Evaluation of a virtual practice placement: A model to increase student capacity.

AIM: To describe the development and evaluation of a novel virtual practice placement. BACKGROUND: Health systems around the world face the challenge of recruiting and retaining sufficient nursing staff to provide high quality care. The need to train more nurses makes it hard to provide sufficient and varied high quality student placements to all students. This paper reports the result of one approach to the provision of a novel virtual placement for pre-registration student nurses. DESIGN: Online virtual placement evaluated by a questionnaire conducted after the placement. METHODS: A total of 195 students attended the virtual practice placement between 10th October 2022 and the 10th March 2023. The survey consisted of eight questions, of which one invited a qualitative response. RESULTS: A total of 188 students completed the questionnaire and provided feedback. Of these 84 were adult nursing students, 67 child, 36 mental health and one learning disability student. The virtual placement required considerable resources to run, however was deemed as valuable by most students. When asked to rate the overall experience out of 5, the median scores were consistently high: adult (Mdn=5), child (Mdn=4), learning disability (Mdn=5) and mental health (Mdn=5) and mean values consistently high across fields: adult (M=4.73), child (M=5), learning disability (M=5) and mental health (M=4.67). Qualitatively, there were four main themes that emerged from the questionnaire responses: increased understanding of community healthcare and holistic approaches to care; developing interpersonal skills; a positive impact on their future career opportunities and the value of realistic case studies. CONCLUSIONS: Virtual placements are a viable addition to traditional placements. However, they require careful planning and considerable resources including experienced and dedicated facilitators. Principles for the delivery of virtual placements were produced to replicate and share best practice.

Low-dose diazoxide is safe and effective in infants with transient hyperinsulinism.

OBJECTIVE: Transient hyperinsulinism (THI) is the most common form of recurrent hypoglycaemia in neonates beyond the first week of life. Although self-resolving, treatment can be required. Consensus guidelines recommend the lower end of the diazoxide 5-15 mg/kg/day range in THI to reduce the risk of adverse events. We sought to determine if doses <5 mg/kg/day of diazoxide can be effective in THI. DESIGN, PATIENTS, MEASURMENTS: Infants with THI (duration <6 months) were treated with low-dose diazoxide from October 2015 to February 2021. Dosing was based on weight at diazoxide start: 2 mg/kg/day in infants 1000-2000 g (cohort 1), 3 mg/kg/day in those 2000-3500 g (cohort 2) and 5 mg/kg/day in those >3500 g. RESULTS: A total of 73 infants with THI (77% male, 33% preterm, 52% small-for-gestational age) were commenced on diazoxide at a median age of 11 days (range 3-43) for a median duration of 4 months (0.3-6.8), with no difference between cohorts. The mean effective diazoxide dose was 3 mg/kg/day (range 1.5-10); 35% (26/73) required an increase from their starting dose, including 60% (9/15) of cohort 1. There was no association between perinatal stress risk factors or treatment-related characteristics and dose increase. Adverse events occurred in 13 patients (18%); oedema (12%) and hyponatraemia (5%) were the most common. Two infants developed suspected necrotising enterocolitis (NEC); none had pulmonary hypertension. CONCLUSION: Diazoxide doses <5 mg/kg/day are effective in THI. While the nature of the association between diazoxide and NEC was unclear, other adverse events were mild. We suggest considering starting doses as low as 2-3 mg/kg/day in THI to balance the side effect risk while maintaining euglycaemia.

Standardised practices in the networked management of congenital hyperinsulinism: a UK national collaborative consensus.

Congenital hyperinsulinism (CHI) is a condition characterised by severe and recurrent hypoglycaemia in infants and young children caused by inappropriate insulin over-secretion. CHI is of heterogeneous aetiology with a significant genetic component and is often unresponsive to standard medical therapy options. The treatment of CHI can be multifaceted and complex, requiring multidisciplinary input. It is important to manage hypoglycaemia in CHI promptly as the risk of long-term neurodisability arising from neuroglycopaenia is high. The UK CHI consensus on the practice and management of CHI was developed to optimise and harmonise clinical management of patients in centres specialising in CHI as well as in non-specialist centres engaged in collaborative, networked models of care. Using current best practice and a consensus approach, it provides guidance and practical advice in the domains of diagnosis, clinical assessment and treatment to mitigate hypoglycaemia risk and improve long term outcomes for health and well-being.

