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BackgroundAmong individuals with hypertension and low diastolic blood pressure (DBP), the optimal BP target remains controversial due to concerns that BP lowering may reduce coronary perfusion. We determined the impact of intensive BP control among individuals with elevated systolic BP who have low DBP and elevated hs-cTnT (high-sensitivity cardiac troponin T) levels.Methods and resultsA total of 8828 participants in SPRINT (Systolic Blood Pressure Intervention Trial) were stratified by baseline DBP. Those with low DBP (

ImportanceReducing the duration of untreated psychosis (DUP) is essential to improving outcomes for people with first-episode psychosis (FEP). Current US approaches are insufficient to reduce DUP to international standards of less than 90 days.ObjectiveTo determine whether population-based electronic screening in addition to standard targeted clinician education increases early detection of psychosis and decreases DUP, compared with clinician education alone.Design, setting, and participantsThis cluster randomized clinical trial included individuals aged 12 to 30 years presenting for services between March 2015 and September 2017 at participating sites that included community mental health clinics and school support and special education services. Eligible participants were referred to the Early Diagnosis and Preventative Treatment (EDAPT) Clinic. Data analyses were performed in September and October 2019 for the primary and secondary analyses, with the exploratory subgroup analyses completed in May 2021.InterventionsAll sites in both groups received targeted education about early psychosis for health care professionals. In the active screening group, clients also completed the Prodromal Questionnaire-Brief using tablets at intake; referrals were based on those scores and clinical judgment. In the group receiving treatment as usual (TAU), referrals were based on clinical judgment alone.Main outcomes and measuresPrimary outcomes included DUP, defined as the period from full psychosis onset to the date of the EDAPT diagnostic telephone interview, and the number of individuals identified with FEP or a psychosis spectrum disorder. Exploratory analyses examined differences by site type, completion rates between conditions, and days from service entry to telephone interview.ResultsTwenty-four sites agreed to participate, and 12 sites were randomized to either the active screening or TAU group. However, only 10 community clinics and 4 school sites were able to fully implement population screening and were included in the final analysis. The total potentially eligible population size within each study group was similar, with 2432 individuals entering at active screening group sites and 2455 at TAU group sites. A total of 303 diagnostic telephone interviews were completed (178 [58.7%] female individuals; mean [SD] age, 17.09 years [4.57]). Active screening sites reported a significantly higher detection rate of psychosis spectrum disorders (136 cases [5.6%], relative to 65 [2.6%]; P

BackgroundThe COVID-19 pandemic spurred publication of a rapid proliferation of studies on potential therapeutic agents. While important for the advancement of clinical care, pressure to collect, analyze, and report data in an expedited manner could potentially increase the rate of important errors, some of which would be captured in published errata. We hypothesized that COVID-19 therapeutic studies published in the early years of the pandemic would be associated with a high rate of published errata and that, within these errata, there would be a high prevalence of serious errors.MethodsWe performed a review of published errata associated with empirical studies of COVID-19 treatments. Errata were identified via a MEDLINE and Embase search spanning January 2020 through September 2022. Errors located within each published erratum were characterized by location within publication, error type, and error seriousness.ResultsOf 47 studies on COVID-19 treatments with published errata, 18 met inclusion criteria. Median time from publication of the original article to publication of the associated erratum was 76 days (range, 12-511 days). A majority of errata addressed issues with author attribution or conflict of interest disclosures (39.5%) or numerical results (25.6%). Only one erratum contained a serious error: a typographical error which could have misled readers into believing that the treatment in question had serious adverse effects when in fact it did not.ConclusionsDespite accelerated publication times, we found among studies of COVID-19 treatments the majority of errata (17/18) reported minor errors that did not lead to misinterpretation of the study results. Retractions, an indicator of scientific misdirection even more concerning than errata, were beyond the scope of this review.

IntroductionDespite the pressing need for primary care-based suicide prevention initiatives and growing acknowledgement of recruitment difficulties and Institutional Review Board (IRB) challenges in suicide research, we are aware of no illustrative examples describing how IRB decisions in the design of a primary care trial can compound recruitment challenges.MethodsThe CDC-funded trial (NCT02986113) of Men and Providers Preventing Suicide aimed to examine the effects of a tailored computer program encourage men with suicidal thoughts (n = 304, ages 35-64) to discuss suicide with a primary care clinician and accept treatment. Before a visit, participants viewed MAPS or a non-tailored control video. Post-visit, both arms were offered telephone collaborative care, as mandated by the institutional review board (IRB). We previously showed that exposure to MAPs led to improvements in communication about suicide in a primary care visit. In this paper, we report data on the study's primary outcome, suicide preparatory behaviors.ResultsAfter screening nearly 4100 men, 48 enrolled. Recruitment challenges, which were exacerabted by an IRB mandate narrowing post-intervention patient management differences between trial arms, limited detection of the effects of MAPS on suicide preparatory behaviors.ConclusionsWhile primary care settings are key sites for suicide prevention trials, issues such as recruitment difficulties and overly restrictive IRB requirements may limit their utility. Methodological innovation to improve recruitment and ethical guidance to inform IRB decision-making are needed.

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as type 1, there also are new and evolving uses of N-of-1 trials that we designate as type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of type 1, a type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare disease, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multistakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.

The mainstay of evidence development in medicine is the parallel-group randomized controlled trial (RCT), which generates estimates of treatment efficacy or effectiveness for the average person in the trial. In contrast, personalized trials (sometimes referred to as 'single-person trials' or 'N-of-1 trials') assess the comparative effectiveness of two or more treatments in a single individual. These single-subject, randomized crossover trials have been used in a scattershot fashion in medicine for over 40 years but have not been widely adopted. An important barrier is the paucity of strong evidence that personalized trials improve outcomes. However, the principal impediment may have less to do with proof of efficacy than with practical aspects of design and implementation. These include decisions about treatment regimen flexibility, blinding, and washout periods as well as organizational, clinician, and patient-level challenges. After reviewing the essential elements of personalized trials, this article addresses these speed bumps and fundamentally asks, 'Why have personalized trials not been more widely adopted, and how can they be made more readily deployable and useful?' The article concludes by suggesting ways in which emerging technologies and approaches promise to overcome existing barriers and open promising vistas for the next generation of personalized-trial researchers and practitioners.

BackgroundMultiple myeloma (MM) is an incurable cancer with complex treatment options. Trusting patient-clinician relationships are essential to promote effective shared decision-making that aligns best clinical practices with patient values and preferences. This study sought to shed light on the development of trust between MM patients and clinicians.MethodsNineteen individual semi-structured interviews were conducted with MM patients within 2 years of initial diagnosis or relapse for this qualitative study. Interviews were recorded and transcripts were coded thematically.ResultsWe identified three main themes: (1) externally validated trust describes patients' predisposition to trust or distrust clinicians based on factors outside of patient-clinician interactions; (2) internally validated trust describes how patients develop trust based on interactions with specific clinicians. Internally validated trust is driven primarily by clinician communication practices that demonstrate competence, responsiveness, listening, honesty, and empathy; and (3) trust in relation to shared decision-making describes how patients relate the feeling of trust, or lack thereof, to the process of shared decision-making.ConclusionMany factors contribute to the development of trust between MM patients and clinicians. While some are outside of clinicians' control, others derive from clinician behaviors and interpersonal communication skills. These findings suggest the possibility that trust can be enhanced through communication training or shared decision-making tools that emphasize relational communication. Given the important role trust plays in shared decision-making, clinicians working with MM patients should prioritize establishing positive, trusting relationships.

