A Number-Needed-to-Treat Analysis of the Use of Respiratory Syncytial Virus Immune Globulin to Prevent Hospitalization

Robbins, James M.; Tilford, John M.; Jacobs, Richard F.; Wheeler, J. Gary; Gillaspy, Stephen R.; Schutze, Gordon E.

doi:10.1001/archpedi.152.4.358

Cited by 46 publications

(20 citation statements)

References 34 publications

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“…[140][141][142][143][144][145][146][147] The primary benefit of immunoprophylaxis with palivizumab is a decrease in the rate of RSV-associated hospitalization. None of the 5 clinical RCTs have demonstrated a significant decrease in rate of mortality attributable to RSV infection in infants who receive prophylaxis.…”

Section: Recommendation 8bmentioning

confidence: 99%

Diagnosis and Management of Bronchiolitis

2006

Pediatrics

885

293

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Bronchiolitis is a disorder most commonly caused in infants by viral lower respiratory tract infection. It is the most common lower respiratory infection in this age group. It is characterized by acute inflammation, edema, and necrosis of epithelial cells lining small airways, increased mucus production, and bronchospasm.The American Academy of Pediatrics convened a committee composed of primary care physicians and specialists in the fields of pulmonology, infectious disease, emergency medicine, epidemiology, and medical informatics. The committee partnered with the Agency for Healthcare Research and Quality and the RTI International-University of North Carolina Evidence-Based Practice Center to develop a comprehensive review of the evidence-based literature related to the diagnosis, management, and prevention of bronchiolitis. The resulting evidence report and other sources of data were used to formulate clinical practice guideline recommendations.This guideline addresses the diagnosis of bronchiolitis as well as various therapeutic interventions including bronchodilators, corticosteroids, antiviral and antibacterial agents, hydration, chest physiotherapy, and oxygen. Recommendations are made for prevention of respiratory syncytial virus infection with palivizumab and the control of nosocomial spread of infection. Decisions were made on the basis of a systematic grading of the quality of evidence and strength of recommendation. The clinical practice guideline underwent comprehensive peer review before it was approved by the American Academy of Pediatrics.This clinical practice guideline is not intended as a sole source of guidance in the management of children with bronchiolitis. Rather, it is intended to assist clinicians in decision-making. It is not intended to replace clinical judgment or establish a protocol for the care of all children with this condition. These recommendations may not provide the only appropriate approach to the management of children with bronchiolitis. INTRODUCTIONTHIS GUIDELINE EXAMINES the published evidence on diagnosis and acute management of the child with bronchiolitis in both outpatient and hospital settings, including the roles of supportive therapy, oxygen, bronchodilators, antiinflammatory agents, antibacterial agents, and antiviral agents and make recommendations to influence clinician behavior on the basis of the evidence. Methods of prevention All clinical practice guidelines from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.The recommendations in this guideline do not indicate an exclusive course of treatment or serve as a standard of care. Variations, taking into account individual circumstances, may be appropriate. Key Word bronchiolitisAbbreviations CAM-complementary and alternative medicine LRTI-lower respiratory tract infection AHRQ-Agency for Healthcare Research and Quality RSV-respiratory syncytial virus AAP-American Academy of Pediatrics AAFP-American Academy...

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Section: Recommendation 8bmentioning

confidence: 99%

Diagnosis and Management of Bronchiolitis

2006

Pediatrics

885

293

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“…14 Estimates of the cost of RSV-related hospitalization vary. Using data from a large managed care organization, Joffe et al (1999) 15 calculated the mean cost of a hospitalization for RSV as $8,502 in 1995 dollars, but Robbins et al (1998) 16 calculated a higher "plausible estimate" of $15,000-$25,000 per RSV hospital admission. A more recent poster abstract report estimated the mean cost of RSV hospitalization, in 2007 dollars, to be $9,014 in full-term infants (n = 1,983), $13,876 in infants born at less than 33 weeks gestational age (n = 46), and $18,403 in infants born at 33-36 weeks gestational age (n = 149).…”

Section: What This Review Adds a Systematic Review Of Compliance Withmentioning

confidence: 99%

A Systematic Review of Compliance with Palivizumab Administration for RSV Immunoprophylaxis

