Evaluation of imprecision in the different detection methods of Zn based on 5 years of data from an external quality assessment program in China.

BACKGROUND: This study examines the imprecision of zinc (Zn) measurements across various clinical detection methods by analyzing the external quality assessment (EQA) data from 2018 to 2022. The findings of this study aim to offer recommendations for enhancing Zn measurements. METHODS: Participating laboratories were grouped into peer categories based on the detection methods. The robust mean and coefficient of variation (CV) of the samples were calculated following ISO 13528 guidelines. The evaluation criteria for optimal, desirable, and minimum allowable imprecision in Zn estimation are 2.50%, 5.05%, and 7.55%, respectively, based on biological variation. Furthermore, the study examined inter-lab CVs, inter-method bias, and the passing rate. The impact of sample concentration on CVs and the pass rate was also investigated. RESULTS: Over the past five years, 4283 laboratories participated in the EQA program, showing a high pass rate that improved as sample concentration increased. Differential pulse polarography (DPP) demonstrated stable and low CVs (0.61-1.86%). Although differential pulse stripping (DPS) was less stable than DPP, it still exhibited a low CV (0.71-3.10%). Graphite furnace atomic absorption spectrometry (GFAAS) and flame atomic absorption spectrometry (FAAS) performed similarly and displayed stable CVs (2.39-4.42%) within the acceptable range of desirable imprecision (5.05%). However, the CVs for ICP-MS were unacceptable in three out of the five years (5.28-6.20%). In 2022, the number of participating laboratories for DDP, DPS, GFAAS, FAAS and ICP-MS is 131, 35, 35, 820 and 72, respectively. CONCLUSION: This study provides reliable insights into the imprecision of Zn measurements in clinical laboratories. The findings indicate that additional efforts are required to reduce the imprecision of ICP-MS in Zn measurements.

Economic Evaluation of an Enhanced Post-Discharge Home-Based Care Program for Stroke Survivors.

OBJECTIVES: To examine the cost-effectiveness of an enhanced postdischarge home-based care program for stroke survivors compared with usual care. METHODS: This was a trial-based economic evaluation study. One hundred and sixteen patients with ischemic stroke were recruited from neurology units in a Chinese hospital and randomized into intervention (n = 58) or usual care groups (n = 58). The intervention commenced with predischarge planning and transitioned to home follow-up postdischarge. Trained nurse case managers supported by an interdisciplinary team provided comprehensive assessment, individualized goal setting, and skill training to support home-based rehabilitation for intervention group participants. Standard care was provided to usual care group participants. Total cost and quality-adjusted life-years gained at 3-month (T1), 6-month (T2), and 12-month (T3) follow-ups were calculated. The incremental cost-effectiveness ratios between the groups were obtained. RESULTS: The intervention group showed a significant increase in utility compared with the usual care group at T1 (P = .003), T2 (P = .007), and T3 (P < .001). The average total QALY gain from baseline for the intervention group was higher than for the usual care group at all time points. The likelihood of being cost-effective ranged from 61.9% to 67.2% from the provider perspective, and from 59.7% to 66.8% from the societal perspective. CONCLUSIONS: The results showed that the intervention program was cost-effective with significantly higher quality-adjusted life-years for stroke survivors when compared with usual care. It provides economic evidence to support the development of home-based stroke rehabilitation program, especially in the low- and middle-income countries.

Commissioning and initial validation of Eclipse eMC algorithm for the electron FLASH research extension (FLEX) system for pre-clinical studies.