BackgroundNarrative communication is often more persuasive for promoting health behaviour change than communication using facts and figures; the extent to which narrative persuasiveness is due to patients' identification with the storyteller vs engagement with the story is unclear.ObjectiveTo examine the relative impacts of patient engagement, age concordance and gender concordance on perceived persuasiveness of video-recorded narrative clips about opioid tapering.MethodsPatient raters watched and rated 48 brief video-recorded clips featuring 1 of 7 different storytellers describing their experiences with opioid tapering. The dependent variable was clips' perceived persuasiveness for encouraging patients to consider opioid tapering. Independent variables were rater engagement with the clip, rater-storyteller gender concordance and rater-storyteller age concordance (

ObjectiveTo compare effectiveness of a narrative-based educational video versus an informational pamphlet for increasing patients' self-efficacy and intention to taper their opioid use.MethodsFive thousand participants recruited from MTurk were screened to identify eligible patients. Eligible participants (n = 365, 49.9 % female, mean age = 37 years) were randomized to either watch the narrative video or read the pamphlet. Linear regression models were used for the main analysis.ResultsParticipants' perceptions of tapering effectiveness were higher in the video group (mean = 4.06) than the pamphlet group (mean = 3.67), adjusted mean difference = 0.34, 95 %CI 0.13 - 0.54,P < 0.001. Participants' perceptions of tapering self-efficacy were also higher in the video group (mean = 3.97) than the pamphlet group (mean = 3.60), adjusted mean difference = 0.32, 95 %CI 0.09 - 0.55, P < 0.001. Perceived tapering effectiveness and self-efficacy were both positively associated with post-intervention tapering intention (Spearman rank correlation coefficient = 0.38 and 0.53, respectively, both P < 0.001).ConclusionA narrative-based video about opioid tapering enhanced patients' perceptions of the effectiveness of tapering and their tapering self-efficacy.Practice implicationsNarrative-based videos may be effective for changing patient attitudes about opioid tapering.

BackgroundAgenda setting is associated with more efficient care and better patient experience. This study develops a taxonomy of visit opening styles to assess use of agenda and non-agenda setting visit openings and their effects on participant experience.MethodsThis observational study analyzed 83 video recorded US primary care visits at a single academic medical center in California involving family medicine and internal medicine resident physicians (n = 49) and patients (n = 83) with chronic pain on opioids. Using conversation analysis, we developed a coding scheme that assessed the presence of agenda setting, distinct visit opening styles, and the number of total topics, major topics, surprise patient topics, and returns to prior topics discussed. Exploratory quantitative analyses were conducted to assess the relationship of agenda setting and visit opening styles with post-visit measures of both patient experience and physician perception of visit difficulty.ResultsWe identified 2 visit opening styles representing agenda setting (agenda eliciting, agenda reframing) and 3 non-agenda setting opening styles (open-ended question, patient launch, physician launch). Agenda setting was only performed in 11% of visits and was associated with fewer surprise patient topics than visits without agenda setting (mean (SD) 2.67 (1.66) versus 4.28 (3.23), p = 0.03).ConclusionsIn this study of patients with chronic pain, resident physicians rarely performed agenda setting, whether defined in terms of "agenda eliciting" or "agenda re-framing." Agenda setting was associated with fewer surprise topics. Understanding the communication context and outcomes of agenda setting may inform better use of this communication tool in primary care  practice.

Patient-clinician interactions are central to technical and interpersonal processes of medical care. Video recordings of these interactions provide a rich source of data and a stable record that allows for repeated viewing and analysis. Collecting video recordings requires navigating ethical and feasibility constraints; further, realizing the potential of video requires specialized research skills. Interdisciplinary collabo-rations involving practitioners, medical educators, and social scientists are needed to provide the clinical perspectives, methodological expertise, and capacity needed to make collecting video worthwhile. Such collaboration ensures that research questions will be based on scholarship from the social sciences, resonate with practice, and produce results that fit educational needs. However, the literature lacks suggested practices for building and sustaining interdisciplinary research collaborations involving video data. In this paper, we provide concrete advice based on our experience collecting and analyzing a single set of video-recorded clinical encounters and non-video data, which have so far yielded nine distinct studies. We present the research process, timeline, and advice based on our experience with interdisciplinary collaboration. We found that integrating disciplines and traditions required patience, compromise, and mutual respect; learning from each other enhanced our enjoyment of the process, our productivity, and the clinical relevance of our research.

PurposeMiddle-aged men are at high risk of suicide. While about half of those who kill themselves visit a primary care clinician (PCC) shortly before death, in current practice, few spontaneously disclose their thoughts of suicide during the visits, and PCCs seldom inquire about such thoughts. In a randomized controlled trial, we examined the effect of a tailored interactive computer program designed to encourage middle-aged men's discussion of suicide with PCCs.MethodsWe recruited men 35-74 years old reporting recent (within 4 weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system. In the office before a visit, men viewed the intervention corresponding to their PCC's random group assignment: Men and Providers Preventing Suicide (MAPS) (20 PCCs), providing tailored multimedia promoting discussion of suicide thoughts, or control (22 PCCs), composed of a sleep hygiene video plus brief non-tailored text encouraging discussion of suicide thoughts. Logistic regressions, adjusting for patient nesting within physicians, examined MAPS' effect on patient-reported suicide discussion in the subsequent office visit.ResultsSixteen of the randomized PCCs had no patients enroll in the trial. From the panels of the remaining 26 PCCs (12 MAPS, 14 control), 48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9 years (SD 11.4). Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]). Logistic regression showed men viewing MAPS were more likely than controls to discuss suicide with their PCC (OR 5.91, 95% CI 1.59-21.94; P = 0.008; nesting-adjusted predicted effect 71% vs. 30%).ConclusionsIn addressing barriers to discussing suicide, the tailored MAPS program activated middle-aged men with active suicide thoughts to engage with PCCs around this customarily taboo topic.

BackgroundPhysicians' fear of difficult patient interactions is an important barrier to discontinuing long-term opioid therapy.ObjectiveTo identify patient statements about opioids that indicate potential openness to tapering opioids or trying non-opioid pain treatments DESIGN: This is an observational study of regularly scheduled primary care visits involving discussion of chronic pain management. A coding system to characterize patient assessments about opioids, physician responses to assessments, and patient-endorsed opioid side effects was developed and applied to transcripts of video-recorded visits. All visits were independently coded by 2 authors.ParticipantsEighty-six established adult patients taking opioids for chronic pain; 49 physicians in 2 academic primary care clinics MAIN MEASURES: Frequency and topic of patients' opioid assessments; proportion of opioid assessments classified as clues (assessments indicating potential willingness to consider non-opioid pain treatments or lower opioid doses); physician responses to patient clues; frequency and type of patient-endorsed side effects KEY RESULTS: Patients made a mean of 3.2 opioid assessments (median 2) per visit. The most common assessment topics were pain relief (51%), effect on function (21%), and opioid safety (14%). Forty-seven percent of opioid assessments (mean 1.5 per visit) were classified as clues. Fifty-three percent of visits included ≥ 1 clue; 21% of visits contained ≥ 3 clues. Physicians responded to patient clues with no/minimal response 43% of the time, sympathetic/empathetic statements 14% of the time, and further explored clues 43% of the time. Fifty-eight percent of patients endorsed ≥ 1 opioid-related side effect; 10% endorsed ≥ 3 side effects. The most commonly endorsed side effects were constipation (15% of patients), sedation (15%), withdrawal symptoms (13%), and nausea (12%).ConclusionsPatient statements suggesting openness to non-opioid pain treatments or lower opioid doses are common during routine primary care visits. Listening for and exploring these clues may be a patient-centered strategy for broaching difficult topics with patients on long-term opioid therapy.

