Patient and Physician Perspectives on Discussing Addiction Recovery and Spirituality in the Primary Care Setting.

BACKGROUND: Spirituality is an important component of recovery for many individuals with substance use disorder (SUD). However, few studies have compared patient and physician attitudes on spirituality in SUD recovery. OBJECTIVE: This study investigates patient and physician beliefs about the role of spirituality in SUD recovery and about discussing spirituality in relationship to recovery in primary care settings. DESIGN: Semi-structured interviews were conducted with primary care physicians recruited at two academic hospitals, and patients recruited from a faith-based residential therapeutic community. Interview transcripts were independently coded by two researchers and a grounded theory approach was used to generate themes that reflected participants' experiences. KEY RESULTS: Interviews were conducted with 15 patients and 10 physicians. Patients had diverse views about the impact of spirituality on their SUD recovery, including positive, negative, and neutral. Patient and physician opinions on discussing spirituality in a primary care setting differed: most physicians felt positively towards this, believing that understanding their patients' spirituality helped them care for their patients as whole people. Many patients felt neutral, stating that they did not feel like these conversations were necessary for their care, and that they believed physicians preferred not to discuss spirituality in medical settings. Tolerance from both the patient and physician, open-ended questioning, and an individualized approach were identified as facilitators to effective discussions about spirituality and recovery. CONCLUSIONS: Spirituality can have diverse effects on an individual's SUD recovery. Physicians endorsed the benefits of discussing spirituality in the context of their patients' recovery, while patients expressed reservations about engaging in these conversations with their physicians. This variation in perspectives highlights the need for additional research to understand the individual and structural factors that contribute to it, as well as best practices for engaging in effective, non-judgmental conversations about spirituality in recovery.

Prioritization of ethical concerns regarding HIV molecular epidemiology by public health practitioners and researchers.

BACKGROUND: HIV molecular epidemiology (HIV ME) can support the early detection of emerging clusters of new HIV infections by combining HIV sequence data routinely obtained during the clinical treatment of people living with HIV with behavioral, geographic, and sociodemographic information. While information about emerging clusters promises to facilitate HIV prevention and treatment efforts, the use of this data also raises several ethical concerns. We sought to assess how those working on the frontlines of HIV ME, specifically public health practitioners (PHPs) and researchers, prioritized these issues. METHODS: Ethical issues were identified through literature review, qualitative in-depth interviews, and stakeholder engagement. PHPs and researchers using HIV ME prioritized the issues using best-worst scaling (BWS). A balanced incomplete block design was used to generate 11 choice tasks each consisting of a sub-set of 5 ethical concerns. In each task, respondents were asked to assess the most and least concerning issue. Data were analyzed using conditional logit, with a Swait-Louviere test of poolability. Latent class analysis was then used to explore preference heterogeneity. RESULTS: In total, 57 respondents completed the BWS experiment May-June 2023 with the Swait-Louviere test indicating that researchers and PHPs could be pooled (p = 0.512). Latent class analysis identified two classes, those highlighting "Harms" (n = 29) (prioritizing concerns about potential risk of legal prosecution, individual harm, and group stigma) and those highlighting "Utility" (n = 28) (prioritizing concerns about limited evidence, resource allocation, non-disclosure of data use for HIV ME, and the potential to infer the directionality of HIV transmission). There were no differences in the characteristics of members across classes. CONCLUSIONS: The ethical issues of HIV ME vary in importance among stakeholders, reflecting different perspectives on the potential impact and usefulness of the data. Knowing these differences exist can directly inform the focus of future deliberations about the policies and practices of HIV ME in the United States.

Perceived Value of Prenatal Ultrasound Screening: A Survey of Pregnant Women.

