The aim of this study was to provide a short German self-report measurement, assessing subjective CRCI for a broad variety of cancer survivors. For this purpose, the AFI (Attentional Function Index) was translated into German and psychometric properties have been presented in the following publication among a sample of 1312 haematological cancer survivors. In the resulting article the factorial structure of the German translation of the AFI, the internal consistency among the total score and each subscale, construct validity and the associations of the AFI sum score with medical and socio-demographic variables are provided. Comparisons to the English version are additionally drawn. With the validated AFI, researchers and clinicians in German-speaking countries may now have new tool to assess, and thus improve an important component of QoL in cancer survivors [38].

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.

BACKGROUND: Patient reported outcomes (PROs) are important cancer outcomes that can be measured electronically but are understudied in the safety-net hospital setting. Routine electronic screening to address social determinants of health (SDH) has been established in primary care clinics and the emergency department of New England’s largest safety-net hospital. The burden of SDH in safety-net oncology patients is less well-studied. This study aimed to determine the feasibility and challenges of routine administration of ePROMs in a safety-net Radiation Oncology clinic, describe treatment toxicities and quality of life (QOL) experienced by this vulnerable population during radiotherapy, and evaluate SDH and the need for SDH screening in the oncology clinic. METHODS: Patients with lung or head and neck cancer scheduled for radiation oncology consultation from 3/2019–1/2020 were deemed eligible for electronic questionnaire participation based on primary language spoken and absence of metastases. At consultation, patients were administered a set of baseline ePROMs (EQ-5D-3L, FACT, PRO-CTCAE) and a social needs screener (THRIVE) using a widely-used cloud-based, patient-centered outcomes platform. Associations between patient demographics and questionnaire completion were retrospectively evaluated. The set of ePROMs were collected at the end of treatment to characterize treatment-related toxicities and changes in self-reported QOL. RESULTS: In total, 99 eligible head and neck cancer (51.5%) and lung cancer (48.5%) patients were identified. Median age was 65. The majority of patients were male (71.7%), and English-speaking (82.8%). Whites, Blacks, and Asians/Others comprised 42.4%, 38.4%, and 6.1% of patients, respectively. Fifteen patients were Hispanic (15.2%). Patients were most likely to have private health insurance (39.4%), followed by joint Medicare-Medicaid (25.3%), Medicaid (17.2%), and Medicare (16.2%). Two patients were insured by Corrections (2.0%). Eight patients (8.1%) no-showed or cancelled, while 91 patients were seen in consultation. Forty-four patients (48.4%) completed the initial questionnaires. For the remaining 47 patients (51.6%), the most common reason for lack of ePROM completion was clinic understaffing and/or clinical decision based on the absence of indication for radiotherapy (n=27, 57.4%). Ten patients refused to complete questionnaires (21.3%), with reasons cited including length of questionnaires and low energy. Ten patients were physically unable to attempt questionnaires (21.3%), for reasons including disabilities and low-literacy. Age, language, race, ethnicity, insurance, marital status, gender, and disease site were not significantly associated with ePROM completion (P≥0.05). For patients who completed the general (QOL) questionnaire EQ-5D-3L, there was no significant difference in general QOL domains nor self-reported overall health score at baseline vs. end of treatment. For head and neck cancer patients, FACT-H&N Total scores, measuring disease-specific QOL, were significantly worse at end of treatment vs. baseline (P=0.006). For lung cancer patients, FACT-L Total scores at the end of radiation treatment were not significantly worse at end of treatment vs. baseline (P=0.953). For head and neck cancer patients who completed PRO-CTCAE, there was a significant increase in the number with moderate to very severe taste issues (P=0.008) and decrease in appetite (P=0.025) by end of treatment. For lung cancer patients, there was a trend towards an increase in the number reporting moderate to very severe nausea (P=0.083). Eighty-one of 99 patients (81.8%) were screened for at least one SDH domain using the THRIVE screener at the study hospital. Nineteen patients (19.1%) had all 8 THRIVE social determinants of health statuses documented. Only housing status was documented for 61 patients (61.6%). There was a trend for married individuals (P=0.068) and females (P=0.074) to be associated with the completion of at least one THRIVE domain. Age, race, language, and insurance status were not associated with THRIVE screening (P>0.05). Transportation to appointments (21.1%), food insecurity (20%), and affording medications (10.5%) were the most prevalent concerns among these oncology patients, with 100% of patients who reported insecurities with medication and transportation requesting resources for these needs. CONCLUSION: Routine ePROs collection in a busy safety-net oncology setting is feasible, but challenging and labor-intensive. Implementation was met with both patient and staff challenges and revealed the need for dedicated project management, staff training, and opportunities to increase patient accessibility. Preliminary PROs analyses revealed several significant detriments in quality of life and increased symptoms for this patient population during treatment, but additional data collection is required. Safety-net oncology patients report significant social needs. Routine SDH screening and resource referral should be considered in these vulnerable patients. Efforts in a specialized department such as Radiation Oncology could fill gaps in existing efforts in a large safety-net hospital. Safety-net oncology clinics can likely help vulnerable cancer patients access available community resources and reduce disparities due to SDH.

