Satisfaction with the Injection Experience of a New, Citrate-Free Formulation of Ixekizumab.

INTRODUCTION: A new, citrate-free ixekizumab formulation, which is bioequivalent to the original formulation, was associated with significant reduction in injection site pain. This study evaluates patient satisfaction with the first injection experience of citrate-free ixekizumab in a real-world setting. METHODS: A non-interventional, observational, web-based survey of adults (≥ 18 years) with psoriasis, psoriatic arthritis, or axial spondyloarthritis was conducted between August 2022 and March 2023. Patients enrolled in the Taltz US Customer Support Program were identified as receiving either the original ixekizumab or initiating citrate-free ixekizumab. Patients receiving original ixekizumab completed one survey at baseline to assess satisfaction with the formulation and one survey after switching to assess satisfaction, willingness to continue using and recommending citrate-free ixekizumab, and formulation preference. Participants previously exposed to ixekizumab completed one survey to assess their satisfaction and willingness to continue using and recommending citrate-free ixekizumab. Descriptive and comparative statistics are reported for patients that switched from original to citrate-free ixekizumab (n = 361); and descriptive statistics are reported for patients not previously exposed to ixekizumab (n = 90). RESULTS: A total of 451 patients were included in the analysis. Significantly more patients were satisfied with their first injection with citrate-free ixekizumab compared to original ixekizumab (83.9% vs. 71.7% respectively; p = 0.0001). Almost all patients who switched from original ixekizumab were definitely or mostly willing to continue using and recommending citrate-free ixekizumab (93.9% and 93.4%, respectively). Additionally, 94.2% of patients who switched from original to citrate-free ixekizumab preferred citrate-free ixekizumab or had no preference. Three-fourths of patients not previously exposed to ixekizumab were satisfied with their first injection with citrate-free ixekizumab and 94.5% were definitely or mostly willing to continue using citrate-free ixekizumab. CONCLUSION: The citrate-free ixekizumab formulation was preferred and well accepted by most patients who switched from the original ixekizumab formulation. Similar findings were seen for those newly initiating citrate-free ixekizumab.

Ixekizumab Real-World Effectiveness at 24 Weeks in Patients with Psoriasis: Data from the United States Taltz Customer Support Program.

INTRODUCTION: Ixekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24 weeks. OBJECTIVE: To describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Customer Support Program. METHODS: This was a 24-week prospective, observational study of commercially insured diagnosis-confirmed adults with PsO. Surveys were completed at weeks 0 (baseline), 2, 4, 8, 12, and 24 and included the Patient Report of Extent of Psoriasis Involvement questionnaire to assess the extent of body surface area (BSA) affected by PsO, itch and pain numeric rating scales, Patient Global Assessment of Disease Severity (PatGA), and Dermatology Life Quality Index (DLQI). RESULTS: 523 patients were included in the analysis. Proportions of patients with ≤ 2% BSA involvement were 34.5%, 40.1%, 50.9%, and 79.9% at weeks 0, 2, 4, and 24, respectively; 54.8% and 75.1% achieved National Psoriasis Foundation preferred (BSA ≤ 1%) and acceptable (BSA ≤ 3% or ≥ 75% improvement) responses at week 12, respectively. Improvements of ≥ 4 points in itch and pain were seen by week 2 in 21.1% and 28.0% of patients, respectively, which increased to 63.1% and 64.8% at week 24. Proportions of patients with PatGA scores of 0 (clear) or 1 were 13.4%, 24.1%, 34.0%, and 69.6% at weeks 0, 2, 4, and 24, respectively; and proportions with DLQI total scores of 0 or 1 [no or minimal impact] were 8.4%, 17.6%, 27.3%, and 53.8% at weeks 0, 2, 4, and 24, respectively. CONCLUSION: Patient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2 weeks after initiation and continued through week 24.

Examining cognitive and behavioural symptoms across binge/purge profiles in adolescents with eating disorders.

