The executive board of the NVvH will assess these guidelines no later than 2020 to determine if they are still valid. If necessary, a new working party will be set up to review the guidelines. If there are new developments, the validity of the guidelines will expire earlier and a review will take place. The working party does not deem it necessary to separately specify validity at a modular level.

As owners of these guidelines, the primary responsibility to keep them up-to-date rests with the NVvH. Other participating professional bodies or users of the guidelines share the responsibility and are required to inform the NVvH about relevant developments in their fields.

The development of these guidelines was financed by the Quality Foundation of the Dutch Medical Specialists (SKMS).

What is the aim (desired effect) of the guidelines?

The recognition and acknowledgement of the complexity of a fracture of the lower limb with significant soft tissue injury is of the greatest of importance in developing an appropriate multidisciplinary treatment strategy. The specialisations involved must be very aware of their own abilities and limitations, and on the basis of these must work in partnership right from when the patient is first presented. Standardisation of therapeutic options by means of a treatment algorithm is necessary. The development of multidisciplinary, evidence-based guidelines contributes to this.

Currently, the treatment of an open lower limb fracture is not managed by a scientifically supported and multidisciplinary policy, but more likely by the local traditions of the hospital at which the patient presents. This often causes confusion about the most appropriate method of primary fixation, the timing and the extent of aggressiveness of the debridement and the planning for definitive coverage of the soft tissues.

In the Netherlands, there is currently no standardised treatment for patients with an open fracture of the lower limb. There are British guidelines on this injury (BAPRAS/BOA, 2009), but these are not always applicable to the Dutch situation for a number of reasons, including the differing ways in which care is organised. National, evidence-based guidelines are of considerable importance in supporting health care professionals in their clinical decision-making and in providing transparency to patients and third parties. It covers topics in several areas including the early and late treatment of open fractures of the lower limb, the timing and kind of  surgical debridement, bone stabilisation, soft tissue cover and rehabilitation. The ultimate goal is to create a primary multidisciplinary treatment pathway whereby patients with complex open fractures of the lower limb can be treated quickly and to a high standard.

Defining the guidelines

The guidelines are aimed at all patients with an open fracture of the lower limb, and in particular at those patients with a grade III (a, b or c) open injury in accordance with the classification of Gustilo and Anderson. The principles of treatment described in these guidelines are also applicable to open fractures in other parts of the skeleton, such as the ankle.

Envisaged users of the guidelines

These guidelines have been written for all members of those professional groups who are involved in the medical care of adults or children with an open fracture of the lower limb: emergency department physicians, trauma surgeons, orthopaedic surgeons, plastic surgeons, rehabilitation physicians, physiotherapists, nurses and wound consultants.

In 2014, a multidisciplinary working party was set up to develop these guidelines. It comprised representatives from all those relevant specialisations involved in the care of patients with a grade III open fracture of the lower limb (see below).

The members of the working party were mandated for participation by their professional organisation. The working party worked for two years to develop these guidelines.

The working party is responsible for the integral text of these guidelines.

• Dr M.J. Elzinga, trauma surgeon (NVvH), Haga Hospital, The Hague (Chair)
• Dr J.M. Hoogendoorn, trauma surgeon (NVvH), Medical Centre Haaglanden-Bronovo, The Hague, The Netherlands.
• Dr P. van der Zwaal, orthopaedic surgeon (NOV), Medical Centre Haaglanden-Bronovo, The Hague, The Netherlands.
• Dr D.J. Hofstee, orthopaedic surgeon (NOV), Noordwest Hospital Group, The Netherlands
• J.G. Klijnsma, physiotherapist (KNGF), University Medical Centre Utrecht, The Netherlands
• Dr P. Plantinga, emergency department physician (NVSHA), Rijnstate Hospital, Arnhem, The Netherlands.
• Dr H.R. Holtslag, rehabilitation physician (VRA), Academic Medical Centre, Amsterdam, The Netherlands.
• Dr E.T. Walbeehm, plastic surgeon (NVPC), Radboud Hospital, Nijmegen, The Netherlands.
• Dr H.A. Rakhorst, plastic surgeon (NVPC), Medisch Spectrum, Twente, The Netherlands.

With the help of:

• Dr W.A. van Enst, senior advisor, Knowledge Institute of Medical Specialists

With thanks to:

• Dr C.W. Ang, medical microbiologist, VU Medical Centre, Amsterdam. The Netherlands.

The perspective of the patient was included by organising a focus group. This report can be found in the appendices. The concept guidelines was presented to the Patient Federation NPCF for their comments.

Introduction

This plan has been drawn up with the aim of advancing the implementation of these guidelines. In order to compile this plan, an inventory of factors that could either facilitate or hinder the recommendations was carried out.  The guideline working group has made recommendations concerning the timeline for implementation, the preconditions necessary for this and the actions that should be taken by various parties.

