An Acupuncture Protocol for the Treatment of Erectile Dysfunction: A Delphi Process.

INTRODUCTION: Erectile dysfunction (ED) is a widespread disorder, and the worldwide incidence is rapidly increasing. Acupuncture, an intervention out of the spectrum of traditional Chinese medicine (TCM), has a long tradition as treatment for ED. Nonetheless, a best-practice treatment protocol is currently missing. A recent systematic review and meta-analysis confirmed a huge diversity of acupuncture treatments for ED and concluded that there is an urgent need to standardise acupuncture treatment for ED. Consequently, the authors conducted a Delphi process with the aim to achieve an expert consensus as a basis for the development of a best-practice protocol. METHODS: The Delphi process consisted of four rounds of questionnaires with closed and open-ended questions. Eleven acupuncture experts participated. The therapeutic aim was defined as "to achieve an erection sufficient for sexual satisfaction." RESULTS: Consensus was achieved on 24 acupoints corresponding to 12 TCM syndromes. The syndromes were KI Yang xu, KI Yin xu, KI Qi xu, Ki and HT not harmonised, LR Qi Stagnation, LR Qi stagnation and Heat, Liver Blood xu, Liver Blood xu and Liver Qi stagnation, Damp-heat sinking to the lower Jiao5, HT and GB Qi xu, SP xu and HT Blood xu, Yin xu. The suggested optimal dose was between 11 and 15 treatments given once or twice a week. CONCLUSION: An expert consensus-based, semi-standardised best-practice treatment protocol for the treatment of ED was developed. Moreover, the Delphi process also revealed inconsistencies as to which signs and symptoms constitute a TCM syndrome. Further Delphi studies including a broader range of experts from various acupuncture traditions are needed to establish further agreement. Nonetheless, the best-practice protocol introduced in this study provides a first point of departure for the implementation of a more standardised treatment approach. Moreover, since a recent meta-analysis concluded that more high-quality clinical studies on the topic are needed, this study provides a first standardised acupuncture treatment protocol for ED.

MASK-air: An OECD (Organisation for Economic Co-operation and Development) Best Practice for Public Health on Integrated Care for Chronic Diseases.

In the recent report of the Organisation for Economic Co-operation and Development (OECD) on Best Practices (BPs) for Integrating Care to Prevent and Manage Chronic Diseases, an app on rhinitis and asthma (MASK-air [Mobile Airways Sentinel networK for airway diseases]) has been listed. The OECD is a reliable source of evidence-based policy analysis and economic data largely used by governments. It has published several BPs on public health. On May 10, 2023, the OECD published 13 BPs for Integrating Care to Prevent and Manage Chronic Diseases in the European Union. The report did not cover all models of integrated care; rather, it "focuse(d) on those that are of key strategic interest to policy makers." New MASK-air studies (not published in the report) include equity, usability of the app in old-age adults, economic impact, quality of life, and allergen immunotherapy. MASK-air is freely available on iOS and Android in 30 countries and has been recently introduced in the United States. The MASK-air OECD BP represents a model of digitally enabled, patient-centered care for chronic diseases using a holistic approach of shared decision making.

Developing a best-practice agenda for music therapy research to support informal carers of terminally ill patients pre- and post-death bereavement: a world café approach.

BACKGROUND: Informal carers of terminally ill patients play a vital role in providing palliative care at home, which impacts on their pre- and post-death bereavement experience and presents an up to 50% greater risk for mental-health problems. However, developing and implementing effective bereavement support remains challenging. There is a need to build the evidence base for music therapy as a potentially promising bereavement support for this vulnerable population. This study aimed to co-design an international best practice agenda for research into music therapy for informal carers of patients pre- and post-death bereavement. METHODS: Online half day workshop using a World Café approach; an innovative method for harnessing group intelligence within a group of international expert stakeholders (music therapy clinicians and academics with experience of music therapy with informal carers at end-of-life). Demographics, experience, key priorities and methodological challenges were gathered during a pre-workshop survey to inform workshop discussions. The online workshop involved four rounds of rotating, 25-minute, small group parallel discussions using Padlet. One final large group discussion involved a consensus building activity. All data were analysed thematically to identify patterns to inform priorities and recommendations. RESULTS: Twenty-two consented and completed the pre-event survey (response rate 44%), from countries representing 10 different time zones. Sixteen participated in the workshop and developed the following best practice agenda. The effectiveness of music therapy in supporting informal carers across the bereavement continuum should be prioritised. This should be done using a mixed methods design to draw on the strengths of different methodological approaches to building the evidence base. It should involve service users throughout and should use a core outcome set to guide the choice of clinically important bereavement outcome measures in efficacy/effectiveness research. CONCLUSIONS: Findings should inform future pre- and post-death bereavement support research for informal caregivers of terminally ill patients. This is an important step in building the evidence base for commissioners and service providers on how to incorporate more innovative approaches in palliative care bereavement services.

