Custom-molded headcases have limited efficacy in reducing head motion during naturalistic fMRI experiments.

Effectively minimizing head motion continues to be a challenge for the collection of functional magnetic resonance imaging (fMRI) data. The use of individual-specific custom molded headcases is a promising solution to this issue, but there has been limited work to date. In the present work, we examine the efficacy of headcases in a larger group of participants engaged in naturalistic scanning paradigms including: long movie-watching scans (~20 to 45min) and a recall task that involved talking aloud inside the MRI. Unlike previous work, we find that headcases do not reliably reduce motion during movie viewing compared to alternative methods such as foam pillows or foam pillows plus medical tape. Surprisingly, we also find that motion is worse when participants talk aloud while wearing headcases. These differences appear to be driven by large, brief rotations of the head as well as translations in the z-plane as participants speak. Smaller, constant head movements appear equivalent with or without headcases. The largest reductions in head motion are observable when participants were situated with both foam pillows and medical tape. Altogether, this work suggests that in a healthy adult population, custom-molded headcases may provide limited efficacy in reducing head motion beyond existing tools available to researchers. We hope this work can help improve the quality of custom headcases, motivate the investigation of additional solutions, and provide additional information about head motion in naturalistic contexts.

The Staff Attitude to Coercion Scale (SACS) - Polish adaptation. / Kwestionariusz Postaw Personelu Wobec Przymusu (SACS) ­ Polska adaptacja.

OBJECTIVES: The aim of the study was to prepare the Polish adaptation of the SACS. The scale is a self-assessment tool designed to measure staff attitudes towards direct coercion of psychiatric wards patients. METHODS: The sample consisted of 120 adults, staff from 7 psychiatric wards. The SACS is a tool created in Norway by Tonje Husum, comprising of 15 items describing psychiatric healthcare professionals attitudes towards direct coercion. The validation procedure incorporated three basic methods to be applied in the reliability analysis - the comparison of double tests with the same method, the analysis of statistical properties of test items as well as analysis of the relation of test items and subscales with the general test result. RESULTS: After a "think aloud" type pilot study and a language validation, the internal consistency was assessed. The Cronbach's alpha ranged from 0.57 to 0.81 in the subscales, and it was 0.82 for the total score. The best solution obtained in exploratory factor analysis was a three-factor model, almost identical to the original one, confirming the division into three subscales: coercion as offending (critical attitude), as care and security (pragmatic attitude) and as treatment (positive attitude). CONCLUSIONS: The psychometric characteristics of the Polish adaptation of the SACS are similar to those reported in the original version. The results allow to recommend the method for scientific research. However, further analyses are necessary to assess validity and discriminative power in larger settings.

Restraints and seclusion in psychiatry: striking a balance between protection and coercion. Critical overview of international regulations and rulings.

Restraint and seclusion (R&S) measures in psychiatric settings are applied worldwide, despite poor scientific evidence to back up their effectiveness. The medical, ethical and medico-legal implications of coercive interventions are broad-ranging and multifaceted. The review aims to shed a light on the most relevant and meaningful standards that have been laid out by international treaties, supranational institutions (United Nations, Council of Europe, World Health Organization), scientific institutions (American Medical Association, Australian Department of Health), legislative bodies and courts of law. Several court cases are herein expounded upon, with a close focus on meaningful analysis, decisions and conclusions that have laid the groundwork for a different, more restrictive and more clearly defined approach towards R&S imposed upon psychiatric patients. It is reasonable to assume that changing norms, civil rights enforcement, court rulings and new therapeutic options have influenced the use of R&S to such an extent that such measures are among the most strictly regulated in psychiatric practice; health care providers should abide by a strict set of cautionary rules when making the decision to resort to R&S, which must never be put in place as a substitute for patient-centered therapeutic planning. Case law shows that R&S should only be weighed in terms of their effectiveness towards therapeutic goals. Being able to prove that R&S was employed as part of a therapeutic path rather than used to maintain order or to exact punishment may go a long way towards shielding operators against negligence lawsuits and litigation.

