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
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
This study was designed to analyze the incidence and spectrum of adverse effects of blood transfusion so as to initiate measures to minimize risks and improve overall transfusion safety in the institute.
Materials and Methods:
During the period from July 2002 to July 2003 all the adverse events related to transfusion of blood and blood components in various clinical specialties were recorded. They were analyzed and classified on the basis of their clinical features and laboratory tests. Attempt was also made to study the predisposing risk factors.
During the study period 56,503 blood and blood components were issued to 29,720 patients. A total of 105 adverse reactions due to transfusion were observed during the study period. A majority of the adverse reactions was observed in hemato-oncology patients 43% (n = 45) and in presensitized patient groups 63% (n = 66). FNHTR 41% (n = 43) and allergic reactions 34% (n = 36) were the most common of all types of adverse transfusion reactions, followed by AcHTR 8.56% (n = 9). Majority of these AcHTR were due to unmonitored storage of blood in the refrigerator of wards resulting in hemolysis due to thermal injury. Less frequently observed reactions were anaphylactoid reactions (n = 4), bacterial sepsis (n = 4), hypervolemia (n = 2), hypocalcemia (n = 2), TRALI (n = 1), DHTR (n = 1), and TAGvHD (n = 1).
Analysis of transfusion-related adverse outcomes is essential for improving safety. Factors such as improvement of blood storage conditions outside the blood bank, improvement in cross-matching techniques, careful donor screening, adherence to good manufacturing practices while component preparation, bedside monitoring of transfusion, and documentation of adverse events will help in reducing transfusion-related morbidity and mortality.
Hemovigilance; transfusion reaction; adverse events of transfusion; haemolytic transfusion reaction; risk associated with transfusion
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
Reports on unexpected donor events (UEs) during preparatory plasmapheresis (PPP) are scarce, and rarely consider technical UEs.
Defined local and systemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into the PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations and UEs from January 1, 2008 to June 30, 2011.
66,822 UEs were observed during 1,107,846 PPPs for a corrected incidence of 6.55% (1.4% local, 0.55% systemic, 4.6% technical UEs). 3.36% of PPPs were accompanied by 1 UE and 1.18% by >1 UE (2-5). 13.7% of donors undergoing PPP for the first time, 9.7% of those having a second PPP and 4.0% of those having a third or more PPPs were associated with UEs. Most common UEs were repeated venipuncture, and broken-off collection due to venous access problems and small hematomas. Severe systemic UEs occurred at a rate of 36 per 100,000 PPPs.
Technical UEs were common with PPP. UEs accompanied first and second donations significantly more frequently than for subsequent donations.
Donor hemovigilance; Plasmapheresis; Methods; Statistics; Adverse effects; Blood banks; Blood supply
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
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.
An audit is a written series of simple, direct questions, which when answered and reviewed, tell whether the laboratory is performing its procedures, activities, and policies correctly and on time.
The aim of this study is to briefly highlight the importance of audit in blood bank services.
Materials and Methods:
An Audit of Blood Bank Services was carried out in a Blood bank of the tertiary care hospital, Central India by using the tool kit, (comprised of checklists) developed by Directorate General of Health Services, Dhaka WHO, July 2008.
After going through these checklists, we observed that there is no system for assessing the training needs of staff in the blood bank. There was no provision for duty doctor's room, expert room, medical technologist room and duty care service. There was no checklist for routine check for observation of hemolysis and deterioration of blood and plasma. There was no facility for separate private interview to exclude sexual disease in the donor. Requisition forms were not properly filled for blood transfusion indications. There was no facility for notification of donors who are permanently deferred. There were no records documented for donors who are either temporarily or permanently deferred on the basis of either clinical examination, history, or serological examination. It was found that wearing of apron, cap, and mask was not done properly except in serology laboratory. When the requisition forms for blood transfusions were audited, it was found that many requisition forms were without indications.
Regular audit of blood bank services needs to be initiated in all blood banks and the results needs to be discussed among the managements, colleagues, and staffs of blood bank. These results will provide a good opportunity for finding strategies in improving the blood bank services with appropriate and safe use of blood.
Audit; blood bank; checklists; quality control
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.
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
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.
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
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 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.
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
Background: Screening of blood is mandatory for transfusion transmitted diseases and is routinely done in the blood banks. As blood is the major source transmission of hepatitis B, hepatitis C, human immunodeficiency virus & many other diseases the hazards can be minimised by effective donor selection and screening.
Aim: To find out the correlation between the transfusion transmitted diseases and blood groups and the seroprevalence of HIV, HBV, HCV & syphilis among the apparently healthy human blood donors.
Study, Setting & Design: This retrospective study was conducted at the blood bank of a tertiary health care teaching centre for a period of four years.
Material and Methods: All voluntary and replacement donors reporting to the blood bank were screened for HIV-1 & 2, HBsAg, HCV and Syphilis. Anti–HIV -1 & 2, HBsAg & anti - HCV was tested using the appropriate Enzyme–linked immunosorbent assay (ELISA) technique using micro–elisa kit supplied by J.Mitra & Co.Ltd. The seropositive samples were again tested on ELISA kits of RFCL &/or BIORAD for further confirmation & ruling out any false positive or false negative results. The rapid plasma reagain (RPR) test was used for estimation of syphilis infection.
