Quality of the Literature

Amy S Weitlauf; Melissa L McPheeters; Brittany Peters; Nila Sathe; Rebekah Travis; Rachel Aiello; Edwin Williamson; Jeremy Veenstra-VanderWeele; Shanthi Krishnaswami; Rebecca Jerome; Zachary Warren

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Weitlauf AS, McPheeters ML, Peters B, et al. Therapies for Children With Autism Spectrum Disorder: Behavioral Interventions Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Aug. (Comparative Effectiveness Review, No. 137.)

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This publication is provided for historical reference only and the information may be out of date.

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Therapies for Children With Autism Spectrum Disorder: Behavioral Interventions Update [Internet].

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Appendix DQuality of the Literature

Table D-1Quality of the literature

First Author Year	Group Design	Random Assignment	Appropriate Comparison Group	Correct Randomization	Systematic Diagnostic Approach	Clear Sample Characterization	Clear Inclusion/Exclusion Criteria	Attrition Reported	Drop out Characteristics Evaluated	Intervention Fully Described	Treatment Fidelity Monitored	Concomitant Interventions Held Steady/Reported	Outcome Measures Reliable and Valid	Primary Outcomes Specified a priori	Outcome Data Collected From Appropriate Sources	Outcomes Coded Blindly	Appropriate Statistical Analysis	Rating
Boyd 2013¹	+	-	+	NA	+	+	+	+	NA	+	+	-	+	+	+	-	-	F
Casenhiser 2013²	+	+	+	+	+	+	+	+	NA	+	+	-	+	+	+	+	+	F
Fujii 2013³	+	+	+	-	+	+	+	+	NA	+	+	+	+	+	+	+	-	F
Goods 2013⁴	+	+	+	+	+	+	+	+	NA	+	+	NA	+	+	+	+	+	G
Ichikawa 2013⁵	+	+	+	+	-	+	+	+	NA	+	-	-	+	+	+	-	+	P
Kasari 2013⁶	+	+	+	+	-	+	+	+	NA	+	+	-	+	+	+	-	+	F
Kenworthy 2013⁷	+	+	+	-	+	+	+	+	+	+	+	+	+	+	+	+	-	G
Malow 2013⁸	+	+	+	+	+	+	+	+	-	+	+	-	+	+	+	-	-	F
McNally-Keehn 2013⁹	+	+	+	+	+	+	+	+	NA	+	+	+	+	+	+	-	+	G
Paynter 2013¹⁰	+	-	+	-	+	+	-	+	NA	+	-	-	+	-	+	-	-	F
Peters-Scheffer 2013¹¹	+	-	+	NA	+	+	+	+	-	+	+	-	+	-	+	-	+	G
Reed 2013¹²	+	-	+	NA	+	+	+	-	-	+	-	-	+	-	+	-	-	P
Schertz 2013¹³	+	+	+	-	+	+	+	+	NA	+	+	-	+	+	+	+	+	F
Schreibman 2013¹⁴	+	+	+	+	+	+	+	+	NA	+	+	+	+	+	+	-	+	G
Sharp 2013¹⁵	+	+	+	-	-	-	+	+	+	+	-	-	+	+	+	-	-	P
Storch 2013¹⁶	+	+	+	-	+	+	+	+	NA	+	+	+	+	+	+	+	-	G
Warreyn 2013¹⁷	+	+	+	-	+	+	+	+	-	+	-	-	+	+	+	-	-	F
Adkins 2012¹⁸	+	+	+	-	+	+	+	+	NA	+	-	+	+	+	+	-	+	F
Cortesi 2010¹⁹	+	+	+	+	+	+	+	+	+	+	-	+	+	+	+	-	-	F
