The impact of elexacaftor/tezacaftor/ivacaftor on cystic fibrosis health-related quality of life and decision-making about daily treatment regimens: a mixed methods exploratory study.

Background: Elexacaftor/tezacaftor/ivacaftor (ETI) has reduced many symptoms of cystic fibrosis (CF). Objectives: We sought to identify the impact of ETI on both symptoms and treatment decisions among adults with CF. Design: Participants were enrolled in a cross-sectional study. Surveys were sent via a RedCap link. Semistructured interviews were administered remotely via Microsoft Teams. Interviews were audio recorded and professionally transcribed. Methods: We assessed Cystic Fibrosis Questionnaire-Revised (CFQ-R) subscales for physical, respiratory, emotion, and treatment, and analyzed semistructured interviews covering CF treatment regimens and daily living. Quantitative and qualitative results were analyzed separately and via a mixed-methods convergence coding matrix. Results: Twenty-four adults with CF taking ETI were included. CFQ-R subscale scores (mean scores/standard deviation) were physical (82.1/22.8), respiratory (83.7/11.2), emotion (65.3/14.2), and treatment (57.5/20.1). Three themes about decision-making for non-ETI-treatments emerged: (1) How I'm feeling, (2) Not noticing a difference, and (3) Uncertainty about long-term impact of modifying treatment regimens, and we found participants weighed each of these factors in their treatment decisions. Key findings from mixed-methods analysis show that among individuals experiencing higher CFQ-R scores for physical and respiratory compared to emotion and treatment, there were statements indicating that while those participants were experiencing better physical health, many continued their burdensome treatment regimens. Conclusion: With little long-term data on the impact of reducing non-ETI treatments, participants weighed how they were feeling, treatment efficacy beliefs, and risk tolerance when making treatment decisions.

The impact of Trikafta on CF health, health-related quality of life, and treatment adherence People with cystic fibrosis may be experiencing many health benefits from taking Trikafta, leading some people to cut back on or stop their other non-Trikafta treatments. We explored the impact of Trikafta on CF health, health-related quality of life, and treatment adherence for people with CF currently taking Trikafta. We compared health-related quality of life subscales from the CF Questionnaire-Revised questionnaire focused on physical symptoms, respiratory symptoms, treatment burden, and emotional well-being to assess whether people with CF were experiencing improved physical and respiratory health compared to emotional health and feelings of treatment burden. We found that many people were feeling better physically, but were still experiencing poor mental health and high treatment burden. We then looked at results from open-ended interviews to see if our qualitative data could explain the differences in the health-related quality of life scores. We found that while people were feeling better physically, many people were still continuing with the pre-Trikafta treatment regimens which may explain why physical health and respiratory health scores were higher than emotional well-being and treatment burden scores. At this time, we believe that more research is needed to guide treatment decisions related to cutting back or stopping burdensome treatment regimens.

Remote endpoints for clinical trials in cystic fibrosis: Report from the U.S. CF foundation remote endpoints task force.

The COVID-19 pandemic necessitated a rapid shift in clinical research to perform virtual visits and remote endpoint assessments, providing a key opportunity to optimize the use of remote endpoints for clinical trials in cystic fibrosis. The use of remote endpoints could allow more diverse participation in clinical trials while minimizing participant burden but must be robustly evaluated to ensure adequate performance and feasibility. In response, the Cystic Fibrosis Foundation convened the Remote Endpoint Task Force (Supplemental Table 1), a multidisciplinary group of CF researchers with remote endpoint expertise and community members tasked to better understand the current and future use of remote endpoints for clinical research. Here, we describe the current use of remote endpoints in CF clinical research, address key unanswered questions regarding their use and feasibility, and discuss the next steps to determine clinical trial readiness.

Addressing Symptom Burden and Palliative Care Needs in Cystic Fibrosis: A Narrative Review of the Literature.