Binge eating and purging profiles may vary in adolescents with eating disorders and this may potentially be a function of a range of cognitive and behavioural constructs. The aim was to determine whether cognitive and behavioural symptoms differed among purging profiles in 229 adolescent females (M age = 15.45). Differences were examined in three binge/purge profiles; (i) regular objective binge eating and purging (OBEP, n = 63), (ii) regular subjective binge eating and purging (SBEP, n = 41), and (iii) purging in the absence of any binge eating (P-noBE, n = 110). Adolescents with objective or subjective binge eating had significantly higher global eating disorder scores and eating, shape, and weight concerns than those without binge eating, but not more frequent compensatory behaviours. There were no significant differences on dietary restraint. The group with objective binge eating (OBEP) had significantly higher eating concerns and self-induced vomiting than adolescents with subjective binge eating (SBEP). Future research is required to understand the reasons for elevated symptoms in the OBE-P group, since the size of binge episodes is not thought to be a salient factor in binge eating. In contrast to the literature, we did not find support for a special relevance of dietary restraint to the purging only presentation (P-noBE), rather it was a universal characteristic of all binge/purge presentations. Eating concerns may be an important target in adolescents with objective binge symptoms. Future research should examine if treatment targeted at different binge/purge profiles improves efficacy of treatment in adolescents.

Measuring What Matters to Individuals with Angelman Syndrome and Their Families: Development of a Patient-Centered Disease Concept Model.

Angelman syndrome (AS) is a complex, heterogeneous, and life-long neurodevelopmental disorder. Despite the considerable impact on individuals and caregivers, no disease-modifying treatments are available. To support holistic clinical management and the development of AS-specific outcome measures for clinical studies, we conducted primary and secondary research identifying the impact of symptoms on individuals with AS and their unmet need. This qualitative research adopted a rigorous step-wise approach, aggregating information from published literature, then evaluating it via disease concept elicitation interviews with clinical experts and caregivers. We found that the AS-defining concepts most relevant for treatment included: impaired expressive communication, seizures, maladaptive behavior, cognitive impairment, motor function difficulties, sleep disturbance, and limited self-care abilities. We highlight the relevance of age in experiencing these key AS concepts, and the difference between the perceptions of clinicians and caregivers towards the syndrome. Finally, we outline the impact of AS on individuals, caregivers, and families.

Association Between Proportion of Workday Treating COVID-19 and Depression, Anxiety, and PTSD Outcomes in US Physicians.

OBJECTIVE: The primary objective of this cross-sectional study was to examine the association between time spent treating patients with Coronavirus disease 2019 (COVID-19) and levels of depression, anxiety, and posttraumatic stress disorder (PTSD) in US physicians. METHODS: The authors conducted an anonymous online survey of US physicians. Linear regression was used to test the association between proportion of day treating COVID-19 and symptoms of depression, anxiety, and PTSD. RESULTS: In a sample of 1724 US physicians, proportion of day treating COVID-19 was positively and significantly associated with depression, anxiety, and PTSD scores (P < 0.001 for each). CONCLUSIONS: Mental health resources should be provided to physicians who treat COVID-19 because the proportion of day treating COVID-19 is associated with depression, anxiety, and PTSD outcomes.

Development of the neurotrophic keratopathy questionnaire: qualitative research.

