RESUMEN
Only about half of eligible individuals undergo colon cancer screening. We have limited knowledge about the patient beliefs that adversely affect screening decisions and about which beliefs might be amenable to change through education. As part of a clinical trial, 641 rural Iowans, aged 52 to 79 years, reported their beliefs about colon cancer screening in response to a mailed questionnaire. Consenting subjects were randomized into four groups, which were distinguished by four levels of increasingly intensive efforts to promote screening. Two of the groups received mailed educational materials and completed a follow-up questionnaire, which allowed us to determine whether their beliefs about screening changed following the education. We also completed a factor analysis to identify underlying (latent) factors that might explain the responses to 33 questions about readiness, attitudes, and perceived barriers related to colon cancer screening. The strongest predictors of a patient's stated readiness to be screened were a physician's recommendation to be screened (1 point difference on 10-point Likert scale, 95 % confidence interval [CI], 0.5 to 1.6 point difference), a family history of colon cancer (0.85-point Likert scale difference, 95 % CI, 0.1 to 1.6), and a belief that health-care decisions should be mostly left to physicians rather than patients (Spearman correlation coefficient 0.21, P < .001). Of the 33 questionnaire items about screening beliefs, 11 (33 %) changed favorably following the educational intervention. In the factor analysis, the 33 items were reduced to 8 underlying factors, such as being too busy to undergo screening and worries about screening procedures. We found a limited number of underlying factors that may help explain patient resistance to colon cancer screening.
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Neoplasias del Colon/diagnóstico , Detección Precoz del Cáncer/psicología , Conocimientos, Actitudes y Práctica en Salud , Educación del Paciente como Asunto , Anciano , Neoplasias del Colon/prevención & control , Neoplasias del Colon/psicología , Cultura , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , PronósticoRESUMEN
Tinea infections are caused by dermatophytes and are classified by the involved site. The most common infections in prepubertal children are tinea corporis and tinea capitis, whereas adolescents and adults are more likely to develop tinea cruris, tinea pedis, and tinea unguium (onychomycosis). The clinical diagnosis can be unreliable because tinea infections have many mimics, which can manifest identical lesions. For example, tinea corporis can be confused with eczema, tinea capitis can be confused with alopecia areata, and onychomycosis can be confused with dystrophic toenails from repeated low-level trauma. Physicians should confirm suspected onychomycosis and tinea capitis with a potassium hydroxide preparation or culture. Tinea corporis, tinea cruris, and tinea pedis generally respond to inexpensive topical agents such as terbinafine cream or butenafine cream, but oral antifungal agents may be indicated for extensive disease, failed topical treatment, immunocompromised patients, or severe moccasin-type tinea pedis. Oral terbinafine is first-line therapy for tinea capitis and onychomycosis because of its tolerability, high cure rate, and low cost. However, kerion should be treated with griseofulvin unless Trichophyton has been documented as the pathogen. Failure to treat kerion promptly can lead to scarring and permanent hair loss.
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Dermatosis del Cuero Cabelludo/microbiología , Tiña/diagnóstico , Tiña/terapia , Adolescente , Antifúngicos/uso terapéutico , Diagnóstico Diferencial , Dermatosis del Pie/microbiología , Dermatosis del Pie/terapia , Dermatosis de la Mano/microbiología , Dermatosis de la Mano/terapia , Humanos , Onicomicosis/diagnóstico , Onicomicosis/terapia , Dermatosis del Cuero Cabelludo/tratamiento farmacológico , Tiña/tratamiento farmacológico , Tiña del Pie/diagnóstico , Tiña del Pie/terapiaRESUMEN
INTRODUCTION: Little is known about trends in the incidence of dependent adult abuse (DAA). OBJECTIVES: To determine the annual incidence of DAA in Iowa from 1984 to 2023. Trends in abuse rates were evaluated for their associations with calendar year, number of caseworkers and abuse laws, political party, and unemployment. METHODS: Iowa Department of Health and Human Services DAA reports, investigations, and substantiations were analyzed. Report data were available for 10 years. Investigation and substantiation data were available for 40 years. Long-term trends over time were described and associations between abuse rates and number of caseworkers and abuse laws, political party, and unemployment were explored. RESULTS: Both investigations and substantiations increased from 50 to 182 per 100 000 adults and 17 to 38 per 100 000 adults between 1984 and 2023, respectively. Increasing calendar year and Democratic party majority in the Iowa legislature were positively and independently associated with investigated and substantiated abuse rates. An inverse correlation between the proportion of reports that were investigated and the proportion of investigations that were substantiated (Spearman's rho = -.81; P < .01) was found. CONCLUSIONS: During the 40-year study period, investigated and substantiated cases of DAA in Iowa have been steadily increasing.
