BACKGROUND: Cervical cancer is a common cancer among young women aged 25-29 in England, and the NHS cervical screening leaflet is the first point of contact for those being invited for their first screening. This study aimed to explore how young women (18-24) understand and engage with the leaflet, as well as the barriers and facilitators associated with its interpretation, engagement, and screening intentions.
METHODS: The study used a mixed-methods approach, including a survey (n = 120) to identify interpretation difficulties and how they were affected by different characteristics, and a follow-up interview (n = 10) to assess the utility of the leaflet, identify issues with its practicality, and determine the factors that influence screening intentions.
RESULTS: The survey results showed that interpretation difficulties were common, particularly regarding HPV assessment, screening results, additional tests/treatment, and screening risks. Lower interpretation accuracy was associated with lower numeracy scores and non-white ethnicity. Despite these difficulties, participants had high confidence and motivation to engage with the leaflet. The interviews revealed knowledge gaps, issues with the leaflet\'s practicality, and a preference for digital information. Factors that were identified as barriers and facilitators of leaflet interpretation, engagement, and screening intentions included knowledge, social influence, beliefs about consequences, environmental context and resources, social role and identity, emotions and intentions.
CONCLUSIONS: The current leaflet does not provide enough information for young women to make an informed decision about screening attendance. Implementing a digital invitation featuring simplified gist representation, targeted behaviour change techniques (BCTs), videos, and interactive tools can enhance education and promote screening behaviour. Future research should consider using digital tools and strategies to address existing barriers related to interpretation and engagement.

Background: Previous studies have suggested that information offered by sellers of health-related direct-to-consumer genetic tests (DTC-GTs) is often incomplete, unbalanced, or too difficult to understand. The extent to which this is the case for sellers accessible to Dutch consumers has not previously been studied. Methods and Goals: The present study aimed to assess the completeness, balance, readability, and findability of informational content on a selection of websites from several health-related DTC-GT sellers accessible to Dutch consumers. An in-depth content analysis was performed based on a recently published checklist outlining key items for policy guidance regarding DTC-GT services. Results: The information provided by sellers did not equally cover all aspects relevant to health-related DTC-GT service provision. The provided information was slightly unbalanced, with benefits of health-related DTC-GT usage being overemphasized compared to its risks and limitations. The readability of the provided information was low, on average requiring college education for proper understanding. A findability analysis showed that information concerning all themes is overall relatively evenly distributed across analyzed sellers\' websites. Conclusions: Information provision by assessed health-related DTC-GT sellers is suboptimal regarding completeness, balance, and readability. To better empower potential consumers to make an informed decision regarding health-related DTC-GT usage, we advocate industry-wide enhancement of information provision.

BACKGROUND: Australian guidelines recommend that people aged 50-70 years consider taking low-dose aspirin to reduce their risk of colorectal cancer (CRC).
OBJECTIVE: To determine the effect of a consultation with a researcher before an appointment in general practice using a decision aid presenting the benefits and harms of taking low-dose aspirin compared with a general CRC prevention brochure on patients\' informed decision making and low-dose aspirin use.
METHODS: Individually randomised controlled trial in six general practices in Victoria, Australia, from October 2020 to March 2021.
METHODS: Participants were recruited from a consecutive sample of patients aged 50-70 years attending a GP. The intervention was a consultation using a decision aid to discuss taking aspirin to reduce CRC risk while control consultations discussed reducing CRC risk generally. Self-reported co-primary outcomes were the proportion of individuals making informed choices about taking aspirin at 1 month and on low-dose aspirin uptake at 6 months, respectively. The intervention effect was estimated using a generalised linear model and reported with Bonferroni-adjusted 95% confidence intervals (CIs) and P-values.
RESULTS: A total of 261 participants (86% of eligible patients) were randomised into trial arms (n = 129 intervention; n = 132 control). Of these participants, 17.7% (n = 20/113) in the intervention group and 7.6% (n = 9/118) in the control group reported making an informed choice about taking aspirin at 1 month, an estimated 9.1% (95% CI = 0.29 to 18.5) between-arm difference in proportions (odds ratio [OR] 2.47, 97.5% CI = 0.94 to 6.52, P = 0.074). The proportions of individuals who reported taking aspirin at 6 months were 10.2% (n = 12/118) of the intervention group versus 13.8% (n = 16/116) of the control group, an estimated between-arm difference of -4.0% (95% CI = -13.5 to 5.5; OR 0.68 [97.5% CI = 0.27 to 1.70, P = 0.692]).
CONCLUSIONS: The decision aid improved informed decision making but this did not translate into long-term regular use of aspirin to reduce CRC risk. In future research, decision aids should be delivered alongside various implementation strategies.

