Category: Statistics

Future Oncol. 2023 Apr 11. doi: 10.2217/fon-2022-0959. Online ahead of print.

ABSTRACT

Aim: Assess the real-world effectiveness of systemic anticancer therapy in advanced (unresectable or metastatic) melanoma. Methods: This was a retrospective cohort study linking routine healthcare data with systemic anticancer therapy prescriptions for patients starting immunotherapy or targeted treatments between 1 November 2010 and 31 December 2017 in the west of Scotland. Results: Among 362 patients identified, median overall survival varied between 18.5 months (95% CI: 14.4-not estimable) for ipilimumab/nivolumab combination and 5.6 months (95% CI: 4.5-7.3) for dabrafenib, but there were differences in the characteristics of each regimen cohort. Raised lactate dehydrogenase levels and Eastern Cooperative Oncology Group performance status ≥2 negatively impacted overall survival. Conclusion: The patients had a shorter median overall survival than those in pivotal trials. This was expected, given that this real-world cohort included patients with poorer prognostic indicators, typically excluded from trials.

PMID:37039001 | DOI:10.2217/fon-2022-0959

Eur J Cancer Prev. 2023 Apr 10. doi: 10.1097/CEJ.0000000000000806. Online ahead of print.

ABSTRACT

OBJECTIVE: We estimated cancer mortality statistics for the current year in seven major Latin American countries.

METHODS: We retrieved official death certification data and population figures from the WHO and the United Nations databases for the 1970-2020 calendar period. We considered mortality from all neoplasms combined and for 10 major cancer sites. We estimated the number of deaths and age-standardized mortality rates for the year 2023.

RESULTS: Age-standardized mortality rates for all cancers combined are predicted to decline in all countries, in both sexes, apart from Venezuelan women. The lowest predicted total cancer mortality rates are in Mexico, 69.8/100 000 men and 62.5/100 000 women. The highest rates are in Cuba with 133.4/100 000 men and 90.2/100 000 women. Stomach cancer is predicted to decline steadily in all countries considered, but remains the first-ranking site for men in Chile (14.3/100 000) and Colombia (11/100 000). Colorectal cancer rates also tended to decline but remain comparatively high in Argentina (14/100 000 men). Breast cancer rates were high in Argentinian women (16.5/100 000) though they tended to decline in all countries. Lung cancer mortality rates are also predicted to decline, however, rates remain exceedingly high in Cuba (30.5/100 000 men and 17.2/100 000 women) as opposed to Mexico (5.6/100 000 men and 3.2/10 000 women). Declines are also projected for cancer of the uterus, but rates remain high, particularly in Argentina and Cuba (10/100 000 women), and Venezuela (13/100 000 women) due to inadequate screening and cervical cancer control.

CONCLUSION: Certified cancer mortality remains generally lower in Latin America (apart from Cuba), as compared to North America and Europe; this may be partly due to death certification validity.

PMID:37038996 | DOI:10.1097/CEJ.0000000000000806

J Antimicrob Chemother. 2023 Apr 11:dkad085. doi: 10.1093/jac/dkad085. Online ahead of print.

ABSTRACT

BACKGROUND: The Antifungal National Antimicrobial Prescribing Survey (AF-NAPS) was developed to undertake streamlined quality audits of antifungal prescribing. The validity and reliability of such tools is not characterized.

OBJECTIVES: To assess the validity and reliability of the AF-NAPS quality assessment tool.

METHODS: Case vignettes describing antifungal prescribing were prepared. A steering group was assembled to determine gold-standard classifications for appropriateness and guideline compliance. Infectious diseases physicians, antimicrobial stewardship (AMS) and specialist pharmacists undertook a survey to classify appropriateness and guideline compliance of prescriptions utilizing the AF-NAPS tool. Validity was measured as accuracy, sensitivity and specificity compared with gold standard. Inter-rater reliability was measured using Fleiss’ kappa statistics. Assessors’ responses and comments were thematically analysed to determine reasons for incorrect classification.

