Definitions of the levels of evidence (I—III) and grades of the recommendation (A, B, C, I) are presented at the end of the "Major Recommendations" field.
Note from the National Academy of Clinical Biochemistry (NACB) and the National Guideline Clearinghouse (NGC): The Laboratory Medicine Practice Guidelines (LMPG) evidence-based practice for point-of-care testing sponsored by the NACB have been divided into individual summaries covering disease- and test-specific areas. In addition to the current summary, the following are available:
Does transcutaneous bilirubin measurement improve clinical outcome, shorten length of stay, or decrease readmission rate for newborns with hyperbilirubinemia, compared with measurement of bilirubin in serum? (Literature Search 3 – Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 6. Assessment of hyperbilirubinemia with use of transcutaneous bilirubin measurements may have utility in decreasing readmission rate of newborns with hyperbilirubinemia and monitoring bilirubin concentrations in newborns. To date, only 1 study has been published that addresses this issue. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome, shorten length of stay, or decrease the readmission rate for newborns with hyperbilirubinemia.
Strength/consensus of recommendation: I
Level of evidence: III (clinical experience, descriptive studies, and opinion)
Is there an optimum frequency, timing, or site of transcutaneous bilirubin measurements that results in best agreement with bilirubin measurements performed using serum? (Literature Search 4 – Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 7. Transcutaneous bilirubin measurements performed on the forehead or sternum are preferable to other sites and provide similar correlation with bilirubin measurements performed in serum when infants have not been exposed to sunlight or phototherapy. Bilirubin concentrations should be assessed by measurement of total bilirubin in serum or transcutaneous bilirubin measurements within the first 24 h after birth in all infants who are jaundiced. The need for and timing of repeated transcutaneous or serum bilirubin measurements should be assessed with nomograms according to the postnatal age and bilirubin concentration.
Strength/consensus of recommendation: B
Level of evidence: II and III (well-designed correlation trials, clinical experience, and consensus opinion)
Is the measurement of bilirubin by use of a transcutaneous method contraindicated for use in newborns who are undergoing phototherapy, premature infants, or newborns who are ill? (Literature Search 5 – Refer to Appendix B - see the "Availability of Companion Documents" field).
Guideline 8. Transcutaneous bilirubin measurements should not be performed on infants undergoing phototherapy. The guideline developers also note that light exposure of infants who are discharged may also adversely affect the utility of transcutaneous measurements. The effect of gestational age on transcutaneous bilirubin measurements is less clear. Some reports suggest limiting the use of transcutaneous bilirubin measurements to newborns <30, 32, or 34 weeks' gestation, whereas others suggest no effect of gestational age. There are too few studies available that address the effect of underlying illness in newborns and its effect on use of transcutaneous bilirubin measurements.
Strength/consensus of phototherapy recommendation: C
Level of evidence: II and III (well-designed clinical trials, descriptive studies, and consensus opinion)
Strength/consensus of premature/gestational age recommendation: C
Level of evidence: II (well-designed clinical trials, descriptive studies)
Strength/consensus of underlying illness recommendation: I
Are transcutaneous bilirubin measurements associated with decreased blood sampling compared with serum bilirubin measurements? Do transcutaneous bilirubin measurements decrease the incidence of complications associated with blood collection such as infection or osteomyelitis? (Literature Search 6 - Refer to Appendix B - see the "Availability of Companion Documents" field).
Guideline 9. There is insufficient evidence available to judge the impact of transcutaneous bilirubin measurements on number of blood samples collected from newborns. Whether there is any effect on complications of blood collection such as infection or osteomyelitis has not been adequately studied.
Strength/consensus of recommendation: I
How does the accuracy of transcutaneous bilirubin measurements compare with total bilirubin measured in serum? (Literature Search 7- Refer to Appendix B - see the "Availability of Companion Documents" field).
Guideline 10. The guideline developers cannot recommend use of the ColorMate III (Chromatics Color Sciences International Inc., New York, NY) bilirubinometer, because of the limited number of published articles describing the performance of this instrument. Evaluation of jaundice with the Air-Shields or BiliChek seems to provide accuracy similar to that of serum bilirubin measurements. The BiliChek and Air-Shield have the advantage, compared with the ColorMate III, of not requiring a baseline measurement. Finally, the guideline developers do not recommend assessment of bilirubin with use of the Ingram icterometer (Thomas A. Ingram and Co, Birmingham, England; distributed in the United States by Cascade Health Care Products, Salem, OR), because of its reliance on observer visualization of depth of yellow color of the skin.
Strength/consensus of recommendation: B
Level of evidence: II (well-designed correlation trials, clinical experience, descriptive studies, and opinion)
Is measurement of bilirubin with a transcutaneous device more cost-effective compared with bilirubin measurements performed in the clinical laboratory? (Literature Search 8 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 11. There is insufficient evidence to evaluate the cost-effectiveness of transcutaneous bilirubin measurements.
Strength/consensus of recommendation: I
Level of Evidence: III (descriptive studies, opinion)
Definitions:
Levels of Evidence
- Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
- Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
- Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information.
Strength of Recommendations
A - The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.
B - The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.
C - The NACB recommends against adoption; there is evidence that it is ineffective or that harms outweigh benefits.
I - The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
