Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial.

Importance: In the United States, more than 50% of cervical cancers are diagnosed in underscreened women. Cervical cancer screening guidelines now include primary human papillomavirus (HPV) testing as a recommended strategy. Home-based HPV self-sampling is a viable option for increasing screening compliance and effectiveness; however, US data are needed to inform health care system implementation. Objective: To evaluate effectiveness of mailed HPV self-sampling kits vs usual care reminders for in-clinic screening to increase detection and treatment of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening. Design, Setting, and Participants: Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018. Interventions: The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics). The intervention group received usual care plus a mailed HPV self-sampling kit. Main Outcomes and Measures: Two primary outcomes were (1) CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection. Screening uptake within 6 months of randomization was a secondary outcome. Results: A total of 19 851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group. All women randomized were included in analysis. In the intervention group, 12 participants with CIN2+ were detected compared with 8 in the control group (relative risk, 1.49; 95% CI, 0.61-3.64) and 12 cases were treated vs 7 in the control group (relative risk, 1.70; 95% CI, 0.67-4.32). Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60). Conclusions and Relevance: Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems. Efforts to increase kit uptake and follow-up of positive results are warranted to maximize detection and treatment of CIN2+. Trial Registration: ClinicalTrials.gov identifier: NCT02005510.

Candidate reference method for determining serum creatinine by isocratic HPLC: validation with isotope dilution gas chromatography-mass spectrometry and application for accuracy assessment of routine test kits.

We present a candidate Reference Method for determining creatinine in serum, based on isocratic HPLC. The chromatographic column, with alkaline-treated aluminum oxide as stationary phase, is eluted with an equivolume mixture of methanol/acetonitrile containing 70 mL/L aqueous NaOH (10 mmol/L), and ultraviolet absorbance is detected at 240 nm. We investigated the ruggedness of the method and validated its performance with isotope dilution gas chromatography-mass spectrometry (ID GC-MS) for a set of 22 patients' sera and 10 commercially available lyophilized control materials. The mean deviation from ID GC-MS was +0.1% (range, -2.2% to +2.2%). The between-day CV, calculated from six independent measurements performed on three different days, was 0.9% (range 0.2% to 1.9%); the within-run CV was 0.8%. The total error of the method was < 3%. These performance characteristics make the method suitable for target-setting of quality-control materials and accuracy assessment of routine test kits. For the latter application, done with split-sample measurements of a panel of 83 patients' specimens, we used the Boehringer Mannheim enzymatic creatinine PAP test on the Hitachi 911, the Kodak Ektachem single-slide enzymatic creatinine test on the Ektachem 700, the Merck Jaffé kinetic assay on the Mega analyzer, and the Roche Jaffé kinetic test on the Cobas Mira.

Antivenom use in Australia. Premedication, adverse reactions and the use of venom detection kits.

OBJECTIVES: To analyse reports of antivenom use and sequelae in Australia from July 1 1989 to June 30 1990. The value of snake venom detection kits (VDKs) was also analysed. METHODS: Information was obtained from antivenom usage reports returned to the Commonwealth Serum Laboratories and from personal letters sent to those reporting doctors. Information on VDKs was obtained from antivenom usage reports or from questionnaires packaged with VDKs. RESULTS: Reported antivenoms used were: red-back spider, 258 cases; funnel-web spider, 3 cases; stonefish, 26 cases; box jellyfish, 6 cases; snake, 91 cases. Immediate reactions followed administration of red-back spider antivenom in only two patients and snake antivenoms in four patients. Delayed reactions (serum sickness) followed use of red-back spider antivenom in three patients, stonefish antivenom in two, and snake antivenoms in three. No reaction was life-threatening. Premedication was used in the majority of red-back spider bites and in 66 of 86 snake bites. Oral corticosteroids were given prophylactically after some uses of snake antivenom to prevent serum sickness. VDKs were used in 181 cases of snake bite and were reported as being useful in selecting appropriate snake antivenom in 31% of cases of antivenom use. (Only 10 of these 181 were also reported on the antivenom usage report.) Appropriate first aid was given in 61% of cases. There were 50% fewer snake bites reported than 10 years ago. CONCLUSIONS: Antivenoms in Australia are well tolerated with few immediate or delayed reactions. The use of premedication and prophylactic oral corticosteroids for four to five days after antivenom administration may be responsible for this low reaction rate. VDK results help select the appropriate antivenom; however, in some cases positive results were obtained from urine samples from patients with no symptoms of envenomation.