RESULTS: Twenty-eight clinicians assessed 59 antifungal prescriptions. Overall accuracy of appropriateness assessment was 77.0% (sensitivity 85.3%, specificity 68.0%). Highest accuracy was seen amongst specialist (81%) and AMS pharmacists (79%). Prescriptions with lowest accuracy were in the haematology setting (69%), use of echinocandins (73%), mould-active azoles (75%) and for prophylaxis (71%). Inter-rater reliability was fair overall (0.3906), with moderate reliability amongst specialist pharmacists (0.5304). Barriers to accurate classification were incorrect use of the appropriateness matrix, knowledge gaps and lack of guidelines for some indications.

CONCLUSIONS: The AF-NAPS is a valid tool, assisting assessors to correctly classify appropriate prescriptions more accurately than inappropriate prescriptions. Specialist and AMS pharmacists had similar performance, providing confidence that both can undertake AF-NAPS audits to a high standard. Identified reasons for incorrect classification will be targeted in the online tool and educational materials.

PMID:37038993 | DOI:10.1093/jac/dkad085

Int J Paediatr Dent. 2023 Apr 11. doi: 10.1111/ipd.13072. Online ahead of print.

ABSTRACT

BACKGROUND: Early childhood caries (ECC) requires systematically collected and standardized data.

AIM: To describe a novel multilevel calibration procedure in primary dentition.

DESIGN: Calibration method involved two calibration levels: the first (L₁ ) involved inter-examiner agreement between three main investigators, the group leaders (GLs) in the following level; the second level (L₂ ) involved three groups of 11 pediatric dentists and inter-examiner agreement assessment according to the GLs in each group. The study sample consisted of 650 primary teeth surfaces in eight children (mean age 6.56±2.22 years). Surface-by-surface percent agreement, tooth-by-tooth percentage agreement, Cohen’s kappa and Fleiss Kappa statistics were used to calculate inter-examiner reliability. Statistical analysis was performed with SPSS 27.0.

RESULTS: Surface-by-surface agreement regarding ICDAS_epi -merged revealed almost perfect agreement (>90.00%) both on L₁ and L₂ . Kappa values and ranges showed good agreement both at L₁ (Overall Kappa=0.95) and L₂ (Overall Kappa=0.98) and almost perfect consistency was detected between GLs at L₁ (>91.30%) and substantial agreement at L₂ (>85.00%). All examiner at L₂ showed almost perfect positive agreement (sensitivity=96.77-100%) when detecting presence of dental plaque.

CONCLUSIONS: The calibration procedure appeared feasible prior to organizing multicenter epidemiological oral health survey in large population groups of preschool children, with higher number of examiners.

PMID:37038983 | DOI:10.1111/ipd.13072

Eur J Cancer Prev. 2023 Apr 10. doi: 10.1097/CEJ.0000000000000778. Online ahead of print.

ABSTRACT

BACKGROUND: In Brazil, there is lack of studies on the incidence and mortality of this malignancy. The aim of this study was to describe the profile of HL in Brazil for incidence, mortality and trends.

METHODS: Data on incidence in Brazil were collected from Population-Based Cancer Registries (1988-2017) and mortality for 1979-2019. Age-standardized incidence and mortality rates were calculated. Average annual percent change was estimated and analyzed in two calendar periods for mortality (1979-1999 and 2000-2019).

RESULTS: Trends in the incidence of HL for males in Brazil declined in two state capitals – Belo Horizonte, -3.7% (95% CI, -7.1 to -0.3); and Salvador, -8.5% (95% CI, -13.0 to -3.8) – and remained stable in other cities. For females, two capitals showed a decrease in incidence: Salvador, -9.5% (95% CI, -15.3 to -3.2) and Porto Alegre, -3.9% (95% CI, -7.0 to -0.8). Mortality rates in males were higher than those in females. However, the decrease in mortality was greater in males, -2.2% (95% CI, -2.5 to -1.8). Age incidence distribution across Brazilian capitals showed a higher incidence among younger (15-30 years) individuals yet no clear incidence among older adults (>60 years).

CONCLUSION: The incidence trend of HL in Brazil has remained stable. While the mortality has decreased for both sex. Age distribution for mortality in young age and older ages follows the bimodal pattern for Brazil as a whole. Finally, further studies are necessary to understand age incidence distribution of HL in Brazil.

PMID:37038979 | DOI:10.1097/CEJ.0000000000000778

Arthritis Care Res (Hoboken). 2023 Apr 11. doi: 10.1002/acr.25128. Online ahead of print.

