Reply to: “Coordinated care models in cirrhosis; the need for further randomized controlled trials”
Authors: Filippo Morando, Salvatore Piano, Paolo Angeli
Journal: Journal of Hepatology (2013)

How to improve care in outpatients with cirrhosis and ascites: A new model of care coordination by consultant hepatologistsJournal of HepatologyVol. 59Issue 2PreviewThe development of ascites in patients with cirrhosis is associated with a high rate of health care utilization. New models of specialized caregiving support are necessary to optimize its management. The aim of the study was to evaluate the efficacy and financial sustainability of the “Care management check-up” as a new model of specialized caregiving support based on a series of diagnostic facilities performed in real time and on the integrated activity of consultant hepatologists at the hospital unit for outpatients, dedicated nurses, physicians in training and primary physicians, compared to standard care in outpatients with cirrhosis and ascites. Full-Text PDF Coordinated care in cirrhosis; the need for further randomized controlled trialsJournal of HepatologyVol. 60Issue 2PreviewTo the Editor: Full-Text PDF Open Access We are making a step forwardTo the Editor:We would like to thank A.J. Wigg et al. for their interest in our study about a new model of care coordination by consultant hepatologists in outpatients with cirrhosis and ascites [[1]Morando F. Maresio G. Piano S. Fasolato S. Cavallin M. Romano A. et al.How to improve care in outpatients with cirrhosis and ascites: a new model of care coordination by consultant hepatologists.J Hepatol. 2013; 59: 257-264Abstract Full Text Full Text PDF PubMed Scopus (114) Google Scholar]. We regret that the Editorialists have not considered their publication but, such is life! Moreover, it should be recognized that the appearance of the two manuscripts on PubMed were very close each to one other. In their letter [[2]Wigg AJ, McCormick R, Wundke R, Woodman RJ. Coordinated care models in cirrhosis; the need for further randomized controlled, trials. J. Hepatol 2014;60:465–466.Google Scholar] A.J. Wigg et al. highlighted once again that our study was not randomized and suggested that the differences in outcomes of the two groups of our work were not linked to the process of management as outpatients, but to confounding factors that were not well balanced between the two groups. The circumstance that our study was not randomized has been already stressed by ourselves and by the editorialists. We also set out to explain the reasons why we decided to perform this type of study. As far as the enrollment and the matching process are concerned, as we stated in the paper, patients were enrolled consecutively on discharge from hospitalization due to acute decompensation of cirrhosis, and subjected to matching for a large number of variables (age, gender, type of ascites, Model for End Stage Liver Disease (MELD) score, Child-Turcotte-Pugh (CTP) score, etiology of cirrhosis, local or not local residences, and co-morbidities evaluated with the Charlson index). Here, it was clear that there were no significant differences in terms of baseline demographic, clinical or laboratory features. We recognize that the propensity score matching may probably be better, but the sample size was too small for its application. However, patients started the assigned care management program at the same time following discharge, as reported in the results.A.J. Wigg et al. have also speculated that there was a lack of process measures performed during the study, for example, regarding the patient’s attendance of scheduled appointments. Our study was not specifically designed to evaluate the compliance of patients, but rather to assess whether the new model “the Care Management Program”, based on an integrated activity of dedicated physicians and nurses and on some facilities such as lab examinations and diagnostic examinations in real time, may improve some outcomes in patients with cirrhosis and ascites as compared to the standard specialized caregiving model in our country. Nonetheless, the patients’ attendance of the scheduled appointments was extremely high in both groups (>90%) with a dropout rate of 2%. This represents a huge difference between our study and that of A.J. Wigg et al., in which the rate of drop out was considerably higher.As regards the relationship between the outcomes and the number of specialist evaluations, it has been clearly reported that the mean global number of specialist evaluations in the care management program was almost double that in the standard program, either when expressed per patient or per patient month of life. We did not introduce this parameter in the univariate analysis because we thought and we continue to think that the philosophy of the new model is more relevant than the single numbers or aspects of the model.Looking to A.J. Wigg et al., they proposed an analysis about the timing of mortality, assuming a too high rate of early and overall mortality in patients followed with the standard of care. Regarding this, we must emphasize the importance of an early intervention in patients with cirrhosis and ascites discharged after a hospitalization related to a complication of cirrhosis: they are a population of frail patients, immunosuppressed and predisposed towards new complications and hospital readmission [[3]Volk M.L. Tocco R.S. Bazick J. Rakoski M.O. Lok A.S. Hospital readmissions among patients with decompensated cirrhosis.Am J Gastroenterol. 