Background: Exemestane is a drug of great interest for breast cancer prevention, because it inhibits estrogen production. Estrogen may operate by increasing breast density, a well-established biomarker for increased breast cancer risk. The NCIC CTG MAP.2 trial examined the efficacy of exemestane in decreasing breast density. Menopausal health-related quality of life (HRQL) and adverse events were also carefully monitored during the study. Purpose: To elucidate the impact of exemestane on menopausal HRQL and to examine the relationship between clinician and participant methods of reporting side effects. Methods: 98 postmenopausal women with increased breast density were randomized to exemestane or placebo daily for one year. HRQL was measured with the MENQOL questionnaire, which has four domains. Mean changes in MENQOL domain scores from baseline were compared between treatment groups using the Wilcoxon rank-sum test. The difference between groups in the proportion of women with a clinically meaningful decline was compared by domain with the Chi-square test; change scores were considered worsened if increased by ≥ 0.5 points. The association between time-to-decline in menopausal HRQL and treatment was evaluated using Cox PH regression. The kappa statistic quantified the level of agreement between participant-reported and clinician-reported symptoms. Kaplan-Meier estimates of time-to-decline as communicated by clinicians and participants were compared, using three thresholds to define meaningful change. Results: No significant differences in mean change scores were detected, however, a significantly greater proportion of women on exemestane experienced a clinically meaningful decline in physical menopausal HRQL at three months (absolute difference=19%, p= 0.03), while the absolute difference approached significance for vasomotor menopausal HRQL at six months (21%, p= 0.05), and at nine months (21%, p=0.06). The rate of decline in physical menopausal HRQL was 2.08 times greater (95% CI 1.10-3.94) in the exemestane group compared to the placebo group. Agreement between raters was low for all symptoms except hot flashes; in general participants detected symptoms more rapidly than clinicians, regardless of the defined cut-off for meaningful change on the MENQOL. Conclusions: A subset of women on exemestane experienced significant declines in physical and vasomotor symptoms. Generally, participants reported symptoms more frequently and faster than clinicians. / Thesis (Master, Community Health & Epidemiology) -- Queen's University, 2012-06-06 23:55:24.011

Objective: To explore the measurement of subsyndromal mood symptoms in relation to studies of maintenance therapy for bipolar disorder. Methods: Literature review of the Medline database using the following selection criteria: (1) ‘bipolar disorder’ plus ‘inter-episode or interepisode or subsyndromal or subclinical or residual or subthreshold’ and (2) ‘bipolar disorder’ plus ‘maintenance or prophylaxis or longitudinal’. Studies of children or adolescents and non-English-language reports were excluded. Results: Of the studies published between 1987 and October 2007, 77 articles about subsyndromal mood symptoms and 257 studies of maintenance therapy agents were found. Only 11 of the 257 studies of maintenance therapy agents discussed subsyndromal mood symptoms. Of the 77 articles, two thirds were published after 2000. Inconsistent definitions of subsyndromal mood symptoms and different evaluation tools and methodologies were used in the studies. Conclusions: There is a need to standardize definitions and validate measuring approaches for subsyndromal mood symptoms. However, when measured in both naturalistic studies and clinical trials, subsyndromal mood symptoms were frequently reported by patients receiving maintenance therapy and were associated with poor functioning. As with other chronic illnesses, knowledge of the patient’s perspective of daily morbidity is important for improving the clinical outcome. Studies of maintenance therapy for bipolar disorder, regardless of the approach, should measure subsyndromal mood symptoms as an additional outcome. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

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.

