Development and acceptability of PETS-Now, an electronic point-of-care tool to monitor treatment burden in patients with multiple chronic conditions: a multi-method study.

BACKGROUND: The aim of this study was to develop a web-based tool for patients with multiple chronic conditions (MCC) to communicate concerns about treatment burden to their healthcare providers. METHODS: Patients and providers from primary-care clinics participated. We conducted focus groups to identify content for a prototype clinical tool to screen for treatment burden by reviewing domains and items from a previously validated measure, the Patient Experience with Treatment and Self-management (PETS). Following review of the prototype, a quasi-experimental pilot study determined acceptability of using the tool in clinical practice. The study protocol was modified to accommodate limitations due to the Covid-19 pandemic. RESULTS: Fifteen patients with MCC and 18 providers participated in focus groups to review existing PETS content. The pilot tool (named PETS-Now) consisted of eight domains (Living Healthy, Health Costs, Monitoring Health, Medicine, Personal Relationships, Getting Healthcare, Health Information, and Medical Equipment) with each domain represented by a checklist of potential concerns. Administrative burden was minimized by limiting patients to selection of one domain. To test acceptability, 17 primary-care providers first saw 92 patients under standard care (control) conditions followed by another 90 patients using the PETS-Now tool (intervention). Each treatment burden domain was selected at least once by patients in the intervention. No significant differences were observed in overall care quality between patients in the control and intervention conditions with mean care quality rated high in both groups (9.3 and 9.2, respectively, out of 10). There were no differences in provider impressions of patient encounters under the two conditions with providers reporting that patient concerns were addressed in 95% of the visits in both conditions. Most intervention group patients (94%) found that the PETS-Now was easy to use and helped focus the conversation with the provider on their biggest concern (98%). Most providers (81%) felt they had learned something new about the patient from the PETS-Now. CONCLUSION: The PETS-Now holds promise for quickly screening and monitoring treatment burden in people with MCC and may provide information for care planning. While acceptable to patients and clinicians, integration of information into the electronic medical record should be prioritized.

Investigating psychological mechanisms linking pain severity to depression symptoms in women cancer survivors at a cancer center with a rural catchment area.

PURPOSE: Women cancer survivors, especially those in rural areas, with high levels of depression may be acutely susceptible to pain due to the ways they think, feel, and behave. The current study seeks to elucidate the relationship between symptoms of depression and pain severity in women cancer survivors, by examining the putative mediators involved in this relationship, specifically their self-efficacy for managing their health, how overwhelmed they were from life's responsibilities, and relational burden. METHODS: Self-report data were collected from 183 cancer survivors of breast, cervical, ovarian, or endometrial/uterine cancer, who were between 6 months and 3 years post-active therapy. RESULTS: Women cancer survivors with higher (vs. lower) symptoms of depression had more severe pain. Individual mediation analyses revealed that survivors with higher levels of depression felt more overwhelmed by life's responsibilities and had lower self-efficacy about managing their health, which was associated with greater pain severity. When all mediators were simultaneously entered into the same model, feeling overwhelmed by life's responsibilities significantly mediated the link between survivors' symptoms of depression and their pain severity. CONCLUSIONS: The relationship between symptoms of depression and pain severity in women cancer survivors may be attributed in part to their self-efficacy and feeling overwhelmed by life's responsibilities. Early and frequent assessment of psychosocial factors involved in pain severity for women cancer survivors may be important for managing their pain throughout the phases of cancer survivorship.

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.

PURPOSE: Stroke survivors often live with significant treatment burden yet our ability to examine this is limited by a lack of validated measurement instruments. We aimed to adapt the 60-item, 12-domain Patient Experience with Treatment and Self-Management (PETS) (version 2.0, English) patient-reported measure to create a stroke-specific measure (PETS-stroke) and to conduct content validity testing with stroke survivors. MATERIALS AND METHODS: Step 1 - Adaptation of PETS to create PETS-stroke: a conceptual model of treatment burden in stroke was utilised to amend, remove or add items. Step 2 - Content validation: Fifteen stroke survivors in Scotland were recruited through stroke groups and primary care. Three rounds of five cognitive interviews were audio recorded and transcribed. Framework analysis was used to explore importance/relevance/clarity of PETS-stroke content. COSMIN reporting guidelines were followed. RESULTS: The adapted PETS-stroke had 34 items, spanning 13 domains; 10 items unchanged from PETS, 6 new and 18 amended. Interviews (n = 15) resulted in further changes to 19 items, including: instructions; wording; item location; answer options; and recall period. CONCLUSIONS: PETS-stroke has content that is relevant, meaningful and comprehensible to stroke survivors. Content validity and reliability testing are now required. The validated tool will aid testing of tailored interventions to lessen treatment burden.IMPLICATIONS FOR REHABILITATIONTreatment burden is reported by stroke survivors but no stroke-specific measure of treatment burden exists.We adapted an existing measure of treatment burden for use in multimorbid patients (PETS) to create a stroke specific version (PETS-stroke).The items in PETS-stroke are relevant and meaningful to people with stroke.Further testing will examine construct validity, reliability, and useability.This measure will be useful in future RCTs to measure treatment burden and to identify stroke patients who are at high risk of treatment burden.

