Acute Care Research Research Articles

"When the Beeping Stops, you Completely Freak Out" - How Acute Care Teams Experience and Use Technology

Technology use in acute care has so far been studied with a predominant focus on safety and efficiency rather than the experience of acute care staff. In the present paper, we report a qualitative study including 130 hours of participant observation on acute care teams and retrospective interviews with nine anesthesiologists on their experiences with technology. Our approach is theoretically guided by four modern HCI perspectives, namely psychological need satisfaction, activity theory, embodied interaction, and media equation theory. We analyzed the interview and observation data using a reflexive thematic analysis and identified four themes. Technology as necessary (evil) describes the pervasiveness of technology and how acute care teams depend on technology. While technology as second patient covers the additional load for anesthesiologists on a functional and emotional level, technology as problem solver and safety net highlights relieving aspects of technology use. Technology as artificial limb focuses on so-called transparent tools that extend the body and capabilities of users. We then discuss the identified themes concerning the previously presented theories. Based on our findings and theoretical perspectives, we report general insights for research and design in acute care, such as the benefits of mixed methods or the importance of the gut feelings of experts. Finally, we propose possible directions for future work, such as developing a UX questionnaire adapted to the context of safety-critical domains, such as acute care.

In perspective: The patient at the heart of research in acute cardiovascular care.

Patient and public involvement is a fundamental part of research design and is increasingly required by research funders and regulators. In addition to the moral and ethical arguments in its favour, it has the potential to improve the accessibility and transparency of research, and to optimise study recruitment and retention. While clinical trials in acute cardiovascular care have traditionally focussed on "hard" outcomes, such as mortality or major adverse cardiovascular events, there is increasing recognition that these fail to capture the full breadth of patient experience. Patient-centred outcomes aim to measure things of greater value to patients, using validated tools to quantify symptoms, patient self-reports, or novel outcomes such as days alive and outside hospital. This In Perspective commentary explores the rationale behind patient and public involvement, the background to and evidence supporting the use of patient-centred outcomes, and discusses potential challenges and how they can be mitigated.

Translational research in acute cardiovascular care: what does the future hold?

Translational research in acute cardiovascular care: what does the future hold?

Phenobarbital for the management of severe acute alcohol withdrawal (the PHENOMANAL trial): a pilot randomized controlled trial

BackgroundBenzodiazepines are considered first-line treatment for patients experiencing severe acute alcohol withdrawal syndrome (sAAWS). Although several medications have been evaluated as potential adjuvant treatments for sAAWS, barbiturates show particular promise.ObjectiveIn the PHENOMANAL trial, we will assess the feasibility of conducting an allocation-concealed, quadruple-blinded, randomized controlled trial (RCT) comparing symptom-triggered benzodiazepine therapy with either a single dose of adjuvant intravenous (IV) phenobarbital (7.5 mg/kg of ideal body weight) or a single dose of matching IV placebo for patients with sAAWS.MethodsWe will recruit adult patients from the Emergency Department, Intensive Care Unit, or hospital wards with a Clinical Institute of Withdrawal – Adult revised (CIWA-Ar) score of 16 or more after receipt of at least 60 mg of diazepam or equivalent within 16 h of diagnosis of sAAWS, and an anticipated need for hospitalization. We will randomize participants (n=39) in a 2:1 manner to treatment and placebo groups, respectively. The primary objective of the PHENOMANAL pilot trial will be to demonstrate our ability to recruit the desired population over the trial period. As secondary objectives, we will evaluate clinician compliance with the treatment protocols, assess crossover rates from the placebo arm to the treatment arm, and obtain preliminary estimates of treatment effect. All trial participants will be followed for 7 days or until hospital discharge.RelevanceThe PHENOMANAL trial is novel in investigating a new treatment for a common and understudied condition, repurposing an existing medication for a novel indication, and addressing an important evidence gap. Through conduct of the multidisciplinary pilot trial, we aim to advance methodology in acute care research through the use of a hybrid consent model and inform the design of a large-scale trial.Trial registrationClinicalTrials.gov Registration NCT03586089; first registered July 13, 2018.

Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin

BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well.

Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness.

