Update on microbiota-derived therapies for recurrent Clostridioides difficile infections.

BACKGROUND: Faecal microbiota transplantation (FMT) is the standard treatment for patients with multiple recurrent Clostridioides difficile infection (rCDI). Recently, new commercially developed human microbiota-derived medicinal products have been evaluated and Food and Drug Administration-approved with considerable differences in terms of composition, administration, and targeted populations. OBJECTIVES: To review available data on the different microbiota-derived treatments at the stage of advanced clinical evaluation and research in rCDI in comparison with FMT. SOURCES: Phase II or III trials evaluating a microbiota-derived medicinal product to prevent rCDI. CONTENT: Two commercial microbiota-derived medicinal products are approved by the Food and Drug Administration: Rebyota (RBX2660 Ferring Pharmaceuticals, marketed in the United States) and VOWST (SER-109 -Seres Therapeutics, marketed in the United States), whereas VE303 (Vedanta Biosciences Inc) will be studied in phase III trial. RBX2660 and SER-109 are based on the processing of stools from healthy donors, whereas VE303 consists of a defined bacterial consortium originating from human stools and produced from clonal cell banks. All have proven efficacy to prevent rCDI compared with placebo in patients considered at high risk of recurrence. However, the heterogeneity of the inclusion criteria, and the time between each episode and CDI diagnostics makes direct comparison between trials difficult. The differences regarding the risk of recurrence between the treatment and placebo arms were lower than previously described for FMT (FMT: Δ = 50.5%; RBX2660-phase III: Δ = 13.1%; SER-109-phase III: Δ = 28%; high-dose VE303-phase-II: Δ = 31.7%). All treatments presented a good overall safety profile with mainly mild gastrointestinal symptoms. IMPLICATIONS: Stool-derived products and bacterial consortia need to be clearly distinguished in terms of product characterization and their associated risks with specific long-term post-marketing evaluation similar to registries used for FMT. Their place in the therapeutic strategy for patients with rCDI requires further studies to determine the most appropriate patient population and administration route to prevent rCDI.

Fidelity evaluation of the dialogue around respiratory illness treatment (DART) program communication training.

OBJECTIVE: To evaluate receipt fidelity of communication training content included in a multifaceted intervention known to reduce antibiotic over-prescribing for pediatric acute respiratory tract infections (ARTIs), by examining the degree to which clinicians implemented the intended communication behavior changes. METHODS: Parents were surveyed regarding clinician communication behaviors immediately after attending 1026 visits by children 6 months to < 11 years old diagnosed with ARTIs by 53 clinicians in 18 pediatric practices. Communication outcomes analyzed were whether clinicians: (A) provided both a combined (negative + positive) treatment recommendation and a contingency plan (full implementation); (B) provided either a combined treatment recommendation or a contingency plan (partial implementation); or (C) provided neither (no implementation). We used mixed effects multinomial logistic regression to determine whether these 3 communication outcomes changed between baseline and the time periods following each of 3 training modules. RESULTS: After completing the communication training, the adjusted probability of clinicians fully implementing the intended communication behavior changes increased by an absolute 8.1% compared to baseline (95% Confidence Interval [CI]: 2.4%, 13.8%, p = .005). CONCLUSIONS: Our findings support the receipt fidelity of the intervention's communication training content. PRACTICAL IMPLICATIONS: Clinicians can be trained to implement communication behaviors that may aid in reducing antibiotic over-prescribing for ARTIs.

Presenting treatment options in breast cancer consultations: Advice and consent in Italian medical care.

Variety, complexity and uncertainty in the therapy outcomes of cancer illness make the treatment recommendation (TR) in oncology a "monumentally difficult task". Previous studies have distinguished unilateral and bilateral formats of treatment recommendations, accordingly to whether, or to what extent, the patient's perspective is included in the consideration of therapeutic options. Others have also shown how the oncologists' presentation of therapeutic options varied accordingly to the severity of the diagnosis and the availability of alternatives. Yet, no study has systemically dentified and compared components of treatment recommendation in oncology on a common set of patients and clinicians. This paper analyzes how different options in breast cancer treatments - radiotherapy, hormone therapy and chemotherapy - are presented and discussed in a set of 12 first post-surgical breast cancer visits carried out by two oncologists of high experience and seniority in two Italian hospitals. Treatment recommendation sequences involving these three option types were analyzed using the methods of conversation analysis. They were also coded for the mention of side effects and treatment burden, and for whether consent to the recommendation was invited, or expressed by the patient. Results show that radiotherapy is presented as presupposed as an extension of surgery and is not further discussed, and hormone therapy is delivered as good news and as not implying any health or lifestyle burdens. Treatment burdens were raised in the much more extensive discussions of chemotherapy, which were also accompanied by a higher chance that the patient was asked for consent to therapy. Implications are drawn as regards the extent to which clinical practice meets theory in communication protocols available in oncology, and how to consider the doctor-patient partnership and the concept of shared decision-making in such an encounter.

