Ethical and methodological challenges slowing progress in primary care-based suicide prevention: Illustrations from a randomized controlled trial and guidance for future research.

INTRODUCTION: Despite 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. METHODS: The 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. RESULTS: After 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. CONCLUSIONS: While 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.

Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial.

BACKGROUND: Patients with acute low back pain frequently request diagnostic imaging, and clinicians feel pressure to acquiesce to such requests to sustain patient trust and satisfaction. Spinal imaging in patients with acute low back pain poses risks from diagnostic evaluation of false-positive findings, patient labeling and anxiety, and unnecessary treatment (including spinal surgery). Watchful waiting advice has been an effective strategy to reduce some low-value treatments, and some evidence suggests a watchful waiting approach would be acceptable to many patients requesting diagnostic tests. METHODS: We will use key informant interviews of clinicians and focus groups with primary care patients to refine a theory-informed standardized patient-based intervention designed to teach clinicians how to advise watchful waiting when patients request low-value spinal imaging for low back pain. We will test the effectiveness of the intervention in a randomized clinical trial. We will recruit 8-10 primary care and urgent care clinics (~ 55 clinicians) in Sacramento, CA; clinicians will be randomized 1:1 to intervention and control groups. Over a 3- to 6-month period, clinicians in the intervention group will receive 3 visits with standardized patient instructors (SPIs) portraying patients with acute back pain; SPIs will instruct clinicians in a three-step model emphasizing establishing trust, empathic communication, and negotiation of a watchful waiting approach. Control physicians will receive no intervention. The primary outcome is the post-intervention rate of spinal imaging among actual patients with acute back pain seen by the clinicians adjusted for rate of imaging during a baseline period. Secondary outcomes are use of targeted communication techniques during a follow-up visit with an SP, clinician self-reported use of watchful waiting with actual low back pain patients, post-intervention rates of diagnostic imaging for other musculoskeletal pain syndromes (to test for generalization of intervention effects beyond back pain), and patient trust and satisfaction with physicians. DISCUSSION: This trial will determine whether standardized patient instructors can help clinicians develop skill in negotiating a watchful waiting approach with patients with acute low back pain, thereby reducing rates of low-value spinal imaging. The trial will also examine the possibility that intervention effects generalize to other diagnostic tests. TRIAL REGISTRATION: ClinicalTrials.gov NCT04255199 . Registered on January 20, 2020.

Tailored Activation of Middle-Aged Men to Promote Discussion of Recent Active Suicide Thoughts: a Randomized Controlled Trial.

PURPOSE: Middle-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. METHODS: We 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. RESULTS: Sixteen 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%). CONCLUSIONS: In 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.

Patients' Hopes for Advanced Cancer Treatment.

CONTEXT: Little is known about the hopes patients with advanced (incurable) cancer have for their treatment. OBJECTIVES: The 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. METHODS: We 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. RESULTS: We 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. CONCLUSION: Advanced 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.

Stakeholder views regarding a planned primary care office-based interactive multimedia suicide prevention tool.

OBJECTIVES: Nearly half of all men who die by suicide visit a primary care clinician (PCC) in the month before death, yet few disclose suicide thoughts. We solicited stakeholders' views to guide development of a tailored multimedia program to activate middle-aged men experiencing suicide thoughts to engage with PCCs. METHODS: We conducted semi-structured interviews with 44 adults self-identifying as: suicide attempt survivor; family member/loved one of person(s) who attempted or died by suicide; PCC; non-PCC office staff; health administrator; and/or prevention advocate. We coded recorded interview transcripts and identified relevant themes using grounded theory. RESULTS: Two thematic groupings emerged, informing program design: structure and delivery (including belief the program could be effective and desire for use of plain language and media over text); and informational and motivational content (including concerns about PCC preparedness; fear that disclosing suicide thoughts would necessitate hospitalization; and influence of male identity and masculinity, respectively, in care-seeking for and interpreting suicide thoughts). CONCLUSION: Stakeholder input informed the design of a primary care tailored multimedia suicide prevention tool. PRACTICE IMPLICATIONS: In revealing a previously unreported barrier to disclosing suicide thoughts to PCCs (fear of hospitalization), and underscoring known barriers, the findings may suggest additional suicide prevention approaches.

Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial.

IMPORTANCE: Observational 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. OBJECTIVE: To 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 PARTICIPANTS: Cluster 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. INTERVENTIONS: Oncologists 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 MEASURES: The 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. RESULTS: Data 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 RELEVANCE: A 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 REGISTRATION: clinicaltrials.gov Identifier: NCT01485627.

Analysis of threats to research validity introduced by audio recording clinic visits: Selection bias, Hawthorne effect, both, or neither?

OBJECTIVE: To identify factors associated with participant consent to record visits; to estimate effects of recording on patient-clinician interactions. METHODS: Secondary analysis of data from a randomized trial studying communication about depression; participants were asked for optional consent to audio record study visits. Multiple logistic regression was used to model likelihood of patient and clinician consent. Multivariable regression and propensity score analyses were used to estimate effects of audio recording on 6 dependent variables: discussion of depressive symptoms, preventive health, and depression diagnosis; depression treatment recommendations; visit length; visit difficulty. RESULTS: Of 867 visits involving 135 primary care clinicians, 39% were recorded. For clinicians, only working in academic settings (P=0.003) and having worked longer at their current practice (P=0.02) were associated with increased likelihood of consent. For patients, white race (P=0.002) and diabetes (P=0.03) were associated with increased likelihood of consent. Neither multivariable regression nor propensity score analyses revealed any significant effects of recording on the variables examined. CONCLUSION: Few clinician or patient characteristics were significantly associated with consent. Audio recording had no significant effect on any of the 6 dependent variables examined. PRACTICE IMPLICATIONS: Benefits of recording clinic visits likely outweigh the risks of bias in this setting.

Potential antidepressant overtreatment associated with office use of brief depression symptom measures.

BACKGROUND: Use of brief depression symptom measures for identifying or screening cases may help to address depression undertreatment, but whether it also leads to diagnosis and treatment of patients with few or no symptoms-a group unlikely to have major depression or benefit from antidepressants-is unknown. We examined the associations of use of a brief depression symptom measure with depression diagnosis and antidepressant recommendation and prescription among patients with few or no depression symptoms. METHODS: We conducted exploratory observational analyses of data from a randomized trial of depression engagement interventions conducted in primary care offices in California. Analyses focused on participants scoring <10 on a study-administered 9-item Patient Health Questionnaire (PHQ-9) (completed immediately before an office visit and not disclosed to the provider) with complete chart review data (n = 595). We reviewed visit notes for evidence of practice administration of a brief symptom measure (independent of the trial) and whether the provider (1) diagnosed depression or (2) recommended and/or prescribed an antidepressant. RESULTS: Among the 545 patients without a practice-administered measure, 57 (10.5%) had a visit diagnosis of depression; 9 (1.6%) were recommended and another 21 (3.8%) prescribed an antidepressant. Among the 50 patients (8.4% of total sample) with a practice-administered measure, 10 (20%) had a visit diagnosis of depression; 6 (12%) were recommended and another 6 (12%) prescribed an antidepressant. Adjusting for nesting within providers, trial intervention, stratification variables, and sample weighting, use of a brief symptom measure was associated with depression diagnosis (adjusted odds ratio, 3.2; 95% confidence interval, 1.1-9.2) and antidepressant recommendation and/or prescription (adjusted odds ratio, 3.80; 95% confidence interval, 1.0-13.9). Analyses using progressively lower PHQ-9 thresholds (<9 to <5) and examining antidepressant prescription alone yielded consistent findings. Analyses by practice-administered measure (PHQ-9 vs PHQ-2) indicated the study findings were largely associated with PHQ-9 use. CONCLUSIONS: These exploratory findings suggest administration of brief depression symptom measures, particularly the PHQ-9, may be associated with depression diagnosis and antidepressant recommendation and prescription among patients unlikely to have major depression. If these findings are confirmed, researchers should investigate the balance of benefits and risks (eg, overdiagnosis of depression and overtreatment with antidepressants) associated with use of a brief symptom measure.

Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

IMPORTANCE: Encouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment. OBJECTIVE: To determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial comparing DEV, IMCP, and control among 925 adult patients treated by 135 primary care clinicians (603 patients with depression and 322 patients without depression, defined by Patient Health Questionnaire-9 [PHQ-9] score) conducted from June 2010 through March 2012 at 7 primary care clinical sites in California. INTERVENTIONS: DEV targeted to sex and income, an IMCP tailored to individual patient characteristics, and a sleep hygiene video (control). MAIN OUTCOMES AND MEASURES: Among depressed patients, superiority assessment of the composite measure of patient-reported antidepressant drug recommendation, mental health referral, or both (primary outcome); depression at 12-week follow-up, measured by the PHQ-8 (secondary outcome). Among nondepressed patients, noninferiority assessment of clinician- and patient-reported antidepressant drug recommendation (primary outcomes) with a noninferiority margin of 3.5%. Analyses were cluster adjusted. RESULTS: Of the 925 eligible patients, 867 were included in the primary analysis (depressed, 559; nondepressed, 308). Among depressed patients, rates of achieving the primary outcome were 17.5% for DEV, 26% for IMCP, and 16.3% for control (DEV vs control, 1.1 [95% CI, -6.7 to 8.9], P = .79; IMCP vs control, 9.9 [95% CI, 1.6 to 18.2], P = .02). There were no effects on PHQ-8 measured depression score at the 12-week follow-up: DEV vs control, -0.2 (95% CI, -1.2 to 0.8); IMCP vs control, 0.9 (95% CI, -0.1 to 1.9). Among nondepressed patients, clinician-reported antidepressant prescribing in the DEV and IMCP groups was noninferior to control (mean percentage point difference [PPD]: DEV vs control, -2.2 [90% CI, -8.0 to 3.49], P = .0499 for noninferiority; IMCP vs control, -3.3 [90% CI, -9.1 to 2.4], P = .02 for noninferiority); patient-reported antidepressant recommendation did not achieve noninferiority (mean PPD: DEV vs control, 0.9 [90% CI, -4.9 to 6.7], P = .23 for noninferiority; IMCP vs control, 0.3 [90% CI, -5.1 to 5.7], P = .16 for noninferiority). CONCLUSIONS AND RELEVANCE: A tailored IMCP increased clinician recommendations for antidepressant drugs, a mental health referral, or both among depressed patients but had no effect on mental health at the 12-week follow-up. The possibility that the IMCP and DEV increased patient-reported clinician recommendations for an antidepressant drug among nondepressed patients could not be excluded. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01144104.

Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers.

BACKGROUND: Communication about prognosis and treatment choices is essential for informed decision making in advanced cancer. This article describes an investigation designed to facilitate communication and decision making among oncologists, patients with advanced cancer, and their caregivers. METHODS/DESIGN: The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study. Drawing upon ecological theory, the intervention uses a two-pronged approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns. Follow-up data will be collected approximately quarterly for up to three years. DISCUSSION: The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes). TRIAL REGISTRATION: Clinical Trials Identifier: NCT01485627.

Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study.