2012; 107: 247-252Crossref PubMed Scopus (300) Google Scholar]. Thus, the prompt management of hyponatremia, renal failure and subclinical bacterial infections that was enabled in patients who were assigned to the “Care Management Program”, can definitively account for the definition of an early difference in the survival curve compared to that of patients who were assigned to the standard model. In addition, the standard treatment group presented a mortality rate that is in line with that reported in the literature on the natural history of cirrhosis, namely a rate of 40% one year after the development of ascites [[4]Guevara M. Cárdenas A. Uriz J. Ginès P. Prognosis in patients with cirrhosis and ascites.in: Ginès P. Arroyo V. Rodés J. Schrier R.W. Ascites and renal dysfunction in liver disease: pathogenesis, diagnosis and treatment. Blackwell, Malden2005: 260-270Crossref Scopus (38) Google Scholar]. As regards the probability of hospital readmission, recently, M.L. Volk and colleagues [[3]Volk M.L. Tocco R.S. Bazick J. Rakoski M.O. Lok A.S. Hospital readmissions among patients with decompensated cirrhosis.Am J Gastroenterol. 2012; 107: 247-252Crossref PubMed Scopus (300) Google Scholar] have shown, in a similar type of patients, a one-week readmission rate of 14%, a one-month readmission rate of 37% and an overall readmission of 69% of patients. These results are perfectly comparable with those found in the standard care group in our study, considering 30 day readmission (42%) and the global readmissions (71%). We are sure that these data are sufficient to reject the idea of A.J. Wigg et al. that the standard caregiving model in our study was below the average. We would like to remind A.J. Wigg et al. that we operated in a region of Italy and of Europe with very high parameters of efficiency and quality of health care system [[5]ISTAT, Sistema sanitario e salute della popolazione, Indicatori Regionali: http://www3.istat.it/dati/catalogo/20081112_00/PDF/cap3.pdf.Google Scholar].Concerning the observation that the MELD is not among the predictors of readmission, the following should be noted: (a) only baseline MELD was considered and (b) patients readmitted to the hospital had a MELD more than 2 points higher than not readmitted patients.It isn’t our duty to underline the limitations of the study of A.J. Wigg and colleagues [[6]Wigg A.J. McCormick R. Wundke R. Woodman R.J. Efficacy of a chronic disease management model for patients with chronic liver failure.Clin Gastroenterol Hepatol. 2013; 11 (e1–4): 850-858Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar]. However, a final comment is needed because the authors did not include a day hospital in their model. This is where we performed all the elective invasive procedures, and more importantly all therapeutic paracenteses. As a consequence, an elective paracentesis or another elective invasive procedure was never a cause of hospital readmission in our study, whereas this represented almost 50% of the reasons for readmission in the intervention group in the study of A.J. Wigg et al. We believe that on providing the Day Hospital in our Care Management Program, we have effectively realized the facility that A.J. Wigg et al. suggested in order to reduce almost half of hospitalizations in patients with cirrhosis and ascites. As a result, the inclusion of the Day Hospital in our Care Management Program has been the key to obtain results both in terms of survival and overall economic sustainability. The editorialists may have intercepted this aspect in our new model as a step forward in the management of these patients.Conflict of interestThe authors declared that they do not have anything to disclose regarding funding or conflict of interest with respect to this manuscript. We are making a step forwardTo the Editor:We would like to thank A.J. Wigg et al. for their interest in our study about a new model of care coordination by consultant hepatologists in outpatients with cirrhosis and ascites [[1]Morando F. Maresio G. Piano S. Fasolato S. Cavallin M. Romano A. et al.How to improve care in outpatients with cirrhosis and ascites: a new model of care coordination by consultant hepatologists.J Hepatol. 