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APRECIACIÓN CRÍTICA DE LA LITERATURA MÉDICA:
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Sres. MÉDICOS DEL AÑO PREVIO:
En este archivo hay material para realizar las siguientes tareas:
A.- ANÁLISIS CRÍTICO DE LA LITERATURA MÉDICA, SOBRE TRABAJOS PUBLICADOS PARA EJERCITACIÓN:
- ENCONTRARÁ LAS FECHAS EN LAS QUE DEBERÁ LLEVAR ANALIZADOS LOS TRABAJOS; SI FALTA NO IMPORTA, DEBE ANALIZARLOS IGUAL. EN EL MOMENTO DE LA CONTRASTACIÓN A UD. SE LE PREGUNTARÁ SU JUICIO DE VALOR, SIN VOLVER A LEER EL TRABAJO. SI NO ENTENDIÓ ALGO, DEBERÁ PREGUNTARLO ANTES DE COMENZAR LA EVALUACIÓN, PORQUE LUEGO DE COMENZADA NO DEBERÁ HACERLO
B.-.LEA TRATANDO DE COMPRENDER Y LUEGO ANALIZAR VALORATIVAMENTE LA RELEVANCIA DEL TRABAJO.
PREGUNTE AL DOCENTES EN EL MOMENTO QUE LO CREA CONVENIENTE. SI NO COMPRENDE Y NO PREGUNTA SE PERJUDICARÁ.
B.1.- LECTURA GLOBAL COMPRENSIVA SOBRE TRATA LA INVESTIGACIÓN
B.2.- LECTURA REFLEXIVA DEL TRABAJO.
B.3.- LECTURA CRÍTICA APLICANDO LAS GUÍAS DEL USUARIO DE LA LITERATURA MÉDICA.
B.4.- LECTURA VALORATIVA.
B.5.- CONCLUSIÓN DEL JUICIO CRÍTICO
ESQUEMA DE ANÁLISIS DE LA LITERATURA MÉDICA:
1.- JUZGUE PERTINENCIA: ¿ES PERTINENTE A SU PRÁCTICA?
COMO UD. SE HALLA APRENDIENDO TODOS LOS TRABAJOS DEBERÁN SER CONSIDERADOS PERTINENTES.
CUANDO UD. SE HALLE EN PLAN DE ACTUALIZACIÓN: NO LEA PUBLICACIONES QUE NO SEAN PERTINENTES A SU PRÁCTICA, DE LA SIGUIENTE MANERA:
SI SU RESPUESTA ES NEGATIVA: ¡NO PIERDA TIEMPO CON ESTA PUBLICACIÓN!
SI SU RESPUESTA ES POSITIVA:
2.- JUZGUE LA RELEVANCIA CIENTÍFICA:
¡A PESAR DE SER PERTINENTE PUEDE SER LITERATURA BASURA!
TENGA EN CUENTA:
TÍTULO DEL TRABAJO:
MÉTODO:
¡JUZGUE!:
A.- ¿A QUÉ TÓPICO PERTENECE Y QUÉ GUÍAS ELIGE PARA JUZGARLO?
TÓPICO PROPUESTO:
¡APLIQUE LAS GUÍAS SECUENCIALMENTE!
* SI NO CUMPLE LAS GUÍAS PRIMARIAS DEBERÁ DESECHARLO; ANTE LA PRIMERA GUÍA QUE NO SE CUMPLA ABANDONE EL ANÁLISIS CRÍTICO: ¡ES LITERATURA BASURA!
* SI NO CUMPLE LAS GUÍAS SECUNDARIAS DEBERÁ PENSAR EN LA POSIBILIDAD DE SESGOS, AL RESPECTO SE SUGIERE TENER EN CUENTA LOS SIGUIENTES ASPECTOS PARA TENER EN CUENTA LA RELEVANCIA DE LOS RESULTADOS:
¿CUÁL ES EL DISEÑO MÁS RELEVANTE AL RESPECTO?
DISEÑO PROPUESTO: ¿PROBLEMAS QUE PRESENTA?
¿SIRVE PARA EL PROBLEMA UN DISEÑO COMO EL PUBLICADO?
¿CÓMO SE DEBE PLANTEAR EL PROBLEMA?
¡HIATO EN EL CONOCIMIENTO!
Background
¡MÉTODO!
ANÁLISIS ESTADÍSTICO UNI Y MULTIVARIADO:
CONCLUSIONES:
B.- ¿QUÉ SESGOS LE DESCUBRIÓ?
C.- ¿COMPRENDIÓ TODO LO QUE DICE?
FECHAS:
ESTIMADOS COLEGAS:
En las fechas que figuran a continuación Ud. deberá concurrir con los Trabajos mencionados analizados según las indicaciones que se hallan en el espacio precedente. Debe ir preparado para realizar la tarea en forma grupal, individual, oral o escrita a modo de evaluación.
4-7: TRABAJO Nº:0 ACTUALIZACIÓN.
8-8: TRABAJO Nº:1 ACTUALIZACIÓN.
8-8: TRABAJO Nº:2
29-8: TRABAJO Nº:3 ACTUALIZACIÓN.
5-9: TRABAJO Nº:4
12-9: TRABAJO Nº:5 Y6 ACTUALIZACIÓN.
3-10: TRABAJO Nº: 7 Y8 ACTUALIZACIÓN.
10-10: TRABAJO Nº: 9 Y 10 ACTUALIZACIÓN.
31-10: TRABAJO Nº: 11Y12 ACTUALIZACIÓN.
7-11: TRABAJO Nº: 13 Y14 ACTUALIZACIÓN.
14-11: TRABAJO Nº: 15 Y16 ACTUALIZACIÓN.
5-12: TRABAJO Nº: 17 Y 18 ACTUALIZACIÓN.
12-12: TRABAJO Nº: 19 Y 20
\\\\\\\ TRABAJO 0 COMPLETO EXPLICACIÓN
\\\\\\\\ TRABAJO Nº: 1
\\\\\\\ TRABAJO Nº: 2
\\\\\\\ TRABAJO Nº: 3
\\\\\\\ TRABAJO Nº: 4
\\\\\\\ TRABAJO Nº: 5
\\\\\\\ TRABAJO Nº: 6
\\\\\\\ TRABAJO Nº: 7
\\\\\\\ TRABAJO Nº: 8
\\\\\\\ TRABAJO Nº: 9
\\\\\\\ TRABAJO Nº: 10 Y 11
\\\\\\\ TRABAJO Nº: 12 Y 13
\\\\\\\ TRABAJO Nº: 14 Y 15
\\\\\\\ TRABAJO Nº: 16 Y 17
\\\\\\\ TRABAJO Nº: 18- 19
\\\\\\\ TRABAJO Nº: 20
0.-
Interacciones farmacológicas de los inhibidores de la bomba de protones con otros fármacos. Dres. Garnett W, Prescott J SIIC. Managed Care Interface 13(9):71-79, Sep 2000
La prescripción conjunta de los inhibidores de la bomba de protones y de otros fármacos es un hecho frecuente. El conocimiento de las eventuales interacciones medicamentosas permite evitar efectos adversos.