Digital Triage Tools for Sexually Transmitted Infection Testing Compared With General Practitioners' Advice: Vignette-Based Qualitative Study With Interviews Among General Practitioners.

BACKGROUND: Digital triage tools for sexually transmitted infection (STI) testing can potentially be used as a substitute for the triage that general practitioners (GPs) perform to lower their work pressure. The studied tool is based on medical guidelines. The same guidelines support GPs' decision-making process. However, research has shown that GPs make decisions from a holistic perspective and, therefore, do not always adhere to those guidelines. To have a high-quality digital triage tool that results in an efficient care process, it is important to learn more about GPs' decision-making process. OBJECTIVE: The first objective was to identify whether the advice of the studied digital triage tool aligned with GPs' daily medical practice. The second objective was to learn which factors influence GPs' decisions regarding referral for diagnostic testing. In addition, this study provides insights into GPs' decision-making process. METHODS: A qualitative vignette-based study using semistructured interviews was conducted. In total, 6 vignettes representing patient cases were discussed with the participants (GPs). The participants needed to think aloud whether they would advise an STI test for the patient and why. A thematic analysis was conducted on the transcripts of the interviews. The vignette patient cases were also passed through the digital triage tool, resulting in advice to test or not for an STI. A comparison was made between the advice of the tool and that of the participants. RESULTS: In total, 10 interviews were conducted. Participants (GPs) had a mean age of 48.30 (SD 11.88) years. For 3 vignettes, the advice of the digital triage tool and of all participants was the same. In those vignettes, the patients' risk factors were sufficiently clear for the participants to advise the same as the digital tool. For 3 vignettes, the advice of the digital tool differed from that of the participants. Patient-related factors that influenced the participants' decision-making process were the patient's anxiety, young age, and willingness to be tested. Participants would test at a lower threshold than the triage tool because of those factors. Sometimes, participants wanted more information than was provided in the vignette or would like to conduct a physical examination. These elements were not part of the digital triage tool. CONCLUSIONS: The advice to conduct a diagnostic STI test differed between a digital triage tool and GPs. The digital triage tool considered only medical guidelines, whereas GPs were open to discussion reasoning from a holistic perspective. The GPs' decision-making process was influenced by patients' anxiety, willingness to be tested, and age. On the basis of these results, we believe that the digital triage tool for STI testing could support GPs and even replace consultations in the future. Further research must substantiate how this can be done safely.

Alcohol use in Australia: countering harm with healing.

Harmful use of alcohol consumption in Australia is a serious socio-political and public health issue that is exacerbated by exploitative marketing campaigns by the alcohol industry. In Indigenous populations harmful alcohol use is directly related to the legacy of colonisation that has led to complex social issues and adverse intergenerational trauma. To effectively address alcohol-related harm in Australia, it is necessary to critically apply the 'Three Pillars of Harm Minimisation', which are demand reduction, supply reduction, and harm reduction. This can be facilitated through approaches such as the 'Interplay Wellbeing Framework', which situates concepts of wellbeing and risky alcohol use within the context of systemic inequities across all social determinants of health. Culturally responsive approaches embody a holistic view of community, mutually respectful collaboration, culture, healing, and self-determined change. This is underpinned by Indigenous leadership that promotes existing resistance, resilience, interpersonal relationships, and strengths that instil healing to counter the harms associated with alcohol use.

Meditation Quality Matters: Effects of Loving-Kindness and Compassion Meditations on Subjective Well-being are Associated with Meditation Quality.

