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OBJECTIVE: Conduct systematic proactive pharmacovigilance screening for symptoms patients experienced after starting new medications using an electronic patient portal. We aimed to design and test the feasibility of the system, measure patient response rates, provide any needed support for patients experiencing potentially drug-related problems, and describe types of symptoms and problems patients report. METHODS: We created an automated daily report of all new prescriptions, excluding likely non-new and various OTC meds, and sent invitations via patient portal inviting patients to inquire if they had started the medication, and if "yes," inquire if they had they experienced any new symptoms that could be potential adverse drug effects. Reported symptoms were classified by clinical pharmacists using SOC MeDra taxonomy, and patients were offered follow-up and support as desired and needed. RESULTS: Of 11,724 included prescriptions for 9360 unique patients, 2758 (29.4%) patients responded. Of 2616 unique medication starts, patients reported at least 1 new symptom that represented a potential adverse drug reaction (ADR) in 678/2616 (25.9%). Nearly one-third of those experiencing new symptoms (30.3%) reported 2 or more new symptoms after initiating the drug. GI disorders accounted for 30% of the total reported ADRs. CONCLUSIONS: Systematic portal-based surveillance for potential adverse drug reactions was feasible, had higher response rates than other methods (such as automated interactive phone calling), and uncovered rates of potential ADRs (roughly 1 in 4 patients) consistent with other methods/studies.
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CONTEXT: Opioid therapy is a cornerstone for treatment of cancer-related pain, but standardized management practices for patients with cancer and aberrant urine drug test (UDT) results are lacking. OBJECTIVES: To identify the prevalence of UDT ordering (both screening and definitive testing) in the oncology setting and to examine clinician management practices for patients with cancer on opioid therapy with aberrant definitive UDT results. METHODS: We conducted a retrospective chart review of patients with cancer on opioid therapy at an academic cancer center in the United States. Outcomes included UDT ordering patterns and clinician management practices in response to aberrant definitive UDT results. RESULTS: Our study revealed an overall UDT ordering rate of 3.7% among 10,371 patients with cancer on opioid therapy. Among 143 patients for whom definitive UDTs were ordered, oncologists only ordered 14 (9.8%) UDTs, while palliative care ordered the majority (n = 129; 90.2%). Fifty-five (38.5%) patients had aberrant results, and the most common aberrancy was presence of illicit drugs 22 [15.4%]. Clinicians rarely made medication changes (20 [36.4%]) when UDT results were aberrant, and in the setting of possible fentanyl use (n = 8), only 3 (37.5%) patients were started/switched to methadone, and none were started/switched to buprenorphine. CONCLUSION: Overall UDT ordering was infrequent for patients with cancer on opioid therapy, especially by oncologists, and clinicians rarely made prescribing changes when definitive UDT results were aberrant. More definitive guidance related to UDT ordering and opioid management are needed for patients with cancer and aberrant UDT results.
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Analgésicos Opioides , Dor do Câncer , Padrões de Prática Médica , Humanos , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/urina , Dor do Câncer/tratamento farmacológico , Idoso , Detecção do Abuso de Substâncias , Cuidados Paliativos , Adulto , Institutos de Câncer , Neoplasias/complicações , Neoplasias/urinaRESUMO
OBJECTIVES: The 2021 US Cures Act may engage patients to help reduce diagnostic errors/delays. We examined the relationship between patient portal registration with/without note reading and test/referral completion in primary care. MATERIALS AND METHODS: Retrospective cohort study of patients with visits from January 1, 2018 to December 31, 2021, and order for (1) colonoscopy, (2) dermatology referral for concerning lesions, or (3) cardiac stress test at 2 academic primary care clinics. We examined differences in timely completion ("loop closure") of tests/referrals for (1) patients who used the portal and read ≥1 note (Portal + Notes); (2) those with a portal account but who did not read notes (Portal Account Only); and (3) those who did not register for the portal (No Portal). We estimated the predictive probability of loop closure in each group after adjusting for socio-demographic and clinical factors using multivariable logistic regression. RESULTS: Among 12 849 tests/referrals, loop closure was more common among Portal+Note-readers compared to their counterparts for all tests/referrals (54.2% No Portal, 57.4% Portal Account Only, 61.6% Portal+Notes, P < .001). In adjusted analysis, compared to the No Portal group, the odds of loop closure were significantly higher for Portal Account Only (OR 1.2; 95% CI, 1.1-1.4), and Portal+Notes (OR 1.4; 95% CI, 1.3-1.6) groups. Beyond portal registration, note reading was independently associated with loop closure (P = .002). DISCUSSION AND CONCLUSION: Compared to no portal registration, the odds of loop closure were 20% higher in tests/referrals for patients with a portal account, and 40% higher in tests/referrals for note readers, after controlling for sociodemographic and clinical factors. However, important safety gaps from unclosed loops remain, requiring additional engagement strategies.