PURPOSE: To investigate the feasibility of commissioning the 16 MeV electron FLASH Extension (FLEX) in the commercial treatment planning system (TPS) for biomedical research with cell and mouse models, and in silico treatment planning studies. METHODS: To commission the FLEX system with the electron Monte Carlo (eMC) algorithm in the commercial TPS, radiochromic film was used to measure the vendor-recommended beam data. Once the beam model was generated for the eMC algorithm, supplemental measurements were collected for validation purposes and compared against the TPS-calculated results. Additionally, the newly commissioned 16 MeV FLASH beam was compared to the corresponding 16 MeV conventional electron beam. RESULTS: The eMC algorithm effectively modeled the FLEX system. The eMC-calculated PDDs and profiles for the 16 MeV electron FLASH beam agreed with measured values within 1%, on average, for 6 × 6 cm2 and 10 × 10 cm2 applicators. Flatness and symmetry deviated by less than 1%, while FWHM and penumbra agreed within 1 mm for both eMC-calculated and measured profiles. Additionally, the small field (i.e., 2-cm diameter cutout) that was measured for validation purposes agreed with TPS-calculated results within 1%, on average, for both the PDD and profiles. The FLASH and conventional dose rate 16 MeV electron beam were in agreement in regard to energy, but the profiles for larger field sizes began to deviate (>10 × 10 cm2) due to the forward-peaked nature of the FLASH beam. For cell irradiation experiments, the measured and eMC-calculated in-plane and cross-plane absolute dose profiles agreed within 1%, on average. CONCLUSIONS: The FLEX system was successfully commissioned in the commercial TPS using the eMC algorithm, which accurately modeled the forward-peaked nature of the FLASH beam. A commissioned TPS for FLASH will be useful for pre-clinical cell and animal studies, as well as in silico FLASH treatment planning studies for future clinical implementation.

Evaluation of blood lead measurements by the 6-year external quality assessment program in China.

BACKGROUND: Blood lead is an important clinical indicator. A typical tool for promoting standardisation or harmonisation is external quality assessment (EQA). Therefore, the National Centre for Clinical Laboratories (NCCL) in China launched the EQA Program for blood lead measurement in 2006 to assess its standardisation process. METHODS: Blood lead EQA samples tested for homogeneity and stability were sent to participating laboratories. The return data were grouped according to the detection method. The robust mean value, robust coefficient of variation (CV) and standard uncertainty were calculated according to ISO 13528. The evaluation criteria were determined based on a thorough analysis of the previous pass rate and the current detection level. Overall trends in the blood lead EQA program over 6 years were investigated by calculating the pass rates of participating laboratories. We compared the pass rates and current issues of different detection methods and analysed the target values, bias and CV results of mainstream detection methods. RESULTS: A total of 4,283 laboratories participated in EQA programs from 2017 to 2022. The pass rates were generally increasing while the inter-laboratory mean CVs were decreasing. For samples with varying concentrations, the higher the concentration, the smaller the CV. According to the evaluation criteria, the most used measurement methods, Graphite Furnace Atomic Absorption Spectrometry (GFAAS) and Tungsten Ship Atomic Absorption Spectrometry (TSAAS) demonstrated better performances than Differential Potentiometric Stripping (DPS), Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Flame Atomic Absorption Spectrometry (FAAS). Furthermore, DPS, ICP-MS and FAAS outperformed Anodic Stripping Voltammetry (ASV). CONCLUSION: Our study provides reliable information on the standardisation of blood lead measurement procedures for manufacturers and clinical laboratories. Further improvements for standardisation are still required to make laboratories more patient-centred.

Environmental impacts and optimization simulation of aerobic anaerobic combination treatment technology for food waste with life cycle assessment.

After the implementation of waste sorting policy in Shanghai, the amount of food waste (FW) separation and treatment demand has increased significantly. It is necessary to establish the life cycle assessment (LCA) to assess the environmental impacts of various treatment technologies comprehensively, thus provide support for sorting, recycling, treatment and disposal strategies of FW. In this study, a local FW treatment plant in Shanghai, using typically aerobic anaerobic combination treatment technology was selected to analyze the environmental impacts with LCA. The process mainly included pretreatment, power, aerobic composting, anaerobic digestion, and further process systems. LCA results showed that the environmental impacts mainly came from the power and aerobic composting systems on the fine particulate matter formation and eutrophication, and freshwater ecotoxicity and terrestrial acidification, respectively. Considering the carbon footprint, the aerobic composting system contributed 3.61E + 02 kg CO2 eq and represented the largest source of carbon emission. The soil conditioner yielded both environmental benefits on eutrophication and terrestrial ecotoxicity, and ecological benefits of 75.33 million CNY per year being the major revenue for the treatment plant. It also suggested that the biogas generation capacity of anaerobic digestion could be increased to achieve electricity self-sufficiency, thus save about 7.12 million CNY per year in electricity costs, and avoid corresponding environmental impacts caused by coal-fired. In summary, the aerobic anaerobic combination treatment could be further optimized and applied in FW treatment to reduce the environmental impacts, and enhance resource recovery and secondary pollution control.