ObjectivesOpioids and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for chronic musculoskeletal pain, despite limited evidence of effectiveness and well-documented adverse effects. We assessed the effects of participating in a structured, personalized self-experiment ("N-of-1 trial") on analgesic prescribing in patients with chronic musculoskeletal pain.MethodsWe randomized 215 patients with chronic pain to participate in an N-of-1 trial facilitated by a mobile health app or to receive usual care. Medical records of participating patients were reviewed at enrollment and 6 months later to assess analgesic prescribing. We established thresholds of ≥ 50, ≥ 20, and > 0 morphine milligram equivalents (MMEs) per day to capture patients taking relatively high doses only, patients taking low-moderate as well as relatively high doses, and patients taking any dose of opioids, respectively.ResultsThere was no significant difference between the N-of-1 and control groups in the percentage of patients prescribed any opioids (relative odds ratio (ROR) = 1.05; 95% confidence interval [CI] = 0.61 to 1.80, p = 0.87). There was a clinically substantial but statistically not significant reduction of the percentage of patients receiving ≥ 20 MME (ROR = 0.58; 95% CI = 0.33 to 1.04, p = 0.07) and also in the percentage receiving ≥ 50 MME (ROR = 0.50; 95% CI = 0.19 to 1.34, p = 0.17). There was a significant reduction in the proportion of patients in the N-of-1 group prescribed NSAIDs compared with control (relative odds ratio = 0.53; 95% CI = 0.29 to 0.96, p = 0.04), with no concomitant increase in average pain intensity. There was no significant change in use of adjunctive medications (acetaminophen, gabapentenoids, or topicals).DiscussionThese exploratory results suggest that participation in N-of-1 trials may reduce long-term use of NSAIDs; there is also a weak signal for an effect on use of opioids. Additional research is needed to confirm these results and elucidate possible mechanisms.Trial registrationClinicalTrials.gov Identifier: NCT02116621.

Although group-level evidence supports the use of behavioral interventions to enhance cognitive and emotional well-being, different interventions may be more acceptable or effective for different people. N-of-1 trials are single-patient crossover trials designed to estimate treatment effectiveness in a single patient. We designed a mobile health (mHealth) supported N-of-1 trial platform permitting US adult volunteers to conduct their own 30-day self-experiments testing a behavioral intervention of their choice (deep breathing/meditation, gratitude journaling, physical activity, or helpful acts) on daily measurements of stress, focus, and happiness. We assessed uptake of the study, perceived usability of the N-of-1 trial system, and influence of results (both reported and perceived) on enthusiasm for the chosen intervention (defined as perceived helpfulness of the chosen intervention and intent to continue performing the intervention in the future). Following a social media and public radio campaign, 447 adults enrolled in the study and 259 completed the post-study survey. Most were highly educated. Perceived system usability was high (mean scale score 4.35/5.0, SD 0.57). Enthusiasm for the chosen intervention was greater among those with higher pre-study expectations that the activity would be beneficial for them (p < 0.001), those who obtained more positive N-of-1 results (as directly reported to participants) (p < 0.001), and those who interpreted their N-of-1 study results more positively (p < 0.001). However, reported results did not significantly influence enthusiasm after controlling for participants' interpretations. The interaction between pre-study expectation of benefit and N-of-1 results interpretation was significant (p < 0.001), such that those with the lowest starting pre-study expectations reported greater intervention enthusiasm when provided with results they interpreted as positive. We conclude that N-of-1 behavioral trials can be appealing to a broad albeit highly educated and mostly female audience, that usability was acceptable, and that N-of-1 behavioral trials may have the greatest utility among those most skeptical of the intervention to begin with.

Background: Care teams are increasingly expected to attend to the needs of patient's personal caregivers (e.g., family members). Improving communication among oncologists, patients with advanced cancer, and their personal caregivers might enhance caregivers' experiences of end-of-life (EoL) cancer care and bereavement outcomes. Objective: To explore the effects of the Values and Options in Cancer Care intervention on caregivers' experiences of EoL care and bereavement outcomes. Design: We developed a brief behavioral intervention to improve communication among oncologists, patients with advanced cancer, and their personal caregivers. The intervention was designed to help patients/caregivers ask questions, express concerns, and help oncologists respond effectively. We randomly assigned oncologists (and their patients/caregivers) to the intervention or usual care. Setting/Subjects: Medical oncologists in NY and CA; patients/personal caregivers with advanced cancer. Measurements: Two months after the patient's death, caregivers completed three instruments assessing their experiences of EoL care. Seven months after the patient's death, caregivers completed the Prolonged Grief Disorder-13 (PG-13; primary prespecified outcome), the Purpose-in-Life scale, and scales assessing mental health function, depression, and anxiety. Results: The intervention did not significantly improve caregivers' scores on the PG-13 (p = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores (p = 0.018). Cohen's d (95% confidence interval) for all three experiences of EoL care outcomes were promising, ranging from 0.22 (-0.19 to 0.63) to 0.39 (-0.07 to 0.86) although none was statistically significant. Conclusion: Preliminary findings show promise that scalable interventions in cancer care settings may improve caregiver experiences with cancer care and some bereavement outcomes.

ContextAlthough patient and physician characteristics are thought to be predictive of discretionary interventions at the end of life (EoL), few studies have data on both parties.ObjectiveTo test the hypothesis that patient preferences and physician attitudes are both independently associated with discretionary interventions at the EoL.MethodsWe report secondary analyses of data collected prospectively from physicians (n = 38) and patients with advanced cancer (n = 265) in the Values and Options in Cancer Care study. Predictor variables were patient attitudes toward EoL care and physician-reported comfort with medical paternalism, assessed indirectly using a modified version of the Control Preference Scale. We explored whether the magnitude of the physician variable was influenced by the inclusion of particular patient treatment-preference variables (i.e., effect modification). Outcomes were a chemotherapy use score (≤14 days before death [scored 2], 15-31 days before death [scored 1], and >31 days [scored 0]) and an emergency department visit/inpatient admission score (two or more admissions in the last 31 days [scored 2], one admission [1], and 0 admissions [0]) in the last month of life.ResultsChemotherapy scores were nearly 0.25 points higher if patients expressed a preference for experimental treatments with unknown benefit at study entry (0.238 points, 95% CI = 0.047-0.429) or reported an unfavorable attitude toward palliative care (0.247 points, 95% CI = 0.047-0.450). A two-standard deviation difference in physician comfort with medical paternalism corresponded to standardized effects of 0.35 (95% CI = 0.03-0.66) for chemotherapy and 0.33 (95% CI = 0.04-0.61) for emergency department visits/inpatient admissions. There was no evidence of effect modification.ConclusionPatient treatment preferences and physician attitudes are independently associated with higher levels of treatment intensity before death. Greater research, clinical, and policy attention to patient treatment preferences and physician comfort with medical paternalism might lead to improvements in care of patients with advanced disease.