Among people with cystic fibrosis (CF), illness burden is multifaceted, and symptoms may fluctuate in intensity across a lifespan. Caregivers of people with CF may also experience distressing symptoms. Recent developments in CF care, including the availability of highly effective modulator therapies (HEMTs) and new palliative care guidelines promoting palliative care screening may help alleviate symptoms. The objective of this review was to present a narrative view of the recent literature on symptom burden in CF, new screening approaches informed by the Cystic Fibrosis Foundation (CFF) palliative care guidelines, and early data from studies examining the impact of HEMTs on CF symptom burden. A review of the relevant literature was conducted using Google Scholar and PubMed. Included articles covered approaches to burden assessment in CF and other chronic illnesses, epidemiology of CF symptom burden, the impact of HEMTs on symptom burden, and the CFF palliative care guidelines. A primary palliative care model implementing the CFF guidelines was also described. Results of this review show that while recent developments in CF care have led to a reduction in physical symptoms, mental health symptoms remain prevalent. Ongoing screening and triage can ensure that physical symptoms, psychological symptoms, social needs, practical problems, and communication concerns are addressed by care teams.

Application of the RE-AIM framework to evaluate the implementation of telehealth pulmonary rehabilitation in a randomized controlled trial among African-American and Hispanic patients with advanced stage Chronic Obstructive Pulmonary Disease.

BACKGROUND: Pulmonary rehabilitation (PR) decreases rehospitalization for people with COPD. However, less than 2% receive PR, partly due to lack of referral and sparsity of PR facilities. This disparity is particularly pronounced in African American and Hispanic persons with COPD. Telehealth-provided PR could increase access and improve health outcomes. METHODS: We applied the RE-AIM framework in a post-hoc analysis of our mixed methods RCT comparing referral to Telehealth-delivered PR (TelePR) versus standard PR (SPR) for African American and Hispanic COPD patients hospitalized for COPD exacerbation. Both arms received a referral to PR for 8 weeks, social worker follow-up, and surveys administered at baseline, 8 weeks, 6, and 12 months. PR sessions were conducted twice a week for 90 min each (16 sessions total). Quantitative data were analyzed using 2-sample t tests or nonparametric Wilcoxon tests for continuous data and χ2/Fisher exact tests for categorical data. Logistic regression-estimated odds ratios (ORs) were used for the intention-to-treat primary outcome. Qualitative interviews were conducted at the end of the study to assess adherence and satisfaction and were analyzed using inductive and deductive methods. The goal was to understand Reach (whether the target population was able to be enrolled), Effectiveness (primary outcome was a composite of 6-month COPD rehospitalization and death), Adoption (proportion of people willing to initiate the program), Implementation (whether the program was able to be executed as intended, and Maintenance (whether the program was continued). RESULTS: Two hundred nine people enrolled out of a 276-recruitment goal. Only 85 completed at least one PR session 57/111 (51%) TelePR; 28/98 (28%) SPR. Referral to TelePR compared to SPR did not decrease the composite outcome of 6-month COPD-readmission rate/death (OR1.35;95%CI 0.69,2.66). There was significant reduction in fatigue (PROMIS® scale) from baseline to 8-weeks in TelePR compared to SPR (MD-1.34; ± SD4.22; p = 0.02). Participants who received TelePR experienced improvements from baseline in several outcomes (ie, before and after 8 weeks of PR) in the following: COPD symptoms, knowledge about COPD management, fatigue, and functional capacity. Among the patients who had 1 initial visit, adherence rates were similar (TelePR arm, 59% of sessions; SPR arm, 63%). No intervention-related adverse events occurred. Barriers to PR adoption included difficulty or reluctance to complete medical clearances and beliefs about PR efficacy. Notably, only 9 participants sustained exercise after program completion. Maintenance of the program was not possible due to low insurance reimbursement and sparsity of Respiratory Therapists. CONCLUSIONS: TelePR can reach COPD patients with health disparities and can be successfully implemented. The small sample size and large confidence intervals prevent conclusion about the relative effectiveness of participating in TelePR compared to SPR. However, improved outcomes were seen for those in TelePR as well as in SPR. Increasing adoption of PR and TelePR requires consideration of comorbidity burden, and perception of PR utility, and must facilitate medical clearances. Given the sparsity of SPR locations, TelePR can overcome at least the barrier of access. However, given the challenges to the uptake and completion of PR - many of the additional barriers in PR (both in TelePR and SPR) need to be addressed. Awareness of these real-world challenges will not only inform implementation of TelePR for clinicians seeking to adopt this platform but will also inform study designers and reviewers regarding the feasibility of approaches to patient recruitment and retention.

