SCAI publications committee manual of standard operating procedures.

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.

Emergency Manual Implementation in a Large Academic Anesthesia Practice: Strategy and Improvement in Performance on Critical Steps.

BACKGROUND: The use of cognitive aids, such as emergency manuals (EMs), improves team performance on critical steps during crisis events. In our large academic anesthesia practice, we sought to broadly implement an EM and subsequently evaluate team member performance on critical steps. METHODS: We observed the phases of implementing an EM at a large academic anesthesia practice from 2013 to 2016, including the formation of the EM implementation team, identification of preferred EM characteristics, consideration of institution-specific factors, selection of the preferred EM, recognition of logistical barriers, and staff education. Utilization of the EM was tested in a regular clinical environment with all available resources using a standardized verbal simulation of 3 crisis events both preimplementation and 6 months postimplementation. Individual members of the anesthesia team were asked to verbalize interventions for specific crisis events over 60 seconds. RESULTS: We introduced a customized version of the Stanford Emergency Manual on January 26, 2015. Fifty-nine total participants (equal proportion of anesthesiology attending physicians, resident physicians, certified registered nurse anesthetists, and student registered nurse anesthetist staff) were surveyed in the preimplementation phase and 60 in the 6-month postimplementation phase. In the postimplementation phase, a minority (41.7%) utilized the EM for the verbal-simulated crisis events. Those who used the EM performed better than those who did not (median 21.0 critical steps out of a possible 30 total steps [70.0%], interquartile range 19-25 vs 18.0 critical steps verbalized [60.0%], interquartile range 16-20; P < .001). Among all subjects, the median number of critical steps verbalized was 16 (53.3%) preimplementation and 19.5 critical steps (65.0%) postimplementation. CONCLUSIONS: Implementation of an EM in a large academic anesthesia practice is not without challenges. While full integration of the EM was not achieved 6 months after implementation, verbalization of critical steps on 3 simulated crisis events improved when the EM was utilized.

Use of an Emergency Manual During an Intraoperative Cardiac Arrest by an Interprofessional Team: A Positive-Exemplar Case Study of a New Patient Safety Tool.

BACKGROUND: An emergency manual (EM) is a set of evidence-based crisis checklists, or cognitive aids, that can improve team performance. EMs are used in other safety-critical industries, and health care simulation studies have shown their efficacy, but use in clinical settings is nascent. A case study was conducted on the use of an EM during one intraoperative crisis, which entailed the assessment of the impact of the EM's use on teamwork and patient care and the identification of lessons for effectively using EMs during future clinical crises. METHODS: In a case study of a single crisis, an EM was used during a cardiac arrest at a tertiary care hospital that had systematically implemented perioperative EMs. Semistructured interviews were conducted with all six clinicians present, interview transcripts were iteratively coded, and thematic analysis was performed. RESULTS: All clinician participants stated that EM use enabled effective team functioning via reducing stress of individual clinicians, fostering a calm work environment, and improving teamwork and communication. These impacts in turn improved the delivery of patient care during a clinical crisis and influenced participants' intended EM use during future appropriate crises. CONCLUSION: In this positive-exemplar case study, an EM was used to improve delivery of evidence-based patient care through effective clinical team functioning. EM use must complement rather than replace good clinician education, judgment, and teamwork. More broadly, understanding why and how things go well via analyzing positive-exemplar case studies, as a converse of root cause analyses for negative events, can be used to identify effective applications of safety innovations.

Development of a cognitive behavioural therapy-based guided self-help intervention for adults with intellectual disability.

BACKGROUND: Despite strong evidence for cognitive behaviour therapy (CBT) in treating mental health, its use, thus far, has been limited for people with intellectual disabilities. This study describes a CBT-based guided self-help (CBT-GSH) manual for individuals with intellectual disability, and focus groups explore the views of clinicians, therapists, support staff and managers. MATERIAL AND METHODS: Using a qualitative methodology, an expert team adapted the manual. Focus groups provided feedback, followed by thematic content analysis for modifications. RESULTS: Participants supported using the manual, with varying views about the delivery. Quality of relationships and competence of the administrator determined the best person to deliver the treatment. Heterogeneity in the intellectual disability population was a challenge to delivering manual-based interventions. Participants made suggestions about language and organization. CONCLUSIONS: Amendments were made to the manual in line with expert feedback. An evaluation is warranted to test for feasibility, delivery, acceptability and efficacy.