Designing persuasive health education for patients seeking unproven stem cell interventions.

Misinformation among clinics advertising unproven stem cell interventions (SCIs) is pervasive and has resulted in patient and societal harms. Most bioethics commentaries have centered on advancing regulatory approaches to curtail the supply side of the market, but insufficient attention has been paid to considering strategies influencing patient demand. In this article, we offer an ethical justification for the design and deployment of persuasive patient education on unproven SCIs and distinguish it from didactic and manipulative education frames. Persuasive education should aim to correct and inoculate against misinformation about unproven SCIs and instill a sense of caution among patients considering experimental interventions outside of a clinical trial. We outline various communication strategies to effectively correct or inoculate against SCI misinformation. The stem cell community needs to invest in understanding patients' informational sources, attitudes, and beliefs about SCIs to develop and implement evidence-based persuasive education to promote informed decision-making about these therapies.

Treatment burden for people experiencing homelessness with a recent non-fatal overdose: a questionnaire study.

BACKGROUND: People experiencing homelessness (PEH) who have problem drug use have complex medical and social needs, with barriers to accessing services and treatments. Their treatment burden (workload of self-management and impact on wellbeing) remains unexplored. AIM: To investigate treatment burden in PEH with a recent non-fatal overdose using a validated questionnaire, the Patient Experience with Treatment and Self-management (PETS). DESIGN AND SETTING: The PETS questionnaire was collected as part of a pilot randomised control trial (RCT) undertaken in Glasgow, Scotland; the main outcome is whether this pilot RCT should progress to a definitive RCT. METHOD: An adapted 52-item, 12-domain PETS questionnaire was used to measure treatment burden. Greater treatment burden was indicated by higher PETS scores. RESULTS: Of 128 participants, 123 completed PETS; mean age was 42.1 (standard deviation [SD] 8.4) years, 71.5% were male, and 99.2% were of White ethnicity. Most (91.2%) had >5 chronic conditions, with an average of 8.5 conditions. Mean PETS scores were highest in domains focusing on the impact of self-management on wellbeing: physical and mental exhaustion (mean 79.5, SD 3.3) and role and social activity limitations (mean 64.0, SD 3.5) Scores were higher than those observed in studies of patients who are not homeless. CONCLUSION: In a socially marginalised patient group at high risk of drug overdose, the PETS showed a very high level of treatment burden and highlights the profound impact of self-management work on wellbeing and daily activities. Treatment burden is an important person-centred outcome to help compare the effectiveness of interventions in PEH and merits inclusion in future trials as an outcome measure.

The impact of childhood psoriasis on the quality of life of parents and caregivers.

We 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.

Understanding the treatment burden of people with chronic conditions in Kenya: A cross-sectional analysis using the Patient Experience with Treatment and Self-Management (PETS) questionnaire.

In Kenya, non-communicable diseases (NCDs) are an increasingly important cause of morbidity and mortality, requiring both better access to health care services and self-care support. Evidence suggests that treatment burdens can negatively affect adherence to treatment and quality of life. In this study, we explored the treatment and self-management burden among people with NCDs in in two counties in Western Kenya. We conducted a cross-sectional survey of people newly diagnosed with diabetes and/or hypertension, using the Patient Experience with Treatment and Self-Management (PETS) instrument. A total of 301 people with diabetes and/or hypertension completed the survey (63% female, mean age = 57 years). They reported the highest treatment burdens in the domains of medical and health care expenses, monitoring health, exhaustion related to self-management, diet and exercise/physical therapy. Treatment burden scores differed by county, age, gender, education, income and number of chronic conditions. Younger respondents (<60 years) reported higher burden for medication side effects (p<0.05), diet (p<0.05), and medical appointments (p = 0.075). Those with no formal education or low income also reported higher burden for diet and for medical expenses. People with health insurance cover reported lower (albeit still comparatively high) burden for medical expenses compared to those without it. Our findings provide important insights for Kenya and similar settings where governments are working to achieve universal health coverage by highlighting the importance of financial protection not only to prevent the economic burden of seeking health care for chronic conditions but also to reduce the associated treatment burden.