Introducción
Los inhibidores de la bomba de protones (IBP) suprimen la secreción ácida gástrica mediante la inhibición selectiva de la ATPasa hidrógeno-potasio de los canalículos de las células parietales gástricas. Estos fármacos son el tratamiento de elección para la enfermedad por reflujo gastroesofágico (ERGE), la esofagitis erosiva, las úlceras pépticas (UP) y otros trastornos dependientes del ácido, como el síndrome de Zollinger-Ellison. Dada la enorme cantidad de personas que reciben IBP, existe una alta probabilidad de que se los utilice en forma conjunta con otros fármacos. En esa situación, es probable que aparezcan efectos adversos debidos a las interacciones farmacológicas.
El objetivo de este trabajo fue determinar con qué frecuencia los pacientes tratados con omeprazol o lansoprazol recibían en forma conjunta otros fármacos que eventualmente pudieran interactuar con ellos. El uso de otros IBP, como el pantoprazol y el rabeprazol, no fue incluido en el análisis por la falta de datos suficientes, dada su posterior introducción en el mercado.
Pacientes y métodos
Este estudio fue de carácter retrospectivo y se basó en la información sobre los trastornos gastrointestinales (GI) y el uso de IBP volcado en los registros de los planes de salud en el curso del año 1996.
La base de datos consultada contaba en ese momento con información sobre 1.500.000 individuos provenientes de distintos lugares de EE.UU.
La edad promedio de los pacientes fue de 40 años, el 51% de ellos eran varones. Se incluyeron los enfermos de 18 a 64 años con 1 o más de las siguientes condiciones clínicas: ERGE, otras alteraciones esofágicas, UP, gastritis y duodenitis, otras alteraciones del estómago y el duodeno, hemorragia digestiva, hernia diafragmática, pirosis, síntomas digestivos inespecíficos, dolor abdominal, síntomas abdominales mal definidos, UP y ERGE, infección por Helicobacter pylori y los que recibían IBP por diagnósticos no especificados.
Los datos de cada paciente fueron analizados en el contexto de un “episodio de tratamiento”, entendido como el período en el cual un sujeto recibió atención (ambulatoria o en internación) y tratamiento farmacológico por una condición clínica específica. Se requirió que dicho período fuera superior a 31 días para ser considerado en el análisis. Se excluyeron las embarazadas.
Un total de 30 749 casos fueron seleccionados para ingresar en el estudio y clasificados según su trastorno digestivo. Como algunos de esos sujetos presentaban más de un trastorno, fueron incluidos en más de un grupo.
Los fármacos para analizar fueron seleccionados basándose en su propensión a interactuar con los IBP o porque era habitual usarlos en forma conjunta con estos para el tratamiento de problemas GI.
Se consideró coprescripción cuando el paciente recibió una o más prescripciones de un IBP (omeprazol o lansoprazol) durante los 2 períodos que se describen a continuación, en forma conjunta con otros fármacos incluidos en el análisis. Los 2 períodos evaluados fueron: el lapso de 120 días antes del inicio de la toma del IBP y el período entre la prescripción del IBP y el momento calculado para finalizar su uso según el número de cápsulas indicadas.
Resultados
Coprescripción de IBP con otros fármacos sin efecto GI
La frecuencia global de coprescripción de IBP con otros fármacos sin efecto GI fue alta.
De los 10625 pacientes tratados con IBP, 5456 (51.4%) recibieron en forma conjunta uno o más de los fármacos seleccionados. Tal situación fue aún más frecuente en los enfermos con infección por H. pylori (86.7% de coprescripción) y en aquellos con síntomas abdominales mal definidos.
Del total de 30749 pacientes que ingresaron en el estudio, 10 625 (34.6%) recibían IBP. Estos fármacos fueron utilizados en el 75% de los casos de infección por H. pylori, 69.3% de aquellos con UP más ERGE, 54.3% de los de ERGE como trastorno único, 50.9% de los de hernia diafragmática, 48.6% de los de pirosis y 48.5% de los de UP. Los autores llaman la atención sobre el hecho de que sólo 20 pacientes de los ingresados tenían infección documentada por H. pylori, mientras que 2 208 eran portadores de UP, un trastorno asociado a menudo con esa bacteria.
Los fármacos más frecuentemente prescriptos en forma conjunta con los IBP fueron los estrógenos, registrados en el 17.2% de los casos; seguidos de las benzodiazepinas, utilizadas por el 12.6% y, en tercer lugar, la claritromicina, un antibiótico macrólido incluido a menudo en el esquema de erradicación de H. pylori. Este último fue consumido por el 12.5% de los enfermos que a su vez recibían IBP. Otros fármacos indicados en forma conjunta fueron los corticoesteroides (7.3%), los anticonceptivos orales (4.9%), la eritromicina (4.6%) y el ibuprofeno (3.9%).
Coprescripción con otros fármacos con efecto GI
Un 44.4% de los enfermos tratados con IBP (n = 4 722) recibían en forma conjunta otros fármacos con efecto GI. Esto se observó con mayor asiduidad en los pacientes con UP más ERGE (59.6%), los portadores de hernias diafragmáticas (54.7%), los infectados por H. pylori (53.3%), y los que padecían trastornos del estómago y el duodeno (50.6%) y ERGE (49.7%).
En un 30.8% de los casos, el fármaco prescripto en forma conjunta con el IBP fue un bloqueante H2; un 15.4% recibió conjuntamente cisaprida y un 4.6%, sucralfato. Con menos frecuencia, se observó la coprescripción con metoclopramida (2.4%) y misoprostol (0.8%).
Discusión
En este estudio se observó una alta incidencia de prescripción conjunta de IBP con otros fármacos. Más de la mitad de los pacientes evaluados recibieron por lo menos otro medicamento sin efecto GI, con la probabilidad de competir por el sistema enzimático citocromo P450 o en la absorción. Tras una revisión de la bibliografía, se encontró que los fármacos que ocasionan efectos adversos con mayor frecuencia al ser prescriptos en forma conjunta con los IBP son ciclosporina, diazepam, digoxina, itraconazol, ketoconazol, nifedipina, fenitoína, propranolol, teofilina y warfarina.
En el numeroso grupo de pacientes considerado en este trabajo, los estrógenos fueron los medicamentos coprescriptos más a menudo. Esto responde a motivos demográficos, ya que los adultos de mayor edad son los que más síntomas de ERGE presentan y son las mujeres menopáusicas quienes requieren tratamiento de reemplazo hormonal. No obstante, no se describen en la bibliografía interacciones farmacológicas entre estos 2 grupos de sustancias.
Los autores consideran el porcentaje de casos con coprescripción de IBP y claritromicina extremadamente bajo (12.5%) y especulan que muchos pacientes con UP vinculada con la infección por H. pylori podrían haber recibido un tratamiento inadecuado. Dada la discordancia entre las infecciones bacterianas documentadas y la cantidad de UP, sostienen que sería necesario evaluar más minuciosamente a los portadores de UP para detectar en ellos la presencia del microorganismo.
Creen también alta la frecuencia con la que se indicaron los IBP en forma conjunta con otros fármacos con efecto GI (44.4%). Una posible explicación para el caso de los IBP y los bloqueantes H2 o la cisaprida sería la incapacidad de los primeros para suprimir la secreción ácida durante las 24 horas, con la consiguiente necesidad de agregar medicación para aliviar los síntomas nocturnos.
Destacan la importancia de conocer la probabilidad de interacción de los IBP con otros fármacos en sus distintos pasos metabólicos para evitar la aparición de efectos adversos. Aun cuando estos últimos fueron comunicados con poca frecuencia, es necesario tener precaución con la asociación de drogas que utilizan el sistema enzimático CYP-450 como paso metabólico. Además, los IBP aumentan el pH gástrico, con lo que la absorción de los fármacos que requieren un pH ácido para ser absorbidos podría alterarse. La administración de omeprazol, por ejemplo, reduce la absorción de la digoxina, la nifedipina, el bismuto y el itraconazol.
