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EVIDENCE REPORT
Simon French
December 2003
SUMMARY STATEMENT
Disclaimer please refer to Appendix 1 for information.
Copyright please refer to Appendix 1 for information.
Publication of materials please use the following format when citing this article:
French, S (2003). Phototherapy in the home for jaundiced neonates. (The Centre for
Clinical Effectiveness), Available: http://www.med.monash.edu.au/healthservices/cce
[Accessed:Access date]
REQUEST
Is conducting phototherapy for jaundiced neonates in the home associated with adverse
effects compared to phototherapy conducted in the hospital?
REQUESTED BY
Minnesha Yasmine, Resource Midwife, Womens and Childrens Program, Monash
Medical Centre.
SUMMARY OF FINDINGS:
The evidence located was methodologically flawed, but concluded that home
phototherapy was a safe and effective alternative to hospital phototherapy.
METHODOLOGY
Search Strategy
The Centre for Clinical Effectiveness defines the best available evidence as that research
we can identify that is least susceptible to bias.
First, we search for systematic reviews, evidence based clinical practice guidelines and
health technology assessments. Then we identify diagnostic studies with independent
blind comparison of an appropriate spectrum of consecutive patients, who have
undergone both the diagnostic test and the reference standard. If we identify sound,
relevant material of this type, the search stops. Otherwise, our search strategy broadens
to include studies that are more prone to bias, less generalisable, or have other
methodologic difficulties. While we cite observational and case series studies, narrative
reviews and consensus statements in our reports, we do not critically appraise them.
These studies can produce accurate results but they are generally too prone to bias to
allow determination of their validity beyond their immediate setting.
Comparator:
Outcomes:
Search terms
(see Appendix 2 for exact search strategy)
Patient (Subject):
Intervention:
Resources Searched
We searched the following databases and internet websites for English language articles:
Resource
17 November 2003
CINAHL (OVID)
Cinch (Informit)
17 November 2003
17 November 2003
Google (Online)
18 November 2003
MEDLINE (OVID)
17 November 2003
MEDLINE
In-Process
PubMED (Online)
17 November 2003
17 November 2003
Inclusion Criteria
Exclusion Criteria
RESULTS:
From the resources searched, we identified 40 potentially relevant articles. If it was not
clear from the abstract, we obtained the full text of these articles to determine their
relevance. After examination of the 40 articles, 37 studies were excluded for the reasons
outlined in Table 1.
Table 1. Reasons for exclusion of studies identified in the search strategy.
Reason for exclusion
Number
10
19
Incorrect comparator
Total
37
The 3 articles that met the inclusion criteria were all cohort studies (Table 2). Two were
prospective studies and one was retrospective.
Table 2. Study designs of included articles
Study Design
Number included
Total
Findings
Three studies met the inclusion criteria. All of these studies were conducted in the United
States, two in the Salt Lake City region. All three studies were at least 10 years old. All
the studies compared home phototherapy to hospital phototherapy.
Overall Results
For one study (James 1993), the primary outcome was the rate of mothers that ceased
breast feeding during the treatment period. The other two studies (Eggert 1985, Slater
1984) measured decrease in bilirubin levels as their primary outcome.
In the study by James (1993), a much high proportion of mothers stopped breast feeding
in the hospital group than the home group (42% vs 9%, p<0.002). Also, mothers of
hospitalised neonates were less likely to resume breast feeding after treatment was
completed (84% vs 100%, p<0.02).
In the two studies that measured daily decrease in bilirubin, there was no significant
difference between those neonates treated at home and those that were treated in the
hospital.
In two of the studies, no complications were reported in either group, and in one study
(Eggert 1985) six of the mothers (10%) reported only mild complications. In the study
by Slater (1984), one infant treated at home was a considered a treatment failure. The
authors stated that this case demonstrated an issue of concern with home treatment,
questioning whether bilirubin values rise fast enough to produce kernicterus before the
next home visit by the supervising health practitioner occurs.
In all three studies, home treatment took longer. In all studies, home treatment was
cheaper.
Research Methodology
Two of the included studies were prospective comparative studies and the remaining
study was a retrospective comparative study (James 1994). All of the studies were
conducted in the United States. Each study compared hospital phototherapy to
supervised home phototherapy.
