Artículo original
Lectura crítica – versión en inglés
Esta lectura crítica se ha llevado a cabo utilizando CASP Systematic Review Checklist (31.05.13) como referencia y el análisis ha sido presentado en dos secciones: puntos fuertes y puntos débiles.
Puntos fuertes:
La revisión y el análisis son meticulosos y bien estructurados con una base lógica establecida*, objetivos y resultados primarios y secundarios claros – (comprobar si la cirugía laparoscópica tiene algún valor adicional con ERAS para pacientes colorrectales, evaluando cuando todos los pacientes reciben:
ERAS bien con laparoscopia o cirugía abierta y
Laparoscopia con o sin ERAS y puntos finales claros.
* no se ha desarrollado ningún meta análisis previo analizando un protocolo ERAS y laparoscopia. (El revisor de este artículo comprobó la veracidad de esta afirmación mediante una búsqueda preliminar usando Cochrane Library).
La metodología es rigurosa, dando criterios de inclusión y exclusión medibles y datos de análisis meticulosos. Los resultados están bien presentados y son fáciles de interpretar, la discusión es válida e incluye referencias a otros estudios pertinentes y explicaciones exhaustivas de las limitaciones del análisis.
Puntos débiles:
El estudio incluye 3 RCTs y 5 CCTs (hay una inexactitud en el abstract, pues dice que son 6 CCTs en el estudio y no todos pueden ser usados para cada parámetro. Se puede argumentar que la importancia de esta cantidad es cuestionable, especialmente dado que los autores afirman que la calidad de la información analizada es ‘de moderada a pobre’.
Los pacientes involucrados (942) no están distribuidos uniformemente entre las áreas de estudio – 408 para Laparoscopia y ERAS; 189 para Laparoscopia y cuidado convencional; 249 para cirugía abierta y ERAS. Los 98 pacientes que recibieron cirugía abierta y cuidados convencionales no aparecen en el estudio en lo que respecta a los datos potencialmente disponibles de este análisis.
El énfasis del estudio – el valor añadido por la laparoscopia dentro de un programa ERAS – es confuso. La cirugía laparoscópica es uno de los aspectos clave dentro de las 17 recomendaciones de grado A dadas, sujeta solo a la disponibilidad de personal entrenado, que, en el tiempo en el que se publicó el estudio era posiblemente un problema mayor que cuando se llevó a cabo.
Los autores sostienen que han utilizado datos que abarcan unos años, lo que obviamente podría influir en los resultados, pero en suma, el número de pacientes que recibieron cirugía laparoscópica frente a los que recibieron cirugía abierta es mayor. (59 vs. 247).
El autor utiliza una ‘hoja de extracción de datos’ especialmente ideada para almacenar información, pero no se proporciona en el artículo.
No está claro por qué los autores han elegido informar sobre los resultados específicos que tienen o la razón por la que unos son ‘primarios’ y otros ‘secundarios’ (Los últimos no están contemplados en la extracción de datos y en la valoración de calidad con respecto al método).
Realizan comentarios pasajeros sobre otros parámetros como la movilidad pero no un desglose pormenorizado de todos los criterios ERAS en los que sea posible.
Los autores citan en varias ocasiones (4) como referencia clave un estudio previo llevado a cabo por dos miembros de su equipo, lo que podría añadir un elemento de parcialidad al artículo.
Sus descubrimientos muestran que hay poca diferencia entre los resultados cuando se usa cirugía laparoscópica haya o no haya ERAS y se refieren a un estudio previo suyo para decir que ERAS es efectivo con cirugía abierta. Dado que los datos de ERAS y cuidado convencional estaban potencialmente disponibles para los autores de este estudio, esta afirmación podría haber sido validada o refutada, cosa que no ha ocurrido.
