Despite the publication of hundreds of trials on gout and hyperuricemia, management of these conditions remains suboptimal. We aimed to assess the quality and consistency of guidance documents for gout and hyperuricemia.
Systematic review and quality assessment using the appraisal of guidelines for research and evaluation (AGREE) II methodology.
PubMed and EMBASE (27 October 2016), two Chinese academic databases, eight guideline databases, and Google and Google scholar (July 2017).
We included the latest version of international and national/regional clinical practice guidelines and consensus statements for diagnosis and/or treatment of hyperuricemia and gout, published in English or Chinese.
Two reviewers independently screened searched items and extracted data. Four reviewers independently scored documents using AGREE II. Recommendations from all documents were tabulated and visualised in a coloured grid.
Twenty-four guidance documents (16 clinical practice guidelines and 8 consensus statements) published between 2003 and 2017 were included. Included documents performed well in the domains of scope and purpose (median 85.4%, range 66.7%–100.0%) and clarity of presentation (median 79.2%, range 48.6%–98.6%), but unsatisfactory in applicability (median 10.9%, range 0.0%–66.7%) and editorial independence (median 28.1%, range 0.0%–83.3%). The 2017 British Society of Rheumatology guideline received the highest scores. Recommendations were concordant on the target serum uric acid level for long-term control, on some indications for urate-lowering therapy (ULT), and on the first-line drugs for ULT and for acute attack. Substantially inconsistent recommendations were provided for many items, especially for the timing of initiation of ULT and for treatment for asymptomatic hyperuricemia.
Methodological quality needs improvement in guidance documents on gout and hyperuricemia. Evidence for certain clinical questions is lacking, despite numerous trials in this field. Promoting standard guidance development methods and synthesising high-quality clinical evidence are potential approaches to reduce recommendation inconsistencies.
The treatment outcome of direct-acting antivirals (DAAs) in chronic hepatitis C patients with hepatocellular carcinoma (HCC) is controversial. The current study aimed to address the treatment efficacy and safety of DAAs in patients with curative or active HCC, compared with those of patients without HCC.
A prospective cohort study
A medical centre and two regional hospitals in Taiwan
A total of 713 Taiwanese patients (601 non-HCC, 74 curative HCC and 38 active HCC patients) who received standard-of-care DAAs were consecutively enrolled in the study.
The primary objective was to determine treatment efficacy, defined as undetectable hepatitis C virus RNA throughout 12 weeks of the post-treatment follow-up period (sustained virological response 12 [SVR12]).
The overall SVR12 rate was 96.9%. The SVR12 rate was similar between the patients with HCC and those without HCC (95.5% vs 97.2%, p=0.37). The HCC patients were divided into two groups, those with curative HCC and those with viable HCC; a substantially but not significantly lower SVR rate, 92.1% (35/38), was observed in the patients with viable HCC compared with the SVR rate, 97.3% (72/74), in those with curative HCC (p=0.33). Compared with the patients with curative HCC, the patients with viable HCC had a significantly higher proportion of serious adverse events (10.5% vs 1.0%, p=0.002), early treatment discontinuation (10.5% vs 2.8%, p=0.03) and mortality (5.3% vs 0.1%, p=0.008).
An equivalently high SVR rate was observed in patients with either past or active HCC compared with those without HCC. The safety concerns in the HCC patients did not compromise treatment efficacy.
We aimed to profile the epidemiological changes of driving under the influence (DUI) in southern Taiwan after the legal blood alcohol concentration (BAC) limit was lowered from 50 to 30 mg/dL in 2013.
Level 1 trauma medical centre in southern Taiwan.
Data from 7447 patients (4375 males and 3072 females) were retrieved from the trauma registry system of a single trauma centre to examine patient characteristics (gender, age and BAC), clinical outcome variables (Abbreviated Injury Score, Injury Severity Score and mortality) and vehicular crash-related factors (vehicle type, airbag use in car crashes, helmet use in motorcycle crashes and time of crash) before and after the BAC limit change.
Our results indicated that the percentage of DUI patients significantly declined from 10.99% (n=373) to 6.64% (n=269) after the BAC limit was lowered. Airbag use in car crashes (OR: 0.30, 95% CI 0.10 to 0.88, p=0.007) and helmet use in motorcycle crashes (OR: 0.20, 95% CI 0.15 to 0.26, p
This study revealed that lowering the BAC limit to 30 mg/dL significantly reduced the number of DUI events, but failed to result in a significant reduction in mortality in these trauma patients.
The purpose of this study was to systematically review the outcomes of the use of one-shot dilation (OSD) and serial tract dilation for percutaneous nephrolithotomy (PCNL).
A systematic review and meta-analysis was conducted. The randomised controlled trials (RCTs) included in the study were identified from EMBASE, MEDLINE and the Cochrane Central Register of Controlled Trials. The last search was performed on 30 April 2018. Summary effects were calculated as risk ratios (RRs) with 95% CIs or mean differences (MDs) with 95% CIs. The endpoints included access time, fluoroscopy time, successful dilation rate, stone-free rate, postoperative decrease in haemoglobin levels, transfusion rate, complication rate and length of postoperative hospital stay.
A total of seven RCTs were included in the study, with clinical data reported for 697 patients. The overall access time was approximately 110 s shorter in the OSD group than in the serial dilation group (MD, –110.14; 95% CI –161.99 to –58.30; p
OSD is a safe and efficacious tract dilation technique that can reduce the access time, fluoroscopy time and postoperative decrease in haemoglobin level. No difference was found in the successful dilation rate, stone-free rate, transfusion rate or rate of complications between the OSD and serial dilation groups. The difference in the length of postoperative hospital stay was uncertain. OSD may be a better method of tract creation for PCNL.
Targeted therapies have been proven to provide clinical benefits to patients with metastatic non-small cell lung cancer (NSCLC). Gefitinib was initially approved and reimbursed as a third-line therapy for patients with advanced NSCLC by the Taiwan National Health Insurance (NHI) in 2004; subsequently it became a second-line therapy (in 2007) and further a first-line therapy (in 2011) for patients with epidermal growth factor receptor mutation-positive advanced NSCLC. Another targeted therapy, erlotinib, was initially approved as a third-line therapy in 2007, and it became a second-line therapy in 2008.
This study is aimed towards an exploration of the impacts of the Taiwan NHI reimbursement policies (removing reimbursement restrictions) related to accessibility of targeted therapies.
We retrieved 2004–2013 claims data for all patients with lung cancer diagnoses from the NHI Research Database.
Using an interrupted time series design and segmented regression, we estimated changes in the monthly prescribing rate by patient number and market shares by cost following each modification of the reimbursement policy for gefitinib and erlotinib for NSCLC treatment.
Totally 92 220 patients with NSCLC were identified. The prescribing rate of the targeted therapies increased by 15.58%, decreased by 10.98% and increased by 6.31% following the introduction of gefitinib as a second-line treatment in 2007, erlotinib as a second-line treatment in 2008 and gefitinib as as first line treatment in 2011, respectively. The average time to prescription reduced by 65.84% and 41.59% following coverage of erlotinib by insurance and gefitinib/erlotinib as second-line treatments in 2007–2008 and following gefitinib as the first-line treatment in 2011.
The changes in reimbursement policies had a significant impact on the accessibility of targeted therapies for NSCLC treatment. Removing reimbursement restrictions can significantly increase the level and the speed of drug accessibility.