a)

conventional phototherapy (single, double or multiple phototherapy)

b)

sunlight

c)

fibreoptic phototherapy (biliblankets, bilibeds and other products)

Newborns with a diagnosis of jaundice (but otherwise well)

Subgroups: preterm babies versus term babies

a)

sunlight*

b)

fibreoptic phototherapy (biliblankets, bilibeds and other products)*

c)

LED phototherapy (LED spot lights)

d)

LED phototherapy (LED pads)

1)

Number of exchange transfusions

2)

Treatment failure (as defined in the study) including cases of rebound jaundice and kernicterus

3)

Mean duration of phototherapy

4)

Staff experience

5)

Adverse events of phototherapy including mortality

1)

Mean change in serum bilirubin and rate of decline of bilirubin

2)

Parental experience/acceptability including access for bonding and breastfeeding

-

studies looking at the effect of phototherapy in combination with other treatments or prophylaxis studies

*A list of excluded studies will be provided following sifting of the database

*Data on all included studies will be extracted into evidence tables

*Where statistically possible, a meta-analytical approach will be used to give an overall summary effect

*For intervention question, all critical and important outcomes from evidence will be presented in GRADE profiles (where appropriate) and further summarized in evidence statements.

Newborns with a diagnosis of jaundice (but otherwise well)

Subgroups: preterm babies versus term babies

1)

Fixed position

2)

Eye coverings

3)

Intermittent feeds (brief interruptions of phototherapy treatment to facilitate breastfeeding and cuddles)

4)

Curtains

5)

Incubators/bassinets

6)

Bulb colour

7)

Size of fibreoptic pads (small vs large)

8)

Light intensity/distance of phototherapy device

1)

Changing position*

2)

No/other types of eye coverings *

3)

Continuous feeds/breast/bottle/nasogastric tube feeding*

4)

No curtains*

5)

No incubators/bassinets*

6)

Different bulb colour

7)

Different sized pad

8)

Different light intensity/distance of phototherapy device

1)

Mean duration of treatment

2)

Cases of purulent eye discharge

3)

Features of conjunctivitis

4)

Hydration

5)

Adverse events of phototherapy including mortality

1)

Mean change in serum bilirubin and rate of decline of bilirubin

2)

Parental experience/acceptability including access for bonding and breastfeeding

*A list of excluded studies will be provided following sifting of the database

*Data on all included studies will be extracted into evidence tables

*Where statistically possible, a meta-analytical approach will be used to give an overall summary effect

*For intervention question, all critical and important outcomes from evidence will be presented in GRADE profiles (where appropriate) and further summarized in evidence statements.

Newborns suspected of neonatal jaundice (eg: a clinical diagnosis) but otherwise well

*Subgroups: preterm versus term babies, and babies of different coloured skins

a)

clinical history and examination

b)

urine/stool examination

c)

icterometer

d)

transcutaneous bilirubin levels/lab testing/near patient testing

1)

Correlation coefficient (r) of the index test with the serum bilirubin levels and agreement (Bland-Altman or other statistical analysis of agreement

2)

Diagnostic accuracy of the index test (sensitivity, specificity, PPV, NPV, LR+/-) in detecting hyperbilirubinaemia/jaundice (serum bilirubin above threshold action for intervention as stated in reference standard)

3)

Concordance correlation coefficient

4)

Summary of ROC curves if data allows for this

-

prospective studies

-

diagnostic accuracy of the test or its correlation evaluated against the reference standard (serum bilirubin levels)

-

test and the reference standard performed within 1 hour of each other (if bilirubin sample has been protected from light)

*A list of excluded studies will be provided following sifting of the database

*Data on all included studies will be extracted into evidence tables

*Where statistically possible, a meta-analytical approach will be used to give an overall summary effect

*For this diagnostic question, all evidence will be presented in modified GRADE profiles and further summarised in evidence statements.

Include:

RCTs, systematic reviews of RCT

Non-randomised studies, systematic reviews of non-randomised studies, including cross sectional surveys.

Published national and international clinical guidelines.

Exclude:

Qualitative studies, case series and case reports.

Note: if no evidence was identified from randomised and non-randomised studies, case series may be considered for inclusion.

Different TSB thresholds used for starting phototherapy based on the age of the babies

Different TSB thresholds used for starting exchange transfusion based on the age of the babies

Number of term babies needing phototherapy

Number of term babies needing exchange transfusion

Number of babies with acute bilirubin encephalopathy

Number of babies with kernicterus

Number of babies with other complications as a results of their hyperbilirubinaemia

Selection of papers:

i)

Selection based on titles and abstracts

ii)

Selection based on full papers

The Committee will be sent the list of included and excluded studies prior to the committee meeting, and the Committee will be requested to cross check whether any studies have been excluded inappropriately, and whether there are any relevant studies they have known of which haven’t been picked up by the searches.

An additional engagement exercise with an existing neonatal expert forum will be conducted and this platform will also be used to double check whether any relevant studies haven’t been picked up by the searches.

Data extraction:

Information from included studies will be extracted into evidence table.

Quality assessment:

As this is neither an intervention question nor a diagnostic question, GRADE methodology will not be used to assess the quality of evidence as the quality criteria will not be fully applicable to this review question.

Depending on the study designs of the included studies, appropriate checklists as recommended in the Developing NICE guidelines: the manual (2014), Appendix H, will be used to assess the quality of included studies accordingly. For any included national and international guidelines, AGREE II will be used to assess the quality.

Reliability of quality assessment:

A full double-scoring quality assessment will not be conducted due to the nature of the review question and the studies that are likely to be included. Other quality assurance mechanisms will be in place as the following: Internal QA by CGUT technical adviser on the quality assessment that is being conducted.

The Committee will be sent the evidence synthesis prior to the committee meeting and the Committee will be requested to comment on the quality assessment, which will serve as another QA function.

To include:

sources to be searched

plans to use any supplementary search techniques, when known at the protocol development stage, and the rationale for their use

limits to be applied to the search