En resumen, el factor fundamental que limita el análisis y el artículo es la calidad de los datos que los autores encontraron disponibles y la potencial parcialidad de los datos comparativos del ‘estudio restrospectivo’, marginalizando por lo tanto la afirmación de que la cirugía laparoscópica mejora a los protocolos ERAS en relación con los factores mórbidos y la duración de la estancia hospitalaria.
16 Julio 2015
Guías de consenso de la Sociedad Francesa de Anestesia y Reanimación. Podéis descargarla (en francés) haciendo click en el enlace.
Guidelines for perioperative haemodynamic optimization
25 Junio 2015
APPRAISAL:
Impact of mechanical bowel preparation on survival after colonic cancer resection – Å. Collin1, B. Jung, E. Nilsson, L. Påhlman1 and J. Folkesson (+ Renehan)
Por Mihai Paduraru
This is a clearly presented paper with specific intention and methodology. The authors identify where there are limitations in their research and suggest how this can be improved upon. However, as has already been identified by A. G. Renehan in his commentary in BJS (2014), a key flaw in the validity of the findings of Jung et al, is the lack of attention paid to the impact of confounding factors over a ten year period, the fact being that the first trial was rigorous as an RCT, with different aims, and the second study is retrospectively analyzing data using the same patient group from the original trial, can lead to confusion. He suggests that the statistical methodology used was insufficient in some cases and lacking in others to support the findings and therefore, the conclusion. Renehan has already commented (BJS 2014) on the insufficiency of some of the statistical analysis and lack of attention to confounding factors.
There are some further points to make in addition to Renehan’s comments. Firstly the high number/proportion of patients from the RCT that were excluded from the data analysis of this second study. The authors give a rationale for this but the end result is a smaller sample size than is considered valid for the results to be significant. Since this is a retrospective cohort study, this is an important point. If all patients had been included, then it has to be considered that the results might have been different. One of the reasons stated for the exclusion of certain patient data was the lack of accuracy of the data base used and the inconsistency of recording, compounded by the changes in reporting over the 10 year period. Again, this factor cannot be ignored and throws into question the accuracy of the patient case records.
Secondly, the higher proportion of patents in the non MBP group with stage III tumor is not discussed sufficiently. The difference between stage II and III is that the cancer has spread to nearby lymph nodes in the latter stage. The expectation then would be for this group to have a lower cancer specific survival rate. Furthermore, each stage has sub classifications (a,b and a,b,c respectively) and we do not know, from the paper, if the stages are pre- or postoperative, nor if the study takes into account the number of nodes in relation to the long term oncological results for stage III (stage IV being excluded). The authors do not provide any data as a reference with regard to overall colon cancer survival for patients undergoing resection with type II and type III tumor stage.
Thirdly, the ‘surgeon factor’ is not discussed at all as a factor. The proficiency of the surgeon has been demonstrated in other studies to play an important role in trial outcomes. This could be another confounding factor, especially with regard to practice 10 years ago and with the debate to prepare mechanicaly or not the colon.
Another confounding factor not accounted for and already mentioned by Renehan, are other/additional kinds of oncological treatment – adjuvance.
In agreement with Renehan, the study has some use in generating further research, but these new studies need to be more thorough in identifying and accounting for the confounding factors.
Overall this paper contributes no hard evidence that MBP could improve colon cancer survival rates, with a low level of evidence for the moment and with high level of bias.
On the other hand, if this study had been a strong one, with a high level of evidence and recommendation (Harbour and Miller), to give it validity, what would the implications for practice be: To choose the option of reducing postoperative complications, including mortality, by not undertaking MBP (as recommended and proven by ERAS); or to choose long term better oncological results re-instating the classical MBP for colon resections? Such a recommendation poses a real ethical dilemma and needs much more concrete evidence than this study offers before we take a step back to the future.
Artículos seleccionados Septiembre 2016
Aquí os traemos los artículos seleccionados para Septiembre de 2016.