Identifying meaningful change on PROMIS short forms in cancer patients: a comparison of item response theory and classic test theory frameworks.

BACKGROUND: This study compares classical test theory and item response theory frameworks to determine reliable change. Reliable change followed by anchoring to the change in categorically distinct responses on a criterion measure is a useful method to detect meaningful change on a target measure. METHODS: Adult cancer patients were recruited from five cancer centers. Baseline and follow-up assessments at 6 weeks were administered. We investigated short forms derived from PROMIS® item banks on anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance. We detected reliable change using reliable change index (RCI). We derived the T-scores corresponding to the RCI calculated under IRT and CTT frameworks using PROMIS® short forms. For changes that were reliable, meaningful change was identified using patient-reported change in PRO-CTCAE by at least one level. For both CTT and IRT approaches, we applied one-sided tests to detect reliable improvement or worsening using RCI. We compared the percentages of patients with reliable change and reliable/meaningful change. RESULTS: The amount of change in T score corresponding to RCICTT of 1.65 ranged from 5.1 to 9.2 depending on domains. The amount of change corresponding to RCIIRT of 1.65 varied across the score range, and the minimum change ranged from 3.0 to 8.2 depending on domains. Across domains, the RCICTT and RCIIRT classified 80% to 98% of the patients consistently. When there was disagreement, the RCIIRT tended to identify more patients as having reliably changed compared to RCICTT if scores at both timepoints were in the range of 43 to 78 in anxiety, 45 to 70 in depression, 38 to 80 in fatigue, 35 to 78 in sleep disturbance, and 48 to 74 in pain interference, due to smaller standard errors in these ranges using the IRT method. The CTT method found more changes compared to IRT for the pain intensity domain that was shorter in length. Using RCICTT, 22% to 66% had reliable change in either direction depending on domains, and among these patients, 62% to 83% had meaningful change. Using RCIIRT, 37% to 68% had reliable change in either direction, and among these patients, 62% to 81% had meaningful change. CONCLUSION: Applying the two-step criteria demonstrated in this study, we determined how much change is needed to declare reliable change at different levels of baseline scores. We offer reference values for percentage of patients who meaningfully change for investigators using the PROMIS instruments in oncology.

Development and Validation of a Kidney-Transplant Specific Measure of Treatment Burden.

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.

The development and initial validation of the PROMIS®+HF-27 and PROMIS+HF-10 profiles.

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.

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.

Lessons Learned: Recruiting Research Participants from an Underrepresented Patient Population at a Safety Net Hospital.

BACKGROUND: Recruiting participants to clinical research studies is challenging, especially when conducted in safety net settings. We sought to compare the efficacy of different recruitment strategies in an NIH-funded study assessing treatment burden in patients with multiple chronic conditions (MCCs). METHODS: Targeted mailing, in-person table-based recruitment ("tabling") in the waiting room, and telephone calling were used to enroll subjects into one of two studies of treatment burden: a survey study to validate a brief measure of treatment burden for quality assessment (study 1) or a qualitative study to develop a treatment burden clinical communication tool (study 2). RESULTS: Over 50% of subjects in each study were African American or African immigrants. In study 1, the enrollment goal of 200 was reached within 4 months. Tabling enrolled 78.5% of patients, while the remainder (21.5%) were enrolled from phone calls to eligible patients identified through the electronic medical record (EMR). In study 2, 340 eligible patients were identified through the EMR, and 7 (2.1%) were successfully enrolled via mailed invitations and responses. Retention rates (66% in study 1 and 71% in study 2) were reasonable in all groups. CONCLUSIONS: Study recruiting goals in our safety net population were rapidly reached using the tabling method, which had substantively higher enrollment rates than mailings or telephone calls based on EMR reports. Future trials could compare recruitment strategies across settings and clinical populations.

Treatment Burden in People with Hypertension is Correlated with Patient Experience with Self-Management.

