Objective The Patient Experience with Treatment and Self-management (PETS) is a valid self-report measure of treatment burden. The objective of this analysis is to determine severity cut points for its scores. Methods Data from two survey studies of adults with multimorbidity were used to determine estimates of low, moderate, and high burden for twelve PETS scores. Anchor-based analyses were used to map mean PETS scores onto scores of other self-report measures, including physical and mental health, self-efficacy, and activity limitations. Low, medium, and high scores on the anchors were based on published thresholds or tertile splits of score distributions. Mean PETS scores were compared across levels of the anchor variable using analysis of variance (ANOVA) then summarized to produce burden severity cut points. Results Study 1 featured survey data from 332 adults with multimorbidity (mean age = 66 years, 56% female); study 2 featured survey data from 439 adults with multimorbidity (mean age = 60 years, 62% female). Anchor measures were correlated with PETS scores at rho≥ 0.30. ANOVAs comparing PETS scores across the levels of each anchor variable were all significant ( p s< .001). Estimates were placed into data tables. Cut scores for discriminating treatment burden severity levels were identified as the midpoint between the mean PETS scores associated with adjacent anchor categories (e.g., low vs. medium and medium vs. high burden), rounded to the nearest whole number. Conclusions Severity thresholds can improve the interpretability of PETS scores. The preliminary estimates derived require verification in future studies.
Burden of Treatment in Patients With Heart Failure
Background Heart failure self‐care can contribute to a high daily workload and treatment burden. The goal of this cohort study was to assess the characteristics and outcomes associated with burden of treatment (BoT). Methods Surveys comprising validated instruments to measure BoT and other constructs were mailed to patients with heart failure in Southeastern Minnesota. Participants were divided into tertiles by BoT scores. Associations of clinical variables with BoT were examined using multinomial logistic regression. Associations of BoT with mortality and hospitalizations were examined using Cox proportional hazard regression and Andersen–Gill models, respectively. Results A total of 609 participants (mean age 76.3 years, 60.3% men, 55.2% urban, 64.3% preserved ejection fraction) completed surveys. Higher BoT was associated with worse health status, more depressive symptoms, lower resilience, less social support, lower medication adherence, and worse health literacy. Mean±SD follow‐up was 14.4 (4.1) months. Estimated 1‐year mortality (8.3% [95% CI, 4.3%–12.1%], 11.0% [95% CI, 6.5%–15.2%], 16.0% [95% CI, 10.8%–21.0%]) and 1‐year mean cumulative hospitalizations (0.57 [95% CI, 0.45–0.72], 0.83 [95% CI, 0.66–1.05], 1.15 [95% CI, 0.93–1.42]) increased across patients reporting low, medium, and high BoT, respectively. Adjustment for health status eliminated any significant association of BoT with risks of death and hospitalization (adjusted hazard ratio [HR], 1.10 [95% CI, 0.58–2.07] and 1.09 [95% CI, 0.74–1.61], respectively, highest versus lowest BoT tertile). Conclusions BoT in heart failure varies by clinical and psychosocial factors. Higher BoT identifies patients at increased risk of adverse health outcomes due to their worse health status. These findings can serve as a foundation for interventions to minimize workload and improve quality of life.
Adaptation and content validation of a patient-reported measure of treatment burden for use in stroke survivors: the patient experience with treatment and self-management in stroke (PETS-stroke) measure
AbstractWe used the Psoriasis Caregiver Impact Scale to explore the quality of life (QoL) of parents/caregivers of children with psoriasis. We found that the QoL of parents of children with psoriasis is negatively affected in numerous domains including family and social life, emotional health, work, activities, and finances.
The Development and Initial Validation of the PROMIS®+HF-27 and PROMIS+HF-10 Profiles
Abstract Aims Heart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®-Plus-HF (PROMIS+HF) profile measure, including universal and HF-specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use. Methods and results Candidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF-27 and PROMIS+HF-10 profiles with summary scores (0–100) for overall, physical, mental, and social health. In a cross-sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman–Brown), test–retest reliability (intraclass coefficient; n = 100), known-groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow-up scores by calculating mean differences and Cohen's d and comparing with paired t-tests. Internal consistency was good to excellent (α 0.82–0.94) for all PROMIS+HF-27 scores and acceptable to good (α/Spearman–Brown 0.60–0.85) for PROMIS+HF-10 scores. Test–retest intraclass coefficients were acceptable to excellent (0.75–0.97). Both profiles demonstrated known-groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF-27 and PROMIS+HF-10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group-based increase of 7.6–8.3 points represented a small to medium change (Cohen's d = 0.40–0.42). For the PROMIS+HF physical summary scores, a group-based increase of 5.0–5.9 points represented a small to medium change (Cohen's d = 0.29–0.35). Conclusions The PROMIS+HF-27 and PROMIS+HF-10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient-centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision-making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline-directed medical therapy.