Investigators conducting studies that include potentially suicidal individuals are obligated to develop a suicide risk management (SRM) protocol. There is little available in the literature to guide researchers in SRM protocol development. The aim of the study was to describe an SRM protocol developed for a randomized controlled trial (RCT) currently enrolling cardiac patients who report moderate to severe levels of hopelessness. The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale risk factor questions. Based on responses, study participants are deemed safe or at low, moderate, or high risk for suicide. The SRM protocol guides research staff through a plan of action based on risk level. The protocol further guides staff through a plan over the course of this prospective study-from hospital enrollment to home-based visits. Research staff are well trained to identify suicidal ideation risk factors, initiate specific questioning about suicidal intent, determine level of risk, identify protective factors and a safe environment, and make referrals if needed. Of the 51 patients hospitalized with cardiac disease who reported moderate to severe hopelessness, 43 scored at a safe suicide risk level and 8 scored at low risk. Thirty-five of the 51 patients enrolled in the RCT. Of the 35 participants who received home visits to date, there have been three instances of low and one instance of moderate suicide risk. The SRM protocol has been consistently and accurately used by research personnel in both hospital and home settings. One modification has been made to the protocol since study activation, namely, the addition of an assessment of counseling history and encouragement of continued counseling. Booster training sessions of research staff will continue throughout the course of the RCT. Use of the SRM protocol identifies study participants who are safe or at risk for suicide in both hospital and home settings, and research staff can refer participants accordingly. The SRM protocol developed for this RCT can serve as a model in the development of SRM protocols for future research in acute care, community, or home-based settings.

Applications of machine learning in acute care research.

Artificial intelligence has been successfully applied to numerous health care and non‐health care‐related applications and its use in emergency medicine has been expanding. Among its advantages are its speed in decision making and the opportunity for rapid, actionable deduction from unstructured data with that increases with access to larger volumes of data. Artificial intelligence algorithms are currently being applied to enable faster prognosis and diagnosis of diseases and to improve patient outcomes.1,2 Despite the successful application of artificial intelligence, it is still fraught with limitations and “unknowns” pertaining to the fact that a model's accuracy is dependent on the amount of information available for training the model, and the understanding of the complexity presented by current artificial intelligence and machine learning algorithms is often limited in many individuals outside of those involved in the field. This paper reviews the applications of artificial intelligence and machine learning to acute care research and highlights commonly used machine learning techniques, limitations, and potential future applications.

Accountability to Population Health in the COVID-19 Pandemic: Designing Health Care Delivery Within a Social Responsibility Framework.

Accountability to Population Health in the COVID-19 Pandemic: Designing Health Care Delivery Within a Social Responsibility Framework.

Partnering With Patients to Bridge Gaps in Consent for Acute Care Research

Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes should be sensitive to the context in which trials are conducted and to needs of patients and surrogate decision-makers. This manuscript describes a collaborative effort between ethicists, researchers, patients, and surrogates to develop patient-driven, patient-centered approaches to consent for clinical trials in acute myocardial infarction and stroke.Our group identified important ways in which existing consent processes and forms for clinical trials fail to meet patients’ and surrogates’ needs in the acute context. We collaborated to create model forms and consent processes that are substantially shorter and, hopefully, better-matched to patients’ and surrogates’ needs and expectations from the perspective of content, structure, and tone. These changes, however, challenge some common conventions regarding consent.

Acute care research competencies for clinical research professionals.

Acute care research (ACR) is uniquely challenged by the constraints of recruiting participants and conducting research procedures within minutes to hours of an unscheduled critical illness or injury. Existing competencies for clinical research professionals (CRPs) are gaining traction but may have gaps for the acute environment. We sought to expand existing CRP competencies to include the specialized skills needed for ACR settings. Qualitative data collected from job shadowing, clinical observations, and interviews were analyzed to assess the educational needs of the acute care clinical research workforce. We identified competencies necessary to succeed as an ACR-CRP, and then applied Bloom's Taxonomy to develop characteristics into learning outcomes that frame both knowledge to be acquired and job performance metrics. There were 28 special interest competencies for ACR-CRPs identified within the eight domains set by the Joint Task Force (JTF) of Clinical Trial Competency. While the eight domains were not prioritized by the JTF, in ACR an emphasis on Communication and Teamwork, Clinical Trials Operations, and Data Management and Informatics was observed. Within each domain, distinct proficiencies and unique personal characteristics essential for success were identified. The competencies suggest that a combination of competency-based training, behavioral-based hiring practices, and continuing professional development will be essential to ACR success. The competencies developed for ACR can serve as a training guide for CRPs to be prepared for the challenges of conducting research within this vulnerable population. Hiring, training, and supporting the development of this workforce are foundational to clinical research in this challenging setting.