Restrictive practice: should all nurses be competent in safe holding and restraint?

Sarah Eales, Senior Lecturer, Mental Health Nursing, Bournemouth University, discusses the idea that all nurses should be able to demonstrate competence in restrictive practices, and the issues that raises.

Identifying determinants for the application of physical or chemical restraint in the management of psychomotor agitation on the critical care unit.

AIMS AND OBJECTIVES: To identify key determinants, which lead to the decision to apply physical or chemical restraint on the critical care unit. BACKGROUND: Psychomotor agitation and hyperactive delirium are frequently cited as clinical rationale for initiating chemical and physical restraint in critical care. Current restraint guidance is over a decade old, and wide variations in nursing and prescribing practice are evident. It is unclear whether restraint use is grounded in evidence-based practice or custom and culture. STUDY DESIGN: Integrative review. METHOD: Seven health sciences databases were searched to identify published and grey literature (1995-2019), with additional hand-searching. The systematic deselection process followed PRISMA guidance. Studies were included if they identified physical or chemical restraint as a method of agitation management in adult critical care units. Quality appraisal was undertaken using Mixed Methods Appraisal Tool. Data were extracted, and thematic analysis undertaken. RESULTS: A total of 23 studies were included. Four main themes were identified: the lack of standardised practice, patient characteristics associated with restraint use, the struggle in practice and the decision to apply restraint. CONCLUSIONS: There are wide variations in restraint use despite the presence of international guidance. Nurses are the primary decision-makers in applying restraint and report that caring for delirious patients is physically and psychologically challenging. The decision to restrain can be influenced by the working environment, patient behaviours and clinical acuity. Enhanced clinical support and guidance for nurses caring for delirious patients is indicated. RELEVANCE TO CLINICAL PRACTICE: Delirium and agitation pose a potential threat to patient safety and the maintenance of life-preserving therapies. Restraint is viewed as one method of preserving patient safety. However, use appears to be influenced by previous adverse experiences and subjective patient descriptors, rather than robust evidence-based knowledge. The need for a precise language to describe restraint and quantify when it becomes necessary is indicated.

Physical restraint in critical care units from the experience of doctors and nursing assistants: In search of an interdisciplinary interpretation. / La contención mecánica en unidades de cuidados críticos desde la experiencia de los médicos y técnicos en cuidados auxiliares de enfermería: buscando una lectura interdisciplinar.

OBJECTIVES: The study aim was to explore the experience of doctors and nursing assistants in the management of physical restraint (PR) in critical care units. METHOD: A multicentre phenomenological study that included 14 critical care units (CCU) in Madrid (Spain). The CCU were stratified according to their use of physical restraint: "frequently used" versus "seldom used". Three focus groups were formed: the first comprised nursing assistants from CCUs that frequently used physical restraint, the second comprised nursing assistants from CCUs that seldom used physical constraint, and the final group comprised doctors from both CCU subtypes. Sampling method: purposive. DATA ANALYSIS: thematic content analysis. Data saturation was achieved. RESULTS: Four principle themes emerged: 1) concept of safety and risk (patient safety versus the safety of the professional), 2) types of restraint, 3) professional responsibilities (prescription, recording, and professional roles) and 4) "zero restraint" paradigm. The conceptualisation regarding the use of physical contentions shows differences in some of the principal themes, depending on the type of CCU, in terms of policies, use and management of physical constraint (frequently used versus seldom used). CONCLUSIONS: The real reduction in the use of physical restraint in CCU must be based on one crucial point: acceptance of the complexity of the phenomenon. The use of physical restraint observed in the different CCU is influenced by individual, group and organisational factors. These factors will determine how doctors and nursing assistants interpret safety and risk, the centre of care (patient or professional-centred care), the concept of restraint, professional responsibilities and interventions, interactions of the team and the leadership.

Factors behind ethical dilemmas regarding physical restraint for critical care nurses.

