Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals (2017) / Chapter Skim
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Appendix E: Supporting Materials for the PBDE (Animal) Systematic Review
Appendix E: Supporting Materials for the PBDE (Animal) Systematic Review
Pages 329-386
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From page 329... ...
PBDEs have been linked to effects on neurodevelopment after developmental exposure in animal studies. OBJECTIVE AND SPECIFIC AIMS Review Question The overall objective of this systematic review is to answer the question is developmental exposure to PBDEs in nonhuman mammals associated with alterations in learning, memory, attention, or response inhibition?
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Examples of tests include Morris water maze, radial arm maze, and operant tests of cognition. METHODS Problem Formulation and Protocol Development The review question and specific aims were developed and refined through a series of problem formulation steps.
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Biographical information on the review team is presented in Section E-1a. Search Methods Search for Existing Systematic Reviews The review team will consider using existing systematic reviews to address or help to address its research question.
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If no relevant systematic reviews are found, an independent systematic review will be performed. Literature Search for Independent Systematic Review The review team will collaborate with an information specialist (JB)
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Updated details to instructions and interpretations for title and abstract screening will be added to Section E-1f to document the process of the review team during the screening process. Full-Text Screening Citations included at the title/abstract screening level will be subject to a full-text review by the same two reviewers involved in title and abstract screening (SM, EM)
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The review team will attempt to contact authors of included studies to obtain missing data considered important for evaluating key study findings (e.g., level of data required to conduct a meta-analysis)
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The criteria describe aspects of study design, conduct, and reporting required to reach risk of bias ratings for each question and specify factors that can distinguish among ratings (e.g., what separates "definitely low" from "probably low" risk of bias)
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X X X X X X 9. Can we be confident in the outcome assessment (including blinding of outcome assessors)
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. 0% d i The review team will also pe m erform sensittivity analyse on the exc es clusion of ind dividual stud dies in succession n.
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2011. Finding What Works in Health Care: Standards for Systematic Reviews.
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2008. Using existing systematic reviews in com plex systematic reviews.
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She creates and implements systematic review search strategies across multiple databases and provides comprehensive reference, research, and information services to multiple departments within the School of Medicine. She received an MLIS from the University of Pittsburgh and an MPA from the University of Baltimore.
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to find all MeSH heading and Supplementary Concept headings that relate to measures of learning, memory, attention, and cognition. The review team will mine the "Entry Terms" list for each of the controlled vocabulary terms identified and include all unique keyword synonyms listed for each.
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The review team will substitute the animal study search filter used in the PubMed search with the comparable Embase filter published in De Vries RBM, Hooijmans CR, Tillema A, Leenaars M, Ritskes-Hoitinga M A search filter for increasing the retrieval of animal studies in Embase.Laboratory Animals.
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OR "marsupialia"[MeSH Terms] OR "monotremata"[MeSH Terms]
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) Embase (‘flame retardant'/de OR ‘2,2`,4,4`,5,5` hexabromodiphenyl ether'/exp OR ‘polybrominated diphenyl ether'/exp OR ‘diphenyl ether derivative'/exp OR ((flame NEXT/1 retard*
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Appendix E diphenyl* OR PentaBDE*
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" OR "fireproofing agent* " OR "FireMaster" OR "Bromkal" OR "diphenyl ether deriv*
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Appendix E "decabromo deriv* " OR "Decabrom" OR "Berkflam B 10E" OR "FR 300BA" OR "FR 300 BA" OR tribromodiphenyl*
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Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity badger OR badgers OR ermine OR mink OR minks OR sable OR sables OR gulo OR gulos OR wolverine OR wolverines OR minks OR mustela OR llama OR llamas OR alpaca OR alpacas OR camelid OR camelids OR guanaco OR guanacos OR chiroptera OR chiropteras OR bat OR bats OR fox OR foxes OR donkey OR donkeys OR mule OR mules OR zebra OR zebras OR shrew OR shrews OR bison OR bisons OR buffalo OR buffaloes OR deer OR deers OR bear OR bears OR panda OR pandas OR "wild hog" OR "wild boar" OR fitchew OR fitch OR beaver OR beavers OR jerboa OR jerboas OR capybara OR capybaras) AND ("Exposure" OR "Exposed" OR "exposures" OR "exposing")
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Study does not include nonhuman mammals Study does not report PBDE exposure Study does not quantify exposure to PBDE Study does not include developmental exposure Study does not assess or report quantitative measures of learning, memory, attention, or response inhibition No comparator group (different doses or vehicle-only treatment) Not in English and unable to determine eligibility Other (explanation required)
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reporting bias) Animal Model Sex Species Strain Source of animals Age or life stage at start of dosing and at health outcome assessment Diet and husbandry information (e.g., diet name/source)
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Indirect evidence that animals were allocated to any study group including controls using a method with a random component (i.e., authors state random allocation, without description of method) , AND evidence that the study used a concurrent control group as an indication that randomization covered all study groups, OR it is deemed that allocation without a clearly random component would not appreciably bias results.
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Indirect evidence that the same vehicle was used in control and experimental animals, OR it is deemed that the vehicle used would not appreciably bias results, AND identical non-treatment-related experimental conditions are assumed if authors did not report differences in housing or husbandry. Probably High Risk of Bias (-)
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Indirect evidence that loss of animals was adequately addressed and reasons were documented when animals were removed from a study, OR it is deemed that the proportion lost would not appreciably bias results. This would include reports of no statistical differences in characteristics of animals removed from the study from those remaining in the study.
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, AND assessed at the same length of time (i.e., same day of life) after initial exposure in all study groups, OR it is deemed that the outcome assessment methods used would not appreciably bias results, AND there is indirect evidence that the outcome assessors were adequately blinded to the study group, and it is unlikely that they could have broken the blinding prior to reporting outcomes, OR it is deemed that lack of adequate blinding of outcome assessors would not appreciably bias results, which is more likely to apply to objective outcome measures.
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Probably Low Risk of Bias (+) Indirect evidence that litter effects were appropriately considered in the study design or analysis, using one of the following approaches: The dam used as the statistical unit of analysis, OR the fetus/pup used as the statistical unit of analysis AND litter-effects were appropriately considered in the analysis BUT the statistic method used to address litter effects was not stated.
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Most recently, he has been working on emerging issues in toxicology and environmental health, including methods to address study quality in terms of risk of bias for human, animal, and mechanistic studies and adaptation of systematic review methods for address ing environmental health questions. He led the team that developed the OHAT approach to sys tematic review.
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SECTION E-2 Results of Literature Searches for Animal Studies on the Effects of Developmental Exposure to PBDEs on Learning, Memory, Attention, or Response Inhibition Literature searches were performed on August 15, 2016, using the search strategy presented in the PBDE (Animal) Systematic Review Protocol (Section E-1)
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SECTION E-3 Funding Sources of the Animal Studies on PBDEs and Learning, Memory, or Attention Sources of funding were used to evaluate publication bias in terms of whether a particular sector funded more studies than another. Reference Governmental NIH/Federal Industry Other Unknown Biesemeier et al.
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2011 C57BL/6J mice GD 0 - PND 21 2 months Morris water maze 0.1 1 Woods et al. 2012 Female Mecp2 308+/- mice GD 0 - PND 21 PND 50-54 Morris water maze None 0.03 Male Mecp2 308+/- mice GD 0 - PND 21 PND 50-54 Morris water maze 0.03 None Female C57Bl6 mice GD 0 - PND 21 PND 50-54 Morris water maze 0.03 None Male C57Bl6 mice GD 0 - PND 21 PND 50-54 Morris water maze 0.03 None NOTE: GD, gestation day; LOAEL, lowest-observed-adverse-effect level; NOAEL, no-observed-adverse-effect level; PND, postnatal day.
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dy e 2011) rep ported decreas memory in the Morris water maze (e.g., prolong latency p sed i ged periods)
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2012 Female Mecp2 308+/- mice M GD 0 - PND 21 54 PND 50-5 Morris wat maze ter Non ne 0.03 Male Me ecp2 308+/- mice GD 0 - PND 21 PND 50-5 54 Morris wat maze ter 0.03 3 None Female C57Bl6 mice C GD 0 - PND 21 PND 50-5 54 Morris wat maze ter 0.03 3 None Male C57Bl6 mice GD 0 - PND 21 PND 50-5 54 Morris wat maze ter 0.03 3 None NOTE: GD gestation day; LOAEL, lowest-observ D, d ved-adverse-eff ffect level; NO OAEL, no-obs served-adverse-effect level; PND postnatal day D, y. Unexplained inconsistenci Downgra U i ies: aded because o the heterog of geneity of the evidence.
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2014 Sprague-Dawley rats GD 1 - PND 21 PND 34-36 Morris water maze 0.2 None NOTE: GD, gestation day; LOAEL, lowest-observed-adverse-effect level; NOAEL, no-observed-adverse-effect level; PND, postnatal day. Learning: There is moderate confidence in the body of evidence on developmental exposure to BDE-99 and learning in mice and rats based on five studies.
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TABLE E4-4 Studies of BDE-99 and Memory in Rod E f M dents NOOAEL LOAEEL Study Species Life Stage Exposed L d Observation T Time Test (m mg/kg-day)
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r Risk of bias: Downgraded twice becaus of serious concerns abo multiple r R se out risk of bias issues, in ncluding lack of randomiz tment; reduce confidence in outcome assessment d to zation of treat ed e due la of blindin of outcome assessors; and definitely high risk of bias ratings for not contr ack ng e a y f rolling fo litter effect in the study design or an or ts y nalysis (see Fi igure E4-5)
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2003 2 NMRI mouse m PND 10 PND 180 Morris water maze r 0.45 0.9 Zhang et al. 2013 2 Sprague e-Dawley rats PND 10 PND 40 Morris water maze r 1 5 Sprague e-Dawley rats PND 10 PND 70 Morris water maze r 1 5 Sprague e-Dawley rats PND 10 PND 40 Passive avoid dance 10 None Sprague e-Dawley rats PND 10 PND 70 Passive avoid dance 5 10 NOTE: LO OAEL, lowest -observed-adve erse-effect leve NOAEL, n el; no-observed-ad dverse-effect le evel; PND, postnatal day.
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2006 NMRI mouse PND 3 PND 90 Morris water maze 16.8 None NMRI mouse PND 10 PND 90 Morris water maze None 16.8 NOTE: LOAEL, lowest-observed-adverse-effect level; NOAEL, no-observed-adverse-effect level; PND, postnatal day. Learning: There is very low confidence in the data to evaluate whether developmental exposure to BDE203 affects learning in mice from the single study available.
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2006 2 NMRI mouse m PND 3 D PND 90 Morris water ma aze 16.8 None NMRI mouse m PND 10 D PND 90 Morris water ma aze 16.8 None NOTE: LO OAEL, lowest -observed-adve erse-effect leve NOAEL, n el; no-observed-ad dverse-effect le evel; PND, postnatal day.
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. Risk of bias: Downgraded twice because of serious concerns about multiple risk of bias issues, including lack of randomization of treatment; reduced confidence in outcome assessment due to lack of blinding of outcome assessors; and a definitely high risk of bias rating for not controlling for litter effects in the study design or analysis.
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Multiple studies show effects on learning at doses of 20 mg/kg-day or greater when learning was assessed using a Morris water maze; other studies, however, show no effects in the same dose range using other test methods. Risk of bias: Downgraded because of serious concerns about multiple risk of bias issues, includ ing reduced confidence in outcome assessment due to lack of blinding of outcome assessors in all studies and a definitely high risk of bias rating in three studies because of failure to control for lit ter effects in the study design or analysis (see Figure E4-7)
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Multiple mouse stud show effe on memo at doses o 3.4 e dies fects ory of mg/kg-day or greater when memor was assess using a M y ry sed Morris water maze; other studies, how r r wever, show no effects on mem e mory at the sa dose range using othe methods. ame er Risk of bias: Downgraded because of se R D erious concer about mul rns ltiple risk of b issues, in bias nclud in reduced co ng onfidence in outcome asses o ssment due to lack of blind o ding of outco assessors in all ome st tudies and a definitely high risk of bias rating in thre studies because of failur to control f lit d h ee re for te effects in th study desig or analysis (see Figure E er he gn s E4-8)
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2013 2 Swis albino mouse ss PND 3-10 PND 60-66 Morris w water maze No one 20 Swis albino mouse ss PND 3-10 PND 60-66 Radial m maze No one 20 Swis albino mouse ss PND 3-10 PND 60-66 Radial m maze No one 20 Verma et al. 2014 2 Swis albino mouse ss PND 3-10 NR Morris w water maze 20 0 None Swis albino mouse ss PND 3-10 NR Radial m maze 20 0 None Swis albino mouse ss PND 3-10 NR Radial m maze 20 0 None NOTE: GD gestation day; LOAEL, lowest-observ D, d ved-adverse-eff ffect level; NO OAEL, no-obs served-adverse-effect level; NR, not reported; PND, postnatal day.
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Risk of bias: Downgraded twice because of serious concerns about multiple risk of bias issues, including reduced confidence in outcome assessment due to lack of blinding of outcome assessors and a definitely high risk of bias rating for exposure characterization in two of the studies (see Figure E4-9)
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. he e m Risk of bias: Downgraded twice becaus of serious concerns abo multiple r R se out risk of bias issues, in ncluding reduuced confidenc in outcome assessment due to lack o blinding of outcome asse ce e of f essors an a definitel high risk of bias rating for exposure characteriza nd ly o g e ation in one of the studies (see Figure E4-10)
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k Risk of bias: Downgraded twice becaus of serious concerns abo multiple r R se out risk of bias issues, in ncluding redu uced confidenc in outcome assessment due to lack o blinding of outcome asse ce e of f essors an a definitel high risk of bias rating for exposure characteriza nd ly o g e ation in one of the studies (see Figure E4-11)
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Other potenti downgrad or upgra O ial des ades: No evid dence of pub blication bias (see Section E-3) , la arge magnitud of effect, or residual co de o onfounding or other related factors that would affect con r d t t fi idence in the estimated effe e ect.
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-4.45 -8.30 -0.60 0.023373 Sensitivity Analyses Overall minus Viberg intrcpt 25.77 20.07 31.46 0.000000 4.95 32.02 0.1180 77.61 et al. 2003 Overall minus Chen intrcpt 25.60 18.33 32.86 0.000000 5.17 22.40 0.3185 81.54 et al.
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FIGURE E5-2 Risk of bias heatmap of studies of PB E b o BDEs and laten in last trial of the Morris water maze w ncy l s without standard de eviations. In HAWC: https:// H /hawcproject.or rg/summary/vi isual/365/.
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They wer not included in the model fitting but are shown for com re d e mparison. There is no obvious bias between studies that rep s ported standard deviations an those that did not.
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tic FIGURE E5-4 Results of meta-analysi of studies of BDE-47 and l E o is f latency in last t trial of the Mor water maze. rris TABLE E5-2 Overall An E nalyses and Se ensitivity Analy of Studies BDE-47 and L yses s Latency in Las Trial of the M st Morris Water Maz ze CI, Lower L CI, Upp er P value for Analysis Estimate Be eta Bounnd Bound au P value ta I2 H Heterogeneity AICc Primary Ana alyses Overall intrcpt 23 3.56 14.04 4 33.07 0.0000 6.
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. TABLE E5-3 Overall An E nalyses and Se ensitivity Analy of Studies BDE-153 and Latency in La Trial of the yses s d ast Morris Wa Maze ater CI, Lowe er CI, Upper Pv value for Analysis Estima ate Beta Bound Bound P value tau I2 He eterogeneity AI ICc Primary Ana alyses Overall intrcpt 25.40 -0.18 50.99 0.052 0 0 0.8 82 32 2.56*
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From page 381... ...
Appendix E Ap FIGURE E5-6 Results of meta-analysi of studies of BDE-153 and latency in last trial of the Morris water ma E o is f d t aze. BDE-209 Sttatistically sig gnificant over effect.
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From page 382... ...
23.92 2 0.01 47.83 0.04990 0.00 0.00 0 0.37 46 6.48 Linear in dose10 dose1 10 7.70 5.32 10.08 0.00000 4.01 22.14 0 0.16 41 1.33 ratic in Linear-Quadr dose10 10 dose1 14.68 5.98 23.39 0.00094 0.00 0.00 0 0.27 46 6.94 ratic in Linear-Quadr dose10 I(dose10^2) -1.60 0 -3.53 0.33 0.10377 0.00 0.00 0 0.27 46 6.94 Sensitivity Analyses A Highest Dose es-Overall intrcp pt 39.61 9.96 69.26 0.00883 14.90 18.95 0 0.27 25 5.90 *
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Appendix E Ap FIGURE E5-8 Results of meta-analysi of studies of BDE-209 and latency in last trial of the Morris water maze.
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Application of Syste ematic Review Methods in an Overall St w Strategy for Ev valuating Low w-Dose Toxic city FIGURE E5-9 Benchmark dose estim mates from stud of BDE-2 and latenc in last trial of the Morris water dies 209 cy maze. REF FERENCES Biesemeier J.A., M.J.
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From page 385... ...
2006. Neonatal exposure to higher brominated diphenyl ethers, hepta-, octa-, or nonabromodiphenyl ether, impairs spontaneous behavior and learning and memory functions of adult mice.
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2013. Lactation exposure to BDE-153 damages learning and memory, disrupts spontaneous behavior and induces hippocampus neuron death in adult rats.
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