BACKGROUND: Depression in primary care is common, yet this costly and disabling condition remains underdiagnosed and undertreated. Persisting gaps in the primary care of depression are due in part to patients' reluctance to bring depressive symptoms to the attention of their primary care clinician and, when depression is diagnosed, to accept initial treatment for the condition. Both targeted and tailored communication strategies offer promise for fomenting discussion and reducing barriers to appropriate initial treatment of depression. METHODS/DESIGN: The Activating Messages to Enhance Primary Care Practice (AMEP2) Study is a stratified randomized controlled trial comparing two computerized multimedia patient interventions -- one targeted (to patient gender and income level) and one tailored (to level of depressive symptoms, visit agenda, treatment preferences, depression causal attributions, communication self-efficacy and stigma)-- and an attention control. AMEP2 consists of two linked sub-studies, one focusing on patients with significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥ 5), the other on patients with few or no depressive symptoms (PHQ-9 < 5). The first sub-study examined effectiveness of the interventions; key outcomes included delivery of components of initial depression care (antidepressant prescription or mental health referral). The second sub-study tracked potential hazards (clinical distraction and overtreatment). A telephone interview screening procedure assessed patients for eligibility and oversampled patients with significant depressive symptoms. Sampled, consenting patients used computers to answer survey questions, be randomized, and view assigned interventions just before scheduled primary care office visits. Patient surveys were also collected immediately post-visit and 12 weeks later. Physicians completed brief reporting forms after each patient's index visit. Additional data were obtained from medical record abstraction and visit audio recordings. Of 6,191 patients assessed, 867 were randomized and included in analysis, with 559 in the first sub-study and 308 in the second. DISCUSSION: Based on formative research, we developed two novel multimedia programs for encouraging patients to discuss depressive symptoms with their primary care clinicians. Our computer-based enrollment and randomization procedures ensured that randomization was fully concealed and data missingness minimized. Analyses will focus on the interventions' potential benefits among depressed persons, and the potential hazards among the non-depressed. TRIAL REGISTRATION: ClinicialTrials.gov Identifier: NCT01144104.

An academic-marketing collaborative to promote depression care: a tale of two cultures.

OBJECTIVES: Commercial advertising and patient education have separate theoretical underpinnings, approaches, and practitioners. This paper aims to describe a collaboration between academic researchers and a marketing firm working to produce demographically targeted public service anouncements (PSAs) designed to enhance depression care-seeking in primary care. METHODS: An interdisciplinary group of academic researchers contracted with a marketing firm in Rochester, NY to produce PSAs that would help patients with depressive symptoms engage more effectively with their primary care physicians (PCPs). The researchers brought perspectives derived from clinical experience and the social sciences and conducted empirical research using focus groups, conjoint analysis, and a population-based survey. Results were shared with the marketing firm, which produced four PSA variants targeted to gender and socioeconomic position. RESULTS: There was no simple, one-to-one relationship between research results and the form, content, or style of the PSAs. Instead, empirical findings served as a springboard for discussion and kept the creative process tethered to the experiences, attitudes, and opinions of actual patients. Reflecting research findings highlighting patients' struggles to recognize, label, and disclose depressive symptoms, the marketing firm generated communication objectives that emphasized: (a) educating the patient to consider and investigate the possibility of depression; (b) creating the belief that the PCP is interested in discussing depression and capable of offering helpful treatment; and (c) modelling different ways of communicating with physicians about depression. Before production, PSA prototypes were vetted with additional focus groups. The winning prototype, "Faces," involved a multi-ethnic montage of formerly depressed persons talking about how depression affected them and how they improved with treatment, punctuated by a physician who provided clinical information. A member of the academic team was present and consulted closely during production. Challenges included reconciling the marketing tradition of audience segmentation with the overall project goal of reaching as broad an audience as possible; integrating research findings across dimensions of words, images, music, and tone; and dealing with misunderstandings related to project scope and budget. CONCLUSION: Mixed methods research can usefully inform PSAs that incorporate patient perspectives and are produced to professional standards. However, tensions between the academic and commercial worlds exist and must be addressed. PRACTICE IMPLICATIONS: While rewarding, academic-marketing collaborations introduce tensions which must be addressed.