BACKGROUND: Physical restraint is among the commonly used methods for ensuring patient safety in intensive care units. However, nurses usually experience ethical dilemmas over using physical restraint because they need to weigh patient autonomy against patient safety. AIM: The aim of this study was to explore factors behind ethical dilemmas for critical care nurses over using physical restraint for patients. DESIGN: This is a qualitative study using conventional content analysis approach, as suggested by Graneheim and Lundman, to analyze the data. METHODS: Seventeen critical care nurses were purposefully recruited from the four intensive care units in Tehran, Iran. Data were collected through in-depth semi-structured interviews and were concurrently analyzed through conventional content analysis as suggested by Graneheim and Lundman. ETHICAL CONSIDERATION: This study was approved by the Ethics Committee of Iran University of Medical Sciences, Tehran, Iran with the code: IR.IUMS.REC.1397.795. Before interviews, participants were provided with explanations about the aim of the study, the confidentiality of the data, their freedom to participate, and the right to withdraw the study, and their free access to the study findings. Finally, their consents were obtained, and interviews were started. RESULTS: Factors behind ethical dilemmas for critical care nurses over using physical restraint were categorized into three main categories, namely the outcomes of using physical restraint, the outcomes of not using physical restraint, and emotional distress for nurses. The outcomes of using physical restraint were categorized into the three subcategories of ensuring patient safety, physical damage to patients, and mental damage to the patient. The outcomes of not using physical restraint fell into two subcategories, namely the risks associated with not using physical restraint and legal problems for nurses. Finally, the two subcategories of the emotional distress for nurses main category were nurses' negative feelings about restraint use and uncertainty over the decision on physical restraint use. CONCLUSION: Decision-making for restraint use is often associated with ethical dilemmas, because nurses need to weight the outcomes of its use against the outcomes of not using it and also consider patient safety and autonomy. Health authorities are recommended to develop clear evidence-based guidelines for restraint use and develop and implement educational and counseling programs for nurses on the principles of ethical nursing practice, patient rights, physical restraint guidelines and protocols, and management of emotional, ethical, and legal problems associated with physical restraint use.

The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package.

BACKGROUND: Invasive interventions can produce fear, anxiety, and pain in children. This may negatively affect the children's treatment and care. AIM: This study was conducted to determine the effects of procedural restraint (PR) and cognitive-behavioral intervention package (CBIP) on venipuncture pain in children between 6-12 years of age. DESIGN: Quasi-experimental study. SETTINGS: The study was conducted in the pediatric blood collection service of the hospital in Turkey between October 1, 2015, and April 1, 2016. PARTICIPANTS/SUBJECTS: The population of the study consisted of children admitted to the blood collection service during the study period who met the inclusion criteria. METHODS: The children included in the study were divided into two groups. Group 1 (n = 31) received PR in accordance with routine clinical practice. Group 2 (n = 30) received the CBIP. The data were collected by the researchers using a questionnaire, the visual analog scale (VAS), and the Wong-Baker FACES (WB-FACES) Pain Rating Scale. RESULTS: The children in the PR group had a mean VAS score of 5.90 ± 3.22 and a mean WB-FACES score of 8.70 ± 2.22. The children in the CBIP group had a mean VAS score of 2.43 ± 2.02 and a mean WB-FACES score of 2.80 ± 2.49. A statistically significant difference was found between the mean VAS and WB-FACES pain scores of the groups (p < .05). CONCLUSIONS: The results of this study showed that the children in the CBIP group had a lower pain level during venipuncture compared to those restrained for the procedure.

BET 1: cervical spine immobilisation in the management of drowning victims.

A short cut review was carried out to establish whether patients presenting to the emergency department after a near drowning should have cervical spine immobilisation. A search of the literature found only three studies directly relevant to the question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these papers are tabulated. The clinical bottom line is that cervical spine injuries are rare in drowning and near drowning unless there is a history of diving or a fall or signs of trauma. Cervical spine immobilisation should be reserved for cases where there is a reasonable suspicion of a spinal injury.

