Quality of Life Research

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Online ISSN: 1573-2649
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Article
Purpose To select and scale items for the seven domains of the Patient-Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) and assess its construct validity. Methods Using an online survey, data on 100 potential items, and other variables for assessing construct validity, were collected from 1055 adults with one or more chronic health conditions. Based on a validated conceptual model, confirmatory factor analysis (CFA) and item response models (IRT) were used to select and scale potential items and assess the internal consistency and structural validity of the PRISM-CC. To further assess construct validity, hypothesis testing of known relationships was conducted using structural equation models. Results Of 100 potential items, 36 (4–8 per domain) were selected, providing excellent fit to our hypothesized correlated factors model and demonstrating internal consistency and structural validity of the PRISM-CC. Hypothesized associations between PRISM-CC domains and other measures and variables were confirmed, providing further evidence of construct validity. Conclusion The PRISM-CC overcomes limitations of assessment tools currently available to measure patient self-management of chronic health conditions. This study provides strong evidence for the internal consistency and construct validity of the PRISM-CC as an instrument to assess patient-reported difficulty in self-managing different aspects of daily life with one or more chronic conditions. Further research is needed to assess its measurement equivalence across patient attributes, ability to measure clinically important change, and utility to inform self-management support.
 
Flow diagram of sample selection
Correlations of health state utilities mapped from each algorithm and the combined algorithms with PedsQL SCD total score. The header of each panel indicates the mapping algorithm, of which the details can be found in Table 1. The text in each panel indicates the Spearman’s correlation coefficient and 95% confidence interval. PedsQL Pediatric Quality of Life Inventory, SCD sickle cell disease
Correlations of final health state utilities with PedsQL SCD module-specific score. The header of each panel indicates the PedsQL SCD module, of which the details can be found in Table 1. The text in each panel indicates the Spearman’s correlation coefficient and 95% confidence interval. PedsQL Pediatric Quality of Life Inventory, SCD sickle cell disease
Article
Purpose There is a paucity of empirically estimated health state utility (HSU) values to estimate health-related quality of life among individuals with sickle cell disease (SCD). This study aims to map the Pediatric Quality of Life Inventory generic core scales (PedsQL GCS) to HSUs for children and adolescents with SCD in the United States, using published algorithms, and to assess the construct validity of these HSUs against SCD-specific PedsQL scores. Methods We used the published mapping algorithms identified in four published articles, in which the PedsQL GCS was mapped to either the EuroQol-5 Dimension 3-Level, Youth Version or the Child Health Utility 9-Dimension to obtain HSUs. We employed the algorithms to calculate HSUs for a sample of children and adolescents from the Sickle Cell Clinical Research and Intervention Program. To assess the construct validity of the mapped HSUs in SCD patients, we computed Spearman’s correlation coefficient comparing the HSUs with the PedsQL SCD total score and separately with each PedsQL SCD dimension-specific score. Results The mean mapped HSU across published algorithms was 0.792 (95% CI: 0.782–0.801). It was significantly higher among children aged 5–12 years than children aged 13–17 years. The Spearman’s correlation coefficient for HSUs versus PedsQL SCD total scores was 0.64 (95% CI: 0.57–0.71). Correlations ranged from 0.40 (95% CI: 0.32–0.48) to 0.60 (95% CI: 0.54–0.66) for HSUs versus PedsQL SCD dimension-specific scores. Conclusions The existing mapping algorithms show acceptable construct validity in children and adolescents with SCD. Additional algorithms are needed for adults and for specific SCD comorbidities.
 
a The Quality-of-Life-Aged Care Consumers (QOL-ACC) scores by self-rated quality of life. b The Quality-of-Life-Aged Care Consumers (QOL-ACC) scores by self-rated health
a The Quality-of-Life-Aged Care Consumers (QOL-ACC) scores by quality of aged care service experience measured by the Quality of Care Experience-Aged Care Consumers (QCE-ACC). b The Quality-of-Life-Aged Care Consumers (QOL-ACC) scores by different types of community-aged care service types (CHSP Commonwealth Home Support Programme, HCP Home Care Package)
Article
Purpose To evaluate the construct (convergent and known group) validity of the Quality-of-Life-Aged Care Consumer (QOL-ACC), an older-person-specific quality-of-life measure designed for application in quality assessment and economic evaluation in aged care. Methods Convergent validity was assessed by examining relationships with other validated preference-based measures (EQ-5D-5L, ASCOT), quality of aged care experience (QCE-ACC) and life satisfaction (PWI) through an online survey. Known-group validity was assessed by testing the ability to discriminate varying levels of care needs, self-reported health and quality of life. Results Older people (aged ≥ 65 years) receiving community-aged care (N = 313) responded; 54.6% were female, 41.8% were living alone and 56.8% were receiving higher-level care. The QOL-ACC and its six dimensions were low to moderately and significantly correlated with the EQ-5D-5L (correlation co-efficient range, ρ = 0.39–0.56). The QOL-ACC demonstrated moderate and statistically significant correlations with ASCOT (ρ = 0.61), the QCE-ACC (ρ = 0.51) and the PWI (ρ = 0.70). Respondents with poorer self-reported health status, quality of life and/or higher-level care needs demonstrated lower QOL-ACC scores (P < 0.001), providing evidence of known-group validity. Conclusions The study provides evidence of the construct validity of the QOL-ACC descriptive system. A preference-weighted value set is currently being developed for the QOL-ACC, which when finalised will be subjected to further validation assessments.
 
Illustration of the change in samples across severity. Figure explained in the main text
Distribution plot of the reported values by the severity of those health states (x axis). Larger circles indicate a larger number of observations for that value/severity combination. Fit plots are included for the BTD data only (upper-stippled line), WTD data only (lower-stippled line), and BTD and WTD data combined (solid line). The circles are scaled based on the number of responses given for a certain severity
Slopes (vertical axis) and intercepts (horizontal axis) for the relation between values and severity for each respondent. Respondents are segmented into groups by their number of WTD preferences, ranging between 0 and 10. Each point in these scatter plots represents the slope and intercept for an individual respondent. The final panel represents the aggregate data
Median slopes (vertical axis) and intercepts (horizontal axis) for each segment. The markers indicate the number of WTD preferences in each segment
Slopes for positive values (vertical axis) and slopes for negative values (horizontal axis) for the relation between values and severity for each respondent (see Eq. 2). Respondents are segmented into groups by their number of WTD preferences, ranging between 0 and 10. Each point in these scatter plots represents the slopes for positive and negative values for an individual respondent. The final panel represents the aggregate data. Respondents with a slope larger than 0.1 for positive values were omitted (n = 41). In the first panel, 0 WTD responses, the slope for negative values is undefined, as respondents do not exhibit WTD preferences. Similarly in panel 10, where all responses are negative, the slope for positive values is undefined. We have set these slopes to 0 in Figure, to enable us to present the slope for positive values in the first panel and the slope for negative values in the 10th panel
Article
Background Recent studies concluded that for health states considered worse than dead (WTD), as measured with the time trade-off (cTTO) method, negative mean values were insensitive to health state severity, which represents a validity problem for the cTTO. However, the aforementioned studies analysed negative values in isolation, which causes selection bias as the value distribution is truncated. Aim To investigate the validity of aforementioned studies and of negative values in general. Methods The ‘threshold explanation’ was formulated: beyond a certain severity threshold, preferences change from better than dead (BTD) to WTD. This threshold differs between respondents. Thus, negative values across severity are obtained from different respondents, and responses added for higher severity contribute negative values close to zero, explaining the aforementioned insensitivity. This explanation was tested using data from the Dutch EQ-5D-5L valuation study. Respondents valued 10 health states. Based on respondents’ number of WTD preferences, segments were constructed, containing respondents with similar severity thresholds. Using regression models for each individual respondent, we examined the relation between values and severity and compared respondents between segments. Results Negative values, when analysed in isolation, were insensitive to severity. However, for individual respondents and within most segments, cTTO values and severity were negatively related. For individual respondents, negative slopes were steeper for segments with more WTD preferences, as predicted by the threshold explanation. Discussion Analysing negative values in isolation leads to biased estimates. Analyses of cTTO values for individual respondents refute the insensitivity of negative cTTO values.
 
The comparison of response distribution for both test and retest data. The pseudo-QALYs was calculated by multiplying the utility value of the health state by the corresponding life duration. The utility value was calculated using the Chinese DCETTO value set [21]. For example, the pseudo-QALY for choice A (121122 with 4 years) in a DCETTO task would be 0.971 * 4 = 3.884 QALYs. TTO time trade-off, DCETTO discrete choice experiment with duration
The Bland–Altman plot of TTO observed values for test and retest
The proportions of respondents gave consistent choices in different pseudo-QALYs categories for DCETTO data. The pseudo-QALYs was calculated by multiplying the utility value of the health state by the corresponding life duration. The utility value was calculated using the Chinese DCETTO value set [21]. For example, the pseudo-QALY for choice A (121122 with 4 years) in a DCETTO task would be 0.971 * 4 = 3.884 QALYs
Article
Objectives To evaluate and compare the test–retest reliability of discrete choice experiments with duration (DCETTO) and time trade-off (TTO) in the Chinese SF-6Dv2 valuation study. Methods During face-to-face interviews, a representative sample of the Chinese general population completed 8 TTO tasks and 10 DCETTO tasks. Retest interviews were conducted after two weeks. For both DCETTO and TTO, the consistency of raw responses between the two tests was firstly evaluated at the individual level. Regressions were conducted to investigate the association between the test–retest reliability and the respondents’ characteristics and the severity of health states. Consistency was then analyzed at the aggregate level by comparing the rank order of the coefficients of dimensions. Results In total, 162 respondents (51.9% male; range 18–80 years) completed the two tests. The intraclass correlations coefficient 0.958 for TTO, with identical values accounting for 59.3% of observations. 76.4% of choices were identical for DCETTO, with a Kappa statistic of 0.528. Respondents’ characteristics had no significant impact while the severity of health states valued in TTO and DCETTO tasks had a significant impact on the test–retest reliability. Both approaches produced relatively stable rank order of dimensions in constrained model estimations between test and retest data. Conclusions Individual responses of both approaches are relatively stable over time. The rank orders of dimensions in model estimations between test and retest for TTO and DCETTO are also consistent. The differences of utility estimation between the two tests for DCETTO need to be further investigated based on a larger sample size.
 