Development and Validation of a Kidney-Transplant Specific Measure of Treatment Burden
Abstract Background Treatment burden refers to the work involved in managing one’s health and its impact on well-being and has been associated with nonadherence in patients with chronic illnesses. No kidney transplant (KT)-specific measure of treatment burden exists. The aim of this study was to develop a KT-specific supplement to the Patient Experience with Treatment and Self-Management (PETS), a general measure of treatment burden. Methods After drafting and pretesting KT-specific survey items, we conducted a cross-sectional survey study involving KT recipients from Mayo Clinic in Minnesota, Arizona, and Florida. Exploratory factor analysis (EFA) was used to identify domains for scaling the KT-specific supplement. Construct and known-groups validity were determined. Results Survey respondents (n = 167) had a mean age of 61 years (range 22–86) and received a KT on average 4.0 years ago. Three KT-specific scales were identified (transplant function, self-management, adverse effects). Higher scores on the KT-specific scales were correlated with higher PETS treatment burden, worse physical and mental health, and lower self-efficacy (p < 0.0001). Patients taking more medications reported higher transplant self-management burden. Conclusions We developed a KT-specific supplement to the PETS general measure of treatment burden. Scores may help providers identify recipients at risk for nonadherence.
Longitudinal trajectories of treatment burden: A prospective survey study of adults living with multiple chronic conditions in the midwestern United States
Objectives Determine whether there are different longitudinal patterns of treatment burden in people living with multiple chronic conditions (MCC) and, if so, explore predictors that might reveal potential routes of intervention. Methods We analyzed data from a prospective mailed survey study of 396 adults living with MCC in southeastern Minnesota, USA. Participants completed a measure of treatment burden, the Patient Experience with Treatment and Self-management (PETS), and valid measures of health-related and psycho-social concepts at baseline, 6, 12, and 24 months. Latent class growth mixture modeling (LCGM) determined trajectories of treatment burden in two summary index scores of the PETS: Workload and Impact. Multivariable logistic regressions were used to identify independent predictors of the trajectories. Results LCGM supported a 2-class model for PETS Workload, including a group of consistently high workload ( N = 69) and a group of consistently low workload ( N = 311) over time. A 3-class model was supported for PETS Impact, including groups of consistently high impact ( N = 62), consistently low impact ( N = 278), and increasing impact ( N = 51) over time. Logistic regression analyses showed that the following factors were associated with patterns of consistently high or increasing treatment burden over time: lower health literacy, lower self-efficacy, more interpersonal challenges with others, and worse subjective reports of physical and mental health (all p < .05). Conclusions Different longitudinal patterns of treatment burden exist among people with MCC. Raising health literacy, enhancing self-efficacy, and lessening the effects of negative social interactions might help reduce treatment burden.
Effects of patient-reported outcome assessment order
Background In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. Methods This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach’s alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran–Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. Results A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach’s alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. Conclusion The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.
Systematic review of patient-reported measures of treatment burden in stroke
Objectives Treatment burden is the workload of healthcare for people with long-term conditions (LTC) and its impact on well-being. A method of measurement is required to identify those experiencing high burden and to measure intervention efficacy. Our aim was to identify, examine and appraise validated patient-reported measures (PRMs) of treatment burden in stroke. Here, stroke serves as an exemplar LTC of older adults. Design A systematic review of published studies that describe the development and validation of PRMs measuring treatment burden in stroke survivors. Data sources We searched MEDLINE, Embase, CINAHL and PsycINFO electronic databases. Eligibility criteria Studies published between January 2000 and 12 April 2019 inclusive, in English language. No restrictions were set based on clinical setting or geographical location. Data extraction and synthesis Screening, data extraction and quality appraisal were conducted by two independent reviewers. Content of the PRMs was compared with a published taxonomy of treatment burden. Quality appraisal was conducted using International Society for Quality of Life Research standards. Results From 3993 articles, 6 relevant PRMs were identified: 3 were stroke specific: The Satisfaction with Stroke Care questionnaire; The Stroke Patient-Reported Outcome Measure and The Barriers to Physical Activity after Stroke scale. Three were generic but validated in stroke: The WHO Quality of Life-100; The Patient’s Questionnaire on Participation in Discharge Planning and The Chao Perception of Continuity scale. None comprehensively measured treatment burden. Examples of omitted burdens included developing coping strategies, managing finances and returning to driving. The most notable issue regarding quality appraisal was that three PRMs lacked any underpinning qualitative research relevant to the sample. Conclusion There is a need to develop a comprehensive PRM of treatment burden for use in stroke, with potential for use in other older populations.
Reserve-building activities attenuate treatment burden in chronic illness: The mediating role of appraisal and social support
This study examines the importance of four psychosocial factors—personality, cognitive appraisal of quality of life, social support, and current reserve-building—in predicting treatment burden in chronically ill patients. Chronically ill patients ( n = 446) completed web-based measures. Structural equation modeling was used to investigate psychosocial factors predicting treatment burden. Reserve-building activities indirectly reduced treatment burden by: (1) reducing health worries appraisals, (2) reducing financial difficulties, (3) increasing calm and peaceful appraisals, and (4) increasing perceived social support. These findings point to key behaviors that chronically ill people can use to attenuate their treatment burden.