Development of a Cystic Fibrosis Primary Palliative Care Intervention: Qualitative Analysis of Patient and Family Caregiver Preferences.

To prevent or mitigate chronic illness burden, people with cystic fibrosis (pwCF) and their family caregivers need primary (generalist-level) palliative care from the time of diagnosis forward. We used qualitative methods to explore their preferences about a screening-and-triage model ("Improving Life with CF") developed to standardize this care. We purposively sampled and interviewed 14 pwCF and caregivers from 5 Improving Life with CF study sites. Thematic analysis was guided by a priori codes using the National Consensus Project's Guidelines for Quality Palliative Care. Participants included 7 adults and 2 adolescents with CF (3 with advanced disease), 4 parents, 1 partner (7 women; 5 people of color). Few were familiar with palliative care. Illness burden was described in multiple domains, including physical (e.g., dyspnea, pain), psychological (e.g., anxiety), and social (e.g., family well-being; impact on work/school). Most preferred survey-based screening with care coordination by the CF team. Preferences for screening approaches varied. PwCF and caregivers experience illness burden and are receptive to a CF-team delivered primary palliative care screening-and-triage model with flexible processes.

US and Dutch Perspectives on the Use of COVID-19 Clinical Prediction Models: Findings from a Qualitative Analysis.

INTRODUCTION: Clinical prediction models (CPMs) for coronavirus disease 2019 (COVID-19) may support clinical decision making, treatment, and communication. However, attitudes about using CPMs for COVID-19 decision making are unknown. METHODS: Online focus groups and interviews were conducted among health care providers, survivors of COVID-19, and surrogates (i.e., loved ones/surrogate decision makers) in the United States and the Netherlands. Semistructured questions explored experiences about clinical decision making in COVID-19 care and facilitators and barriers for implementing CPMs. RESULTS: In the United States, we conducted 4 online focus groups with 1) providers and 2) surrogates and survivors of COVID-19 between January 2021 and July 2021. In the Netherlands, we conducted 3 focus groups and 4 individual interviews with 1) providers and 2) surrogates and survivors of COVID-19 between May 2021 and July 2021. Providers expressed concern about CPM validity and the belief that patients may interpret CPM predictions as absolute. They described CPMs as potentially useful for resource allocation, triaging, education, and research. Several surrogates and people who had COVID-19 were not given prognostic estimates but believed this information would have supported and influenced their decision making. A limited number of participants felt the data would not have applied to them and that they or their loved ones may not have survived, as poor prognosis may have suggested withdrawal of treatment. CONCLUSIONS: Many providers had reservations about using CPMs for people with COVID-19 due to concerns about CPM validity and patient-level interpretation of the outcome predictions. However, several people who survived COVID-19 and their surrogates indicated that they would have found this information useful for decision making. Therefore, information provision may be needed to improve provider-level comfort and patient and surrogate understanding of CPMs. HIGHLIGHTS: While clinical prediction models (CPMs) may provide an objective means of assessing COVID-19 prognosis, provider concerns about CPM validity and the interpretation of CPM predictions may limit their clinical use.Providers felt that CPMs may be most useful for resource allocation, triage, research, or educational purposes for COVID-19.Several survivors of COVID-19 and their surrogates felt that CPMs would have been informative and may have aided them in making COVID-19 treatment decisions, while others felt the data would not have applied to them.

Prognostic models for COVID-19 needed updating to warrant transportability over time and space.