Conclusión
Dada la importante cantidad de pacientes tratados con IBP, la probabilidad de que reciban otra medicación en forma conjunta es extremadamente alta. Los fármacos que son metabolizados por el CYP-450 y los que tienen una absorción que varía según el pH del medio tendrán la posibilidad de interactuar con los IBP. Los autores recomiendan que los médicos tratantes tengan en cuenta estas eventuales interacciones para evitar posibles efectos adversos.
1.-
Review: Low-dose aspirin causes a small increase in gastrointestinal bleeding. Laine L.
ACP Journal Club. 2007 Jan-Feb;146:13.
Aliment Pharmacol Ther. 2006;24:897-908. [PubMed ID: 16948802]
Question
What is the effect of low-dose aspirin on gastrointestinal (GI) bleeding and development of endoscopic ulcers?
Methods
Data sources: MEDLINE (1966 to 2005).
Study selection and assessment: Randomized placebo-controlled trials (RCTs) and systematic reviews that evaluated aspirin, 75 to 325 mg/d, and assessed upper GI bleeding or development of endoscopic ulcers. Cohort and case–control studies were also sought to identify risk factors for bleeding associated with low-dose aspirin.
Outcomes: GI bleeding and development of endoscopic ulcers.
Main results
14 RCTs of low-dose aspirin for cardiovascular indications and a meta-analysis of the 14 trials showed a pooled absolute increase of 0.12%/y (95% CI 0.07 to 0.19) in GI bleeding with low-dose aspirin (Table). A meta-analysis of 24 RCTs of low-dose aspirin used as an antiplatelet agent also showed an increase in GI bleeding (Table). Doses ranged from 50 to 1500 mg/d; when meta-analysis included trials of 50 to 162.5 mg/d only, the increase in bleeding was similar to the overall results (odds ratio [OR] 1.59, CI 1.40 to 1.81). The Women’s Health Initiative RCT showed that 100 mg of aspirin every other day increased GI bleeding requiring transfusion by 0.018%/y (Table). Evidence was weak or inconclusive regarding increased development of endoscopic ulcers. 1 RCT (n = 768) of 81 mg/d of aspirin in patients with osteoarthritis showed a nonsignificant 1% absolute increase (CI −4.4% to 6.4%) in ulcer rate. Evidence from cohort and case–control studies shows that increased risk for GI bleeding from low-dose aspirin is associated with a previous history of ulcers or GI bleeding, use of corticosteroids or anticoagulant therapy, and the addition of a nonsteroidal antiinflammatory drug (NSAID) to aspirin.
Conclusions
Low-dose aspirin produces a minor increase in serious gastrointestinal bleeding compared with the incidence of bleeding found with placebo. No difference is seen in rate of development of endoscopic ulcers.
Sources of funding: Bayer; Merck; Pfizer; Novartis.
For correspondence: Dr. L. Laine, University of Southern California, Los Angeles, CA, USA. E-mail llaine@usc.edu.
2.-
Celecoxib combined with esomeprazole prevented recurrent ulcer bleeding in patients with previous NSAID-induced ulcer bleeding Chan FK, Wong VW, Suen BY, et al.
ACP Journal Club. 2007 Sep-Oct;147:38. Lancet. 2007;369:1621-6. [PubMed ID: 17499604]
Question
In patients with previous nonsteroidal antiinflammatory drug (NSAID)–induced ulcer bleeding, is combination treatment with celecoxib and esomeprazole more effective than celecoxib alone for preventing recurrent ulcer bleeding?
Methods
Design: Randomized controlled trial.
Allocation: Concealed.*
Blinding: Blinded (clinicians, patients, outcome assessors, {data collectors, data analysts, and safety and monitoring committee}†).*
Follow-up period: Median 13 months (range 0.4 to 13 mo).
Setting: Prince of Wales Hospital, Hong Kong, China.
Patients: 273 patients (mean age 71 y, 52% women) who were taking nonselective NSAIDs for arthritis and presented to the hospital with upper gastrointestinal (GI) bleeding. All patients discontinued NSAIDs and took proton-pump inhibitors (PPIs) for 8 weeks. Patients were enrolled after their ulcers had healed by endoscopy if they tested negative for Helicobacter pylori infection and required regular use of NSAIDs during the trial. Exclusion criteria included concomitant use of low-dose aspirin (ASA), anticoagulants, or corticosteroids before index bleeding; previous gastric or duodenal surgery except patch repair; allergy to celecoxib; or erosive esophagitis, gastric outlet obstruction, terminal illness, cancer, or renal failure (serum creatinine > 200 µmol/L). After the cardiovascular hazards of cyclooxygenase-2 inhibitors became known, patients were allowed to take prophylactic low-dose ASA during the study period.
Intervention: Celecoxib, 200 mg, plus esomeprazole, 20 mg (n = 137), or celecoxib alone (n = 136), twice daily for 12 months.
Outcomes: Recurrent ulcer bleeding (hematemesis or melena with ulcers or bleeding erosions confirmed by endoscopy, or decrease in hemoglobin 20 g/L with ulcers or erosions), global assessment of disease activity, arthritis pain, and adverse events.
Patient follow-up: 84% (intention-to-treat analysis).
Main results
At a median 13 months, the combination-treatment group had a lower cumulative incidence of recurrent ulcer bleeding than did the celecoxib-alone group (Table). Groups did not differ for global assessment of disease activity, arthritis pain, or incidence of adverse events.
Conclusion
Combination treatment with celecoxib and esomeprazole was more effective than celecoxib alone for preventing recurrent ulcer bleeding in patients with previous nonsteroidal antiinflammatory drug–induced ulcer bleeding.
Source of funding: Research Grant Council of Hong Kong.
3.-
The Rational Clinical Examination
.- Does this Child have appendicitis? JAMA 2007;298:438-451 David G Bundy, Julie S Byerley, Allen liles, Eliana M Perrin, Jessica Katznelson, Henry E Rice.
CONTEXT:
La evaluación del dolor abdominal en los niños puede ser dificultosa. UIn rápido y exacto diagnóstico de apendicitis reduce la morbilidad de esta causa común; la evaluación clínica puede ayudar a identificar cuales niños con dolor abdominal y probabilidad de apendicitis deden ir rápidamente a la consulta quirúrgica por la potencial apendicectomía y cuales con presentación equívoca debe someterse a evaluación diagnóstica.
DATA SOURCES:
Medlinne desde 1966 a 2007; Cochrane Database. Se tuvieron en cuenta lose studios que incluían historia, examen físico, datos de laboratorio y confirmación o exclusión de apendicitis por hallazgos patológicos en cirugía, observación clínica y seguimiento. 42 con criterios de inclusión sobre 256.
DATA EXTRACCIÓN: 25/42 fueron evaluados con criterios de calidad de nivel 3 o major. Los datos de esos estudios fueron extra{idos por dos revisores en forma independiente.
RESULTS:
En los niños con dolor abdominal la fiebre fue el dato simple más útil: la presencia de fiebre aumentó la probabilidad +LR 3,4(95% CI: 2,4-4,8) Su ausencia disminuye la chance –LR 0,32(95% CI:0,16-0,64).
