Browsing by Subject "Validation"

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  • DAGIS Consortium Grp (2018)
    Validated methodological aids for food quantification are needed for the accurate estimation of food consumption. Our objective was to assess the validity of an age-specific food picture book, which contains commonly eaten foods among Finnish children, for parents and early educators in estimating food portion sizes. The food picture book was developed to assist in portion size estimation when filling in food records in the Increased health and wellbeing in preschools (DAGIS) study. All ninety-five food pictures in the book, each containing three or four different portion sizes, were evaluated at real-time sessions. Altogether, seventy-three parents and 107 early educators or early education students participated. Each participant evaluated twenty-three or twenty-four portions by comparing presented pre-weighed food portions against the corresponding picture from the food picture book. Food portions were not consumed by participants. The total proportion of correct estimations varied from 36% (cottage cheese) to 100% (fish fingers). Among the food groups, nearly or over 90% of the estimations were correct for bread, pastries and main courses (piece products' such as meatballs and chicken nuggets). Soups, porridges, salads and grated and fresh vegetables were least correctly estimated (
  • Kanerva, Noora; Harald, Kennet; Männistö, Satu; Kaartinen, Niina E.; Maukonen, Mirkka; Haukkala, Ari; Jousilahti, Pekka (2018)
    Studies indicate that the healthy Nordic diet may improve heart health, but its relation to weight change is less clear. We studied the association between the adherence to the healthy Nordic diet and long-term changes in weight, BMI and waist circumference. Furthermore, the agreement between self-reported and measured body anthropometrics was examined. The population-based DIetary, Lifestyle and Genetic Determinants of Obesity and Metabolic syndrome Study in 2007 included 5024 Finns aged 25-75 years. The follow-up was conducted in 2014 (n 3735). One-third of the participants were invited to a health examination. The rest were sent measuring tape and written instructions along with questionnaires. The Baltic Sea Diet Score (BSDS) was used to measure adherence to the healthy Nordic diet. Association of the baseline BSDS and changes in BSDS during the follow-up with changes in body anthropometrics were examined using linear regression analysis. The agreement between self-reported and nurse-measured anthropometrics was determined with Bland-Altman analysis. Intra-class correlation coefficients between self-reported and nurse-measured anthropometrics exceeded 0.95. The baseline BSDS associated with lower weight (beta = -0.056, P = 0.043) and BMI (beta = -0.021, P=0.031) over the follow-up. This association was especially evident among those who had increased their BSDS. In conclusion, both high initial and improved adherence to the healthy Nordic diet may promote long-term weight maintenance. The self-reported/measured anthropometrics were shown to have high agreement with nurse-measured values which adds the credibility of our results.
  • Lommi, Sohvi; Viljakainen, Heli T.; Weiderpass, Elisabete; de Oliveira Figueiredo, Rejane Augusta (2020)
    Purpose To validate the Children's Eating Attitudes Test (ChEAT) in the Finnish population. Materials and methods In total 339 children (age 10-15 years) from primary schools in Southern Finland were evaluated at two time points. They answered the ChEAT and SCOFF test questions, and had their weight, height and waist circumference measured. Retesting was performed 4-6 weeks later. Test-retest reliability was evaluated using intra-class correlation (ICC), and internal consistency was examined using Cronbach's alpha coefficient (C-alpha). ChEAT was cross-calibrated against SCOFF and background variables. Factor analysis was performed to examine the factor structure of ChEAT. Results The 26-item ChEAT showed high internal consistency (C-alpha 0.79), however, a 24-item ChEAT showed even better internal consistency (C-alpha 0.84) and test-retest reliability (ICC 0.794). ChEAT scores demonstrated agreement with SCOFF scores (p <0.01). The mean ChEAT score was higher in overweight children than normal weight (p <0.001). Exploratory factor analysis yielded four factors (concerns about weight, limiting food intake, pressure to eat, and concerns about food), explaining 57.8% of the variance. Conclusions ChEAT is a valid and reliable tool for measuring eating attitudes in Finnish children. The 24-item ChEAT showed higher reliability than the 26-item ChEAT.
