Protocol Citation: Artur Nogueira de São José, Zilma Reis, Maria Cândida Ferrarez Bouzada, Márcia Gomes Penido Machado, Ursula do Carmo Resende, Hilton de Oliveira Mota, Adson Ferreira da Rocha, Marcelo Lopes Pereira Júnior, Paulo de Jesus Hartmann Nader 2024. The effect of climate change on lactating mammalian milk: a systematic review protocol. protocols.io https://dx.doi.org/10.17504/protocols.io.4r3l2qxxxl1y/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: In development
We are still developing and optimizing this protocol
National Council for Scientific and Technological Development (CNPq)
Grant ID: Bolsista de Produtividade Desen. Tec. e Extensão Inovadora do CNPq - Nível 2. Grant number: CNPq 305837/2021-4
National Council for Scientific and Technological Development (CNPq)
Grant ID: Bolsista de Produtividade em Pesquisa do CNPq - Nível 1C. Grant number: CNPq 315331/2023-2
Abstract
The search will be carried out in the following databases: MEDLINE (PubMed), Cochrane Library, Embase-Elsevier, Scopus-Elsevier, Web of Science, LILACS-BVS, IEEE. To define the search strategies, we will have support from the library of the Faculty of Medicine of the Univesidade Federal de Minas Gerais (one of the institutions that are part of this project). Furthermore, we will use the software StaRt‱ to manage all the bibliographical references and to centralize all information necessary to build a database for this systematic review. References retrieved from search strategies will be exported to the software StaRt‱, and duplicates will be removed. After this procedure, two independent reviewers will select potential titles and abstracts, assessed for the inclusion criteria outlined above. Potentially relevant studies will have their full-text versions then independently assessed by two reviewers to determine if they meet the inclusion criteria. Discrepancies will be resolved by a third investigator. Excluded articles will be documented along with the reasons for exclusion. A total of nine reviewers is involved in this process. The final selection of included studies will be carried out for qualitative and quantitative analysis. Subsequently, data will be extracted, and the characteristics of the included studies will be detailed.
1. Review title. Give the working title of the review, for example the one used for obtaining funding. Ideally the title should state succinctly the interventions or exposures being reviewed and the associated health or social problems. Where appropriate, the title should use the PI(E)COS.
The effect of climate change on lactating mammalian milk: a systematic review protocol
2. Original language title.
The present review will be written in English.
3. Anticipated or actual start date. Give the date when the systematic review commenced, or is expected to commence.
September 1st, 2024
4. Anticipated completion date. Give the date by which the review is expected to be completed.
Dezember 1st, 2024
5. Stage of review at time of this submission.
Formal screening of search results against eligibility criteria is in progress.
6. Named contact.
Prof. Artur Nogueira de São José
7. Named contact email.
anog@ene.unb.br
8. Named contact address.
Universidade de Brasília
Campus Universitário Darcy Ribeiro
Asa Norte, Brasília-DF, CEP 70910-900, Brazil
9. Named contact phone number.
+55 (61) 3107-5510 (Office)
10. Organisational affiliation of the review. Full title of the
organisational affiliations for this review and website address if
available. This field may be completed as 'None' if the review is not
affiliated to any organisation.
Institution #1
Universidade de Brasília
Faculdade de Tecnologia, Departamento de Engenharia Elétrica
Website: http://www.ene.unb.br/
Location: Brasilia, Brazil
Institution #2
Universidade Federal de Minas Gerais
Faculdade de Medicina, Departamento de Ginecologia e Obstetrícia
Website:
https://www.medicina.ufmg.br/
Faculdade de Medicina, Departamento de Pediatria
Website:
https://www.medicina.ufmg.br/ped/
Escola de Engenharia, Departamento de Engenharia Elétrica
Website: https://dee.ufmg.br/
Location: Belo Horizonte, Brazil
Institution #3 Centro Federal de Educação Tecnológica de Minas Gerais
Departamento de Engenharia Elétrica
Website: https://www.dee.cefetmg.br/
Location: Belo Horizonte, Brazil
Institution #4
Hospital Universitário de Canoas (HU CANOAS)
Location: Canoas, Brazil
11. Review team members and their organisational affiliations. Give the
personal details and the organisational affiliations of each member
of the review team. Affiliation refers to groups or organisations to
which review team members belong. NOTE: email and country are now
mandatory fields for each person.