Accuracy and impact on quality of life of real-time continuous glucose monitoring in children with hyperinsulinaemic hypoglycaemia.

Objective: Continuous glucose monitoring (CGM) is the standard of care for glucose monitoring in children with diabetes, however there are limited data reporting their use in hyperinsulinaemic hypoglycaemia (HH). Here, we evaluate CGM accuracy and its impact on quality of life in children with HH. Methods: Real-time CGM (Dexcom G5 and G6) was used in children with HH aged 0-16years. Data from self-monitoring capillary blood glucose (CBG) and CGM were collected over a period of up to 28days and analysed. Quality of life was assessed by the PedsQL4.0 general module and PedsQL2.0 family impact module, completed by children and their parents/carers before and after CGM insertion. Analysis of accuracy metrics included mean absolute relative difference (MARD) and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of reference glucose values >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses. Results: Prospective longitudinal study with data analysed from 40 children. The overall MARD between reference glucose and paired CGM values (n=4,928) was 13.0% (Dexcom G5 12.8%, Dexcom G6 13.1%). The proportion of readings meeting %15/15 and %20/20 were 77.3% and 86.4%, respectively, with CEG analysis demonstrating 97.4% of all values in zones A and B. Within the hypoglycaemia range (<70 mg/dL), the median ARD was 11.4% with a sensitivity and specificity of 64.2% and 91.3%, respectively. Overall PedsQL child report at baseline and endpoint were 57.6 (50.5 - 75.8) and 87.0 (82.9 - 91.2), and for parents were 60.3 (44.8 - 66.0) and 85.3 (83.7 - 91.3), respectively (both p<0.001). Conclusion: Use of CGM for children with HH is feasible, with clinically acceptable accuracy, particularly in the hypoglycaemic range. Quality of life measures demonstrate significant improvement after CGM use. These data are important to explore use of CGM in disease indications, including neonatal and paediatric diabetes, cystic fibrosis and glycogen storage disorders.

Adding mini meals to a nasogastric refeeding protocol for patients with eating disorders can be achieved on general hospital wards.

BACKGROUND: Treatment of medically compromised patients with eating disorders is difficult in general hospital wards. There is currently no consensus on the best feeding method; however, previous research has demonstrated the safety of using enteral feeding. Because an oral diet has benefits on psychological and behavioural pathways, concurrent feeding requires further investigation. The present study aimed to examine acceptability and safety of implementing mini meals to a previously nil-by-mouth 7-day enteral feeding protocol. METHODS: This was mixed methods research including a retrospective observational study and participant survey. Patients admitted to a tertiary hospital in Brisbane, Australia, between July 2020 and March 2021 were eligible. Eligible participants were provided mini meals from day 5. Type and quantity of meals consumed alongside clinical incident data were collected. The survey examined acceptability of mini meals. Descriptive statistics were used to interpret findings. Content analyses were conducted on survey responses. RESULTS: Sixty-four participants (95%, n = 57/60 female, 25.2 ± 8.9 years; 75%, n = 45/60 diagnosed with anorexia nervosa) were included. At least half of the participants consumed some or all of the mini meals at each meal period. No clinical incidents were reported. Twenty-six (50%, n = 26/52) surveys were returned. Half (54%, n = 14/26) agreed-strongly agreed that mini meals improved their experience. Eleven participants desired more choice in menu items. CONCLUSIONS: The present study found that introducing mini meals into an enteral feeding protocol is acceptable and safe for patients with eating disorders. Participants reported benefits in returning to eating; however, some items on the menu require reconsideration to enable increased consumption.

Patient Confidence and Information Preferences During the Treatment Decision-making Process: Results From a Large Multiple Myeloma Patient Survey Across 12 Countries in Europe and Israel.