  • Plikk, Anna; Engels, Stefan; Luoto, Tomi P.; Nazarova, Larisa; Salonen, J. Sakari; Helmens, Karin F. (2019)
  • Richter, Martinus; Agren, Per-Henrik; Besse, Jean-Luc; Coester, Maria; Kofoed, Hakon; Maffulli, Nicola; Steultjens, Martijn; Irgit, Kaan; Miettinen, Mikko; Repo, Jussi P.; Uygur, Esat (2020)
    Background The Score Committee of the European Foot and Ankle Society (EFAS) developed, validated, and published the EFAS Score in seven European languages (English, German, French, Italian, Polish, Dutch, Swedish). From other languages under validation, the Finnish and Turkish versions finished data acquisition and underwent further validation. Methods The EFAS Score was developed and validated in three stages: 1) item (question) identification (completed during initial validation study), 2) item reduction and scale exploration (completed during initial validation study), 3) confirmatory analyses and responsiveness of Finnish and Turkish version (completed during initial validation study in seven other languages). The data were collected pre-operatively and post-operatively at a minimum follow-up of 3 months and mean follow-up of 6 months. Item reduction, scale exploration, confirmatory analyses and responsiveness were executed using classical test theory and item response theory. Results The internal consistency of the scale was confirmed in the Finnish and Turkish versions (Cronbach's Alpha>0.8). Responsiveness was good, with moderate to large effect sizes in both languages, and evidence of a statistically significant positive association between the EFAS Score and patient-reported improvement. Conclusions The Finnish and Turkish EFAS Score versions were successfully validated in the orthopaedic ankle and foot surgery patients, including a wide variety of foot and ankle pathologies. All score versions are freely available at www.efas.co.
  • Meinila, Jelena; Valkama, Anita; Koivusalo, Saila B.; Stach-Lempinen, Beata; Lindstrom, Jaana; Kautiainen, Hannu; Eriksson, Johan G.; Erkkola, Maijaliisa (2016)
    Background: The aim was to develop and validate a food-based diet quality index for measuring adherence to the Nordic Nutrition Recommendations (NNR) in a pregnant population with high risk of gestational diabetes (GDM). Methods: This study is a part of the Finnish Gestational Diabetes Prevention Study (RADIEL), a lifestyle intervention conducted between 2008 and 2014. The 443 pregnant participants (61 % of those invited), were either obese or had a history of GDM. Food frequency questionnaires collected at 1st trimester served for composing the HFII; a sum of 11 food groups (available score range 0-17) with higher scores reflecting higher adherence to the NNR. Results: The average HFII of the participants was 10.2 (SD 2.8, range 2-17). Factor analysis for the HFII component matrix revealed three factors that explained most of the distribution (59 %) of the HFII. As an evidence of the component relevance 9 out of 11 of the HFII components independently contributed to the total score (item-rest correlation coefficients Conclusions: The HFII components reflect the food guidelines of the NNR, intakes of relevant nutrients, and characteristics known to vary with diet quality. It largely ignores energy intake, its components have independent contribution to the HFII, and it exhibits reproducibility. The main shortcomings are absence of red and processed meat component, and the validation in a selected study population. It is suitable for ranking participants according to the adherence to the NNR in pregnant women at high risk of GDM.
