Evidence Table C-3Key Questions 1, 2, and 3: Quality Observational

Study Characteristics
Background
Inclusion/Exclusion Criteria
Randomization
Interventions/Exposure
Contamination
Blinding
Soundness of Information
Follow-Up
Analysis Comparability/Outcome
Author Year
Barnes-Boyd et al., 2001

Hypothesis/Aim/ Objective of Study Described?
No

Criteria Clearly Stated?
No

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
Cannot determine

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Prospective documentation

Outcomes Measured in Valid and Reliable Manner?
NR
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
Cannot determine

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
Yes (14% at 2 months and 44% at 11 months for REACH-Futures and 25% and 42% for REACH, respectively)

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No

Does Analysis Control for Baseline Differences?
No

Confounding and Modifying Variables Accounted for?
No (no assessment of secular trend; this is a historical comparison)

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
Cannot determine

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
No (no RR reported)

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
No

Quality Rating
Poor
Author Year
Beckham et al., 2008

Hypothesis/Aim/ Objective of Study Described?
Yes

Criteria Clearly Stated?
NA

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
Yes

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
NA

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective (clinical reports, lab findings, previously validated measures)

Outcomes Measured in Valid and Reliable Manner?
Objective (clinical reports, lab findings, previously validated measures)
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
No

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
No

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
Yes

Does Analysis Control for Baseline Differences?
NA

Confounding and Modifying Variables Accounted for?
No

Analysis Conducted on ITT Basis?
No

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
NA

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Partially

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
Partially

Quality Rating
Fair
Author Year
Bone et al., 1989

Hypothesis/Aim/ Objective of Study Described?
Yes

Criteria Clearly Stated?
Partially

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium (odd that it is described in results rather than methods section)

Is Usual Clinical Care Described?
Yes

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
NA

Could Variation from Protocol have Compromised Study Findings?
Yes

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
prospective documentation

Outcomes Measured in Valid and Reliable Manner?
Prospective documentation (return to ED for follow up visit)
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
CD

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
No

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
Cannot determine (this is really just one prospective cohort, they did not a priori define analysis plan and only in results define those that CHWs were unable to reach as comparison group)

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No or cannot determine, not reported

Does Analysis Control for Baseline Differences?
Cannot determine, no description of analysis

Confounding and Modifying Variables Accounted for?
CD

Analysis Conducted on ITT Basis?
No

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
NA, methods not reported

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
Partially

Quality Rating
Poor
Author Year
Caulfield et al., 1998

Hypothesis/Aim/ Objective of Study Described?
Yes

Criteria Clearly Stated?
Yes

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
Yes

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
Yes

Could Variation from Protocol have Compromised Study Findings?
Yes

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective measure, not validated

Outcomes Measured in Valid and Reliable Manner?
Retrospective self-report (patient/participant response)
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
No

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
Yes

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
Yes

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No

Does Analysis Control for Baseline Differences?
Yes

Confounding and Modifying Variables Accounted for?
Yes

Analysis Conducted on ITT Basis?
No

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
Yes a bit

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Partially

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
Partially

Quality Rating
Poor
Author Year
Earp et al., 2002

Hypothesis/Aim/ Objective of Study Described?
Yes

Criteria Clearly Stated?
Yes

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
Partially

Level of Detail in Describing Intervention/Exposure?
Low

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
Yes

Could Variation from Protocol have Compromised Study Findings?
NA

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
NR

Outcomes Measured in Valid and Reliable Manner?
Retrospective self-report
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
Yes

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
No

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No (for income, lack of medical visits, perceived barriers to screening, knowledge about breast cancer)

Does Analysis Control for Baseline Differences?
Yes

Confounding and Modifying Variables Accounted for?
Yes

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Partially

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
Yes

Quality Rating
Poor
Author Year
Erwin et al., 1997

Hypothesis/Aim/ Objective of Study Described?
Yes

Criteria Clearly Stated?
No

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
Cannot determine

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective measure, not validated

Outcomes Measured in Valid and Reliable Manner?
Retrospective self-report (patient/participant response)
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
No

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
No

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No

Does Analysis Control for Baseline Differences?
Yes

Confounding and Modifying Variables Accounted for?
Partially

Analysis Conducted on ITT Basis?
NA

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
Yes

Quality Rating
Fair
Author Year
Forst et al., 2004

Hypothesis/Aim/ Objective of Study Described?
Yes

Criteria Clearly Stated?
Partially

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
Yes

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
No (authors do not describe any variation, or lack of variation, from protocol; however, there is fair potential for contamination)

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective, not validated

Outcomes Measured in Valid and Reliable Manner?
Retrospective self-report
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
Yes

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
Yes - about 30% overall (note: 83 subjects were excluded at end b/c one CHW admitted to completing questionnaires herself)

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
Cannot determine

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
Cannot determine

Does Analysis Control for Baseline Differences?
NA

Confounding and Modifying Variables Accounted for?
No

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
Partially

Quality Rating
Poor
Author Year
Frate et al., 1985

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
No

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Low

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
NA

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective

Outcomes Measured in Valid and Reliable Manner?
Objective
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
Cannot determine

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
Cannot determine

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
Cannot determine

Does Analysis Control for Baseline Differences?
NA

Confounding and Modifying Variables Accounted for?
No

Analysis Conducted on ITT Basis?
No

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
No

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
No

Quality Rating
Extra Poor
Author Year
Nacion et al., 2000

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
Yes

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Low

Is Usual Clinical Care Described?
NA

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
NA

Could Variation from Protocol have Compromised Study Findings?
NA

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Prospective documentation

Outcomes Measured in Valid and Reliable Manner?
NR
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
No

