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1.
BMC Med Res Methodol ; 18(1): 10, 2018 01 12.
Artículo en Inglés | MEDLINE | ID: mdl-29329525

RESUMEN

BACKGROUND: This article corresponds to a literature review and analyze how heterogeneity of treatment (HTE) is reported and addressed in cohort studies and to evaluate the use of the different measures to HTE analysis. METHODS: prospective cohort studies, in English language, measuring the effect of a treatment (pharmacological, interventional, or other) published among 119 core clinical journals (defined by the National Library of Medicine) in the last 16 years were selected in the following data source: Medline. One reviewer randomly sampled journal articles with 1: 1 stratification by journal type: high impact journals (the New England Journal of Medicine, JAMA, LANCET, Annals of Internal Medicine, BMJ and Plos Medicine) and low impact journal (the remaining journals) to identify 150 eligible studies. Two reviewers independently and in duplicate used standardized piloted forms to screen study reports for eligibility and to extract data. They also used explicit criteria to determine whether a cohort study reported HTE analysis. Logistic regression was used to examine the association of prespecified study characteristics with reporting versus not reporting of heterogeneity of treatment effect. RESULTS: One hundred fifty cohort studies were included of which 88 (58%) reported HTE analysis. High impact journals (Odds Ratio: 3.5, 95% CI: 1.78-7.5; P < 0.001), pharmacological studies (Odds Ratio: 0.26, 95% CI: 0.13-0.51; P < 0.001) and studies published after 2014 (Odds Ratio: 0.5, 95% CI: 0.25-0.97; P = 0.004) were associated with more frequent reporting of HTE. 27 (31%) studies which reported HTE used an interaction test. CONCLUSION: More than half cohort studies report some measure of heterogeneity of treatment effect. Prospective cohort studies published in high impact journals, with large sample size, or studying a pharmacological treatment are associated with more frequent HTE reporting. The source of funding was not associated with HTE reporting. There is a need for guidelines on how to perform HTE analyses in cohort studies.


Asunto(s)
MEDLINE , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Resultado en la Atención de Salud/normas , Informe de Investigación/normas , Estudios de Cohortes , Quimioterapia/métodos , Quimioterapia/normas , Quimioterapia/estadística & datos numéricos , Guías como Asunto , Humanos , Modelos Logísticos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos
2.
BMC Med Res Methodol ; 17(1): 128, 2017 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-28830464

RESUMEN

BACKGROUND: The common frequentist approach is limited in providing investigators with appropriate measures for conducting a new trial. To answer such important questions and one has to look at Bayesian statistics. METHODS: As a worked example, we conducted a Bayesian cumulative meta-analysis to summarize the benefit of patient-specific instrumentation on the alignment of total knee replacement from previously published evidence. Data were sourced from Medline, Embase, and Cochrane databases. All randomised controlled comparisons of the effect of patient-specific instrumentation on the coronal alignment of total knee replacement were included. The main outcome was the risk difference measured by the proportion of failures in the control group minus the proportion of failures in the experimental group. Through Bayesian statistics, we estimated cumulatively over publication time of the trial results: the posterior probabilities that the risk difference was more than 5 and 10%; the posterior probabilities that given the results of all previous published trials an additional fictive trial would achieve a risk difference of at least 5%; and the predictive probabilities that observed failure rate differ from 5% across arms. RESULTS: Thirteen trials were identified including 1092 patients, 554 in the experimental group and 538 in the control group. The cumulative mean risk difference was 0.5% (95% CrI: -5.7%; +4.5%). The posterior probabilities that the risk difference be superior to 5 and 10% was less than 5% after trial #4 and trial #2 respectively. The predictive probability that the difference in failure rates was at least 5% dropped from 45% after the first trial down to 11% after the 13th. Last, only unrealistic trial design parameters could change the overall evidence accumulated to date. CONCLUSIONS: Bayesian probabilities are readily understandable when discussing the relevance of performing a new trial. It provides investigators the current probability that an experimental treatment be superior to a reference treatment. In case a trial is designed, it also provides the predictive probability that this new trial will reach the targeted risk difference in failure rates. TRIAL REGISTRATION: CRD42015024176 .


