal or Dukes D colorectal cancer were randomly assigned (1:1) to the Family Connect telephone intervention or usual care. Caregivers in the intervention group received four standardized telephone calls in the 10 weeks following patient hospital discharge. Caregivers' quality of life (QOL), caregiver burden, unmet supportive care needs and distress were assessed at 3 and 6 months. Patients' QOL, unmet supportive care needs, distress and health service utilization were also assessed at these time points. Caregivers (128) were randomized to intervention or usual care groups. At 3 months, caregiver QOL scores and other caregiver-reported outcomes were similar in both groups. Intervention group participants experienced a greater sense of social support (p = .049) and reduced worry about finances (p = .014). Patients whose caregiver was randomized to the intervention also had fewer emergency department presentations and unplanned hospital readmissions at 3 months post-discharge (total 17 vs. 5, p = .01). This standardized intervention did not demonstrate any significant improvements in caregiver well-being but did result in a decrease in patient emergency department presentations and unplanned hospital readmissions in the immediate post-discharge period. The trend towards improvements in a number of caregiver outcomes and the improvement in health service utilization support further development of telephone-based caregiver-focused supportive care interventions.

Effects on readiness to change of an educational intervention on depressive disorders for general physicians in primary care based on a modified Prochaska model--a randomized controlled study.

PubMed

Shirazi, M; Zeinaloo, A A; Parikh, S V; Sadeghi, M; Taghva, A; Arbabi, M; Kashani, A Sabouri; Alaeddini, F; Lonka, K; Wahlström, R

2008-04-01

The Prochaska model of readiness to change has been proposed to be used in educational interventions to improve medical care. To evaluate the impact on readiness to change of an educational intervention on management of depressive disorders based on a modified version of the Prochaska model in comparison with a standard programme of continuing medical education (CME). This is a randomized controlled trial within primary care practices in southern Tehran, Iran. The participants included 192 general physicians working in primary care (GPs) were recruited after random selection and randomized to intervention (96) and control (96). Intervention consisted of interactive, learner-centred educational methods in large and small group settings depending on the GPs' stages of readiness to change. Change in stage of readiness to change measured by the modified version of the Prochaska questionnaire was the The final number of participants was 78 (81%) in the intervention arm and 81 (84%) in the control arm. Significantly (P < 0.01), more GPs (57/96 = 59% versus 12/96 = 12%) in the intervention group changed to higher stages of readiness to change. The intervention effect was 46% points (P < 0.001) and 50% points (P < 0.001) in the large and small group setting, respectively. Educational formats that suit different stages of learning can support primary care doctors to reach higher stages of behavioural change in the topic of depressive disorders. Our findings have practical implications for conducting CME programmes in Iran and are possibly also applicable in other parts of the world.

Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model.

PubMed

Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

2010-01-01

To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD: 15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism.

Assessing health system interventions: key points when considering the value of randomization

PubMed Central

Schellenberg, Joanna; Todd, Jim

2011-01-01

Abstract Research is needed to help identify interventions that will improve the capacity or functioning of health systems and thereby contribute to achieving global health goals. Well conducted, randomized controlled trials (RCTs), insofar as they reduce bias and confounding, provide the strongest evidence for identifying which interventions delivered directly to individuals are safe and effective. When ethically feasible, they can also help reduce bias and confounding when assessing interventions targeting entire health systems. However, additional challenges emerge when research focuses on interventions that target the multiple units of organization found within health systems. Hence, one cannot complacently assume that randomization can reduce or eliminate bias and confounding to the same degree in every instance. While others have articulated arguments in favour of alternative designs, this paper is intended to help people understand why the potential value afforded by RCTs may be threatened. Specifically, it suggests six points to be borne in mind when exploring the challenges entailed in designing or evaluating RCTs on health system interventions: (i) the number of units available for randomization; (ii) the complexity of the organizational unit under study; (iii) the complexity of the intervention; (iv) the complexity of the cause–effect pathway, (v) contamination; and (vi) outcome heterogeneity. The authors suggest that the latter may be informative and that the reasons behind it should be explored and not ignored. Based on improved understanding of the value and possible limitations of RCTs on health system interventions, the authors show why we need broader platforms of research to complement RCTs. PMID:22271948

Efficacy of SISTA South Africa on sexual behavior, HIV stigma and relationship control among isiXhosa women in the Western Cape Province, South Africa: Results of a Randomized Controlled Trial