  • Alaraudanjoki, Viivi; Saarela, Henna; Pesonen, Reetta; Laitala, Marja-Liisa; Kiviahde, Heikki; Tjaderhane, Leo; Lussi, Adrian; Pesonen, Paula; Anttonen, Vuokko (2017)
    Objectives: To assess the reliability of the BEWE index on 3D models and to compare 3D-assessed erosive tooth wear scores with clinically detected scores. Methods: In total, 1964 members of the Northern Finland Birth Cohort 1966 participated in a standardized clinical dental examination including the Basic Erosive Wear Examination (BEWE) and dental 3D modelling at the age of 45-46 years. Of those examined, 586 were randomly selected for this study. 3D models were assessed using the same BEWE criteria as in the clinical examination. Calculated kappa values as well as the prevalence and severity of erosive wear according to the clinical examination and 3D models were compared. Re-examinations were performed to calculate intra-and inter-method and-examiner agreements. Results: The BEWE index on 3D models was reproducible; the mean intra-and inter-examiner agreement were 0.89 and 0.87, respectively, for sextant level, and 0.64 and 1, respectively, for BEWE sum scores. Erosive tooth wear was recorded as more severe in 3D models than in the clinical examination, and intermethod agreement was 0.41 for severe erosive wear (BEWE sum > 8). The biggest inter-method differences were found in upper posterior sextants. Conclusions: The BEWE index is reliable for recording erosive tooth wear on 3D models. 3D models seem to be especially sensitive in detecting initial erosive wear. Additionally, it seems that erosive wear may be underscored in the upper posterior sextants when assessed clinically. Due to the nature of 3D models, the assessment of erosive wear clinically and on 3D models may not be entirely comparable. Clinical significance: 3D models can serve as an additional tool to detect and document erosive wear, especially during the early stages of the condition and in assessing the progression of wear. When scoring erosive wear clinically, care must be taken especially when assessing upper posterior sextants. (C) 2017 Elsevier Ltd. All rights reserved.
  • Simonsen, Nina; Koponen, Anne M.; Suominen, Sakari (2018)
    Background: To meet the challenges of the rising prevalence of chronic diseases, such as type 2 diabetes, new approaches to healthcare delivery have been initiated; among these the influential Chronic Care Model (CCM). Valid instruments are needed to evaluate the public health impact of these frameworks in different countries. The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item quality of care measure that, from the perspective of the patient, measures the extent to which care is congruent with the CCM. The aim of this study was to evaluate the psychometric properties of the Finnish translation of the PACIC questionnaire, in terms of validity and reliability, in a large register-based sample of patients with type 2 diabetes. Method: The PACIC items were translated into Finnish in a standardized forward-backward procedure, followed by a cross-sectional survey among patients with type 2 diabetes (response rate 56%; n = 2866). We assessed the Finnish version of the PACIC scale for the following psychometric properties: content validity, internal consistency reliability, convergent and construct validity. We also present descriptive data on total scale as well as predetermined subscale levels. Results: The item-response on the PACIC scale was high with only small numbers of missing data (0.5-1.1%). Ceiling effects were low (0.3-5.3%) whereas floor effects were over 20% for two of the predetermined subscales (problem solving and follow-up/coordination). The total PACIC scale showed a reasonable distribution and excellent internal consistency (alpha 0.94) while the internal consistency of the subscales were at least acceptable (0.74-0.86). The principal component analysis identified a two-or three-factor solution instead of the proposed five-dimensional. In other respects, the PACIC scale showed the hypothesized relationships with quality of care and outcome measures, thus demonstrating convergent and construct validity. Conclusion: A Finnish version of the PACIC scale is now validated in the primary care setting among patients with type 2 diabetes. The findings suggest comparable psychometric properties of the Finnish scale as of the original English instrument and earlier translations, and reasonable levels of validity and reliability.
  • Simonsen, Nina; Koponen, Anne M; Suominen, Sakari (BioMed Central, 2018)
    Abstract Background To meet the challenges of the rising prevalence of chronic diseases, such as type 2 diabetes, new approaches to healthcare delivery have been initiated; among these the influential Chronic Care Model (CCM). Valid instruments are needed to evaluate the public health impact of these frameworks in different countries. The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item quality of care measure that, from the perspective of the patient, measures the extent to which care is congruent with the CCM. The aim of this study was to evaluate the psychometric properties of the Finnish translation of the PACIC questionnaire, in terms of validity and reliability, in a large register-based sample of patients with type 2 diabetes. Method The PACIC items were translated into Finnish in a standardized forward-backward procedure, followed by a cross-sectional survey among patients with type 2 diabetes (response rate 56%; n = 2866). We assessed the Finnish version of the PACIC scale for the following psychometric properties: content validity, internal consistency reliability, convergent and construct validity. We also present descriptive data on total scale as well as predetermined subscale levels. Results The item-response on the PACIC scale was high with only small numbers of missing data (0.5–1.1%). Ceiling effects were low (0.3–5.3%) whereas floor effects were over 20% for two of the predetermined subscales (problem solving and follow-up/coordination). The total PACIC scale showed a reasonable distribution and excellent internal consistency (alpha 0.94) while the internal consistency of the subscales were at least acceptable (0.74–0.86). The principal component analysis identified a two- or three-factor solution instead of the proposed five-dimensional. In other respects, the PACIC scale showed the hypothesized relationships with quality of care and outcome measures, thus demonstrating convergent and construct validity. Conclusion A Finnish version of the PACIC scale is now validated in the primary care setting among patients with type 2 diabetes. The findings suggest comparable psychometric properties of the Finnish scale as of the original English instrument and earlier translations, and reasonable levels of validity and reliability.
