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.

A randomized controlled trial of a preventive intervention for the children of parents with depression: mid-term effects, mediators and moderators.

BACKGROUND: In a parallel randomized controlled trial the effectiveness of the family- and group-based cognitive-behavioural "Gug-Auf" intervention in preventing depression in children of depressed parents was evaluated. We hypothesized that the intervention would be associated with reduced incidence of depression at 15 months as well as with reduced symptom severity at 6, 9, and 15 months. We also explored the role of a number of mediators and moderators. METHODS: Families were included if a parent (n = 100, mean age = 46.06, 61% female) had experienced depression and children (n = 135, aged 8-17 years, 53% female) had no mental illness. Families (91.5% German) were randomly allocated (50:50 block-wise; stratified by child age and parental depression) to the 12-session "GuG-Auf" intervention or no intervention. Outcomes were assessed (on an intention-to-treat basis) at 0-(T1), 6-(T2), 9-(T3) and 15-months (T4) after baseline. Primary outcome (onset of depression; T4) was assessed with standardized (blinded) clinical interviews. Secondary (unblinded) outcome was risk of depression (at T2-T4) indicated by self- and parent-reported symptoms of internalizing, externalizing and depressive disorder. Potential mediators were emotion regulation, attributional style, knowledge of depression and parenting style. Potential moderators were parental depression severity and negative life events. RESULTS: None of the children who received the intervention developed depression, whereas two of those in the control group did. The intervention significantly reduced depression risk (indicated by severity of self-reported internalizing symptoms) at T3 (p = .027, d = -0.45) and T4 (p = .035, d = -0.44). Both groups showed reduced depressive symptoms (p = .029, d = -0.44). Cognitive problem-solving and negative parenting emerged as mediators. There was no evidence that the intervention was associated with parent-reported internalizing symptoms or externalizing symptoms. No adverse events were observed. CONCLUSIONS: Children of parents with depression showed an increase in self-reported (but not parent-reported) internalizing symptoms over time. This increase was not present in children who received the GuG-Auf intervention. The intervention was not associated with changes in externalizing symptoms. Conclusions regarding prevention of the onset of depression were not possible. Despite some limitations in the generalizability, these findings contribute to reducing the burden of youth depression. REGISTRATION: The trial was registered on 16/04/2014 at ClinicalTrials.gov ( NCT02115880 ) and study protocol published in BMC Psychiatry ( https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-014-0263-2 ).

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.

Beyond the familial: The development of emotional communication with mothers, fathers, and strangers.

Interaction with unfamiliar partners is a component of social life from infancy onward. Yet little is known about preverbal communication with strangers. This study compared the development of infant communication with strangers to communication with mothers and fathers and examined the contribution of temperament to partner-specific communication patterns. A sample of 58 infants was observed at four and eight months during separate home-based face-to-face interactions with three partners (mother, father, and stranger). Infant visual, facial, and vocal communication behaviors were coded microanalytically. Each parent reported on infant temperament at both ages. Multilevel regression analyses indicated that infants gazed longer at strangers than at fathers, exhibited less smiling to strangers than to mothers, and produced fewer vocalizations with strangers than with either parent. Both age and temperament moderated these differences. Vocal communication with fathers became more frequent at eight months; smiling to mothers was accentuated among infants with higher levels of temperamental surgency. Importantly, levels of communication behaviors with strangers were concurrently and longitudinally associated with those with mothers and fathers. Overall, findings suggest that infant emotional communication patterns are modulated by individual temperamental differences and are reproduced in and over time, though at different levels, when interacting with novel partners.

Response shift in results of patient-reported outcome measures: a commentary to The Response Shift-in Sync Working Group initiative.