En grupo selecto de niños con sospecha de apendicitis, el dolor a la descompresión +LR 3,0(95% CI: 2,3-3,9), mientras que la ausencia reduce la la probabilidad –LR 0,28(95% CI:0,14-0,55).
Dolor centro abdominal migratorio a FID: +LR fluctuante entre 1,9 a 3,1 aumentó la probabilidad más que el dolor en FID propiamente dicho +LR 1,2(95% CI:1,0-1,5).
Recuento de glóbulos blancos <10.000/uL disminuye la probabilidad de apendicitis -LR 0,22(95% CI:0,17-0,30); un recuento absoluto de neutrófilos de 6750/uL o menor, -LR 0,06(95% CI 0,03-0,16).
Los síntomas y signos son más útiles en combinación, particularmente para la identificación de niños que no requieren posteriores evaluaciones o intervención.
CONCLUSIONS:
Si bien el examen clínico no establece un diagnóstico de apendicitis con certeza, es útil para determinar que niños con dolor abdominal deben ir a consulta inmediata con cirugía para poner en consideración la apendicectomía y cuales pueden se autorizados a evaluación diagnóstica. Son necesarios más datos específicos de niños y estratificados por edad para mejorar la utilidad del examen clínico para el diagnóstico de apendicitis en niños.
4.-
10-day sequential therapy was more effective than 10-day triple-drug therapy for eradicating Helicobacter pylori infection. Vaira D, Zullo A, Vakil N, et al.
ACP Journal Club. 2008 Sep-Oct;147:40. Ann Intern Med. 2007;146:556-63. [PubMed ID: 17438314]
Question
In patients with dyspepsia or peptic ulcer disease, is 10-day sequential therapy more effective than 10-day triple-drug therapy for eradicating Helicobacter pylori infection?
Methods
Design: Randomized controlled trial.
Allocation: {Concealed}†.*
Blinding: Blinded (patients, investigators, {data collectors, outcome assessors, data analysts, and safety and monitoring committee}†).*
Follow-up period: 8 weeks.
Setting: 2 hospitals in Bologna and Rome, Italy.
Patients: 300 patients 18 years of age (mean age 49 y, 64% women) with dyspepsia or peptic ulcers who had never received treatment for H. pylori infection. Exclusion criteria included use of proton-pump inhibitors, H2-receptor antagonists, bismuth preparations, or antibiotics in the past 2 weeks; concomitant use of anticoagulants or ketoconazole and glucocorticoids; the Zollinger-Ellison syndrome; surgery of the esophagus or upper gastrointestinal tract; severe or unstable cardiovascular, pulmonary, or endocrine disease; renal or hepatic disease or dysfunction; hematologic disorders; cancer in the past 5 years; Barrett esophagus or high-grade dysplasia; and severe psychiatric or neurologic disorders.
Intervention: Sequential (n = 150) or standard triple-drug therapy (n = 150). Sequential therapy consisted of pantoprazole, 40 mg, amoxicillin, 1 g, and placebo twice daily for 5 days; and pantoprazole, 40 mg, clarithromycin, 500 mg, and tinidazole, 500 mg, twice daily for the next 5 days. Standard therapy consisted of pantoprazole, 40 mg, clarithromycin, 500 mg, and amoxicillin, 1 g, twice daily for 10 days.
Outcomes: Eradication of H. pylori infection (negative results on 13C-urea breath tests at 4 and 8 wk). Secondary outcomes were eradication of clarithromycin- or metronidazole-resistant H. pylori infection, treatment adherence (> 90% of medication taken), and adverse events.
Patient follow-up: 96% (100% included in the intention-to-treat analysis).
Main results
The sequential-therapy group had higher eradication rates for H. pylori and clarithromycin-resistant H. pylori infection than did the standard-therapy group (Table). Groups did not differ for eradication of metronidazole-resistant H. pylori infection (Table), treatment adherence, or incidence of major or minor adverse events. Adverse events included epigastric pain and mild diarrhea.
Conclusion
10-day sequential therapy was more effective than 10-day triple-drug therapy for eradicating Helicobacter pylori infection in patients with dyspepsia or peptic ulcer disease.
Source of funding: No external funding.
5.-
Does This Patient Have an Exudative Pleural Effusion? The Rational Clinical Examination Systematic Review
- Elizabeth Wilcox, MD, MPH1; Christopher A. K. Y. Chong, MD2; Matthew B. Stanbrook, MD, PhD3; Andrea C. Tricco, PhD4; Camilla Wong, MD, MHSc5; Sharon E. Straus, MD, MSc4,5
JAMA. 2014;311(23):2422-2431.
Importance Thoracentesis is performed to identify the cause of a pleural effusion. Although generally safe, thoracentesis may be complicated by transient hypoxemia, bleeding, patient discomfort, reexpansion pulmonary edema, and pneumothorax.
Objective To identify the best means for differentiating between transudative and exudative effusions and also to identify thoracentesis techniques for minimizing the risk of complications by performing a systematic review the evidence.
Data Sources We searched The Cochrane Library, MEDLINE, and Embase from inception to February 2014 to identify relevant studies.
Study Selection We included randomized and observational studies of adult patients undergoing thoracentesis that examined diagnostic tests for differentiating exudates from transudates and evaluated thoracentesis techniques associated with a successful procedure with minimal complications.
Data Extraction and Synthesis Two investigators independently appraised study quality and extracted data from studies of laboratory diagnosis of pleural effusion for calculation of likelihood ratios (LRs; n = 48 studies) and factors affecting adverse event rates (n = 37 studies).
Results The diagnosis of an exudate was most accurate if cholesterol in the pleural fluid was greater than 55 mg/dL (LR range, 7.1-250), lactate dehydrogenase (LDH) was greater than 200 U/L (LR, 18; 95% CI, 6.8-46), or the ratio of pleural fluid cholesterol to serum cholesterol was greater than 0.3 (LR, 14; 95% CI, 5.5-38). A diagnosis of exudate was less likely when all Light’s criteria (a ratio of pleural fluid protein to serum protein >0.5, a ratio of pleural fluid LDH to serum LDH >0.6, or pleural fluid LDH >two-thirds the upper limit of normal for serum LDH) were absent (LR, 0.04; 95% CI, 0.02-0.11). The most common complication of thoracentesis was pneumothorax, which occurred in 6.0% of cases (95% CI, 4.0%-7.0%). Chest tube placement was required in 2.0% of procedures (95% CI, 0.99%-2.9%) in which a patient was determined to have radiographic evidence of a pneumothorax. With ultrasound, a radiologist’s marking the needle insertion site was not associated with decreased pneumothorax events (skin marking vs no skin marking odds ratio [OR], 0.37; 95% CI, 0.08-1.7). Use of ultrasound by any experienced practitioner also was not associated with decreased pneumothorax events (OR, 0.55; 95% CI, 0.06-5.3).
Conclusions and Relevance Light’s criteria, cholesterol and pleural fluid LDH levels, and the pleural fluid cholesterol-to-serum ratio are the most accurate diagnostic indicators for pleural exudates. Ultrasound skin marking by a radiologist or ultrasound-guided thoracentesis were not associated with a decrease in pneumothorax events.
6.-
Early infusion of high-dose omeprazole before endoscopy reduced the need for endoscopic therapy. Lau JY, Leung WK, Wu JC, et al.
ACP Journal Club. 2007 Jul-Aug;147:18. N Engl J Med. 2007;356:1631-40. [PubMed ID: 17442905]
Question
In patients with bleeding peptic ulcers, does early intravenous (IV) infusion of high-dose omeprazole before endoscopy reduce the need for endoscopic therapy?