Background: Patient-reported outcomes (PRO) assess disease burden and indicate unmet needs. Home-based electronic PRO measures (ePROMs) can support tumor aftercare (TAC). Creating an ePROM is the next step after implementing the software “OncoFunction” to assess PROs during TAC of head- and neck-cancer patients (HNC). Therefore, internet use and perception on ePROMs of ENT and TAC patients were evaluated. Methods: From May–July 2020, ENT patients at a high- volume outpatient department aged >18 without need for emergency treatment were invited to complete a questionnaire concerning internet use and access, hardware, and opinion on the chances, requirements, and designs of ePROMs. Results: 415 questionnaires were evaluated; 46.3% of the respondents visited the common consultation hour (CCH) and 44.3% TAC; 71.9% were internet users, being younger than non-internet users; and 36.4% of TAC patients were non-internet users and 16.3% of them were without a web-enabled device. Significant differences existed in age and assessment of future perspectives between internet-/non-internet users and TAC/CCH patients, respectively. Regarding the design of ePROMs, patients preferred quarterly and short surveys. Data safety and feedback were important. Conclusions: ePROMs are not suitable for everyone because of missing internet access and experience. A tailored approach to implement ePROMs in TAC is needed

Chronic low back pain (CLBP) is a nonspecific and persistent ailment that entails many physiological, psychological, social, and economic consequences for individuals and societies. Although there is a plethora of treatments available to treat CLBP, each treatment has varying efficacy for different patients, and it is currently unknown how to best link patients to their ideal treatment. However, it is known that biopsychosocial influences associated with CLBP affect the way that we move. It has been hypothesized that identifying phenotypes of spinal motion could facilitate an objective and repeatable method of determining the optimal treatment for each patient. The objective of this research was to develop an array of high deflection strain gauges to monitor spinal motion, and use that information to identify spinal-motion phenotypes. The high deflection strain gauges used in this endeavor exhibit highly nonlinear electrical signal due to their viscoelastic material properties. Two sub-models were developed to account for these nonlinearities: the first characterizes the relationship between quasistatic strain and resistance, and the second accounts for transient electrical phenomena due to the viscoelastic response to dynamic loads. These sub-models are superimposed to predict and interpret the electrical signal under a wide range of applications. The combined model accurately predicts sensor strain with a mean absolute error (MAE) of 1.4% strain and strain rate with an MAE of 0.036 mm/s. Additionally, a multilayered architecture was developed for the strain gauges to provide mechanical support during high strain, cyclic loads. The architecture significantly mitigates sensor creep and viscoplastic deformation, thereby reducing electrical signal drift by 74%. This research also evaluates the effects of CLBP on patient-reported outcomes. An exploratory factor analysis revealed that there are five primary components of well-being: Pain and Physical Limitations, Psychological Distress, Physical Activity, Sleep Deprivation, and Pain Catastrophizing. The presence of CLBP has adverse effects on all these components. It was also observed that different patient reported outcomes are highly correlated with each other, and the presence of CLBP is a significant moderating factor in many of these relationships. Arrays of high-deflection strain gauges were used to collect spinal kinematic data from 274 subjects. Seven phenotypes of spinal motion were identified among study participants. Statistical analyses revealed significant differences in the patient-reported outcomes of subjects who exhibited different phenotypes. This is a promising indication that the phenotypes may also provide important information to clinicians who treat patients suffering from CLBP. Future research will be conducted to develop and identify the optimal treatments for patients according to their phenotypes, which has the potential to reduce medical costs, expedite recovery, and improve the lives of millions of patients worldwide.

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a leading patient-reported outcome measure of disability. However, patients' perspective of the WHODAS 2.0 self-administered Swedish version have not been sufficiently described. Similarly, knowledge of its construct validity in the general population is missing. This creates a gap because updated norm data to use as reference is also missing. The overall aim of this study was to establish evidence of the measurement properties of the self-administered Swedish version of the WHODAS 2.0. Both qualitative and quantitative methods were adopted. In Study I, interviews with patients (n = 12) with orthopaedic or psychiatric conditions were performed and data were analysed by deductive content analysis. In Study II, a cross-sectional general population survey (n = 3 482) was conducted, and statistical methods based on classical test theory were used in the data analysis. The results show that the items were well understood, acceptable and easy to answer by outpatients, with the exception of six items (Study I).The internal consistency reliability was good or excellent and the construct validity was overall acceptable, with partial support for the factor structure in the general populations (Study II). The self-administered Swedish 36-item version of the WHODAS 2.0 is comparable to other language versions of the instrument. Some of the previous known weaknesses of its construct validity in relation to the item content and insufficient instructions were confirmed. The evidence of overall good content and construct validity together with available norm data supports its use in clinical settings and research.

<p><strong>Objectives: </strong>To assess the reliability and validity of the Patient Specific Functional Scale when administered to people living with Parkinson’s Disease.<strong></strong></p> <p><strong>Methods and Materials: </strong>Twenty six people living with Parkinson’s Disease from Hamilton and Burlington were interviewed four times within a four month period. The participants answered the Movement Disorders Sponsored Unified Disease Rating Scale part II, the Parkinson’s Disease Questionnaire 39, and the Patient Specific Functional Scale. Reliability assessment addressed test-retest reliability and reliability of the change scores using Intraclass Correlation Coefficients. Validity assessment focused on convergent construct validity and longitudinal validity by correlating the Patient Specific Functional Scale with the other measures administered.</p> <p><strong>Results: </strong>The<strong> </strong>test retest reliability of the scores yielded by the PSFS was ICCpre= 0.72 (95%CI=0.47-0.86); ICCpost=0.83 (95%CI=0.66-0.92). The reliability of change scores was 0.50. In relation to the validity, no significant correlations were found between the Patient Specific Functional Scale and the other measures. <strong></strong></p> <p><strong>Conclusions: </strong>The PSFS yields reliable scores when it is administered to people living with PD. The Patient Specific Functional Scale does not target the same outcomes as the MDS-UPDRS part II and the PDQ-39. The PSFS does not detect change in functioning in people living with PD within a four month period.</p> / Master of Science (MSc)

No / Patient-reported outcome measurement has become accepted as an important component of comprehensive outcomes research. Researchers wishing to use a patient-reported measure must either develop their own questionnaire (called an instrument in the research literature) or choose from the myriad of instruments previously reported. This article summarizes how previously developed instruments are best assessed using a systematic process and we propose a system of quality assessment so that clinicians and researchers can determine whether there exists an appropriately developed and validated instrument that matches their particular needs. These quality assessment criteria may also be useful to guide new instrument development and refinement. We welcome debate over the appropriateness of these criteria as this will lead to the evolution of better quality assessment criteria and in turn better assessment of patient-reported outcomes.