Asunto(s)
Ensayos Clínicos como Asunto , Teorema de Bayes , Sesgo , Humanos , Funciones de Verosimilitud , Resultado del Tratamiento
3.
Int Orthop ; 41(11): 2401-2405, 2017 11.
Artículo en Inglés | MEDLINE | ID: mdl-28842782

RESUMEN

PURPOSE: Local control of soft tissue sarcomas frequently involves adjuvant radiation to the surgical resection. When opting for post-operative radiation, care should be taken that radiation is started within some reasonable time after the surgery. We were interested to the proportion of patients who did not recieve optimal post-operative radiation and the variables associated. METHODS: We retrospectively analyzed a series of 77 patients operated on for an extremity soft-tissue sarcoma and due for post-operative radiotherapy. Patients were considered to have received radiation optimally if radiation was started within 12 weeks of surgery. Variables associated with not receiving radiation optimally were looked for using univariable and multivariable regression models. RESULTS: Overall, 26 patients (34%; 95% CI: 23-45%) did not receive radiation optimally. Twenty (26%) did not start radiation within the 12-weeks mark and six (8%) could not have radiation at all. The main reason identified for not receiving radiation on time was the occurrence of a wound complication (14 (54%) patients). An increased body mass index (OR: 1.14; 95% CI: 1.02-1.26; p = 0.02) and an older age (OR: 1.55; 95% CI: 1.18-2.14; p = 0.04; of note, the OR are for a 10 year change) were significantly associated with not receiving radiation optimally. Patients with a social fragility (p = 0.04), metastatic spread at presentation (p = 0.04), and increased duration of surgery (p = 0.02) were more likely to develop a wound complication. CONCLUSIONS: About 34% of patients do not receive optimal post-operative radiation treatment. Older and obese patients have a higher risk of not receiving radiation optimally. The decision for pre- or post-operative radiation should account for these findings.


Asunto(s)
Radioterapia Adyuvante/estadística & datos numéricos , Sarcoma/cirugía , Adulto , Anciano , Extremidades/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Periodo Posoperatorio , Estudios Retrospectivos , Sarcoma/radioterapia
4.
J Arthroplasty ; 31(12): 2784-2788, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27311496

RESUMEN

BACKGROUND: Leg length discrepancy after total hip arthroplasty is a frequent complication. The aim of this study was to assess the validity (correlation) and reproducibility (inter-rater agreement) of various intraoperative hip radiographs measures to estimate leg length. METHODS: Patients were included if they were aged 15 years or older; were eligible for a total hip arthroplasty, and were operated in lateral recumbent. An intraoperative hip radiograph was performed with the definitive implants in place. At 6 weeks postoperatively, anteroposterior pelvis radiograph was taken. We used 3 measures to assess leg length: the height from the ischial tuberosity to the lesser trochanter (LTI), the height from the center of femoral head to the greater trochanter (GTC), and to the inferior teardrop (TC). RESULTS: The study group consisted of 71 hips with an average age of 69 years (range, 24-92 years). The correlation was 0.545 (95% CI: 0.35-0.69) for GTC, 0.75 (95% CI: 0.61-0.84) for TC, and 0.70 (95% CI: 0.56-0.80) for LTI. Intraoperative and postoperative measures were statistically different for GTC (<0.0001) and TC (<0.0001), and not significant for LTI (P = .06). Reproducibility of these measures were excellent with intraclass correlation coefficients of 0.977, 0.814, and 0.983 for the GTC, TC, and LTI, respectively. CONCLUSION: None of the parameters used to assess leg-length based on an intraoperative radiograph showed good correlation with the postoperative radiograph.


