Clinical Trial Service Unit

About: Clinical Trial Service Unit is a based out in . It is known for research contribution in the topics: Population & Stroke. The organization has 428 authors who have published 1387 publications receiving 181920 citations.

Diabetes, plasma glucose and incidence of colorectal cancer in Chinese adults: a prospective study of 0.5 million people.

Abstract: Background Diabetes is associated with higher risk of colorectal cancer (CRC). Uncertainty remains about the relevance of duration of diabetes and about the association of blood glucose with CRC risk among individuals without diabetes. Methods The prospective China Kadoorie Biobank recruited 512 713 participants in 2004–2008 from 10 diverse areas in China. After 10 years of follow-up, 3024 incident cases of CRC (1745 colon, 1716 rectal) were recorded among 510 136 participants without prior cancer at baseline. Cox regression was used to estimate adjusted HRs for CRC associated with diabetes (previously diagnosed or screen-detected) and, among those without previously diagnosed diabetes, with levels of random plasma glucose (RPG). Results Overall 5.8% of participants had diabetes at baseline. Individuals with diabetes had an adjusted HR of 1.18 (95% CI 1.04 to 1.33) for CRC, with similar risk for colon and rectal cancer (1.19 [1.01 to 1.39] vs 1.14 [0.96 to 1.35]). The HRs decreased with longer duration of diabetes (p for trend 0.03). Among those without previously diagnosed diabetes, RPG was positively associated with CRC, with adjusted HRs per 1 mmol/L higher baseline RPG of 1.04 (1.02 to 1.05) for CRC, again similar for colon and rectal cancer (1.03 [1.01to 1.05] and 1.04 [1.02 to 1.06], respectively). The associations of diabetes and RPG appeared stronger in men than in women, but the differences were non-significant (p for heterogeneity 0.3 and 0.2). Discussion Among Chinese adults, diabetes and higher blood glucose levels among those without known diabetes are associated with higher risk of CRC.

Prospective evaluation of quality of life in children treated in UKALL 2003 for acute lymphoblastic leukaemia: A cohort study

Abstract: Background: Health-related quality of life (HRQoL) from diagnosis until end of treatment for children with Acute Lymphoblastic Leukaemia (ALL) was investigated, examining effects of age, gender, risk stratified treatment regimen (A,B,C) and therapy intensity (1 vs 2 ‘delayed intensifications’: DI). Method: In a multi-centre prospective study, parents reported their child’s generic and disease specific HRQoL and their own care-giving burden at five time-points. From 1428 eligible patients, 874 parents completed questionnaires at least once during treatment. Results: At each time-point, generic HRQoL was significantly lower than equivalent norm scores for healthy children. HRQoL decreased significantly at the start of treatment, before recovering gradually (but remained below pre-treatment levels). Parents reported that older children worried more about side effects and their appearance but showed less procedural anxiety than younger children. Concern for appearance was greater among girls than boys. Compared to regimen B (i.e.additional doxorubicin during induction and additional cyclophosphamide and cytarabine during consolidation chemotherapy), patients receiving regimen A had fewer problems with pain and nausea. There were no statistically significant differences in HRQoL by number of DI blocks received. Interpretation: HRQoL is compromised at all stages of treatment, and is partly dependent on age. The findings increase understanding of the impact of therapy on children’s HRQoL and parental caregiving burden, and will contribute to the design of future trials.

Risk of Intraocular Bleeding With Novel Oral Anticoagulants Compared With Warfarin: A Systematic Review and Meta-analysis.

Abstract: Importance It is unclear if the risk of intraocular bleeding with novel oral anticoagulants differs compared with warfarin. Objective To characterize the risk of intraocular bleeding with novel oral anticoagulants compared with warfarin. Data Sources A systematic review and meta-analysis was undertaken in an academic medical setting. MEDLINE and ClinicalTrials.gov were searched for randomized clinical trials published up until August 2016. This search was supplemented by manual bibliography searches of identified trials and other review articles. Study Selection Studies were eligible for inclusion if they were phase 3 randomized clinical trials, enrolled patients with atrial fibrillation or venous thromboembolism, compared a novel oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban) with warfarin, and recorded event data on intraocular bleeding. Data on intraocular bleeding were pooled using inverse-variance, weighted, fixed-effects meta-analysis. Data Extraction and Synthesis The PRISMA guidelines were used for abstracting data and assessing quality. Independent extraction was performed by 2 investigators. Main Outcomes and Measures Intraocular bleeding events and associated risk ratio for novel oral anticoagulants compared with warfarin. Results Twelve trials investigating 102 627 patients were included. Randomization to novel oral anticoagulants was associated with a 22% relative reduction in intraocular bleeding compared with warfarin (risk ratio, 0.78; 95% CI, 0.61-0.99). There was no significant heterogeneity observed ( I2 = 4.8%, P = .40). Comparably lower risks of intraocular bleeding with novel oral anticoagulants were seen in subgroup analyses, with no significant difference according to the indication for anticoagulation ( P for heterogeneity = .49) or the novel oral anticoagulant type ( P for heterogeneity = .15). Summary estimates did not differ materially when random-effects meta-analytic techniques were used. Conclusions and Relevance These results suggest that novel oral anticoagulants reduce the risk of intraocular bleeding by approximately one-fifth compared with warfarin. Similar benefits were seen in both patients with atrial fibrillation and venous thromboembolism. Our data have particular relevance for patients at higher risk of spontaneous retinal and subretinal bleeding. These findings may also have important implications in the perioperative period, in which the use of novel oral anticoagulants may be superior. Future studies are required to better characterize the optimal management of patients with both ophthalmic disease and cardiovascular comorbidities requiring anticoagulation.

Meta‐analyses using individual patient data

Abstract: Systematic reviews of randomized controlled trials often provide the most reliable information on which to base treatment policy. However, to be reliable, such reviews need to contain a high proportion of all the relevant randomized evidence. This relates both to the need to find all trials and the need to analyse data on all participants. One way to achieve this is through a collaboration in which those responsible for the trials supply data on each randomized patient for an individual patient data meta-analysis. However, such projects require more time and resources than more conventional reviews and are still rare. This paper illustrates how they can help to achieve the aim of using complete data in a systematic review.