Feeling labeled, judged, lectured, and rejected by family and friends over depression: cautionary results for primary care clinicians from a multi-centered, qualitative study.

BACKGROUND: Family and friends may help patients seek out and engage in depression care. However, patients' social networks can also undermine depression treatment and recovery. In an effort to improve depression care in primary care settings, we sought to identify, categorize, and alert primary care clinicians to depression-related messages that patients hear from friends and family that patients perceive as unhelpful or detrimental. METHODS: We conducted 15 focus groups in 3 cities. Participants (n = 116) with a personal history or knowledge of depression responded to open-ended questions about depression, including self-perceived barriers to care-seeking. Focus group conversations were audio-recorded and analyzed using iterative qualitative analysis. RESULTS: Four themes emerged related to negatively-received depression messages delivered by family and friends. Specifically, participants perceived these messages as making them feel labeled, judged, lectured to, and rejected by family and friends when discussing depression. Some participants also expressed their interpretation of their families' motivations for delivering the messages and described how hearing these messages affected depression care. CONCLUSIONS: The richness of our results reflects the complexity of communication within depression sufferers' social networks around this stigmatized issue. To leverage patients' social support networks effectively in depression care, primary care clinicians should be aware of both the potentially beneficial and detrimental aspects of social support. Specifically, clinicians should consider using open-ended queries into patients' experiences with discussing depression with family and friends as an initial step in the process. An open-ended approach may avoid future emotional trauma or stigmatization and assist patients in overcoming self-imposed barriers to depression discussion, symptom disclosure, treatment adherence and follow-up care.

Relational barriers to depression help-seeking in primary care.

OBJECTIVE: To identify attitudinal and interpersonal barriers to depression care-seeking and disclosure in primary care and in so doing, evaluate the primary care paradigm for depression care in the United States. METHODS: Fifteen qualitative focus group interviews in three cities. Study participants were English-speaking men and women aged 25-64 with first-hand knowledge of depression. Transcripts were analyzed iteratively for recurring themes. RESULTS: Participants expressed reservations about the ability of primary care physicians (PCPs) to meet their mental health needs. Specific barriers included problems with PCP competence and openness as well as patient-physician trust. While many reflected positively on their primary care experiences, some doubted PCPs' knowledge of mental health disorders and believed mental health concerns fell outside the bounds of primary care. Low-income participants in particular shared stories about the essentiality, and ultimate fragility, of patient-PCP trust. CONCLUSION: Patients with depression may be deterred from care-seeking or disclosure by relational barriers including perceptions of PCPs' mental health-related capabilities and interests. PRACTICE IMPLICATIONS: PCPs should continue to develop their depression management skills while supporting vigorous efforts to inform the public that primary care is a safe and appropriate venue for treatment of common mental health conditions.

"I didn't know what was wrong:" how people with undiagnosed depression recognize, name and explain their distress.

BACKGROUND: Diagnostic and treatment delay in depression are due to physician and patient factors. Patients vary in awareness of their depressive symptoms and ability to bring depression-related concerns to medical attention. OBJECTIVE: To inform interventions to improve recognition and management of depression in primary care by understanding patients' inner experiences prior to and during the process of seeking treatment. DESIGN: Focus groups, analyzed qualitatively. PARTICIPANTS: One hundred and sixteen adults (79% response) with personal or vicarious history of depression in Rochester NY, Austin TX and Sacramento CA. Neighborhood recruitment strategies achieved sociodemographic diversity. APPROACH: Open-ended questions developed by a multidisciplinary team and refined in three pilot focus groups explored participants' "lived experiences" of depression, depression-related beliefs, influences of significant others, and facilitators and barriers to care-seeking. Then, 12 focus groups stratified by gender and income were conducted, audio-recorded, and analyzed qualitatively using coding/editing methods. MAIN RESULTS: Participants described three stages leading to engaging in care for depression - "knowing" (recognizing that something was wrong), "naming" (finding words to describe their distress) and "explaining" (seeking meaningful attributions). "Knowing" is influenced by patient personality and social attitudes. "Naming" is affected by incongruity between the personal experience of depression and its narrow clinical conceptualizations, colloquial use of the word depression, and stigma. "Explaining" is influenced by the media, socialization processes and social relations. Physical/medical explanations can appear to facilitate care-seeking, but may also have detrimental consequences. Other explanations (characterological, situational) are common, and can serve to either enhance or reduce blame of oneself or others. CONCLUSIONS: To improve recognition of depression, primary care physicians should be alert to patients' ill-defined distress and heterogeneous symptoms, help patients name their distress, and promote explanations that comport with patients' lived experience, reduce blame and stigma, and facilitate care-seeking.