Eikeseth 2012²⁰	+	-	+	NA	-	+	-	+	-	+	-	-	+	+	+	-	-	F
Eldevik 2012²¹	+	-	+	NA	-	+	+	+	NA	+	-	-	+	-	+	-	+	F
Flanagan 2012²²^-²⁷	+	-	+	NA	+	+	+	NA	-	+	-	-	+	+	+	-	+	F
Kaale 2012²⁸	+	+	+	+	+	+	+	+	NA	+	+	+	+	+	+	+	+	F
Kasari 2012²⁹	+	+	+	+	+	+	+	+	NA	+	-	-	+	+	+	-	+	F
Lawton 2012³⁰	+	+	+	+	+	+	+	+	NA	+	+	+	+	+	+	+	-	F
Lerner 2012³¹	+	+	+	-	-	+	-	+	NA	+	+	-	+	+	+	+	+	F
Reaven 2012³²	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	G
Rogers 2012³³^,³⁴	+	+	+	+	+	+	+	-	-	+	+	+	+	+	+	-	-	F
Strauss 2012³⁵^,³⁶	+	-	+	NA	+	+	+	+	NA	+	+	-	+	+	+	-	+	G
Thomeer 2012³⁷	+	+	+	-	-	+	+	+	NA	+	+	+	+	+	+	-	+	F
Venker 2012³⁸	+	+	+	-	+	+	-	-	-	+	+	-	+	+	+	-	+	F
Williams 2012³⁹	+	+	+	+	+	+	+	+	NA	+	+	-	+	+	+	+	+	G
Young 2012⁴⁰	+	+	+	-	+	+	+	+	NA	+	+	-	+	+	+	-	+	F
Begeer 2011⁴¹	+	+	+	+	+	+	+	+	NA	+	+	-	+	+	+	-	+	F
Carter 2011⁴²	+	+	+	+	+	+	+	+	-	+	+	-	+	+	+	+	+	F
Castorina 2011⁴³	+	-	+	NA	-	+	+	+	NA	+	+	-	+	+	+	-	+	F
DeRosier 2011⁴⁴	+	+	+	-	-	+	+	+	+	+	+	-	+	+	+	-	+	F
Landa 2011⁴⁵^,⁴⁶	+	+	+	-	+	+	+	+	NA	+	+	+	+	+	+	+	+	G
Murdock 2011⁴⁷	+	-	+	NA	-	+	+	+	NA	+	-	-	+	+	+	-	-	P
Pajareya 2011⁴⁸	+	+	+	+	+	+	+	+	NA	+	-	+	+	+	+	-	+	F
Roberts 2011⁴⁹	+	+	+	+	+	+	+	+	-	+	+	+	+	+	+	+	+	G
Scarpa 2011⁵⁰	+	+	+	-	+	+	+	+	NA	+	-	-	-	+	+	-	+	F
Strain 2011⁵¹	+	+	+	-	-	+	+	+	NA	+	+	-	+	+	+	-	+	F
Sung 2011⁵²	+	+	+	-	+	+	+	+	-	+	+	+	+	+	+	-	-	G
Wood 2011⁵³^-⁵⁵	+	+	+	+	+	+	+	+	-	+	+	-	+	+	+	+	+	G
Ingersoll 2010⁵⁶^,⁵⁷	+	+	+	-	+	+	+	+	NA	+	+	-	+	+	+	+	+	G
Itzchak 2010⁵⁸^,⁵⁹	+	-	+	NA	+	+	+	-	-	+	-	-	+	+	+	-	-	F
Kasari 2010⁶⁰	+	+	+	+	+	+	+	+	NA	+	+	+	+	+	+	+	+	G
Keen 2010⁶¹	+	-	+	NA	+	+	-	+	NA	+	+	-	+	+	+	-	+	G
Koenig 2010⁶²	+	+	+	+	+	+	+	+	NA	+	+	+	+	+	+	+	-	G
Kouijzer 2010⁶³	+	+	+	-	+	+	+	+	NA	+	NA	-	+	+	+	-	-	F
Lopata 2010⁶⁴	+	+	+	+	-	+	+	+	NA	+	+	+	+	+	+	-	+	F
McConkey 2010⁶⁵	+	-	-	NA	-	+	+	+	-	+	-	-	+	-	+	-	+	P
Oosterling 2010⁶⁶	+	+	+	-	+	+	+	+	-	+	+	-	+	+	+	-	-	F
Peters-Sheffer 2010⁶⁷	+	-	+	NA	+	+	+	+	NA	+	-	+	+	+	+	-	+	F
Reed 2010⁶⁸	+	-	+	NA	+	+	+	-	-	+	-	-	+	+	+	+	-	F
Siller 2010⁶⁹	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	F
Wong 2010⁷⁰	+	+	+	-	+	+	+	+	NA	-	-	-	+	+	+	+	-	P
Dawson 2009⁷¹^,⁷²	+	+	+	+	+	+	+	+	-	+	+	+	+	+	-	-	-	G
Kouizjer 2009⁷³^,⁷⁴	+	-	+	NA	-	+	+	NA	NA	+	-	-	+	-	+	-	-	P
RUPP 2009⁷⁵^-⁷⁸	+	+	+	-	+	+	+	+	-	+	+	+	+	+	+	-	+	F
Remington 2007⁷⁹^,⁸⁰	+	-	+	NA	+	+	+	+	-	-	-	+	+	+	+	-	-	P
Kasari 2006⁸¹^-⁸⁴	+	+	+	-	+	+	+	+	-	+	+	-	+	+	+	+	+	F
Aldred 2004⁸⁵^,⁸⁶	+	+	+	+	+	+	+	+	NA	+	-	-	+	+	+	+	+	G

: F=fair; G=good; NA=not applicable; P=poor

Quality/Risk of Bias Assessment Approach

Study Design

Did the study employ a group design?
- Group designs may include randomized controlled trials, prospective or retrospective cohorts, case-control studies
  + = yes
  − = no
Were the groups randomly assigned?
- + = yes
  − = no
Was there an appropriate comparison group?
- The comparison group should accurately represent the characteristics of the intervention group in the absence of the intervention. Specifically, factors that are likely to be associated with the intervention selected and with outcomes observed should be evenly distributed between groups, if possible. These factors may include, for example, age, IQ, severity, etc.
  + = yes
  − = no or not reported (NR)
If an RCT, was randomization done correctly?
- + = yes
  − = no
  NR
  NA for all non-RCTs
- Considerations:
  Was the approach to randomization described? Were random techniques like computer-generated, sequentially numbered opaque envelope used?
  Were technically non-random techniques, like alternate days of the week used?
  Any studies with randomization techniques not reported (NR) will also be reviewed by the team.

Participant Ascertainment/Inclusion

Was a valid diagnostic approach for ASD used within the study, or were referred participants diagnosed using a valid approach?
1. clinical DSM-IV-based diagnosis + ADI-R and/or ADOS
2. [clinical DSM-IV-based diagnosis + other] OR [ADOS + other, such as SRS, CARS, SCQ, CAST, ASSQ, OR STAT, MCHAT for under 30 months]
3. Only clinical DSM-IV-based diagnosis OR Only ADOS
4. Neither clinical DSM-IV-based diagnosis NOR ADOS
Was the sample clearly characterized (e.g., information provided to characterize participants in terms of impairments associated with their ASD, such as cognitive or developmental level)?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Are baseline measures of IQ, mental age, language facility, etc. reported?
  How reproducible is the study in terms of the sample participants? Do the authors provide enough information that you could recreate the study population in a new study?
Were inclusion and exclusion criteria clearly stated?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Did the authors report this information?
Do the authors report attrition?
- + = yes
  − = no
- Considerations:
  Do they report loss to follow-up and/or drop-out?
  If there is no attrition (i.e., baseline and follow up Ns are the same), score as YES
Were characteristics of drop-out group evaluated for differences with the participant group as a whole?
- + = yes
  − = no or not reported (NR)
  NA or attrition was minimal
- Considerations:
  Were reasons for dropping out evaluated?
  Does the paper describe a comparison between drop-outs and the whole group?
  Score as NA if attrition was minimal.

Intervention

Was the intervention fully described?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Is there sufficient detail to allow replication of the intervention?
  Does the study describe the dosage, formulation, timing, duration, intensity, etc. of the intervention?
  Do the authors refer to a treatment manual (score as YES if so, even is manual is unpublished)?
For behavioral studies, was treatment fidelity monitored in a systematic way?
- + = yes
  − = no or not reported (NR)
  NA
- Considerations:
  Was a method in place to assess whether people providing he intervention were adherent to a manual/process? We're not assessing the quality of the fidelity, just whether it was performed.
Did the authors measure and report adherence to the intended treatment process?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Does the study report number of hours of treatment or treatment sessions or time period receiving therapy (planned vs. actually received)? Do they provide pill count data or parental medication diary, etc. for pharmacologic interventions?
Did the authors report differences in or hold steady all concomitant interventions?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Was an attempt made to assess/determine if other interventions were ongoing?