Asunto(s)
Artroplastia de Reemplazo de Cadera/efectos adversos , Fémur/diagnóstico por imagen , Diferencia de Longitud de las Piernas/diagnóstico por imagen , Complicaciones Posoperatorias/diagnóstico por imagen , Radiografía/métodos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Fémur/cirugía , Cabeza Femoral/cirugía , Articulación de la Cadera/cirugía , Humanos , Cuidados Intraoperatorios , Diferencia de Longitud de las Piernas/etiología , Masculino , Persona de Mediana Edad , Cuidados Posoperatorios , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Reproducibilidad de los Resultados , Adulto Joven
5.
Reprod Biomed Online ; 29(2): 187-92, 2014 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-24832373

RESUMEN

The number of procedures required for a trainee to reach proficiency in oocyte retrieval and the criteria applied to define performance are not well defined. To evaluate the learning curve of oocyte retrieval, this study prospectively evaluated three trainees over 6 months. Oocyte retrieval was monitored by the learning curve-cumulative summation test (LC-CUSUM), a specific statistical tool designed to indicate when a predefined level of performance is reached. Oocytes were retrieved from one ovary by the trainee and from the second ovary by a senior operator in a randomized manner. The main outcome measure was the ratio of oocytes collected and follicles aspirated. A trainee's ratio of ≥ 80% of the senior operator's defined success. From 17 to >50 procedures were necessary for the trainees to reach the predefined level of performance. Cumulative summation tests implemented after the learning phase confirmed that performance was maintained. The present study confirms the large variability in acquiring proficiency for surgical procedures. It provides an exportable model for a quantitative tailored monitoring of the learning curve and for continuous monitoring of performance in oocyte retrieval.


Asunto(s)
Capacitación en Servicio/normas , Curva de Aprendizaje , Recuperación del Oocito , Adulto , Femenino , Humanos , Masculino , Estudios Prospectivos
6.
J Arthroplasty ; 29(7): 1418-22, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-24612735

RESUMEN

Chemotherapy may reduce osseointegration of tumor endoprosthesis, while delaying chemotherapy may reduce survival. We studied the effects of chemotherapy and cemented fixation on tumor endoprosthesis survivorship with a retrospective analysis of 50 consecutive patients receiving lower limb salvage surgery. We compared rates of radiographic loosening/revision and effect of cement fixation between chemotherapy/no chemotherapy cohorts. Chemotherapy increased the total revision rate (HR = 3.8 [1-14], P = 0.033), but did not affect aseptic loosening. Cement fixation reduced revision for loosening (HR = 0.09 (0.008-0.98), P = 0.012) and showed less radiographic loosening (HR = 0.09 (0.02-0.51), P = 0.00066). Cement fixation had lower rates of revision for loosening and radiographic loosening regardless of whether chemotherapy was given. We conclude that for these implants, cement fixation provides superior results to uncemented fixation.


Asunto(s)
Antineoplásicos/uso terapéutico , Cementos para Huesos/uso terapéutico , Neoplasias/tratamiento farmacológico , Neoplasias/cirugía , Adulto , Condrosarcoma/tratamiento farmacológico , Condrosarcoma/cirugía , Femenino , Prótesis de Cadera , Humanos , Masculino , Persona de Mediana Edad , Osteosarcoma/tratamiento farmacológico , Osteosarcoma/cirugía , Diseño de Prótesis , Falla de Prótesis , Reoperación , Estudios Retrospectivos , Terapia Recuperativa
7.
J Arthroplasty ; 29(3): 586-9, 2014 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-23998991

RESUMEN

Despite advances in surgical techniques and instrumentation, optimal cup positioning in total hip arthroplasty (THA) is challenging with a limited accuracy. We evaluated whether a learning curve exists for the optimal cup positioning, using the LC-CUSUM test (Learning curve cumulative summation test). We evaluated the first 100 consecutive THA performed by two surgeons, who had a year of fellowship training in the same teaching hospital. A learning curve of cup positioning was plotted in each series using the LC-CUSUM score. There was no significant difference of numbers of outlier between two surgeons (P = 0.079). Both surgeons completed the learning curve of optimal cup positioning before 50 procedures, and maintained competence. A substantial learning period is necessary in the optimal positioning of an acetabular cup.