Methods
Design: Randomized placebo-controlled trial.
Allocation: Concealed.*
Blinding: Blinded (clinicians, patients, {data collectors, outcome assessors, data analysts, and data safety and monitoring committee}†).*
Follow-up period: Up to 30 days from randomization.
Setting: Accident and Emergency Department (ED) at the Prince of Wales Hospital, Hong Kong, China.
Patients: 638 patients 18 years of age who presented to the ED with upper gastrointestinal bleeding (melena or hematemesis with or without hypotension). Exclusion criteria included continued hypotensive shock despite resuscitation, allergy to proton pump inhibitors (PPIs), regular use of aspirin for cardiovascular protection, or pregnancy.
Intervention: Omeprazole (IV bolus injection, 80 mg followed by continuous infusion, 8 mg/h until endoscopic examination the next morning) (n = 319), or matching placebo (n = 319).
Outcomes: Need for endoscopic therapy. Secondary outcomes were actively bleeding ulcers (spurting or oozing), all-cause mortality at 30 days, recurrent bleeding at 30 days, length of hospital stay, urgent endoscopy, emergency surgery, or blood transfusion.
Patient follow-up: 631 patients (mean age 62 y, 65% men) (99% included in the intention-to-treat analysis).
Main results
Fewer patients in the omeprazole group had endoscopic therapy and actively bleeding ulcers than did the placebo group (Table). The omeprazole group had more patients who stayed in hospital for < 3 days than did the placebo group (Table). Groups did not differ for all-cause mortality, recurrent bleeding, urgent endoscopy, blood transfusion, or emergency surgery.
Conclusion
Early intravenous infusion of high-dose omeprazole before endoscopy reduced the need for endoscopic therapy and actively bleeding peptic ulcers.
Source of funding: Institute of Digestive Disease, Chinese University of Hong Kong.
7.-
The Rational Clinical Examination Systematic Review. Does This Patient Have Generalized Anxiety or Panic Disorder? Nathaniel R. Herr, PhD1; John W. Williams Jr, MD, MHSc2,3; Sophiya Benjamin, MD4,5; Jennifer McDuffie, PhD2,3. JAMA. 2014;312(1):78-84.
Importance In primary care settings, generalized anxiety disorder (GAD) and panic disorder are common but underrecognized illnesses. Identifying accurate and feasible screening instruments for GAD and panic disorder has the potential to improve detection and facilitate treatment.
Objective To systematically review the accuracy of self-report screening instruments in diagnosing GAD and panic disorder in adults.
Data Sources We searched MEDLINE, PsycINFO, and the Cochrane Library for relevant articles published from 1980 through April 2014.
Study Selection Prospective studies of diagnostic accuracy that compared a self-report screening instrument for GAD or panic disorder with the diagnosis made by a trained clinician using Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases criteria.
Results We screened 3605 titles, excluded 3529, and performed a more detailed review of 76 articles. We identified 9 screening instruments based on 13 articles from 10 unique studies for the detection of GAD and panic disorder in primary care patients Across all studies, diagnostic interviews determined that 257 of 2785 patients assessed had a diagnosis of GAD while 224 of 2637 patients assessed had a diagnosis of panic disorder. The best-performing test for GAD was the Generalized Anxiety Disorder Scale 7 Item (GAD-7), with a positive likelihood ratio of 5.1 (95% CI, 4.3-6.0) and a negative likelihood ratio of 0.13 (95% CI, 0.07-0.25). The best-performing test for panic disorder was the Patient Health Questionnaire, with a positive likelihood ratio of 78 (95% CI, 29-210) and a negative likelihood ratio of 0.20 (95% CI, 0.11-0.37).
Conclusions and Relevance Two screening instruments, the GAD-7 for GAD and the Patient Health Questionnaire for panic disorder, have good performance characteristics and are feasible for use in primary care. However, further validation of these instruments is needed because neither instrument was replicated in more than 1 primary care population.
GAD-7 Ansiedad
- Feeling nervous, anxious, or on edge
- Not being able to sleep or control worrying
- Worrying too much about different things
- Trouble relaxing
- Being so restless that it is hard to sit still
- Becoming easily annoyed or irritable
- Feeling afraid, as if something awful might happen
8.-
Review: Opiate administration may alter physical examination findings, but does not increase management errors in acute abdominal pain. Ranji SR, Goldman LE, Simel DL, Shojania KG.
ACP Journal Club. 2007 Jan-Feb;146:21. JAMA. 2006;296:1764-74. [PubMed ID: 17032990]
Question
In patients with acute abdominal pain, does opiate administration for pain relief alter history and physical examination findings, and increase management errors?
Methods
Data sources: MEDLINE (to May 2006), EMBASE/Excerpta Medica, and bibliographies of relevant studies.
Study selection and assessment: Randomized controlled trials (RCTs) or quasi-randomized controlled trials that compared opiate analgesia with placebo and reported changes in history, physical examination findings, or clinical management in patients with acute abdominal pain. 12 RCTs, 9 in adults (n = 1062) and 3 in children (n = 291), met the selection criteria. Quality assessment of individual studies was based on allocation concealment and blinding. Most RCTs had methodological problems.
Outcomes: Changes in history or physical examination findings, and management errors.
Main results
Meta-analyses using a random-effects model showed that administration of opiates led to changes in physical examination results (Table). Subgroup analyses for adults and children showed trends that did not reach statistical significance (Table). Groups did not differ for management errors (Table). None of the included RCTs reported changes in history.
Conclusion
In patients with acute abdominal pain, opiate administration may alter physical examination findings, but does not increase management errors.
Source of funding: No external funding.
9.-
The Rational Clinical Examination
Does This Coughing Adolescent or Adult Patient Have Pertussis?
Paul B. Cornia, MD; Adam L. Hersh, MD; Benjamin A. Lipsky, MD; Thomas B. Newman, MD, MPH; Ralph Gonzales, MD, MSPH JAMA. 2010;304(8):890-896.
Context Pertussis is often overlooked as a cause of chronic cough, especially in adolescents and adults. Several symptoms are classically thought to be suggestive of pertussis, but the diagnostic value of each of them is uncertain.
Objective To systematically review the evidence regarding the diagnostic value of 3 classically described symptoms of pertussis: paroxysmal cough, posttussive emesis, and inspiratory whoop.
Data Sources, Study Selection, and Data Extraction We searched MEDLINE (January 1966–April 2010), EMBASE (January 1969 to April 2010), and the bibliographies of pertinent articles to identify relevant English-language studies. Articles were selected that included children older than 5 years, adolescents, or adults and confirmed the diagnosis of pertussis among patients with cough illness (of any duration) with an a priori–defined accepted reference standard. Two authors independently extracted data from articles that met selection criteria and resolved any discrepancies by consensus.
Data Synthesis Five prospective studies met inclusion criteria; 3 were used in the analysis. Presence of posttussive emesis (summary likelihood ratio [LR], 1.8; 95% confidence interval [CI], 1.4-2.2) or inspiratory whoop (summary LR, 1.9; 95% CI, 1.4-2.6) increases the likelihood of pertussis. Absence of paroxysmal cough (summary LR, 0.52; 95% CI, 0.27-1.0) or posttussive emesis (summary LR, 0.58; 95% CI, 0.44-0.77) reduced the likelihood. Absence of inspiratory whoop was less useful (summary LR, 0.78; 95% CI, 0.66-0.93). No studies evaluated combinations of findings.
