Author Affiliations: Department of General Surgery (Zhang M, Zhou SY, Xu J, Shi XX and Zheng SS) and Library (Xing MY), First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China

Corresponding Author: Shu-Sen Zheng, MD, PhD, FACS, Department of General Surgery, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China (Tel: +86-571-87236570; Email: shusenzheng@zju.edu.cn)

 

© 2014, Hepatobiliary Pancreat Dis Int. All rights reserved.

doi: 10.1016/S1499-3872(14)60279-4

Published online July 17, 2014.

 

 

Acknowledgement: We thank Dr. Sun-Yi Ye for his help in completing this project.

Contributors: ZM and ZSS proposed and designed the study. ZM and ZSY wrote the first draft. ZSY, XMY, XJ and SXX extracted and analyzed the data. All authors read and approved the final manuscript. ZSS is the guarantor.

Funding: This study was supported by a grant from the National Key Technology Research and Development Program of China (2008BAH27B06).

Ethical approval: Not needed.

Competing interest: No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

 

 

BACKGROUND: Laparoscopic cholecystectomy (LC) is one of the most frequent abdominal surgical procedures. The present meta-analysis aimed to estimate the clinical effects of implementing a clinical pathway for LC compared with standard medical care by evaluating the length of hospital stay, costs, and the outcomes of patients undergoing LC.

 

DATA SOURCES: Data were extracted from the following databases: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese Medical Citation Index (CMCI), Chinese Medical Current Contents (CMCC), and China BioMedical Literature Database (CBM). We also searched the reference lists of the relevant articles and conference articles. Only randomized controlled trials and controlled clinical trials published from 1980 to 2013 were included. We did not set restrictions on language and country of publications. All of the data were evaluated and analyzed by two reviewers independently with RevMan software (version 5.0).

 

RESULTS: A total of 7 trials with 1187 patients were included. The patients who underwent LC with clinical pathway had shorter hospital stay [weighted mean difference=-1.90, 95% CI: -2.65 to -1.16, P<0.00001], lower cost [standard mean difference=-0.69, 95% CI: -0.82 to -0.56, P<0.00001], and better questionnaires based satisfaction with the medical services.

 

CONCLUSIONS: The applications of the clinical pathway for LC effectively reduced hospital stay and total costs. However, there was insufficient evidence for proving the differences in postoperative complications. Future research should focus on patient outcomes and identify the mechanisms underlying the effect of the clinical pathway.

 

(Hepatobiliary Pancreat Dis Int 2014;13:348-353)

 

KEY WORDS: laparoscopic cholecystectomy; clinical pathways; complications

Laparoscopic cholecystectomy (LC) has become the gold standard for treating uncomplicated gallbladder disease because of its minimal invasiveness, short hospital stay and fewer complications.^[1] It is also a suitable model for implementing clinical pathways as one of the most frequent minimally invasive abdominal surgical procedure.^[2]

 

The clinical pathways were developed to manage medical resources and to provide high-quality cost-effective care. More than 80 percent of United States hospitals are already using clinical pathways.^[3] Numerous studies have reported that properly designed and well-implemented clinical pathways are effective in sustaining quality while decreasing costs for surgical procedures.^[4-7] However, the effectiveness of clinical pathways was doubted by some researchers because of inconsistent studies and various biases.^[8-11]

 

The current study aimed to estimate the value of clinical pathways in LC compared with non-clinical pathway applied standard medical care in terms of length of hospital stay, hospital costs and patient outcomes.

 

 

PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese Medical Citation Index (CMCI), Chinese Medical Current Contents (CMCC), and China BioMedical Literature Database (CBM) were searched with the following medical subject headings (MeSH): "critical pathway" [MeSH] AND ("cholecystectomy" [MeSH] OR "cholecystectomy, laparoscopic" [MeSH]).