  • Tiirikainen, Kati; Haravuori, Henna; Ranta, Klaus; Kaltiala-Heino, Riittakerttu; Marttunen, Mauri (2019)
    Symptoms of generalized anxiety disorder (GAD) are common among adolescents and can lead to severe psychosocial impairment, yet there is a lack of a good quality scale to measure symptoms of generalized anxiety in young people. The 7-item Generalized Anxiety Disorder Scale (GAD-7) is a self-report scale used to measure GAD symptoms and has been validated in adult populations, but the measures psychometric properties regarding adolescents are unknown. The aim of this study was to investigate the reliability, factorial validity, and construct validity of the GAD-7 in adolescents in a nationally representative sample from a general population. Our study was based on Finnish survey data on 111,171 adolescents aged 14-18 years. Our results show that the GAD-7 demonstrates good psychometric properties in adolescents. The internal consistency of the GAD-7 was good (Cronbach's alpha = 0.91) and the instrument's unidimensional factor structure was supported. The associations of GAD-7 sum scores with self-report measures of depression and social anxiety supported construct validity. The psychometric properties of the GAD-7 in this sample of adolescents were similar to those reported among adults. However, studies in which diagnostic interviews are performed are needed to demonstrate the diagnostic efficacy of the measure in this age group.
  • Unemo, Magnus; Hansen, Marit; Hadad, Ronza; Puolakkainen, Mirja; Westh, Henrik; Rantakokko-Jalava, Kaisu; Thilesen, Carina; Cole, Michelle J; Boiko, Iryna; Lan, Pham T; Golparian, Daniel; Ito, Shin; Sundqvist, Martin (BioMed Central, 2020)
    Abstract Background Four new variants of Chlamydia trachomatis (nvCTs), detected in several countries, cause false-negative or equivocal results using the Aptima Combo 2 assay (AC2; Hologic). We evaluated the clinical sensitivity and specificity, as well as the analytical inclusivity and exclusivity of the updated AC2 for the detection of CT and Neisseria gonorrhoeae (NG) on the automated Panther system (Hologic). Methods We examined 1004 clinical AC2 samples and 225 analytical samples spiked with phenotypically and/or genetically diverse NG and CT strains, and other potentially cross-reacting microbial species. The clinical AC2 samples included CT wild type (WT)-positive (n = 488), all four described AC2 diagnostic-escape nvCTs (n = 170), NG-positive (n = 214), and CT/NG-negative (n = 202) specimens. Results All nvCT-positive samples (100%) and 486 (99.6%) of the CT WT-positive samples were positive in the updated AC2. All NG-positive, CT/NG-negative, Trichomonas vaginalis (TV)-positive, bacterial vaginosis-positive, and Candida-positive AC2 specimens gave correct results. The clinical sensitivity and specificity of the updated AC2 for CT detection was 99.7 and 100%, respectively, and for NG detection was 100% for both. Examining spiked samples, the analytical inclusivity and exclusivity were 100%, i.e., in clinically relevant concentrations of spiked microbe. Conclusions The updated AC2, including two CT targets and one NG target, showed a high sensitivity, specificity, inclusivity and exclusivity for the detection of CT WT, nvCTs, and NG. The updated AC2 on the fully automated Panther system offers a simple, rapid, high-throughput, sensitive, and specific diagnosis of CT and NG, which can easily be combined with detection of Mycoplasma genitalium and TV.