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Portais do Paciente , Humanos , Leitura , Estudos Retrospectivos , Registros Eletrônicos de Saúde , Testes Diagnósticos de Rotina , Atenção Primária à SaúdeRESUMO
BACKGROUND: A frequent, preventable cause of diagnostic errors involves failure to follow up on diagnostic tests, referrals, and symptoms-termed "failure to close the diagnostic loop." This is particularly challenging in a resident practice where one third of physicians graduate annually, and rates of patient loss due to these transitions may lead to more opportunities for failure to close diagnostic loops. The aim of this study was to determine the prevalence of failure of loop closure in a resident primary care clinic compared to rates in the faculty practice and identify factors contributing to failure. METHODS: This retrospective cohort study included all patient visits from January 1, 2018, to December 31, 2021, at two academic medical center-based primary care practices where residents and faculty practice in the same setting. The primary outcome was prevalence of failure to close the loop for (1) dermatology referrals, (2) colonoscopy, and (3) cardiac stress testing. The primary predictor was resident vs. faculty status of the ordering provider. The authors present an unadjusted analysis and the results of a multivariable logistic regression analysis incorporating all patient factors to determine their association with loop closure. RESULTS: Of 12,282 orders for referrals and tests for the three studied areas, 1,929 (15.7%) were ordered by a resident physician. Of resident orders for all three tests, 52.9% were completed within the designated time vs. 58.4% for orders placed by attending physicians (p < 0.01). In an unadjusted analysis by test type, a similar trend was seen for colonoscopy (51.4% completion rate for residents vs. 57.5% for attending physicians, p < 0.01) and for cardiac stress testing (55.7% completion rate for residents vs. 61.2% for attending physicians), though a difference was not seen for dermatology referrals (64.2% completion rate for residents vs. 63.7% for attending physicians). In an adjusted analysis, patients with resident orders were less likely than attendings to close the loop for all test types combined (odds ratio 0.88, 95% confidence interval 0.79-0.98), with low rates of test completion for both physician groups. CONCLUSION: Loop closure for three diagnostic interventions was low for patients in both faculty and resident primary care clinics, with lower loop closure rates in resident clinics. Failure to close diagnostic loops presents a safety challenge in primary care and is of particular concern for training programs.