Frogel

Stewart²,

Hoopes³

et al. 2010

JMCP

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BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, accounting for approximately 75,000-125,000 hospitalizations per year. It is estimated that in 2000, RSV infection accounted for 1.7 million office visits, 402,000 emergency room visits, and 236,000 hospital outpatient visits per year for children younger than 5 years of age. Palivizumab, a humanized monoclonal antibody directed against RSV, is the only immunoprophylaxis therapy approved by the FDA for prevention of serious lower respiratory tract disease caused by RSV in infants (up to 2 years of age) who meet 1 or more of the following criteria for high risk: (a) gestational age up to 35 weeks; (b) diagnosis of chronic lung disease (CLD, formerly bronchopulmonary dysplasia [BPD]); or (c) diagnosis of cyanotic or complex congenital heart disease. The RSV season typically occurs between November and March but may vary by region. During the period of our review, depending on local duration of the RSV season, infants usually required 5 monthly (every 28-30 days) intramuscular injections of palivizumab. Infants born in the middle of the season received their palivizumab doses from the time of birth to the end of the season and, therefore, may have required less than 5 doses. It is unclear if compliance with monthly doses is a problem and whether noncompliance increases the risk of RSV hospitalizations in routine clinical practice.

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“…One study measured cost per detected case of syphilis [16] and two studies measured costs per avoided hospitalisations [17,18]. The remaining three studies measured cost per extra clinical pregnancy [19], avoided urinary tract infections [20] and avoided head injuries [21].…”

Section: Use Of Nnt For Economic Evaluation^in Practicementioning

confidence: 99%

“…In several of the studies, the treatment options could not be adequately valued by use of one dimension of effect alone. Robbins estimates the number needed to treat to avoid one hospitalisation for a particular virus infection [18]. However, no systematic account was taken of the many side effects reported in the paper.…”

Section: Use Of Nnt For Economic Evaluation^in Practicementioning

confidence: 99%

“…For CEAs to be valid it is important that intermediate outcomes are reasonable proxies for the final outcomes. Secondly, two studies which both evaluate interventions aimed at avoiding virus infections in pre-term infants [17,18], both look at the cost of avoiding hospitalisation and compare the cost of hospitalisation with the cost of the intervention. This approach merely represents a cost analysis since health consequences are omitted from the evaluations.…”

Section: Use Of Nnt For Economic Evaluation^in Practicementioning

confidence: 99%

See 1 more Smart Citation

Cost‐effectiveness analysis based on the number‐needed‐to‐treat: common sense or non‐sense?

Kristiansen

Gyrd‐Hansen

2003

Health Economics

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This paper explores and critically discusses some of the methodological limitations of using the number-needed-to-treat (NNT) in economic evaluation. We argue that NNT may be a straightforward measure of benefit when the effect of an intervention is immediate, but that serious problems arise when the effect is delay rather than avoidance of an adverse event. In this case, NNT is not a robust or accurate measure of effect, but will vary considerably and inconsistently over time. This weakness will naturally spill over onto any CEA based on NNT. A literature review demonstrated that CEAs based on NNT were all published within the last five years, and that all studies suffered from important limitations. A major weakness of using NNT is the imposed restrictions on the outcome measure, which can only be strictly uni-dimensional and non-generic. Using NNT in economic evaluations is obtained at a cost in terms of both methodological shortcomings, and a reduced ability for such evaluations to serve as a useful tool in decision making processes. The use of NNT in economic evaluations might be better avoided. To every complicated question, there is a simple, straightforward, easy--and probably wrong answer (Occam's Sledgehammer).

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A Number-Needed-to-Treat Analysis of the Use of Respiratory Syncytial Virus Immune Globulin to Prevent Hospitalization

Cited by 46 publications

References 34 publications

Diagnosis and Management of Bronchiolitis

Diagnosis and Management of Bronchiolitis

A Systematic Review of Compliance with Palivizumab Administration for RSV Immunoprophylaxis

Cost‐effectiveness analysis based on the number‐needed‐to‐treat: common sense or non‐sense?

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