BACKGROUND: Risk-based breast cancer (BC) screening raises new questions regarding information provision and risk communication. This study aimed to: 1) investigate women\'s beliefs and knowledge (i.e., mental models) regarding BC risk and (risk-based) BC screening in view of implications for information development; 2) develop novel informational materials to communicate the screening result in risk-based BC screening, including risk visualizations of both quantitative and qualitative information, from a Human-Centered Design perspective.
METHODS: Phase 1: Interviews were conducted (n = 15, 40-50 years, 5 lower health literate) on women\'s beliefs about BC risk and (risk-based) BC screening. Phase 2: In three participatory design sessions, women (n = 4-6 across sessions, 40-50 years, 2-3 lower health literate) made assignments and created and evaluated visualizations of risk information central to the screening result. Prototypes were evaluated in two additional sessions (n = 2, 54-62 years, 0-1 lower health literate). Phase 3: Experts (n = 5) and women (n = 9, 40-74 years) evaluated the resulting materials. Two other experts were consulted throughout the development process to ensure that the content of the information materials was accurate. Interviews were transcribed literally and analysed using qualitative thematic analysis, focusing on implications for information development. Notes, assignments and materials from the participatory design sessions were summarized and main themes were identified.
RESULTS: Women in both interviews and design sessions were positive about risk-based BC screening, especially because personal risk factors would be taken into account. However, they emphasized that the rationale of risk-based screening and classification into a risk category should be clearly stated and visualized, especially for higher- and lower-risk categories (which may cause anxiety or feelings of unfairness due to a lower screening frequency). Women wanted to know their personal risk, preferably visualized in an icon array, and wanted advice on risk reduction and breast self-examination. However, most risk factors were considered modifiable by women, and the risk factor breast density was not known, implying that information should emphasize that BC risk depends on multiple factors, including breast density.
CONCLUSIONS: The information materials, including risk visualizations of both quantitative and qualitative information, developed from a Human-Centered Design perspective and a mental model approach, were positively evaluated by the target group.

Maintaining and enhancing vaccine confidence continues to be a challenge. Making an informed decision not only helps to avoid potential future regret but also reduces susceptibility to misinformation. There is an urgent need for interventions that facilitate informed decision-making about vaccines. This paper describes the systematic development of two interventions designed to promote informed decision making and indirectly, acceptance of maternal pertussis vaccination (MPV) in the Netherlands.
The 6-step Intervention Mapping (IM) protocol was used for the development of an online tailored decision aid and Centering Pregnancy-based Group Antenatal Care (CP) intervention. A needs assessment was done using empirical literature and conducting a survey and focus groups (1), intervention objectives were formulated at the behavior and determinants levels (2), theoretical methods of behavior change were selected and translated into practical applications (3), which were further developed into the two interventions using user-centered design (4). Finally, plans were developed for implementation (5), and evaluation (6) of the interventions.
The needs assessment showed that pregnant women often based their decision about MPV on information sourced online and conversations with their partners, obstetric care providers, and peers. Responding to these findings, we systematically developed two interactive, theory-based interventions. We created an online tailored decision aid, subjecting it to four iterations of testing among pregnant women, including those with low literacy levels. Participants evaluated prototypes of the intervention positively on relevance and usability. In addition, a CP intervention was developed with midwives.
Using IM resulted in the creation of an online decision aid and CP intervention to promote informed decision making regarding MPV. This description of the systematic development of the interventions not only serves to illustrate design rationales, it will also aid the interpretation of the evaluation of the interventions, the development of future interventions promoting informed decision and acceptance of vaccines, and comparisons with other interventions.