BACKGROUND: Supporting decisions for patients who present to the emergency department (ED) with COVID-19 requires accurate prognostication. We aimed to evaluate prognostic models for predicting outcomes in hospitalized patients with COVID-19, in different locations and across time. METHODS: We included patients who presented to the ED with suspected COVID-19 and were admitted to 12 hospitals in the New York City (NYC) area and 4 large Dutch hospitals. We used second-wave patients who presented between September and December 2020 (2137 and 3252 in NYC and the Netherlands, respectively) to evaluate models that were developed on first-wave patients who presented between March and August 2020 (12,163 and 5831). We evaluated two prognostic models for in-hospital death: The Northwell COVID-19 Survival (NOCOS) model was developed on NYC data and the COVID Outcome Prediction in the Emergency Department (COPE) model was developed on Dutch data. These models were validated on subsequent second-wave data at the same site (temporal validation) and at the other site (geographic validation). We assessed model performance by the Area Under the receiver operating characteristic Curve (AUC), by the E-statistic, and by net benefit. RESULTS: Twenty-eight-day mortality was considerably higher in the NYC first-wave data (21.0%), compared to the second-wave (10.1%) and the Dutch data (first wave 10.8%; second wave 10.0%). COPE discriminated well at temporal validation (AUC 0.82), with excellent calibration (E-statistic 0.8%). At geographic validation, discrimination was satisfactory (AUC 0.78), but with moderate over-prediction of mortality risk, particularly in higher-risk patients (E-statistic 2.9%). While discrimination was adequate when NOCOS was tested on second-wave NYC data (AUC 0.77), NOCOS systematically overestimated the mortality risk (E-statistic 5.1%). Discrimination in the Dutch data was good (AUC 0.81), but with over-prediction of risk, particularly in lower-risk patients (E-statistic 4.0%). Recalibration of COPE and NOCOS led to limited net benefit improvement in Dutch data, but to substantial net benefit improvement in NYC data. CONCLUSIONS: NOCOS performed moderately worse than COPE, probably reflecting unique aspects of the early pandemic in NYC. Frequent updating of prognostic models is likely to be required for transportability over time and space during a dynamic pandemic.

Usability preferences of people living with cystic fibrosis about a lung transplant education website.

People living with cystic fibrosis (CF) need educational resources about lung transplant prior to engaging in shared decision making with their medical providers. We conducted a usability study to elicit preferences of people living with CF about how didactic and experiential content could be used in an educational resource to learn about lung transplant. We created two prototypes with different design features that participants used in a scenario-based task and evaluated using the System Usability Scale. We interviewed participants and analyzed the data to understand their preferences for educational content and design. Study participants indicated that didactic resource articles were important to understanding their illness trajectory, while experiential patient stories supported fear reduction and knowledge discovery. When learning about lung transplant participants stated a preference to control the amount of information they receive and preferred a combination of didactic and experiential knowledge.

Humanizing the ICU Patient: A Qualitative Exploration of Behaviors Experienced by Patients, Caregivers, and ICU Staff.

OBJECTIVES: To understand how patients and family members experience dehumanizing or humanizing treatment when in the ICU. DESIGN: Qualitative study included web-based focus groups and open-ended surveys posted to ICU patient/family social media boards. Focus groups were audio recorded and transcribed. Social media responses were collected and organized by stakeholder group. Data underwent qualitative analysis. SETTING: Remote focus groups and online surveys. PATIENTS: ICU patient survivors, family members, and ICU teams. INTERVENTIONS: Not available. MEASUREMENTS AND MAIN RESULTS: Semi-structured questions and open-ended survey responses. We enrolled 40 patients/family members and 31 ICU team members. Focus groups and surveys revealed three primary themes orienting humanizing/dehumanizing ICU experiences: 1) communication, 2) outcomes, and 3) causes of dehumanization. Dehumanization occurred during "communication" exchanges when ICU team members talked "over" patients, made distressing remarks when patients were present, or failed to inform patients about ICU-related care. "Outcomes" of dehumanization were associated with patient loss of trust in the medical team, loss of motivation to participate in ICU recovery, feeling of distress, guilt, depression, and anxiety. Humanizing behaviors were associated with improved recovery, well-being, and trust. "Perceived causes" of dehumanizing behaviors were linked to patient, ICU team, and healthcare system factors. CONCLUSIONS: Behaviors of ICU clinicians may cause patients and families to feel dehumanized when in the ICU. Negative behaviors are noticed by patients and families, possibly contributing to poor outcomes including mental health, recovery, and lack of trust in ICU teams. Supporting ICU clinicians may enable a more empathic environment and in turn more humanizing clinician-patient encounters.

Developing a Decision Aid to Facilitate Informed Decision Making About Invasive Mechanical Ventilation and Lung Transplantation Among Adults With Cystic Fibrosis: Usability Testing.