Information on the SELFIE project
Example choice task DCE
Relative importance of the outcome measures. (Note: All relative importance weights sum up to 1. The relative importance of each outcome measure was based on the coefficient of its attribute-level 3 divided by the sum of all level 3 coefficients. For instance, ‘Enjoyment of life’ had a coefficient of 5.571 for its level-3 attribute (see Table 3), and it yielded a relative importance weight of 5.571/25.164 = 0.221, where 25.164 was the sum of level-3 coefficients across all domains.)
Results latent class analysis: coefficients of attribute-level 3. *Significant preference within the class (P < 0.05)
Overlap in perspectives of respondents
Article
Purpose For an integrated care programme to be successful, preferences of the stakeholders involved should be aligned. The aim of this study is to investigate to which extent outcomes beyond health are valued and to study the heterogeneity of preferences of those involved in integrated care. Methods A discrete choice experiment (DCE) was conducted to elicit preferences for eight Triple Aim outcomes, i.e., physical functioning, psychological well-being, social relationships & participation, enjoyment of life, resilience, person-centeredness, continuity of care and total health and social care costs. Stakeholders were recruited among Dutch persons with multi-morbidity, informal caregivers, professionals, payers, and policymakers. A Bayesian mixed-logit model was used to analyse the data. Subsequently, a latent class analysis was performed to identify stakeholders with similar preferences. Results 739 stakeholders completed the DCE. Enjoyment of life was perceived as the most important outcome (relative importance: 0.221) across stakeholders, while total health and social care costs were perceived as least important (0.063). The latent class analysis identified four classes. The first class (19.9%) put most weight on experience with care outcomes. The second class (39%) favoured enjoyment of life. The third class (18%) focused relatively more on physical health. The fourth class (24%) had the least consistent preferences. Conclusion This study has highlighted the heterogeneity in views of stakeholders in integrated care on what is important in health(care) for persons with multi-morbidity. To accurately value integrated care a variety of outcomes beyond health–e.g., enjoyment of life and experience with care–should be taken into account.
 
Pain in other anatomical sites other than the low back region
Article
Purpose Low back pain (LBP) is the most prevalent public health problem globally, second only to headaches in the ranking of painful disorders that affect human beings. However, evidence about the profile of LBP patients is lacking in low-income countries for appropriate management approaches. This study examined the profile of individuals with LBP and factors defining chronicity of pain in Ethiopia. Methods A population-based cross-sectional study design was used to collect data from 1812 adults (≥ 18 years) with LBP at present. Data were collected by interviewing the study participants using an instrument developed and validated in the same study population. The instrument includes socio-demographic information, health behaviours/lifestyle habits, beliefs about pain, and pain and general health-related characteristics of the participants. Data analysis was performed using R version 3.5.1. Both unconditional and conditional logistic regression models were fitted and Odds Ratio (OR) with 95% confidence intervals (95% CIs) were computed to identify factors significantly associated with chronicity of pain at p ≤ 0.05 significance level. Results Negative beliefs about pain, a varying degree of pain interference with daily and social activities, complaining of pain in other anatomical sites other than the low back region, general health status rated as not excellent , depressive symptomology, and sleeping problems/insomnia were common within the profile of individuals with LBP. Age, educational level, residential setting, beliefs about pain, and depressive symptomology were found to have a statistically significant association with chronicity of pain. Conclusions This study provides an overview of the profile of individuals with LBP and factors defining chronicity of pain, assisting clinicians to design appropriate management strategies to improve patients' outcomes.
 
Comparison of the Philippine and Thai EQ-5D-5L value set: A density curve of utilities, B differences per simple score of level digits, C utilities per simple score of level digits
Article
Background The Philippines has recommended the use of Quality-Adjusted Life Years (QALYs) in government health technology assessments (HTA). We aimed to develop a value set for the EQ-5D-5L based on health preferences of the healthy general adult population in the Philippines. Methods Healthy, literate adults were recruited from the Philippine general population with quota targets based on age, sex, administrative region, type of residence, education, income, and ethnolinguistic groups. Each participant’s preference was elicited by completing Composite Time Trade-Off (C-TTO) and Discrete Choice Experiment (DCE) tasks. Tasks were computer-assisted using the EuroQol Valuation Technology 2.0. To estimate the value set, we explored 20- and 8-parameter models that either use c-TTO-only data or both c-TTO and DCE (also called hybrid models). Final model choice was guided by principles of monotonicity, out-of-sample likelihood, model fit, and parsimony. Results We recruited 1000 respondents with demographic characteristics that approximate the general population such as 49.6% Female, 82% Roman Catholic, 40% in urban areas, and 55% finished high school. None of the 20-parameter models demonstrated monotonicity (logical worsening of coefficients with increasing severity). From the 8-parameter models, the homoscedastic TTO-only model exhibited the best fit. From this model, mobility and pain/ discomfort had the highest effect on utilities. Conclusion The selected model for representing the Philippine general population preferences for EQ-5D-5L health states was an 8-parameter homoscedastic TTO-only model. This value set is recommended for use in QALY calculations in support of HTA-informed coverage decisions in the Philippines.
 
Article
Purpose We sought to explore the Health-Related Quality of Life (HRQoL) of Breast Cancer (BC) and Colorectal Cancer (CRC) patients receiving active chemotherapy. Methods A cross-sectional study was conducted among a convenient sample of BC and CRC patients between May 2018 and June 2019. HRQoL was measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B; 36 items, score range 0–144)) and the Functional Assessment of Cancer Therapy-Colon (FACT-C; 34 items, score range 0–136) scales. Both scales measured Physical Well-Being (PWB), Social Well-Being (SWB), emotional well-being, Functional Well-Being (FWB), and an additional disease-specific HRQoL items. Results A total of 209 BC and 159 CRC patients were included, with a mean age 49.73 ± 10.41 and 55.38 ± 11.35 years, respectively. 110 (52.6%) of BC and 86 (54.1%) CRC patients were dependent on caregivers, and 115 (55%) of BC and 92 (57.9%) CRC patients slept > 7 h/night. Reported HRQoL mean scores of BC (FACT-B) and CRC (FACT-C) were 85.53 ± 14.81 and 87.69 ± 20.21, respectively. For BC, the PWB score of patients aged >49 years (postmenopausal) was statistically significantly (p = 0.013) worse than those aged ≤49 years (premenopausal). Patients dependent on caregivers had statistically significant better PWB and worse EWB (p = 0.041; p = 0.027, respectively). CRC patients’ dependent on caregivers had better statistically significant differences scoring in FACT-C (p = <0.001), PWB (p = 0.001), EWB (p = <0.001), and FWB (p = 0.001). Conclusion In this study, BC and CRC patients who received active chemotherapy were more likely to have poor HRQoL. BC and CRC HRQoL should be addressed early and continuously, to limit their effects on treatment plan.
 
Flow chart of the study participants
Quality of life trajectories in older adults with stable/decrease in comorbidities by polypharmacy strata. PCS physical component summary, MCS mental component summary
Article
Background Health-related quality of life (HRQoL) is an important outcome measure when considering medical treatment; however, the impact of polypharmacy on trajectories of HRQoL over time is unknown. This study aimed to investigate the association between polypharmacy status and trajectories of HRQoL in older adults. Methods A longitudinal cohort study of 2181 community-dwelling adults, 65 years and older, who participated in the 2013 to 2017 waves of the Household Income and Labour Dynamics in Australia (HILDA) Survey. Polypharmacy was defined as the regular use of ≥ 5 prescription medications. Polypharmacy status was categorised into no polypharmacy, in 2013 only (baseline only polypharmacy), in 2017 only (incident polypharmacy) or at both time points (persistent polypharmacy). HRQoL was assessed through the SF-36 questionnaire generating two summary scores: physical component summary (PCS) and mental component summary (MCS). Linear mixed-effects models stratified according to polypharmacy status and change in comorbidities were used to assess trajectories of HRQoL. Results Older adults with persistent polypharmacy had lowest scores for HRQoL measures from 2013 to 2017. After adjusting for all covariates, those with incident polypharmacy had the steepest annual decline in both the PCS and MCS: − 0.86 in PCS and − 0.76 in MCS for those with decreasing or stable comorbidities, and − 1.20 in PCS and − 0.75 in MCS for those with increasing comorbidities. Conclusions Polypharmacy was associated with poorer HRQoL, even after adjusting for confounders. Incident polypharmacy was found to be associated with a clinically important decline in HRQoL and this should be considered when prescribing additional medication to older adults.
 
Article
Purpose Using patient-reported outcomes in routine cancer care may improve health outcomes. However, a lack of information about which scores are problematic in specific populations can impede use. To facilitate interpretation of the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), we identified cut-off scores that indicate need for support by comparing each scale to relevant items from the Supportive Care Needs Survey (SCNS-LF59) in a young adult (YA) population. Methods We conducted a cross-sectional survey amongst YAs with cancer ages 25–39 at diagnosis. Participants completed the EORTC QLQ-C30 and SCNS-LF59. Patient, clinician and research experts matched supportive care needs from the SCNS-LF59 to quality of life domains of the EORTC QLQ-C30. We evaluated the EORTC QLQ-C30 domain score’s ability to detect patients with need using receiver operator characteristic (ROC) analysis, calculating the area under the ROC curve and sensitivity and specificity for selected cut-offs. Cut-offs were chosen by maximising Youden’s J statistic and ensuring sensitivity passed 0.70. Sensitivity analyses were conducted to examine the variability of the cut-off scores by treatment status. Results Three hundred and forty-seven YAs took part in the survey. Six experts matched SCNS-LF59 items to ten EORTC QLQ-C30 domains. The AUC ranged from 0.78 to 0.87. Cut-offs selected ranged from 8 (Nausea and Vomiting and Pain) to 97 (Physical Functioning). All had adequate sensitivity (above 0.70) except the Financial Difficulties scale (0.64). Specificity ranged from 0.61 to 0.88. Four of the cut-off scores differed by treatment status. Conclusion Cut-offs with adequate sensitivity were calculated for nine EORTC QLQ-C30 scales for use with YAs with cancer. Cut-offs are key to interpretability and use of the EORTC QLQ-C30 in routine care to identify patients with supportive care need.
 