PubMed Central

Wingood, Gina M.; Reddy, Priscilla; Lang, Delia L.; Saleh-Onoya, Dorina; Braxton, Nikia; Sifunda, Sibusiso; DiClemente, Ralph J

2013-01-01

Background The HIV epidemic has a devastating impact among South-African women. The current study evaluated the efficacy of SISTA South Africa, a culturally congruent HIV intervention for isiXhosa women in South Africa that was adapted from SISTA, an HIV intervention for African American women. Methods A randomized controlled trial recruited 342 isiXhosa women 18 – 35 years of age. Participants were randomized to the general health comparison or the SISTA South Africa intervention. Xhosa speaking peer health educators tailored the SISTA South Africa curriculum, while maintaining the core elements of the original SiSTA intervention. Participants completed assessments at baseline and 6 months follow-up. Results Relative to participants in the comparison, participants in the HIV intervention reduced the frequency of unprotected vaginal intercourse acts (adjusted mean difference = 1.06; p = .02), were more likely to report not desiring dry sex (AOR = .229; 95% CI = .10, .47; p = .0001) and, were more likely to perceive that their main sexual partner did not desire dry sex (AOR = .24; 95% CI = .11, .52; p = .0001). Additionally, women randomized to the intervention also reported an increase in HIV knowledge, greater relationship control and had more accepting attitudes towards HIV stigma. The HIV intervention did not reduce STI incidence. Conclusions This trial demonstrates that an HIV intervention which is adapted to enhance its gender and cultural relevance for rural isiXhosa women can reduce self-reported sexual risk behaviors and enhance mediators of HIV among this vulnerable population. PMID:23673889

A clustered randomized trial of the effects of feedback using academic detailing compared to postal bulletin on prescribing of preventative cardiovascular therapy.

PubMed

Naughton, Corina; Feely, John; Bennett, Kathleen

2007-10-01

Interventions to promote prescribing of preventive therapies in patients with cardiovascular disease (CVD) or diabetes have reported variable success. (i) To evaluate the effect of prescribing feedback on GP practice using academic detailing compared to postal bulletin on prescribing of CVD preventive therapies in patients with CVD or diabetes at 3 and 6 months post intervention and (ii) to evaluate the intervention from a GP's perspective. Volunteer GP practices (n = 98) were randomized to receive individualized prescribing feedback via academic detailing (postal bulletin plus outreach visit) (n = 48) or postal bulletin (n = 50). The proportion of CVD or diabetic patients on statins and antiplatelet agents/warfarin pre- and post-intervention was calculated for each GP practice. Multivariate regression with a random effects model was used to compare differences between the groups adjusting for GP clustering and confounding factors. beta-Coefficients and 95% confidence intervals (CIs) are presented. There was a 3% increase in statin prescribing in CVD patients at 6 months post-intervention for both randomized groups, but there was no statistical difference between the groups (beta = 0.004; 95% CI = -0.01 to 0.02). Statin and antiplatelet/warfarin prescribing also increased in the diabetic population; there was no significant differences between the groups. GPs participating in the project expressed a high level of satisfaction with both interventions. Prescribing of preventive therapies increased in both randomized groups over the study period. But academic detailing did not have an additional effect on changing prescribing over the postal bulletin alone.

The Moderating Role of Perceived Social Support on Alcohol Treatment Outcomes.

PubMed

Mavandadi, Shahrzad; Helstrom, Amy; Sayers, Steven; Oslin, David

2015-09-01

This study examined the extent to which perceived social support is related to longitudinal treatment outcomes among heavy drinkers randomized to a brief, telephone-based care management intervention versus standard care. This is a secondary analysis of data from a randomized trial comparing an enhanced, brief alcohol intervention to standard care. Participants comprised 136 male, heavy drinkers (mean age = 57.3 years) receiving primary care at Corporal Michael J. Crescenz Veterans Affairs Medical Center clinics. Participants in the intervention arm received a telephone-based care management intervention focused on helping patients reduce their alcohol use. Primary measures included the Timeline Followback method for number of heavy drinking days and the Multidimensional Scale of Perceived Social Support for self-reported baseline social support. Although there was no significant main effect for baseline perceived social support on number of heavy drinking days over time, there was a significant three-way interaction (Perceived Social Support × Randomization Group × Time). Specifically, among patients reporting high support, those randomized to the intervention arm experienced significantly greater declines in number of heavy drinking days over time. Conversely, among patients reporting low support, those randomized to standard care experienced more improvement over the course of followup. Perceived social support may be related to differential outcomes depending on whether patients are in care management or standard care. For those receiving brief intervention, certain therapy techniques may mobilize pre-existing social resources and/or enhance the ability for patients to use their social supports, suggesting the need for replication and further research in understanding this interaction.