Mixed methods approach and its implications in acute care research

Background: The acute care settings have the potential to facilitate robust epidemiological and public health research necessary for evidence-based system. The methods in emergency research are well suited for mixed methods research. Despite the use of quantitative and qualitative data in emergency settings, mixed methods studies in this field are limited to help researchers to address health care issues. Therefore, we aim to assess the prospects and implications of mixed methods approach in acute care settings. 
 Materials and Methods: We have reviewed the published English literature using the research databases (PubMed, Medline, CINHAL and Google Scholar) related to the implications of mixed methods in emergency research, in order to understand and broaden the scope of patient care in time critical conditions.
 Results: Basically, there are four mixed method approaches which integrate qualitative and quantitative methods (such as Triangulation, Embedded, Explanatory and Exploratory design) which can be selected depending upon the research question. In a single study, appropriate selection of mixed method approach enables quality research which involves understanding of the different aspects of human interaction and paradigms to characterize complex healthcare systems from societal standpoint. So, the combination approach may answer key issues in emergency settings which enriches and enhances the healthcare practice that may influence patient outcomes. Notably, emergency research has wider range of parameters which not only benefit the patients but also help in overcoming system-related clinical challenges. Of note, the ethical conduct of study is crucial in a complex emergency situation which remains challenging for recruitment and obtaining informed consent from subject or their nest of kin. Another impediment is the lack of trained emergency researcher to support the research activities and data collection in the emergent settings.
 Conclusion: Application of mixed approach is of great importance in emergency medicine to enhance our understanding of critical care research that may add valuable insight on various aspects of human behavior. Therefore, appropriate planning and integration of study design may help researchers to explore newer avenues to improve patients care in emergency settings.

Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

BackgroundInformed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate.Methods and ResultsWe conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P‐CARE (Patient‐Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient‐centered interviews. In‐depth interviews used open‐ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study.ConclusionsBarriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow‐up.

METHODOLOGICAL STRATEGIES AND CHALLENGES FOR EVALUATING PARTICIPANT VIEWS ON DEMENTIA RESEARCH RECRUITMENT

There is an urgent need to expand enrollment in clinical Alzheimer’s disease (AD) research. Current recruitment methods for AD research predominantly identify patients from primary/specialty clinic settings, potentially creating barriers for individuals unconnected to care. In response to these challenges, the 2018 National Strategy for Research Recruitment and Participation has called for the development of an applied science of recruitment to inform best strategies. However, progress in this area is hindered by methodological challenges to accurately measure AD patient/caregiver participant views on research participation. The objective of this presentation is to report methodological strategies developed to during a prospective qualitative study to investigate AD patient/caregiver views on acute care research recruitment and participation. Participants included patients with dementia (N=2) who had recently been hospitalized and/or their informal caregivers (N=15). We engaged in iterative development and revision of data collection approaches (i.e. semi-structured questions, audiovisual tools, interview guidance) through collaboration with a Community Advisory Board (CAB). Detailed memos were generated to document interview-related challenges, successes and revisions. Therapeutic misconception in delineating research from clinical care was common during interviews regardless of prior research participation. Interview strategies that focus on lived experiences, remove ambiguity from hypothetical recruitment scenarios, and incorporate supportive visual tools that clarify processes around recruitment improved data collection. Challenges included the lack of a common, shared language around recruitment, which was addressed through CAB guidance and input. In conclusion, thoughtful collaboration with community/lay advisers can successfully inform and data collection methods used in applied recruitment research.

84 Students Get Involved: A Novel Approach to Process Improvement Evaluation in Acute Care

Our objective is to describe a model for process improvement evaluation that utilizes trained undergraduate student research assistants to collect provider-patient encounter data in the acute care environment. Process evaluation is imperative when making changes in a complex environment. This is especially true when the overall goal is to improve process efficiency and outcomes for critically ill and injured patients. The department of emergency medicine at the University of New Mexico uses an iterative approach to evaluate protocol changes in its Emergency Department Resuscitation Unit (EDRU), a nine-bed acute care unit internal to our emergency department. The collection of provider-patient encounter data by our student research assistants provides department leadership with evidence for assessing implementation problems and evaluating outcomes for protocol and practice changes. As part of a multi-semester course entitled Research in Acute Care, students collect data on provider-patient encounters in the EDRU on a secure electronic tool. Findings from the data collection are compiled and regularly presented to a workgroup of EM clinical faculty who in turn make recommendations on protocol revisions and continued education and training for personnel in the EDRU. In 2018, student research assistants spent over 1500 hours in the EDRU. This resulted in the collection of data on 1327 provider-patient encounters, including 26 instances of cardiopulmonary resuscitation (CPR), 418 of high acuity trauma, 112 strokes, and 164 cases of sepsis. During this same time period, the workgroup met 9 times to review findings from this and other data collections. The program has resulted in recommendations for additional training activities, identification and solutions for protocol related tools and missing equipment in the EDRU, and the identification of areas for research on patient-provider encounters. Our dynamic program is capable of meeting many of the department’s process improvement data gathering needs. The program provides invaluable experience in emergency medicine to future health care professionals through clinical environment exposure and first-hand experience in quality improvement research. We will continue to adapt our data collection program as existing protocols are revised and new protocols are implemented. We hope to expand our program and its data collection capabilities through increasing student coverage in the EDRU and possibly expanding to other units in the emergency department.