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Internato e Residência , Humanos , Estudos Retrospectivos , Centros Médicos Acadêmicos , Encaminhamento e Consulta , Atenção Primária à SaúdeRESUMO
BACKGROUND: Rectal bleeding is the most common presenting symptom of colorectal cancer, and guidelines recommend timely follow-up, usually with colonoscopy to ensure timely diagnoses of colorectal cancer. OBJECTIVE: Identify loop closure rates and vulnerable process points for patients with rectal bleeding. DESIGN: Retrospective cohort study, using medical record review of patients aged ≥ 40 with index diagnosis of rectal bleeding at 2 primary practices-an urban academic practice and affiliated community health center, between January 1, 2018, and December 31, 2020. Patients were classified as having completed recommended follow-up workup ("closed loop") vs. not ("open loop"). Open loop patient cases were categorized into six types of process failures. PARTICIPANTS: A total of 837 patients had coded diagnoses of rectal bleeding within study window. Sixty-seven were excluded based on prior colectomy, clinical presentation more consistent with upper GI bleed, no rectal bleeding documented on chart review, or expired during the follow-up period, leaving 770 patients included. MAIN MEASURES: Primary outcomes were percentages of patient cases classified as "open loops" and distribution of these cases into six categories of process failure that were identified. KEY RESULTS: 22.3% of patients (N = 172) failed to undergo timely recommended workup for rectal bleeding. Largest failure categories were patients for whom no procedure was ordered (N = 62, 36%), followed by patients with procedures ordered but never scheduled (N = 44, 26%) or scheduled but subsequently cancelled or not kept (N = 31, 18%). While open loops increased after the onset of the COVID-19 pandemic, this difference was not significant within our study period. CONCLUSIONS: Significant numbers of patients presenting to primary care with rectal bleeding fail to undergo recommended workup. The majority either have no procedure ordered, or procedure ordered but never scheduled or cancelled and not kept, suggesting these are important failure modes to target in future interventions. Ensuring reliable ordering and processes for timely scheduling and completion of procedures represent critical areas for improving the diagnostic process for patients with rectal bleeding in primary care.
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Importance: Use of telehealth has increased substantially in recent years. However, little is known about whether the likelihood of completing recommended tests and specialty referrals-termed diagnostic loop closure-is associated with visit modality. Objectives: To examine the prevalence of diagnostic loop closure for tests and referrals ordered at telehealth visits vs in-person visits and identify associated factors. Design, Setting, and Participants: In a retrospective cohort study, all patient visits from March 1, 2020, to December 31, 2021, at 1 large urban hospital-based primary care practice and 1 affiliated community health center in Boston, Massachusetts, were evaluated. Main Measures: Prevalence of diagnostic loop closure for (1) colonoscopy referrals (screening and diagnostic), (2) dermatology referrals for suspicious skin lesions, and (3) cardiac stress tests. Results: The study included test and referral orders for 4133 patients (mean [SD] age, 59.3 [11.7] years; 2163 [52.3%] women; 203 [4.9%] Asian, 1146 [27.7%] Black, 2362 [57.1%] White, and 422 [10.2%] unknown or other race). A total of 1151 of the 4133 orders (27.8%) were placed during a telehealth visit. Of the telehealth orders, 42.6% were completed within the designated time frame vs 58.4% of those ordered during in-person visits and 57.4% of those ordered without a visit. In an adjusted analysis, patients with telehealth visits were less likely to close the loop for all test types compared with those with in-person visits (odds ratio, 0.55; 95% CI, 0.47-0.64). Conclusions: The findings of this study suggest that rates of loop closure were low for all test types across all visit modalities but worse for telehealth. Failure to close diagnostic loops presents a patient safety challenge in primary care that may be of particular concern during telehealth encounters.
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Telemedicina , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Boston/epidemiologia , Encaminhamento e Consulta , Estudos Retrospectivos , IdosoRESUMO
Diagnostic excellence is based on six fundamental principles of healthcare quality proposed by the Institute of Medicine in 2001, which state that diagnoses must be safe, effective, patient-centered, timely, efficient, and equitable.
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OBJECTIVES: The quest to measure and improve diagnosis has proven challenging; new approaches are needed to better understand and measure key elements of the diagnostic process in clinical encounters. The aim of this study was to develop a tool assessing key elements of the diagnostic assessment process and apply it to a series of diagnostic encounters examining clinical notes and encounters' recorded transcripts. Additionally, we aimed to correlate and contextualise these findings with measures of encounter time and physician burnout. DESIGN: We audio-recorded encounters, reviewed their transcripts and associated them with their clinical notes and findings were correlated with concurrent Mini Z Worklife measures and physician burnout. SETTING: Three primary urgent-care settings. PARTICIPANTS: We conducted in-depth evaluations of 28 clinical encounters delivered by seven physicians. RESULTS: Comparing encounter transcripts with clinical notes, in 24 of 28 (86%) there was high note/transcript concordance for the diagnostic elements on our tool. Reliably included elements were red flags (92% of notes/encounters), aetiologies (88%), likelihood/uncertainties (71%) and follow-up contingencies (71%), whereas psychosocial/contextual information (35%) and mentioning common pitfalls (7%) were often missing. In 22% of encounters, follow-up contingencies were in the note, but absent from the recorded encounter. There was a trend for higher burnout scores being associated with physicians less likely to address key diagnosis items, such as psychosocial history/context. CONCLUSIONS: A new tool shows promise as a means of assessing key elements of diagnostic quality in clinical encounters. Work conditions and physician reactions appear to correlate with diagnostic behaviours. Future research should continue to assess relationships between time pressure and diagnostic quality.