Getting to "no": strategies primary care physicians use to deny patient requests.

BACKGROUND: Physicians need strategies for addressing patient requests for medically inappropriate tests and treatments. We examined communication processes that physicians use to deal with patient requests of questionable appropriateness. METHODS: Data come from audio-recorded visits and postvisit questionnaires of standardized patient visits to primary care offices in Sacramento and San Francisco, California, and Rochester, New York, from May 2003 to May 2004. Investigators performed an iterative review of visit transcripts in which patients requested, but did not receive, an antidepressant prescription. Measurements include qualitative analysis of strategies for communicating request denial. The relationship between strategies and satisfaction reports in postvisit questionnaires was examined using the Fisher exact test. RESULTS: Standardized patients requested antidepressants in 199 visits; the antidepressants were not prescribed in 88 visits (44%), 84 of which were available for analysis. In 53 of 84 visits (63%), physicians used 1 or more of the following 3 strategies that explicitly incorporated the patient perspective: (1) exploring the context of the request, (2) referring to a mental health professional, and (3) offering an alternative diagnosis. Twenty-six visits (31%) involved emphasis on biomedical approaches: prescribing a sleep aid or ordering a diagnostic workup. In 5 visits (6%), physicians rejected the request outright. Standardized patients reported significantly higher visit satisfaction when approaches relying on the patient perspective were used to deny the request (P = .001). CONCLUSIONS: Strategies for saying no may be used to communicate appropriate care plans, to reduce provision of medically inappropriate services, and to preserve the physician-patient relationship. These findings should be considered in the context of physician education and training in light of increasing health care costs.

Which providers should communicate which critical information about a new medication? Patient, pharmacist, and physician perspectives.

OBJECTIVES: To investigate older patient, pharmacist, and physician perspectives about what information is essential to impart to patients receiving new medication prescriptions and who should provide the information. DESIGN: Qualitative focus group discussions. SETTINGS: Senior centers, retail pharmacies, and primary care physician offices. PARTICIPANTS: Forty-two patients aged 65 and older, 13 pharmacists, and 17 physicians participated in eight focus groups. MEASUREMENT: Qualitative analysis of transcribed focus group interviews and consensus through iterative review by multidisciplinary auditors. RESULTS: Patient, pharmacist, and physician groups all affirmed the importance of discussing medication directions and side effects and said that physicians should educate about side effects and that pharmacists could adequately counsel about certain important issues. However, there was substantial disagreement between groups about which provider could communicate which critical elements of medication-related information. Some pharmacists felt that they were best equipped to discuss medication-related issues but acknowledged that many patients want physicians to do this. Physicians tended to believe that they should provide most new-medication education for patients. Patients had mixed preferences. Patients aged 80 and older listed fewer critical topics of discussion than younger patients. CONCLUSION: Patients, pharmacists, and physicians have incongruent beliefs about who should provide essential medication-related information. Differing expectations could lead to overlapping, inefficient efforts that result in communication deficiencies when patients receive a new medication. Collaborative efforts to ensure that patients receive complete information about new medications could be explored.