Structural features shared by ICUs belonging to research networks an international survey. “Critical care research network survey”

PurposeMajor acute care research is conducted within critical care research networks (CCRN). Our aims were to describe CCRN and participating ICUs. MethodsA cross-sectional survey was conducted among all CCRNs belonging to the International Forum of Acute Care Trialists. A network questionnaire was sent to CCRN directors and an ICU e-questionnaire was sent to participating ICUS. ResultsSurvey was answered by 366 ICUs from 17 CCRNs (median response rate 21% [12–38]). CCRNs have different organizations (ownership, memberships, funding). The number of studies conducted, patients included and publications varied a lot across CCRNs. The collaboration with other research networks or health authorities was very frequent (n = 13, 76%). Most ICUs (n = 315; 86%) are located in large teaching hospitals in high income countries with a mean volume of 968 (842–1102 (95% CI)) annual admissions. The recognition at the academic level (n = 133; 70%), the collaboration with experts (n = 284; 85%), and improving practices (n = 286; 86%) are incentives reported to belong to a CCRN. ConclusionsDespite different organizations, CCRN share similar ventures including the value of improving quality of critical care delivery. Participating ICUs share several structural and managerial patterns. These observations enlighten the importance of CCRN to enhance quality of critical care delivery.

Emergency department charges may be associated with mortality in patients with severe sepsis and septic shock: a cohort study

BackgroundSepsis severity of illness is challenging to measure using claims, which makes sepsis difficult to study using administrative data. We hypothesized that emergency department (ED) charges may be associated with hospital mortality, and could be a surrogate marker of severity of illness for research purposes. The objective of this study was to measure concordance between ED charges and mortality in admitted patients with severe sepsis or septic shock.MethodsCohort study of all adult patients presenting to a 60,000-visit Midwestern academic ED with severe sepsis or septic shock (by ICD-9 codes) between July 1, 2008 and June 30, 2010. Data on demographics, admission APACHE-II score, and disposition was extracted from the medical record, and comorbidities were identified from diagnosis codes using the Elixhauser methodology. Summary statistics were reported and bivariate concordance was tested using Pearson correlation. Logistic regression models for 28-day mortality were developed to measure the independent association with mortality.ResultsWe included a total of 294 patients in the analysis. We found that ED charges were inversely related to mortality (adjusted OR 0.829 per $1000 increase in total ED charges, 95%CI 0.702–0.980). ED charges were also independently associated with 28-day hospital-free and ICU-free days (0.74 days increase per $1000 additional ED charges, 95%CI 0.06–1.41 and 0.81 days increase per $1000 additional ED charges, 95%CI 0.05–1.56, respectively). ED charges were also associated with APACHE-II score ($34 total ED charges per point increase in APACHE-II score, 95%CI $6–62).ConclusionsED charges in administrative data sets are associated with in-hospital mortality and health care utilization, likely related to both illness severity and intensity of early sepsis resuscitation. ED charges may have a role in risk adjustment models using administrative data for acute care research.

A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research

BackgroundA challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research.MethodsWe performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, in the paediatric emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis.ResultsThirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation.ConclusionOur review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps.

2479 Acute care research competencies for clinical research professionals: A practitioner inquiry approach and assessment

OBJECTIVES/SPECIFIC AIMS: Acute care research is a unique area of clinical research that demands specialized skills, knowledge, and talents from empathetic professionals working in the field. Building off existing competencies for clinical research professionals, the Cincinnati Acute Care Research Council (ACRC) developed additional areas of competency for professionals working in the acute care research discipline. METHODS/STUDY POPULATION: Qualitative data obtained from job shadowing, clinical observations, and interviews were analyzed to understand the educational needs and desires of the acute care research workforce. We then utilized Bloom’s Taxonomy to build acute care research competencies that are measurable for job performance and build off of foundational clinical research professionals’ domains and competencies developed by the Joint Task Force of Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: Results suggest 35 special interest competencies for acute care clinical research professionals under 8 common domains set by the Joint Task Force of Clinical Trial Competency. Additionally an approved ACRC tactic, from actionable learnings through community assessments throughout 2017, is the creation of a Task Force made up of acute care research Principal Investigators and Clinical Research Directors to focus on the identified training and professional development obstacles in the clinical research enterprise. DISCUSSION/SIGNIFICANCE OF IMPACT: The competencies developed for acute care research should serve as guidelines for training a workforce prepared for the challenges of conducting research with each acute audience, as its own vulnerable population. These competencies will guide development of a multi-pronged program of professional development that will include new hire onboarding, new hire on-job training, and ongoing on-job training.