A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents.

PubMed

Kolanowski, Ann; Litaker, Mark; Buettner, Lin; Moeller, Joyel; Costa, Paul T

2011-06-01

To test the main and interactive effects of activities derived from the Need-Driven Dementia-Compromised Behavior model for responding to behavioral symptoms in nursing home residents. Randomized double-blind clinical trial. Nine community-based nursing homes. One hundred twenty-eight cognitively impaired residents randomly assigned to activities adjusted to functional level (FL) (n=32), personality style of interest (PSI) (n=33), functional level and personality style of interest (FL+PSI) (n=31), or active control (AC) (n=32). Three weeks of activities provided twice daily. Agitation, passivity, engagement, affect, and mood assessed from video recordings and real-time observations during baseline, intervention, random times outside of intervention, and 1 week after intervention. All treatments improved outcomes during intervention except mood, which worsened under AC. During intervention the PSI group demonstrated greater engagement, alertness, and attention than the other groups; the FL+PSI group demonstrated greater pleasure. During random times, engagement returned to baseline levels except in the FL group in which it decreased. There was also less agitation and passivity in groups with a component adjusted to PSI. One week after the intervention, mood, anxiety, and passivity improved over baseline; significantly less pleasure was displayed after withdrawal of treatment. The hypothesis that activities adjusted to FL+PSI would improve behavioral outcomes to a greater extent than partially adjusted or nonadjusted activities was partially supported. PSI is a critical component of individualized activity prescription. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

Deep Dyspareunia in Endometriosis: A Proposed Framework Based on Pain Mechanisms and Genito-Pelvic Pain Penetration Disorder.

PubMed

Yong, Paul J

2017-10-01

Endometriosis is a common chronic disease affecting 1 in 10 women of reproductive age, with half of women with endometriosis experiencing deep dyspareunia. A review of research studies on endometriosis indicates a need for a validated question or questionnaire for deep dyspareunia. Moreover, placebo-controlled randomized trials have yet to demonstrate a clear benefit for traditional treatments of endometriosis for the outcome of deep dyspareunia. The reason some patients might not respond to traditional treatments is the multifactorial nature of deep dyspareunia in endometriosis, which can include comorbid conditions (eg, interstitial cystitis and bladder pain syndrome) and central sensitization underlying genito-pelvic pain penetration disorder. In general, there is a lack of a framework that integrates these multifactorial causes to provide a standardized approach to deep dyspareunia in endometriosis. To propose a clinical framework for deep dyspareunia based on a synthesis of pain mechanisms with genito-pelvic pain penetration disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Narrative review after literature search with the terms (endometriosis AND dyspareunia) OR (dyspareunia AND deep) and after analysis of placebo-controlled randomized trials. Deep dyspareunia presence or absence or deep dyspareunia severity on a numeric rating scale or visual analog scale. Four types of deep dyspareunia are proposed in women with endometriosis: type I that is directly due to endometriosis; type II that is related to a comorbid condition; type III in which genito-pelvic pain penetration disorder is primary; and type IV that is secondary to a combination of types I to III. Four types of deep dyspareunia in endometriosis are proposed, which can be used as a framework in research studies and in clinical practice. Research trials could phenotype or stratify patients by each type. The framework also could give rise to more personalized care for patients by targeting appropriate treatments to each deep dyspareunia type. Yong PJ. Deep Dyspareunia in Endometriosis: A Proposed Framework Based on Pain Mechanisms and Genito-Pelvic Pain Penetration Disorder. Sex Med Rev 2017;5:495-507. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

PubMed

Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

2014-11-01

Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

Changes in Brain Volume and Cognition in a Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders

PubMed Central

Mortimer, James A.; Ding, Ding; Borenstein, Amy R.; DeCarli, Charles; Guo, Qihao; Wu, Yougui; Zhao, Qianhua; Chu, Shugang

