Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

A pathway to developing and testing quality measures aimed at improving adult vaccination rates in the United States.

Despite recommendations for vaccinating adults and widespread availability of immunization services (e.g., pharmacy venues, workplace wellness clinics), vaccination rates in the United States remain low. The U.S. National Adult Immunization Plan identified the development of quality measures as a priority and key strategy to address low adult vaccination coverage rates. The use of quality measures can provide incentives for increased utilization of preventive services. To address the lack of adult immunization measures, the National Adult and Influenza Immunization Summit, a coalition of adult immunization partners led by the Immunization Action Coalition, Centers for Disease Control and Prevention, and National Vaccine Program Office, spearheaded efforts to (1) identify gaps and priorities in adult immunization quality performance measurement; (2) explore feasibility of data collection on adult immunizations through pilot testing and engaging stakeholders; and (3) develop and test quality measure specifications. This paper outlines the process by which a public-private partnership drove the development of two adult immunization performance measures-an adult immunization status measure for influenza, tetanus and diphtheria (Td) and/or tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap), herpes zoster and pneumococcal vaccines, and a prenatal immunization status measure for influenza and Tdap vaccinations in pregnant women. These measures have recently been added to the 2019 Healthcare Effectiveness Data and Information Set (HEDIS®), a widely used set of performance measures reportable by private health plans.

Promoting Adult Immunization Using Population-Based Data for a Composite Measure.

INTRODUCTION: A composite adult immunization status measure is currently under consideration for adoption into the Healthcare Effectiveness Data and Information Set. This paper complements the Healthcare Effectiveness Data and Information Set health plan-level measure testing efforts by examining use of survey-based self-reported vaccination data to assess composite adult immunization coverage and identify limitations to using survey data to measure progress. METHODS: The 2015 National Health Interview Survey data were used in 2017 to calculate estimates for a composite of selected vaccines routinely recommended for adults aged ≥19 years, overall and in three age groups: 19-59, 60-64, and ≥65 years for tetanus and diphtheria toxoids (Td); tetanus toxoid; reduced diphtheria toxoid; and tetanus, diphtheria, acellular pertussis vaccine (Tdap); and herpes zoster, pneumococcal, and influenza vaccines. RESULTS: Composite coverage for adults aged ≥19 years including receipt of Tdap in the past 10 years and influenza vaccination was 11.9%, ranging from 6.3% in adults aged 60-64 years to 13.7% in adults aged 19-59 years. Excluding influenza, composite coverage was 20.7%, ranging from 8.1% (adults aged 60-64 years) to 25.2% (adults aged 19-59 years). In a composite including any Td-containing vaccine in the past 10 years, coverage including influenza vaccination for adults aged ≥19 years was 23.4%, ranging from 12.6% (adults aged 60-64 years) to 25.7% (adults aged 19-59 years). Excluding influenza, composite coverage was 51.4%, ranging from 15.8% (adults aged 60-64 years) to 63.0% (adults aged 19-59 years). CONCLUSIONS: Survey-based vaccination data may under- or over-estimate coverage, but most adults require at least one additional vaccination by any metric. A composite measure provides a single focal point to promote adherence to standards of care.

The U.S. military's Neisseria gonorrhoeae resistance surveillance initiatives in selected populations of five countries.

Multi-drug resistant Neisseria gonorrhoeae (GC) threatens the successful treatment of gonorrhea. This report presents preliminary findings with regard to the prevalence of laboratory-confirmed GC and the extent of drug-resistance among sample populations in five countries. Between October 2010 and January 2013, 1,694 subjects (54% male; 45% female; 1% unknown) were enrolled and screened for the presence of laboratory-confirmed GC in the United States, Djibouti, Ghana, Kenya, and Peru. Overall, 108 (6%) of enrolled subjects tested positive for GC. Antimicrobial susceptibility testing results were available for 66 GC isolates. Resistance to at least three antibiotics was observed at each overseas site. All isolates tested in Ghana (n=6) were resistant to ciprofloxacin, penicillin, and tetracycline. In Djibouti, preliminary results suggested resistance to penicillin, tetracycline, ciprofloxacin, cefepime, and ceftriaxone. The small sample size and missing data prevent comparative analysis and limit the generalizability of these preliminary findings.

Contributions of the Global Emerging Infections Surveillance and Response System Network to global health security in 2011.

In its 15th year, the Global Emerging Infections Surveillance and Response System (GEIS) continued to make significant contributions to global public health and emerging infectious disease surveillance worldwide. As a division of the US Department of Defense's Armed Forces Health Surveillance Center since 2008, GEIS coordinated a network of surveillance and response activities through collaborations with 33 partners in 76 countries. The GEIS was involved in 73 outbreak responses in fiscal year 2011. Significant laboratory capacity-building initiatives were undertaken with 53 foreign health, agriculture and/or defense ministries, as well as with other US government entities and international institutions, including support for numerous national influenza centers. Equally important, a variety of epidemiologic training endeavors reached over 4,500 individuals in 96 countries. Collectively, these activities enhanced the ability of partner countries and the US military to make decisions about biological threats and design programs to protect global public health as well as global health security.