BACKGROUND: The relapsing nature of multiple myeloma (MM) means that patients typically receive different and multiple lines of therapy, requiring many treatment decisions over the disease course. The aim of this study was to explore patient confidence and information preferences during the treatment decision-making process. PATIENTS AND METHODS: A multinational, cross-sectional survey enrolled patients with MM. It was co-developed and distributed by Myeloma Patients Europe across 12 countries in Europe and Israel from May 2019 to March 2020. Eligibility criteria included a self-reported diagnosis of MM and being able to recall the decision-making process at the start of their latest treatment line. RESULTS: A total of 1559 patients were included, with complete responses received from 1081 (69%) patients. The median age range was 54 to 64 years; there was an equal gender split and 57% had their latest treatment decision made within the past year. Overall, 54% of patients felt "very confident" in the latest treatment decision. Patients deemed the most important information to be safety/tolerability and treatment effectiveness, but the latter was among the least frequently received. Most patients reported that their primary physician treating MM was their main source for all types of information (range, 62%-94%), with 87% of patients reporting a "very good" or "good" relationship with them. CONCLUSION: Over half of patients felt very confident in their latest treatment decision; however, patients reported not routinely receiving important treatment effectiveness information. Addressing the discrepancies between information that patients receive and consider important may enhance confidence in decision-making.

Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study.

INTRODUCTION: Ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy, has demonstrated early, deep, and durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), and improvements in health-related quality of life (HRQoL) in CARTITUDE-1 (NCT03548207). Patient perspectives on treatment provide context to efficacy outcomes and are an important aspect of therapeutic evaluation. METHODS: Qualitative interviews were conducted in a subset of CARTITUDE-1 patients (n = 36) at screening, Day 100, and Day 184 post cilta-cel on living with MM, therapy expectations, and treatment experiences during the study. RESULTS: Patients most wanted to see change in symptoms with the greatest impact on HRQoL: pain (85.2%) and fatigue (74.1%). The primary treatment expectation was achieving remission (40.7%), followed by extended life expectancy (14.8%). Patients most often defined meaningful change as improvement in symptoms (70.4%) and return to normalcy (40.7%). The percentage of patients reporting symptoms (pain, fatigue, bone fracture, gastrointestinal, neuropathy, and weakness) decreased from 85.2% to 22.2% across symptom types at baseline to 29.2% to 0% on Day 184 after cilta-cel. Improved symptoms and positive sentiments corresponded with improved perception of overall health status and reduced pain level, respectively. Most patients reported that their expectations of cilta-cel treatment had been met (70.8%) or exceeded (20.8%) at Day 184, and 70.8% of patients considered cilta-cel therapy better than their previous treatments. CONCLUSION: Overall HRQoL improvements and qualitative interviews showed cilta-cel met patient expectations of treatment and suggest the long treatment-free period also contributed to positive sentiments.

Re-Thinking Hyperkalaemia Management in Chronic Kidney Disease-Beyond Food Tables and Nutrition Myths: An Evidence-Based Practice Review.

Potassium dysregulation can be life-threatening. Dietary potassium modification is a management strategy for hyperkalaemia. However, a 2017 review for clinical guidelines found no trials evaluating dietary restriction for managing hyperkalaemia in chronic kidney disease (CKD). Evidence regarding dietary hyperkalaemia management was reviewed and practice recommendations disseminated. A literature search using terms for potassium, hyperkalaemia, and CKD was undertaken from 2018 to October 2022. Researchers extracted data, discussed findings, and formulated practice recommendations. A consumer resource, a clinician education webinar, and workplace education sessions were developed. Eighteen studies were included. Observational studies found no association between dietary and serum potassium in CKD populations. In two studies, 40-60 mmol increases in dietary/supplemental potassium increased serum potassium by 0.2-0.4 mmol/L. No studies examined lowering dietary potassium as a therapeutic treatment for hyperkalaemia. Healthy dietary patterns were associated with improved outcomes and may predict lower serum potassium, as dietary co-factors may support potassium shifts intracellularly, and increase excretion through the bowel. The resource recommended limiting potassium additives, large servings of meat and milk, and including high-fibre foods: wholegrains, fruits, and vegetables. In seven months, the resource received > 3300 views and the webinar > 290 views. This review highlights the need for prompt review of consumer resources, hospital diets, and health professionals' knowledge.

What matters most to patients with multiple myeloma? A Pan-European patient preference study.

