What do people appreciate in physicians' communication? An international study with focus groups using videotaped medical consultations.

BACKGROUND: The literature shows that the quality of communication is usually determined from a professional perspective. Patients or lay people are seldom involved in the development of quality indicators or communication. OBJECTIVE: To give voice to the lay people perspective on what constitutes 'good communication' by evoking their reactions to variations in physician communication. DESIGN: Lay people from four different countries watched the same videotaped standardized medical encounters and discussed their preferences in gender-specific focus groups who were balanced in age groups. SETTING AND PARTICIPANTS: Two hundred and fifty-nine lay people (64 NL, 72 IT, 75 UK and 48 BE) distributed over 35 focus groups of 6-8 persons each. MAIN VARIABLES STUDIED: Comments on doctors' behaviours were classified by the GULiVer framework in terms of contents and preferences. RESULTS: Participants prevalently discussed 'task-oriented expressions' (39%: competency, self-confident, providing solutions), 'affective oriented/emotional expressions' (25%: empathy, listening, reassuring) and 'process-oriented expressions' (23%: flexibility, summarizing, verifying). 'Showing an affective attitude' was most appreciated (positive percentage within category: 93%, particularly facilitations and inviting attitude), followed by 'providing solution' (85%). Among disfavoured behaviour, repetitions (88%), 'writing and reading' (54%) and asking permission (42%) were found. CONCLUSIONS: Although an affective attitude is appreciated by nearly everybody, people may vary widely in their communication needs and preferences: what is 'good communication' for one person may be disliked or even a source of irritation for another. A physician should be flexible and capable of adapting the consultation to the different needs of different patients. This challenges the idea of general communication guidelines.

GULiVER--travelling into the heart of good doctor-patient communication from a patient perspective: study protocol of an international multicentre study.

BACKGROUND: The project GULiVer explores how lay people in Belgium (Gent), the Netherlands (Utrecht), the UK (Liverpool) and Italy (Verona) evaluate physicians' communicative skills. The aims are to present the study design and to assess the quality of collected data. METHODS: In each centre one out of two sets of four videotaped consultations involving medical students with varying communication skills were shown to eight lay panels of six to nine participants each (n = 259). The selection of lay participants was stratified by gender and age in order to obtain a heterogeneous sample. Background characteristics included socio-demographics, participants' general physical (COOP-WONCA) and mental health (GHQ), communication preferences (QUOTE-com) and trust in doctors (TMP). Participants were asked to give quantitative and qualitative evaluations of the student doctors' performance in a mixed-methods design. Quality assessment of the collected data and protocol adherence of the four centres was carried out by Generalized Linear Model (GLM). RESULTS: The overall sample comprised 259 participants. Participants were equally distributed among the centres and balanced in terms of age, gender and OSCE scenario, confirming the quality of collected data. CONCLUSION: The study design and the applied procedures will ensure a great richness of data allowing a wider European perspective on lay persons' views, assessed both individually and through focus group discussion.

Involving patients in decisions during psychiatric consultations.

BACKGROUND: Patient involvement in the decision-making process is a key element for good clinical practice. Few data are available on patient involvement in psychiatry. AIMS: To assess in a psychiatric out-patient context how psychiatrists involve patients in therapeutic decisions and to determine the extent to which patient and psychiatrist characteristics contribute to patient involvement. METHOD: Eighty transcripts from audiotaped first out-patient consultations, conducted by 16 psychiatrists, were rated with the OPTION (observing patient involvement) scale. Interrater reliability indices were obtained for 30 randomly selected interviews. Associations between OPTION scores and some clinical and socio-demographic variables were tested using t-test, ANOVA and Pearson's correlation coefficient where appropriate. The distribution of scores for each psychiatrist was assessed by intracluster correlation coefficients. RESULTS: Interrater reliability and internal consistency of the OPTION scale in the psychiatric setting were satisfactory. The total score and the ratings for the single OPTION items showed a skewed distribution, with a prevalence of scores in the low range of abilities, corresponding to minimal attempts to involve patients or a minimal skill level. CONCLUSIONS: The OPTION scale proves to be a reliable instrument to assess patient involvement in a psychiatric setting. Psychiatrists showed poor patient involvement abilities parallel to previous findings in psychiatry and primary care. They need to be encouraged to share treatment decisions with their patients and to apply patient involvement skills. Further research is needed to establish which patient variables and clinical settings in psychiatry are more amenable to shared decisions, and how participation of psychiatric patients in treatment decisions will affect the outcome.

