Hospital-Level Variation in Practice Patterns and Patient Outcomes for Pediatric Patients Hospitalized With Functional Constipation

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1 RESEARCH ARTICLE Hospital-Level Variation in Practice Patterns and Patient Outcomes for Pediatric Patients Hospitalized With Functional Constipation Jamie Librizzi, MD, MSHS, a Samuel Flores, MD, a Keith Morse, MD, a Kelly Kelleher, MD, a Jodi Carter, MD, a Ryan Bode, MD b BACKGROUND AND OBJECTIVE: Constipation is a common pediatric condition with a prevalence of 3% to 5% in children aged 4 to 17 years. Currently, there are no evidence-based guidelines for the management of pediatric patients hospitalized with constipation. The primary objective was to evaluate practice patterns and patient outcomes for the hospital management of functional constipation in US children s hospitals. ABSTRACT METHODS: We conducted a multicenter, retrospective cohort study of children aged 0 to 18 years hospitalized for functional constipation from 2012 to 2014 by using the Pediatric Health Information System. Patients were included by using constipation and other related diagnoses as classified by International Classification of Diseases, Ninth Revision. Patients with complex chronic conditions were excluded. Outcome measures included percentage of hospitalizations due to functional constipation, therapies used, length of stay, and 90-day readmission rates. Statistical analysis included means with 95% confidence intervals for individual hospital outcomes. RESULTS: A total of hospitalizations were included, representing unique patients. The overall percentage of hospitalizations due to functional constipation was 0.65% (range: 0.19% 1.41%, P,.0001). The percentage of patients receiving the following treatment during their hospitalization included: electrolyte laxatives: 40% to 96%; sodium phosphate enema: 0% to 64%; mineral oil enema: 0% to 61%; glycerin suppository: 0% to 37%; bisacodyl 0% to 47%; senna: 0% to 23%; and docusate 0% to 11%. Mean length of stay was 1.97 days (range: days, P,.0001). Mean 90-day readmission rate was 3.78% (range: 0.95% 7.53%, P,.0001). CONCLUSIONS: There is significant variation in practice patterns and clinical outcomes for pediatric patients hospitalized with functional constipation across US children s hospitals. Collaborative initiatives to adopt evidence-based best practices guidelines could help standardize the hospital management of pediatric functional constipation. DOI: Copyright 2017 by the American Academy of Pediatrics Address correspondence to Jamie Librizzi, MD, MSHS, Department of Pediatric Hospital Medicine, Phoenix Children s Hospital, 1919 East Thomas Rd, Phoenix, AZ jlibrizzi@phoenixchildrens.com HOSPITAL PEDIATRICS (ISSN Numbers: Print, ; Online, ). FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose. FUNDING: No external funding. POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose. Drs Bode and Carter conceptualized and designed the study and reviewed drafts of the manuscript for submission; Dr Librizzi drafted the initial manuscript, made revisions, and approved the final manuscript as submitted; Drs Kelleher and Flores drafted the initial manuscript and approved the final manuscript as submitted; and Dr Morse carried out the data analyses and reviewed drafts of the manuscript for submission. a Department of Pediatric Hospital Medicine, Phoenix Children s Hospital, Phoenix, Arizona; and b Department of Pediatric Hospital Medicine, Nationwide Children s Hospital, Columbus, Ohio 320 LIBRIZZI et al

2 Constipation is a common pediatric condition with a prevalence of 3% to 5% in children aged 4 to 17 years and is responsible for 35% of all visits to pediatric gastroenterologists. 1 The health care cost for children with constipation is 3 times greater than for children without constipation, with an estimated additional $3.9 billion required annually. 2 A recent study reported that for all patients (up to 85 years of age), those who were 1 to 17 years old were the highest emergency department (ED) users for constipationrelated complaints. In addition, this study demonstrated that the rate of constipationrelated ED visits in this age group increased by.50% between 2006 and Despite the high prevalence and high resource use of pediatric constipation, there is limited literature dedicated to the hospital management and treatment of functional constipation. The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition released clinical guidelines for the evaluation and treatment of functional constipation in infants and children in 1999, which were updated in 2006 and These guidelines are intended for patients aged 0 to 18 years diagnosed as having functional constipation by using the established Rome III criteria and excluding those patients with other underlying medical conditions that may cause or contribute to constipation. The NASPGHAN clinical guidelines attempt to provide evidence-based recommendations for the diagnostic value of testing, the effect of nonpharmacologic treatment, and the most effective and safest pharmacologic treatment in children with functional constipation. Within the guidelines, there is not a distinction specifically for the hospital management of functional constipation. Regarding pharmacologic treatment of fecal disimpaction, the NASPGHAN guideline recommendations are based on only 1 study comparing the effect of polyethylene glycol to enemas. 