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Desempleo , Iowa/epidemiología , Humanos , Adulto , Incidencia , Femenino , Masculino , Desempleo/estadística & datos numéricos , Desempleo/tendencias , Política , Persona de Mediana EdadRESUMEN
Physicians often have difficulty diagnosing a generalized rash because many different conditions produce similar rashes, and a single condition can result in different rashes with varied appearances. A rapid and accurate diagnosis is critically important to make treatment decisions, especially when mortality or significant morbidity can occur without prompt intervention. When a specific diagnosis is not immediately apparent, it is important to generate an inclusive differential diagnosis to guide diagnostic strategy and initial treatment. In part I of this two-part article, tables listing common, uncommon, and rare causes of generalized rash are presented to help generate an inclusive differential diagnosis. The tables describe the key clinical features and recommended tests to help accurately diagnose generalized rashes. If the diagnosis remains unclear, the primary care physician must decide whether to observe and treat empirically, perform further diagnostic testing, or refer the patient to a dermatologist. This decision depends on the likelihood of a serious disorder and the patient's response to treatment.
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Exantema/diagnóstico , Exantema/etiología , Niño , Preescolar , Dermatología , Diagnóstico Diferencial , Exantema/terapia , Medicina Familiar y Comunitaria , Humanos , Lactante , Derivación y ConsultaRESUMEN
Although it is important to begin the evaluation of generalized rash with an inclusive differential diagnosis, the possibilities must be narrowed down by taking a focused history and looking for key clinical features of the rash. Part I of this two-part article lists the common, uncommon, and rare causes of generalized rashes. In part II, the clinical features that help distinguish these rashes are described. These features include key elements of the history (e.g., travel, environmental exposures, personal or family history of atopy); characteristics of individual lesions, such as color, size, shape, and scale; areas of involvement and sparing, with particular attention to palms, soles, face, nails, sun-exposed areas, and extensor and flexor surfaces of extremities; pruritic or painful lesions; systemic symptoms, especially fever; and dermatologic signs, such as blanching, and the Koebner phenomenon.
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Exantema/complicaciones , Exantema/diagnóstico , Biopsia , Niño , Preescolar , Dermatología , Exantema/terapia , Medicina Familiar y Comunitaria , Humanos , Lactante , Derivación y Consulta , Factores de RiesgoRESUMEN
OBJECTIVES: The objective of the study was to determine how many patient-related questions emergency medicine physicians have and how they answer them at the point of care. METHODS: We conducted an observational study of 26 physicians at 2 institutions. All physicians were followed for at least 2 shifts. The number and type of questions were recorded. The percentage answered, resources used, and barriers to answering questions were also recorded. RESULTS: Physicians had 235 questions or approximately 5 questions per 8-hour shift . They attempted to answer 81% of them and were successful 87% of the time. The 2 most commonly used information sources were drug information resources (Personal digital assistant [PDA], pocket pharmacopeia [37% of the time]) followed by electronic resources (Google, UpToDate [29% of the time]). The most common reason for not pursuing a question was lack of time and distractions or interruptions, followed by a belief that an answer would not be found. When an answer was not found to a pursued question, non-emergency department physicians were the most common resource consulted (28%). CONCLUSIONS: Emergency department physicians in this study pursued and found answers for most questions posed at the point of care. Rapid access to electronic resources and drug-prescribing references were critical for answering questions at the point of care.