2013-01-01

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRIs were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks, and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models. Compared to the No Intervention group, significant increases in brain volume were seen in the Tai Chi and Social Intervention groups (p < 0.05). Improvements also were observed in several neuropsychological measures in the Tai Chi group, including the Mattis Dementia Rating Scale score (p = 0.004), the Trailmaking Test A (p = 0.002) and B (p = 0.0002), the Auditory Verbal Learning Test (p = 0.009), and verbal fluency for animals (p = 0.01). The Social Interaction group showed improvement on some, but fewer neuropsychological indices. No differences were observed between the Walking and No Intervention groups. The findings differ from previous clinical trials in showing increases in brain volume and improvements in cognition with a largely non-aerobic exercise (Tai Chi). In addition, intellectual stimulation through social interaction was associated with increases in brain volume as well as with some cognitive improvements. PMID:22451320

Results of Mujeres Felices por ser Saludables: a dietary/breast health randomized clinical trial for Latino women.

PubMed

Fitzgibbon, Marian L; Gapstur, Susan M; Knight, Sara J

2004-10-01

Data are limited on the efficacy of health-focused interventions for young, low-acculturated Latino women. Because breast cancer is the most commonly diagnosed cancer and the most common cause of cancer mortality in this population, combined interventions that address both early detection and dietary patterns could help reduce both morbidity and mortality associated with breast cancer in this underserved population. Mujeres Felices por ser Saludables was randomized intervention study designed to assess the efficacy of an 8-month combined dietary and breast health intervention to reduce fat and increase fiber intake as well as to increase the frequency and proficiency of breast self-examination (BSE) and reduce anxiety related to BSE among Latinas. Blocked randomization in blocks of 6 was used to randomize 256 20- to 40-year-old Latinas to the intervention (n = 127) or control group (n = 129). The intervention group attended an 8-month multicomponent education program designed specifically for low-acculturated Latinas. The control group received mailed health education material on a schedule comparable to the intervention. A total of 195 women (76.2%) completed both the baseline and 8-month follow-up interviews. The intervention and control groups were similar on baseline sociodemographic characteristics. At the 8-month follow up, the intervention group reported lower dietary fat (P < .001) and higher fiber intake (p = .06); a higher proportion reported practicing BSE at the recommended interval (p < .001) and showed improved BSE proficiency (p < .001) compared to the control group. BSE-related anxiety was low for both groups at baseline, and no difference in reduction was observed. This project provides a successful model for achieving dietary change and improving breast health behavior in young, low-acculturated Latinas.

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

PubMed

Robinson, Thomas N; Matheson, Donna; Desai, Manisha; Wilson, Darrell M; Weintraub, Dana L; Haskell, William L; McClain, Arianna; McClure, Samuel; Banda, Jorge A; Sanders, Lee M; Haydel, K Farish; Killen, Joel D

2013-11-01

To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. © 2013 Elsevier Inc. All rights reserved.

A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity): rationale, design and methodology of a randomized controlled trial in Nanjing city, China.

PubMed

Xu, Fei; Ware, Robert S; Tse, Lap Ah; Wang, Zhiyong; Hong, Xin; Song, Aiju; Li, Jiequan; Wang, Youfa

2012-06-15

The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group). Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a) classroom curriculum, (including physical education and healthy diet education), b) school environment support, c) family involvement, and d) fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools' regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. ChiCTR-ERC-11001819.

Internet Delivered Support for Tobacco Control in Dental Practice: Randomized Controlled Trial

PubMed Central

Richman, Joshua S; Ray, Midge N; Allison, Jeroan J; Gilbert, Gregg H; Shewchuk, Richard M; Kohler, Connie L; Kiefe, Catarina I

2008-01-01

Background The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized. Objective To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings. Methods Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention. Results Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices’ mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK. Conclusion This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit. Trial Registration clinicaltrials.gov NCT00627185; http://clinicaltrials.gov/ct2/show/NCT00627185 (Archived by WebCite at http://www.webcitation.org/5c5Kugvzj) PMID:18984559

Changes in brain volume and cognition in a randomized trial of exercise and social interaction in a community-based sample of non-demented Chinese elders.