4 In general, published literature on the treatment of chronic constipation and fecal disimpaction is largely based in the outpatient setting 5 18 and/or based on reviews of the literature without incorporating quality assessments of the studies Inconsistencies and heterogeneity in the definitions and outcome measures used for randomized controlled trials on pediatric functional constipation have been identified and contribute to the challenges in forming true evidence-based recommendations. 21 Arecentstudyby Stephens et al 22 examined health care use and spending for constipation based on the number of complex chronic conditions (CCC), which included inpatient use, but there are few studies whose primary objectives include clinical outcomes, such as specific medications used, length of stay (LOS), and readmission rates, for functional constipation in the hospitalized population. With the lack of strong evidence-based guidelines on the inpatient management of functional constipation, we hypothesize that significant variation exists in the management and clinical outcomes of patients hospitalized for functional constipation. The primary objective of this study was to evaluate practice patterns and patient outcomes for the hospital management of functional constipation in US children s hospitals. METHODS Data Source We conducted a multicenter, retrospective cohort study of patients hospitalized with functional constipation using the Pediatric Health Information System (PHIS), an administrative database of 46 freestanding, tertiary care children s hospitals within the United States. PHIS contains data regarding inpatient demographics, diagnoses, procedures (with International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes), and resource use. A unique coded patient identifier permits tracking of multiple, same-hospital admissions. Data quality and reliability are ensured through the Children s Hospital Association and participating hospitals. Study Population Patients ages 0 to 18 years hospitalized within PHIS children s hospitals with functional constipation from January 1, 2012 to December 31, 2014 were included. Patients were identified using one of the primary ICD-9-CM discharge diagnosis codes: to (constipation), (encopresis), (psychogenic constipation), or (fecal impaction). To ensure a primary diagnosis of functional constipation and exclude secondary causes of constipation, patients were excluded by using the CCC classification system developed by Feudtner et al 23 in 2000 and updated in This classification system provides a comprehensive set of ICD-9-CM and International Classification of Diseases, Tenth Revision codes for 10 CCC categories (cardiovascular, respiratory, neuromuscular, renal, gastrointestinal, hematologic or immunologic, metabolic, other congenital, or genetic, malignancy, and premature/neonatal) along with domains of complexity from dependence on medical technology and having received bone marrow or organ transplantation. Both inpatient and observation hospitalizations were included in the data set. Outcome Measures Demographic characteristics collected included patient age, sex, ethnicity, and payer source. Outcome variables collected included the calculated percentage of hospitalizations due to functional constipation (including inpatient and observation hospitalizations), treatments administered (including electrolyte laxative, sodium phosphate enema, mineral oil enema, bisacodyl, glycerin suppository, senna, and docusate), LOS (in days, with adaydefined as crossing midnight), and 90-day readmission rate for constipation. The 90-day readmission rate was chosen in an effort to capture the chronic morbidity associated with functional constipation. Only readmissions for constipation with the same inclusion criteria of the index case were included. Both observation and inpatient status readmissions were included. One hospital was excluded from analysis because of concern for inaccurate data due to incomplete submission of diagnostic and therapeutic reporting. Data Analysis All statistical analyses were performed by using R version 3.2.2, 24 and Figs 1, 3, and HOSPITAL PEDIATRICS Volume 7, Issue 6, June

3 FIGURE 1 Hospitalization rates for functional constipation. Percentage of hospitalizations due to functional constipation calculated at the individual hospital level as the number of functional constipation hospitalizations divided by total all-cause hospitalizations with 95% confidence intervals. 4 were developed by using Plotly (Plotly Technologies, Inc). 