Global burden of common cancers attributable to metabolic risks from 1990 to 2019.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is usually accompanied by metabolic syndrome, which is associated with increased risk of cancer. To inform a tailored cancer screen in patients at higher risks, we estimated the global burden of cancer attributable to metabolic risks. METHODS: Data of common metabolism-related neoplasms (MRNs) were derived from the Global Burden of Disease (GBD) 2019 database. Age-standardized, disability-adjusted life year (DALY) rates and death rates of patients with MRNs were extracted from the GBD 2019 database and stratified by metabolic risk, sex, age, and level of socio-demographic index (SDI). The annual percentage changes of age-standardized DALYs and death rates were calculated. FINDINGS: Metabolic risks, consisting of high body mass index and fasting plasma glucose, contributed substantially to the burden of neoplasms, including colorectal cancer (CRC), tracheal, bronchus, and lung cancer (TBLC), etc. Globally, in 2019, there was an estimated age-standardized DALY rate (ASDR) of 234 (95% confidence interval [CI] 124-376) per 100,000 person years for neoplasms attributable to metabolic risks. ASDRs of MRNs were higher for CRC, TBLC, men, patients aged ≥50 years, and patients with high or high-middle SDI. CONCLUSIONS: The findings of this study further underpin the correlation between NAFLD and intrahepatic and extrahepatic cancers and highlight the possibility of tailored cancer screening for the NAFLD population at higher risks. FUNDING: This work was supported by the National Natural Science Foundation of China and Natural Science Foundation of Fujian Province of China.

Spatial distribution of potentially harmful trace elements and ecological risk assessment in Zhanjiang mangrove wetland, South China.

Global mangrove wetlands face increasing anthropogenic impacts along the coast. The Zhanjiang mangrove wetland is the largest and adjacent to the most developed bay area in China. Surface sediments were collected in different plant transit and used for potentially harmful trace elements (PHTEs) measurement. Mean contents of Hg, Cr, Ni, Cu, Zn, As, Cd and Pb were 0.01 mg/kg, 56.16 mg/kg, 10.06 mg/kg, 9.61 mg/kg, 43.58 mg/kg, 8.76 mg/kg, 0.25 mg/kg, 28.12 mg/kg. Most of the PHTEs were slightly enriched but the Cd pollution is significant, and the potential ecological risk is moderate. The risk of the mangrove wetland is larger than the grassland and the farmland. The PCA and PMF indicate Hg, Ni, Cu, Zn, As, and Pb mainly originated from local anthropogenic activities, Cr originated from the natural geological process, and Cd mainly originated from atmospheric deposition of regional industrial pollution. In view of the impact of surrounding industry and agriculture and the signs of PHTEs pollution, it is necessary to implement the wetland protection law more strictly to truly realize the construction of ecological civilization. This provides a valid reference for the wetland conservation and management in coastal cities.

Spatial spillover effect of green finance on economic development, environmental pollution, and clean energy production across China.

Although the extensive development model carries China's economy at the forefront of the world, it has brought great environmental pollution problems. The Chinese government hopes to control environmental pollution through green finance and achieve high-quality economic development. Based on the panel data of 30 provinces and cities in China from 2009 to 2019, this paper examines the impact of green finance (GF) on China's high-quality economic development (EQD), environmental pollution (EP), and clean energy production (CEP). In order to study the spatial impact of GF, we put spatial geographic factors into the analysis category, and use the spatial Durbin model to empirically examine the spatial effect of GF on EQD, EP, and CEP. It is found that GF can promote EQD and curb EP in China. However, GF also weakens China's CEP.

Video-Based Behaviorally Coded Movement Assessment for Adolescents with Intellectual Disabilities: Application in Leg Dribbling Performance.

Measuring motor performance in individuals with intellectual disabilities (ID) is quite challenging. The objective of this study was to compare the motor performances of individuals with ID and those with typical development (TD) during soccer dribbling through video-based behavior-coded movement assessment along with a wearable sensor. A cross-sectional research design was adopted. Adolescents with TD (N = 25) and ID (N = 29) participated in the straight-line and zigzag soccer dribbling tests. The dribbling performance was videotaped, and the footage was then analyzed with customized behavior-coding software. The coded parameters were the time for movement completion, the number of kicks, blocks, steps, the number of times the ball went out of bounds, the number of missed cones, and the trunk tilt angle. Participants with ID exhibited significantly poorer performance and demonstrated greater variances in many time and frequency domain parameters. It also revealed that participants with ID kicked with both feet while dribbling, whereas those with TD mainly used the dominant foot. The present findings demonstrated how the ID population differed from their peers in lower-extremity strategic control. The customized video-based behavior-coded approach provides an efficient and effective way to gather behavioral data and calculate performance parameter statistics in populations with intellectual disabilities.