Outcome Measurement

Did outcome measures demonstrate adequate reliability and validity (including interobserver reliability for behavior observation coding)?
- + = yes
  − = no or not reported (NR)
- Considerations:
  If the study used an established measure, has validity been established previously and do the authors provide a reference?
  If the study used a new measure, was validity established?
  For interobserver coding, was reliability and /or validity tested?
Were the primary & secondary outcomes clearly specified a priori?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Was there a “called shot?”
Were outcome data collected from sources appropriate to the target outcome (e.g. parent report, teacher report, direct behavior observation)?
- + = yes
  − = no or not reported (NR)
- Considerations:
  Ex: Parent report for home-focused outcomes, teacher report for academic/school-focused, etc.
Were outcomes coded by individuals blinded to the intervention status of the participants?
- + = yes
  − = no or not reported (NR)

Analysis

1.

Was an appropriate statistical analysis used?

+ = yes
− = no

1a.

For RCT's, was there an intent-to treat analysis?

+ = yes
− = no
NA
Considerations:
Does the study report ITT analyses or last observation carried forward or note that all subjects were included in the final analyses?
If ≤2 participants were lost to follow-up, consider the analysis as ITT.

1b.

For negative studies, was a power calculation provided?

+ = yes
− = no
NA

1c.

Did the study correct for multiple testing?

+ = yes
− = no
NA

1d.

For observational studies, were potential confounders and effect measure modifiers captured?

+ = yes
− = no
NA
Considerations:
Were the groups well categorized at baseline? Were baseline differences assessed?

1e.

For observational studies, were potential confounders and effect measure modifiers handled appropriately?

+ = appropriate analysis
− = inappropriate analysis
NA
Considerations:
Confounders are variables that are associated both with the intervention and the outcome and that change the relationship of the intervention to the outcome. These are variables that we would control for in analysis.
Effect measure modifiers are variables that we think of as stratifying, in that the relationship between the intervention and outcome is fundamentally different in different strata of the effect modifier. Observational research should include an assessment of potential confounders and modifiers, and if they are observed, analysis should control for or stratify on them.
Was the candidate variable selection discussed/noted?
Was the model-building approach described?
Were any variables unrelated to the studied variables that could have altered the outcome handled appropriately?
Were any variables not under study that affected the causal factors handled appropriately?

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Weitlauf AS, McPheeters ML, Peters B, et al. Therapies for Children With Autism Spectrum Disorder: Behavioral Interventions Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Aug. (Comparative Effectiveness Review, No. 137.) Appendix D, Quality of the Literature.
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Quality of the Literature - Therapies for Children With Autism Spectrum Disorder
Quality of the Literature - Therapies for Children With Autism Spectrum Disorder
complement decay-accelerating factor precursor [Rattus norvegicus]
complement decay-accelerating factor precursor [Rattus norvegicus]
gi|77020281|ref|NP_071605.2|
Protein
Etheostoma vitreum isolate EvitF cytochrome b (cytb) gene, partial cds; mitochon...
Etheostoma vitreum isolate EvitF cytochrome b (cytb) gene, partial cds; mitochondrial
gi|2335190798|gb|OP689438.1|
Nucleotide
Cyprinella chloristia voucher UTEIC 44.11800 ectodermal-neural cortex 1-like pro...
Cyprinella chloristia voucher UTEIC 44.11800 ectodermal-neural cortex 1-like protein (ENC1) gene, partial cds
gi|336317853|gb|HQ446793.1|
Nucleotide
UTP--glucose-1-phosphate uridylyltransferase isoform c [Homo sapiens]
UTP--glucose-1-phosphate uridylyltransferase isoform c [Homo sapiens]
gi|1798182236|ref|NP_001364456.1|
Protein

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