Characteristics and Severity of Agitation Associated With Use of Sedatives and Restraints in the Emergency Department.

BACKGROUND: Agitated patients frequently present to emergency departments, but limited evidence exists regarding clinical decisions to use chemical sedatives and physical restraints. OBJECTIVE: We examined attributes and levels of agitation impacting thresholds for sedative and restraint use in the emergency setting. METHODS: This was a secondary study focusing on agitation characteristics within a prospective observational study of agitated patients in the emergency department at an urban, tertiary referral center. We recorded scores on 3 validated agitation scales: the Agitated Behavior Scale, the Overt Aggression Scale, and the Severity Scale. Consecutive patients requiring security presence or scoring ≥1 on an agitation scale were enrolled during randomized 8-h blocks. RESULTS: Ninety-five agitation events on unique patients were observed. The median age was 42 years, and 62.1% were male. Highest frequency triage chief complaints were alcohol/drug use (37.9%) and psychiatric (23.2%). Most events (73.7%) were associated with sedative or restraint use. Factors related to treatment course or interactions with staff were commonly cited (56.8%) as the primary etiology for agitation. A logistic regression model found no association between demographics and odds of sedative/restraint use. Overt Aggression Scale scores were associated with significantly higher odds of sedative use (adjusted odds ratio [AOR] 1.62 [range 1.13-2.32]), while Severity Scale scores had significantly higher odds of restraint use (AOR 1.39 [range 1.12-1.73]) but significantly lower odds of sedative use (AOR 0.79 [range 0.64-0.98]). CONCLUSION: External factors may be important targets for behavioral techniques in agitation management. Further study of the Severity Scale scale may allow for earlier detection of agitation and identify causal links between agitation severity and use of sedatives and restraints.

Development and initial validation of a Theory of Planned Behaviour questionnaire to assess critical care nurses' intention to use physical restraints.

AIMS: To develop and psychometrically test a Theory of Planned Behaviour (TPB) questionnaire to assess nurses' intention to use physical restraints (PRs) in intubated patients. DESIGN: A psychometric instrument validation study conducted in three phases. METHODS: A theory-driven questionnaire was developed. Eight experts validated the content of the preliminary 58-item questionnaire. A pilot study was conducted including 101 critical care nurses to test the reliability of the items. Construct validity and reliability were tested in a cross-sectional study of 12 units from eight hospitals in Spain (N = 354) from October - December 2017. Participants completed the questions based on the TPB, and socio-demographic and professional variables. RESULTS: The instrument comprised 48 items. All the direct and indirect constructs exhibited acceptable reliability. Confirmatory factor analysis indicated satisfactory fit indices for factorial structure according to the TPB. Nurses showed favourable attitudes, low perception of social pressure and modest perception of behaviour control. Perceived behavioural control and attitude were moderately positively correlated with the intention to use restraints, whereas subjective norm revealed the lowest correlation. Overall, the model explained 33% of the variance in intention. CONCLUSIONS: The Physical Restraint TPB questionnaire is a 48-item self-reporting theoretically based instrument with acceptable reliability and construct validity to identify nurses' intentions to use PRs in intubated patients. IMPACT: Unravelling the key determinants of nurses' intentions to use PRs should be examined to tailor quality improvement projects aimed at de-implementing restraints use in practice and to promote safer care.

Open doors by fair means: Study protocol for a 3-year prospective controlled study with a quasi-experimental design towards (or to implement) an open Ward policy in acute care units.