 

A full-text search was performed based on the following search strings: ("clinical pathway" OR "critical pathway" OR "care map" OR "clinical path" OR "multidisciplinary approach") AND (cholecystectomy OR laparoscopic OR LC OR laparoscopic cholecystectomy). Since the clinical pathways were only conceptualized during the 1980s,^[12] the search was limited to articles published from 1980 to 2013. There was no language and country restrictions.

 

Only the inpatients who had undergone LC were included in this study. Outpatient LC and emergency surgeries were excluded. Reviews, comments, expert opinions and editorials were also excluded. Publications that did not describe pathway development and implementation, as well as studies that focus on the nursing critical pathways were excluded.

 

Randomized controlled trials (RCTs) and controlled clinical trials (CCTs, including quasi-randomized and controlled before-after trials) were included in the meta-analysis. The included studies were compared in terms of the standard medical care, i.e., the procedure without undergoing a clinical pathway.

 

Studies were included when the effects of the clinical pathway affected at least one of the following indices: 1) length of hospital stay (defined as the length of hospitalization from admission to discharge); 2) hospital costs (defined as the total cost of hospitalization, including the costs of all tests, medications, operations, nursing hours and supplies); 3) frequency and severity of postoperative complications (defined as complications that lead to prolonged hospital stay or even readmission, such as postoperative bleeding, bile duct injury, bile leakage, wound infections, chest infections, urinary tract infections, deep vein thrombosis, pressure ulcers and postoperative ileus); and 4) patient satisfaction (defined as the appraisal, by patients or their relatives of the extent to which the care provided met their expectations and preferences during hospitalization).

 

For continuous variables, studies that did not report the standard deviations were also excluded because means are influenced by extremes of values.

 

Two reviewers independently assessed and abstracted the data, which were extracted systematically from the included publications: author, publication year, journal name, country of origin, study inclusion and exclusion criteria, study design, sample size, intervention, implementation process, and definitions of key outcomes. Because the included studies had no RCTs, the meta-analyses scores from observational studies have questionable validity; thus, the quality of the methodologies was not scored.^[13]

Review Manager (RevMan 5.0) of the Cochrane Collaboration was selected to calculate pooled effects during the meta-analysis. We preferred a random-effects model, rather than a fixed-effects model with ignoring heterogeneity, because it can estimate the effect with inevitable heterogeneity during the implementation. The comparative results were presented as Forest plots, and funnel plots were used to represent potential publication bias. Treatment effects were expressed as either weighted mean difference (WMD) or standard mean difference (SMD).

 

 

Among the 78 studies we initially screened, only 7 met the inclusion criteria,^[14-20] which included 1187 patients (Table 1). No RCTs but 7 CCTs were included (4 before-after controlled trials^[14-17] and 3 quasi-randomized trials^[18-20]). Three studies were conducted in China, two in Japan, one in Switzerland and one in Spain.

 

The length of hospital stay is an indicator for the effects of the studies on clinical pathway. As shown in Fig. 1, both the before-after controlled trials (WMD=-1.46, 95% CI: -2.39 to -0.54, P=0.002) and the quasi-randomized trials (WMD=-2.53, 95% CI: -4.17 to -0.88, P=0.003) indicated that the clinical pathway groups had significantly lower length of hospital stay compared with the standard care groups. The aggregated results exhibit significantly shortened length of hospital stay (WMD=-1.90, 95% CI: -2.65 to -1.16, P<0.00001). However, both the before-after controlled trials (I²=80%) and the quasi-randomized controlled trials exhibited substantial heterogeneity between studies (I²=88%) in terms of the various interventions that each site implemented. The funnel plot is shown in Fig. 2.