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Comunicación , Medicina de Emergencia , Servicio de Urgencia en Hospital , Relaciones Médico-Paciente , HumanosRESUMEN
BACKGROUND AND OBJECTIVES: Physicians often accuse their peers of being "black clouds" if they repeatedly have more than the average number of hospital admissions while on call. Our purpose was to determine whether the black-cloud phenomenon is real or explainable by random variation. METHODS: We analyzed hospital admissions to the University of Iowa family medicine service from July 1, 2010 to June 30, 2015. Analyses were stratified by peer group (eg, night shift attending physicians, day shift senior residents). We analyzed admission numbers to find evidence of black-cloud physicians (those with significantly more admissions than their peers) and white-cloud physicians (those with significantly fewer admissions). The statistical significance of whether there were actual differences across physicians was tested with mixed-effects negative binomial regression. RESULTS: The 5-year study included 96 physicians and 6,194 admissions. The number of daytime admissions ranged from 0 to 10 (mean 2.17, SD 1.63). Night admissions ranged from 0 to 11 (mean 1.23, SD 1.22). Admissions increased from 1,016 in the first year to 1,523 in the fifth year. We found 18 white-cloud and 16 black-cloud physicians in simple regression models that did not control for this upward trend. After including study year and other potential confounding variables in the regression models, there were no significant associations between physicians and admission numbers and therefore no true black or white clouds. CONCLUSIONS: In this study, apparent black-cloud and white-cloud physicians could be explained by random variation in hospital admissions. However, this randomness incorporated a wide range in workload among physicians, with potential impact on resident education at the low end and patient safety at the high end.
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Cuerpo Médico de Hospitales/estadística & datos numéricos , Admisión del Paciente/estadística & datos numéricos , Carga de Trabajo/estadística & datos numéricos , Recolección de Datos , Hospitalización , Humanos , Internado y Residencia , Modelos Estadísticos , Médicos , Estudios RetrospectivosRESUMEN
OBJECTIVE: To describe the characteristics of unanswered clinical questions and propose interventions that could improve the chance of finding answers. DESIGN: In a previous study, investigators observed primary care physicians in their offices and recorded questions that arose during patient care. Questions that were pursued by the physician, but remained unanswered, were grouped into generic types. In the present study, investigators attempted to answer these questions and developed recommendations aimed at improving the success rate of finding answers. MEASUREMENTS: Frequency of unanswered question types and recommendations to increase the chance of finding answers. RESULTS: In an earlier study, 48 physicians asked 1062 questions during 192 half-day office observations. Physicians could not find answers to 237 (41%) of the 585 questions they pursued. The present study grouped the unanswered questions into 19 generic types. Three types accounted for 128 (54%) of the unanswered questions: (1) "Undiagnosed finding" questions asked about the management of abnormal clinical findings, such as symptoms, signs, and test results (What is the approach to finding X?); (2) "Conditional" questions contained qualifying conditions that were appended to otherwise simple questions (What is the management of X, given Y? where "given Y" is the qualifying condition that makes the question difficult.); and (3) "Compound" questions asked about the association between two highly specific elements (Can X cause Y?). The study identified strategies to improve clinical information retrieval, listed below. CONCLUSION: To improve the chance of finding answers, physicians should change their search strategies by rephrasing their questions and searching more clinically oriented resources. Authors of clinical information resources should anticipate questions that may arise in practice, and clinical information systems should provide clearer and more explicit answers.
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Atención al Paciente , Médicos , Atención Primaria de Salud , Comunicación , Humanos , Almacenamiento y Recuperación de la Información , Obras Médicas de ReferenciaRESUMEN
The Agency for Healthcare Research and Quality Quality Indicator tools were used to identify risk factors for maternal birth-related trauma rates in the 2003 Nationwide Inpatient Sample and the 2002-2004 Iowa State Inpatient Database. Risk-adjusted analyses of these datasets isolated salient risk factors for maternal trauma. The rates of Iowa's risk factors for the most serious types of trauma--third/fourth-degree lacerations--were compared with national rates. The comparisons suggest that episiotomy, artificial rupture of membranes, obstructed labor, and late pregnancies are the most salient risk factors for third/fourth-degree lacerations within Iowa. Thus, this research suggested that a combination of maternal, baby, and episiotomy factors contributed to the high prevalence of third/fourth-degree lacerations in vaginal deliveries in Iowa. Finally, our risk-adjustment methodology could be used in a similar manner to analyze other discharge datasets for opportunities to improve maternal outcomes.
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Parto Obstétrico/efectos adversos , Parto Obstétrico/estadística & datos numéricos , Laceraciones/epidemiología , Complicaciones del Embarazo/epidemiología , Seguridad , Adolescente , Adulto , Factores de Edad , Episiotomía/estadística & datos numéricos , Femenino , Humanos , Iowa/epidemiología , Complicaciones del Trabajo de Parto/epidemiología , Embarazo , Calidad de la Atención de Salud/estadística & datos numéricos , Grupos Raciales , Factores de RiesgoRESUMEN
OBJECTIVES: To categorise questions that emergency department physicians have during patient encounters. METHODS: An observational study of 26 physicians at two institutions. All physicians were followed for at least two shifts. All questions that arose during patient care were recorded verbatim. These questions were then categorised using a taxonomy of clinical questions. RESULTS: Physicians had 271 questions in the course of the study. The most common questions were about drug dosing (35), what drug to use in a particular case (28), "what are the manifestations of disease X" (23), and what laboratory test to do in a situation (21). Notably lacking were questions about medication costs, administrative questions, questions about services in the community, and pathophysiology questions. CONCLUSIONS: Emergency department physicians tend to have questions that cluster around practical issues such as diagnosis and treatment. In routine practice they have fewer epidemiologic, pathophysiologic, administrative, and community services questions.
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Medicina de Emergencia/estadística & datos numéricos , Servicio de Urgencia en Hospital , Conocimientos, Actitudes y Práctica en Salud , Competencia Clínica , Encuestas de Atención de la Salud , Humanos , Iowa , Relaciones Médico-PacienteRESUMEN
BACKGROUND AND OBJECTIVES: Effective management of patients with medically unexplained symptoms may be influenced by physicians' goals. This study's objective was to identify physicians' goals for managing primary care patients with unexplained symptoms. METHODS: This was a qualitative study of patients and clinicians from primary care clinics in Iowa and Illinois. Interviews were conducted with 47 patients who had unexplained symptoms and the 36 primary care clinicians who managed them. The interviews were transcribed and coded independently by two investigators. Categories for coding responses were derived from the data and the literature. RESULTS: Eleven goals were identified and grouped into four classes based on whether they were disease centered, patient centered, society centered, or clinician centered. The three goals most commonly held by patients were patient centered: clinician support (62%), functional improvement (45%), and patient coping (43%). The most common clinician goals were symptom alleviation (38%), patient coping (32%), and functional improvement (30%). Only one clinician (2%) cited making the patient feel supported as a goal. CONCLUSIONS: The goals of clinician support and patient coping appear to have value to patients beyond being means for achieving symptom alleviation. Although receiving physician support is an important goal for patients, it was not a commonly recognized goal by physicians. Clearly identified management goals may improve the care of patients with medically unexplained symptoms and help clinicians achieve greater satisfaction with the management of these patients.
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Objetivos , Médicos de Familia , Atención Primaria de Salud/métodos , Adaptación Psicológica , Adulto , Anciano , Anciano de 80 o más Años , Instituciones de Atención Ambulatoria , Femenino , Humanos , Entrevistas como Asunto , Iowa , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Atención Dirigida al PacienteRESUMEN
In this article we review current evidence on strategies to evaluate diagnostic error solutions, discuss the methodological challenges that exist in investigating the value of these strategies in patient care, and provide recommendations for methods that can be applied in investigating potential solutions to diagnostic errors. These recommendations were developed iteratively by the authors based upon initial discussions held during the Research Summit of the 7th Annual Diagnostic Error in Medicine Conference in September 2014. The recommendations include the following elements for designing studies of diagnostic research solutions: (1) Select direct and indirect outcomes measures of importance to patients, while also practical for the particular solution; (2) Develop a clearly-stated logic model for the solution to be tested; (3) Use rapid, iterative prototyping in the early phases of solution testing; (4) Use cluster-randomized clinical trials where feasible; (5) Avoid simple pre-post designs, in favor of stepped wedge and interrupted time series; (6) Leverage best practices for patient safety research and engage experts from relevant domains; and (7) Consider sources of bias and design studies and their analyses to minimize selection and information bias and control for confounding. Areas of diagnostic error mitigation research identified for further attention include: role of competing diagnoses, understanding the impacts of organizational culture, timing of diagnosis, and sequencing of research studies. Future research will likely require novel clinical, health services, and qualitative research methods to address the age-old problem of arriving at an accurate diagnosis.
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OBJECTIVE: To identify the most frequent obstacles preventing physicians from answering their patient-care questions and the most requested improvements to clinical information resources. DESIGN: Qualitative analysis of questions asked by 48 randomly selected generalist physicians during ambulatory care. MEASUREMENTS: Frequency of reported obstacles to answering patient-care questions and recommendations from physicians for improving clinical information resources. RESULTS: The physicians asked 1,062 questions but pursued answers to only 585 (55%). The most commonly reported obstacle to the pursuit of an answer was the physician's doubt that an answer existed (52 questions, 11%). Among pursued questions, the most common obstacle was the failure of the selected resource to provide an answer (153 questions, 26%). During audiotaped interviews, physicians made 80 recommendations for improving clinical information resources. For example, they requested comprehensive resources that answer questions likely to occur in practice with emphasis on treatment and bottom-line advice. They asked for help in locating information quickly by using lists, tables, bolded subheadings, and algorithms and by avoiding lengthy, uninterrupted prose. CONCLUSION: Physicians do not seek answers to many of their questions, often suspecting a lack of usable information. When they do seek answers, they often cannot find the information they need. Clinical resource developers could use the recommendations made by practicing physicians to provide resources that are more useful for answering clinical questions.
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Atención al Paciente , Médicos , Adulto , Comunicación , Bases de Datos como Asunto/estadística & datos numéricos , Medicina Familiar y Comunitaria , Femenino , Humanos , Servicios de Información , Almacenamiento y Recuperación de la Información , Medicina Interna , Entrevistas como Asunto , Masculino , Pediatría , Obras Médicas de Referencia , Derivación y ConsultaRESUMEN
BACKGROUND: Many diagnostic errors are caused by premature closure of the diagnostic process. To help prevent premature closure, we developed checklists that prompt physicians to consider all reasonable diagnoses for symptoms that commonly present in primary care. METHODS: We enrolled 14 primary care physicians and 100 patients in a randomized clinical trial. The study took place in an emergency department (5 physicians) and a same-day access clinic (9 physicians). The physicians were randomized to usual care vs. diagnostic checklist. After completing the history and physical exam, checklist physicians read aloud a differential diagnosis checklist for the chief complaint. The primary outcome was diagnostic error, which was defined as a discrepancy between the diagnosis documented at the acute visit and the diagnosis based on a 1-month follow-up phone call and record review. RESULTS: There were 17 diagnostic errors. The mean error rate among the seven checklist physicians was not significantly different from the rate among the seven usual-care physicians (11.2% vs. 17.8%; p=0.46). In a post-hoc subgroup analysis, emergency physicians in the checklist group had a lower mean error rate than emergency physicians in the usual-care group (19.1% vs. 45.0%; p=0.04). Checklist physicians considered more diagnoses than usual-care physicians during the patient encounters (6.5 diagnoses [SD 4.2] vs. 3.4 diagnoses [SD 2.0], p<0.001). CONCLUSIONS: Checklists did not improve the diagnostic error rate in this study. However further development and testing of checklists in larger studies may be warranted.
RESUMEN
As physicians, we take pride in our ability to generate, from memory, a complete differential diagnosis for our patients' presenting symptoms. We expect this of ourselves and our trainees, but we do not do it reliably. Studies have found that the most common cause of diagnostic error is the physician's failure to consider the correct diagnosis as a possibility. Other professionals, like airline pilots and nuclear plant operators, have accepted the fallibility of their memories and have learned how to ensure reliable completion of critical tasks by using checklists. But our culture in medicine glorifies physicians who complete the critical task of diagnosis using their memories and disparages those who cheat by referring to a list. Recent studies have supported the use of checklists in the operating room and intensive care unit, but so far they have not been used to make diagnosis more reliable. This essay explores a possible use for differential-diagnosis checklists by describing the author's experience with them in a primary care clinic.