BACKGROUND: Cystic fibrosis (CF) is a life-limiting genetic disease that causes chronic lung infections. We developed an internet-based decision aid (DA) to help patients with CF make better informed decisions regarding treatments and advance care planning. We built the DA around two major treatment decisions: whether to have a lung transplant and whether to agree to invasive mechanical ventilation (intubation). OBJECTIVE: This study aims to conduct usability testing of the InformedChoices CF DA among key stakeholder groups. METHODS: We performed a patient needs assessment using think-aloud usability testing with patients with CF, their surrogates, and CF clinicians. Think-aloud participants provided feedback while navigating the DA, and after viewing, they answered surveys. Transcripts from the think-aloud sessions and survey results were categorized into common, generalizable themes and optimizations for improving content, comprehension, and navigation. We assessed the ease of use of the DA (System Usability Scale) and also assessed the participants' perceptions regarding the overall tone, with an emphasis on emotional reactions to the DA content, level of detail, and usefulness of the information for making decisions about either intubation or lung transplantation, including how well they understood the information and were able to apply it to their own decision-making process. We also assessed the DA's ease of navigation, esthetics, and whether participants were able to complete a series of usability tasks (eg, locating specific information in the DA or using the interactive survival estimates calculator) to ensure that the website was easy to navigate during the clinic-based advance care planning discussions. RESULTS: A total of 12 participants from 3 sites were enrolled from March 9 to August 30, 2018, for the usability testing: 5 CF clinicians (mean age 48.2, SD 12.0 years), 5 adults with CF, and 2 family and surrogate caregivers of people with CF (mean age of CF adults and family and surrogate caregivers 38.8, SD 10.8 years). Among the 12 participants, the average System Usability Scale score for the DA was 88.33 (excellent). Think-aloud analysis identified 3 themes: functionality, visibility and navigation, and content and usefulness. Areas for improvement included reducing repetition, enhancing comprehension, and changing the flow. Several changes to improve the content and usefulness of the DA were recommended, including adding information about alternatives to childbearing, such as adoption and surrogacy. On the basis of survey responses, we found that the navigation of the site was easy for clinicians, patients, and surrogates who participated in usability testing. CONCLUSIONS: Usability testing revealed areas of potential improvement. Testing also yielded positive feedback, suggesting the DA's future success. Integrating changes before implementation should improve the DA's comprehension, navigation, and usefulness and lead to greater adoption.

Assessing Practices, Beliefs, and Attitudes about Palliative Care among People with Cystic Fibrosis, Their Caregivers, and Clinicians: Results of a Content Analysis.

Background: Individuals with cystic fibrosis (CF) experience symptoms affecting quality of life and may benefit from palliative care (PC). Objectives: To present results of content analysis from open-ended survey questions assessing knowledge and experiences with PC among CF stakeholders. Design, Setting, Subjects: Online surveys were sent to CF stakeholders through CF-specific listservs predominantly in the United States. Measurements: Responses to five open-ended questions about CF PC-delivery, health care provider training, and lung transplant-underwent content analysis. Responses were coded using NVivo12 Software™. Results: Forty-eight CF adults, 59 caregivers, and 229 providers responded to the open-ended survey questions. Analysis showed 5 primary categories related to CF PC: (1) stakeholder perceptions of PC for CF, (2) delivering PC to people with CF, (3) conversations about PC for CF, (4) perceptions that PC services are underutilized for people with CF, and (5) beliefs that PC services are critical for people with CF considering or pursuing lung transplant. Analysis showed variation among and within groups in defining PC for CF, when, and how to deliver it. Many respondents felt PC was underutilized in CF. Most saw PC as particularly important when considering lung transplant, managing anxiety around transplant, and for goals of care discussions. Some believed PC and lung transplant were mutually exclusive. Conclusion: Respondents felt PC is underutilized for CF, and that people with CF may miss out on the benefits of PC. Among stakeholders, respondents felt people with CF would benefit from access to primary and secondary PC services.

Models of Palliative Care Delivery for Individuals with Cystic Fibrosis: Cystic Fibrosis Foundation Evidence-Informed Consensus Guidelines.