 

Inpatient hospital costs are another indicator for the effects of the studies on the clinical pathway. One study classified the total costs into three parts (tests, infrastructure and nursing).^[16] All three had standard deviations, except for the total costs. We emailed the author requesting for such data, but received no reply. As shown in Fig. 3, implementing the clinical pathway significantly decreased the total costs both in the before-after controlled trials (SMD=-0.48, 95% CI: -0.63 to -0.32, P<0.00001) and in the quasi-randomized trials (SMD=-1.25, 95% CI: -1.51 to -1.00, P<0.010). The aggregated results (SMD=-0.69, 95% CI: -0.82 to -0.56, P<0.00001) also indicated that the clinical pathway had lower costs during hospital stay. Both the before-after controlled trials (I²=45%) and the quasi-randomized controlled trials exhibited substantial heterogeneity between studies (I²=95%), probably because of the aforementioned reason. The funnel plot is shown in Fig. 4. The studies that did not report the standard deviation^[16] also showed significantly decreased total costs (3879 € vs 5092 €, P<0.001)in the clinical pathway groups.

 

Of the 7 studies (Table 2), 3 were before-after controlled trials and 4 were quasi-randomized controlled trials. There was a significant heterogeneity in costs between two different study designs (χ²=25.98, P<0.00001, df=1, I²=96.2%).

 

No study included in this meta-analysis reported the detailed information on patient outcomes, especially postoperative complications. Müller et al^[16] studied the postoperative complications of general surgery (included LC) before and after implementing the clinical pathway, which indicated that there was no difference between the clinical pathway group and the control group for the complication rates and the severity of complications (7% vs 14%, P=0.07).

 

The three quasi-randomized controlled trials^[18-20] reported that there was significant difference in patient satisfaction between the clinical pathway and the control groups. However only one reported the ratio and its standard deviation value; thus, comparisons of the variables were impossible. In the study by Soria,^[14] 97% of the patients in the clinical pathway groups had positive responses.

 

 

The current study showed that the clinical pathway significantly reduces the length of hospital stay and the total hospital costs. However, the evidence was not sufficient to prove the differences in postoperative complications.

 

All of the studies exhibited a reduction in length of hospital stay; however, only three studies showed differences in times of postoperative hospitalization between the patients with and without a clinical pathway. Only one article mentioned preoperative hospitalization times, wherein both preoperative and postoperative hospitalization times were reduced. Uchiyama et al^[15] concluded that preoperative outpatient examinations are the major factor in decreasing length of hospital stay with clinical pathways in LC. On the other hand, the decrease in length of hospital stay may have resulted from better organization of the medical care when implementing clinical pathways.^[21,22] Most of the studies about implementing clinical pathways are cohort studies that used historical control groups. Therefore, the actual medical care systems are exhibiting a continuous reduction in length of hospital stay unlike the control group.^[23]

 

Implementing clinical pathways decreased the total hospital costs. However, most of the articles did not show the details of these costs. A detailed calculation of costs based on resources used, costs of all tests, infrastructure and nursing indicated a significant decrease between the clinical pathway and control groups.^[16] This finding implies that, by decreasing the diagnostic tests and the length of hospital stay, the infrastructure costs were decreased and therefore, the total cost was reduced. Yanagi et al^[17] found that the application of the clinical pathway reduced the total costs, but increased the costs per day, thereby reduce the cost of hospitalization per patient and increase the profit per bed. However, in the costs analysis none of the included studies mentioned or investigated the resources and the costs of the development and implementation of clinical pathways. In addition, low-volume hospitals would benefit less from implementing clinical pathways.^[24]

 

Patient satisfaction was another facet analyzed in most of the studies in China (2/3). The patients in the clinical pathway groups had higher satisfaction than those in the control groups, as well as shorter length of hospital stay and lower hospital cost and the patients were provided better medical service and more resources. However, only one article out of China^[17] analyzed this outcome, probably because conducting the survey was cheaper and easier in China. Few studies mentioned the patient satisfaction when the survey was conducted. However, the results would have been more credible if the survey were conducted at the end of hospitalization.^[17]

 

One systematic review found that the majority of studies on clinical pathways were of poor quality; 91.3% of the studies were retrospective and 59% adopted parametric statistical test.^[25] Instead of RCTs, only some CCTs using historical control groups with low-quality evidence were included. Some included clinical pathway studies with small sample sizes might have introduced selective bias. Since the clinical pathway was developed in the 1980s, none of the studies followed up the patients after discharge, limiting the validity of the results.

 

As the results shown above, there were large heterogeneities in the outcomes (both in length of hospital stay and costs). All the included studies were CCTs with low-quality evidence, and the contents of implementation of the clinical pathway were various in different hospitals without following up after discharge. So, there was little effect on decreasing the heterogeneity by turning the fixed-effect analysis into the random-effect analysis model, referring to the statistical heterogeneity and the various clinical heterogeneities mentioned above.

 

Considering the clinical pathway involves complex interventions, few researchers have reported the detailed methods or contents that the clinical pathways implemented at each site; thus, different active components may have been evaluated in some of the studies included in the meta-analysis, causing different effects.

 

The funnel plot is not appropriate because the power of methods for publication bias test is low for meta-analyses of 10 or fewer trials. However, it may suggest that the data have significant publication bias for the small sample sizes of the studies included and the relatively high heterogeneity both in the implementation and statistical analysis. The positive or beneficial results especially for new techniques and methods were more likely to be reported or published.^{[24, 26]} In this article, we performed a random-effect analysis to minimize the heterogeneity and to increase the robustness of the evidence.^[27-29]

 

In conclusion, the results of the meta-analysis suggested that the clinical pathway shortens the length of hospital stay and reduces the costs for patients undergoing LC. However, evidence to prove that both hospitals and patients benefit from the clinical pathway was insufficient because of the lack of detailed studies on the costs of implementation and development of the clinical pathway and the costs of patients' home-care after discharge. Because of few of the studies meeting the inclusion criteria and the insufficient sample size and the lack of evidence on postoperative complications, large sample and multicenter studies with a follow-up survey should be performed. We will also perform further studies on the mechanism underlying the effects of the clinical pathway. 

 

 

1 Holzinger F, Klaiber Ch. Laparoscopic cholecystectomy as trendsetter in minimal-invasive surgery. Ther Umsch 2005;62:65-68. PMID: 17237916

2 Topal B, Peeters G, Verbert A, Penninckx F. Outpatient laparoscopic cholecystectomy: clinical pathway implementation is efficient and cost effective and increases hospital bed capacity. Surg Endosc 2007;21:1142-1146. PMID: 15756913

3 Saint S, Hofer TP, Rose JS, Kaufman SR, McMahon LF Jr. Use of critical pathways to improve efficiency: a cautionary tale. Am J Manag Care 2003;9:758-765. PMID: 14626473

4 Calland JF, Tanaka K, Foley E, Bovbjerg VE, Markey DW, Blome S, et al. Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway. Ann Surg 2001;233:704-715. PMID: 11323509

5 Collier PE. Do clinical pathways for major vascular surgery improve outcomes and reduce cost? J Vasc Surg 1997;26:179-185. PMID: 9279303

6 Jain PK, Hayden JD, Sedman PC, Royston CM, O'Boyle CJ. A prospective study of ambulatory laparoscopic cholecystectomy: training economic, and patient benefits. Surg Endosc 2005;19:1082-1085. PMID: 16021378

7 Skattum J, Edwin B, Trondsen E, Mjåland O, Raede J, Buanes T. Outpatient laparoscopic surgery: feasibility and consequences for education and health care costs. Surg Endosc 2004;18:796-801. PMID: 15216863

8 Porter GA, Pisters PW, Mansyur C, Bisanz A, Reyna K, Stanford P, et al. Cost and utilization impact of a clinical pathway for patients undergoing pancreaticoduodenectomy. Ann Surg Oncol 2000;7:484-489. PMID: 10947015

9 Quaglini S, Cavallini A, Gerzeli S, Micieli G; GLADIS Study Group (Guideline Application for the Decision making in Ischemic Stroke). Economic benefit from clinical practice guideline compliance in stroke patient management. Health Policy 2004;69:305-315. PMID: 15276310