Enhanced recovery care after colorectal surgery in elderly patients. Compliance and outcomes of a multicenter study from the Spanish working group on ERAS
http://www.ncbi.nlm.nih.gov/pubmed/27378580
Large-scale implementation of enhanced recovery programs after surgery. A francophone experience
http://www.ncbi.nlm.nih.gov/pubmed/27638322
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Lectura crítica – Laparoscopic Versus Open Colorectal Resection Within Fast Track Programs: An Update Meta-Analysis Based on Randomized Controlled Trials (Qiu-Cheng Leia , Xin-Ying Wanga, b, e , Hua-Zhen Zhengc , Xian-Feng Xiad, Jing-Cheng Bib, Xue-Jin Gaoa , Ning) EN
Por Mihai Paduraru
Descarga el artículo original
This meta-analysis is focused on assessing the safety and efficacy of laparoscopic surgery within a fast track program for colorectal resection patients by comparing this approach to open surgery. In order to evaluate the value of this study we need to consider the validity of the methodology; the clinical importance of the results; and applicability of the findings.
The rigour of the methodology in this study is variable. The search strategy is lacking in certain details. One example is the search was initially over a 25 year time period but the RCTs included were in the last 10 years. A rationale for the study was the fact that similar ones had only used a small number of trials on which to base their findings. The value of this study was to be an analysis of more trials than previously evaluated, therefore it would have strengthened this meta-analysis to have identified as many trials as possible. It is not clear if this was attempted or not. The study was also limiting in its inclusion criteria by selecting trials reporting on ‘any’ one of the primary or secondary outcome criteria. This limited the scope of the results reported on as not all seven trials reviewed gave outcome data for all six outcomes reported on.
The method of study selection and data extraction was more rigorous and the statistical analysis thorough. The authors used the Cochrane tool to assess risk of bias in the RCTs but state that this quality control was based on the authors’ judgment, therefore admitting that the assessment was subjective. Little discussion is devoted to the risk of bias in the trials even though there is a high degree reported with regard to 4/7 elements. Sample size of the trials is also questioned but not validated.
Although the statistical analysis of the data was well conducted, with results being supported by Confidence Intervals and Relative Risk, there is not enough detail about the individual studies to support these results. The authors state that there is no significant heterogeneity between trials yet there are factors which should be reported on, for example age. There is a twenty year mean age difference between some trials. Similarly, rectal surgery treatment is known to be such that length of stay is longer for these patients than for colon surgical patients. These aspects could be confounding factors. They also report in Table 1 ‘cancer type’ but not all trial patients are operated on for cancer only.
One big limitation of the study is in the lack of analysis of fast track in the context it is applied by the RCTs. No definition is given; seven elements are selected as ones implemented by the trials, but obviously not exclusively nor necessarily with the same degree of compliance. Bowel preparation for example is undertaken by a number of trials, some of which do not include rectal surgical patients; in the others, it is not clear if this is for all patients or only rectal surgical, as recommended by ERAS. Any further elements included in the fast track program of each trial are merely reported on as a total figure and catagorised as ‘other’. Indeed the authors do not categorically state that ERAS is the official fast track program used. All these factors have important implications for verification of the results and therefore their clinical value. The findings mirror those of a similar analysis, but with fewer RCTs, thus adding some weight to the overall body of evidence. The scarcity of detail however in some qualitative aspects of the study questions the accuracy of the results.
Finally, it is worth noting that in terms of applicability, this is an analysis of a small sample of the population and is not specific to one geographical area or demography, and, although results are apparently similar despite this, they are not necessarily representative enough to inform local practice, especially since the authors state that their aim is to look at the efficacy and not the efficiency of laparoscopic surgery and fast track for colorectal surgical patients.
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Lectura Crítica: S.R. and Meta-Analysis for Laparoscopy vs. Open Colon Surgery with or without an ERAS Programme – Spanjersberg et al, 2014
Artículo original
Lectura crítica – versión en inglés
Esta lectura crítica se ha llevado a cabo utilizando CASP Systematic Review Checklist (31.05.13) como referencia y el análisis ha sido presentado en dos secciones: puntos fuertes y puntos débiles.