BACKGROUND: Neurotrophic keratopathy/keratitis (NK) is a rare disease of the cornea that can lead to anatomical loss of the eye. Little is known about the NK experience from the patients' perspective. The objectives of this study were to examine the symptomatic experience and impacts of NK on patients and assess the overall comprehension, relevance, and content validity of a new questionnaire. METHODS: This was a cross-sectional, qualitative study conducted with NK patients with varying levels of disease severity, recruited from one clinical site. One-on-one interviews using concept elicitation and cognitive interviewing techniques were conducted. RESULTS: Fourteen NK patients participated; 64.3% were female (n = 9), mean age was 65.7 ± 13.3, and 14.3% (n = 2), 21.4% (n = 3), and 64.3% (n = 9) were classified as Mackie stage I, stage II, or stage III, respectively. Participants reported 24 concepts, including: redness (n = 12, 86%), sensitivity to light (n = 11, 79%), general discomfort (n = 9, 64%), dry eye (n = 9, 64%), reduced visual acuity (n = 9, 64%), blurred vision (n = 8, 57%), and eye fatigue (n = 8, 57%). No new concepts were reported after the 13th interview. The most frequently reported impacts included frustration (n = 10, 71%), driving impairment (n = 8, 57%), reading impairment (n = 7, 50%), difficulty watching television (n = 7, 50%), and concern with potentially losing their eyesight due to NK (n = 6, 43%). Participants provided positive feedback on the draft NK Questionnaire (NKQ) and felt that it was comprehensive and relevant to their experience with NK. Additionally, the recall period, instructions, item concepts, and response options were well-understood by participants. Minor revisions were made to the tool for consistency (i.e., the timeframe "in the past 7 days" was added to items 12-14); item 14 was modified to include "how often"; examples were added to item 9. CONCLUSIONS: The results of the concept elicitation portion of the qualitative study support the content validity of the draft NKQ. The clinically significant concepts identified in the literature and raised during concept elicitation are included as items in the questionnaire. Further assessment of the psychometric properties should be conducted in support of this new tool to measure the effect of new treatments on symptoms and impacts associated with NK.

Consensus-based perspectives of pediatric inpatient eating disorder services.

OBJECTIVE: There are few evidence-based guidelines for inpatient pediatric eating disorders. The aim was to gain perspectives from those providing and receiving inpatient pediatric eating disorder care on the essential components treatment. METHOD: A modified Delphi technique was used to develop consensus-based opinions. Participants (N = 74) were recruited for three panels: clinicians (n = 24), carers (n = 31), and patients (n = 19), who endorsed three rounds of statements online. RESULTS: A total of 167 statements were rated, 79 were accepted and reached a consensus level of at least 75% across all panels, and 87 were rejected. All agreed that families should be involved in treatment, and thatpsychological therapy be offered in specialist inpatient units. Areas of disagreement included that patients expressed a desire for autonomy in sessions being available without carers, and that weight gain should be gradual and admissions longer, in contrast to carers and clinicians. Carers endorsed that legal frameworks should be used to retain patients if required, and that inpatients are supervised at all times, in contrast to patients and clinicians. Clinicians endorsed that food access should be restricted outside meal times, in contrast to patients and carers. DISCUSSION: The findings indicate areas of consensus in admission criteria, and that families should be involved in treatment, family involvement in treatment, while there was disagreement across groups on topics including weight goals and nutrition management. Perspectives from patients, carers, and clinicians may be useful to consider during future revisions of best practice guidelines.

The Anorexia Nervosa Genetics Initiative: Study description and sample characteristics of the Australian and New Zealand arm.

OBJECTIVES: Anorexia nervosa is a severe psychiatric disorder with high mortality rates. While its aetiology is poorly understood, there is evidence of a significant genetic component. The Anorexia Nervosa Genetics Initiative is an international collaboration which aims to understand the genetic basis of the disorder. This paper describes the recruitment and characteristics of the Australasian Anorexia Nervosa Genetics Initiative sample, the largest sample of individuals with anorexia nervosa ever assembled across Australia and New Zealand. METHODS: Participants completed an online questionnaire based on the Structured Clinical Interview Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) eating disorders section. Participants who met specified case criteria for lifetime anorexia nervosa were requested to provide a DNA sample for genetic analysis. RESULTS: Overall, the study recruited 3414 Australians and 543 New Zealanders meeting the lifetime anorexia nervosa case criteria by using a variety of conventional and social media recruitment methods. At the time of questionnaire completion, 28% had a body mass index ⩽ 18.5 kg/m2. Fasting and exercise were the most commonly employed methods of weight control, and were associated with the youngest reported ages of onset. At the time of the study, 32% of participants meeting lifetime anorexia nervosa case criteria were under the care of a medical practitioner; those with current body mass index < 18.5 kg/m2 were more likely to be currently receiving medical care (56%) than those with current body mass index ⩾ 18.5 kg/m2 (23%). Professional treatment for eating disorders was most likely to have been received from general practitioners (45% of study participants), dietitians (42%) and outpatient programmes (42%). CONCLUSIONS: This study was effective in assembling the largest community sample of people with lifetime anorexia nervosa in Australia and New Zealand to date. The proportion of people with anorexia nervosa currently receiving medical care, and the most common sources of treatment accessed, indicates the importance of training for general practitioners and dietitians in treating anorexia nervosa.

