3.1. Introduction

The Clinical Practice Guideline for the Management of Patients with Schizophrenia was edited and presented in December 2003. Two years after its publication, a bibliographic review process was initiated, and the need for the guideline’s updating was analysed, resulting in the development of this CPG that updates certain aspects and complements other relevant topics that were not addressed in the first edition.

Given that the update has substantially changed the initial content, and has even incorporated a new chapter, it has been decided not to highlight changes in the text. Despite this, new recommendations have been shaded to distinguish them from reviewed recommendations.

3.2. Working group members

The development group for the update of the CPG was composed of professionals from different fields involved in this disorder. Hence, not only psychiatrists participated in this process, but also psychologists, nurses, social workers and occupational therapists, comprising a multidisciplinary team that contributed new perspectives. Likewise, two members of the Catalan Agency for Health Technology Assessment and Research (CAHTA) also participated, providing methodological support.

The working groups that contributed to the development of the CPG were:

a) Coordinator group: comprised, in part, by the members who developed the previous CPG and who, led by a coordinator, carried out the organization of the CPG, the establishment of the scope and objectives, the formulation of clinical questions, as well as methodological and support aspects to aid the development group.

b) Development group: composed of health care professionals who were in charge of the review and synthesis of the scientific literature, as well as the development of the recommendations that had to be updated. The members of this group were divided into four subgroups that addressed the different aspects covered in the CPG: biological treatment and somatic management, psychosocial interventions, psychosocial rehabilitation and modalities of care to the community.

In the authorship and collaborations chapter the affiliation and specialty of the members of the working group (coordinator and development) is presented.

3.3. Review and synthesis of the biomedical literature

A general bibliographic search was carried out for CPGs and recommendations on the management of schizophrenia and incipient psychotic disorder in the main medical and psychology databases: Pubmed/Medline, The Cochrane Database of Systematic Reviews, The Cochrane Controlled Trials Register, The Health Technology Assessment Database, Database of Abstracts of Reviews of Effects (DARE), Psycinfo, Psicodoc and CPG directories such as the National Guidelines Clearinghouse, the Scottish Intercollegiate Guidelines Network (SIGN), the New Zealand Guidelines Group, the National Institute for Clinical Excellence (NICE), the CPG INFOBASE and EBM Guidelines. The same search terms used in the previous CPG were applied (annex 7). The search period spanned from the completion of the previous CPG (2002) to July 2007.

In the bibliographic search 11 CPGs or consensus documents with recommendations for the treatment of schizophrenia were identified.^{1-4, 36-42} With the aim of obtaining the highest quality CPGs, the AGREE questionnaire for CPG assessment was applied to the documents identified, and the contributions of each CPG were analysed (annex 6). Finally, four CPGs were selected, serving as the basis for this update. However, other aspects of interest were examined in the other CPGs, such as specific pharmacological⁴⁰ or first episodes content.⁴¹ The following table lists the selected CPGs:

Table 1. Selected clinical practice guidelines

Selected clinical practice guidelines	Abbreviation used
Schizophrenia. Full national clinical guideline on core interventions in primary and secondary care. National Collaborating Centre for Mental Health. National Institut for Clinical Excellence (NICE). The Royal College of Psychiatrists & The British Psychological Society. London, 20033.	NICE (2003)
McGorry P, Killackey E, Lambert T, Lambert M, Jackson H, Codyre D, et al. Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of schizophrenia and related disorders. Aust N Z J Psychiatry. 2005; 39(1- 2):1-30.1	New Zealand (2005)
Practice guideline for the treatment of patients with schizophrenia (Second Edition). American Psychiatric Association; Steering Committee on Practice Guidelines. 2004.4	APA (2004)
Clinical practice guidelines. Treatment of schizophrenia. Can J Psychiatry.2005; (50) 13 Suppl 1: 7S-57S.2	CPG (2005)

It should be noted that the main recommendations of the selected CPGs were extracted and compared with recommendations from the previous CPG, enabling the addition, replacement or elimination of some of the prior recommendations. In order to facilitate the subsequent consensus work of the group, the corresponding values of the grades of recommendation of each selected CPG and this CPG were determined, taking the scientific evidence scale employed by each one of them into account.

Additionally, with the aim of updating and expanding contents, several specific searches were performed, according to the area of intervention and some aspects that had not been addressed in the previous CPG, such as incipient psychotic disorder. These searches were conducted in the main medicine and psychology databases: Pubmed/Medline, The Cochrane Database of Systematic Reviews, The Cochrane Controlled Trials Register, The Health Technology Assessment Database, Database of Abstracts of Reviews of Effects (DARE), Science Citation Index, Psycinfo, etc., and pages of different organizations, scientific societies, etc., were reviewed. A search was conducted for potential systematic reviews of the scientific evidence (SRSE) and, in some cases, randomised clinical trials (RCT), covering the 2002-2007 period. The different searches and main strategies of each one of them can be consulted in annex 7. Furthermore, other manual searches of bibliographic references included in selected articles, or through other access channels. The bibliographic references obtained were managed using the Reference Manager program, which facilitated the detection of duplicates and the management of references in the development of the document.

The following step was to perform a first selection of the scientific literature by reading the titles and summaries of recovered documents, which met the inclusion and exclusion criteria determined by the group (based on the clinical questions established, the study period, language, etc.). Finally, the last selection was carried out after the critical reading of the complete text of the studies included (Figure 1). In cases of greater difficulty or methodological doubts, two independent reviewers performed the selection. The information extracted from the articles and their quality assessment was synthesized in tables of scientific evidence.

The selection, review and synthesis of the biomedical literature were carried out by the four previously mentioned subgroups, according to the type or area of intervention. Likewise, each subgroup selected and reached consensus on the recommendations that were going to be formulated based on those extracted from the selected CPGs and from the scientific articles that completed the information. Annex 1 presents the scale with the levels of evidence and the classification of recommendations used in this project.

In this update, the recommendations extracted from the selected CPGs maintain the grade of recommendation, even though they do not incorporate the level of scientific evidence that is already referenced in the original CPG.

Figure 1. Selection process of references identified in the bibliographic search

3.4. Presentation formats

The presentation formats of the CPG update that have been agreed upon are:

- A complete version. Core document that is the result of the work carried out by the working group applying the methodology that has been mentioned in the previous section.

- A summarized version. Summary that stems from the complete version, containing the main points of interest, recommendations and algorithms of clinical practice.

- A quick version. Easy-to-use document, with the main recommendations and algorithms of clinical practice.

- A version for patients. Document aimed at people with schizophrenia and their families, friends or people they are involved with.

The CPG update will be published in electronic format (available at www.aatrm.net and www.guiasalud.es ) and in paper format.

3.5. External review

The external review was performed by professionals from different fields and national health care settings, as well as by some representatives from schizophrenia foundations (see chapter on authorship and collaborations). All reviewers received an assessment questionnaire. The form used and a summary of the responses obtained are presented in annex 8.

Finally, the changes suggested by the reviewers were discussed in the working group for later modification, applying the external review method of The schizophrenia patient outcomes research team (PORT) studies. That is, recommendations were modified only if they were supported by scientific evidence, meaning opinion by itself was not considered sufficient enough reason to modify the recommendation.⁴³ In this sense, recent bibliography (outside the time range selected for the initial review and synthesis of the biomedical literature) has been included, given that the relevance of the contents justified their inclusion in the CPG.

3.6. Performance of the pilot test

In the previous CPG, a pilot test was performed in which 22 professionals from different fields (psychologists, psychiatrists, nurses and social workers) and different community mental health centres, day hospitals and psychiatry services of general hospitals participated. In order to approve the CPG, they were delivered the document with an assessment questionnaire and a letter explaining the process to be followed to analyze both the presentation format and the feasibility of application and acceptance of recommendations. They were requested to use the CPG in their clinical practice over a period of two weeks and subsequently conduct their assessment. The suggestions obtained were incorporated into the format of algorithms and in a new pamphlet design, achieving the main objective: to improve the presentation of the CPG before its edition and publication.

Given that this CPG updates and complements specific aspects, the working group did not deem the performance of a new pilot test necessary.

3.7. Review and/or update planning

Once the updated CPG is published, the same review procedure described in this document will be followed: in two years, a new bibliographic search will be conducted to decide if it is necessary to update or modify the guideline. If an update is necessary, the indications of the GuiaSalud Clinical Practice Guideline Update Manual shall be followed. The updated version is expected to be available four or five years after the publication of this edition.