Hepatitis B

The following data were collected: demographic information (age, sex, body mass index; clinical history (hepatitis B or C virus carriers, alcohol consumption, diabetes, hypertension, cardiovascular disease, pulmonary disease, chronic kidney disease, Child–Pugh class, and BCLC staging); laboratory data (levels of aspartate transaminase, alanine transaminase, total bilirubin, albumin, platelet count, and serum alpha-fetoprotein); tumor factors (size and number of tumors); and imaging response within 1 month after the initial TACE. The up-to-seven criteria were calculated by the summation of the largest tumor diameter in cm and the number of tumors. Two strata of the scores included the summation of scores ≤ 7 or > 7^{18 (link)}. The clinical and laboratory information were collected from the electronic medical records.

The EMRMS was established in November, 2016 to assist rheumatologists in conducting ASDAS assessments and comprehensively evaluating clinical outcomes in all patients with AS attending TCVGH. The EMRMS database contains information necessary to determite ASDAS, including CRP, level and erythrocyte sedimentation rate [ESR], patient comorbidities, patient history, and family history. The reliability and validity of the data have been verified^{14 (link)}.Patients with AS were consecutively enrolled in the TCVGH-AS cohort after they received a confirmed AS diagnosis from a TCVGH rheumatologist according to the 1984 modified New York criteria^{10 (link)}. The CRP and ESR data were automatically uploaded to the TCVGH healthcare information system (HIS) to reduce human error. The baseline information, which was collected by trained nurses during the initial visit, including clinical characteristics, onset age, comorbidities at presentation (hypertension, diabetes mellitus, hyperlipidemia, hepatitis B, hepatitis C, renal insufficiency, gout, coronary artery disease, stroke, periodontal disease, osteoporosis, and tuberculosis history), periarticular extraspinal features (synovitis, enthesitis, and dactylitis) and nonarticular manifestations (psoriasis, uveitis, and IBD), family history of autoimmune disease, and patient history of arthropathy, obtained through standardized questionnaires and worksheets to ensure reproducibility and adherence to good laboratory practice. The rheumatologist in charge then confirmed patients’ clinical characteristics, and nurses assisted the patients with AS to complete the self-assessment questionnaires for disease evaluation. The following measures were used: global assessment of disease activity on a numerical rating scale (NRS) of 0–10, back pain on an NRS of 0–10, duration of morning stiffness on an NRS of 0–10, and peripheral pain or swelling on an NRS of 0–10. Before every 3-month visiting clinic, the patient would first to have blood examination. Blood reports can be uploaded to EMRMS through the HIS system, trained nurses assist patient fills out the questionnaire on EMRMS, the assessment of disease activity completed before visiting the doctor. All laboratory data, including CRP and ESR, have been uploaded to the HIS. The IT at TCVGH help "feed-forward" the patient reported outcomes to HIS, and do the auto-calculation of ASDAS-ESR, ASDAS-CRP using the ESR, CRP data in HIS, then "feed-back" these data to both HIS and EMRMS, showing the data on the summary overview "dashboard" in the EMRMS, which was shown both in HIS and the devices (iPAD handled by a nurse in charge and smartphones of patients with AS).

This report updates and expands CDC recommendations for hepatitis B screening of adults published in 2008 (14 (link)). CDC evaluated the addition of a universal screening recommendation among adults as well as testing persons expected to be at increased risk for HBV infection that were not included in the 2008 testing recommendations.
Members of the CDC Guidelines Work Group (hereafter referred to as the work group) followed CDC guideline development and reporting standards (28 (link)) to develop research questions needed to assess the proposed updates; conduct systematic reviews; assess the quality of the evidence; and review existing systematic reviews, meta-analyses, and cost-effectiveness analyses, when available (Supplementary Appendix 2; Supplementary Tables 1, 4, and 7, https://stacks.cdc.gov/view/cdc/124432). Comprehensive systematic literature reviews were conducted for recommendations on 1) expanding screening to all adults (i.e., universal screening), 2) periodic testing for HBV infection among persons with hepatitis C virus (HCV) infection, and 3) testing for HBV infection among persons with a history of incarceration.
For all three systematic reviews, literature searches were conducted by CDC librarians with direction from subject matter experts. Searches were conducted for English-language literature published worldwide in Medline (OVID), Embase (OVID), CINAHL (Ebsco), and Cochrane Library. Duplicates were identified and removed using Endnote (version 20; Clarivate Analytics) and DistillerSR systematic review software (version 2.35; Evidence Partners) automated “find duplicates” functions.
CDC’s Viral Hepatitis Steering Committee considered multiple methods to assess quality of evidence. The Mixed Methods Appraisal Tool (MMAT) was selected because it is a validated tool for assessing nonrandomized analytic and descriptive studies, which comprise most of the HBV infection prevalence literature (29 (link)). MMAT users rate each study on methodological quality criteria, indicating whether criteria were met with “Yes,” “No,” or “Can’t Tell.” Calculating a summary score is not recommended for the tool because presenting a single number is not informative about which aspects of the studies are problematic. Economic analyses were evaluated by assessing whether the study met the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) (30 (link)).
CDC determined that the new recommendations constituted influential scientific information that will have a clear and substantial impact on important public policies and private sector decisions. Therefore, the Information Quality Act required peer review by specialists in the field who were not involved in the development of these recommendations. CDC solicited nominations for reviewers from AASLD, the Infectious Disease Society of America, and the American College of Physicians (ACP). Five clinicians with expertise in hepatology, gastroenterology, internal medicine, or infectious diseases provided structured peer reviews and any edits made in response were documented (Supplementary Appendices 2 and 3, https://stacks.cdc.gov/view/cdc/124432). No CDC staff or external peer reviewers reported a conflict of interest. In addition, feedback from the public was solicited through a Federal Register notice announcing the availability of the draft recommendations for public comment from April 4 through June 3, 2022. CDC received 28 public comments on the draft document from nonprofit/advocacy groups, providers, industry groups, medical professional organizations, the public, academia, and a consulting group. Public comments were considered by the work group and any edits made in response were documented (Supplementary Appendix 4, https://stacks.cdc.gov/view/cdc/124432).
The work group also presented these guidelines to the CDC/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, but did not seek consensus decision-making from this advisory committee. The steering committee considered results of the systematic reviews in conjunction with cost-effectiveness analyses, supplemental literature, practicality of implementing guidelines, public health benefits, subject matter expertise, and reviewer and public feedback.