A comparison of error detection rates between the reading aloud method and the double data entry method

Data entry and its verification are important steps in the process of data management in clinical studies. In Japan, a kind of visual comparison called the reading aloud (RA) method is often used as an alternative to or in addition to the double data entry (DDE) method. In a typical RA method, one operator reads previously keyed data aloud while looking at a printed sheet or computer screen, and another operator compares the voice with the corresponding data recorded on case report forms (CRFs) to confirm whether the data are the same. We compared the efficiency of the RA method with that of the DDE method in the data management system of the Japanese Registry of Renal Transplantation. Efficiency was evaluated in terms of error detection rate and expended time. Five hundred sixty CRFs were randomly allocated to two operators for single data entry. Two types of DDE and RA methods were performed. Single data entry errors were detected in 358 of 104,720 fields (per-field error rate=0.34%). Error detection rates were 88.3% for the DDE method performed by a different operator, 69.0% for the DDE method performed by the same operator, 59.5% for the RA method performed by a different operator, and 39.9% for the RA method performed by the same operator. The differences in these rates were significant (p<0.001) between the two verification methods as well as between the types of operator (same or different). The total expended times were 74.8 hours for the DDE method and 57.9 hours for the RA method. These results suggest that in detecting errors of single data entry, the RA method is inferior to the DDE method, while its time cost is lower.     

The efficacy and safety of mizoribine for maintenance therapy in patients with myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA)-associated vasculitis: the usefulness of serum mizoribine monitoring

Clinical and Experimental Nephrology - The life prognosis of elderly patients with myeloperoxidase–anti-neutrophil cytoplasmic antibodies-associated vasculitis (MPO-AAV) has been improved by...     

Correction to: Renal involvement of monoclonal immunoglobulin deposition disease associated with an unusual monoclonal immunoglobulin A glycan profile

Clinical and Experimental Nephrology -     

Efficacy of tolvaptan on advanced chronic kidney disease with heart failure: a randomized controlled trial

Clinical and Experimental Nephrology - Tolvaptan (TLV) is reported to improve diuretic effects in patients with chronic kidney disease (CKD) when furosemide (FUR) is not sufficiently effective....     

Can an enhanced thin-slice computed tomography delineate the right adrenal vein and improve the success rate?

Purpose

To evaluate the usefulness of enhanced thin-slice computed tomography (TSCT) for delineating the right adrenal vein (RAV) anatomy before adrenal vein sampling (AVS).

Materials and methods

A total of 151 consecutive AVSs with CT during angiography (interventional CT) were included. Of them, TSCT was performed before AVS for 72 patients. Successful RAV cannulation was confirmed using cortisol measurement. The RAV on TSCT was classified as certain, probable, or unidentified, and cases with certain or probable RAV identification were classified as useful. In the cases where AVS was successful, the anatomical features of the presumed RAV from the useful TSCT, including the position along the inferior vena cava, vertebral level, and distance from the upper pole of the right kidney, were compared with the RAV features identified on interventional CT. Estimated successful cannulation rates before interventional CT were compared between patients with and without useful TSCT.

Results

In total, 66 TSCTs were classified as useful. The anatomical features identified on TSCT were significantly correlated with those on interventional CT. The estimated successful cannulation rates for cases with and without useful TSCT were 92.4 and 82.4 %, respectively.

Conclusions

TSCT clearly shows the anatomical features of the RAV, facilitating accurate sampling and increasing the success rate.

     

Clinical outcomes and nadir prostate-specific antigen (PSA) according to initial PSA levels in primary androgen deprivation therapy for metastatic prostate cancer

Purpose

To investigate the clinical outcomes of metastatic prostate cancer patients and the relationship between nadir prostate-specific antigen (PSA) levels and different types of primary androgen deprivation therapy (PADT). This study utilized data from the Japan Study Group of Prostate Cancer registry, which is a large, multicenter, population-based database.

Methods

A total of 2982 patients treated with PADT were enrolled. Kaplan–Meier analysis was used to compare progression-free survival (PFS) and overall survival (OS) in patients treated using combined androgen blockade (CAB) and non-CAB therapies. The relationships between nadir PSA levels and PADT type according to initial serum PSA levels were also investigated.

Results

Among the 2982 enrolled patients, 2101 (70.5 %) were treated with CAB. Although CAB-treated patients had worse clinical characteristics, their probability of PFS and OS was higher compared with those treated with a non-CAB therapy. These results were due to a survival benefit with CAB in patients with an initial PSA level of 500–1000 ng/mL. Nadir PSA levels were significantly lower in CAB patients than in non-CAB patients with comparable initial serum PSA levels.

Conclusions

A small survival benefit for CAB in metastatic prostate cancer was demonstrated in a Japanese large-scale prospective cohort study. The clinical significance of nadir PSA levels following PADT was evident, but the predictive impact of PSA nadir on OS was different between CAB and non-CAB therapy.

     

Chronic active EBV infection with features of granulomatosis with polyangiitis

Herein, we report the case of a 13‐year‐old boy with multiple recurrent ulcers on his legs. He developed severe sinusitis at 10 years of age and had significant weight loss (6 kg) in the 2 months prior to admission. Histology of tissue biopsied from the ulcer indicated small vessel vasculitis and granulomatous inflammation. Given that these findings met the diagnostic criteria for granulomatosis with polyangiitis (GPA), he was treated with immunosuppressive agents. Further pathology, however, indicated Epstein–Barr virus (EBV)‐encoded RNA (EBER) in most lymphocytes in the same sample. The EBER‐positive lymphocytes were mainly CD4‐positive T cells. The EBV‐DNA load in the peripheral blood was also abnormally increased (1.0 × 10⁴ copies/μg DNA). Thus, the diagnosis was established as chronic active EBV infection (CAEBV). This case illustrates the necessity of careful differential diagnosis of CAEBV owing to its clinical resemblance and pathological overlap with GPA.