Asunto(s)
Acetábulo/cirugía , Artroplastia de Reemplazo de Cadera/métodos , Articulación de la Cadera , Prótesis de Cadera , Artropatías/cirugía , Curva de Aprendizaje , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
8.
Ann Surg Oncol ; 20(6): 1858-64, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23370669

RESUMEN

PURPOSE: Local recurrence of a bone or soft-tissue sarcoma is a devastating complication. Minimizing the proportion of positive surgical margins, or tumor contamination, during resection is of paramount importance. METHODS: Resections of sarcomas were prospectively evaluated and considered inadequate if unplanned microscopic or macroscopic positive surgical margins were identified or if inadvertent tumor contamination of the wound occurred. Monitoring of performance was continuously performed with a statistical process control method, the cumulative sum test, and regular meetings were held to discuss the reasons for failures. A target performance of 5 % inadequate procedures was chosen. RESULTS: A total of 146 sarcomas-106 soft tissue and 40 bone-were resected during the monitoring period. Six (4 %) procedures were considered inadequate: three patients had inadvertent tumor contamination of the wound, two patients had unplanned microscopic positive margins, and one patient had both. Performance was considered to be adequate during the whole monitoring period. CONCLUSIONS: With adequate preoperative planning and surgical technique, the risk of an inadequate resection can be limited. Implementation of a statistical process control method allows for ongoing performance monitoring and ensures that quality remains adequate over time.


Asunto(s)
Neoplasias Óseas/cirugía , Recurrencia Local de Neoplasia/patología , Siembra Neoplásica , Garantía de la Calidad de Atención de Salud , Sarcoma/cirugía , Neoplasias de los Tejidos Blandos/cirugía , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/prevención & control , Neoplasia Residual
9.
Clin Orthop Relat Res ; 471(3): 905-14, 2013 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-22968530

RESUMEN

BACKGROUND: Biopsies of musculoskeletal tumors lead to alterations in treatment in almost 20% of cases. Control charts are useful to ensure that a process is operating at a predetermined level of performance, although their use has not been demonstrated in assessing the adequacy of musculoskeletal biopsies. QUESTIONS/PURPOSES: We therefore (1) assessed the incidence of and the reasons for inadequate musculoskeletal biopsies when following guidelines for performing the procedure; and (2) implemented a process control chart, the CUSUM test, to monitor the proportion of inadequate biopsies. METHODS: We prospectively studied 116 incisional biopsies. The biopsy was performed according to 10 rules to (1) minimize contamination in the tissues surrounding the tumor; and (2) improve accuracy. A frozen section was systematically performed to confirm that a representative specimen was obtained. Procedures were considered inadequate if: (1) another biopsy was necessary; (2) the biopsy tract was not appropriately placed; and (3) the treatment provided based on the diagnosis from the biopsy was not appropriate. RESULTS: Five (4.3%) of the 116 incisional biopsy procedures were considered failures. Three patients required a second repeat open biopsy and two were considered to receive inappropriate treatment. No alarm was raised by the control chart and the performance was deemed adequate over the monitoring period. CONCLUSIONS: The proportion of inadequate musculoskeletal open biopsies performed at a referral center was low. Using a statistical process control method to monitor the failures provided a continuous measure of the performance.


Asunto(s)
Biopsia/normas , Neoplasias Óseas/patología , Neoplasias de los Músculos/patología , Indicadores de Calidad de la Atención de Salud/normas , Adulto , Neoplasias Óseas/terapia , Errores Diagnósticos/prevención & control , Femenino , Adhesión a Directriz , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Modelos Estadísticos , Neoplasias de los Músculos/terapia , Guías de Práctica Clínica como Asunto , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Derivación y Consulta/normas , Centros de Atención Terciaria/normas , Procedimientos Innecesarios
10.
J Arthroplasty ; 28(2): 220-226.e1, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-22770856

RESUMEN

This is a retrospective study comparing the clinical outcomes of mobile vs fixed medial unicompartmental knee replacements. Patients were identified from a prospectively collected database. Demographic data and pre- and postoperative outcomes (Oxford, Western Ontario and McMaster Universities Osteoarthritis Index, Short Form Health Survey-12, and satisfaction) were collected-104 knees (90 patients) with minimum 2-years of follow-up: 37 mobile and 67 fixed-bearing. At baseline, the median age was 60 years (mobile) and 66 (fixed); body mass index was significantly higher (32) for the mobile group than for the fixed (28). At follow-up, the groups differed only in the Oxford score: median 83 (mobile) and 90 (fixed). There is no difference in outcomes between mobile and fixed unicompartmental knee replacements.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Prótesis de la Rodilla , Osteoartritis de la Rodilla/cirugía , Calidad de Vida , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Rango del Movimiento Articular , Estudios Retrospectivos , Resultado del Tratamiento
11.
Cancer ; 118(23): 5867-77, 2012 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-22648518