Member #1
Full name: Artur Nogueira de São José
Affiliation: Universidade de Brasília, Faculdade de Tecnologia,
Departamento de Engenharia Elétrica
Role: Professor
Email: anog@ene.unb.br
Location: Brasilia, Brazil
Member #2
Full name: Zilma Silveira Nogueira Reis
Affiliation: Universidade Federal de Minas Gerais, Faculdade de
Medicina, Departamento de Ginecologia e Obstetrícia
Role: Professor
Email: zilma@ufmg.br
Location: Belo Horizonte, Brazil
Member #3
Full name: Maria Cândida Ferrarez Bouzada
Affiliation: Universidade Federal de Minas Gerais, Faculdade de
Medicina, Departamento de Pediatria
Role: Professor
Email: mariacfbv@ufmg.br
Location: Belo Horizonte, Brazil
Member #4
Full name: Márcia Gomes Penido Machado
Affiliation: Universidade Federal de Minas Gerais, Faculdade de
Medicina, Departamento de Pediatria
Role: Professor
Email: mgpenido@ufmg.br
Location: Belo Horizonte, Brazil
Member #5
Full name: Ursula do Carmo Resende
Affiliation: Centro Federal de Educação Tecnológica de Minas
Gerais, Departamento de Engenharia Elétrica
Role: Professor
Email: resendeursula@cefetmg.br
Location: Belo Horizonte, Brazil
Member #6
Full name: Hilton de Oliveira Mota
Affiliation: Universidade Federal de Minas Gerais, Escola de
Engenharia, Departamento de Engenharia Elétrica
Role: Professor
Email: hilton@ufmg.br
Location: Belo Horizonte, Brazil
Member #7
Full name: Adson Ferreira da Rocha
Affiliation: Universidade de Brasília, Faculdade de Tecnologia,
Departamento de Engenharia Elétrica
Role: Professor
Email: adson@unb.br
Location: Brasilia, Brazil
Member #8
Full name: Marcelo Lopes Pereira Júnior
Affiliation: Universidade de Brasília, Faculdade de Tecnologia,
Departamento de Engenharia Elétrica
Role: Professor
Email: marcelo.lopes@unb.br
Location: Brasilia, Brazil
Member #9
Full name: Paulo de Jesus Hartmann Nader
Affiliation: Hospital Universitário de Canoas (HU CANOAS)
Role: Medical Director
Email: pj.nader@gmail.com
Location: Canoas, Brazil
12. Funding sources/sponsors. Give details of the individuals,
organizations, groups or other legal entities who take responsibility
for initiating, managing, sponsoring and/or financing the review.
Include any unique identification numbers assigned to the review by
the individuals or bodies listed.
Zilma Silveira Nogueira Reis received a grant from the National Council for
Scientific and Technological Development (CNPq). Grant category in
Portuguese: Bolsista de Produtividade Desen. Tec. e Extensão
Inovadora do CNPq - Nível 2. Grant number: CNPq 305837/2021-4.
Adson Ferreira da Rocha received a grant from the National Council for
Scientific and Technological Development (CNPq). Grant category in
Portuguese: Bolsista de Produtividade em Pesquisa do CNPq - Nível
1C. Grant number: CNPq 315331/2023-2.
13. Conflicts of interest. List any conditions that could lead to actual or perceived
undue influence on judgements concerning the main topic investigated
in the review.
The authors declare that they have no known competing financial interests
or personal relationships that could have appeared to influence the
work reported in this study.
14. Collaborators. Give the name and affiliation of any individuals or
organisations who are working on the review but who are not listed as
review team members. NOTE: email and country are now mandatory fields
for each person.
Not applicable.
15. Review question. State the question(s) to be addressed by the review,
clearly and precisely. Review questions may be specific or broad. It
may be appropriate to break very broad questions down into a series
of related more specific questions. Questions may be framed or
refined using PI(E)COS where relevant.
Main research question
Are there any effects of climate change on nursing mammals that alter the
composition or properties of raw milk?
