The goal of hemovigilance is to increase the safety and quality of blood transfusion. Identification of the adverse reactions will help in taking appropriate steps to reduce their incidence and make blood transfusion process as safe as possible.
To determine the frequency and type of transfusion reactions (TRs) occurring in patients, reported to the blood bank at our institute.
Materials and Methods:
A retrospective review of all TRs reported to the blood bank at the All India Institute of Medical Sciences, between December 2007 and April 2012 was done. All the TRs were evaluated in the blood bank and classified using standard definitions.
During the study period a total of 380,658 bloods and blood components were issued by our blood bank. Out of the total 196 adverse reactions reported under the hemovigilance system, the most common type of reaction observed was allergic 55.1% (n = 108), followed by febrile non-hemolytic transfusion reaction (FNHTR) 35.7% (n = 70). Other less frequently observed reactions were Anaphylactoid reactions 5.1% (n = 10), Acute non-immune HTRs 2.6% (n = 5), Circulatory overload 0.5% (n = 1), Transfusion related acute lung injury 0.5% (n = 1), Delayed HTRs 0.5% (n = 1). Not a single case of bacterial contamination was observed.
The frequency of TRs in our patients was found to be 0.05% (196 out of 380,658). This can be an underestimation of the true incidence because of under reporting. It should be the responsibility of the blood transfusion consultant to create awareness amongst their clinical counterpart about safe transfusion practices so that proper hemovigilance system can be achieved to provide better patient care.
Adverse transfusion reactions; blood transfusion; hemovigilance
In recent years, pulmonary transfusion reactions have gained increasing importance as serious adverse transfusion events.
Review of the literature.
Pulmonary transfusion reactions are not extremely rare and, according to hemovigilance data, important causes of transfusion-induced major morbidity and death. They can be classified as primary with predominant pulmonary injury and secondary as part of another transfusion reaction. Primary reactions include transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and transfusion-associated dyspnea (TAD). Secondary pulmonary reactions are often observed in the wake of hemolytic transfusion reactions, hypotensive/anaphylactic reactions, and transfusion-transmitted bacterial infections.
Knowledge and careful management of cases of pulmonary transfusion reactions are essential for correct reporting to blood services and hemovigilance systems. Careful differentiation between TRALI and TACO is important for taking adequate preventive measures.
Acute lung injury; Transfusion reaction; Transfusion risks
Hemovigilance is an organized system of surveillance throughout the transfusion chain
intended to evaluate information in order to prevent the appearance or recurrence of
adverse reactions related to the use of blood products.
The aims of this study were to assess the late reporting of incidents related to
possible seroconversion in respect to age, marital status and ethnical background,
annual variations in late reporting, the number of reports opened and closed,
seroconversion of donors and transfusions of blood products within the window period.
This retrospective, descriptive study used data on blood donations in the blood bank in
Uberaba during the period from 2004 to 2011. Some socio-epidemiological characteristics
of the donors and serology test results of donors and recipients were analyzed in
respect to the late reporting of incidents related to possible seroconversion. The
Chi-square test, odds ratio and a regression model were used for statistical analysis.
From 2004 to 2011, the blood bank in Uberaba collected 117,857 blood bags, 284 (0.24%)
of which were investigated for late reported incidents. The profile of the donors was
less than 29 years old, unmarried and non-Whites. Differences in age (p-value <
0.0001), marital status (p-value = 0.0002) and ethnical background (p-value <
0.0001) were found to be statistically significant. There was no statistical difference
between men and women (0.24% and 0.23% respectively; p-value = 0.951). The number of
late reported incidents increased until 2008 followed by a downward trend until 2011.
There were twelve cases of seroconversion in subsequent donations (seven human
immunodeficiency virus, four hepatitis B and one hepatitis C) with proven human
immunodeficiency virus infection after screening of only one recipient.
The twelve cases of seroconversion in donors with subsequent infection proven in one
recipient underscores the importance of this tool to increase transfusion safety.
Blood safety; Serology; Blood donors; Blood transfusion/adverse effects; Communicable diseases/transmission; Quality assurance, health care; Retrospective studies
The transmission of pathogens via blood transfusion is still a major threat. Expert conferences established the need for a pro-active approach and concluded that the introduction of a pathogen inactivation/reduction technology requires a thorough safety profile, a comprehensive pre-clinical and clinical development and an ongoing hemovigilance program.