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BACKGROUND: Many adults have not been screened for colon cancer, a potentially preventable cause of death. METHODS: This was a randomized controlled trial conducted between December 2008 and April 2011 to improve CRC screening in 16 rural family physician offices. Subjects due for CRC screening were randomized within each practice to 1 of 4 groups: (1) usual care; (2) physician chart reminder; (3) physician chart reminder, mailed education, CRC reminder magnet, and fecal immunochemical test (FIT) (mailed education/FIT); or (4) all the preceding plus a structured telephone call to the patient from project staff to provide education, assess interest in screening, explain the screening tests, and address barriers (mailed education/FIT plus phone call). The main outcome was completion of any CRC screening. RESULTS: This study enrolled 743 patients. CRC screening was completed by 17.8% in the usual care group, 20.5% in the chart reminder group, 56.5% in the mailed education/FIT group, and 57.2% in the mailed education/FIT plus phone call group. We found no effect from the chart reminder compared with usual care (odds ratio [OR], 1.2; 95% confidence interval [CI], 0.7-2.0); and a beneficial effect from the mailed education/FIT (OR, 6.0; 95% CI, 3.7-9.6) and the mailed education/FIT plus phone call (OR, 6.2; 95% CI, 3.8-9.9). Both FIT and colonoscopy rates increased significantly in both mailed education groups. CONCLUSION: CRC screening rates increased significantly among patients who were overdue for screening after they received mailed educational materials and a FIT. The addition of a phone call did not further increase screening rates.
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Neoplasias del Colon/diagnóstico , Colonoscopía/estadística & datos numéricos , Educación en Salud , Sangre Oculta , Sistemas Recordatorios , Población Rural , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Iowa , Masculino , Tamizaje Masivo/métodos , Tamizaje Masivo/estadística & datos numéricos , Persona de Mediana Edad , Mejoramiento de la Calidad , Servicios de Salud RuralRESUMEN
BACKGROUND: Diagnostic errors occur more commonly than other kinds of errors, they are more likely to harm patients, and they are more likely to be preventable. Little is known about the presenting complaints, initial (incorrect) diagnoses, and physicians' personal lessons learned related to diagnostic errors. METHODS: In 2009 and 2010, we invited a random sample of 200 family physicians, 200 general internists, and 200 general pediatricians practicing in Iowa to describe an important diagnostic error using a 1-page, mailed questionnaire. The data were analyzed using quantitative and qualitative methods. RESULTS: The response rate was 34% (202 of 600 physicians). Common presenting complaints included abdominal pain (n = 27 of 202 patients, 13%); fever (n = 19; 9%); and fatigue (n = 15, 7%). Common initial (incorrect) diagnoses included benign viral infections (n = 35, 17%); musculoskeletal pain (n = 21, 10%); and chronic obstructive pulmonary disease/asthma (n = 13, 6%). The 202 responding physicians described 254 personal lessons learned, which we used to develop a taxonomy of 24 generic lessons. Three common lessons were: (1) consider diagnosis X in patients presenting with symptom Y (n = 37 lessons, 15%; eg, "Any discomfort above the umbilicus may be coronary artery disease."); (2) look beyond the initial, most obvious diagnosis (n = 26 lessons, 10%); and (3) be alert to atypical presentations of disease (n = 24 lessons, 9%). CONCLUSIONS: In this study, diagnostic errors often were preceded by common symptoms and common, relatively benign initial diagnoses. The lessons learned often involved various aspects of broadening the differential diagnosis.
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Errores Diagnósticos , Aprendizaje , Atención Primaria de Salud , Femenino , Humanos , Iowa , Masculino , Médicos de Atención Primaria , Calidad de la Atención de Salud , Encuestas y CuestionariosRESUMEN
BACKGROUND: Only about half of eligible Americans are adherent with colorectal cancer (CRC) screening. Because patients generally access CRC screening via their primary care physicians, interventions to improve screening should be tested in the primary care setting. This article describes the recruitment and baseline characteristics of patients from 16 practice-based research network practices for a study to improve CRC screening. METHODS: A total of 8327 invitations were mailed to patients of these practices, and 1685 returned consent forms and baseline surveys. RESULTS: Of those who consented, 942 were up to date with screening, which indicates that office databases were unable to provide information about those who were already screened. The 743 due for screening were younger (mean age, 61 vs. 63 years), less likely to have an immediate family member with CRC (11% vs. 19%), less likely to have Medicare (29% vs. 40%), more likely to have no insurance (5% vs. 1%), and less likely to report a physician/nurse recommendation for CRC screening (63% vs. 92%) for all comparisons. CONCLUSIONS: Our experiences for this practice-based research network randomized clinical intervention trial may be useful to others. Practice and patient recruitment processes were onerous with institutional review board issues, poorly prepared patient databases, and discarding of mail by the US Postal Service.