INTRODUCTION: Maintaining or improving health-related quality of life (HRQoL) is as important as extending survival in metastatic colorectal cancer. We report an HRQoL analysis from FRESCO-2 (NCT04322539). METHODS: Patients were randomized to fruquintinib +best supportive care (BSC; n = 461) or placebo +BSC (n = 230). Instruments of EORTC QLQ-C30 and 5-level EQ-5D, and ECOG performance status (PS) were assessed. Changes from baseline scores for QLQ-C30 and EQ-5D were evaluated and minimally important difference thresholds were used to define stable, improved, or deteriorated QoL. Time to deterioration (TTD) was assessed. RESULTS: With fruquintinib versus placebo, baseline QLQ-C30 global health status (GHS) and EQ-5D visual analog scale (VAS) scores were 65.2 versus 64.6 and 67.0 versus 66.6, respectively. Least-squares mean changes from baseline fluctuated throughout treatment. At end of treatment (EOT), mean scores with fruquintinib versus placebo were 53.8 versus 52.3 (QLQ-C30 GHS) and 58.9 versus 58.5 (EQ-5D VAS). For QLQ-C30 GHS, 38.3 % versus 36.5 % of patients receiving fruquintinib versus placebo had stable or improved scores at EOT; median TTD was 2.1 versus 1.8 months (HR, 0.9; 95 % CI, 0.7-1.0). For EQ-5D VAS, 47.9 % versus 42.7 % had stable or improved scores at EOT; median TTD was 2.6 versus 1.9 months (HR, 0.8; 95 % CI, 0.6-0.9). Median TTD to ECOG PS ≥ 2 or death within 30+ /7 days after EOT was 6.6 versus 2.9 months with fruquintinib versus placebo (HR, 0.6; 95 % CI, 0.4-0.7). CONCLUSIONS: Fruquintinib delayed TTD of ECOG PS and did not negatively impact HRQoL versus placebo.

• Klíčová slova
• EORTC QLQ-C30, EQ-5D-5L, Fruquintinib, Health-related quality of life, Metastatic colorectal cancer,
• MeSH
• benzofurany * terapeutické užití   MeSH
• chinazoliny * terapeutické užití   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• kolorektální nádory * farmakoterapie   patologie   psychologie   MeSH
• kvalita života * MeSH
• lidé středního věku MeSH
• lidé MeSH
• metastázy nádorů MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• benzofurany * MeSH
• chinazoliny * MeSH
• HMPL-013 MeSH Prohlížeč

Meta-analyses, which present the best source of information on the effectiveness of interventions, are influenced by several biases. One category relates to the convenience of selective inclusion of those primary studies, which are more easily available than others. This availability bias includes bias from excluding the grey literature, bias from excluding non-English literature, and bias from excluding older studies. Existing studies are not conclusive about the impacts of this bias; in addition, none of them focus on road safety meta-analyses. To fill this gap, the present paper consisted of two studies: (1) exploring the presence of availability bias in road safety meta-analyses, and (2) demonstrating the impact of availability bias in several example meta-analyses. Based on an analysis of 80 existing meta-analyses, the first study concluded that compared to the medicine meta-analyses, the road safety meta-analyses use a longer time range, are more often restricted in terms of language, and less often involve the grey literature. The second study utilized selected unrestricted data samples to demonstrate the impact of availability bias in seven meta-analyses. The differences in intervention effectiveness in terms of crash frequency changes between unrestricted and restricted scenarios were identified. This shows that the search restrictions clearly lead to availability bias, which influences the differences in meta-analysis results.

• Klíčová slova
• Availability bias, Meta-analysis, Road safety, Systematic review,
• MeSH
• bezpečnost * MeSH
• dopravní nehody * prevence a kontrola   statistika a číselné údaje   MeSH
• lidé MeSH
• metaanalýza jako téma * MeSH
• přehledová literatura jako téma MeSH
• zkreslení výsledků (epidemiologie) MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

