Méthode d'élaboration des guides d'affections de longue durée (ALD) à destination des médecins et des listes des actes et prestations - Preparing doctors' guides and lists of procedures and services for chronic conditions
Description
Posted on Dec 06 2006 These recommendations take the form of a guide for doctors and a list of procedures and services required for the clinical management of a given disease. These tools are intended to serve as a basis for the care protocol for a patient with a chronic condition. This protocol is to be drawn up by the patient’s doctor, validated by the National Health Insurance (NHI) medical adviser, and signed by the patient (Article L. 324-1 of the Social Security Code).The recommendations may also address :the conditions under which these procedures and services should be provided, and in particular how often they should be performedthe period for which the care protocol is valid, and the procedures and services not normally required in the treatment of the conditions in question. The aim of this document is to explain how to produce the doctors’ guides and the associated lists of procedures and services. These recommendations take the form of a guide for doctors and a list of procedures and services required for the clinical management of a given disease. These tools are intended to serve as a basis for the care protocol for a patient with a chronic condition. This protocol is to be drawn up by the patient’s doctor, validated by the National Health Insurance (NHI) medical adviser, and signed by the patient (Article L. 324-1 of the Social Security Code).The recommendations may also address :the conditions under which these procedures and services should be provided, and in particular how often they should be performedthe period for which the care protocol is valid, and the procedures and services not normally required in the treatment of the conditions in question. The aim of this document is to explain how to produce the doctors’ guides and the associated lists of procedures and services. Posted on Dec 06 2006
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| Publié par | haute-autorite-sante-methodologie |
| Publié le | 01 avril 2007 |
| Nombre de lectures | 16 |
| Licence : |
En savoir + Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
|
| Langue | Français |
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METHODOLOGY GUIDE
Preparing doctors’ guides and lists of procedures and services fo conditions
April 2007 (update)
r chronic
This guide may be downloaded from the HAS website www.has-sante.fr
Haute Autorité de santé Communications Department 2 avenue du Stade de France - F 93218 Saint-Denis La Plaine CEDEX Tel.: +33 (0)1 55 93 70 00 Fax: +33 (0)1 55 93 74 00 -
This document was validated by the HAS Board in April 2007 © Haute Autorité de santé 2007
Contents
Introduction ..................................................................................................... 2
I Main stages of production .................................................................... 5
1. Critical appraisal of the literature......................................................... 5 1.1 Literature search .................................................................................... 5 1.2 ......................................................................... 5Analysis of the literature
2. 2.1 2.2
Selection and aims of the working groups ......................................... 5 Appointment of working group members ............................................... 6 Aims and composition of WG1 and WG2............................................... 6
3. and assessment of the version submitted to thePreparation members of WG1 ............................................................................................ 7 3.1 First draft ................................................................................................ 7 3.2 7 .........................................................Assessment by specialty societies 3.3 Analysis of responses ............................................................................ 8 3.4 Meeting of WG1...................................................................................... 9
4. and assessment of the version submitted to thePreparation members of WG2 ............................................................................................ 9 4.1 Assessment by the members of WG2.................................................... 9 4.2 Opinions of AFSSAPS and the HAS Drugs Assessment Department... 10 4.3 Meeting of WG2...................................................................................... 10
5.
Validation and distribution.................................................................... 10
II Updates........................................................................................................ 11
1.
2.
3.
Yearly LPS updates ............................................................................... 11
3-yearly updates of the doctors’ guides.............................................. 12
Update validation and distribution....................................................... 12
1
Introduction HAS is charged with three complementary missions in the area of chronic conditions (affections de longue durée, or ALDs) (Article R. 161-71 of the Social Security Code): 1. to issue its opinion on the decree establishing the list of chronic conditions 2. to draw up recommendations on the medical criteria used in defining these chronic conditions 3. to draw up recommendations on the procedures and services required to manage these conditions. These recommendations take the form of a guide for doctors and a list of procedures and services required for the clinical management of a given disease. These tools are intended to serve as a basis for the care protocol for a patient with a chronic condition. This protocol is to be drawn up by the patient’s doctor, validated by the National Health Insurance (NHI) medical adviser, and signed by the patient (Article L. 324-1 of the Social Security Code). The recommendations may also address the conditions under which these procedures and services should be provided, and in particular how often they should be performed the period for which the care protocol is valid, and the procedures and services not normally required in the treatment of the conditions in question. The aim of this document is to explain how to produce the doctors’ guides and the associated lists of procedures and services.
HAS plans to review the whole list of chronic conditions by the end of 2007. Certain chronic conditions require a special approach, in that they potentially
cover a large number of conditions under the same heading (e.g. ALD 30 ‘malignant tumour, malignant condition of lymphatic or haematopoietic tissue’ actually covers the whole of oncology).
