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This study evaluated the accuracy of synthetic computed tomography (sCT), as compared to CT, for the 3D assessment of the hip morphology. Thirty male patients with asymptomatic hips, referred for magnetic resonance (MR) imaging and CT, were included in this retrospective study. sCT images were generated from three-dimensional radiofrequency-spoiled T1-weighted multi-echo gradient-echo MR images using a commercially available deep learning-enabled software and were compared with CT images through mean error and surface distance computation and by means of eight clinical morphometric parameters relevant for hip care. Parameters included center-edge angle (CEA), sharp angle, acetabular index, extrusion index, femoral head center-to-midline distance, acetabular version (AV), and anterior and posterior acetabular sector angles. They were measured by two senior orthopedic surgeons and a radiologist in-training on CT and sCT images. The reliability and agreement of CT- and sCT-based measurements were assessed using intraclass correlation coefficients (ICCs) for absolute agreement, Bland-Altman plots, and two one-sided tests for equivalence. The surface distance between CT- and sCT-based bone models were on average submillimeter. CT- and sCT-based measurements showed moderate to excellent interobserver and intraobserver correlation (0.56 0.75). For CEA, the intraobserver agreement was good (ICC > 0.75) and the interobserver agreement was moderate (ICC > 0.69). Limits of agreements were similar between intraobserver CT and intermodal measurements. All measurements were found statistically equivalent, with average intermodal differences within the intraobserver limits of agreement. In conclusion, sCT and CT were equivalent for the assessment of the hip joint bone morphology.

Purpose The Australian prisoner population has experienced a dramatic increase in the number of older inmates over the past decade, consistent with the greying of the prisoner population that is being observed worldwide. Reviews suggest the need for further evidence and practice outside of the USA. This paper aims to review and discuss the cost and social implications of the rising health-care needs of this population in Australia. Design/methodology/approach A review of international research and policies is presented, as well as the results of basic economic modelling relating to the expected rise in health-care costs of the ageing prisoner population in Australia. Findings Taking into consideration the continued rise in incarceration rates, the calculations show that the health costs of prisoners could increase by anywhere between 17% and 90% depending on whether the increase of older prisoners continues as it has in the past decade. These trends are likely to continue over the next decade and will result in higher health costs of prisons under a number of different imprisonment scenarios. Policy responses in Australia have been slow so far, with most initiatives being undertaken in the USA with promising results. Practical implications The authors suggest that in the absence of a coordinated policy response, covering a range of interventions, costs will continue to increase, particularly as this population continues to age more rapidly than the general population due to an accumulation of risk factors. Well-conceived interventions would be a worthwhile investment from both financial and social perspectives. Originality/value To the best of the authors’ knowledge, this is the first commentary to acknowledge this rising public health issue and to both review and model its implications for the future.

Background Dynamic myocardial CT perfusion (CTP) has emerged as a potential strategy to combine anatomical and functional evaluation in a single modality. However, this method results in a high radiation dose. Methods Dynamic CTP was performed in 56 patients with suspected or known ischemic heart disease of whom 48 had complete CT-data. Datasets with reduced sampling rate of 2- and 3 RR-intervals (2RR and 3RR) were constructed post hoc. Myocardial blood flow (MBF) estimates from the 2RR and 3RR datasets were compared with estimates based on the full dataset (1RR) using the two one-sided test of equivalence for paired samples. Results Significant equivalence was found for rest MBFLV (p ​ Conclusion MBF can be quantitated with dynamic CTP using a sampling strategy of one volume for every second heartbeat. This strategy could lead to a significant reduction in radiation dose.

Background In Brazil, there are no instruments available to measure the presence, frequency, severity and distress related to heart failure (HF) symptoms. Aims To adapt the Symptom Status Questionnaire - HF (SSQ-HF) into Brazilian Portuguese and to examine the content validity of the adapted version. Methods The instrument was translated, back-translated and evaluated by an expert committee for semantic, idiomatic, cultural, and conceptual equivalences. An agreement ≥80% was considered adequate. The adapted version was evaluated by both an expert committee (n = 9) for clarity, theoretical relevance and practical relevance (acceptable content validity coefficient (CVC): ≥0.70), and by a patient committee regarding understanding (n = 40). Results The adapted version obtained 100% agreement regarding the equivalences. The total instrument CVC was 0.99. All patients understood the items. Conclusion The SSQ-HF-Brazilian version has satisfactory evidence of equivalence and content validity. Additional psychometric tests are deemed to confirm that the instrument can be used in Brazil.

This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC0–inf); AUC from time zero to the last quantifiable concentration (AUC0–last); and maximum serum concentration (Cmax). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC0–inf, AUC0–last, and Cmax were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars.

AIMS To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT-P17 administered via autoinjector (CT-P17 AI) or prefilled syringe (CT-P17 PFS) in healthy subjects. METHODS This phase I, open-label study (ClinicalTrials.gov: NCT04295356) randomised subjects (1:1) to receive a single 40-mg (100 mg/mL) dose of CT-P17 AI or CT-P17 PFS. Primary endpoint was pharmacokinetic equivalence of CT-P17 AI to CT-P17 PFS for: area under the concentration-time curve from time zero to infinity (AUC0-inf ); area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last ); maximum serum concentration (Cmax ). Equivalence was determined if the 90% confidence interval for the geometric least-squares mean ratio was within the 80-125% equivalence margin. Additional pharmacokinetic endpoints, safety and immunogenicity were evaluated. RESULTS Of 193 subjects who were randomised (98 CT-P17 AI; 95 CT-P17 PFS), 180 received study drug. Pharmacokinetic equivalence was demonstrated: 90% confidence intervals were within the 80-125% equivalence margin (AUC0-inf : 93.98-114.29; AUC0-last : 91.09-121.86; Cmax : 94.08-111.90). Mean serum CT-P17 concentrations, secondary pharmacokinetic parameters and numbers of subjects with antidrug antibodies (ADAs) or neutralising ADAs were comparable between groups. AUC0-inf , AUC0-last and Cmax were numerically lower for ADA-positive than for ADA-negative subjects (both groups); pharmacokinetic equivalence was also demonstrated among ADA-positive subjects. CT-P17 AI and CT-P17 PFS were well tolerated, with comparable overall safety profiles. CONCLUSIONS CT-P17 AI and CT-P17 PFS were pharmacokinetically equivalent. Overall safety and immunogenicity were comparable between the 2 delivery devices.