  • Unemo, Magnus; Hansen, Marit; Hadad, Ronza; Puolakkainen, Mirja; Westh, Henrik; Rantakokko-Jalava, Kaisu; Thilesen, Carina; Cole, Michelle J.; Boiko, Iryna; Lan, Pham T.; Golparian, Daniel; Ito, Shin; Sundqvist, Martin (2020)
    Background Four new variants ofChlamydia trachomatis(nvCTs), detected in several countries, cause false-negative or equivocal results using the Aptima Combo 2 assay (AC2; Hologic). We evaluated the clinical sensitivity and specificity, as well as the analytical inclusivity and exclusivity of the updated AC2 for the detection of CT andNeisseria gonorrhoeae(NG) on the automated Panther system (Hologic). Methods We examined 1004 clinical AC2 samples and 225 analytical samples spiked with phenotypically and/or genetically diverse NG and CT strains, and other potentially cross-reacting microbial species. The clinical AC2 samples included CT wild type (WT)-positive (n = 488), all four described AC2 diagnostic-escape nvCTs (n = 170), NG-positive (n = 214), and CT/NG-negative (n = 202) specimens. Results All nvCT-positive samples (100%) and 486 (99.6%) of the CT WT-positive samples were positive in the updated AC2. All NG-positive, CT/NG-negative,Trichomonas vaginalis(TV)-positive, bacterial vaginosis-positive, andCandida-positive AC2 specimens gave correct results. The clinical sensitivity and specificity of the updated AC2 for CT detection was 99.7 and 100%, respectively, and for NG detection was 100% for both. Examining spiked samples, the analytical inclusivity and exclusivity were 100%, i.e., in clinically relevant concentrations of spiked microbe. Conclusions The updated AC2, including two CT targets and one NG target, showed a high sensitivity, specificity, inclusivity and exclusivity for the detection of CT WT, nvCTs, and NG. The updated AC2 on the fully automated Panther system offers a simple, rapid, high-throughput, sensitive, and specific diagnosis of CT and NG, which can easily be combined with detection ofMycoplasma genitaliumand TV.
  • Wu, Teddy Y.; Sobowale, Oluwaseun; Hurford, Robert; Sharma, Gagan; Christensen, Soren; Yassi, Nawaf; Tatlisumak, Turgut; Desmond, Patricia M.; Campbell, Bruce C. V.; Davis, Stephen M.; Parry-Jones, Adrian R.; Meretoja, Atte (2016)
    Haematoma and oedema size determines outcome after intracerebral haemorrhage (ICH), with each added 10 % volume increasing mortality by 5 %. We assessed the reliability of semi-automated computed tomography planimetry using Analyze and Osirix softwares. We randomly selected 100 scans from 1329 ICH patients from two centres. We used Hounsfield Unit thresholds of 5-33 for oedema and 44-100 for ICH. Three raters segmented all scans using both softwares and 20 scans repeated for intra-rater reliability and segmentation timing. Volumes reported by Analyze and Osirix were compared to volume estimates calculated using the best practice method, taking effective individual slice thickness, i.e. voxel depth, into account. There was excellent overall inter-rater, intra-rater and inter-software reliability, all intraclass correlation coefficients > 0.918. Analyze and Osirix produced similar haematoma (mean difference: Analyze -aEuroeOsirix = 1.5 +/- 5.2 mL, 6 %, p aecurrency signaEuroe0.001) and oedema volumes (-0.6 +/- 12.6 mL, -3 %, p = 0.377). Compared to a best practice approach to volume calculation, the automated haematoma volume output was 2.6 mL (-11 %) too small with Analyze and 4.0 mL (-18 %) too small with Osirix, whilst the oedema volumes were 2.5 mL (-12 %) and 5.5 mL (-25 %) too small, correspondingly. In scans with variable slice thickness, the volume underestimations were larger, -29%/-36 % for ICH and -29 %/-41 % for oedema. Mean segmentation times were 6:53 +/- 4:02 min with Analyze and 9:06 +/- 5:24 min with Osirix (p <0.001). Our results demonstrate that the method used to determine voxel depth can influence the final volume output markedly. Results of clinical and collaborative studies need to be considered in the context of these methodological differences.
  • Myllyaho, Lalli Santeri; Raatikainen, Mikko; Männistö, Tomi; Mikkonen, Tommi; Nurminen, Jukka K (2021)
    Context: Artificial intelligence (AI) has made its way into everyday activities, particularly through new techniques such as machine learning (ML). These techniques are implementable with little domain knowledge. This, combined with the difficulty of testing AI systems with traditional methods, has made system trustworthiness a pressing issue. Objective: This paper studies the methods used to validate practical AI systems reported in the literature. Our goal is to classify and describe the methods that are used in realistic settings to ensure the dependability of AI systems. Method: A systematic literature review resulted in 90 papers. Systems presented in the papers were analysed based on their domain, task, complexity, and applied validation methods. Results: The validation methods were synthesized into a taxonomy consisting of trial, simulation, model-centred validation, and expert opinion. Failure monitors, safety channels, redundancy, voting, and input and output restrictions are methods used to continuously validate the systems after deployment. Conclusions: Our results clarify existing strategies applied to validation. They form a basis for the synthesization, assessment, and refinement of AI system validation in research and guidelines for validating individual systems in practice. While various validation strategies have all been relatively widely applied, only few studies report on continuous validation.
  • Hallanvuo, S.; Herranen, M.; Jaakkonen, A.; Nummela, M.; Ranta, J.; Botteldoorn, N.; De Zutter, L.; Fredriksson-Ahomaa, M.; Hertwig, S.; ohannessen, G.S.; Ludewig, M.; Messelhäußer, U.; Sigvart-Mattila, P.; Thisted-Lambertz, S.; Thure, T.; Vatunen, E.; Interlaboratory study group (Elsevier, 2018)
    EN ISO 10273 method for the detection of pathogenic Yersinia enterocolitica in foods was validated in the project Mandate M/381 funded by European Commission. A total of 14 laboratories from five European countries participated in the interlaboratory study (ILS) organized during 2013 and 2014. Before the ILS, the method was revised by an international group of experts and the performance of the revised method was assessed in an ILS study. The results are published as a part of the standard EN ISO 10273 revision. The study included three rounds with different sample types; raw milk, iceberg lettuce and minced meat, inoculated with a low and high level of pathogenic Y. enterocolitica strains representing major pathogenic bioserotypes 4/O:3 and 2/O:9. The homogeneity and stability of the samples were verified before dispatching them to the laboratories. The results demonstrated the method sensitivity of 96% in raw milk, 97% in minced meat, and 98% in lettuce at high inoculation level of pathogenic Y. enterocolitica. The specificity was 100% in raw milk, 96% in minced meat, and 98% in lettuce. The level of detection, LOD50, varied between study rounds, being 9.4 CFU/25 ml in raw milk, 9.9 CFU/25 g in minced meat and 63 CFU/25 g in lettuce samples. During the study, confirmation by using real-time PCR method ISO/TS 18867 together with pyrazinamidase testing was also validated, as alternative to conventional biochemical confirmation. When comparing different isolation steps used in the revised method during the study rounds, PSB enrichment and plating on CIN after alkaline (KOH) treatment showed the highest sensitivity (52–92%) in raw milk and minced meat samples. In lettuce samples, however, ITC with KOH treatment before plating on CIN showed higher sensitivity (64% at low level; 82% at high level) than plating on CIN from PSB with KOH treatment (44% at low level; 74% at high level). Statistical analysis of different isolation steps supported the use of two enrichment media, PSB and ITC, in the revised method. Recovery of pathogenic Y. enterocolitica on CIN was most efficient after KOH treatment and, based on the analysis, plating on CIN agar without KOH treatment could be left as optional procedure in the method.