Which patient and doctor behaviours make a medical consultation more effective from a patient point of view. Results from a European multicentre study in 31 countries.

OBJECTIVE: To assess European patients' preferences regarding seven aspects of doctor-patient communication. METHODS: 6049 patients from 31 European countries evaluated 21 doctor and 12 patient behaviours, through a patient-generated questionnaire (PCVq). Multilevel models explored the effects of patient characteristics, contextual and cultural dimensions on preferences. RESULTS: Patients attributed more responsibility to doctors, by giving greater importance to doctor than to patient factors, in particular to Treating the patient as a partner and as a person and Continuity of care. Gender, age, education, the presence of chronic illness and two of Hofstede's cultural dimensions, Individualism and Indulgence, showed differential evaluations among patients. Women gave greater importance to all seven communication aspects, older patients to being prepared for the consultation, lower educated patients to Treating patient as a person and Thoughtful planning. Patients from countries with an indulgent background rated all seven communication aspects of greater importance. A more individualistic orientation was related to lower importance regarding the four doctor's factors and the patient factor Open and Honest. CONCLUSIONS: Treating the patient as a person and providing continuity of care emerged as universal values. PRACTICE IMPLICATIONS: The findings should represent a landmark for the adaptation of patient-generated communication guidelines and programs in Europe.

Cues and concerns by patients in medical consultations: a literature review.

The aim of the current article is to review the peer-reviewed research literature on cues and concerns published between 1975 and 2006. To be included, articles had to report observational studies based on patient-physician consultations and report findings on patient expressions of cues and/or concerns. Quantitative and qualitative studies from different medical settings were considered. Fifty-eight original articles based on the analysis of audio- or videotaped medical consultations were tracked down. Definition of cues and concerns and methodological approaches differed widely. Physicians missed most cues and concerns and adopted behaviors that discouraged disclosure. Communication training improved the detection of cues and concerns. Future research progress would require different methodological approaches more appropriate for studying verbal interactions and the complexity of the various levels that influence interactions.

Sequence analysis in multilevel models. A study on different sources of patient cues in medical consultations.

The aims of the study were to explore the importance of macro (patient, physician, consultation) and micro (doctor-patient speech sequences) variables in promoting patient cues (unsolicited new information or expressions of feelings), and to describe the methodological implications related to the study of speech sequences. Patient characteristics, a consultation index of partnership and doctor-patient speech sequences were recorded for 246 primary care consultations in six primary care surgeries in Verona, Italy. Homogeneity and stationarity conditions of speech sequences allowed the creation of a hierarchy of multilevel logit models including micro and macro level variables, with the presence/absence of cues as the dependent variable. We found that emotional distress of the patient increased cues and that cues appeared among other patient expressions and were preceded by physicians' facilitations and handling of emotion. Partnership, in terms of open-ended inquiry, active listening skills and handling of emotion by the physician and active participation by the patient throughout the consultation, reduced cue frequency.

Shared decision making: the reliability of the OPTION scale in Italy.