Cross-cultural equivalence, country and gender differences, and external relations with other measures were examined on a new, brief measure of test anxiety, the Test Anxiety Measure for College Students-Short Form (TAMC-SF), in a sample of Canadian and US higher education students. The sample of 1204 students completed the TAMC-SF and other measures online. The results of tests of invariance found support for partial scalar invariance across country and gender on the TAMC-SF. In addition, results of a multivariate analysis of variance (MANOVA) and analysis of variances (ANOVAs) found country and gender differences on the TAMC-SF scales. Furthermore, validity evidence for the TAMC-SF scores with the scores of external measures was found. Overall, the findings support the use of the same test score interpretation for Canadian and US higher education students on the TAMC-SF and the use of the TAMC-SF in Canadian higher education students.

Background The English version of the FACE-Q rhinoplasty module, developed according to Rasch measurement theory, has recently been translated into Dutch. Before conclusions can be drawn from the Dutch version, this translation must also fit the item analysis by the Rasch model. Objectives The primary aim of this study was to evaluate cross-cultural equivalence between the Dutch and English versions of the FACE-Q rhinoplasty module by applying Rasch methodology. Methods Rasch analysis performed with Winsteps (Beaverton, OR) was used to evaluate the Dutch version of the FACE-Q nose and nostrils scales with data from a prospective consecutive cohort of 100 Dutch-speaking septorhinoplasty patients. New Dutch-related conversion tables were constructed for the FACE-Q nose and nostrils scales and compared to the original ones. Psychometric cross-validation was performed by receiver operating characteristics (ROC) analysis. Results Both questionnaires adequately met the requirement of invariance. Within an acceptable range, some issues with item and person fit were found, as well as some local item dependency and differential item functioning. However, comparison of the Dutch- and English-related conversion tables by ROC analysis demonstrated identical results for the FACE-Q nose and nostrils scales. Conclusions Item analysis by the Rasch model on the data of a Dutch-speaking population proved the conceptual correspondence with the original English version.

Cadmium-zinc-telluride (CZT) SPECT/CT cameras with large field of view offer a higher sensitivity than conventional Anger cameras. This prospective study aimed to determine the equivalence between a conventional protocol and a reduced acquisition time protocol for 201-Thallium myocardial perfusion imaging (MPI) using a whole-body CZT SPECT camera. Stress MPI was obtained for 103 consecutive patients on a DISCOVERY-CZT camera. Images were anonymized and post-processed to simulate a 25% (D75 dataset) and 50% (D50 dataset) decrease in total recorded counts. Concerning the number of segments displaying a tracer uptake

Objective To test for equivalence between providers with and without advanced degrees in multiple domains related to delivery of evidence-based treatment. Data source Provider and client data from an effectiveness trial of Alternatives for Families: A Cognitive Behavioral Therapy (AF-CBT) in a major metropolitan area in the United States. Study design We tested for equivalence between providers (N = 182) with and without advanced degrees in treatment-related knowledge, practices, and attitudes; job demands and stress; and training engagement and trainer-rated competence in AF-CBT. We also conducted exploratory analyses to test for equivalence in family clinical outcomes. Data collection Providers completed measures prior to randomization and at 6-month follow-up, after completion of training and consultation in AF-CBT. Children and caregivers completed assessments at 0, 6, 12, and 18 months. Principal findings Providers without advanced degrees were largely non-inferior to those with advanced degrees in treatment-related knowledge, practices, and attitudes, while findings for job demands and stress were mixed. Providers without advanced degrees were non-inferior to providers with advanced degrees in consultation attendance (B = -1.42; confidence interval (CI) = -3.01-0.16; margin of equivalence (Δ) = 2), number of case presentations (B = 0.64; CI = -0.49-1.76; Δ = 2), total training hours (B = -4.57; CI = -10.52-1.37; Δ = 3), and trainer-rated competence in AF-CBT (B = -0.04; CI = -3.04-2.96; Δ = 4), and they were significantly more likely to complete training (odds ratio = 0.66; CI = 0.10-0.96; Δ = 30%). Results for clinical outcomes were largely inconclusive. Conclusions Provider-level outcomes for those with and without advanced degrees were generally comparable. Additional research is needed to examine equivalence in clinical outcomes. Expanding evidence-based treatment training to individuals without advanced degrees may help to reduce workforce shortages and improve reach of evidence-based treatments.

Highlights • Different trial types require different sample size calculation and interpretation. • Statistical modeling may help to minimize confounding effects and bias. • Statistical pitfalls can be avoided by following correct statistical guidance., Purpose To facilitate understanding statistical principles and methods for clinicians involved in cancer research. Methods An overview of study design is provided on cancer research for both observational and clinical trials addressing study objectives and endpoints, superiority tests, non-inferiority and equivalence design, and sample size calculation. The principles of statistical models and tests including contemporary standard methods of analysis and evaluation are discussed. Finally, some statistical pitfalls frequently evident in clinical and translational studies in cancer are discussed. Results We emphasize the practical aspects of study design (superiority vs non-inferiority vs equivalence study) and assumptions underpinning power calculations and sample size estimation. The differences between relative risk, odds ratio, and hazard ratio, understanding outcome endpoints, purposes of interim analysis, and statistical modeling to minimize confounding effects and bias are also discussed. Conclusion Proper design and correctly constructed statistical models are critical for the success of cancer research studies. Most statistical inaccuracies can be minimized by following essential statistical principles and guidelines to improve quality in research studies.

Objectives Resources for care among women are crucial for children’s growth and development. The objectives of this cross-sectional study were to determine if: (1) the factor structure of measures of maternal resources for care was comparable across countries and consistent with the theoretical constructs and (2) the measures showed equivalence across contexts. Methods The study included 4400, 4029 and 2746 women from Bangladesh, Vietnam, and Ethiopia, respectively. The measures of resources for care were maternal education, knowledge, height, body mass index, mental well-being, financial autonomy, decision-making, employment, support in chores, and perceived support. Results The factor analysis demonstrated that a two-factor solution best explained the structure of resources for care in all three countries. The first factor was associated with financial autonomy and employment in all three countries and with decision-making in two countries. The second factor was associated with education and knowledge in all three countries. The measures of resources for care had measurement equivalence across countries. Conclusion for Practice Resources for care were structurally similar and measurement equivalent across countries and can be used for measurement in low- and middle-income countries. Additional work examining the structure and cross-context equivalence of resources for care in other settings is warranted.

Contains fulltext : 236666.pdf (Publisher’s version ) (Open Access) Changes from traditional face-to-face to internet-delivered psychological assessment are urgently needed given the long-lasting pandemic, the general need for fast and efficient tests and test procedures, and easier availability and access for test-takers in remote settings. We used a quasi-experimental non-randomized group design for the comparison of two word fluency test procedures: one traditional that is face-to-face (n = 30) and one supervised via internet (n = 30). Participants were 17-31 years, education level high school and Bachelor. The letters S, K, T were used for the phonemic fluency test, for the emotion word fluency test subjects had to generate words related to subjective emotional feelings or the expression of emotions. The results showed that traditional administered and internet-delivered testing are equivalent (our hypothesis) as seen from the absence of significant differences between the two groups in the performances of all four word fluency tests (p > .05) and small effect sizes (Cohen's d range < .5). Significant correlations were found between the fluency tasks, irrespective of the way of test administration (p < .05). It can be concluded that the word fluency tasks can be assessed by supervised internet-delivered testing, but this is limited to a sample of young adults. 15 p.

Background General equivalence mappings (GEMs) were developed to facilitate a transition from International Classification of Diseases, Ninth Revision (ICD-9) to ICD, Tenth Revision (ICD-10). Validation of GEMs is suggested as coding errors have been reported for adult populations. The purpose of this study was to illustrate limitations of the GEMs for pediatric surgical procedures. Methods Using the 2014 to 2016 National Inpatient Sample, we evaluated all patients undergoing inguinal hernia repair. ICD-9 codes for the repair were independently classified as laparoscopic or open approach by two surgeons. Conversions of the ICD-9 to ICD-10 codes were compared between the GEMs strategy and surgeons' manual mapping. National trends were compared for overall, adult, and pediatric populations. Results We found significant inconsistencies in the proportion of laparoscopic inguinal hernia repair based on mapping strategies employed. For adults, the comparison of the proportions in 2016 was 17.79% (GEMs) versus 21.44% (Manual). In pediatric population, the contrast was 0.45% (GEMs) versus 17.75% (Manual), and no laparoscopic repair cases were found using GEMs in the last quarter of 2015. Conclusion Some conversions of ICD-9 and ICD-10 using the current GEMs are not valid for certain populations and procedures. Clinical validation of coding conversions is essential. Level of evidence Level V.

The objectives of this study were to evaluate the cross-cultural measurement equivalence of the Healthy Eating Index (HEI) for children aged 1–2 years and to analyse the quality of nutrition of preterm infants. This was a cross-sectional study with 106 premature infants attended in two specialised outpatient clinics of university hospitals. The quality of the diet was analysed through an adapted HEI to meet the dietary recommendations of Brazilian children aged 1–2 years. Food consumption was measured by 24-h recalls. The reliability of the instrument was evaluated by internal consistency analysis and inter-observer reliability using Cronbach’s α coefficient and κ with quadratic ponderation. The construct validity was evaluated by principal component analysis and by Spearman’s correlation coefficient with total energy and consumption of some groups’ food. The diet quality was considered adequate when the total HEI score was over 80 points. Cronbach’s α was 0·54. Regarding inter-observer reliability, ten items showed strong agreement (κ > 0·8). The item scores had low correlations with energy consumed (r ≤ 0·30), and positive and moderate correlation of fruit (r 0·67), meat (r 0·60) and variety of diet (r 0·57) with total scores. When analysing the overall quality of the diet, most patients need improvement (median 78·7 points), which can be attributed to low total vegetable intake and the presence of ultraprocessed foods in the diet. The instrument showed auspicious psychometric properties, being promising to evaluate the quality of the diet in children aged 1–2 years.

The randomized controlled trial (RCT) is considered the best interventional design to assess issues related to treatment and prevention. The RCTs can have different designs including superiority, equivalence, or non-inferiority design. A superiority trial aims to detect the potential superiority of new therapy compared to an active comparator or a placebo, an equivalence trial tends to demonstrate that a new therapy is an equivalent (within margins) to its active comparator, and a non-inferiority trial (NIT) is going to show that the new therapy is not worse than the comparator, as a typical active drug. Increasingly, major trials are conducted to see if the efficacy of a new treatment is as good as a standard treatment. The new treatment usually has some other advantages (e.g., fewer side effects, ease of administration, lower cost), making it worthwhile to demonstrate non-inferiority in respect to efficacy. Thus, NIT is going to determine whether a new treatment is not worse than a reference treatment by more than an acceptable amount. Among the challenges of NITs compared with superiority, trials are the choices of the non-inferiority margin (NIM), the primary population for analysis, and the comparator treatment considering several choices for the comparator arm in an NIT. This article is going to review the current knowledge about NIM.

Because of structural complexity, a “biosimilar” will not be exactly the same as its reference biologic treatment, but is required to be equivalent in all relevant attributes, including efficacy. T...

Objective The suggested high costs of endovascular aneurysm repair (EVAR) hamper the choice of insurance companies and financial regulators for EVAR as the primary option for elective abdominal aortic aneurysm (AAA) repair. However, arguments used in this debate are impeded by time related aspects such as effect modification and the introduction of confounding by indication, and by asymmetric evaluation of outcomes. Therefore, a re-evaluation minimising the impact of these interferences was considered. Methods A comparative analysis was performed evaluating a period of exclusive open repair (OR; 1998–2000) and a period of established EVAR (2010–2012). Data from four hospitals in The Netherlands were collected to estimate resource use. Actual costs were estimated by benchmark cost prices and a literature review. Costs are reported at 2019 prices. A break even approach, defining the costs for an endovascular device at which cost equivalence for EVAR and OR is achieved, was applied to cope with the large variation in endovascular device costs. Results One hundred and eighty-six patients who underwent elective AAA repair between 1998 and 2000 (OR period) and 195 patients between 2010 and 2012 (EVAR period) were compared. Cost equivalence for OR and EVAR was reached at a break even price for an endovascular device of €13 190. The main cost difference reflected the longer duration of hospital stay (ward and Intensive Care Unit) of OR (€11 644). Re-intervention rates were similar for OR (24.2%) and EVAR (24.6%) (p = .92). Conclusion Cost equivalence for EVAR and OR occurs at a device cost of €13 000 for EVAR. Hence, for most routine repairs, EVAR is not costlier than OR until at least the five year follow up.

Background and objective The 4-item Psoriatic Arthritis Uncluttered Screening Evaluation (PURE-4) questionnaire is a useful tool for identifying patients with suspected psoriatic arthritis before referring them to a rheumatology department for confirmation. The original English version has good discriminant validity (sensitivity, 85.7%; specificity 83.6%). We aimed to produce an adapted Spanish version of the PURE-4 for validation and use in Spain. Material and method We applied the method recommended by the International Society for Pharmacoeconomic and Outcome Research for the cultural adaptation of patient-centered measurement tools. The phases in the processes involved forward translation, reconciliation, back translation review, harmonization, cognitive debriefing and review, and proofreading. Results We obtained the permission of the author of the original questionnaire. Two native-speaking translators translated the questionnaire into Spanish. Small changes, mainly in the way the items were expressed, were then made in order to reconcile the 2 translations. The questionnaire was then back translated to English and revised to achieve a version equivalent to the original. A Spanish translation derived from the revision was tested for understandability in 7 patients, and the final Spanish version was then produced. During the translation phases, the project manager and a scientific committee made up of a dermatologist and a rheumatologist reviewed the different versions. Team members exchanged information throughout the process, providing for harmonization and the quality control that guaranteed conceptual equivalence. Conclusions This adaptation of the PURE-4 questionnaire for use in Spain has been the first step toward using it in routine clinical practice. The standardized method we used ensures that the Spanish and the original versions are equivalent.

Background Concepts such as participation and environment may differ across cultures. Consequently, to use a measure like the Participation and Environment Measure for Children and Youth (PEM-CY) in other than the original English-speaking contexts, cultural adaptation needs to be assured. The aim of this study was to cross-culturally translate and adapt the PEM-CY into German as it is used in Germany, Austria and Switzerland. Methods Fifteen parents of children and adolescents with disabilities from three German speaking countries participated in three rounds of think-aloud interviews. We followed the procedure of cultural equivalence guidelines including two additional steps. Data was analyzed by content analysis using semantic, idiomatic, experiential and conceptual equivalence. Results Results show adaptations mainly focused on experiential and conceptual equivalence, with conceptual equivalence being the most challenging to reach. Examples of experiential equivalence included adapting the examples of activities in the PEM-CY to reflect those typical in German speaking countries. Conceptual equivalence mainly addressed aspects of “involvement” and “environment” of children and adolescents and was reached through adaptations such as enhanced instructions and structures, and additional definitions. Conclusions This study presents a cross-cultural translation and adaptation process to develop a German version of the PEM-CY that is suitable for Germany, Austria and Switzerland. Using a modified cultural adaptation process, a culturally adapted version of PEM-CY (German) is now available for research, practice and further validation.

Purpose The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions The equivalence testing results support the voice script’s validity for administration of the QLQ-C30 via telephone.

The authors investigated the agreement between StepWatch3™ (SW3) and ActiGraph™ wGT3X+ monitors for measuring step-based metrics in patients with peripheral artery disease and older adults. In 23 patients with peripheral artery disease and 38 older participants, the authors compared the metrics obtained during an outdoor (400-m track) walking session (step count) and a 7-day free-living period (step count and 60/30/5/1-min maximal or peak step accumulation) using the SW3 (ankle) and the wGT3X+ (hip) with the low-frequency extension filter enabled (wGT3X+/LFE) or not (wGT3X+/N). During outdoor walking session, agreement was high, particularly for wGT3X+/LFE: correlations ≥.98, median absolute percentage errors

OBJECTIVES To test the null hypothesis that vertical peri-implant bone level alterations (��IBL) are equivalent in immediately (IL) and 3-month post-placement (DL) loaded implants in mandibular implant overdentures (IODs) on two implants. MATERIALS AND METHODS Thirty-two patients receiving two interforaminal implants, one with a platform-switched and one with a platform-matching abutment were randomly assigned to the IL or DL group (allocation ratio 1:1). All implants were primarily splinted with chairside-customized bars, converting the existing removable complete dentures to IODs. Standardized radiographs were recorded. The influence of the loading protocol (IL vs. DL), implant platform (platform switched vs. platform matching), implant site (43 vs. 33), participant age (���65 vs. >65��years), and definition of baseline (implant placement vs. implant loading) were analyzed, applying linear regression analyses (����=��0.05). The equivalence range was [-0.4; 0.4]. RESULTS Three participants of the IL group were lost during follow-up. The overall mean ��IBL was -0.96������0.89��mm. The ��IBL was equivalent in terms of the implant platform and implant site but not in terms of participant age (in favor of more elderly participants) and the loading protocol. A significantly smaller ��IBL was observed in the IL when the baseline was considered to be implant placement (p��=��.017), but not when it was considered to be implant loading (p��=��.084). CONCLUSION Immediate loading of primary-splinted implants in two-implant bar-retained overdentures, seems beneficial relative to loading 3��months post-placement, with respect to ��IBL. The ��IBL were equivalent in terms of platform switching.

Introduction The Rutgers Acquired Equivalence Test is a visually guided equivalence learning paradigm that involves rule acquisition and generalization. Earlier we found impaired performance in this paradigm among adult migraine patients without aura. The aim of the study was to investigate if similar impairments can be found already in the pediatric form of the disease and to compare the performance of the pediatric study population with that of an adult study population. We hypothesized that the deficits observed in adults would be observable already in the pediatric population. Methods Twenty-seven children and adolescents newly diagnosed with migraine without aura and 27 age- and sex-matched healthy controls were tested with the Rutgers Acquired Equivalence Test. Their performance data were compared to each other and those of an earlier adult study population involving 22 patients and 22 age- and sex-matched healthy controls. Four parameters characterizing performance in the two main phases of the paradigm were calculated for each of the four groups. Performance parameters were compared with Mann-Whitney U test. Results In contrast to the decreased performance of the adult patients in the Rutgers Acquired Equivalence Test, no significant difference was found between pediatric patients and controls in any phase of the paradigm. Conclusion Children living with migraine without aura do not exhibit the same cognitive deficits in the Rutgers Acquired Equivalence Test as their adult counterparts. It can be hypothesized that the deficit of equivalence learning is not an inherent feature of the migrainous cognitive profile, rather the result of the interference of the disease with normal development.