Material and Methods
The INTERCEPT Blood System utilizes amotosalen and UVA light and enables for the treatment of platelets and plasma in the same device. Preclinical studies of pathogen inactivation and toxicology and a thorough program of clinical studies have been conducted and an active he-movigilance-program established.
INTERCEPT shows robust efficacy of inactivation for viruses, bacteria (including spirochetes), protozoa and leukocytes as well as large safety margins. Furthermore, it integrates well into routine blood center operations. The clinical study program demonstrates the successful use for very diverse patient groups. The hemovigilance program shows safety and tolerability in routine use. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide. The system is in clinical use since class III CE-mark registration in 2002. The safety and efficacy has been shown in routine use and during an epidemic.
The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections.
Pathogen inactivation; Platelets; Plasma; Amotosalen
The Agence Française de Securite Sanitaire des Produits de Santé (Afssaps; French Health Products Safety Agency) is responsible, through its hemovigilance unit, for the organization and the functioning of the national hemovigilance network. In accordance with the French law, it receives all data on adverse transfusion reactions regardless of their severity. With the aim of evaluating the tolerance of two kinds of labile blood products (LBP), pooled platelet concentrates (PP) and apheresis platelet concentrates (APC), we screened the French national database from January 1, 2000 to December 31, 2006. We observed that the number of transfusion incident reports is more than twice as high with APC (8.61:1,000 LBP) than with PP (4.21:1,000 LBP). The difference between these two ratios is statistically significant as shown by chi-square test (e = 21.00 with α = 5%). The risk to suffer adverse reactions of any type, except for alloimmunization, is higher with APC, and the major type of diagnosis related to APC is allergic reaction (1:200 APC issued) even if those allergic reactions are rarely serious. The new French National Hemovigilance Commission should impel a working group evaluating this topic and above all the impact of additive solutions which have been used since 2005 to put forward preventives measures.
French hemovigilance; Apheresis platelet concentratece; Pooled platelet concentrate; Adverse reaction
A centralized hemovigilance program to assure patient safety and to promote public health has been launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. National Institute of Biologicals (NIB) will be the National Coordinating Centre for Hemovigilance. This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC). All medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform.
Hemovigilance; India; Medical colleges; Transfusion Reaction Reporting Form
Epidemiological data are essential for monitoring trends and outbreaks of infectious diseases in the general population. The reporting system pursuant to the Infection Protection Act in Germany results in a very good quality of timely nationwide data on all reportable diseases including those relevant for the blood supply: HIV, hepatitis C, hepatitis B and syphilis. Notifications of acute hepatitis B and first-time diagnosed hepatitis C infections in the general population showed a declining trend in the past years, but the number of reports of HIV and syphilis infections increased until 2007 especially among men who have sex with men. New preventive strategies should also address changes in sexual behavior. The specific surveillance of blood donors is an important part of the hemovigilance system. The highly effective donor selection process results in a small number of confirmed infections among donors in Germany. The surveillance data enable us to identify specific trends that might challenge blood safety like the increase in HIV infections among repeat donors. Specific evaluations are performed when needed. These additional studies can be used to modify guidelines or recommendations and to (re)evaluate the need for or the effect of further testing.
Blood donation; HBV; HCV; Hemovigilance; HIV; Epidemiology
Blood safety must be maintained throughout the whole transfusion chain to prevent the transfusion of incorrect blood components. The estimated risk of an incorrect transfusion is in the order of 1 per 10,000 units of blood. Although several kinds of errors contribute to “wrong blood” events, 70% of errors occur in clinical areas with the most common being due to failure of the pre-transfusion bedside checking procedure.
Materials and Methods
Several methods are available to reduce such errors. The I-TRAC Plus system by Immucor consists of an identification bracelet which is a bar-coded wristband and a handheld portable computer that identifies patients and blood bags by a scanner and prints the information through a portable printer. The labels attached on the blood order forms and on the sample tubes are read and recorded in the blood bank’s informatics system (EmoNet INSIEL). Labels showing the bar-code of the assigned number, which includes the ID number of the patient, the ID number of the unit and a code identifying the kind of product and use (allogeneic or autologous), are generated and applied to the blood components. The transfusions are administered after checking the unit and the patient’s wristband using the scanner of a portable PC.