OBJECTIVE: To provide psychometric characteristics of the Italian language version of the OPTION scale and descriptive statistics on patients' involvement. The OPTION scale assesses the extent to which clinicians involve patients in therapeutic decisions. The English language version has a Cohen's kappa score for individual items ranging from 0.45 to 0.98 and an intraclass correlation coefficient (ICC) for the total score of 0.77. METHODS: Six male GPs provided 235 audiotaped consultations with consecutive patients who had attended for a new illness episode over a 2-month period. Thirty interviews were rated by two raters to assess inter- and intra rater as well as test-retest reliability of the Italian language version of the OPTION scale. Based on the whole sample, Cronbach's alpha and an exploratory factor analysis were performed to assess internal validity and to determine factor loadings. RESULTS: Cohen's kappa values were comprised between 0.29 and 0.73, the ICC at test and retest was 0.85 and 0.81 and Cronbach's alpha 0.82. The ratings for each OPTION item showed a skewed distribution: the majority of scores (>70%) were between 0 (behaviour absent) and 2 (minimum skill level). CONCLUSION: The reliability indices were satisfactory and similar to those reported for the original OPTION. PRACTICE IMPLICATIONS: OPTION can be used for both teaching purposes and research, as well as for future cross-national comparisons.

Verona Coding Definitions of Emotional Sequences (VR-CoDES): Conceptual framework and future directions.

OBJECTIVE: To discuss the theoretical and empirical framework of VR-CoDES and potential future direction in research based on the coding system. METHODS: The paper is based on selective review of papers relevant to the construction and application of VR-CoDES. RESULTS: VR-CoDES system is rooted in patient-centered and biopsychosocial model of healthcare consultations and on a functional approach to emotion theory. According to the VR-CoDES, emotional interaction is studied in terms of sequences consisting of an eliciting event, an emotional expression by the patient and the immediate response by the clinician. The rationale for the emphasis on sequences, on detailed classification of cues and concerns, and on the choices of explicit vs. non-explicit responses and providing vs. reducing room for further disclosure, as basic categories of the clinician responses, is described. CONCLUSIONS: Results from research on VR-CoDES may help raise awareness of emotional sequences. Future directions in applying VR-CoDES in research may include studies on predicting patient and clinician behavior within the consultation, qualitative analyses of longer sequences including several VR-CoDES triads, and studies of effects of emotional communication on health outcomes. PRACTICE IMPLICATIONS: VR-CoDES may be applied to develop interventions to promote good handling of patients' emotions in healthcare encounters.

Five years of EACH (European Association for Communication in Healthcare).

Five years after launching EACH (European Association for Communication in Healthcare) we look back at what EACH achieved so far and announce new ideas and activities EACH plans to carry out in the near future. During the past five years several scientific, educational as well as societal changes have taken place in the area of communication in healthcare that all underline the need for continued international collaboration in line with the activities employed by EACH so far. Within communication research the focus has shifted from counting communication utterances to unraveling sequences of patient cues and provider responses. In the field of teaching it is becoming more and more common to attend to the training of trainers as well. Within these developments, new areas of interest arise and need attention. To comply with these increasing demands, EACH invites new persons to become a member of one of the recently launched committees in the area of research, teaching and publishing.

How patients would like to improve medical consultations: Insights from a multicentre European study.

OBJECTIVE: In a previous qualitative study (GULiVer-I), a series of lay-people derived recommendations ('tips') was listed for doctor and patient on 'How to make medical consultation more effective from the patient's perspective'. This work (GULiVer-II) aims to find evidence whether these tips can be generally applied, by using a quantitative approach, which is grounded in the previous qualitative study. METHODS: The study design is based on a sequential mixed method approach. 798 patients, representing United Kingdom, Italy, Belgium and the Netherlands, were invited to assess on four point Likert scales the importance of the GULiVer-I tips listed in the 'Patient Consultation Values questionnaire'. RESULTS: All tips for the doctor and the patient were considered as (very) important by the majority of the participants. Doctors' and patients' contributions to communicate honestly, treatment and time management were considered as equally important (65, 71 and 58% respectively); whereas the contribution of doctors to the course and content of the consultation was seen as more important than that of patients. CONCLUSIONS: The relevance of GULiVer-I tips is confirmed, but tips for doctors were assessed as more important than those for patients. PRACTICE IMPLICATIONS: Doctors and patients should pay attention to these "tips" in order to have an effective medical consultation.

The English version of the Verona medical interview classification system (VR-MICS). An assessment of its reliability and a comparative cross-cultural test of its validity.