Prevention of eating disorders: A systematic review of randomized, controlled trials.

OBJECTIVE: This systematic review evaluated the efficacy of universal, selective, and indicated eating disorder prevention. METHOD: A systematic literature search was conducted in Medline, PsycINFO, Embase, Scopus, and the Cochrane Collaboration Library databases to January 2016. Studies were included if they were randomized, controlled trials (RCT) and tested an eating disorder prevention program. We retrieved 13 RCTs of universal prevention (N = 3,989 participants, 55% female, M age = 13.0 years), 85 RCTs of selective prevention (N = 11,949 participants, 99% female, M age = 17.6 years), and 8 RCTs of indicated prevention (N = 510 participants, 100% female, M age = 20.1 years). Meta-analysis was performed with selective prevention trials. As there were a limited number of universal and indicated trials, narrative synthesis was conducted. RESULTS: Media literacy had the most support for universal prevention. Most universal approaches showed significant modest effects on risk factors. Dissonance-based was the best supported approach for selective prevention. Cognitive-behavior therapy (CBT), a healthy weight program, media literacy, and psychoeducation, were also effective for selective prevention and effects were maintained at follow-up. CBT was supported for indicated prevention and effects were maintained at follow-up. DISCUSSION: The modest effects for universal prevention were likely due to floor effects. The evidence for selective prevention suggests that empirically supported approaches should be disseminated on a wider basis. Our findings suggest CBT should be offered for indicated populations. Overall, results suggest efficacy of several prevention programs for reducing risk for eating disorders, and that wider dissemination is required. © 2016 Wiley Periodicals, Inc.

Eating disorder examination: Factor structure and norms in a clinical female pediatric eating disorder sample.

OBJECTIVE: The factor structure of the eating disorder examination (EDE) has never been tested in a clinical pediatric sample, and no normative data exist. METHOD: The factor structure of an adapted EDE was examined in a clinical sample of 665 females aged 9-17 years with anorexia nervosa spectrum (70%), bulimia nervosa spectrum (12%), purging disorder (3%), and unspecified feeding and eating disorders (15%). RESULTS: The original four-factor model was a good fit in a confirmatory factor analysis as well a higher order model with three dimensions of restraint, eating concern, and combined weight concern/shape concern. Normative data are reported for clinicians to identify the percentiles in which their patients' score. DISCUSSION: The findings support dimensions of restraint, eating concern, weight concern, and shape concern in a clinical pediatric sample. This supports the factorial validity of the EDE, and the norms may assist clinicians to evaluate symptoms in females under 18 years.

Clinical presentation of eating disorders in young males at a tertiary setting.

BACKGROUND: Young males with eating disorders are a neglected study population in eating disorders. The aim of this study was to provide knowledge about the clinical presentation of eating disorders in young males. METHODS: The data source was the Helping to Outline Paediatric Eating Disorders (HOPE) Project (N ~ 1000), a prospective, ongoing registry comprising consecutive paediatric (<18 years) tertiary eating disorder referrals. Young males with DSM-5 eating disorders (n = 53) were compared with young females with eating disorders (n = 704). RESULTS: There was no significant difference in the prevalence of diagnosis of bulimia nervosa (2 % vs 11 %, p = 0.26) among sexes. Males had comparable duration of illness (9 months; p = 0.28) and a significantly earlier age of onset (M = 12 years; p <0.001). Shape concern (2.39 vs 3.57, p <0.001) and weight concern (1.97 vs 3.09, p <0.001) were lower in males, and body mass index z score (-1.61 vs -1.42, p = 0.29) and medical compromise (odds ratio [OR] = 0.64, 95 % CI: 0.36, 1.12) were comparable. Males had a two-folder higher odds of being diagnosed with unspecified feeding or eating disorders (40 % vs 22 % for females, p = 0.004). Driven exercise to control weight and shape was common and comparable in prevalence among males and females (51 % vs 47 %, p = 0.79) and males were less likely to present with self-induced vomiting (OR = 0.23, 95 % CI: 0.09, 0.59). CONCLUSION: Boys with eating disorders are an understudied group with similarities and differences in clinical presentation from girls with eating disorders. Parents and physicians are encouraged to consider changes in weight, disturbed vital signs, and driven, frequent exercise for the purposes of controlling weight or shape, as possible signs of eating disorders among male children. Diagnostic classification, assessment instruments, conceptualisation, and treatment methods need to be refined to improve application to young males.