RESUMEN

BACKGROUND: The objective of this study was to examine the effect of known predictors of local recurrence of soft tissue sarcoma in a competing risk setting. METHODS: The outcome of interest was the cumulative probability of local recurrence per category of relevant predictors, with death as a competing event. In total, 1668 patients with a localized soft tissue sarcoma of the extremity or trunk were included. RESULTS: Tumor size (hazard ratio, 3.3), depth (hazard ratio, 3.2), and histologic grade (hazard ratio, 4.5) were the variables that had the most effect on the risk of metastasis and, accordingly, were the most likely to induce competition. Surgical margins (hazard ratio, 3.3), histologic grade (hazard ratio, 2.1), presentation status (hazard ratio, 2.4), and tumor depth (hazard ratio, 1.5) were the variables that had the most effect on the risk of local recurrence. The 10-year cumulative probabilities of local recurrence were markedly different within categories for presentation status (P < .001) and surgical margin status (P < .001). However, because of the competing effect of death, there was little difference in the 10-year cumulative probabilities of local recurrence with regard to tumor depth (12% and 11.4% for deep and superficial tumors, respectively; P = .2), tumor size (10.6% and 13.3% for large and small tumors, respectively; P = .99), or histologic tumor grade (12.6%, 10.7%, and 11.1% for high, intermediate, and low-grade tumors, respectively; P = .17). CONCLUSIONS: Because of the competition between local recurrence and death, histologic tumor grade, tumor size, and tumor depth had little influence on the cumulative probability of local recurrence. The authors concluded that local management should be based on presentation status and surgical margins rather than other, previously acknowledged factors.


Asunto(s)
Recurrencia Local de Neoplasia/etiología , Sarcoma/patología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Probabilidad , Sarcoma/cirugía
12.
Int Orthop ; 36(6): 1155-61, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22207406

RESUMEN

PURPOSE: Infection of a total hip replacement is potentially a devastating complication. Statistical process control methods have been generating interest as a means of improving the quality of healthcare, and we report our experience with the implementation of such a method to monitor the one year infection rate after primary total hip replacement. METHOD: Infection was defined as the growth of the same organism in cultures of at least two aspirates or intra-operative specimens, or growth of one pathogen in a patient with local signs of infection such as erythema, abscess or draining sinus tract. The cumulative summation test (CUSUM test) was used to continuously monitor the one year postoperative infection rate. The target performance was 0.5% and the test was set to detect twice that rate. RESULTS: Over the three year study period, 2006 primary total hip replacements were performed. Infection developed within one year after surgery in eight (0.4%) hips. The CUSUM test generated no alarms during the study period, indicating that there was no evidence that the process was out of control. CONCLUSION: The one year infection rate after primary total hip replacement was in control. The CUSUM test is a useful method to continuously ensure that performance is maintained at an adequate level.


Asunto(s)
Artroplastia de Reemplazo de Cadera/normas , Evaluación de Resultado en la Atención de Salud , Infección de la Herida Quirúrgica/epidemiología , Artroplastia de Reemplazo de Cadera/efectos adversos , Infecciones Bacterianas/epidemiología , Infecciones Bacterianas/etiología , Infecciones Bacterianas/microbiología , Bases de Datos Factuales , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Masculino , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/microbiología , Insuficiencia del Tratamiento
13.
Oncologist ; 16(12): 1771-9, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-22147000