Treatment integrity of elaborated semantic feature analysis aphasia therapy delivered in individual and group settings.

BACKGROUND & AIMS: This study ran within the framework of the Thales Aphasia Project that investigated the efficacy of elaborated semantic feature analysis (ESFA). We evaluated the treatment integrity (TI) of ESFA, i.e., the degree to which therapists implemented treatment as intended by the treatment protocol, in two different formats: individual and group therapy. METHODS & PROCEDURES: Based on the ESFA manual, observation of therapy videos and TI literature, we developed two ESFA integrity checklists, for individual and group therapy, and used them to rate 15 videos of therapy sessions, delivered by three speech-language therapists (SLTs). Thirteen people with aphasia (PwA) were involved in this study. Reliability of the checklists was checked using Kappa statistics. Each session's TI was calculated. Differences in TI scores between the two therapy approaches were calculated using independent sample t-tests. Treating SLTs' views on what facilitates TI were also explored through a survey. OUTCOMES & RESULTS: Inter- and intra-rater reliability were excellent (.75 ≤ κ ≤ 1.00) for all but one video (κ = .63). Overall, a high TI level (91.4%) was achieved. Although both approaches' TI was high, TI for individual therapy sessions was significantly higher than for group sessions (94.6% and 86.7% respectively), t(13) = 2.68, p = .019. SLTs found training, use of the treatment manual, supervision and peer support useful in implementing ESFA therapy accurately. CONCLUSIONS & IMPLICATIONS: ESFA therapy as delivered in Thales is well described and therapists can implement it as intended. The high TI scores found enhance the internal validity of the main research project and facilitate its replication. The need for more emphasis on the methodological quality of TI studies is discussed.

Cognitive Processing Therapy for Spanish-speaking Latinos: A Formative Study of a Model-Driven Cultural Adaptation of the Manual to Enhance Implementation in a Usual Care Setting.

OBJECTIVE: As part of a larger implementation trial for cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) in a community health center, we used formative evaluation to assess relations between iterative cultural adaption (for Spanish-speaking clients) and implementation outcomes (appropriateness and acceptability) for CPT. METHOD: Qualitative data for the current study were gathered through multiple sources (providers: N = 6; clients: N = 22), including CPT therapy sessions, provider fieldnotes, weekly consultation team meetings, and researcher fieldnotes. Findings from conventional and directed content analysis of the data informed refinements to the CPT manual. RESULTS: Data-driven refinements included adaptations related to cultural context (i.e., language, regional variation in wording), urban context (e.g., crime/violence), and literacy level. Qualitative findings suggest improved appropriateness and acceptability of CPT for Spanish-speaking clients. CONCLUSION: Our study reinforces the need for dual application of cultural adaptation and implementation science to address the PTSD treatment needs of Spanish-speaking clients.

Training Psychiatry Residents in Psychotherapy: The Role of Manualized Treatments.

Evidence-based treatment and manualized psychotherapy have a recent but rich history. As interest and research have progressed, defining the role of treatment manuals in resident training and clinical practice has become more important. Although there is not a universal definition of treatment manual, most clinicians and researchers agree that treatment manuals are an essential piece of evidence-based therapy, and that despite several limitations, they offer advantages in training residents in psychotherapy. Requirements for resident training in psychotherapy have changed over the years, and treatment manuals offer a simple and straightforward way to meet training requirements. In a search limited to only depression, two treatment manuals emerged with the support of research regarding both clinical practice and resident training. In looking toward the future, it will be important for clinicians to remain updated on further advances in evidence based manualized treatment as a tool for training residents in psychotherapy, including recent developments in online and smartphone based treatments.

The Importance of Considering Clinical Utility in the Construction of a Diagnostic Manual.

The development of major diagnostic manuals primarily has been guided by construct validity rather than clinical utility. The purpose of this article is to summarize recent research and theory examining the importance of clinical utility when constructing and evaluating a diagnostic manual. We suggest that construct validity is a necessary but not sufficient criterion for diagnostic constructs. This article discusses components of clinical utility and how these have applied to the current and forthcoming diagnostic manuals. Implications and suggestions for future research are provided.

