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Not so simple: a quasi-experimental study of how researchers adjudicate genetic research results.

ABSTRACT: Ethicists contend that researchers are obliged to report genetic research findings to individual study participants when they are clinically significant, that is, when they are clinically useful or personally meaningful to participants. Yet whether such standards are well understood and can be consistently applied remains unknown. We conducted an international, cross-sectional survey of cystic fibrosis (CF) and autism genetics researchers using a quasi-experimental design to explore factors influencing researchers' judgments. Eighty percent of researchers agreed, in principle, that clinically significant findings should be reported to individual participants. Yet judgments about when a specific finding was considered clinically significant or warranted reporting varied by scientific factors (replication, robustness, intentionality, and disease context), capacity of the research team to explain the results, and type of research ethics guidance. Further, judgments were influenced by the researchers' disease community (autism or CF), their primary role (clinical, molecular, statistical) and their beliefs regarding a general reporting obligation. In sum, judgments about the clinical significance of genetic research results, and about whether they should be reported, are influenced by scientific parameters as well as contextual factors related to the specific research project and the individual researcher. These findings call into question the assumption that the conditions under which an obligation to disclose arises are uniformly understood and actionable. Adjudicating the clinical readiness of provisional data may be a responsibility better suited to evaluative experts at arms' length of the provisional data in question, rather than a responsibility imposed upon researchers themselves.

SUBMITTER: Hayeems RZ

PROVIDER: S-EPMC3137502 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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Not so simple: a quasi-experimental study of how researchers adjudicate genetic research results.

Hayeems Robin Zoe RZ Miller Fiona Alice FA Li Li L Bytautas Jessica Peace JP

European journal of human genetics : EJHG 20110316 7

Ethicists contend that researchers are obliged to report genetic research findings to individual study participants when they are clinically significant, that is, when they are clinically useful or personally meaningful to participants. Yet whether such standards are well understood and can be consistently applied remains unknown. We conducted an international, cross-sectional survey of cystic fibrosis (CF) and autism genetics researchers using a quasi-experimental design to explore factors infl ...[more]

PMID: 21407262

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Project description:Individuals from racial minority backgrounds, especially those in low income situations, are at increased risk for obesity. Family meals positively impact child nutritional health; however, there is limited evidence examining the impact on caregivers, particularly racial minority and income-restricted individuals. The objective of this intervention study was to determine the effect of Simple Suppers, a 10 week family meals program, on caregiver diet and nutrition outcomes. Intervention versus waitlist control participants were compared from baseline (T0) to post-intervention (T1). In addition, intervention participants were assessed at a 10 week follow-up time point (T2). This study was a two-group quasi-experimental intervention trial. Lessons (10 total) were delivered on a weekly basis for 90 min. Data were collected from intervention and waitlist control participants at T0 and T1, and intervention participants at T2. After baseline (T0) data collection, families enrolled in the immediate upcoming session of Simple Suppers (intervention group) or waited for 10 weeks (waitlist control group) to begin the program. Participants were caregivers of children ages 4-10 years. This study was conducted in a faith-based community center for underserved families in Columbus, Ohio. Primary outcomes were: diet quality assessed by Healthy Eating Index (HEI) total and component scores, and total energy intake (kcal/day); body mass index (BMI) (kg/m2), waist circumference (cm), systolic and diastolic blood pressure (BP) (mmHG); and self-efficacy for having healthy meals and menu planning (both scalar). The impact of the intervention (T0:T1) was assessed using generalized mixed-effects linear regression models. Maintenance of change in study outcomes among intervention participants (T1:T2) was examined with paired t-tests. 109 caregivers enrolled in this study. The retention rate at T1 was 90% (i.e., 98 participants). 56 of 68 intervention participants completed T2, resulting in a retention rate of 82%. Almost all (99%) were female, 61% were Black, and 50% were between 31 and 40 years old. In total, 40% had low income and 37% had low or very low food security. At T1, intervention vs. waitlist controls had a lower daily energy intake (p = 0.04), but an HEI-2010 component score for fatty acids (adequacy) that was lower indicating a lower dietary intake of fatty acids (p = 0.02), and a component score for empty calories (moderation) that was significantly lower indicating a higher intake of empty calorie foods (p = 0.03). At T1, intervention vs. waitlist controls also had a lower BMI (p < 0.001) and systolic BP (p = 0.04), and higher self-efficacy (p = 0.03). There were no group differences in other outcomes. At T2, intervention participants maintained the changes in daily energy intake, BMI, systolic BP, and self-efficacy that improved during the intervention period. There was no change (improvement) in the component score for fatty acids; however, the component score for empty calories significantly improved (p = 0.02). Engagement in the Simple Suppers program led to improvements in caregivers' daily caloric intake, weight status, systolic blood pressure, and self-efficacy for family meals. Future research should further explore the dietary and nutritional health benefits of family meals among caregivers at the highest risk for obesity.

Project description:BackgroundTo improve quality of care for patients with hip and knee osteoarthritis (OA), general practitioners (GPs) and physiotherapists (PTs) in a Norwegian municipality initiated an intervention. The intervention aimed to increase provision of core OA treatment (information, exercise, and weight control) prior to referral for surgery, rational use of imaging for assessing OA and improve communication between healthcare professionals. This study assessed the effectiveness of this intervention.MethodsForty-eight PTs and one hundred one GPs were invited to the intervention that included two interactive workshops outlining best practice and an accompanying template for PT discharge reports. Using interrupted time series research design, the study period was divided into three: pre-implementation, transition (implementation) and post-implementation. Comparing the change between pre- and post-implementation, the primary outcome was patient-reported quality of OA care measured with the OsteoArthritis Quality Indicator questionnaire. Secondary outcomes were number of PT discharge reports, information included in GP referral letters to orthopaedic surgeon, the proportion of GP referral letters indicating use of core treatment, and the use of imaging within OA assessment. Analyses involved linear mixed and logistic regression models.ResultsThe PT workshop had 30 attendees, and 31 PTs and 33 GPs attended the multidisciplinary workshop. Two hundred eight and one hundred twenty-five patients completed the questionnaire during pre- and post-implementation, respectively. The adjusted model showed a small, statistically non-significant, increase in mean total score for quality of OA care (mean change = 4.96, 95% CI -0.18, 10.12, p:0.057), which was mainly related to items on OA core treatment. Patients had higher odds of reporting receipt of information on treatment alternatives (odds ratio (OR) 1.9, 95% CI 1.08, 3.24) and on self-management (OR 2.4, 95% CI 1.33, 4.32) in the post-implementation phase. There was a small, statistically non-significant, increase in the proportion of GP referral letters indicating prior use of core treatment modalities. There were negligible changes in the number of PT discharge reports, in the information included in the GP referral letters, and in the use of imaging for OA assessment.ConclusionThis study suggests that a primary care intervention including two inter-active workshops can shift the quality of care towards best practice recommendations.Trial registrationClinicalTrials.gov: NCT02876120 .

Project description:The primary aim of this paper is to describe the design of a project evaluating the effects of using a research-based strategy for managing housing adaptations (HAs). The evaluation targets clients' perspectives in terms of activity, participation, usability, fear of falling, fall incidence, use of mobility devices, and health-related quality of life, and determines the societal effects of HAs in terms of costs. Additional aims of the project are to explore and describe this strategy in relation to experiences and expectations (a) among clients and cohabitants and (b) occupational therapists in ordinary practice.This study is a quasi-experimental trial applying a multiphase design, combining quantitative and qualitative data. At the experimental sites, the occupational therapists (OTs) apply the intervention, i.e. a standardized research-based strategy for HA case management. At the control site, the occupational therapists are following their regular routine in relation to HA. Three municipalities in south Sweden will be included based on their population, their geographical dispersion, and their similar organizational structures for HA administration. Identical data on outcomes is being collected at all the sites at the same four time points: before the HA and then 3, 6, and 12 months after the HA. The data-collection methods are semi-structured qualitative interviews, observations, clinical assessments, and certificates related to each client's HA.The intervention in this study has been developed and tested through many years of research and in collaboration with practitioners. This process includes methodological development and testing research aimed at identifying the most important outcomes and research targeting current HA case-management procedures in Swedish municipalities. When the study is completed, the results will be used for further optimization of the practice strategy for HA, in close collaboration with the data-collecting OTs.No: NCT01960582.

Project description:Background:There is increasing evidence that research misbehaviour is common, especially the minor forms. Previous studies on research misbehaviour primarily focused on biomedical and social sciences, and evidence from natural sciences and humanities is scarce. We investigated what academic researchers in Amsterdam perceived to be detrimental research misbehaviours in their respective disciplinary fields. Methods:We used an explanatory sequential mixed methods design. First, survey participants from four disciplinary fields rated perceived frequency and impact of research misbehaviours from a list of 60. We then combined these into a top five ranking of most detrimental research misbehaviours at the aggregate level, stratified by disciplinary field. Second, in focus group interviews, participants from each academic rank and disciplinary field were asked to reflect on the most relevant research misbehaviours for their disciplinary field. We used participative ranking methodology inducing participants to obtain consensus on which research misbehaviours are most detrimental. Results:In total, 1080 researchers completed the survey (response rate: 15%) and 61 participated in the focus groups (3 three to 8 eight researchers per group). Insufficient supervision consistently ranked highest in the survey regardless of disciplinary field and the focus groups confirmed this. Important themes in the focus groups were insufficient supervision, sloppy science, and sloppy peer review. Biomedical researchers and social science researchers were primarily concerned with sloppy science and insufficient supervision. Natural sciences and humanities researchers discussed sloppy reviewing and theft of ideas by reviewers, a form of plagiarism. Focus group participants further provided examples of particular research misbehaviours they were confronted with and how these impacted their work as a researcher. Conclusion:We found insufficient supervision and various forms of sloppy science to score highly on aggregate detrimental impact throughout all disciplinary fields. Researchers from the natural sciences and humanities also perceived nepotism to be of major impact on the aggregate level. The natural sciences regarded fabrication of data of major impact as well. The focus group interviews helped to understand how researchers interpreted 'insufficient supervision'. Besides, the focus group participants added insight into sloppy science in practice. Researchers from the natural sciences and humanities added new research misbehaviours concerning their disciplinary fields to the list, such as the stealing of ideas before publication. This improves our understanding of research misbehaviour beyond the social and biomedical fields.

Project description:BackgroundDespite an increasing number of studies highlighting the health benefits of community gardening, the literature is limited by cross-sectional designs. The "JArDinS" quasi-experimental study aimed to assess the impact of community garden participation on the adoption of more sustainable lifestyles among French adults.MethodsIndividuals entering a community garden in Montpellier (France) in 2018 (n = 66) were compared with pairwise matched individuals with no experience in community gardening (n = 66). Nutritional quality, environmental impact and cost of monthly household food supplies, level of physical activity measured by accelerometers, as well as mental and social well-being, sensitivity to food waste, and connection with nature were evaluated at baseline (t0) and 12 months later (t1) to explore sustainability of lifestyles in social/health, environmental and economic dimensions. Linear mixed models were used to determine the independent effect of community gardening on investigated lifestyles components. In-depth interviews were conducted at t1 with 15 gardeners to better understand changes that may have occurred in gardeners' lives during the first year of gardening.ResultsAt t0, gardeners had lower education level, lower BMI and their household reported lower percentage of meals consumed outside of the home compared to non-gardeners (p < 0.05). Participating in the community garden had no significant impact, in spite of sufficient statistical power, on fruit and vegetables supplies (main outcome), nor on physical activity parameters, nor on others of the social/health, environmental and economic lifestyles components investigated. Qualitative interviews suggested the existence of pre-established health and environmental consciousness in some gardeners and revealed several barriers to the participation such as lack of time, lack of gardening knowledge, physical difficulty of gardening, health problems and conflicts with other gardeners.ConclusionsThe health benefits of community gardening previously reported by cross-sectional studies might be confounded by selection bias. The JArDinS study highlights the need to identify solutions to overcome barriers related to community garden participation when designing relevant public health interventions for the promotion of sustainable lifestyles.Trial registrationThe study was registered at clinicaltrials.gov as NCT03694782 . Date of registration: 3rd October 2018, retrospectively registered.

Project description:ImportanceGenetic researchers must have access to databases populated with data from diverse ancestral groups to ensure research is generalizable or targeted for historically excluded communities.ObjectiveTo determine genetic researchers' interest in doing research with diverse ancestral populations, which database stewards offer adequate samples, and additional facilitators for use of diverse ancestral data.Design, setting, and participantsThis survey study was conducted from June to December 2022 and was part of an exploratory sequential mixed-methods project in which previous qualitative results informed survey design. Eligible participants included genetic researchers who held US academic affiliations and conducted research using human genetic databases.ExposureInternet-administered survey to genetic research professionals.Main outcomes and measuresThe survey assessed respondents' experience and interest in research with diverse ancestral data, perceptions of adequacy of diverse data across database stewards (ie, private, government, or consortia), and identified facilitators for encouraging use of diverse ancestral data. Descriptive statistics, χ2 tests, and z tests were used to describe respondents' perspectives and experiences.ResultsA total of 294 researchers (171 men [58.5%]; 121 women [41.2%]) were included in the study, resulting in a response rate of 20.4%. Across seniority level, 109 respondents (37.1%) were senior researchers, 85 (28.9%) were mid-level researchers, 71 (24.1%) were junior researchers, and 27 (9.2%) were trainees. Significantly more respondents worked with data from European ancestral populations (261 respondents [88.8%]) compared with any other ancestral population. Respondents who had not done research with Indigenous ancestral groups (210 respondents [71.4%]) were significantly more likely to report interest in doing so than not (121 respondents [41.2%] vs 89 respondents [30.3%]; P < .001). Respondents reported discrepancies in the adequacy of ancestral populations with significantly more reporting European samples as adequate across consortium (203 respondents [90.6%]), government (200 respondents [89.7%]), and private (42 respondents [80.8%]) databases, compared with any other ancestral population. There were no significant differences in reported adequacy of ancestral populations across database stewards. A majority of respondents without access to adequate diverse samples reported that increasing the ancestral diversity of existing databases (201 respondents [68.4%]) and increasing access to databases that are already diverse (166 respondents [56.5%]) would increase the likelihood of them using a more diverse sample.Conclusions and relevanceIn this survey study of US genetic researchers, respondents reported existing databases only provide adequate ancestral samples for European populations, despite their interest in other ancestral populations. These findings suggest there are specific gaps in access to and composition of genetic databases, highlighting the urgent need to boost diversity in research samples to improve inclusivity in genetic research practices.

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Not so simple: a quasi-experimental study of how researchers adjudicate genetic research results.

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Not so simple: a quasi-experimental study of how researchers adjudicate genetic research results.

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