Brief report: Correlates of inpatient psychiatric admission in children and adolescents with eating disorders.

OBJECTIVE: To examine the prevalence and importance of psychological, behavioural, and situational correlates of impending psychiatric inpatient admissions in children and adolescents with eating disorders. METHOD: The sample consisted of 285 patients (8-17 years, M = 14.4, SD = 1.49) with DSM-5 eating disorders assessed between 2006 and 2013 from the Helping to Outline Pediatric Eating Disorders (HOPE) Project. The sample was split into two groups, those with (n = 38) and without (n = 247) impending psychiatric admission; Discriminant function analysis was used to examine correlates. RESULTS: The prevalence of impending psychiatric admission was 13.3%. Suicidal ideation provided the greatest discriminating power, followed by eating pathology, depressive symptoms, anxiety, multiple methods of weight control, binge eating, and family functioning. CONCLUSIONS: Earlier recognition of comorbid symptoms in eating disorders in the community may reduce the number of young people with eating disorders who present needing critical psychiatric care.

A decade of data from a specialist statewide child and adolescent eating disorder service: does local service access correspond with the severity of medical and eating disorder symptoms at presentation?

BACKGROUND: Eating disorders affect up to 3% of children and adolescents, with recovery often requiring specialist treatment. A substantial literature has accrued suggesting that lower access to health care services, experienced by rural populations, has a staggering effect on health-related morbidity and mortality. The aim of this study was to evaluate whether lower service access foreshadowed a more severe medical and symptom presentation among children and adolescents presenting to a specialist eating disorders program. METHOD: The data source was the Helping to Outline Paediatric Eating Disorders (HOPE) Project registry (N ~1000), a prospective ongoing registry study comprising consecutive paediatric tertiary eating disorder referrals. The sample consisted of 399 children and adolescents aged 8 to 16 years (M =14.49, 92% female) meeting criteria for a DSM-5 eating disorder. RESULTS: Consistent with the hypotheses, lower service access was associated with a lower body mass index z-score and a higher likelihood of medical complications at intake assessment. Contrary to our hypothesis, eating pathology assessed at intake was associated with higher service access. No relationship was observed between service access and duration of illness or percentage of body weight lost. CONCLUSIONS: Lower service access is associated with more severe malnutrition and medical complications at referral to a specialist eating disorder program. These findings have implications for service planning and provision for rural communities to equalize health outcomes.

Parent skills training treatment for parents of children and adolescents with eating disorders: a qualitative study.

OBJECTIVE: This study examined the experience of parents of children with eating disorders after having participated in a skills-based training intervention. METHOD: Eleven parents were interviewed and transcripts were analysed using inductive thematic analysis. RESULTS: Parent responses were organised around key themes of (1) effectiveness and acceptability of the intervention; (2) interpersonal experience of the group process; and (3) feedback on intervention content. Overall, the transfer of specialist skills was highly valued by parents and applied within the home and hospital setting. DISCUSSION: This study contributes preliminary evidence that skills-based training may improve parent self-efficacy,psychological distress, anxiety, and burden.This intervention can also be a cost-effective method for supporting carers,and future research is required to contribute data on treatment efficacy for patients in addition to parents.

Comparative study of children and adolescents referred for eating disorder treatment at a specialist tertiary setting.