Article
Purpose To establish the content validity of LIMB-Q Kids, a new patient-reported outcome measure (PROM) for children with lower limb deformities. This study focused on three key components of content validity, i.e., comprehension, comprehensiveness, and relevance. Methods Cognitive debriefing interviews (CDIs) with children with lower limb deformities were performed, and expert input from parents and clinicians directly involved in the care of children with lower limb deformities was obtained. CDIs were conducted with children from sites in Australia, Canada, and the USA. All interviews were recorded and transcribed verbatim. Analyses were conducted using the reparative approach, which involved close examination of the transcribed interviews and summarising edits after each interview. Results Forty patients, experts, and parents reviewed LIMB-Q Kids and provided feedback. At the start, LIMB-Q Kids had 10 scales and 124 total items. Five rounds of input was obtained from children, parents, and experts. Overall, 37 new items were added. Thirty-three of the new items were included to measure symptoms experienced in different parts of the legs. Final version of LIMB-Q Kids had 11 scales and 159 items. Conclusion This study established content validity of the LIMB-Q Kids, a new PROM for children with lower limb deformities. An international field-test study is underway. Translation and cultural adaptation are underway for sites where English is not the first language. Scoring algorithms will be developed, following which the scale could be used to inform clinical practice and research.
 
Conceptual model for inter-relations of patient-reported outcomes (PROs) in sickle cell disease (SCD). The model includes the inter-relations of four PRO groups (emotional distress, social functioning, pain impact, and fatigue, sleep and cognitive functioning) with health behaviors (acute healthcare utilization and preventive care), SCD complications (number of complications and pain frequency/severity), SCD-related factors (genotype, hydroxyurea, chronic transfusion history), patient related factors (education, employment, income, marital status, diabetes and depression) and barriers to care (systemic and individual). All inter-relations are adjusted for age and gender identity
Article
Purpose To examine the relations between patient-reported outcomes (PROs) within a conceptual model for adults with sickle cell disease (SCD) ages 18 – 45 years enrolled in the multi-site Sickle Cell Disease Implementation Consortium (SCDIC) registry. We hypothesized that patient and SCD-related factors, particularly pain, and barriers to care would independently contribute to functioning as measured using PRO domains. Methods Participants (N = 2054) completed a 48-item survey including socio-demographics and PRO measures, e.g., social functioning, pain impact, emotional distress, and cognitive functioning. Participants reported on lifetime SCD complications, pain episode frequency and severity, and barriers to healthcare. Results Higher pain frequency was associated with higher odds of worse outcomes in all PRO domains, controlling for age, gender and site (OR range 1.02–1.10, 95% CI range [1.004–1.12]). Reported history of treatment for depression was associated with 5 of 7 PRO measures (OR range 1.58–3.28 95% CI range [1.18–4.32]). Fewer individual barriers to care and fewer SCD complications were associated with better outcomes in the emotion domain (OR range 0.46–0.64, 95% CI range [0.34–0.86]). Conclusions Study results highlight the importance of the biopsychosocial model to enhance understanding of the needs of this complex population, and to design multi-dimensional approaches for providing more effective interventions to improve outcomes.
 
Article
Purpose Although cross-sectional studies have demonstrated that trans people present with lower quality of life and wellbeing than the general population, few studies have explored the factors associated with this, particularly in those who have medically transitioned some time ago. This paper aims to fill the gap in the literature on what factors are associated with wellbeing in trans people who initiated medical transition some time ago. Methods This study used semi-structured one-to-one interviews with 23 participants to investigate the factors that impact upon the wellbeing of trans people who had initiated Gender Affirming Medical Treatment five or more years ago. The content of the interviews were analysed with an inductive, grounded theory approach to identify common themes within them. Results The four themes identified include some consistencies with cisgender populations (while being viewed through the lens of trans experience), as well as those more specific to the trans experience. Together these themes were : Interactions with healthcare services; Seeking societal acceptance; Quality of social support; The ‘double-edged sword’ of media and social media . Each of the themes identifies a factor that participants highlighted as impacting, either positively or negatively, on their wellbeing. Conclusions The results highlight the importance of social support, protective legislations, awareness of trans issues in the general public, and the need of improving the knowledge held by non-specialist healthcare providers.
 
Visual illustration of the NNMF method
Power (%) of the LRT to detect uniform DIF for latent trait correlations of 0.3 and sample size of R1000/F1000 (R Reference group F Focal group) stratified by the missing data mechanism and magnitude of DIF (20% of the items exhibited DIF). MCAR Missing completely at random, MAR Missing at random, MNAR Missing not at random
Power (%) of the LRT to detect uniform DIF for latent trait correlations of 0.5 and sample size of R1000/F1000 (R Reference group, F Focal group) stratified by the missing data mechanism and magnitude of DIF (20% of the items exhibited DIF). MCAR Missing completely at random, MAR Missing at random, MNAR Missing not at random
A two-dimensional graded response model for the physical component summary (PCS) and mental component summary (MCS) of the SF-12 in the real-world data. The numbers shown represent the unstandardized slopes with the associated standard errors (in parentheses), and standardized slopes in boldface font. Variances of the PCS and MCS were fixed to 1
Article
Purpose Item non-response (i.e., missing data) may mask the detection of differential item functioning (DIF) in patient-reported outcome measures or result in biased DIF estimates. Non-response can be challenging to address in ordinal data. We investigated an unsupervised machine-learning method for ordinal item-level imputation and compared it with commonly-used item non-response methods when testing for DIF. Methods Computer simulation and real-world data were used to assess several item non-response methods using the item response theory likelihood ratio test for DIF. The methods included: (a) list-wise deletion (LD), (b) half-mean imputation (HMI), (c) full information maximum likelihood (FIML), and (d) non-negative matrix factorization (NNMF), which adopts a machine-learning approach to impute missing values. Control of Type I error rates were evaluated using a liberal robustness criterion for α = 0.05 (i.e., 0.025–0.075). Statistical power was assessed with and without adoption of an item non-response method; differences > 10% were considered substantial. Results Type I error rates for detecting DIF using LD, FIML and NNMF methods were controlled within the bounds of the robustness criterion for > 95% of simulation conditions, although the NNMF occasionally resulted in inflated rates. The HMI method always resulted in inflated error rates with 50% missing data. Differences in power to detect moderate DIF effects for LD, FIML and NNMF methods were substantial with 50% missing data and otherwise insubstantial. Conclusion The NNMF method demonstrated comparable performance to commonly-used non-response methods. This computationally-efficient method represents a promising approach to address item-level non-response when testing for DIF.
 
Before and after propensity score matching of the two groups
Article
Purpose This study identified individual, social, and environmental factors affecting the health-related quality of life (HRQoL) of older individuals living in urban and non-urban areas of the Republic of Korea and investigated their effects on HRQoL. Methods A secondary data analysis study was conducted using raw data from Korea’s 2017 Community Health Survey. Propensity score matching (PSM) was performed to compare the individual, social, and environmental characteristics of older individuals living in urban and non-urban areas (16,695 and 29,106 individuals, respectively). Statistical analyses were performed using R program 4.0.5. The differences between variables were analyzed using chi-squared and t-tests, whereas factors influencing HRQoL were analyzed using multiple regression analysis. Results Among the individual factors, the living arrangement (p = 0.001, confidence interval [CI] = 0.00–0.02) was an influencing factor in urban areas, whereas it showed no statistical significance in non-urban areas. Moreover, Helping their neighbors (p = 0.001, CI = 0.00–0.01) among the social factors and satisfaction with the living environment (p = 0.011, CI = 0.00–0.02) and with healthcare services (p = 0.047, CI = 0.00–0.01) among the environmental factors were influencing factors in urban areas, whereas they showed no statistical significance in non-urban areas. Conclusion Satisfaction with the living environment and with healthcare services was positively associated with HRQoL among older individuals living in urban areas. Therefore, factors associated with regional health inequality should be identified, and health equality sought through the development of local government policies that consider diversity in population composition and health indicators by region.
 
Response option characteristic curves for the ten items of the abbreviated Connor–Davidson Resilience Scale
A Item information curves for the ten items of the abbreviated Connor–Davidson Resilience Scale. B Test information curves for ten-item and two-item abbreviations of the Connor–Davidson Resilience Scale
Receiver operating characteristic and Precision-recall curve plots of CD-RISC-2 scale’s ability to discriminate high CD-RISC-10 scale scores in the derivation subsample
Article
Purpose Psychometric validity/reliability of 10-item and 2-item abbreviations of the Connor–Davidson Resilience Scale (CD-RISC-10; CD-RISC-2) was investigated via item response theory and classic approaches. Methods We sampled 5023 adult American participants in a June/July 2020 survey on the COVID-19 pandemic’s psychological effects. Our questionnaire incorporated the CD-RISC-10 with other validated measures. CD-RISC-10 items were ranked on item-to-scale correlations, loadings on a one-factor confirmatory factor analysis model, and item slope/threshold parameters plus information curves from a unidimensional graded response model. Concurrent validity of the highest ranked item pair was evaluated vis-à-vis the CD-RISC-10 and CD-RISC−2. Internal consistency, based on average variance extracted (AVE) and multiple reliability coefficients, was also compared. Convergent/divergent validity was tested by correlating anxiety, depression, fear of COVID-19, anxiety sensitivity, coping, and personality measures with both scales and the highest ranked item pair. Binary agreement/classification indexes assessed inter-rater reliability. Results Items 2 and 9 from CD-RISC-10 ranked the highest. Reliability coefficients were > 0.93, > 0.72, and > 0.82 for the CD-RISC-10, CD-RISC-2, vs summation of items 2 and 9. AVEs were 0.66, 0.67, and 0.77. CD-RISC abbreviations and the summation of items 2 and 9 correlated negatively with anxiety (> − 0.43), depression (> − 0.42), and fear of COVID-19 (> − 0.34); positively with emotional stability (> 0.53) and conscientiousness (> 0.40). Compared to the CD-RISC-2, summative scores of items 2 and 9 more efficiently classified/discriminated high resilience on the CD-RISC-10. Conclusion We confirmed construct validity/reliability of copyrighted CD-RISC abbreviations. The CD-RISC-10’s items 2 and 9 were psychometrically more salient than the CD-RISC−2.
 