Puntos fuertes:
La revisión y el análisis son meticulosos y bien estructurados con una base lógica establecida*, objetivos y resultados primarios y secundarios claros – (comprobar si la cirugía laparoscópica tiene algún valor adicional con ERAS para pacientes colorrectales, evaluando cuando todos los pacientes reciben:
ERAS bien con laparoscopia o cirugía abierta y
Laparoscopia con o sin ERAS y puntos finales claros.
* no se ha desarrollado ningún meta análisis previo analizando un protocolo ERAS y laparoscopia. (El revisor de este artículo comprobó la veracidad de esta afirmación mediante una búsqueda preliminar usando Cochrane Library).
La metodología es rigurosa, dando criterios de inclusión y exclusión medibles y datos de análisis meticulosos. Los resultados están bien presentados y son fáciles de interpretar, la discusión es válida e incluye referencias a otros estudios pertinentes y explicaciones exhaustivas de las limitaciones del análisis.
Puntos débiles:
El estudio incluye 3 RCTs y 5 CCTs (hay una inexactitud en el abstract, pues dice que son 6 CCTs en el estudio y no todos pueden ser usados para cada parámetro. Se puede argumentar que la importancia de esta cantidad es cuestionable, especialmente dado que los autores afirman que la calidad de la información analizada es ‘de moderada a pobre’.
Los pacientes involucrados (942) no están distribuidos uniformemente entre las áreas de estudio – 408 para Laparoscopia y ERAS; 189 para Laparoscopia y cuidado convencional; 249 para cirugía abierta y ERAS. Los 98 pacientes que recibieron cirugía abierta y cuidados convencionales no aparecen en el estudio en lo que respecta a los datos potencialmente disponibles de este análisis.
El énfasis del estudio – el valor añadido por la laparoscopia dentro de un programa ERAS – es confuso. La cirugía laparoscópica es uno de los aspectos clave dentro de las 17 recomendaciones de grado A dadas, sujeta solo a la disponibilidad de personal entrenado, que, en el tiempo en el que se publicó el estudio era posiblemente un problema mayor que cuando se llevó a cabo.
Los autores sostienen que han utilizado datos que abarcan unos años, lo que obviamente podría influir en los resultados, pero en suma, el número de pacientes que recibieron cirugía laparoscópica frente a los que recibieron cirugía abierta es mayor. (59 vs. 247).
El autor utiliza una ‘hoja de extracción de datos’ especialmente ideada para almacenar información, pero no se proporciona en el artículo.
No está claro por qué los autores han elegido informar sobre los resultados específicos que tienen o la razón por la que unos son ‘primarios’ y otros ‘secundarios’ (Los últimos no están contemplados en la extracción de datos y en la valoración de calidad con respecto al método).
Realizan comentarios pasajeros sobre otros parámetros como la movilidad pero no un desglose pormenorizado de todos los criterios ERAS en los que sea posible.
Los autores citan en varias ocasiones (4) como referencia clave un estudio previo llevado a cabo por dos miembros de su equipo, lo que podría añadir un elemento de parcialidad al artículo.
Sus descubrimientos muestran que hay poca diferencia entre los resultados cuando se usa cirugía laparoscópica haya o no haya ERAS y se refieren a un estudio previo suyo para decir que ERAS es efectivo con cirugía abierta. Dado que los datos de ERAS y cuidado convencional estaban potencialmente disponibles para los autores de este estudio, esta afirmación podría haber sido validada o refutada, cosa que no ha ocurrido.
En resumen, el factor fundamental que limita el análisis y el artículo es la calidad de los datos que los autores encontraron disponibles y la potencial parcialidad de los datos comparativos del ‘estudio restrospectivo’, marginalizando por lo tanto la afirmación de que la cirugía laparoscópica mejora a los protocolos ERAS en relación con los factores mórbidos y la duración de la estancia hospitalaria.