Conclusions In a nonoutbreak setting, data to determine the diagnostic usefulness of symptoms classically associated with pertussis are limited and of relatively weak quality. The presence or absence of posttussive emesis or inspiratory whoop modestly change the likelihood of pertussis; therefore, clinicians must use their overall clinical impression to decide about additional testing or empirical treatment.
10.-
Etiology Review: High alcohol intake increases mortality in both men and women
ACP Journal Club. 2007 Mar-Apr;146:48. Di Castelnuovo A, Costanzo S, Bagnardi V, et al. Alcohol dosing and total mortality in men and women: an updated meta-analysis of 34 prospective studies. Arch Intern Med. 2006;166:2437-45. [PubMed ID: 17159008]
Question
What is the relation between alcohol intake and mortality in men and women?
Methods
Data sources: PubMed (to December 2005) and reference lists.
Study selection and assessment: Prospective cohort studies that reported all-cause mortality in adults by level of alcohol intake and separately for men and women. 34 studies met the selection criteria and provided 56 dose-response curves: 37 curves in men (n = 705 596 participants and 78 592 deaths) and 19 curves in women (n = 310 239 participants and 15 941 deaths). The reference category was never-drinkers in 30 curves and may have included occasional or former drinkers in 26 curves. 48 curves were adjusted for such potentially confounding factors as age, social status, and diet. Median duration of follow-up was 11 years (range 5.5 to 26 y).
Outcomes: All-cause mortality.
Main results
The 56 combined curves presented a J-shaped relation between alcohol intake (on the x axis) and mortality (on the y axis), with the mortality rate of the reference groups set at 1.0. A low intake of alcohol (up to 6 g/d or about half a drink/d) resulted in a sharp reduction in mortality of 19% (Table). From that point mortality rates gradually increased with increasing alcohol consumption, until the curve crossed above the line corresponding to the mortality rate of the reference groups at about 4 drinks/d (Table). The 48 curves that were adjusted at least for age gave slightly more conservative results (Table). The maximum protection against mortality and the alcohol intake level at which this occurred were similar in men and women; however, the upward slope of the curve with increasing alcohol intake was sharper in women, such that mortality protection was lost at lower alcohol intake levels in women (about 2 drinks/d) than in men (about 4 drinks/d) (Table). Mortality risk of alcohol drinkers surpassed that of nondrinkers at about 3.5 drinks/d in women and 4.5 drinks/d in men and continued to increase with increasing consumption.
Conclusions
In both men and women, high alcohol intake is associated with increased mortality compared with nondrinkers, whereas moderate alcohol intake is associated with decreased mortality. Maximum protection against mortality occurs when alcohol intake averages half a drink/day.
Source of funding: Italian Ministry of Education, University and Research.
11.-
Does this patient have a hemorrhagic stroke? clinical findings distinguishing hemorrhagic stroke from ischemic stroke Shauna Runchey, MD, MPH; Steven McGee, MD JAMA. 2010;303(22):2280-2286.
Context The 2 fundamental subtypes of stroke are hemorrhagic stroke and ischemic stroke. Although neuroimaging is required to distinguish these subtypes, the diagnostic accuracy of bedside findings has not been systematically reviewed.
Objective To determine the accuracy of clinical examination in distinguishing hemorrhagic stroke from ischemic stroke.
Data Sources MEDLINE and EMBASE searches of English-language articles published from January 1966 to April 2010.
Study Selection Prospective studies of adult patients with stroke that compared initial clinical findings with accepted diagnostic standards of hemorrhagic stroke (computed tomography or autopsy).
Data Extraction Both authors independently appraised study quality and extracted relevant data.
Data Synthesis Nineteen prospective studies meeting inclusion criteria were identified (N = 6438 patients; n = 1528 [24%] with hemorrhage stroke). Several findings significantly increase the probability of hemorrhagic stroke: coma (likelihood ratio [LR], 6.2; 95% confidence interval [CI], 3.2-12), neck stiffness (LR, 5.0; 95% CI, 1.9-12.8), seizures accompanying the neurologic deficit (LR, 4.7; 95% CI, 1.6-14), diastolic blood pressure greater than 110 mm Hg (LR, 4.3; 95% CI, 1.4-14), vomiting (LR, 3.0; 95% CI, 1.7-5.5), and headache (LR, 2.9; 95% CI, 1.7-4.8). Other findings decrease the probability of hemorrhage: cervical bruit (LR, 0.12; 95% CI, 0.03-0.47) and prior transient ischemic attack (LR, 0.34; 95% CI, 0.18-0.65). A Siriraj score greater than 1 increases the probability of hemorrhage (LR, 5.7; 95% CI, 4.4-7.4) while a score lower than –1 decreases the probability (LR, 0.29; 95% CI, 0.23-0.37). Nonetheless, many patients with stroke lack any diagnostic finding, and 20% have Siriraj scores between 1 and –1, which are diagnostically unhelpful (LR, 0.94; 95% CI, 0.77-1.1).
Conclusion In patients with acute stroke, certain findings accurately increase or decrease the probability of intracranial hemorrhage, but no finding or combination of findings is definitively diagnostic in all patients, and diagnostic certainty requires neuroimaging.
Author Affiliations: Department of Medicine, University of Washington, Seattle.
12.-
Review: Evidence from observational studies, but not randomized trials, suggests that long-term aspirin prevents colorectal cancer. Dub A C, Rostom A, Lewin G, et al.
ACP Journal Club. 2007 Jul-Aug;147:15. Ann Intern Med. 2007;146:365-75. [PubMed ID: 17339622]
Question
Is aspirin effective and safe for primary prevention of colorectal cancer?
Methods
Data sources: MEDLINE (to December 2006), preMEDLINE (to April 2005), EMBASE/Excerpta Medica (to April 2005), the Cochrane Library (Issue 4, 2004), and the PubMed Cancer subset.
Study selection and assessment: English-language studies that evaluated the efficacy of aspirin for primary prevention of colorectal cancer in persons at average risk and systematic reviews that assessed the harms of long-term aspirin use. Studies of familial colon cancer were excluded. 4 randomized controlled trials (RCTs) (n = 63 340), 9 cohort studies (n = 1 303 573), 13 case control studies (n = 1 148 086), and 12 reviews met the selection criteria.
Outcomes: Colorectal cancer mortality, colorectal cancer, colorectal adenoma, hemorrhagic stroke, and gastrointestinal bleeding.
Main results
Evidence from cohort and case control studies, but not RCTs, indicated that long-term aspirin use prevented colorectal cancer mortality, colorectal cancer, and colorectal adenomas (Table). Aspirin was effective for secondary prevention of colorectal adenomas (Table). The benefits of aspirin were greater with higher doses and longer duration of treatment. Aspirin increased risks for hemorrhagic stroke and gastrointestinal bleeding (Table), especially at higher doses.
Conclusions
Evidence from observational studies suggests that aspirin prevents colorectal adenomas, colorectal cancer, and death from colorectal cancer, but these findings were not confirmed by 2 randomized trials. Aspirin is associated with increased risks for hemorrhagic stroke and gastrointestinal bleeding.
Sources of funding: Centers for Disease Control and Prevention for the Agency for Healthcare Research and Quality and the U.S. Preventive Services Task Force.
13.-
The Rational Clinical Examination
Does this patient with diabetes have large-fiber peripheral neuropathy?