PubMed

Mortimer, James A; Ding, Ding; Borenstein, Amy R; DeCarli, Charles; Guo, Qihao; Wu, Yougui; Zhao, Qianhua; Chu, Shugang

2012-01-01

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRIs were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks, and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models. Compared to the No Intervention group, significant increases in brain volume were seen in the Tai Chi and Social Intervention groups (p < 0.05). Improvements also were observed in several neuropsychological measures in the Tai Chi group, including the Mattis Dementia Rating Scale score (p = 0.004), the Trailmaking Test A (p = 0.002) and B (p = 0.0002), the Auditory Verbal Learning Test (p = 0.009), and verbal fluency for animals (p = 0.01). The Social Interaction group showed improvement on some, but fewer neuropsychological indices. No differences were observed between the Walking and No Intervention groups. The findings differ from previous clinical trials in showing increases in brain volume and improvements in cognition with a largely non-aerobic exercise (Tai Chi). In addition, intellectual stimulation through social interaction was associated with increases in brain volume as well as with some cognitive improvements.

Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials.

PubMed

Matteson, Michelle L; Russell, Cynthia

2010-10-01

Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

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.

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines

PubMed Central

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-01-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4–10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child’s health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. PMID:24134922

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

An intervention to preschool children for reducing screen time: a randomized controlled trial.

PubMed

Yilmaz, G; Demirli Caylan, N; Karacan, C D

2015-05-01

Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.

A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

PubMed

Leow, Mabel; Chan, Sally; Chan, Moon

2015-03-01

To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


Parenting acceptance and commitment therapy: a randomised controlled trial of an innovative online course for families of children with cerebral palsy.

PubMed

Whittingham, Koa; Sheffield, Jeanie; Boyd, Roslyn N

2016-10-19

Cerebral palsy (CP) impacts on the entire family in a manner that is long-term, complex and multifactorial. In addition, the quality of the parent-child relationship impacts on many and varied child outcomes, making the provision of easily accessible and evidence-based support to parents of children with CP a priority. This paper reports the protocol of a randomised controlled trial of an innovative and translatable online intervention, parenting acceptance and commitment therapy (PACT), for families of children with CP. We predict that participating in the PACT programme will be associated with improvements in the parent-child relationship, in child functioning and in adjustment and quality of life for both parent and child. We aim to recruit 66 parents of children (2-10 years old) diagnosed with CP to this study. Families will be randomly assigned to two groups: wait-list control and PACT. PACT is a parenting intervention grounded in acceptance and commitment therapy (ACT) and developed into an online course 'PARENT101 Parenting with Purpose' using the edX platform. All participants will be offered PACT before completion of the study. Assessments will take place at baseline, following completion of PACT and at 6-month follow-up (retention) and will focus on the parent-child relationship, parent and child adjustment and parent and child quality of life. Analysis will follow standard methods for randomised controlled trials using general linear models, specifically analysis of variance or analysis of covariance. Ethics approvals have been obtained through the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/15/QRCH/115) and The University of Queensland (2015001743). If efficacy is demonstrated, then the PARENT101 course has the potential to be disseminated widely in an accessible manner and at minimal cost. Further, the PACT framework may provide a blueprint for similar online courses with parents in a full range of contexts. ACTRN12616000351415; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Role of amino acid supplementation in the prevention of necrotizing enterocolitis in preterm neonates - a review of current evidences.

PubMed

Garg, Bhawan Deep; Kabra, Nandkishor S

2018-09-01

Necrotizing enterocolitis (NEC) is one of the most common acute and fatal gastrointestinal emergency in very low birth weight (VLBW) preterm neonates with mortality range from 15 to 30%. NEC is likely due to multifactorial process such as oxidative injury, ischemic necrosis, and over-reactive inflammatory response to intestinal microbes. To evaluate the role of amino acid supplementation for reduction of neonatal NEC in preterm neonates. The literature search was done for various randomized control trial (RCT) by searching the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, Web of Science, Scopus, Index Copernicus, African Index Medicus (AIM), Thomson Reuters (ESCI), Chemical Abstracts Service (CAS) and other database. This review included 15 RCTs that fulfilled inclusion criteria. The total neonates enrolled in these different RCT are 3424 (amino acid group 1711 and control 1713). Almost all participating neonates were of VLBW or extremely low birth weight (ELBW). In two trials, birth weight was between 1500-2000 grams. The intervention was started within first few days after birth and continued up to 30th day of postnatal age in most of the trials. In two trials, intervention was continued up to 120th day of postnatal age. Arginine, glutamine and N-acetyl cysteine (NAC) were used at the dose of 1.5 mol/kg/day (261 mg/kg/day), 0.3 grams/kg/day and 16-32 mg/kg/day, respectively. Role of amino acid in the prevention of neonatal NEC is not exclusively supported by the current evidence. Only three studies were able to show reduction in the incidence of NEC with amino acid supplementation (arginine, glutamine), and the remaining studies did not report any positive effect. Amino acid supplementation was not associated with significant reduction in mortality due to any causes. However, arginine supplementation was associated with significant reduction in mortality due to NEC. Two studies on glutamine were reported significant reduction in the incidence of invasive infection. Only one study reported significant positive effects on growth parameters and less time to reach full enteral feeds. None of the studies showed any effect on the duration of hospital stay.