[Quality Assurance in Sociomedical Evaluation by Peer Review: A Pilot Project of the German Statutory Pension Insurance]. / Qualitätssicherung in der Sozialmedizinischen Begutachtung durch Peer Review - ein Pilotprojekt der Deutschen Rentenversicherung.

BACKGROUND: The sociomedical evaluation by the German Pension Insurance serves the purpose of determining entitlement to disability pensions. A quality assurance concept for the sociomedical evaluation was developed, which is based on a peer Review process. Peer review is an established process of external quality assurance in health care. The review is based on a hierarchically constructed manual that was evaluated in this pilot project. METHODS: The database consists of 260 medical reports for disability pension of 12 pension insurance agencies. 771 reviews from 19 peers were included in the evaluation of the inter-rater reliability. Kendall's coefficient of concordance W for more than 2 raters is used as primary measure of inter-rater reliability. RESULTS: Reliability appeared to be heterogeneous. Kendalls W varies for the particular criteria from 0.09 to 0.88 and reached for primary criterion reproducibility a value of 0.37. CONCLUSION: The reliability of the manual seemed acceptable in the context of existing research data and is in line with existing peer review research outcomes. Nevertheless, the concordance is limited and requires optimisation. Starting points for improvement can be seen in a systematic training and regular user meetings of the peers involved.

Effectiveness of an educational handbook in improving psychiatry resident knowledge of second-generation antipsychotics.

OBJECTIVE: The authors describe a pilot evaluation of an educational handbook designed to increase resident knowledge of second-generation antipsychotic (SGA) use in the pediatric population, with an emphasis on metabolic monitoring. METHODS: An educational handbook focusing on SGA use in children and adolescents was introduced to psychiatry residents undergoing a child psychiatry rotation. Baseline and post-intervention questionnaires were administered to determine whether SGA knowledge increased. RESULTS: Baseline and post-intervention questionnaires were completed by 32 residents. At baseline, most residents (92.9 %) had interacted with an adult patient requiring an SGA and had prescribed SGAs at least five times (70.9 %) in the previous month. Baseline SGA knowledge was limited such that only 5.4 % of participants scored greater than 80 %, and 28.6 % scored below 60 %. Mean total score improved significantly from pre-test (18.4 ± 4.23) to post-test (21.2 ± 3.28, p = 0.001). Stratified analysis suggested a significant improvement of scores (post-test versus pre-test, respectively) in females (21.8 ± 3.11 versus 18.0 ± 4.94, p = 0.003) and junior residents (21.3 ± 3.34 versus 18.1 ± 4.37, p = 0.001). While significant improvements were documented in questions related to Health Canada-approved and other off-label evidence-based indications, and the appropriate physical examination components and laboratory tests to perform at SGA initiation and follow-up, no improvements were documented regarding the distinguishing properties, side effects, and appropriate history-taking prior to SGA initiation. CONCLUSIONS: Implementation of an educational handbook can improve resident knowledge related to SGA use in children over the short-term. However, future research should be directed at the effectiveness of more interactive web-based formats in optimizing learning for male residents and ensuring more comprehensive knowledge uptake. While the introduction of an education handbook is the first step in addressing some of the barriers to metabolic monitoring, prospective longitudinal studies are required to determine whether such an intervention will ultimately improve prescriber adherence over the long-term.

The disconnect between evidence and practice: a systematic review of person-centred interventions and training manuals for care home staff working with people with dementia.

OBJECTIVE: The overall objective is to determine the availability of person-centred intervention and training manuals for dementia care staff with clinical trial evidence of efficacy. DESIGN: Interventions were identified using a search of electronic databases, augmented by mainstream search engines, reference lists, hand searching for resources and consultation with an expert panel. The specific search for published manuals was complemented by a search for randomised control trials focussing on training and activity-based interventions for people with dementia in care homes. Manuals were screened for eligibility and rated to assess their quality, relevance and feasibility. RESULTS: A meta-analysis of randomised control trials indicated that person-centred training interventions conferred significant benefit in improving agitation and reducing the use of antipsychotics. Each of the efficacious packages included a sustained period of joint working and supervision with a trained mental health professional in addition to an educational element. However, of the 170 manuals that were identified, 30 met the quality criteria and only four had been evaluated in clinical trials. CONCLUSIONS: Despite the availability of a small number of evidence-based training manuals, there is a widespread use of person-centred intervention and training manuals that are not evidence-based. Clearer guidance is needed to ensure that commissioned training and interventions are based on robust evidence.