PURPOSE: The Working Group undertook a critical, comprehensive synthesis of the response shift work to date. We aimed to (1) describe the rationale for this initiative; (2) outline how the Working Group operated; (3) summarize the papers that comprise this initiative; and (4) discuss the way forward. METHODS: Four interdisciplinary teams, consisting of response shift experts, external experts, and new investigators, prepared papers on (1) definitions and theoretical underpinnings, (2) operationalizations and response shift methods, (3) implications for healthcare decision-making, and (4) on the published magnitudes of response shift effects. Draft documents were discussed during a two-day meeting. Papers were reviewed by all members. RESULTS: Vanier and colleagues revised the formal definition and theory of response shift, and applied these in an amended, explanatory model of response shift. Sébille and colleagues conducted a critical examination of eleven response shift methods and concluded that for each method extra steps are required to make the response shift interpretation plausible. Sawatzky and colleagues created a framework for considering the impact of response shift on healthcare decision-making at the level of the individual patient (micro), the organization (meso), and policy (macro). Sajobi and colleagues are conducting a meta-analysis of published response shift effects. Preliminary findings indicate that the mean effect sizes are often small and variable across studies that measure different outcomes and use different methods. CONCLUSION: Future response shift research will benefit from collaboration among diverse people, formulating alternative hypotheses of response shift, and conducting the most conclusive studies aimed at testing these (falsification).

Response shift in patient-reported outcomes: definition, theory, and a revised model.

PURPOSE: The extant response shift definitions and theoretical response shift models, while helpful, also introduce predicaments and theoretical debates continue. To address these predicaments and stimulate empirical research, we propose a more specific formal definition of response shift and a revised theoretical model. METHODS: This work is an international collaborative effort and involved a critical assessment of the literature. RESULTS: Three main predicaments were identified. First, the formal definitions of response shift need further specification and clarification. Second, previous models were focused on explaining change in the construct intended to be measured rather than explaining the construct at multiple time points and neglected the importance of using at least two time points to investigate response shift. Third, extant models do not explicitly distinguish the measure from the construct. Here we define response shift as an effect occurring whenever observed change (e.g., change in patient-reported outcome measures (PROM) scores) is not fully explained by target change (i.e., change in the construct intended to be measured). The revised model distinguishes the measure (e.g., PROM) from the underlying target construct (e.g., quality of life) at two time points. The major plausible paths are delineated, and the underlying assumptions of this model are explicated. CONCLUSION: It is our hope that this refined definition and model are useful in the further development of response shift theory. The model with its explicit list of assumptions and hypothesized relationships lends itself for critical, empirical examination. Future studies are needed to empirically test the assumptions and hypothesized relationships.

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.

Well-being of mothers with epilepsy with school-aged children.

PURPOSE: The purpose of the study was to examine different aspects of well-being in mothers with epilepsy with school-aged children. METHODS: In an observational study, mothers, identified from the European Registry of Antiepileptic Drugs and Pregnancy database in the Netherlands, completed questions on epilepsy, the impact of epilepsy on daily functioning, quality of life, behavioral problems, and parenting stress. Descriptive analyses were performed to examine the prevalence of behavioral problems and the impact of epilepsy on different aspects of the mother's daily functioning and family life. We subsequently investigated which factors contributed most to the impact of maternal epilepsy using regression analyses. RESULTS: One hundred fifty-six (46%) of the 342 invited mothers with epilepsy participated. The majority (89%) had low epilepsy severity, with well-controlled seizures. Internalizing problems within the borderline or clinical range were reported by 23% of the mothers. Behavioral problems were significantly correlated with epilepsy severity (r = 0.26, p = .002), impact of epilepsy on daily functioning (r = 0.32, p < .001), and quality of life (r = -0.52, p < 01). Quality of life was in general good (mean = 8, standard deviation [SD] = 1), with low impact of epilepsy. Epilepsy affected mostly maternal self-confidence, work, and general health. Mothers indicated to experience no to little impact of epilepsy on the relationship with their children, partner, or family. Regression analyses showed that epilepsy severity (1.0, 95% confidence interval [CI]: 0.4 to 1.6; p = .002) and quality of life (-1.3, CI: -2.3 to -0.4; p = .007) were significant contributors to the impact of epilepsy on daily functioning, while other factors (maternal education, family type, behavioral problems, and parenting stress) were nonsignificant. DISCUSSION: The current study shows that mothers with epilepsy generally fared well. Epilepsy negatively impacted the lives of some mothers, though. As maternal well-being is of importance for mother-child interaction and child development, clinicians should be aware of the impact of epilepsy on maternal psychosocial outcomes and family life of women with epilepsy.

Risk of Depression in the Offspring of Parents with Depression: The Role of Emotion Regulation, Cognitive Style, Parenting and Life Events.