Flowchart of studies included in the systematic review according to the PRISMA statement
Visual distribution of results of studies included in the systematic review on neurocognitive and HRQoL outcomes
Article
Objective This study systematically reviewed recent findings on neurocognitive functioning and health-related quality of life (HRQoL) of children after pediatric intensive care unit admission (PICU). Data sources Electronic databases searched included Embase, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar. The search was limited to studies published in the last five years (2015–2019). Study selection Original studies assessing neurocognitive functioning or HRQoL in children who were previously admitted to the PICU were included in this systematic review. Data extraction Of the 3649 identified studies, 299 met the inclusion criteria based on title abstract screening. After full-text screening, 75 articles were included in the qualitative data reviewing: 38 on neurocognitive functioning, 33 on HRQoL, and 4 on both outcomes. Data synthesis Studies examining neurocognitive functioning found overall worse scores for general intellectual functioning, attention, processing speed, memory, and executive functioning. Studies investigating HRQoL found overall worse scores for both physical and psychosocial HRQoL. On the short term (≤ 12 months), most studies reported HRQoL impairments, whereas in some long-term studies HRQoL normalized. The effectiveness of the few intervention studies during and after PICU admission on long-term outcomes varied. Conclusions PICU survivors have lower scores for neurocognitive functioning and HRQoL than children from the general population. A structured follow-up program after a PICU admission is needed to identify those children and parents who are at risk. However, more research is needed into testing interventions in randomized controlled trials aiming on preventing or improving impairments in critically ill children during and after PICU admission.
 
Time-to-event curves for self-assessed poor vs. non-poor health status for mortality
Article
Purpose Self-assessed poor health status is associated with increased risk of mortality in several cardiovascular conditions, but has not been investigated in patients with endocarditis. We examined health status and mortality in patients with endocarditis. Methods This is a re-specified substudy of the randomized POET endocarditis trial, which included 400 patients. Patients completed the single-question self-assessed health status from the Short-Form 36 questionnaire at time of randomization and were categorized as having poor or non-poor (excellent/very good, good, or fair) health status. Self-assessed health status and all-cause mortality were examined by a Cox regression model. Results Self-assessed health status was completed by 266 (67%) patients with a mean age of 68.0 years (± 11.8), 54 (20%) were females, and 86 (32%) had one or more major concurrent medical conditions besides endocarditis. The self-assessed health status distribution was poor (n = 21, 8%) and non-poor (n = 245, 92%). The median follow-up was 3.3 years and death occurred in 9 (43%) and 48 (20%) patients reporting poor and non-poor health status, respectively, and mortality rates [mortality/100 person-years, 95% confidence interval (CI)] were 18.1 (95% CI 9.4–34.8) and 5.4 (95% CI 4.1–7.2), i.e., the crude hazard ratio for death was 3.4 (95% CI: 1.7–7.0, p < 0.01). Conclusion Self-assessed poor health status compared with non-poor health status as assessed by a single question was associated with a threefold increased long-term mortality in patients with endocarditis. POET ClinicalTrials.gov number, NCT01375257. Trial registry POET ClinicalTrials.gov number, NCT01375257.
 
The C-TTO tasks
A pairwise DCE with forced choice
A visual presentation of the C-TTO FM
Article
Purpose To identify patterns and problems in completing composite time trade-off (C-TTO) and discrete choice experiment (DCE) exercises for the valuation of the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) to inform the optimisation of a valuation protocol. Methods Fourteen cognitive interviews were conducted in the UK using concurrent and retrospective think-aloud and probing techniques. Each participant completed 8 C-TTO tasks and 8 DCE tasks within a computer-assisted personal interview setting. Verbal information was transcribed verbatim. Axial coding and thematic analysis were used to organise the qualitative data and identify patterns and problems with the completion of tasks. Results While participants found the tasks generally manageable, five broad themes emerged to explain and optimise the response to the tasks. (1) Format and structure: attention to the design of practice examples, instructions, and layout were needed. (2) Items and levels: underlying relationships were discovered across different combinations of levels of SWEMWBS items. (3) Decision heuristics: participants engaged in diverse strategies to assist trade-off decisions. (4) Valuation feasibility: certain states were difficult to imagine, compare and quantify. (5) Valuation outcome: the data quality was affected by participants’ discriminatory ability across states and their time trade-off decisions. Conclusion The interviews contributed insights regarding the robustness of the proposed methods. The application of C-TTO and DCE valuation techniques was practical and suitable for capturing individual attitudes towards different mental well-being scenarios. A modified protocol informed by the results is being tested in a larger sample across the UK.
 
Article
Purpose The relation between diet and maternal mental health during pregnancy might be relevant to prevent adverse materno-foetal outcomes. This study examined the association of Mediterranean diet (MD) adherence and MD components with mental health during pregnancy. Methods This secondary analysis of the GESTAFIT trial included longitudinal data from 152 pregnant women. Dietary habits were assessed with a food frequency questionnaire, and MD adherence was derived from it using the Mediterranean Food pattern. Psychological ill-being (i.e., negative affect, anxiety, and depression) and well-being (i.e., emotional intelligence, resilience, positive affect) were assessed with the Spanish version of well-established self-reported questionnaires. Cross-sectional (16th gestational week [g.w.]) and longitudinal associations (34th g.w.) between MD and mental health were studied using linear regression models. Results A greater MD adherence was inversely associated with negative affect and anxiety; and positively associated with emotional regulation, resilience and positive affect at the 16th and 34th g.w. (|β| ranging from 0.179 to 0.325, all p < 0.05). Additionally, a higher intake of whole grain cereals, fruits, vegetables, fish, olive oil and nuts, and a lower intake of red meat and subproducts and sweets were associated with lower negative affect, anxiety, depression and higher emotional regulation, resilience and positive affect throughout gestation (|β| ranging from 0.168 to 0.415, all p < 0.05). Conclusion A higher intake of whole grain cereals, fruits, vegetables, fish, olive oil and nuts, together with a lower intake of red meat and sweets, resulted in a higher MD adherence, which was associated with a better mental health during pregnancy.
 
Conceptual model for the social participation and subjective well-being relationship moderated by sex
Sample selection in National Health and Aging Trends Study (NHATS) Round 9 data
Unadjusted model of the association between social participation and subjective well-being, with sex as moderator (results shown for males as the reference category), among older adults using pain medications. Reg Coef = regression coefficient. Estimate (95% confidence interval). Given the use of males as the reference category, the paths specified in this figure have the following interpretations: Reg Coef A = the relationship between social participation and subjective well-being for males; Reg Coef B = the difference between males and females in terms of the relationship between social participation and subjective well-being; Reg Coef C = the difference between males and females on subjective well-being among those scoring zero on social participation
Article
Purpose To examine the relationship between social participation and subjective well-being (SWB) among older adults using pain medications and evaluate the impact of sex on this relationship. Methods A cross-sectional analysis was conducted using the 2019 National Health and Aging Trends Study data, a nationally-representative sample of Medicare beneficiaries 65 years and older. Individuals were included if they reported taking pain medications for five days or more per week over the last month. Social participation was operationalized using the sum score of four items: visiting family and friends, going out for enjoyment, attending religious services, and participation in other organized activities. SWB was operationalized as a latent variable using four items reflecting positive and negative emotions, and three items reflecting self-evaluation. Structural equation modeling was used to test the relationship between key study constructs, as well as the moderating effect of sex on the relationship between social participation and SWB. Results A total of 964 (weighted N = 7,660,599) participants were included in the study. Most participants were female (61.3%), White (81.0%), community-dwelling (94.9%) older adults. Confirmatory factor analysis showed appropriate fit for SWB. Social participation had a statistically significant association with SWB (unstandardized regression coefficient = 0.133; 95% CI 0.071, 0.196; p < 0.001) after adjusting for covariates. However, this relationship was not moderated by sex (p = 0.836). Conclusion Social participation is positively and significantly associated with SWB among older adults using pain medications. Interventions aimed at improving SWB should consider incorporating a social activities component.
 
Steps of conducting the umbrella review
The international classification of functioning, disability and health linking decision tree
Article
Background and objective While several mobility measures exist, there is large variability across measures in how mobility is conceptualized, the source of information and the measurement properties making it challenging to select relevant mobility measures for individuals with acquired brain injury (ABI). Therefore, the objective was to conduct a comprehensive synthesis of existing evidence on the measurement properties, the interpretability and the feasibility of mobility measures from various sources of information (patients, clinicians, technology) using an umbrella review of published systematic reviews among individuals with ABI. Methods Ovid MEDLINE, CINHAL, Cochrane Library and EMBASE electronic databases were searched from 2000 to March 2020. Two independent reviewers appraised the methodological quality of the systematic reviews using the Joanna Briggs Institute critical appraisal checklist. Measurement properties and quality of evidence were applied according to COnsensus-based Standards for the Selection of Health Measurement Instrument (COSMIN) guidelines. Mobility measures were categorized using international standards with the international classification of functioning, disability and health (ICF). Results Thirty-five systematic reviews were included covering 147 mobility measures, of which 85% were mapped to the ICF Activity and Participation component. Results showed an acceptable overall "sufficient" rating for reliability, construct validity and responsiveness for 132 (90%), 127 (86%) and 76 (52%) of the measures, respectively; however, among these measures, ≤ 25% of the methods for evaluating these properties were rated as ‘high’ quality of evidence. Also, there was limited information that supports measure feasibility and scoring interpretability. Conclusions Future systematic reviews should report measures’ content validity to support the use of the measure in clinical care and research. More evaluations of the minimal important difference and floor and ceiling effects are needed to help guide clinical interpretation. Registration information International Prospective Register of Systematic Reviews (PROSPERO); ID: CRD42018100068.
 