In 5 years a total of 71,400 units of blood components were transfused to 15,430 patients using the I-TRAC Plus system. The system prevented 12 cases of mis-identification of patients (5 in 2003, 0 in 2004, 1 in 2005, 1 in 2006 and 5 in 2007).
In 2003 we introduced the use of a bar-code matching system between a patient’s wristband and the blood bag to avoid mistakes at the bedside. In 5 years the system provided benefits by avoiding errors in the identification of patients, thus preventing “wrong blood” transfusions.
Recipient identification; transfusion safety; mistransfusion
To optimize blood ordering and accurately assess transfusion practice, in 1987, an "on line" computerized, knowledge-based, blood order critiquing system was integrated into the HELP Hospital Information System (HIS) at LDS Hospital. Evaluations of the computerized ordering system demonstrated its benefits and limitations on transfusion practice. Based on this experience, a second generation blood ordering system using a consultation mode was developed. A pilot test of this blood order consultant system, using historical data in the HELP system's database, was performed. This pilot test demonstrated that the consultation system provided accurate recommendations for red blood cell (RBC) and platelet orders. Comparing the appropriateness of blood orders with the recommendations made by the director of the blood bank, the orders recommended by the computer "consultant" agreed 95.5% of the time. The computer consultation system also recommended fewer RBC units for transfusion. Preliminary results obtained using the consultant approach suggest that we may be able to simplify blood ordering practice and also reduce the number of units of blood products ordered. Based on these findings we are now preparing to compare the "critiquing" and "consultation" approaches using a clinical trial.
OBJECTIVE: To develop and implement a computerized version of the International Classification of Primary Care. To create a data bank and to conduct a descriptive study of our clinic's clientele. DESIGN: Testing a software program and creating a data bank. SETTING: Family Medicine Unit at Enfant-JÃ©sus Hospital, Quebec City. PARTICIPANTS: All Family Medicine Unit doctors and patients seen between July 1, 1990, and June 30, 1993. MAIN OUTCOME MEASURE: Description of our clientele's health problems using the ICPC. RESULTS: During the study, 48,415 diagnostic codes for 33,033 visits were entered into the bank. For close to 50% of these visits, two or more health problems were coded. There was good correlation between the description of our clientele and descriptions in other studies in the literature. CONCLUSION: This article describes the development of a data bank in a family medicine unit using a software program based on the ICPC. Our 3-year experiment demonstrated that the method works well in family physicians' daily practice. A descriptive study of our clientele is presented, as well as a few examples of the many applications of such a data bank.
A data processing system designed to improve the management and usage of blood and blood products has been developed as a pilot for general application throughout the West Midlands Regional Health Authority. The package provides for the routine clerical, patient record, and stock management aspects of a hospital blood bank laboratory. It can be tailored to the individual requirements of different laboratories and may be implemented in a variety of ways on a family of computer systems of differing power and capacity, thus accommodating widely varying workloads and archiving requirements. Bar code readers are included in the system design, and may be used for data input where standard Codabar labels are affixed to blood products by blood transfusion centres. The system has been installed in one hospital laboratory and preliminary results indicate a high degree of acceptability at all levels. Further refinement of the software to meet minor deficiencies and the requirements of the recent DHSS Health Circular BLD/2/13 are currently being specified.
The Transfusion Advisor is a knowledge-based system designed to facilitate the review of transfusion requests in the hospital blood bank. We have developed and performed an evaluation of a research prototype of the system which draws conclusions about twelve hemostatic disorders and critiques the appropriateness of the use of frozen plasma, cryoprecipitate (cryo), and platelets, which are products most commonly used for the treatment of hemostatic disorders. Our evaluation of the system revealed that there was closer agreement of the expert system with the domain expert than with the clinicians ordering the transfusions, and that the use of the transfusion advisor to screen transfusion requests may result in a substantial decrease in the use of these blood products.