INTRODUCTION: New hypertension guidelines in the United States may require more people to take multiple medications or implement lifestyle changes. Increased treatment burden may be an unintended consequence and lead to worse health outcomes. Our study examined whether treatment burden is associated with factors related to self-management in those with hypertension. METHODS: We conducted a cross-sectional mailed survey of patients from 2 medical centers in Minnesota. Participants with 2 or more medical conditions completed the Patient Experience with Treatment and Self-management (PETS), a validated treatment burden questionnaire, as well as measures of confidence in self-management ability, health literacy, health care-related financial difficulties, and perception of provider interpersonal skills. We used partial correlation analyses, controlling for age, sex, race, and education, to test relationships among study variables. RESULTS: Of 254 respondents who had a diagnosis of hypertension, 54% were female, 74% were non-Hispanic White, and the mean age was 67 years. People with hypertension who reported having lower confidence in self-management ability, lower health literacy, more financial difficulties, and health care providers with poorer interpersonal skills reported higher treatment burden scores (PETS scales correlation magnitude range 0.09 to 0.62, P < .05 on all but 4). The strongest associations were observed for medical information and physical/mental exhaustion with self-management (correlation magnitudes from 0.25 to 0.54, P < .01). DISCUSSION: Hypertension treatment guideline stringent blood pressure criteria may lead to more interventions-medical or lifestyle-creating strains on populations already challenged by abstract disease self-management and at risk of experiencing disparities in cardiovascular health outcomes.

Score equivalence of paper-, tablet-, and interactive voice response system-based versions of PROMIS, PRO-CTCAE, and numerical rating scales among cancer patients.

BACKGROUND: The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS®), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures. METHODS: Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference. RESULTS: For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI's were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers. CONCLUSION: Across all mode comparisons, there were some measures with CI's not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible.

Functional Outcomes and Health-Related Quality of Life Before and After Primary Total Knee Replacement for Patients From Diverse Geographic Regions.

BACKGROUND: The purpose of this study was to investigate whether patient-reported knee function and health status before and after primary total knee replacement (TKR) at an academic medical center differs among patients from diverse geographic regions. METHODS: We assessed patient-reported outcomes (PROs) as measured by the Oxford Knee Score (OKS) and EuroQoL-5D (EQ-5D) in 2855 TKR patients at preprimary and one year postprimary TKR procedure between January 1, 2012 and June 30, 2014. We compared the demographic characteristics, response rates, and changes in OKS, EQ-5D, and EQ visual analog scale among local, regional, and national patient groups. Patient- or hospital-related predictors of the postoperative scores were identified after controlling for preoperative scores on the PRO measures. RESULTS: Local patients had more comorbid conditions. Groups were similar in clinical outcomes such as length of stay at hospital, complication, and reoperation rates. Local, regional, and national patients had similar response rates and reported a similar level of knee function and health-related quality of life before and after TKR. Eighty nine percent had clinically important improvement on OKS, 69% on EQ-5D index, and 28% EQ visual analog scale, and there were no differences among groups in the proportions of clinically meaningful change. Better postoperative PRO scores were associated with older age, shorter hospital stay, fewer comorbidities, nonsmoking status, fewer complications, and private health insurance. CONCLUSION: Some patient characteristics such as comorbidities were greater in the local patient cohort versus the national cohort. Nevertheless, clinical outcomes and PROs were comparable across all geographic tiers.

Deriving and validating a brief measure of treatment burden to assess person-centered healthcare quality in primary care: a multi-method study.

BACKGROUND: In primary care there is a need for more quality measures of person-centered outcomes, especially ones applicable to patients with multiple chronic conditions (MCCs). The aim of this study was to derive and validate a short-form version of the Patient Experience with Treatment and Self-management (PETS), an established measure of treatment burden, to help fill the gap in quality measurement. METHODS: Patient interviews (30) and provider surveys (30) were used to winnow items from the PETS (60 items) to a subset targeting person-centered care quality. Results were reviewed by a panel of healthcare providers and health-services researchers who finalized a pilot version. The Brief PETS was tested in surveys of 200 clinic and 200 community-dwelling MCC patients. Surveys containing the Brief PETS and additional measures (e.g., health status, medication adherence, quality of care, demographics) were administered at baseline and follow-up. Correlations and t-tests were used to assess validity, including responsiveness to change of the Brief PETS. Effect sizes (ES) were calculated on mean differences. RESULTS: Winnowing and panel review resulted in a 34-item Brief PETS pilot measure that was tested in the combined sample of 400 (mean age = 57.9 years, 50% female, 48% white, median number of conditions = 5). Reliability of most scales was acceptable (alpha > 0.70). Brief PETS scores were associated with age, income, health status, and quality of chronic illness care at baseline (P < .05; rho magnitude range: 0.16-0.66). Furthermore, Brief PETS scores differentiated groups based on marital and education status, presence/absence of a self-management routine, and optimal/suboptimal medication adherence (P < .05; ES range: 0.25-1.00). Declines in patient-reported physical or mental health status over time were associated with worsening PETS burden scores, while improvements were associated with improving PETS burden scores (P < .05; ES range: 0.04-0.44). Among clinic patients, 91% were willing to complete the Brief PETS as part of their clinic visits. CONCLUSIONS: The Brief PETS (final version: 32 items) is a reliable and valid tool for assessing person-centered care quality related to treatment burden. It holds promise as a means of giving voice to patient concerns about the complexity of disease management.