  • Interlab Study Grp; Hallanvuo, Saija; Herranen, Mirkka; Jaakkonen, Anniina; Nummela, Maria; Ranta, Jukka; Botteldoornl, Nadine; De Zutter, Lieven; Fredriksson-Ahomaa, Maria; Hertwig, Stefan; Johannessen, Gro S.; Ludewig, Martina; Messelhaeusser, Ute; Sigvart-Mattila, Pia; Thisted-Lambertz, Susanne; Thure, Tiina; Vatunen, Elina (2019)
    EN ISO 10273 method for the detection of pathogenic Yersinia enterocolitica in foods was validated in the project Mandate M/381 funded by European Commission. A total of 14 laboratories from five European countries participated in the interlaboratory study (ILS) organized during 2013 and 2014. Before the ITS, the method was revised by an international group of experts and the performance of the revised method was assessed in an ILS study. The results are published as a part of the standard EN ISO 10273 revision. The study included three rounds with different sample types; raw milk, iceberg lettuce and minced meat, inoculated with a low and high level of pathogenic Y. enterocolitica strains representing major pathogenic bioserotypes 4/O:3 and 2/O:9. The homogeneity and stability of the samples were verified before dispatching them to the laboratories. The results demonstrated the method sensitivity of 96% in raw milk, 97% in minced meat, and 98% in lettuce at high inoculation level of pathogenic Y. enterocolitica. The specificity was 100% in raw milk, 96% in minced meat, and 98% in lettuce. The level of detection, LOD50, varied between study rounds, being 9.4 CFU/25 ml in raw milk, 9.9 CFU/25 g in minced meat and 63 CFU/25 g in lettuce samples. During the study, confirmation by using real-time PCR method ISO/TS 18867 together with pyrazinamidase testing was also validated, as alternative to conventional biochemical confirmation. When comparing different isolation steps used in the revised method during the study rounds, PSB enrichment and plating on CIN after alkaline (KOH) treatment showed the highest sensitivity (52-92%) in raw milk and minced meat samples. In lettuce samples, however, ITC with KOH treatment before plating on CIN showed higher sensitivity (64% at low level; 82% at high level) than plating on CIN from PSB with KOH treatment (44% at low level; 74% at high level). Statistical analysis of different isolation steps supported the use of two enrichment media, PSB and ITC, in the revised method. Recovery of pathogenic Y. enterocolitica on ON was most efficient after KOH treatment and, based on the analysis, plating on CIN agar without KOH treatment could be left as optional procedure in the method.
  • ReACCh-Out NoSPeR Investigators; Rypdal, Veronika (2019)
    Background: Models to predict disease course and long-term outcome based on clinical characteristics at disease onset may guide early treatment strategies in juvenile idiopathic arthritis (JIA). Before a prediction model can be recommended for use in clinical practice, it needs to be validated in a different cohort than the one used for building the model. The aim of the current study was to validate the predictive performance of the Canadian prediction model developed by Guzman et al. and the Nordic model derived from Rypdal et al. to predict severe disease course and non-achievement of remission in Nordic patients with JIA. Methods: The Canadian and Nordic multivariable logistic regression models were evaluated in the Nordic JIA cohort for prediction of non-achievement of remission, and the data-driven outcome denoted severe disease course. A total of 440 patients in the Nordic cohort with a baseline visit and an 8-year visit were included. The Canadian prediction model was first externally validated exactly as published. Both the Nordic and Canadian models were subsequently evaluated with repeated fine-tuning of model coefficients in training sets and testing in disjoint validation sets. The predictive performances of the models were assessed with receiver operating characteristic curves and C-indices. A model with a C-index above 0.7 was considered useful for clinical prediction. Results: The Canadian prediction model had excellent predictive ability and was comparable in performance to the Nordic model in predicting severe disease course in the Nordic JIA cohort. The Canadian model yielded a C-index of 0.85 (IQR 0.83-0.87) for prediction of severe disease course and a C-index of 0.66 (0.63-0.68) for prediction of non-achievement of remission when applied directly. The median C-indices after fine-tuning were 0.85 (0.80-0.89) and 0.69 (0.65-0.73), respectively. Internal validation of the Nordic model for prediction of severe disease course resulted in a median C-index of 0.90 (0.86-0.92). Conclusions: External validation of the Canadian model and internal validation of the Nordic model with severe disease course as outcome confirm their predictive abilities. Our findings suggest that predicting long-term remission is more challenging than predicting severe disease course.