The individual supported living (ISL) manual: a planning and review instrument for individual supported living arrangements for adults with intellectual and developmental disabilities.

BACKGROUND: Following the closure of large residential facilities over the past several decades, emphasis on community living for adults with developmental disabilities has strengthened. However, the concept of community living is ambiguous. The term is often associated with congregation of people with disabilities in ordinary houses 'in' the community. Group homes, the most common contemporary formal expression of 'community living', may use ordinary houses and accommodate a small number of residents comparable to a large family. Individual supported living (ISL) arrangements around a single person with a disability using person-centred principles are occurring with increasing frequency. The ISL manual was developed over 4 years in two sequential research projects to produce a quality framework articulating ISL and operationalising the framework into a review and planning instrument for ISL arrangements. METHOD: The ISL manual was developed in three stages and overseen by a reference group of key stakeholders purposively recruited as well-versed in ISL. The first stage operationalised the quality framework over two half-day workshops with a group of key informants. Participants identified indicators and sources of evidence for each attribute of the quality framework. The quality framework, indicators, and sources of evidence were compiled into an initial evaluation instrument of nine themes consisting of 27 attributes. This was piloted in two rounds to enhance the utility of the instrument and develop the final manual which contained eight themes and 21 attributes. A comprehensive literature search was carried out to identify relevant empirical ISL studies. RESULTS: The literature search identified four empirical studies that incorporated ISL over the preceding 3 years. A previous literature search from the first research project that produced the quality framework spanned 27 years and identified five empirical studies. We concluded that the empirical base for developing evidence for the nature and outcomes of ISL arrangements was sparse. The ISL manual and scoring booklet developed in the current research project includes six illustrative case studies of ISL, instructions for potential users to review living arrangements or set up a new arrangement, and the review framework consisting of descriptions of themes and attributes, indicators, and sources of evidence. CONCLUSIONS: The dearth of empirical studies of ISL arrangements for people with developmental disabilities, despite increased policy emphasis on individualised options, underscores the importance of planning and review tools to promote quality outcomes. The ISL manual can assist adults with developmental disabilities, families, carers, and service providers to plan and review ISL arrangements. Further research will enhance the properties of this instrument and establish the relationship between quality of ISL arrangements and outcomes such as quality of life, and participation and inclusion.

[Anxiety disorders in DSM-5: an overview on changes in structure and content]. / Angststörungen im DSM-5 : Ein Überblick über Änderungen in Struktur und Inhalt.

The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) "anxiety, obsessive-compulsive spectrum, posttraumatic, and dissociative disorders" work group addressed reconceptualization issues regarding all anxiety-related disorders. Based on systematic literature reviews, reanalyses of available data and evaluation of results following the DSM-5 principles it was decided to rearrange the disorder spectrum into separate groupings for the classical anxiety disorders, trauma- and stressor-related disorders, obsessive-compulsive and related disorders, and dissociative disorders. Among the classical anxiety disorders DSM-5 now also includes selective mutism and separation anxiety disorder. A major change from DSM-IV is a drastically simplified classification of panic disorder and agoraphobia. Both conditions can be separately coded in DSM-5 and the overlap is disclosed by a comorbid double diagnosis. The anxiety disorder criteria have been generally harmonized regarding content and order. It was assured that criteria are applicable to all age, gender and cultural groups. Furthermore, diagnosis-specific and cross-cutting dimensional anxiety scales have been developed to supplement categorical diagnosis which appears to facilitate assessment of severity and course of treatment.

[Bipolar disorders in DSM-5]. / Bipolare Störungen im DSM-5.

