scholarly journals Assessing Dietary Outcomes in Intervention Studies: Pitfalls, Strategies, and Research Needs

Nutrients ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 1001 ◽  
Author(s):  
Sharon Kirkpatrick ◽  
Clare Collins ◽  
Ruth Keogh ◽  
Susan Krebs-Smith ◽  
Marian Neuhouser ◽  
...  

To inform strategies to improve the dietary intakes of populations, robust evaluations of interventions are required. This paper is drawn from a workshop held at the International Society of Behavioral Nutrition and Physical Activity 2017 Annual Meeting, and highlights considerations and research priorities relevant to measuring dietary outcomes within intervention studies. Self-reported dietary data are typically relied upon in such studies, and it is recognized that these data are affected by random and systematic error. Additionally, differential error between intervention and comparison groups or pre- and post-intervention can be elicited by the intervention itself, for example, by creating greater awareness of eating or drinking occasions or the desire to appear compliant. Differential reporting can render the results of trials incorrect or inconclusive by leading to biased estimates and reduced statistical power. The development of strategies to address intervention-related biases requires developing a better understanding of the situations and population groups in which interventions are likely to elicit differential reporting and the extent of the bias. Also needed are efforts to expand the feasibility and applications of biomarkers to address intervention-related biases. In the meantime, researchers are encouraged to consider the potential for differential biases in dietary reporting in a given study, to choose tools carefully and take steps to minimize and/or measure factors such as social desirability biases that might contribute to differential reporting, and to consider the implications of differential reporting for study results.

1987 ◽  
Vol 17 (4) ◽  
pp. 160-164 ◽  
Author(s):  
Stephen D. Bluen ◽  
Caroline van Zwam

The relationship between union membership and job satisfaction, and the moderating role of race and sex is considered in this study. Results show that both race and sex interact with union membership in predicting job satisfaction. A significant 2 × 2 × 2 (union membership × race × sex) interaction showed that white, non-unionized females were less satisfied with their work than black, non-unionized females. In addition, sex moderated the relationship between union membership and co-worker satisfaction: Whereas unionized males were more satisfied with their co-workers than unionized females, the opposite was true for the non-unionized subjects. Finally, union members and non-members differed regarding promotion opportunities: Union members were more satisfied with their promotion opportunities than non-union members. On the basis of the findings, implications and future research priorities are discussed.


2014 ◽  
Vol 75 (2) ◽  
pp. 64-71 ◽  
Author(s):  
Anne-Sophie Morisset ◽  
Julie Anne Côté ◽  
Andréanne Michaud ◽  
Julie Robitaille ◽  
Marie-Christine Dubé ◽  
...  

Purpose: Changes were examined in energy intakes and percentage of energy from macronutrients in response to nutritional intervention in women with gestational diabetes mellitus (GDM). Methods: The study included 17 women with GDM and 27 women with normal glucose tolerance (controls). Women with GDM were followed by a multidisciplinary team; they received dietary counselling by a registered dietitian, and were prescribed diets with 40% to 45% energy from carbohydrate (CHO), 20% to 25% from protein, and 30% to 35% from fat. Dietary intakes were assessed with food frequency questionnaires before the intervention (26.9 ± 3.8 weeks) and after the intervention (32.6 ± 0.6 weeks). Results: After the intervention, women with GDM reduced their total energy intake to reach lower values than did controls (P value for time-group interaction ≤0.05). A concomitant reduction in total CHO and glucose intakes in women with GDM led to significantly lower values compared with intakes in controls (P values for time-group interaction ≤0.001 for all). The post-intervention rate of weight gain in women with GDM was within the Institute of Medicine (IOM)-recommended values, while the post-intervention rate of weight gain in controls was above IOM-recommended values (0.30 ± 0.27 versus 0.61 ± 0.50 kg/week, P≤0.05). Conclusions: These results suggest that this multidisciplinary medical and nutritional intervention was effective in the achievement of prescribed macronutrient distribution and controlling gestational weight gain in Canadian women with GDM.


2020 ◽  
Author(s):  
Brody Holohan ◽  
Raphael Laderman

AbstractGene-environment interactions are at the heart of why many complex traits are not fully heritable, and why prediction of disease incidence and individual response to environmental changes based on genetics has been underwhelming in utility. Understanding these interactions is the primary limiting factor for the application of personalized medicine, but current methods are not well suited for dealing with complex traits that pose both a dimensionality and sparse data problem to unsupervised analysis methods. Genteract has developed a proprietary analytical technique that allows for detection and interpretation of GxEs regarding specific pairs of a single phenotype with a single environmental factor; these methods allow us to develop a platform that can be used to predict how individuals will respond to changes in their environment based on their genetics. To validate the methods we performed two types of testing: cross-validation against a dataset of clinical study results, and application of the methods in a simulated dataset. These tests enable a greater understanding of the methods’ utility, statistical power and predictive capabilities.