BACKGROUND: Acute psychiatric wards in Germany are often locked due to the assumption that opening could endanger patients and society. On the contrary, some findings suggest that aversive events such as absconding and attempted suicides do not occur more often on wards with an open-door policy. However, these data are probably biased with regard to differing patient populations on open and locked wards. To our best knowledge, the present study is the first prospective controlled study with a quasi-experimental design dealing with this issue. METHODS: This study investigates whether indicators of an open-door policy, as measured by a priori determined outcomes, can be improved by a defined complex intervention on two intervention wards in two psychiatric hospitals, compared to two control wards with otherwise very similar conditions. Both hospitals contain two wards identical in structure and patient admittance policies, so that a similar study protocol can be followed with similar patient populations. Both hospitals have a defined catchment area and receive voluntary and involuntary admissions. In a baseline phase, wards will be opened facultatively (i.e., if it seems possible to staff). In the following intervention period, one ward per hospital will establish an enhanced open-door policy by applying additional strategic and personnel support. As a control group, the control ward will continue to be opened facultatively. After one year, control wards will be opened according to the open-door policy as well. Interventions will include the continuous identification of patients at risk as well as the development of individual care concepts and additional staffing. For this purpose, nursing and medical staff will be methodically supported on an ongoing basis by study staff. Outcomes variables will be the percentage of door opening on each ward between 8 a.m. and 8 p.m., the percentage of all treatment days with the door opened and the number of involuntary treatment days with open doors. Data on frequencies of aggressive incidents, absconding, police searches, and seclusion or restraint will be used as control variables. Additional costs will be calculated. DISCUSSION: Treating mentally ill patients on locked wards is a highly relevant and critically discussed topic. In particular, it is controversially discussed whether changes in door policy can be established without increasing risks to patients and others. This study aims to gain robust data on this issue, going beyond beliefs and questionable retrospective observational studies. TRIAL REGISTRATION: Our trial "Open Doors By Fair Means" is retrospectively registered with DRKS (DRKS00015154) on Sept. 10th 2018 and displayed on the public web site. It is searchable via its Meta-registry ( http://apps.who.int/trialsearch/ ).

Staged Implementation of Awakening and Breathing, Coordination, Delirium Monitoring and Management, and Early Mobilization Bundle Improves Patient Outcomes and Reduces Hospital Costs.

OBJECTIVES: To measure the impact of staged implementation of full versus partial ABCDE bundle on mechanical ventilation duration, ICU and hospital lengths of stay, and cost. DESIGN: Prospective cohort study. SETTING: Two medical ICUs within Montefiore Healthcare Center (Bronx, NY). PATIENTS: One thousand eight hundred fifty-five mechanically ventilated patients admitted to ICUs between July 2011 and July 2014. INTERVENTIONS: At baseline, spontaneous (B)reathing trials (B) were ongoing in both ICUs; in period 1, (A)wakening and (D)elirium (AD) were implemented in both full and partial bundle ICUs; in period 2, (E)arly mobilization and structured bundle (C)oordination (EC) were implemented in the full bundle (B-AD-EC) but not the partial bundle ICU (B-AD). MEASUREMENTS AND MAIN RESULTS: In the full bundle ICU, 95% patient days were spent in bed before EC (period 1). After EC was implemented (period 2), 65% of patients stood, 54% walked at least once during their ICU stay, and ICU-acquired pressure ulcers and physical restraint use decreased (period 1 vs 2: 39% vs 23% of patients; 30% vs 26% patient days, respectively; p < 0.001 for both). After adjustment for patient-level covariates, implementation of the full (B-AD-EC) versus partial (B-AD) bundle was associated with reduced mechanical ventilation duration (-22.3%; 95% CI, -22.5% to -22.0%; p < 0.001), ICU length of stay (-10.3%; 95% CI, -15.6% to -4.7%; p = 0.028), and hospital length of stay (-7.8%; 95% CI, -8.7% to -6.9%; p = 0.006). Total ICU and hospital cost were also reduced by 24.2% (95% CI, -41.4% to -2.0%; p = 0.03) and 30.2% (95% CI, -46.1% to -9.5%; p = 0.007), respectively. CONCLUSIONS: In a clinical practice setting, the addition of (E)arly mobilization and structured (C)oordination of ABCDE bundle components to a spontaneous (B)reathing, (A)wakening, and (D) elirium management background led to substantial reductions in the duration of mechanical ventilation, length of stay, and cost.