Study flow chart detailing the screening and inclusion process
Distribution of MacDermid critical appraisal tool scores
Article
Purpose To systematically review patient-reported outcome measures (PROMs) of musicians' musculoskeletal symptoms (MSS) and psychosocial factors and their psychometric properties. Methods Six databases were searched. Studies evaluating at least one psychometric property of a PROM developed for or adapted to adult musicians and measuring MSS or occupational psychosocial factors were included. Study quality was evaluated using mainly the COSMIN checklist. Results Twenty-eight studies were included, yielding 27 PROMs. Most COSMIN scores are Doubtful or Inadequate. Validity and internal consistency are the most evaluated psychometric properties. Test–retest reliability was evaluated in five studies (all inadequate sample sizes), measurement error in one, and responsiveness in none. The English, German and Polish Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM), the 40-item English and Peruvian Spanish Kenny Music Performance Anxiety Inventory (KMPAI) and the Psychosocial Risks Questionnaire for Musicians (PRQM, Polish) are the most robust scales for their constructs. Their internal consistency is sufficient (Cronbach's α ≥ 0.70). Test–retest reliability and construct validity are only sufficient for the German MPIIQM (intraclass correlation coefficients ≥ 0.70). However, results are based on one study per PROM; all require further validation before validity, reliability and responsiveness can be confirmed. Conclusion Due to generally poor methodological quality and one study per PROM on average, none can be confirmed valid, reliable and responsive. Yet, preliminary validation recommends prudent use of some PROMs pending further validation. Robust PROM studies are needed to fill the important literature gap regarding musician-specific, validated PROMs.
 
Study setting
Standardized scores of the QoL domains by the clusters
Associated factors of quality of life in community-dwelling older adults aged 60–74 years (n = 3573)
Article
Purpose Against the backdrop of the ever-increasing aging population in Sri Lanka and the scarcity of local evidence on quality of life (QoL) among rural elderly, this study was conducted to assess the QoL of the community-dwelling older adults in rural Sri Lanka. Methods This cross-sectional study was conducted among community-dwelling older adults (60–74 years) in a selected rural setting in Sri Lanka. K-means cluster analysis was used to stratify participants into 'low' and 'high' levels of QoL and then significant associations between these clusters and underlying socio-demographic and self-reported health related factors were estimated using bivariate and subsequent multivariable binary logistic regression models. Results The final sample consisted of 3573 community-dwelling older adults (response rate 97.8%). The mean (SD) age of the sample was 66.7 (4.3) years and the majority were females (n = 2130, 59.6%). Amongst the six QoL domains assessed (physical, psychological, social, functional, environmental and spiritual domains), the highest and the lowest mean (SD) scores were reported for the functional [63.4 (16.9)] and the physical [52.9 (15.0)] domains, respectively. Aged 70 years or more, either unmarried/widowed/divorced, lower educational levels and having chronic illnesses were statistically significant associations of QoL (p < 0.05). Conclusion The QoL among community-dwelling older adults in rural Sri Lanka is moderate. As having social support, absence of chronic diseases and good education level were found to be associated with better QoL, strengthening community-based interventions to improve these aspects by incorporating the evidence generated by other longitudinal studies is recommended.
 
Measurement model of the Shift and Persist Questionnaire with loadings from the confirmatory factor analysis
Article
  • Karly M. MurphyKarly M. Murphy
  • Edith ChenEdith Chen
  • Edward H. IpEdward H. Ip
  • [...]
  • John M. SalsmanJohn M. Salsman
Purpose The Shift and Persist model provides an informative framework to understand how adolescent and young adult (AYA) cancer patients and survivors (ages 15–39) may withstand stress and thrive despite adversity. The goal of the present study was to examine the psychometric properties of the Shift and Persist Questionnaire (SPQ) in this population and provide guidelines for interpretation. Methods AYA cancer patients and survivors were recruited via an online research panel. Participants reported demographics and health history and completed the SPQ and Patient-Reported Outcome Measurement Information System 29-item profile (PROMIS®-29). We evaluated the structural validity, internal consistency, and construct validity of the SPQ. Minimally important differences (MIDs) were estimated to inform SPQ score interpretation. Results 572 eligible individuals completed the survey. On average, participants were aged 24 (SD = 7) at evaluation. Of the participants, 43.5% were female, 77.1% were white, and 17.5% were Hispanic (across races). The two-factor structure of the SPQ demonstrated very good structural validity (CFI > 0.95, SRMR < 0.08), and construct validity with PROMIS-29® domains (convergent Rs = 0.17 to 0.43, divergent Rs = − 0.11 to − 0.51). Internal consistency was adequate (ω = 0.76–0.83). Recommended MIDs were 1 point for the Shift subscale, 1–2 point(s) for the Persist subscale, and 2–3 points for the total SPQ score. Conclusion The SPQ is a psychometrically sound measure of skills that contribute to resilience in AYA cancer patients and survivors. MID recommendations enhance the interpretability of the SPQ in this population. Future studies examining shifting and persisting in this population may benefit from administering the SPQ.
 
Article
Purpose This qualitative study aimed to investigate the importance of subjective well-being (SWB) as an outcome of psoriasis treatment from patient’s perspective. We focused on the affective component of SWB as assessed with the Daily Experience Sampling Questionnaire (DESQ), a validated daily diary. Methods Semi-structured qualitative telephone interviews were conducted with in-patients of a dermatological rehabilitation clinic, after participants had completed the DESQ for up to seven days to get familiar with the concept of SWB. Patients were asked to reflect on the importance of SWB as treatment goal and on its relative importance as compared with other treatment outcomes. We also addressed whether SWB could be an indirect measure of benefit in that it reflects other important outcomes. Transcripts were analyzed using content analysis. Results Eleven patients participated (24–63 years, mean 53 years, 8 male, 3 female). Participants uniformly confirmed that changes in SWB reflected treatment benefit. All but one considered SWB to be a central aspect of treatment benefit—either as the most important treatment goal or as an indirect benefit indicator. In particular, participants described positive associations of SWB with other outcomes, such as symptoms. They reported that both the disease and the medical treatment had an impact on their SWB, which was reflected in the DESQ. Conclusion Our findings suggest that SWB is a relevant indicator of treatment benefit for patients with psoriasis. Therefore, SWB measures, such as the DESQ, could be used to operationalize patient-relevant benefit of psoriasis treatment, complementing outcome measures currently used.
 
Flowchart of participant selection from the NutriNet-Santé web cohort
Article
Introduction Periodontitis, as a chronic, multifactorial inflammatory disease, has complex relationships with other diseases and ultimately with well-being. The aim of this cross-sectional study was to investigate the association between self-report periodontitis, as measured with the recently developed and validated modified Periodontal Screening Score (mPESS), and oral health-related quality of life (OHRQol) in a large population-based sample derived from the French NutriNet-Santé e-cohort. Methods The sample was composed of 32,714 adults (75.5% women) with a mean age of 48.8 ± 13.9 years. Periodontitis was assessed based on age, smoking, and oral health status data obtained in 2011–2012, which allowed calculating the mPESS. An mPESS ≥ 5 was used to identify individuals at risk of severe periodontitis (main exposure). OHRQoL was measured with the Oral Health Impact Profile (OHIP-14) (main outcome) and the total score was dichotomized for analysis. Multivariable logistic regression analyses, considering physical health status, dietary and lifestyle confounding variables, were performed. Results Overall, 6407 participants (19.6%) were at a high risk of severe periodontitis. A total of 7383 participants (22.6%) presented a relatively poor OHRQoL (OHIP-14 > 8, highest quartile). In the multivariable model, each of the following variables was independently and significantly associated with lower OHRQoL: older age (50–64 years), female sex, obesity, snacking between meals, frequent consumption of soft drinks and sweets/chocolate, risk of severe periodontitis, and having < 20 natural teeth were significantly. An mPESS ≥ 5 showed the highest odds for relatively poor OHRQoL (OR = 3.45; 95% CI 3.21–3.72). Conclusion The results support the association between periodontitis and OHRQoL in non-clinical samples. The use of mPESS could be tested in future prevention programs aiming at improving OHRQoL.
 
ROC curves by PROMIS domain based on the optimal PROMIS Global Health item (Table 3). AUC Area under the curve
Article
Purpose Patient-reported outcome measures (PROMs), including global health and construct-specific measures, are collected across healthcare systems. Efforts should be made to reduce data collection burden and individualize survey administration to patient needs. Our study evaluated the ability of utilizing items on a global health measure to identify patients who may require additional screening. Methods A cross-sectional study was conducted of patients who completed PROMIS Global Health (GH) as part of routine care, as well as additional construct-specific surveys, in a large healthcare system from 1/1/2016 to 12/31/2018. Receiver operating characteristic (ROC) analysis identified optimal thresholds for PROMIS GH items identifying clinically meaningful thresholds on construct-specific PROMs: PHQ-9 score ≥10, Neuro-QoL Cognitive Function, PROMIS Physical Function, and Satisfaction with Social Roles and Activities T-score ≤40, PROMIS Anxiety, Fatigue, Sleep Disturbance, and Pain Interference T-score ≥60. Results There were 206,685 patients who completed PROMIS GH and additional construct-specific surveys. Scores ≤3 on PROMIS GH item 10 (emotional problems) had 90.0% sensitivity (area under the curve (AUC) = 0.821) for identifying patients with moderate-severe depressive symptoms on PHQ-9. Similarly high sensitivities and AUCs were demonstrated for PROMIS GH items assessing mental and physical health, fatigue, and pain to identify poor scores on their corresponding construct-specific PROMs. Conclusions Our study provides preliminary support for the ability of utilizing PROMIS GH items as screening tools to identify patients with poor scores on additional construct-specific PROMs. Through directing construct-specific PROMs to patients for whom they are most applicable, survey burden could be reduced for many patients, allowing a more efficient and targeted use of PROMs in healthcare decision-making.
 