Chimeric Antigen Receptor T-cell (CAR-T) therapy has revolutionized the treatment of patients with hematologic malignancies, yet treatment may coincide with the potential for life-threatening toxicities. Currently, no studies have investigated how oncologists communicate with patients about CAR-T therapy or what patients and their caregivers want to know prior to consenting for CAR-T therapy. This study characterizes the content of oncologist communication with patients and caregivers about the risks and benefits of CAR-T therapy and explore the information preferences of patients and their caregivers about CAR-T therapy. We conducted a multimethod study of 20 patients with hematologic malignancies referred for CAR-T therapy at the Massachusetts General Hospital and 10 caregivers. We audio recorded the initial outpatient visit with the oncologist to review and sign consent for CAR-T therapy. We subsequently surveyed patients and caregivers about information gaps that remained after consent. We then interviewed patients and caregiver about their perceptions of oncologist communication and information preferences after the consent visit, 1 month, and 3 months post-CAR-T therapy treatment. Qualitative data analysis was conducted using the framework approach. Six major themes regarding communication about CAR-T therapy were identified: (1) oncologists create a narrative of power and innovation about CAR-T therapy, (2) oncologists set clear expectations regarding CAR-T therapy, (3) oncologists preferentially discuss positive treatment outcomes and less frequently address treatment failures or uncertainties, (4) oncologists couple their discussion about risks of CAR-T therapy with assurances about risk mitigation strategies, (5) oncologists engage in empathetic communication throughout the consent visit, (6) patients and caregivers vary in their preferences regarding communication about CAR-T therapy but largely favor a positive discourse during the consent visit and (7) patients who completed CAR-T therapy and their caregivers report significant knowledge gaps during and after treatment. Overall, patients and caregivers felt well informed about CAR T-therapy yet identified communication gaps regarding, advanced care planning, treatment failure and treatment toxicities. A predominantly positive discourse between patients, caregivers, and oncologists around CAR-T therapy leaves patients and caregivers with significant knowledge gaps about negative outcomes. Further research is needed to help oncologists communicate about treatment uncertainties and help patients and their caregivers prepare for negative outcomes of CAR-T therapy.

To facilitate informed decision making on participating in colorectal cancer (CRC) screening, we assessed the benefit-harm balance of CRC screening for a wide range of subgroups over different time horizons.
The study combined incidence proportions of benefits and harms of (not) participating in CRC screening estimated by the Adenoma and Serrated pathway to CAncer microsimulation model, a preference eliciting survey, and benefit-harm balance modeling combining all outcomes to determine the net health benefit of CRC screening over 10, 20, and 30 years. Probability of net health benefit was estimated for 210 different subgroups based on age, sex, previous participation in CRC screening, and lifestyle.
CRC screening was net beneficial in 183 of 210 subgroups over 30 years (median probability [MP] of 0.79, interquartile range [IQR] of 0.69-0.85) across subgroups. Net health benefit was greater for men (MP 0.82; IQR 0.69-0.89) than women (MP 0.76; IQR 0.67-0.83) and for those without history of participation in previous screenings (MP 0.84; IQR 0.80-0.89) compared with those with (MP 0.69; IQR 0.59-0.75). Net health benefit decreased with increasing age, from MP of 0.84 (IQR 0.80-0.86) at age 55 to 0.61 (IQR 0.56-0.71) at age 75. Shorter time horizons led to lower benefit, with MP of 0.70 (IQR 0.62-0.80) over 20 years and 0.54 (IQR 0.48-0.67) over 10 years.
Our benefit-harm analysis provides information about net health benefit of screening participation, based on important characteristics and preferences of individuals, which could assist screening invitees in making informed decisions on screening participation.