INTRODUCTION: Routine prenatal screening ultrasounds primarily serve to diagnose major fetal anomalies which may prompt further testing and inform clinical decision-making, including possible pregnancy termination. Meanwhile, expectant parents may view the ultrasound experience and information gained differently from their clinicians. In this setting, how to best counsel patients, especially regarding the increasing findings of indeterminant clinical significance, is unclear. Greater understanding of women's views before undergoing their ultrasound may help to guide anticipatory counseling about the purpose of screening and interpretation of results. METHODS: We surveyed 289 patients presenting for scheduled prenatal ultrasounds at an academic tertiary care center. Discrete and open-ended questions assessed views surrounding the receipt of abnormal results and management of the pregnancy once fetal anomalies are detected. Qualitative responses were analyzed using thematic analysis. RESULTS: Most (95%) desired information about abnormal sonographic findings, although only half would consider pregnancy termination for anomalies. Reasons for wanting return of abnormal results included preparedness, valuing knowledge, and to a lesser extent, informing decision-making. When considering potential termination as a result of ultrasound findings, participants' rationales demonstrated deontological (seeing termination as inherently impermissible or permissible), relational (duties arising from the role of being a mother), and consequentialist (weighing harms and benefits) reasoning. CONCLUSION: This study highlights women's perceptions of prenatal ultrasounds as an inherently valuable source of information and preparedness, beyond their role in informing clinical decision-making. Identifying the ethical constructs underpinning patients' perspectives may help direct development of counseling tools responsive to individual needs and values regarding prenatal ultrasound findings.

Capacity for wonder among medical students: Assessment and educational implications.

OBJECTIVE: The capacity for wonder (CfW) is a personal disposition related to lifelong learning and moral character development, two highly valued characteristics of health professionals. We previously developed and validated a CfW measure among college students. Here we describe how the scale performs among medical students. METHODS: We invited all students at a top-tier U.S. medical school (N = 477) to participate in an online survey including the CfW measure, year in medical school, and demographics. We performed confirmatory factor analysis on the CfW measure and reassessed its reliability. RESULTS: 276 students completed the survey for an overall response rate of 58%. Factor analysis resulted in a 10-item scale with an alpha of 0.79 and an eigen value of 3.57. Factor loadings ranged from 0.43 to 0.77. The mean total score was 39.3 (SD = 8.9) out of a possible high score of 60. Total scores varied by year in school with significantly lower scores among 2nd year students (32.9 vs. 41.5; p < 0.001). CONCLUSION: We confirmed the reliability of a 10-item CfW scale in 4 cohorts of medical students. Results suggest that the 2nd year of medical school poses the greatest risk to students' capacity for wonder. Efforts should be made to understand this phenomenon and develop interventions to mitigate it. Future research should explore the validity of the CfW scale, its utility in evaluating interventions designed to cultivate the capacity for wonder, its applicability to other groups of health professionals, and its association with ethical decision-making and practice.

Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.

BACKGROUND: Collateral findings in pragmatic clinical trials are findings that may have implications for patients' health but were not generated to address a trial's primary research questions. It is uncertain how best to communicate these collateral findings to patients. OBJECTIVES: To determine how reactions to a letter communicating collateral findings relate to who signed the letter, the type of finding, or whether the letter specified that the finding arose from a pragmatic clinical trial. RESEARCH DESIGN: Web-based survey experiment using a between-subjects design in which respondents were randomly assigned within education strata to view and respond to 1 of 16 hypothetical scenarios. SUBJECTS: Adults recruited from an online panel constructed from a probability sample of US-based postal addresses. MEASURES: The primary outcomes were the action the respondent would take next (i.e., contact a doctor immediately or something else) and the respondent's emotional reactions (i.e., all positive, all negative, mixed, or none). RESULTS: A total of 4080 respondents had analyzable data. Although some effects were statistically significant (P < .05), none exceeded a prespecified threshold for policy relevance (15 or more percentage points). Ratings of letter clarity and level of understanding were lower for letters that included a description of the clinical trial. CONCLUSIONS: Signatory and level of detail about collateral findings did not substantially affect people's intentions to take the recommended action of contacting their doctor. Deciding whether to include a description of the pragmatic clinical trial requires a trade-off between transparency and more difficulty understanding the contents of the letter.

Tolerance for Uncertainty and Professional Development: a Normative Analysis.