RESUMEN

BACKGROUND: Enchondromatosis is characterized by the presence of multiple benign cartilage lesions in bone. While Ollier disease is typified by multiple enchondromas, in Maffucci syndrome these are associated with hemangiomas. Studies evaluating the predictive value of clinical symptoms for development of secondary chondrosarcoma and prognosis are lacking. This multi-institute study evaluates the clinical characteristics of patients, to get better insight on behavior and prognosis of these diseases. METHOD: A retrospective study was conducted using clinical data of 144 Ollier and 17 Maffucci patients from 13 European centers and one national databank supplied by members of the European Musculoskeletal Oncology Society. RESULTS: Patients had multiple enchondromas in the hands and feet only (group I, 18%), in long bones including scapula and pelvis only (group II, 39%), and in both small and long/flat bones (group III, 43%), respectively. The overall incidence of chondrosarcoma thus far is 40%. In group I, only 4 patients (15%) developed chondrosarcoma, in contrast to 27 patients (43%) in group II and 26 patients (46%) in group III, respectively. The risk of developing chondrosarcoma is increased when enchondromas are located in the pelvis (odds ratio, 3.8; p = 0.00l). CONCLUSIONS: Overall incidence of development of chondrosarcoma is 40%, but may, due to age-dependency, increase when considered as a lifelong risk. Patients with enchondromas located in long bones or axial skeleton, especially the pelvis, have a seriously increased risk of developing chondrosarcoma, and are identified as the population that needs regular screening on early detection of malignant transformation.


Asunto(s)
Neoplasias Óseas/complicaciones , Enfermedades de los Cartílagos/complicaciones , Condrosarcoma/complicaciones , Encondromatosis/complicaciones , Hemangioma/complicaciones , Neoplasias Cutáneas/complicaciones , Adolescente , Adulto , Anciano , Niño , Preescolar , Condrosarcoma/diagnóstico , Condrosarcoma/epidemiología , Condrosarcoma/patología , Encondromatosis/patología , Europa (Continente)/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Factores de Riesgo
14.
Am J Obstet Gynecol ; 204(3): 218.e1-9, 2011 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21111398

RESUMEN

OBJECTIVE: We sought to determine the learning curve (LC) for fetoscopic laser photocoagulation (FLP) as a model for the evaluation of training in surgical procedures. STUDY DESIGN: A retrospective review of consecutive case series of FLP from 2 centers with 3 operators (operator I [O-I], observer trained; operator II [O-II], hands-on trained; and operator III [O-III], clinical fellow) was performed and the LC-cumulative summation (CUSUM) test was plotted. RESULTS: The acceptable and unacceptable success rates for at least 1 fetus survival after FLP were set at 82% and 70%, respectively, from a systematic review. A total of 171 consecutive cases were performed by the 3 operators (O-I, 91; O-II, 49; and O-III, 31). From LC-CUSUM test O-I needed 60 procedures, O-II needed 20 procedures, and O-III needed 20 procedures to reach an acceptable performance rate for at least 1 survivor. CONCLUSION: The LC-CUSUM test can be used to accurately assess the LC in a surgical procedure in obstetrics and gynecology. Hands-on trained operators exhibit a shorter LC.


Asunto(s)
Fetoscopía/educación , Terapia por Láser , Curva de Aprendizaje , Obstetricia/educación , Adulto , Competencia Clínica , Evaluación Educacional , Femenino , Transfusión Feto-Fetal/cirugía , Humanos , Modelos Educacionales , Embarazo , Estudios Retrospectivos , Adulto Joven
15.
Int Orthop ; 35(2): 151-5, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20652695

RESUMEN

In medical research, commonly, one is interested in the time to the occurrence of a particular event, such as the revision of an implant, and the analysis of these data is referred to as survival analysis. However, for some patients, the event is not observed and their observations are censored. These censored observations are particular to survival data and require specific methods for estimation. The Kaplan and Meier method is a popular method to estimate the probability of being free of the event over time and it is now widely applied in orthopaedics such as to report implant survival. However, one of the assumptions underlying the Kaplan-Meier estimator implies that patients whose observations are censored have the same risk of occurrence of the event than patients remaining in the study. However, because the revision of an implant cannot occur after a patient dies, and that dead patients have their observations censored in the Kaplan-Meier method, another setting must be considered. In the sequel we will demonstrate the inadequacy of the Kaplan-Meier method to estimate implant survival and detail the cumulative incidence estimator.


