Immune Globulin for Patients with Primary Immune Deficiency: An Evidence Based Practice Guideline
Bibliographic record
Abstract
Abstract Background: The original use of immune globulin (IG) was for replacement in patients with primary immune deficiency (PID). The evidence supporting this stems from the 19650s; however there have not been any rigorously developed evidence based clinical practice guidelines (CPGs) for the use of IG for PID. In 2007, Canadian Blood Services and the National Advisory Committee on Blood and Blood Products in Canada convened a panel of Canadian immunologists and a methodologist to develop a CPG for the use of IG in patients with PID. The objectives of this guideline are to examine the evidence for the use of IG in patients who have PID and to provide guidance for practitioners involved in the care of PID patients and transfusion medicine specialists on the use of IG. Methods: The panel identified key clinical questions and a systematic, expert and bibliography literature search up to July 2008 was conducted to ensure all relevant publications were included. The panel generated recommendations based on the evidence. The levels of evidence and grading of recommendations were adapted from the Canadian Task Force on Preventative Health Care. To validate conclusions and recommendations, the practice guideline will be sent to immunologists internationally and to a patient representative in September 2008. The guideline will be disseminated to all immunologists, internists and pediatricians in Canada to aid implementation of the guideline. The National Advisory Committee of Blood and Blood Products in Canada will assess the performance of the guideline and will renew the guideline at timely intervals. Results and Conclusions: The panel identified the following key clinical questions: what is the prevalence of the PIDs that require IG; does treatment with IG improve morbidity and mortality; and what criteria should be used to monitor the effectiveness of IVIG. The literature search was conducted in August 2007 and updated to July 2008. 1087 citations were reviewed. 101 reports, 1 systematic review and 3 consensus documents/guidelines were included. Current estimates suggest PID is under-diagnosed. Although more than 75% of patients require IG at some point in their treatment, the actual incidence of requiring IG is unknown. There is ample evidence that IG reduces infections, hospitalization and days lost from work/school. There is some evidence to suggest that IG may ameliorate chronic illnesses in patients with PID however, there is no data of the effect of IG on malignancy and insufficient data on the effect of IG on autoimmune disease in this patient population to make a recommendation. Quality of life (QoL) has not been adequately assessed in the literature; however the reduction in infections and hospitalizations likely translates to an improved QoL. Although, there is no evidence to suggest clinical superiority of one IVIG formulation over another, for patients with autoimmune manifestations and PID, there is insufficient evidence that subcutaneous IG is equivalent to IVIG. The vaccination of these patients is an evolving field. Due to the complex nature of the management of patients with PID, the panel recommended assessment by an immunologist prior to the initiation of IG and monitoring by a comprehensive care clinic. Clinical outcomes such as frequency of infections, hospitalization, days missed from school/work should be used to monitor the effectiveness of IVIG. Specific recommendations for dosing and interval of IG therapy were made within the guideline based on the literature The development of a national registry for patients with primary immune deficiency, and the development of a surveillance system for adverse events from IG particularly infections were considered priorities for future development.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.039 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.006 | 0.006 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.005 | 0.002 |
| Research integrity | 0.009 | 0.006 |
| Insufficient payload (model declined to judge) | 0.004 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".