Commutability Assessment of Candidate External Quality Assessment Materials for Aminotransferase Activity Measurements Based on Different Approaches in China.

BACKGROUND: Using commutable external quality assessment (EQA) materials is important for monitoring successful harmonization efforts. We assessed the commutability of four human serum pool (HSP) preparations to identify candidate EQA materials for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activity measurement. METHODS: One set each of 85 clinical samples (CSs) was collected for ALT and AST activity measurement. The 15 candidate EQA materials included four types of HSP preparations (A to D): materials A, C, and D contained human original recombinant (HOR) aminotransferases; materials B was mixed leftover samples. The CSs and 15 candidate EQA materials were analyzed using seven routine assays, and the ln-transformed results were analyzed in 21 assay pairs. Commutability was assessed using Deming regression, with a 95% prediction interval (CLSI approach) and the difference in bias with an error component model (International Federation of Clinical Chemistry and Laboratory Medicine [IFCC] approach). RESULTS: For ALT, all materials were commutable for 14-21 assay pairs according to the CLSI and IFCC approaches. For AST, B01-03 showed commutability for 14-21 assay pairs, and C01-03 and D01-03 showed commutability for no less than 10 assay pairs according to the two approaches. A01-06 were commutable for 9-16 assay pairs according to the CLSI approach, but for 6-9 assay pairs according to the IFCC approach. CONCLUSIONS: Mixed leftover samples showed desirable commutability characteristics as candidate EQA materials for routine aminotransferase activity measurements. Human serum bases supplemented with HOR were commutable for most routine ALT activity measurements.

Commutability of possible external quality assessment materials for progesterone measurement.

BACKGROUND: The commutability of control materials used for external quality assessment (EQA) programs is of great importance. Evaluating the commutability of control materials is crucial to assess their suitability for EQA programs. METHODS: Forty-eight individual patient serum samples, commercial EQA samples, human serum pools (HSPs), commercially available sterile filtered charcoal stripped serum (CS) and swine serum were analyzed using the isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS) comparative method and six immunoassays for progesterone. The commutability was assessed according to the EP14-A2 guideline and the difference in bias approach, respectively. RESULTS: According to the EP14-A2 guideline, HSPs and CS were commutable for all the tested immunoassays, while swine serum showed positive matrix effects in some assays. Based on the difference in bias approach, a large number of inconclusive and noncommutable results appeared. CONCLUSIONS: The commutability of the processed materials varied depending on which evaluation approach and criterion was applied. Noncommutability of the EQA materials was observed. And HSPs and CS were possible commutable candidate control materials according to the EP14-A2 guideline.

[The development of basic research in the field of male reproductive health in China over the past 30 years supported by the National Natural Science Foundation of China].

Reproductive health is a key aim of the population health strategy, and male reproductive health constitutes an important part of reproductive health. This article systematically analyzes the applications to and grants from the National Natural Science Foundation of China (NSFC) and some related scientific problems in the field of male reproductive health in the past 30 years. It also discusses the development of the basic researches on male reproductive health in China and the facilitating role of NSFC in this field.

[Profile Characteristics of VOCs from Wood and Economic Crop Burning].