Children of depressed parents are at heightened risk for developing depression, yet relatively little is known about the specific mechanisms responsible. Since preventive interventions for this risk group show small effects which diminish overtime, it is crucial to uncover the key risk factors for depression. This study compared various potential mechanisms in children of depressed (high-risk; n = 74) versus non-depressed (low-risk; n = 37) parents and explored mediators of parental depression and risk in offspring. A German sample of N = 111 boys and girls aged 8 to 17 years were compared regarding children's (i) symptoms of depression and general psychopathology, (ii) emotion regulation strategies, (iii) attributional style, (iv) perceived parenting style and (v) life events. Children in the high-risk group showed significantly more symptoms of depression and general psychopathology, less adaptive emotion regulation strategies, fewer positive life events and fewer positive parenting strategies in comparison with the low-risk group. Group differences in positive and negative attributional style were small and not statistically significant in a MANOVA test. Maladaptive emotion regulation strategies and negative life events were identified as partial mediators of the association between parental depression and children's risk of depression. The study highlights the elevated risk of depression in children of depressed parents and provides empirical support for existing models of the mechanisms underlying transmission. Interestingly, the high-risk group was characterised by a lack of protective rather than increased vulnerability factors. These results are crucial for developing more effective preventive interventions for this high-risk population.

Behavioral problems in children of mothers with epilepsy prenatally exposed to valproate, carbamazepine, lamotrigine, or levetiracetam monotherapy.

OBJECTIVE: To examine the behavioral functioning of children prenatally exposed to carbamazepine (CBZ), lamotrigine (LTG), levetiracetam (LEV), or valproate (VPA) monotherapy. METHODS: In collaboration with the European Registry of Antiepileptic Drugs and Pregnancy (EURAP), the Dutch EURAP & Development study was designed, a prospective observational study. Between January 2015 and March 2018, the Child Behavior Checklist and the Social Emotional Questionnaire were used to examine the nature and severity of behavioral problems. VPA-exposed children were compared to children exposed to CBZ, LTG, or LEV, taking potential confounders into account. A direct comparison was also made between LTG and LEV, as these are first-choice treatments for many women with epilepsy of childbearing potential. RESULTS: Of the 405 invited, 181 children were included; 26 were exposed to VPA, 37 to CBZ, 88 to LTG, and 30 to LEV. For most children, both parents completed the behavioral questionnaires. Across all four antiepileptic drug (AED) exposure groups, high percentages of children with clinically relevant behavior problems were found, with behavioral problems occurring in 32% of VPA-exposed children, 14% of CBZ, 16% of LTG, and 14% of LEV. After controlling for potential confounders, VPA-exposed children had significantly more social problems than those exposed to LTG (-2.8, 95% confidence interval [CI] = -5.2 to -0.4; P = 0.022) or LEV (-3.2, CI: -6.1 to -0.3; P = 0.028), and significantly more attention problems than LEV-exposed children (-3.7, CI: -6.7 to -0.8; P = 0.013). LTG-exposed children had significantly more attention deficit (-9.2, CI: -17.3 to 1.1; P = 0.026), but significantly less anxious behavior when compared to LEV-exposed children (9.0, CI: 0.3-17.6; P = 0.042). SIGNIFICANCE: Compared to population norms, a high proportion of children of mothers with epilepsy exposed prenatally to monotherapy with four common AEDs had clinical behavioral problems reported by parents. Different patterns were seen, with some but not all subscales raised for all AED exposure groups. It is important that prenatally AED-exposed children are regularly screened for behavioral problems so that appropriate help can be provided.

Maternal epilepsy and behavioral development of the child: Family factors do matter.

PURPOSE: The purpose of the study was to examine whether mothers with epilepsy experience family problems and to investigate the possible mediating role of distinct family factors in the relationship between maternal epilepsy and child behavioral problems, in which it is also investigated whether more proximal family factors mediate the more distal family factors. METHODS: In an observational study, with children identified from the European Registry of Antiepileptic Drugs and Pregnancy database in the Netherlands (EURAP-NL), parents completed questionnaires on maternal epilepsy, family factors (proximal, distal, contextual, global), and child behavior. Hierarchical multilevel regression analyses were performed to examine the relative contribution of epilepsy-related and family factors on child internalizing and externalizing problems. RESULTS: Between January 2015 and March 2018, the questionnaires were completed for 175 children. Mothers with epilepsy showed significantly more parenting stress and problems with parenting than mothers from the general population. Family factors were significantly associated with child behavioral problems. For internalizing problems, maternal epilepsy, global, contextual, and distal family factors were each found to have significant added value. Distal family factors contributed most to internalizing problems and showed a mediating role for epilepsy-related factors and previous added family factors in the model. Global, contextual, distal, and proximal factors were all found to be significant contributors to externalizing problems, with the factor most proximal to the child (quality of parent-child interaction) showing the largest effect. DISCUSSION: Including family factors in research regarding children of mothers with epilepsy is important as they can have a contribution additional to the teratogenic risks of prenatal exposure to antiepileptic drugs (AEDs). Family factors, in particular distal and proximal family factors, can weaken or strengthen child development and may provide starting points for interventions.

Improvements of adolescent psychopathology after insomnia treatment: results from a randomized controlled trial over 1 year.

BACKGROUND: Adolescent insomnia can be treated effectively with cognitive behavioural therapy for insomnia (CBTI). However, little is known about effects of CBTI on psychopathology in adolescents. This study aimed to investigate whether (a) CBTI improves psychopathology in Internet- (IT) and face-to-face group treatment (GT) compared to waitlist (WL), (b) improvement in psychopathology can be attributed to reduced insomnia, (c) improvement in psychopathology remains stable for up to 1 year. METHODS: One hundred and sixteen participants (age = 15.6 years, 25% males) with DSM-5 insomnia, were randomly assigned to IT, GT or WL. CLINICAL TRIAL REGISTRATION: http://www.controlledtrials.com (ISRCTN33922163). Assessments of psychopathology, insomnia and objectively and subjectively measured sleep occurred at baseline, post-treatment, and at 2-, 6- and 12-month follow-up. Multilevel and mediation analyses were run to test hypotheses. The CBTI protocol, 'Sleeping Smart' for both IT and GT consisted of six weekly sessions and a booster session after 2 months. RESULTS: Psychopathology symptoms, insomnia and sleep problems as measured by actigraphy and sleep logs decreased substantially in IT and GT compared with WL at 2-month follow-up with medium to large effect sizes (ESs). Psychopathology symptoms remained stable or further improved for up to 12-month follow-up. ESs at 12-month follow-up for IT and GT were respectively: affective (d = -0.87 and -0.97), anxiety (d = -0.81 for IT), somatic (d = -0.38 and d = -0.52), oppositional (d = -0.42 for GT) and attention deficit hyperactivity disorder (ADHD) problems (d = -0.47 and -0.46). Mediation analyses indicated that reduction of insomnia symptoms after CBTI fully mediated the effects of CBTI on affective and anxiety problems, and partially mediated the effect on ADHD problems. CONCLUSIONS: This is the first study demonstrating that Internet and face-to-face CBT for insomnia achieves long-term reduction in adolescent psychopathology and does so by improving insomnia. This finding can have profound implications for youth mental health care.

Chronic sleep reduction in adolescents-clinical cut-off scores for the Chronic Sleep Reduction Questionnaire (CSRQ).

The Chronic Sleep Reduction Questionnaire is a validated questionnaire that measures symptoms of prolonged insufficient and/or poor sleep and therefore accounts for individuals' sleep need and sleep debt. This study extends its psychometric properties by providing cut-off scores, using a matched sample of 298 healthy adolescents (15.38 ± 1.63 years, 37.9% male, mean Chronic Sleep Reduction Questionnaire score: 32.98 ± 6.51) and 298 adolescents with insomnia/delayed sleep-wake phase disorder (15.48 ± 1.62 years; 37.9% male, mean Chronic Sleep Reduction Questionnaire score: 42.59 ± 7.06). We found an area under the curve of 0.84 (95% confidence interval: 0.81-0.87). Cut-off scores for optimal sensitivity, optimal specificity and based on Youden's criterion are provided. These cut-off scores are highly relevant for use of the Chronic Sleep Reduction Questionnaire in future studies and clinical practice.

Exposure to antiepileptic drugs in pregnancy: The need for a family factor framework.

PURPOSE: Children exposed to antiepileptic drugs (AEDs) in utero are at risk for developmental problems. Maternal epilepsy, its impact on the family system, and other family factors may also contribute. We reviewed the possible associations between family factors and developmental outcome in children who had been exposed to AED during pregnancy. METHODS: We conducted a narrative review and searched MEDLINE, Embase, Google Scholar, and PsycINFO on the following terms: in utero exposure, pregnancy outcome, and AEDs. A family factor framework (the ABCX model) served as the basis to review distinct family factors in children who were exposed to AEDs in pregnancy. RESULTS: Few studies have investigated these factors. Mothers with epilepsy have problems caring for themselves and for the child and experience more parenting stress. There is a paucity of studies of the possible impact of family factors on the neurocognitive and behavioral development of children of mothers with epilepsy. DISCUSSION: Further work is required to ascertain which family factors are associated with child development in addition to the effects of AED exposure and their potential interaction. As epilepsy may have considerable impact on intrafamily factors and as children are especially vulnerable to such effects, study designs incorporating family factors should be encouraged.

The Structure of Challenging Parenting Behavior and Associations With Anxiety in Dutch and Australian Children.

Challenging parenting behavior (CPB), a novel construct involving active physical and verbal behaviors that encourage children to push their limits, has been identified as a potential buffer against child anxiety. This study aimed to (a) evaluate the measurement invariance of the Challenging Parenting Behavior Questionnaire (CPBQ4-6) across Dutch and Australian mothers and fathers of preschoolers, (b) examine differences in levels of CPB across mothers and fathers and across countries, and (c) examine whether parents' CPB predicts less child anxiety symptoms and disorders. Participants were 312 families-146 Dutch and 166 Australian-with their 3- to 4-year-old child (55.8% girls). Fathers' and mothers' CPB was measured using the CPBQ4-6, and child anxiety symptoms and presence of anxiety disorders were assessed using maternal reports. Multigroup confirmatory factor analyses revealed equivalence of factor structure and factor loadings (all significant) of the CPBQ4-6 across mothers and fathers and across countries. Evidence of partial scalar invariance indicated that the groups differed on some subscales of the CPBQ4-6. Australian mothers scored lower on the CPB factor than Australian fathers and Dutch parents. Structural equation models showed that CPB predicted fewer child anxiety symptoms and anxiety disorders for all groups. The study confirms that the CPBQ4-6 is appropriate for use with Dutch and Australian parents of preschool-age children and identifies CPB as a multifaceted and coherent construct. The negative relations between CPB and child anxiety suggest that CPB has a protective role in childhood anxiety and is important to examine in future research and interventions.

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.

Uptake of the human papillomavirus vaccine in Kenya: testing the health belief model through pathway modeling on cohort data.

BACKGROUND: Many studies investigate HPV vaccine acceptability, applying health behavior theories to identify determinants; few include real uptake, the final variable of interest. This study investigated the utility of the Health Belief Model (HBM) in predicting HPV vaccine uptake in Kenya, focusing on the importance of promotion, probing willingness to vaccinate as precursor of uptake and exploring the added value of personal characteristics. METHODS: Longitudinal data were collected before and after a pilot HPV vaccination program in Eldoret among mothers of eligible girls (N = 255). Through pathway modeling, associations between vaccine uptake and the HBM constructs, willingness to vaccinate and adequate promotion were examined. Adequate promotion was defined as a personal evaluation of promotional information received. Finally, baseline cervical cancer awareness and socio-demographic variables were added to the model verifying their direct, mediating or moderating effects on the predictive value of the HBM. RESULTS: Perceiving yourself as adequately informed at follow-up was the strongest determinant of vaccine uptake. HBM constructs (susceptibility, self-efficacy and foreseeing father's refusal as barrier) only influenced willingness to vaccinate, which was not correlated with vaccination. Baseline awareness of cervical cancer predicted uptake. CONCLUSIONS: The association between adequate promotion and vaccination reveals the importance of triggers beyond personal control. Adoption of new health behaviors might be more determined by organizational variables, such as promotion, than by prior personal beliefs. Assessing users' and non-users' perspectives during and after implementing a vaccination program can help identifying stronger determinants of vaccination behavior.