Bilirubin assesment JOURNAL CLUB TCB (1).pptx

Transcutaneous bilirubin assessment in covered skin in preterm and term

1. JOURNAL CLUB By Dr. Mounika

2. STUDY IN BRIEF STUDY DESIGN : Prospective Observational Study STUDY SITE : Neonatology unit of a level III hospital( Alvaro Cunqueiro hospital , Vigo , Spain) STUDY PERIOD : June 2016 – June 2018 STUDY SAMPLE : 217 patients PUBLISHED : 25 November , 2019

3. ETHICAL ISSUES INFORMED CONSENT Obtained from parents when infants were admitted to nicu ETHICAL APPROVAL local ethics committee FUNDING not known CONFLICT OF INTEREST none

4. INTRODUCTION Jaundice is a frequent and usually physiological problem in the neonate. However, it can become serious and produce neurological sequelae . Patients undergoing phototherapy require frequent monitoring of serum bilirubin levels to monitor response . A noninvasive alternative is the determination of transcutaneous bilirubin (TCB). The new transcutaneous bilirubinometers use multiwavelength spectral reflectance to measure the optical density of cutaneous bilirubin and greater precision than former devices

5. RESEARCH QUESTION PATIENT Infants (<37 weeks) with diagnosis of hyperbilirubinemia INTERVENTION UTCB , PTCB COMPARISION TSB OUTCOME Mean difference between TCB , TSB at 0 , 24 , 48 , 72 hrs TIME June 2016 – June 2018

6. STUDY AIM To evaluate the correlation existing between the TCB, measured with a specific bilirubinometer (JM 105) on covered skin with an alternative removable patch, and the TSB during the treatment with phototherapy.

7. SUBJECTS INCLUSION CRITERIA term and preterm infants (< 37 weeks) with diagnosis of hyperbilirubinemia and indication of treatment with phototherapy.

8. STUDY DESIGN A prospective observational study

9. METHODOLOGY I ndication to start phototherapy was based on Bhutani modified normogram for term and preterm infants. During the treatment with phototherapy the neonates remained naked, with diaper & eye protection. P art of the anterior thorax (sternum) was covered with an opaque photo-reflective aluminum patch which has a flap that can be easily removed and that is not adhered to the skin of the newborn. In each patient, several sets of simultaneous TCB and TSB measurements were performed .

10. Prior to the start of phototherapy, a single TCB determination was made at the sternum . A fter phototherapy TCB determinations were made in two locations: on the skin under the patch, and on the exposed naked skin close to it. TSB was determined by diazo -reaction technique. Subsequently, both types of measurements (TCB and TSB) were prospectively collected at 24, 48, and 72 h of treatment .

11. PRIMARY OUTCOME Correlation between PTCB vs TSB

12. STATISTICAL ANALYSIS Data analysis was performed by the biostatisticians . Employed the SPSS programme (IBM SPSS Statistics 23.0). The method of Bland and Altman was used to evaluate the agreement between bilirubin levels in blood and skin.

13. SAMPLE SIZE A total of 217 patients were studied, 111 (51.2%) were fullterm and 106 (48.8%) were preterm (27–36 + 6 weeks).

14. BASELINE CHARACTERISTICS

15. RESULTS After the initiation of phototherapy, the good correlation between TSB and TCB continued for measurements on skin covered with a patch at 24, 48, and 72 h of therapy, both for preterm and term children. However, a significant loss of reliability of TCB on uncovered skin was observed. The difference between TCB on exposed and unexposed skin with respect to TSB reached statistical significance at 24 and 48 h (p <0.001 ) and at 72 h (p < 0.01 ).

16. DISCUSSION Our study showed a significant decrease in the correlation between TCB and TSB in light exposed skin, with mean differences exceeding 6–8 points . In our series the good correlation between TSB and PTCB improves as the treatment time progresses, reaching the maximum correlation (0.27 mg/ dL ) at 48 h, showing the usefulness of this technology for the follow-up during phototherapy . The best agreement as the hours of treatment and postnatal age increase could be related to the balance established between the TSB and the TCB in the skin with time . This effect has been observed in term and preterm children .

17. Finally, in relation to clinical application of our findings, we note that the differences in serum and transcutaneous values in covered skin barely exceed two points of difference in the most unfavorable and infrequent scenario. Therefore it can be recommended as a follow-up method during treatment, with the advantage of fewer blood tests. However , it would be advisable to confirm the value of TCB with a blood test in those cases in which a difference of two points in the bilirubin value implies a change in the therapeutic attitude.

18. OTHER STUDIES

19. CRITICAL APRAISAL Title and abstract: a) Indicate the study’s design with a commonly used term in the title or the abstract -yes b) Provide in the abstract an informative and balanced summary of what was done and what was found - yes

20. Introduction Background/Rationale Explain the scientific background and rationale for the investigation being reported - yes Objectives 3. State specific objectives, including any prespecified hypothesis - yes

21. Methods: Study Design Present key elements of study design early in the paper (what design, what was compared) - yes Setting 5. Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection - yes

22. Methods - continued Variables 7. Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers - yes

23. Methods - continued Data sources/measurement 8 For each variable of interest, give sources of data and details of methods of assessment (measurement) Describe comparability of assessment met there is more than one group - yes

24. Study size 10. Explain how the study size was arrived at -no Quantitative variables 11. Explain how quantitative variables were handled in the analyses - yes

25. Methods - continued Statistical methods a) Describe all statistical methods, including those used to control confounding - not mentioned b) Describe any methods used to examine subgroups and interactions - yes c) Explain how missing data were addressed - yes

26. completing follow-up, and analysed b) Give reasons for non-participation at each stage - yes c) Consider use of a flow diagram - no Results Participants 13. a) Report numbers of individuals at each stage of study - e.g., numbers potentially eligible, examined eligibility, confirmed eligible, included in the study - yes

27. Results - continued Descriptive data 14. a) Give characteristics of study participants (e.g. demographic, clinical, social) and information on exposures and potential confounders - yes

28. Results - continued Main results a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (e.g. 95%CI). Make clear which confounders were adjusted for and why they were included - yes b) Report category boundaries when continuous variables were categorised - not applicable c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period - not applicable

29. Results - continued Other analyses 17. Report other analyses done, e.g. analyses of subgroups and interactions, and sensitivity analyses - yes Discussion Key results 18. Summarize key results with reference to study objectives - yes Limitations 19. Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both not direction and magnitude of any potential bias – not mentioned

30. Discussion - continued Interpretation 20. Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence - no Generalisability 21. Discuss the generalisability (external validity) of the study result - not mentioned

31. Other information Funding 22. Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based - not mentioned

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