Reducing Antibiotic Prescribing in Primary Care for Respiratory Illness.

BACKGROUND: One-third of outpatient antibiotic prescriptions for pediatric acute respiratory tract infections (ARTIs) are inappropriate. We evaluated a distance learning program's effectiveness for reducing outpatient antibiotic prescribing for ARTI visits. METHODS: In this stepped-wedge clinical trial run from November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges. Visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection for children 6 months to <11 years old without recent antibiotic use were included. Clinicians received the intervention as 3 program modules containing online tutorials and webinars on evidence-based communication strategies and antibioti c prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months. The primary outcome was overall antibiotic prescribing rates for all ARTI visits. Mixed-effects logistic regression compared prescribing rates during each program module and a postintervention period to a baseline control period. Odds ratios were converted to adjusted rate ratios (aRRs) for interpretability. RESULTS: Among 72 723 ARTI visits by 29 762 patients, intention-to-treat analyses revealed a 7% decrease in the probability of antibiotic prescribing for ARTI overall between the baseline and postintervention periods (aRR 0.93; 95% confidence interval [CI], 0.90-0.96). Second-line antibiotic prescribing decreased for streptococcal pharyngitis (aRR 0.66; 95% CI, 0.50-0.87) and sinusitis (aRR 0.59; 95% CI, 0.44-0.77) but not for acute otitis media (aRR 0.93; 95% CI, 0.83-1.03). Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70). CONCLUSIONS: This program reduced antibiotic prescribing during outpatient ARTI visits; broader dissemination may be beneficial.

The diagnostic moment: A study in US primary care.

This paper conceptualizes the act of diagnosis in primary care as a 'diagnostic moment,' comprising a diagnostic utterance in a 'diagnostic slot,' together with a patient response. Using a dataset of 201 treated conditions drawn from 255 video recorded medical visits with 71 physicians across 33 clinical practices in the Western United States, we investigate the incidence of diagnostic moments, aspects of their verbal design, and patient responsiveness. We find that only 53% of treated conditions in the dataset are associated with a diagnostic moment. Physicians present 66% of these diagnoses as hedged or otherwise doubtful, and deliver 30% of them without gazing at the patient. In the context of these diagnostic moments, patients are non- or minimally responsive 59% of the time. These findings underscore the different significance that may be accorded diagnosis in primary care in contrast to care in other medical contexts. The paper concludes that the analysis of sequences of action which empirically realize diagnosis are underrepresented in the sociology of diagnosis, and that better understanding of the diagnostic moment would enhance our understanding of diagnostic processes in primary care.

Findings from a feasibility study to improve GP elicitation of patient concerns in UK general practice consultations.

OBJECTIVES: To establish: a) feasibility of training GPs in a communication intervention to solicit additional patient concerns early in the consultation, using specific lexical formulations ("do you have 'any' vs. 'some' other concerns?") noting the impact on consultation length, and b) whether patients attend with multiple concerns and whether they voiced them in the consultation. METHODS: A mixed-methods three arm RCT feasibility study to assess the feasibility of the communication intervention. RESULTS: Intervention fidelity was high. GPs can be trained to solicit additional concerns early in the consultation (once patients have presented their first concern). Whilst feasible the particular lexical variation of 'any' vs 'some' seemed to have no bearing on the number of patient concerns elicited, on consultation length or on patient satisfaction. The level of missing questionnaire data was low, suggesting patients found completion of questionnaires acceptable. CONCLUSION: GPs can solicit for additional concerns without increasing consultation length, but the particular wording, specifically 'any' vs. 'some' may not be as important as the placement of the GP solicitation. PRACTICE IMPLICATIONS: GPs can solicit early for additional concerns and GPs can establish patients' additional concerns in the opening of the consultation, which can help to plan and prioritise patients multiple concerns.

Closing the Deal: A Cross-Cultural Comparison of Treatment Resistance.

