METHODS: It is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized trial of individuals with kidney biopsy-confirmed IgAN, proteinuria ≥1 g/day, and an estimated GFR of 20-120 mL/min/1.73 m2, following at least 3 months of standard of care including maximum labelled (or tolerated) dose of renin-angiotensin system blockade. The original study design randomized participants 1:1 to oral methylprednisolone (0.6-0.8 mg/kg/day, maximum 48 mg/day) for 2 months, with subsequent weaning by 8 mg/day/month over 6-8 months, or matching placebo. The intervention was modified in 2016 (due to an excess of serious infection) to low-dose methylprednisolone (0.4 mg/kg/day, maximum 32 mg/day) for 2 months, followed by weaning by 4 mg/day/month over 6-9 months, or matching placebo. Participants recruited after 2016 also received prophylaxis against Pneumocystis jirovecii pneumonia during the first 12 weeks of treatment.
RESULTS: The study recruitment period extended from May 2012 to November 2019. By the time the excess of serious infections was observed, 262 participants had been randomized to the original full-dose treatment algorithm, and an interim analysis was reported in 2016. Subsequently, 241 additional participants were randomized to a revised low-dose protocol, for a total of 503 participants from China (373), India (78), Canada (24), Australia (18), and Malaysia (10). The mean age of randomized participants was 38, 39% were female, mean eGFR at randomization was 62.7 mL/min/1.73 m2, and mean 24-h urine protein 2.54 g. The primary endpoint is a composite of 40% eGFR decline from baseline or kidney failure (dialysis, transplantation, or death due to kidney disease), and participants will be followed until the primary outcome has been observed in at least 160 randomized participants. Analyses will also be made across predefined subgroups. Effects on eGFR slope and albuminuria will also be assessed overall, as well as by the steroid dosing regimen.
CONCLUSIONS: The TESTING study (combined full and low dose) will define the benefits of corticosteroid use on major kidney outcomes, as well as the risks of therapy, and provide data on the relative effects of different doses, in individuals with high-risk IgAN.
OBJECTIVE: To use an individual participant data meta-analysis to evaluate the accuracy of two PHQ-9 diagnostic algorithms for detecting major depression and compare accuracy between the algorithms and the standard PHQ-9 cutoff score of ≥10.
METHODS: Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, Web of Science (January 1, 2000, to February 7, 2015). Eligible studies that classified current major depression status using a validated diagnostic interview.
RESULTS: Data were included for 54 of 72 identified eligible studies (n participants = 16,688, n cases = 2,091). Among studies that used a semi-structured interview, pooled sensitivity and specificity (95% confidence interval) were 0.57 (0.49, 0.64) and 0.95 (0.94, 0.97) for the original algorithm and 0.61 (0.54, 0.68) and 0.95 (0.93, 0.96) for a modified algorithm. Algorithm sensitivity was 0.22-0.24 lower compared to fully structured interviews and 0.06-0.07 lower compared to the Mini International Neuropsychiatric Interview. Specificity was similar across reference standards. For PHQ-9 cutoff of ≥10 compared to semi-structured interviews, sensitivity and specificity (95% confidence interval) were 0.88 (0.82-0.92) and 0.86 (0.82-0.88).
CONCLUSIONS: The cutoff score approach appears to be a better option than a PHQ-9 algorithm for detecting major depression.
STUDY DESIGN: A cross-sectional survey.
METHODS: A questionnaire was developed for exploring the sociodemographic characteristics of the respondents, their self-medication status, and important considerations. The questionnaire includes several scales including Health Literacy Scale-Short Form (HLS-SF), EQ-5D Visual Analog Scale (EQ-5D-VAS), Big Five Inventary-10 Items (BFI-10), and New General Self Efficacy Scale (NGSES). After carrying out a multi-stage sampling method, the questionnaire was conducted nationwide from July 10 to September 15, 2021. Next, descriptive statistics were conducted to analyze the general features. Logistic regression was then used to analyze the related factors of the possibility that the respondents took the suggestions of medical staff as an important consideration when purchasing OTC drugs.
RESULTS: Nine thousand two hundred fifty-six qualified questionnaires were received. 99.06% of Chinese adults had self-medication behaviors. The types of OTC drugs purchased most by the respondents were NSAIDs (5,421/9,256 people, 58.57%) and vitamins/minerals (4,851/9,256 people, 52.41%). 86.2% of the respondents took the suggestions of medical staff as an important consideration when purchasing OTC drugs. The results of multi-factor logistic regression showed that women, those living in the central and western regions of China, those suffering from chronic diseases, those with high agreeableness, high conscientiousness, high neuroticism and openness, high health literacy, high EQ-5D-VAS, and those with high self-efficacy are more likely to take medical staff's suggestions as important factors to consider.
CONCLUSION: The vast majority of Chinese adults have self-medication behavior. Important considerations when purchasing OTC drugs include medical staff's suggestions, drug safety and drug efficacy. Whether residents take the suggestions of medical staff as an important consideration is related to their sociological characteristics, agreeableness, conscientiousness, neuroticism, openness, health literacy, self-assessment health status, and self-efficacy. When purchasing and using OTC drugs, residents should carefully listen to the suggestions from medical staff. They should also carefully consider their own conditions before buying OTC drugs.