Focused Appraisal
All the studies were observational studies and the investigators had influence over which
group patients were allocated to. There are inherent biases in this type of study design
for intervention studies.
None of the studies performed a random allocation of patients to the intervention groups.
This is problematic when testing an intervention. Only one of the studies (Slater 1984)
described how a subject was allocated to home or hospital phototherapy. There may be
other differences between the groups, other than the difference in intervention provided.
For example, in the study by James (1993), mothers may have chosen home
phototherapy specifically because they wanted to continue breast feeding, whereas the
hospital group mothers may not have wanted to continue breast feeding. Randomisation
of neonates to home or hospital phototherapy would reduce this possible bias.
None of the studies blinded the assessor who determined the outcome of the neonates.
Blinding increases the validity of a study by removing the possibility that the assessor is
influenced by the intervention to which the patient is allocated.
The setting for all of the studies was the United States, which may not be generalisable
to the Australian setting. Protocols and practices may vary from hospital to hospital and
country to country.
All the studies employed a small sample size. Only one study (Eggert 1985) was of more
than 100 infants. A small sample size results in decreased generalisability. Also, when
there is no difference between the groups, as for all three of these studies, it may be that
the sample was not large enough to detect any difference (Type II Error).
None of the included studies described clear criteria for the diagnosis of
hyperbilirubinemia. This is a problem as it is not possible to know exactly what their case
definition was. Also, it is not possible to determine a treatment failure without any
criteria to go by.
Conclusion
All three of the included studies concluded that home phototherapy was feasible, safe
and effective alternative to hospital phototherapy. However, weaknesses in study design
as discussed above necessitate that these conclusions be interpreted with caution. There
is currently no high level evidence to answer this evidence request. A randomised
controlled trial is required where one group of neonates is allocated to hospital
phototherapy and another is allocated to home phototherapy in order to definitively
address this topic.
EVIDENCE SUMMARIES
Format
Evidence summaries are presented as spreadsheets attached to this report. Each
spreadsheet contains the article citation, details of the study design, patient description,
scientific validity of the article, results, pertinent remarks from the study authors and
Centre for Clinical Effectiveness reviewer.
REFERENCES
ARTICLES CRITICALLY APPRAISED FOR THIS REPORT
James JM, Williams SD & Osborn LM (1993). Discontinuation of breast-feeding infrequent
among jaundiced neonates treated at home. Pediatrics 92(1): 153-5.
Eggert LD, Pollary RA, Folland DS & Jung AL (1985). Home phototherapy treatment of
neonatal jaundice. Pediatrics 76(4): 579-84.
Slater L & Brewer MF (1984). Home versus hospital phototherapy for term infants with
hyperbilirubinemia: a comparative study. Pediatrics 73(4): 515-9.
Dyk J (1990). Home phototherapy: reliable equipment, family education assure quality
treatment. Continuing Care 9(9): 44-6.
Fuller J (1990). Home phototherapy. Caring 9(12): 8-11.
Ludwig MA (1990). Phototherapy in the home setting. Journal of Pediatric Health Care
4(6): 304-8.
Rose BS (1990). Phototherapy: all wrapped up? Pediatric Nursing 16(1): 57-8.
Savinetti-Rose B, Kempfer-Kline RE & Mabry CM (1990). Home phototherapy with the
fiberoptic blanket. The nurse's role in caring for newborns and their caregivers. Journal of
Perinatology 10(4): 435-8.
Greenwald JL (1988). Hyperbilirubinemia in otherwise healthy infants. American Family
Physician 38(6): 151-8.
Shibley B (1988). Now newborns can stay home for phototherapy. RN 51(2): 69-71.
Grabert BE (1986). Home phototherapy recommendations questioned. Pediatrics 78(2):
373-4.
Hartsell MB (1986). Home phototherapy. Journal of Pediatric Nursing 1(4): 282-3.
Sapala S & Belkengren R (1986). Pediatric management problems (neonatal jaundice).
Pediatric Nursing 12(4): 301.
Anonymous (1985). American Academy of Pediatrics. Committee on Fetus and Newborn.
Home phototherapy. Pediatrics 76(1): 136-7.
DeLoache WR (1985). Stop home phototherapy. Pediatrics 75(5): 987-8.
Roeder BJ & Williams DN (1985). Diagnosis-specific home care. The Park Nicollet model.
Postgraduate Medicine 77(2): 79-81.
Incorrect comparator
George P & Lynch M (1994). Ohmeda Biliblanket vs Wallaby Phototherapy System for the
reduction of bilirubin levels in the home-care setting. Clinical Pediatrics 33(3): 178-80.
Schuman AJ & Karush G (1992). Fiberoptic vs conventional home phototherapy for
neonatal hyperbilirubinemia. Clinical Pediatrics 31(6): 345-52.
Woodall D & Karas JG (1992). A new light on jaundice. A pilot study. Clinical Pediatrics
31(6): 353-6.
Van Enk A & de Leeuw R (1987). Phototherapy: the hospital as risk factor. British Medical
Journal Clinical Research Ed 294(6574): 747-9.
EVIDENCE SUMMARIES
Evidence Summary
Therapy/Intervention
Phototherapy in the home for
jaundiced neonates
Study 1
James JM, Williams SD & Osborn LM (1993). Discontinuation of
breast-feeding infrequent among jaundiced neonates treated at
home. Pediatrics 92(1): 153-5.
Study 2
Eggert LD, Pollary RA, Folland DS & Jung AL (1985). Home
phototherapy treatment of neonatal jaundice. Pediatrics 76(4):
579-84.
DESCRIPTION:
Patients (subjects), Intervention,
Comparisons, Outcomes,
Inclusion & Exclusion Criteria
VALIDITY:
Methodology, rigour, selection
RESULTS:
Generally favourable or
unfavourable, specific outcomes
of interest, estimate of
experimental effect and precision
if appropriate
AUTHOR(S) CONCLUSIONS:
Limitations, implications for
practice and research
10
OUR COMMENTS:
Opportunity for bias, weakness
and strength
No randomisation
Retrospective
Small sample
No randomisation
Small sample
No blinding of assessors
11
Evidence Summary
Therapy/Intervention
Phototherapy in the home for
jaundiced neonates
Study 3
Slater L & Brewer MF (1984). Home versus hospital phototherapy for term infants with hyperbilirubinemia: a comparative study.
Pediatrics 73(4): 515-9.
DESCRIPTION:
Patients (subjects), Intervention,
Comparisons, Outcomes,
Inclusion & Exclusion Criteria
VALIDITY:
Methodology, rigour, selection
RESULTS:
Generally favourable or
unfavourable, specific outcomes
of interest, estimate of
experimental effect and precision
if appropriate
AUTHOR(S) CONCLUSIONS:
Limitations, implications for
practice and research
OUR COMMENTS:
Opportunity for bias, weakness
and strength
No randomisation
Allocation to the two groups was different, which may have led to a bias in outcome.
Weakness/es:
No blinding of assessors.
Small sample.
Strength/s:
Definition of hyperbilirubinaemia provided, although no accepted standard was available at time of study.
12
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APPENDIX 1
Copyright
This publication is the copyright of Southern Health. Other than for the purposes and
subject to the conditions prescribed under the Copyright Act 1968 as amended, no part of this
publication may, in any form or by any means (electric, mechanical, microcopying,
photocopying, recording or otherwise), be reproduced, stored in a retrieval system or
transmitted without prior written permission. Inquiries should be addressed to Centre for
Clinical Effectiveness.
Disclaimer
The information in this report is a summary of that available and is primarily designed to give
readers a starting point to consider currently available research evidence. Whilst appreciable
care has been taken in the preparation of the materials included in this publication, the authors
and Southern Health do not warrant the accuracy of this document and deny any
representation, implied or expressed, concerning the efficacy, appropriateness or suitability of
any treatment or product. In view of the possibility of human error or advances of medical
knowledge the authors and Southern Health cannot and do not warrant that the information
contained in these pages is in every aspect accurate or complete. Accordingly, they are not
and will not be held responsible or liable for any errors of omissions that may be found in this
publication. You are therefore encouraged to consult other sources in order to confirm the
information contained in this publication and, in the event that medical treatment is required,
to take professional expert advice from a legally qualified and appropriately experienced
medical practitioner.
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APPENDIX 2
Search strategy (only MEDLINE search is shown)
Search terms for MEDLINE
1
Infant, Newborn/
(neonate or newborn).mp.
infant.tw.
Or/1-3
5 or 6
10
biliblanket or uv light.tw.
11
12
Or/8-10
13
4 and 7 and 11
14
15