BackgroundInappropriate antibiotic use is implicated in antibiotic resistance and resultant morbidity and mortality. Overuse is particularly prevalent for outpatient respiratory infections, and perceived patient expectations likely contribute. Thus, various educational programs have been implemented to educate the public.MethodsWe systematically identified public-directed interventions to promote antibiotic awareness in the United States. PubMed, Google Scholar, Embase, CINAHL, and Scopus were queried for articles published from January 1996 through January 2016. Two investigators independently assessed titles and abstracts of retrieved articles for subsequent full-text review. References of selected articles and three review articles were likewise screened for inclusion. Identified educational interventions were coded for target audience, content, distribution site, communication method, and major outcomes.ResultsOur search yielded 1,106 articles; 34 met inclusion criteria. Due to overlap in interventions studied, 29 distinct educational interventions were identified. Messages were primarily delivered in outpatient clinics (N = 24, 83%) and community sites (N = 12, 41%). The majority included clinician education. Antibiotic prescription rates were assessed for 22 interventions (76%). Patient knowledge, attitudes, and beliefs (KAB) were assessed for 10 interventions (34%). Similar rates of success between antibiotic prescription rates and patient KAB were reported (73 and 70%, respectively). Patient interventions that did not include clinician education were successful to increase KAB but were not shown to decrease antibiotic prescribing. Three interventions targeted reductions in Streptococcus pneumoniae resistance; none were successful.ConclusionsMessaging programs varied in their designs, and many were multifaceted in their approach. These interventions can change patient perspectives regarding antibiotic use, though it is unclear if clinician education is also necessary to reduce antibiotic prescribing. Further investigations are needed to determine the relative influence of interventions focusing on patients and physicians and to determine whether these changes can influence rates of antibiotic resistance long-term.

BackgroundPatient requests for tests, treatments, or referrals occur frequently during primary care visits and pose challenges for clinicians to address, but little is known about patient characteristics that may predict requests.ObjectiveTo identify patient characteristics associated with a higher rate of patient requests during primary care visits.Design, setting, and sampleCross-sectional analyses of data from 1141 adult patients attending 1319 visits with 56 primary care physicians (including 45 resident and 11 faculty physicians) in an academic family medicine practice.MeasurementsPostvisit patient surveys including measures of patient requests for tests, prescriptions, and referrals; sociodemographics; mental and physical health status; symptom bother or worry (3-item scale; range, 3 to 15; Cronbach's α = 0.83); global life satisfaction; medical skepticism; and Five Factor Model personality traits.ResultsPatients made 1 or more requests in 867 visits (65.7%). In multivariate analyses of the within-visit request count, the following patient variables were statistically significantly associated with a higher rate of requests: age in years (incidence rate ratio [IRR], 1.01 [95% CI, 1.00 to 1.01]), increased symptom bother or worry (IRR, 1.06 [95% CI, 1.03 to 1.08]), a more extroverted personality (IRR, 1.12 [95% CI, 1.03 to 1.08]), greater life satisfaction (IRR, 1.01 [95% CI, 1.00 to 1.02]), and any prior encounter with the visit physician (IRR, 1.17 [95% CI, 1.04 to 1.32]).ConclusionsPrimary care physicians should expect a greater frequency of requests from older patients, patients with greater symptoms bother or worry, more extroverted patients, patients with greater global life satisfaction, and patients with whom they have had prior visits.

Clinical guidelines discourage prescribing opioids for chronic pain, but give minimal advice about how to discuss opioid tapering with patients. We conducted focus groups and interviews involving 21 adults with chronic back or neck pain in different stages of opioid tapering. Transcripts were qualitatively analyzed to characterize patients' tapering experiences, build a conceptual model of these experiences, and identify strategies for promoting productive discussions of opioid tapering. Analyses revealed 3 major themes. First, owing to dynamic changes in patients' social relationships, emotional state, and health status, patients' pain and their perceived need for opioids fluctuate daily; this finding may conflict with recommendations to taper by a certain amount each month. Second, tapering requires substantial patient effort across multiple domains of patients' everyday lives; patients discuss this effort superficially, if at all, with clinicians. Third, patients use a variety of strategies to manage the tapering process (eg, keeping an opioid stash, timing opioid consumption based on planned activities). Recommendations for promoting productive tapering discussions include understanding the social and emotional dynamics likely to impact patients' tapering, addressing patient fears, focusing on patients' best interests, providing anticipatory guidance about tapering, and developing an individualized tapering plan that can be adjusted based on patient response. Perspective: This study used interview and focus group data to characterize patients' experiences with opioid tapering and identify communication strategies that are likely to foster productive, patient-centered discussions of opioid tapering. Findings will inform further research on tapering and help primary care clinicians to address this important, often challenging topic.

ContextLittle is known about the hopes patients with advanced (incurable) cancer have for their treatment.ObjectivesThe objective of this study was to describe the treatment hopes of advanced cancer patients, factors associated with expressing specific hopes, and the persons with whom hopes are discussed.MethodsWe surveyed 265 advanced cancer patients in the U.S. about their hopes for treatment at the baseline and after three months. We developed a taxonomy of hopes for treatment, which two investigators used to independently code patient responses. We explored associations between hopes for cure and patient covariates.ResultsWe developed eight categories of hopes. We were able to apply these codes reliably, and 95% of the patient's responses fit at least one hope category. The hope categories in order of descending baseline prevalence were as follows: quality of life, life extension, tumor stabilization, remission, milestone, unqualified cure, control not otherwise specified, and cure tempered by realism. Most patients reported discussing hopes with partners, family/friends, and oncologists; a minority reported discussing hopes with nurses, primary care physicians, clergy, or support groups. In logistic regression analysis, unqualified hopes for cure were more likely in younger patients and in those who did not endorse discussing their hopes with primary care physicians.ConclusionAdvanced cancer patients harbor a range of treatment hopes. These hopes often are not discussed with key members of the health care team. Younger age and lack of discussion of hopes with primary care physicians may lead to less realistic hopes for cure.