Introduction: Given the rapid increase in novel treatments for patients with multiple myeloma (MM), this patient preference study aimed to establish which treatment attributes matter most to MM patients and evaluate discrete choice experiment (DCE) and swing weighting (SW) as two elicitation methods for quantifying patients' preferences. Methods: A survey incorporating DCE and SW was disseminated among European MM patients. The survey included attributes and levels informed by a previous qualitative study with 24 MM patients. Latent class and mixed logit models were used to estimate the DCE attribute weights and descriptive analyses were performed to derive SW weights. MM patients and patient organisations provided extensive feedback during survey development. Results: 393 MM patients across 21 countries completed the survey (M years since diagnosis=6; M previous therapies=3). Significant differences (p<.01) between participants' attribute weights were revealed depending on participants' prior therapy experience, and their experience with side-effects and symptoms. Multivariate analyses showed that participants across the three MM patient classes identified via the latent class model differed regarding their past number of therapies (F=4.772, p=.009). Patients with the most treatments (class 1) and those with the least treatments (class 3) attached more value to life expectancy versus quality of life-related attributes such as pain, mobility and thinking problems. Conversely, patients with intermediary treatment experience (class 2) attached more value to quality of life-related attributes versus life expectancy. Participants highlighted the difficulty of trading-off between life expectancy and quality of life and between physical and mental health. Participants expressed a need for greater psychological support to cope with their symptoms, treatment side-effects, and uncertainties. With respect to patients' preferences for the DCE or SW questions, 42% had no preference, 32% preferred DCE, and 25% preferred SW. Conclusions: Quality of life-related attributes affecting MM patients' physical, mental and psychological health such as pain, mobility and thinking problems were considered very important to MM patients, next to life expectancy. This underscores a need to include such attributes in decision-making by healthcare stakeholders involved in MM drug development, evidence generation, evaluation, and clinical practice. This study highlights DCE as the preferred methodology for understanding relative attribute weights from a patient's perspective.

The Burden of a Multiple Myeloma Diagnosis on Patients and Caregivers in the First Year: Western European Findings.

Background: This research aimed to quantify the burden of illness (BoI) in transplant eligible (TE) and transplant non-eligible (TNE) newly diagnosed multiple myeloma (NDMM) patients and their caregivers, in the first year after diagnosis: at months 0, 3, and 12. Methods: Prospective, cross-sectional, observational NDMM study of TE and TNE patients and their caregivers from France, Germany, Italy, and Spain was conducted between May 2019 and January 2021. A structured, online questionnaire measuring disease burden, direct and costs, out-of-pocket expenses, and health-related quality of life (HRQoL) was used. Descriptive statistics were performed. Results: A total of 164, 160, and 190 NDMM patients [>65 years; self-described healthy; not working; living with caregiver] answered at months 0, 3, and 12. Patients lost independence to perform daily activities; mean pain intensity rose and opioid utilization increased, more significantly among TNE patients. Overall health status and HRQoL remained stable. Median 3-month direct medical costs peaked at month 3. Specialist consultations and hospital admissions were the greatest cost amongst TE and TNE patients. Home adaptations increased out-of-pocket expenditures amongst TNE patients. Patients describing themselves as working spent a median 0 hours in the office at all time points. A total of 131, 122, and 124 caregivers answered at months 0, 3, and 12. Mean self-rated burden score rose. By month 12, half of caregivers developed stress, anxiety or depression. Most employed caregivers continued working. Productivity was low at month 0 with a trend of recovering at month 12. Caregivers of TNE compared to TE patients reported greater time burden. Caregivers' HRQoL was stable over time. Conclusion: NDMM is burdensome for patients and caregivers in the first year after diagnosis. TNE patients are more dependent on caregivers and incur higher care costs than TE patients. Despite the financial, physical, and emotional burden, HRQoL remains stable possibly indicating resilience and illness adjustment amongst patients and caregivers.

Enhancing the clinical supervision experience of staff members working within primary and community care: a best practice implementation project.

OBJECTIVES: The project aimed to assess compliance with evidence-based criteria regarding the use of clinical supervision amongst district nurses and to improve knowledge and engagement in clinical supervision activities within the workplace. INTRODUCTION: It is important to provide clinical support to all healthcare workers that provide opportunities to develop and be listened to in a supervised environment. Clinical supervision is seen as a key element to provide this support. It provides a professional working relationship between two or more members of staff where the reflection of practice and personal emotion can be discussed, which is outlined in many policies and guidelines. METHODS: A baseline audit was carried out using the JBI Practical Application of Clinical Evidence System program involving 16 participants in one district nursing team in South Wales. The first step involved the development of the project and generating the evidence. Following this, a baseline audit was conducted, and educational training on clinical supervision was undertaken followed by clinical supervision sessions. A postimplementation re-audit was conducted following implementation. RESULTS: A total of 16 participants enrolled on the project. Receiving basic training and participating in clinical supervision was much higher than the baseline audit with both increasing to 100% compliance. Furthermore, 94% of participants were aware of clinical supervision activities and 88% knew of existing records on clinical supervision. The project results show a large increase in compliance with all of the criteria. CONCLUSION: Overall the implementation project achieved an improvement in evidence-based practice regarding clinical supervision in primary care.

Access to and affordability of CAR T-cell therapy in multiple myeloma: an EBMT position paper.

Chimeric antigen receptor (CAR) T-cell therapy is a promising immunotherapeutic approach in the treatment of multiple myeloma, and the recent approval of the first two CAR T-cell products could result in improved outcomes. However, it remains a complex and expensive technology, which poses challenges to health-care systems and society in general, especially in times of crises. This potentially accelerates pre-existing inequalities as access to CAR T-cell therapy varies, both between countries, depending on the level of economic development, and within countries, due to structural disparities in access to quality health care-a parameter strongly correlated with socioeconomic status, ethnicity, and lifestyle. Here, we identify two important issues: affordability and access to CAR T-cell treatment. This consensus statement from clinical investigators, clinicians, nurses, and patients from the European Society for Blood and Marrow Transplantation (EBMT) proposes solutions as part of an innovative collaborative strategy to make CAR T-cell therapy accessible to all patients with multiple myeloma.

Online Virtual Nursing Placements: A Case Study on Placement Expansion.

Introduction: A need to increase student placements, in a culture that is under unprecedented demand, means that practice providers and partner higher education institutions need to find new and innovative ways to ensure quality learning experiences for students. Virtual placements are just one way of providing student placements, and this study presents a case for this. Objective: This research aims to explore the student's experience of virtual blended placements and to consider future sustainability. Method: This is a qualitative, exploratory study observing the attitudes, thoughts, and feelings of student nurse experiences of online virtual nursing placements. Key cases were identified, and two participants were asked to reflect upon their experiences of the blended virtual learning placement. Student evaluations, and virtual placement day plans, form part of the data collection, and results are presented in a theory building and comparative approach, adopting pattern matching. Results: Three themes emerged from the narratives, supported by student evaluations and day plans. Students reviewed the placement positively in that they were able to achieve their required practice proficiencies. Second, they discussed the way in which the virtual days were facilitated and that building relationships with professionals and peers while on placement was of high importance. Conclusion: This case study presents a novel and unique student experience within a 0-19 community nursing service, which through 3 days of practice placement supported by two virtually taught days, students were able to reach their practice proficiencies. This virtual placement model offers a unique way to reduce the pressures on frontline staff and enriches the students' experiences.

Observed High Adherence to Recombinant Human Growth Hormone Treatment Using a Multi-Component Approach to Improve Adherence in Individuals with Growth Disorders.

We explored whether a multi-component approach - using a digital health device, the easypod™ auto-injector, the 'MySupport' patient support programme (PSP) and a Patient Activation Measure® (PAM®) - could improve adherence in patients receiving recombinant human growth hormone (r-hGH). A 13-item PAM was used to assess caregiver self-reported knowledge, resulting in two PAM scores for 88 patients at four UK hospitals after an average of 5.6 months. Most patients improved their PAM score by ≥1 level (43%) or maintained it (>-1 and <1; 21%). In parallel, 74% of patients maintained (-5 to +5%) or improved (≥5%) their adherence. Further studies are required to evaluate a multi-component approach to adherence in a larger population and for a longer duration.

Variation in Glycemic Outcomes in Focal Forms of Congenital Hyperinsulinism-The UK Perspective.

Context: In focal congenital hyperinsulinism (CHI), localized clonal expansion of pancreatic ß-cells causes excess insulin secretion and severe hypoglycemia. Surgery is curative, but not all lesions are amenable to surgery. Objective: We describe surgical and nonsurgical outcomes of focal CHI in a national cohort. Methods: Patients with focal CHI were retrospectively reviewed at 2 specialist centers, 2003-2018. Results: Of 59 patients with focal CHI, 57 had heterozygous mutations in ABCC8/KCNJ11 (51 paternally inherited, 6 de novo). Fluorine-18 L-3,4 dihydroxyphenylalanine positron emission tomography computed tomography scan identified focal lesions in 51 patients. In 5 patients, imaging was inconclusive; the diagnosis was established by frozen section histopathology in 3 patients, a lesion was not identified in 1 patient, and 1 declined surgery. Most patients (n = 56) were unresponsive to diazoxide, of whom 33 were unresponsive or partially responsive to somatostatin receptor analog (SSRA) therapy. Fifty-five patients underwent surgery: 40 had immediate resolution of CHI, 10 had persistent hypoglycemia and a focus was not identified on biopsy in 5. In the 10 patients with persistent hypoglycemia, 7 underwent further surgery with resolution in 4 and ongoing hypoglycemia requiring SSRA in 3. Nine (15% of cohort) patients (1 complex surgical access; 4 biopsy negative; 4 declined surgery) were managed conservatively; medication was discontinued in 8 children at a median (range) age 2.4 (1.5-7.7) years and 1 remains on SSRA at 16 years with improved fasting tolerance and reduction in SSRA dose. Conclusion: Despite a unifying genetic basis of disease, we report inherent heterogeneity in focal CHI patients impacting outcomes of both surgical and medical management.

POTS and Pregnancy: A Review of Literature and Recommendations for Evaluation and Treatment.

Postural Orthostatic Tachycardia Syndrome (POTS) is a disorder of the autonomic nervous system most commonly affecting women of reproductive age. Studies on POTS and pregnancy are limited, and there is a lack of clinical guidelines regarding assessment and management of pregnant women with POTS. The purpose of this review is to summarize data from the available studies on the topic of pregnancy in POTS and common comorbid conditions and to provide the clinical recommendations regarding evaluation and treatment of POTS in pregnant women, based on the available studies and clinical experience. We conclude that pregnancy appears to be safe for women with POTS and is best managed by a multi-disciplinary team with knowledge of POTS and its various comorbidities. Importantly, large, prospective studies are needed to better delineate the course and outcomes of pregnancy, as well as possible pregnancy-related complications in women with POTS. Clinicians should be aware of the clinical presentation, diagnostic criteria, and treatment options in pregnant women with POTS to optimize outcomes and improve medical care during pregnancy and post-partum period.

The EHA Research Roadmap: Immune-based Therapies for Hematological Malignancies.

In 2016, the European Hematology Association (EHA) published the EHA Roadmap for European Hematology Research1 aiming to highlight achievements in the diagnostics and treatment of blood disorders, and to better inform European policy makers and other stakeholders about the urgent clinical and scientific needs and priorities in the field of hematology. Each section was coordinated by 1-2 section editors who were leading international experts in the field. In the 5 years that have followed, advances in the field of hematology have been plentiful. As such, EHA is pleased to present an updated Research Roadmap, now including 11 sections, each of which will be published separately. The updated EHA Research Roadmap identifies the most urgent priorities in hematology research and clinical science, therefore supporting a more informed, focused, and ideally a more funded future for European Hematology Research. the 11 EHA Research Roadmap sections include normal hematopoiesis; malignant lymphoid diseases; malignant myeloid diseases; anemias and related diseases; platelet disorders; blood coagulation and hemostatic disorders; transfusion medicine; infections in hematology; hematopoietic stem cell transplantation; CAR-T and Other cell-based immune therapies; and gene therapy.

Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study.

Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are associated with a range of characteristics and uncertainties regarding long term side-effects and efficacy. This raises questions about what matters most to patients living with this disease. This study aimed to understand which characteristics MM patients find most important, and hence should be included as attributes and levels in a subsequent quantitative preference survey among MM patients. Methods: This qualitative study involved: (i) a scoping literature review, (ii) discussions with MM patients (n = 24) in Belgium, Finland, Romania, and Spain using Nominal Group Technique, (iii) a qualitative thematic analysis including multi-stakeholder discussions. Results: MM patients voiced significant expectations and hopes that treatments would extend their lives and reduce their cancer signs and symptoms. Participants however raised concerns about life-threatening side-effects that could cause permanent organ damage. Bone fractures and debilitating neuropathic effects (such as chronic tingling sensations) were highlighted as major issues reducing patients' independence and mobility. Patients discussed the negative impact of the following symptoms and side-effects on their daily activities: thinking problems, increased susceptibility to infections, reduced energy, pain, emotional problems, and vision problems. MM patients were concerned with uncertainties regarding the durability of positive treatment outcomes, and the cause, severity, and duration of their symptoms and side-effects. Patients feared short-term positive treatment responses complicated by permanent, severe side-effects and symptoms. Conclusions: This study gained an in-depth understanding of the treatment and disease-related characteristics and types of attribute levels (severity, duration) that are most important to MM patients. Results from this study argue in favor of MM drug development and individual treatment decision-making that focuses not only on extending patients' lives but also on addressing those symptoms and side-effects that significantly impact MM patients' quality of life. This study underscores a need for transparent communication toward MM patients about MM treatment outcomes and uncertainties regarding their long-term efficacy and safety. Finally, this study may help drug developers and decision-makers understand which treatment outcomes and uncertainties are most important to MM patients and therefore should be incorporated in MM drug development, evaluation, and clinical practice.

Decreasing the Use of Restraints on Children Admitted for Behavioral Health Conditions.

OBJECTIVES: Pediatric behavioral health admissions to children's hospitals for disposition planning are steadily increasing. These children may exhibit violent behaviors, which can escalate to application of physical limb restraints for safety. Using quality improvement methodology, we sought to decrease physical restraint use on children admitted to our children's hospital for behavioral health conditions from a baseline mean of 2.6% of behavioral health patient days to <1%. METHODS: We included all children ≥3 years of age admitted to our hospital medicine service with a primary behavioral health diagnosis from July 1, 2016, to February 1, 2020. A multidisciplinary team, formed in July 2018, tested interventions based on key drivers targeted toward our aim. The primary outcome measure was the percent of behavioral health patient days on which physical restraints were ordered. The balancing measure was the percent of patient days with a staff injury event. Statistical process control charts were used to view and analyze data. RESULTS: Our cohort included 3962 consecutive behavioral health patient encounters, encompassing a total of 9758 patient days. A 2-year baseline revealed physical restraint orders placed on 2.6% of behavioral health patient days, which was decreased to 0.9% after interventions and has been sustained over 19 months without any change in staff injuries. CONCLUSIONS: Team-based quality improvement methodology was associated with a sustained reduction in physical restraint use on children admitted for behavioral health conditions to our children's hospital. These results indicate that physical restraint use can be safely reduced in children's hospitals.

Development of an international template to support patient submissions in Health Technology Assessments.

OBJECTIVES: To develop an international template to support patient submissions in Health Technology Assessments (HTAs). This was to be based on the experience and feedback from the implementation and use of the Scottish Medicines Consortium's (SMC) Summary Information for Patient Groups (SIP). METHODS: To gather feedback on the SMC experience, web-based surveys were conducted with pharmaceutical companies and patient groups familiar with the SMC SIP. Semistructured interviews with representatives from HTA bodies were undertaken, along with patient group discussions with those less familiar with the SIP, to explore issues around the approach. These qualitative data informed the development of an international SIP template. RESULTS: Survey data indicated that 82 percent (18 of 22 respondents) of pharmaceutical company representatives felt that the SIP was worthwhile; 88 percent (15/17) of patient group respondents found the SIP helpful. Both groups highlighted the need for additional support and guidance around plain language summaries. Further suggestions included provision of a glossary of terms and cost-effectiveness information. Patient group interviews supported the survey findings and led to the development of a new template. HTA bodies raised potential challenges around buy-in, timing, and bias connected to the SIP approach. CONCLUSIONS: The international SIP template is another approach to support deliberative processes in HTA. Although challenges remain around writing summaries for lay audiences, along with feasibility considerations for HTA bodies, the SIP approach should support more meaningful patient involvement in HTAs.