OBJECTIVE: To examine child and adolescent differences in the clinical presentation of eating disorders (EDs) at referral to a specialist pediatric program. METHOD: This study compared cognitive, behavioral, and physical and medical features of children (≤ 12 years) and adolescents (13-18 years) with EDs presenting to a state-wide specialist pediatric ED service over two decades (N = 656; 8-18 years; 94% female). RESULTS: Significant differences were found between the groups. Children were more commonly male (p < .001), had lower eating pathology scores (p < .001), were less likely to binge eat (p = .02), purge (p < .001) or exercise for shape and weight control (p < .001), and lost weight at a faster rate than adolescents (p = .009), whereas adolescents were more likely to present with bulimia nervosa spectrum disorders (p = .004). Children and adolescents did not differ significantly on mean body mass index z-score, percentage of body weight lost, or indicators of medical compromise (p > .05). DISCUSSION: The clinical presentation of EDs differs among children and adolescents, with eating pathology and behavioral symptoms less prominent among children. Frontline health professionals require knowledge of these differences to assist with early detection, diagnosis, and prognosis.

Parent-child concordance in reporting of child eating disorder pathology as assessed by the eating disorder examination.

OBJECTIVE: The aim of this study was to examine parent-youth concordance in reporting of eating disorder pathology, as assessed by the Eating Disorder Examination (EDE) in a clinical pediatric sample. METHOD: The sample comprised 619 parent-youth dyads of youth (8-18 years) presenting for treatment at a specialist eating disorder clinic. A cross-sectional correlational design was used to examine the association between parent and youth symptom reports. RESULTS: On the whole, parent-youth inter-rater agreement was poor to moderate. Agreement was acceptable for the presence of behavioral symptoms, with the exception of excessive exercise (PAK = 0.48-0.98). There was poor inter-rater agreement on frequency of behavioral symptoms, with parents providing lower estimates than youth (ICC = 0.07-0.52). Although we predicted that inter-rater agreement on cognitive symptoms would by higher with adolescents than children, both groups were discordant with parent reports. Younger children identified less severe eating disorder cognitions than parents and the opposite occurred for adolescents. An anorexia nervosa presentation and lower malnutrition were not associated with lower inter-rater agreement, as might have been expected through ego syntonicity. Youth with bulimia nervosa presentations reported significantly higher severity of cognitive symptoms and more frequent disordered eating behaviors compared with their parents. DISCUSSION: Results support the utility of parent-youth assessment via the EDE to obtain a wider clinical picture of eating disorder psychopathology in children and adolescents, particularly for younger children. Clinical implications pertinent to administration of the EDE and parent literacy regarding eating disorder symptoms are discussed.

A hub and spokes approach to building community capacity for eating disorders in rural Western Australia.

OBJECTIVE: To determine whether an outreach community-based training program on eating disorders enhances perceived capacity of rural health and education professionals to respond to and manage eating disorders. DESIGN: Survey conducted upon completion of outreach training. SETTING: Rural Western Australia. PARTICIPANTS: Health and education professionals working in rural Western Australia. MAIN OUTCOME MEASURES: Questionnaire responses analysed via descriptive statistics and inferential tests. RESULTS: There was a significant increase in perceived ability to identify, support and/or treat people with eating disorders among health and education professionals. CONCLUSIONS: Outreach training up-skilled rural gatekeepers and introduced systemic health system benefits of increased consultation and liaison, a fine-tuning of referral processes, a reduction in hospital admissions and better uptake of local services by patients discharged from hospital.

Psychotropic drug prescribing in an Australian specialist child and adolescent eating disorder service: a retrospective study.