Wood and economic crops are still widely used in rural areas of China. Although their combustion is an important source of volatile organic compounds (VOCs), study on their emission characteristics is relatively weak. In this study, three kinds of wood (poplar, cedarwood, and citrus branches) and six economic crop straws (soybean stalk, sesame stalk, corn cob, cotton stalk, peanut stalk, and corn stalk) were selected and their burning was simulated in the laboratory. A dilution tunnel system was used to dilute the smoke, and then Tedlar bags were used to collect the smoke. The compositions of 102 VOCs were analyzed by Agilent 7820A/5977E gas chromatography/mass spectrometry. The ozone formation potential (OFP) of VOCs for different types of biomass burning was analyzed. The results indicated that there are differences in the VOC compositions of different types of biomass burning emissions. Ethane (11.1%), trans-2-pentene (15.4%), ethylene (8.3%), and dichloromethane (11.9%) are the main VOCs emitted from poplar and cedarwood burning. Toluene (49.8%) is the most abundant species of VOC emitted from burning of citrus branches. Ethylene (11.8%-17.5%) and acetone (9.2%-14.7%) are the main VOCs components of straw burning. Corn stalks, peanut stalks, and citrus branches have similar VOC source profiles, with the coefficient of divergence less than 0.1. The benzene/toluene ratio for biomass burning emissions obtained in this study and in the literature is in the range of 0.030-6.48. It is arguable that a value higher than 1 indicated the impact of biomass burning. The contributions of alkenens, oxygenated VOCs, and aromatic hydrocarbons to the OFP of biomass burning were 30.6%-80.3%, 6.5%-21.0%, and 3.8%-56.5%, respectively. The components contributing more than 10.0% to the OFP are ethylene, propylene, trans-2-pentene, cis-2-pentene, toluene, and propionaldehyde.

Bachelor groups in primate multilevel society facilitate gene flow across fragmented habitats.

In the face of ongoing habitat fragmentation, many primate species have experienced reduced gene flow resulting in a reduction of genetic diversity, population bottlenecks, and inbreeding depression, including golden snub-nosed monkeys Rhinopithecus roxellana. Golden snub-nosed monkeys live in a multilevel society composed of several 1 male harem units that aggregate to form a cohesive breeding band, which is followed by one or more bachelor groups composed of juvenile, subadult, and adult male members. In this research, we examine the continuous landscape resistance surface, the genetic diversity and patterns of gene flow among 4 isolated breeding bands and 1 all-male band in the Qinling Mountains, China. Landscape surface modeling suggested that human activities and ecological factors severely limit the movement of individuals among breeding bands. Although these conditions are expected to result in reduced gene flow, reduced genetic diversity, and an increased opportunity for a genetic bottleneck, based on population genetic analyses of 13 microsatellite loci from 188 individuals inhabiting 4 isolated breeding bands and 1 all-male band, we found high levels of genetic diversity but low levels of genetic divergence, as well as high rates of gene flow between males residing in the all-male band and each of the 4 breeding bands. Our results indicate that the movement of bachelor males across the landscape, along with their association with several different breeding bands, appears to provide a mechanism for promoting gene flows and maintaining genetic diversity that may counteract the otherwise isolating effects of habitat fragmentation.

Driving risk assessment using driving behavior data under continuous tunnel environment.

Objective: Driving behavior is the key feature for determining the nature of traffic stream qualities and reflecting the risk of operating environments. However, evaluating the driving risk accurately and practically in continuous tunnels (tunnels with a space more than 250 m and less than 1000 m) still faces severe challenges due to the complex driving conditions. The objective of this study is to predict the driving risk indicators and determine different risk levels.Methods: The naturalistic driving system equipped with a road environment and driving behavior data acquisition system combined with the fixed-point test method was used for data collection in 130 tunnels on four highways. A traditional AASHTO braking model and convex hull algorithm were adopted to predict the critical safety speed and the critical time headway of each risk feature point in tunnels. According to the risk constraints under free-flow, car-following and lane-changing conditions, the average traffic flow risk index (TFRI) representing six risk levels and the safety threshold of the corresponding risk indicators were determined.Results: The findings of this study revealed that the critical safety speed at nighttime is slower than in other daytime conditions in continuous tunnels. The time headway slightly changes under 90 km/h. As the speed continues to increase, speed has a significant influence on the critical time headway. The only reliable interaction involved the different adverse weather conditions on the mean critical safety speed in the continuous tunnels (short plus long) (F = 9.730, p＜0.05) and single long tunnels (F = 12.365, p＜0.05).Conclusions: It can be concluded that driving behaviors significantly vary in different tunnel risk feature points and the combined effect of high speed and luminance variation may result in high driving risk. The performance validation indicted that the risk assessment level determined by the proposed approach is consistent with the real safety situations. The study provides an effective and generally acceptable method for identifying driving risk criteria that can also be applied for traffic management and safety countermeasures with a view to possible implementation in continuous tunnels.

Commutability of external quality assessment materials for serum magnesium and calcium measurements.

The commutability of pooled patient sera (PPS) and control materials (CM) should be evaluated to investigate their suitability for use in an external quality assessment (EQA) program. Individual human samples, PPS and CM were analyzed by four routine methods and inductively coupled plasma mass spectrometry reference methods for magnesium and calcium measurements. The commutability was analyzed according to EP14-A3 protocol and the difference in bias approach, respectively. For magnesium measurements, all PPS were commutable and 3/5 CM were commutable for all measurement systems according to the EP14-A3 protocol. For calcium measurements, most PPS were commutable for all measurement systems, but the CM were only commutable with the Cobas c702 system. The IFCC approach produced similar commutability profiles, except that a large number of inconclusive results appeared. The routine methods exhibited excellent linearity and precision. The majority of relative biases between the routine and reference methods were beyond the bias limits. The commutability of the CM and PPS vary depending on which evaluation approach and criterion is applied. Superiority in the commutability of PPS over CM was observed whichever evaluation approach is applied.

Commutability of external quality assessment materials for serum sodium and potassium measurements.

Background The commutability of electrolyte trueness verification materials (ETVs) and commercial general chemistry materials (GCs) was evaluated to investigate their suitability for use in an external quality assessment (EQA) program for serum sodium and potassium measurements. Methods Eighty fresh individual human samples (40 for sodium measurements and 40 for potassium measurements), six ETVs and three GCs were analyzed by five routine methods (validated methods) and by inductively coupled plasma mass spectrometry reference methods (comparative methods) for the determination of sodium and potassium. The commutability was analyzed according to Clinical and Laboratory Standards Institute (CLSI) EP14-A3 protocol and difference in bias approach, respectively. The linearity, bias and imprecision of the routine methods were also assessed according to CLSI guidelines. Results According to EP14-A3 protocol, ETVs were commutable for all assays, and GCs were commutable for 3/5 assays for sodium. ETVs were commutable in most assays except Cobas C501, while GCs showed no commutability except in case of AU5821 for potassium. According to a difference in bias approach, the commutability of ETVs was inconclusive for most routine assays for both sodium and potassium, and GCs were inconclusive for sodium and non-commutable for potassium in most routine assays. The routine methods exhibited excellent linearities and precisions. The majority and minority of relative biases between the routine and reference methods were beyond the bias limits for sodium and potassium, respectively. Conclusions Superiority in the commutability of ETVs over GCs was observed among the sodium and potassium assays whichever evaluation approach was applied.

Commutability of control materials for external quality assessment of serum apolipoprotein A-I measurement.

BACKGROUND: The aim of the current study was to evaluate the commutability of commercial control materials and human serum pools and to investigate the suitability of the materials for the external quality assessment (EQA) of serum apolipoprotein A-I (apo A-I) measurement. METHODS: The Clinical and Laboratory Standards Institute (CLSI) EP14-A3 protocol was used for the commutability study. Apo A-I concentrations in two levels of commercial control materials used in EQA program, two fresh-frozen human serum pools (FSPs) and two frozen human serum pools prepared from residual clinical specimens (RSPs) were measured along with 50 individual samples using nine commercial assays. Measurement results of the 50 individual samples obtained with different assays were pairwise analyzed by Deming regression, and 95% prediction intervals (PIs) were calculated. The commutability of the processed materials was evaluated by comparing the measurement results of the materials with the limits of the PIs. RESULTS: The FSP-1 was commutable for all the 36 assay pairs, and FSP-2 was commutable for 30 pairs; RSP-1 and RSP-2 showed commutability for 27/36 and 22/36 assay pairs, respectively, whereas the two EQA materials were commutable only for 4/36 and 5/36 assay pairs, respectively. CONCLUSIONS: Non-commutability of the tested EQA materials has been observed among current apo A-I assays. EQA programs need either to take into account the commutability-related biases in the interpretation of the EQA results or to use more commutable materials. Frozen human serum pools were commutable for most of the assays.

Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.

PURPOSE: Cancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 (NCT01387282) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). METHODS: In the ROMANA 2 trial, 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 203 patients who reached the week 12 visit at the time of data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12. RESULTS: Two 4-item scales (fatigue/activity and appetite/eating) from the FACIT-F and FAACT questionnaires, respectively, demonstrated good internal consistency reliability, validity, and responsiveness (also referred to as the Simplified Evaluation of Fatigue (SEF) and Simplified Evaluation of Appetite (SEA), respectively). The estimated important difference for each scale was 1-2 points. CONCLUSIONS: These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine the clinical utility of these scales and their impact on treatment decision-making.