BACKGROUND: In spring 2013 the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) edited by the American Psychiatric Association was published. The DSM-5 has also brought some important changes regarding bipolar disorders. OBJECTIVES: The goal of this manuscript is to review the novelties in DSM-5 and to evaluate the implications of these changes. MATERIALS AND METHODS: The diagnostic criteria as well as the additional remarks provided in the running text of DSM-5 were carefully appraised. RESULTS: For the first time diagnostic criteria are provided for disorders which up to now have been considered as subthreshold bipolar disorders. Furthermore, mixed episodes were eliminated and instead a mixed specifier was introduced. An increase in goal-directed activity/energy is now one of the obligatory symptoms for a (hypo)manic episode. Diagnostic guidance is provided as to when a (hypo)manic episode that has developed during treatment with an antidepressant has to be judged to be causally related to antidepressants and when this episode has only occurred coincidentally with antidepressant use. CONCLUSIONS: While some of the novelties are clearly useful, e.g. addition of increased goal-directed activity/energy as obligatory symptom for (hypo)manic episodes, this remains to be demonstrated for others, such as the definition of various subthreshold bipolar disorders.

[Trauma and stressor-related disorders: diagnostic conceptualization in DSM-5]. / Trauma- und stressorbezogene Störungen : Diagnostische Konzeptualisierung im DSM-5.

The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) includes a distinct diagnostic group of trauma and stressor-related disorders that has been set apart from anxiety disorders. From a perspective of adult psychiatry this new disorder category includes posttraumatic stress disorder (PTSD), acute stress disorder (ASD), and adjustment disorders. The PTSD is based on narrower trauma criteria that focus on acute life-threatening situations, serious injury, or sexual violence by way of direct confrontation, witnessing or indirect confrontation. Indirect confrontation, however, is reserved only for violent or accidental events that occurred to close family members or friends. The former A2 criterion of an intense emotional reaction to trauma has been removed. A deliberately broad approach to clinical PTSD phenomenology has created an empirically driven new cluster of persistent negative alterations in cognition and mood due to experiencing traumatic events. The ASD has been reconceptualized as an intense stress syndrome with a clear need of acute treatment during the early course after traumatic exposure. Adjustment disorders continue to emphasize maladaptive emotional and behavioral responses to unspecific, non-traumatic stressors in an intensity that is beyond social or cultural norms. Neither complex PTSD nor prolonged grief disorders have received an independent diagnostic status within DSM-5. With respect to stress-related disorders major divergences between DSM-5 and the future International Classification of Diseases 11 (ICD-11) are to be expected.

[Schizophrenia and other psychotic disorders in DSM-5: summary of the changes compared to DSM-IV]. / Schizophrenie und andere psychotische Störungen im DSM-5 : Zusammenfassung der Änderungen gegenüber DSM-IV.

With the introduction of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) numerous changes in the area of the schizophrenia spectrum and psychotic disorders have been implemented. Establishing a metastructure based on the characteristics of the spectrum of psychopathological disturbances should improve clarity. The classical subtypes of schizophrenia were eliminated and specific psychopathological dimensions for the assessment of disease severity were added. The special role of Schneiderian first rank symptoms was abandoned and a higher delineation towards schizoaffective disorders is made. The nosological status of catatonia is clarified and occurs together with a consistent use of catatonic disturbances over all chapters. The attenuated psychosis syndrome is added as a new condition for further study. The shared psychotic disorder in the sense of a folie à deux is no longer maintained. However, the initial goal to integrate more disorder-specific etiopathogenetic information into the reconceptualization could not be achieved. Contemporaneously to the development process of DSM-5 the National Institute of Mental Health (NIMH) carried out the research domain criteria project (RDoC) attempting to incorporate the current growth in knowledge of genetics, neurocognitive and cognitive sciences in future diagnostic systems. This article gives an overview of the changes that have been made within the revision process from DSM-IV to DSM-5.

[Neurocognitive disorders in DSM-5: pervasive changes in the diagnostics of dementia]. / Neurokognitive Störungen im DSM-5 : Durchgreifende Änderungen in der Demenzdiagnostik.