Cystic fibrosis (CF) affects more than 70,000 individuals and their families worldwide. Although outcomes for individuals with CF continue to improve, it remains a life-limiting condition with no cure. Individuals with CF manage extensive symptom and treatment burdens and face complex medical decisions throughout the illness course. Although palliative care has been shown to reduce suffering by alleviating illness-related burdens for people with serious illness and their families, little is known regarding the components and structure of various delivery models of palliative care needed to improve outcomes for people affected by CF. The Cystic Fibrosis Foundation (CFF) assembled an expert panel of clinicians, researchers, individuals with CF, and family caregivers, to develop consensus recommendations for models of best practices for palliative care in CF. Eleven statements were developed based on a systematic literature review and expert opinion, and address primary palliative care, specialty palliative care, and screening for palliative needs. These recommendations are intended to comprehensively address palliative care needs and improve quality of life for individuals with CF at all stages of illness and development, and their caregivers.

Palliative care skills in CF: Perspectives of adults with CF, caregivers, and CF care team members.

BACKGROUND: The role of cystic fibrosis (CF) care team members in delivering palliative care (PC) remains undefined. We aimed to understand the PC skills of CF care teams. METHODS: CF care team members ("clinicians"), adults with CF ("patients"), and family caregivers ("caregivers") rated the ability of CF clinicians to provide aspects of PC using a five-point scale ("poor" to "excellent"). Median ratings were compared between groups. RESULTS: A total of 70 patients, 100 caregivers, and 350 clinicians participated. Clinicians consistently rated their PC skills higher than patients or caregivers rated them, particularly for advanced PC skills. While clinicians, patients, and caregivers rated clinicians as "very good" at basic pain assessment and "good" at discussing prognostic uncertainty, clinicians rated themselves more highly at providing most skills, including simultaneous PC and standard CF care (P < .0001), basic depression assessment (P < .001), and discussing transplant, advance directives, end of life, code status, and hospice (all P < .0001). Respondents affiliated with adult CF care teams rated clinicians more highly than respondents affiliated with pediatric CF care teams at discussing lung transplant (P < .001), end of life (P = .006), advance directives (P < .001), code status (P = .012), and hospice (P = .016). Most patients (69%) and caregivers (60%) felt CF clinicians should receive more PC training. CONCLUSIONS: Discrepancies exist among patient/caregiver and clinician perceptions of PC skills in CF, and skills of adult and pediatric teams may differ. Patients and caregivers feel clinicians' more advanced PC skills are lacking. CF clinicians may benefit from PC training to enhance skills and to understand how and when to utilize specialty PC services.

Palliative Care Needs of Individuals with Cystic Fibrosis: Perspectives of Multiple Stakeholders.

Background: Studies suggest palliative care may be different in cystic fibrosis (CF) than in other conditions. To provide quality palliative care to individuals with CF, unique needs must be understood. Objective: To examine perceptions of how palliative care may be different in CF, top palliative needs of individuals with CF, and barriers to palliative care in CF. Methods: Online surveys with closed- and open-ended questions about palliative care needs were administered to multiple stakeholders in CF care, including adults with CF, caregivers of individuals with CF, and CF care team members from U.S. centers. We used descriptive statistics to report survey findings. Results: A total of 70 adults with CF, 100 caregivers, and 350 care team members completed surveys. While care team members reported they introduce palliative care to patients a majority of the time, adults with CF and caregivers rarely recalled learning about it. Very few reported having seen a palliative care specialist. A majority of participants reported that palliative care is valuable in CF care. Over 80% of participants felt palliative care is different in CF, most often citing the unpredictable disease course. Top palliative care needs identified include emotional support, emotional symptom management, and communication about treatment decisions. Major barriers to palliative care identified include perception that it is for dying people and lack of CF care team knowledge and training in palliative care. Conclusions: Participants felt palliative care is valuable in CF and identified many palliative care needs, and also barriers that can be addressed with education and training. Our findings will be used to develop interventions targeting specific needs and inform guidelines to enhance provision of palliative care in CF.

Using qualitative methods to inform the design of a decision aid for people with advanced cystic fibrosis: The InformedChoices CF patient decision aid.