Loving-kindness and compassion meditations (LKCM) are considered a promising practice for increasing long-term well-being. While previous studies have mainly focused on meditation practice quantity, the current study provides an initial exploration of the quality of meditation during multiweek LKCM training. Data were collected through offline (Study 1; N = 41) and online (Study 2; N = 243) LKCM interventions. Quality of meditation was measured using two kinds of difficulties experienced during LKCM each week/unit (i.e., difficulty in concentration and difficulty in generating prosocial attitudes). Subjective well-being (SWB) was assessed by life satisfaction before and after training as well as positive and negative emotions each week/unit. Two studies consistently suggested that meditation quality was significantly associated with changes in SWB. Study 1 even showed that quality had a stronger association with SWB than did meditation quantity. Moreover, both short-term (measured each week/unit) and long-term (measured across the entire training period) associations between the quality of meditation and SWB were significant. Focusing on meditation quality, our findings provide theoretical and methodological pathways for understanding the contribution of meditation practice to LKCM training, which is helpful for guiding future research and best practices. Supplementary Information: The online version contains supplementary material available at 10.1007/s10902-022-00582-7.

Chaplains and telechaplaincy: best practices, strengths, weaknesses-a national study.

Telechaplaincy is the use of telecommunications and virtual technology to deliver religious/spiritual care. It has been used for decades, but chaplains' understanding of telehealth lags behind other disciplines. The purpose of this study was to describe the use of telechaplaincy in the United States and chaplains' perceptions of the practice. Researchers surveyed chaplains through chaplain-certifying-body email-listservs, then conducted in-depth interviews with 36 participants identified through maximum variation sampling. Quantitative analysis and qualitative, thematic analysis were conducted. Quantitative results show that in 2019, approximately half of surveyed chaplains performed telechaplaincy. Rural chaplains were more likely to have practiced. Chaplains who had not practiced were more willing to try if they believed it was effective at meeting religious/spiritual needs. Qualitative findings describe chaplains' perceptions of strengths, weaknesses, and best practices.

Best Practice in the chemical characterisation of extracts used in pharmacological and toxicological research-The ConPhyMP-Guidelines.

Background: Research on medicinal plants and extracts derived from them differs from studies performed with single compounds. Extracts obtained from plants, algae, fungi, lichens or animals pose some unique challenges: they are multicomponent mixtures of active, partially active and inactive substances, and the activity is often not exerted on a single target. Their composition varies depending on the method of preparation and the plant materials used. This complexity and variability impact the reproducibility and interpretation of pharmacological, toxicological and clinical research. Objectives: This project develops best practice guidelines to ensure reproducibility and accurate interpretations of studies using medicinal plant extracts. The focus is on herbal extracts used in pharmacological, toxicological, and clinical/intervention research. Specifically, the consensus-based statement focuses on defining requirements for: 1) Describing the plant material/herbal substances, herbal extracts and herbal medicinal products used in these studies, and 2) Conducting and reporting the phytochemical analysis of the plant extracts used in these studies in a reproducible and transparent way. The process and methods: We developed the guidelines through the following process: 1) The distinction between the three main types of extracts (extract types A, B, and C), initially conceptualised by the lead author (MH), led the development of the project as such; 2) A survey among researchers of medicinal plants to gather global perspectives, opportunities, and overarching challenges faced in characterising medicinal plant extracts under different laboratory infrastructures. The survey responses were central to developing the guidelines and were reviewed by the core group; 3) A core group of 9 experts met monthly to develop the guidelines through a Delphi process; and. 4) The final draft guidelines, endorsed by the core group, were also distributed for feedback and approval to an extended advisory group of 20 experts, including many journal editors. Outcome: The primary outcome is the "Consensus statement on the Phytochemical Characterisation of Medicinal Plant extracts" (ConPhyMP) which defines the best practice for reporting the starting plant materials and the chemical methods recommended for defining the chemical compositions of the plant extracts used in such studies. The checklist is intended to be an orientation for authors in medicinal plant research as well as peer reviewers and editors assessing such research for publication.

Characterising Australian memory clinics: current practice and service needs informing national service guidelines.