Hemorrhage is the major cause of cardiac arrest developing in the operating room. Many human factors including surgical procedures, transfusion practices, blood supply, and anesthetic management are involved in the process that leads to hemorrhage developing into a critical situation. It is desirable for hospital transfusion committees to prepare hospital regulations on 'actions to be taken to manage critical hemorrhage', and practice the implementation of these regulations by simulated drills. If intraoperative hemorrhage seems to be critical, a state of emergency should immediately be declared to the operating room staff, the blood transfusion service staff, and blood bank staff in order to organize a systematic approach to the ongoing problem and keep all responsible staff working outside the operating room informed of events developing in the operating room. To rapidly deal with critical hemorrhage, not only cooperation between anesthesiologists and surgeons but also linkage of operating rooms with blood transfusion services and a blood bank are important. When time is short, cross-matching tests are omitted, and ABO-identical red blood cells are used. When supplies of ABO-identical red blood cells are not available, ABO-compatible, non-identical red blood cells are used. Because a systematic, not individual, approach is required to prevent and manage critical hemorrhage, whether a hospital can establish a procedure to deal with it or not depends on the overall capability of critical and crisis management of the hospital.
Crisis management; Hemorrhage; Risk management; Transfusion
The French Hemovigilance Network has been established in 1994 and records all adverse events associated with the transfusion of a labile blood products (LBP) regardless of their severity. From 1994 to 2006 35,423,172 LBP were issued, 85,812 adverse transfusion reactions notified, and 139 cases of transfusion related acute lung injury (TRALI) observed. The LBP most at risk is fresh frozen plasma (FFP), followed by platelets concentrates (PC) and packed red cells (PRC). However, because the use of FFP is not frequent in France, it only accounts for about 10% of TRALI, whereas PRC and PC are involved in the remaining cases. In no case, pooled FFP treated with solvent-detergent were involved. Patients’ profiles are peculiar with a high disease burden. Therefore, targeting a prevention policy only on FFP would result in a marginal reduction of TRALI in France.
TRALI; Hemovigilance; Blood transfusion; Sickle cell disease; Public health
In 2004, the Korean government and blood transfusion community deliberated on the issue of a national blood system reform and agreed to implement a 5-year project (2004-2009) to further improve safety measures. Our study delineates the basis of the current national blood program and analyzes the performance of this 5-year project initiated by the Korean government.
A performance review of the 5-year project was conducted from May 2009 to February 2010 using various approaches. Numerous data and documentation were collected from the Korean Red Cross and the Korean Centers for Disease Control and Prevention and reviewed by experts. Approximately 20 interviews with representatives of stakeholder groups were conducted to gather information, opinions, and perceptions. We conducted a nationwide field survey on a total of 144 blood donor centers.
Among the 5 major categories of the 5-year project, blood donor recruitment, laboratory testing, and product manufacturing were improved in terms of quality performance. Specifically, government's financial support ensured that the infrastructure of blood donor centers and blood laboratory centers improved. The pivotal role of the government contributed to improvements in the national blood program and enhanced national surveillance for blood safety.
Korea has made a tremendous effort with positive outcomes to provide safety measures for blood products for transfusion in its citizens. In all areas of blood management, from blood donations to transfusions, continuous developments in monitoring safety standards and practices are paramount.
Blood safety; Improvement project; Quality performance
The National Practitioner Data Bank became operational September 1, 1990, as a flagging system to identify health care practitioners who may have been involved in incidents of medical incompetence. Query volumes have grown substantially over the Data Bank's first 4 years of operation. The greatest increase has come in the number of voluntary queries. By the end of 1994, the Data Bank had processed more than 4.5 million requests for information on practitioners, more than 1.5 million of which were received in 1994 alone. The proportion of queries for which the Data Bank contains information on the practitioner in question has grown as the Data Bank has come to contain more reports. During 1994, 7.9 percent of queries were matched. The Data Bank contained more than 97,500 reports at the end of 1994. More than 82 percent of the reports concerned malpractice payments. Licensure reports made up the bulk of the rest. Physicians predominate in reports, accounting for slightly more than 76 percent of the total. The remainder are related to dentists (16 percent) and all other types of practitioners (8 percent). Since reporting of adverse actions is mandatory only for physicians and dentists, the proportion of reports attributable to these types of practitioners is higher than it would be if adverse action reporting requirements were uniform for all practitioners. State malpractice payment rates and adverse action rates vary widely, but a State's rate in any given year is highly correlated with its rate in any other year. State malpractice rates are not strongly correlated with adverse action rates, neither are the rates for physicians strongly correlated with those for dentists. There is a weak tendency for States with smaller physician populations to have higher levels of licensure and privileging actions.