Methodology

In order to arrive at this plan, the working party has applied the following to each recommendation in the guidelines:

• the time point by which the recommendations should have been nationally implemented;
• the expected impact of implementation of the recommendation on healthcare costs; preconditions necessary to be able to implement the recommendation; possible barriers to the implementation of the recommendation; possible actions to advance the implementation of the recommendation; the party responsible for the actions to be undertaken.

Readers of this implementation plan should take the differences between ‘strong’ recommedations and ‘weak’ recommendations into account. In the former case, the guideline committee clearly states what should or should not be done. In the latter case, the recommendation is less strong and the working party expresses a preference but leaves more room for alternatives. One reason for this could be that there is insufficient research evidence to support the recommendation. A weak recommendation can be recognised by its formulation and may begin with something like ‘Consider the…’. The working party has considered the implementation of both weak and strong recommendations. A time frame for implementation is only indicated for strong recommendations.

Time frames for implementation

Strong recommendations should be followed as strictly as possible. In most cases, this will mean that the recommedations should be implemented within one year of the publication of the guidelines.

However, some recommedations will not be directly implemented everywhere. This could be due to a lack of facilities, expertise or correct organisational structure. In some cases, account should be taken of the learning curve. In addition, the unavailability of staff or facilities or lack of agreement between professionals may hinder the implementation  in the short term.

It is for these reasons that the following recommendations are based on estimates made by the guideline working group, and an implementation period of between one and three years should be allowed for:

The following recommendations are based on estimates made by the guideline committee, and an implementation period of between three to five years should be allowed for:

Impact on healthcare costs

Many of these recommendations will have few or no consequences for the cost of healthcare. However, the deployment of a multidisciplinary team will possibly increase direct costs. Conversely, if the guidelines are adhered to the number of infections and reoperations will be reduced thus reducing costs. The savings are larger than the cost of the multidisciplinary team. Other recommendations do not affect costs, or may even save them. 

Actions to be undertaken by each party

Below is a list of actions that in the opinion of the guideline working group should be undertaken to facilitate the implementation of the guidelines.

All academic and professional organisations that are directly involved (NVvH, NVPC, NOV, VRA, KNGF).

• Tell members about the guidelines. Publicise the guidelines by writing about them in journals and disseminating news of them at congresses.
• Provide professional education and training to ensure that the expertise required to follow the guidelines is available.
• Where relevant and possible, develop resources, instruments and/or digital tools to facilitate the implementation of the guidelines.
• Monitor the way in which the recommendations are put into practice by means of audits and quality inspections.
• Include indicators developed for these guidelines in quality registrations and indicator sets.
• Make interprofessional agreements about implementing continuous modular maintenance of the guidelines.

Initiatives to be undertaken by the professional organisation NVvH

• Hospital management boards and other system stakeholders (where applicable), should be kept informed of recommedations that could have an effect on the organisation of care and on costs, and on what may be expected by the party concerned.
• Publicise the guidelines to other interested academic and professional bodies.

Local professional groups / individual medical professionals

• Discuss the recommendations at meetings of professional groups and local working parties.
• Tailor local protocols to fit the recommendations from the guidelines.
• Follow the continuing professional education on these guidelines (yet to be developed). 
• Modify local information for patients using the materials that the professional bodies will make available. 
• Make agreements with other disciplines involved to ensure the implementation of the recommedations in practice.
• Register pre- and postoperative factors and, as far as is possible, include important considerations for decision-making in existing protocols and the electronic dossier.

The system stakeholders (including health insurers, NZA, hospital managers and their associations, IGZ)

In relation to the financing of care for patients with open fracture of the lower limb, it is expected that hospital management boards will be prepared to make the investments necessary to enable the implementation of these guidelines (see impact on healthcare costs above). In addition, hospital managers are expected to monitor those medical professionals concerned and ascertain how familiar they are with the new guidelines and how they are putting them into practice.

Health insurers are expected to reimburse the costs of the care that is prescribed in these guidelines. When the time frames for implementation have elapsed, health insurers can use the strong recommendations in these guidelines for purposes of purchasing care.

Researchers and subsidy providers

Initiate research into the knowledge gaps, preferably in a European setting.

Knowledge Institute of Medical Specialists

Publicise these guidelines among the staff and contect to development of related guidelines, e.g. on ankle fractures and post-osteosynthesis infection.

Add guidelines to guideline database. Incorporate this implementation plan in a place where all parties will be able to find it.

AGREE II

These guidelines were developed in accordance with the publication Medical Specialists Guidelines  2.0 report from the advisory committee on Guidelines from the Committee on Quality. This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (http://www.agreetrust.org/agree-ii/). This is a widely-accepted internationally used instrument and is based on  ‘Guideline to guideline for the assessment of quality of guidelines (http://www.zorginstituutnederland.nl/).