10 Roberts HC, Pickering RM, Onslow E, Clancy M, Powell J, Roberts A, et al. The effectiveness of implementing a care pathway for femoral neck fracture in older people: a prospective controlled before and after study. Age Ageing 2004;33:178-184. PMID: 14960435

11 Bailey R, Weingarten S, Lewis M, Mohsenifar Z. Impact of clinical pathways and practice guidelines on the management of acute exacerbations of bronchial asthma. Chest 1998;113:28-33. PMID: 9440564

12 Zander K. Integrated care pathways: Eleven international trends. Journal of Integrated Care Pathways 2002;6:101-107.

13 Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000;283:2008-2012. PMID: 10789670

14 Soria V, Pellicer E, Flores B, Carrasco M, Candel Maria F, et al. Evaluation of the clinical pathway for laparoscopic cholecystectomy. Am Surg 2005;71:40-45. PMID: 15757055

15 Uchiyama K, Takifuji K, Tani M, Onishi H, Yamaue H. Effectiveness of the clinical pathway to decrease length of stay and cost for laparoscopic surgery. Surg Endosc 2002;16: 1594-1597. PMID: 12085145

16 Müller MK, Dedes KJ, Dindo D, Steiner S, Hahnloser D, Clavien PA. Impact of clinical pathways in surgery. Langenbecks Arch Surg 2009;394:31-39. PMID: 18521624

17 Yanagi K, Sasajima K, Miyamoto M, Suzuki S, Yokoyama T, Maruyama H, et al. Evaluation of the clinical pathway for laparoscopic cholecystectomy and simulation of short-term hospitalization. J Nippon Med Sch 2007;74:409-413. PMID: 18084134

18 Xie YL, Zhu YF, Chen G, Huang WQ, Yin JH, Han M, et al. Analysis on the effect of clinical pathway in patients underwent laparoscopic cholecystectomy. Shanghai Yu Fang Yi Xue Za Zhi 2005;17:S14-17.

19 Xue J, Huang XT. Analysis and discussion of the application effect of clinical pathway in gallstone patients undergoing laparoscopic cholecystectomy. Chinese Hospital Management 2009;29:41-43.

20 Kang JF, Hu WF, Lin TY, Han R. Analysis the application effect of clinical pathway in patients underwent laparoscopic cholecystectomy. Nong Geng Yi Xue Za Zhi 2005;27:474-475.

21 Panella M, Marchisio S, Di Stanislao F. Reducing clinical variations with clinical pathways: do pathways work? Int J Qual Health Care 2003;15:509-521. PMID: 14660534

22 Van Herck P, Vanhaecht K, Sermeus W. Effects of clinical pathways: do they work? Journal of Integrated Care Pathways 2004;8:95-105.

23 Barbieri A, Vanhaecht K, Van Herck P, Sermeus W, Faggiano F, Marchisio S, et al. Effects of clinical pathways in the joint replacement: a meta-analysis. BMC Med 2009;7:32. PMID: 19570193

24 Rotter T, Kugler J, Koch R, Gothe H, Twork S, van Oostrum JM, et al. A systematic review and meta-analysis of the effects of clinical pathways on length of stay, hospital costs and patient outcomes. BMC Health Serv Res 2008;8:265. PMID: 19094244

25 El Baz N, Middel B, van Dijk JP, Oosterhof A, Boonstra PW, Reijneveld SA. Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research. J Eval Clin Pract 2007;13:920-929. PMID: 18070263

26 Sutton AJ, Duval SJ, Tweedie RL, Abrams KR, Jones DR. Empirical assessment of effect of publication bias on meta-analyses. BMJ 2000;320:1574-1577. PMID: 10845965

27 Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983;309:1358-1361. PMID: 6633598

28 Deeks JJ, Dinnes J, D'Amico R, Sowden AJ, Sakarovitch C, Song F, et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003;7:iii-x, 1-173. PMID: 14499048

29 Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med 1982;72:233-240. PMID: 7058834