Quality assessment of cancer cachexia clinical practice guidelines.

OBJECTIVES: The aim of this study was to investigate the quality of clinical practice guidelines of cancer cachexia and identify gaps limiting knowledge. METHODS: A systematic search of relevant guideline websites and literature databases (including PubMed, NCCN, NGC, SIGN, NICE, and google) was undertaken from inception to March 2017 to identify and select clinical guidelines related to cancer cachexia. Four independent reviewers assessed the eligible guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Agreement among reviewers of the guidelines was measured by using intra-class correlation coefficient (ICC). The number of recommendations, strength of recommendation, and levels of evidence were determined. RESULTS: Nine cancer cachexia guidelines published from 2006 to 2017 were identified. An overall high degree of agreement among reviewers to each domain was observed (ICC ranged from 0.75 to 0.91). The median scores and range for each AGREE II domain were as follows: (i) scope and purpose (median = 61.1%, range: 13.9% to 80.7%); (ii) stakeholder involvement (median = 26.4%, range: 8.3% to 81.9%); (iii) rigour of development (median = 35.9%, range: 3.6% to 84.4%); (iv) clarity and presentation (median = 56.9%, range: 30.6% to 76.4%); (v) applicability (median = 19.8%, range: 0% to 77.1%) and (vi) editorial independence (median = 27.1%, range: 0% to 85.4%). Two cancer cachexia guidelines (ESPEN, 2017 and University of Queensland, 2013) scored higher on all domains and were classified as recommended for clinical practice, among which, one was developed by European Society for Parenteral and Enteral Nutrition and European Partnership for Action Against Cancer, and the other was developed by University of Queensland. In addition, more than a half recommendations were based on nonrandomized studies (Level C, 50.0%) and expert opinion (Level D, 8.2%). CONCLUSIONS: The quality of cancer cachexia guidelines was highly heterogeneous among different domains even within the same guideline. There is significant room for improvement to develop high quality cancer cachexia guidelines, which urgently warrants first-class research to minimize the vital gaps in the evidence for formulation of cancer cachexia guidelines.

Legislation for trial registration and data transparency.

Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

Combinative method using HPLC quantitative and qualitative analyses for quality consistency assessment of a herbal medicinal preparation.

A selective and efficient quality consistency assessment system was developed for monitoring the manufacturing processes of a Chinese herbal preparation, qingfu guanjieshu (QFGJS) capsule, and for assessing its stability over time. This system is based on quantitative determination of four marker compounds, i.e., sinomenine, paeoniflorin, paeonol, and curcumin, and on qualitative fingerprinting analysis of QFGJS using high-performance liquid chromatography-photodiode array detection (HPLC-DAD) method. The separation was performed on a Phenomenex ODS column by gradient elution with acetonitrile and aqueous phase (containing 0.1% phosphoric acid, adjusted with triethylamine to pH 3.5+/-0.2) at a flow-rate of 1.0 ml/min. In fingerprinting analysis, the chemical characteristics of four herbs present in QFGJS (excluding radix Aconiti Lateralis Preparata) were present in the HPLC chromatographic file. In addition, quantitative determination of hypaconitine was carried out with our published HPLC method as a supplement for quality control of the radix Aconiti Lateralis Preparata in QFGJS. The results showed that the contents of these five marker compounds and HPLC fingerprint profiles of three batches of QFGJS products collected at 3 months after production in the stability testing were relatively consistent. This well-developed method could be used for quality assessment of the complex preparations of herbal medicine.