  • Rypdal, Veronika; Guzman, Jaime; Henrey, Andrew; Loughin, Thomas; Glerup, Mia; Arnstad, Ellen D; Aalto, Kristiina; Rygg, Marite; Nielsen, Susan; Herlin, Troels; Fasth, Anders; Berntson, Lillemor; Rypdal, Martin; Nordal, Ellen (BioMed Central, 2019)
    Abstract Background Models to predict disease course and long-term outcome based on clinical characteristics at disease onset may guide early treatment strategies in juvenile idiopathic arthritis (JIA). Before a prediction model can be recommended for use in clinical practice, it needs to be validated in a different cohort than the one used for building the model. The aim of the current study was to validate the predictive performance of the Canadian prediction model developed by Guzman et al. and the Nordic model derived from Rypdal et al. to predict severe disease course and non-achievement of remission in Nordic patients with JIA. Methods The Canadian and Nordic multivariable logistic regression models were evaluated in the Nordic JIA cohort for prediction of non-achievement of remission, and the data-driven outcome denoted severe disease course. A total of 440 patients in the Nordic cohort with a baseline visit and an 8-year visit were included. The Canadian prediction model was first externally validated exactly as published. Both the Nordic and Canadian models were subsequently evaluated with repeated fine-tuning of model coefficients in training sets and testing in disjoint validation sets. The predictive performances of the models were assessed with receiver operating characteristic curves and C-indices. A model with a C-index above 0.7 was considered useful for clinical prediction. Results The Canadian prediction model had excellent predictive ability and was comparable in performance to the Nordic model in predicting severe disease course in the Nordic JIA cohort. The Canadian model yielded a C-index of 0.85 (IQR 0.83–0.87) for prediction of severe disease course and a C-index of 0.66 (0.63–0.68) for prediction of non-achievement of remission when applied directly. The median C-indices after fine-tuning were 0.85 (0.80–0.89) and 0.69 (0.65–0.73), respectively. Internal validation of the Nordic model for prediction of severe disease course resulted in a median C-index of 0.90 (0.86–0.92). Conclusions External validation of the Canadian model and internal validation of the Nordic model with severe disease course as outcome confirm their predictive abilities. Our findings suggest that predicting long-term remission is more challenging than predicting severe disease course.
  • de la Fuentes, Javier; Cabello, Maria; Levola, Jonna; Felix Caballero, Francisco; Luis Ayuso-Mateos, Jose; Pitkänen, Tuuli (2018)
    Objectives: Psychosocial difficulties (PSDs) are common in people with substance use disorders (SUDs). The PARADISE24 has been shown to be an adequate tool for measuring PSDs in inpatients with SUDs. The aim of this study is to evaluate the psychometric properties of the PARADISE24 in a sample of patients with SUDs. Methods: 2637 participants with SUDs completed the PARADISE24 questionnaire during their treatment. The latent structure of the PARADISE24 questionnaire was analyzed in the outpatient sample by means of exploratory and confirmatory factor analysis (EFA and CFA). Metric invariance was then assessed in relation to the inpatient sample using multiple group CFA. Finally, evidences of known-groups validity were checked to test the ability of the questionnaire to differentiate between socio-demographic and clinical groups. Results: The one-factor model presented an adequate fit in both the EFA (CFI = 0.98; TLI = 0.98; RMSEA = 0.07) and the CFA (CFI = 0.98; TLI = 0.98; RMSEA = 0.07) solutions. The reliability of the scale was found to be high (alpha = 0.93). Strict metric invariance between inpatients and outpatients was achieved (RMSEA = 0.063; TLI = 0.983; CFI = 0.981). The PARADISE24 was able to discriminate between the inpatients and outpatients at both latent (d = 0.98) and observed levels (d = 0.86). Conclusions: The PARADISE24 is a unidimensional tool that is reliable for assessing and comparing PSDs in both outpatients and inpatients with SUDs. Further research is required for evaluating the ability of the PARADISE24 to quantify longitudinal changes in PSDs.