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

PubMed

Von Korff, M; Moore, J E; Lorig, K; Cherkin, D C; Saunders, K; González, V M; Laurent, D; Rutter, C; Comite, F

1998-12-01

Randomized, controlled trial. To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.

No evidence for intervention-dependent influence of methodological features on treatment effect.

PubMed

Jacobs, Wilco C H; Kruyt, Moyo C; Moojen, Wouter A; Verbout, Ab J; Oner, F Cumhur

2013-12-01

The goal of this systematic review was to evaluate if the influence of methodological features on treatment effect differs between types of intervention. MEDLINE, Embase, Web of Science, Cochrane methodology register, and reference lists were searched for meta-epidemiologic studies on the influence of methodological features on treatment effect. Studies analyzing influence of methodological features related to internal validity were included. We made a distinction among surgical, pharmaceutical, and therapeutical as separate types of intervention. Heterogeneity was calculated to identify differences among these types. Fourteen meta-epidemiologic studies were found with 51 estimates of influence of methodological features on treatment effect. Heterogeneity was observed among the intervention types for randomization. Surgical intervention studies showed a larger treatment effect when randomized; this was in contrast to pharmaceutical studies that found the opposite. For allocation concealment and double blinding, the influence of methodological features on the treatment effect was comparable across different types of intervention. For the remaining methodological features, there were insufficient observations. The influence of allocation concealment and double blinding on the treatment effect is consistent across studies of different interventional types. The influence of randomization although, may be different between surgical and nonsurgical studies. Copyright © 2013 Elsevier Inc. All rights reserved.

A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students

PubMed Central

Saravanan, Coumaravelou; Kingston, Rajiah

2014-01-01

Background: Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Materials and Methods: Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1st year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. Results: After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P < 0.01) and high intrinsic and extrinsic motivation (P < 0.01) in the postassessment compared with their preassessment scores. Conclusion: Overall psychological intervention is effective to reduce anxiety scores and its related variables. PMID:25097619

A Randomized Controlled Trial Testing the Efficacy of a Brief Online Alcohol Intervention for High School Seniors.

PubMed

Doumas, Diana M; Esp, Susan; Flay, Brian; Bond, Laura

2017-09-01

The purpose of this randomized controlled study was to examine the efficacy of a brief, web-based personalized feedback intervention (the eCHECKUP TO GO) on alcohol use and alcohol-related consequences among high school seniors. Participants (n = 221) were high school seniors randomized by class period to either a brief, web-based personalized feedback intervention (the eCHECKUP TO GO) or an assessment-only control group. Participants completed online surveys at baseline and at a 6-week follow-up. Students participating in the eCHECKUP TO GO intervention reported a significant reduction in weekly drinking quantity, peak drinking quantity, and frequency of drinking to intoxication relative to those in the control group. Intervention effects were moderated by high-risk status (one or more episodes of heavy episodic drinking in the past 2 weeks reported at baseline) such that intervention effects were significant for high-risk students only. Results for alcohol-related consequences were not significant. Providing a brief, web-based personalized feedback intervention in the school setting is a promising approach for reducing problem alcohol use among high school seniors who report recent heavy episodic drinking.