2013; 59: 257-264Abstract Full Text Full Text PDF PubMed Scopus (114) Google Scholar]. We regret that the Editorialists have not considered their publication but, such is life! Moreover, it should be recognized that the appearance of the two manuscripts on PubMed were very close each to one other. In their letter [[2]Wigg AJ, McCormick R, Wundke R, Woodman RJ. Coordinated care models in cirrhosis; the need for further randomized controlled, trials. J. Hepatol 2014;60:465–466.Google Scholar] A.J. Wigg et al. highlighted once again that our study was not randomized and suggested that the differences in outcomes of the two groups of our work were not linked to the process of management as outpatients, but to confounding factors that were not well balanced between the two groups. The circumstance that our study was not randomized has been already stressed by ourselves and by the editorialists. We also set out to explain the reasons why we decided to perform this type of study. As far as the enrollment and the matching process are concerned, as we stated in the paper, patients were enrolled consecutively on discharge from hospitalization due to acute decompensation of cirrhosis, and subjected to matching for a large number of variables (age, gender, type of ascites, Model for End Stage Liver Disease (MELD) score, Child-Turcotte-Pugh (CTP) score, etiology of cirrhosis, local or not local residences, and co-morbidities evaluated with the Charlson index). Here, it was clear that there were no significant differences in terms of baseline demographic, clinical or laboratory features. We recognize that the propensity score matching may probably be better, but the sample size was too small for its application. However, patients started the assigned care management program at the same time following discharge, as reported in the results.A.J. Wigg et al. have also speculated that there was a lack of process measures performed during the study, for example, regarding the patient’s attendance of scheduled appointments. Our study was not specifically designed to evaluate the compliance of patients, but rather to assess whether the new model “the Care Management Program”, based on an integrated activity of dedicated physicians and nurses and on some facilities such as lab examinations and diagnostic examinations in real time, may improve some outcomes in patients with cirrhosis and ascites as compared to the standard specialized caregiving model in our country. Nonetheless, the patients’ attendance of the scheduled appointments was extremely high in both groups (>90%) with a dropout rate of 2%. This represents a huge difference between our study and that of A.J. Wigg et al., in which the rate of drop out was considerably higher.As regards the relationship between the outcomes and the number of specialist evaluations, it has been clearly reported that the mean global number of specialist evaluations in the care management program was almost double that in the standard program, either when expressed per patient or per patient month of life. We did not introduce this parameter in the univariate analysis because we thought and we continue to think that the philosophy of the new model is more relevant than the single numbers or aspects of the model.Looking to A.J. Wigg et al., they proposed an analysis about the timing of mortality, assuming a too high rate of early and overall mortality in patients followed with the standard of care. Regarding this, we must emphasize the importance of an early intervention in patients with cirrhosis and ascites discharged after a hospitalization related to a complication of cirrhosis: they are a population of frail patients, immunosuppressed and predisposed towards new complications and hospital readmission [[3]Volk M.L. Tocco R.S. Bazick J. Rakoski M.O. Lok A.S. Hospital readmissions among patients with decompensated cirrhosis.Am J Gastroenterol. 2012; 107: 247-252Crossref PubMed Scopus (300) Google Scholar]. Thus, the prompt management of hyponatremia, renal failure and subclinical bacterial infections that was enabled in patients who were assigned to the “Care Management Program”, can definitively account for the definition of an early difference in the survival curve compared to that of patients who were assigned to the standard model. In addition, the standard treatment group presented a mortality rate that is in line with that reported in the literature on the natural history of cirrhosis, namely a rate of 40% one year after the development of ascites [[4]Guevara M. Cárdenas A. Uriz J. Ginès P. Prognosis in patients with cirrhosis and ascites.in: Ginès P. Arroyo V. Rodés J. Schrier R.W. Ascites and renal dysfunction in liver disease: pathogenesis, diagnosis and treatment. Blackwell, Malden2005: 260-270Crossref Scopus (38) Google Scholar]. As regards the probability of hospital readmission, recently, M.L. Volk and colleagues [[3]Volk M.L. Tocco R.S. Bazick J. Rakoski M.O. Lok A.S. Hospital readmissions among patients with decompensated cirrhosis.Am J Gastroenterol. 