A 20-year Review: The Use of Exception From Informed Consent and Waiver of Informed Consent in Emergency Research.

Due to the acuity and time-sensitive needs of their clinical condition, patients presenting with certain emergent pathologies may lack capacity to provide meaningful prospective informed consent to participate in clinical research. For these reasons, these populations have often been excluded from research investigations. To mitigate this, regulations allowing exception from informed consent (EFIC; 21 CFR 50.24) or waiver of informed consent (WIC; 45 CFR 46.101) were developed in 1996. The purpose of this study was to identify trends in the utilization of EFIC and WIC in emergency research. We also sought to describe the disclosure of necessary prestudy regulatory requirements and justification for the use of EFIC/WIC as reported in completed EFIC/WIC clinical trials. This study is a review of 20 years of published trials using EFIC or WIC as the primary method of patient consent. Studies were identified using a MEDLINE search; ClinicalTrials.gov; queries to emergency and resuscitation researchers, research directors, department chairs, and principal investigators of acute care research networks; clinical review papers; and a query of the Federal Drug Administration (FDA) docket. All eligible studies were reviewed by three investigators and study data of interest were abstracted. Data are presented descriptively. We identified 45 potentially eligible studies; 11 were ongoing (with no data yet available), four were completed (with no publications or data available), and two did not use EFIC or WIC. Of the remaining 28 studies, 24 (86%) used EFIC and four used WIC. The most common pathologies under study were cardiac arrest (10), hemorrhagic shock (six), and traumatic brain injury (five). Completion of the prestudy regulatory requirements was reported as follows: FDA investigational new drug/investigational device exemption application (for FDA regulated studies; 14, 50%), community consultation (13, 46%), public disclosure (10, 36%), and opt-out procedures if requested by the institutional review board (seven, 25%). The justification of the need for the use of EFIC or WIC in the reported clinical trial, as defined as mention of at least one of the eight established criteria, was described in the text of 13 (46%) publications. Since their implementation in 1996, the EFIC/WIC regulations have allowed progress in research aimed at determining optimal care for devastating life-threatening conditions. However, consistent and rigorous report of regulatory prestudy requirements and justification of the use of EFIC/WIC is lacking in clinical trial publications or on websites such as ClinicalTrials.gov. Since research without consent is an ethically sensitive issue and not widely understood, better justification of its needs within the presentation of the research itself may educate the general medical community and also reduce concerns about whether or not the regulations are being properly applied.

Don't ask me what's the matter, ask me what matters: Acute mental health facility experiences of people living with autism spectrum conditions.

Background This qualitative study explored how mental health inpatients with autistic spectrum conditions (ASCs) experience and cope with anxiety when admitted to an acute mental health inpatient facility in the United Kingdom. Anxiety is a common characteristic for people who live with ASCs and whilst a plethora of studies on anxiety in this population is published which correlate anxiety with mental health service experience, little is known about the actual triggers of anxiety and its manifestations. This study adds to a body of evidence which considers anxiety experienced by people with autism. The rationale for this study includes the need to heighten mental health practitioners' understanding, of the responses, motivations to engage and support required to overcome fears and anxieties when admitted to a mental health inpatient unit. Method The study used a qualitative naturalistic research design, to explore the emotional and psychological experiences of being a mental health inpatient living with an ASC. During 2015-2017. audio-recorded semistructured interviews captured the experiences of 20 adults from the east of England who were former psychiatric inpatients with an established diagnosis of ASC. Interpretative phenomenological analysis enabled the identification of broad themes which explained in rich detail, participant reflections regarding the situations and events within the acute care mental health facility that triggered their anxiety, manifestations of anxiety and responses to their anxiety. Findings Broad response patterns were identified that could be associated with their anxiety that is isolating themselves from others, including patients and staff, ceasing to eat and sleep adequately and all too often self-harming or exhibiting aggressive and violent responses. Conclusions The anxiety caused by the physical environment appears to be overlooked by mental health practitioners so attention to anxiety-inducing encounters is needed when planning acute care mental health service improvement and research is required to clearly understand the experiences of this vulnerable group.