OBJECTIVE: This study aimed to assess the inter-rater and intra-rater reliability of the English translation of the original Italian version of the VR-MICS and to evaluate its sensitivity by comparing the coding of English and Italian general practice consultations with emotionally distressed and non-distressed patients, as defined by the 12-item General Health Questionnaire (GHQ-12). METHOD: Six male GPs from Manchester (UK) and six from Verona (Italy) each contributed five consultations, which were coded using the VR-MICS. Intra-rater and inter-rater reliability were assessed both for the division of interviews into speech units and the speech unit coding. Interaction and main effects of GHQ-12 status and nationality on patient and GP expressions were assessed by two-way ANOVA. RESULTS: Agreement indices for the division of speech units varied between 88-96 and 87-93% for GP and patient speech, respectively; those for coding categories between 88-91 and 82-86%, with Cohen's Kappa values between 0.86-0.91 and 0.80-0.85 for GP and patient speech, respectively. Cross-cultural comparisons of patient and GP speech showed no interaction effects between GHQ-12 status and nationality. The Italian GPs were more 'doctor-centred', while the UK GPs tended to use a more 'sharing' consulting style. Independent of nationality, distressed patients talked more, gave more psychosocial cues and increased amounts of positive talk compared to non-distressed patients. GPs in both settings, when interviewing distressed patients, reduced social conversation and increased psychosocial information-giving, checking questions and reassurance. CONCLUSION: The English translation of the VR-MICS showed satisfactory reliability indices and similar sensitivity to patients' verbal behaviours in relation to their emotional state in the two settings. PRACTICE IMPLICATIONS: The VR-MICS may be an useful coding instrument to support collaborative research on doctor-patient communication between the two countries.

Information-giving sequences in general practice consultations.

RATIONALE, AIMS AND OBJECTIVE: Most patients want to be involved in the decision-making process regarding their health and doctors need to improve their ability to meet these needs. Before implementing educational interventions, a better understanding of how information is provided in routine clinical practice is necessary. Aim of this study was to analyse the information-giving sequence of general practice consultations. METHODS: This is an observational study that involved six general practitioners (GPs) in single-handed practices and patients (aged between 16 and 74) who consulted over a 2-month period for a new illness episode. Transcripts of 252 consultations were coded using the Verona Medical Interview Classification System that provides three categories for information giving (information on illness management; instructions on illness management and information and instructions on psychosocial aspects). Lag1 and lag2 sequential analyses were performed. RESULTS: Information represented about one-third of the average consultation length. Medical and psychosocial information were preceded most often by patients' replies to previous questions (36% and 41%, respectively) and by listening and agreement (21% and 23%, respectively), less frequently by expression of opinions (10% and 6%, respectively). Listening and agreement were the most likely patient response after information (36%). GPs rarely tried to find out patients' view before and after the delivery of information or an instruction (<1%). CONCLUSION: The low frequency of expressions of opinions and questions immediately before and after GPs' information and instructions, and the lack of facilitating questions indicate a limited degree of patient involvement in the information-giving sequence.

Information needs of female Italian breast cancer patients during their first oncological consultation.

PURPOSE: Questions asked by patients during consultations reflect their most immediate information needs. The aim of this study is to observe the frequency and type of questions asked by Italian breast cancer patients and to explore associated factors. METHODS: Breast cancer patients at their first meeting with the oncologist were asked to complete five questionnaires (STAI-X1, PHQ-9, GHQ-12, CPS and DSES) before the consultation and three other questionnaires (PEI, SDM-Q, SWD) after. Consultations were audio taped and subsequently analyzed for the content and number of questions to identify patients' information requests. RESULTS: Patients asked an average of 18 questions, mainly about illness management: patients who were prescribed chemo-therapy asked more questions (t = -3.17, dof = 23.45, p < 0.01). Other factors related to a greater number of questions were younger age (r = -0.24, p = 0.05), being employed (t-test = 0.32; p = 0.04), and longer consultation length (r = 0.47, p < 0.01). CONCLUSION: Italian breast cancer patients asked on average more questions than in other countries. Knowledge of the factors associated with information needs can contribute to achieve a major involvement and consequently a better quality of patient-centered care.

