Introduction and methodology - Guidelines on Parenteral Nutrition, Chapter 1.

Guidelines for Parenteral Nutrition were prepared by the German Society for Nutritional Medicine (http://www.dgem.de/), in collaboration with other medical associations to provide guidance for quality assurance for parenteral nutrition (PN) practice, and to promoting health and quality of life of patients concerned. A coordination team proposed topics, working group leaders who along with working group members performed systematic literatur searches and drafted recommendations in a nominal group process. Recommendations were discussed and agreed upon in a structured consensus conference process, followed by a Delphi consensus. The current English version of the guidelines was written and updated during the period between the last quarter of 2007 and the first quarter of 2009. The recommendations of the guidelines should be reviewed, and if necessary updated five years after publication.

Introduction

Parenteral nutrition (PN) is, for many patients, not only an important but also a life-saving therapeutic measure. These “Guidelines for Parenteral Nutrition” were prepared with the aims of providing guidance for quality assurance for PN practice, and of promoting the health and quality of life of the patients concerned. The guidelines are intended to provide a reference for professional groups involved in the application of PN, based on either scientific evidence or, in case of inadequate scientific evidence, on expert consensus.

The guidelines were prepared under the direction of the German Society for Nutritional Medicine (Deutsche Gesellschaft für Ernährungsmedizin e. V., http://www.dgem.de/), in collaboration with specialist medical associations named in the overview. The principles in preparing guidelines provided by the Joint Committee for Scientific Specialist Medical Associations (AWMF) and the Agency for Quality in Medicine (AQuMed/AEZQ) were followed [1], [2], [3], [4].

Methodology

The DGEM appointed Professor Dr. Berthold Koletzko, M.D. and Professor Dr. Karl-Walter Jauch, M.D. (Table 1 (Tab. 1)) to be the managers of the guideline development project. They formed a coordination team together with Sabine Verwied-Jorky, Ph.D. (responsible for the organisation of the project), Kathrin Krohn, M.D. and Maria-Angelica Trak-Fellermeier, M.Sc., who were joined by Rashmi Mittal, M.D. during the preparation of english version of the guideline. The coordination team drew up a project plan which included the individual topics to be covered, proposed leaders of the working groups (WG) for these topics, and also compiled an inital list of possible working group members. The project plan was reviewed and approved by the DGEM council (Table 1 (Tab. 1)).

Table 1

Timeline and steps involved in the planning, organisation and execution of the project plan for the production of the guidelines (DGEM = The German Society for Nutritional Medicine)

In order to finance the expenses incurred during the development of the guidelines (organisational costs and costs of consensus conferences), requests were made for financial grants to the German Federal Ministry for Health and Social Security, as well as to various health insurance companies. All of these requests were rejected and some insurance companies did not even answer. Subsequent to negotiations by the DGEM council, agreements were signed on the donation of external funds to the University Hospital of Munich by various manufacturers of PN products (Baxter Germany GmbH, B. Braun Melsungen AG, and Fresenius Kabi Germany GmbH). The donors of the funds agreed to bear the logistic and organisational costs for the development of the guidelines, including travelling expenses to meetings and consensus conferences by the working group leaders. In these contracts, it was explicitly stated that the companies donating these funds would not in any way influence topics, structure and content of the guidelines. Accordingly, no representative of these companies took part in any of the meetings or conferences of the working groups.

Setting up of the working groups; declaration of conflict of interest

The coordination team and the working group leaders selected by voting the other members of the working groups. The voting aimed to ensure that each team was multidisciplinary and included members from various professional groups such as doctors from various specialities, pharmacists, nutrition scientists, dietitians, professional carers and legal experts. Experts from the industry were excluded from being members of the working groups. The authors working together on the guidelines are named in the list of authors provided at the beginning of these guidelines, with the list indicating both, the leaders of the working groups and the affiliations of the experts involved. All working group members worked on a voluntary basis, and received no fees. Travelling expenses were reimbursed in line with the guidelines for travelling expenses according to the usual guidelines for public institutes of higher education.

During the meetings between the coordination team and working group leaders, possible conflicts of interest were discussed. In the interest of transparency, it was decided to request a completed declaration of potential conflicts of interest from participant (Table 2 (Tab. 2)). These were reviewed by the coordination team who concluded that none of the experts working on the development of these guidelines were either a representative or spokesperson for any particular company or range of products.

Table 2

Declaration of conflict of interest by members of working groups for preparing the Guidelines for Parenteral Nutrition (according to the guidelines manual provided by the AWMF and the AQuMed/AEZQ [4])

Literature searches and evaluation

The individual working groups carried out a comprehensive literature search of scientific publications since 1990 in English or German (Table 3 (Tab. 3)). Some relevant publications, which had been published prior to 1990, were also considered, if deemed necessary by the concerned working group. The publications relevant to the proposed questions were evaluated, with regards to the degree of adequacy as scientific evidence, by at least two working group members, independently of each other (Table 4 (Tab. 4)). The recommendations were then derived, in a stepwise manner, from this information as recommended by the Scottish Intercollegiate Guidelines Network (Figure 1 (Fig. 1)) [5].