2020 ◽  
pp. 1-15
Author(s):  
Aimee Boidin ◽  
Ryan Tam ◽  
Lachlan Mitchell ◽  
Gregory R. Cox ◽  
Helen O’Connor

Abstract Nutrition education programmes for athletes aim to enhance nutrition knowledge and more importantly support positive dietary change to enhance performance, health and well-being. This systematic review assessed changes in the dietary intakes of athletes in response to nutrition education programmes. A search was conducted which included studies providing quantitative dietary intake assessment of athletes of any calibre aged between 12 and 65 years in response to a nutrition education programme. Standardised differences (effect sizes) were calculated (when possible) for each dietary parameter. The search yielded 6285 papers with twenty-two studies (974 participants (71·9 % female)) eligible for inclusion. Studies described athletes competing at high school (n 3) through to college level or higher (n 19). Study designs were either single arm with an intervention-only group (twelve studies; n 241) or double arm including an intervention and control group (ten studies; n 689). No control groups received an alternative or ‘sham’ intervention. Face-to-face lectures (9/22) and individual nutrition counselling (6/22) were the most common education interventions. Non-weighed, 3-d diet records (10/22) were the most frequently utilised dietary assessment method. Although 14/22 studies (n 5 single and n 9 double) reported significant change in at least one nutrition parameter, dietary changes were inconsistent. Poor study quality and heterogeneity of methods prohibit firm conclusions regarding overall intervention success or superior types of educational modalities. Of note, carbohydrate intakes ‘post-intervention’ when assessed often failed to meet recommended guidelines (12/17 studies). Given the substantial investment made in nutrition education interventions with athletes, there is a need for well-designed and rigorous research to inform future best practice.


Diagnostics ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. 67
Author(s):  
John Peabody ◽  
Mary Tran ◽  
David Paculdo ◽  
Czarlota Valdenor ◽  
Trever Burgon ◽  
...  

Demonstrating clinical utility for diagnostic tests and securing coverage and reimbursement requires high quality and, ideally, randomized controlled trial (RCT) data. Traditional RCTs are often too costly, slow, and cumbersome for diagnostic firms. Alternative data options are needed. We evaluated four RCTs using virtual patients to demonstrate clinical utility. Each study used a similar pre-post intervention, two round design to facilitate comparison. Representative samples of physicians were recruited and randomized into control and intervention arms. All physicians were asked to care for their virtual patients during two assessment rounds, separated by a multi-week time interval. Between rounds, intervention physicians reviewed educational materials on the diagnostic test. All physician responses were scored against evidence-based care criteria. RCTs using virtual patients can demonstrate clinical utility for a variety of diagnostic test types, including: (1) an advanced multi-biomarker blood test, (2) a chromosomal microarray, (3) a proteomic assay analysis, and (4) a multiplex immunofluorescence imaging platform. In two studies, utility was demonstrated for all targeted patient populations, while in the other two studies, utility was only demonstrated for a select sub-segment of the intended patient population. Of these four tests, two received positive coverage decisions from Palmetto, one utilized the study results to support commercial payer adjudications, and the fourth company went out of business. RCTs using virtual patients are a cost-effective approach to demonstrate the presence or absence of clinical utility.


2004 ◽  
Vol 87 (1) ◽  
pp. 15-32 ◽  
Author(s):  
Kenneth J. Kopecky ◽  
Scott Davis ◽  
Thomas E. Hamilton ◽  
Mark S. Saporito ◽  
Lynn E. Onstad

Nutrients ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 1052 ◽  
Author(s):  
Caleigh Sawicki ◽  
Kara Livingston ◽  
Alastair Ross ◽  
Paul Jacques ◽  
Katie Koecher ◽  
...  