Asunto(s)
Análisis de Falla de Equipo/métodos , Falla de Prótesis , Interpretación Estadística de Datos , Análisis de Falla de Equipo/estadística & datos numéricos , Humanos , Estimación de Kaplan-Meier , Complicaciones Posoperatorias , Reoperación/estadística & datos numéricos , Medición de Riesgo , Factores de Riesgo
16.
Sarcoma ; 2011: 395180, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-22190863

RESUMEN

Introduction. Ewing's sarcomas (EWSs) of bone and soft tissue are neuroectodermal tumors that affect both axial and appendicular locations. We hypothesized that axial location predicted poor outcome in EWS patients. Materials and Methods. Sixty-seven patients (57 with bone EWS and 10 with soft tissue EWS) were identified from our database. Thirty-four (51%) had axial EWS and 33 (49%) had appendicular EWS. Statistical analyses identified predictors of poor outcome. Results and Discussion. Axial location, large size, metastases at presentation, lack of definitive treatment, and positive surgical margins all correlated with poor outcome in univariate analysis. In multivariate analysis, axial location still predicted poor outcome when adjusted for pretreatment variables. Axial location was not statistically predictive of poor outcome when adjusted for treatment variables. Conclusions. Anatomic location has a negative effect on outcome in EWS that cannot be completely explained by pretreatment or treatment factors. Additional studies are required to determine if there is a biologic difference between axial and appendicular EWS.

17.
Hum Reprod ; 25(2): 380-6, 2010 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-19923166

RESUMEN

BACKGROUND: Embryo transfer, a crucial step for achieving pregnancy after in vitro fertilization, is an operator-dependent technique but the number of procedures required for a trainee to reach proficiency is unknown. We set out to evaluate the learning curve (LC) of embryo transfer using a specifically designed statistical tool. METHODS: The first embryo transfers performed by five trainees were monitored by the cumulative summation test for learning curve (LC-CUSUM), a statistical tool designed to indicate when a process has reached a predefined level of performance. The main outcome measure was a positive hCG test. A 40% pregnancy rate (PR) per transfer was chosen to define adequate performance and a PR of 20% was considered inadequate. After the learning phase, standard CUSUM were implemented to ensure that performance was maintained. The same CUSUM parameters were also applied to monitor 241 consecutive embryo transfers performed by a senior gynaecologist. RESULTS: Between 11 and 99 embryo transfers were necessary for the trainees to reach the predefined level of performance. Simple and intuitive graphical representations of the LCs were generated. CUSUM tests confirmed that performance was maintained after the learning phase. The PR of the senior gynaecologist was 42.7% and the CUSUM showed that performance remained adequate throughout the 241 procedures. CONCLUSIONS: This study provides an exportable model for a quantitative monitoring of the LC of embryo transfer as well as a reference curve for continuous monitoring of performance in embryo transfer. The length of the LC of embryo transfer is highly variable, justifying a tailored training to learn this procedure.


Asunto(s)
Evaluación Educacional , Transferencia de Embrión/métodos , Competencia Clínica , Femenino , Fertilización In Vitro/métodos , Humanos , Embarazo , Índice de Embarazo , Inyecciones de Esperma Intracitoplasmáticas/métodos
18.
Stat Med ; 29(18): 1900-9, 2010 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-20680983

RESUMEN

The cumulative summation (CUSUM) test is increasingly being used in medicine to monitor a wide variety of processes such as cardiac surgery or disease outbreaks. The CUSUM sequentially tests the null hypothesis that the process is in control, i.e. its mean is equal to a given target. Thus, it detects when the process changes to an out of control state. Conversely, monitoring the learning curve requires detecting the time when the process reaches an in control state. In this work we develop an alternative to the CUSUM, the learning curve CUSUM (LC-CUSUM), that serves to detect when a process deviates from an out of control state to an in control state. The test is based on a two one-sided tests procedure where the null hypothesis is that the process is out of control. This can be written as H(0): |mu-mu(0)|> or =delta tested against H(1): |mu-mu(0)|< delta. The null hypothesis is thus the union of two one-sided hypotheses and is rejected when both are rejected. A CUSUM test statistic is then constructed for each hypothesis in a traditional way. The properties of the test are investigated through numerical simulations, and are illustrated on the learning curve of an endoscopist performing endoscopic retrograde cholangiopancreatographies for biliary tract disorders.