OBJECTIVE: To assess information needs of adults with Cystic Fibrosis and their families toward designing a patient decision aid about invasive mechanical ventilation (IMV) and lung transplant. METHODS: Focus groups and in-depth interviews explored participants' knowledge, prior clinical conversations, and decisions about IMV and lung transplant. Interviews and focus groups were recorded and transcribed for analysis. RESULTS: N = 24 participants were recruited. Themes identified were: prior communication with clinicians, decision-making process, and living with CF. Participants having prior conversations with CF clinicians regarding: lung transplant (N = 17/74%), and IMV (N = 3/13%). Most 15(65%) felt it was important to hear patients' real-life experience, others (3/13%) relied on their CF doctors for information. Most people (16/70%) believed hearing prognosis was helpful, but 5(22%) found this information frightening. High degrees of social isolation and a desire for more interaction with other CF adults were found. CONCLUSIONS: Qualitative methods helped identify areas important for decision making about IMV and LT for CF adults. Future directions include usability and feasibility testing of the decision aid. PRACTICE IMPLICATIONS: Because IMV is rarely discussed with CF adults, clinicians might approach this topic, as with transplant, as lung function begins to decline. CF-care teams should also foster CF patient-level information exchange.

Does Calculated Prognostic Estimation Lead to Different Outcomes Compared With Experience-Based Prognostication in the ICU? A Systematic Review.

Little is known about the impact of providing calculator/guideline based versus clinical experiential-based prognostic estimates to patients/caregivers in the ICU. We sought to determine whether studies have compared types of prognostic estimation in the ICU and associations with outcomes. DATA SOURCES: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, databases searched were PubMed, Embase, Web of Science, and Cochrane Library. The search was run on January 4, 2016, and April 12, 2017. References for included articles were searched. STUDY SELECTION: Studies meeting the following criteria were included in the analysis: communication of prognostic estimates, a comparator group, and in the adult ICU setting. DATA EXTRACTION: Titles/abstracts were reviewed by two researchers. We identified 10,704 articles of which 10 met inclusion criteria. Seven of the studies included estimates obtained from calculators/guidelines and three were based on subjective estimation wherein clinicians were asked to estimate prognosis based on experience. Only the seven using calculated/guideline based estimation were used for pooled analysis. Of these, one was a randomized trial, and six were nonrandomized before/after studies. All of the studies communicated the calculated/guideline-based estimates to the clinician. Two studies involved the communication of calculated prognostic estimates to the ICU physicians for all ICU patients. Four included identification of high-risk patients based on guidelines or review of historical local data which triggered a palliative care/ethics consultation, and one study included communication to physicians about guideline based likely outcomes for neurologic recovery for patients with out-of-hospital cardiac arrest survivors. The comparator arm in all studies was usual care without protocolized prognostication. DATA SYNTHESIS: Included studies were assessed for risk of bias. The most common outcomes measured were hospital mortality; do-not-resuscitate status; and medical ICU length of stay. In pooled analyses, there was an association between calculated/guideline based prognostic estimation and decreased medical ICU length of stay as well as increased do-not-resuscitate status, but no difference in hospital mortality. CONCLUSIONS: Protocolized assessment of calculator/guideline based prognosis in ICU patients is associated with decreased medical ICU length of stay and increased do-not-resuscitate status but does not have a significant effect on mortality. Future studies should explore how communicating these estimates to physicians changes behaviors including communication to patients/families and whether calculator/guideline based prognostication is associated with improved patient and family rated outcomes.

It takes two to tango: A dyadic approach to understanding the medication dialogue in patient-provider relationships.

OBJECTIVE: To describe typologies of dyadic communication exchanges between primary care providers and their hypertensive patients about prescribed antihypertensive medications. METHODS: Qualitative analysis of 94 audiotaped patient-provider encounters, using grounded theory methodology. RESULTS: Four types of dyadic exchanges were identified: Interactive (53% of interactions), divergent-traditional (24% of interactions), convergent-traditional (17% of interactions) and disconnected (6% of interactions). In the interactive and convergent-traditional types, providers adopted a patient-centered approach and used communication behaviors to engage patients in the relationship. Patients in these interactions adopted either an active role in the visit (interactive), or a passive role (convergent-traditional). The divergent-traditional type was characterized by provider verbal dominance, which inhibited patients' ability to ask questions, seek information, or check understanding of information. In the disconnected types, providers used mainly closed-ended questions and terse directives to gather and convey information, which was often disregarded by patients who instead diverted the conversation to psychosocial issues. CONCLUSIONS: This study identified interdependent patient-provider communication styles that can either facilitate or hinder discussions about prescribed medications. PRACTICE IMPLICATIONS: Examining the processes that underlie dyadic communication in patient-provider interactions is an essential first step to developing interventions that can improve the patient-provider relationship and patient health behaviors.