For each chronic condition, an HAS project manager is responsible for drafting the doctor’s guide, for executing and coordinating all the work on the
condition, and for monitoring all medical and scientific developments in the field.
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The total time taken to produce a doctors' guide and list of procedures and services, from the literature search to validation of the guide by the Board, is about 9 months (see flowchart on next page).
These guides and lists are expected to be updated at least once every 3 years.
The method described in this guide does not apply to the formulation of HAS’ opinions on the decree establishing the list of chronic conditions nor to the production of recommendations on the medical criteria used in defining the chronic conditions. These will be covered elsewhere. Nor does it apply to the national diagnosis and care protocols for rare diseases, which have their own guide.1
1 HAS (SALDAC),protocole national de diagnostic et deMéthode d’élaboration du soins et de la liste des actes et prestations par le centre de référence d’une maladie rare [Guide for drafting the national diagnosis and care protocol and the list of procedures and services for use by rare disease reference centres], March 2006.
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· · ·
Stage 1 Preparation of version WG1 Literature search (2 weeks) pointment of WG1 members ppraisal of the literature and drafting (6 weeks) Collection of patients associations’ expectations sessment by learned societies (3 weeks) alysis of responses (2 weeks) Meeting of WG1 (1 day) Post-WG1 revision (2 weeks)
Stage 2: Preparation of version WG2 sessment by WG2 members (3 weeks) alysis of responses (2 weeks) Submission to AFSSAPS and the Transparency Committee (3 weeks) Meeting of WG2 (1 day)
Analysis of financial impact of the LPS by a technical working Mg, roDuSpS , cDoRmEpoEse2d of HAS, UNCAM, UNOCA S
Stage 3: Validation and distribution
Post-WG2 finalisation (2 weeks) Submission of the doctors’ guide and LPS to the PBSR Committee at 2 meetings (9 weeks) Validation by the HAS Board (3 weeks) Distribution
Production flowchart and timescale
2 WG: Working Group; UNCAM: Association of National Health Insurance (NHI) Funds; UNOCAM: Association of Complementary Health Insurance Funds; DSS: MoM, Social Security Directorate; DREES: MoM, Directorate for Research, Surveys, Assessment and Statistics; LPS: List of procedures and services; PBSR: HAS Specialist Committee for Healthcare Cover for Long-Term Conditions
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I
1.
Main stages of production
Critical appraisal of the literature
The aim of the critical appraisal of the literature is to assess the amount and level of evidence available on the disease in question. In order to produce doctors' guides, there must be existing guidelines, produced in France or elsewhere, and preferably published within the last 5 years.3
1.1 Literature search
The literature search is carried out by a researcher in consultation with the project manager. The aim is to identify first French and then foreign guidelines and consensus conferences dating from the last 5 years.
To be considered, guidelines must include the following information: % description of their method of production exact % search and critical appraisal literature %an explicit validated grading of the guidelines, with evidence levels.
1.2 Analysis of the literature
The project manager draws up the care pathway for a patient with a chronic condition from the existing guidelines.
Special attention must be given to proposed procedures and services that do not currently qualify for reimbursement in the NHI scheme. In the absence of sound scientific evidence for these non-reimbursable services, a fully documented consensus opinion of experts should be sought.
2. Selection and aims of the working groups
Doctors’ guides and lists of procedures and services (LPS) are produced in collaboration with all the stakeholders involved in the care pathway for the
chronic condition being examined. Two successive working groups (WGs) are set up, each with a different aim
3 Except for rare diseases (see HAS,Méthode d’élaboration du protocole national de diagnostic et de soins et de la liste des actes et prestations par le centre de référence d’une maladie rarea sisong erac dntinae thia dalon tfol si ocolprot the andedf rod artfni g [Gui procedures and services for use by rare disease reference centres], March 2006).
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2.1
Appointment of working group members
Doctors and ancillary medical staff The medical and ancillary medical experts in the two working groups (WG1 and WG2) are appointed from the membership of medical and ancillary specialty societies. The relevant societies must be identified and asked to
nominate their experts at least 2 months in advance of the working group meeting.
Patients’ associations The appropriate patients’ associations, if any, should be selected from directories and in consultation with the CISS4 sitting on the representative PBSR5 (Committee. These associations will first be consulted during the drafting stage, when their expectations are collected, and then asked to take part in the second working group (WG2).
Medical advisers to National Health Insurance (NHI) They are appointed to WG2 by the representatives of the three NHI funds6 sitting on the PBSR Committee.
2.2 Aims and composition of WG1 and WG2
The two working groups meet for at most one day each, approximately two and a half months apart.