Asunto(s)
Curva de Aprendizaje , Evaluación de Procesos, Atención de Salud/estadística & datos numéricos , Algoritmos , Competencia Clínica/estadística & datos numéricos , Humanos
19.
Clin Orthop Relat Res ; 468(3): 834-45, 2010 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19851817

RESUMEN

UNLABELLED: The use of allograft-prosthesis composites for reconstruction after bone tumor resection at the proximal femur has generated considerable interest since the mid1980s on the basis that their use would improve function and survival, and restore bone stock. Although functional improvement has been documented, it is unknown whether these composites survive long periods and whether they restore bone stock. We therefore determined long-term allograft-prosthesis composite survival, identified major complications that led to revision, and determined whether allograft bone stock could be spared at the time of revision. We also compared the radiographic appearance of allografts sterilized by gamma radiation and fresh-frozen allografts. We retrospectively reviewed 32 patients with bone malignancy in the proximal femur who underwent reconstruction with a cemented allograft-prosthesis composite. The allograft-prosthesis composite was a primary reconstruction for 23 patients and a revision procedure for nine. The minimum followup was 2 months (median, 68 months; range, 2-232 months). The cumulative incidence of revision for any reason was 14% at 5 years (95% confidence interval, 1%-28%) and 19% at 10 years (95% confidence interval, 3%-34%). Nine patients (28%) had revision of the reconstruction during followup; four of these patients had revision surgery for infection. Allografts sterilized by gamma radiation showed worse resorption than fresh-frozen allografts. Based on reported results, allograft-composite prostheses do not appear to improve survival compared with megaprostheses. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.


Asunto(s)
Neoplasias Óseas/cirugía , Fémur/cirugía , Prótesis de la Rodilla , Procedimientos de Cirugía Plástica/efectos adversos , Adulto , Criopreservación , Femenino , Estudios de Seguimiento , Rayos gamma , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Falla de Prótesis , Infecciones Relacionadas con Prótesis , Reoperación , Estudios Retrospectivos , Esterilización , Factores de Tiempo , Trasplante Homólogo
20.
Clin Orthop Relat Res ; 468(12): 3248-54, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-20532718

RESUMEN

BACKGROUND: The treatment of recurrent dislocation after total hip arthroplasty remains challenging. Dual mobility sockets have been associated with a low rate of dislocation but it is not known whether they are useful for treating recurrent dislocation. QUESTIONS/PURPOSES: We therefore asked whether a cemented dual mobility socket would (1) restore hip stability following recurrent dislocation; (2) provide a pain-free and mobile hip; and (3) show durable radiographic fixation. METHODS: We retrospectively reviewed 51 patients treated with a cemented dual mobility socket for recurrent dislocation after total hip arthroplasty between August 2002 and June 2005. The mean age at the time of the index procedure of was 71.3 years. Of the 51 patients, 47 have had complete clinical and radiographic evaluation data at a mean followup of 51.4 months (range, 25-76.3 months). RESULTS: The cemented dual mobility socket restored complete stability of the hip in 45 of the 47 patients (96%). The mean Merle d'Aubigné hip score was 16 ± 2 at the latest followup. Radiographic analysis revealed no or radiolucent lines less than 1 mm thick located in a single acetabular zone in 43 of 47 hips (91.5%). The cumulative survival rate of the acetabular component at 72 months using revision for dislocation and/or mechanical failure as the end point was 96% ± 4% (95% confidence interval, 90%-100%). CONCLUSIONS: A cemented dual mobility socket was able to restore hip stability in 96% of recurrent dislocating hips. However, longer-term followup is needed to ensure that dislocation and loosening rates will not increase.


Asunto(s)
Artroplastia de Reemplazo de Cadera/instrumentación , Cementos para Huesos/uso terapéutico , Articulación de la Cadera/cirugía , Prótesis de Cadera , Luxaciones Articulares/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Artroplastia de Reemplazo de Cadera/efectos adversos , Femenino , Francia , Articulación de la Cadera/diagnóstico por imagen , Articulación de la Cadera/fisiopatología , Humanos , Luxaciones Articulares/diagnóstico por imagen , Luxaciones Articulares/etiología , Luxaciones Articulares/fisiopatología , Inestabilidad de la Articulación/etiología , Inestabilidad de la Articulación/cirugía , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Radiografía , Rango del Movimiento Articular , Recuperación de la Función , Recurrencia , Reoperación , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
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