Low back pain in healthy postmenopausal women and the effect of physical activity: A secondary analysis in a randomized trial

PubMed Central

Marini, Mirca; Bendinelli, Benedetta; Assedi, Melania; Occhini, Daniela; Castaldo, Maria; Fabiano, Jacopo; Petranelli, Marco; Migliolo, Mario; Monaci, Marco; Masala, Giovanna

2017-01-01

Epidemiological studies on the prevalence of musculoskeletal pain have consistently shown that this is a relevant health problem, with non-specific low back pain (LBP) being the most commonly reported in adult females. Conflicting data on the association between LBP symptoms and physical activity (PA) have been reported. Here, we investigated the prevalence of LBP and the effect of a 24-month non-specific PA intervention on changes in LBP prevalence in a series of Italian healthy postmenopausal women. We performed a secondary analysis in the frame of the DAMA trial, a factorial randomized intervention trial aimed to evaluate the ability of a 24-month intervention, based on moderate-intensity PA, and/or dietary modification, in reducing mammographic breast density in healthy postmenopausal women. The PA intervention included at least 1 hour/day of moderate PA and a more strenuous weekly activity, collective walks and theoretical group sessions. A self-administered pain questionnaire was administered at baseline and at the end of the intervention. The questionnaire was specifically structured to investigate the occurrence of musculoskeletal pain, the body localization, intensity and duration of the pain. Two hundred and ten women (102 randomized to PA intervention, 108 not receiving the PA intervention) filled out the questionnaires. At baseline LBP was present in 32.9% of the participants. Among women randomized to the PA intervention, LBP prevalence at follow up (21.6%) was lower than at baseline (33.3%) (p = 0.02), while in women who did not receive the PA intervention the LBP prevalence at baseline and follow up were 32.4% and 25.9%, respectively (p = 0.30). Overall, there was no significant between-group effect of PA intervention on LBP. Further studies are needed to understand the role of non-specific PA intervention, aimed to improve overall fitness, on LBP prevalence. PMID:28489877

Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach.

PubMed

Simon, Steven R; Trinacty, Connie Mah; Soumerai, Stephen B; Piette, John D; Meigs, James B; Shi, Ping; Ensroth, Arthur; Ross-Degnan, Dennis

2010-07-01

The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing. We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes. In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71-1.22]) and no effect of the intervention on any of the secondary outcomes. Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes.

Effects of the SAFE Children preventive intervention on developmental trajectories of attention-deficit/hyperactivity disorder symptoms.

PubMed

Fowler, Patrick J; Henry, David B; Schoeny, Michael; Gorman-Smith, Deborah; Tolan, Patrick H

2014-11-01

This study examined whether a family-based preventive intervention for inner-city children entering the first grade could alter the developmental course of attention-deficit/hyperactivity disorder (ADHD) symptoms. Participants were 424 families randomly selected and randomly assigned to a control condition (n = 192) or Schools and Families Educating Children (SAFE) Children (n = 232). SAFE Children combined family-focused prevention with academic tutoring to address multiple developmental-ecological needs. A booster intervention provided in the 4th grade to randomly assigned children in the initial intervention (n =101) evaluated the potential of increasing preventive effects. Follow-up occurred over 5 years with parents and teachers reporting on attention problems. Growth mixture models identified multiple developmental trajectories of ADHD symptoms. The initial phase of intervention placed children on more positive developmental trajectories for impulsivity and hyperactivity, demonstrating the potential for ADHD prevention in at-risk youth, but the SAFE Children booster had no additional effect on trajectory or change in ADHD indicators.

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

PubMed

Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

2014-12-01

To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

Evaluation of a Drowning Prevention Program Based on Testimonial Videos: A Randomized Controlled Trial.

PubMed

Shen, Jiabin; Pang, Shulan; Schwebel, David C

2016-06-01

Unintentional drowning is the most common cause of childhood death in rural China. Global intervention efforts offer mixed results regarding the efficacy of educational programs. Using a randomized controlled design, we evaluated a testimonial-based intervention to reduce drowning risk among 280 3rd- and 4th-grade rural Chinese children. Children were randomly assigned to view either testimonials on drowning risk (intervention) or dog-bite risk (control). Safety knowledge and perceived vulnerability were measured by self-report questionnaires, and simulated behaviors in and near water were assessed with a culturally appropriate dollhouse task. Children in the intervention group had improved children's safety knowledge and simulated behaviors but not perceived vulnerability compared with controls. The testimonial-based intervention's efficacy appears promising, as it improved safety knowledge and simulated risk behaviors with water among rural Chinese children. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.