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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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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
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
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
Importance: More conservative prescribing has the potential to reduce adverse drug events and patient harm and cost; however, no method exists defining the extent to which individual clinicians prescribe conservatively. One potential domain is prescribing a more limited number of drugs. Personal formularies-defined as the number and mix of unique, newly initiated drugs prescribed by a physician-may enable comparisons among clinicians, practices, and institutions. Objectives: To develop a method of defining primary care physicians' personal formularies and examine how they differ among primary care physicians at 4 institutions; evaluate associations between personal formularies and patient, physician, and practice site characteristics; and empirically derive and examine the variability of the top 200 core drugs prescribed at the 4 sites. Design, Setting, and Participants: This retrospective cohort study was conducted at 4 US health care systems among 4655 internal and family medicine physicians and 4â¯930â¯707 patients who had at least 1 visit to these physicians between January 1, 2017, and December 31, 2018. Exposures: Personal formulary size was defined as the number of unique, newly initiated drugs. Main Outcomes and Measures: Personal formulary size and drugs used, physician and patient characteristics, core drugs, and analysis of selected drug classes. Results: The study population included 4655 primary care physicians (2274 women [48.9%]; mean [SD] age, 48.5 [4.4] years) and 4â¯930â¯707 patients (16.5% women; mean [SD] age, 51.9 [8.3] years). There were 41â¯378â¯903 outpatient prescriptions written, of which 9â¯496â¯766 (23.0%) were new starts. Institution median personal formulary size ranged from 150 (interquartile range, 82.0-212.0) to 296 (interquartile range, 230.0-347.0) drugs. In multivariable modeling, personal formulary size was significantly associated with panel size (total number of unique patients with face-to-face encounters during the study period; 1.2 medications per 100 patients), physician's total number of encounters (5.7 drugs per 10% increase), and physician's sex (-6.2 drugs per 100 patients for female physicians). There were 1527 unique, newly prescribed drugs across the 4 sites. Fewer than half the drugs (626 [41.0%]) were used at every site. Physicians' prescribing of drugs from a pooled core list varied from 0% to 100% of their prescriptions. Conclusions and Relevance: Personal formularies, measured at the level of individual physicians and institutions, reveal variability in size and mix of drugs. Similarly, defining a list of commonly prescribed core drugs in primary care revealed interphysician and interinstitutional differences. Personal formularies and core medication lists enable comparisons and may identify outliers and opportunities for safer and more appropriate prescribing.
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Atenção à Saúde/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Médicos de Atenção Primária/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Feminino , Formulários Farmacêuticos como Assunto , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados UnidosRESUMO
OBJECTIVE: Alert presentation of clinical decision support recommendations is a common method for providing information; however, many alerts are overridden suggesting presentation design improvements can be made. This study attempts to assess pediatric prescriber information needs for drug-drug interactions (DDIs) alerts and to evaluate the optimal presentation timing and presentation in the medication ordering process. METHODS: Six case scenarios presented interactions between medications used in pediatric specialties of general medicine, infectious disease, cardiology, and neurology. Timing varied to include alert interruption at medication selection versus order submission; or was noninterruptive. Interviews were audiotaped, transcribed, and independently analyzed to derive central themes. RESULTS: Fourteen trainee and attending clinicians trained in pediatrics, cardiology, and neurology participated. Coders derived 8 central themes from 929 quotes. Discordance exists between medication prescribing frequency and DDI knowledge; providers may commonly prescribe medications for which they do not recognize DDIs. Providers wanted alerts at medication selection rather than at order signature. Alert presentation themes included standardizing text, providing interaction-specific incidence/risk information, DDI rating scales, consolidating alerts, and providing alternative therapies. Providers want alerts to be actionable, for example, allowing medication discontinuation and color visual cues for essential information. Despite alert volume, participants did not "mind being reminded because there is always the chance that at that particular moment (they) do not remember it" and acknowledged the importance of alerts as "essential in terms of patient safety." CONCLUSION: Clinicians unanimously agreed on the importance of receiving DDI alerts to improve patient safety. The perceived alert value can be improved by incorporating clinician preferences for timing and presentation.
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Interações Medicamentosas , Pessoal de Saúde/psicologia , Percepção , Sistemas de Alerta , Hospitais , Humanos , Pediatria , Inquéritos e Questionários , Fatores de TempoAssuntos
Betacoronavirus , Doença Crônica/epidemiologia , Doença Crônica/tendências , Infecções por Coronavirus/epidemiologia , Gerenciamento Clínico , Epidemias , Pneumonia Viral/epidemiologia , COVID-19 , Doença Crônica/terapia , Infecções por Coronavirus/terapia , Testes Diagnósticos de Rotina/tendências , Prescrições de Medicamentos , Humanos , Pandemias , Pneumonia Viral/terapia , SARS-CoV-2RESUMO
The commentary below was written by Dr. Gordon Schiff and Maria Mirica for the PRIDE (Primary Care Research in Diagnostic Errors) project, an initiative of the Betsy Lehman Center for Patient Safety and Brigham and Women's Hospital Center for Patient Safety Research and Practice with support from the Gordon and Betty Moore Foundation. It highlights some of the key issues related to diagnostic accuracy issues for COVID-19 and beyond.
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Betacoronavirus/genética , Técnicas de Laboratório Clínico/estatística & dados numéricos , Infecções por Coronavirus/diagnóstico , Erros de Diagnóstico/estatística & dados numéricos , Pneumonia Viral/diagnóstico , COVID-19 , Teste para COVID-19 , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Diagnóstico Diferencial , Reações Falso-Negativas , Reações Falso-Positivas , Humanos , Pandemias , Segurança do Paciente , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , SARS-CoV-2 , Sensibilidade e EspecificidadeRESUMO
While electronic prescribing has been shown to reduce medication errors and improve prescribing safety, it is vulnerable to error-prone processes. We review six intersecting areas in which changes to electronic prescribing systems, particularly in the outpatient setting, could transform medication ordering quality and safety. We recommend incorporating medication indications into electronic prescribing, establishing a single shared online medication list, implementing the transmission of electronic cancellation orders to pharmacies (CancelRx) to ensure that drugs are safely and reliably discontinued, implementing standardized structured and codified prescription instructions, reengineering clinical decision support, and redesigning electronic prescribing to facilitate the ordering of nondrug alternatives.