Known-groups validity and responsiveness to change of the Patient Experience with Treatment and Self-management (PETS vs. 2.0): a patient-reported measure of treatment burden.

PURPOSE: The purpose of this study was to test the known-groups validity and responsiveness to change of the Patient Experience with Treatment and Self-management (PETS, vs. 2.0), a measure of treatment burden. METHODS: The PETS and other standard measures were mailed at baseline and 12-month follow-up to adults living with multiple chronic conditions in southeast Minnesota (USA). A sample of 365 people (mean age = 62.1 years) completed both surveys. Baseline, 12-month, and changes in PETS burden scores were examined. Clinical anchors used to test validity included number of diagnoses (2-4 vs. 5+), mental health diagnosis (yes/no), medication adherence and health literacy (suboptimal/optimal), and changes in self-efficacy, global physical, and global mental health (worsening/improving). Independent-samples t-tests were used to compare scores. RESULTS: PETS scales showed good internal consistency (αs ≥ 0.80). There were few differences across number of diagnoses, but having a mental health diagnosis was associated with higher baseline PETS burden scores (Ps < .05). Suboptimal medication adherence and health literacy over time were associated with worse 12-month PETS burden scores (Ps < .05). Compared with improvements, declines over time in self-efficacy, global physical health, and global mental health were each associated with worsening change scores on PETS impact summary, medical expenses, and bother due to medication reliance and medication side effects (Ps < .05). CONCLUSION: Among multi-morbid adults, the PETS demonstrated evidence of known-groups validity and responsiveness to change across both objective (e.g., mental health diagnoses) and subjective anchors (e.g., changes in self-efficacy, global physical, and global mental health).

Confirmatory Factor Analyses and Differential Item Functioning of the Patient Experience with Treatment and Self-Management (PETS vs. 2.0): A Measure of Treatment Burden.

PURPOSE: To examine the factor structure and differential item functioning (DIF) of the Patient Experience with Treatment and Self-management (PETS version 2.0), a measure of treatment burden. PATIENTS AND METHODS: Version 2.0 of the PETS has 60 items, extending the previously-validated 48-item version 1.0 by three domains (nine items) and three additional items in an existing domain. We conducted confirmatory factor analyses (CFA) on survey responses of 439 community-dwelling adults living with multiple chronic conditions who completed PETS version 2.0, using R packages, "lavaan" and "semTools." We tested fit of second-order factors to explore simplifying the reporting of PETS scores. We examined DIF for the two second-order factors with "lordif" R package, testing groups by gender, education, and health literacy, using the McFadden pseudo R 2 change criterion of ≥0.02 to flag items with DIF. Cronbach's alpha and the intraclass correlation coefficient (ICC) were used to determine the reliability of PETS domains. RESULTS: The first-order CFA model featuring 12 multi-item domains had an excellent fit (Comparative Fit Index [CFI]=0.989), as did the second-order CFA model (CFI=0.987), specifying two superordinate factors of treatment burden (workload and impact). Items in the workload and impact second-order factors did not show any DIF across gender, education, and health literacy groups as shown by McFadden pseudo R 2 changes <0.02. Cronbach's alphas for all multi-item domain scales were ≥0.80, and ICCs of ten scales were ≥0.70, meeting the threshold for adequate test-retest reliability. CONCLUSION: Findings support the construct validity and reliability of PETS version 2.0. The fit of a factor model featuring superordinate (ie, second-order) factors of workload and impact supports index scoring that will simplify reporting of PETS scores. DIF analyses indicate that items from these indices can be interpreted in the same way, regardless of gender, education, or health literacy.