BACKGROUND: To describe the rates, indications, and adverse effects of psychotropic drug prescription in a specialist tertiary hospital child and adolescent eating disorder service. METHODS: Retrospective case note study of all active eating disorder patients (N = 115) over the period of treatment from referral to time of study (M = 2 years), covering patient demographics, clinical characteristics, drug prescriptions, indications, and adverse effects. RESULTS: Psychotropic drugs were prescribed in 45% of cases, most commonly antidepressants (41%), followed by anxiolytics (29%) and antipsychotics (22%), with 8% initiated before referral to the specialist eating disorder program. Common indications were depressed mood, agitation, anxiety, and insomnia. Patient clinical severity and complexity was associated with prescribing. Adverse effects, mostly minor, were recorded in 23% of antidepressant prescriptions, 39% of antipsychotic prescriptions, and 13% of anxiolytic prescriptions. Second generation antipsychotic prescription was associated with subsequent new onset binge eating, in this preliminary observational study. Self-harm by overdose of psychotropics occurred in 11% of patients prescribed medication. CONCLUSIONS: Psychotropic medications were frequently prescribed to adolescent eating disorder patients to treat distressing symptoms. Prospective randomised controlled trials to clarify efficacy and safety are needed. Given the difficulties of conducting clinical trials in this population, services are encouraged to monitor and audit medication safety and efficacy in everyday practice, and to report their findings.

The HOPE (Helping to Outline Paediatric Eating Disorders) Project: development and debut of a paediatric clinical eating disorder registry.

BACKGROUND: The HOPE (Helping to Outline Paediatric Eating Disorders) Project is an ongoing registry study made up of a sequential cross-sectional sample prospectively recruited over 17 years, and is designed to answer empirical questions about paediatric eating disorders. This paper introduces the HOPE Project, describes the registry sample to-date, and discusses future directions and challenges and accomplishments. The project and clinical service were established in a tertiary academic hospital in Western Australia in 1996 with a service development grant. Research processes were inbuilt into the initial protocols and data collection was maintained in the following years. Recognisable progress with the research agenda accelerated only when dedicated research resources were obtained. The registry sample consists of consecutive children and adolescents assessed at the eating disorder program from 1996 onward. Standardised multidisciplinary data collected from family intake interview, parent and child clinical interviews, medical review, parent, child and teacher psychometric assessments, and inpatient admission records populate the HOPE Project database. RESULTS: The registry database to-date contains 941 assessments, of whom 685 met DSM-IV diagnostic criteria for an eating disorder at admission. The majority of the sample were females (91%) from metropolitan Perth (83%). The cases with eating disorders consist of eating disorders not otherwise specified (68%), anorexia nervosa (25%) and bulimia nervosa (7%). Among those with eating disorders, a history of weight loss since illness onset was almost universal (96%) with fear of weight gain (71%) common, and the median duration of illness was 8 months. CONCLUSIONS: Over the next five years and more, we expect that the HOPE Project will make a strong scientific contribution to paediatric eating disorders research and will have important real-world applications to clinical practice and policy as the research unfolds.

Psychometric assessment of the Injection Pen Assessment Questionnaire (IPAQ): measuring ease of use and preference with injection pens for human growth hormone.

PURPOSE: To examine the psychometric properties of the Injection Pen Assessment Questionnaire (IPAQ) including the following: 1) item and scale characteristics (e.g., frequencies, item distributions, and factor structure), 2) reliability, and 3) validity. METHODS: Focus groups and one-on-one dyad interviews guided the development of the IPAQ. The IPAQ was subsequently tested in 136 parent-child dyads in a Phase 3, 2-month, open-label, multicenter trial for a new Genotropin(®) disposable pen. Factor analysis was performed to inform the development of a scoring algorithm, and reliability and validity of the IPAQ were evaluated using the data from this two months study. Psychometric analyses were conducted separately for each injection pen. RESULTS: Confirmatory factor analysis provides evidence supporting a second order factor solution for four subscales and a total IPAQ score. These factor analysis results support the conceptual framework developed from previous qualitative research in patient dyads using the reusable pen. However, the IPAQ subscales did not consistently meet acceptable internal consistency reliability for some group level comparisons. Cronbach's alphas for the total IPAQ score for both pens were 0.85, exceeding acceptable levels of reliability for group comparisons. CONCLUSIONS: The total IPAQ score is a useful measure for evaluating ease of use and preference for injection pens in clinical trials among patient dyads receiving hGH. The psychometric properties of the individual subscales, mainly the lower internal consistency reliability of some of the subscales and the predictive validity findings, do not support the use of subscale scores alone as a primary endpoint.