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Purpose We examined self‐reported financial toxicity and out‐of‐pocket expenses among adult women with breast cancer. Methods Patients spoke English, Spanish, or Mandarin Chinese, were aged 18+ years, had stage I–IIIA breast cancer, and were eligible for breast‐conserving and mastectomy surgery. Participants completed surveys about out‐of‐pocket costs and financial toxicity at 1 week, 12 weeks, and 1 year postsurgery. Results Three hundred ninety‐five of 448 eligible patients (88.2%) from the parent trial completed surveys. Excluding those reporting zero costs, crude mean ± SD out‐of‐pocket costs were $1,512 ± $2,074 at 1 week, $2,609 ± $6,369 at 12 weeks, and $3,308 ± $5,000 at 1 year postsurgery. Controlling for surgery, cancer stage, and demographics with surgeon and clinic as random effects, higher out‐of‐pocket costs were associated with higher financial toxicity 1 week and 12 weeks postsurgery (p < .001). Lower socioeconomic status (SES) was associated with lower out‐of‐pocket costs at each time point (p = .002–.013). One week postsurgery, participants with lower SES reported financial toxicity scores 1.02 points higher than participants with higher SES (95% confidence interval [CI], 0.08–1.95). Black and non‐White/non‐Black participants reported financial toxicity scores 1.91 (95% CI, 0.46–3.37) and 2.55 (95% CI, 1.11–3.99) points higher than White participants. Older (65+ years) participants reported financial toxicity scores 2.58 points lower than younger (, The term “financial toxicity” describes both the financial hardship and the psychological distress associated with health care costs. This article examines financial toxicity of women diagnosed with breast cancer at three time points up to 1 year post‐surgery, assessing demographic and clinical variables associated with higher financial toxicity and higher out‐of‐pocket expenses.

Background Conversation aids can facilitate shared decision-making and improve patient-centered outcomes. However, few examples exist of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored factors that will promote the sustained use of two early-stage breast cancer conversation aids. We examined differences in opinions between the two conversation aids and across socioeconomic strata. Methods We nested this study within a randomized controlled trial that demonstrated the effectiveness of two early-stage breast cancer surgery conversation aids, one text-based and one picture-based. These conversation aids facilitated more shared decision-making and improved the decision process, among other outcomes, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a purposive sample of patient participants across conversation aid assignment and socioeconomic status (SES) and collected observations and field notes. We interviewed trial surgeons and other stakeholders. Two independent coders conducted framework analysis using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on conversation aid assignment and patient SES. Results We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision-making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids enhanced their usual care after using it a few times, and most patients felt it appeared part of their normal routine. Conclusions Key factors that will guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics, and communication preferences. Trial registration ClinicalTrials.gov Identifier: NCT03136367, registered on May 2, 2017

Background Many randomized controlled trials fail to reach their target sample size. When coupled with the omission and underrepresentation of disadvantaged groups in randomized controlled trials, many trials fail to obtain data that accurately represents the true diversity of their target population. Policies and practices have been implemented to increase representation of disadvantaged groups in many randomized controlled trials, with some trials specifically targeting such groups. To our knowledge, no systematic review has quantified the enrollment metrics and effectiveness of inclusion and retention strategies in randomized controlled trials focused on disadvantaged populations specifically. Methods We will conduct a systematic search across EMBASE, MEDLINE, Web of Science, and CINAHL as well as grey literature, conference proceedings, research monographs, and Google Scholar from inception onwards. We will include randomized controlled trials where at least 50% of enrolled participants are considered to be disadvantaged, as per the RCT authors’ definition and in line with our inclusion criteria. Two independent researchers per article will conduct preliminary title and abstract screening, subsequent full text review, and data extraction for the selected trials, with a third reviewer available to resolve conflicts. We will assess the quality of all included studies using specific criteria regarding data reporting, external validity, and internal validity. We will combine all selected studies and conduct a narrative synthesis to assess enrollment metrics. If there is sufficient homogeneity and sufficient trials comparing recruitment strategies within disadvantaged populations, we will conduct a random effects meta-analysis to evaluate the effectiveness of strategies designed to maximize the inclusion of disadvantaged populations in randomized controlled trials. Discussion The findings of this systematic review will establish baseline recruitment and enrollment metrics of trials targeting disadvantaged populations to elucidate the scope of the challenge of recruiting such populations. We hope that our findings will promote future research on the distinct barriers that may prevent disadvantaged populations from participating in health intervention research, will encourage more trials exploring effective, tailored recruitment strategies, and will establish a foundation to track future progress in the recruitment of disadvantaged populations. Trial registrations PROSPERO ID: CRD42020152814