Compartir esta entrada
Guidelines for perioperative haemodynamic optimization
16 Julio 2015
Guías de consenso de la Sociedad Francesa de Anestesia y Reanimación. Podéis descargarla (en francés) haciendo click en el enlace.
Guidelines for perioperative haemodynamic optimization
Compartir esta entrada
Comentarios a Impact of mechanical bowel preparation on survival after colonic cancer resection ( Br J Surg 2014: 101: 1594–1600)
25 Junio 2015
APPRAISAL:
Impact of mechanical bowel preparation on survival after colonic cancer resection – Å. Collin1, B. Jung, E. Nilsson, L. Påhlman1 and J. Folkesson (+ Renehan)
Por Mihai Paduraru
This is a clearly presented paper with specific intention and methodology. The authors identify where there are limitations in their research and suggest how this can be improved upon. However, as has already been identified by A. G. Renehan in his commentary in BJS (2014), a key flaw in the validity of the findings of Jung et al, is the lack of attention paid to the impact of confounding factors over a ten year period, the fact being that the first trial was rigorous as an RCT, with different aims, and the second study is retrospectively analyzing data using the same patient group from the original trial, can lead to confusion. He suggests that the statistical methodology used was insufficient in some cases and lacking in others to support the findings and therefore, the conclusion. Renehan has already commented (BJS 2014) on the insufficiency of some of the statistical analysis and lack of attention to confounding factors.
There are some further points to make in addition to Renehan’s comments. Firstly the high number/proportion of patients from the RCT that were excluded from the data analysis of this second study. The authors give a rationale for this but the end result is a smaller sample size than is considered valid for the results to be significant. Since this is a retrospective cohort study, this is an important point. If all patients had been included, then it has to be considered that the results might have been different. One of the reasons stated for the exclusion of certain patient data was the lack of accuracy of the data base used and the inconsistency of recording, compounded by the changes in reporting over the 10 year period. Again, this factor cannot be ignored and throws into question the accuracy of the patient case records.
Secondly, the higher proportion of patents in the non MBP group with stage III tumor is not discussed sufficiently. The difference between stage II and III is that the cancer has spread to nearby lymph nodes in the latter stage. The expectation then would be for this group to have a lower cancer specific survival rate. Furthermore, each stage has sub classifications (a,b and a,b,c respectively) and we do not know, from the paper, if the stages are pre- or postoperative, nor if the study takes into account the number of nodes in relation to the long term oncological results for stage III (stage IV being excluded). The authors do not provide any data as a reference with regard to overall colon cancer survival for patients undergoing resection with type II and type III tumor stage.
Thirdly, the ‘surgeon factor’ is not discussed at all as a factor. The proficiency of the surgeon has been demonstrated in other studies to play an important role in trial outcomes. This could be another confounding factor, especially with regard to practice 10 years ago and with the debate to prepare mechanicaly or not the colon.
Another confounding factor not accounted for and already mentioned by Renehan, are other/additional kinds of oncological treatment – adjuvance.
In agreement with Renehan, the study has some use in generating further research, but these new studies need to be more thorough in identifying and accounting for the confounding factors.
Overall this paper contributes no hard evidence that MBP could improve colon cancer survival rates, with a low level of evidence for the moment and with high level of bias.
On the other hand, if this study had been a strong one, with a high level of evidence and recommendation (Harbour and Miller), to give it validity, what would the implications for practice be: To choose the option of reducing postoperative complications, including mortality, by not undertaking MBP (as recommended and proven by ERAS); or to choose long term better oncological results re-instating the classical MBP for colon resections? Such a recommendation poses a real ethical dilemma and needs much more concrete evidence than this study offers before we take a step back to the future.
Compartir esta entrada
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