2012; 107: 247-252Crossref PubMed Scopus (300) Google Scholar] have shown, in a similar type of patients, a one-week readmission rate of 14%, a one-month readmission rate of 37% and an overall readmission of 69% of patients. These results are perfectly comparable with those found in the standard care group in our study, considering 30 day readmission (42%) and the global readmissions (71%). We are sure that these data are sufficient to reject the idea of A.J. Wigg et al. that the standard caregiving model in our study was below the average. We would like to remind A.J. Wigg et al. that we operated in a region of Italy and of Europe with very high parameters of efficiency and quality of health care system [[5]ISTAT, Sistema sanitario e salute della popolazione, Indicatori Regionali: http://www3.istat.it/dati/catalogo/20081112_00/PDF/cap3.pdf.Google Scholar].Concerning the observation that the MELD is not among the predictors of readmission, the following should be noted: (a) only baseline MELD was considered and (b) patients readmitted to the hospital had a MELD more than 2 points higher than not readmitted patients.It isn’t our duty to underline the limitations of the study of A.J. Wigg and colleagues [[6]Wigg A.J. McCormick R. Wundke R. Woodman R.J. Efficacy of a chronic disease management model for patients with chronic liver failure.Clin Gastroenterol Hepatol. 2013; 11 (e1–4): 850-858Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar]. However, a final comment is needed because the authors did not include a day hospital in their model. This is where we performed all the elective invasive procedures, and more importantly all therapeutic paracenteses. As a consequence, an elective paracentesis or another elective invasive procedure was never a cause of hospital readmission in our study, whereas this represented almost 50% of the reasons for readmission in the intervention group in the study of A.J. Wigg et al. We believe that on providing the Day Hospital in our Care Management Program, we have effectively realized the facility that A.J. Wigg et al. suggested in order to reduce almost half of hospitalizations in patients with cirrhosis and ascites. As a result, the inclusion of the Day Hospital in our Care Management Program has been the key to obtain results both in terms of survival and overall economic sustainability. The editorialists may have intercepted this aspect in our new model as a step forward in the management of these patients. To the Editor: We would like to thank A.J. Wigg et al. for their interest in our study about a new model of care coordination by consultant hepatologists in outpatients with cirrhosis and ascites [[1]Morando F. Maresio G. Piano S. Fasolato S. Cavallin M. Romano A. et al.How to improve care in outpatients with cirrhosis and ascites: a new model of care coordination by consultant hepatologists.J Hepatol. 2013; 59: 257-264Abstract Full Text Full Text PDF PubMed Scopus (114) Google Scholar]. We regret that the Editorialists have not considered their publication but, such is life! Moreover, it should be recognized that the appearance of the two manuscripts on PubMed were very close each to one other. In their letter [[2]Wigg AJ, McCormick R, Wundke R, Woodman RJ. Coordinated care models in cirrhosis; the need for further randomized controlled, trials. J. Hepatol 2014;60:465–466.Google Scholar] A.J. Wigg et al. highlighted once again that our study was not randomized and suggested that the differences in outcomes of the two groups of our work were not linked to the process of management as outpatients, but to confounding factors that were not well balanced between the two groups. The circumstance that our study was not randomized has been already stressed by ourselves and by the editorialists. We also set out to explain the reasons why we decided to perform this type of study. As far as the enrollment and the matching process are concerned, as we stated in the paper, patients were enrolled consecutively on discharge from hospitalization due to acute decompensation of cirrhosis, and subjected to matching for a large number of variables (age, gender, type of ascites, Model for End Stage Liver Disease (MELD) score, Child-Turcotte-Pugh (CTP) score, etiology of cirrhosis, local or not local residences, and co-morbidities evaluated with the Charlson index). Here, it was clear that there were no significant differences in terms of baseline demographic, clinical or laboratory features. We recognize that the propensity score matching may probably be better, but the sample size was too small for its application. However, patients started the assigned care management program at the same time following discharge, as reported in the results. A.J. Wigg et al. have also speculated that there was a lack of process measures performed during the study, for example, regarding the patient’s attendance of scheduled appointments. Our study was not specifically designed to evaluate the compliance of patients, but rather to assess whether the new model “the Care Management Program”, based on an integrated activity of dedicated physicians and nurses and on some facilities such as lab examinations and diagnostic examinations in real time, may improve some outcomes in patients with cirrhosis and ascites as compared to the standard specialized caregiving model in our country. Nonetheless, the patients’ attendance of the scheduled appointments was extremely high in both groups (>90%) with a dropout rate of 2%. This represents a huge difference between our study and that of A.J. Wigg et al., in which the rate of drop out was considerably higher. As regards the relationship between the outcomes and the number of specialist evaluations, it has been clearly reported that the mean global number of specialist evaluations in the care management program was almost double that in the standard program, either when expressed per patient or per patient month of life. We did not introduce this parameter in the univariate analysis because we thought and we continue to think that the philosophy of the new model is more relevant than the single numbers or aspects of the model. Looking to A.J. Wigg et al., they proposed an analysis about the timing of mortality, assuming a too high rate of early and overall mortality in patients followed with the standard of care. Regarding this, we must emphasize the importance of an early intervention in patients with cirrhosis and ascites discharged after a hospitalization related to a complication of cirrhosis: they are a population of frail patients, immunosuppressed and predisposed towards new complications and hospital readmission [[3]Volk M.L. Tocco R.S. Bazick J. Rakoski M.O. Lok A.S. Hospital readmissions among patients with decompensated cirrhosis.Am J Gastroenterol. 2012; 107: 247-252Crossref PubMed Scopus (300) Google Scholar]. Thus, the prompt management of hyponatremia, renal failure and subclinical bacterial infections that was enabled in patients who were assigned to the “Care Management Program”, can definitively account for the definition of an early difference in the survival curve compared to that of patients who were assigned to the standard model. In addition, the standard treatment group presented a mortality rate that is in line with that reported in the literature on the natural history of cirrhosis, namely a rate of 40% one year after the development of ascites [[4]Guevara M. Cárdenas A. Uriz J. Ginès P. Prognosis in patients with cirrhosis and ascites.in: Ginès P. Arroyo V. Rodés J. Schrier R.W. Ascites and renal dysfunction in liver disease: pathogenesis, diagnosis and treatment. Blackwell, Malden2005: 260-270Crossref Scopus (38) Google Scholar]. As regards the probability of hospital readmission, recently, M.L. Volk and colleagues [[3]Volk M.L. Tocco R.S. Bazick J. Rakoski M.O. Lok A.S. Hospital readmissions among patients with decompensated cirrhosis.Am J Gastroenterol. 2012; 107: 247-252Crossref PubMed Scopus (300) Google Scholar] have shown, in a similar type of patients, a one-week readmission rate of 14%, a one-month readmission rate of 37% and an overall readmission of 69% of patients. These results are perfectly comparable with those found in the standard care group in our study, considering 30 day readmission (42%) and the global readmissions (71%). We are sure that these data are sufficient to reject the idea of A.J. Wigg et al. that the standard caregiving model in our study was below the average. We would like to remind A.J. Wigg et al. that we operated in a region of Italy and of Europe with very high parameters of efficiency and quality of health care system [[5]ISTAT, Sistema sanitario e salute della popolazione, Indicatori Regionali: http://www3.istat.it/dati/catalogo/20081112_00/PDF/cap3.pdf.Google Scholar]. Concerning the observation that the MELD is not among the predictors of readmission, the following should be noted: (a) only baseline MELD was considered and (b) patients readmitted to the hospital had a MELD more than 2 points higher than not readmitted patients. It isn’t our duty to underline the limitations of the study of A.J. Wigg and colleagues [[6]Wigg A.J. McCormick R. Wundke R. Woodman R.J. Efficacy of a chronic disease management model for patients with chronic liver failure.Clin Gastroenterol Hepatol. 2013; 11 (e1–4): 850-858Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar]. However, a final comment is needed because the authors did not include a day hospital in their model. This is where we performed all the elective invasive procedures, and more importantly all therapeutic paracenteses. As a consequence, an elective paracentesis or another elective invasive procedure was never a cause of hospital readmission in our study, whereas this represented almost 50% of the reasons for readmission in the intervention group in the study of A.J. Wigg et al. We believe that on providing the Day Hospital in our Care Management Program, we have effectively realized the facility that A.J. Wigg et al. suggested in order to reduce almost half of hospitalizations in patients with cirrhosis and ascites. As a result, the inclusion of the Day Hospital in our Care Management Program has been the key to obtain results both in terms of survival and overall economic sustainability. The editorialists may have intercepted this aspect in our new model as a step forward in the management of these patients. Conflict of interestThe authors declared that they do not have anything to disclose regarding funding or conflict of interest with respect to this manuscript. The authors declared that they do not have anything to disclose regarding funding or conflict of interest with respect to this manuscript.