OBJECTIVE: Effective interventions are needed to promote informed decision making about vaccination.
BACKGROUND: We developed a group-antenatal care (CP; Centering Pregnancy) intervention, i.e., a session about MPV within existing group-care settings, to promote informed decision making about Maternal Pertussis Vaccination in the Netherlands.
OBJECTIVE: This study aimed to assess (1) to what extent the intervention was implemented as intended, (2) to what extent the intervention met the needs and wishes of pregnant individuals and midwives facilitating CP.
METHODS: We conducted exploratory interviews with 6 CP facilitators and 10 CP participants to assess the implementation of the intervention, and how the intervention and its different components were perceived. Interviews were analysed using thematic analysis. In addition, we conducted a pre- and post-intervention survey amongst 35 participants, measuring knowledge about MPV, and MPV attitude and intention.
RESULTS: The CP intervention was implemented as intended in 6 out of 7 groups. Participants were positive about the interactive CP-methods used to discuss MPV. Participants and facilitators evaluated the intervention as positive and relevant, although the intervention was time-consuming, and some participants had already made the de decision about MPV. Those who had not yet decided indicated that the session was helpful for their decision.
CONCLUSIONS: Discussing MPV in CP care settings is a feasible strategy to support decision making about MPV during pregnancy. The intervention could be improved by discussing the MPV sooner than 16-18 weeks of pregnancy. A larger-scale study is needed to assess effects on MPV uptake and informed decision making.

UNASSIGNED: The Informed Health Choices (IHC) Key Concepts is a framework that provides a basis for developing educational resources and evaluating people\'s ability to think critically about health actions. We developed the original Key Concepts framework by reviewing texts and checklists for the public, journalists, and health professionals and collecting structured feedback from an international advisory group. We revised the original 2015 framework yearly from 2016 to 2018 based on feedback and experience using the framework. The objectives of this paper are to describe the development of the framework since 2018 and summarise their basis.
UNASSIGNED: For the 2019 version, we responded to feedback on the 2018 version. For the current 2022 version, in addition to responding to feedback on the 2019 version, we reviewed the evidence base for each of the concepts. Whenever possible, we referenced systematic reviews that provide a basis for a concept. We screened all Cochrane methodology reviews and searched Epistemonikos, PubMed, and Google Scholar for methodology reviews and meta-epidemiological studies.
UNASSIGNED: The original framework included 32 concepts in six groups. The 2019 version and the current 2022 version include 49 concepts in the same three main groups that we have used since 2016. There are now 10 subgroups or higher-level concepts. For each concept, there is an explanation including one or more examples, the basis for the concept, and implications. Over 600 references are cited that support the concepts, and over half of the references are systematic reviews.
UNASSIGNED: There is a large body of evidence that supports the IHC key concepts and we have received few suggestions for changes since 2019.

Adapt and test a measure of knowledge for caregivers of children with attention-deficit/hyperactivity disorder (ADHD) and evaluate the impact of the information component of a decision aid (DA) on participant knowledge.
A set of seven knowledge items were created based on prior knowledge measures and clinical guidelines. As part of a larger cross-sectional survey study of caregivers of children diagnosed with ADHD, caregivers were randomized to one of two arms: 1) a DA arm, where participants reviewed the information component of the Cincinnati Children\'s Hospital\'s DA, and 2) a control arm, where participants were not shown a DA. All participants completed the seven knowledge items. Knowledge items were assessed for difficulty, quality of distractors, acceptability, and redundancy. Total knowledge scores (0-100) for the DA and control arm were compared.
Caregivers were assigned to the DA arm (n = 243) or the control arm (n = 260). All 7 knowledge items were retained as no items were too difficult or too easy, all response options were used, there were little missing data, and no items were redundant. The overall knowledge score was normally distributed, and almost covered the full range of scores (5-100). Those who received the DA component had higher knowledge scores (M=68, SD=23) than those who did not receive the DA component (M=60, SD=19, P < .01, d=0.4).
The Caregiver ADHD Knowledge (CAKe) measure was acceptable and demonstrated construct validity as those who were assigned to review the DA component demonstrated greater knowledge than those who were not assigned to review the DA component.