Scholars from a range of disciplines including medicine, sociology, psychology, and philosophy have addressed the concepts of ambiguity and uncertainty in medical practice and training. Most of this scholarship has been descriptive, focusing on defining and measuring ambiguity and uncertainty tolerance or tracking clinicians' responses to ambiguous and uncertain situations. Meanwhile, scholars have neglected some fundamental normative questions: Is tolerance of uncertainty good; if so, to what extent? Using a philosophical approach to these questions, we show that neither tolerance nor intolerance of uncertainty is necessarily a good or bad trait. Rather, both tolerance and intolerance of uncertainty can give physicians advantages while at the same time exposing them to pitfalls in clinical practice. After making this case, we argue that cultivating certain virtues-like courage, diligence, and curiosity-could help clinicians avoid the dangers of excessive tolerance and intolerance of uncertainty. Finally, we suggest that medical educators develop curricula and career counseling beginning with matriculation and proceeding through specialty choice and residency training that explicitly address trainees' responses to clinical uncertainty. These programs should encourage trainees, students and residents, to be mindful of their reactions to uncertainty and help them develop virtues that will allow them to avoid the hazards of extreme tolerance or intolerance of uncertainty.

Development of a Scale to Measure Trust in Public Health Authorities: Prevalence of Trust and Association with Vaccination.

Infectious disease outbreaks highlight the importance of trust in public health authorities to avoid fear and improve adherence to recommendations. There is currently no established and validated measure for trust in public health authorities. We aimed to develop and validate an instrument that measures trust in public health authorities and to assess the association between trust in public health authorities and vaccine attitudes. We developed 20 items to measure trust in public health authorities. After implementing a survey in January 2020, we investigated relationships between the items, reduced the number of items, and identified latent constructs of the scale. We assessed variability in trust and how trust was associated with vaccine attitudes, beliefs, and self-reported vaccine acceptance. The pool was reduced to a 14-item trust in public health authorities scale and we found that this trust model was strongly associated with acceptance of vaccines. Our scale can be used to examine the relationship between trust in public health authorities and adherence to public health recommendations. The measure needs to be validated in other settings to determine whether they are associated with other areas where the public question public health authority recommendations.

What If the Influenza Vaccine Did Not Offer Such Variable Protection?

BACKGROUND: The protection that an influenza vaccine offers can vary significantly from person to person due to differences in immune systems, body types, and other factors. The question, then, is what is the value of efforts to reduce this variability such as making vaccines more personalized and tailored to individuals. METHODS: We developed a compartment model of the United States to simulate different influenza seasons and the impact of reducing the variability in responses to the influenza vaccine across the population. RESULTS: Going from a vaccine that varied in efficacy (0-30%) to one that had a uniform 30% efficacy for everyone averted 16.0-31.2 million cases, $1.9-$3.6 billion in direct medical costs, and $16.1-$42.7 billion in productivity losses. Going from 0-50% in efficacy to just 50% for everyone averted 27.7-38.6 million cases, $3.3-$4.6 billion in direct medical costs, and $28.8-$57.4 billion in productivity losses. Going from 0-70% to 70% averted 33.6-54.1 million cases, $4.0-$6.5 billion in direct medical costs, and $44.8-$64.7 billion in productivity losses. CONCLUSIONS: This study quantifies for policy makers, funders, and vaccine developers and manufacturers the potential impact of efforts to reduce variability in the protection that influenza vaccines offer (eg, developing vaccines that are more personalized to different individual factors).

Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study.

BACKGROUND: Pragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems. OBJECTIVE: We sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided. DESIGN: Prospective, qualitative focus group study. PARTICIPANTS: Focus groups were conducted in Baltimore, MD; Houston, TX; and Seattle, WA (overall N = 66), during July and August 2019. APPROACH: All groups discussed a hypothetical scenario involving the detection of a PCT-CF of contraindicated medications. Participants were asked about their reactions to the PCT-CF and issues related to its disclosure. KEY RESULTS: Reactions to learning about the PCT-CF were mixed, ranging from fear of a significant health problem, anger that the contraindicated medications had gone unnoticed and/or for being included in research without their permission, to gratitude for the information. Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. Many wanted their treating clinician to be informed of the PCT-CF so that they would be prepared to answer patients' questions and to discuss treatment options. CONCLUSIONS: The detection of PCT-CFs is likely to increase with further expansion of PCTs. As such, clinicians will undoubtedly become involved in the management of PCT-CFs. Our data illustrate some of the challenges clinicians may face when their patients are informed of a PCT-CF and the need to develop guidance for disclosing PCT-CFs in ways that align with patients' preferences and values.

