Changes In Health-related Quality Of Life Research Articles

Abstract 4122307: Longitudinal Changes in Parent-reported Quality of Life in Children with Single Ventricle

Introduction: Increased knowledge of quality of life (QOL) and the potential impact of the Fontan on QOL is essential to improving outcomes in patients with single ventricle. The primary aim of the Pediatric Heart Network Single Ventricle Reconstruction (SVR) trial II was to investigate outcomes in subjects with SV at age 6 yrs while SVR III characterized outcomes in this cohort at age 10-12 yrs. Aims: The purpose of this study was to evaluate changes in health-related QOL from SVR II to SVR III and to identify factors associated with changes in QOL over time. Methods: Parents completed proxy-reports for their child using the Pediatric Quality of Life Inventory (PedsQL) generic and cardiac scales at SVR II and SVR III. Within-subject differences in PedsQL scores and proportions scoring in the ‘at-risk’ range for significantly impaired QOL between time points were examined using one-sample t-test and McNemar’s tests, respectively. Factors associated with changes in QOL were evaluated using standard univariate tests. Results: A total of 163 patients were included (63% male, 89% Caucasian, 16% Hispanic). PedsQL scores reported by parents decreased across all domains: total score -6.1 ± 17.1, p <.0001; physical -4.0 ± 22.3, p=0.02; psychosocial -7.2 ± 17.4, p<.0001; emotional -6.5 ± 20.7, p=.0001; social -6.6 ± 22.6, p= 0.0003; and school -8.6 ± 22.5, p<.0001, functioning. No significant change in parent-reported heart problems/cardiac symptoms was detected across timepoints (-1.0 ± 20.4, p=0.52). Proportions with impaired QOL increased over time: total 28 to 39%, p=.01, physical 27 to 39%, p=.01, psychosocial 25 to 40%, p=.002, emotional 20 to 34%, p=.001, social 22 to 31%, p=.06, and school 21 to 38%, p=.0001. Only treatment for a psychological or behavioral disorder (n=26) was significantly associated with decline in psychosocial (mean -14.0 vs. -5.9; p=.03) and emotional (mean -17.1 vs. -4.5; p=.004) functioning scores. There was no significant association between socioeconomic status, Vineland adaptive scores at SVR II, or interval complications or procedures and changes in QOL. Conclusion: As perceived by their parents, health-related QOL in children with SV decreases over time unrelated to cardiac symptoms and complications. The greatest decline was in school functioning with 1 in 3 children having significantly impaired school QOL at SVR III. Greater attention to assessment of learning and psychosocial needs is essential to improve QOL in patients with SV.

Exploring geriatric assessment-driven rehabilitation referral patterns and its influence on functional outcomes and survival in older adults with advanced cancer.

Older adults with advanced cancer experience functional disability that warrants rehabilitation services; however, evidence indicates inconsistencies in referral. The purpose was to (1) identify predictors of geriatric assessment (GA)-driven referrals to rehabilitation services and (2) explore associations between referral and change in function, health-related quality of life (HRQoL), and overall survival among older adults with advanced cancer. This was a secondary analysis (NCT020107443, UG1CA189961) of a nationwide GA clinical trial. Patients were older adults with advanced cancer who had at least one GA-defined physical performance or functional status impairment. Primary outcomes were oncologist-initiated discussion about or referral to rehabilitation services after the GA (Aim 1) and decline in activities of daily living (ADL), Instrumental ADL (IADL), and HRQoL within 3 months, and overall survival at 1 year (Exploratory Aims). Analyses included multivariable logistic regression and Cox proportional hazards models. Demographic and clinical factors were controlled for by using 1:1 propensity score matching. In total 265 patients were analyzed. After adjustment, impaired cognition (odds ratio [OR] = 2.25, p = 0.01), Karnofsky score indicating disability (OR = 2.86, p < 0.01), and receipt of monoclonal antibodies (OR = 1.95, p = 0.04) were associated with higher odds of referral. In contrast, polypharmacy was associated with lower odds of referral (OR = 0.31, p < 0.01). Referred patients were less likely to decline in ADL (OR 0.30, p = 0.07) and IADL (OR 0.64, p = 0.35), but more likely to decline in HRQoL (OR 1.20, p = 0.67) and have worse survival (HR 1.18, p = 0.62). Cancer treatment, polypharmacy, cognition, and disability status likely influence oncologists' decision to refer for rehabilitation. Referral was not independently associated with change in functional disability, HRQoL, or survival. Future studies should evaluate patients' utilization of rehabilitation services post-referral and determine whether dose/timing of rehabilitation services influence clinical outcomes.