This study investigates patient resistance to doctors' treatment recommendations in a cross-national comparison of primary care. Through this lens, we explore English and American patients' enacted priorities, expectations, and assumptions about treating routine illnesses with prescription versus over-the-counter medications. We perform a detailed analysis of 304 (American) and 393 (English) naturally occurring treatment discussions and conclude that American and English patients tend to use treatment resistance in different prescribing contexts to pursue different ends. While American patients are most likely to resist recommendations for non-prescription treatment and display an expectation for prescription treatment in these interactions, English patients show a high level of resistance to recommendations for all types of treatment and display an expectation of cautious prescribing. These behavioral trends reflect broader structural forces unique to each national context and ultimately maintain distinct cultural norms of good-practice prescribing.

Treatment Recommendations as Actions.

From the earliest studies of doctor-patient interaction (Byrne & Long, 1976), it has been recognized that treatment recommendations may be expressed in more or less authoritative ways, based on their design and delivery. There are clear differences between I'm going to start you on X and We can give you X to try and Would you like me to give you X? Yet little is known about this variation, its contexts, or its consequences. In this paper, we develop a basic taxonomy of treatment recommendations in primary care as a first step toward a more comprehensive investigation. We take as our point of departure the observation that treatment recommendations such as those above represent not only different formulations but also different social actions. We distinguish five main treatment recommendation actions: pronouncements, suggestions, proposals, offers, and assertions. We ask: what are the main dimensions on which these recommendations vary and to what end? And what sorts of factors shape a clinician's use of one action type over another with respect to recommending a medication in the primary care context?

Online Commentary in Primary Care and Emergency Room Settings.

This paper describes a communication practice called "online commentary" that is in widespread use in primary care in the USA. Online commentary is talk by a clinician that describes what he or she is finding in the course of the physical examination of the patient. The paper reviews the primary features of online commentary, with a special focus on its role in forecasting the likely results of the physical examination during the examination itself. It also describes patient outcomes that are associated with this use. It then uses data from an emergency room in the western USA to extend the notion of online commentary from primary care to the emergency setting. It proposes that online commentary facilitates effective teamwork by forecasting next actions, allowing members of the emergency team to anticipate probable next steps in the investigation and treatment of patient injuries.

Agenda-setting revisited: When and how do primary-care physicians solicit patients' additional concerns?

OBJECTIVE: Soliciting patients' complete agendas of concerns (aka. 'agenda setting') can improve patients' health outcomes and satisfaction, and physicians' time management. We assess the distribution, content, and effectiveness of physicians' post-chief-complaint, agenda-setting questions. METHODS: We coded videotapes/transcripts of 407 primary-, acute-care visits between adults and 85 general-practice physicians operating in 46 community-based clinics in two states representing urban and rural care. Measures are the incidence of physicians' questions, their linguistic format, position within visits, likelihood of being responded to, and the nature of such responses. RESULTS: Physicians' questions designed to solicit concerns additional to chief concerns occurred in only 32% of visits (p<.001). Compared to questions whose communication format explicitly solicited 'questions' (e.g., "Do you have any questions?"), those that were formatted so as to allow for 'concerns' (e.g., "Any other concerns?") were significantly more likely to generate some type of agenda item (Chi(2) (1, N=131)=11.96, p=.001), and to do so more frequently when positioned 'early' vs. 'late' during visits (Chi(2) (1, N=73)=4.99, p=.025). CONCLUSIONS: Agenda setting is comparatively infrequent. The communication format and position of physicians' questions affects patients' provision of additional concerns/questions. PRACTICE IMPLICATIONS: Physicians should increase use of optimized forms of agenda setting.

How patients understand physicians' solicitations of additional concerns: implications for up-front agenda setting in primary care.

In the more than 1 billion primary-care visits each year in the United States, the majority of patients bring more than one distinct concern, yet many leave with "unmet" concerns (i.e., ones not addressed during visits). Unmet concerns have potentially negative consequences for patients' health, and may pose utilization-based financial burdens to health care systems if patients return to deal with such concerns. One solution to the problem of unmet concerns is the communication skill known as up-front agenda setting, where physicians (after soliciting patients' chief concerns) continue to solicit patients' concerns to "exhaustion" with questions such as "Are there some other issues you'd like to address?" Although this skill is trainable and efficacious, it is not yet a panacea. This article uses conversation analysis to demonstrate that patients understand up-front agenda-setting questions in ways that hamper their effectiveness. Specifically, we demonstrate that up-front agenda-setting questions are understood as making relevant "new problems" (i.e., concerns that are either totally new or "new since last visit," and in need of diagnosis), and consequently bias answers away from "non-new problems" (i.e., issues related to previously diagnosed concerns, including much of chronic care). Suggestions are made for why this might be so, and for improving up-front agenda setting. Data are 144 videotapes of community-based, acute, primary-care, outpatient visits collected in the United States between adult patients and 20 family-practice physicians.