ImportanceIndividually designed single-patient multi-crossover (n-of-1) trials can facilitate tailoring of treatments directed at various conditions, including chronic musculoskeletal pain (CMSP) but are potentially burdensome, which may limit uptake in research and practice.ObjectivesTo determine whether patients randomized to participate in an n-of-1 trial supported by a mobile health (mHealth) app would experience less pain and improved global health, adherence, satisfaction, and shared decision making compared with patients assigned to usual care.Design, setting, and participantsThis randomized clinical trial compared participation in an individualized, mHealth-supported n-of-1 trial vs usual care. The participating 215 patients had CMSP for at least 6 weeks, had a smartphone or tablet with a data plan, were enrolled in northern California from July 2014 through July 2016, and were followed for up to 1 year by 48 clinicians in academic, community, Veterans Affairs, and military settings.InterventionsIntervention patients met with their clinicians and used a desktop interface to select treatments and trial parameters for an n-of-1 trial comparing 2 pain-management regimens. The mHealth app provided reminders to take designated treatments on assigned days and to upload responses to daily questions on pain and treatment-associated adverse effects. Control patients received care as usual.Main outcomes and measuresThe primary outcome was change in the PROMIS (Patient-Reported Outcomes Measurement Information System) pain-related interference 8-item short-form scale (full scale range, 41-78) from baseline to 6 months. Secondary outcomes included patient-reported pain intensity, overall health, analgesic adherence, trust in clinician, satisfaction with care, medication-related shared decision making, and, for the n-of-1 group only, participant engagement and experience.ResultsAmong 215 patients (108 randomized to the n-of-1 intervention and 107 to control), 102 (47%) were women, and the mean (SD) age was 55.5 (11.1) years. At the 6-month follow-up, pain interference was reduced in both groups, though there was no difference between the intervention and control groups (-1.36 points; 95% CI, -2.91 to 0.19 points; P = .09). There were no advantages in secondary outcomes for intervention patients vs control patients except for higher medication-related shared decision making at 6 months (between-group difference, 11.9 points; 95% CI, 2.6-21.2 points; P = .01). Among patients assigned to the n-of-1 group, 88% (n = 86) affirmed that the mHealth app could help people like them manage their pain.Conclusions and relevanceIn this population of patients with CMSP, mHealth-supported n-of-1 trials were feasible and associated with a satisfactory user experience, but n-of-1 trial participation did not significantly improve pain interference at 6 months vs usual care.Trial registrationClinicalTrials.gov identifier: NCT02116621.

The expansion of Medicaid under the Affordable Care Act has strained the capacity of many academic health centers (AHCs) to deliver primary and specialty care to this traditionally underserved population. The authors, longtime faculty members in the University of California, Davis Health (UCDH) system, discuss the challenges of UCDH's participation in Medi-Cal, the nation's largest Medicaid program, and their institution's controversial decision in 2015 to withdraw from its last Medi-Cal primary care contract, which has had untoward effects on UCDH's social and educational missions. The authors call on AHCs to leverage their considerable intellectual and human capital as well as their focus on education and research to aggressively pursue innovative models of high-value primary care for underserved populations in their local communities, highlighting several recent successful examples of such programs. The UCDH experience has implications for other AHCs grappling with the financial realities of an increasingly competitive, value-based health care marketplace and the inherent difficulty in balancing educational, research, patient care, and social or community service missions.

ObjectiveTo identify predictors of participation of patients with advanced cancer in clinical encounters with oncologists and to assess the impact of patient and caregiver participation on perceptions of physician support.MethodsThis is a secondary data analysis from the Values and Options in Cancer Care study, a cluster randomized clinical trial of a patient-centered communication intervention. Patients and caregivers completed pre-visit and post-visit health and communication measures. Audio recorded patient-caregiver (when present)-physician encounters were coded for active patient/caregiver participation behaviors (eg, question asking, expressing concern) and for physicians' facilitative communication (eg, partnership-building, support). Mixed linear regression models were used to identify patient, physician, and situational factors predicting patient and patient plus caregiver communication behaviors and post-visit outcomes.ResultsPhysician partnership building predicted greater expressions of concern and more assertive responses from patients and patient-caregiver pairs. Patients' perceptions of greater connectedness with their physician predicted fewer patient expressions of concern. Patient perceptions of physician respect for their autonomy were lower among patients accompanied by caregivers. Caregiver perceptions of physician respect for patient autonomy decreased with increasing patient age and varied by site.ConclusionsIn advanced cancer care, patient and caregiver communication is affected by ecological factors within their consultations. Physicians can support greater patient participation in clinical encounters through facilitative communication such as partnership-building and supportive talk. The presence of a caregiver complicates this environment, but partnership building techniques may help promote patient and caregiver participation during these visits.

OBJECTIVE:Individual patients with the same condition may respond differently to similar treatments. Our aim is to summarise the reporting of person-level heterogeneity of treatment effects (HTE) in multiperson N-of-1 studies and to examine the evidence for person-level HTE through reanalysis. STUDY DESIGN:Systematic review and reanalysis of multiperson N-of-1 studies. DATA SOURCES:Medline, Cochrane Controlled Trials, EMBASE, Web of Science and review of references through August 2017 for N-of-1 studies published in English. STUDY SELECTION:N-of-1 studies of pharmacological interventions with at least two subjects. DATA SYNTHESIS:Citation screening and data extractions were performed in duplicate. We performed statistical reanalysis testing for person-level HTE on all studies presenting person-level data. RESULTS:We identified 62 multiperson N-of-1 studies with at least two subjects. Statistical tests examining HTE were described in only 13 (21%), of which only two (3%) tested person-level HTE. Only 25 studies (40%) provided person-level data sufficient to reanalyse person-level HTE. Reanalysis using a fixed effect linear model identified statistically significant person-level HTE in 8 of the 13 studies (62%) reporting person-level treatment effects and in 8 of the 14 studies (57%) reporting person-level outcomes. CONCLUSIONS:Our analysis suggests that person-level HTE is common and often substantial. Reviewed studies had incomplete information on person-level treatment effects and their variation. Improved assessment and reporting of person-level treatment effects in multiperson N-of-1 studies are needed.

Patients and physicians report that communication about chronic pain and opioids is often challenging, but there is little empirical research on whether patient-physician communication about pain affects patient and physician visit experience. This study video recorded 86 primary care visits involving 49 physicians and 86 patients taking long-term opioids for chronic musculoskeletal pain, systematically coded all pain-related utterances during these visits using a custom-designed coding system, and administered previsit and postvisit questionnaires. Multiple regression was used to identify communication behaviors and patient characteristics associated with patients' ratings of their visit experience, physicians' ratings of visit difficulty, or both. After adjusting for covariates, 2 communication variables-patient-physician disagreement and patient requests for opioid dose increases-were each significantly associated with both worse ratings of patient experience and greater physician-reported visit difficulty. Patient desire for increased pain medicine was also significantly positively associated with both worse ratings of patient experience and greater physician-reported visit difficulty. Greater pain severity and more patient questions were each significantly associated with greater physician-reported visit difficulty, but not with patient experience. The association between patient requests for opioids and patient experience ratings was wholly driven by 2 visits involving intense conflict with patients demanding opioids. Patient-physician communication during visits is associated with patient and physician ratings of visit experience. Training programs focused on imparting communication skills that assist physicians in negotiating disagreements about pain management, including responding to patient requests for more opioids, likely have potential to improve visit experience ratings for both patients and physicians.

Purpose Some research has suggested that discussion of prognosis can disrupt the patient-physician relationship. This study assessed whether physician discussion of prognosis is associated with detrimental changes in measures of the strength of the patient-physician relationship. Methods This was a longitudinal cohort study of 265 adult patients with advanced cancer who visited 38 oncologists within community- and hospital-based cancer clinics in Western New York and Northern California. Prognostic discussion was assessed by coding transcribed audio-recorded visits using the Prognostic and Treatment Choices (PTCC) scale and by patient survey at 3 months after the clinic visit. Changes in the strength of the patient-physician relationship were computed as differences in patient responses to The Human Connection and the Perceived Efficacy in Patient-Physician Interactions scales from baseline to 2 to 7 days and 3 months after the clinic visit. Results Prognostic discussion was not associated with a temporal decline in either measure. Indeed, a one-unit increase in PTCC during the audio-recorded visit was associated with improvement in The Human Connection scale at 2 to 7 days after the visit (parameter estimate, 0.10; 95% CI, -0.02 to 0.23) and 3 months after the visit (parameter estimate, 0.18; 95% CI, 0.02 to 0.35) relative to baseline. Standardized effect sizes (SES) associated with an increase of two standard deviations in the PTCC at each time point were consistent with small beneficial effects (SES, 0.14 [95% CI, -0.02 to 0.29] at 2 to 7 days; SES, 0.24 [95% CI, 0.02 to 0.45] at 3 months), and lower bounds of CIs indicated that substantial detrimental effects of prognostic discussion were unlikely. Conclusion Prognostic discussion is not intrinsically harmful to the patient-physician relationship and may even strengthen the therapeutic alliance between patients and oncologists.