OBJECTIVE: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression. METHODS: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support. The resulting psychedelic experience (Five-Dimensional Altered States of Consciousness questionnaire [5D-ASC] and Emotional Breakthrough Inventory [EBI]) were measured. These proximal variables and outcome 3 weeks post-administration (change in Montgomery-Åsberg Depression Rating Scale [MADRS]) were explored using correlation analysis. RESULTS: The mean intensity of psychedelic effects was dose-related, but distributions of scores for different doses overlapped considerably. Depression response correlated with select aspects of the psychedelic experience overall and for individual doses. At the 25 mg dose, 5D-ASC dimensions Oceanic Boundlessness (Pearson correlation coefficient r = -0.508) and Visual Restructuralization (r = -0.516), and EBI (r = -0·637) were the variables with the strongest correlation to the Week 3 change from Baseline in MADRS score. LIMITATIONS: The existence of correlation does not establish causation and exploratory findings require further replication, preferably in larger independent samples. CONCLUSIONS: The intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses.

• Klíčová slova
• Dose-response, Psilocybin, Psychedelic, Psychedelic experience, Randomized-control trial, Treatment-resistant depression,
• MeSH
• deprese nereagující na léčbu * farmakoterapie   MeSH
• depresivní porucha unipolární farmakoterapie   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• halucinogeny * aplikace a dávkování   farmakologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• psilocybin * farmakologie   aplikace a dávkování   MeSH
• psychiatrické posuzovací škály MeSH
• výsledek terapie MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• halucinogeny * MeSH
• psilocybin * MeSH

BACKGROUND: Observational data on composite scores often comes with missing component information. When a complete-case (CC) analysis of composite scores is unbiased, preferable approaches of dealing with missing component information should also be unbiased and provide a more precise estimate. We assessed the performance of several methods compared to CC analysis in estimating the means of common composite scores used in axial spondyloarthritis research. METHODS: Individual mean imputation (IMI), the modified formula method (MF), overall mean imputation (OMI), and multiple imputation of missing component values (MI) were assessed either analytically or by means of simulations from available data collected across Europe. Their performance in estimating the means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) in cases where component information was set missing completely at random was compared to the CC approach based on bias, variance, and coverage. RESULTS: Like the MF method, IMI uses a modified formula for observations with missing components resulting in modified composite scores. In the case of an unbiased CC approach, these two methods yielded representative samples of the distribution arising from a mixture of the original and modified composite scores, which, however, could not be considered the same as the distribution of the original score. The IMI and MF method are, thus, intrinsically biased. OMI provided an unbiased mean but displayed a complex dependence structure among observations that, if not accounted for, resulted in severe coverage issues. MI improved precision compared to CC and gave unbiased means and proper coverage as long as the extent of missingness was not too large. CONCLUSIONS: MI of missing component values was the only method found successful in retaining CC's unbiasedness and in providing increased precision for estimating the means of BASDAI, BASFI, and ASDAS-CRP. However, since MI is susceptible to incorrect implementation and its performance may become questionable with increasing missingness, we consider the implementation of an error-free CC approach a valid and valuable option. TRIAL REGISTRATION: Not applicable as study uses data from patient registries.

• Klíčová slova
• Axial spondyloarthritis, Complete-case analysis, Composite score, Missing components, Multiple imputation,
• MeSH
• ankylózující spondylitida MeSH
• axiální spondyloartritida * MeSH
• C-reaktivní protein analýza   MeSH
• interpretace statistických dat MeSH
• lidé MeSH
• stupeň závažnosti nemoci MeSH
• výzkumný projekt MeSH
• zkreslení výsledků (epidemiologie) MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH
• Názvy látek
• C-reaktivní protein MeSH