Introduction Administering patient-reported outcome measures (PROMs) by text message may improve response rate in hard-to-reach populations. This study explored cultural acceptability of PROMs and compared measurement equivalence of the EQ-5D-3L administered on paper and by text message in a rural South African setting. Materials and methods Participants with upper or lower limb orthopaedic pathology were recruited. The EQ-5D was administered first on paper and then by text message after 24 h and 7 days. Differences in mean scores for paper and text message versions of the EQ-5D were evaluated. Test–retest reliability between text message versions was evaluated using Intraclass Correlation Coefficients (ICCs). Results 147 participants completed a paper EQ-5D. Response rates were 67% at 24 h and 58% at 7 days. There were no differences in means between paper and text message responses for the EQ-5D Index (p = 0.95) or EQ-5D VAS (p = 0.26). There was acceptable agreement between the paper and 24-h text message EQ-5D Index (0.84; 95% Confidence Interval (CI) 0.78–0.89) and EQ-5D VAS (0.73; 95% CI 0.64–0.82) and acceptable agreement between the 24-h and 7-day text message EQ-Index (0.72; CI 0.62–0.82) and EQ-VAS (0.72; CI 0.62–0.82). Non-responder traits were increasing age, Xhosa as first language and lower educational levels. Conclusions Text messaging is equivalent to paper-based measurement of EQ-5D in this setting and is thus a viable tool for responders. Non-responders had similar socioeconomic characteristics and attrition rates to traditional modes of administration. The EQ-5D by text message offers potential clinical and research uses in hard-to-reach populations.

Background Achieving deep brain stimulation (DBS) dose equivalence is challenging, especially with pulse width tuning and directional contacts. Further, the precise effects of pulse width tuning are unknown, and recent reports of the effects of pulse width tuning on neural selectivity are at odds with classic biophysical studies. Methods We created multicompartment neuron models for two axon diameters and used finite element modeling to determine extracellular influence from standard and segmented electrodes. We analyzed axon activation profiles and calculated volumes of tissue activated. Results We find that long pulse widths focus the stimulation effect on small, nearby fibers, suppressing distant white matter tract activation (responsible for some DBS side effects) and improving battery utilization when equivalent activation is maintained for small axons. Directional leads enable similar benefits to a greater degree. Reexamining previous reports of short pulse stimulation reducing side effects, we explore a possible alternate explanation: non-dose equivalent stimulation may have resulted in reduced spread of neural activation. Finally, using internal capsule avoidance as an example in the context of subthalamic stimulation, we present a patient-specific model to show how long pulse widths could help increase the biophysical therapeutic window. Discussion We find agreement with classic studies and predict that long pulse widths may focus the stimulation effect on small, nearby fibers and improve power consumption. While future pre-clinical and clinical work is necessary regarding pulse width tuning, it is clear that future studies must ensure dose equivalence, noting that energy- and charge-equivalent amplitudes do not result in equivalent spread of neural activation when changing pulse width.

We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95-95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.

O presente trabalho teve por objetivo avaliar as características da dor crônica que apresentam distúrbios musculoesqueléticos e sua correlação com o uso indiscriminado de analgésicos e anti-inflamatórios não esteroides. Participaram da pesquisa 104 indivíduos de ambos os sexos, com faixa etária de 30 e 90 anos, os quais realizaram tratamento Fisioterapêutico na clínica que presta atendimento para o Sistema Único de Saúde, localizada no interior do Médio Paraíba. Na metodologia proposta, foi utilizado um Inventário Resumido da Dor (BriefPainInventory – BPI), sendo avaliadas a existência, severidade, localização, interferência funcional, estratégias terapêuticas aplicadas e eficácia do tratamento da dor, feito por quatro itens (máximo, mínimo, em média e neste momento) com escalas numéricas de classificação (de 0 a 10).Os dados foram analisados estatisticamente e os resultados mostraram correlações significativas com outros estudos com uma equivalência da dor moderada a forte, entre os entrevistados, tanto na intensidade quanto na interferência da dor nas atividades gerais. A partir desse resultado, foi possível concluir que na falta de um tratamento adequado, a dor se torna incapacitante e os pacientes tendem a diminuir a procura por especialistas, ocasionando o uso irracional de medicamentos.

Purpose To determine the measurement equivalence of computer touch screen assessment (CTSA) and paper based assessment (PBA) of the oral health impact profile (OHIP-14). Patients and Methods A randomized crossover trial was conducted. Sixty participants were randomized to either i) Arm A: completed CTSA then PBA of OHIP-14, or ii) Arm B: PBA and then CTSA of OHIP-14 within the same day. User preference and time taken to complete the assessments were recorded. Agreement between CTSA and PBA was determined using directional difference (DD), absolute difference (AD), and intraclass correlation coefficient (ICC). Results There was no significant difference in CTSA and PBA OHIP-14 scores (P>0.05). The magnitude of the DD in scores between assessment methods was small for overall scores and all domains (

Videolaryngoscopy is widely believed to give a superior view to that obtained by direct laryngoscopy. Published literature suggests this benefit extends to both hyper-angulated and Macintosh-style videolaryngoscopes. Notwithstanding, our clinical experience shows that the videoscopic view with a Macintosh-style videolaryngoscope is often no different or only marginally better than the directly sighted peroral view. A human cadaver equivalence study was performed in which four experienced laryngoscopists obtained pre-assigned laryngeal views by direct sighting using the single-use Macintosh blades of the GlideScope® Spectrum™ (GS) DirectView Macintosh (DVM) and C-MAC®S videolaryngoscopes. Blinded to the laryngoscopist’s view, two independent observers rated the videoscopic view presented on the proximal video monitor at the same time. Directly sighted and videoscopic views obtained by the laryngoscopist and video scorers were recorded on a visual analogue scale (VAS) for each device as the primary outcome measures and compared. On the VAS, the C-MAC®S videoscopic view revealed only approximately 0.9% more (99% confidence interval [CI], -2.5% to 4.3%) of the laryngeal inlet than the directly sighted view. Using GS DVM, the videoscopic view revealed 6.7% (99% CI, 2.3% to 11.0%) more of the laryngeal inlet than the directly sighted view. Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view. This study failed to corroborate previously published findings of a clinically significantly improved videoscopic view compared with direct peroral sighting using Macintosh-style videolaryngoscopes. Further study of this class of device is warranted in human subjects.

Made available in DSpace on 2020-12-10T20:03:52Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-03-15 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Study Design. Cross-sectional study. Objective. To investigate the equivalence of electronic and paper version of self-report questionnaires for the assessment of disability, pain, fear of movement, depression, and physical activity of patients with chronic low back pain (LBP). Summary of Background Data. Paper and electronic versions of self-report questionnaires are commonly used for assessment of patients with LBP. However, the equivalence of self-report questionnaires commonly used for assessment of patients with chronic LBP remains unclear. Methods. Seventy-nine individuals with chronic LBP seeking physiotherapy care were recruited. Participants attended the clinic twice with an interval of 1 week and completed the self-reported questionnaires in a random order. The following questionnaires were administered: Roland Morris Disability Questionnaire (RMDQ); 11-point numerical rating scale (NRS); Tampa Scale for Kinesiophobia (TSK); Center for Epidemiological Studies-Depression (CES-D), and Baecke Habitual Physical Activity Questionnaire (BPAQ). To investigate the equivalence between the two questionnaire versions, intraclass correlation coefficient with 95% confidence interval and Bland-Altman plotting was used. Results. The paper and electronic versions of the RMDQ, TSK, and CES-D showed good reliability and the showed moderate reliability. In contrast, the NRS showed poor reliability between the electronic and paper versions. Conclusion. Our findings support that the electronic version of the RMDQ, TSK, CES-D, and BPAQ can be administered in clinical and research settings for assessment of patients with chronic LBP. Nevertheless, electronic version of the NRS for assessment of pain intensity should not be used interchangeably in clinical practice in patients with chronic LBP. Univ Estadual Paulista, Dept Fisioterapia, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Fed Minas Gerais UFMG, Dept Phys Therapy, Belo Horizonte, MG, Brazil Univ Estadual Paulista, Dept Educ Fis, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Estadual Paulista, Dept Fisioterapia, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Estadual Paulista, Dept Educ Fis, Fac Ciencias & Tecnol, Presidente Prudente, Brazil FAPESP: 2017/21336-8 FAPESP: 2016/03826-5 FAPESP: 2017/12246-5

Cross-sectional validation study. To conduct a literature search for existing energy expenditure (EE) predictive algorithms using ActiGraph activity monitors for manual wheelchairs users (MWUs) with spinal cord injury (SCI), and evaluate their validity using an out-of-sample dataset. Research institution in Pittsburgh, USA. A literature search resulted in five articles containing five sets of predictive equations using an ActiGraph activity monitor for MWUs with SCI. Out-of-sample data were collected from 29 MWUs with chronic SCI who were asked to follow an activity protocol while wearing an ActiGraph GT9X Link on the dominant wrist. They also wore a portable metabolic cart which provided the criterion measure for EE. The out-of-sample dataset was used to evaluate the validity of the five sets of EE predictive equations. None of the five sets of predictive equations demonstrated equivalence within 20% of the criterion measure based on an equivalence test. The mean absolute error for the five sets of predictive equations ranged from 0.87 to 6.41 kilocalories per minute (kcal min−1) when compared with the criterion measure, and the intraclass correlation estimates ranged from 0.06 to 0.59. The range between the Bland–Altman upper and lower limits of agreement was from 4.70 kcal min−1 to 25.09 kcal min−1. The existing EE predictive equations based on ActiGraph monitors for MWUs with SCI showed varied performance when compared with the criterion measure. Their accuracies may not be sufficient to support future clinical and research use. More work is needed to develop more accurate EE predictive equations for this population.

Objectives. Sound field (SF) audiometry tests are usually conducted in audiometric booths measuring greater than 2×2 m in size. However, most private ENT clinics carry about 1×1-m-sized audiometric booths, making SF audiometry testing difficult to perform. The aims of this study were to develop an SF audiometry system for use in smaller audiometric booths and compare its performance with traditional system.Methods. The newly developed SF audiometry system can yield an SF signal at a distance of about 30 cm from the subject’s ears. Its height can be adjusted according to the subject’s head height. We compared SF hearing results between the new SF system and the traditional SF audiometry system in 20 adults with normal hearing (40 ears) and 24 adults with impaired hearing levels (38 ears) who wore hearing aids. Comparative parameters included warble tone audiometry threshold, a speech reception threshold (SRT), and a speech discrimination score (SDS). For statistical analysis, paired t-test was used. The equivalence of both SF systems was tested using two one-sided test (TOST) with a margin of 5 dB (normal hearing participants) and 10 dB (hearing aids wearing participants).Results. Among participants with normal hearing, warble tone hearing thresholds of 0.5, 1, 2, and 4 kHz, average values of these four frequencies, and SRT were similar between the two systems (all P>0.05). Participants with hearing aids showed similar warble tone threshold and SRT (P>0.05) in both systems except for threshold of 4 kHz (P=0.033). SDS was significantly higher in the newly developed system (P

Purpose The purpose of this study was to verify the equivalence of 2 alternate test forms with nonoverlapping content generated by an item response theory (IRT)–based computer-adaptive test (CAT). The Philadelphia Naming Test (PNT; Roach, Schwartz, Martin, Grewal, & Brecher, 1996)was utilized as an item bank in a prospective, independent sample of persons with aphasia. Method Two alternate CAT short forms of the PNT were administered to a sample of 25 persons with aphasia who were at least 6 months postonset and received no treatment for 2 weeks before or during the study. The 1st session included administration of a 30-item PNT-CAT, and the 2nd session, conducted approximately 2 weeks later, included a variable-length PNT-CAT that excluded items administered in the 1st session and terminated when the modeled precision of the ability estimate was equal to or greater than the value obtained in the 1st session. The ability estimates were analyzed in a Bayesian framework. Results The 2 test versions correlated highly ( r = .89) and obtained means and standard deviations that were not credibly different from one another. The correlation and error variance between the 2 test versions were well predicted by the IRT measurement model. Discussion The results suggest that IRT-based CAT alternate forms may be productively used in the assessment of anomia. IRT methods offer advantages for the efficient and sensitive measurement of change over time. Future work should consider the potential impact of differential item functioning due to person factors and intervention-specific effects, as well as expanding the item bank to maximize the clinical utility of the test. Supplemental Material https://doi.org/10.23641/asha.11368040

The quantitative electroencephalographic (QEEG) theta/beta power ratio (TBR) has been shown to have an association with attention-deficit hyperactivity disorder (ADHD), with a previous tacit assumption of equivalence across hardware and software systems. Therefore, the International Collaborative ADHD Neurofeedback (ICAN) randomized clinical trial used a fixed TBR ≥ 4.5 cutoff as measured by the Thought Technology Monastra-Lubar Assessment Suite as an inclusion criterion, 1.5 SD above norms collected with that system. However, a difference was noted between the TBR calculated by that assessment suite and the TBR computed by EEGer, the neurofeedback software used for treatment, leading us to investigate the discrepancy. The difference may arise from different calculation methods. This article explains and compares various computational methods used to calculate and display EEG values, including TBR, elucidating why the values are not equivalent across equipment and software programs. Two major sources of variance are (1) how “spectral leakage” at the ends of bands is handled and (2) whether voltages of bins within a band are first averaged and then squared to get bandwidth power or are first squared to get power (turning negative voltages into positive power) and then averaged to get the bandwidth power; the latter method results in higher band power. This article compares methods of computing the TBR. Biofeedback practitioners and investigators should be aware of the algorithms their systems use when interpreting TBRs and require normative comparison data collected with the same system.

Purpose To evaluate the equivalence of the volumes obtained using different anatomic references to measure the nasopharynx and oropharynx on cone-beam computed tomography (CBCT) scans. We hypothesized that no variations would be found in the nasopharynx and oropharynx dimensions when measured using different measurement methods. Materials and Methods A total of 40 CBCT scans of patients with skeletal Class I (age range, 20 to 50 years) were measured independently by 2 of us. The nasopharynx and oropharynx subregions were volumetrically measured using the adopted limits of 5 different measurement methods (3 for the nasopharynx and 2 for the oropharynx) and InVivoDental software, version 5.4 (Anatomage, San Jose, CA). The minimum area and the minimum area of localization were also evaluated. The intra- and interexaminer concordance for the measurements from the different methods were verified using the interclass correlation coefficient (ICC). The analysis of variance for repeated measures was used to compare the measurements from the 3 nasopharynx methods. The paired t test was used to compare the measurements from the 2 oropharynx methods. The statistical tests were performed at the 5% significance level using SPSS software, version 22.0 (IBM Corp, Armonk, NY). Results The intra- and interexaminer ICC values were greater than 0.8. We found a statistically significant difference in the volume measurements among the 3 nasopharynx methods (P = .001). However, no differences were found in the minimum area or minimum area of localization comparisons. Statistically significant differences were also observed for the volume, minimum area, and minimum area of localization between the 2 oropharynx methods (P = .001). Conclusions Studies that have used different methods of measurement should not be directly compared. The different measurement methods used for nasopharynx and oropharynx evaluations should not be compared.

Objectives We evaluated the analytical performance characteristics and the biological equivalence of the Atellica TnIH assay. Methods Precision, detection capability, linearity, and sex specific 99th percentiles were determined de novo. Classification of patients relative to the 99th percentiles was used to assess biological equivalence. Results Analytical precision and detection capability of the Atellica TnIH assay is excellent with a limit of blank ≥±1.96) occurred in 65% (95% CI 53–76%) of 99th percentile discordant patients compared to 2.7% (p Conclusions The 99th percentile discordant and the concordantly elevated groups are more alike with respect to their z≥±1.96 rates. This favours an overestimated Atellica TnIH 99th percentile as more likely, and we hypothesize that antibody interference resulting in asymmetric scatter of nearly 5% samples may be the underlying mechanism. Analytical accuracy and interferences in cardiac troponin assays should be investigated and resolved with high priority.

Objective: To translate and validate Clinically Useful Depression Outcome Scale on Urdu speaking Pakistani population. Method: This cross-sectional study was conducted in Rawalpindi and Islamabad from January 2018 to November 2019 on a conveniently available sample. The process of translation and validation was conducted in two phases. In the first phase the scale was forward and backward translated. In the second phase it was validated on a convenient sample of 170 subjects. 85 of these were from clinical and 85 were from non-clinical setting. After descriptive analysis, Cronbach’s alpha as a reliability coefficient, test-retest reliability, item-to-total correlation for internal consistency, Pearson product-moment for convergent and discriminant validity, and independent sample t-test for contrast group mean comparison were computed for validation purpose on the data through SPSS 22. Cross-language validation and mean comparison of the original and translated scale were established on a separate sample of 82 participants as indicators for equivalence. Result: The translated scale was found to be internally consistent with satisfactory Cronbach’s alpha and test-retest reliabilities. Convergent and discriminant validity were in assumed directions. Significant mean differences between clinical and non-clinical groups indicated the diagnostic capability of the scale. Significant cross-language correlations and non-significant mean differences between original and translated version showed that the Urdu version can be considered as equivalent to original English version. Conclusion: Results of the study found the translated scale to be as a reliable and valid Instrument. Keywords: Depression, Urdu-translation, psychometrics, reliability, validity. Continuous....

STUDY OBJECTIVES: The clinical performance of home sleep apnea tests (HSATs) can be described by their (diagnostic) accuracy, defined as the percentage agreement with the obstructive sleep apnea severity category (normal, mild, moderate, and severe) based on polysomnography. Rather than reporting on accuracy, there has been a strong reliance in the literature to report correlation coefficients between the apnea-hypopnea index of HSATs and polysomnography to support claims of diagnostic performance. This is surprising, as it has been well described that correlation coefficients are inadequate to evaluate equivalence between 2 parameters. The aim of this study was to systematically investigate the magnitude of the discrepancies between correlation coefficients and diagnostic accuracy reported in or retrievable from HSAT validation studies. METHODS: We compared the discrepancy between accuracy and apnea-hypopnea index correlation coefficients of all validation papers that met the inclusion criteria. A total of 20 papers were retained, representing a participant pool of 1,652. RESULTS: The weighted average apnea-hypopnea index correlation across all 20 papers was 0.82 and the weighted average accuracy was 0.61, highlighting a discrepancy of 0.21 and an overall misdiagnosis rate of 39%. CONCLUSIONS: The results of our study confirm the need for increased scientific rigor in selecting primary performance endpoints to support clinical performance claims of HSATs. CITATION: Massie F, Van Pee B, Bergmann J. Correlations between home sleep apnea tests and polysomnography outcomes do not fully reflect the diagnostic accuracy of these tests. J Clin Sleep Med. 2022;18(3):871–876.

Objectives Patient-reported outcome measures (PROMs) are evaluated in randomized controlled trials (RCTs) in patients with systemic lupus erythematosus (SLE), but not widely used in clinical practice. However, interest in incorporating PROMs into the management of SLE is increasing as PROMs provide a unique insight into the patient’s perception of lupus disease activity. The objective was to assess agreement in PROMs answered using a web app versus an outpatient touchscreen among patients with SLE. Methods In a crossover RCT, SLE patients answered the following PROMs in a random order using the web app and the outpatient touchscreen: Systemic Lupus Erythematosus Activity Questionnaire (SLAQ) Global Health, SLAQ Symptom, SLAQ Total, SLAQ Worsening, Pain Visual Analog Scale (VAS), Fatigue VAS, Patient Global Health VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Acceptable Symptom State (PASS), and an Anchoring Question. Equivalence between the two device types was demonstrated if the 95% confidence interval (95% CI) of the difference in PROM scores was within the prespecified equivalence margin. Agreement between the two device types was assessed using mixed linear models. Results Thirty-four patients with SLE were included. Equivalence was demonstrated between the two device types for SLAQ Global Health with a difference of −0.21 (95% CI: −0.65 to 0.23). Moreover, equivalence was also found for HAQ-DI, Pain VAS, and Fatigue VAS whereas only comparability within the limits of the Minimal Clinically Important Difference (MCID) was demonstrated for VAS Patient Global Health. Statistical comparability was demonstrated for SLAQ Total, SLAQ Worsening, PASS, and Anchoring Question (no predefined MCID/equivalence margins available). However, a statistically significant difference between device types was observed for the SLAQ Symptom of −0.56 (95% CI: −1.10 to −0.01). The difference was, however, very small when considering the scale range of 0–24; thus, it was not judged to be of clinical relevance. Preference for the web app was very high (91.2%). Conclusion For the first time ever, equivalence and comparability between two electronic device types for various PROMs were demonstrated among patients with SLE. Implementation of the device is expected to improve the management of SLE.

Accurate measurement requires assessment of measurement equivalence/invariance (ME/I) to demonstrate that the tests/measurements perform equally well and measure the same underlying constructs across groups and over time. Using structural equation modeling, the measurement properties (stability and responsiveness) of intervention measures used in a study of metabolic syndrome (MetS) treatment in primary care offices, were assessed. The primary study (N = 293; mean age = 59 years) had achieved 19% reversal of MetS overall; yet neither diet quality nor aerobic capacity were correlated with declines in cardiovascular disease risk. Factor analytic methods were used to develop measurement models and factorial invariance were tested across three time points (baseline, 3-month, 12-month), sex (male/female), and diabetes status for the Canadian Healthy Eating Index (2005 HEI-C) and several fitness measures combined (percentile VO2 max from submaximal exercise, treadmill speed, curl-ups, push-ups). The model fit for the original HEI-C was poor and could account for the lack of associations in the primary study. A reduced HEI-C and a 4-item fitness model demonstrated excellent model fit and measurement equivalence across time, sex, and diabetes status. Increased use of factor analytic methods increases measurement precision, controls error, and improves ability to link interventions to expected clinical outcomes.

BACKGROUND Both the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines recommend that clinical trials follow a study framework that aligns with their objective to test the relative efficacy or safety (equality) or effectiveness (superiority, noninferiority, or equivalence) between interventions. We conducted a systematic review to assess the proportion of studies that demonstrated inconsistency between the framing of their research question, sample size calculation, and conclusion and those that should have framed their research question differently based on the compared interventions. METHODS We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 interventions using patient-reported outcome measures. RESULTS We included 228 studies. The sample size calculation was reported in 60.5% (n = 138) of studies. Of these, 52.2% (n = 72) were inconsistent between the framing of their research question, sample size calculation, and conclusion. The majority (n = 137) of sample size calculations were for equality, but 43.8% of these studies concluded superiority, noninferiority, or equivalence. Studies that framed their research question as equality (n = 186) should have been framed as superiority (n = 129), equivalence (n = 52), or noninferiority (n = 3). Only 2 studies correctly framed their research question as equality. CONCLUSIONS Studies published in high-impact journals were inconsistent between the framing of their research question, sample size calculation, and conclusion. Authors may be misinterpreting research findings and making clinical recommendations solely based on p values. Researchers are encouraged to state and justify their methodological framework and choice of margin(s) in a publicly published protocol as they have implications for sample size and the applicability of conclusions. CLINICAL RELEVANCE The results of clinical research must be interpreted using confidence intervals, with careful consideration as to how the confidence intervals relate to clinically meaningful differences in outcomes between treatments. The more typical practice of relying on p values leaves the clinician at high risk of erroneous interpretation, recommendation, and/or action.

Assessing children’s literacy skills is a key requirement for successful learning. However, standardized assessments are almost exclusively available as paper-and-pencil tests, discarding digital testing’s advantages. In this article, we develop and evaluate two different tablet versions for a paper-based reading fluency test for German primary school children: one true-to-original design (TDId) and a tablet-optimized design (TDOpt). We investigate the reliability, equivalence, and user experience of the tablet-based versions by comparing it to each other and to the paper-based version in a user test with 21 fourth graders. The results suggest very high reliability of both tablet-based versions (r’s >.94). Children scored significantly higher on TDId than on the other tests while reading scores assessed with TDOpt matched the conventional test. Children preferred both tablet versions over the paper-based test, whereby TDOpt was consistently rated best. This study suggests that a tablet-optimized reading fluency test not only retains test reliability but is also more appealing to primary school children.

Background The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS®), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures. Methods Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference. Results For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI’s were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers. Conclusion Across all mode comparisons, there were some measures with CI’s not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible.

Equivalence in a clinical trial may be assessed through a three-arm trial (test drug, reference drug, and placebo). A three-arm equivalence trial consists of three hypothesis tests in practice, with two hypothesis tests demonstrating the superiority of the test and reference drugs against placebo, and the other one demonstrating the equivalence of the test and reference drugs. When designing a three-arm equivalence clinical trial, the practitioner should minimize the chances that a test drug will be found to be equivalent to the reference drug but non-superior to the placebo. One way to minimize these chances at the design stage, for a three-arm equivalence trial with a binary primary outcome, is to test the equivalence through hypotheses based upon the ratio of the differences of the proportions. In this article, we derived the test statistics and the power functions based on maximum likelihood estimate (MLE) and restricted MLE for the proposed hypotheses. The required sample size for achieving the desired power at the given significance level can be obtained by solving the power function. We illustrated the proposed design through an example and investigated the required sample sizes for various conditions.