Background: Little is known regarding the health-related quality of life among myocardial infarction (MI) survivors in the United States. The purpose of this population-based study was to identify differences in health-related quality of life domains between MI survivors and propensity score matched controls. Methods: This retrospective, cross-sectional matched case-control study examined differences in health-related quality of life (HRQoL) among MI survivors of myocardial infarction compared to propensity score matched controls using data from the 2015 Behavioral Risk Factor Surveillance System (BRFSS) survey. Propensity scores were generated via logistic regression for MI survivors and controls based on gender, race/ethnicity, age, body mass index (BMI), smoking status, and comorbidities. Chi-square tests were used to compare differences between MI survivors to controls for demographic variables. A multivariate analysis of HRQoL domains estimated odds ratios. Life satisfaction, sleep quality, and activity limitations were estimated using binary logistic regression. Social support, perceived general health, perceived physical health, and perceived mental health were estimated using multinomial logistic regression. Significance was set at p < 0.05. Results: The final sample consisted of 16,729 MI survivors matched to 50,187 controls (n = 66,916). Survivors were approximately 2.7 times more likely to report fair/poor general health compared to control (AOR = 2.72, 95% CI: 2. 43-3.05) and 1.5 times more likely to report limitations to daily activities (AOR = 1.46, 95% CI: 1.34-1.59). Survivors were more likely to report poor physical health > 15 days in the month (AOR = 1.63, 95% CI: 1.46-1.83) and poor mental health > 15 days in the month (AOR = 1.25, 95% CI: 1.07-1.46) compared to matched controls. There was no difference in survivors compared to controls in level of emotional support (rarely/never: AOR = 0.75, 95% CI: 0.48-1. 18; sometimes: AOR = 0.73, 95% CI: 0.41-1.28), hours of recommended sleep (AOR = 1.14, 95% CI: 0.94-1.38), or life satisfaction (AOR = 1.62, 95% CI: 0.99-2.63). Conclusion: MI survivors experienced lower HRQoL on domains of general health, physical health, daily activity, and mental health compared to the general population.

Articular cartilage defects in the knee are common, and can result in pain, decreased function and decreased quality of life. Untreated defects are considered to be a risk factor for developing osteoarthritis, a progressive degenerative joint disease with minimal treatment options. To address these issues, various surgical procedures are available to treat articular cartilage defects in the knee. While these procedures overall have positive results, after surgery patients experience large and persistent deficits in quadriceps strength. A contributing factor to this post-surgical weakness is believed to be the extended post-operative non-weight bearing period, with full weight bearing not initiated until approximately 4 – 6 weeks after surgery. During this non-weight bearing period a minimal amount of demand is placed upon the muscle. Subsequently, the quadriceps muscle undergoes a large degree of atrophy with a significant decrease in muscle strength. Muscular strength deficits reduce the knee joint stability, also increasing the risk of osteoarthritis development. Interventions that can be used to facilitate quadriceps strength while protecting the articular cartilage repair are needed. Neuromuscular electrical stimulation (NMES) is an effective post-knee surgery rehabilitation technique to regain quadriceps musculature. In recent years manufactures have been developing knee sleeve garments integrated with NMES allowing for portability of the NMES treatment. The primary aim of this study was to evaluate the effectiveness of a 12-week home-based neuromuscular electrical stimulation treatment on post-surgical clinical outcomes (quadriceps strength, lower extremity function, and patient reported outcomes) after articular cartilage knee surgery. Patients were randomized between a standard of care home-treatment group and a NMES home-treatment group. Patients completed isometric quadriceps strength testing, the Y-balance test, and the Knee Injury and Osteoarthritis Outcome Score (KOOS) before surgery and at 3-months after surgery. The secondary aims of this study were to determine the most effective NMES parameters for post-surgical quadriceps strength; and to develop a framework to identify factors that may influence a patient’s adherence to a prescribed therapy program. From our results we can make several conclusions. First, we found only a small number of studies utilize similar parameters for post-surgical quadriceps strength treatments. The majority of the parameters reported in the literature were highly variable between studies. Second, clinicians can utilize the expanded Health Belief Model to identify situational and personal factors unique to a patient that may impact adherence to a prescribed treatment. Clinicians can then implement the proposed interventional strategies to address the identified situational and personal factors. Finally, there was no difference in quadriceps strength, lower extremity function, or self-reported scores at 3-month between a home-based NMES treatment and a standard of care home-based treatment. Patients’ adherence to the treatment protocols may have been a major factor contributing to these results. Utilizing a model, such as the proposed expanded Health Belief Model, may assist clinicians in improving a patients’ adherence to future prescribed home-treatment programs.