The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) proposes an innovative chapter on neurocognitive disorders (NCD) as a substitute for the dementia, delirium and amnestic disorders chapter in DSM-IV. This NCD chapter promotes a most innovative change compared to DSM-IV. While the term delirium is preserved, the commonly used term dementia does not occur as a diagnostic entity. Neurocognitive disorders are more inclusive than dementias; they also cover early prodromal stages of dementias below the DSM-IV threshold. The diagnosis of NCDs requires essentially neuropsychological testing preferentially with standardized instruments. Special focus is given to etiological subtyping taking former diagnostic consensus processes by expert groups into consideration. The subsequent more extensive concept of NCD also allows the diagnosis of etiological-specific prodromal states of cognitive impairments. The changes from DSM-IV to DSM-5 are critically discussed.

[DSM-5: important changes in the field of addictive diseases]. / DSM-5: wichtige Änderungen im Bereich der Suchterkrankungen.

There are two major changes in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) concerning the field of addiction. Firstly, the previous distinction between abuse and dependence has been abolished and both disorders are now subsumed under the category addiction and related disorders. Secondly, pathological gambling has now been included in the section of addiction with slight changes in diagnostic criteria. Both changes have major implications for the definition and conceptualization of what we call a psychiatric "disease" or "disorder", which have also been addressed in the introductory statement of DSM-5. Concerning the category of abuse that is now part of substance use disorders, there is a concern that a well-defined disorder ("dependence") is now mixed with a less well-defined syndrome ("abuse"). The inclusion of non-substance, behavioral addictions poses the danger of pathologizing a wide range of human behavior in future revisions of the classification. Both concerns are further addressed in this article.

[Preoperational study for the improvement of hygiene conditions in long-term care facilities]. / Modellprojekt zur Verbesserung der Hygiene in stationären Pflegeeinrichtungen.

Hygiene is becoming more and more important in long-term care facilities. Long-term care facilities are subject to monitoring by the Public Health Service (PHS) and other authorities. For the PHS in Bavaria the Bavarian Health and Food Safety Authority (Landesamt für Gesundheit und Lebensmittelsicherheit, LGL) published a hygiene monitoring concept and there exists an inspection guide developed by a specialist department for nursing homes and institutions for the handicapped (Fachstelle für Pflege und Behinderteneinrichtungen, FQA). Because inspections are performed in multiprofessional teams, it makes sense to use a coordinated inspection catalog. The aim was to integrate hygienic requirements specified in the Bavarian guidelines for hygiene by the LGL into the inspection guide published by the FQA to obtain a quality assured surveillance. The involved parties were questioned about the inspection guide and their hygiene management and then the hygiene criteria of the LGL were implemented into the inspection guide. Questions dealing with hygiene requirements concerning intensive care, management of multidrug resistant bacteria and interviews with the person responsible for infection control in the facility itself were developed for the first time and were integrated into the inspection guide. The revised inspection guide was tested for its applicability. With the revised inspection guide there now exists a tool which allows not only comprehensive inspections of the facilities including hygiene issues but also a good cooperation of the various parties involved. There are many actions which have to be conveyed into the future, especially programs to train staff to apply the inspection guide and to enhance the ability of all participants to act in cooperation. The guide will also allow the facilities to cooperate more easily and more closely, as the guide takes the respective problems and challenges of the different facilities into consideration. Additionally the development of legal guidelines regarding hygiene can support general healthcare of residents.

[Development and validating an educational booklet for childbirth companions]. / Construção e validação de manual educativo para acompanhtes durante o trabalho de parto e parto.

OBJECTIVE: The article describes the steps in producing and validating an educational booklet for childbirth companions. METHOD: Methodological study conducted in 2011 consisting of the following steps: situational assessment; establishing brochure content; content selection and referencing; drafting the text; design of illustrations; layout; consultation of specialists; consultation of target audience; amendments; proofreading; evaluation using the Flesch Reading Ease Formula. The topics portrayed the sequence of events involving support from gestation to the postpartum period. RESULTS: The concordance rate among companions was greater than or equal to 81.8% for the topics organisation, writing style, presentation and motives. The overall Content Validity Index of the booklet was 0.94. The booklet was classified as easy reading or very easy reading according to the results of the Flesch Reading Ease Formula. CONCLUSION: The presentation and content of the manual were validated for use with the target audience by the specialists and representatives of the target audience.