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1. Research White Paper Biorepositories Addendum Registries For Evaluating Patient Outcomes Third Edition (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/biorepositories-registries-guide-3rd-ed-addendum-white-paper.pdf
   February 01, 2018 - with the donors or the recipient of the data and samples from third parties. … The repository will also need to outline the procedures for acquisition of samples. … as when and to whom the samples are released. … Broad Consent for Research with Biological Samples: Workshop Conclusions. … Research with stored biological samples: what do research participants want?

2. C-Diff-Infections-Surveillance-140925 (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/related_files/c-diff-infections-surveillance-140925.pdf
   January 01, 2014 - with toxin-negative samples (58% for illumigene vs. 100% for Xpert; P<0.001). … difficile and the presence of the PCR ribotype 027 in stool samples. … Compared to those with feces samples cultured positive for C. difficile type 027, the sensitivity, … difficile assays stool samples and 50 retrospective stool samples neutralization assay (CCNA); … was recovered from 218 samples using a combination of all media.

3. Methods Guide for Medical Test Reviews Chapter 11 (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-tests-genetic_methods.pdf
   July 01, 2012 - In general, preanalytic steps are those involved in obtaining, fixing or preserving, and storing samples … Important analytic variables include the type of assay chosen and its reliability, types of samples, … What types of samples were used? How were samples obtained? … How were samples handled and stored prior to analysis? Analytic What type of assay was used? … When were samples analyzed (compared to when they were collected)?

4. breast-biopsy-update-130920 (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/pdf/breast-biopsy-update_research-protocol.pdf
   September 20, 2013 - There are currently three techniques for obtaining samples from suspicious breast lesions: fine-needle … Samples obtained by any of these methods are evaluated by pathologists and classified into histological … Because a core-needle biopsy often samples only part of the breast abnormality, there is the risk that … The biopsy may be carried out with needles of varying diameters, and one or more samples of tissue may … A device used to obtain core-needle samples.

5. Engaging Patients in Information Sharing and Data Collection: The Role of Patient-Powered Registries and Research Networks (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/pdf/stakeholders-engagement-others_white-paper.pdf
   September 01, 2013 - clinical outcomes, diagnostic reports or images, hospital records, collected/donated blood or tissue samples … Patient registries may also include the collection of tissue or blood samples collected in a variety … Several PPRs have biobanks, or repositories, where patients can provide samples of blood or tissue to … a variety of patient and family needs, the foundation’s co-founder, Nancy Wexler, also collected samples … success is its ability to attract patients and/or family members who will contribute information or samples

6. PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/pdf/prostate-cancer-antigen-3-gene_research.pdf
   April 01, 2013 - PCA3 measured in archived samples from patients identified as biopsy-positive or biopsy- negative in … in these samples. … There may be costs associated with obtaining and using samples and data. … While this approach has the advantage that it often facilitates identification of samples for study, … There may be costs associated with obtaining and using samples and data.

7. Executive Summary: ADHD Diagnosis and Treatment in Children and Adolescents (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-267-adhd-executive-summary.pdf
   March 01, 2024 - reliability, no findings have been replicated prospectively using the same measure in independent samples … reliability, no findings have been replicated prospectively using the same measure in independent samples

8. Core-Needle Biopsy for Breast Abnormalities (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/pdf/breast-biopsy-update_clinician.pdf
   May 01, 2016 - . ��� 95% CrI = 95-percent credible interval Because core-needle biopsy samples only part of the suspicious … Open surgical biopsy samples most or all of the lesion, so it is considered to have a smaller risk of

9. Hepatic-Fibrosis White-Paper (pdf file)
   effectivehealthcare.ahrq.gov/sites/default/files/pdf/hepatic-fibrosis_white-paper.pdf
   April 01, 2014 - Diagnostic accuracy of tests for fibrosis a Fibrosis Test (cutoff) Number of Samples Sensitivity … Diagnostic accuracy of tests for fibrosis a (continued) Fibrosis Test (cutoff) Number of Samples … Diagnostic accuracy of tests for fibrosis a (continued) Fibrosis Test (cutoff) Number of Samples … ratio bAdditional data for study(s) with discrepancy in reported data c first number is number of samples … for sensitivity/second number is number of samples for specificity dAdditional data for study(s) without

10. Disposition of Comments for Child Exposure to Trauma: Comparative Effectiveness of Interventions Addressing Maltreatment (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/trauma-interventions-maltreatment-child_disposition-comments.pdf
    April 15, 2013 - CERs, and 3) to avert yet more heterogeneity due to inconsistent, vague, or absent definitions of samples … aura of exactitude and finality, not worrying enough about the results than might obtain were other samples … of small sample sizes in that it is difficult to statistically identify moderate effects in small samples … interaction terms in statistical models and estimating these interaction terms require very large samples … Many of the a priori hypotheses had to be eliminated because there were insufficient samples to meet

11. Disposition of Comments Report for Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma-Cell Dyscrasias (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/plasma-cell-dyscrasias-sflc-assay_disposition-comments.pdf
    August 23, 2012 - If that is the case, then it should not be necessary to include only studies with all samples sent for … testing and exclude studies that start with diagnostic samples obtained from patients with a diagnosis … It is likely that studies using diagnostic samples will yield inflated estimates and Key Question 1 … Finally, BMT CTN 0702 will be prospectively collecting serum samples for light chain analysis along … recently independently reported that urine protein electrophoresis was inaccurate in 20% to 30% of samples