Aims and composition of WG1
The aim of WG1 is to validate the first version of the doctors’ guide and associated LPS by means of a professional consensus based on the critical appraisal of the literature. WG1 must also give its opinion on the medical relevance of the current medical criteria for eligibility to the chronic condition scheme.
WG1 should be limited in size to about 9 members and should try to maintain a balance between general practitioners and professionals from the main medical and ancillary specialties involved in managing the disease.
4CISS : Federation of health syst em users 5PBSR: HAS Specialist Committee for Healthcare Cover for Long-Term Conditions 6Funds for salaried workers, independent workers, and agricultural workers
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In order to provide a broader view at first reading, representative medical and ancillary medical staff who are less regularly involved in managing the disease may be asked for their input in writing.
Aims and composition of WG2 WG2 has the following aims, which should be clearly announced when the meeting opens: to discuss points on which the members of WG1 were unable to decide to consult on the operational aspects of the guide and LPS7 draft guide and LPS with the patientsto check the acceptability of the concerned and all the professionals involved in treating them.
WG2 will include all the stakeholders involved in the healthcare pathway, with 15 to 20 members on average. In addition to the members of WG1, it will include representatives of NHI funds
patients’ associations the other medical and ancillary medical professions involved.
3. Preparation and assessment of the version submitted to the members of WG1
3.1 First draft
After the literature appraisal, the project manager will draft a first version of the doctors’ guide and LPS based on the existing guidelines and liaise with the appropriate patients’ associations to determine their expectations. He/she will then finalise the draft before submitting it for review to the members of WG1.
3.2 Assessment by specialty societies
The draft of the doctors’ guide and LPS is submitted for first reading to the members of WG1 and, if necessary, to professionals indirectly involved.The aim of this first reading is to assess both content and form, particularly in relation to the relevance,
7 LPS: List of Products and Services
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applicability and acceptability of the recommendations. WG1 members rate all items of the draft on an assessment grid prior to meeting.
If a member of the group does not agree with the content of the draft, they should give their reasons and back them up with scientific papers that have not been taken into account.
Assessment rules Group members must complete the questionnaire in full and rate each proposal for (i) relevance, (ii) applicability and (iii) acceptability on a scale from 1 to 9: a score of 1 to 3 means that the proposition is completely inappropriate or unacceptable a score of 7 to 9 means that the proposition is completely appropriate or acceptable scores of 4 to 6 represent intermediate situations.
1 2 3 Completely inappropriate or unacceptable
4
5
6
7 8 9 Completely appropriate or acceptable
The group members must rate each proposal listed by circling one of the numbers from 1 to 9. They should not give a rating that falls between two numbers or that straddles two numbers. If they give a rating in the range [1 to 3], they should indicate their reasons.
3.3 Analysis of responses
The responses for each proposal will be analysed by determining their range on a scale of 1 to 9 (i.e. the minimum and maximum scores) and calculating the median.
Range of responses The range of the responses will show whether the group members agree or disagree on a given proposal. If they agree, the analysis of their responses will show how strongly they agree:
if the range of responses lies within the limits of just one of the three regions [1 to 3] or [4 to 6] or [7 to 9], there is strong agreement among the group members as to whether the proposal is appropriate, inappropriate or uncertain (for definitions, see ‘Position of the median’ below)
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if the range of responses straddles two regions (e.g. a range of [1 to 4] or [ 5 to 8]), there is relative agreement among the group members if the responses are spread over all three regions or the two outer regions [1 to 3] and [7 to 9], there is disagreement among the group members as to the appropriateness of the proposal.
Position of the median If there is strong or relative agreement, the median will fall in one of three regions:
region of acceptability [7 to 9]: the proposal is appropriate or acceptable region of uncertainty [4 to 6]: the group members are in agreement but cannot decide whether or not the proposal is appropriate or acceptable region of unacceptability [1 to 3]: the proposal is inappropriate or unacceptable.
3.4 Meeting of WG1
The members of WG1 will meet at HAS for one day at most in order to revise the draft doctors’ guide and LPS in accordance with the rating results. A professional consensus should be achieved by the end of the meeting. A sub-group may be set up to work on any unresolved points. It will present its findings at the meeting of WG2.
4. Preparation and assessment of the version submitted to the members of WG2
After being revised in line with the conclusions reached at the WG1 meeting, the draft doctors’ guide and LPS are passed on to the members of WG2 for peer review. AFSSAPS8Assessment Department are asked for theirand the HAS Drugs opinions on the section of the draft relating to drug prescribing.
4.1 Assessment by the members of WG2
Once validated by WG1 for scientific content, the draft doctors’ guide and LPS are submitted to the members of WG2 (drawn from patients’ associations, NHI funds, and other medical and ancillary medical
8 AFSSAPS: French Healthcare Products Safety Agency
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