A systematic review and meta-analysis of health-related quality of life (HRQoL) outcomes in randomised controlled trials for pulmonary arterial hypertension (PAH)

Abstract Introduction ESC guidelines recognise the under use of disease-specific health-related quality of life (HRQoL) instruments. These include CAMPHOR, PAH-SYMPACT, Emphasis-10 and Living with Pulmonary Hypertension (LPH). Patients highly value HRQoL as a treatment outcome in PAH. This is the first meta-analysis to evaluate HRQoL instruments and outcomes in RCTs in pulmonary arterial hypertension (PAH). Purpose To evaluate which PAH-RCT interventions improve HRQoL outcomes and compare the suitability of HRQoL instruments used. Method We searched MEDLINE (Jan 1970 to Dec 2023) and Cochrane Library from Jan 1990 to Dec 2023 (EMBASE, CT.gov, ICTRP, CINAHL) for RCTs in PAH. Abstracts and unpublished studies were excluded and PRISMA reporting structure followed. Trials meeting final selection criteria included HRQoL instruments sufficiently powered to detect a minimal clinically important difference (MCID). Effective sample sizes were calculated in GPower3.1 from a two independent means model for 80% power, 5% significance, one-tailed test. Meta-analysis was performed in SPSSv28.1. Full search criteria are registered on PROSPERO (ID: CRD42024484021). Results After removal of duplicates, 896 records were screened, 43 studies included a HRQoL endpoint. 8 studies were included in the meta-analysis after exclusion for insufficient data (n=10) or power (n=25). 3 of these did not meet the MCID (&amp;gt;33m) for six-minute walk distance (6MWD) and evaluated separately to discriminate accuracy of HRQoL instrument. Instruments available for comparison were Short Form-36(SF-36), EuroQol (EQ-5D-5L) and Living with Pulmonary Hypertension (LPH). Studies not reaching MCID for 6MWD also showed no change in HRQoL (figure 1). Ambrisentan and exercise training demonstrate a significant improvement (p&amp;lt;0.05) in SF-36 physical(P) component (figure 2). This component was anchored to determine 6MWD MCID; other HRQoL values responded variably. Utility weighting to account for geographical variation was not reported with EQ-5D-5L and SF-36 in multicentre studies however AIR 2002 (Iloprost) was significant for both EQ-5D-5L instruments. The total component score of the disease-specific LPH was more sensitive to functional improvements and overall change in HRQoL compared to EQ-5D-5L (p&amp;lt;0.05). Conclusion Fewer than 10% of all RCTs in PAH have adequately considered a HRQoL outcome measure. 8 RCTs were powered to assess HRQoL. Iloprost, ambrisentan, riociguat and exercise training interventions demonstrate significant improvement in HRQoL. LPH was the only PAH-instrument powered to detect change. LPH was more sensitive to HRQoL than generic instruments and is multidimensional. Geographical indexing should be considered for generic instruments such as EQ-5D-5L and SF-36 in multicentre trials. As a highly valued outcome for patients, future studies should prioritise HRQoL as an endpoint.Figure 1Figure 2

Does perceived usability of a multi-component mobile device intervention improve health-related quality of life?