'What Brings Him Here Today?': Medical Problem Presentation Involving Children with Autism Spectrum Disorders and Typically Developing Children.

Conversation and discourse analyses were used to examine medical problem presentation in pediatric care.Healthcare visits involving children with ASD and typically developing children were analyzed. We examined how children's communicative and epistemic capabilities, and their opportunities to be socialized into a competent patient role are interactionally achieved. We found that medical problem presentation is designed to contain a 'pre-visit' account of the interactional and epistemic work that children and caregivers carry out at home to identify the child's health problems; and that the intersubjective accessibility of children's experiences that becomes disrupted by ASD presents a dilemma to all participants in the visit. The article examines interactional roots of unmet healthcare needs and foregone medical care of people with ASD.

Communication practices and antibiotic use for acute respiratory tract infections in children.

PURPOSE: This study examined relationships between provider communication practices, antibiotic prescribing, and parent care ratings during pediatric visits for acute respiratory tract infection (ARTI). METHODS: A cross-sectional study was conducted of 1,285 pediatric visits motivated by ARTI symptoms. Children were seen by 1 of 28 pediatric providers representing 10 practices in Seattle, Washington, between December 2007 and April 2009. Providers completed post-visit surveys reporting on children's presenting symptoms, physical examination findings, assigned diagnoses, and treatments prescribed. Parents completed post-visit surveys reporting on provider communication practices and care ratings for the visit. Multivariate analyses identified key predictors of prescribing antibiotics for ARTI and of parent visit ratings. RESULTS: Suggesting actions parents could take to reduce their child's symptoms (providing positive treatment recommendations) was associated with decreased risk of antibiotic prescribing whether done alone or in combination with negative treatment recommendations (ruling out the need for antibiotics) [adjusted risk ratio (aRR) 0.48; 95% CI, 0.24-0.95; and aRR 0.15; 95% CI, 0.06-0.40, respectively]. Parents receiving combined positive and negative treatment recommendations were more likely to give the highest possible visit rating (aRR 1.16; 95% CI, 1.01-1.34). CONCLUSION: Combined use of positive and negative treatment recommendations may reduce the risk of antibiotic prescribing for children with viral ARTIs and at the same time improve visit ratings. With the growing threat of antibiotic resistance at the community and individual level, these communication techniques may assist frontline providers in helping to address this pervasive public health problem.

The Influence of Provider Communication Behaviors on Parental Vaccine Acceptance and Visit Experience.

OBJECTIVES: We investigated how provider vaccine communication behaviors influence parental vaccination acceptance and visit experience. METHODS: In a cross-sectional observational study, we videotaped provider-parent vaccine discussions (n = 111). We coded visits for the format providers used for initiating the vaccine discussion (participatory vs presumptive), parental verbal resistance to vaccines after provider initiation (yes vs no), and provider pursuit of recommendations in the face of parental resistance (pursuit vs mitigated or no pursuit). Main outcomes were parental verbal acceptance of recommended vaccines at visit's end (all vs ≥ 1 refusal) and parental visit experience (highly vs lower rated). RESULTS: In multivariable models, participatory (vs presumptive) initiation formats were associated with decreased odds of accepting all vaccines at visit's end (adjusted odds ratio [AOR] = 0.04; 95% confidence interval [CI] = 0.01, 0.15) and increased odds of a highly rated visit experience (AOR = 17.3; 95% CI = 1.5, 200.3). CONCLUSIONS: In the context of 2 general communication formats used by providers to initiate vaccine discussions, there appears to be an inverse relationship between parental acceptance of vaccines and visit experience. Further exploration of this inverse relationship in longitudinal studies is needed.

The architecture of provider-parent vaccine discussions at health supervision visits.

OBJECTIVE: To characterize provider-parent vaccine communication and determine the influence of specific provider communication practices on parent resistance to vaccine recommendations. METHODS: We conducted a cross-sectional observational study in which we videotaped provider-parent vaccine discussions during health supervision visits. Parents of children aged 1 to 19 months old were screened by using the Parent Attitudes about Childhood Vaccines survey. We oversampled vaccine-hesitant parents (VHPs), defined as a score ≥50. We developed a coding scheme of 15 communication practices and applied it to all visits. We used multivariate logistic regression to explore the association between provider communication practices and parent resistance to vaccines, controlling for parental hesitancy status and demographic and visit characteristics. RESULTS: We analyzed 111 vaccine discussions involving 16 providers from 9 practices; 50% included VHPs. Most providers (74%) initiated vaccine recommendations with presumptive (e.g., "Well, we have to do some shots") rather than participatory (e.g., "What do you want to do about shots?") formats. Among parents who voiced resistance to provider initiation (41%), significantly more were VHPs than non-VHPs. Parents had significantly higher odds of resisting vaccine recommendations if the provider used a participatory rather than a presumptive initiation format (adjusted odds ratio: 17.5; 95% confidence interval: 1.2-253.5). When parents resisted, 50% of providers pursued their original recommendations (e.g., "He really needs these shots"), and 47% of initially resistant parents subsequently accepted recommendations when they did. CONCLUSIONS: How providers initiate and pursue vaccine recommendations is associated with parental vaccine acceptance.

Characterizing providers' immunization communication practices during health supervision visits with vaccine-hesitant parents: a pilot study.

OBJECTIVE: To determine the feasibility of using direct observation of provider-parent immunization discussions and to characterize provider communication practices with vaccine-hesitant parents. METHODS: Over a 6 month period in 2010, we videotaped immunization discussions between pediatric providers and vaccine-hesitant parents during health supervision visits involving children 2-15 months old (N=24) in the Seattle area, Washington, USA. Videotapes were analyzed using the qualitative method of conversation analysis. RESULTS: We approached 96 parents seen by 9 different providers. Of those who were eligible (N=56), we enrolled 43% (N=24). Four videotaped visits were excluded from analysis for failure to obtain parental HIPAA authorization. Of the remaining 20 visits, there were ≥2 visits each that involved children aged 2, 4, 6, 9, 12, and 15 months, and all videotaped visits contained at least a brief immunization discussion. We identified 6 communication practices and several behavior types within each practice relevant to immunization: Practice 1, providers' initiations of the topic of vaccination; Types: participatory or presumptive format; Practice 2, parents' responses to providers' topic initiations; Types: strong or weak acceptance or resistance; Practice 3, providers' follow-ups to parent's responses; Types: no, immediate, or delayed pursuit; Practice 4, parents' vaccine-related questions or statements; Types: fact- or concern-based; Practice 5, providers' explicit solicitations of parent's questions/concerns; Types: designed to discourage or encourage discussion; and Practice 6, parents' responses to providers' solicitations of questions/concerns; Types: no question or fact- or concern-based inquiry. CONCLUSION: Direct observation of immunization discussions in the primary care pediatric setting is feasible and yields insight into several provider-parent immunization communication practices that are worthy of further study to determine which are effective at improving parental acceptance of immunization.

Preserving the child as a respondent: initiating patient-centered interviews in a US outpatient tertiary care pediatric pain clinic.

This article identifies some of the challenges of implementing patient-centeredness in multiparty clinical visits. Specifically, it describes four interview practices with which clinicians address these challenges in a US outpatient tertiary care pediatric pain clinic. Using the qualitative method of conversation analysis, we analyze clinicians' child-directed (ages 10-18) interviewing during the initial stage of 51 intake visits. In particular, we analyze the challenges involved in open-ended questioning, a form of interviewing associated with patient-centeredness. Open-ended questioning presents participants with competing demands: although it gives children an opportunity to talk about their illness in their own terms, it also asks them to be responsible for a larger part of the communication work. Moreover, the presence of a parent as an alternative informant can lead to the loss of the child as an informant if clinicians fail to give the child, particularly younger ones, enough guidance in answering. We argue that a flexible range of interviewing practices may be a step towards offsetting children's and parents'past negative experiences with clinicians, improving patient outcomes and implementing child/patient-centeredness.

The interaction order and clinical practice: Some observations on dysfunctions and action steps.

OBJECTIVE: This paper examines three dysfunctional communication processes in the primary care consultation using conversation analysis theory and methods: dysfunctions in problem presentation, medical questioning that limits the expression of additional concerns, and the emergence of discordance between physicians and patients in the context of treatment recommendations. RESULTS: It is proposed that these dysfunctions arise from the transfer of normative conventions that function well in the practice of ordinary conversation into medical contexts where they serve to limit the effectiveness of communication. Because these conventions are rooted in, and reinforced by, the activities of daily life, they may be difficult to eradicate from the medical visit. PRACTICE IMPLICATIONS: Reduction of these dysfunctions is most likely to emerge when physicians recognize the nature of these dysfunctional practices and their roots in everyday social life. Recognition of these practices together with their functions and dysfunctions may hold a solid prospect for improvements in medical communication.