BackgroundPatient experience measures are widely used to compare performance at the individual physician level.ObjectiveTo assess the impact of unmeasured patient characteristics on visit-level patient experience measures and the sample sizes required to reliably measure patient experience at the primary care physician (PCP) level.DesignRepeated cross-sectional design.SettingAcademic family medicine practice in California.ParticipantsOne thousand one hundred forty-one adult patients attending 1319 visits with 56 PCPs (including 45 resident and 11 faculty physicians).MeasurementsPost-visit patient experience surveys including patient measures used for standard adjustment as recommend by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Consortium and additional patient characteristics used for expanded adjustment (including attitudes toward healthcare, global life satisfaction, patient personality, current symptom bother, and marital status).ResultsThe amount of variance in patient experience explained doubled with expanded adjustment for patient characteristics compared with standard adjustment (R2 = 20.0% vs. 9.6%, respectively). With expanded adjustment, the amount of variance attributable to the PCP dropped from 6.1% to 3.4% and the required sample size to achieve a reliability of 0.90 in the physician-level patient experience measure increased from 138 to 255 patients per physician. After ranking of the 56 PCPs by average patient experience, 8 were reclassified into or out of the top or bottom quartiles of average experience with expanded as compared to standard adjustment [14.3% (95% CI: 7.0-25.2%)].ConclusionsWidely used methods for measuring PCP-level patient experience may not account sufficiently for influential patient characteristics. If methods were adapted to account for these characteristics, patient sample sizes for reliable between-physician comparisons may be too large for most practices to obtain.

BackgroundFamily members often play important roles in the lives of depressed older men and frequently attend primary care visits with their loved ones, yet surprisingly little is known about how to most effectively engage and include family members in depression treatment. However, including family in depression treatment may be difficult due to several factors, such as depression stigma and family conflicts. The objective of this study was to describe challenges in engaging family members in older men's depression treatment and potential strategies to overcome those challenges.MethodsA cross-sectional, qualitative descriptive interview study was conducted in a safety-net, Federally Qualified Health Center in California's Central Valley. A total of 37 stakeholders were recruited, including 15 depressed older (i.e. age ≥ 60) men, 12 family members, and 10 clinic staff. Depressed men were identified through mail outreach, waiting room screening, and referral. Depressed men identified family members who were later approached to participate. We also recruited a purposeful sample of clinic staff. Interviews explored stakeholder perspectives on family involvement in men's depression treatment as part of a primary care intervention. Interviews were conducted using a semi-structured interview guide, tape-recorded, transcribed verbatim, and translated if the interview was conducted in Spanish.ResultsFour themes were identified representing core challenges: engaging men at the right time; preserving men's sense of autonomy; managing privacy concerns; and navigating family tensions. Stakeholders also provided practical suggestions and advice about how each of these challenges might be addressed.ConclusionsWhile engaging family is a promising approach to strengthen depression care for older men in primary care settings, several potential challenges exist. Family- centered depression intervention development and clinical practice need to anticipate these challenges and to develop approaches and guidelines to address them.

ObjectiveAssess patient-physician agreement on management goals for chronic musculoskeletal pain and its associations with patient and physician visit experiences.Materials and methodsPre-visit and post-visit questionnaires for 87 primary care visits that involved patients taking opioids for chronic musculoskeletal pain and primary care resident physicians. After each visit, patients and physicians independently ranked 5 pain treatment goals from most to least important.ResultsIn total, 48% of patients ranked reducing pain intensity as their top priority, whereas 22% ranked finding a diagnosis as most important. Physicians ranked improving function as the top priority for 41% of patients, and ranked reducing medication side effects as most important for 26%. The greatest difference between patient and physician rankings was for reducing pain intensity. In regression analyses, neither overall agreement on goals (ie, the physician's first or second priority included the patient's top priority) nor difference in patient versus physician ranking of pain intensity was significantly associated with patient-reported visit experience (β for overall agreement, -0.08; 95% confidence interval [CI], -0.45 to 0.30; P=0.69; β for intensity, -0.06; 95% CI, -0.17 to 0.04; P=0.24) or physician-reported visit difficulty (β for overall agreement, 1.92; 95% CI, -2.70 to 6.55; P=0.41; β for intensity, 0.42; 95% CI, -0.87 to 1.71; P=0.53).DiscussionPatients and physicians prioritize substantially different goals for chronic pain management, but there is no evidence that agreement predicts patient experience or physician-reported visit difficulty. Primary care physicians may have adapted to new recommendations that emphasize functional goals and avoidance of long-term opioid therapy, whereas patients continue to focus on reducing pain intensity.

Purpose To build on results of a cluster randomized controlled trial (RCT) of a combined patient-oncologist intervention to improve communication in advanced cancer, we conducted a post hoc analysis of the patient intervention component, a previsit patient coaching session that used a question prompt list (QPL). We hypothesized that intervention-group participants would bring up more QPL-related topics, particularly prognosis-related topics, during the subsequent oncologist visit. Patients and Methods This cluster RCT with 170 patients who had advanced nonhematologic cancer (and their caregivers) recruited from practices of 24 participating oncologists in western New York. Intervention-group oncologists (n = 12) received individualized communication training; up to 10 of their patients (n = 84) received a previsit individualized communication coaching session that incorporated a QPL. Control-group oncologists (n = 12) and patients (n = 86) received no interventions. Topics of interest identified by patients during the coaching session were summarized from coaching notes; one office visit after the coaching session was audio recorded, transcribed, and analyzed by using linear regression modeling for group differences. Results Compared with controls, more than twice as many intervention-group participants brought up QPL-related topics during their office visits (70.2% v 32.6%; P < .001). Patients in the intervention group were nearly three times more likely to ask about prognosis (16.7% v 5.8%; P =.03). Of 262 topics of interest identified during coaching, 158 (60.3%) were QPL related; 20 (12.7%) addressed prognosis. Overall, patients in the intervention group brought up 82.4% of topics of interest during the office visit. Conclusion A combined coaching and QPL intervention was effective to help patients with advanced cancer and their caregivers identify and bring up topics of concern, including prognosis, during their subsequent oncologist visits. Considering that most patients are misinformed about prognosis, more intensive steps are needed to better promote such discussions.

