Guidelines for the management of low back pain in Europe

Obiettivo

A. INTRODUCTION
Non-specific, or common low back pain (henceforth, low back pain) is defined as pain in the lumbosacral region, usually accompanied by painful limitation of motion, influenced by strain and the adoption of certain postures, and which may be associated with referred pain. When diagnosed it is assumed that there are no underlying conditions such as fractures, spondylitis, direct trauma, or neoplastic, infectious, vascular, metabolic or endocrinologic-related processes which might cause pain.
Low back pain is attributed to degenerative processes of disks or facet joints, disk protrusion or herniation, muscular strains, and other disorders associated with the position or movement of the spine, such as scoliosis or spondylolisthesis. In most cases, however, it is not possible to establish an organic cause for the symptomatology.
In industrialised countries, low back pain is the main cause of public expense in terms of medical care and work absenteeism, and up to 80% of the population reports having suffered from it at some time in their lives. The expenses generated in Holland in 1991 represented 1,7% of the Gross Domestic Product, and in 1993 in Sweden, low back pain caused 25% of the total number of sick leaves.
Many different diagnostic methods (radiography, CT scan, MRI, electromyography, myelography) are used in patients with low back pain. The frequency with which the different diagnostic methods are used varies with the location. Only a few methodologically correct studies have looked at the usefulness of these tests in cases of low back pain, and their results suggest that the regular use of these methods is unjustified and unnecessarily troublesome to the patients, and that it generates superfluous expenses in the Public Health
System.
A wide range of treatments is used in cases of low back pain, but only a few of them have been evaluated according to appropriate standards of scientific quality. Among those, only a few have proved to be truly effective.
As alarming as the lack of scientifically valid studies is the fact that clinical practice is not based on the scarce existing scientific evidence. Data suggest that abuse of diagnostic and therapeutic procedures whose usefulness has not been validated is common, whereas other useful procedures are seldom used. This factor could determine the poor results achieved in chronic cases of low back pain and the enormous expense generated by its management.
The inadequate prescription of surgery in cases of low back pain illustrates the unnecessary expense and negative consequences derived from ignoring the available scientific evidence. Studies of the results of surgery in cases of low back pain have established concrete, restrictive criteria to identify those patients for whom this kind of treatment is recommended. They represent 1% of affected patients.
The inadequate prescription of surgery is one of the main causes of surgical failure in this pathology. Data suggest that surgery is prescribed for a considerable number of patients that do not meet the exact criteria, and this not only generates public expense but can be harmful to the health of the patients.
Several attempts have been made in the United States, Australia and, lately, in the United Kingdom, to implement management guidelines - including those diagnostic and therapeutic procedures which have proved useful in cases of low back pain - in order to help clinicians in decision-making and to standardise the management of low back pain according to adequate standards of scientific quality.
These guidelines have been based on scientific evidence or, at least, on the consensus of specialists where this evidence does not exist. However, not all of these guidelines meet the required criteria, and none of them has involved the common effort of several European countries. The existence in European countries of National Health Services maintained with public funds implies the need of taking into account aspects such as prevention, cost/effectiveness, and equal access to diagnostic and therapeutic services. These are not priorities in countries with health services of a different kind.
On the other hand, some of the systematic reviews taken into account for the elaboration of these guidelines have only regarded the articles published in a single language, thus ignoring high quality scientific evidence published in other languages. Other guidelines have defined treatment groups to which they have paid a special attention. This could have left aside those treatments which are difficult to fit into one of those groups.
Finally, and above all, there are no data indicating that those guidelines have been really useful, i.e. that what they recommend has actually been applied in practice. The strategy for the dissemination of a guideline is very important to that effect.
In order to override these problems and to avoid duplicating efforts, this programme will:
1. take as starting point the results of previous works, including those of the guidelines previously developed, such as those from USA, UK, Switzerland, Germany or Australia;
2. take into account the scientific evidence that may have been disregarded in those guidelines for reasons other than its scientific quality, as well as that which may have appeared since their elaboration. These aspects are most important in order to achieve a successful dissemination of the results, if it is desired that the target population take these results into account;
3. pay special attention to the dissemination strategy of the resulting guideline, to the mechanisms aimed at promoting their application, and to their feasibility.
B. ESSENTIAL OBJECTIVES
The main goal of this programme is to implement management guidelines for acute and chronic low back pain. These guidelines will include the guidelines of the work previously carried out at the local or national level and should combine, in the most effective and efficient way, those procedures that have proved scientifically effective for the prevention, diagnosis, treatment or rehabilitation of low back pain, in order to improve the quality of the medical care received by European patients.
This objective should contribute to:
(a) help clinicians to base their decisions on scientific evidence;
(b) improve the results of medical care;
(c) justify the enormous expense generated by this problem, by means of a more rational and efficient use of resources;