Jamil N. Kanji, MD; Rebecca E. S. Anglin, MD; Dereck L. Hunt, MD, MSc, FRCPC; Akbar Panju, MB, ChB, FRCPC JAMA. 2010;303(15):1526-1532.
CONTEXT Diabetic peripheral neuropathy predisposes patients to foot ulceration that heals poorly and too often leads to amputation. Large-fiber peripheral neuropathy (LFPN), one common form of diabetic neuropathy, when detected early prompts aggressive measures to prevent progression to foot ulceration and its associated morbidity and mortality.
OBJECTIVE To systematically review the literature to determine the clinical examination findings predictive of asymptomatic LFPN before foot ulceration develops.
DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION MEDLINE (January 1966–November 2009) and EMBASE (1980-2009 [week 50]) databases were searched for articles on bedside diagnosis of diabetic peripheral neuropathy. Included studies compared elements of history or physical examination with nerve conduction testing as the reference standard.
DATA SYNTHESIS Of 1388 articles, 9 on diagnostic accuracy and 3 on precision met inclusion criteria. The prevalence of diabetic LFPN ranged from 23% to 79%. A score greater than 4 on a symptom questionnaire developed by the Italian Society of Diabetology increases the likelihood of LFPN (likelihood ratio [LR], 4.0; 95% confidence interval [CI], 2.9-5.6; negative LR, 0.19; 95% CI, 0.10-0.38). The most useful examination findings were vibration perception with a 128-Hz tuning fork (LR range, 16-35) and pressure sensation with a 5.07 Semmes-Weinstein monofilament (LR range, 11-16). Normal results on vibration testing (LR range, 0.33-0.51) or monofilament (LR range, 0.09-0.54) make LFPN less likely. Combinations of signs did not perform better than these 2 individual findings.
CONCLUSIONS Physical examination is most useful in evaluating for LFPN in patients with diabetes. Abnormal results on monofilament testing and vibratory perception (alone or in combination with the appearance of the feet, ulceration, and ankle reflexes) are the most helpful signs.
14.-
Therapeutics Review: NSAIDs and COX-2 inhibitors may prevent colorectal cancer but increase gastrointestinal and cardiovascular harm. Rostom A, Dub A C, Lewin G, et al.
ACP Journal Club. 2007 Jul-Aug;147:16. Ann Intern Med. 2007;146:376-89. [PubMed ID: 17339623]
Question
Are nonsteroidal antiinflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors effective and safe for primary prevention of colorectal cancer?
Methods
Data sources: MEDLINE (to December 2006), preMEDLINE (to April 2005), EMBASE/Excerpta Medica (to April 2005), the Cochrane Library (Issue 4, 2004), the PubMed Cancer subset, U.S. Food and Drug Administration News Digest, and Health Canada’s Health Product Information mailing list.
Study selection and assessment: English-language studies that evaluated the efficacy of NSAIDs or COX-2 inhibitors for primary prevention of colorectal cancer in persons at “average†risk and systematic reviews that assessed the harms of these agents. Studies of familial colon cancer were excluded. 4 randomized controlled trials (RCTs) (n = 6056), 5 cohort studies (n = 486 264), 19 case control studies (n = 69 788), and 23 reviews met the selection criteria.
Outcomes: Colorectal cancer mortality, colorectal cancer, colorectal adenoma, cardiovascular events, and gastrointestinal harm.
Main results
Evidence from cohort and case control studies showed that long-term NSAID use prevented colorectal cancer and colorectal adenomas (Table). COX-2 inhibitors were effective for secondary prevention of colorectal adenomas (Table). The benefits of NSAIDs were greater with higher doses and longer duration of treatment in some, but not all, studies. Nonnaproxen nonaspirin NSAIDs and COX-2 inhibitors increased risk for serious cardiovascular events (Table). Nonaspirin NSAIDs increased risk for peptic ulcers and gastrointestinal bleeding, but COX-2 inhibitors did not (Table).
Conclusions
Evidence from observational studies suggests that nonsteroidal antiinflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors prevent colorectal adenomas and colorectal cancer. COX-2 inhibitors prevent recurrence of colorectal adenomas. Both NSAIDs and COX-2 inhibitors increase risk for cardiovascular harm.
Sources of funding: Centers for Disease Control and Prevention for the Agency for Healthcare Research and Quality and the U.S. Preventive Services Task Force.
15.-
The Rational Clinical Examination
Does This Patient With Diabetes Have Osteomyelitis of the Lower Extremity?
Sonia Butalia, MD; Valerie A. Palda, MD, MSc; Robert J. Sargeant, MD, MSc, PhD; Allan S. Detsky, MD, PhD; Ophyr Mourad, MD, MSc JAMA. 2008;299(7):806-813.
Context Osteomyelitis of the lower extremity is a commonly encountered problem in patients with diabetes and is an important cause of amputation and admission to the hospital. The diagnosis of lower limb osteomyelitis in patients with diabetes remains a challenge.
Objective To determine the accuracy of historical features, physical examination, and laboratory and basic radiographic testing. We searched for systematic reviews of magnetic resonance imaging (MRI) in the diagnosis of lower extremity osteomyelitis in patients with diabetes to compare its performance with the reference standard.
Data Sources MEDLINE search of English-language articles published between 1966 and March 2007 related to osteomyelitis in patients with diabetes. Additional articles were identified through a hand search of references from retrieved articles, previous reviews, and polling experts.
Study Selection Original studies were selected if they (1) described historical features, physical examination, laboratory investigations, or plain radiograph in the diagnosis of lower extremity osteomyelitis in patients with diabetes mellitus, (2) data could be extracted to construct 2 x 2 tables or had reported operating characteristics of the diagnostic measure, and (3) the diagnostic test was compared with a reference standard. Of 279 articles retrieved, 21 form the basis of this review. Data from a single high-quality meta-analysis were used to summarize the diagnostic characteristics of MRI in osteomyelitis.
Data Extraction Two authors independently assigned each study a quality grade using previously published criteria and abstracted operating characteristic data using a standardized instrument.
Data Synthesis The gold standard for diagnosis is bone biopsy. No studies were identified that addressed the utility of the history in the diagnosis of osteomyelitis. An ulcer area larger than 2 cm2 (positive likelihood ratio [LR], 7.2; 95% confidence interval [CI], 1.1-49; negative LR, 0.48; 95% CI, 0.31-0.76) and a positive «probe-to-bone» test result (summary positive LR, 6.4; 95% CI, 3.6-11; negative LR, 0.39; 95% CI, 0.20-0.76) were the best clinical findings. A erythrocyte sedimentation rate of more than 70 mm/h increases the probability of a diagnosis of osteomyelitis (summary LR, 11; 95% CI, 1.6-79). An abnormal plain radiograph doubles the odds of osteomyelitis (summary LR, 2.3; 95% CI, 1.6-3.3). A positive MRI result increases the likelihood of osteomyelitis (summary LR, 3.8; 95% CI, 2.5-5.8). However, a normal MRI result makes osteomyelitis much less likely (summary LR, 0.14; 95% CI, 0.08-0.26). The overall accuracy (ie, the weighted average of the sensitivity and specificity) of the MRI is 89% (95% CI, 83.0%-94.5%).
Conclusions An ulcer area larger than 2 cm2, a positive probe-to-bone test result, an erythrocyte sedimentation rate of more than 70 mm/h, and an abnormal plain radiograph result are helpful in diagnosing the presence of lower extremity osteomyelitis in patients with diabetes. A negative MRI result makes the diagnosis much less likely when all of these findings are absent. No single historical feature or physical examination reliably excludes osteomyelitis. The diagnostic utility of a combination of findings is unknown.