Background: The International Classification of Function, Disability and Health (ICF) describes health using 1424 categories from 4 components: body functions (BF), body structures (BS), activities and participation (AP) and contextual factors (environmental (EF) and personal (PF)). In this study the ICF was used to describe and compare aspects of ANCA-Associated Vasculitis (AAV) measured in clinical trials and those important to clinicians and patients. Methods: Individual interviews and focus groups were used to capture the perspective of AAV patients. Clinicians’ perspective was obtained with an email-based questionnaire. Outcomes used in AAV randomized trials were extracted from results of a systematic review of literature. Identified concepts were mapped to the ICF according to previously published ICF linking rules, and the resulting lists of relevant AAV outcomes were compared descriptively. Results: Twelve individual interviews and 2 focus groups represented the patient perspective while responses from 27 clinicians yielded the clinicians’ perspective. Systematic literature review identified 67 clinical trials and 28 abstracts from which measured outcomes were extracted. All three perspectives demonstrated detailed coverage of ICF components BF and BS. In the component AP patients and clinicians identified similar ICF categories, a number of which were under-sampled by AAV trials. Contextual factors appear to be significantly more relevant to patients than clinicians and researchers. Conclusion: Patients and clinicians have different views of the relevance of various AAV outcomes, and these views differ from what is measured in clinical trials of AAV. This highlights the need for a broad and standardized approach to developing and selecting outcomes for complex medical conditions such as AAV.

Objective: To explore quality of life in patients with multiple sclerosis. Concept Analysis: A concept analysis of quality of life in multiple sclerosis was conducted using Rodgers’ evolutionary concept analysis method. Eighty-three studies were reviewed. Study Proposal for Secondary Analysis: The proposal was for a secondary analysis using a quantitative, longitudinal, repeated measures design to determine if stem cell transplant has an impact on the quality of life of multiple sclerosis patients with aggressive disease. Summary of Findings: A concept analysis provided valuable insight into the use and understanding of the concept of quality of life in the multiple sclerosis literature. The subjective and multidimensional attributes of quality of life in multiple sclerosis were similar to findings in previous concept analyses of quality of life in general and in other diseases. The other attributes of the concept being measureable, modifiable and predictable revealed the uniqueness of quality of life in multiple sclerosis and provided a foundation for the development of future research. The results of the secondary analysis will provide new knowledge of a novel treatment for multiple sclerosis and its impact on quality of life. This advancement of knowledge in nursing and across health care disciplines will aid in the delivery of collaborative and comprehensive patient-centred care to ultimately improve the lives of multiple sclerosis patients.