BACKGROUND: Memory clinics (MCs) play a key role in accurate and timely diagnoses and treatment of dementia and mild cognitive impairment. However, within Australia, there are little data available on current practices in MCs, which hinder international comparisons for best practice, harmonisation efforts and national coordination. Here, we aimed to characterise current service profiles of Australian MCs. METHODS: The 'Australian Dementia Network Survey of Expert Opinion on Best Practice and the Current Clinical Landscape' was conducted between August-September 2020 as part of a larger-scale Delphi process deployed to develop national MC guidelines. In this study, we report on the subset of questions pertaining to current practice including wait-times and post-diagnostic care. RESULTS: Responses were received from 100 health professionals representing 60 separate clinics (45 public, 11 private, and 4 university/research clinics). The majority of participants were from clinics in metropolitan areas (79%) and in general were from high socioeconomic areas. While wait-times varied, only 28.3% of clinics were able to offer an appointment within 1-2 weeks for urgent referrals, with significantly more private clinics (58.3%) compared to public clinics (19.5%) being able to do so. Wait-times were less than 8 weeks for 34.5% of non-urgent referrals. Only 20.0 and 30.9% of clinics provided cognitive interventions or post-diagnostic support respectively, with 7.3% offering home-based reablement programs, and only 12.7% offering access to group-based education. Metropolitan clinics utilised neuropsychological assessments for a broader range of cases and were more likely to offer clinical trials and access to research opportunities. CONCLUSIONS: In comparison to similar countries with comprehensive government-funded public healthcare systems (i.e., United Kingdom, Ireland and Canada), wait-times for Australian MCs are long, and post-diagnostic support or evidence-based strategies targeting cognition are not common practice. The timely and important results of this study highlight a need for Australian MCs to adopt a more holistic service of multidisciplinary assessment and post-diagnostic support, as well as the need for the number of Australian MCs to be increased to match the rising number of dementia cases.

Developing a best practice framework for clinical competency education in the traditional East-Asian medicine curriculum.

BACKGROUND: While clinical competency is crucial for traditional East-Asian medical education, available studies on the educational system for fostering clinical performance are scarce. This study aimed to review the educational system, curriculum, facilities, and management of current traditional East-Asian medicine in a well-established university of Korea and develop a Best Practice Framework (BPF) of clinical competency education. METHODS: The clinical competency education system in Pusan National University School of Korean Medicine was systematically described through 5 steps of governance of the educational system, competency of the graduates, educational resources, assessment strategies and tools, and gaps in the curriculum. We also reviewed the experiences in education and the points to be improved. RESULTS: The Office of Traditional Korean Medicine Education governs the development, implementation, and evaluation of the educational curriculum for cultivating students' clinical competency. Medical students have undertaken 39 modules of clinical biomedicine and 21 of traditional medicine during the clinical clerkship courses in an affiliated hospital, Clinical Skill Practice Center, clinical research center, practice lab for medical herb, and other locations. After training, 15 modules of simulated clinical training using standardized patients, students' clinical competency are evaluated by a Clinical Performance Test using a Clinical Performance Examination (CPX) and an Objective Structured Clinical Examination (OSCE) for biomedical and traditional medical skills. CONCLUSIONS: A clinical competency framework is required for a qualified physician of traditional East-Asian medicine. This study reviewed the current well-organized educational system of Korean traditional medicine in detail, which can be used for the BPF of competency-based clinical education. We expect the current study to be a representative reference for establishing an educational system of traditional medicine such as acupuncture and medical herbs in other countries.

Adapting practice in mental healthcare settings during the COVID-19 pandemic and other contagions: systematic review.

BACKGROUND: During the global COVID-19 pandemic, there has been guidance concerning adaptations that physical healthcare services can implement to aid containment, but there is relatively little guidance for how mental healthcare services should adapt service provision to better support staff and patients, and minimise contagion spread. AIMS: This systematic review explores service adaptations in mental health services during the COVID-19 pandemic and other contagions. METHOD: The Allied and Complementary Medicine database (AMED), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, Medline, PsycINFO and Web of Science were systematically searched for published studies from database inception to April 2020. Data were extracted focusing on changes to mental health services during contagion outbreaks. Data were analysed with thematic analysis. RESULTS: Nineteen papers were included: six correspondence/point-of-view papers, five research papers, five reflection papers, two healthcare guideline documents and one government document. Analysis highlighted four main areas for mental health services to consider during contagion outbreaks: infection control measures to minimise contagion spread, including procedural and practical solutions across different mental health settings; service delivery, including service changes, operational planning and continuity of care; staff well-being (psychological and practical support); and information and communication. CONCLUSIONS: Mental health services need to consider infection control measures and implement service changes to support continuity of care, and patient and staff well-being. Services also need to ensure they are communicating important information in a clear and accessible manner with their staff and patients, regarding service delivery, contagion symptoms, government guidelines and well-being.