Participants flow into the analytic sample, and missing data
Distribution of PCS and MCS scores and SF-6D utility values
Mean SF-36 component summary scores and SF-6D utility score by physical violence and serious injury, waves 2–20
Article
Objective This study aims to investigate the effect of physical violence and serious injury on health-related quality of life in the Australian adult population. Methods This study utilised panel data from the Household, Income and Labour Dynamics in Australia (HILDA) Survey. HRQoL was measured through the physical component summary (PCS), mental component summary (MCS), and short-form six-dimension utility index (SF-6D) of the 36-item Short-Form Health Survey (SF-36). Longitudinal fixed-effect regression models were fitted using 19 waves of the HILDA Survey spanning from 2002 to 2020. Results This study found a negative effect of physical violence and serious injury on health-related quality of life. More specifically, Australian adults exposed to physical violence and serious injury exhibited lower levels of health-related quality of life. Who experienced physical violence only had lower MCS (β = −2.786, 95% CI: −3.091, −2.481) and SF-6D (β = −0.0214, 95% CI: −0.0248, −0.0181) scores if switches from not experiencing physical violence and serious injury. Exposed to serious injury had lower PCS (β = −5.103, 95% CI: −5.203, −5.004), MCS (β = −2.363, 95% CI: −2.480, −2.247), and SF-6D (β = −0.0585, 95% CI: −0.0598, −0.0572) score if the adults not experiencing physical violence and serious injury. Further, individuals exposed to both violence and injury had substantially lower PCS (β = -3.60, 95% CI: -4.086, -3.114), MCS (β = −6.027, 95% CI: −6.596, −5.459), and SF-6D (β = −0.0716, 95% CI: −0.0779, −0.0652) scores relative to when the individuals exposed to none. Conclusion Our findings indicate that interventions to improve Australian adults’ quality of life should pay particular attention to those who have experienced physical violence and serious injury. Our findings suggest unmet mental health needs for victims of physical violence and serious injuries, which calls for proactive policy interventions that provide psychological and emotional therapy.
 
Changes in the intensity of depression (A) and anxiety (B) symptoms from 3-month follow-up (T1) to 1 year (T2). In Blue: Changes to normal or mild depression and anxiety symptoms at T2. In Red: Changes to moderate, moderate-severe, or severe depression and anxiety symptoms at T2
Article
Purpose To assess health-related quality of life (HRQoL) and its associated factors in patients who survived COVID-19 and to assess a prospective evaluation of the prevalence and severity of their depression and anxiety symptoms. Methods We followed up a sample of hospitalized patients who survived COVID-19 at 3 and 12 months after discharge. We assessed HRQoL (Euroqol-5D-5L) through telephone interviews. Any problem in any dimension of Euroqol-5D-5L was considered as low HRQoL. The depression and anxiety symptoms were measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 tools, respectively. We estimated the adjusted prevalence ratios (aPR) to low HRQoL using Poisson regression and the changes on their depression and anxiety symptoms during the follow-up. Results We included 119 patients with a mean follow-up time of 363.6 days. 74% of the participants had low HRQoL at one year after hospital discharge and were associated with being ≥ 41 years old (aPR: 1.95), having a previous history of psychiatric diagnoses before COVID-19 infection (aPR: 1.47), having any COVID-19 symptom during the follow-up at one year (aPR: 1.84), and having a family member who had died from COVID-19 during the first wave (aPR: 1.24). In addition, the clinically relevant depression symptoms were frequent, and they increased from 3 (14.3%) to 12 months (18.5%). Conclusion One year after COVID-19 hospitalization discharge, patients had low HRQoL, and their depression symptoms increased. These findings acknowledge the need to provide services that adequately address mental health sequels and HRQoL to reduce the burden of the COVID-19.
 
Distribution of the EQ-5D-5L instrument by three proxies of household air pollution. (According to the medium, short-duration cooking was defined as cooking duration < 1.5 h/day, long-duration cooking was defined as cooking duration ≥ 1.5 h/day.)
Associations of HAP with HRQoL in different physical activity subgroups (Estimate β values and 95%CIs were assessed by generalized linear models. Models were adjusted by age, gender, BMI, educational level, average monthly income, marital status, smoking status, drinking status, high-fat diet, vegetables and fruits intake, fuel type, cooking duration, and ventilation. The point estimates values were represented by the corresponding blue square. The 95%CI were represented by the black lines.)
Article
Background and purpose Limited research focused on the association between household air pollution (HAP) and health-related quality of life (HRQoL). This study aimed to investigate the association of HAP with HRQoL and the effect modification of physical activity. Method A total of 16,761 eligible participants were derived from the Henan Rural Cohort Study. Based on structured questionnaires, HAP was assessed by fuel type, cooking duration and kitchen ventilation; HRQoL was measured with utility index and VAS score from the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L); physical activity was assessed by the International Physical Activity Questionnaire. Generalized linear models and tobit regression models were utilized to explore the relationship of HAP with HRQoL. Further sensitivity analyses were conducted using structural equation models. Results Compared with those who cooked with clean fuels, short-duration, or good kitchen ventilation, participants who cooked with solid fuels, long-duration, and poor ventilation had lower utility index and VAS score (All P < 0.001). The decrease in utility index for solid fuel users vs. clean fuel users were 0.06 [95%confidence interval (CI) 003, 0.08], 0.03 (95%CI 0.01, 0.04) and 0.02 (95%CI 0.01, 0.04) in low, moderate and high physical activity group, respectively, which decreased with physical activity levels (Pfor interaction < 0.05). Similar results were observed in associations of kitchen ventilation with utility index and VAS score. Conclusion HAP negatively associated with HRQoL in rural population, and potential intervention aimed at maintaining adequate physical activity. Trail registration The Henan Rural Cohort Study has been registered at Chinese Clinical Trial Register (Registration number: ChiCTR-OOC-15006699). Date of registration: 06 July, 2015. http://www.chictr.org.cn/showproj.aspx?proj=11375.
 
PRISMA flow diagram of paper selection for quantitative studies that assessed health-related quality-of-life in low-grade glioma patients
Article
Purpose Low-grade glioma (LGG) patients may face health-related quality-of-life (HRQoL) impairments, due to the tumour, treatment and associated side-effects and prospects of progression. We systematically identified quantitative studies assessing HRQoL in adult LGG patients, for: aspects of HRQoL impacted; comparisons with non-cancer controls (NCC) and other groups; temporal trends; and factors associated with HRQoL. Methods MEDLINE, CINAHL, Embase, PubMed, and PsycINFO were systematically searched from inception to 14th September 2021. Following independent screening of titles and abstracts and full-texts, population and study characteristics, and HRQoL findings were abstracted from eligible papers, and quality appraised. Narrative synthesis was conducted. Results Twenty-nine papers reporting 22 studies (cross-sectional, n = 13; longitudinal, n = 9) were identified. Papers were largely good quality, though many excluded patients with cognitive and communication impairments. Comparators included high-grade gliomas (HGG) ( n = 7); NCCs ( n = 6) and other patient groups ( n = 3). Nineteen factors, primarily treatment (n = 8), were examined for association with HRQoL. There was substantial heterogeneity in HRQoL instruments used, factors and aspects of HRQoL assessed and measurement timepoints. HRQoL, primarily cognitive functioning and fatigue, in adult LGG patients is poor, and worse than in NCCs, though better than in HGG patients. Over time, HRQoL remained low, but stable. Epilepsy/seizure burden was most consistently associated with worse HRQoL. Conclusion LGG patients experience wide-ranging HRQoL impairments. HRQoL in those with cognitive and communication impairments requires further investigation. These findings may help clinicians recognise current supportive care needs and inform types and timings of support needed, as well as inform future interventions.
 
Article
Purpose Quality of life research often collects daily information and averages this over a week, producing a summary score. When data are missing, arbitrary rules (such as requiring at least 4/7 observations) are used to determine whether a patient’s summary score is created or set to missing. This simulation work aimed to assess the impact of missing data on the estimates produced by summary scores, the psychometric properties of the resulting summary score estimates and the impact on interpretation thresholds. Methods Complete longitudinal data were simulated for 1000 samples of 400 patients with different day-to-day variability. Data were deleted from these samples in line with missingness mechanisms to create scenarios with up to six days of missing data. Summary scores were created for complete and missing data scenarios. Summary score estimates, psychometric properties and meaningful change estimates were assessed for missing data scenarios compared to complete data. Results In most cases, the 4/7 day rule was supported, but this depended on daily variability. Fewer days of data were sometimes acceptable, but this was also dependent on the proportion of patients with missing data. Tables and figures allow researchers to assess the potential impact of missing data in their own studies. Conclusions This work suggests that the missing data rule used to create summary scores impacts on the estimate, measurement properties and interpretation thresholds. Although a general rule of 4/7 days is supported, the way the summary score is derived does not have a uniform impact across psychometric analyses. Recommendations are to use the 4/7 rule, but plan for sensitivity analyses with other missing data rules.
 