Lateral ankle sprains are the most common musculoskeletal injury among the general population and U.S. military personnel. Despite the common perception of being a minor injury, at least 1 out of 3 individuals with a previous ankle sprain will develop chronic ankle instability (CAI). This clinical phenomenon creates a significant barrier for patients to return to their prior level of physical function. Specifically, CAI is associated with reductions in physical activity level, leading to decreases in lower health-related quality of life and increase risk of developing of post-traumatic ankle osteoarthritis. Current evidence has largely focused on characterizing the mechanical and sensorimotor insufficiencies associated with CAI in adolescent and young-adult populations, with little attention on middle- and older-aged adults. This restricts our understanding of how these insufficiencies associated with CAI that develop in early adulthood progress over time and contribute to other chronic diseases such as post-traumatic osteoarthritis. Therefore, the overall objective of this study was to compare self-reported and physical function between three age groups: 1) young, 2) middle-aged, and 3) older-aged adults with and without CAI. We hypothesized participants with CAI would have age-related changes in self-reported and physical function compared to non-injured individuals across the lifespan. The objective of this dissertation was to compare regional and global health- related quality of life (HRQoL), static and dynamic balance, spinal reflex excitability of the soleus muscle, open- and closed-kinetic chain dorsiflexion range of motion and spatiotemporal gait parameters between those with and without CAI across the lifespan. Her callIt was hypothesized that all self-reported and physical characteristics would be decrease with age, but significantly more in those with CAI compare to non-injured individuals. Results from the first study demonstrated participants with CAI had worse regional HRQoL compared to healthy-controls as evidenced by the lower Foot and Ankle Disability Index scores. Likewise, participants with CAI reported having worse overall physical function and pain interference during activity compared to healthy-controls. There was no significant interaction for Injury (CAI and healthy-control) and Age group (young, middle, and old) for any dependent variable. In the second, it was determined that static and dynamic balance, spinal reflex excitability, ankle (dorsiflexion and plantarflexion) and hip extension torque were all lower in the older-aged participants compared to the younger-aged adults. In addition, it was determined that participants with CAI had decreased dorsiflexion range of motion, ankle (dorsiflexion and plantar flexion) and hip extension peak isometric torque compared to the healthy-control group. However, no significant interaction was found for Injury (CAI & healthy-control) and Age (young, middle, old) for any dependent variable. In the third study, there were no differences in spatiotemporal gait parameters between groups (CAI vs. healthy-controls) or age categories. It can be concluded from this dissertation that regardless of the age, individuals with CAI have worse region-specific HRQoL, lower overall physical function, greater pain interference, limited dorsiflexion range of motion, and decreased ankle and hip peak isometric torque compared to healthy-controls. Several age-related observations were found including decreased static and dynamic balance, ankle and hip strength, and spinal reflex excitability. Though no relationship was found between CAI and age, several interactions were found to be trending towards significance. Therefore, future work is needed to better understand the consequences of CAI on middle- and older-aged adults.

Research elucidating high rates of burnout, depression, and suicide among US clinicians has caused national concern for the sustainability of our healthcare workforce and the quality of patient care. In response, US healthcare organizations are using measures of clinician burnout in new contexts beyond their traditional use in research. Outcome measures of clinician burnout are being used to evaluate health system performance, identify demographic disparities, and educate individual clinicians regarding their own outcomes. Yet, critical gaps in the literature exist regarding the measurement properties of burnout assessments in these contexts and the relationship between clinician distress and healthcare quality. This dissertation contains three studies on measuring clinician distress and its relationship with healthcare quality. Studies 1 and 2 aim to advance what is known regarding the interpretability, reliability, and validity of a commonly used clinician burnout assessment, the Maslach Burnout Inventory-Human Services Survey for Medical Personnel (MBI-HSS). In Study 1, we aimed to improve the interpretation of the MBI-HSS by using item response theory to describe the burnout symptoms and precision associated with MBI-HSS scores in US physicians. We produced response profiles that allow health policy makers and healthcare leaders to relate actionable, qualitative meaning regarding individuals’ and groups’ burnout symptom burden to the MBI-HSS’s quantitative subscale scores. In Study 2, we examined whether demographic disparities in US physician burnout are explained by differences in the MBI-HSS’s functioning across physician age, gender, and specialty groups. Our findings revealed that differences in the MBI-HSS’s functioning across age, gender, and specialty groups did not account for observed disparities, supporting the use of the MBI-HSS as a valid tool for identifying demographic disparities in physician burnout. In Study 3, we examined the association of clinician depression, anxiety, and burnout with the inappropriate use of antibiotic prescriptions for acute respiratory tract infections (RTIs) in a retrospective cohort study of outpatient visits at Boston Medical Center. We found a significant positive association between clinician depression, anxiety, and burnout and inappropriate prescribing for acute RTIs, which depended on the visit location and diagnosis group. Our findings suggest that clinician depression, anxiety, and burnout may play an important role in the quality of routine outpatient care. As federal agencies and healthcare organizations seek to address clinician distress on local and national levels, our findings offer important implications for future assessment and intervention. / 2023-01-19T00:00:00Z