ObjectiveTo compare how coder ratings of standardized patient (SP) visit recordings and SP ratings of the visits detect primary care physician (PCP) training in self-efficacy enhancing interviewing techniques (SEE IT).MethodsAnalyses of data from 50 PCPs who participated in a randomized controlled trial of SEE IT training, which led to increased SEE IT use during three SP visits 1-3 months post-intervention. Untrained SPs rated SEE IT use post-visit. Subsequently, three trained coders generated a consensus SEE IT rating from visit audio recordings. SPs and coders were blinded to provider study arm, and coders to SP ratings.ResultsSP and coder ratings were correlated (r=0.62). In detecting the intervention effect, the areas under the receiver operating characteristic curve were 0.80 (95% CI 0.74-0.87) and 0.76 (95% CI 0.69-0.84) for consensus coder and SP ratings, respectively (difference 0.04, 95% CI -0.04-0.11; z=1.04, p=0.30).ConclusionSP ratings were not significantly different from coder ratings of SP visit recordings in detecting PCP SEE IT training.Practice implicationsIf similar findings are observed in larger studies, it would suggest a greater role for SP ratings in detecting provider interviewing skills training, given the relative simplicity, low cost, and non-intrusiveness of the approach.

ImportanceObservational studies demonstrate links between patient-centered communication, quality of life (QOL), and aggressive treatments in advanced cancer, yet few randomized clinical trials (RCTs) of communication interventions have been reported.ObjectiveTo determine whether a combined intervention involving oncologists, patients with advanced cancer, and caregivers would promote patient-centered communication, and to estimate intervention effects on shared understanding, patient-physician relationships, QOL, and aggressive treatments in the last 30 days of life.Design, setting, and participantsCluster RCT at community- and hospital-based cancer clinics in Western New York and Northern California; 38 medical oncologists (mean age 44.6 years; 11 (29%) female) and 265 community-dwelling adult patients with advanced nonhematologic cancer participated (mean age, 64.4 years, 146 [55.0%] female, 235 [89%] white; enrolled August 2012 to June 2014; followed for 3 years); 194 patients had participating caregivers.InterventionsOncologists received individualized communication training using standardized patient instructors while patients received question prompt lists and individualized communication coaching to identify issues to address during an upcoming oncologist visit. Both interventions focused on engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information. Control participants received no training.Main outcomes and measuresThe prespecified primary outcome was a composite measure of patient-centered communication coded from audio recordings of the first oncologist visit following patient coaching (intervention group) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QOL, and aggressive treatments and hospice use in the last 30 days of life.ResultsData from 38 oncologists (19 randomized to intervention) and 265 patients (130 intervention) were analyzed. In fully adjusted models, the intervention resulted in clinically and statistically significant improvements in the primary physician-patient communication end point (adjusted intervention effect, 0.34; 95% CI, 0.06-0.62; P = .02). Differences in secondary outcomes were not statistically significant.Conclusions and relevanceA combined intervention that included oncologist communication training and coaching for patients with advanced cancer was effective in improving patient-centered communication but did not affect secondary outcomes.Trial registrationclinicaltrials.gov Identifier: NCT01485627.

BackgroundThe Internet is valuable for those with limited access to health care services because of its low cost and wealth of information. Our objectives were to investigate how the Internet is used to obtain health-related information and how individuals with differing socioeconomic resources navigate it when presented with a health decision.MethodsStudy participants were recruited from public settings and social service agencies. Participants listened to one of two clinical scenarios - consistent with influenza or bacterial meningitis - and then conducted an Internet search. Screen-capture video software captured the Internet search. Participant Internet search strategies were analyzed and coded for pre- and post-Internet search guess at diagnosis and information seeking patterns. Individuals who did not have a college degree and were recruited from locations offering social services were categorized as "lower socioeconomic status" (SES); the remainder was categorized as "higher SES." Participants were 78 Internet health information seekers, ranging from 21-35 years of age, who experienced barriers to accessing health care services.ResultsLower-SES individuals were more likely to use an intuitive, rather than deliberative, approach to Internet health information seeking. Lower- and higher-SES participants did not differ in the tendency to make diagnostic guesses based on Internet searches. Lower-SES participants were more likely than their higher-SES counterparts to narrow the scope of their search.ConclusionsOur findings suggest that individuals with different levels of socioeconomic status vary in the heuristics and search patterns they rely upon to direct their searches. The influence and use of credible information in the process of making a decision is associated with education and prior experiences with healthcare services. Those with limited resources may be disadvantaged when turning to the Internet to make a health decision.

BackgroundWhen subgroup analyses are not correctly analyzed and reported, incorrect conclusions may be drawn, and inappropriate treatments provided. Despite the increased recognition of the importance of subgroup analysis, little information exists regarding the prevalence, appropriateness, and study characteristics that influence subgroup analysis. The objective of this study is to determine (1) if the use of subgroup analyses and multivariable risk indices has increased, (2) whether statistical methodology has improved over time, and (3) which study characteristics predict subgroup analysis.MethodsWe randomly selected randomized controlled trials (RCTs) from five high-impact general medical journals during three time periods. Data from these articles were abstracted in duplicate using standard forms and a standard protocol. Subgroup analysis was defined as reporting any subgroup effect. Appropriate methods for subgroup analysis included a formal test for heterogeneity or interaction across treatment-by-covariate groups. We used logistic regression to determine the variables significantly associated with any subgroup analysis or, among RCTs reporting subgroup analyses, using appropriate methodology.ResultsThe final sample of 416 articles reported 437 RCTs, of which 270 (62 %) reported subgroup analysis. Among these, 185 (69 %) used appropriate methods to conduct such analyses. Subgroup analysis was reported in 62, 55, and 67 % of the articles from 2007, 2010, and 2013, respectively. The percentage using appropriate methods decreased over the three time points from 77 % in 2007 to 63 % in 2013 (p

ObjectiveTo explore how physician training in self-efficacy enhancing interviewing techniques (SEE IT) affects patient psychological health behavior change mediators (HBCMs).MethodsWe analyzed data from 131 patients visiting primary care physicians ≥4 months after the physicians participated in a randomized controlled trial. Experimental arm physicians (N=27) received SEE IT training during three ≤20min standardized patient instructor (SPI) visits. Control physicians (N=23) viewed a diabetes medications video during one SPI visit. Physicians were blinded to patient participation. Outcomes were self-care self-efficacy, readiness, and health locus of control (Internal, Chance, Powerful Others), examined as a summary HBCM score (average of standardized means) and individually. Analyses adjusted for pre-visit values of the dependent variables.ResultsPatients visiting SEE IT-trained physicians had higher summary HBCM scores (+0.42, 95% CI 0.07-0.77; p=0.021). They also had greater self-care readiness (AOR 3.04, 95% CI 1.02-9.03, p=0.046) and less Chance health locus of control (-0.27 points, 95% CI -0.50-0.04, p=0.023), with no significant differences in other HBCMs versus controls.ConclusionImprovement in psychological HBCMs occurred among patients visiting SEE IT-trained physicians, PRACTICE IMPLICATIONS: If further research shows the observed HBCM effects improve health behaviors and outcomes, SEE IT training might be offered widely to physicians.