Background Few studies have examined the best way to convey the probability of serious events occurring in the future (i.e., risk of stroke or death) to persons with low numeracy or graph literacy proficiency. To address this gap, we developed and user-tested a bar graph and compared it to icon arrays to assess its impact on understanding and preference for viewing risk information. Objectives To determine the: (i) formats’ impact on participants’ understanding of risk information; (ii) formats’ impact on understanding and format preference across numeracy and graph literacy subgroups; (iii) rationale supporting participants’ preference for each graphical display format. Methods An online sample (evenly made up of participants with high and low objective numeracy and graph literacy) was randomized to view either the icon array or the bar graph. Each format conveyed the risk of major stroke and death five years after choosing surgery, a stent, or medication to treat carotid artery stenosis. Participants answered questions to assess their understanding of the risk information. Lastly, both formats were presented in parallel, and participants were asked to identify their preferred format to view risk information and explain their preference. Results Of the 407 participants, 197 were assigned the icon array and 210 the bar graph. Understanding of risk information and format preference did not differ significantly between the two trial arms, irrespective of numeracy and graph literacy proficiency. High numeracy and graph literacy proficiency was associated with high understanding (p Conclusion We found no evidence to demonstrate the superiority of one format over another on understanding. The majority of participants preferred viewing the risk information using the bar graph format.

Background Some researchers argue that the successful implementation of patient decision aids (PDAs) into clinical workflows depends on their integration into electronic health records (EHRs). Anecdotally, we know that EHR integration is a complex and time-consuming task; yet, the process has not been examined in detail. As part of an implementation project, we examined the work involved in integrating an encounter PDA for symptomatic uterine fibroids into Epic EHR systems. Objective This study aims to identify the steps and time required to integrate a PDA into the Epic EHR system and examine facilitators and barriers to the integration effort. Methods We conducted a case study at 5 academic medical centers in the United States. A clinical champion at each institution liaised with their Epic EHR team to initiate the integration of the uterine fibroid Option Grid PDAs into clinician-facing menus. We scheduled regular meetings with the Epic software analysts and an expert Epic technologist to discuss how best to integrate the tools into Epic for use by clinicians with patients. The meetings were then recorded and transcribed. Two researchers independently coded the transcripts and field notes before categorizing the codes and conducting a thematic analysis to identify the facilitators and barriers to EHR integration. The steps were reviewed and edited by an Epic technologist to ensure their accuracy. Results Integrating the uterine fibroid Option Grid PDA into clinician-facing menus required an 18-month timeline and a 6-step process, as follows: task priority negotiation with Epic software teams, security risk assessment, technical review, Epic configuration; troubleshooting, and launch. The key facilitators of the process were the clinical champions who advocated for integration at the institutional level and the presence of an experienced technologist who guided Epic software analysts during the build. Another facilitator was the use of an emerging industry standard app platform (Health Level 7 Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources) as a means of integrating the Option Grid into existing systems. This standard platform enabled clinicians to access the tools by using single sign-on credentials and prevented protected health information from leaving the EHR. Key barriers were the lack of control over the Option Grid product developed by EBSCO (Elton B Stephens Company) Health; the periodic Epic upgrades that can result in a pause on new software configurations; and the unforeseen software problems with Option Grid (ie, inability to print the PDA), which delayed the launch of the PDA. Conclusions The integration of PDAs into the Epic EHR system requires a 6-step process and an 18-month timeline. The process required support and prioritization from a clinical champion, guidance from an experienced technologist, and a willing EHR software developer team.

Background Women of lower socioeconomic status (SES) with early‐stage breast cancer are more likely to report poorer physician‐patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. Methods We conducted a 3‐arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon‐level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence‐based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre‐consultation) to T5 (1‐year after surgery. Results Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self‐reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. Conclusions Paper‐based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. Lay Summary The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices.Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text‐only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education.Conversation aids with pictures and text helped women make better breast cancer surgery choices., A paper‐based pictorial conversation aid (pictures plus text) is beneficial to all patients with early‐stage breast cancer and particularly to disadvantaged patients. Between‐surgeon variation suggests that the maximal impact of such interventions requires standardized physician training combined with these interventions.

To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated.Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE).From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering.Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated.Healthcare providers could implement these conversation aids in real-world settings.