Abstract Background Good health-related quality of life (HRQL) is essential to healthy aging. Prior studies have demonstrated that mobile device technologies can promote HRQL in older adults. However, evidence of technology acceptance in older adults is often inconsistent and poorly understood. Purpose This study aims to 1) describe technology acceptance using efficiency, learnability, user experience (i.e., acceptability), and perceived control from the USABILITY survey of a multi-component mobile device intervention consisting of a wearable activity tracker (Fitbit Versa), access to Lose It app, and text messages (for experimental group only) in older adults at risk for cardiovascular disease, and 2) examine the correlation between technology acceptance and changes in HRQL before and after using each component of the digital intervention. Methods Data were collected using a purpose-built technology usability survey, and HRQL was assessed using the 12-Item Short Form Survey (SF-12), which measured perceived physical and mental health. Correlations were used to identify associations between technology acceptance and HRQL. Results The mean age of participants (n=54) was 65.4 ± 6.0 years; a majority were females (60%), married (53%), Hispanic (66%), and had a high school education or higher (76%). Table 1 shows that the experimental group had considerably higher HRQL at three months, but no differences in technology acceptance were noted. Fitbit technology adoption was found to be correlated with physical HRQL (r=304, p=0.027). The Lose It app showed no correlation with HRQL. Despite receiving higher usability ratings, SMS messages were not correlated with physical or mental HRQL. Conclusion Our findings demonstrate that older persons at risk for cardiovascular disease find mobile device intervention components acceptable. However, each component affected physical and mental health differently. These findings inform more complete technology acceptance models for older individuals' technology design, education, and deployment. Older persons prefer personalized communication, such as customized text messages, as the most favored aspect of the multi-component mobile device intervention. It warrants a larger clinical trial to determine its efficacy on HRQL.

Associations Between Physical, Cognitive, and Mental Health Domains of Post-Intensive Care Syndrome and Quality of Life: A Longitudinal Multicenter Cohort Study.

To explore associations between the physical, cognitive, and mental post-intensive care syndrome (PICS) health domains with changes in health-related quality of life (HRQoL) following ICU admission. A longitudinal prospective multicenter cohort study. Patients (n = 4092) from seven Dutch ICUs. None. At ICU admission, 3 and 12 months post-ICU, patients completed validated questionnaires regarding physical health problems, cognitive health problems, mental health problems, and HRQoL. Composite scores were created for the physical health domain (physical problems and fatigue) and mental health domain (anxiety, depression, and post-traumatic stress disorder). Adjusted multivariable linear regression analyses were performed, including covariables (e.g., patient characteristics, disease severity, pre-ICU HRQoL, etc.) to explore associations between the physical, cognitive, and mental health domains of PICS and changes in HRQoL at 3 and 12 months post-ICU. At 3 months (n = 3368), physical health problems (β = -0.04 [95% CI, -0.06 to 0.02]; p < 0.001), cognitive health problems (β = -0.05 [95% CI, -0.09 to -0.02]; p < 0.001), and mental health problems (β = -0.08 [95% CI, -0.10 to -0.05]; p < 0.001) were negatively associated with changes in HRQoL. Also, at 12 months (n = 2950), physical health problems (β = -0.06 [95% CI, -0.08 to -0.03]; p < 0.001), cognitive health problems (β = -0.04 [95% CI, -0.08 to -0.01]; p < 0.015), and mental health problems (β = -0.06 [95% CI, -0.08 to -0.03]; p < 0.001) were negatively associated with changes in HRQoL. PICS symptoms in the physical, cognitive, and mental domains are all negatively associated with changes in HRQoL at 3 and 12 months post-ICU. At 3 months, PICS symptoms in the mental domain seem to have the largest negative associations. At 12 months, the associations of PICS in the mental and physical domains are the same. This implies that daily ICU care and follow-up care should focus on preventing and mitigating health problems across all three PICS domains to prevent a decrease in HRQoL.

QUALITY OF LIFE IN PATIENTS WITH SKULL BASE CHORDOMA AND CHONDROSARCOMA TREATED WITH PENCIL BEAM SCANNING PROTON THERAPY

Abstract AIMS The objective of this study is to assess the health-related quality of life (HRQoL) of skull base chor- doma/chondrosarcoma patients treated with proton therapy (PT). METHOD Seventy seven adult patients with skull base chordoma/chondrosarcoma completed the EORTC-QLQ-C30 and the BN20 Questionnaires prior to PT, Clinical outcome and therapy related acute and late toxicities have been recorded in course of the follow-up. The data was collected, categorized and analyzed, comparing the posttreatment scores to each patient’s baseline. In order to assess the impact of the clinical outcome and toxicities on HRQoL, the scores were correlated to collected clinical outcomes. RESULTS Median follow-up was 51 months. 6-year overall survival and local failure free survival rates observed were 85.1% and 80.3%. One G3 brain radiation necrosis and one G4 optic nerve disorder were documented during FU. HRQL deteriorated after the completion of proton therapy and returned to baseline values one year thereafter. After the second and third year, we observed further decrease in HRQL. This development was unrelated to tumor relapse. However, comparing the whole cohort over time, global QoL did not change substantially over the course of follow-up. GTR was correlated to better QoL at all time points. Disease progression was correlated with overall worse QoL and higher neurological symptoms already before PT, and higher symptom burden one year thereafter. Males had better QoL before and one year after PT than females. CONCLUSION PT achieves an excellent local and distant control in patients with skull base chordoma/chondrosarcoma. The HRQoL in these patients decreases immediately after the treatment completion, returns to the baseline from one year thereafter, and tends to deteriorate again with longer FU. The observed changes in global HRQoL were however not substantial in the whole cohort over the course of follow-up.