ABSTRACT

OBJECTIVE: In this study we obtained descriptive data on the beliefs, behaviors, and openness regarding dietary changes for rheumatic diseases (RMDs) in an urban U.S. Hispanic RMD patient population, as foundational data for future intervention design.

METHODS: We distributed a voluntary survey to our primarily Hispanic population at an outpatient rheumatology clinic for 19 weeks. This survey queried individuals’ behaviors as it related to dietary intake used for RMD treatment, perceptions of the effect of food groups on RMD activity, barriers to physician-recommended diets, and willingness to try future interventions. We used descriptive statistics and Pearson’s chi-square test to evaluate associations.

RESULTS: Over 40% of survey respondents from our primarily (88%) Hispanic population noted a link between what they ate and their underlying RMD activity. Over a third of patients had, at some point, modified dietary intake to affect their RMD. Vegetables, fruit, and white meats were commonly reported to improve disease, while red meat and processed foods were reported to worsen disease. Barriers to following a pre-specified diet included cost and lack of knowledge. Over 70% of respondents indicated willingness to attempt certain eating patterns should it help their underlying RMD.

CONCLUSION: In this primarily Hispanic RMD patient population, many have not only noted a correlation between dietary intake and RMD activity, but are also open to future nutrition-related interventions. As this population experiences poor RMD outcomes and a high rate of lifestyle-related comorbidities, an intervention to optimize healthy eating patterns would likely be beneficial as well as acceptable.

PMID:37038969 | DOI:10.1002/acr.25128

Arthritis Care Res (Hoboken). 2023 Apr 11. doi: 10.1002/acr.25127. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the relationship between sleep disturbance, catastrophizing, and knee pain in middle-aged and older persons.

DESIGN: Data from the Osteoarthritis Initiative (OAI) cohort from months 48 to 96 were used, where month 48 was treated as baseline. Knee pain (the Western Ontario and McMaster Osteoarthritis Index [WOMAC] pain scale ≥5, 0-20), catastrophizing (extracted from the Coping Strategies Questionnaire [CSQ] ≥3, 0-6), and sleep quality (extracted from the Center for Epidemiologic Studies Depression Scale [CES-D], 1-4) were assessed annually. We described the association of sleep disturbance with the presence and risk of knee pain and catastrophizing. The mediation effect of knee pain and catastrophizing on sleep-catastrophizing and sleep-pain association was evaluated, respectively.

RESULT: Catastrophizing and knee pain were reported in 346 (10%) and 917 (24%) of the 3813 participants (mean 64.9 years, 58% female) at baseline. Participants with worse sleep disturbance were more likely to have knee pain (prevalence ratios [PR]1.4-2.0, Ptrend <0.001) and catastrophizing (PR 1.4-3.1, Ptrend <0.001). Sleep disturbance at baseline predicted the risk of knee pain (risk ratios [RR] 1.1, Ptrend <0.001) and catastrophizing (RR 1.2-1.7, Ptrend <0.001) during the follow-up. No statistically significant interactions between sleep disturbance and knee pain or catastrophizing were observed. Knee pain and catastrophizing mediated the sleep-catastrophizing and sleep-pain association respectively at baseline, and knee pain negatively mediated the sleep-catastrophizing association longitudinally.

CONCLUSION: Sleep disturbance was associated with the presence and risk of catastrophizing and knee pain. Sleep interventions may have a universal and independent effect in preventing incident knee pain.

PMID:37038964 | DOI:10.1002/acr.25127

Nucl Med Commun. 2023 Apr 10. doi: 10.1097/MNM.0000000000001695. Online ahead of print.

ABSTRACT

AIM OF WORK: To determine the predictive value of initial [18F]FDG PET/computed tomography (CT) volumetric and radiomics-derived analyses in patients with head and neck squamous cell carcinoma (HNSCC).

METHODS: Forty-six adult patients had pathologically proven HNSCC and underwent pretherapy [18F]FDG PET/CT were enrolled. Semi-quantitative PET-derived volumetric [(maximum standardized uptake value (SUVmax) and mean SUV (SUVmean), total lesion glycolysis (TLG) and metabolic tumor volume (MTV)] and radiomics analyses using LIFEx 6.73.3 software were performed.