Item does not contain fulltext OBJECTIVE: Assess the effect of pictorial health information on patients' and consumers' health behaviors and outcomes, evaluate these effects in lower health literacy populations, and examine the attributes of the interventions. METHODS: We included randomized controlled trials (RCTs) that assessed the effect of pictorial health information on patient and consumer health behaviors and outcomes. We conducted a meta-analysis of RCTs that assessed knowledge/understanding, recall, or adherence, and a subgroup analysis of those outcomes on lower health literacy populations. We narratively reviewed characteristics of pictorial health interventions that significantly improved outcomes for lower health literacy populations. RESULTS: From 4160 records, we included 54 RCTs (42 in meta-analysis). Pictorial health information moderately improved knowledge/understanding and recall overall, but largely increased knowledge/understanding for lower health literacy populations (n = 13), all with substantial heterogeneity. Icons with few words may be most helpful in conveying health information. CONCLUSION: Our results support including pictures in health communication to improve patient knowledge. Our results should be interpreted with caution considering the significant heterogeneity of the meta-analysis outcomes. PRACTICE IMPLICATIONS: Future research should assess which types and characteristics of pictures that best convey health information and are most useful and the implementation and sustainability in healthcare contexts. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018084743.

Background. Patients frequently worry about care costs, but clinicians seldom address the topic. Cost information is not typically included in patient decision aids (DAs). We examined whether including cost information in an encounter DA, with clinician training, influenced cost conversations. Method. As part of a larger trial, 14 surgeons from 4 cancer centers were randomized to 1 of 3 interventions: (1) Picture Option Grid DA that included a prompt to discuss relative treatment costs, hereafter called “cost prompt group”; (2) a text-only Option Grid DA that did not include cost information; (3) usual care. Groups 2 and 3 hereafter are referred to as “non-cost prompt groups.” Adult (18+) female patients, with stages I-IIIA breast cancer, eligible for both breast-conserving surgery and mastectomy were included. We gave surgeons feedback about adherence to the study protocol at 3, 6, and 12-months. We adapted a checklist to code the content of the audio-recorded clinical encounters. Results. 424/622 (68%) patients consented; 311 (73%) were eligible and successfully recorded (143 in the cost prompt group, 168 in the non-cost prompt groups). Costs were discussed in 132/311 (42.4%) encounters, and occurred more often in the cost prompt versus non-cost prompt groups (66.7% versus 33.3%; p

ObjectiveIn this study, we aim to compare shared decision-making (SDM) knowledge and attitudes between US-based physician assistants (PAs), nurse practitioners (NPs) and physicians across surgical and family medicine specialties.SettingWe administered a cross-sectional, web-based survey between 20 September 2017 and 1 November 2017.Participants272 US-based NPs, PA and physicians completed the survey. 250 physicians were sent a generic email invitation to participate, of whom 100 completed the survey. 3300 NPs and PAs were invited, among whom 172 completed the survey. Individuals who met the following exclusion criteria were excluded from participation: (1) lack of English proficiency; (2) area of practice other than family medicine or surgery; (3) licensure other than physician, PA or NP; (4) practicing in a country other than the US.ResultsWe found few substantial differences in SDM knowledge and attitudes across clinician types, revealing positive attitudes across the sample paired with low to moderate knowledge. Family medicine professionals (PAs) were most knowledgeable on several items. Very few respondents (3%; 95% CI 1.5% to 6.2%) favoured a paternalistic approach to decision-making.ConclusionsRecent policy-level promotion of SDM may have influenced positive clinician attitudes towards SDM. Positive attitudes despite limited knowledge warrant SDM training across occupations and specialties, while encouraging all clinicians to promote SDM. Given positive attitudes and similar knowledge across clinician types, we recommend that SDM is not confined to the patient-physician dyad but instead advocated among other health professionals.

IntroductionMost health information is verbal or written, yet words alone may not be the most effective way to communicate health information. Lower health literacy is prevalent in the US and is linked to limited understanding of one’s medical condition and treatment. Pictures increase comprehension, recall, adherence and attention in health settings. This is called pictorial superiority. No systematic review has examined the impact of pictorial health information among patients and consumers, including those with lower health literacy.Methods and analysisThis systematic review and meta-analysis will assess the characteristics and effectiveness of pictorial health information on patient and consumer health behaviours and outcomes, as well as differentially among individuals of lower literacy/lower health literacy. We will conduct a systematic search across selected databases, as well as grey literature, from inception until June 2018. We will include randomised controlled trials in all languages with all types of participants that assess the effect of pictorial health information on patients’ and consumers’ health behaviours and outcomes. Two independent reviewers will conduct the primary screening of articles and data extraction for the selected articles with a third individual available to resolve conflicts. We will assess the quality of all included studies using the Cochrane risk of bias tool. We will combine all selected studies and do a test of heterogeneity. If there is sufficient homogeneity, we will pool studies into a meta-analysis. Independent of the heterogeneity of included studies, we will also conduct a narrative synthesis.Ethics and disseminationNo ethics approval is required. The results will be published in a peer-reviewed journal and presented at relevant conferences.PROSPERO registration numberCRD42018084743.