The effectiveness of interventions to treat severe acute malnutrition in young children

334 Pages·2012·1.66 MB·English

by  Picot J

Health Technology Assessment 2012; Vol. 16: No.191
Chapter 6
Health Technology Assessment 2012; Vol. 16: No. 19 ISSCNo 1n3c6lu6s-i5o2n7s8
ISSN 1366-5278
Implications for service provision
AbSsturBgahgcuettstate edt r easl.e a1r9c9h4 p53riorities
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DeAcplapreendd cixo m10p e ting interests of advisory group
ExecQutuievset isounm 7:m daartya extraction tables 203
Contribution of authors
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ReferOeTbnrejcehecatsniv eest al. 201060
Methods
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treat severe acute malnutrition in young DFeCulpnilhidbi iensrgttuod eyt t oa ls. p2e0c0if5y6 t3he research question
LitHereaiktuernes s eeta raclh. 199464
children: a systematic review ChSaptKutdheyar ni1nu c mlu seito nal. 199465
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QDuAeapsliptcyer inapsdtisoixen s1 os2mf uenndterlying health problem
Question 8: data extraction tables 239
DCatuar rseynnt tsheersviisce provision
Doherty et al. 199868
Overall aims and objectives of assessment
J Picot, D Hartwell, P Harris, D Mendes, AppenGdaixth 2er u et al. 198870
ChTahpGeteo Prld r2ee n fe arnredd G Roledpeon r1ti9n9g2 I7t1ems for Systematic Reviews and Meta-Analyses checklist
AJ Clegg and A Takeda
MHeetmhoaldasth fao er tt hael. D1e99lp3h72i process and systematic review of clinical effectiveness
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SIedMaeranckthiofi cdnanatetieonsn ,e oet fx aasltm.u 2dp0ilee0s 3se74a,7r5ch strategy and grey literature sources 119
InSccluhsleiosnin gaenrd e etx callu. s1io9n9 2c7r6iteria and process for screening studies
Appendix 4
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Quality assessment 121
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Guidance for use of the quality assessment tool – severe malnutrition project
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Appendix 5
Manary and Brewster 199780
Delphi study 127
ChapPtheirli p3 e t al. 198281
Round 1: question sheet
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Round 2: question sheet
Round 1
Round 3: question sheet
DAepvpeelonpdmixe 1n3t o f question sheet and scoring in round 2 and round 3
Ongoing studies 307
Appendix 6
Chapter 4
Table of excluded studies 137
HeaAlsths eTsescmhneonlto ogfy c Alisnsiceasls emffeenctt ipvreongersasmme
What methods are effective for treating severe acute malnutrition among infants < 6 months
Appendix 7
old? (Q19, rank 1 = )
Question 19: data extraction tables 143
Which form of intravenous fluid administration is most effective for treating shock? (Q21, rank 1 = )
Nu Shwe 200347
What are the best treatments for children with severe acute malnutrition who have
Hossain et al. 200948
diarrhoea? (Q22, rank 1 = )
What methods are effective in treating infection? (Q7, rank 5 = )
Appendix 8
QWuehsattio isn t2h1e: cdliantiac ael xetfrfaeccttiiovne ntaebssle os f interventions in different settings (e.g. hospital, 149
Ackoemchm eutn aityl., 2e0m1e0r4g9ency)? (Q14, rank 9)
Which methods for correcting micronutrient deficiencies are effective? (Q8, rank 10)
AOppnegnodinixg 9s t udies
April 2012 Question 22: data extraction tables 157
ChAaplatmer e 5t al. 200051
10.3310/hta16190
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The effectiveness of interventions to treat
severe acute malnutrition in young children:
a systematic review
J Picot,1 D Hartwell,1 P Harris,1 D Mendes,1 AJ Clegg1*
and A Takeda1,2
1Southampton Health Technology Assessments Centre, University of Southampton,
Southampton, UK
2Centre for Primary Care and Public Health, Barts and the London School of
Medicine and Dentistry, London, UK
*Corresponding author
Declared competing interests of the authors: none
Published April 2012
DOI: 10.3310/hta16190
This report should be referenced as follows:
Picot J, Hartwell D, Harris P, Mendes D, Clegg AJ and Takeda A. The effectiveness of interventions to
treat severe acute malnutrition in young children: a systematic review. Health Technol Assess
2012;16(19).
Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta
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DOI: 10.3310/hta16190 Health Technology Assessment 2012; Vol. 16: No. 19 iii
Abstract
The effectiveness of interventions to treat severe acute
malnutrition in young children: a systematic review
J Picot,1 D Hartwell,1 P Harris,1 D Mendes,1 AJ Clegg1* and A Takeda1,2
1Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK
2Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry,
London, UK
*Corresponding author
Background: Severe acute malnutrition (SAM) arises as a consequence of a sudden period
of food shortage and is associated with loss of a person’s body fat and wasting of their
skeletal muscle. Many of those affected are already undernourished and are often
susceptible to disease. Infants and young children are the most vulnerable as they require
extra nutrition for growth and development, have comparatively limited energy reserves
and depend on others. Undernutrition can have drastic and wide-ranging consequences
for the child’s development and survival in the short and long term. Despite efforts made to
treat SAM through different interventions and programmes, it continues to cause
unacceptably high levels of mortality and morbidity. Uncertainty remains as to the most
effective methods to treat severe acute malnutrition in young children.
Objectives: To evaluate the effectiveness of interventions to treat infants and children aged
< 5 years who have SAM.
Data sources: Eight databases (MEDLINE, EMBASE, MEDLINE In-Process & Other Non-
Indexed Citations, CAB Abstracts Ovid, Bioline, Centre for Reviews and Dissemination,
EconLit EBSCO and The Cochrane Library) were searched to 2010. Bibliographies of
included articles and grey literature sources were also searched. The project expert
advisory group was asked to identify additional published and unpublished references.
Review methods: Prior to the systematic review, a Delphi process involving international
experts prioritised the research questions. Searches were conducted and two reviewers
independently screened titles and abstracts for eligibility. Inclusion criteria were applied to
the full texts of retrieved papers by one reviewer and checked independently by a second.
Included studies were mapped to the research questions. Data extraction and quality
assessment were undertaken by one reviewer and checked by a second reviewer.
Differences in opinion were resolved through discussion at each stage. Studies were
synthesised through a narrative review with tabulation of the results.
Results: A total of 8954 records were screened, 224 full-text articles were retrieved, and 74
articles (describing 68 studies) met the inclusion criteria and were mapped. No evidence
focused on treatment of children with SAM who were human immunodeficiency virus sero-
positive, and no good-quality or adequately reported studies assessed treatments for SAM
among infants < 6 months old. One randomised controlled trial investigated fluid
resuscitation solutions for shock, with none adequately treating shock. Children with acute
diarrhoea benefited from the use of hypo-osmolar oral rehydration solution (H-ORS)
compared with the standard World Health Organization-oral rehydration solution (WHO-
ORS). WHO-ORS was not significantly different from rehydration solution for malnutrition
© Queen’s Printer and Controller of HMSO 2012. This work was produced by Picot et al. under the terms of a commissioning contract issued by the
Secretary of State for Health.
iv Abstract
(ReSoMal), but the safety of ReSoMal was uncertain. A rice-based ORS was more
beneficial than glucose-based ORSs, and provision of zinc plus a WHO-ORS had a
favourable impact on diarrhoea and need for ORS. Comparisons of different diets in
children with persistent diarrhoea produced conflicting findings. For treating infection,
comparison of amoxicillin with ceftriaxone during inpatient therapy, and routine provision of
antibiotics for 7 days versus no antibiotics during outpatient therapy of uncomplicated
SAM, found that neither had a significant effect on recovery at the end of follow-up. No
evidence mapped to the next three questions on factors that affect sustainability of
programmes, long-term survival and readmission rates, the clinical effectiveness of
management strategies for treating children with comorbidities such as tuberculosis and
Helicobacter pylori infection and the factors that limit the full implementation of treatment
programmes. Comparison of treatment for SAM in different settings showed that children
receiving inpatient care appear to do as well as those in ambulatory or home settings on
anthropometric measures and response time to treatment. Longer-term follow-up showed
limited differences between the different settings. The majority of evidence on methods for
correcting micronutrient deficiencies considered zinc supplements; however, trials were
heterogeneous and a firm conclusion about zinc was not reached. There was limited
evidence on either supplementary potassium or nicotinic acid (each produced some
benefits), and nucleotides (not associated with benefits). Evidence was identified for four of
the five remaining questions, but not assessed because of resource limitation.
Limitations: The systematic review focused on key questions prioritised through a Delphi
study and, as a consequence, did not encompass all elements in the management of SAM.
In focusing on evidence from controlled studies with the most rigorous designs that were
published in the English language, the systematic review may have excluded other forms of
evidence. The systematic review identified several limitations in the evidence base for
assessing the effectiveness of interventions for treating young children with severe acute
malnutrition, including a lack of studies assessing the different interventions; limited details
of study methods used; short follow-up post intervention or discharge; and heterogeneity
in participants, interventions, settings, and outcome measures affecting generalisability.
Conclusions: For many of the most highly ranked questions evidence was lacking or
inconclusive. More research is needed on a range of topic areas concerning the treatment
of infants and children with SAM. Further research is required on most aspects of the
management of SAM in children < 5 years, including intravenous resuscitation regimens for
shock, management of subgroups (e.g. infants < 6 months old, infants and children with
SAM who are human immunodeficiency virus sero-positive) and on the use of antibiotics.
Funding: The National Institute for Health Research Technology Assessment programme.
DOI: 10.3310/hta16190 Health Technology Assessment 2012; Vol. 16: No. 19 v
Contents
List of abbreviations vii
Executive summary ix
1. Background 1
Description of underlying health problem 1
Current service provision 6
Overall aims and objectives of assessment 8
2. Methods for the Delphi process and systematic review of clinical effectiveness 11
Delphi process 11
Identification of studies 11
Inclusion and exclusion criteria and process for screening studies 12
Mapping the evidence to the prioritised research questions 14
Data extraction strategy 14
Quality assessment strategy 14
Method of data synthesis 14
3. Results of the Delphi process 15
Round 1 15
Development of question sheet and scoring in round 2 and round 3 15
4. Assessment of clinical effectiveness 17
What methods are effective for treating severe acute malnutrition among infants
< 6 months old? (Q19, rank 1 = ) 20
Which form of intravenous fluid administration is most effective for treating shock?
(Q21, rank 1 = ) 20
What are the best treatments for children with severe acute malnutrition who have
diarrhoea? (Q22, rank 1 = ) 26
What methods are effective in treating infection? (Q7, rank 5 = ) 45
What is the clinical effectiveness of interventions in different settings (e.g. hospital,
community, emergency)? (Q14, rank 9) 54
Which methods for correcting micronutrient deficiencies are effective? (Q8, rank 10) 63
Ongoing studies 87
5. Discussion 89
Statement of principal findings 89
Strengths and limitations of the assessment 95
Uncertainties 97
Other relevant factors 98
6. Conclusions 99
Implications for service provision 99
Suggested research priorities 99
© Queen’s Printer and Controller of HMSO 2012. This work was produced by Picot et al. under the terms of a commissioning contract issued by the
Secretary of State for Health.
vi Contents
Acknowledgements 101
References 105
Appendix 1 Protocol methods 113
Appendix 2 The Preferred Reporting Items for Systematic Reviews and
Meta-Analyses checklist 117
Appendix 3 Search dates, example search strategy and grey literature sources 119
Appendix 4 Quality assessment 121
Appendix 5 Delphi study 127
Appendix 6 Table of excluded studies 137
Appendix 7 Question 19: data extraction tables 143
Appendix 8 Question 21: data extraction tables 149
Appendix 9 Question 22: data extraction tables 157
Appendix 10 Question 7: data extraction tables 203
Appendix 11 Question 14: data extraction tables 215
Appendix 12 Question 8: data extraction tables 239
Appendix 13 Ongoing studies 307
Health Technology Assessment programme 311
DOI: 10.3310/hta16190 Health Technology Assessment 2012; Vol. 16: No. 19 vii
List of abbreviations
ANZCTR Australian New Zealand Clinical Trials Register
AOM acute otitis media
ARS amylase-resistant starch
ART antiretroviral therapy
AUC area under the curve
BMI body mass index
CCT controlled clinical trial (non-randomised)
CDC Centers for Disease Control
CENTRAL Cochrane Central Register of Controlled Trials
CFR case fatality ratio
CHA community health aide
CI confidence interval
CRD Centre for Reviews and Dissemination
CRT capillary refill time
CTRI Clinical Trials Registry – India
DARE Database of Abstracts of Reviews of Effects
H/A height-for-age
HAS human albumin solution
HIV human immunodeficiency virus
HIV–ve human immunodeficiency virus sero-negative
HIV+ve human immunodeficiency virus sero-positive
H-ORS hypo-osmolar oral rehydration solution
HSD/5D half-strength Darrow’s in 5% dextrose
HTA health technology assessment
IAP Indian Academy of Pediatrics
ICDDR International Centre for Diarrhoeal Disease Research
ICMH Institute of Child and Mother Health
ICTRP WHO International Clinical Trials Registry Platform
i.m. intramuscular
IQR interquartile range
ITT intention to treat
i.v. intravenous
KY khitchri and yoghurt
LQ lower quartile
MEIP MEDLINE In-Process & Other Non-Indexed Citations
MUAC mid-upper arm circumference
NCHS National Center for Health Statistics
NGO non-governmental organisation
NHS EED Economic Evaluation Database
NIHR National Institute for Health Research
NT nucleotide
OR odds ratio
ORS oral rehydration solution
PEM protein–energy malnutrition
PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
RCT randomised controlled trial
ReSoMal rehydration solution for malnutrition
RL Ringer’s lactate isotonic fluid
© Queen’s Printer and Controller of HMSO 2012. This work was produced by Picot et al. under the terms of a commissioning contract issued by the
Secretary of State for Health.
viii List of abbreviations
RR risk ratio
RUTF ready-to-use therapeutic food
SAM severe acute malnutrition
SD standard deviation
SE standard error
SHTAC Southampton Health Technology Assessment Centre
TB tuberculosis
TFC therapeutic feeding centre
UKCRN UK Clinical Research Network
UNICEF United Nations Children’s Fund
UQ upper quartile
W/A weight-for-age
W/H weight-for-height
W/L weight-for-length
WHO World Health Organization
All abbreviations that have been used in this report are listed here unless the abbreviation is well
known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only
in figures/tables/appendices, in which case the abbreviation is defined in the figure legend or in
the notes at the end of the table.