25 Significance testing of proportion-based data were calculated by using a 2-tailed test for equality of proportions without continuity correction. Significance testing of mean-based data were calculated by using Kruskal-Wallis rank-sum testing. Cohort mean statistics were calculated as the mean of individual hospital proportion or mean statistics. Therapy use rates represent the percent of functional constipation hospitalizations that received at least 1 administration of the indicated treatment, as identified in the PHIS pharmacy data set. Deidentified hospital identification numbers remain consistent across all figures. The Phoenix Children s Hospital Institutional Review Board in Phoenix, Arizona approved the study. RESULTS During the study period, there were unique patients representing hospitalizations for constipation identified across the PHIS hospitals. Using our exclusion criteria, 5764 patients with CCCs were excluded, leaving hospitalizations for functional constipation included in the analysis. Table 1 includes the patient demographic information. Of the included patients with functional constipation, 2.1% were,2 months,24.6%were2monthsto 5 years, 52.3% were 5 to 13 years, and 21.0% were 13 to 18 years old. There were similar percentages of boy and girl patients. A total of 53.1% of the included patients had Medicaid as the identified payer source. The overall percentage of all hospitalizations due to functional constipation, calculated at the individual hospital level as the number of functional constipation hospitalizations divided by total all-cause hospitalizations, was0.65%.therewassignificant variation in the percentage of hospitalizations due to functional constipation across the included hospitals with a range of 0.19% to 1.41% (P,.0001) (Fig 1). Figure 2 represents the frequencies of the various therapies used to treat functional constipation. The values represent the percentage of patients who received at least 1 dose of each represented treatment during their hospitalization. Across hospitals, the percentage of patients receiving the following treatments included: electrolyte laxatives: 40% to 96%; sodium phosphate enema: 0% to 64%; mineral oil enema: 0% to 61%; glycerin suppository: 0% to 37%; bisacodyl: 0% to 47%; senna: 0% to 23%; and docusate: 0% to 11%. When stratified by age (0 4 years, 5 12 years, years), variation in the therapies used remained. There were not significant differences in the frequency of the various therapies used with electrolyte laxatives remaining the most commonly used treatment across all ages. Among all included hospitals, the mean LOS was 1.97 days. There was significant variation in the mean LOS between all hospitals with a range of 1.31 to 2.73 days (P,.0001) (Fig 3). The mean 90-day readmission rate for constipation was 3.78% with a range of 0.95% to 7.53% (P,.0001) (Fig 4). DISCUSSION This study revealed significant variation in practice patterns and clinical outcomes for patients hospitalized with functional constipation in US children s hospitals. There were statistically significant differences in the percentage of hospitalizations due to functional constipation, LOS, and 90-day readmission rates with wide variation in therapies used across all hospitals. By exclusively examining the hospital management of functional constipation, 322 LIBRIZZI et al

4 FIGURE 2 Frequencies of therapies used for functional constipation. Percentages in each box represent the percentage of functional constipation admissions that received at least 1 administration of the given treatment, by hospital. Data sorted by descending electrolyte laxative frequency. IV, intravenous fluids. this study highlights the need for stronger evidence-based guidelines with effective dissemination of recommendations for this patient population to standardize care. The NASPGHAN guidelines are based on a relative paucity of quality studies, do not include inpatient management, and are not well disseminated. In 2006, Focht et al 26 performed a cross-sectional survey of pediatricians across the United States and found that pediatricians reported using many different medications in the treatment of constipation, and only 8% of the responding pediatricians were aware that NASPGHAN had published clinical practice guidelines for the management of childhood constipation. More recently, in 2015, Yang and Punati 27 evaluated HOSPITAL PEDIATRICS Volume 7, Issue 6, June

5 FIGURE 3 Mean LOS for functional constipation by hospital with 95% confidence intervals. pediatricians familiarity with the NASPGHAN guidelines and how closely their approaches adhere to the guidelines. Of those surveyed, 84.3% reported being unfamiliar or only slightly familiar with the guidelines, and there was increased variability in management of functional constipation with fecal incontinence. 27 Improved efforts to effectively disseminate the current NASPGHAN guidelines should be pursued. Additionally, more studies on the inpatient management of functional constipation are needed to strengthen the evidence-based recommendations for this population within the guidelines. Although this study was designed to be purely descriptive and was not designed to identify associations among variables studied, one might postulate potential reasons the identified variation exists. The percentage of patients hospitalized with functional constipation ranged from 0.19% to 1.41%. Although regional variation in socioeconomic status and thus access to health care could impact the severity of the presenting illness, it is unlikely that there is regional variation in the organic severity of functional constipation to account for increased rates of hospitalization for fecal FIGURE 4 The 90-day rate of readmission for constipation, calculated as the number of readmissions for constipation, by hospital, with 95% confidence intervals. 324 LIBRIZZI et al

6 TABLE 1 Demographics impaction at certain hospitals. Rather, it is likely that variation or lack of outpatient management of chronic functional constipation as well as comfort level with outpatient bowel cleanout regimens significantly contributes to this variability in hospitalization. Stephens et al 22 found that 40.5% of hospitalized constipation patients did not have a previous outpatient visit for constipation. Similarly, inconsistent ED management and protocols for the treatment of acute fecal impaction likely contribute to the need for hospitalization. We did not determine the percentage of patients who required hospitalization through evaluation in the ED versus those sent to the hospital as direct admissions from their primary care physician. Additionally, we were unable to quantify the number of patients who were previously evaluated by and/or referred for hospitalization by a gastroenterologist, but presumably this could also impact the variable hospitalization rates. Additional elucidation of the source of hospitalization might provide insight for directed interventions to improve both the outpatient and/or ED management of these patients and decrease hospitalizations for those All Constipation Functional Constipation Hospitalizations, N Patients, N Age at first hospitalization, n (%),2 mo 310 (1.7) 266 (2.1) 2moto,5 y 4540 (24.5) 3155 (24.6) 5to,13 y 9135 (49.2) 6696 (52.3) $13 y 4583 (24.7) 2687 (21.0) Sex, n (%) Girl 8856 (47.7) 6117 (47.8) Boy 9712 (52.3) 6687 (52.2) Ethnicity, n (%) Hispanic or Latino 3201 (17.2) 2266 (17.7) Not Hispanic or Latino (76.1) 9664 (75.5) Unknown 1241 (6.7) 874 (6.8) Hospitalization payer source, n (%) Medicaid (53.6) 7567 (53.1) Commercial 8062 (37.1) 5286 (37.1) Other 2040 (9.4) 1390 (9.8) Functional constipation includes all patients with a discharge diagnosis of constipation and not excluded by the CCC classification system. institutions with higher hospitalization rates. During a hospitalization, there are multiple treatment options for functional constipation with varying routes of administration and mechanisms of action. The results of this study indicate a variety of different medications are being used to treat fecal impaction due to functional constipation within the hospital. This study did not determine the doses and frequency of medications administered or the route of administration (ie, oral versus nasogastric administration of electrolyte laxative) from the PHIS database, but we hypothesize that they also varied significantly. Electrolyte laxatives (ie, polyethylene glycol) are the most commonly administered medication across all hospitals. Polyethylene glycol is one of the most studied medications in the treatment of functional constipation with evidence supporting its efficacy and tolerability; however, the majority of studies evaluate its use as a maintenance therapy for chronic constipation in the outpatient setting. 5 7,9,10,14,16 18,20 These findings may not necessarily be generalizable to the hospital population because, presumably, children requiring hospitalization have more severe fecal impaction requiring increased treatment interventions. There was greatest variation among hospitals in the administration of sodium phosphate enemas. The NASPGHAN clinical guidelines base their recommendation for the treatment of fecal disimpaction on a single study, which found enemas and polyethylene glycol equally effective in treating rectal fecal impaction in the outpatient setting. Thus, it was concluded that both treatments should be considered equally for first-line therapy. The NASPGHAN working group, however, opted to give preference to polyethylene glycol because it could be administered orally. 4 There are limited placebo-controlled studies to evaluate the effect of oral laxatives or enemas on disimpaction, limited dose-response studies in general, and no treatment studies devoted exclusively to the hospital setting. With the paucity of high-quality evidence on this topic, this study s observations would suggest that the wide variation in practice found between hospitals is likely driven by differences in treatment philosophy and local practice patterns. The clinical outcomes measured in this study included LOS (in days) and the 90-day readmission rate for constipation. This study attempted to exclude other complex medical conditions associated with constipation in an effort to reduce potential confounding factors impacting patient outcomes and include only children with functional constipation. Therefore, in what could be considered a relatively straightforward condition in an included population with minimal comorbidities, one could question why 1 children s hospital has a mean LOS of 1.3 days whereas another has a mean LOS of almost 3 days. Similarly, it is interesting that 1 hospital experiences a 7.5% 90-day readmission rate for functional constipation whereas another has a mere 0.95% 90-day readmission rate. It was outside the scope of this article to identify whether associations existed between specific therapies used and LOS and/or readmission rates; therefore, we were unable to identify drivers of these outcomes with our study design. The acknowledgment that variation exists, however, is an important first step in HOSPITAL PEDIATRICS Volume 7, Issue 6, June

7 addressing the need for standardization of care for this population. Similar variation in care has been demonstrated in other common pediatric conditions, including appendicitis, viral lower respiratory illness, pneumonia, and urinary tract infections Clinical practice guidelines and protocols have been implemented to guide the management of many of these conditions with the aim of standardizing care and reducing resource use. 35 With increasing emphasis on costcontainment and value-based care, it is important to identify areas where variation in care and resource use offer the greatest opportunities for quality improvement. Although resource use is not the sole marker for value care, wide variation in practice is often strongly associated with a similar degree of variation surrounding quality and outcomes. Once variation has been identified, however, clinically relative outcomes must be defined to establish benchmarks for value-based care. As stated previously, thus far, there have been inconsistencies and heterogeneity in the definitions and outcome measures used for pediatric functional constipation. Therefore, these variations must first be reconciled to successfully proceed with standardization of care. Additionally, once best practices have been established, successful dissemination to stakeholders is crucial. A main limitation of this study is the retrospective study design based on administrative data. Although there are processes for quality surveillance of data within the PHIS database, there is always the risk of misreporting and incorrect coding leading to missing patients with functional constipation. Using the PHIS database, which is limited to freestanding children s hospitals, may also limit the generalizability. The findings of this study may not be representative of management of functional constipation outside of the PHIS hospital network. Practice patterns relating to the diagnosis and management of functional constipation in this analysis may differ markedly from those that exist in the community and at other nondesignated children s hospitals. This study did not identify those patients with chronic constipation and determine their outpatient management before hospitalization. It was impossible to determine the type of provider involved in these patients care during the hospitalization, such as trainees and/or subspecialists (ie, gastroenterologists), which may influence their clinical outcomes. As mentioned previously, we were unable to ascertain specifics regarding the treatment administered (ie, dosing, frequency, prescriber), which limited our ability to draw any conclusions on the impact of treatment on patient outcomes. CONCLUSIONS This study demonstrates that there is significant variation in hospitalization rates, therapies used, LOS, and 90-day readmission rates for functional constipation. This variability represents an opportunity for benchmarking, standardization, and quality improvement for the hospital management of functional constipation. Additional research is needed to identify drivers of variability to allow for directed interventions as well as stronger evidence based-guidelines, specifically for the inpatient management of functional constipation. Improved dissemination, awareness, and adherence to the current NASPGHAN guidelines may also contribute to reducing variability of care and avoiding unnecessary interventions. Through collaboration efforts, there remains great potential to reduce practice variation and improve clinical outcomes in pediatric functional constipation. REFERENCES 1. Tabbers MM, DiLorenzo C, Berger MY, et al; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. 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9 Hospital-Level Variation in Practice Patterns and Patient Outcomes for Pediatric Patients Hospitalized With Functional Constipation Jamie Librizzi, Samuel Flores, Keith Morse, Kelly Kelleher, Jodi Carter and Ryan Bode Hospital Pediatrics 2017;7;320 DOI: /hpeds originally published online May 18, 2017; Updated Information & Services References Permissions & Licensing Reprints including high resolution figures, can be found at: This article cites 32 articles, 7 of which you can access for free at: Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: ml Information about ordering reprints can be found online:

10 Hospital-Level Variation in Practice Patterns and Patient Outcomes for Pediatric Patients Hospitalized With Functional Constipation Jamie Librizzi, Samuel Flores, Keith Morse, Kelly Kelleher, Jodi Carter and Ryan Bode Hospital Pediatrics 2017;7;320 DOI: /hpeds originally published online May 18, 2017; The online version of this article, along with updated information and services, is located on the World Wide Web at: Hospital Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since Hospital Pediatrics is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, Copyright 2017 by the American Academy of Pediatrics. All rights reserved. Print ISSN: