Background: Multiple studies have shown that people who have experienced a serious health problem such as an injury tend to overrate the quality of health they had before that event. The main objective of this study was to test whether the phenomenon of respondents overrating their past health can also be observed in people from the general population. A second aim was to test whether habitual optimism is indeed focused on events in the future. Method: A representatively selected community sample from Leipzig, Germany (n = 2282, age range: 40–75 years) was examined. Respondents were asked to assess their current health, their past health (5 years before), and their expected future health (in 5 years) on a 0–100 scale. In addition, the study participants completed several questionnaires on specific aspects of physical and mental health. Results: Respondents of all age groups assessed their health as having been better in the past than it was at present. Moreover, they also assessed their earlier state of health more positively than people 5 years younger did their current state. Habitual optimism was associated with respondents having more positive expectations of how healthy they will be in 5 years time (r = 0.37), but the correlation with their assessments of their current health was nearly as high (r = 0.36). Conclusion: Highly positive scores of retrospectively assessed health among people who have experienced a health problem cannot totally be accounted for by a response to that health problem.

La qualité de vie relative à la santé (QdV) est désormais un des objectifs majeurs des essais cliniques en cancérologie pour pouvoir s’assurer du bénéfice clinique de nouvelles stratégies thérapeutiques pour le patient. Cependant, les résultats des données de QdV restent encore peu pris en compte en pratique clinique en raison de la nature subjective et dynamique de la QdV. De plus, les méthodes statistiques pour son analyse longitudinale doivent être capables de tenir compte de l’occurrence des données manquantes et d’un potentiel effet Response Shift reflétant l’adaptation du patient vis-à-vis de la maladie et de la toxicité du traitement. Ces méthodes doivent enfin proposer des résultats facilement compréhensibles par les cliniciens.Dans cette optique, les objectifs de ce travail ont été de faire le point sur ces facteurs limitants et de proposer des méthodes adéquates pour une interprétation robuste des données de QdV longitudinales. Ces travaux sont centrés sur la méthode du temps jusqu’à détérioration d’un score de QdV (TJD), en tant que modalité d’analyse longitudinale, ainsi que sur la caractérisation de l’occurrence de l’effet Response Shift.Les travaux menés ont donné lieu à la création d’un package R pour l’analyse longitudinale de la QdV selon la méthode du TJD avec une interface facile d’utilisation. Certaines recommandations ont été proposées sur les définitions de TJD à appliquer selon les situations thérapeutiques et l’occurrence ou non d’un effet Response Shift. Cette méthode attractive pour les cliniciens a été appliquée dans le cadre de deux essais de phase précoces I et IL La méthode de pondération par probabilité inversée du score de propension a été investiguée conjointement avec la méthode du TJD afin de tenir compte de l’occurrence de données manquantes dépendant des caractéristiques des patients. Une comparaison de trois approches statistiques pour l’analyse longitudinale a montré la performance du modèle linéaire mixte et permet de donner quelques recommandations pour l’analyse longitudinale selon le design de l’étude. Cette étude a également montré l’impact de l’occurrence de données manquantes informatives sur les méthodes d’analyse longitudinale. Des analyses factorielles et modèles issus de la théorie de réponse à l’item ont montré leur capacité à caractériser la Response Shift conjointement avec la méthode Then-test. Enfin, bien que les modèles à équation structurelles soient régulièrement appliqués pour caractériser cet effet sur le questionnaire de QdV générique SF-36, ils semblent peu adaptés à la structure des questionnaires spécifiques du cancer du groupe « European Organization of Research and Treatment of Cancer » (EORTC / Health-related quality of life (HRQoL) has become one of the major objectives of oncology clinical trials to ensure the clinical benefit of new treatment strategies for the patient. However, the results of HRQoL data remain poorly used in clinical practice due to the subjective and dynamic nature of HRQoL. Moreover, statistical methods for its longitudinal analysis hâve to take into account the occurrence of missing data and the potential Response Shift effect reflecting patient’s adaptation of the disease and treatment toxicities. Finally, these methods should also propose some results easy understandable for clinicians.In this context, this work aimed to review these limiting factors and to propose some suitable methods for a robust interprétation of longitudinal HRQoL data. This work is focused on both the Time to HRQoL score détérioration (TTD) as a modality of longitudinal analysis and the characterization of the occurrence of the Response Shift effect.This work has resulted in the création of an R package for the longitudinal HRQoL analysis according to the TTD with an easy to use interface. Some recommendations were proposed on the définitions of the TTD to apply according to the therapeutic settings and the potential occurrence of the Response Shift effect. This attractive method was applied in two early stage I and II trials. The inverse probability weighting method of the propensity score was investigated in conjunction with the TTD method to take into account the occurrence of missing data depending on patients’ characteristics. A comparison between three statistical approaches for the longitudinal analysis showed the performance of the linear mixed model and allows to give some recommendations for the longitudinal analysis according to the study design. This study also highlighted the impact of the occurrence of informative missing data on the longitudinal statistical methods. Factor analyses and Item Response Theory models showed their ability to characterize the occurrence of the Response Shift in conjunction with the Then- test method. Finally, although the structural équations modeling are often used to characterize this effect on the SF-36 generic questionnaire, they seem not appropriated to the particular structure of the HRQoL cancer spécifie questionnaires of the European Organization of Research and Treatment of Cancer (EORTC) HRQoL group

En cancérologie, la qualité de vie relative à la santé (QdV) est considérée comme second critère de jugement principal dans les essais cliniques en l’absence d’effet sur la survie globale. L’interprétation des scores de QdV et d’une différence de scores cliniquement pertinente entre deux temps de mesure est un problème majeur en QdV. Cette différence peut être significative d’un point de vue statistique sans être cliniquement significative du point de vue du patient. La différence minimale cliniquement importante (DMCI) a ainsi été définie comme la plus petite différence de score de QdV qui serait considérée comme ayant un sens clinique pour le patient. L’analyse longitudinale de la QdV est complexe, en particulier en raison de l’occurrence de l’effet « Response Shift » qui est susceptible de biaiser les résultats d’analyse longitudinal et en particulier les résultats de la DMCI. Dans ce contexte, le premier objectif de ce travail de thèse est une revue de la littérature concernant la détermination de la DMCI selon les méthodes les plus couramment utilisées : les méthodes basées sur l’ancre et les méthodes basées sur la distribution. Deuxièmement, calculer la DMCI par les méthodes basées sur l’ancre et la distribution en appliquant différents critères de distribution et plusieurs ancres différentes. L’objectif est de comparer les résultats obtenus par les différentes méthodes et de les comparer également avec les résultats obtenus par les études antérieures. Enfin, étudier l’impact de l’occurrence de l’effet Response Shift sur la détermination de la DMCI pour les questionnaires de QdV en cancérologie. / In oncology, the health-related quality of life (HRQOL) is generally considered as a second endpoint in the clinical trials. The interpretation of the results of the longitudinal analysis of such data must be made in both statistical and clinical point of view in order to produce meaningful results for both patients and clinicians. The main objective is to assess the impact of the treatment on patient’s HRQOL level over time. The minimal clinically important difference (MCID) was defined as the smallest change between two scores in a treatment outcome that a patient would identify as important. Indeed, the longitudinal analysis of HRQOL remains complex, particularly due to the potential occurrence of a Response Shift effect characterizing the process of adaptation of the patient in relation to the illness and its treatment. Hence, the first objective of this work is a literature review concerning the determination of the MCID by the most commonly used methods: anchor-based and distribution-based methods. Secondly, calculating the MCID using anchor-based and distribution-based methods by applying different distribution criteria and several different anchors. The objective is to compare the results obtained by the different methods and to compare them to others obtained by previous studies. Finally, studying the impact of the Response Shift effect on the determination of MCID for the HRQOL questionnaires in cancer research using several data corresponding to different therapeutic situations and cancer locations.

Over the last 5 decades, the retrospective pretest has been used in behavioral science research to battle key threats to the internal validity of posttest-only control-group and pretest-posttest only designs. The purpose of this study was to compare outcome measures resulting from four research design implementations incorporating the retrospective pretest: (a) pre-post-then, (b) pre-post/then, (c) post-then, and (d) post/then. The study analyzed the interaction effect of pretest sensitization and post-intervention survey order on two subjective measures: (a) a control measure not related to the intervention and (b) an experimental measure consistent with the intervention. Validity of subjective measurement outcomes were assessed by correlating resulting to objective performance measurement outcomes. A Situational Leadership® II (SLII) training workshop served as the intervention. The Work Involvement Scale of the self version of the Survey of Management Practices Survey served as the subjective control measure. The Clarification of Goals and Objectives Scale of the self version of the Survey of Management Practices Survey served as the subjective experimental measure. The Effectiveness Scale of the self version of the Leader Behavior Analysis II® served as the objective performance measure. This study detected differences in measurement outcomes from SLII participant responses to an experimental and a control measure. In the case of the experimental measure, differences were found in the magnitude and direction of the validity coefficients. In the case of the control measure, differences were found in the magnitude of the treatment effect between groups. These differences indicate that, for this study, the pre-post-then design produced the most valid results for the experimental measure. For the control measure in this study, the pre-post/then design produced the most valid results. Across both measures, the post/then design produced the least valid results.

The effectiveness of treatments for degenerative spine conditions, where the primary symptom is back pain, is typically determined using patient-reported quality of life (QoL) measures. However, patients may adjust their internal standards when scoring QoL based on factors other than their health. This response shift phenomenon could confound the interpretation of study data and impact effectiveness conclusions. In the current study, response shift was examined using structural equation modeling (SEM) and previously collected clinical trial data comparing 2 minimally invasive medical devices in lumbar spinal stenosis patients through 1 year postintervention. In subject QoL results, reprioritization shift between 3 months and 12 months that could confound standard analysis was identified. Treatment group did not influence response shift identified at 12 months. SEM provided an effective and practical tool for clinical investigators to assess response shift in available clinical study data. As response shift could lead to invalid conclusions when QoL measures are analyzed, clinical investigators should include response shift assessment in the design of clinical trials. This research into how response shift phenomenon can impact clinical trial results improves the ability of clinical investigators to interpret clinical trial data, potentially preventing erroneous conclusions. This research may also assist researchers and government regulators in the identification and reimbursement of beneficial, cost-effective medical treatments for patients worldwide. For clinical research designers, this study demonstrates a practical application of response shift assessment.

Golembiewski, Billingsly, and Yeager (1976) conceptualized three distinct types of change that might result from development interventions, called alpha, beta, and gamma change. Recent research has found that beta and gamma change do occur as hypothesized, but the phenomena are somewhat infrequent and the precise conditions under which they occur have not been established. This study used confirmatory factor analysis and item response theory to identify gamma and beta change on a multidimensional, multisource managerial performance appraisal instrument and to examine relations among the change types, training program content, and raters' implicit theories of performance. Results suggested that coverage in training was a necessary but not sufficient condition for beta and gamma change to occur. Further, although gamma change was detected only in the trainee group, beta change was detected in self-ratings from trainees and in ratings collected from their superiors. Because trainees' superiors were involved in post-training follow-up, this finding was interpreted as a possible diffusion of treatments effect (Campbell & Stanley, 1963). Contrary to expectations, there were no interpretable relations between raters' implicit theories of performance and either of the change types. Perhaps relatedly, more implicit theory change was detected among individuals providing observer ratings than in the trainees themselves. The implications of these findings for future research on plural change were discussed. / Ph. D.

健康相關生活品質越來越重視病人主觀的感受，然而將這個部分納入測量之後，許多研究結果卻出現殘疾悖論(disability paradox)的現象，也就是重度疾病病人的自評生活品質並不比程度輕微或甚至健康的人差。反應轉移理論認為，造成這個現象的原因在於個人的自評生活品質會受到個體對於生活品質定義的改變（重新構念）、內在測量尺度標準的改變（重新校準）、以及價值的改變（重新權重）的影響，到目前為止，反應轉移尚未發展出合適的測量工具。 SEIQoL-DW (Schedule for the Evaluation of Individual Quality of Life- direct weighting)做為一個生活品質測量個人化的代表，其評估分成三個步驟，分別是提名重要的生活領域、評估提名領域的滿意程度、以及評估提名領域的相對權重，許多研究者嘗試用SEIQoL-DW在兩點間的領域變化做為重新構念，權重變化做為重新權重，重新校準則需要搭配then test來測量，then test是在第二個測量點時邀請受試重新對第一個時間點的提名領域進行評估，然而這三個成分指標的操作型定義不一，then test也有使用上的不便，同時過去這些指標對生活品質的效用檢驗也都未達顯著。本研究分認為，若能解決上述的問題，將有助於解釋殘疾悖論，同時可以區辨不同類別病人的反應轉移模式，並運用在臨床來幫助病人進行調適。 本研究以立意取樣招募3期以上之慢性腎臟病患者、以及血液透析、腹膜透析未滿一年以上之三組病患共85名，除了背景和臨床資料外，在間隔三個月的兩點分別填寫SEIQoL-DW、ideal scale（評估期待）、生活滿意問卷、正負向情緒問卷，並在後測時填寫then test。研究結果顯示，三組病人的生活品質符合殘疾悖論，並無顯著差別。重新構念、重新校準、和重新權重當中，僅重新校準有助於生活品質的提升，並能夠顯著解釋生活品質的改變。 對腎臟病患者來說，期待越高，生活品質提升得越多，進一步的分析顯示，受試會捨棄相對權重較低的領域，新提名領域的滿意程度、期待、和相對權重都顯著高於捨棄的舊領域，這可以作為臨床上協助病人調適的策略。雖然then test的結果顯著，但實證結果和理論卻相當混亂，尚待未來研究釐清。 / Health-related quality of life (HRQoL) is increasingly recognized as being subjective, which emphasized patient-reported outcomes. Many HRQoL studies reported that people with serious illness perceived no less quality of life (QoL) than those without such illness. This phenomenon is labeled as disability paradox. Response shift theory provides an explanation for it and refers to a change in the meaning of one’s self-evaluation of QoL as a result of changes in internal standards (recalibration), values (reprioritization), and reconceptualization of QoL. It is these changes that will influenced perceived QoL. Current methods to detect Response Shift are still evolving. SEIQoL-DW (Schedule for the Evaluation of Individual Quality of Life- direct weighting) is one of individualized QoL instruments and measures three elements of QoL, including five important aspects of life, current satisfaction with each aspect, and relative importance of each aspect. Many researchers tried to use SEIQoL-DW to detect response shift. Changes in the content of aspects of life between two time points reflect reconceptualization. Changes in the relative weighting between two time points reflect reprioritization. Recalibration is measured by then test, which is a method by asking respondents at time two to provide a renewed rating of their aspects of life given at time one. However, there are no consensus operational definition of indices of reconceptualization , reprioritization, and recalibration. The examination between indices and improvements in QoL was not significant, either. Besides, then test with SEIQoL-DW has a disadvantage when aspects nominated between time one and two are different. This study tried to resolve issues above. If these issues are resolved, disability paradox will be explained. Response Shift will possibly differentiate patients of various disease, and provide ideas to help patients adjust to illness. 85 patients were recruited, including those with renal disease stage 3-5, and those undergoing hemodialysis or peritoneal dialysis within one year. All patients completed SEIQoL-DW, ideal scale, Satisfaction with Life Scale, the Positive And Negative Affect Scale at time one and three months after , except questionnaire on personal background and biological information (at time one) and then test (at time two). Results indicated that the QoLs of these three groups of patients showed no different, which confirmed disability paradox. Only recalibration showed helpful. Regression analyses also showed that recalibration indices were better predictors in QoLs. For End-stage Renal Disease patients, higher expectation suggested higher QoL improvement. Further analysis showed that patients would abandon lower-weighted aspect of life. Compared to the abandoned aspects, higher satisfaction, expectation and weighting were seen in new-nominated aspect. This finding could be useful in helping patients adjust. Although then test also reached significance, evidences was contradicted to its prediction. More research is needed in the future.

Background Health education programs that are aimed at improving individuals' skills to self-manage are increasingly recognised as a critical component of chronic disease management. Despite the apparent need for such interventions, current studies show inconsistent results regarding program effectiveness, with meta-analyses indicating only marginal effects for some disease groups. A closer examination of these studies however suggests that the magnitude and inconsistency of the findings may be related to the types of outcomes that were assessed rather than specific disease groups. Where self-report measures were used, results tended to be smaller and inconsistent. It is therefore possible that current studies do not adequately reflect program effects because self-report outcomes have a high risk to be confounded by a range of potential biases. Objective The aim of this thesis was to identify and quantify the potential influence of biases in the measurement of change in chronic disease self-management interventions using self-report. Methods The research design targeted the processes that individuals undergo when filling out questionnaires and whether this has an influence on their self-report outcomes. This was achieved by developing a three-group research design. The Health Education Impact Questionnaire (heiQ) was used to collect outcomes data. While pretest questionnaires were identical across groups, three questionnaire versions were randomly distributed at posttest. One of the groups filled out traditional posttest questions (n=331), whereas the other two groups were asked to provide data in addition to posttest questions, with one group providing transition questions (n=304) and one providing retrospective pretest data (n=314). Resulting datasets were further examined for possible confounding effects through response shift and social desirability bias. Through the random allocation of the heiQs it was ensured that data were not influenced by potential intra-group effects. Results The thesis revealed that the design of the posttest questionnaire significantly influenced people's ratings of their posttest levels. In particular, when participants were asked to provide ratings of their retrospective pretest levels in addition to their posttest levels, the latter scores were significantly higher than those of participants who did not perform this additional task. Subsequent analyses however suggested that these differences could neither be explained by response shift nor by social desirability bias. Conclusions This research has provided important insight into the measurement of outcomes of chronic disease self-management interventions. While the threat to the validity of traditional pretest-posttest data due to confounding effects through response shift and social desirability biases could not be supported, the thesis has highlighted that the cognitive task that subjects are asked to perform when providing data at posttest significantly influenced their self-reported outcomes. Given that previous research has predominantly focused on other aspects of validity - such as applying control group designs to circumvent common threats to internal and external validity - this study suggests that more attention must be paid to the design of questionnaires. The thesis concludes that further research, in particular into the influence of cognitive tasks on obtained scores, is important to improve the interpretation of self-report outcomes data derived from participants of self-management interventions.