Consumption of whole grains have been associated with reduced risk of chronic diseases in many observational studies; yet, results of intervention studies are mixed. We aimed to use evidence mapping to capture the methodological and reporting variability in whole grain intervention studies that may contribute to this inconsistency. We conducted a reproducible search in OVID Medline for whole grain human intervention studies (published 1946 to February 2018). After screening based on a priori criteria, we identified 202 publications describing a total of 213 unique trials. Over half (55%) were acute trials, lasting ≤1 day, 30% were moderate duration studies (up to 6 weeks) and 15% were of longer duration (more than 6 weeks). The majority of acute trials (75%) examined measures of glycaemia and/or insulinemia, while most of the longer trials included measures of cardiometabolic health (71%), appetite/satiety (57%) and weight/adiposity (56%). Among the moderate and long duration trials, there was a wide range of how whole grains were described but only 10 publications referenced an established definition. Only 55% of trials reported the actual amount of whole grains (in grams or servings), while 36% reported the amount of food/product and 9% did not report a dose at all. Of the interventions that provided a mixture of whole grains, less than half (46%) reported the distribution of the different grain types. Reporting of subject compliance also varied and only 22% used independent biomarkers of whole grain intake. This evidence map highlights the need to standardize both study protocols and reporting practices to support effective synthesis of study results and provide a stronger foundation to better inform nutrition scientists and public health policy.


Author(s):  
Daniel Flynn ◽  
Conall Gillespie ◽  
Mary Joyce ◽  
Ailbhe Spillane

Objectives: Previous research indicates that dialectical behaviour therapy for adolescents (DBT-A) is effective in treating emotionally dysregulated adolescents with self-harm and/or suicidal ideation. As part of the DBT-A programme, parents attend the weekly skills group with their child. However, few studies have evaluated parental outcomes in DBT-A. This multi-site study aims to explore the outcomes and experiences of parents who participated in a 16-week DBT-A programme in Ireland. Methods: This study was conducted in community-based child and adolescent mental health services (CAMHS) in the national public health system in Ireland. Participants were parent/guardians of adolescents attending a DBT-A programme in their local CAMHS. Participants attended the group skills component of the DBT-A programme. This study utilised a mixed methods approach where both quantitative and qualitative data were collected from participants. Self-report measures of burden, grief and parental stress were completed at pre-intervention, post-intervention and 16-week follow-up. Qualitative written feedback was obtained at post-intervention. The data were analysed using multi-level linear mixed-effects models and content analysis. Results: One hundred participants (76% female) took part in this study. Significant decreases were reported for objective burden, subjective burden, grief and parental stress from pre- to post-intervention (p < 0.01). Participants reported that the skills component of DBT-A was useful in meeting their own needs and the needs of their child. Discussion: DBT-A shows promise for parents as well as their adolescent child. Future studies should evaluate changes to family relationships following completion of the programme and also include controlled comparison groups.


2019 ◽  
pp. 1-16 ◽  
Author(s):  
Juan Carlos López Alfonso ◽  
Jan Poleszczuk ◽  
Rachel Walker ◽  
Sungjune Kim ◽  
Shari Pilon-Thomas ◽  
...  

PURPOSE Early-stage cancers are routinely treated with surgery followed by radiotherapy (SR). Radiotherapy before surgery (RS) has been widely ignored for some cancers. We evaluate overall survival (OS) and disease-free survival (DFS) with SR and RS for different cancer types and simulate the plausibility of RS- and SR-induced antitumor immunity contributing to outcomes. MATERIALS AND METHODS We analyzed a SEER data set of early-stage cancers treated with SR or RS. OS and DFS were calculated for cancers with sufficient numbers for statistical power (cancers of lung and bronchus, esophagus, rectum, cervix uteri, corpus uteri, and breast). We simulated the immunologic consequences of SR, RS, and radiotherapy alone in a mathematical model of tumor-immune interactions. RESULTS RS improved OS for cancers with low 20-year survival rates (lung: hazard ratio [HR], 0.88; P = .046) and improved DFS for cancers with higher survival (breast: HR = 0.64; P < .001). For rectal cancer, with intermediate 20-year survival, RS improved both OS (HR = 0.89; P = .006) and DFS (HR = 0.86; P = .04). Model simulations suggested that RS could increase OS by eliminating cancer for a broader range of model parameters and radiotherapy-induced antitumor immunity compared with SR for selected parameter combinations. This could create an immune memory that may explain increased DFS after RS for certain cancers. CONCLUSION Study results suggest plausibility that radiation to the bulk of the tumor could induce a more robust immune response and better harness the synergy of radiotherapy and antitumor immunity than postsurgical radiation to the tumor bed. This exploratory study provides motivation for prospective evaluation of immune activation of RS versus SR in controlled clinical studies.


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