The aim of this study was to evaluate the effects of pleuran (β-glucan isolated from Pleurotus ostreatus) on asthma control and respiratory morbidity in children on conventional GINA-based asthma treatment who had partially controlled perennial asthma. A double-blind, placebo-controlled multicentre clinical trial with a 2-arm, parallel design was conducted across three countries; 230 children aged 7 to 17 years were randomised (1:1) into an active group (receiving a pleuran/vitamin C combination) or a placebo group (receiving vitamin C only). This study consisted of 24 weeks of treatment (2 capsules a day) and then 24 weeks of follow-up. The primary endpoints included the effects of active treatment versus placebo on asthma control and respiratory tract infections (RTIs). Secondary endpoints included changes in the following measures: number of asthma exacerbations, with or without respiratory infection; quality of life of both asthmatic children and their caregivers; spirometric indices; fractional exhaled nitric oxide (FeNO) levels; safety after 24 weeks of treatment and also after the full 48-week study period. Overall, 206 children completed this study; 113 of these children were in the active group and received a pleuran/vitamin C combination for 24 weeks. After the 24-week treatment period, children below 12 years of age who were in the active group achieved significant improvements in asthma control compared to those in the placebo group (21.8 ± 3.5 vs. 20.3 ± 4.0; P = 0.02); while children at least 12 years old who were in the active group reported lower numbers of RTIs (0.7 ± 1.0 vs. 1.9 ± 1.7; P = 0.002) compared to children of this age in the placebo group. In addition, children below 12 years of age in the active group showed a significant decrease in asthma exacerbations compared to those in the placebo group (2.5 ± 1.6 vs. 3.3 ± 1.9; P = 0.05). At the end of the 48-week trial, a statistically significant improvement in asthma control was observed in 84.7% of children who received pleuran/vitamin C treatment compared to 67.0% of children who received vitamin C only (P = 0.01). The pleuran/vitamin C combined treatment was safe and well-tolerated, and no related serious adverse events were reported. This study highlights the favourable safety profile of pleuran/vitamin C supplementation and demonstrates positive effects of this treatment on asthma control and RTI incidence in children with allergic perennial asthma that was partially controlled by conventional therapy.

• Klíčová slova
• Asthma control, Asthmatic children, Beta-glucan, Polysaccharide, Respiratory tract infections, Tolerability,
• MeSH
• beta-glukany terapeutické užití   aplikace a dávkování   MeSH
• bronchiální astma * farmakoterapie   MeSH
• dítě MeSH
• dvojitá slepá metoda MeSH
• infekce dýchací soustavy * farmakoterapie   MeSH
• kvalita života MeSH
• kyselina askorbová terapeutické užití   aplikace a dávkování   MeSH
• lidé MeSH
• mladiství MeSH
• Pleurotus chemie   MeSH
• výsledek terapie MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• beta-glukany MeSH
• kyselina askorbová MeSH

BACKGROUND AND OBJECTIVES: Patients with multiple sclerosis (MS) may demonstrate better disease control when treatment is initiated on high-efficacy disease-modifying therapies (DMTs) from onset. This subgroup analysis assessed the long-term efficacy and safety profile of the high-efficacy DMT ocrelizumab (OCR) as first-line therapy for early-stage relapsing MS (RMS). METHODS: Post hoc exploratory analyses of efficacy and safety were performed in a subgroup of treatment-naive patients with RMS who received ≥1 dose of OCR in the multicenter OPERA I/II (NCT01247324/NCT01412333) studies. Patients were randomized to OCR or interferon β-1a for 96 weeks (double-blind controlled treatment period [DBP]), before switching to OCR in the open-label extension (OLE). Efficacy assessments included no evidence of disease activity (NEDA-3), 24-week confirmed disability progression (CDP), MRI lesion activity, change in whole-brain volume; with safety outcomes assessed over a 9-year treatment period. RESULTS: Overall, 757 patients were included (interferon-treated n = 382, mean age 36.3 years, 65.7% female; OCR-treated n = 375, mean age 35.5 years, 64.0% female); 505 of 757 (66.7%) completed 9 years of follow-up. The difference in NEDA status between OCR-treated and interferon-treated patients achieved during the DBP (72.5% and 43.8%, respectively, odds ratio 3.48, 95% CI 2.52-4.81) was maintained throughout the 7-year OLE (48.2% vs 25.7%; odds ratio 2.72, 95% CI 1.94-3.82). No 24-week CDP was observed in 78.7% of OCR-treated patients over 9 years. Brain volume loss over the entire study period remained numerically higher among patients starting OCR later (p = 0.09 at OLE at week 336). During the DBP, safety profiles in both groups were similar; no new safety signals were observed during the OLE. Over >9 years of continuous OCR treatment, the rate of infections remained low and stable over time. DISCUSSION: A higher proportion of OCR-treated patients achieved NEDA status compared with interferon-treated patients during the DBP, which was maintained throughout the OLE. After switching to OCR, disability accrual and brain volume loss among interferon-treated patients became similar to the OCR-OCR group, but disability and brain volume loss accrued during interferon treatment were not recovered. Possible study limitations include assessment bias due to unmaintained blinding during the OLE. These data support OCR as first-line therapy for these patients. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that OCR delays disease progression in treatment-naïve patients with early-stage RMS.

• MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• humanizované monoklonální protilátky * škodlivé účinky   terapeutické užití   aplikace a dávkování   MeSH
• imunologické faktory * škodlivé účinky   aplikace a dávkování   terapeutické užití   MeSH
• interferon beta 1a terapeutické užití   aplikace a dávkování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• progrese nemoci MeSH
• relabující-remitující roztroušená skleróza * farmakoterapie   diagnostické zobrazování   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• humanizované monoklonální protilátky * MeSH
• imunologické faktory * MeSH
• interferon beta 1a MeSH
• ocrelizumab MeSH Prohlížeč

Background/Objectives: Given the crucial health benefits of vitamin D, addressing severe deficiencies is a pressing medical concern. This study aimed to evaluate the effectiveness and safety of two new weekly doses of calcifediol (100 µg and 125 µg) for long-term management in patients with severe vitamin D deficiency, defined as plasma 25(OH)D levels ≤10 ng/mL. Methods: This study was a randomized, two-cohort, controlled, double-blind, multicentre phase II-III trial. Subjects were randomized 2:2:1 to weekly calcifediol 100 µg, 125 µg or a placebo. The primary endpoint was the proportion of patients achieving plasma 25(OH)D levels of ≥20 ng/mL and/or ≥30 ng/mL by week 16. Results: A total of 276 patients (mean age: 55.2 years, SD 15.42) were randomized. By week 16, 92.3% and 91.8% of patients in the calcifediol 100 µg and 125 µg groups, respectively, reached ≥20 ng/mL, compared to 7.3% in the placebo group. Levels of ≥30 ng/mL were achieved by 49% (100 µg) and 76.4% (125 µg) of participants, with none in the placebo group. Calcifediol demonstrated superior efficacy at all response levels and time points (p < 0.0001). Plasma 25(OH)D concentrations increased by week 24 and remained stable. The incidence of adverse events was comparable across groups. Conclusions: A weekly calcifediol dose of 100 µg demonstrates the best profile of efficacy and tolerability, providing a reliable solution for achieving and maintaining adequate vitamin D levels in patients with severe deficiency.

• Klíčová slova
• calcifediol, efficacy, safety, vitamin D deficiency, weekly treatment,
• MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• kalcifediol * krev   aplikace a dávkování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nedostatek vitaminu D * farmakoterapie   krev   MeSH
• potravní doplňky MeSH
• rozvrh dávkování léků MeSH
• senioři MeSH
• vitamin D krev   analogy a deriváty   aplikace a dávkování   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• 25-hydroxyvitamin D MeSH Prohlížeč
• kalcifediol * MeSH
• vitamin D MeSH

BACKGROUND: Inflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events. METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients who had myocardial infarction to receive either colchicine or placebo and either spironolactone or placebo. The results of the colchicine trial are reported here. The primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, evaluated in a time-to-event analysis. C-reactive protein was measured at 3 months in a subgroup of patients, and safety was also assessed. RESULTS: A total of 7062 patients at 104 centers in 14 countries underwent randomization; at the time of analysis, the vital status was unknown for 45 patients (0.6%), and this information was most likely missing at random. A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 patients (9.3%) in the placebo group over a median follow-up period of 3 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.16; P = 0.93). The incidence of individual components of the primary outcome appeared to be similar in the two groups. The least-squares mean difference in C-reactive protein levels between the colchicine group and the placebo group at 3 months, adjusted according to the baseline values, was -1.28 mg per liter (95% CI, -1.81 to -0.75). Diarrhea occurred in a higher percentage of patients with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), but the incidence of serious infections did not differ between groups. CONCLUSIONS: Among patients who had myocardial infarction, treatment with colchicine, when started soon after myocardial infarction and continued for a median of 3 years, did not reduce the incidence of the composite primary outcome (death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization). (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).