Midwives perceptions: Birth unit environment and the implementation of best intrapartum care practices.

PROBLEM: Midwives related avoidable factors causing maternal morbidity and mortality rates continue to occur despite the existing intrapartum care-related evidence-based practice guidelines and continuing staff development initiatives. RESEARCH QUESTION: What are your perceptions regarding a birth unit environment that supports the implementation of best intrapartum care practices. OBJECTIVE: To explore and describe midwives' perceptions about the birth environment that supports the implementation of best intrapartum care practices. METHOD: A qualitative design that is explorative, descriptive, and contextual in nature using a descriptive phenomenology approach. SETTING: A public hospital birth unit in the Gauteng Province in South Africa. POPULATION AND SAMPLE: The population comprised of 56 permanently employed female registered midwives. A purposive sampling method was used to select 26 participants who met the selection criteria, these participants were willing to participate in the study and to sign the consent form. Data collection process involved three focus group interviews using semi-structured interviews. A qualitative data analysis method was used to analyse data. Trustworthiness was ensured and ethical considerations were adhered to. FINDINGS: Three main themes emerged namely, interpersonal skills, improved staff development, and adequate resources. DISCUSSION: Conducive birth environment is crucial to childbirth outcomes. Midwives' constant introspection is essential in fulfilling their obligation to render competent and ethical intrapartum care. CONCLUSION: Midwives identified perceived birth environment barriers affecting their implementation of best intrapartum care practices. Adoption of a comprehensive approach to address the birth unit environment-related factors is suggested to support midwives in their endeavour to provide the best care to women during childbirth.

Clinical Aromatherapy.

Clinical aromatherapy is an alternative medicine therapy that can be beneficial in the inpatient or outpatient setting for symptom management for pain, nausea, general well-being, anxiety, depression, stress, and insomnia. It is beneficial for preoperative anxiety, oncology, palliative care, hospice, and end of life. Essential oils can be dangerous and toxic, with some being flammable, causing skin dermatitis, being phototoxic with risk of a chemical burn, or causing oral toxicity or death. The article investigates history, supporting theories, guidelines, plant sources, safety, pathophysiologic responses, and clinical nursing aromatherapy. Recommendations for developing a best practice clinical nursing aromatherapy program are provided.

Frailty in orthopaedics: is age relevant?

Over the last decade, national guidelines and the Best Practice Tariff (BPT) have been created to incentivise quality care in patients aged over 60 with hip fractures. This has resulted in significantly decreased length of stay, mortality and post-operative complications in this patient cohort. However, there is increasing recognition of frail patients in all age groups sustaining all fragility fractures. Until recently, these patients experienced poorer outcomes and were excluded from the dedicated care pathways that hip fracture patients received. The BPT and other national guidelines are now expanding inclusion criteria into care packages between guidelines which were initially reserved for hip fracture patients. This expansion is placing increasing pressure on limited NHS resources. Current variations between society guidelines risks producing regional and departmental inconsistencies in care. There is therefore a need to provide consistent guideline targeted at the most vulnerable trauma patients of this expanded cohort. Although the current BPT applies to over 60s only, there is limited evidence to support age-related prognosis in trauma. In contrast, frailty is being increasingly recognised as a global indicator of patient outcomes irrespective of age, with use of Clinical Frailty Scale (CFS) being adopted in various medical fields. BOAST is already using CFS as an inclusion criterion for major trauma and there is increasing data to suggest that frail trauma patients benefit most from comprehensive geriatric care and expedient time-to-operation. We suggest that CFS should take precedence over age when ascertaining clinical priority and producing Best Practice Tariffs. Further research is required to investigate frailty-related outcomes in trauma and the impact of comprehensive care bundles on the outcomes of frail orthopaedic patients.

Local Anesthetic Systemic Toxicity (LAST): Increasing Awareness Through Education.

PURPOSE: Local anesthetics are used for procedures in various settings. Although complications related to local anesthetic use is rare, adverse events do occur. A significant knowledge deficit was identified regarding local anesthetic systemic toxicity (LAST) signs, symptoms, and treatment. DESIGN: A learning needs assessment was performed at a local hospital to determine the nurses' baseline knowledge of LAST signs, symptoms, and treatment. METHODS: A self-paced web-based learning module was developed and completed by clinical nurses with an immediate post survey and 6-month follow-up survey. FINDINGS: The repeat learning needs assessment immediately after education resulted in more than 50% improvement in nurses' knowledge of LAST. A 6-month follow-up survey indicated that the gain in knowledge, signs, symptoms, and treatment of LAST was maintained. CONCLUSIONS: An educational gap was identified regarding clinical nurses' knowledge of LAST. An educational program was designed to improve baseline knowledge. The program goal was successfully met with more than half of nurses being able to identify signs, symptoms, and treatment of LAST.

Spa therapy and rehabilitation of musculoskeletal pathologies: a proposal for best practice in Italy.

Spa therapy is a heterogeneous collection of treatments and methods based on natural resources. It is often considered as an option in the common therapeutic approach to many musculoskeletal disorders, as well as respiratory, vascular, and dermatological disorders. The objective of this paper is to highlight possible interactions between rehabilitation and spa medicine in the field of musculoskeletal disorders, through an analysis of the scientific literature, in order to give the practitioner the ability to integrate good clinical practice in the field of rehabilitation through practical application involving spa therapies. The literature search was conducted using Medline, PEDro, Cochrane Database, and Google Scholar. Only studies published in English and works concerning the implementation of spa thermal treatment in neuro-musculoskeletal diseases were included. Specifically, the publications analyzed dealt with the treatment of diseases such as arthritis, rheumatic arthritis, ankylosing spondylitis, and low back pain through the use of thermal spa therapies. In conjunction with its widespread use in clinical practice, many studies in the literature suggest the effectiveness of crenobalneotherapy for a number of musculoskeletal disorders, generally those which are chronic and debilitating, finding significant clinical improvement both in terms of pain and functional limitations. Some of the guidelines formulated by national and international bodies on the treatment of specific diseases, such as the Italian Rheumatology Society (SIR) and the Osteoarthritis Research Society International (OARSI) guidelines, recognize the value of thermal medicine as a complement, but not a replacement, for conventional therapy (pharmacological or not).

Research and Publication Ethics in Journal of Functional Morphology and Kinesiology.

Research is required to minimize uncertainty and to be reproducible, that is, the design, implementation, evaluation, interpretation, and reporting of the presented data, must follow a good practice. An appropriate experimental design, an accurate execution of the study, a strict criticism of the obtained data while avoiding overestimation, as well as a suitable interpretation of main outcomes, represent key aspects in reporting and disseminating research to the scientific community. Furthermore, author contribution, responsibility, funding, acknowledgement, and adequately declaring any conflict of interest play important roles in science. The Journal of Functional Morphology and Kinesiology (JFMK), a member of the Committee on Publication Ethics (COPE), is committed to the highest scientific and ethical standards and encourages all authors to take into account and to comply, as much as possible, with the contents and issues reported in this technical note. This could be useful to improve the quality of the manuscripts and avoid misconduct, as well as to stimulate interest and debate, reflecting upon uses and misuses within our disciplines belonging to the medicine area (sports medicine and movement sciences) categories: anatomy, histology, orthopedics and sports medicine, rheumatology, sports sciences, physical therapy, sports therapy, and rehabilitation.

Inter-professional education and primary care: EFPC position paper.

Inter-professional education (IPE) can support professionals in developing their ability to work collaboratively. This position paper from the European Forum for Primary Care considers the design and implementation of IPE within primary care. This paper is based on workshops and is an evidence review of good practice. Enablers of IPE programmes are involving patients in the design and delivery, providing a holistic focus, focussing on practical actions, deploying multi-modal learning formats and activities, including more than two professions, evaluating formative and summative aspects, and encouraging team-based working. Guidance for the successful implementation of IPE is set out with examples from qualifying and continuing professional development programmes.

Best practices in bioassay development to support registration of biopharmaceuticals.

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

[The latest best practice guidelines relating to seclusion and restraint]. / Les dernières recommandations de bonnes pratiques sur l'isolement et la contention.

Several measures relating to seclusion and restraint are included in the French public health code. The best practice guidelines of the French National Health Authority, published in 2017, define these two notions and advise on the behaviour to adopt with regard to their implementation and monitoring. Likewise, informing and supporting the patient when these measures are lifted are critical moments which the teams must also be able to manage correctly.