12. Research Protocol: Clostridium difficile Infection Update (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/c-difficile-update_research-protocol.pdf
    December 23, 2014 - For example, one study isolated C. difficile spores from air samples in a UK hospital, 4 to 7 weeks … Tests to validate a technique in “known” or proven samples. … Tests in which the reference standard is not applied to all samples. … cytotoxicity neutralization assay (CCNA) or toxigenic culture as the reference standard applied to all samples … One can use RCT and controlled cohort data, but they generally have small samples and short followups

13. Technical Brief 13: Gene Expression Profiling for Predicting Outcomes in Stage II Colon Cancer (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/colon-cancer-gene-profiling_technical-brief.pdf
    December 01, 2012 - GEP tests use defined protocols to evaluate the specimens to be analyzed: preparing the RNA samples, … This approach results in a non-standard approach to specimen-handing, especially for frozen samples, … 42 Core Gene Classifier (Eschrich 2005)19 Frozen samples Microdissected so >80% tumor cells … It is expected that 1,800 to 2,400 patients will be enrolled in order to obtain 575 analyzable samples …  Sample size (number of patients/specimens) o If samples are from previous studies, which studies?

14. Layout 1 (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/c-diff-infections_executive.pdf
    December 01, 2011 - environments, C. difficile is also common in the community, being easily isolated from soil and water samples … that concurrently compared at least two diagnostic tests in the same laboratory using the same stool samples … excluded studies that used only intermediate outcomes, such as reduced spore count in environmental samples … would alter clinician samples suspected CDI decisionmaking • Unknown influence of patient and stool … Six rapid tests for direct detection of Clostridium difficile and its toxins in fecal samples compared

15. Cell-Free-Dna-Appendix-C-Prepub-Final (xls file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/cell-free-dna-appendix-c-prepub-final.xlsx
    January 01, 2025 - Additional samples were acquired from ILSBio/Bioreclamation. No ethnicity data were included. … Custom software was used to classify samples using source models that recognized methylation patterns … V2: The levels of 6 proteins were measured from plasma samples using the Bioplex 200 platform - AFP, … were serum, V2 samples were plasma Fresh 5,919 (V1); 1,817 (V2) NR NR NR 363 (V1); 1,005 (V1) 5,556 … Sekiguchi, 2020 Unclear Yes Yes Unclear Unclear whether a random or consecutive samples was analyzed

16. Cell-Free-Dna-Final-App-C (xls file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/cell-free-dna-final-app-c.xlsx
    January 01, 2025 - Additional samples were acquired from ILSBio/Bioreclamation. No ethnicity data were included. … Custom software was used to classify samples using source models that recognized methylation patterns … V2: The levels of 6 proteins were measured from plasma samples using the Bioplex 200 platform - AFP, … were serum, V2 samples were plasma Fresh 5,919 (V1); 1,817 (V2) NR NR NR 363 (V1); 1,005 (V1) 5,556 … Sekiguchi, 2020 Unclear Yes Yes Unclear Unclear whether a random or consecutive samples was analyzed

17. PREGNANCY, INCLUDING PRETERM BIRTH #12 (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/12_pregnancy_potential_high_impact_june_2012.pdf
    January 01, 2012 - They transfer milk from the donation container to a glass flask, mixing samples from about three to … PST workers then distribute the milk evenly into smaller glass bottles and prepare the samples for … Milk samples that have passed inspection are frozen and stored until delivered to a recipient’s hospital … When comparing our PST samples to previous published amino acid means, our PST samples had significantly … The authors concluded, “Risk scores for trisomy 21 and 18 were given for 397 of the 400 samples that

18. Hepatitis-C-Screening Executive (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/hepatitis-c-screening_executive.pdf
    November 01, 2012 - (APRI) vs. liver biopsy High For fibrosis, the median AUROC was 0.76 (range 0.58 to 0.95) in 44 samples … ELF) vs. liver biopsy Moderate For fibrosis, the median AUROC was 0.81 (range 0.72 to 0.87) in 7 samples … For cirrhosis, the median AUROC was 0.88 (range 0.78 to 0.91) in 6 samples reported in 3 studies. … Index vs. liver biopsy High For fibrosis, the median AUROC was 0.75 (range 0.60 to 0.86) in 16 samples … For cirrhosis, the median AUROC was 0.89 (range 0.88 to 0.94) in 8 samples reported in 7 studies.

19. Interventions Targeting Sensory Challenges in Children With Autism Spectrum Disorders - An Update (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/related_files/asd-interventions-disposition.pdf
    May 26, 2017 - Comments Sensory interventions/Abstract: ”likely overlapping populations in four studies” should be ”samples … TEP Reviewer #2 Methods It seems to me that independence of samples is critical to evaluating risk … In the case where samples are not clearly independent (massage therapy), I think that there must inherently … We concur that potential overlap of samples is an important consideration that have noted explicitly … The same group repeating the same protocol in potentially overlapping samples seems to be the definition

20. Liver-Cancer Research-Protocol (pdf file)
    effectivehealthcare.ahrq.gov/sites/default/files/pdf/liver-cancer_research-protocol.pdf
    July 24, 2013 - technique’s test performance modified by use of various reference standards (e.g., explanted liver samples … technique’s test performance modified by use of various reference standards (e.g., explanted liver samples … technique’s test performance modified by use of various reference standards (e.g., explanted liver samples … test performance will be evaluated, including the reference standards used (e.g., explanted liver samples … test performance will be evaluated, including the reference standards used (e.g., explanted liver samples