Distribution of scores for AQoL-8D, EQ-5D-5L and EQ-VAS
Bland Altman plot for differences in means for AQoL-8D and EQ-5D-5L utilities
Article
Purpose Idiopathic pulmonary fibrosis (IPF) is a progressive and debilitating chronic lung disease with a high symptom burden, which has a substantial impact on health-related quality of life (HRQoL). Our study aimed to assess the suitability of the EuroQol five-dimension (EQ-5D-5L) and the Assessment of Quality of Life- eight-dimension (AQoL-8D) questionnaires in measuring HRQoL as health state utility values (HSUVs) in an Australian IPF cohort. Methods Data for estimation of health state utility values (HSUVs) were collected from participants of the Australian IPF Registry (AIPFR) using self-administered surveys which included the EQ-5D-5L and the AQoL-8D. Data on lung function and disease specific HRQoL instruments were collected from the AIPFR. Performance of the two instruments was evaluated based on questionnaire practicality, agreement between the two instruments and test performance (internal and construct validity). Results Overall completion rates for the EQ-5D-5L and AQoL-8D were 96% and 85%, respectively. Mean (median) HSUVs were 0.65 (0.70) and 0.69 (0.72) for the EQ-5D-5L and AQoL-8D, respectively. There was reasonable agreement between the two instruments based on the Bland–Altman plot mean difference (−0.04) and intraclass correlation coefficient (0.84), however there were some fundamental differences. A larger range of values was observed with the EQ-5D-5L (−0.57–1.00 vs 0.16–1.00). The EQ-5D-5L had a greater divergent sensitivity and efficacy in relation to assessing HSUVs between clinical groupings. The AQoL-8D ,however, had a higher sensitivity to measure psychosocial aspects of HRQoL in IPF. Conclusion The EQ-5D-5L demonstrated superior performance when compared to AQoL-8D in persons with IPF. This may be attributable to the high symptom burden which is physically debilitating to which the EQ-5D-5L may be more sensitive.
 
Distribution of PROMIS PF10a raw change scores
a ROC plot for anchor-based deterioration value of PROMIS PF10a. b ROC plot for anchor-based improvement value of PROMIS PF10a
a PROMIS PF10a change scores by PGIC-indicated physical function deterioration. b PROMIS PF10a change scores by PGIC-indicated physical function improvement
Article
Purpose Individual change on a patient-reported outcome (PRO) measure can be assessed by statistical significance and meaningfulness to patients. We explored the relationship between these two criteria by varying the confidence levels of the coefficient of repeatability (CR) on the Patient-Reported Outcomes Measurement Information System (R) Physical Function (PF) 10a (PF10a) measure. Methods In a sample of 1129 adult cancer patients, we estimated individual-change thresholds on the PF10a from baseline to 6 weeks later with the CR at 50%, 68%, and 95% confidence. We also assessed agreement with group- and individual-level thresholds from anchor-based methods [mean change and receiver operating characteristic (ROC) curve] using a PF-specific patient global impression of change (PGIC). Results CRs at 50%, 68%, and 95% confidence were 3, 4, and 7 raw score points, respectively. The ROC- and mean-change-based thresholds for deterioration were −4 and −6; for improvement they were both 2. Kappas for agreement between anchor-based thresholds and CRs for deterioration ranged between κ = 0.65 and 1.00, while for improvement, they ranged between 0.35 and 0.83. Agreement between the PGIC and all CRs always fell below “good” (κ < 0.40) for deterioration (0.30–0.33) and were lower for improvement (0.16–0.28). Conclusions In comparison to the CR at 95% confidence, CRs at 50% and 68% confidence (considered likely change indexes) have the advantage of maximizing the proportion of patients appropriately classified as changed according to statistical significance and meaningfulness.
 
Article
Purpose There is limited knowledge about oral health-related quality of life (OHRQoL) in children with celiac disease (CD). This study aimed to assess OHRQoL in children with CD compared to healthy controls. Methods This case–control study included children with CD and healthy controls. Three scales were used to assess OHRQoL in different age groups: 6–7 years, 8–10 years, and 11–14 years. The OHRQoL scores were compared between cases and controls to examine the possible associations between OHRQoL and demographics, socioeconomic status, and oral health. Results Overall, 104 children with CD and 104 healthy children (controls) were included. The mean age was 10.67 ± 2.39 years in CD patients and 10.69 ± 2.36 in controls (P = 0.971). Male and female children constituted 50% of each group. Children with CD had significantly higher OHRQoL scores than controls (P = 0.003). Low education levels of parents of children with CD and a higher number of siblings in controls were associated with high OHRQoL scores (P = 0.002, P < 0.020, and P = 0.010, respectively). Recurrent aphthous stomatitis (RAS) increased the OHRQoL scores by 7.5 on average (P = 0.016). Conclusion Children with CD had poor OHRQoL compared with healthy controls. Poor OHRQoL in children with CD was associated with RAS and with lower parental income and education. RAS was an independent predictor of poor OHRQoL in children with CD.
 
Selection process of included studies
Article
Purpose: Healthcare interventions for middle-old and oldest-old individuals are often (economically) evaluated using the EQ-5D to measure health-related quality of life (HrQoL). This requires sufficient measurement properties of the EQ-5D. Therefore, the current study aimed to systematically review studies assessing the measurement properties of the EQ-5D in this population. Methods: The databases PubMed, Cochrane library, Web of Science, Embase, and EconLit were searched for studies providing empirical evidence of reliability, validity, and/or responsiveness of the EQ-5D-3L and EQ-5D-5L in samples with a mean age ≥ 75 years. Studies were selected by two independent reviewers, and the methodological quality was assessed using the COSMIN Risk of Bias checklist. Results were rated against updated criteria for good measurement properties (sufficient, insufficient, inconsistent, indeterminate). The evidence was summarized, and the quality of evidence was graded using a modified GRADE approach. Results: For both EQ-5D versions, high-quality evidence for sufficient convergent validity was found. Known-groups validity was sufficient for the EQ-5D-5L (high-quality evidence), whereas the results were inconsistent for the EQ-5D-3L. Results regarding the reliability were inconsistent (EQ-5D-3L) or entirely lacking (EQ-5D-5L). Responsiveness based on correlations of change scores with instruments measuring related/similar constructs was insufficient for the EQ-5D-3L (high-quality evidence). For the EQ-5D-5L, the available evidence on responsiveness to change in (Hr)QoL instruments was limited. Conclusion: Since the responsiveness of the EQ-5D in a population of middle-old and oldest-old individuals was questionable, either using additional instruments or considering the use of an alternative, more comprehensive instrument of (Hr)QoL might be advisable, especially for economic evaluations.
 
Flow diagram of study participants in the three cohorts (2012, 2014, and 2018)
Article
Purpose Oral health-related quality of life (OHRQoL) is a complex construct that reflects the interaction among well-being, socioeconomic, oral health status, and also contextual factors. This study aimed to verify the association between poorer socioeconomic background and oral health condition on OHRQoL throughout adolescence. Methods A cohort study followed a random sample of 1134 participants aged 12 years in 2012 (T1), 770 adolescents with an average age of 14 years in 2014 (T2; retention rate, 67.9%), and 768 adolescents with an average age of 17.5 years in 2018 (T3; retention rate, 67.8%). OHRQoL was collected three times using the Brazilian short version of the Childhood Perception Questionnaire 11–14 (CPQ 11–14). At baseline, the adolescents were clinically assessed by dentists, and their demographic data, socioeconomic status, use of dental services, and toothache were evaluated. The mean income of the neighborhood was used as a proxy of contextual factors. This variable was obtained from an official municipal publication. Poisson multilevel regression analyses were performed using a hierarchical approach to assess the predictors of OHRQoL over time. Results Adolescents living in a neighborhood with low mean income, low household income, low education levels, girls, and nonwhite individuals reported poor OHRQoL. Clinical variables such as gingival bleeding and malocclusion were also associated with higher overall scores on CPQ11-14, indicating poor OHRQoL. Conclusion Our results showed that the unfavorable contextual and individual socioeconomic environment, and oral disease negatively influenced OHRQoL during adolescence.
 
Article
Purpose We examined multidimensional, heterogeneous reactions to the COVID-19 pandemic and associated measures to provide further insights into the developmental processes of risk and adaptation. Method We used three-wave questionnaire data from 8156 individuals participating in the Norwegian County Public Health Survey assessed 1–5 months before and three (June 2020) and nine (December 2020) months after the outbreak. Latent profile and latent transition analyses were used to identify latent quality of life (QoL) classes and multiform changes, their probabilities, and predictors. Results We identified five distinct QoL classes of varying proportions, namely Flourishing (i.e. 24–40%), Content (31–46%), Content-Symptomatic (8–10%), Languishing (14–20%), and Troubled (2–5%). Despite higher levels of negative affect and lower levels of life satisfaction and positive emotions, most individuals remained in their pre-pandemic QoL profiles. Yet, changes occurred for a meaningful proportion, with transition to a less favourable class more common than to a favourable. Between time 1 and 3, the flourishing and troubled groups decreased by 40% and 60%, while the content and languishing groups increased by 48% and 43%, respectively. Favourable pre-pandemic relational (marital status, support, interpersonal trust, and belonging), health, and economy-related status predicted significantly lower odds of belonging to the high-risk groups both pre-pandemic and during the pandemic. Conclusions Overall, this study shows lower levels of QoL amid the COVID-19 pandemic, but substantial stability in the QoL distribution, and an overall levelling of the QoL distribution. Our findings also underscore the importance of financial, health-related, and social capital to QoL.
 
Simplified Causal Loop Diagram. The extended version showing all variables is presented in the appendix
Article
Purpose System science offers a unique set of tools, including causal loop diagrams (CLDs), for stakeholders to better grasp the complexity of factors surrounding quality of life. Because the health-related quality of life (HRQoL) of cancer immunotherapy patients exists within an intricate system affected by and affecting many factors across multiple dimensions, the development of a systems-level model can provide a powerful framework to aid the understanding of this complexity. We developed a CLD for HRQoL of cancer immunotherapy patients. Methods We first applied a literature-based approach to construct a CLD for patients following immunotherapy. We then iteratively reviewed and enhanced the CLD through interviews with subject matter experts. Results Based on the reviewed literature and subject matter expert input, we produced a CLD representing the system surrounding cancer immunotherapy patients’ HRQoL. Several feedback loops are identified that span clinical experiences, oncology teams’ perceptions about immunotherapy, social support structures, and further research and development in cancer immunotherapy, in addition to other components. The CLD enables visualization of thought experiments regarding how a change anywhere in the system can ultimately worsen or improve patients’ HRQoL. Conclusion The CLD illustrates the valuable contribution of a systems perspective to quality-of-life research. This systems-based qualitative representation gives insight on strategies to inhibit harmful effects, enhance beneficial effects, and inherent tradeoffs within the system. The CLD identifies gaps in the literature and offers a communication tool for diverse stakeholders. Our research method provides an example for studying the complexities of quality of life in other health domains.
 
