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Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)

Por: Pal · A. · Stapleton · S. · Yap · C. · Lai-Kwon · J. · Daly · R. · Magkos · D. · Baikady · B. R. · Minchom · A. · Banerji · U. · De Bono · J. · Karikios · D. · Boyle · F. · Lopez · J.
Introduction

Early phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures—this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.

Methods and analysis

This is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).

Ethics and dissemination

Ethics approval was granted by the National Health Service Health Research Authority on 15 June 2020—IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.

Trial registration number

NCT04407676; Pre-results.

Nurse‐Family Partnership nurses’ attitudes and confidence in identifying and responding to intimate partner violence: An explanatory sequential mixed methods evaluation

Abstract

Aims

To evaluate the effect of an intimate partner violence intervention education component on nurses’ attitudes in addressing intimate partner violence; complementary aims included understanding nurses’ perceptions of the education and how it influenced their attitudes and confidence to address intimate partner violence in practice.

Design

An explanatory sequential mixed methods design embedded within a 15-site cluster randomized clinical trial that evaluated an intimate partner violence intervention within the Nurse-Family Partnership programme.

Methods

Data were collected between February 2011 and September 2016. Quantitative assessment of nurses’ attitudes about addressing intimate partner violence was completed by nurses in the intervention (n = 77) and control groups (n = 101) at baseline, 12 months and at study closure using the Public Health Nurses’ Responses to Women Who Are Abused Scale. Qualitative data were collected from nurses in the intervention group at two timepoints (n = 14 focus groups) and focused on their perceptions of the education component. Data were analysed using content analysis.

Results

Nurses in the intervention group reported large improvements in their thoughts, feelings and perceived behaviours related to addressing intimate partner violence; a strong effect of the education was found from baseline to 12 months and baseline to study closure timepoints. Nurses reported that the education component was acceptable and increased their confidence to address intimate partner violence.

Conclusion

Nurses reported improved attitudes about and confidence in addressing intimate partner violence after receiving the education component. However, these findings need to be considered together with trial results showing no main effects for clients, and a low level of intervention fidelity.

Impact

These evaluation findings underscore that improvement in nurses’ self-reported educational outcomes about addressing intimate partner violence cannot be assumed to result in adherence to intervention implementation or improvement in client outcomes. These are important considerations for developing nurse education on intimate partner violence.

Integrative Review of Dietary Choice Revealed by fMRI: Considerations for Obesity Prevention and Weight‐Loss Education

Abstract

Background

Emerging findings from neuroimaging studies investigating brain activity associated with dietary behavior are illuminating the interaction of biological and behavioral mechanisms that have implications for obesity prevention. Globally, A total of 1.9 billion adults are overweight, and 650 million are obese. Obesity and being overweight are major risk factors for chronic illness and death. Behaviorally based health interventions have had limited success in curbing the obesity epidemic. Greater understanding of brain responses to food cues will contribute to new knowledge and shape public health efforts in obesity prevention. However, an integration of this knowledge for obesity prevention education has not been published.

Aims

This study links evidence generated from brain activation studies generated in response to diet and food images and highlights educational recommendations for nurses engaged in obesity prevention and weight‐loss education.

Methods

An integrative review of the literature was conducted using the MeSH keywords “magnetic resonance imaging,” “diet,” and “food images” in PubMed, MEDLINE Complete, CINAHL, and Cochrane databases from their first appearance in 2006 through March 2018. Studies published in English and using functional magnetic resonance imaging to measure brain response to diet, and food images were initially identified. Animal models, those whose primary focus was a specific disease, and intervention studies were excluded.

Results

Of 159 studies identified, 26 met inclusion criteria. Findings from neuroimaging studies may help explain the relationship between brain mechanisms and behavioral aspects of dietary choice and inform patient education in obesity prevention. Awareness of this evidence is applicable to nursing education efforts. This review contributes several recommendations that should be considered by nurses providing individualized weight‐loss education.

Linking Evidence to Action

Nurses engaged in patient education for obesity prevention should consider personalized interventions that cultivate internal awareness for dietary adherence, self‐care, exercise, hydration, and mood state; avoid using caloric deprivation approaches, such as skipping breakfast, for weight‐loss interventions; and note the importance of individualized obesity prevention and weight‐loss education.

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