Inventory of problem areas

During the preparation stage, the Chair of the Working Party and the Advisor made an inventory of problem areas. The Dutch health insurance companies were invited to contribute their problem areas to the guidelines.

Clinical questions and outcome measures

Based on the outcomes of the problem area analysis, the Chair and the Advisor compiled concept clinical questions. These were discussed with the working party, after which time the working party approved the definitive clinical questions. The working party then decided which outcome measures of each of the clinical questions are relevant to the patient, and both desirable and undesirable effects were examined. The working party then rated these outcome measures and categorised their relative importance as crucial, important or unimportant. In as far as was possible, the working party also defined what they found to be clinically relevant difference in the outcome measures, i.e. if the improvement in outcome was an improvement for the patient.

Strategy for searching and selecting the literature

For purposes of orientation, we looked for existing guidelines from outside the Netherlands (Guidelines International Network, Trip and National guideline clearing house (USA) European and American professional organisations), and systematic reviews (Medline, Embase, Cochrane Database of Systematic Reviews). Then, using specific search terms from the individual clinical questions, the working party searched for published studies in various electronic databases. Studies from the reference lists of the selected articles were also included in the search. Initially, studies with the highest level of evidence were searched for. The members of working party then went through the articles found in the search and selected articles based on predetermined selection criteria. The selected articles were used to answer the clinical questions. The databases searched, the search action or key words of the search action and the selection criteria used are defined in the search strategy of the clinical question concerned.

Quality evaluation of individual studies

In order to estimate the risk of bias in the study results, individual studies were systematically evaluated on the basis of previously determined methodological quality criteria. These evaluations can be found in the methodological checklists.

Summary of the literature

The relevant data from all studies included are shown in evidence tables. The most important findings from the literature were described in the summary of the literature. In the event of enough agreement between studies, the data were summarised quantitatively in a meta-analysis. This was done with Review Manager software from the Cochrane Collaboration.

Evaluation of the strength of scientific evidence

A) Intervention and diagnostic questions

Evaluation of the strength of scientific evidence was determined in accordance with the GRADE method. GRADE stands for  ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/) (Atkins, 2004).

GRADE distinguishes four grades of quality of evidence, i.e. high, moderate, low and very low. These grades indicate the degree of confidence in the conclusions in the literature (see http://www.guidelinedevelopment.org/handbook/). 

B) Questions concerning aetiology and prognosis

GRADE cannot be applied in this type of question. The strength of evidence of the conclusion is determined in accordance with the EBRO method (van Everdingen, 2004).

Formulating the conclusions

Evidence concerning questions about the value of diagnostic tests, injury or side effects, aetiology and prognosis, has been summarised in one or more conclusions in which the level of the most relevant evidence is given.

In questions relating to intervention and diagnosis, the conclusion does not refer to one or more articles, but is drawn on the basis of the whole body of evidence. In this the members of the working party did an analysis for each intervention. In making these calculations, the beneficial and unfavourable effects for the patient were weighed off against one other.

Considerations

In order to produce a recommendation, aspects other than research evidence are also important. These include the expertise of the members of the working party, patient preferences, costs, availability of facilities and organisational matters. In as far as they are not part of the literature summary, these aspects are reported under the heading ‘Considerations’.

Development of recommendations

The recommendations answer the clinical question and are based on the best available scientific evidence and the most important considerations. The strength of the scientific evidence and the weight accorded the considerations by the working party together determine the strength of the recommendation. In accordance with the GRADE methodology, a low grade of evidence from a conclusion in the systematic literature analysis does not exclude a strong recommendation, and a high grade of evidence does not exclude a weaker recommendation. The strength of the recommendation is always determined by weighing up all relevant arguments together.

Preconditions (Organisation of care)

In the analysis of problem areas and the development of the guidelines, account was taken explicitly of the organisation of care: all those aspects that are preconditions for the provision of care. These include coordination, communication, materials, financial means, work force and infrastructure. Preconditions that are relevant to the answering of a specific clinical question are part of the considerations related to that specific question.

Development of indicators

At the same time as the concept guidelines were developed, internal quality indicators were also developed in order to be able to follow and to strengthen the application of a guideline in practice. More information about the method of developing indicators can be requested from the secretariat of the Knowledge Institute of Medical Specialists (secretariaat@kennisinstituut.nl).

Knowledge gaps

In the development of these guidelines, we systematically searched for research whose results contributed to answering one of the clinical questions. The working party examined each clinical question and they considered the desirability of further research. An overview of their recommendations for further research can be seen in Knowledge gaps (see related products).

Comment and authorisation stage

To follow (after comment stage)

Implementation

At each stage of the development of the guidelines, account was taken of the implementation of the guidelines and the feasibility of the recommendations in practice. In this, particular attention was paid to factors that may advance or hinder the implementation of the guidelines.

Searches are available upon request. Please contact the Richtlijnendatabase.