Thèses sur le sujet « Outcomes validation »

Statement of the problem: Many methods for surrogate outcome validation require individual patient data which is often inaccessible by clinical trialists. Methods: A review was performed to identify statistical methods for surrogate outcome validation that may be implemented using summary data from published clinical trials. The methods were used to evaluate carotid intima-media thickness (CIMT) as a surrogate outcome for cardiovascular events in a systematic review of randomized trials of interventions for atherosclerosis. Results: the review of methods identified five procedures. At two or more years of follow-up, there was a marginally significant association of CIMT with myocardial infarction and a statistically significant association with cardiovascular mortality. At ≥ four years of follow-up, a statistically significant, negative relationship was observed between CIMT and stroke. Conclusions: CIMT may be a valid surrogate outcome for myocardial infarction and cardiovascular mortality. Additional data is needed to evaluate CIMT in specific drug classes.

Previous scholarship has highlighted the validity and reliability of a bidimensional acculturation model for migrants, allowing for simultaneous endorsement of one’s heritage and national culture. So far, however, no empirical research has explored whether the bidimensional acculturation model can be extended from migrants to members of the mainstream society (i.e., locals). Thus, the broad aims of this dissertation were threefold: (a) to validate a new framework, termed the Extended Acculturation Model for Locals (EAML), which consists of two dimensions (i.e., national culture maintenance and multicultural adaptation), and (b) to examine the outcomes as well as (c) antecedents of these dimensions. In this dissertation, the General Introduction outlines the growth of multiculturalism across societies, followed by a review of existing acculturation research on migrants and the analogous work on locals. It is noted that migrants’ acculturation process implies individual-level changes, whilst locals’ acculturation process implies attitudes and behaviours which hinder or foster migrants’ individual-level changes. The Study Overview outlines the dimensionality of locals’ acculturation process, their adjustment outcomes and antecedents. Using a modified Vancouver Index of Acculturation (Multi-VIA), Study 1 found support for a bidimensional acculturation model for locals consisting of two reliable and valid subscales indicating national culture maintenance and multicultural adaptation. Study 2 buttresses the validity and reliability of the Multi-VIA across cultures as well as demonstrates the ability of national culture maintenance and multicultural adaptation to predict locals’ sociocultural and psychological adjustment outcomes. Study 3 explains why the correlation between locals’ national culture maintenance and multicultural adaptation is either orthogonal or positive oblique; more specifically, the correlation is moderated by locals’ degree of multicultural exposure, their likeliness to compartmentalize or blend their multicultural identity as well as through high or low self-construal endorsement. Study 4 demonstrates that national culture maintenance and multicultural adaptation predict local employees’ organizational behaviour in multinational corporations. Study 5 revealed that cultural values endorsed at the individual-level predicted locals’ national culture maintenance and multicultural adaptation. Moreover, these individual-level value-outcome associations were moderated by compatible societal-level pro-diversity messages. The General Discussion reviews all of the study findings as well as discusses their implications. The General Limitations and Future Directions describes the theoretical and methodological shortcomings of the Extended Acculturation Model for Locals whilst setting future directions for research. Last, the Final Remarks stresses the overall strengths of the present dissertation – that is, it fills the present research gap on locals’ acculturation towards multiculturalism, and in turn, provides a new route towards harmonious intergroup relations and social cohesion in mixing societies.

Prognostic models are developed to guide the clinical management of patients or to assess the performance of health institutions. It is essential that performances of these models are evaluated using appropriate validation measures. Despite the proposal of several validation measures for survival outcomes, it is still unclear which measures should be generally used in practice. In this thesis, a simulation study was performed to investigate a range of validation measures for survival outcomes in order to make practical recommendations regarding their use. Measures were evaluated with respect to their robustness to censoring and their sensitivity to the omission of important predictors. Based on the simulation results, from the discrimination measures, Gonen and Heller's K statistic can be recommended for validating a survival risk model developed using the Cox proportional hazards model, since it is both robust to censoring and reasonably sensitive to predictor omission. Royston and Sauerbrei's D statistic can be recommended provided that the distribution of the prognostic index is approximately normal. Harrell's C-index was affected by censoring and cannot be recommended for use with data with more than 30% censoring. The calibration slope can be recommended as a measure of calibration since it is not affected by censoring. The measures of predictive accuracy and explained variation (Graf et al's integrated Brier Score and its R-square version, and Schemper and Henderson's V) cannot be recommended due to their poor performance in the presence of censored data. In multicentre studies patients are typically clustered within centres and are likely to be correlated. Typically, random effects logistic and frailty models are fitted to clustered binary and survival outcomes, respectively. However, limited work has been done to assess the predictive ability of these models. This research extended existing validation measures for independent data, such as the C-index, D statistic, calibration slope, Brier score, and the K statistic for use with random effects/frailty models. Two approaches: the `overall' and `pooled cluster-specific' are proposed. The `overall' approach incorporates comparisons of subjects both within-and between-clusters. The `pooled cluster-specific' measures are obtained by pooling the cluster-specific estimates based on comparisons of subjects within each cluster; the pooling is achieved using a random effects summary statistics method. Each approach can produce three different values for the validation measures, depending on the type of predictions: conditional predictions using the estimates of the random effects or setting these as zero and marginal predictions by integrating out the random effects. Their performances were investigated using simulation studies. The `overall' measures based on the conditional predictions including the random effects performed reasonably well in a range of scenarios and are recommended for validating models when using subjects from the same clusters as the development data. The measures based on the marginal predictions and the conditional predictions that set the random effects to be zero were biased when the intra-cluster correlation was moderate to high and can be used for subjects in new clusters when the intra-cluster correlation coefficient is less than 0.05. The `pooled cluster-specific' measures performed well when the clusters had reasonable number of events. Generally, both the `overall' and `pooled' measures are recommended for use in practice. In choosing a validation measure, the following characteristics of the validation data should be investigated: the level of censoring (for survival outcome), the distribution of the prognostic index, whether the clusters are the same or different to those in the development data, the level of clustering and the cluster size.

Aims: Anxiety disorders and aphasia are common following stroke. This study investigated the psychometric properties of the Behavioural Outcomes of Anxiety scale (BOA) in a sample of aphasic stroke survivors. The BOA relies upon the observations of a carer to rate the anxiety of the stroke survivor. The Generalised Anxiety Disorder-7 measure (GAD-7) is a brief screen for general anxiety which has not been investigated in stroke. A secondary aim of this study was to evaluate the performance of an observational version of the GAD-7 for aphasic stroke survivors. Design: Cross-sectional questionnaires, with repeated measures and a relaxation intervention for a subsample. Correlational and ROC analysis to assess psychometric properties, repeated measures MANOVA to assess the outcome of the intervention. Method: One hundred and eleven stroke survivor-carer dyads were recruited through voluntary sector organisations. All survivors completed a visual self-report anxiety screen, the Tension Rating Circles (TRCs), and the Frenchay Aphasia Severity Test (FAST). Carers completed the BOA and adapted versions of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) and GAD-7. A sub-group of 29 survivor-carer dyads repeated the measures two weeks later to assess test-retest reliability. Within this sub-group, stroke survivors were randomly allocated to a relaxation training or control group. Results: 41.4% of these aphasic stroke survivors were identified as anxious which is higher than prevalence rates in general stroke samples. The BOA and the GAD-7 correlated significantly with each other and with all the other measures of anxiety. When using the HADS-A (≥7) as a criterion standard against the BOA, the area under the ROC curve (AUC) was 0.90 (excellent range of accuracy). A cut-off score on the BOA >16 achieved recommended levels of sensitivity (0.85) and specificity (0.85). For the GAD-7, using the same criterion standard, the AUC (0.94) also fell within the excellent range of accuracy, and was significantly greater than an AUC of 0.50. Optimal cut-off for identifying anxiety was a score of >4 (sensitivity: 0.91, specificity: 0.83). Significantly greater reductions in the BOA scores occurred in survivors who completed relaxation training than in the controls, providing evidence of construct validity. The BOA and the GAD-7 both showed good test-retest reliability of 0.91 and 0.67 respectively. Feedback from carers revealed that the BOA was easy and quick to use and prompted further reflection on the emotional status of the survivors. Conclusions: The carer-completed BOA appears to be a valid and reliable screen for anxiety in stroke survivors with aphasia. Preliminary support for the validity of the GAD-7 is provided and further studies are warranted. Clinical and theoretical implications of the study findings are discussed and recommendations for future research are outlined.

Background: The Adult Social Care Outcomes Toolkit was developed to measure outcomes of social care in England. In this study, we translated the four level self-completion version (SCT-4) of the ASCOT for use in the Netherlands and performed a cross-cultural validation. Methods: The ASCOT SCT-4 was translated into Dutch following international guidelines, including two forward and back translations. The resulting version was pilot tested among frail older adults using think-aloud interviews. Furthermore, using a subsample of the Dutch ACT-study, we investigated test-retest reliability and construct validity and compared response distributions with data from a comparable English study. Results: The pilot tests showed that translated items were in general understood as intended, that most items were reliable, and that the response distributions of the Dutch translation and associations with other measures were comparable to the original English version. Based on the results of the pilot tests, some small modifications and a revision of the Dignity items were proposed for the final translation, which were approved by the ASCOT development team. The complete original English version and the final Dutch translation can be obtained after registration on the ASCOT website (http://www.pssru.ac.uk/ascot). Conclusions: This study provides preliminary evidence that the Dutch translation of the ASCOT is valid, reliable and comparable to the original English version. We recommend further research to confirm the validity of the modified Dutch ASCOT translation. (authors' abstract)

This study was conducted to develop a standardized agricultural literacy assessment using the National Agricultural Literacy Outcomes (NALOs) as benchmarks. The need for such an assessment was born out of previous research, which found that despite numerous programs dedicated to improving agricultural literacy, many students and adults remain at low or very low levels of literacy. Low literacy levels lead to negative associations with the production and processing of food, clothing, and shelter, as well as misinformed public perceptions and policies. Agricultural literacy researchers recognized that the development of a standardized assessment for post-12th grade, or equivalent, could unify both research and program development efforts. The assessment was developed by forming two groups of experts. Teaching experts and agricultural content experts worked together in an iterative process. They crafted 45 questions using research methods and models. The 45 items were placed in an online survey to be tested for validity by a participant group. During the Fall 2018 semester, 515 Utah State University students between the ages of 18-23 years old participated in the online assessment. The participant data assisted in determining which questions were valid and reliable for determining agricultural literacy, as aligned to the NALO standards. Additional demographic information was also collected from participants. The demographic items asked students to self-report their level of exposure to agriculture and their self-perceived level of agricultural literacy. The study concluded that two separate 15-item Judd-Murray Agricultural Literacy Instruments (JMALI) were valid and reliable for determining agricultural proficiency levels based on the NALOs. Participant scores were reported as a single proficiency stage: exposure, factual literacy, or applicable proficiency. The study also determined that students who had a “great deal” or higher level of exposure to agriculture also had a strong, positive correlation with a “good” or higher level of agricultural literacy. Findings show participants who reported a “good” level of agricultural literacy shared a positive correlation with either performing at a factual literacy (middle) or applicable proficiency (highest) level on the assessment. The results suggest JMALI instruments have the potential to assist in improving current agricultural education endeavors by providing a critical tool for determining the agricultural literacy proficiency stages of adult populations.

Mutations in the X-linked Mecp2 gene are responsible for the typical form of Rett syndrome (RTT), a devastating neurodevelopmental disorder that affects almost 1 out of 10,000 females born alive. Although mutations in the Cdkl5 gene have initially been associated with an atypical form of RTT, Cdkl5 Deficiency Disorder is now an independent disease (CDD). Nonetheless, both pathologies share a plethora of symptoms and they are primarily identified by neurodevelopmental delay. To date, no effective cure is available for RTT and CDD, even though it was demonstrated that reactivation of gene-causing disease in animal models leads to the reversal of neurological symptoms. Both diseases lack solid biomarkers capable of quantitatively measuring structural, functional or metabolic changes, permitting the assessment of disease progression and the actual benefits of therapeutic approaches. To fulfil this gap of knowledge, my thesis principally aimed at identifying sensitive measurable outcomes for both diseases. We exploited multiple approaches of ex vivo and in vivo Magnetic Resonance Imaging (MRI) to investigate anatomical and neurochemical properties of different cerebral regions in preclinical models of RTT and CDD. No difference in brain morphology was found in the Cdkl5 KO mouse, whereas a strong deregulation of metabolites related to mitochondrial homeostasis led us to unveil altered ATP and activated AMP-protein kinase (AMPK) levels. To validate those results, we started a pharmacological treatment acting on AMPK, that significantly ameliorated behavioural phenotypes of the Cdkl5 mouse. On the other hand, we longitudinally compared a full Mecp2 knockout mouse to a knock-in mouse harbouring a pathogenic missense mutation (Mecp2-Y120D). In vivo MRI on both genders revealed how developmental trajectory of the brain evolves in a comparable but not overlapping way, thus highlighting relevant gender and genotype discrepancies. Concomitantly, magnetic spectroscopy unveiled dysregulation of metabolites mainly related to energy homeostasis and neurotransmission. Collectively, we revealed the great potential of MRI in monitoring the disease progression in specific models of RTT and CDD and in identifying relevant pathways to pursue ad hoc pharmacological approaches. Further, they have highlighted that Mecp2 deficiency diversely affect the disease progression depending on the genetic lesion, gender and region of the brain.
Le mutazioni nel gene Mecp2, sito sul cromosoma X, sono responsabili per la forma “tipica” della sindrome di Rett (RTT), una devastante patologia del neurosviluppo che colpisce 1:10.000 bambine nate vive. Sebbene anche le mutazioni nel gene Cdkl5 erano state inizialmente associate alla forma “atipica” della RTT, oggi la Sindrome da Deficienza di Cdkl5 (CDD) è considerata una patologia a sé stante. Entrambe le patologie presentano una sintomatologia simile e sono caratterizzate perlopiù da un ritardo del neurosviluppo. Ad oggi, purtroppo, non esistono cure efficaci, anche se è stato dimostrato che riattivando i geni responsabili delle malattie in modelli animali può portare al recupero dei sintomi neurologici. Uno dei principali limiti nello sviluppo di una strategia terapeutica è dato dalla mancanza di solidi biomarcatori che possano misurare oggettivamente modificazioni strutturali, funzionali e metaboliche, permettendo quindi di seguire il decorso della patologia ma anche gli effetti benefici di un trattamento. Per ovviare a questa problematica, la mia tesi mira ad identificare biomarcatori per entrambe le patologie. Abbiamo utilizzato diversi approcci di risonanza magnetica (MRI) per investigare le proprietà anatomiche e neurochimiche di diverse regioni cerebrali in modelli murini di RTT e CDD. Nel topo nullo per Cdkl5 non sono state riscontrate differenze anatomiche, tuttavia la spettroscopia di risonanza magnetica ha rivelato una deregolazione in metaboliti coinvolti nell’omeostasi energetica. Studi molecolari hanno confermato un forte decremento di ATP e della proteina AMPK nell’ippocampo nullo per Cdkl5. Abbiamo quindi iniziato un primo studio preclinico che mira a modulare i livelli di AMPK e nei topi KO trattati è stato riscontrato un miglioramento in diversi test comportamentali. Dall’altra parte, abbiamo seguito e comparato longitudinalmente in vivo il topo nullo per Mecp2 e un topo avente una mutazione missenso (Mecp2-Y120D). La MRI strutturale su topi di entrambi i sessi ha mostrato come lo sviluppo cerebrale nei diversi modelli sia comparabile ma non sovrapponibile, evidenziando differenze relative sia al sesso che al genotipo. Allo stesso tempo, tramite la spettroscopia di risonanza magnetica abbiamo riscontrato la deregolazione di metaboliti legati alla neurotrasmissione e al metabolismo energetico. In conclusione, il nostro studio sottolinea il grande potenziale della MRI nel monitorare il decorso di diverse patologie in specifici modelli di RTT e CDD, così come la sua rilevanza nell’identificare pathways importanti nello sviluppo di approcci farmacologici mirati. In più, abbiamo mostrato come la deficienza da Mecp2 affligga diversamente lo sviluppo della patologia a seconda del tipo di mutazione, del sesso e della regione cerebrale.

BACKGROUND:Researchers are finding limitations of currently available disease-focused questionnaire tools for outcome studies in complementary and alternative medicine/integrative medicine (CAM/IM).METHODS:Three substudies investigated the new one-item visual analogue Arizona Integrative Outcomes Scale (AIOS), which assesses self-rated global sense of spiritual, social, mental, emotional, and physical well-being over the past 24 hours and the past month. The first study tested the scale's ability to discriminate unhealthy individuals (n = 50) from healthy individuals (n = 50) in a rehabilitation outpatient clinic sample. The second study examined the concurrent validity of the AIOS by comparing ratings of global well-being to degree of psychological distress as measured by the Brief Symptom Inventory (BSI) in undergraduate college students (N = 458). The third study evaluated the relationships between the AIOS and positively- and negatively-valenced tools (Positive and Negative Affect Scale and the Positive States of Mind Scale) in a different sample of undergraduate students (N = 62).RESULTS:Substudy (i) Rehabilitation patients scored significantly lower than the healthy controls on both forms of the AIOS and a current global health rating. The AIOS 24-hours correlated moderately and significantly with global health (patients r = 0.50
controls r = 0.45). AIOS 1-month correlations with global health were stronger within the controls (patients r = 0.36
controls r = 0.50). Controls (r = 0.64) had a higher correlation between the AIOS 24-hour and 1-month forms than did the patients (r = 0.33), which is consistent with the presumptive improvement in the patients' condition over the previous 30 days in rehabilitation. Substudy (ii) In undergraduate students, AIOS scores were inversely related to distress ratings, as measured by the global severity index on the BSI (rAIOS24h = -0.42, rAIOS1month = -0.40). Substudy (iii) AIOS scores were significantly correlated with positive affect (rAIOS24h = 0.56, rAIOS1month = 0.57) and positive states of mind (rAIOS24h = 0.42, rAIOS1month = 0.45), and inversely correlated with negative affect (rAIOS24h = -0.41, rAIOS1month = -0.59).CONCLUSIONS:The AIOS is able to distinguish relatively sicker from relatively healthier individuals
and correlates in expected directions with a measure of distress and indicators of positive and negative affect and positive states of mind. The AIOS offers a tool for CAM/IM research that extends beyond a disease emphasis.

Cardiovascular diseases (CVD) and diabetes are the most significant chronic diseases globally due to their high prevalence and mortality. People with CVD or diabetes need to know how to self-manage their health conditions to promote, maintain, and restore their health status. The Nursing Outcomes Classification (NOC) has assisted nurses and other health care providers to evaluate and quantify the status of the patient and has reflected the current health care issues that are to prevent progression of chronic diseases. Based on the current health focus, additional knowledge and self-management NOC outcomes were developed and added to the latest edition of NOC published in 2013. Generally, validation of measurement tools is required to provide trustworthy evidence for use in practice. As measurement tools, NOC outcomes with their definitions, indicators, and measurement scales need to be validated for accuracy, meaningfulness, and usefulness before they are widely used in various health settings. To provide clinical evidence for effective nursing practice such as accurate assessments and evaluations, validation of NOC outcomes is required. The purpose of this study was to validate 12 NOC outcomes focused on knowledge and self-management for people with CVD and diabetes. A descriptive exploratory design was used to validate the selected NOC outcomes, and a two round survey using the Delphi technique was used to collect data from the invited experts via email. Two subject populations were invited. The first expert group was related to standardized nursing languages (SNL) and invited experts were members of NANDA International or a fellow of the Center for Nursing Classification and Clinical Effectiveness (CNC). The second expert group was related to self-management and invited experts were members of two research interest groups which are Health Promoting Behaviors Across the Lifespan and Self Care in the Midwest Nursing Research Society (MNRS). Descriptive statistics were used to determine the definition adequacy, clinical usefulness of measurement scales, and similarity between content of knowledge and self-management outcomes. The Outcome Content Validity (OCV) method was used for the content validity of outcomes and their indicators. A total of 46 and 27 nurse experts participated in the first and second round surveys, respectively. The mean age of participants was 51.87 years (SD=13.03) and the mean of experience in nursing was 27.67 (SD=14.75) years. Most participants had experience using SNL (82.6%). Each outcome reported acceptable psychometric properties. The range of definition adequacy of the 12 NOC outcomes was from 3.71 to 4.29 (perfect score is 5.0). The range of clinical usefulness for using measurement scales was from 3.77 to 4.29. The range of content similarity of the six pairs was from 3.88 to 4.35. Every evaluated NOC outcome identified as critical with over .80 OCV scores (perfect score 1.0). More than 80% of indicators were categorized in the critical level in the first round. Thus, psychometric properties of the 12 NOC outcomes were acceptable to use in the clinical settings. By using validated NOC outcomes, nurses caring of patients with CVD or diabetes can evaluate patient outcomes effectively, and determine the effect of nursing interventions accurately. Development of new NOC outcomes and validation of them will provide nurses with measurement tools to use with patients, clinical evidence for quality improvement and knowledge development in nursing.

In Minnesota’s workers’ compensation system, injured employees at risk for sustaining permanent disability may be eligible for receipt of vocational rehabilitation (VR) services if they are determined to be capable of benefitting from such services. VR services can be a valuable resource to injured employees who need assistance minimizing their work disability and maximizing their residual wage-earning capacity. However, for VR services to be effective at a system level, it is necessary to precisely and accurately identify an injured employee’s rehabilitation potential. Failure to do so is likely to result in the misallocation of a scarce and costly resource. Given recent trends in Minnesota’s workers’ compensation system (e.g., higher VR service costs and lower RTW rates among injured employees with indemnity claims), this study was conducted with the purpose of developing and validating an objective, evidence-based method of predicting the RTW status as of claim closure of injured Minnesota employees who sustained permanent impairment and received VR services. To accomplish this purpose, a closed-claim, retrospective design was implemented. Data for this cross-sectional study was obtained from the Minnesota administrative claims database. There were 15,372 claims that met all eligibility criteria. With guidance from the biopsychosocial disablement models developed by Nagi and the World Health Organization, 15 discrete predictor variables that represented medical, individual, and workplace factors were selected for study inclusion. Descriptive and predictive analyses were used to assess the relationship between this study’s RTW outcome and its set of RTW predictors. Using logistic regression, an optimal RTW model was first developed and then internally validated with a split-dataset approach. The optimal RTW model included four main effects (attorney involvement; severity of permanent impairment; age; job tenure) and three first-order interaction effects (pre-injury average weekly wage X pre-injury industry; attorney involvement X severity of permanent impairment; attorney involvement X job tenure). Though not retained in the optimal RTW model, part of body affected and education also had notable bivariate relationships with the outcome. The optimal RTW model’s performance regarding goodness-of-fit and clinical usefulness suggests it may be of value to those assessing rehabilitation potential within Minnesota’s workers’ compensation system.

This study concerned the development of measures for youth civic development in Malaysia with four major goals in mind, namely conceptual, measurement, baseline/pragmatic, and predictive goals. It was a preliminary study of its kind in Malaysia as Malaysia did not participate in any international or regional study such as the IEA Civic Study. The central intention of the study was to establish a conceptually valid assessment framework and psychometrically sound instruments for the measurement of youth civic development in Malaysia. This would, in turn, provide some baseline information upon which future research on youth civic development in Malaysia could build. Civics as a subject was removed from the Malaysian school curriculum in the early 1980s and Civic and Citizenship Education as a specific subject, with an explicit structure and curriculum framework, was reintroduced only in 2005. It was not feasible at the time when this study was conducted to conduct a specific assessment on the outcomes for school-aged students as explicated and expected in the curriculum framework. Therefore, the post-school-aged group of young undergraduates in public universities within the age range of 17-28 was selected as the target population. Firstly, a conceptualisation of youth civic development was synthesized by identifying current views on citizenship, as set out in the international literature and, specifically, in Malaysia in two major documents – the Rukenagara and Vision2020. Civic development consists of three variables of Civic Knowledge (CK) (knowledge about the legal status and associated rights and responsibilities of citizens); Civic Disposition (CD) (views on identity and attitudes as a citizen); and Civic Engagement (CE) (participation as a citizen). The relationship between civic development variables was explicated through a Neo-Vygotskian cultural-historical theory of human development. In addition, Bronfenbrenner’s Socio-Ecological Theory of human development was adopted for the selection of contextual and individual factors (the independent variables) for the conceptual model. To help ensure cross-cultural validity for use within the Malaysian socio-cultural context, the three dependent variables of CK, CD and CE, and the independent variables were appraised for their suitability for use within the Malaysian socio-cultural context before they were operationalized into observable indicators. Secondly, the Rasch measurement paradigm, framework and model were adopted as the foundation for instrument development and validation. The procedures for instrument development followed Wilson’s model of four building blocks of instrument development (Wilson, 2005). Three instruments were developed for this study, namely The Malaysian Civic Knowledge Inventory (MCKI), The Malaysian Civic Disposition Inventory (MCDI), and the Malaysian Civic Engagement Inventory (MCEI). Items from existing instruments in international literature were adopted or adapted for the three instruments, especially the MCEI, if there was construct equivalence in Rukunegara and Vision 2020. This was to ensure a cumulative tradition in research on youth civic development. Most of the items in the MCKI and the MCDI however were developed specifically for this study to capture the specificity of the civic culture of Malaysia. The target population for the study was undergraduate students enrolled in Malaysian public universities. Students at one public university were chosen as the accessible population. Data were collected in February 2006 (pilot study) and from July to August 2006 (main study). The sample for this study (N=1391) was drawn through multistage cluster sampling by study concentration, level of study, and clusters based on lecture/tutorial group. The sample also, by default, included major inherent characteristics of the target population, particularly gender (Male and Female) and ethnicity (Malay, Chinese, Indian and other ethnic groups). Rasch analyses confirmed the three-dimensional structure of youth civic development. Three measurement scales with acceptable psychometric properties were established to provide measures for the three dependent variables of CK, CD and CE. The hypotheses about civic development (in terms of CK, CD and CE) as a ‘tool and result’ activity were tested through path analyses of mediational relationships based on Baron and Kenny’s criteria (1986) using the Rasch-derived linearized scores from the main study. Analyses provided statistical support for a bidirectional association between each pair of CK, CD and CE, despite the low inter-correlations between them. This study revealed that, on average, youth in this study demonstrated a moderately high level of CK (Mean =1.11, SD = 0.77), a positive CD (Mean = 1.25; SD = 0.63) but a moderately low CE (Mean = -0.44; SD = 0.92). The Malay sub-sample scored, on average, higher on all three dimensions of civic development. The results of hierarchical multiple regressions however showed the effect of ethnicity (Malay or Non-Malay) was statistically non-significant when other contextual (home, curricular and co-curricular) variables were entered into the regression equation. This indicates it is not ethnicity that predicts levels of civic development, but rather it is the differences in other socio-political entitlements and status associated with ethnic status. Three selected collective social-contextual factors of home, curriculum and co-curriculum explained only a fairly modest but statistically significant amount of variance (10 to 20%) in the dependent variables. Finally, the findings were discussed in relation to the theoretical perspectives undergirding this study. Pragmatic implications for policy planning as well as other relevant stakeholders involved in youth civic development are also discussed.

Across the United States, higher education institutions increasingly employ a holistic review of prospective students’ application materials. In a holistic review process, admissions offices consider a student’s personal and academic context when reviewing applications for admission. A key feature of a holistic review is a student’s application essay, or personal statement. However, admissions offices rarely standardize their essay review process and very little research exists regarding whether student essays predict successful outcomes in college. This paper summarizes a quality improvement study conducted within the University of Vermont Admissions Office. It examines the extent to which non-cognitive student characteristics present in student admissions essays (e.g., grit, creativity, intrinsic motivation, leadership, community engagement, cultural fluency) are correlated with pre-admission factors and subsequent college outcomes. The study involved developing a new essay scoring rubric and evaluating the usefulness of this rubric by scoring 320 undergraduate admission essays. Findings suggest that the rubric is useful in identifying evidence of non-cognitive factors in student essays, but that overall scores do not strongly correlate with pre-admissions characteristics or first-fall college GPA. The study supports the practice of holistic review and provides insight into how admissions offices can begin to operationalize the review of essays and non-cognitive factors in their admissions processes.

Syncope is defined as sudden transient loss of consciousness with spontaneous, complete recovery. Syncope is usually associated with loss/of postural tone leading to falling. Of the various risk stratification instruments available, the San Francisco Syncope Rule is the only one that has been prospectively derived and validated, included all serious outcomes, focuses on short-term outcomes rather than long-term outcomes and adhered to the accepted guidelines for developing a clinical decision rule. This thesis is on retrospective validation of the San Francisco Syncope rule. The study will also attempt to refine the rule if needed and collect basic epidemiological characteristics of syncope patients presenting to a tertiary care emergency department. The objectives of this study were: (1) To assess the performance of the San Francisco Syncope Rule when applied retrospectively to Canadian syncope patients. (2) To assess the potential, impact on resource utilization (in the form of admission rates) if the San Francisco Syncope Rule was applied in Canada. (3) To determine, if needed, the potential for refining the San Francisco Syncope Rule to improve its performance. (4) To describe the basic epidemiological characteristics of emergency department syncope visits to a tertiary care emergency department. The main outcome of the study was to evaluate the performance characteristics of the San Francisco Syncope Rule in its ability to predict serious outcomes within 30 days. The outcome was a composite serious outcome that included anyone of the serious outcomes: death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant bleeding anywhere, any procedural intervention to treat a related cause of syncope, any condition causing/likely to cause a return emergency visit or hospitalization for a related event within 30 days. 505 patient visits were included in the study. 49 (9.7%) of these visits were associated with serious outcomes with 22 (44.9%) occurring in the emergency department and 27 (55.1%) occurring outside the emergency department either during their inpatient stay or outside the hospital. The sensitivity and specificity of the San Francisco Syncope Rule for all serious outcomes was 90% (95% CI 78, 95) and 40% (95% CI 39, 41), for the serious outcomes occurring after discharge from the emergency department was 96% (95% CI 82, 99) and 40% (95% CI 39, 40). 12.3% of the study patients were admitted to the hospital. The rule would have required 63% of the study patients to be admitted. Exploration for refining the rule yielded a preliminary decision rule by recursive partitioning with 3 variables: (1) Age ≥ 65 years, (2) Lowest emergency department systolic blood pressure < 80 mm of Hg and (3) abnormal electrocardiogram [defined as non-sinus rhythm (supraventricular tachycardia, multifocal atrial tachycardia, atrial flutter, atrial fibrillation, junctional rhythm, idioventricular rhythm), significant atrioventricular block (second and third degree), bifasicular block, first degree atrioventricular block in the presence of left or right bundle branch block and cardiac monitor abnormalities]. This preliminary rule had a sensitivity 100% ((95% CI 93, 100) and 53% (95% CI 52, 53) for predicting serious outcomes within 30 days of the emergency visit for syncope. Using this new rule will require 52% of the patients to be admitted to the hospital. Syncope and pre-syncope were common complaints presenting to the emergency department accounting for I% of all emergency visits. The San Francisco Syncope Rule did not perform as well as previously reported. It is feasible to develop a better clinical decision rule based on the San Francisco Syncope Rule to improve the sensitivity and specificity. It also possible to prospectively clarify and improve the performance the 'abnormal electrocardiogram' variable. (Abstract shortened by UMI.)

Health-related quality of life HRQOL is central to the management of chronic diseases such as Parkinson's disease PD. Several disease specific and generic instruments have been used to measure quality of life in PD, but nobody has to date identified which disease-specific or generic measure has the most relevant domains and optimal psychometric properties reliability, validity and sensitivity for use in the PD population. The aims of the study were therefore to compare the measurement properties of available instruments in PD population and recommend the most appropriate ones for use in future clinical research and routine practice. The UKSIP a generic HRQoL instrument which had not been previously assessed in the PD population or compared against the PDQ-39 demonstrated good test-retest reliability Spearman's r 0.70 and convergent validity p 0.001 of the UKSIP overall score with all domains of the PDQ-39 in a postal survey of PD patients n 91 mean age 70 64male. The UKSIP overall score correlated most strongly with the PDQ-39 mobility and activities of daily living scales. The strong Cronbach's a values 0.70 for the UKSIP physical and psychosocial summary scores gave an indication that their items were internally consistent. Interestingly, much of the dysfunction reported by PD patients was related to non-physical difficulties according to the UKSIP and vice versa for the PDQ-39. This study highlighted the robustness and reliability of the UKSIP in this PD population. When comparing the UKSIP against a benchmark generic instrument, the SF-36, in a sample of patients n 36 mean age 69 24male from a neurology out-patients clinic, it had comparable psychometric properties with a PD clinical measure of disease severity, the Hoehn and Yahr H Y scale. The two questionnaires were also able to discriminate between stage I, II and III/IV of PD as measured by the H Y scale p 0.05 for most domains. However, the UKSIP exhibited evidence of responsiveness to change over time in some domains of interest p 0.05 amongst patients reporting deterioration as assessed by the H Y scale, a pattern that was not repeated by the SF-36. Furthermore, items in the SF-36 were identified as redundant as they had little bearing in the elderly population whereas the UKSIP detected impairment in areas of interest to PD patients such as sexual activity, impairment in cognition, and sleep disturbance which are not addressed in the SF-36. Having established that the UKSIP was the more suitable generic instrument to use in PD the established disease-specific instrument, the PDQ-39 was assessed against the relatively new disease-specific Parkinson's Impact Scale PIMS. The PIMS exhibited varying levels of internal consistency reliability which were found to be erratic between baseline and follow-up visits n 47 mean age 65 25male. Also, the internal consistency of the PIMS column which was completed by fluctuating patients were wide-ranging a 0.284 - 0.731 for each of the PIMS dimensions at baseline. On the other hand, all PDQ-39 domains exhibited good internal consistency reliability Cronbach's a 0.70 which was stable across the baseline and follow-up visits. Though there was evidence of convergent validity for the PIMS with strong correlations with the PDQ-39 domain scores this was only for the non-fluctuating patients. Also, none of the correlation coefficients were found to be statistically significant at p 0.05 between PIMS domains and the clinical measure, the H Y, indicating a lack of association between this clinical outcome measure and the domains of HRQoL measured by the PIMS. The PDQ-39 exhibited strong correlation p 0.005 against the UPDRS score and against the H Y. The PIMS did highlight that there was a difference in dimension scores between stable and fluctuating patients. An important observation from this study was that the PIMS was not well comprehended by the PD patients as was reflected by the high rate of missing data in what is a relatively short instrument. The study which was conducted across four neurology out-patient centres n 145 mean age 65 80male revealed that the PDQ-39 was able to identify that patients with fluctuating disease and dyskinesia experience greater impairment in the relevant domains of HRQoL compared to stable patients, and in particular for the domain of emotional well-being. The responsiveness of the PDQ-39 was partially confirmed as levels of significance p 0.05 were reached for the domains of mobility in the motor fluctuation group with no dyskinesia and communication for the stable group, who were deemed to have deteriorated at the follow-up visit as indicated by an increase in the total UPDRS score. Finally, the study observed that greater caregiver distress was evident for the motor fluctuating and dyskinetic groups compared to the carers of the stable patients.

The objective of this study was, firstly, to investigate the reliability of a measure of qualitative and quantitative job insecurity and, secondly, to determine the relationship between qualitative and quantitative job insecurity, job satisfaction, affective organisational commitment, turnover intention and locus of control. A cross–sectional survey design was used which included participants randomly selected from a retail banking group across junior, supervisory and middle management levels (n=178). The job insecurity scales of Hellgren, Sverke and Isaksson (1999); job satisfaction scale of Hellgren, Sjöberg and Sverke (1997); affective organisational commitment scale of Allen and Meyer (1990); turnover intention scale of Sjöberg and Sverke (2001) and the locus of control scale of Levenson (1981) were administered. Descriptive statistics were used in order to analyse the data. Structural equivalence was used for the comparison of the factor structures of the job insecurity scale for the three language groups. Furthermore, in order to determine the relationships between the variables, the Pearson product–moment correlation coefficients were used, while the dependent variable turnover intention was predicted by means of a regression analysis. As indicated at the outset, two research articles form the basis of this mini–dissertation: Based on the first article, results indicate that both the qualitative and quantitative scale presented satisfactory levels of reliability across different language groups, and a relationship between these dimensions (quantitative and qualitative) was noticeable. However, the item “I think my future prospects and opportunities within the organisation are good” included in the qualitative job insecurity scale could well be problematic, the deduction being that language barriers probably played a role in participants’ interpretation of the question. According to the second article, both qualitative and quantitative job insecurity positively related to turnover intentions. Furthermore, job satisfaction reported a negative relationship with turnover intention, and a negative relationship between qualitative job insecurity and job satisfaction came to the fore. Locus of control, on the other hand, had a direct bearing on qualitative job insecurity, while only job satisfaction and quantitative job insecurity directly predicted employees’ turnover intention in the banking sector. Finally, locus of control seemingly had no mediating effect when predicting turnover intention. Based on the afore–going, this mini–dissertation will conclude by offering deductions and making recommendations for further research as well as offering possible solutions to the commercial banking sector as far as the retention of staff is concerned.
Thesis (M.Com. (Human Resource Management))--North-West University, Potchefstroom Campus, 2012.

Background With the expansion of an aging population and the rise in the prevalence of chronic conditions, medicine use has increasingly become prevalent, with global annual costs over 1.2 trillion dollars. If used appropriately, medicines are powerful weapons which can relieve debilitating symptoms, cure diseases, prevent morbidity and mortality and improve patient health outcomes. However, medicines are often used inappropriately. The inappropriate use of medicines can have significant adverse consequences. Additionally, irrespective of the appropriateness of medicine use, there is often inherent burden associated with long term multiple medicine taking, which may impact on post treatment Health-Related Quality of Life (HRQoL) outcomes. For patients, requiring long term medicines, there is often associated psychological and physical difficulties, socioeconomic challenges, and sometimes social exclusion. The inherent burden along with inappropriate use of medicine place patients at greater risk of experiencing significant clinical, economic and humanistic burden. Research has shown that medicine-focused and patient-centered services also known as ‘Pharmaceutical care (PC)’ have been effective in improving medication related clinical outcomes and saving medicine related health care expenditure. The economic and clinical benefits of PC services have been well demonstrated. However, despite the increasing number of studies evaluating the impact of PC on humanistic outcomes over the last 30 years, results are often mixed and conflicting. The complete picture of the benefit of PC services in improving humanistic outcomes remains unclear to date. The following section describes two potential reasons for this. First, in contrast to economic and clinical outcomes which have well-established measures to evaluate and quantify these outcomes, there is no medicine-related standard measure to evaluate humanistic outcomes specific to PC services. Second, apart from biological manifestations of medicines (e.g. side effects), the social, psychological and functional burden of taking medicines has not been well explored in peer-reviewed literature. However, measurement of clinical or economic outcomes are not enough to understand the entire spectrum of medicine related impact on a patient’s health. Thus, this third humanistic construct is necessary to compliment clinical and economic outcomes, and to understand the entire spectrum of medicine related health outcomes. In addition to providing insights into the burden of medicine on health and well-being, such a measure may facilitate evaluation of humanistic outcomes of practice and research. Aims and objectives The overall aim of this thesis was to develop and validate a medicine-specific quality of life measure intended to (i) Assess the burden of medicine on functioning and well-being (ii) Evaluate the benefit of pharmaceutical care interventions on medicine specific quality of life outcomes. The specific objectives of this thesis were to: (1) Explore the physical, social, psychological determinants of medicine impact on patient’s health, and well-being. (2) Determine the sensitivity of domains of HRQoL measures to PC interventions. (3) Investigate the gap in the HRQoL measures used in PC studies. Methods The development and validation of the proposed measure was undertaken in three phases. Phase I involved two stages. The first stage involved an in-depth understanding of the impact of medication burden and the development of a theoretical and conceptual framework. This was achieved through meta-synthesis of qualitative studies (Chapter Three) and provided a foundation for item generation. In the second stage, the need for a new measure was established based on evidence generated from a meta-analysis of the impact of PC on HRQoL outcomes and a content analysis of HQRQoL measures used in PC studies (Chapters Four and Five). Phase II involved generating an item bank, developing and refining of a pool of items, and determining the response format. Phase III involved psychometric evaluation of the tool (Chapter Six). To evaluate psychometric properties of MRB-QoL, consumers aged 18 and older, living with chronic medical conditions and on multiple medicines completed the MRB-QoL survey. The instrument was psychometrically tested for reliability and validity. Exploratory Factor Analysis (EFA) was used to determine factor structure underlying the MRB-QoL items. Additionally, objective measurements of medication burden such as Medication Regimen Complexity Index (MRCI), Drug BurdenI (DBI), and a disease burden -Charlson’s Comorbidity Index (CCI) were used for testing construct validity (e.g convergent, discriminant, known groups) of MRB-QoL. Finally, the applicability of MRB-QoL as a measure of medication related quality of life outcome was tested through an exploratory cross-sectional study (Chapter Seven). Association between domains of MRB-QoL and medical condition related factors (i.e number of comorbidities, CCI), medication related factors (i.e number of medicines, DBI, MRCI), and demographic factors was explored using simple linear regression and then multiple linear regression analyses. Results A meta-synthesis of Medication-Related Burden (MRB) and Patient’s Lived Experience with Medicine (PLEM) in Chapter Three provided new insights into MRB which had not been previously reported in the literature, prior to the commencement of this thesis. It uncovered consumers’ experience of taking medicines and the burden they encounter in their day-to-day life. It generated evidence that MRB has a negative impact on patient’s health and wellbeing, beliefs and behavior towards medicine and that it is a potential risk for Drug Related Problems (DRPs). The review also highlighted clinical implications of the findings, emphasizing the need and importance of considering MRB during pharmacotherapeutic decision making, to meet a patient’s medication related needs and improve medication therapy outcomes. Chapter Four presents a systematic review and meta-analysis of 48 studies and identified that PC had significant improvement in at least one domain of HRQoL in 18 of 32 studies which used a generic measure and 16 of 32 studies which used a disease specific measure. It showed the sensitivity of some domains of HRQoL measures to PC interventions, such as general health (Standardized mean difference/SMD 0.36; 95% CI= 0.12, 0.59), social functioning (SMD 0.59; 95% CI= 0.14, 1.04) and physical functioning (SMD 0.30; 95% CI= 0.11, 0.48) of the Short Form 36 items health survey (SF-36). The review did not demonstrate a significant impact of PC on HRQoL when heart failure-specific (SMD -0.17; 95% CI= -0.43, 0.09), asthma-specific (SMD 0.17; 95% CI= -0.03, 0.36), and chronic obstructive pulmonary disease-specific (SMD -0.09; 95% CI= -0.37, 0.19) measures of HRQoL were used. Emphasizing the lack of sensitivity of evaluated measures, this review reported that existing HRQoL measures are insufficient to reflect the complete picture of the benefit of PC interventions in improving HRQoL outcomes. A systematic review and content analysis in Chapter Five followed, identifying 1019 items from 10 generic and 27 disease specific measures of HRQoL used in 117 PC studies published between 1990 and 2015. This review indicated a paucity of items pertaining specifically to medicines, with only 34 of 1019 items related to medicine. It revealed that measures of HRQoL used in PC studies provided a very limited coverage of items related to the burden of medicine taking, therefore, had limited potential for use as a sole humanistic measure in evaluating PC interventions. The next part of this thesis discussed the development and psychometric testing of MRB-QoL tool. After undergoing item reduction using Exploratory Factor Analysis (EFA), MRB-QoL items were reduced from 76 items to 31-items, with a 5 factor solution explaining 72% of the total variance. The five factors were interpreted as: Routine and regimen complexity (11 items), Psychological burden (6 items), Functional and role limitation (7 items), Therapeutic relationship (3 items), and Social burden (4 items). All factors showed good internal consistency reliability (Cronbach’s alpha ranging from 0.87 to 0.95). Discriminant validity was demonstrated via the tool’s correlations with MRCI (r -0.16 to 0.05), DBI (r 0.12 to 0.28), and CCI (r -0.23 to -0.15). Patients on polypharmacy, multiple morbidity, and DBI>0 had higher scores of MRB-QoL indicating evidence for known group validity. In a cross-sectional study conducted applying MRB-QoL as an outcome measure, exposure to medicines with anticholinergic and sedative effects (DBI>0) was the only medicine related factor significantly associated with multiple domains of MRB-QoL. In a multivariate linear regression analysis, an increase in DBI was significantly associated with a decrease in psychological (β -0.15, p<0.001) and functional well-being (β -1.79, p<0.001) whereas both polypharmacy and MRCI were not associated with any of the MRB-QoL domains. Overall, this study provided preliminary evidence for potential factors associated with MRB-QoL outcomes. Future longitudinal studies are proposed to better understand predictors of MRB-QoL, with then the potential for this tool to be utilized as a robust measure in clinical intervention studies as an appropriate humanistic measure of the impact of PC services. Conclusions Prior to the commencement of this thesis, the sensitivity and specificity of HRQoL measures to PC interventions was unknown. Specifically, no systematic body of work had been conducted to provide an in-depth insight into the magnitude of PC interventions on HRQoL, the extent of sensitivity of the domains of HRQoL to PC interventions, nor whether the items of HRQoL pertained specifically to medicines. Additionally, comprehensive investigation into Medication-Related Burden (MRB) had not been attempted. The body of work presented in this thesis uncovered the gap in the literature regarding evidence pertaining to the impact of PC on HRQoL outcomes, and the sensitivity of measures of HRQoL to PC interventions. This thesis has demonstrated that existing HRQoL measures have limited use as sole humanistic measures for evaluation of PC interventions, they do not have focus on the burden imposed by medicines. Thus, the judicious selection of HRQoL measures for evaluation of PC interventions is crucial from research, practice and policy perspectives. This includes consideration of the proximity of the content of HRQoL measure to PC services, and their sensitivity to capture changes in quality of life attributed to the burden of medicine. This thesis has also demonstrated a wholistic and profound understanding of MRB i.e. the physical, social, psychological and financial burden of medicine use on patient’s health and well-being (Chapter Three, Figure 4). MRB has been conceptualized as the difference between the observed and theoretically expected post treatment HRQoL (Figure 3). The overall work presented in this thesis resulted in the development and validation of MRB-QoL, which is the first comprehensive measure of the burden of medicine use on functioning and well-being. With good initial psychometric properties (i.e. internal consistency reliability, construct, known groups, discriminant and convergent validity), MRB-QoL is a promising patient self-reported measure of physical, social and psychological burden of medicine use. It is a tool that has the potential to be applied in research pertaining to the evaluation of medication focused interventions. In clinical practice, it may aid screening of patients at high risk of experiencing medication related burden. Identification of high risk patients and detection of the particular burden encountered, is an opportunity for health care providers to make an informed decision about ongoing therapies for patients. In the future, with further psychometric testing of MRB-QoL along with good uptake in clinical practice and research, MRB-QoL has the potential to inform patient care and thereby help minimize the burden of medicine taking on health and well-being of patients

Background: Health-Related Quality of Life (HRQOL) can be negatively affected in patients living with arrhythmias and many patients experience a pronounced symptom burden. The arrhythmia can cause both uncertainty and limitations, including interference with work, reluctance to perform and plan for leisure activities and leading to self-imposed restrictions in daily life situations. There are patients striving to find strategies to manage the arrhythmia and for some this can become the focus in their lives. Treatment options are often a choice between pharmaceuticals and radiofrequency ablation (RFA) where RFA is an option for many arrhythmia-patients to be cured. In the care of arrhythmia-patients it is of great importance to combine objective examinations with patient-reported outcomes (PROs) to achieve patient’s own experiences of treatment efficacy and arrhythmias interference in daily life situations. Aims: The overall aims of this thesis were to assess symptom burden and HRQOL in patients with arrhythmias and to develop and validate an arrhythmia-specific questionnaire, suitable for most arrhythmia-patients. Design and Methods: Studies I and II were single-centre studies including patients referred for RFA, with two different arrhythmia diagnoses. Assessments of patient-reported outcomes (PROs) concerning HRQOL were performed using two questionnaires, SF-36 and EQ-5D (I-II). Further, patients were asked some disease-specific questions (I). Study I describes assessments before the RFA treatment and Study II the follow-up assessments at three and twelve months after RFA. Patients’ scoring of HRQOL was compared to age and gender matched reference groups before and after RFA (I-II). Studies III and IV describe the development and validation of a disease-specific questionnaire ASTA (Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia) assessing symptom burden and HRQOL. Studies III and IV were multicentre studies. Patients planned for DC-conversion, AF patients seeking emergency care and those with different forms of arrhythmias referred for RFA were included. Results: Patients scored significantly lower HRQOL in seven of SF-36’s eight scales compared to the age and gender matched reference groups before RFA treatment. Frequent arrhythmia attacks had a great negative impact on HRQOL, and female gender and older age were factors contributing to worse HRQOL (I). Treatment with RFA restored the patients’ HRQOL. Most positive effects were seen at three months follow-up. One year after treatment patients and the matched reference group scored their HRQOL to a similar level, assessed with SF-36 and EQ-5D index (II). The validated ASTA questionnaire was found to have good psychometric properties. Construct validity was confirmed with sufficient levels of item-total correlations in the ASTA symptom burden scale and HRQOL scales. The dimensionality of the ASTA HRQOL scale was established with confirmatory factor analysis, supporting a physical and a mental subscale. The internal consistency, demonstrated with Cronbach’s alpha (α), was satisfactory for the ASTA symptom burden scale and the ASTA HRQOL scales, varying from α 0.79 to α 0.91 (III-IV). Conclusions and clinical implications: The studies in this thesis confirmed how negatively affected the arrhythmia-patients can be with a pronounced symptom burden and impaired HRQOL. Treatment with RFA was demonstrated to restore the patients HRQOL to an equal level of that of the matched reference group. PROs are important to take into consideration in the care of arrhythmia-patients, to achieve the patients’ subjective experiences of their daily life situation. To the best of our knowledge ASTA is the first arrhythmia-specific questionnaire assessing symptom burden and HRQOL, suitable for most arrhythmia forms. The newly validated ASTA questionnaire can be an important contribution to assessment of PROs in arrhythmia-patients.

This conceptual paper outlines the descriptive theoretical foundations or kernel theories for designing an information and communication technology (ICT) tool to assess professional competences in the Austrian trade and craft sector. Upon completion, the ICT-tool serves as a boundary object in which applicants and assessors can interact. While this paper consists of a literature review and conceptual discussion, the overall project is methodologically placed within a multidisciplinary design-science paradigm. Design science scaffolds and structures the development of a theoretical model, the generation of assessment-items and the ICT-tool itself. This paper discusses the necessary descriptive knowledge or kernel theories on which the design of the ICT-tool rests. First, we describe the validation of prior learning - a process advocated by the European Union to make professional competences visible. Second, we describe the process how professional competences come about: through formal, non-formal and informal learning. Subsequently, we outline a knowledge-driven discourse on professional competences and discuss how different definitions of professional competence afford different approaches for its assessment. By presenting a use-case, we outline how the ICT-tool may guide applicants and assessors through this process.

Studies investigating exposure to disinfection by-products (DBPs) via chlorinated waters during pregnancy and adverse fetal growth outcomes have been limited by potential exposure measurement error, lack of exposure assessment validation and potential residual confounding. Factors driving DBP exposure are poorly understood, making it difficult to target resources appropriately in order to improve exposure assessment. These issues were investigated through DBP exposure assessment and validation for a new investigation of DBPs and fetal growth within the Born in Bradford (BiB) cohort study. Analysis of individual water use in the BiB cohort found that water consumption, showering, bathing and swimming varied by demographic and lifestyle factors. Sampling, analysis, and modelling of trihalomethanes (THMs) in tap water showed that THM concentrations exhibited clear seasonal variation, but spatial variability was limited across the study area. Various metrics of exposure to THMs during pregnancy were created, including ‘personalised’ semi-individual metrics. Analysis of these metrics revealed individual water use to be the main driver of THM exposure in this cohort, with spatial and temporal variability having little influence. Compared with a fully integrated THM exposure metric (incorporating ingestion, showering/bathing and swimming), metrics based only on THM concentrations or THM ingestion misclassified over 50% of women. A nested validation study was conducted using a 7-day water diary and urinary trichloroacetic acid (TCAA) biomarker. This found error in self-reported water use and TCAA ingestion estimates to vary by employment status - error being greater for employed women. Urinary TCAA was not correlated with TCAA in tap water, reinforcing that individual water use is the most influential driver of DBP exposure in this cohort. Recommendations for future research include improved individual water use assessment covering more activities and time-points in pregnancy, stratified analysis of questionnaire validation studies, and use of urinary TCAA as a main exposure measure in epidemiological studies.

The Oxford Knee Score (OKS) is a popular single summary questionnaire developed to measure the effect of knee replacement surgery from the patients' perspective. There has been a recent interest in the use of the OKS in populations of patients and in roles it has not been originally developed for. To date, no evidence has been provided about the measurement properties of the OKS when it is used outside the context or purpose for which it was originally designed. The general aim of this thesis is to investigate the measurement properties of the OKS when used in extended roles: a) within the population for which the OKS was originally intended and developed for (knee replacement) and, b) when applied on a different population, viz. patients undergoing non-operative treatment for knee osteoarthritis (OA). Four existing large-scale databases of patients undergoing knee replacement surgery and a database obtained from a prospective study on patients undergoing non-surgical management for knee OA were analyzed. The results demonstrate that: 1) it is possible to extract separate information on pain and functional disability from the OKS in a meaningful way (in the form of subscales). 2) For the first time, anchor-based Minimal Important Change (MIC) of 9 points and Minimal Important Difference (MID) of 5 points were established for joint replacement surgery. 3) The OKS demonstrated satisfactory evidence reliability, validity, responsiveness, and interpretability, when used in patients who are undergoing non-operative management for their knee OA. 4) Further evidence of validity was demonstrated by fitting the OKS to the Rasch model. 5) Lastly, it was demonstrated that thresholds can be applied on the OKS to distinguish between patients who consider their knee problem to be severe enough to warrant joint replacement surgery versus patients who do not. This supports the potential use of the OKS in decision making aids for secondary care referral. Overall the thesis provides critical evidence, not previously existing, to support the continued use, and extended use, of the OKS in orthopaedic medicine.

This doctoral thesis aimed to better understand the relationship between coping and achievement in the post-secondary academic setting within the classic transactional model of stress and coping (Lazarus, 1991, 1999). Article 1 included the development of the Coping Inventory for Academic Striving (CIAS). The CIAS was developped to address limitations in the measurement of coping in the post-secondary setting. The results of two studies supported a psychometrically sound questionnaire measuring 11 coping strategies organized within task-oriented and disengagement-oriented coping dimensions. Tests of the concurrent, predictive, and incremental validity examining the relationships between the antecedents and outcomes of coping supported the conceptual independence of the task- and disengagement-oriented coping dimensions. Using this conceptual framework in Article 2 and 3, two daily diary studies were conducted in university students to examine the relationship between coping and goal progress. Individual differences in coping exist because not all students are coping the same way (i.e., between-person level). However, coping behaviours are also likely to vary from one day to the other during a typical week of the academic year (i.e., within-person level). Therefore in Article 2, new research questions pertaining to appraisal, coping, and goal progress were examined at both the between-person and within-person levels of analysis. While most effects were homologous, different within-person and between-person associations were found. Importantly, individual tendencies toward threat appraisal related to goal disengagement, but the momentary appraisal of threat can bring awareness to goal interferences redirecting goal directed behaviour. Finally, Article 3 tested an experimental coping skills training program whereby students in the experimental condition set if-then coping plans to manage negative emotions detrimental to the pursuit of daily studying goals. Daily over the course of a week, students in the experimental group reported lower levels of stress and negative emotions and higher levels of studying time in comparison to students in the control group. However, the effect of the intervention on some indicators of performance and emotions were only applicable to students with a limited coping repertoire. The development of this coping training skills program aimed to create bridges between coping theory and preventive coping interventions.

The use of Patient-Reported Outcomes Measures (PROMs), which considers the patient\'s perspective on his/her own health and treatment, has gained importance on clinical practice and research. The Patient-Reported Outcomes Measurement Information System (PROMIS®) revolutionized the area when it started providing precise and valid item banks in different health domains, calibrated by the Item Response Theory (IRT), and used for the evaluation of the impact of different chronic diseases on the patient\'s quality of life. The aim of this study was to translate, cross-culturally adapt and validate the PROMIS® Global Health Item Bank into Portuguese. The Functional Assessment of Chronic Illness Therapy (FACIT) methodology was used to translate and cross-culturally adapt the ten items of the bank. The final version of the assessment tool translated into Portuguese was self-administered in 1010 patients. The statistical analysis conducted were: ceiling and floor effects, internal consistency reliability, test-retest reliability, convergent validity, construct validity through exploratory and confirmatory factor analysis, and item calibration through Samejima\'s Graded Response Model (GRM). Four global items needed to be adjusted after pre-test. The analysis of the psychometric properties showed that the PROMIS® Global Health Item Bank has good reliability Cronbach\'s alpha was 0.83 and intra-class correlation coefficient was 0.89. The correlation between the assessment tool and the physical and psychological domains of the WHOQOL-bref ranged from moderated to strong (rho = 0.478 and 0.571, respectively). The exploratory and confirmatory factor analysis confirmed the validity of the item bank, since they showed a good adjustment to the two dimensional model previously established (Global Physical Health scale: CFI = 0.99, TLI = 0.98, RMSEA = 0.04, SRMR = 0.019; Global Mental Health scale: CFI = 1.00, TLI = 1.00, RMSEA = 0.00, SRMR = 0.011). The Global Physical Health and Global Mental Health scales showed good coverage of the latent trait according to Samejima s Graded Response Model. The PROMIS® Global Health Item Banks translated into Portuguese achieved conceptual, semantic, cultural, and operational equivalences, and demonstrated satisfactory psychometric properties regarding its use in Brazilian patients for clinical practice and research.
A utilização das Medidas de Resultados Relatados pelo Paciente (MRRP), as quais, incorporam a perspectiva do próprio paciente acerca de sua saúde e tratamento, tem ganhado relevância na prática clínica e em pesquisa. O Patient-Reported Outcomes Measurement Information System (PROMIS®) revolucionou esta área ao fornecer bancos de itens precisos e válidos, de vários domínios da saúde, calibrados pela Teoria de Resposta ao Item (TRI) e destinados à avaliação do impacto de diversas doenças crônicas na qualidade de vida dos indivíduos. O objetivo do presente estudo foi traduzir, adaptar transculturalmente e validar o Banco de Itens Saúde Global do PROMIS® para a língua portuguesa. Os dez itens Saúde Global foram traduzidos e adaptados transculturalmente por meio da metodologia proposta pelo Functional Assessment of Chronic Illness Therapy (FACIT). A versão final do instrumento para a língua portuguesa foi autoadministrada em 1010 participantes. As análises estatísticas realizadas foram: efeito piso e teto, confiabilidade da consistência interna, confiabilidade teste-reteste, validade convergente, validade de construto por meio da análise fatorial exploratória e confirmatória, e calibração dos itens por meio do Modelo de Resposta Gradual proposto por Samejima. Quatro itens globais necessitaram de ajustes após a realização do pré-teste. A análise das propriedades psicométricas demonstrou que o Banco de Itens Saúde Global tem boa confiabilidade, com coeficiente alfa Cronbach de 0,83 e coeficiente de correlação intraclasse de 0,89. A correlação entre este instrumento e os domínios físico e psicológico do WHOQOL-bref foi de moderada a forte (rho = 0,478 e 0,571, respectivamente). As análises fatoriais exploratória e confirmatória comprovaram a validade deste banco de itens, pois revelaram um bom ajuste ao modelo previamente estabelecido de duas dimensões (escala Saúde Física Global: CFI = 0,99, TLI = 0,98, RMSEA = 0,04, SRMR = 0,019; e escala Saúde Mental Global: CFI = 1,00, TLI = 1,00, RMSEA = 0,00, SRMR = 0,011). As escalas Saúde Física Global e Saúde Mental Global apresentaram uma boa cobertura do traço latente de acordo com o Modelo de Resposta Gradual. Os itens Saúde Global do PROMIS® para a língua portuguesa apresentaram equivalência conceitual, semântica, cultural e operacional em relação à versão original em inglês norte-americano e propriedades psicométricas satisfatórias para aplicação direcionada à população brasileira na prática clínica e em pesquisas.
Mestre em Ciências da Saúde

L’objectiu global d’aquesta tesis doctoral va ser identificar les fortaleses i limitacions de les mesures de Qualitat de Vida Relacionada amb la Salut desenvolupades específicament per pacients amb insuficiència cardíaca. Una revisió sistemàtica va trobar 7 qüestionaris de Qualitat de Vida Relacionada amb la Salut específics per insuficiència cardíaca: Chronic Heart Failure Assessment Tool (CHAT), Cardiac Health Profile congestive heart failure (CHPchf), Kansas City Cardiomyopathy questionnaire (KCCQ), Left Ventricular Disease Questionnaire (LVDQ), Minnesota Living with Heart Failure questionnaire (MLHFQ), i Quality of Life in Severe Heart Failure Questionnaire (QLSHFQ). L’evidència publicada fins 2006 senyalava el MLHFQ com el qüestionari més estès i recomanable. La versió espanyola del MLHFQ va mostrar característiques similars a l’original, així com també l’avaluació conjunta de versions de 20 països. A més, l’avaluació del model de mesura va confirmar la unidimensionalitat de la puntuació total del MLHFQ, i les seves dimensions física, emocional i social. L’actualització al 2011 de la revisió sistemàtica juntament amb l’avaluació estandarditzada per experts, varen destacar les propietats mètriques del KCCQ per sobre de les del MLHFQ.

A relevância desta investigação está em descrever os Resultados de Enfermagem (RE) propostos pela Classificação dos Resultados de Enfermagem (NOC), passíveis de utilização na prática clínica. Os objetivos deste estudo foram identificar, na primeira etapa, os dois Diagnósticos de Enfermagem (DE) mais frequentes em internações de pacientes clínicos, cirúrgicos e de terapia intensiva em um hospital universitário; validar, na segunda etapa, os REs NOC para os dois DEs em estudo; e validar, na terceira etapa, os indicadores dos REs da NOC validados anteriormente para o DE mais freqüente. A validação dos REs e de seus respectivos indicadores foi realizada tendo por base adaptação do modelo de Fehring, obtendo-se o consenso de 12 enfermeiros peritos que concordaram em participar da pesquisa, aprovada em comitê de pesquisa e ética das instituições envolvidas. O instrumento de coleta de dados na segunda etapa se constituiu dos REs propostos pela NOC para os dois DEs em estudo, sua definição e uma escala Likert de cinco pontos, destinada à pontuação conforme seu grau de importância na opinião dos peritos. Na terceira etapa, os indicadores de cada RE anteriormente validado também foram pontuados em escala Likert. Os dados foram analisados por estatística descritiva, considerando-se a média ponderada dos escores. Foram validados os REs que obtiveram médias iguais ou maiores a 0.80. O DE Risco de Infecção foi o mais freqüente, sendo validados oito (38,1%) dos 21 REs propostos pela NOC. O DE Déficit no Autocuidado: Banho/Higiene foi o segundo DE mais freqüente e cinco (14,28%) dos 35 REs foram validados. Dos 132 indicadores propostos para os oito REs validados para Risco de Infecção, 67 (50,75%) foram validados. A utilização da NOC, embora recente em nosso meio, apresenta-se como uma alternativa viável para avaliar e identificar as melhores práticas de cuidado de enfermagem.
La relevancia de esta investigación es describir los Resultados de Enfermería (RE) propuesto por la Clasificación de los Resultados de Enfermería (NOC), que pueden ser utilizados en la práctica clínica. Los objetivos de este estudio fueron identificar, en la primera etapa, los dos Diagnósticos de Enfermería (DE) más frecuentes en los pacientes clínicos, quirúrgicos y críticos hospitalizados en un hospital universitario; validar en la segunda etapa, los resultados NOC de los dos DEs en el estudio, y validar, en la tercera etapa, los indicadores de los REs NOC previamente validado para el DE con más frecuencia. La validación de los REs y sus respectivos indicadores se ha realizado sobre la adaptación del modelo de Fehring, obteniendo el consenso de 12 enfermeros expertos que han aceptado participar en la investigación, aprobadas en Comisión y Ética de la Investigación de las instituciones involucradas. El instrumento de recolección de datos, en la segunda etapa, consistió de los REs propuesto por la NOC para los dos DEs en el estudio, las definiciones, y una escala Likert de cinco puntos, para la puntuación de su nivel de importancia en la opinión de los expertos. En la tercera fase, los indicadores de cada RE previamente validado también recibieron calificaciones en una escala de Likert. Los datos fueron analizados por estadística descriptiva, teniendo en cuenta la media ponderada de las puntuaciones. Fueron validados los REs que obtuvieron un promedio igual o superior a 0,80. El DE más frecuente fue Riesgo de Infección, que tuvo ocho (38,1%) de los 21 REs propuestos por la NOC validados. El DE Déficit en el Autocuidado: Baño/Higiene fue el segundo más frecuente y cinco (14,28%) de 35 REs fueron validados. De los 132 indicadores para los ocho REs validado para Riesgo de Infección, 67 (50,75%) fueron validados. El uso de la NOC, aunque reciente en nuestro país, se presenta como una alternativa viable para evaluar y determinar las mejores prácticas en la atención de enfermería.

Na prática clínica, o enfermeiro precisa sistematizar o cuidado baseado em aspectos que visam garantir a segurança e a qualidade do cuidado aos pacientes. Entre esses aspectos salienta-se que os registros de enfermagem sejam realizados de maneira plena e, principalmente, que sejam compreendidos e valorizados. É nessa perspectiva que a utilização de uma terminologia e sistemas eletrônicos aliados ao processo de enfermagem ganham espaço, favorecendo a qualidade dos registros. A avaliação da qualidade desses registros pode se dar por meio de um instrumento denominado Quality of Diagnoses, Interventions and Outcomes (Q-DIO), publicado em língua inglesa e validado apenas na Suíça. O Q-DIO tem como principal objetivo avaliar a qualidade dos registros de enfermagem. Somado a isso, tem sido utilizado como um indicador para comparar a qualidade dos registros com e sem linguagem padronizada, definir metas, avaliar o impacto da implementação de programas educacionais e ainda, em sistemas de auditoria. Existe uma lacuna no Brasil, assim como nos Estados Unidos da América (EUA), de instrumentos que avaliem questões relativas à qualidade dos registros de enfermagem. Foi nessa perspectiva que esse estudo metodológico foi desenvolvido para validar o Q-DIO no Brasil e nos EUA. O Q-DIO é composto por 29 itens, dividido em quatro domínios (diagnósticos de enfermagem como processo, diagnósticos de enfermagem como produto, intervenções de enfermagem, resultados de enfermagem), composto por escala Likert de três pontos. Para validação do instrumento foram elegíveis registros de pacientes em pós-operatório de cirurgia cardíaca que tiveram registrados em prontuário o histórico, as evoluções e as prescrições de enfermagem entre um período mínimo de quatro dias. A amostra foi de 180 registros, distribuídos igualmente entre os três centros do estudo, dois no Brasil (centros 1 e 2) e um nos EUA (centro 3). Dentre as propriedades psicométricas, foram avaliadas fidedignidade (consistência interna e estabilidade) e a validade de constructo divergente. Os valores do alfa de Cronbach para as 29 questões foram superiores a 0,70 para todos os centros. Com relação à estabilidade, o coeficiente de correlação intraclasse variou entre 0,64 e 0,85 para intraobservador e 0,68 a 0,82 para interobservador, o que indica níveis satisfatórios e excelentes de concordância. Na validade de constructo divergente observou-se diferença estatística significativa entre as médias da soma dos 29 itens do instrumento entre os três centros. O centro 1 (registros eletrônicos com linguagem padronizada) apresentou média de 36,8(±4,5) [IC95%: 35,63-37,94]; o centro 2 (registros manuais sem linguagem padronizada) obteve média de 11,533(±6,2) [IC95%:9,93-13,14]; o centro 3 (registros eletrônicos sem linguagem padronizada) teve média de 31,2(±5,3) [IC95%: 29,87-32,63]. Esses resultados indicam que o Q-DIO é fidedigno e válido para avaliar a qualidade de registros de enfermagem eletrônicos ou não, e que utilizem ou não linguagem padronizada no Brasil; também nos EUA esse instrumento se mostrou fidedigno e válido para dados eletrônicos sem uso de terminologia padrão.
In clinical practice, nurses must systematize their practice based in certain aspects intended to ensure the safety and quality of the patient care. Among such aspects should be noted that the nursing records must be fully completed, understood, and valued. Taking this into consideration, the use of terminology and electronic systems along with the nursing processes favor the quality of nursing records. The assessment of the quality of such records may be obtained through an instrument called Quality of Diagnoses, Interventions and Outcomes (Q-DIO), published in English and validated in Switzerland. The Q-DIO's main objective is to assess the quality of the nursing records, although it has also been used as an indicator to compare the quality of records with and without standardized language, to set goals, to evaluate the impact of implementing educational programs, and to give some help in audit systems. There is a lack of instruments capable of assessing issues related to the quality of nursing records in Brazil and in the United States (U.S.). It was because of it that this methodological study was developed: to validate the Q-DIO instrument in Brazil and in the U.S. The Q-DIO is composed of 29 items, divided into four domains (nursing diagnoses as process, nursing diagnoses as product, nursing interventions, and nursing outcomes), composed of a three-point Likert scale. To validate the instrument, records from patients in the period after a cardiac surgery, and who had in their historical records trends and nursing prescriptions between a minimum of four days, were selected. The sample has a total of 180 records, divided equally between the three study centers, being two located in Brazil (center 1 and 2) and one in the U.S. (center 3). Among the psychometric properties, reliability (internal consistency and stability) and divergent construct validity were those evaluated. The values of Cronbach's Alpha for the 29 questions were superior to 0.70 for all centers. Regarding stability, the intraclass correlation coefficient ranged between 0.64 to 0.85 for intraobserver, and 0.68 to 0.82 for inter-observer, which indicates excellent and satisfactory levels of agreement. In divergent construct validity, statistically significant differences were observed in the average of the sum of the 29 items of the instrument among the three centers. Center 1 (electronic records with standardized language) had an average of 36.8 (± 9.5) [95%CI: 35.63-37.94]; center 2 (manual records without standardized language) had an average of 11.53 (± 6,2) [95%CI: 9.93-13.14]; and center 3 (electronic records without standardized language) presented an average of 31.2 (± 5.3) [95%CI: 29.87-32.63]. These results indicate that Q-DIO is valid and reliable for assessing the quality of nursing records, being them electronic or not, using standardized language or not, at least in Brazil. In the U.S., this instrument has also proved to be reliable and valid for electronic nursing records without use of standardized language.
En la práctica clínica el enfermero precisa sistematizar el cuidado a partir de aspectos que objetivan garantizar seguridad y calidad del cuidado a los pacientes. Entre esos aspectos destacamos que los registros de enfermería sean realizados de manera plena y principalmente que sean comprendidos, valorados. Es en esta perspectiva, que la utilización de una terminología y de sistemas electrónicos coligados al proceso de enfermería obtienen espacio favoreciendo la calidad de los registros. La evaluación de la calidad de dichos registros puede ser a través de un instrumento nombrado Quality of Diagnoses, Interventions and Outcomes (Q-DIO) publicado en idioma inglés y validado solamente en Suiza. Q-DIO posee por objetivo principal evaluar la calidad de los registros en enfermería. A eso se suma su utilización como un indicador para comparar la calidad de registros con y sin lenguaje patrón, establecer fines, evaluar impacto de la implementación de programas educativos y aún, en sistemas de auditoría. Existe una falla en Brasil, así como en Estados Unidos de América (EUA) sobre instrumentos que evalúen cuestiones relacionadas a la calidad de los registros de enfermería. Fue en esa perspectiva que este estudio metodológico ha sido desarrollado para validar el Q-DIO en Brasil y EUA. Q-DIO está compuesto de 29 puntos, dividido en cuatro aspectos (diagnósticos de enfermería como proceso, diagnósticos de enfermería como producto, intervenciones de enfermería, resultados de enfermería), compuesto por escala Likert de tres puntos. Para validación del instrumento han sido elegidos registros de pacientes en pos operatorio de cirugía cardiaca, que tuvieron registrados en prontuario o histórico y las evoluciones y prescripciones de enfermería entre un periodo mínimo de cuatro días. La muestra fue de 180 registros, distribuidos igualmente entre los tres centros del estudio; dos en Brasil (centro 1 y 2) y uno en EUA (centro 3). Entre las propiedades psicométricas fueron evaluadas la fidedignidad (consistencia interna y estabilidad) y la validez del constructo divergente. Los valores de Alfa de Cronbach para las 29 cuestiones fueron superiores a 0,70 para todos los centros. En lo que se refiere a la estabilidad, el coeficiente de correlación intra-clase tuvo variación entre 0,64 y 0,85 para intra-observador y 0,68 a 0,82 para inter-observador, lo que indica niveles satisfactorios y excelentes de concordancia. En la validad de constructo divergente se pudo observar una diferencia estadística significativa entre las medias de la suma de los 29 puntos del instrumento entre los tres centros. El centro 1 (registros electrónicos con lenguaje patrón) presentó media de 36,8 (+_ 4,5) [IC95%: 35,63 – 37,94], centro 2 (registros manuales sin lenguaje patrón) obtuvo media de 11,53 (+_ 6,2) [IC 95%: 9,93-13,14] y el centro 3 (registros electrónicos sin lenguaje patrón) con media de 31,2 (+_5,3) [IC95%: 29,87-32,63]. Tales resultados indican que Q-DIO es fidedigno y válido para evaluar la calidad de los registros de enfermería, sean ellos electrónicos o no, y que utilicen lenguaje patrón o no en Brasil, así como, en EUA dicho instrumento también se ha mostrado fidedigno y válido para datos electrónicos sin uso de la terminología patrón.

There has been a long-standing need in the field of psychotherapy to document progress and show effectiveness. The evidence-based practice (EBP) movement has had considerable influence in the field of psychology as evidenced by the APA task force that adopted the stance of evidence-based practice in psychology (EBPP) to ensure quality and accountability for psychological services as well as the integration of science and practice. One of the primary components of EBPP is the use of routine outcome measures (ROMs), which seek to integrate research with practice while simultaneously documenting progress and enhancing treatment. Despite the wave of ROM in the field, implementation rates have remained low. Research has brought forth many practical and philosophical concerns of therapists using these measures in routine practice including time burden and local validity. The Clinically Adaptive Multidimensional Outcome Survey (CAMOS) was created to directly address clinicians' concerns with a specific focus on concerns of local validity. The CAMOS was designed to monitor several dimensions of functions, thus covering a wide range of issues. In this study the item pool proposed for the CAMOS was factor analyzed, and acceptable fit was found for a 6-factor model that contained 42 items. The 6 factors include (a) psychological distress, (b) relationship distress, (c) therapy expectations, (d) spiritual distress, (e) physical health distress, and (f) work/school distress. It is of note that spirituality emerged as a distinct factor with this data set and the implications and applications are discussed. With this multidimensional foundation, clinicians could more flexibly use the CAMOS to increase local validity. Clinical applications and future directions are discussed.

Head and neck cancer (HNC) is the second most common cancer in India due to high rates of tobacco & alcohol consumption. Its proximity to anatomical sites involving appearance, communication, & eating, may result in unique effects. Unmet needs & psychological morbidity are likely to be high in this population, but assessments have been hampered by the lack of patient-reported outcome measures (PROMs) in Indian languages. This study aimed to find HNC-relevant PROMs assessing body image, unmet needs, anxiety & depression; translate them into Tamil, Telugu and Hindi and achieve linguistic & psychometric validation. Systematic reviews identified PROMs which were then translated following international guidelines. Health care professionals & HNC population speaking the chosen languages were recruited from cancer centres in India. For the validation study, consenting participants completed translated versions of Body image scale (BIS), Patient Concerns Inventory (PCI), Zung’s self-rating anxiety scale (SAS) & Patient health questionnaire-9 (PHQ-9). Health-related quality of life (HRQL) information were also obtained. Nine healthcare professionals & 29 HNC patients participated in the linguistic validation study; semantic, cultural and conceptual issues were identified and resolved to achieve equivalence between translated and original versions of the PROMs. For the validation study, 621 HNC population (Tamil = 205, Telugu = 216 & Hindi = 200) participated. PROMs were reliable & valid and as hypothesized, HRQL correlated with PROMs across all three languages. Results from PCI showed ‘fear of cancer recurrence’ & ‘cancer treatment’ were commonly reported. Routine assessment of psychological morbidity in HNC population is an efficient and cost-effective means of identifying psychosocial impact of HNC & treatment. Translated PROMs are acceptable and can be used in both research & clinical settings to help improve services for Indian HNC populations around the globe.

Thesis (MScPhysio (Interdisciplinary Health Sciences))--Stellenbosch University, 2008.
Introduction In clinical physiotherapy, there is a growing importance for the accuracy and reliability of assessment and outcome measures. The purpose of this study is to develop a valid outcome measure for orthopaedic trauma inpatients. Item generation was done by conducting a systematic review of published functional outcome measures and patients' interview. Item reduction was conducted by using a panel of physiotherapists and patients. Objectives The overall study objectives were: 1) To determine if a functional outcome measurement scale for trauma inpatients exists and has been published; 2) To generate functional items for the construction of a new outcome measurement tool for trauma inpatients; 3) To construct a new outcome measurement tool for trauma inpatients and assess elements of validity and reliability (face and content validity, response to change, internal consistency and floor and ceiling effects) of the new developed outcome measure. Methodology Convenience sampling was applied to collect data from 35 trauma inpatients in trauma wards at Rashid Hospital in Dubai, UAE. 88% of the trauma inpatients were male (total sample n= 100), mean age =34.75, and the standard deviation = 14.46. 21 functional activity items were generated from the collated results of the patient interviews. Internal consistency reliability, responsiveness and floor and ceiling effect were assessed. Data analysis was conducted using Statistica Version 7. Results The final number of functional activity items included in the newly developed Functional Scale outcome measure was 29 activity items relevant for trauma inpatients. A Cronbach's alpha ranged between 0.76 and 0.97. The lowest alpha result was for the 'ADL' activities at follow-up (0.76). The highest alpha result was for 'out of bed' activity at admission and discharge (0.97). The response to change of the Functional Scale for trauma inpatients over time results illustrates that there was a significant difference in the mean scores over three administrations of 'Bed', 'Out of bed' and 'ADL' activity items of Functional Scale for trauma inpatients (p=O.OOOO). In general, there was no significant floor and ceiling effects at admission or discharge for 'bed', 'out of bed' and 'ADL' activities, except there was a floor effect noted at discharge for 'bed' activities and 'ADL' activities, and a ceiling effect noted at admission for 'out of bed activities' only. Discussion and Conclusion The newly developed Functional Scale outcome measurement for trauma inpatients has been shown to be internally consistent and appears to be valid with respect to response to change in this sample of trauma inpatients. The results of this study thus suggest that the Functional Scale for trauma inpatients may be an appropriate tool when the goal is the assessment of change in disability functions in trauma inpatients, although further psychometric testing may be required.

La présente étude s’intéresse au développement et à la validation d’une version pour téléphone intelligent de la version française du Schwartz Outcome Scale – 10 (SOS-10F; Blais et coll., 1999; Laux et coll. 2006). Quarante-quatre participants recrutés dans la communauté universitaire de l’Université Laval ont rempli la version papier et la version pour téléphone intelligent du SOS-10F afin d’en évaluer l’équivalence. Les participants ont également rempli un questionnaire destiné à évaluer l’acceptabilité de la nouvelle mesure. L’accord entre les mesures tel qu’estimé était excellent (ICC = 0.98), suggérant que les deux versions du SOS-10F peuvent être utilisées de façon interchangeable. L’analyse de Bland-Altman suggère également que les différences obtenues entre les deux versions sont adéquates dans un contexte clinique. L’acceptabilité de la version pour téléphone intelligent était forte avec 86,4% des participants considérant cette version comme aussi ou plus facile d’utilisation que la version papier et 70,5% préférant autant ou plus cette version que la version papier. Cette étude suggère que la version pour téléphone intelligent du SOS-10F pourrait être utilisée de façon équivalente à la version papier, mais davantage de recherche sera nécessaire avant de le recommander dans un contexte clinique.
This study is about the development and validation of a smartphone version of the french-language translation of the Schwartz Outcome Scale – 10 (SOS-10F; Blais et coll., 1999; Laux et coll. 2006). Forty-four participants were recruited from the Université Laval community and completed both the paper and smartphone version of the SOS-10F in order to assess the agreement between the two. Participants also completed a questionnaire to evaluate the acceptability of the new instrument. The measured agreement between the two instruments was excellent (ICC = 0.98), suggesting that the two versions of the SOS-10F can be used interchangeably. A Bland-Altman analysis also suggests that the observed differences between the instruments were adequate for usage in a clinical setting. The acceptability of the smartphone version was high with 86,4% of participants saying this version was as easy or easier to use than the paper version and 70,5% preferring this version as much or more than the paper version. Results suggest that the smartphone version of the SOS-10F could be used interchangeably with the paper version, but more research is necessary before this version could be recommended in a clinical setting.

Maternal obesity is associated with adverse effects for mothers and offspring. The primary aim of this thesis was to assess food intake and physical activity (PA) using validated self-administered questionnaires, and whether these were associated with gestational weight gain (GWG) and birthweight (BWT), in severely obese (body mass index, BMI≥40kg/m2) compared with lean pregnant women (BMI 20-25kg/m2). The secondary aims were to validate self-reports against food diary (FD) and accelerometry; to assess the prevalence of under or over-reporting of energy intake; and to carry out a pilot study to assess total energy expenditure, as well as self-reporting accuracy, by using doubly-labelled water (DLW) technique, in subgroups of participants. Pregnant women were recruited from an ongoing study of severe obesity in pregnancy at the Royal Infirmary of Edinburgh, UK. Assessments were done in early (12-20 weeks) and late (28-32 weeks) pregnancy. A subgroup of women also completed questionnaires on appetite, general nutrition knowledge, and eating behaviours. All results were adjusted for age, parity, ethnic origin and deprivation category score. Self-reported total energy intake was not significantly different between obese and lean during early (median 2,444 vs 2,312 kcal/day) and late (2,173 vs 2,354 kcal/day) pregnancy. However when validated with FD, the relative validity of the food frequency questionnaire was lower in obese compared to lean. Under-reporting of total energy intake was higher in obese compared to lean (49% vs 15%, P<0.01) through comparison of selfreported energy intake with estimated total energy expenditure, and this was supported by the DLW pilot study results. The DLW also showed possible over-reporting of PA by the obese group. Obese women reported significantly lower appetite than lean throughout pregnancy (P<0.01). They also had lower scores in general nutrition knowledge, but these were no longer significant after controlling for confounders. Obese women had significantly higher scores of restrained and emotional eating behaviours than, and similar scores of external eating behaviours to, lean. Appetite, nutrition knowledge, restraint and emotional eating behaviours scores were not associated with food intake in either obese or lean. On the other hand, increased intakes of total calories and fats were influenced by increasing score of external eating behaviour in both groups. Obese women reported doing similar amounts of total PA but significantly less of vigorous and sports and exercise activities than lean (P<0.05). Accelerometry showed obese women had lower average activity counts/day, although they did have significantly greater energy expenditure in light-intensity activity than lean (P<0.01). Obese women had less GWG than lean (Mean ± SD, 5.3± 52 vs 10.8±3.7kg, P<0.001). Increased GWG was associated with increased self-reported total energy intake in lean, but this was not seen in obese. GWG was not associated with PA in either group. BWT was not significantly different between obese and lean (3,547±549g vs 3,567±516g). In lean, increased BWT was associated with increased energy intake and total PA. BWT in obese was not associated with diet but with increased with PA in early pregnancy. In conclusion, self-reported methods were less reliable in assessment of diet and PA in severely obese compared to lean pregnant women. These exploratory studies found that obese women did not appear to have the same factors as lean women affecting GWG and BWT, though this may be complicated by the poor reliability of self-reports. Therefore, quantitative assessments such as measurement of serum micronutrient levels (to evaluate nutritional status), and accelerometry (to assess physical activity) may be necessary in this poorly understood population.

Given the high rates of treatment drop-out and non-compliance within empirically-based treatments for OCD, it is important to increase our understanding of factors that impact the treatment process. Two studies were conducted to evaluate the clinical utility of the Obsessive Compulsive Consequences Scale-Revised (OCCS-R) and increase understanding of the relationships between the prognostic factors of motivation, insight, treatment compliance and treatment outcome. Study 1 used maximum likelihood Confirmatory Factor Analysis to show the OCCS-R's four factor solution was an adequate fit in a sub-clinical college population. Study 2 evaluated the clinical utility of the OCCS-R for predicting treatment outcome and its relationship to identified predictor variables. The OCCS-R predicted treatment drop-out but did not predict symptom improvement. Some support was found for predicted relationships between the OCCS-R and its factors, a general measure of motivation and treatment compliance. No variables predicted symptom improvement. Insight and initial symptom severity predicted treatment motivation which in turn predicted treatment compliance.
Ph. D.

Background: in 1970’s the seminal work of Cohen and Jago initiated an interest in the measurement of health related quality of life measures in dentistry. Clinical measures to assess oral health from the dentist’s perspective do not necessarily measure well-being. The patient reported outcome measures are an important tool to measure and improve the quality of care. Aim: The aim of the project was to create and validate a brief instrument for measuring patient-based oral health outcomes associated with endodontic care. Method: Based on the literature review of the currently used core oral health outcome measures, items from established instruments were selected to generate pool of items for the new measure. All subjects attending primary dental care at a local dental teaching hospital specifically for endodontic treatment provided by undergraduates self-completed this outcome measure prior to, immediately following care and at one month follow-up visit. Using multicollinearity, factor analysis, regression modelling and an expert based approach items were identified for a brief instrument. The newly developed brief instrument was tested for its reliability, validity and responsiveness on patients attending for endodontic treatment in the same clinical setting using the self-completed questionnaire at the baseline and after completion of the treatment. Results: 46 Items from OHIP-49 (Oral Health Impact Profile) and 12 items from GOHAI (General Oral Health Assessment Index) were used as the basis for development of an endodontic outcome measure. Multicollinearity, factor analysis and regression analysis of the long-form of the instrument (58 items) identified 15 significant items associated with improved oral health.

The ability to monitor client change in psychotherapy over time is vital to quality assurance in psychotherapy as well as the continuing improvement of psychotherapy research. Currently there is not a free and comprehensive outcome measure for psychotherapy that meets current research and treatment goals. This study took further steps to validate a suite of measures to aid in treatment and research, theoretically based in the research domain criteria (RDoC) and the phase model of change frameworks. Items previously tested in a community sample were further tested in a clinical population in psychotherapy training clinics and a community clinical sample Data was analyzed using bi-factor confirmatory factor analysis and multidimensional item response theory. Additional exploratory analyses were conducted to explore differential item functioning in these samples.

Traumatic brain injury (TBI) involves both an initial primary insult to the brain and a delayed secondary injury in the hours and days thereafter. The delayed nature of secondary brain injury leaves open the possibility for a window of therapeutic intervention to prevent neurodegeneration. As there are currently no approved drugs for the treatment and prevention of secondary injury after TBI, my approach has been to first identify molecular pathways associated with a differential outcome from injury, followed by validation of these pathways by targeting them with a variety of therapeutic strategies ranging from genetic manipulation to novel drug compounds, and dietary supplementation. The Apolipoprotein E (APOE) gene has three major alleles, APOE2, APOE3 and APOE4, the latter of which confers risk for poor outcome following TBI. Using quantitative Liquid Chromatography-Mass Spectrometry, large proteomic datasets can be generated, and the difference in protein expression in response to TBI between transgenic mice expressing APOE3 or APOE4 can reveal changes that reflect a "better" or "worse" outcome, respectively. Analyzing such datasets from APOE3 and APOE4 transgenic mice at a wide range of time points, we examined the differential response to TBI and identified several protein pathways of interest, including: CD40 signaling, NF-kB signaling, and APP related proteins. Optimizing several behavioral I testing paradigms (Rotarod, Morris Water Maze, and Barnes Maze), we characterized spatial memory and motor function deficits resulting from TBI in order to quantify a "good" or "poor" response. Using a variety of targeted intervention strategies (CD40L knockout, administration of (-)-Nllvadipine, or anatabine) to modulate the protein pathways of interest, we showed improvement in response to TBI. Overall, these experiments provide demonstrate the effectiveness of using a systems biology approach to find potential targets for therapeutic intervention.

Charcot-Marie-Tooth disease (CMT) is the most commonly inherited neuropathy. Many genetic subtypes of CMT show signs of symptomatic disease during the earliest years of life. This might be the ideal time to intervene before progression of clinical sequelae due to demyelination and axonal loss. No outcome measures have been validated for infants <3 years with CMT, a barrier to conducting trials for disease-modifying interventions, as well as running natural history studies (Chapter One). Existing outcome measures for the assessment of disease severity for infants with neuromuscular disease were systematically reviewed (Chapter Two). No CMT-specific outcome measures were identified, yet several items were appropriate to contribute to a new outcome measure: the CMT Infant Scale (CMTInfS). Peer review by 12 experts in the NIH-funded Inherited Neuropathies Consortium, and pilot testing of 22 infants confirmed the 31-item preliminary CMTInfS to undergo validation studies across 7 international sites (Chapter Three). In Chapter Four, excellent intra-rater and inter-rater reliability of CMTInfS total scores showed acceptable agreement both within (ICC3,1 0.994, 95% CI3,1 0.985 – 0.997) and between (ICC2,10.997, 95% CI 0.993 – 0.999) evaluators. Validation studies were conducted based on data from 128 infants: 26 confirmed CMT cases, 7 ‘at risk’ cases of CMT and 95 healthy controls (Chapter Five). Item, Factor and Rasch analyses produced a psychometrically robust 15-item functional outcome measure. The CMTInfS can be completed in 20min, requiring minimal training for experienced paediatric clinicians/researchers. Using age-matched z-scores to account for normal growth and development, the CMTInfS can discriminate between infants with CMT and controls. There was good agreement with the CMT Pediatric Scale. With further longitudinal data collection of different CMT genetic subtypes (Chapter Six), the CMTInfS will be trial-ready to evaluate potential treatments for CMT.

Managed Mental Health Care (MMHC) began blanketing the United States when cost of care rose exponentially. MMHC is one avenue many employers and insurance companies have chosen to provide employees with mental health treatment at controlled costs. However, not all employers view supplying their employees with mental health treatment beneficial, as they do not know mental health problems can significantly decrease work productivity. Brown and Jones (2005) used the Social Role Scale (SR) of the Severe Outcome Questionnaire (SOQ) to estimate work productivity in employees under the assumption that the scale measures work productivity. The purpose of this study was to move closer to an estimation of the relationship between improved mental health and improved workplace functioning by examining the relationships among a self-report measure of mental health (i.e., the SR), a self-report measure of work productivity (i.e., the Work Productivity and Activity Impairment Scale [WPAI]), and objective measures of work productivity (i.e., the quality and timeliness of institutional records, supervisor ratings, and sick hours used). It was thought that understanding the relationships among these measures might assist in estimating the cost/benefit of investing in psychotherapy. Participants in this study were employees and inpatients at the Utah State Hospital. Statistical analyses indicated the SR did predict two WPAI scales (i.e., Presenteeism and Activity Impairment) for employees. Specific relationships among measures, and suggestions for future research, are discussed.

Functional improvement is an important outcome following total knee arthroplasty (TKA). According to recent research, three-dimensional motion analysis is the most scientific method of measuring dynamic knee function. Nevertheless, current protocols are too time consuming and complicated for routine clinical use. This study developed a clinic-appropriate motion capture system, and investigated the feasibility of its use in a clinical environment. A compact motion capture system (Dimensions: 3.5(L)x2.1(H)x1.1(W)m) and bespoke cluster-based biomechanical model were developed. Assessments for quantifying knee range of motion (ROM), knee strength, gait kinematics, and gait stability were incorporated into the software. Most results were reported in real-time. Validation studies of the assessments against clinical standard tools showed few clinically significant differences between the results, suggesting that the assessments could be used as accurate and reliable alternatives to the traditional tools. The system was then used clinically to report the functional outcome of Medacta GMK Sphere TKA patients. Patients underwent functional testing pre-, 6-weeks, and 1-year post-operatively. Average recorded assessment time was 16.8±2.4 minutes. On average, knee ROM, gait kinematics, spatio-temporal parameters of gait and gait stability improved post-operatively. Knee strength decreased over the first year however, suggesting that TKA patients require strength training post operatively in order to optimise functional outcome. The results reported in this trial were generally consistent with the current literature, implying that the system returned valid data for this patient cohort,and that the Medacta GMK Sphere TKA was successful at improving knee function, especially in frontal and transverse planes during gait. To conclude, this thesis has shown that motion capture technology can feasibly be used in the clinical environment to assess the function of TKA patients in an acceptable clinical time frame. The system developed and presented here can therefore justifiably be used clinically to better report the functional outcome of TKA.

Background: Disease-specific patient-based questionnaires are being used increasingly to evaluate treatment outcomes in coronary heart disease (CHD) from the patient's perspective. However, most have been developed to evaluate health-related quality of life (HRQoL) in medically rather than surgically treated patients and many have not been rigorously evaluated against required standards. There are currently no validated questionnaires to measure patient- based outcomes after coronary revascularisation, the surgical treatment for CHD. Objectives: To develop a new patient-based instrument, the Coronary Revascularisation Outcome Questionnaire (CROQ), to measure health outcomes and HRQoL before and after coronary artery bypass graft surgery (CABG) and percutaneous transluminal coronary angioplasty (PTCA). To evaluate the psychometric properties of the CROQ using classical psychometric methods. Design: Psychometric study. Subjects: A total of 725 (79% male) patients undergoing CABG and 643 (71% male) patients undergoing PTCA at three hospitals in the UK. Methods: Qualitative methods (literature review, review of existing instruments, patient interviews, and expert opinion) were used to develop two versions of the eROQ (CROQ-CABG and CROQ-PTCA). Two field tests were then conducted by postal survey to patients before and 3-months after revascularisation firstly, to identify possible items for elimination (item reduction) and secondly, to evaluate the psychometric properties (reliability, validity, responsiveness) of the item- reduced CROa in independent samples. Results: The CROQ was acceptable to patients, satisfied tests of scaling assumptions, showed good internal consistency, test-retest reliability, validity, and responsiveness. 4 Conclusions: The CROQ is a new l psychometrically rigorous patient-based measure of outcome for coronary revascularisation. The CROQ has many potential uses in evaluative research l such as in clinical trials of effectiveness I and as a routine clinical audit tool to assist providers of CABG and PTCA in monitoring the outcomes of care

Syftet med studien var att validera den svenska översättningen av självskattningsinstrumentet Norwegian Outcome Response System for Evaluation (NORSE), ett instrument som används för att mäta psykiskt mående. Data har samlats in genom en digital enkät. Urvalet var icke-kliniskt och bestod av totalt 228 individer. Av de 228 individerna gjorde 30 personer enkäten vid två tillfällen för att testa instrumentets stabilitet över tid. För att validera NORSE användes ett redan validerat och etablerat instrument, Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) som standardreferens. Resultatet visade att den svenska översättningen av NORSE har hög intern konsistens och god test-retest reliabilitet, såväl som god reliabilitet och validitet. Resultaten visade även att NORSE och CORE-OM täcker liknande områden men är samtidigt långt ifrån identiska. Föreliggande studie indikerar att det kan finnas ett användningsområde för den svenska översättningen av NORSE i den svenska primärvården.
The aim of this study was to validate the Swedish translation of the self-report instrument Norwegian Outcome Response System for Evaluation (NORSE), an instrument used to evaluate psychological well-being. Data was collected using a digital questionnaire. The sample was non-clinical and consisted of a total of 228 individuals. Out of the 228 individuals, 30 participants took the questionnaire on two occasions to test the stability of the instrument over time. In order to validate NORSE, an already validated and established instrument, Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) was used as a reference standard. The results showed that the Swedish translation of NORSE has a high internal consistency and good test-retest reliability, as well as a good internal reliability and concurrent validity. Results also showed that NORSE and CORE-OM cover similar areas but are far from identical, thus indicating that there could be a use for NORSE in Swedish primary health care.

Mental health problems are associated with significant losses in work productivity and, consequently, have significant ramifications for business entities and the general economy. Several instruments have been developed to measure productivity-related constructs such as absenteeism and presenteeism. The current study examines the utility of the Outcome Questionnaire-45 (OQ), a commonly used mental health questionnaire, in predicting work productivity. This relationship is explored as a preliminary step in assessing the degree to which changes in mental health brought about by psychotherapy will improve work productivity. Forty-nine participants were recruited from a call center in a small market research firm based in the Western United States. Work productivity was measured using four subscales of the Work Productivity and Activity Impairment (WPAI) questionnaire as well as an objective measure. The OQ and WPAI were administered on a weekly basis over the course of five weeks. Participant characteristic variables and work-time variables were also measured. A mixed models analysis of covariance (ANCOVA) with repeated measures showed that the Social Role (SR) Scale, a subscale of the OQ, was a significant predictor of Presenteeism, Overall Work Impairment, and Activity Impairment subscales. Latent growth modeling (LGM) was used to examine the relationship between the variables while accounting for individual trajectory differences. Although the results suggested that an unconditional model of Overall Work Impairment with SR as a time-varying covariate provided a good fit for the data, standardized regression weights between the variables were not significant. Implications of findings, limitations, and recommendations for future research are discussed.

Introduction: This retrospective comparative study was to define the validity and reliability of a translated, culturally adapted Chinese version questionnaire of the New Knee Society Knee Scoring System (NKSS). This study is aim to investigate the validity and reliability of the translated Chinese version of the NKSS and assess its feasibility of measuring the scale on Chinese patients by performing its cross-cultural adaptation for patients after Total Knee Arthroplasty (TKA) in Hong Kong. Methods: A total of 104 knees from 64 Chinese patients performed TKA were included in the study using the translated, culturally adapted Chinese version of the NKSS. All Patients were operated on from October 2010 to May 2013 at Queen Mary Hospital. Patients who participated in this study have been clinically screened and established a set of including criteria. The outpatients were evaluated by completing the five questionnaires containing the NKSS, the Knee Society Clinical Rating System (KSS), Medial Outcomes Study 36+Item Short Form (SF-36), Bristol Knee Score and Oxford Knee Score. Reliability was evaluated using the Split-half reliability, Chronbach's α coefficient and inter-item correlation. To assess validity, all patients filled in the same NKSS questionnaire, and previously validated Chinese version of the SF-36, Bristol Knee Score and Oxford Knee Score. The validity was determined with Content Validity and Contract Validity. Results: The NKSS showed ideal split-half reliability as evidenced by the high correlation coefficient (R>0.7, P<0.05). Chronbach's α coefficient for five major domains demographics, objective knee score, expectations, satisfaction and function was high (α>0.7. P<0.05). Also, the inter-item correlation was also excellent for all domains. For validity, the NKSS was found to have excellent correlation with Bristol Knee Score and Oxford Knee Score, good correlation with KSS and SF 36 Discussion: The NKSS as a validated approach is adapted to the diverse health-related quality of lives and activities of contemporary patients with TKA. Orthopaedics surgeons are allowed to appreciate differences in the priorities of individual patients and the interplay among function, expectation, symptoms, and satisfaction after TKA using this assessment instrument. Conclusion: The results of this study show that the NKSS as a functional status questionnaire has been translated into Chinese without missing any psychometric properties of the original version. This culturally and linguistics adapted Chinese version of the NKSS outcome assessment has satisfactory internal consistency and good validity. It is an adequate and helpful instrument for the evaluation of Chinese speaking patients after TKA in clinical studies.
published_or_final_version
Medical Sciences
Master
Master of Medical Sciences