Inter and intra individual variations in physicians' verbal behaviour during primary care consultations.

It is well established that most medical interviews in primary care are characterised by a scarcity of patient-centred interventions and a predominance of doctor-centred behaviours. Less information is available on the intra- and inter-individual variability between the physicians' use of these categories. The study aimed to examine the impact of physician, physician's attribution of emotional distress, patients' GHQ-12 status and gender on the frequency of doctor and patient-centred verbal behaviours. A matched pair design involved six General Practitioners (GPs) and 238 patients. GPs'speech was classified using nine main categories derived from the Verona medical interview classification system (VR-MICS/D). Frequencies of the behaviours were calculated as percentages of total utterances per interview. Parametric and non-parametric ANOVAs were performed with GHQ-12 score, GP attribution of psychological distress, gender, and the six GPs as main factors. GPs varied in their use of the various interviewing behaviours. GHQ-12 status had no impact on GPs' interview behaviour, while GPs' distress attribution was associated with an increase of closed psychosocial questions and a decrease of closed medical questions. Within comparisons showed that each GP tended to change very little and only as a function of attribution: four out of six GPs increased closed psychosocial questions with patients they thought to be distressed. Patients' gender did not significantly alter GPs' interviewing behaviour. The variability in the use of specific verbal behaviours among GPs indicates a highly individualised approach and the lack of a common interview strategy. The fact that GPs' interviewing styles did not change according to patient characteristics, such as emotional distress, but only according to attribution further indicates that GPs untrained in communication techniques tend to use a predominant doctor-centred approach to the medical interview.

The biopsychosocial domains and the functions of the medical interview in primary care: construct validity of the Verona Medical Interview Classification System.

Factor analysis (FA) is a powerful method of testing the construct validity of coding systems of the medical interview. The study uses FA to test the underlying assumptions of the Verona Medical Interview Classification System (VR-MICS). The relationship between factor scores and patient characteristics was also examined. The VR-MICS coding categories consider the three domains of the biopsychosocial model and the main functions of the medical interview-data gathering, relationship building and patient education. FA was performed on the frequencies of the VR-MICS categories based on 238 medical interviews. Seven factors (62.5% of variance explained) distinguished different strategies patients and physicians use to exchange information, build a relationship and negotiate treatment within the domains of the biopsychosocial model. Three factors, Psychological, Social Inquiry and Management of Patient Agenda, were related to patient data: sociodemographic (female gender, age and employment), social (stressful events), clinical (GHQ-12 score), personality (chance external health locus of control) and clinical characteristics (psychiatric history, chronic illness, attributed presence of emotional distress).

How patients want their doctor to communicate. A literature review on primary care patients' perspective.

OBJECTIVE: To review the literature on the communicative behaviours primary care patients want from a "good" physician. METHODS: An electronic search used the key words doctor-patient relation AND patient desires OR patient expectations OR patient preferences (from now on referred to as expectations). The qualitative and quantitative articles meeting the selection criteria were analysed separately, comparing methods, definitions, measures and outcomes. The physician behaviours desirable from a patient perspective were grouped by linking them to the communicative functions of an effective medical encounter as defined from a professional perspective. RESULTS: Twenty-seven studies were included. Critical issues were the heterogeneity of definitions and measures and the lack of integration between quantitative and qualitative findings. Most of the expectations in qualitative studies were related to the function "Fostering the relationship". Similar expectations arose less often in quantitative studies. CONCLUSIONS: Patients do have concrete expectations regarding each of the functions to be met in the medical encounters. The research approach tends to bias the results. PRACTICE IMPLICATIONS: The collected expectations suggest how physicians may perform each of their tasks according to the patient perspective. Future research on patients' communicative expectations needs to overcome the gap between qualitative and quantitative findings.