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Médicos , Condições de Trabalho , Humanos , Estudos Prospectivos , Previsões , Atenção Primária à SaúdeRESUMO
Importance: Communication of information has emerged as a critical component of diagnostic quality. Communication of diagnostic uncertainty represents a key but inadequately examined element of diagnosis. Objective: To identify key elements facilitating understanding and managing diagnostic uncertainty, examine optimal ways to convey uncertainty to patients, and develop and test a novel tool to communicate diagnostic uncertainty in actual clinical encounters. Design, Setting, and Participants: A 5-stage qualitative study was performed between July 2018 and April 2020, at an academic primary care clinic in Boston, Massachusetts, with a convenience sample of 24 primary care physicians (PCPs), 40 patients, and 5 informatics and quality/safety experts. First, a literature review and panel discussion with PCPs were conducted and 4 clinical vignettes of typical diagnostic uncertainty scenarios were developed. Second, these scenarios were tested during think-aloud simulated encounters with expert PCPs to iteratively draft a patient leaflet and a clinician guide. Third, the leaflet content was evaluated with 3 patient focus groups. Fourth, additional feedback was obtained from PCPs and informatics experts to iteratively redesign the leaflet content and workflow. Fifth, the refined leaflet was integrated into an electronic health record voice-enabled dictation template that was tested by 2 PCPs during 15 patient encounters for new diagnostic problems. Data were thematically analyzed using qualitative analysis software. Main Outcomes and Measures: Perceptions and testing of content, feasibility, usability, and satisfaction with a prototype tool for communicating diagnostic uncertainty to patients. Results: Overall, 69 participants were interviewed. A clinician guide and a diagnostic uncertainty communication tool were developed based on the PCP interviews and patient feedback. The optimal tool requirements included 6 key domains: most likely diagnosis, follow-up plan, test limitations, expected improvement, contact information, and space for patient input. Patient feedback on the leaflet was iteratively incorporated into 4 successive versions, culminating in a successfully piloted prototype tool as an end-of-visit voice recognition dictation template with high levels of patient satisfaction for 15 patients with whom the tool was tested. Conclusions and Relevance: In this qualitative study, a diagnostic uncertainty communication tool was successfully designed and implemented during clinical encounters. The tool demonstrated good workflow integration and patient satisfaction.
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Pessoal de Saúde , Software , Humanos , Incerteza , Pesquisa Qualitativa , Atenção Primária à SaúdeRESUMO
OBJECTIVES: To understand the relationship between stressful work environments and patient care by assessing work conditions, burnout, and elements of the diagnostic process. METHODS: Notes and transcripts of audiotaped encounters were assessed for verbal and written documentation related to psychosocial data, differential diagnosis, acknowledgement of uncertainty, and other diagnosis-relevant contextual elements using 5-point Likert scales in seven primary care physicians (PCPs) and 28 patients in urgent care settings. Encounter time spent vs time needed (time pressure) was collected from time stamps and clinician surveys. Study physicians completed surveys on stress, burnout, and work conditions using the Mini-Z survey. RESULTS: Physicians with high stress or burnout were less likely to record psychosocial information in transcripts and notes (psychosocial information noted in 0% of encounters in 4 high stress/burned-out physicians), whereas low stress physicians (n=3) recorded psychosocial information consistently in 67% of encounters. Burned-out physicians discussed a differential diagnosis in only 31% of encounters (low counts concentrated in two physicians) vs. in 73% of non-burned-out doctors' encounters. Burned-out and non-burned-out doctors spent comparable amounts of time with patients (about 25 min). CONCLUSIONS: Key diagnostic elements were seen less often in encounter transcripts and notes in burned-out urgent care physicians.