Bakgrund: Bröstcancer-relaterat lymfödem (BCRL) är en vanlig komplikation efter bröstcancerbehandling. Tidigare forskning visar varierande förekomst av BCRL, tillståndet tros vara underdiagnostiserat. Tidiga tecken kan beskrivas som en vag tyngdkänsla och/eller spänningskänsla. Detta kan leda till stora negativa konsekvenser vilket motiverar vikten att detektera BCRL i ett tidigt stadie då tidig behandling förbättrar prognosen.  Syfte: Undersöka förekomst av tidiga besvär/symtom samt undersöka sambandet mellan patientrapporterade tidiga besvär/symtom och läkarens bedömning av besvär vid samma tillfälle.  Metod: Kvinnor som genomgått kurativ behandling mot bröstcancer deltog i studien. Datainsamlingen skedde vid återbesöket på onkologmottagningen 3 månader efter avslutad behandling. Data samlades in med patientenkät (avseende besvär/symtom från armen) och läkarbedömning, inom ramen för ett kliniskt utvecklingsprojekt.   Resultat: 61 enkäter ingick i studien. 22 deltagare upplevde besvär från armen på den opererade sidan. 70% av de 43 deltagarna som skattade symtom angav förekomst av ≥1 symtom. I 76% av de 55 läkarbedömningarna hade bedömningen inga besvär gjorts. Samband kunde påvisas gällande frekvensen av patientrapporterade besvär och läkarens bedömning av armsvullnad (p=0,005) och handödem (p=0,003) samt mellan patientrapporterade symtom och läkarens bedömning av armsvullnad (p=0,008). I de fall patienten skattat besvär/symtom fanns en signifikant andel där läkaren bedömt att det inte förekom ödem/svullnad. I de fall patienten inte rapporterade besvär hade läkaren också bedömt frånvaro av ödem/svullnad. Konklusion: Det är vanligt att patienten upplever besvär/symtom från armen på den opererade sidan, och att patienter upplever symtom i större utsträckning än att läkaren gjort bedömningen att handödem, subcutant ödem eller armsvullnad förekommer. / Background: Breast cancer-related lymphedema (BCRL) is a complication following breast cancer treatment, it is probably underdiagnosed and the prevalence varies in previous studies. Early signs can be subtle sensations of heaviness and/or tightness in limbs. BCRL can have several negative impact, this motivates the importance of early detection because early intervention improves the prognosis.   Aim: Investigate the prevalence of early signs/symtoms of BCRL and investigate the association between patient reported outcomes and the physician assessment of BCRL.  Method: Women who underwent curative treatment of breast cancer was included. Data was collected at the follow-up 3 months after finished treatment in purpose for a clinical project. A questionnaire was used for the patient (regarding signs/symtoms from the arm) and physician rescpectively. Results: 61 participants were included. 22 participants reported signs from the arm on the affected side. 70% of those who reported symptoms, reported a presence of ≥1 symtoms. The physicians estimated no signs in 76% of 55 participants. There was an association between the frequency of patient reported signs from the arm and the physicians assessment of armswelling (p=0,005), hand edema (p=0,003) and between patient reported symtoms and the physicians assessment of armswelling (p=0,008). When the patient reported signs/symptoms, there was a significant proportion where the physician estimated no edema/swelling. In cases when the patient reported no signs/symptoms, the physician also assessed absence of edema/swelling. Conclusion: Patients often experience signs/symptoms from the arm on the affected side, and patients reports symptoms more frequent than physicians assess presence of early signs of BCRL.