(d) meet existing European norms regarding the safety and effectiveness standards demanded by European patients in all procedures and treatments that they undergo;
(e) identify the areas in which scientific evidence is lacking, in order to define priority research areas. This programme intends neither to quantify the cost of low back pain in Europe nor describe its present management. Rather, its goal is to implement guidelines for its optimum clinical management based on the existing scientific evidence, and to disseminate those guidelines in order to introduce them into daily clinical practice.
C. SCIENTIFIC PROGRAMME
1. Definition of the minimum standards of scientific quality applicable in the evaluation of the preventive, diagnostic, and therapeutic procedures to be studied throughout the programme. The standards used in the existing guidelines will be considered for that purpose.
2. Identification and collection of scientific studies on preventive, diagnostic and therapeutic procedures compliant with the established quality criteria, that have not been included in previous guidelines due to reasons other than their scientific quality. To avoid duplicating efforts in this respect, this task will take as a starting point the results of previous work carried out by other groups (Cochrane Collaboration work on clinical trials, Agency for Health Care, Policy and Research, Evidence based Medicine Centres, etc.).
3. Definition of:
- categories for the quality of the evidence on which scientific studies will be classified, according to their methodology and consistency;
- categories for the recommendations derived from that evidence (ranging from advising the use of a particular procedure to recommending its disuse).
To avoid duplicating efforts in this respect, this definition will be based on the work previously carried out by other groups (US Task Force on Preventive Health Care, Evidence Based Medicine Centres, etc.).
4. Classification of the identified procedures (point 2) within the defined categories (point 3).
5. Establishment of preventive, diagnostic and therapeutic strategies. This implies also the specification - if the available scientific evidence allows it - of criteria for clinical adequacy and the ideal conditions for utilisation of each procedure. The quality of the scientific evidence supporting each recommendation will be included.
6. Definition of the areas in which scientific evidence is scarce, of low quality or contradictory, in order to identify priority research areas in this field.
7. Writing of the final report and of clinical management guidelines for low back pain.
8. Dissemination of the guidelines, as extensively as possible, with and among those who provide health care to patients with low back pain in COST countries. In addition, the results of each phase of the programme will be sent to a renowned scientific journal for publication. This will guarantee the scientific quality of the work, provide an opportunity for discussion of the criteria utilised among members of the scientific community not included in the Committee, and provide a greater audience for dissemination of the conclusions of the action.
D. ORGANISATION AND CALENDAR
D.1 ORGANISATION
(a) Participants
Although the complexity of the sociological, psychological, economic, and health factors involved in low back pain is well known, a programme focused on all of these aspects would be at risk of being inoperative due to the different approaches and interests of its members.
Therefore, this proposal for European researchers interested in low back pain is mainly addressed to:
- researchers with training in the methodology of clinical research, and preferably those with experience in the field of low back pain, and
- clinicians with experience in this field, preferably those who have previously taken part in clinical research.
Nevertheless, for the implementation of guidelines that actually improve clinical practice, clinicians' representative organisations should be consulted in order to obtain their support. To this end, the representatives of this COST programme in each country will assess the convenience of disseminating information about this initiative and inviting the representative of Medical Associations to participate, i.e. those representative of rheumatologists, orthopaedic surgeons, neurosurgeons, etc. Two workshops will be held with the participation of representatives from these organisations (see Workshops).
(b) Target
Primary target: Health professionals who provide health care to patients with low back pain; mainly physicians, but also physiotherapists, psychologists, etc.
Secondary target: Administrative and health authorities.
(c) Dissemination of the results
Although the detailed strategy will be defined by the Management Committee, some of the requirements it must meet seem obvious, considering previous experience.
c.1 The guideline must be presented to the target population as an extension and summary of previous works, to avoid the confusion that the profusion of local and national guidelines may cause to them. To that effect, the work of the Management Committee and the European dimension brought forward by the COST organisation is specially relevant.
c.2 Involvement of qualified representatives of the target population in its elaboration, in order to make them consider the guideline as a help for their work, rather than an imposition from the experts. To that end, two workshops are planned with the participation of the representatives of the target population.
c.3 Public endorsement of the recommendations by the opinion leaders of the target population; although it is important to develop an evidence-based guideline, this endorsement is important in order to promote its application. To that end, the guidelines are expected to be published in peer-reviewed scientific journals of the specialties and professions involved, and presented in national and international scientific meetings, with the support of local, national and international opinion leaders of the target population.
c.4 Applicability of the guidelines, which means that they must be accessible and simple, in order to guarantee their application by the target population. Accessibility: To this end, the guidelines will be disseminated through Internet, published in paper and disseminated as widely as possible among the target population, and subject to debate in national and international scientific meetings. In each case, the language of the target population will be used.