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Esgotamento Psicológico , Médicos , Humanos , Pessoal de Saúde , Diagnóstico Diferencial , IncertezaRESUMO
PURPOSE: To identify current challenges in detection of medication-related symptoms, and review technology-based opportunities to increase the patient-centeredness of postmarketing pharmacosurveillance to promote more accountable, safer, patient-friendly, and equitable medication prescribing. SUMMARY: Pharmacists have an important role to play in detection and evaluation of adverse drug reactions (ADRs). The pharmacist's role in medication management should extend beyond simply dispensing drugs, and this article delineates the rationale and proactive approaches for pharmacist detection and assessment of ADRs. We describe a stepwise approach for assessment, best practices, and lessons learned from a pharmacist-led randomized trial, the CEDAR (Calling for Detection of Adverse Drug Reactions) project. CONCLUSION: Health systems need to be redesigned to more fully utilize health information technologies and pharmacists in detecting and responding to ADRs.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Informática Médica , Humanos , Farmacêuticos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Prescrições de Medicamentos , Papel ProfissionalRESUMO
Ideally, urgent dermatology referrals for evaluation of a lesion concerning for skin cancer should be triaged and processed with appropriate urgency by primary care and dermatology, respectively. We performed a retrospective single-institution study by conducting chart reviews of all dermatology referrals designated by primary care as urgent for evaluation of a lesion concerning for skin cancer. We identified 320 referrals placed between January 1 and December 31, 2018. Dermatology encounters for these patients occurred on or before 30 days for 50.6% of referrals and on or after 31 days for 38.4% of referrals, with 10.9% never completed. The percentage of all races excluding whites, non-Hispanic in the delayed appointment group (≥ 31 days) was 15.1% higher (95% CI 5.3-24.9) than in the timely appointment group (≤ 30 days). Similarly, the percentage of non-English languages in the delayed group was 7.1% higher (95% CI 0.5-13.7) than in the timely group. Overall, 15.8% of these referrals yielded diagnoses of malignancy, while 76.8% and 7.4% resulted in benign and pre-malignant diagnoses, respectively. The primary care team documented referral status (i.e., completed, incomplete, or pending) during their subsequent visits with the patients in only 37.5% of these referrals. Our findings demonstrate the need to improve the reliability of urgent referrals to ensure they occur in a timely manner with confirmation of "referral loop" closure at the referring clinician's end.
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Dermatologia , Neoplasias Cutâneas , Humanos , Dermatologia/métodos , Estudos Retrospectivos , Reprodutibilidade dos Testes , Neoplasias Cutâneas/diagnóstico , Encaminhamento e Consulta , Atenção Primária à SaúdeRESUMO
BACKGROUND: The environment in which clinicians provide care and think about their patients is a crucial and undervalued component of the diagnostic process. CONTENT: In this paper, we propose a new conceptual model that links work conditions to clinician responses such as stress and burnout, which in turn impacts the quality of the diagnostic process and finally patient diagnostic outcomes. The mechanism for these interactions critically depends on the relationship between working memory (WM) and long-term memory (LTM), and ways WM and LTM interactions are affected by working conditions. SUMMARY: We propose a conceptual model to guide interventions to improve work conditions, clinician reactions and ultimately diagnostic process, accuracy and outcomes. OUTLOOK: Improving diagnosis can be accomplished if we are able to understand, measure and increase our knowledge of the context of care.