Author Affiliations: Department of Medicine, St Michael’s Hospital (Drs Butalia, Palda, Sargeant, and Mourad), Mt Sinai Hospital and University Health Network (Dr Detsky), Department of Health Policy Management and Evaluation, University of Toronto (Drs Palda and Detsky), Toronto, Ontario, Canada. Dr Butalia is now with the University of Calgary, Calgary, Alberta, Canada.
16.-
Daily polyethylene glycol over 6 months was effective for chronic constipation. DiPalma JA, Cleveland MV, McGowan J, Herrera JL.
ACP Journal Club. 2008 Jan-Feb;148:18. Am J Gastroenterol. 2007;102:1436-41. [PubMed ID: 17403074]
Question
In adults with chronic constipation, is daily use of polyethylene glycol (PEG) for 6 months effective and safe?
Methods
Design: Randomized placebo-controlled trial.
Allocation: Unclear allocation concealment.*
Blinding: Blinded (unclear which groups were blinded).*
Follow-up period: 6 months.
Setting: 50 centers in the United States.
Patients: 306 patients with chronic constipation over the past 3 months (< 3 satisfactory stools per wk without laxative use and 1 of the following Rome criteria: straining, lumpy or hard stools, or sensation of incomplete evacuation in > 25% of defecations) and during a 14-day observation period (< 3 satisfactory bowel movements per wk). Exclusion criteria were prior or current treatment with or sensitivity to study medication; use of medications affecting bowel function; the irritable bowel syndrome; pregnancy or lactation; past gastrointestinal (GI) surgery; known or suspected GI obstruction; ileus; ascites; or chronic bowel, liver, or cardiopulmonary disorders.
Intervention: PEG, 17 g (n = 204), or placebo (n = 100) to be mixed in 8 oz of juice or other beverage and taken daily.
Outcomes: Overall treatment success ( 50% of treatment weeks with 3 satisfactory stools, no use of rescue laxatives, and 1 of the following in > 25% of defecations: straining, lumpy or hard stools, or sensation of incomplete evacuation). Secondary outcomes included “super efficacy,†defined as 1 week with no constipation symptoms (Rome criteria) and no use of rescue laxatives; and adverse events.
Patient follow-up: 99% (mean age 53 y, 85% women) were included in the intention-to-treat analysis. 170 patients completed all 6 months of the study.
Main results
More patients in the PEG group than in the placebo group had overall treatment success (Table). The mean number of weeks that patients met the criteria for treatment success and for super efficacy was higher in the PEG group (12 vs 3.4 wk and 9.2 vs 2.2 wk, respectively, P < 0.001 for both). GI complaints were more common with PEG (40% vs 25%, P = 0.015); groups did not differ for other adverse effects.
Conclusion
In adults with chronic constipation, daily polyethylene glycol over 6 months reduced constipation more than placebo.
Source of funding: Braintree Laboratories, Inc.
For correspondence: Dr. J.A. DiPalma, University of South Alabama Digestive Health Centre, Mobile, AL, USA. E-mail gastro@usouthal.edu.
17.-
The Rational Clinical Examination
.- Does this patient have a family history of cancer? JAMA 2004; 292:1480-1489 Harvey J Murff, David R Spigel, Sapna Syhgal
CONTEXT:
Una historia familiar de ciertos cánceres se asocia con un aumento del riesgo de desarrollo de cáncer. Ambas decisiones, screening y derivación a servicios de genética frecuentemente se basan en la información comunicada.
DATA SOURCES:
Medline 1966 a 2004. MeSH: family, genetic predisposition to disease, medical history taking, neoplasm, and reproducibility of results.
DATA EXTRACCIÓN:
Dos de tres investigadores independientes revisaron y resumieron los datos, LRs de las informaciones sobre historia familiares de cánceres. Sólo fueron incluidos los datos que comunicaban ambas +LR y –LR. 14 estudios reunieron criterios de inclusión.
RESULTS:
Para pacientes sin historia personal de cáncer , la probabilidad positiva y negativa de historia familiar de los siguientes cánceres en familares de primer grado fueron:
CCR: +LR 23,9 (95% CI: 6,4 – 81,0) y –LR 0,25 (95% CI: 0,10 – 0,63)
Ca Mama: +LR 8,9 (95% CI :5,4 – 15,0) y –LR 0,20 (95% CI: 0,08 – 0,49)
Endometrial: +LR 14,0(95% CI: I2,2 – 83,4) y –LR 0,68 (95% CI: 0,31 – 1,52)
Ovárico: +LR 34,0(95% CI: 5,7 – 202,0) y –LR 0,51(95% CI: 0,13 – 2,10)
Próstata: +LR 12,3(955 CI : 6,5 – 24,0) y –LR 0,32(95% CI: 0,18 – 0,55)
Los valores predictivos tienden a ser mejor en familiares de primero que de segundo grado.
CONCLUSIONS:
Los datos comunicadas sobre riesgos para historias de cáncer familiares son exactos y valiosos para familiares de primer grado en càncer de mama y colorrectal. Las comunicaciones de historia familiar negativa para ovario y endometrio son menos útiles, si bien la prevalencia de ellos dentro de las familias es baja.
18.-
Orlistat, sibutramine, and rimonabant reduce weight in overweight and obese persons. Rucker D, Padwal R, Li SK, Curioni C, Lau DC
ACP Journal Club. 2008 Mar-Apr;148:50. BMJ. 2007;335:1194-9. [PubMed ID: 18006966]
Question
In overweight or obese persons, what is the long-term efficacy of antiobesity drugs (AODs) for reducing weight and improving health status?
Methods
Data sources: MEDLINE, EMBASE/Excerpta Medica, Cochrane Controlled Trials Register, and Current Science meta-register of controlled trials (all from December 2002 to 2006); and reference lists.
Study selection and assessment: Randomized, double-blind, placebo-controlled trials (RCTs) that lasted 1 year, used intention-to-treat analysis, and evaluated the efficacy of AODs on weight, overall mortality, cardiovascular (CV) risk factors, CV morbidity, and CV mortality in overweight or obese participants 18 years of age. Open-label crossover trials, quasi-RCTs, and abstracts were excluded. Quality assessment of individual studies was based on 9 criteria of the Verhagen Delphi list. 30 RCTs (mean age range 38 to 59 y) met the selection criteria.
Outcomes: Included changes in weight; triglyceride, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and total cholesterol levels; blood pressure (BP); diabetes; and adverse events.
Main results
Meta-analysis showed that orlistat (OST), sibutramine (SBT), and rimonabant (RMB) reduced weight more than did placebo (Table). Compared with placebo, OST reduced LDL, HDL, and total cholesterol levels and BP; SBT increased HDL cholesterol and BP and reduced triglycerides; and RMB increased HDL cholesterol and reduced triglyceride levels and BP (Table). In participants with diabetes, OST and RMB improved glycemic control (Table). In 1 RCT, OST reduced the incidence of diabetes compared with placebo (hazard ratio 0.63, 95% CI 0.46 to 0.86). OST increased risk for gastrointestinal adverse events; SBT increased risk for insomnia, nausea, dry mouth, and constipation; and RMB increased risk for psychiatric disorders.
Conclusion
Orlistat, sibutramine, and rimonabant reduce weight and improve some health measures in overweight and obese persons.
Source of funding: No external funding.