Secondary questions:
1 - If so, what are the components or properties of the raw milk that change?
2 - What techniques are used to identify these changes?
3 - Is there evidence of climate change effects on human raw milk?
(P) Lactating mammals under climatic effects
(E) The exposure consists of a set of environmental conditions
(temperature, humidity, rainfall indices, solar radiation etc) of a
given geographical area that have been changed due to climate change
(C) Non-exposure refers to environmental conditions unaffected by climate change
(O)The main result is the comparison of raw milk components or
biological properties under the effect of climate change against the
natural state of the climate. Additional results are techniques and
methods to assess climate change affecting raw milk; and any other
evidence of climate change effects on human milk.
16. Searches. State the sources that will be searched. Give the search
dates, and any restrictions (e.g. language or publication period). Do
NOT enter the full search strategy (it may be provided as a link or
attachment.)
Sources: MEDLINE
(PubMed), Cochrane Library, Embase-Elsevier, Scopus-Elsevier, Web of
Science, LILACS-BVS, IEEE.
Search date:
September 19th, 2024.
Restriction:
no language restriction except that the articles must have their
title and abstract available in English; no restriction regarding the
publication date.
17. URL to search strategy. Give a link to a published pdf/word document
detailing either the search strategy or an example of a search
strategy for a specific database if available (including the keywords
that will be used in the search strategies), or upload your search
strategy.
Database:
MEDLINE (PubMed)
Search
strategy: ((Milk[Title/Abstract] OR "Human Milk"[Title/Abstract]
OR Lactation[Title/Abstract] OR "Breastfeeding
Women"[Title/Abstract] OR "Breast Feeding"[Title/Abstract]
OR "Suckling Animals"[Title/Abstract])) AND ((("Climate
Change"[Title/Abstract] OR "Global Warming"[Title/Abstract]
OR "Sea Level Rise"[Title/Abstract] OR "Air
Pollutants"[Title/Abstract])))
Database:
Cochrane Library
Search
strategy: (Milk OR "Human Milk" OR Lactation OR
"Breastfeeding Women" OR "Breast Feeding" OR
"Suckling Animals") AND ("Climate Change" OR
"Global Warming" OR "Sea Level Rise" OR "Air
Pollutants")
Database:
Embase-Elsevier
Search
strategy: (milk:ab,ti OR 'breast milk':ab,ti OR lactation:ab,ti OR
'breastfeeding women':ab,ti OR 'breast feeding':ab,ti OR 'suckling
animal':ab,ti) AND ('climate change':ab,ti OR 'greenhouse
effect':ab,ti OR 'sea level rise':ab,ti OR 'air pollutant':ab,ti)
Database:
Scopus-Elsevier
Seach
strategy: (Milk OR "Human Milk" OR Lactation OR
"Breastfeeding Women" OR "Breast Feeding" OR
"Suckling Animals") AND ("Climate Change" OR
"Global Warming" OR "Sea Level Rise" OR "Air
Pollutants")
Database:
Web of Science
Search
strategy: (Milk OR "Human Milk" OR Lactation OR
"Breastfeeding Women" OR "Breast Feeding" OR
"Suckling Animals") AND ("Climate Change" OR
"Global Warming" OR "Sea Level Rise" OR "Air
Pollutants")
Database:
LILACS-BVS
Search
strategy: (("Mudança Climática" OR "Climate Change"
OR "Cambio Climático" OR "Changement climatique"
OR "Alterações Climáticas" OR "Aquecimento Global"
OR "Global Warming" OR "Calentamiento Global" OR
"Réchauffement de la planète" OR "Elevação do
Nível do Mar" OR "Sea Level Rise" OR "Elevación
del Nivel del Mar" OR "Élévation du niveau de la mer"
OR "Impactos da Poluição na Saúde" OR "Impacts of
Polution on Health" OR "Impactos de la Polución en la
Salud" OR "Impacts sur la Santé" OR "Poluentes
Atmosféricos" OR "Air Pollutants" OR "Contaminantes
Atmosféricos" OR "Polluants atmosphériques")) AND
(("Mulheres Lactantes" OR "Breastfeeding Women"
OR "Madres Lactantes" OR "Femmes allaitantes" OR
"Animais Lactentes" OR "Animals, Suckling" OR
"Animales Lactantes" OR "Animaux allaités" OR
"Aleitamento Materno" OR "Breast Feeding" OR
"Lactancia Materna" OR "Allaitement naturel" OR
"Animais Lactentes" OR "Animals, Suckling" OR
"Animales Lactantes" OR "Animaux allaités" OR
leite OR milk OR leche OR lait OR "Leite Humano" OR "Milk,
Human" OR "Leche Humana" OR "Lait humain" OR
lactação OR lactation OR lactancia OR lactation)) AND (
db:("LILACS" OR "WPRIM" OR "BINACIS" OR
"CUMED" OR "IBECS" OR "LIPECS"))
Database:
IEEE
Search
strategy: ("All Metadata":("All Metadata":Milk)
OR "All Metadata":("All Metadata":Human Milk) OR
"All Metadata":("All Metadata":Lactation) OR "All
Metadata":("All Metadata":Breastfeeding Women) OR "All
Metadata":("All Metadata":Breast Feeding) OR "All
Metadata":("All Metadata":Suckling Animals)) AND ("All
Metadata":("All Metadata":Climate Change) OR "All
Metadata":("All Metadata":Global Warming) OR "All
Metadata":("All Metadata":Sea Level Rise) OR "All
Metadata":("All Metadata":Air Pollutants))
18. Condition or domain being studied. Give a short description of the
disease, condition or healthcare domain being studied. This could
include health and wellbeing outcomes.
We seek to find evidence in the scientific literature regarding possible effects of climate change on the health of female mammals. More specifically, we will investigate scenarios where such effects affect the nutritional quality of raw breast milk produced by these mammals during the breastfeeding phase. Processed milk is out of the scope of this investigation. Our research will consider various environmental variables, such as temperature, humidity, altitude, rainfall levels, presence of tsunamis etc. Any
environmental conditions not attributed to climate changes will be ignored, even if they are abnormal.
19. Participants/population. Give summary criteria for the participants
or populations being studied by the review. The preferred format
includes details of both inclusion and exclusion criteria.
Participant: Studies of Mammalian milk`s composition
Inclusion criteria:
Presence of adverse environmental effects that have been attributed to climate change
Studies on female lactating mammals (human or not)
Studies that analyze fresh milk (collected during breastfeeding)
Studies with a clear definition of climate change.
Exclusion criteria:
Presence of adverse environmental effects that have not been attributed to climate change
Effects on processed milk (freeze-dried, refrigerated, stored in a milk bank etc)
Study does not assess the effects of climate change on milk
20. Intervention(s), exposure(s). Give full and clear descriptions
or definitions of the nature of the interventions or the exposures to
be reviewed.
The exposure consists of a set of environmental conditions (temperature, humidity, rainfall indices, solar radiation etc) of a given geographical area that have been changed due to climate change. Any
abnormal environmental condition not attributed to climate changes will not be considered.
21. Comparator(s)/control. Where relevant, give details of the
alternatives against which the main subject/topic of the review will
be compared (e.g. another intervention or a non-exposed control
group). The preferred format includes details of both inclusion and
exclusion criteria.
Non-exposure
refers to environmental conditions unaffected by climate change. Even
if the environmental conditions are abnormal, they will be ignored if
there is no known link with climate change.
22. Types of study to be included. Give details of the types of study
(study designs) eligible for inclusion in the review. If there are no
restrictions on the types of study design eligible for inclusion, or
certain study types are excluded, this should be stated. The
preferred format includes details of both inclusion and exclusion
criteria.
There are no
restrictions on the types of study design eligible for inclusion.
23. Context. Give
summary details of the setting and other relevant characteristics
which help define the inclusion or exclusion criteria.
According
to the United Nations, “climate change refers to long-term shifts
in temperatures and weather patterns”. These phenomena “can be
natural, such as changes in the sun’s activity or significant
volcanic eruptions.” However, “human activities have been the
main driver of climate change, primarily due to burning fossil fuels
like coal, oil, and gas”. Negative effects on human health may be
associated with extreme climate changes, including people suffering
from floods, storm catastrophes, and significant temperature
variations throughout the year. In such a scenario, the effect of
climatic stress on the milk produced by mammals during their
breastfeeding phase has still not been deeply investigated. This
review intends to assess whether climate change affects lactating
females with any repercussions on the milk in terms of quality and
amount.
24. Main outcome(s).
Give the pre-specified main (most important) outcomes of the review,
including details of how the outcome is defined and measured and when
these measurements are made, if these are part of the review
inclusion criteria.
Main
outcome: any reported change in the nutritional quality of milk of
animal or human origin due to abnormal environmental conditions.
Measures
of effect: any reported disparity between the typical concentration
levels of milk nutrients and the concentration levels of the same
nutrients under an abnormal environmental condition.
25.
Additional outcome(s). List the pre-specified additional outcomes of
the review, with a similar level of detail to that required for main
outcomes. Where there are no additional outcomes please state ‘None’
or ‘Not applicable’ as appropriate to the review.
Additional
outcome #1: any list of milk properties or nutrients whose
concentrations or any other physicochemical properties were affected
by climate change.
Measure
of effect: any quantitative and comparative analysis of the milk
nutrients’ physicochemical
properties in both normal and harsh environmental conditions.
Additional
outcome #2: any reported measurement technique with a demonstrated
efficiency to detect abnormalities in the nutritional status of any
type of milk.
Measure
of effect: high correlation between the measured concentration of
milk nutrients and a reference value.
26. Data extraction (selection and coding).
Describe how studies will be selected for inclusion. State what data
will be extracted or obtained. State how this will be done and
recorded.
The search will be carried out in the following
databases: MEDLINE (PubMed), Cochrane Library, Embase-Elsevier,
Scopus-Elsevier, Web of Science, LILACS-BVS, IEEE. To define the
search strategies, we will have support from the library of the
Faculty of Medicine of the Univesidade Federal de Minas Gerais (one
of the institutions that are part of this project). Furthermore, we
will use the software StaRt‱ to manage all the bibliographical
references and to centralize all information necessary to build a
database for this systematic review.
References
retrieved from search strategies will be exported to the software
StaRt‱, and duplicates will be removed. After this procedure, two
independent reviewers will select potential titles and abstracts,
assessed for the inclusion criteria outlined above. Potentially
relevant studies will have their full-text versions then
independently assessed by two reviewers to determine if they meet the
inclusion criteria. Discrepancies will be resolved by a third
investigator. Excluded articles will be documented along with the
reasons for exclusion.
The
final selection of included studies will be carried out for
qualitative and quantitative analysis. Subsequently, data will be
extracted, and the characteristics of the included studies will be
detailed.
27. Risk of bias
(quality) assessment. Describe the method of assessing risk of bias
or quality assessment. State which characteristics of the studies
will be assessed and any formal risk of bias tools that will be used.
Once
the search is performed in the seven mentioned databases, the team is
divided into pairs of reviewers. Both reviewers will have access to
the same articles. Each of them will independently perform each step
of the selection and extraction process. Independence is necessary to
ensure that one reviewer will not influence his peer’s analysis.
Then, they will meet to compare their individual decisions on
acceptance or rejection of the papers. Any disagreements will be
resolved by discussion or by involving a third author. The risk of
bias of the individual studies will be assessed using the Prediction
Model Risk of Bias Assessment Tool (PROBAST) for each article.
28. Strategy for
data synthesis. Provide details of the planned synthesis including a
rationale for the methods selected. This must not be generic text but
should be specific to your review and describe how the proposed
analysis will be applied to your data.
The data extraction and synthesis processes
will be assisted by the software StArt. This software will be used to
manage articles, identify duplicates and facilitate the selection
based on inclusion and exclusion criteria. In summary, useful data
will be finely extracted from the initial database by peer reviewers
with the aid of StArt software.
After extraction, data will be summarized in tables according to
the following criteria:
Country where data was collected
Geographical coverage of the study – Possible Answers: Local
(restricted to a city), Regional (more than one city), National
(several regions/states of a country), Multicenter (more than one
country)
Main goal of the study
Species of mammals analyzed
Study design – Possible
Answers: Observational (bench),
Observational (real scenario), Observational (cohort), Experimental
(humans or animals exposed to climate change and monitored over
time), Experimental (clinical trial), Simulation, Cross-sectional
study
Milk sample collection technique
Milk sample storage technique
Milk sample processing technique
Milk features (substances or properties) analyzed
Sensing technology employed to detect changes in milk properties
Have the effects of climate change on
lactating mammals been proven in raw milk composition or properties?
– Possible Answers: Yes,
No, Inconclusive; For the case where the answer is ‘Yes’: Which
effect was observed?
Apart from questions B, E, and K, free answers
will be allowed.
29.
Analysis of subgroups or subsets. State any planned investigation of
‘subgroups’. Be clear and specific about which type of study or
participant will be included in each group or covariate investigated.
State the planned analytic approach.
Not applicable.
30. Type and method of review. Select the type of review and the
review method from the lists below. Select the health area(s) of
interest for your review.
A
B
Type of review
Cost effectiveness
No
Diagnostic
No
Epidemiologic
No
Individual patient data (IPD) meta-analysis
No
Intervention
No
Meta-analysis
No
Methodology
No
Narrative synthesis
No
Network meta-analysis
No
Pre-clinical
No
Prevention
No
Prognostic
No
Prospective meta-analysis (PMA)
No
Review of reviews
No
Service delivery
No
Synthesis of qualitative studies
No
Systematic review
Yes
Other
No
Health area of the review
Alcohol/substance misuse/abuse
No
Blood and immune system
No
Cancer
No
Cardiovascular
No
Care of the elderly
No
Child health
Yes
Complementary therapies
No
COVID-19
No
Crime and justice
No
Dental
No
Digestive system
No
Ear, nose and throat
No
Education
No
Endocrine and metabolic disorders
No
Eye disorders
No
General interest
Yes
Genetics
No
Health inequalities/health equity
No
Infections and infestations
No
International development
No
Mental health and behavioural conditions
No
Musculoskeletal
No
Neurological
No
Nursing
No
Obstetrics and gynaecology
Yes
Oral health
No
Palliative care
No
Perioperative care
No
Physiotherapy
No
Pregnancy and childbirth
Yes
Public health (including social determinants of health)
Yes
Rehabilitation
No
Respiratory disorders
No
Service delivery
No
Skin disorders
No
Social care
No
Surgery
No
Tropical Medicine
No
Urological Wounds, injuries and accidents
No
Violence and abuse
No
31. Language. Select
each language individually to add it to the list below, use the bin
icon to remove any added in error.
English
32. Country. Select
the country in which the review is being carried out from the drop
down list. For multi-national collaborations select all the countries
involved.
Brazil
33. Other
registration details. Give the name of any organisation where the
systematic review title or protocol is registered (such as with The
Campbell Collaboration, or The Joanna Briggs Institute) together with
any unique identification number assigned. (N.B. Registration details
for Cochrane protocols will be automatically entered). If extracted
data will be stored and made available through a repository such as
the Systematic Review Data Repository (SRDR), details and a link
should be included here. If none, leave blank.
Not applicable.
34.
Reference and/or URL for published protocol. Give the citation and
link for the published protocol, if there is one.
No
I do not make this file publicly available until the review is
complete.
35. Dissemination
plans. Give brief details of plans for communicating essential
messages from the review to the appropriate audiences.
Scientific articles.
Do you intend to
publish the review on completion? Yes.
36. Keywords. Give
words or phrases that best describe the review. Separate keywords
with a semicolon or new line. Keywords will help users find the
review in the Register (the words do not appear in the public record
but are included in searches). Be as specific and precise as
possible. Avoid acronyms and abbreviations unless these are in wide
use.
37. Details of any
existing review of the same topic by the same authors. Give details
of earlier versions of the systematic review if an update of an
existing review is being registered, including full bibliographic
reference if possible.
Not applicable.
38.
Current review status. Review status should be updated when the
review is completed and when it is published. For new registrations
the review must be Ongoing.
Paper
will be submitted for review soon.
39.
Any additional information. Provide any other information the review
team feel is relevant to the registration of the review.
Not applicable.
40. Details of final
report/publication(s). This field should be left empty until details
of the completed review are available