How do lay people assess the quality of physicians' communicative responses to patients' emotional cues and concerns? An international multicentre study based on videotaped medical consultations.

OBJECTIVE: to establish which kind of physician communicative responses to patient cues and concerns are appreciated by lay people. METHODS: A balanced sample (259 people) was recruited in public places to participate in a full day observation of four videotaped standardized medical consultations. In a two-step procedure participants gave their individual quality ratings of the whole consultations and then of a set of four fragments from each consultation. They contained a patient negative emotional expression and the subsequent physician response, according to the VR-CoDES. RESULTS: Higher quality ratings were given to physician responses which provided space to the patient to talk and to the explicit expressions of empathy. The explicit responses were favored above non-explicit responses. Participants' global evaluation of the whole consultation affected their quality assessments of the fragments (halo-effect). In a multivariate model, lay people's background characteristics appeared to be relevant: to be female, of lower educational level and living in Belgium or Italy predicted higher ratings. CONCLUSIONS: Providing space to patients is appreciated by all participants, combined with the need for tailor made communication. PRACTICE IMPLICATIONS: To teach physicians listening skills and how to show empathy with distressed patients should be a core element in medical education.

INvolvement of breast CAncer patients during oncological consultations: a multicentre randomised controlled trial--the INCA study protocol.

INTRODUCTION: Studies on patient involvement show that physicians make few attempts to involve their patients who ask few questions if not facilitated. On the other hand, the patients who participate in the decision-making process show greater treatment adherence and have better health outcomes. Different methods to encourage the active participation during oncological consultation have been described; however, similar studies in Italy are lacking. The aims of the present study are to (1) assess the effects of a preconsultation intervention to increase the involvement of breast cancer patients during the consultation, and (2) explore the role of the attending companions in the information exchange during consultation. METHODS AND ANALYSIS: All female patients with breast cancer who attend the Oncology Out-patient Services for the first time will provide an informed consent to participate in the study. They are randomly assigned to the intervention or to the control group. The intervention consists of the presentation of a list of relevant illness-related questions, called a question prompt sheet. The primary outcome measure of the efficacy of the intervention is the number of questions asked by patients during the consultation. Secondary outcomes are the involvement of the patient by the oncologist; the patient's perceived achievement of her information needs; the patient's satisfaction and ability to cope; the quality of the doctor-patient relationship in terms of patient-centeredness; and the number of questions asked by the patient's companions and their involvement during the consultation. All outcome measures are supposed to significantly increase in the intervention group. ETHICS AND DISSEMINATION: The study was approved by the local Ethics Committee of the Hospital Trust of Verona. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01510964.

How emotions emerge and are dealt with in first diagnostic consultations in psychiatry.

OBJECTIVE: To illustrate how patients introduce cues and concerns during clinical consultations and how psychiatrists respond to them. METHOD: Sixteen psychiatrists recorded 104 first diagnostic consultations, coded with the Verona Coding Definitions of Emotional Sequences (VR-CoDES). Cues, concerns and responses were analyzed in relation to patient gender and ICD-10 diagnosis, and psychiatrists' age, gender, clinical experience and consultation process. RESULTS: Cues were more frequent among female patients and were equally distributed among diagnostic categories. Concerns were more frequent among patients with "Mood" or "Neurotic" disorders. Psychiatrists' responses to cues tended to "provide space" without being explicit. Referral to the affective part was restricted to concerns which had been solicited by the psychiatrist. Empathic responses were infrequent. Cues and concerns received more attention by female psychiatrists. CONCLUSION: The study confirms gender differences in expressing and dealing with emotions both by patients and psychiatrists. Females tend to give more space to this topic. Psychiatrists 'responses differed according to cues, concerns, gender, diagnosis and to who prompted the cue/concern, showing a preference for topics introduced by themselves. PRACTICE IMPLICATIONS: The VR-CoDES is a useful tool to define the strategies psychiatrists adopt when handling patients' emotions in terms of cues and concern.

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial.

BACKGROUND: Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services. METHODS/DESIGN: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in 'real-world' clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction.