Coeliac disease (CD) is a chronic gastrointestinal condition, the only treatment for which is a gluten-free diet (GFD). Following a GFD is restrictive, burdensome, and can impact health-related quality of life (HRQOL). People with CD can experience long delays to diagnosis and evidence suggests large variations in follow-up care, but the relationship between health care experiences and HRQOL is unknown. The main aim of this research was to develop a patient-reported outcome measure and patient experience questionnaire, and use these to investigate the relationship between adults' experiences of health care services and HRQOL in CD. The questionnaires, named the Coeliac Disease Assessment Questionnaire (CDAQ) and the Coeliac Disease Patient Experience Questionnaire (CD-PEQ), were developed following qualitative interviews with adults with CD, and refined with input from experts, and cognitive interviews. The CDAQ was also subject to a translatability assessment to assess its linguistic and cultural translatability, and a cross-sectional survey to assist with item reduction and scale generation. Members of Coeliac UK (n=267) completed the CDAQ and CD-PEQ, together with the SF-36v2 and demographic questions as part of a postal survey. Psychological health, vitality, general health, and dietary burden were found to have the greatest impact on HRQOL, with physical health and social isolation the least affected. HRQOL was found to have a strong correlation with patients' experiences of health care services. Aspects most strongly related were: the provision of information; communication with HCPs; difficulty obtaining prescriptions; and GPs' knowledge. This research has identified aspects of health care services that are strongly related to HRQOL in CD. Health care providers are recommended to focus service improvement efforts on these areas. A reliable and valid disease-specific patient-reported outcome measure and patient experience questionnaire have been developed as part of this study. The CDAQ is suitable for use in research studies, including clinical trials, to assess HRQOL in CD.

Tradition measures of recovery, such as patient-reported symptoms, objective measures such as balance, specific dimensions such as depression, fatigue, cognitive status, and exercise tolerance do not fully capture the impact of the concussion on performing individual activities and participating in life situations as experienced by the patient. No concussion-specific measure of functional status currently exists. Objectives The overarching purpose of this dissertation was to develop a concussion-specific measure of functional status. There were two specific objectives: 1. To examine the concept of functioning post-concussion; 2. To generate questionnaire items based on a conceptual model of functioning. Methods This dissertation follows the recommendations of the Association for Medical Education in Europe as a framework with which to meet the objectives. The first objective was addressed by (1) generating a list of concussion-specific concepts through a systematic review (Chapter 3), and (2) qualitative interviews with individuals with persistent post-concussion symptoms and clinicians with concussion expertise (Chapter 4). The relationships between the concepts that emerged from those studies are presented graphically in a conceptual model to meet the second objective. The concepts were then transformed into questionnaire items and pretested through cognitive interviews with individuals with PPCS and clinicians with concussion expertise. Finally, the questionnaire items were critically evaluated for proportion of shared content against existing measures used in concussion clinical trials by coding all items to the International Classification of Functioning, Disability and Health. Results Objective 1 Three main themes emerged from the qualitative findings: (1) functioning at the level of the individual and society; (2) environmental barriers and facilitators; and (3) capacity, defined as the length of time one could perform a task before the onset of symptoms, and the length of time it took to recovery from those symptoms. Objective 2 The final questionnaire is presented as the CORE-Q, which is comprised of 53 items over three complimentary subscales, namely the Post-Concussion Functional Scale, the Concussion Modifiers Scale, and the Global Functional Recovery Scale. Each subscale corresponds to one of the three main themes. No existing outcome measure contained more than 40% of the content within the CORE-Q, or 55% of any subscale. Conclusions The CORE-Q is a unique measure of functional status post-concussion that considers functioning from a biopsychosocial perspective. Further studies are needed to assess the psychometric properties of the CORE-Q before it is adopted into clinical practice and intervention trials.

The purpose of the study was to explore the inter-rater reliability of the Multi-Dimensional Outcome Measure (MDOM) in the following areas: overall reliability, differences in reliability between samples, differences in reliability between scales, and increasing reliability over time. The study was to assist mental health professionals by clarifying the technical properties of an evaluation tool which could be used to document program outcomes for policy makers and to develop more effective treatment methodologies. The MDOM was administered to two groups, a mentally and emotionally disturbed sample of thirty-five Subjects from an inpatient facility and a normal sample of thirty-three community college Subjects. The MDOM was given in back-to-back interviews by two interviewers alternating in first interviewer, second interviewer roles. The data indicated acceptable inter-rater reliability for the Multi-Dimensional Outcome Measure. For anyone sample, all twelve scales showed acceptable reliability according to the criterion of a .75 product moment correlation coefficient. However, four scales did not meet the .75 level: Productivity I (.55), Productivity II (.74), Interpersonal Isolation--Family (.71) when administered to the inpatient sample, and Drug Abuse (.74) when administered to the community college sample. Assessment of the differences in reliability between samples showed higher reliability for the community college sample than for the inpatient sample with the exception of the Drug Abuse scale. Exploration of the differences in reliability between scales showed some scales contained items which were more relevant for the college student than for the inpatient. Other scales included items which were ambiguous or worded in an awkward manner which may have contributed to their lower reliability. Reliability could be increased as a result of the increased skill and clarification of questionable items. Scales which demonstrated unacceptable reliability the first weeks of the study indicated an acceptable level the last week. The data suggested that interviewers should be trained to insure acceptable reliability. The MDOM was seen to be suitable for monitoring the functioning of a community based sample; however, consideration should be given to the inherent limitations before administering the instrument to an inpatient sample.

CHAPTER 1: Introduction: The most common craniofacial congenital anomaly is the cleft lip and/or palate (CLP). The CLEFT-Q is the first condition-specific comprehensive patient reported outcome instrument (PROM) for patients with CLP. Other measures used in assessment of patients with CLP are Child Oral Health Impact Profile (COHIP) and Cleft Hearing, Appearance and Speech Questionnaire (CHASQ). The development and validation of the CLEFT-Q have been completed in three phases. In phase I, 138 patients with CLP from six countries were interviewed, and data were used to form 13 scales measuring appearance, facial function and health-related quality of life (HR-QOL). In phase II, scales were field-tested internationally with 2434 patients to examine reliability and validity as well as develop a common scoring algorithm for international use. Phase III, the focus of this thesis, aimed to examine further construct validity and responsiveness of the CLEFT-Q scales. CHAPTER 2: Methods: Patients were recruited at six cleft centres in Canada, USA and UK between January 2018 and October 2019. The sample included patients aged 8-29 seeking rhinoplasty, orthognathic, cleft lip scar revision and alveolar bone graft (ABG) operations. Before and six months after surgery, participants were asked to complete the CLEFT-Q scales relevant to their operation and two other PROMs frequently used in cleft research, i.e., COHIP and CHASQ. Cross-sectional construct validity was examined by testing prespecified hypotheses about expected relationships between CLEFT-Q, CHASQ and COHIP instruments. Internal responsiveness was examined using the distribution-based method. Data were analysed using paired sample t-tests and calculation of effect sizes (ESs) and minimally important differences (MIDs). CHAPTER 3: Results: Examination of cross-sectional construct validity of the CLEFT-Q scales using the COHIP and CHASQ subscale resulted in 39/53 (74%) hypotheses having been supported by the results. The required sample size to examine responsiveness using the anchor-based approach was not reached. Assessment of internal responsiveness using the distribution-based approach demonstrated that the appearance scales were highly responsive to change following cleft-specific surgeries, with statistically significant results and ESs ranging from 0.4 (small) to 1.8 (large). Change on the CLEFT-Q HR-QOL scales was not statistically significant. As predicted, the ESs on scales measuring facial aspects most affected by rhinoplasty and orthognathic surgeries were larger than the ESs on scales measuring facial aspects least affected by these surgeries. MIDs for each scale in each operation were determined. CHAPTER 4: Discussion: Assessment of cross-sectional construct validity demonstrated that CLEFT-Q performs as it was intended when compared with other similar measures (i.e., CHASQ and COHIP). The CLEFT-Q appearance scales were responsive to change following rhinoplasty, orthognathic and cleft lip scar revision operations. As predicted, the CLEFT-Q appearance scales did not detect change following the ABG operation as this operation does not result in visible difference. As hypothesized, the CLEFT-Q HR-QOL scales were less responsive to change than appearance scales as HR-QOL is a more distal construct than appearance in relation to the cleft-related surgeries performed. The preliminary MIDs estimated by the distribution-based approach should be confirmed in studies with diverse CLP populations and larger sample sizes using the anchor-based approach. The findings of this phase III study build on the results of another CLEFT-Q validation study, which demonstrated the ability of the CLEFT-Q scales to detect differences between groups with varying surgical status, i.e., need surgery, have had surgery and never needed surgery. CHAPTER 5: Conclusion: Cross-sectional construct validity of the CLEFT-Q scales was supported by most prespecified hypotheses. The CLEFT-Q scales were found to be responsive to change. MIDs were determined. The results of this phase III study should be confirmed in a larger and more culturally diverse patient population. Future studies to examine reproducibility and measurement error as well as external responsiveness of the CLEFT-Q scales may be beneficial to add to the psychometric evaluation process. / Thesis / Master of Science (MSc)

No description available.

Yes / Purpose: To develop and validate the first patient-reported outcome measure (PROM) to quantify vision-related dizziness. Dizziness is a common, multifactorial syndrome that causes reductions in quality of life and is a major risk factor for falls, but the role of vision is not well understood. Methods: Potential domains and items were identified by literature review and discussions with experts and patients to form a pilot PROM, which was completed by 335 patients with dizziness. Rasch analysis was used to determine the items with good psychometric properties to include in a final PROM, to check undimensionality, differential item functioning, and to convert ordinal questionnaire data into continuous interval data. Validation of the final 25-item instrument was determined by its convergent validity, patient, and item-separation reliability and unidimensionality using data from 223 patients plus test–retest repeatability from 79 patients. results: 120 items were originally identified, then subsequently reduced to 46 to form a pilot PROM. Rasch analysis was used to reduce the number of items to 25 to produce the vision-related dizziness or VRD-25. Two subscales of VRD-12-frequency and VRD-13-severity were shown to be unidimensional, with good psychometric properties. Convergent validity was shown by moderately good correlations with the Dizziness Handicap Inventory (r = 0.75) and good test–retest repeatability with intra-class correlation coefficients of 0.88. conclusion: VRD-25 is the only PROM developed to date to assess vision-related dizziness. It has been developed using Rasch analysis and provides a PROM for this under-researched area and for clinical trials of interventions to reduce vision-related dizziness. / College of Optometrists (UK) research studentship.

In order to provide effective social, emotional, and behavioral supports to all students, there is a need for formative assessment tools that can help determine the responsiveness of students to intervention. Schoolwide positive behavior support (SWPBS) is one framework that can provide evidence-based intervention within a 3-tiered model to reach students at all levels of risk. This dissertation begins the process of developing a brief, teacher-completed rating scale, intended to be used with students in grades K-8 for the formative assessment of positive classroom behavior. An item pool of 93 positively worded rating scale items was drawn from or adapted from existing rating scales. Teachers (n = 142) rated the importance of each item to their concept of "positive classroom behavior." This survey yielded 30 positively worded items for inclusion on the pilot rating scale. The pilot scale was used by teachers to rate students in two samples drawn from general education K-8 classrooms: a universal tier group of randomly selected students (n = 80) and a targeted tier group of students with mild to moderate behavior problems (n = 82). Pilot scale ratings were significantly higher in the universal group than the targeted group by about one standard deviation, with no significant group by gender interaction. Strong results were found for the split-half reliability (.94) and the internal consistency (.98) of the pilot scale. All but two items showed medium to large item-total correlations (> .5). Factor analysis indicated a unidimensional factor structure, with 59.87% of the variance accounted for by a single factor, and high item loadings (> .4) from 26 of the 30 factors. The unidimensional factor structure of the rating scale indicates its promise for potential use as a general outcome measure (GOM), with items reflecting a range of social, emotional, and behavioral competencies. Future research is suggested in order to continue development and revision of the rating scale with a larger, more diverse sample, and to begin exploring its suitability for screening and formative assessment purposes.

<p>Radial head arthroplasty (RHAP) is proposed as the treatment of choice of complex radial head fractures not amenable to reconstruction. With advances in the understanding of elbow biomechanics and subsequently implant designs, low morbidity, few complications and good success has been reported with RHAP compared to internal fixation. Much of the success/complication post RHAP has been attributed to the fracture pattern and presence of associated injuries. While these are important parameters to reflect on, however, the outcome of surgery cannot be solely attributed to the methods of dealing with the radial head fracture. Importantly, the outcomes of RHAP are also influenced by patient factors. Hence, the purpose of this thesis was to assess the existing knowledge of functional outcomes post RHAP and explore the role of acute post surgical pain as a predictor of those outcomes.</p> <p>The first manuscript in the thesis systematically examines the current available English literature regarding the functional outcomes of metal RHAP. Studies reviewed revealed significant heterogeneity in the study and patient characteristics. Likewise, the method of reporting fracture classification, clinician and patient reported outcomes are inconsistent. Based on the level 4 evidence studies in the review, we concluded that RHAP provides good to excellent outcomes in short-midterm follow up, with no evidence regarding the superiority of one implant over another.</p> <p>The second manuscript explored the role of acute post surgical pain in development of chronic functional impairment post RHAP using the EVOLVE (Wright Medical Technology, Arlington, Tennessee) implant at 2 years post surgery. A total of 59 adults with complex radial head fractures treated with EVOLVE metal radial head implant were followed for a period of two years. Demographics, American Shoulder and Elbow Surgeon's-Elbow (ASES-e) pain subscale and Disability of Arm, Hand and Shoulder Questionnaire (DASH) data were collected at baseline and two years. Regression analyses revealed that acute post operative pain post RHAP is significantly related to the functional outcome at 2 years post RHAP. An ASES-e pain cut off score of 32/50 predicted the development of chronic functional impairment two years post RHAP.</p> <p>The results of this thesis highlight the need for prospective longitudinal studies, comparative analyses and standardized methods of reporting concerning effectiveness of RHAP. It also emphasizes the significance of quantifying pain levels in the immediate post operative period and classifying the patient in high/low risk groups for developing chronic functional impairment based on the pain level.</p> / Master of Science (MSc)

<p><strong>Objective</strong>: To perform an environmental survey of clinical practice amongst surgeons and physiotherapists in making return to sport (RTS) decisions following ACL reconstruction (ACLR); to gain a better understanding of how clinicians and patients define successful return to sport; and to compare patients’ level of satisfaction with their current level of activity following ACLR.</p> <p><strong>Design: </strong>Multidisciplinary cross sectional study.</p> <p><strong>Setting</strong>: Online</p> <p><strong>Participants:</strong> Orthopaedic surgeons and registered physiotherapists; and patients who had undergone ACLR within the previous 6-18 months.</p> <p><strong>Interventions: </strong>Surgeons and physiotherapists completed separate web surveys, each consisting of 10 closed format questions that included sections on demographics, outcome measures, treatment procedures, and RTS decisions. Patients completed a web survey consisting of 19 questions about their activity level, their experience surrounding the process of rehabilitation after ACLR, and their decisions surrounding RTS.</p> <p><strong>Main Outcome Measures</strong><strong>: </strong>Descriptive and subjective data were collected for all groups. Clinician responses were compared for differences in frequencies of clinical outcome measures used to decide RTS readiness. Frequency data were collected for all groups for the definition of successful RTS following ACLR using a self-report form. The relationship between patient satisfaction and current level of activity following ACLR was compared using the Tegner Activity Scale and Single Assessment Numeric Evaluation (SANE).</p> <p><strong>Results:</strong> All patients were unanimous in their definition of successful RTS post ACLR as the ability to fully participate in pre-injury level of sport with no limitations or deficits (100%), and restoring functional stability (100%). Mean Tegner activity level scores of respondents decreased a mean of 3.4 (SD ± 2.5) from pre-injury to current level of activity (p < 0.011). However, no significant decrease from pre-injury level of activity to expected level of activity post surgery was seen. A statistically significant correlation was demonstrated between patients’ level of satisfaction and current level of activity (r = 0.84, p = 0.02), with higher levels of activity associated with increased levels of satisfaction. Overall, the majority of clinician respondents reported that jump tests, range of motion (ROM), Lachman clinical test of stability, pain, swelling, functional movement and giving way contributed to their RTS decisions. Unanimous consensus existed between clinicians for the ability to participate in any level of sport, with or without limitations, as the definition of successful RTS following ACLR.</p> <p><strong>Conclusions:</strong> Following ACLR, medically cleared patients had not met their high expectations of functional stability and ability to return to their pre-injury level of sport. The discordance between unmet expectations and current level of sporting activity was reflected in lower rates of patient satisfaction. Most clinicians reported using primarily impairment based not self-report measures to contribute to their RTS decisions. Clinicians and patients expressed subtle differences in their definition of successful RTS.</p> <p><strong>Clinical Relevance: </strong>Establishing an operational definition of success, and professional consensus on measures which include patient reported outcomes is an important next step in the development of goal oriented RTS guidelines.</p> / Master of Science Rehabilitation Science (MSc)

No / Improving cognition is service users' top research priority for life after stroke, and future research should include outcomes that they deem important. Patient perspectives on outcomes are collected using patient-reported outcome measures (PROMs). There is currently no patient-centred PROM specific for cognitive rehabilitation trials. Objective Inform PROM development by exploring stroke survivor perspectives on the important, measurable impacts of persisting post-stroke cognitive problems. Design Qualitative semi-structured interviews in participants' homes. Participants Purposive sample of 16 cognitively impaired stroke survivors at least six months post-stroke. Methods Interviews used a schedule and communication aids developed through patient consultation. Interviews were transcribed verbatim with non-verbal communication recorded using field notes. Data were analysed using a framework approach to find commonalities to shape the focus and content of an outcome measure. Results Participants identified important impacts of their ‘invisible’ cognitive problems, outside of other stroke-related impairments. Cognitive problems exacerbated emotional issues and vice versa. Changes in self-identity and social participation were prominent. Impact was not spoken about in terms of frequency but rather in terms of the negative affect associated with problems; terms like ‘bothered’ and ‘frustration’ were often used. Conclusions The results support the development of a PROM specifically designed to address the impact of cognitive problems. It should: include items addressing a comprehensive range of cognitive skills; ask questions about mood, self-identity and social participation; use accessible wording that respondents understand and endorse; measure impact rather than frequency; and explore perceived impact on carers.