Introduction

A bundle is a group of therapies for a disease that, when implemented together, may result in better outcomes than if implemented individually. In recent years, bundles that define mandatory items or procedures to be performed in clinical practice have been increasingly used in guidelines [1]. Compliance with bundles results in the preparation of guidelines as well as an improved prognosis of targeted diseases arising from the use of the guidelines [2, 3]. Levy et al. [4] reported that data from 15,022 subjects at 165 sites were analyzed to determine compliance with bundle targets and association with hospital mortality, and compliance with the entire resuscitation bundle increased linearly from 10.9 % in the first site quarter to 31.3 % by the end of 2 years. Furthermore the odds ratio for mortality improved the longer a site was in the Surviving Sepsis Campaign, resulting in an adjusted absolute drop of 0.8 % per quarter and 5.4 % over 2 years.

Murata et al. [5, 6] examined a total of 60,842 patients with acute cholangitis using the Japanese national administrative database. This report demonstrated the improved prognosis of in-hospital mortality with odds ratio of 0.856 among patients who were managed with high compliance with the items of recommendation Grades A and B in Tokyo Guidelines 2007 (TG07) as compared with the patients who were low-compliance. This shows the importance of preparing bundles by setting the recommended items to be observed in the guidelines. Although TG07 did not prepare bundles at that time, the updated Tokyo Guidelines 2013 (TG13) have adopted the management bundles for acute cholangitis and cholecystitis. The care bundles are designed to be easily achievable and sustainable both to implement and to audit.

Furthermore, we made a checklist. We hope to use the acute cholangitis and cholecystitis bundle checklist to help track your organization’s compliance with implementing each element of these bundles.

Efficacy of the bundle

In the process of developing TG13, mandatory items or procedures to be included in the management bundles have been discussed and defined among the Tokyo Guidelines Revision Committee members. The bundles have been developed and finalized by obtaining consensus. Based on the recommendations in TG13, items which are expected to yield favorable treatment results are included in the bundles. To underscore the time course or timing of the performance of each item, management bundles for acute cholangitis and cholecystitis have been developed. A checklist has also been prepared to confirm compliance with the bundles.

The bundles such as sepsis bundle [7–9], ventilator bundle [10, 11] or central line bundle [12], when implemented together, may result in better outcomes than if implemented individually. Good prognosis is also reported in cases in which a bundle has been achieved, but this may show that those cases which have achieved a bundle are in such good condition as to enable achievement of a bundle.

However, the improvement in prognosis in patients achieved through education concerning bundles demonstrates that implementation of bundles and education concerning them have been useful [9, 13].

Controversial points and harmful effects of bundles

There are many problems to be solved for the spread and implementation of bundles. In the guidelines, even if useful items have been implemented, the prognosis in patients is not improved without common knowledge of management bundles among medical care workers [13]. Furthermore, it is not possible to put bundles into practice without sufficient manpower and equipment [14], which should be improved, if possible. If improvement is impossible, an alternative treatment should be provided or patients should be transferred to a medical facility where the contents of bundles can be put into practice [15].

There is also a concern that bundles are used not for the purpose of improving the prognosis in patients and increasing efficiency, but for limiting the contents of medical care to keep health care costs down. Furthermore, failure to carry out the contents of bundles should not lead to lawsuits [15].

Acute cholangitis management bundle (Table 1)

Items in the cholangitis management bundle are described in Table 1. The content of every bundle is developed from the recommendation of TG13. The mandatory items or procedures to be included in the management bundles have been discussed and defined among the Tokyo Guidelines Revision Committee members. The diagnostic criteria and the severity assessment of acute cholangitis in TG13 was made based on the article of Kiriyama et al. [16].

Table 1 Management bundle of acute cholangitis
Full size table

Acute cholecystitis management bundle (Table 2)

Items in the cholecystitis management bundle are described in Table 2. The content of every bundle is classified into the recommendation of TG13. The mandatory items or procedures to be included in the management bundles have been discussed and defined among the Tokyo Guidelines Revision Committee members. The diagnostic criteria and the severity assessment of acute cholecystitis in TG13 was made based on the article of Yokoe et al. [17].

Table 2 Management bundle of acute cholecystitis
Full size table

Check list for the use of management bundles for acute cholangitis and cholecystitis (Tables 3, 4)

A check list is shown for the effective use of bundles. The use of this list for medical care ensures standards, and is thought to improve effectiveness of the bundles. These check lists, including procedures, laboratories, monitoring and interventions required, should be placed by the bedside.

Table 3 Acute cholangitis bundle checklist
Full size table
Table 4 Acute cholecystitis bundle checklist
Full size table

Conclusions

Bundles consist of important items for the effective use of TG13. Compliance with the bundles is expected to improve the prognosis of acute cholangitis and acute cholecystitis. Reports from various facilities have demonstrated that improved prognosis is expected through the use of the Tokyo Guidelines for acute cholangitis and cholecystitis. Furthermore, good use of those reports will contribute to evidence construction and future revision of TG13.