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Esgotamento Profissional , Memória de Curto Prazo , Humanos , Memória de Curto Prazo/fisiologia , Cognição , Esgotamento Profissional/diagnósticoRESUMO
Reliable systems that track the continuation, progression, or resolution of a patient's symptoms over time are essential for reliable diagnosis and ensuring that patients harboring more worrisome diagnoses are safely followed up. Given their first-contact role and increasing stresses on busy primary care clinicians and practices, new processes that make these tasks easier rather than creating more work for busy clinicians are especially needed.Some symptoms are sufficiently worrisome that they demand an urgent diagnosis and treatment while others result in a differential that can be more safely explored over time, or less differentiated and worrisome that they are best managed with the "test of time" to see if they resolve, worsen, or evolve into symptoms that are more worrisome. Regardless, it is essential that clinicians are able to reliably track symptoms over time, yet this capacity is rarely available or explicit. Working with systems engineers, we are developing prototypes for such systems and are working on their implementation and evaluation. In this commentary, we describe approaches to this essential, but underappreciated, problem in primary care.
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Atenção Primária à Saúde , Avaliação de Sintomas , HumanosRESUMO
Importance: Following up on recommendations from radiologic findings is important for patient care, but frequently there are failures to carry out these recommendations. The lack of reliable systems to characterize and track completion of actionable radiology report recommendations poses an important patient safety challenge. Objectives: To characterize actionable radiology recommendations and, using this taxonomy, track and understand rates of loop closure for radiology recommendations in a primary care setting. Design, Setting, and Participants: Radiology reports in a primary care clinic at a large academic center were redesigned to include actionable recommendations in a separate dedicated field. Manual review of all reports generated from imaging tests ordered between January 1 and December 31, 2018, by primary care physicians that contained actionable recommendations was performed. For this quality improvement study, a taxonomy system that conceptualized recommendations was developed based on 3 domains: (1) what is recommended (eg, repeat a test or perform a different test, specialty referral), (2) specified time frame in which to perform the recommended action, and (3) contingency language qualifying the recommendation. Using this framework, a 2-stage process was used to review patients' records to classify recommendations and determine loop closure rates and factors associated with failure to complete recommended actions. Data analysis was conducted from April to July 2021. Main Outcomes and Measures: Radiology recommendations, time frames, and contingencies. Rates of carrying out vs not closing the loop on these recommendations in the recommended time frame were assessed. Results: A total of 598 radiology reports were identified with structured recommendations: 462 for additional or future radiologic studies and 196 for nonradiologic actions (119 specialty referrals, 47 invasive procedures, and 43 other actions). The overall rate of completed actions (loop closure) within the recommended time frame was 87.4%, with 31 open loop cases rated by quality expert reviewers to pose substantial clinical risks. Factors associated with successful loop closure included (1) absence of accompanying contingency language, (2) shorter recommended time frames, and (3) evidence of direct radiologist communication with the ordering primary care physicians. A clinically significant lack of loop closure was found in approximately 5% of cases. Conclusions and Relevance: The findings of this study suggest that creating structured radiology reports featuring a dedicated recommendations field permits the development of taxonomy to classify such recommendations and determine whether they were carried out. The lack of loop closure suggests the need for more reliable systems.
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Radiologia , Comunicação , Diagnóstico por Imagem , Humanos , Radiologistas , Encaminhamento e ConsultaRESUMO
BACKGROUND: Studies consider the clinical encounter as linear, comprising six phases (opening, problem presentation, history-taking, physical examination, diagnosis, treatment and closing). This study utilizes formal conversation analysis to explore patient-physician interactions and understanding diagnostic utterances during these phases. METHODS: This study is a qualitative sub-analysis that explores how the diagnosis process, along with diagnostic uncertainty, are addressed during 28 urgent care visits. We analyzed physicians' hypothesis-generation process by focusing on: location of diagnostic utterances during the encounter; whether certain/uncertain diagnostic utterances were revised throughout the encounter; and how physicians tested their hypothesis-generation and managed uncertainty. We recruited 7 primary care physicians (PCPs) and their 28 patients from Brigham and Women's Hospital (BWH) in 3 urgent care settings. Encounters were audiotaped, transcribed, and coded using NVivo12 qualitative data analysis software. Data were analyzed inductively and deductively, using formal content and conversation analysis. RESULTS: We identified 62 diagnostic communication utterances in 12 different clinical situations. In most (24/28, 86%) encounters, the diagnosis process was initiated before the diagnosis phase (57% during history taking and 64% during physical examination). In 17 encounters (61%), a distinct diagnosis phase was not observed. Findings show that the diagnosis process is nonlinear in two ways. First, nonlinearity was observed when diagnostic utterances occurred throughout the encounter, with the six encounter phases overlapping, integrating elements of one phase with another. Second, nonlinearity was noted with respect to the resolution of diagnostic uncertainty, with physicians acknowledging uncertainty when explaining their diagnostic reasoning, even during brief encounters. CONCLUSIONS: Diagnosis is often more interactive and nonlinear, and expressions of diagnostic assessments can occur at any point during an encounter, allowing more flexible and potentially more patient-centered communication. These findings are relevant for physicians' training programs and helping clinicians improve their communication skills in managing uncertain diagnoses.