Is it time for international guidelines on physical restraint in psychiatric patients?

The freedom-restraining measures used during Involuntary Health Treatment (IHT) are highly criticized in the medical community. Physical restraint techniques are currently largely used worldwide in Psychiatry. The use of restraints against the patient's will can be considered a serious intrusion of basic human rights and even an act of violence against the patient. In all cases, the restraint should not lead to injuries or damage to the patient's health and should be implemented with a respect of the human rights and dignity. Generally, the use of restraint should be considered as a last resource, when all the other methods have failed. Since it represents the principal freedom-limitation measure, it should be constantly monitored by physicians who apply these methods. The case of a 58 years-old white male, affected by chronic schizoaffective disorder and cannabinoid dependence, was under involuntary medical treatment as a consequence of antisocial behavior. During the IHT he suffered firstly a pharmacological restraint and then a physical restraint in order to suppress a slight state of agitation. The patient was completely blocked to the bed for more than 80 hours and died after three days of hospitalization. The aim of this study is to evaluate the suitability of restrictive methods for psychiatric patients in order to establish specific rules to prevent abuse of restraint techniques and even to help physicians to treat psychiatric patients.

[Seclusion and restraint: From prescription to decision]. / Isolement et contention : de la prescription à la décision.

Psychiatric care has always included patients in crisis who are potentially dangerous or agitated. Faced with the many issues they may encounter, the therapeutic relationship has always been prioritized over all other considerations. However, the practice of seclusion and restraint has been steadily increasing in the past few decades. Their use is becoming customary rather than exceptional and consequently fosters less thought by the care teams. In the Healthcare System Modernization Act of January 26th, 2016, the lawmakers sought to underline the freedom-destroying nature of these practices and the necessity of their regulation. This law represents a fundamental change in the nature of seclusion and restraint. What was but a simple prescription becomes a conscious decision of depriving someone of her or his freedom and must only be considered as a last resort. The changes in the Law and the recent changes in the recommendations for clinical practice by the French National Institute of Health invite reflection. Many questions remain about the origins of violence, the reasons for the increasing use of seclusion and restraint measures, and the alternatives that have been developed. Many theories suggest that the less stressful and constrained an environment is, the more empowered the patient will be. He is an actor in his own care and is considered a full active participant. The Law is reconciled with caregivers initiating a reflection on the benefits of these measures regarding the violation of fundamental freedoms. Reflection on psychiatric care and the quality of its management must be the focus when caring for patients in crisis.

Restraint in mental health settings: is it time to declare a position?

The emergence of a drive to reduce restrictive interventions has been accompanied particularly in the UK by a debate focussing on restraint positions. Any restraint intervention delivered poorly can potentially lead to serious negative outcomes. More research is required to reliably state the risk attached to a particular position in a particular clinical circumstance.Declaration of interestF.S. is a consultant psychiatrist in Psychiatric Intensive Care at the Maudsley Hospital, London. He is on the Executive Committee of the National Association of Psychiatric Intensive Care and Low Secure Units, and was a member of the National Institute for Health and Care Excellence Guideline Development Group for the Short-Term Management of Aggression and Violence (2015). J.P. is a senior lecturer at the Faculty of Health and Life Sciences, Coventry University. E.B. is a consultant and expert witness in violence reduction and the use of physical interventions, independent expert to the High Secure Hospitals Violence Reduction Manual Steering Group and a member of the College of Policing Guideline Committee Steering Group and Mental Health Restraint Expert Reference Group. B.P. is the clinical director for Crisis and Aggression Limitation and Management (CALM) Training and formerly a senior lecturer for the Faculty of Health, University of Stirling. He is a nurse and psychotherapist and presently chairs the European Network for Training in the Management of Aggression. A.O'B. is a consultant psychiatrist, the Director of Educational Programmes for the National Association of Psychiatric Intensive Care and Low Secure Units, and the Dean for Students at St George's University of London.