Statistical Analysis: The data entry was carried out using Microsoft office excel worksheet and was analysed by percentage and comparison.
Results: Total of 6000 donors were screened which included voluntary and replacement donors. Seroprevalence of HIV (0.1833 %), HCV (1.28%), HBsAg (1.5833 %) and syphilis (0.4333 %) was detected. In the study done it was also noted - that the NEGATIVE blood groups were more prone to TTIs. Blood group A negative was more prone to TTIs with HIV, HBsAg and VDRL while blood group B negative was more affected by HCV.
Conclusion: Seroprevalence of these infections shows that routine screening is a must for blood and blood product safe transfusion.
Do negative blood groups predispose to TTIs? A finding which makes us think….
Blood donors; Seroprevalence; Transfusion transmitted diseases; Human immunodeficiency virus; Hepatitis C; Hepatitis B surface antigen
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
This paper describes the psychometric properties of the PROMIS Pain Interference (PROMIS-PI) bank. An initial candidate item pool (n=644) was developed and evaluated based on review of existing instruments, interviews with patients, and consultation with pain experts. From this pool, a candidate item bank of 56 items was selected and responses to the items were collected from large community and clinical samples. A total of 14,848 participants responded to all or a subset of candidate items. The responses were calibrated using an item response theory (IRT) model. A final 41-item bank was evaluated with respect to IRT assumptions, model fit, differential item function (DIF), precision, and construct and concurrent validity. Items of the revised bank had good fit to the IRT model (CFI and NNFI/TLI ranged from 0.974 to 0.997), and the data were strongly unidimensional (e.g., ratio of first and second eigenvalue = 35). Nine items exhibited statistically significant DIF. However, adjusting for DIF had little practical impact on score estimates and the items were retained without modifying scoring. Scores provided substantial information across levels of pain; for scores in the T-score range 50-80, the reliability was equivalent to 0.96 to 0.99. Patterns of correlations with other health outcomes supported the construct validity of the item bank. The scores discriminated among persons with different numbers of chronic conditions, disabling conditions, levels of self-reported health, and pain intensity (p< 0.0001). The results indicated that the PROMIS-PI items constitute a psychometrically sound bank. Computerized adaptive testing and short forms are available.
Quality-of-life outcomes; quality-of-life measurement; pain
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
Thrombotic and bleeding complications are major concerns during orthopedic surgery. Given the frequency of orthopedic surgical procedures and the limited data in the literature, we sought to investigate the incidence and risk factors for thrombotic (myocardial necrosis and infarction) and bleeding events in patients undergoing orthopedic surgery.
Methods and Results
We performed a retrospective cohort analysis of 3,082 consecutive subjects ≥ 21 years of age undergoing hip, knee, or spine surgery between November 1, 2008, and December 31, 2009. Patient characteristics were ascertained using ICD-9 diagnosis coding and retrospective review of medical records, and laboratory/blood bank databases. In-hospital outcomes included myocardial necrosis (elevated troponin), major bleeding, coded myocardial infarction (MI), and coded hemorrhage as defined by ICD-9 coding. Of the 3,082 subjects, mean age was 60.8 ± 13.3 years and 59% were female. Myocardial necrosis, coded MI, major bleeding, and coded hemorrhage occurred in 179 (5.8%), 20 (0.7%), 165 (5.4%), and 26 (0.8%) subjects, respectively. Increasing age (P<0.001), CAD (P<0.001), cancer (P=0.004), and chronic kidney disease (P=0.01) were independent predictors of myocardial necrosis, while procedure type (P<0.001), cancer (P<0.001), female sex (P<0.001), CAD (P<0.001), and COPD (P=0.01) were independent predictors of major bleeding.
There is a delicate balance between thrombotic and bleeding events in the perioperative period following orthopedic surgery. Perioperative risk of both thrombosis and bleeding deserve careful attention in preoperative evaluation and future prospective studies aimed at attenuating this risk are warranted.
arterial thrombosis; major bleeding; perioperative management
Recently, the National Institutes of Health Roadmap for Medical Research initiative led a large-scale effort to develop the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS’s main goal was to develop a set of item banks and computerized adaptive tests for the clinical research community. Asthma, as the most common chronic childhood disease, was chosen for a disease-specific pediatric item bank.
The primary objective of this research is to present the details of the psychometric analyses of the asthma domain items.
Item response theory (IRT) analyses were conducted on a 34–asthma item bank. Test forms containing PROMIS Pediatric Asthma domain items were completed by 622 children ages 8 to 12. Items were subsequently evaluated for local dependence, scale dimensionality, and differential item functioning.
A 17-item pool and an 8-item short form for the new PROMIS Pediatric Asthma Impact Scale (PAIS) were generated using IRT. The recommended 8-item short form contains the item set that provides the maximum test information at the mean (50) on the T-score metric. If more score precision is required, the complete 17-item pool is recommended and may be used in toto or as the basis of a computerized adaptive test (CAT). A shorter test form can also be created and scored on the same scale.
The present study presents the PROMIS Pediatric Asthma Impact Scale (PAIS) developed with IRT, and provides the initial calibration data for the items.
asthma; pediatric; quality-of-life; item response theory