SARS-CoV-2 safer infection sites: moral entitlement, pragmatic harm reduction strategy or ethical outrage?

The pandemic of SARS-CoV-2 has led to unprecedented changes to society, causing unique problems that call for extraordinary solutions. We consider one such extraordinary proposal: 'safer infection sites' that would offer individuals the opportunity to be intentionally infected with SARS-CoV-2, isolate, and receive medical care until they are no longer infectious. Safer infection could have value for various groups of workers and students. Health professionals place themselves at risk of infection daily and extend this risk to their family members and community. Similarly, other essential workers who face workplace exposure must continue their work, even if have high-risk household members and live in fear of infecting. When schools are kept closed because of the fear that they will be sites of significant transmission, children and their families are harmed in multiple ways and college students who are living on campus, whether or not they are attending classes in person, are contributing to high rates of transmission and experiencing high rates of exposure. We consider whether offering safer infection sites to these groups could be ethically defensible and identify the empirical unknowns that would need to resolve before reaching definitive conclusions. This article is not an endorsement of intentional infection with the coronavirus, but rather is meant to spark conversation on the ethics of out-of-the-box proposals. Perhaps most meaningfully, our paper explores the value of control and peace of mind for those among us most impacted by the pandemic: those essential workers risking the most to keep us safe.

Ethics and Collateral Findings in Pragmatic Clinical Trials.

Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as ?pragmatic clinical trial collateral findings,? or ?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice.

A Multicenter Comparison of Complementary and Alternative Medicine (CAM) Discussions in Oncology Care: The Role of Time, Patient-Centeredness, and Practice Context.

BACKGROUND: Little is known about how complementary and alternative medicine (CAM) is discussed in cancer care across varied settings in the U.S. METHODS: In two practices affiliated with one academic medical center in southern California (SoCal), and one in the upper Midwest (UM), we audio-recorded patient-clinician interactions in medical oncology outpatient practices. We counted the frequency and duration of CAM-related conversations. We coded recordings using the Roter Interaction Analysis System. We used chi-square tests for bivariate analysis of categorical variables and generalized linear models for continuous variables to examine associations between dialogue characteristics, practice setting, and population characteristics with the occurrence of CAM discussion in each setting followed by multivariate models adjusting for clinician clustering. RESULTS: Sixty-one clinicians and 529 patients participated. Sixty-two of 529 (12%) interactions included CAM discussions, with significantly more observed in the SoCal university practice than in the other settings. Visits that included CAM were on average 6 minutes longer, with CAM content lasting an average of 78 seconds. In bivariate tests of association, conversations containing CAM included more psychosocial statements from both clinicians and patients, higher patient-centeredness, more positive patient and clinician affect, and greater patient engagement. In a multivariable model including significant bivariate terms, conversations containing CAM were independently associated with higher patient-centeredness, slightly longer visits, and being at the SoCal university site. CONCLUSION: The frequency of CAM-related discussion in oncology varied substantially across sites. Visits that included CAM discussion were longer and more patient centered. IMPLICATIONS FOR PRACTICE: The Institute of Medicine and the American Society of Clinical Oncology have called for more open discussions of complementary and alternative medicine (CAM). But little is known about the role population characteristics and care contexts may play in the frequency and nature of those discussions. The present data characterizing actual conversations in practice complements a much larger literature based on patient and clinician self-report about CAM disclosure and use. It was found that CAM discussions in academic oncology visits varied significantly by practice context, that the majority were initiated by the patient, and that they may occur more when visit time exists for lifestyle, self-care, and psychosocial concerns.

The Practice of Respect in the ICU.

Although "respect" and "dignity" are intuitive concepts, little formal work has addressed their systematic application in the ICU setting. After convening a multidisciplinary group of relevant experts, we undertook a review of relevant literature and collaborative discussions focused on the practice of respect in the ICU. We report the output of this process, including a summary of current knowledge, a conceptual framework, and a research program for understanding and improving the practice of respect and dignity in the ICU. We separate our report into findings and proposals. Findings include the following: 1) dignity and respect are interrelated; 2) ICU patients and families are vulnerable to disrespect; 3) violations of respect and dignity appear to be common in the ICU and overlap substantially with dehumanization; 4) disrespect may be associated with both primary and secondary harms; and 5) systemic barriers complicate understanding and the reliable practice of respect in the ICU. Proposals include: 1) initiating and/or expanding a field of research on the practice of respect in the ICU; 2) treating "failures of respect" as analogous to patient safety events and using existing quality and safety mechanisms for improvement; and 3) identifying both benefits and potential unintended consequences of efforts to improve the practice of respect. Respect and dignity are important considerations in the ICU, even as substantial additional research remains to be done.

Climate of Respect Evaluation in ICUs: Development of an Instrument (ICU-CORE).

OBJECTIVES: To develop a valid, reliable measure that reflected the environment of respectfulness within the ICU setting. DESIGN: We developed a preliminary survey instrument based on conceptual domains of respect identified through prior qualitative analyses of ICU patient, family member, and clinician perspectives. The initial instrument consisted of 21 items. After five cognitive interviews and 16 pilot surveys, we revised the instrument to include 23 items. We used standard psychometric methods to analyze the instrument. SETTINGS: Eight ICUs serving adult patients affiliated with a large university health system. SUBJECTS: ICU clinicians. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Based on 249 responses, we identified three factors and created subscales: General Respect, Respectful Behaviors, and Disrespectful Behaviors. The General Respect subscale had seven items (α = 0.932) and reflected how often patients in the ICU are treated with respect, in a dignified manner, as an individual, equally to all other patients, on the "same level" as the ICU team, as a person, and as you yourself would want to be treated. The Respectful Behaviors subscale had 10 items (α = 0.926) and reflected how often the ICU team responds to patient and/or family anxiety, makes an effort to get to know the patient and family as people, listens carefully, explains things thoroughly, gives the opportunity to provide input into care, protects patient modesty, greets when entering room, and talks to sedated patients. The subscale measuring disrespect has four items (α = 0.702) and reflects how often the ICU team dismisses family concerns, talks down to patients and families, speaks disrespectfully behind their backs, and gets frustrated with patients and families. CONCLUSIONS: We created a reliable set of scales to measure the climate of respectfulness in intensive care settings. These measures can be used for ongoing quality improvement that aim to enhance the experience of ICU patients and their families.

A Direct Observation Checklist to Measure Respect and Dignity in the ICU.

OBJECTIVE: Treating patients and family members with respect and dignity is a core objective of health care, yet it is unclear how best to measure this in the ICU setting. Accordingly, we sought to create a direct observation checklist to assess the "respect and dignity status" of an ICU. DESIGN: A draft checklist based on previous work was iteratively revised to enhance accuracy and feasibility. SETTING: Seven ICUs within the Johns Hopkins Health System. SUBJECTS: A total of 351 patient-clinician encounters with 184 different patients. INTERVENTIONS: Four study team members pilot tested the checklist between January and August 2015. MEASUREMENTS AND MAIN RESULTS: Standard psychometric analyses were performed. The direct observation checklist exhibits strong content and face validity as well as high reliability and internal consistency. All items load on one factor that supports the unidimensionality of the total index. Furthermore, concurrent validity of the direct observation checklist is demonstrated by statistically significant differences in mean scores between ICUs, between types of clinicians, and between patients' clinical status and mood. CONCLUSIONS: We rigorously developed, pilot tested, and analyzed a direct observation checklist designed to assess the extent to which patients and families in the ICU setting are treated with respect and dignity. Future research should validate this checklist in other settings and compare its results with other measures. Data gathered about individual items on the direct observation checklist could be used to target areas for training and education; doing so should help facilitate more respectful treatment of patients and their families.

Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.

When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.

What patients with addiction disorders need from their primary care physicians: A qualitative study.

BACKGROUND: Although strong relationships between primary care providers (PCPs) and patients with addictive disease are essential for care, these relationships are often strained. Providers frequently have negative attitudes about treating these patients, in part due to the practical and psychosocial challenges that come with addictive disease. Resulting hostility frequently causes avoidance of primary care by patients with potentially increased morbidity. However, gaining knowledge of patient perspectives on these relationships could improve physician attitudes toward patients with addictive disease and relatedly improve care. METHODS: The authors conducted 18 semistructured interviews of patients with current or prior debilitating addictive disease recruited from a primary care practice in East Baltimore. Interview transcripts were analyzed using editing analysis to reveal major themes. RESULTS: Participants elucidated several provider characteristics that were essential for successful relationships. Providers needed to be knowledgeable about addiction, feel responsible for treating these patients, emphasize overall health, and engage patients in their own care. Additionally, participants strongly desired providers who treated them as "people" that they cared about. Interestingly, interviewees also frequently cited patient characteristics that could affect the strength of patient-provider relationships. These included being concerned about their health, feeling deserving of care, and having appropriate psychiatric care for concomitant mental health conditions. Practical obstacles and a disorganized mindset impeded patient-provider relationships. CONCLUSIONS: The interpersonal dynamics of the patient-provider relationship are particularly important for patients with addictive disease, as this relationship may be one of the most stable and rewarding in their lives. Patients felt that greater understanding of the practical and psychosocial challenges of addiction enabled providers to more effectively address their health concerns and to be more caring and less judgmental. It is hoped that this work will contribute to providers' understanding of patients with addictions, thus allowing them to form stronger relationships and ultimately provide better care.

'Someone should oversee it': patient perspectives on the ethical issues arising with the regulation of probiotics.

BACKGROUND: Although many probiotic products are currently available in yogurt or pill form in the United States (US), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population. OBJECTIVE: This study examined how patients with chronic gastrointestinal (GI) diseases view the regulation of probiotics. DESIGN: We conducted a multi-site qualitative study consisting of focus groups of patients with chronic gastrointestinal diseases at three tertiary hospitals: at [institutions removed for blinded review]. RESULTS: We conducted 22 focus groups with 136 patients with major gastrointestinal (GI) diseases between March and August 2009. Participants were not familiar with the existing regulation of probiotic products but wanted assurances of accurate labelling of strain as well as safety. Participants raised concerns that regulation of probiotics might be accompanied by greater costs, reduced access and increased involvement of pharmaceutical companies. Although participants voiced significant doubt of government regulators, they felt that products containing genetically modified probiotic strains should have oversight comparable to that of pharmaceutical drugs. DISCUSSION AND CONCLUSION: If GI patient perspectives are indicative of public perceptions of therapeutic probiotics in the United States, consumers may expect more rigorous regulation in the future while simultaneously wanting low costs, easy access and low involvement of pharmaceutical companies. Manufacturers, translational scientists, clinicians and regulators should be sensitive to consumer attitudes when designing, testing and regulating new therapeutic probiotics.

Was a decision made? An assessment of patient-clinician discordance in medical oncology encounters.

BACKGROUND: Shared decision making is promoted to improve cancer care quality. Patients and clinicians may have different ideas about what constitutes a cancer care decision, which may limit the validity of self-reported measures of shared decision making. We sought to estimate the extent to which patients and clinicians agree on whether a cancer care decision was made during an outpatient encounter. METHODS: We surveyed patients and clinicians immediately after an oncology encounter at a large, tertiary medical centre and calculated agreement in response to the single-item question, 'Was a specific decision about cancer care made during the appointment today?' Answer options were 'yes' and 'no'. Participants were 315 oncology patients, with any solid tumour malignancy and at any stage of management, and their clinicians (22 staff oncologists, nine senior fellows and five nurse practitioners). RESULTS: Patients and clinicians reported having made a cancer care decision in 184 (58%) and 174 (55%) of encounters, respectively. They agreed on whether a cancer care decision was made in 213 (68%) of encounters (chance-adjusted agreement was 0.34); in 56 of the 102 discordant encounters, the patient reported making a decision while the clinician did not. We found no significant correlates with discordance. CONCLUSIONS: Patients and clinicians do not always agree on whether a cancer care decision was made. As such, measures that ask patients and/or clinicians to evaluate a decision-making process or outcome may be methodologically insufficient when they do not explicitly orient respondents towards the thing they are being asked to assess.