Immunoglobulin utilization in Canada: a comparative analysis of provincial guidelines and a scoping review of the literature.

BACKGROUND: Canada has high immunoglobulin (IG) product utilization, raising concerns about appropriate utilization, cost and risk of shortages. Currently, there is no national set of standardized IG guidelines, and considerable variations exist among the existing provincial guidelines. The aims of this study were: (1) to compare the existing Canadian provincial guidelines on the use of IG products to identify their consistencies and differences and (2) to examine the existing research in Canada on IG supply and utilization following the establishment of IG guidelines to understand the scope of research and pinpoint the gaps. METHODS: A comparative analysis accounted for the differences across provincial IG guidelines. We highlighted similarities and differences in recommendations for medical conditions. A scoping review of citations from MEDLINE, PubMed, Scopus and Embase databases was conducted for studies published from January 01, 2014, to April 12, 2023. RESULTS: While provincial guidelines represented a considerable overlap in the medical conditions delineated and relatively uniform dose calculations, numerous differences were observed, including in recommendation categories, provision of pediatric dosing, and divergent recommendations for identical conditions based on patient demographics. The scoping review identified 29 studies that focused on the use of IG in Canada. The themes of the studies included: IVIG utilization and audits, the switch from IVIG to SCIG, patient satisfaction with IVIG and/or SCIG, the economic impact of self-administered SCIG versus clinically administered IVIG therapy, and the efficacy and cost-effectiveness of alternative medications to IG treatment. CONCLUSION: The differences in guidelines across provinces and the factors influencing IVIG/SCIG use, patient satisfaction, and cost savings are highlighted. Future research may focus on clarifying costs and comparative effectiveness, exploring factors influencing guideline adherence, and evaluating the impact of updated guidelines on IG use and patient outcomes.

Psychometric properties of the Quick Inventory of Depressive Symptomatology in adolescents.

OBJECTIVE: The clinician-rated (QIDS-C16) and self-report (QIDS-SR16) versions of the 16-item Quick Inventory of Depressive Symptomatology have been extensively examined in adult populations. This study evaluated both versions of the QIDS and the 17-item Children's Depressive Rating Scale - Revised (CDRS-R) in an adolescent outpatient sample. METHOD: Both the QIDS-C16 and QIDS-SR16 were completed for the adolescents. Three different methods were used to complete the QIDS-C16: (a) adolescents' responses to clinician interviews; (b) parents' responses to clinician interview; and (c) a composite score using the most pathological response from the two interviews. Both classical and item response theory methods were used. Factor analyses evaluated the dimensionality of each scale. RESULTS: The sample included 140 adolescent outpatients. All versions of the QIDS, save the parent interview, and the CDRS-R were very reliable (α ≥ 0.8). All four versions of the QIDS are reasonably effective and unidimensional. The CDRS-R was clearly at least two-dimensional. The CDRS-R was the most discriminating among low and extremely high levels of depression. The QIDS-SR16 was the most discriminating at moderate levels of depression. There was no relation between the QIDS scores and concurrent Axis III comorbidities. CONCLUSION: The QIDS-C16 and the QIDS-SR16 are suitable for use in adolescents.

A Comparison of the QIDS-C16, QIDS-SR16, and the MADRS in an Adult Outpatient Clinical Sample.

BACKGROUND: This study compared the 16-item Clinician and Self-Report versions of the Quick Inventory of Depressive Symptomatology (QIDS-C16 and QIDS-SR16) and the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) in adult outpatients. The comparison was based on psychometric features and their performance in identifying those in a major depressive episode as defined by the Mini-International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. METHODS: Of 278 consecutive outpatients, 181 were depressed. Classical test theory, factor analysis, and item response theory were used to evaluate the psychometric features and receiver operating characteristic (ROC) analyses. RESULTS: All three measures were unidimensional. All had acceptable reliability (coefficient a=.87 for MADRS10, .82 for QIDS-C16, and .80 for QIDS-SR16). Test information function was higher for the MADRS (ie, it was most sensitive to individual differences in levels of depression). The MADRS and QIDS-C16 slightly but consistently outperformed the QIDS-SR16 in differentiating between depressed versus nondepressed patients. CONCLUSION: All three measures have satisfactory psychometric properties and are valid screening tools for a major depressive episode.

A pilot study of an electronic, adolescent version of the quick inventory of depressive symptomatology.

BACKGROUND: Adolescent depression assessments are time-intensive, often requiring separate interviews with an adolescent and a parent/ informant. In adults, a self-rated, interactive voice response (IVR) version of the Quick Inventory of Depressive Symptomatology (QIDS-IVR) has been shown to be reliable, valid, and sensitive to change. An adolescent version of the QIDS (QIDS-A-IVR) was created using speaker-independent voice recognition technology. An informant version, QIDS-P-IVR, collects ratings from parents or other knowledgeable adults. METHOD: The study included 27 adolescents ranging from 12 to 17 years of age, 48% of whom were female. During a single office visit, adolescents completed the QIDS-A-IVR and parents completed the QIDS-P-IVR. A clinician completed the clinician-rated adult version of the QIDS separately for adolescents (QIDS-C-A) and parents (QIDS-C-P) and the Children's Depression Rating Scale-Revised (CDRS-R). The study was conducted from October 2005 to April 2006. RESULTS: Cronbach alpha of the QIDS-A-IVR was .85. The QIDS-A-IVR correlated significantly with the QIDS-C-A (r = 0.95) and the CDRS-R (r = 0.76), both p < .01. Conversely, the correlations of the QIDS-A-IVR with the QIDS-P-IVR and the QIDS-C-P were small and nonsignificant. The QIDS-A-IVR required adolescents a mean of 6 minutes and 31 seconds to complete (SD = 41 seconds). The voice recognition technology correctly identified the adolescents' spoken words in 92% of the 483 spoken responses. The system recognized a response from all adolescents on all items. CONCLUSIONS: This study supports the reliability and validity of the QIDS-A-IVR as an adolescent depression measure. The QIDS-A-IVR may provide clinicians and researchers with a sound, technology-based method of assessing adolescent depression. Future research is needed on the informational value of parent ratings of adolescent depression.

Enrolling research subjects from clinical practice: ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial is a multi-site effectiveness study funded by the National Institute of Mental Health (NIMH) with the aim of identifying successful, acceptable and cost-effective treatment strategies for outpatients with unremitted depression. With enrollment of 4,041 adults with major depressive disorder (MDD), it is the largest controlled psychiatric treatment study ever undertaken. In the course of developing procedures to ensure that ambitious enrollment goals were met, a number of ethical and practical issues became apparent that underscore the conflicts between effectiveness research and human subject protections. These are delineated as they relate to study design; eligibility criteria; incentives to subjects; investigators and clinical sites; the complementary roles of clinical research coordinators (CRCs) and study clinicians; and recruitment and consent procedures. The STAR*D trial exemplifies the interplay and tension between those strategies that integrate research and clinical aims and roles in the service of enhancing external validity, site participation, and recruitment and retention versus those strategies that differentiate research and clinical treatment in the service of research integrity and human subject protections. We hope that a discussion of these key challenges and dilemmas and how they have been addressed will help inform future discussions concerning design and conduct of ethical effectiveness trials designed to optimize care in real world clinical settings.