Simplicity: Special attention will be paid to simplicity and pragmatism in the presentation of the recommendations. To this respect, the opinion of the representatives of the target population will be taken into account.
(d) Organisational Structure
According to calculations made during the design phase of this programme: the Management Committee (MC) will meet once or twice a year, seven working groups (WG) will be formed, and two workshops (WS) will be held. Their goals will be the following:
Working Group 1
To define the minimum standards of scientific quality applicable to the preventive, diagnostic and therapeutic procedures to be evaluated throughout the programme, considering the standards used for the elaboration of the existing guidelines.
Working Group 2
To collect all the scientific studies on preventive, diagnostic and therapeutic procedures practised for low back pain that have been disregarded in previous guidelines for reasons other than their scientific quality, and to classify them into one of the following categories: "Preventive methods", "Diagnostic procedures", and "Therapeutic procedures".
At the same time, and through the Scientific Secretariat, the MC will check for possible links to other European Community activities in this field.
Working Group 3
To establish categories based on the study, selection, and/or summary of those defined by previously elaborated guidelines:
(a) categories for the quality of the evidence on which scientific studies will be classified.
(b) categories for the recommendations derived from that evidence (ranging from advising the use of a particular procedure to recommending its disuse).
Working Group 4
In relation to the diagnostic procedures identified by WG 2:
(a) to classify those procedures into the categories established by WG 3, including the recommendations for use of each procedure based on the available scientific evidence, and the quality of the scientific evidence on which the recommendation is based;
(b) to arrange the recommended diagnostic procedures according to their involvement, risk, cost/effectiveness, etc, thus completing the recommendations of one or more of the existing guidelines.
Working Group 5
In relation to the preventive and therapeutic procedures identified by WG 2:
(a) to classify those procedures into the categories established by WG 3, including the recommendations for use of each procedure based on the available scientific evidence, and the quality of the scientific evidence on which the recommendation is based;
(b) to arrange the recommended preventive and therapeutic procedures in order according to their involvement, risk, cost/effectiveness, etc., thus completing the recommendations of one or more of the existing guidelines.
Working Group 6
To produce clinical management guidelines for acute and chronic low back pain, based on one or several of the existing ones, and incorporating the recommendations of WG 4 and 5.
Working Group 7
To identify priority research areas related to prevention, diagnosis and treatment of low back pain.
Workshop 1
1. To involve in the programme the representatives of those who provide health care to patients with low back pain. These representatives will be heads of domestic or European organisations which represent medical specialties and other health professions related to low back pain, i.e. primary care physicians, Orthopaedists, Neurosurgeons, Rheumatologists, psychologists, physiotherapists etc.
2. To discuss with those representatives the work carried out by WG 2 and 3, once it has been approved by the Management Committee.
Workshop 2
1. To give an advance of the results of the programme to the representatives of the target population.
2. To discuss those results with them and hear their suggestions before the preparation, by the MC, of the final conclusions.
3. To facilitate the dissemination, and practical application by the target population, of the clinical management guidelines produced by the MC.
D.2 CALENDAR
It is obviously too soon to establish a detailed calendar of the action; that will be defined by the Management Committee in its first meeting. A provisional estimation could be as follows:
Day 0: Constitution and first meeting of the MC.
Month 1-6: Constitution and first meeting of WG 1.
Second meeting of WG 1.
Final Meeting and dissolution of WG 1.
Month 6: Second meeting of the MC.
Months 6-21: Constitution and first meeting of WG 2 and 3
Second and third meetings of WG 2 and 3.
Final meeting and dissolution of WG 2 and 3.
Month 21: Third meeting of the MC.
Months 21 to 22: First workshop.
Months 21 to 36: Constitution and first meeting of WG 4 and 5.
Second and third meetings of WG 4 and 5.
Final meeting and dissolution of WG 4 and 5.
Month 36: Fourth meeting of the MC.
Months 36-51: Constitution and first meeting of WG 6 and 7.
Second and third meetings of WG 6 and 7.
Final meeting and dissolution of WG 6 and 7.
Month 51: Second workshop.
Fifth meeting of the
MC.
Months 51-60: Preparation of the
final report and scientific articles.
Month 60: Last meeting of the
MC.
E. ECONOMIC DIMENSION
The following countries have taken an active part in the preparation of this programme or have indicated their interest: Spain (proposer state), Austria, Belgium, Denmark, Finland, France, Germany, Norway, Sweden, The Netherlands.
According to the calculations of the representatives from these countries, and taking into account that coordination expenses will be covered by the COST budget of the European Commission, the approximate total cost of the action to be carried out under this programme is EUR 8 800 000, (according to 1998 prices). Coordination costs amount to, approximately, EUR 598 803. This has been calculated on the basis that two representatives from each country will attend each WG and MC (13), and one will attend each WS (2). It has also been considered that 10 external advisors per participating country and representatives of the target population could be invited to the Workshops. This estimate has been made under the assumption that all of the abovementioned countries, and none other, will take part in the programme. Consequently, any changes in this respect would also change the total cost.

Programma(i)

IC-COST - European cooperation in the field of scientific and technical research (COST), 1971-

Argomento(i)

7 - Medical Research

Invito a presentare proposte

Data not available

Meccanismo di finanziamento

Data not available

Coordinatore

N/A

Contributo UE

Nessun dato

Indirizzo

Regno Unito

Costo totale