ImportancePatients with advanced cancer often report expectations for survival that differ from their oncologists' expectations. Whether patients know that their survival expectations differ from those of their oncologists remains unknown. This distinction is important because knowingly expressing differences of opinion is important for shared decision making, whereas patients not knowing that their understanding differs from that of their treating physician is a potential marker of inadequate communication.ObjectiveTo describe the prevalence, distribution, and proportion of prognostic discordance that is due to patients' knowingly vs unknowingly expressing an opinion that differs from that of their oncologist.Design, setting, and participantsCross-sectional study conducted at academic and community oncology practices in Rochester, New York, and Sacramento, California. The sample comprises 236 patients with advanced cancer and their 38 oncologists who participated in a randomized trial of an intervention to improve clinical communication. Participants were enrolled from August 2012 to June 2014 and followed up until October 2015.Main outcomes and measuresWe ascertained discordance by comparing patient and oncologist ratings of 2-year survival probability. For discordant pairs, we determined whether patients knew that their opinions differed from those of their oncologists by asking the patients to report how they believed their oncologists rated their 2-year survival.ResultsAmong the 236 patients (mean [SD] age, 64.5 [11.4] years; 54% female), 161 patient-oncologist survival prognosis ratings (68%; 95% CI, 62%-75%) were discordant. Discordance was substantially more common among nonwhite patients compared with white patients (95% [95% CI, 86%-100%] vs 65% [95% CI, 58%-73%], respectively; P = .03). Among 161 discordant patients, 144 (89%) did not know that their opinions differed from that of their oncologists and nearly all of them (155 of 161 [96%]) were more optimistic than their oncologists.Conclusions and relevanceIn this study, patient-oncologist discordance about survival prognosis was common and patients rarely knew that their opinions differed from those of their oncologists.

BackgroundBetween 9.5% and 31.3% of college students suffer from depression (American college health association national college health assessment II: reference group executive summary spring 2013. Amer. Coll. Health Assoc. 2013; Eagan K, Stolzenberg EB, Ramirez JJ, Aragon, MC, Suchard, RS, Hurtado S. The American freshman: national norms fall 2014. Higher Educ. Res. Inst.; 2015). Universities need to understand the factors that relate to care-seeking behavior.ObjectiveAcross 3 studies, to relate attitudes, social norms, and perceived behavioral control to intention to seek mental health services, and to investigate barriers to care-seeking.ParticipantsUniversity college students (N = 845, 64% female, 26% male, and 10% unspecified).MethodsNew measures were created in Studies 1 and 2, and were examined using structural equation modeling in Study 3.ResultsPartially consistent with the Theory of Planned Behavior (Ajzen, I, Fishbein, M. Understanding Attitudes and Predicting Social Behavior. Englewood Cliffs, NJ: Prentice-Hall; 1980), a model with an excellent fit revealed that more positive attitudes about care and higher perceived behavioral control directly predicted higher intention to seek mental health services.ConclusionsEducating college students about mental health disorders and treatments, enhancing knowledge about available services, and addressing limited access to long-term care might improve treatment rates for students suffering from depression.

ObjectiveTo describe the development and initial application of the Chronic Pain Coding System.DesignSecondary analysis of data from a randomized clinical trial.SettingSix primary care clinics in northern California.SubjectsForty-five primary care visits involving 33 clinicians and 45 patients on opioids for chronic noncancer pain.MethodsThe authors developed a structured coding system to accurately and objectively characterize discussions about pain and opioids. Two coders applied the final system to visit transcripts. Intercoder agreement for major coding categories was moderate to substantial (kappa = 0.5-0.7). Mixed effects regression was used to test six hypotheses to assess preliminary construct validity.ResultsGreater baseline pain interference was associated with longer pain discussions (P = 0.007) and more patient requests for clinician action (P = 0.02) but not more frequent negative patient evaluations of pain (P = 0.15). Greater clinician-reported visit difficulty was associated with more frequent disagreements with clinician recommendations (P = 0.003) and longer discussions of opioid risks (P = 0.049) but not more frequent requests for clinician action (P = 0.11). Rates of agreement versus disagreement with patient requests and clinician recommendations were similar for opioid-related and non-opioid-related utterances.ConclusionsThis coding system appears to be a reliable and valid tool for characterizing patient-clinician communication about opioids and chronic pain during clinic visits. Objective data on how patients and clinicians discuss chronic pain and opioids are necessary to identify communication patterns and strategies for improving the quality and productivity of discussions about chronic pain that may lead to more effective pain management and reduce inappropriate opioid prescribing.

ObjectiveWe examined rheumatologists' approaches to and perceptions of depression in everyday practice.MethodsA questionnaire was mailed to 470 practicing rheumatologists in California; 226 were included in the final analyses. Respondents provided information on demographics, practice characteristics, and attitudes, perceptions, and practices related to depression. Logistic regression models were constructed to assess the relationship of rheumatologists' personal and practice characteristics with their depression-related practices.ResultsFifty-one percent of respondents reported that at least half of their patients had depression. Nearly all providers (99%) reported addressing mental health issues during some visits. Rheumatologists were about equally likely to prescribe antidepressants, refer to a psychiatrist, or return the patient to the primary care physician, with roughly 60% often applying each of the 3 strategies. Respondents identified access to services and patients' resistance to mental health diagnoses as major barriers to effective depression management. In logistic regression models, greater number of patient visits per week, greater percentage of patients with fibromyalgia, and private practice setting were associated with more prescription of antidepressants (P < 0.05).ConclusionsDepression is common in rheumatologic practice, yet systems for identification, treatment, and referral of depressed patients are not universal. Rheumatologists' awareness of the need for mental health services is high, but they may lack the confidence, time, and/or referral networks to provide consistently effective care for depressed patients. Improving depression care in rheumatology may require a combination of clinician-level interventions (e.g., enhanced behavioral health training) and practice-level reforms (e.g., collaborative care).

ObjectivesTo evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials.Study design and settingThrough a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between January 1, 1985, and December 31, 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus.ResultsWe identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2,278 patients. Overall, kappa agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% confidence interval: 0.79, 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements reported in the Methods was 41% (range, 16-87%), and the median percentage in the Results was 38% (range, 32-93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in articles published in journals with relatively high-impact factors (P = 0.004).ConclusionThe quality of reporting of published N-of-1 trials is variable and in need of improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future.

BackgroundPrimary care providers (PCPs) have few tools for enhancing patient self-efficacy, a key mediator of myriad health-influencing behaviors.ObjectiveTo examine whether brief standardized patient instructor (SPI)-delivered training increases PCPs' use of self-efficacy-enhancing interviewing techniques (SEE IT).DesignRandomized controlled trial.ParticipantsFifty-two family physicians and general internists from 12 primary care offices drawn from two health systems in Northern California.InterventionsExperimental arm PCPs received training in the use of SEE IT training during three outpatient SPI visits scheduled over a 1-month period. Control arm PCPs received a single SPI visit, during which they viewed a diabetes treatment video. All intervention visits (experimental and control) were timed to last 20 min. SPIs portrayed patients struggling with self-care of depression and diabetes in the first 7 min, then delivered the appropriate intervention content during the remaining 13 min.Main measuresThe primary outcome was provider use of SEE IT (a count of ten behaviors), coded from three audio-recorded standardized patient visits at 1-3 months, again involving depression and diabetes self-care. Two five-point scales measured physician responses to training: Value (7 items: quality, helpfulness, understandability, relevance, feasibility, planned use, care impact), and Hassle (2 items: personal hassle, flow disruption).Key resultsPre-intervention, study PCPs used a mean of 0.7 behaviors/visit, with no significant between-arm difference (P = 0.23). Post-intervention, experimental arm PCPs used more of the behaviors than controls (mean 2.7 vs. 1.0 per visit; adjusted difference 1.7, 95 % CI 1.1-2.2; P