The World Health Organization (WHO) recommends the creation of national blood transfusion services. Burkina Faso has a CNTS (Centre national de transfusion sanguine - National Blood Transfusion Center) but it currently covers only 53% of the national blood supply versus 47% produced by independent hospital blood banks.
To evaluate blood collection, testing, preparation and prescription practices in the regions of Burkina Faso that are not covered by the CNTS, we conducted a cross-sectional survey.
Data were collected by trained professionals from May to June 2009, at 42 autonomous blood centers not covered by the CNTS.
Blood collection was supervised in all sites by laboratory technicians without specific training. There was no marketing of community blood donation nor mobile collection. Donation was restricted to replacement (family) donors in 21.4% of sites. Pre-donation screening of donors was performed in 63.4% of sites, but some did not use written questionnaires. Testing for HIV, hepatitis B virus and syphilis was universal, although some sites did not screen for hepatitis C virus. In 83.3% of the sites blood typing was performed without reverse ABO typing. In 97.6% of the sites, nurses acted alone or in conjunction with a physician to order blood transfusions.
Shortcomings in non-CNTS blood centers argue for the development of a truly national CNTS. Such a national center should coordinate and supervise all blood transfusion activities, and is the essential first step for improving and institutionalizing blood transfusion safety and efficacy in a developing country.
Blood transfusion; Blood donors; HIV; HBV; HCV–Africa; Burkina Faso
ESPRE, a knowledge-based system designed to facilitate good platelet transfusion practices, is under development at the University of Minnesota Hospital and Clinic. This microcomputer based decision support system aids Blood Bank personnel in evaluating requests for platelet transfusions. Because of a direct link with the laboratory computers, most patient data need not be entered manually, but rather can be accessed directly. ESPRE uses a combination of frames and rules during its inference procedure and generates an explanation of its line of reasoning. In a preliminary comparison of the system with blood bank personnel in evaluating transfusion requests, four discrepant cases were found among fifty-eight cases evaluated.
Content validity of patient-reported outcomes (PROs) is evaluated primarily during item development, but subsequent psychometric analyses, particularly for item-response theory (IRT)-derived scales, often result in considerable item pruning and potential loss of content. After selecting items for the PROMIS banks based on psychometric and content considerations, we invited external content expert reviews of the degree to which the initial domain names and definitions represented the calibrated item bank content.
A minimum of four content experts reviewed each item bank and recommended a domain name and definition based on item content. Domain names and definitions then were revealed to the experts who rated how well these names and definitions fit the bank content and provided recommendations for definition revisions.
These reviews indicated that the PROMIS domain names and definitions remained generally representative of bank content following item pruning, but modifications to two domain names and minor to moderate revisions of all domain definitions were needed to optimize fit with the item bank content.
This reevaluation of domain names and definitions following psychometric item pruning, although not previously documented in the literature, appears to be an important procedure for refining conceptual frameworks and further supporting content validity.
content validity; conceptual framework; domain definition; item-response theory
Supported by a grant from the Agency for Healthcare Research and Quality, a
University of Iowa Hospitals and Clinics interdisciplinary research
team created an online data-capture-response tool utilizing wireless
mobile devices and bar code technology to track and improve blood products
administration process. The tool captures 1) sample collection, 2) sample
arrival in the blood bank, 3) blood product dispense from blood
bank, and 4) administration. At each step, the scanned patient wristband
ID bar code is automatically compared to scanned identification
barcode on requisition, sample, and/or product, and the system presents
either a confirmation or an error message to the user. Following an
eight-month, 5 unit, staged pilot, a ‘big bang,’ hospital-wide
implementation occurred on February 7, 2005. Pilot period and
preliminary house-wide data indicate improved error capture with the
new barcode process over the old manual process.
Bombay phenotype is extremely rare in Caucasian with an incidence of 1 in 250,000. When individuals with the Bombay phenotype need blood transfusion, they can receive only autologous blood or blood from another Bombay blood group. Transfusing blood group O red cells to them can cause a fatal hemolytic transfusion reaction. In this study, we report a case with the rare Bombay blood group that was misdiagnosed as the O blood group and developed a hemolytic transfusion reaction. This highlights the importance of both forward and reverse typing in ABO blood grouping and standard cross-matching and performing standard pretransfusion laboratory tests in hospital blood banks.
ABO blood-group system; blood group incompatibility; blood transfusion; Bombay phenotype; transfusion reaction
The American Blood Commission has designed a recommended uniform blood labeling system. A central feature of the new label is the bar-code, which allows the label to be read by automated equipment as well as by the human eye. In addition, the label is characterized by new levels of simplicity and uniformity in design over the multitude of labels previously in use in the country's blood banks and hospitals.
The Food and Drug Administration, the federal agency with a regulatory mandate in the area of blood labeling, has announced that it will issue regulations requiring the use of this uniform label, as a means of furthering public safety in transfusion.
Altered signaling in B-cells is a predominant feature of systemic lupus erythematosus (SLE). The genes BANK1 and BLK were recently described as associated with SLE. BANK1 codes for a B-cell-specific cytoplasmic protein involved in B-cell receptor signaling and BLK codes for an Src tyrosine kinase with important roles in B-cell development. To characterize the role of BANK1 and BLK in SLE, we performed a genetic interaction analysis hypothesizing that genetic interactions could reveal functional pathways relevant to disease pathogenesis.
We Used the method GPAT16 to analyze the gene-gene interactions of BANK1 and BLK. Confocal microscopy was used to investigate co-localization, and immunoprecipitation was used to verify the physical interaction of BANK1 and BLK.
Epistatic interactions between BANK1 and BLK polymorphisms associated with SLE were observed in a discovery set of 279 patients and 515 controls from Northern Europe. A meta-analysis with 4399 European individuals confirmed the genetic interactions between BANK1 and BLK.
As BANK1 was identified as a binding partner of the Src tyrosine kinase LYN, we tested the possibility that BANK1 and BLK could also show a protein-protein interaction. We demonstrated co-immunoprecipitation and co-localization of BLK and BANK1. In a Daudi cell line and primary naïve B-cells the endogenous binding was enhanced upon B-cell receptor stimulation using anti-IgM antibodies.
Here, we show a genetic interaction between BANK1 and BLK, and demonstrate that these molecules interact physically. Our results have important consequences for the understanding of SLE and other autoimmune diseases and identify a potential new signaling pathway.
systemic lupus erythematosus; genetics; polymorphism; B-cells; autoantibodies
An aim of the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) initiative is to develop item banks and computerized adaptive tests (CAT) that are applicable across a wide variety of chronic disorders. The PROMIS Pediatric Cooperative Group has concentrated on the development of pediatric self-report item banks for ages 8-17 years. The objective of the present study is to describe the Item Response Theory (IRT) analysis of the NIH PROMIS pediatric pain item bank and the measurement properties of the new unidimensional PROMIS Pediatric Pain Interference Scale. Test forms containing pediatric pain items were completed by a total of 3,048 respondents. IRT analyses regarding scale dimensionality, item local dependence, and differential item functioning were conducted. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. The recommended 8-item unidimensional short form for the PROMIS Pediatric Pain Interference Scale contains the item set which provides the maximum test information at the mean (50) on the T-score metric. A simulated CAT was computed that provides the most information at five possible score locations (30, 40, 50, 60, and 70 on the T-score metric).
Pain; pediatrics; PROMIS; pain interference; Item Response Theory
The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to develop self-reported item banks for clinical research. The PROMIS pediatrics (aged 8–17) project focuses on the development of item banks across several health domains (physical function, pain, fatigue, emotional distress, social role relationships, and asthma symptoms). The psychometric properties of the anxiety and depressive symptom item banks are described.
Participants (n = 1,529) were recruited in public school settings, hospital-based outpatient and subspecialty pediatrics clinics. The anxiety (k = 18) and depressive symptoms (k = 21) items were split between two test administration forms. Hierarchical confirmatory factor-analytic models (CFA) were conducted to evaluate scale dimensionality and local dependence. IRT analyses were then used to finalize item banks and short forms.
CFA results confirmed that anxiety and depressive symptoms are separate constructs and indicative of negative affect. Items with local dependence and DIF were removed resulting in 15 anxiety and 14 depressive symptoms items. The psychometric differences between short forms and simulated computer adaptive tests are presented.
PROMIS pediatric item banks were developed to provide efficient assessment of health-related quality of life domains. This sample provides initial calibrations of anxiety and depressive symptoms item banks and creates PROMIS pediatric instruments, version 1.0.
PROMIS; Anxiety; Depressive symptoms; HRQOL; PRO; Scale development; Surveys; Pediatrics