Table 3

Minimum requirements for literature searches to be carried out by the individual working groups

Table 4

Degree of adequacy as scientific evidence for evaluating studies according to ZQ (in accordance with the guidelines manual from the AWMF und AQuMed/AEZQ [4])

Figure 1

Derivation of degrees of adequacy as scientific evidence (modified according to [5])

Nominal Group Process

The various working groups made core statements and recommendations on the basis of the systematic literature searches. The working groups were encouraged to follow the 'Nominal Group Process' method, i.e. the individual members of the working groups were expected to develop their own proposals, which were then combined to form a group consensus [4]. Individual working groups were responsible for processing the texts using the Delphi method (written questions and answers in several rounds). The final version was accessible for comments and criticisms, via a password-protected home page, by members of all working groups and representatives of other specialist medical associations. The suggested amendments were considered by the pertinent working group as well as the coordination team. The initial recommendations were discussed, amended if considered necessary, and voted upon by the working groups in separate rooms at the working group meetings held before the first consensus conference. This method of working in small groups was in accordance with the Nominal Group Process, which ensured that all members of the groups made their opinions clear, and had the chance to influence the group voting. However, as the number of groups (18) was large, with each group having only a maximum of six members, it was decided not to carry out a formal Nominal Group Process. The experts in the methodology of guideline development, Koller M und Celik I, assisted the process by visiting the individual working groups, and performing the role of methodology enforcers and observers.

Consensus conferences, Delphi consensus and the final editing

A first consensus conference was held in Munich in March, 2005 with 29 working group members, at which the members of the individual working groups presented their recommendations. These provisional recommendations were discussed, if necessary revised, and then voted upon. The recommendations were allocated into categories according to the guidelines provided by the AWMF and AQuMed/AEZQ (Table 5 (Tab. 5)). The results as well as an account of the proceedings of the consensus conference were recorded in writing.

Table 5

Allocation to recommendation categories (in accordance with the guidelines manual from the AWMF und AQuMed/AEZQ [5])

The suggested amendments, discussed in the consensus conference, were incorporated into the recommendations using another round of the Delphi method. A password-protected home page was set up by the DGEM, was made accessible to all working group members, who then voted on the amendments.

At a second consensus conference in May, 2004, also held in Munich, the amended manuscripts were again discussed, amended where necessary, and voted upon. The working group Ethics and Law presented only an interim report as they were unable to complete their work by that time. After further amendments, the working group leaders posted their manuscripts in the section 'completed manuscripts' or, in the case of suggestions which had not yet been voted upon, in the section 'Delphi round' of the password-protected home page, so that the participants could once again review and comment upon the proposals. The final group consensus emerged in this way from several rounds of proposals, reviews and amendments. During the process, the coordination team met several times to review and edit all contributions. The English version of the guidelines was written and updated during the period between the last quarter of 2007 and the first quarter of 2009.

Use and implementation of the guidelines

The aim of the current guidelines is to improve the quality of applying PN in practice. It must, however, be noted that the guidelines are not mandatory directives or procedural regulations, but they are intended to provide guidance to the medical and nursing profession on how to deal with specific situations. Special circumtances pertaining to an individual patient, progress in medical knowledge, and development of new techniques may justify a deviation from the recommendations included in these guidelines.

The implementation of guidelines is often difficult. It involves taking into consideration the infrastructure and the personnel available, and the availability of experts in the field in one’s own settings. Many times, although the guidelines are available, it is not feasible to implement them either due to lack of resources or information.

The Leeds Castle conference on implementation of guidelines recommended against individual and isolated methods of implementation [6]. It concluded that implementation must be carried out as a strategy with several steps, with the aim of changing the attitudes and behaviour of those affected. Accordingly, it was important that a plan which incorporated both dissemination of information as well as encouraged a change in bedside practice, according to the guidelines, was formulated.

At the second consensus conference, the following steps for an implementation strategy were decided upon:

Publication in German language magazines like the 'Nutrition Medicine Today'.

Publication in English to enable dissemination in non-German-speaking countries.

Publication in an abbridged form – small enough to slip into the pocket of a doctor's white coat – increasing the availability and the possibility of practical implementation of the guidelines, where they are needed, i.e. at the bedside.

Dissemination at various meetings and congresses of medical specialists

Production and distribution of training CDs with practical examples.

Identification of nutrition support teams in hospitals and outpatient settings, and of the information they might need.

Identification of hospitals that will commit themselves to implementation of the guidelines, and also will give feedback regarding the implementation process (duplicator effect).

Awarding CME points to doctors within the framework of training activities.

Updating of the guidelines

The recommendations of the guidelines should be reviewed, and if necessary updated five years after publication by the DGEM e.V.

Notes

This article is part of the publication of the Guidelines on Parenteral Nutrition from the German Society for Nutritional Medicine (overview and corresponding address under http://www.egms.de/en/journals/gms/2009-7/000086.shtml).

English version edited by Sabine Verwied-Jorky, Rashmi Mittal and Berthold Koletzko, Univ. of Munich Medical Centre, Munich, Germany.

Acknowledgements

The work involved in the preparation of the guidelines was financially supported by the German Society for Nutritional Medicine e.V. as well as grants by the following companies provided to the University of Munich Medical Center: Baxter Germany GmbH, Unterschleissheim, B. Braun Melsungen AG, Melsungen, and Fresenius Kabi Germany GmbH, Bad Homburg.