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No

Does Analysis Control for Baseline Differences?
No

Confounding and Modifying Variables Accounted for?
Cannot determine

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
NA

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
Yes

Quality Rating
Fair
Author Year
Sauaia et al., 2007;
Welsh et al., 2005

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
Yes

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
NA

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Prospective documentation

Outcomes Measured in Valid and Reliable Manner?
objective measure
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
NA

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
NA

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
CD

Does Analysis Control for Baseline Differences?
NA

Confounding and Modifying Variables Accounted for?
Partially

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
NA

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
Yes

Quality Rating
Fair
Author Year
Schwarz et al., 1993

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
Yes

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
Not really

Could Variation from Protocol have Compromised Study Findings?
Yes

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No: “health department personnel were not blinded to intervention or control status of each household”

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective measure, not validated

Outcomes Measured in Valid and Reliable Manner?
Objective measure, not validated
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
No

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No

Does Analysis Control for Baseline Differences?
No

Confounding and Modifying Variables Accounted for?
No

Analysis Conducted on ITT Basis?
No

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Partially

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
Partially

Quality Rating
Poor
Author Year
St. James et al., 1999

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
Partially

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Low

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
Yes

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
Yes

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective measure, not validated

Outcomes Measured in Valid and Reliable Manner?
Objective
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
NA

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
NA

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
CD

Does Analysis Control for Baseline Differences?
CD

Confounding and Modifying Variables Accounted for?
CD

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
NA

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
No

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
No

Conclusions Supported by Results?
No

Quality Rating
Fair
Author Year
Tessaro et al., 1997;
Navaie-Waliser, et al., 2000

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
Yes

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Low

Is Usual Clinical Care Described?
No

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
Yes

Could Variation from Protocol have Compromised Study Findings?
Cannot determine

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
NR

Interventions/Exposures Measured in Valid and Reliable Manner?
NR

Outcomes Measured in Valid and Reliable Manner?
Combination of validated scales/questionnaires and responses to interview questions
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
Yes

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
Yes

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
Yes - G1 34%; G2 40%

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
No

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
No, differences in age, race, marital status, education, annual family income. (Baseline data for a number of other important factors NR)

Does Analysis Control for Baseline Differences?
Yes

Confounding and Modifying Variables Accounted for?
Partially

Analysis Conducted on ITT Basis?
Yes

Impact of Loss to Follow-up (or Differential Loss to Follow- up) Assessed?
No

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Partially (a great number of analyses conducted w/multiple comparisons and several regressions; no description of primary outcomes; no sample size calculations; no adjustment for multiple comparisons; potential data mining)

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
No

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
No (conclusions do not reflect potential biases in results)

Quality Rating
Poor
Author Year
Wendell et al., 2003

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
NA

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
No

Level of Detail in Describing Intervention/Exposure?
Medium

Is Usual Clinical Care Described?
NA

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
Yes

Could Variation from Protocol have Compromised Study Findings?
Cannot determine

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
Objective measure, not validated

Outcomes Measured in Valid and Reliable Manner?
Objective measure, not validated
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
NA

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
NA

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
NA

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
Yes

Does Analysis Control for Baseline Differences?
NA

Confounding and Modifying Variables Accounted for?
Yes

Analysis Conducted on ITT Basis?
NA

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
NA

Statistical Methods Used to Assess Primary Outcomes Appropriate to Data?
Yes

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
Yes

Quality Rating
Fair
Author Year
Wilson et al., 2008

Hypothesis/Aim/Objective of Study Described?
Yes

Criteria Clearly Stated?
No

Power Analysis or Some Other Basis for Determining Adequacy of Study Group Sizes for Primary Outcome(s)?
Yes

Level of Detail in Describing Intervention/Exposure?
Low

Is Usual Clinical Care Described?
NA

Researchers Rule out Impact from Unintended Intervention/Exposure that Might Bias Results?
No

Could Variation from Protocol have Compromised Study Findings?
NA

Outcome Assessors Blinded to Intervention/Exposure Status of Participants?
No

Interventions/Exposures Measured in Valid and Reliable Manner?
NR

Outcomes Measured in Valid and Reliable Manner?
retrospective self-report
Same Length of Follow-up or Adjustment for Different Length of Follow-up?
NA

Is Length of Time Following Intervention/Exposure Sufficient to Support Conclusions?
NA

Did Attrition for Any Group Exceed 20% After Allocation of Treatment?
NA

Did Attrition Differ by More Than 15 Percentage Points After Allocation of Treatment?
NA

Baseline Characteristics Similar in Exposed/Comparison Cohorts?
NR

Does Analysis Control for Baseline Differences?
NA

Confounding and Modifying Variables Accounted for?
No

Analysis Conducted on ITT Basis?
NA

Impact of Loss to Follow-up (or Differential Loss to Follow-up) Assessed?
NA
Statistical Methods Used to Assess Primary

Outcomes Appropriate to Data?
Partially

For Cohort Studies Only, If Outcome has Greater than 10% Prevalence, is Risk Ratio and Relative Risk Calculated Directly?
NA

Does Study Report Appropriate Estimates of Random Variability in Data for Main Outcomes?
Yes

Conclusions Supported by Results?
Yes

Quality Rating
Poor

From: Appendix C, Evidence Tables

Cover of Outcomes of Community Health Worker Interventions
Outcomes of Community Health Worker Interventions.
Evidence Reports/Technology Assessments, No. 181.
Viswanathan M, Kraschnewski J, Nishikawa B, et al.

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