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Comunicação , Médicos , Feminino , Humanos , Gravação em Fita , IncertezaRESUMO
OBJECTIVES: Opioid misuse has resulted in significant morbidity and mortality in the United States, and safer opioid use represents an important challenge in the primary care setting. This article describes a research collaborative of health service researchers, systems engineers, and clinicians seeking to improve processes for safer chronic opioid therapy management in an academic primary care center. We present implementation results and lessons learned along with an intervention toolkit that others may consider using within their organization. METHODS: Using iterative improvement lifecycles and systems engineering principles, we developed a risk-based workflow model for patients on chronic opioids. Two key safe opioid use process metrics-percent of patients with recent opioid treatment agreements and urine drug tests-were identified, and processes to improve these measures were designed, tested, and implemented. Focus groups were conducted after the conclusion of implementation, with barriers and lessons learned identified via thematic analysis. RESULTS: Initial surveys revealed a lack of knowledge regarding resources available to patients and prescribers in the primary care clinic. In addition, 18 clinicians (69%) reported largely "inheriting" (rather than initiating) their chronic opioid therapy patients. We tracked 68 patients over a 4-year period. Although process measures improved, full adherence was not achieved for the entire population. Barriers included team structure, the evolving opioid environment, and surveillance challenges, along with disruptions resulting from the 2019 novel coronavirus. CONCLUSIONS: Safe primary care opioid prescribing requires ongoing monitoring and management in a complex environment. The application of a risk-based approach is possible but requires adaptability and redundancies to be reliable.
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COVID-19 , Dor Crônica , Transtornos Relacionados ao Uso de Opioides , Humanos , Estados Unidos , Analgésicos Opioides/efeitos adversos , Dor Crônica/tratamento farmacológico , Dor Crônica/induzido quimicamente , Padrões de Prática Médica , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológicoRESUMO
OBJECTIVES: A lack of consensus around definitions and reporting standards for diagnostic errors limits the extent to which healthcare organizations can aggregate, analyze, share, and learn from these events. In response to this problem, the Agency for Healthcare Research and Quality (AHRQ) began the development of the Common Formats for Event Reporting for Diagnostic Safety Events (CFER-DS). We conducted a usability assessment of the draft CFER-DS to inform future revision and implementation. METHODS: We recruited a purposive sample of quality and safety personnel working in 8 U.S. healthcare organizations. Participants were invited to use the CFER-DS to simulate reporting for a minimum of 5 cases of diagnostic safety events and then provide written and verbal qualitative feedback. Analysis focused on participants' perceptions of content validity, ease of use, and potential for implementation. RESULTS: Estimated completion time was 30 to 90 minutes per event. Participants shared generally positive feedback about content coverage and item clarity but identified reporter burden as a potential concern. Participants also identified opportunities to clarify several conceptual definitions, ensure applicability across different care settings, and develop guidance to operationalize use of CFER-DS. Findings led to refinement of content and supplementary materials to facilitate implementation. CONCLUSIONS: Standardized definitions of diagnostic safety events and reporting standards for contextual information and contributing factors can help capture and analyze diagnostic safety events. In addition to usability testing, additional feedback from the field will ensure that AHRQ's CFER-DS is useful to a broad range of users for learning and safety improvement.