A Decision Aid to Support Shared Decision Making About Mechanical Ventilation in Severe Chronic Obstructive Pulmonary Disease Patients (InformedTogether): Feasibility Study.

BACKGROUND: Severe Chronic Obstructive Pulmonary Disease patients are often unprepared to make decisions about accepting intubation for respiratory failure. We developed a Web-based decision aid, InformedTogether, to facilitate severe Chronic Obstructive Pulmonary Disease patients' preparation for decision making about whether to accept invasive mechanical ventilation for respiratory failure. OBJECTIVE: We describe feasibility testing of the InformedTogether decision aid. METHODS: Mixed methods, pre- and postintervention feasibility study in outpatient pulmonary and geriatric clinics. Clinicians used InformedTogether with severe Chronic Obstructive Pulmonary Disease patients. Patient-participants completed pre- and postassessments about InformedTogether use. The outcomes measured were the following: feasibility/acceptability, communication (Combined Outcome Measure for Risk Communication [COMRADE], Medical Communication Competency Scale [MCCS], Observing Patient Involvement [OPTION] scales), and effectiveness of InformedTogether on changing patients' knowledge, Decisional Conflict Scale, and motivation. RESULTS: We enrolled 11 clinicians and 38 Chronic Obstructive Pulmonary Disease patients at six sites. Feasibility/acceptability: Clinicians and patients gave positive responses to acceptability questions (mean 74.1/89 max [SD 7.24] and mean 59.63/61 [SD 4.49], respectively). Communication: 96% of clinicians stated InformedTogether improved communication (modified MCCS mean 44.54/49 [SD 2.97]; mean OPTION score 32.03/48 [SD 9.27]; mean COMRADE Satisfaction 4.31/5.0 [SD 0.58]; and COMRADE Confidence 4.18/5.0 [SD 0.56]). Preference: Eighty percent of patients discussed preferences with their surrogates by 1-month. Effectiveness: Knowledge scores increased significantly after using InformedTogether (mean difference 3.61 [SD 3. 44], P=.001) and Decisional Conflict decreased (mean difference Decisional Conflict Scale pre/post -13.76 [SD 20.39], P=.006). Motivation increased after viewing the decision aid. CONCLUSIONS: InformedTogether supports high-quality communication and shared decision making among Chronic Obstructive Pulmonary Disease patients, clinicians, and surrogates. The increased knowledge and opportunity to deliberate and discuss treatment choices after using InformedTogether should lead to improved decision making at the time of critical illness.

Other Ways of Knowing.

BACKGROUND: Patients with advanced-stage chronic obstructive pulmonary disease (COPD) may suffer severe respiratory exacerbations and need to decide between accepting life-sustaining treatments versus foregoing these treatments (choosing comfort care only). We designed the InformedTogether decision aid to inform this decision and describe results of a pilot study to assess usability focusing on participants' trust in the content of the decision aid, acceptability, recommendations for improvement, and emotional reactions to this emotionally laden decision. METHODS: Study participants ( N = 26) comprising clinicians, patients, and surrogates viewed the decision aid, completed usability tasks, and participated in interviews and focus groups assessing comprehension, trust, perception of bias, and perceived acceptability of InformedTogether. Mixed methods were used to analyze results. RESULTS: Almost all participants understood the gist (general meaning) of InformedTogether. However, many lower literacy participants had difficulty answering the more detailed questions related to comprehension, especially when interpreting icon arrays, and many were not aware that they had misunderstood the information. Qualitative analysis showed a range of emotional reactions to the information. Participants with low verbatim comprehension frequently referenced lived experiences when answering knowledge questions, which we termed "alternative knowledge." CONCLUSIONS: We found a range of emotional reactions to the information and frequent use of alternative knowledge frameworks for deriving meaning from the data. These observations led to insights into the impact of lived experiences on the uptake of biomedical information presented in decision aids. Communicating prognostic information could potentially be improved by eliciting alternative knowledge as a starting point to build communication, in particular for low literacy patients. Decision aids designed to facilitate shared decision making should elicit this knowledge and help clinicians tailor information accordingly.