BACKGROUND:Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which the content and format is refined through cognitive interviews.METHODS:We conducted cognitive interviews across five iterations of questionnaire refinement with a culturally diverse sample of 28 CAM users. In each iteration, participant critiques were used to revise the questionnaire, which was then re-tested in subsequent rounds of cognitive interviews. Following all five iterations, transcripts of cognitive interviews were systematically coded and analyzed to examine participants' understanding of the format and content of the final questionnaire. Based on this data, we established summary descriptions and selected exemplar quotations for each word pair on the final questionnaire.RESULTS:The final version of the Self-Assessment of Change questionnaire (SAC) includes 16 word pairs, nine of which remained unchanged from the original draft. Participants consistently said that these stable word pairs represented opposite ends of the same domain of experience and the meanings of these terms were stable across the participant pool. Five pairs underwent revision and two word pairs were added. Four word pairs were eliminated for redundancy or because participants did not agree on the meaning of the terms. Cognitive interviews indicate that participants understood the format of the questionnaire and considered each word pair to represent opposite poles of a shared domain of experience.CONCLUSIONS:We have placed lay language and direct experience at the center of questionnaire revision and refinement. In so doing, we provide an innovative model for the development of truly patient-centered outcome measures. Although this instrument was designed and tested in a CAM-specific population, it may be useful in assessing multi-dimensional shifts in well-being across a broader patient population.

Introduction: There has been a continuous development of new technologies in healthcare that are derived from national quality registries. However, this innovation needs to be translated into the workflow of healthcare delivery, to enable children with long-term conditions to get the best support possible to manage their health during everyday life. Since children living with long-term conditions experience different interference levels in their lives, healthcare professionals need to assess the impact of care on children’s day-to-day lives, as a complement to biomedical assessments. Aim: The overall aim of this thesis was to explore and describe the use of instruments about health-related quality of life (HRQOL) in outpatient care for children with long-term conditions on the basis of a national quality registry system. Methods: The research was conducted by using comparative, cross-sectional and explorative designs and data collection was performed by using different methods. The questionnaire DISABKIDS Chronic Generic Measure -37 was used as well as semi-structured interviews and video-recordings from consultations. Altogether, 156 children (8–18 years) and nine healthcare professionals participated in the studies. Children with Type 1 Diabetes (T1D) (n 131) answered the questionnaire DISABKIDS and children with rheumatic diseases, kidney diseases and T1D (n 25) were interviewed after their consultation at the outpatient clinic after the web-DISABKIDS had been used. In total, nine healthcare professionals used the HRQOL instrument as an assessment tool during the encounters which was video-recorded (n 21). Quantitative deductive content analysis was used to describe content in different HRQOL instruments. Statistical inference was used to analyse results from DISABKIDS and qualitative content analysis was used to analyse the interviews and video-recordings. Results: The findings showed that based on a biopsychosocial perspective, both generic and disease-specific instruments should be used to gain a comprehensive evaluation of the child’s HRQOL. The DISABKIDS instrument is applicable when describing different aspects of health concerning children with T1D. When DISABKIDS was used in the encounters, children expressed positive experiences about sharing their results with the healthcare professional. It was discovered that different approaches led to different outcomes for the child when the healthcare professionals were using DISABKIDS during the encounter. When an instructing approach is used, the child’s ability to learn more about their health and how to improve their health is limited. When an inviting or engaging approach is used by the professional, the child may become more involved during the conversations. Conclusions: It could be argued that instruments of HRQOL could be used as a complement to biomedical variables, to promote a biopsychosocial perspective on the child’s health. According to the children in this thesis, feedback on their results after answering to web-DISABKIDS is important, which implies that healthcare professionals need to prioritize time for discussions about results from HRQOL instruments in the encounters. If healthcare professionals involve the child in the discussion of the results of the HRQOL, misinterpreted answers could be corrected during the conversation. Concurrently, this claims that healthcare professionals invite and engage the child.