Participant flow diagram
Article
Purpose Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device [LVAD]-related self-care, adverse events) to research study enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL). Methods In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study. Results Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; “respondents”) and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was “as expected.” Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery. Conclusions Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement. Trial registration NCT03044535 (accessible at https://clinicaltrials.gov/ct2/show/NCT03044535), registered February 7, 2017.
 
Overview of the study design at different time points (pre-treatment, treatment, post-treatment, and follow-up)
Flow diagram showing the number of participants and randomization (CONSORT model; 2010)
Comparison of pre-, post- and follow-up treatment assessment of the eight SF-36 subscales for the different tDCS stimulation groups (M1, DLPFC, OIC and Sham). Higher scores indicate improvement in QoL
Comparison of pre-, post- and follow-up treatment assessment of the FIQ-R sub-scales for the different tDCS stimulation groups (M1, DLPFC, OIC and Sham). Lower scores represent improvement (i. e., decrease in symptom severity, impact, or functioning) in FM patients
Article
Purpose Fibromyalgia (FM) is a chronic pain syndrome with a strong impact on quality of life (QoL). Treatment of this condition remains a challenge, due to the scarce evidence for the effectiveness of the therapeutic approaches available. Current attention is focused on transcranial direct current stimulation (tDCS), which has yielded promising results for pain treatment. Rather than focusing only on pain relief, in this study, we aimed to determine how active or sham tDCS (over three cortical targets -the primary motor cortex, the dorsolateral prefrontal cortex and the operculo-insular cortex-) affect QoL in patients with FM. Methods Using a double-blind, placebo-controlled design, we applied fifteen tDCS sessions of 20’ to initial 130 participants (randomized to any of the four treatment groups). We evaluated the QoL (assessed by SF-36) and the symptoms’ impact (assessed by FIQ-R) in baseline, after treatment and at 6 months follow-up. Results All groups were comparable as regards age, medication pattern and severity of symptoms before the treatment. We found that QoL and symptoms’ impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months. However, we did not observe any group effect nor group*treatment interaction. Conclusions After the intervention, we observed a non-specific effect that may be due to placebo, favoured by the expectations of tDCS efficacy and psychosocial variables inherent to the intervention (daily relationship with therapists and other patients in the clinic). Therefore, active tDCS is not superior to sham stimulation in improving QoL in FM.
 
Quality of life subscales for the latent profile classes
Article
Purpose Quality of life can be negatively impacted by the formation of a stoma and is influenced by a number of factors. Research to date treats people with a stoma as a homogenous group based on their quality of life. We attempted to identify subgroups based upon self-reported quality of life and explored variables associated with group membership. Methods The present study is a secondary analysis of a cross-sectional sample of 1419 people with a stoma. Participants completed validated questionnaires for quality of life, physical activity and clinical and demographic characteristics. Latent profile analysis was used to identify the optimal number of subgroups (profiles) and multinomial regression modelling was conducted to identify variables associated with profile membership. Results The analysis revealed 4 distinct profiles of people with a stoma: ‘consistently good quality of life’ [N = 891 (62.8%)], ‘some quality of life concerns’ [N = 184 (13.0%)], ‘low quality of life’ [N = 181 (12.8%)] and ‘financial concerns’ [N = 163 (11.5%)]. Modelling revealed that people with a recent stoma (formed < 2 years previously), who have a hernia and are less physically active were more likely to belong to the ‘low quality of life’ profile. Furthermore, those aged 16–55 were more likely to have financial concerns. Conclusion This study was the first to identify latent profiles within this population and assess whether certain variables are associated with membership. Future research should build upon this to identify additional variables associated with these profiles, which can help to provide the basis for targeting and tailoring future interventions to specific subgroups of people with a stoma.
 
Venn diagram of the inclusion period and variables from the DBDS questionnaires 1, 2, and 3. BMI body mass index, DBDS Danish Blood Donor Study, HH hyperhidrosis, HRQoL health-related quality of life, PSS perceived stress scale, Q questionnaire
Article
Purpose Hyperhidrosis has been associated with a reduced health-related quality of life (HRQoL). The role of common confounding factors of this association such as stress and socioeconomic status, however, remain largely unexplored, and may affect the management strategy for hyperhidrosis. Therefore, the study objective was to compare the HRQoL in individuals with and without hyperhidrosis while adjusting for confounders. Methods In this retrospective cohort study, data on the HRQoL measured by the short-form-12 questionnaire and self-reported hyperhidrosis were collected from the Danish Blood Donor Study-cohort. Data on international classification of disease-10 codes and redeemed prescriptions were collected from nationwide registries. Linear regression investigated the association between hyperhidrosis and HRQoL. Results Total 2794 (9.1%) of 30,808 blood donors had self-reported hyperhidrosis and 284 (0.2%) of 122,225 had hospital diagnosed hyperhidrosis. Self-reported hyperhidrosis was associated with a reduced mental HRQoL (adjusted beta coefficient − 1.10; 95% confidence interval − 1.37, − 0.82; p < 0.001) and physical HRQoL (adjusted beta coefficient − 0.90; 95% confidence interval − 1.09, − 0.70; p < 0.001). Hospital diagnosed hyperhidrosis was associated with a reduced mental HRQoL (adjusted beta coefficient − 0.91; 95% confidence interval − 1.82, − 0.04; p = 0.049). Conclusion Hyperhidrosis is associated with a reduced HRQoL, independently of confounders or mode of diagnosis. This supports an approach primarily targeting hyperhidrosis.
 
Central themes and sub-themes deduced from patient interviews regarding experiences of living with cryptoglandular anal fistula
Article
Purpose Cryptoglandular anal fistula continues to be a subject of extensive surgical research due to the lack of effective and enduring treatments, some of which incur risks to continence and quality of life. However, the patient experience of disease has seldom been reported. The aims of this study are to understand the impact of living with a fistula and the treatment outcomes that are valued by patients. Methods Patients with cryptoglandular anal fistula were recruited using purposive sampling from two tertiary referral centres in the UK and the Netherlands. Patients underwent semi-structured interviews that were audio-recorded and transcribed verbatim. Dutch transcripts were translated into English and underwent independent, thematic analysis using open coding by two study team members to identify common themes and sub-themes. Results Twenty interviews were conducted before saturation was reached (11 male, median age 49, Interquartile range 39–55 years). Four broad themes emerged, covering the physical symptoms of fistula, the patient journey towards understanding the condition, life impact, and treatment. Several inter-related sub-themes were found, reflecting the extensive impact and adjustment that the disease entails. Conclusion The impact of cryptoglandular anal fistula extends beyond the physical symptoms of pain and discharge, requires significant readjustment, and often negatively impacts psycho-social wellbeing. These aspects of disease should receive greater attention in future assessment of treatment and quality of life.
 
Depiction of feasibility-tested PRO-cision Medicine intervention vs. usual care. At the top, depiction of care delivery under usual care (if the patient had not been enrolled in the study). This example illustrates a patient who would have had in-person visits monthly. Between visits, if the patient had issues, the patient could have contacted the provider by phone call or MyChart message. There is no symptom monitoring. At the bottom, depiction of care delivery under the tested PRO-cision Medicine intervention. The patient is only pre-scheduled for half as many visits (every other month), is asked to complete symptom reports monthly, with the option to report symptoms in the intervening weeks. Clinicians’ offices can follow up on concerning scores by phone, MyChart message, or add a visit. Throughout, the patient may contact the provider by phone or MyChart message. There is no change to the schedule of laboratory testing and imaging studies (not depicted)
Article
Purpose PRO-cision medicine refers to personalizing care using patient-reported outcomes (PROs). We developed and feasibility-tested a PRO-cision Medicine remote PRO monitoring intervention designed to identify symptoms and reduce the frequency of routine in-person visits. Methods We conducted focus groups and one-on-one interviews with metastatic breast (n = 15) and prostate (n = 15) cancer patients and clinicians (n = 10) to elicit their perspectives on a PRO-cision Medicine intervention’s design, value, and concerns. We then feasibility-tested the intervention in 24 patients with metastatic breast cancer over 6-months. We obtained feedback via end-of-study surveys (patients) and interviews (clinicians). Results Focus group and interview participants reported that remote PRO symptom reporting could alert clinicians to issues and avoid unneeded/unwanted visits. However, some patients did not perceive avoiding visits as beneficial. Clinicians were concerned about workflow. In the feasibility-test, 24/236 screened patients (10%) enrolled. Many patients were already being seen less frequently than monthly (n = 97) or clinicians did not feel comfortable seeing them less frequently than monthly (n = 31). Over the 6-month study, there were 75 total alerts from 392 PRO symptom assessments (average 0.19 alert/assessment). Patients had an average of 4 in-person visits (vs. expected 6.5 without the intervention). Patients (n = 19/24) reported high support on the end-of-study survey, with more than 80% agreeing with positive statements about the intervention. Clinician end-of-study interviews (n = 11/14) suggested that PRO symptom monitoring be added to clinic visits, rather than replacing them, and noted the increasing role of telemedicine. Conclusions Future research should explore combining remote PRO symptom monitoring with telemedicine and in-person visits.
 
Top-cited authors
Caroline B Terwee
  • Amsterdam University Medical Center
Henrica De Vet
  • Amsterdam University Medical Center
Michael Herdman
Lidwine B Mokkink
  • Amsterdam University Medical Center
Lex Bouter
  • Amsterdam University Medical Centers