• MeSH
• C-reaktivní protein * analýza   MeSH
• cévní mozková příhoda prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• infarkt myokardu * prevence a kontrola   mortalita   MeSH
• Kaplanův-Meierův odhad MeSH
• kolchicin * terapeutické užití   škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• recidiva MeSH
• sekundární prevence MeSH
• senioři MeSH
• spironolakton terapeutické užití   škodlivé účinky   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• C-reaktivní protein * MeSH
• kolchicin * MeSH
• spironolakton MeSH

BACKGROUND: Mineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain. METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo. The results of the spironolactone trial are reported here. The two primary outcomes were a composite of death from cardiovascular causes or new or worsening heart failure, evaluated as the total number of events; and a composite of the first occurrence of myocardial infarction, stroke, new or worsening heart failure, or death from cardiovascular causes. Safety was also assessed. RESULTS: We enrolled 7062 patients at 104 centers in 14 countries; 3537 patients were assigned to receive spironolactone and 3525 to receive placebo. At the time of our analyses, the vital status was unknown for 45 patients (0.6%). For the first primary outcome, there were 183 events (1.7 per 100 patient-years) in the spironolactone group as compared with 220 events (2.1 per 100 patient-years) in the placebo group over a median follow-up period of 3 years (hazard ratio adjusted for competing risk of death from noncardiovascular causes, 0.91; 95% confidence interval [CI], 0.69 to 1.21; P = 0.51). With respect to the second primary outcome, an event occurred in 280 of 3537 patients (7.9%) in the spironolactone group and 294 of 3525 patients (8.3%) in the placebo group (hazard ratio adjusted for competing risk, 0.96; 95% CI, 0.81 to 1.13; P = 0.60). Serious adverse events were reported in 255 patients (7.2%) in the spironolactone group and 241 (6.8%) in the placebo group. CONCLUSIONS: Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure. (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).

• MeSH
• antagonisté mineralokortikoidních receptorů * terapeutické užití   škodlivé účinky   MeSH
• cévní mozková příhoda mortalita   MeSH
• dvojitá slepá metoda MeSH
• infarkt myokardu * mortalita   farmakoterapie   MeSH
• Kaplanův-Meierův odhad MeSH
• kardiovaskulární nemoci mortalita   prevence a kontrola   MeSH
• koronární angioplastika MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• spironolakton * terapeutické užití   škodlivé účinky   MeSH
• srdeční selhání * farmakoterapie   mortalita   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• antagonisté mineralokortikoidních receptorů * MeSH
• spironolakton * MeSH

Laboratory measurements used for safety assessments in clinical trials are subject to the limits of the used laboratory equipment. These limits determine the range of values which the equipment can accurately measure. When observations fall outside the measurable range, this creates a problem in estimating parameters of the normal distribution. It may be tempting to use methods of estimation that are easy to implement, however selecting an incorrect method may lead to biased estimates (under- or overestimation) and change the research outcomes, for example, incorrect result of two-sample test about means when comparing two populations or biased estimation of regression line. In this article, we consider the use of four methods: ignoring unmeasured observations, replacing unmeasured observations with a multiple of the limit, using a truncated normal distribution, and using a normal distribution with censored observations. To compare these methods we designed a simulation study and measured their accuracy in several different situations using relative error μ ̂ - μ μ $$ \frac{\hat{\mu}-\mu }{\mu } $$ , ratio σ ̂ σ $$ \frac{\hat{\sigma}}{\sigma } $$ , and mean square errors of both parameters. Based on the results of this simulation study, if the amount of observations outside of measurable range is below 40%, we recommend using a normal distribution with censored observations in practice. These recommendations should be incorporated into guidelines for good statistical practice. If the amount of observations outside of measurable range exceeds 40%, we advise not to use the data for any statistical analysis. To illustrate how the choice of method can affect the estimates, we applied the methods to real-life laboratory data.

• Klíčová slova
• clinical trial, estimation techniques, limit of detection, limit of quantitation, measurable range, simulation study,
• MeSH
• interpretace statistických dat MeSH
• klinické zkoušky jako téma metody   MeSH
• lidé MeSH
• normální rozdělení MeSH
• počítačová simulace * MeSH
• statistické modely MeSH
• výzkumný projekt MeSH
• zkreslení výsledků (epidemiologie) MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH