Why a Dual Pathology Clinical Guideline? Analysis of the evidence

In 2013, the Spanish Society of Biological Psychiatry, through its president, Miguel Bernardo, raised the possibility of preparing clinical guidelines for dual pathology because of the absence of clear evidence on how to define and approach this pathology in clinical settings.

The therapeutic algorithms currently used exclude patients with psychiatric disorders and substance abuse, although there are indeed differential decision trees for patients with a psychiatric disorder and for those with substance abuse. Comprehensive treatments and individualised treatments plans have been developed over the last 2 decades. Consequently, there is growing demand for multidisciplinary treatment guidelines in which simultaneous interventions for patients with both disorders is integrated.

In turn, upon analysing the existing information in this field, great variability was observed in the approach to and treatment of patients having a psychiatric disorder together with a disorder for substance abuse (dual pathology). This variability caused some uncertainty among clinicians when decisions were necessary, fundamentally related to treatment. In addition, morbidity and mortality for dual pathology has led to an important health problem in the last few years. In the field of mental illness treatment, newly-appeared drugs and psychological approaches should be assessed so that therapeutic recommendations for this patient collective can be made, in an attempt to improve the attention given to this emerging condition. Given that practically all of these circumstances concur in the field of dual pathology,¹ the decision was made to follow this procedure to prepare guidelines for pharmacological and/or psychological treatment of patients with dual pathology.

Given the characteristics of the guidelines, active participation of several scientific societies involved in this field was considered essential. Examples are the Spanish Society of Psychiatry, the Spanish Society of Biological Psychiatry, the Spanish Drug Addiction Society, the Spanish Society for Dual pathology, the Spanish Scientific Society for Studies on Alcohol, Alcoholism and other Addictions (Socidrogalcohol) and the Galician Association of Psychiatry (which has participated as the entity that has funded the preparation of the guidelines). Other institutions that have supported this project are CIBERSAM and RTA.

Formally, clinical practice guidelines (CPGs) are a set of systematically developed recommendations to help professionals and patients to make decisions as to the most appropriate healthcare attention, and to choose the most adequate diagnostic or therapeutic options for approaching a health problem or a specific clinical condition.² Basically, CPGs seek to reduce variability and improve clinical practice for the professionals. Over the last several years, especially since the instrument AGREE was published, the thoroughness and quality of elaboration of the CPGs have advanced. In Spain, the 2006 implementation of the Programme for Preparing Clinical Practice Guides in the National Heath System (SNS in Spanish), coordinated by GuíaSalud, has meant a qualitative leap forward in CPG development in our environment. This programme, through a ministerial agreement between the SNS Agency for Quality and the agencies and units for healthcare technology assessment, committed to both preparing common methods for CPG preparation and to implementing and up-dating them as well.

Methods for developing the Clinical Practice Guidelines for Dual Pathology

For the preparation of the Clinical Practice Guidelines for Dual Pathology, the development of the CPG of the SNS was assumed to be the process that includes the following stages: preparation, adaptation, up-dating, assessment and implementation of the CPG.^2–4

It is evident that the field of dual pathology is very broad if we consider aspects such as its epidemiology, etiopathogenesis, neurobiology, clinical signs and symptoms, differential diagnosis and treatment. For this reason, a national group of experts was created that included psychiatrists, psychologists and pharmacologists to establish the work methods and define the objectives of the Guidelines. In the first meeting (in Madrid, 18 June 2013), the decision was made for the Guidelines to focus exclusively on pharmacological and/or psychological treatment of the adult population. It was also decided to select psychiatric illnesses of greater severity (such as schizophrenia and bipolar disorder) and of greater prevalence (such as affective disorders, anxiety disorders and attention deficit and hyperactivity disorder). The decision was also made to limit the number of comorbid substances with the psychiatric diagnoses included, to make the Guidelines manageable and easily to read for the professionals. Consequently, the literature related to disorder from use of alcohol, cannabis, cocaine and nicotine was reviewed.

PICO questions

Following the methods established mentioned earlier, the next step consisted of formulating the questions to which the Guidelines should reply, which are known as PICO questions. The letters in this acronym correspond to Population, Intervention, Comparison and Outcomes. That is, each of the questions to which the Guidelines respond should specify the following: (1) what the population studied is (in our cases, adult patients with dual pathology); (2) what type of interventions are carried out (pharmacological and/or psychological treatment); (3) what is to be compared (different pharmacological and/or psychological treatments, including studies against placebo), and (4) what results are expected in terms of health (in our case, improvement of the clinical manifestations of the psychiatric diagnosis, improvement in substance abuse, and other health results considered relevant). The panel of experts had to score these questions on a scale from 1 to 9, depending on their clinical relevance, and only the questions that were agreed upon as being the most relevant were included in the Guidelines.

Bibliographical search

After the PICO questions had been prepared, a documentalist carried out a bibliographical search, establishing a series of search strategies for PubMed, Cochrane and TRIP using MeSH terminology, free language and different filters to limit the search of the scientific literature existing in the field to the maximum extent possible. To facilitate communication among all the participants, besides the face-to-face meetings held, work was carried out using new communication technologies (Dropbox) to be able to share all the documentation that was being generated.

GRADE

Publications that were selected were systematic reviews, meta-analyses and randomised clinical trials, with a methodology that guaranteed the quality of the results. During the entire process of preparation, the publications selected were analysed and the most relevant data from these studies were introduced in the GRADE (whose initials correspond to Grades of Recommendation, Assessment, Development and Evaluation) system. This platform makes it possible to evaluate the quality of evidence for each of the outcomes and establish their quality. At the end of the process, and depending on the degree or quality of the evidence, a series of recommendations or suggestions was posed in favour of or against, which permitted replying to the PICO questions formulated earlier.

Recommendations and future steps

After writing up the recommendations to which the panel of experts agreed, the entire Guidelines will be sent to the Agency for Quality and Healthcare Assessment in Catalonia to be evaluated using the CPG assessment instrument AGREE II. This tool was developed to examine the variability in the quality of guidelines and assess the methodological precision and transparency with which these documents were prepared.

In parallel, the Guidelines will be sent to a series of national and international experts. As clinical experts not involved in the preparation of the Guidelines, they will act as external assessors and will be able to make suggestions to the expert group. This group will, in turn, evaluate whether a modification is necessary or not in the Guidelines wording. This activity serves the purpose of evaluating CPG quality so that users can trust its recommendations when using it in their daily clinical practice.

Once all this process has been completed, the Guidelines will be published in paper and electronically in the SNS, allowing free access for all interested professionals. This is the plan for implementing the Guidelines; that is, transferring the CPG recommendations to clinical practice. Such implementation consequently implies the use of effective communication strategies to encourage change. The implementation of a CPG require a planning process in which special attention must be given to the context – both institutional and social – to the barriers and facilitators that make change in practice more difficult or favour it, and to the evaluation of the strategies of intervention that (in accordance with what has been indicated before) can be more effective and efficient in completing the implementation of this CPG successfully.

Conflict of interests

Luis San has received research funds and has acted as a consultant or been a speaker for the following companies and entities: Adamed, Eli Lilly, Ferrer, Janssen-Cilag, Lundbeck, Otsuka, Rovi and Servier.

Belén Arranz has acted as a consultant/speaker for the following companies and entities: Adamed, Esteve, Janssen-Cilag, Lundbeck, Otsuka, Rovi and Servier.