Response shift results of quantitative research using patient-reported outcome measures: a descriptive systematic review.

PURPOSE: The objective of this systematic review was to describe the prevalence and magnitude of response shift effects, for different response shift methods, populations, study designs, and patient-reported outcome measures (PROM)s. METHODS: A literature search was performed in MEDLINE, PSYCINFO, CINAHL, EMBASE, Social Science Citation Index, and Dissertations & Theses Global to identify longitudinal quantitative studies that examined response shift using PROMs, published before 2021. The magnitude of each response shift effect (effect sizes, R-squared or percentage of respondents with response shift) was ascertained based on reported statistical information or as stated in the manuscript. Prevalence and magnitudes of response shift effects were summarized at two levels of analysis (study and effect levels), for recalibration and reprioritization/reconceptualization separately, and for different response shift methods, and population, study design, and PROM characteristics. Analyses were conducted twice: (a) including all studies and samples, and (b) including only unrelated studies and independent samples. RESULTS: Of the 150 included studies, 130 (86.7%) detected response shift effects. Of the 4868 effects investigated, 793 (16.3%) revealed response shift. Effect sizes could be determined for 105 (70.0%) of the studies for a total of 1130 effects, of which 537 (47.5%) resulted in detection of response shift. Whereas effect sizes varied widely, most median recalibration effect sizes (Cohen's d) were between 0.20 and 0.30 and median reprioritization/reconceptualization effect sizes rarely exceeded 0.15, across the characteristics. Similar results were obtained from unrelated studies. CONCLUSION: The results draw attention to the need to focus on understanding variability in response shift results: Who experience response shifts, to what extent, and under which circumstances?

Implications of the syntheses on definition, theory, and methods conducted by the Response Shift - in Sync Working Group.

PURPOSE: Our aim is to advance response shift research by explicating the implications of published syntheses by the Response Shift - in Sync Working Group in an integrative way and suggesting ways for improving the quality of future response shift studies. METHODS: Members of the Working Group further discussed the syntheses of the literature on definitions, theoretical underpinnings, operationalizations, and response shift methods. They outlined areas in need of further explication and refinement, and delineated additional implications for future research. RESULTS: First, the proposed response shift definition was further specified and its implications for the interpretation of results explicated in relation to former, published definitions. Second, the proposed theoretical model was further explained in relation to previous theoretical models and its implications for formulating research objectives highlighted. Third, ways to explore alternative explanations per response shift method and their implications for response shift detection and explanation were delineated. The implications of the diversity of the response shift methods for response shift research were presented. Fourth, the implications of the need to enhance the quality and reporting of the response shift studies for future research were sketched. CONCLUSION: With our work, we intend to contribute to a common language regarding response shift definitions, theory, and methods. By elucidating some of the major implications of earlier work, we hope to advance response shift research.

Response Shift After Cognitive Behavioral Therapy Targeting Severe Fatigue: Explorative Analysis of Three Randomized Controlled Trials.

BACKGROUND: Cognitive behavioral therapy (CBT) is an evidence-based intervention for severe fatigue. Changes in patients' fatigue scores following CBT might reflect not only the intended relief in fatigue but also response shift, a change in the meaning of patients' self-evaluation. Objectives were to (1) identify the occurrence of response shift in patients undergoing CBT, (2) determine the impact of response shift on the intervention effect, and (3) investigate whether changes in fatigue-related cognitions and perceptions, targeted during CBT, are associated with response shift. METHODS: Data of three randomized controlled trials testing the efficacy of CBT in individuals with chronic fatigue syndrome (CFS, n = 222), cancer (n = 123), and diabetes (n = 107) were re-analyzed. Fatigue severity was measured with 8 items from the Checklist Individual Strength, a valid and widely used self-report questionnaire. Structural equation modelling was applied to assess lack of longitudinal measurement invariance, as indication of response shift. RESULTS: As expected, in all three trials, response shift was indicated in the CBT groups, not the control groups. Response shift through reprioritization was indicated for the items "Physically, I feel exhausted" (CFS) and "I tire easily" (cancer, diabetes), which became less vs. more important to the measurement of fatigue, respectively. However, this did not affect the intervention effects. Some changes in cognitions and perceptions were associated with the response shifts. CONCLUSIONS: CBT seems to induce response shift through reprioritization across patient groups, but its occurrence does not affect the intervention effect. Future research should corroborate these findings and investigate whether patients indeed change their understanding of fatigue.

Response shift after coronary revascularization.

PURPOSE: The aims of this study were to investigate (1) the extent to which response shift occurs among patients with coronary artery disease (CAD) after coronary revascularization, (2) whether the assessment of changes in health-related quality of life (HRQoL), controlled for response shift, yield more valid estimates of changes in HRQoL, as indicated by stronger associations with criterion measures of change, than without controlling for response shift, and (3) if occurrences of response shift are related to patient characteristics. METHODS: Patients with CAD completed the SF-36 and the Seattle Angina Questionnaire (SAQ7) at baseline and 3 months after coronary revascularization. Sociodemographic, clinical and psychosocial variables were measured with the patient version of the New York Heart Association-class, Subjective Significance Questionnaire, Reconstruction of Life Events Questionnaire (RE-LIFE), and HEXACO personality inventory. Oort's Structural Equation Modeling (SEM) approach was used to investigate response shift. RESULTS: 191 patient completed questionnaires at baseline and at 3 months after treatment. The SF-36 showed recalibration and reprioritization response shift and the SAQ7 reconceptualization response shift. Controlling for these response shift effects did not result in more valid estimates of change. One significant association was found between reprioritization response shift and complete integration of having CAD into their life story, as indicated by the RE-LIFE. CONCLUSION: Results indicate response shift in HRQoL following coronary revascularization. While we did not find an impact of response shift on the estimates of change, the SEM approach provides a more comprehensive insight into the different types of change in HRQoL following coronary revascularization.

Critical examination of current response shift methods and proposal for advancing new methods.

PURPOSE: This work is part of an international, interdisciplinary initiative to synthesize research on response shift in results of patient-reported outcome measures. The objective is to critically examine current response shift methods. We additionally propose advancing new methods that address the limitations of extant methods. METHODS: Based on literature reviews, this critical examination comprises design-based, qualitative, individualized, and preference-based methods, latent variable models, and other statistical methods. We critically appraised their definition, operationalization, the type of response shift they can detect, whether they can adjust for and explain response shift, their assumptions, and alternative explanations. Overall limitations requiring new methods were identified. RESULTS: We examined 11 methods that aim to operationalize response shift, by assessing change in the meaning of one's self-evaluation. Six of these methods distinguish between change in observed measurements (observed change) and change in the construct that was intended to be measured (target change). The methods use either (sub)group-based or individual-level analysis, or a combination. All methods have underlying assumptions to be met and alternative explanations for the inferred response shift effects. We highlighted the need to address the interpretation of the results as response shift and proposed advancing new methods handling individual variation in change over time and multiple time points. CONCLUSION: No single response shift method is optimal; each method has strengths and limitations. Additionally, extra steps need to be taken to correctly interpret the results. Advancing new methods and conducting computer simulation studies that compare methods are recommended to move response shift research forward.

Analytical power calculations for structural equation modeling: A tutorial and Shiny app.

Conducting a power analysis can be challenging for researchers who plan to analyze their data using structural equation models (SEMs), particularly when Monte Carlo methods are used to obtain power. In this tutorial, we explain how power calculations without Monte Carlo methods for the χ2 test and the RMSEA tests of (not-)close fit can be conducted using the Shiny app "power4SEM". power4SEM facilitates power calculations for SEM using two methods that are not computationally intensive and that focus on model fit instead of the statistical significance of (functions of) parameters. These are the method proposed by Satorra and Saris (Psychometrika 50(1), 83-90, 1985) for power calculations of the likelihood ratio test, and that described by MacCallum, Browne, and Sugawara (Psychol Methods 1(2) 130-149, 1996) for RMSEA-based power calculations. We illustrate the use of power4SEM with examples of power analyses for path models, factor models, and a latent growth model.

Risk factors of unmet needs among women with breast cancer in the post-treatment phase.

OBJECTIVE: Unmet health care needs require additional care resources to achieve optimal patient well-being. In this nationwide study we examined associations between a number of risk factors and unmet needs after treatment among women with breast cancer, while taking into account their health care practices. We expected that more care use would be associated with lower levels of unmet needs. METHODS: A multicenter, prospective, observational design was employed. Women with primary breast cancer completed questionnaires 6 and 15 months post-diagnosis. Medical data were retrieved from medical records. Direct and indirect associations between sociodemographic and clinical risk factors, distress, care use, and unmet needs were investigated with structural equation modeling. RESULTS: Seven hundred forty-six participants completed both questionnaires (response rate 73.7%). The care services received were not negatively associated with the reported levels of unmet needs after treatment. Comorbidity was associated with higher physical and daily living needs. Higher age was associated with higher health system-related and informational needs. Having had chemotherapy and a mastectomy were associated with higher sexuality needs and breast cancer-specific issues, respectively. A higher level of distress was associated with higher levels of unmet need in all domains. CONCLUSIONS: Clinicians may use these results to timely identify which women are at risk of developing specific unmet needs after treatment. Evidence-based, cost-effective (online) interventions that target distress, the most influential risk factor, should be further implemented and disseminated among patients and clinicians.

I am a total failure: associations between beliefs and anxiety and depression in patients with inflammatory bowel disease with poor mental quality of life.

BACKGROUND: According to cognitive behavioural theory, cognitive factors (i.e. underlying general dysfunctional beliefs and (situation) specific illness beliefs) are theorized to lead to outcomes like anxiety and depression. In clinical practice, general dysfunctional beliefs are generally not tackled directly in short-term-therapy. AIMS: The goal of the present study was to investigate the associations of general versus specific illness beliefs on anxiety and depressive symptoms and psychiatric disorders among a subgroup of patients with inflammatory bowel disease (IBD) with poor mental quality of life (QoL). METHOD: This study concerns cross-sectional data, collected at baseline from a randomized clinical trial. One hundred and eighteen patients, recruited at four Dutch hospitals, with poor QoL (score ≤23 on the mental health subscale of the Short-Form 36-item Health-Survey; SF-36) were included. General dysfunctional beliefs were measured by the Dysfunctional Attitude Scale (DAS), specific illness beliefs by the Illness Perceptions Questionnaire-Revised (IPQ-R), anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS), and psychiatric disorders by the Structured Clinical Interview for DSM-IV Axis-I Disorders (SCID-I). RESULTS: Univariate analyses showed associations between the level of anxiety and/or depression and general dysfunctional beliefs and four specific illness beliefs (consequences, personal control, emotional representations and treatment control). Among patients with IBD with psychiatric disorders, only the DAS was significantly associated with anxiety and depression (DAS added to IPQ-R and IPQ-R added to DAS). CONCLUSIONS: Psychological interventions may have to target general dysfunctional beliefs of patients with IBD with co-morbid psychiatric disorders to be effective. These patients with IBD are especially in need of psychological treatment.

Studying medical communication with video vignettes: a randomized study on how variations in video-vignette introduction format and camera focus influence analogue patients' engagement.

BACKGROUND: Video vignettes are used to test the effects of physicians' communication on patient outcomes. Methodological choices in video-vignette development may have far-stretching consequences for participants' engagement with the video, and thus the ecological validity of this design. To supplement the scant evidence in this field, this study tested how variations in video-vignette introduction format and camera focus influence participants' engagement with a video vignette showing a bad news consultation. METHODS: Introduction format (A = audiovisual vs. B = written) and camera focus (1 = the physician only, 2 = the physician and the patient at neutral moments alternately, 3 = the physician and the patient at emotional moments alternately) were varied in a randomized 2 × 3 between-subjects design. One hundred eighty-one students were randomly assigned to watch one of the six resulting video-vignette conditions as so-called analogue patients, i.e., they were instructed to imagine themselves being in the video patient's situation. Four dimensions of self-reported engagement were assessed retrospectively. Emotional engagement was additionally measured by recording participants' electrodermal and cardiovascular activity continuously while watching. Analyses of variance were used to test the effects of introduction format, camera focus and their interaction. RESULTS: The audiovisual introduction induced a stronger blood pressure response during watching the introduction (p = 0.048, [Formula: see text]= 0.05) and the consultation part of the vignette (p = 0.051, [Formula: see text]= 0.05), when compared to the written introduction. With respect to camera focus, results revealed that the variant focusing on the patient at emotional moments evoked a higher level of electrodermal activity (p = 0.003, [Formula: see text]= 0.06), when compared to the other two variants. Furthermore, an interaction effect was shown on self-reported emotional engagement (p = 0.045, [Formula: see text]= 0.04): the physician-only variant resulted in lower emotional engagement if the vignette was preceded by the audiovisual introduction. No effects were shown on the other dimensions of self-reported engagement. CONCLUSIONS: Our findings imply that using an audiovisual introduction combined with alternating camera focus depicting patient's emotions results in the highest levels of emotional engagement in analogue patients. This evidence can inform methodological decisions during the development of video vignettes, and thereby enhance the ecological validity of future video-vignettes studies.

Development and validation of an abbreviated version of the Trust in Oncologist Scale-the Trust in Oncologist Scale-short form (TiOS-SF).

PURPOSE: The original 18-item, four-dimensional Trust in Oncologist Scale assesses cancer patients' trust in their oncologist. The current aim was to develop and validate a short form version of the scale to enable more efficient assessment of cancer patients' trust. METHODS: Existing validation data of the full-length Trust in Oncologist Scale were used to create a short form of the Trust in Oncologist Scale. The resulting short form was validated in a new sample of cancer patients (n = 92). Socio-demographics, medical characteristics, trust in the oncologist, satisfaction with communication, trust in healthcare, willingness to recommend the oncologist to others and to contact the oncologist in case of questions were assessed. Internal consistency, reliability, convergent and structural validity were tested. RESULTS: The five-item Trust in Oncologist Scale Short Form was created by selecting the statistically best performing item from each dimension of the original scale, to ensure content validity. Mean trust in the oncologist was high in the validation sample (response rate 86%, M = 4.30, SD = 0.98). Exploratory factor analyses supported one-dimensionality of the short form. Internal consistency was high, and temporal stability was moderate. Initial convergent validity was suggested by moderate correlations between trust scores with associated constructs. CONCLUSIONS: The Trust in Oncologist Scale Short Form appears to efficiently, reliably and validly measures cancer patients' trust in their oncologist. It may be used in research and as a quality indicator in clinical practice. More thorough validation of the scale is recommended to confirm this initial evidence of its validity.

Item bias detection in the Hospital Anxiety and Depression Scale using structural equation modeling: comparison with other item bias detection methods.

PURPOSE: Comparison of patient-reported outcomes may be invalidated by the occurrence of item bias, also known as differential item functioning. We show two ways of using structural equation modeling (SEM) to detect item bias: (1) multigroup SEM, which enables the detection of both uniform and nonuniform bias, and (2) multidimensional SEM, which enables the investigation of item bias with respect to several variables simultaneously. METHOD: Gender- and age-related bias in the items of the Hospital Anxiety and Depression Scale (HADS; Zigmond and Snaith in Acta Psychiatr Scand 67:361-370, 1983) from a sample of 1068 patients was investigated using the multigroup SEM approach and the multidimensional SEM approach. Results were compared to the results of the ordinal logistic regression, item response theory, and contingency tables methods reported by Cameron et al. (Qual Life Res 23:2883-2888, 2014). RESULTS: Both SEM approaches identified two items with gender-related bias and two items with age-related bias in the Anxiety subscale, and four items with age-related bias in the Depression subscale. Results from the SEM approaches generally agreed with the results of Cameron et al., although the SEM approaches identified more items as biased. CONCLUSION: SEM provides a flexible tool for the investigation of item bias in health-related questionnaires. Multidimensional SEM has practical and statistical advantages over multigroup SEM, and over other item bias detection methods, as it enables item bias detection with respect to multiple variables, of various measurement levels, and with more statistical power, ultimately providing more valid comparisons of patients' well-being in both research and clinical practice.

Using structural equation modeling to detect response shifts and true change in discrete variables: an application to the items of the SF-36.

PURPOSE: The structural equation modeling (SEM) approach for detection of response shift (Oort in Qual Life Res 14:587-598, 2005. doi: 10.1007/s11136-004-0830-y ) is especially suited for continuous data, e.g., questionnaire scales. The present objective is to explain how the SEM approach can be applied to discrete data and to illustrate response shift detection in items measuring health-related quality of life (HRQL) of cancer patients. METHODS: The SEM approach for discrete data includes two stages: (1) establishing a model of underlying continuous variables that represent the observed discrete variables, (2) using these underlying continuous variables to establish a common factor model for the detection of response shift and to assess true change. The proposed SEM approach was illustrated with data of 485 cancer patients whose HRQL was measured with the SF-36, before and after start of antineoplastic treatment. RESULTS: Response shift effects were detected in items of the subscales mental health, physical functioning, role limitations due to physical health, and bodily pain. Recalibration response shifts indicated that patients experienced relatively fewer limitations with "bathing or dressing yourself" (effect size d = 0.51) and less "nervousness" (d = 0.30), but more "pain" (d = -0.23) and less "happiness" (d = -0.16) after antineoplastic treatment as compared to the other symptoms of the same subscale. Overall, patients' mental health improved, while their physical health, vitality, and social functioning deteriorated. No change was found for the other subscales of the SF-36. CONCLUSION: The proposed SEM approach to discrete data enables response shift detection at the item level. This will lead to a better understanding of the response shift phenomena at the item level and therefore enhances interpretation of change in the area of HRQL.

Taking into account the impact of attrition on the assessment of response shift and true change: a multigroup structural equation modeling approach.

PURPOSE: Missing data due to attrition present a challenge for the assessment and interpretation of change and response shift in HRQL outcomes. The objective was to handle such missingness and to assess response shift and 'true change' with the use of an attrition-based multigroup structural equation modeling (SEM) approach. METHOD: Functional limitations and health impairments were measured in 1,157 cancer patients, who were treated with palliative radiotherapy for painful bone metastases, before [time (T) 0], every week after treatment (T1 through T12), and then monthly for up to 2 years (T13 through T24). To handle missing data due to attrition, the SEM procedure was extended to a multigroup approach, in which we distinguished three groups: short survival (3-5 measurements), medium survival (6-12 measurements), and long survival (>12 measurements). RESULTS: Attrition after third, sixth, and 13th measurement occasions was 11, 24, and 41 %, respectively. Results show that patterns of change in functional limitations and health impairments differ between patients with short, medium, or long survival. Moreover, three response-shift effects were detected: recalibration of 'pain' and 'sickness' and reprioritization of 'physical functioning.' If response-shift effects would not have been taken into account, functional limitations and health impairments would generally be underestimated across measurements. CONCLUSIONS: The multigroup SEM approach enables the analysis of data from patients with different patterns of missing data due to attrition. This approach does not only allow for detection of response shift and assessment of true change across measurements, but also allow for detection of differences in response shift and true change across groups of patients with different attrition rates.

Method variation in the impact of missing data on response shift detection.

PURPOSE: Missing data due to attrition or item non-response can result in biased estimates and loss of power in longitudinal quality-of-life (QOL) research. The impact of missing data on response shift (RS) detection is relatively unknown. This overview article synthesizes the findings of three methods tested in this special section regarding the impact of missing data patterns on RS detection in incomplete longitudinal data. METHODS: The RS detection methods investigated include: (1) Relative importance analysis to detect reprioritization RS in stroke caregivers; (2) Oort's structural equation modeling (SEM) to detect recalibration, reprioritization, and reconceptualization RS in cancer patients; and (3) Rasch-based item-response theory-based (IRT) models as compared to SEM models to detect recalibration and reprioritization RS in hospitalized chronic disease patients. Each method dealt with missing data differently, either with imputation (1), attrition-based multi-group analysis (2), or probabilistic analysis that is robust to missingness due to the specific objectivity property (3). RESULTS: Relative importance analyses were sensitive to the type and amount of missing data and imputation method, with multiple imputation showing the largest RS effects. The attrition-based multi-group SEM revealed differential effects of both the changes in health-related QOL and the occurrence of response shift by attrition stratum, and enabled a more complete interpretation of findings. The IRT RS algorithm found evidence of small recalibration and reprioritization effects in General Health, whereas SEM mostly evidenced small recalibration effects. These differences may be due to differences between the two methods in handling of missing data. CONCLUSIONS: Missing data imputation techniques result in different conclusions about the presence of reprioritization RS using the relative importance method, while the attrition-based SEM approach highlighted different recalibration and reprioritization RS effects by attrition group. The IRT analyses detected more recalibration and reprioritization RS effects than SEM, presumably due to IRT's robustness to missing data. Future research should apply simulation techniques in order to make conclusive statements about the impacts of missing data according to the type and amount of RS.

Development of the Informing Relatives Inventory (IRI): Assessing Index Patients' Knowledge, Motivation and Self-Efficacy Regarding the Disclosure of Hereditary Cancer Risk Information to Relatives.

BACKGROUND: Despite the use of genetic services, counselees do not always share hereditary cancer information with at-risk relatives. Reasons for not informing relatives may be categorized as a lack of: knowledge, motivation, and/or self-efficacy. PURPOSE: This study aims to develop and test the psychometric properties of the Informing Relatives Inventory, a battery of instruments that intend to measure counselees' knowledge, motivation, and self-efficacy regarding the disclosure of hereditary cancer risk information to at-risk relatives. METHOD: Guided by the proposed conceptual framework, existing instruments were selected and new instruments were developed. We tested the instruments' acceptability, dimensionality, reliability, and criterion-related validity in consecutive index patients visiting the Clinical Genetics department with questions regarding hereditary breast and/or ovarian cancer or colon cancer. RESULTS: Data of 211 index patients were included (response rate = 62%). The Informing Relatives Inventory (IRI) assesses three barriers in disclosure representing seven domains. Instruments assessing index patients' (positive) motivation and self-efficacy were acceptable and reliable and suggested good criterion-related validity. Psychometric properties of instruments assessing index patients knowledge were disputable. These items were moderately accepted by index patients and the criterion-related validity was weaker. CONCLUSION: This study presents a first conceptual framework and associated inventory (IRI) that improves insight into index patients' barriers regarding the disclosure of genetic cancer information to at-risk relatives. Instruments assessing (positive) motivation and self-efficacy proved to be reliable measurements. Measuring index patients knowledge appeared to be more challenging. Further research is necessary to ensure IRI's dimensionality and sensitivity to change.

Learning curve on the TrEndo laparoscopic simulator compared to an expert level.

BACKGROUND: The aim of this study was to determine growth in trainee laparoscopic skill as recorded by the TrEndo laparoscopic simulator during a laparoscopic training course, compared to an expert level. METHODS: A prospective observational cohort study was conducted between February 1 and November 31, 2010. Trainees in laparoscopic surgery completed a basic laparoscopic suturing task on a laparoscopic box trainer at three successive assessment points during a laparoscopic training course. Experts were assessed only once to define an expert level. The TrEndo recorded four motion analysis parameters (MAPs) individually for each hand and the amount of time taken to complete the suturing task. RESULTS: Seventy-two residents and 56 experts were included in this study. Overall, the amount of time taken on the suturing task and seven out of eight MAPs significantly increased toward an expert level during the course, representing an improvement in task efficiency. During the first training day, the amount of time spent on the suturing task and five out of eight MAPs improved significantly. After the retention period, five out of eight MAPS demonstrated a significant improvement compared to the end of the first training day. CONCLUSIONS: Laparoscopic skill of trainees as recorded by the TrEndo laparoscopic simulator grows toward an expert level during a laparoscopic training course in a large and heterogeneous study group. Construct validity of the TrEndo is established.

Guidelines for secondary analysis in search of response shift.

OBJECTIVE: Response shift methods have developed substantially in the past decade, with a notable emphasis on model-based methods for response shift detection that are appropriate for the analysis of existing data sets. These secondary data analyses have yielded useful insights and motivated the continued growth of response shift methods. However, there are also challenges inherent to the successful use of secondary analysis for response shift detection. Based on our experience with a number of secondary analyses, we propose guidelines for the optimal implementation of secondary analysis for detecting response shift. METHODS: We review the definition of response shift and recent advances in response shift theory. We describe current statistical methods that have been developed for or applied to response shift detection. We then discuss lessons learned when using these methods to test specific hypotheses about response shift in existing data and of the features of a data set that could guide early decision-making about undertaking a secondary analysis. RESULTS: A checklist is provided that includes guidelines for secondary analyses focusing on: (1) selecting an appropriate data set to investigate response shift; (2) prerequisites of data sets and their preparation for analysis; (3) managing missing data; (4) confirming that the data fit the requirements and assumptions of the selected response shift detection technique; (5) model fit evaluation; (6) interpreting results/response shift effect sizes; and (7) comparing findings across methods. CONCLUSIONS: The guidelines-checklist has the potential to stimulate rigorous and replicable research using existing data sets and to assist investigators in assessing the appropriateness and potential of a data set and model-based methods for response shift research.

Open knot-tying skills: resident skills assessed.

AIM: Open knot-tying and suturing skills are fundamental surgical skills, founding many alternative knot-tying techniques. It is therefore mandatory for residents to possess adequate basic open knot-tying skills. The aim of this study was to compare an objective assessment of open knot-tying skills by residents to a resident's own estimation of his or her knot-tying skills, before and after a knot-tying course. MATERIAL AND METHODS: A prospective observational cohort study was performed. At baseline level, after 1 training day in the Advanced Suturing Course (ASC) in the Netherlands and Belgium and after 6 weeks of autonomous practice (i.e. self-practice), 99 residents' open knot-tying skills were objectively evaluated using the Objective Structured Assessment of Technical Skills (OSATS). The resident's own confidence in these skills was also evaluated. RESULTS: The ASC substantially and significantly improved residents' knot-tying skills according to the OSATS between baseline and post-measurement. The observed improvement after 1 training day decreased after 6 weeks of autonomous practice. Self-confidence increased directly after the training program and was maintained 6 weeks later. Residents having completed the first 3 years of residency displayed an overall greater self-confidence than residents not having completed the first 3 years of residency, although the increase in self-confidence was significantly larger in the latter after 6 weeks' autonomous training. CONCLUSION: There is a divergence between residents' objectified open knot-tying skills and self-confidence in these skills. The ASC improved open knot-tying skills according to the OSATS, however this improvement decreased after a 6-week period of autonomous practice. Self-confidence, in contrast, was maintained or increased. Further research is needed to correlate validated training programs with clinical outcomes and to determine whether residents' open knot-tying skills and self-confidence are retained beyond 1 year.

Validation of a new box trainer-related tracking device: the TrEndo.

BACKGROUND: There is an increasing demand for structured objective ex vivo training and assessment of laparoscopic psychomotor skills prior to implementation of these skills in practice. The aim of this study was to establish the internal validity of the TrEndo, a motion-tracking device, for implementation on a laparoscopic box trainer. METHODS: Face validity and content validity were addressed through a structured questionnaire. To assess construct validity, participants were divided into an expert group and a novice group and performed two basic laparoscopic tasks. The TrEndo recorded five motion analysis parameters (MAPs) and time. RESULTS: Participants demonstrated a high regard for face and content validity. All recorded MAPs differed significantly between experts and novices after performing a square knot. Overall, the TrEndo correctly assigned group membership in 84.7 and 95.7% of cases based on two laparoscopic tasks. CONCLUSION: Face, content, and construct validities of the TrEndo were established. The TrEndo holds real potential as a (home) training device.

Condition or cognition? Mechanism of change in fatigue in a randomized controlled trial of graded exercise therapy or cognitive behavior therapy for severe fatigue in patients with advanced cancer.

OBJECTIVE: Fatigue remains one of the most common and distressing symptoms during treatment for advanced cancer. The TIRED trial demonstrated cognitive behavior therapy's (CBT) significant and clinically relevant effects to reduce fatigue among patients with advanced cancer, while graded exercise therapy (GET) did not prove beneficial. The present study aims to determine the mechanisms by which CBT and GET affect fatigue. METHOD: The TIRED trial randomized 134 patients with advanced cancer to CBT (n = 46), GET (n = 42), or usual care (n = 46). At 14 weeks, 126 evaluable patients provided fatigue data and of those 117 received ≥1 CBT or GET session or usual care. We tested a prespecified multiple mediation model with four potential mediators (physical activity, exercise capacity, self-efficacy, and fatigue catastrophizing) assessed at baseline and at 14 weeks. Post-hoc analyses also included perceived physical activity and emotional functioning as potential mediators. RESULTS: A total of 82 of 117 patients completed all required measures. CBT reduced fatigue indirectly through its effect on self-efficacy, ab = -3.292; 97.5% bootstrap CI [-6.518 to -0.598]. CBT participants experienced an increase in fatigue self-efficacy, with greater self-efficacy associated with decreased fatigue severity. There was no evidence that changes in physical activity, exercise capacity, perceived physical activity, fatigue catastrophizing, or emotional functioning mediated CBT's or GET's effects on fatigue. CONCLUSIONS: The effect of CBT was attributable to changes in cognition, that is, increased self-efficacy led to reduced fatigue severity. No significant mediators for GET were found. The findings inform further refinement of interventions for fatigue in this seriously ill population. (PsycInfo Database Record (c) 2021 APA, all rights reserved).