Extended semen examinations in the sixth edition of the WHO Laboratory Manual for the Examination and Processing of Human Semen: contributing to the understanding of the function of the male reproductive system.

In the sixth edition of the World Health Organization manual for the examination and processing of human semen, extended examination methods to provide key diagnostics in the investigation of the male reproductive system function are elaborated. These go beyond the basic analysis of semen and may be useful in more specifically guiding the clinical characterization of fertile or infertile men. Among the extended examinations included in the chapter, the use of multiparametric scoring for sperm morphological defects, sperm DNA fragmentation, and the roles for computer-assisted analysis of sperm or semen are arguably those that will be the most widely used and may also cause the most debate.

The sixth edition of the WHO Laboratory Manual for the Examination and Processing of Human Semen: ensuring quality and standardization in basic examination of human ejaculates.

A basic semen investigation has established principles that are necessary for ascertaining reliable and internationally comparable results. Although these principles have been present in the WHO manual since its inception, the baseline issue across most published studies and practice in reproductive medicine (in which the male is considered) is repetitive failure to adhere to these principles, thereby leading to relevant comparable data and accuracy. To address this failure, the sixth edition of the WHO manual includes revised basic methods, and a complementary formal standard of the International Standards Organization (ISO23162:2021) for basic semen examination has been published. Perhaps the most significant change in the sixth edition is the reintroduction of the four-category distinction of sperm motility, which causes additional work for laboratories in changing reporting parameters but is clinically important. Another essential change is the widened focus from mainly a prognostic tool for medically assisted reproduction to additionally raising awareness of semen examination as a measure of male reproductive functions and general male health.

Evolution of the WHO "Semen" processing manual from the first (1980) to the sixth edition (2021).

As stated clearly in all editions of the WHO Laboratory Manual for the Examination and Processing of Human Semen, the goal of the manual is to meet the growing needs for the standardization of semen analysis procedures. With constant advances in andrology and reproductive medicine and the advent of sophisticated assisted reproductive technologies for the treatment of infertility, the manual has been continuously updated to meet the need for new, evidence-based, validated tests to not only measure semen and sperm variables but also to provide a functional assessment of spermatozoa. The sixth edition of the WHO manual, launched in 2021, can be freely downloaded from the WHO website, with the hope of gaining wide acceptance and utilization as the essential source of the latest, evidence-based information for laboratory procedures required for the assessment of male reproductive function and health.

Validation of educational material for the care of people with intestinal stoma.

OBJECTIVE: to validate an educational booklet for people with intestinal stoma as a technological resource in the teaching of self-care. METHOD: a methodological research for the construction and validation of an educational booklet by nine expert judges and 25 people with stomas. The agreement index of at least 80% was considered to guarantee the validation of the material. RESULTS: regarding the objectives of the booklet, all the judges evaluated the items as "adequate" or "totally adequate", with a content validity index of 1.00. Regarding the structure and presentation of the booklet, the total index was 0.84. Regarding relevance, the total was 0.97 and the general index of the educational booklet was 0.89, confirming the validation with the judges. All items of the organization, writing style, appearance and motivation of the material were considered as validated by the target audience, reaching a total agreement index of 0.99. CONCLUSION: in the context of health education, the booklet was considered valid and suitable for the care of people with intestinal stoma, and can be used in teaching, research, extension and care for people with intestinal stoma.

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.

A nationwide investigation of CPR courses, books, and skill retention.

INTRODUCTION: Survival from Out-of-Hospital Cardiac Arrest is highly associated with bystander cardiopulmonary resuscitation. The quality of bystander CPR is influenced by citizens attending Basic Life Support (BLS) courses and the quality of these courses. The purpose of the study was to investigate content, quality and compliance with the European Resuscitation Council (ERC) guidelines in national Danish BLS courses and the skill retention. METHODS: Books from 16 different course providers were analyzed for compliance with guidelines using the principle of mutually exclusive and collectively exhaustive questioning. Observation of 56 BLS courses were conducted using an evaluation sheet, with a five-point Likert scale including theoretical, technical, and non-technical skills. BLS skills of participants were assessed with a follow-up test 4-6 months after a course using a modified Cardiff Test. RESULTS: Analysis of the books, showed compliance with ERC guidelines of 69% on the examined items. Courses using ERC educational structure and having maximum six participants per instructor were associated with high quality in the course observations and a better follow-up test. Especially, the use of automated external defibrillator showed significant odds ratio (OR) of 21.8 (95% CI 4.1-114.7) to 31.3 (95% CI 3.7-265.1) of achieving high quality on courses with similar results in the follow-up test. CONCLUSION: National BLS courses had significant variation in the content of books, and compliance to ERC guidelines during courses and in skills retention 4-6 months after the courses. This study can be used to further improve and standardize BLS courses.

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.

Emergency Manuals: How Quality Improvement and Implementation Science Can Enable Better Perioperative Management During Crises.

How can teams manage critical events more effectively? There are commonly gaps in performance during perioperative crises, and emergency manuals are recently available tools that can improve team performance under stress, via multiple mechanisms. This article examines how the principles of implementation science and quality improvement were applied by multiple teams in the development, testing, and systematic implementations of emergency manuals in perioperative care. The core principles of implementation have relevance for future patient safety innovations perioperatively and beyond, and the concepts of emergency manuals and interprofessional teamwork are applicable for diverse fields throughout health care.

The CAM-ICU has now a French "official" version. The translation process of the 2014 updated Complete Training Manual of the Confusion Assessment Method for the Intensive Care Unit in French (CAM-ICU.fr).

INTRODUCTION: Delirium is common in Intensive-Care-Unit (ICU) patients but under-recognized by bed-side clinicians when not using validated delirium-screening tools. The Confusion-Assessment-Method for the ICU (CAM-ICU) has demonstrated very good psychometric properties, and has been translated into many different languages though not into French. We undertook this opportunity to describe the translation process. MATERIAL AND METHODS: The translation was performed following recommended guidelines. The updated method published in 2014 including introduction letters, worksheet and flowsheet for bed-side use, the method itself, case-scenarios for training and Frequently-Asked-Questions (32 pages) was translated into French language by a neuropsychological researcher who was not familiar with the original method. Then, the whole method was back-translated by a native English-French bilingual speaker. The new English version was compared to the original one by the Vanderbilt University ICU-delirium-team. Discrepancies were discussed between the two teams before final approval of the French version. RESULTS: The entire process took one year. Among the 3692 words of the back-translated version of the method itself, 18 discrepancies occurred. Eight (44%) lead to changes in the final version. Details of the translation process are provided. CONCLUSIONS AND RELEVANCE: The French version of CAM-ICU is now available for French-speaking ICUs. The CAM-ICU is provided with its complete training-manual that was challenging to translate following recommended process. While many such translations have been done for other clinical tools, few have published the details of the process itself. We hope that the availability of such teaching material will now facilitate a large implementation of delirium-screening in French-speaking ICUs.

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.

Design of instructions for evacuating disabled adults.

We investigated how the design of instructions can affect performance in preparing emergency stair travel devices for the evacuation of disable individuals. We had three hypotheses: 1) Design of instructions would account for a significant portion of explained performance variance, 2) Improvements in design of instructions would reduce time on task across device type and age group, and 3) There would be a performance decrement for older adults compared to younger adults based on the slowing of older adult information processing abilities. Results showed that design of instructions does indeed account for a large portion of explained variance in the operation of emergency stair travel devices, and that improvements in design of instructions can reduce time on task across device type and age group. However, encouragingly for real-world operations, results did not indicate any significant differences between older versus younger adults. We look to explore ways that individuals with disabilities can exploit these insights to enhance the performance of emergency stair travel devices for use.

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.

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.

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.