RESULTS: In the current study group, the receiver operating characteristic curve marked a cutoff point of 21.105 for primary MTV with area under the curve (AUC) of 0.727, sensitivity of 62.5%, and specificity of 86.8% (P value 0.041) to distinguish responders from non-responders, while no statistically significant primary SUVmean or max or primary TLG cut off points could be determined. It also marked the cutoff point for survival prediction of 10.845 for primary MTV with AUC 0.728, sensitivity of 80%, and specificity of 77.8% (P value 0.026). A test of the synergistic performance of PET-derived volumetric and textural features significant parameters was conducted in an attempt to develop the most accurate and stable prediction model. Therefore, multivariate logistic regression analysis was performed to detect independent predictors of mortality. With a high specificity of 97.1% and an overall accuracy of 89.1%, the combination of primary tumor MTV and the textural feature gray-level co-occurrence matrix correlation provided the most accurate prediction of mortality (P value < 0.001).

CONCLUSION: Textural feature indices are a noninvasive method for capturing intra-tumoral heterogeneity. In our study, a PET-derived prediction model was successfully generated with high specificity and accuracy.

PMID:37038954 | DOI:10.1097/MNM.0000000000001695

Nucl Med Commun. 2023 Apr 10. doi: 10.1097/MNM.0000000000001693. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study is to evaluate the prognostic role of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and quantitative 68Ga-DOTATATE PET/computed tomography parameters such as maximum standardized uptake value (SUVmax), mean SUV (SUVmean), DOTATATE tumor volume (DTV), total lesion DOTATATE (TLD) in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with 177Lu-DOTATATE.

MATERIAL AND METHOD: Our retrospective study included 21 patients with GEP-NETs treated with 177Lu-DOTATATE between January 2017 and January 2022. SUVmax, SUVmean, SUVmax/spleenSUVmax (SUVmax/Sx), DTV, TLD, SUVmean/spleenSUVmean (SUVmean/Sm), TLD/Sm values were calculated and recorded for all patients before and after 177Lu-DOTATATE treatment.

RESULTS: A total of 319 metastases were detected in the patients included in the study, and a total of 68 target lesions were selected. In univariant Cox regression analysis, TLD/Sm percent change (∆TLD/Sm) was found to be statistically significant on overall survival (OS) (P = 0.044). The 3-year survival in nonresponders was 50% (P = 0.034) based on ∆SUVmax/Sx values, 50% (P = 0.002) based on RECIST values, 50% based on ∆TDTV + new lesion values (P = 0.033), and according to ∆TTLD + new lesion values, it was 66% (P = 0.030).

CONCLUSION: In our study, we showed that SUVmax/Sx, RECIST, ∆TDTV + new lesion, and ∆TTLD + new lesion parameters can predict OS in the evaluation of response to treatment.

PMID:37038931 | DOI:10.1097/MNM.0000000000001693

Crit Rev Clin Lab Sci. 2023 Apr 11:1-15. doi: 10.1080/10408363.2023.2195496. Online ahead of print.

ABSTRACT

Reference intervals (RIs) are the cornerstone for evaluation of test results in clinical practice and are invaluable in judging patient health and making clinical decisions. Establishing RIs based on clinical laboratory data is a branch of real-world data mining research. Compared to the traditional direct method, this indirect approach is highly practical, widely applicable, and low-cost. Improving the accuracy of RIs requires not only the collection of sufficient data and the use of correct statistical methods, but also proper stratification of heterogeneous subpopulations. This includes the establishment of age-specific RIs and taking into account other characteristics of reference individuals. Although there are many studies on establishing RIs by indirect methods, it is still very difficult for laboratories to select appropriate statistical methods due to the lack of formal guidelines. This review describes the application of real-world data and an approach for establishing indirect reference intervals (iRIs). We summarize the processes for establishing iRIs using real-world data and analyze the principle and applicable scope of the indirect method model in detail. Moreover, we compare different methods for constructing growth curves to establish age-specific RIs, in hopes of providing laboratories with a reference for establishing specific iRIs and giving new insight into clinical laboratory RI research. (201 words).

PMID:37038925 | DOI:10.1080/10408363.2023.2195496