Reducing the risk of bias in health behaviour change trials: Improving trial design,reporting or bias assessment criteria? A review and case study

Objective: It has been suggested that randomised controlled trials (RCTs) of health behaviour change (HBC) interventions are less rigorously designed than – for example– drug trials. This study presents an approach to clarifying whether this is due to poor trial design, incomplete trial reporting and/or the inappropriateness of commonly applied risk of bias assessment criteria.

Design: First, a framework of key sources of bias and common strategies for reducing bias risk is developed based on a literature review. Second, we describe the design of a multi-site RCT evaluating the cost-effectiveness of an HIV-treatment adherence intervention (case study). The choices made by the multidisciplinary team trying to minimise the risk of bias are compared against the risk of bias framework.

Main outcome measures: Implementation of common strategies for reducing the risk of bias in the case study; alternative or additional strategies applied; a justification for each deviation from the risk of bias framework.

Results: Most of the common strategies for reducing the risk of bias could be implemented. Alternative strategies were developed for minimising the risk of performance bias and contamination. Several additional, domain-specific risk of bias strategies were implemented.

Conclusions: The literature provides useful guidance for reducing the risk of bias in HBC trials. Yet, the case study suggests that HBC trial designers may face specific challenges that require alternative/additional measures for reducing the risk of bias. Using the risk of bias justification table (RATIONALE) could lead to better-designed HBC trials, more comprehensive trial reports and the data necessary for evaluating the appropriateness of commonly applied risk of bias assessment criteria to HBC trials.     

Student Service Members/Veterans’ Mental Health: Who Is at a Greater Risk for Posttraumatic Stress Symptoms on College Campuses?

Using a cross-sectional design, this study surveyed 144 students on campus who are service members and veterans to determine whether posttraumatic stress (PTS) symptoms are significantly correlated with demographic factors (e.g., age, race and marital status), risk factors (e.g., military branch and combat exposure), and resources (e.g., social support and religiosity). The results confirm previous findings on correlates of PTS symptoms, provide new information about service members on campus that are at a greater risk for PTS and highlight resources that are associated with reduced PTS symptoms. These findings not only give institutions of higher learning insight into identifying specific demographics that are at a greater risk for PTS symptoms on college campuses, but also point to ways of supporting student service members/veterans by accurately targeting existing resources to the most affected populations.     

Development of a Communication Aid to Facilitate Risk Communication in Consultations with Unaffected Women from High Risk Breast Cancer Families: A Pilot Study

The literature on risk perception in women from high-risk breast cancer families reveals persistent over-estimation of risk, even after counseling. In this study, a communication aid was designed to facilitate discussion of risk between clinical geneticists and genetic counselors and women from this high-risk population. Method: Stage 1. The aid was developed by an expert panel of clinical geneticists, genetic counselors, psychologists, an epidemiologist, an oncologist, linguists and a consumer. It was guided by the international literature on risk communication and a large multi-centre Australian study of risk communication. The 13 page full-color communication aid used varying formats of words, numbers, graphs and pie-charts to address (a) the woman’s subjective risk; (b) the population risk of breast cancer; c) the risk of inherited breast cancer; (d) the cumulative risk for women with BRCA1 and BRCA2 mutations; (e) family risk factors; (f) the woman’s suitability for genetic testing; (h) screening and management recommendations, and (i) a re-assessment of the woman’s subjective risk. Stage 2: A before–after pilot study of 38 women who were unaffected with breast cancer and were attending four Australian familial cancer clinics was undertaken. Baseline and follow-up questionnaires were completed by 27 women. Outcomes were compared to those observed in 107 similar women undergoing genetic counseling without the communication aid in 2001. Results: The risk communication aid appears to be beneficial; breast cancer genetics knowledge improved in some areas and importantly, risk perceptions improved in the cohort receiving the communication aid. Psychological measures showed no difference in anxiety or depression between the group receiving the communication aid and the comparison cohort. Women and clinicians were very positive about the usefulness of the communication aid as an adjunct to the genetic counseling consultation.     

If We Build It … Will They Come? – Establishing a Cancer Genetics Services Clinic for an Underserved Predominantly Latina Cohort

Background: Cancer genetic counseling and testing is a standard of care option for appropriate families and can identify individuals at increased risk prior to diagnosis, when prevention or detection strategies are most effective. Despite documented efficacy of cancer risk reduction in high-risk individuals, underserved and minority individuals have a disproportionate cancer burden and limited access to genetic counseling. Methods: A needs assessment survey documented gaps in knowledge and interest in prevention. Satellite clinics were established at two indigent healthcare systems. Cancer genetics CME lectures were conducted and referral guidelines disseminated to clinicians who referred patients for counseling. Results: An increase in clinician knowledge was demonstrated post-CME and reflected by quality referrals. Eighty-eight percent of patients kept their appointments. In the predominantly Latina⁶ (n=77) clinic population, 71.4% were affected with cancer, and 17 mutation positive families were identified. Preliminary data shows a positive impact on patients' motivation and behavior. The majority has expressed satisfaction and reduction in anxiety. Conclusions: This study demonstrates feasibility and acceptability of cancer genetics services in this population, suggesting the potential to reduce cancer morbidity in underserved, high-risk families.“Latino” is the most common census term for individuals of Spanish, Mexican, Central and South American, Cuban, or Puerto Rican descent, referring to ethnicity, and is generally considered a more ethnically/culturally based term for individuals of the aforementioned groups. As this cohort is female the feminine noun “Latina” is used     

A Survey of Patients’ Experiences with the Cancer Genetic Counseling Process: Recommendations for Cancer Genetics Programs

In order to promote ongoing quality improvement of not only the Penn State Cancer Genetics Program, but also other cancer risk assessment programs throughout the country, we developed, piloted and conducted a survey to explore patient expectations, experiences, and satisfaction with the cancer genetic counseling process. The comprehensive survey was mailed to 340 eligible patients, 156 (45.9%) of whom returned the completed survey within the allotted time. Responses to closed-ended questions were tallied and open-ended questions were content analyzed. Major findings show that: (1) Patients were seeking cancer-related information and support throughout the cancer risk assessment process and were interested in participating in available research studies; (2) The setting in which patients are seen for cancer risk assessment may pose potential emotional ramifications; (3) Misperceptions regarding insurance discrimination and lack of insurance coverage persist; (4) Patients view the genetic counselor as responsible for updating them about new discoveries. Specific recommendations for cancer genetics programs are included.     

A common representational system governed by Weber's law: nonverbal numerical similarity judgments in 6-year-olds and rhesus macaques

This study compared nonverbal numerical processing in 6-year-olds with that in nonhuman animals using a numerical bisection task. In the study, 16 children were trained on a delayed match-to-sample paradigm to match exemplars of two anchor numerosities. Children were then required to indicate whether a sample intermediate to the anchor values was closer to the small anchor value or the large anchor value. For two sets of anchor values with the same ratio, the probability of choosing the larger anchor value increased systematically with sample number, and the psychometric functions superimposed when plotted on a logarithmic scale. The psychometric functions produced by the children also superimposed with the psychometric functions produced by rhesus monkeys in an analogous previous experiment. These examples of superimposition demonstrate that nonverbal number representations, even in children who have acquired the verbal counting system, are modulated by Weber's law.     

A Community Practice Model for Community Psychologists and Some Examples of the Application of Community Practice Skills from the Partnerships for Success Initiative in Ohio

This paper provides an opportunity to consider the concept of community practice from the vantage point of community psychology. The author argues that community psychology has significant potential to change organizations, communities, and other settings to benefit setting occupants. However, it is the author's contention that the full realization of this potential is contingent upon an organized effort to engage in formal community practice. The author defines community practice in terms of four skill sets related to mobilization, planning, implementation, and evaluation. The author also describes settings that might support community practice and discusses implications for training and the field of community psychology in general. Finally, the author illustrates several community practice skills and roles in the context of a local community-based initiative in Ohio called Partnerships for Success.     

Do Investment Risk Tolerance Attitudes Predict Portfolio Risk?

We investigated a new instrument designed to assess investment risk tolerance, the Risk Tolerance Questionnaire (RTQ). RTQ scores were positively correlated with scores on two other investment risk measures, but were not correlated with a measure of sensation-seeking (Zuckerman, 1994), suggesting that investment risk tolerance is not explainable by a general cross-domain appetite for risk. Importantly, RTQ scores were positively correlated with the riskiness of respondents’ actual investment portfolios, meaning that investors with high risk-tolerance score tend to have higher-risk portfolios. Finally, respondents with relatively more investment experience had more risk-tolerant responses and higher-risk portfolios than less experienced investors.

结直肠癌患者术后寻求中医药治疗的质性研究

为了解结直肠癌术后患者寻求中医药治疗的目的、体验、信念.采用目的抽样的办法,选取18位结直肠癌术后患者进行个人深入访谈.发现结直肠癌术后的患者,选择中医药治疗的目的主要有以下几个方面：减轻放、化疗的不良反应,使身体尽快恢复,提高生活质量,防止复发转移等.随着治疗的进行,患者对中医的认识逐步提高.中医药的疗效主要体现在各种症状及客观指标的改善上,近期良好的治疗体验使患者对实现远期目标更具信心.