Establishing the minimum clinically important difference of the Quality of Life in Childhood Epilepsy Questionnaire.

To estimate the minimum clinically important difference (MCID) for the parent-reported 55-item Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) and its shortened 16-item version, QOLCE-16. Data came from 74 children with epilepsy (CWE) (ages 4-10, mean age = 8 [SD = 1.8]) enrolled in the Making Mindfulness Matter in Epilepsy (M3-E) trial, a pilot, parallel randomized-controlled trial of a mindfulness-based intervention. Both anchor-based and distribution-based methods were used to estimate MCID values for the QOLCE-55 and QOLCE-16. For the anchor-based approach, the Patient Centered Global Ratings of Change (PCGRC) scale and linear regression analysis were used to estimate the MCID. For the distribution-based approach, .5 SD of the health-related quality of life (HRQOL) change score distribution was used to estimate the MCID. For the QOLCE-55, the MCID obtained using an anchor-based approach was 10 points and using a distribution-based method was 6 points. For the QOLCE-16, the MCID obtained using an anchor-based method was 13 points and using a distribution-based method was 7 points. This is the first study to estimate MCID values for the QOLCE-55 and the QOLCE-16. It has been well documented that CWE are at risk of experiencing psychological, behavioral, and cognitive impairments, which can negatively impact their HRQOL. Reporting MCID values for the QOLCE-55 and QOLCE-16 is important in determining whether changes in HRQOL observed are meaningful to CWE themselves, as a key factor in shaping the nature of epilepsy care delivered.

Estimating Change in Health-Related Quality of Life before and after Stroke: Challenges and Possible Solutions.

Estimating change in health-related quality of life (HRQOL) from pre- to poststroke is challenging because HRQOL is rarely collected prior to stroke. Leveraging HRQOL data collected both before and after stroke, we sought to estimate the change in HRQOL from prestroke to early poststroke. Stroke survivors completed the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) scale at both pre- and early poststroke. Patient characteristics were compared for those who did and did not complete the PROMIS-GH. The mean change in PROMIS-GH T-score was estimated using complete case analysis, multiple imputation, and multiple imputation with delta adjustment. A total of 4,473 stroke survivors were included (mean age 63.1 ± 14.1 y, 47.5% female, 82.6% ischemic stroke). A total of 993 (22.2%) patients completed the PROMIS-GH at prestroke while 2,298 (51.4%) completed it early poststroke. Compared with those without PROMIS-GH, patients with PROMIS-GH prestroke had worse comorbidity burden. Patients who completed PROMIS-GH early poststroke had better early poststroke clinician-rated function and shorter hospital length of stay. Complete case analysis and multiple imputation revealed patients' PROMIS-GH T-scores worsened by 2 to 3 points. Multiple imputation with delta adjustment revealed patients' PROMIS-GH T-scores worsened by 4 to 10 points, depending on delta values chosen. Systematic differences in patients who completed the PROMIS-GH at both pre- and early poststroke suggest that missing PROMIS-GH scores may be missing not at random (MNAR). Multiple imputation with delta adjustment, which is better suited for MNAR data, may be a preferable method for analysis of change in HRQOL from pre- to poststroke. Given our study's large proportion of missing HRQOL data, future studies with less missing HRQOL data are necessary to verify our results. Estimating the change in health-related quality of life from pre- to poststroke is challenging because health-related quality-of-life data are rarely collected prior to stroke. Previously used methods to assess the burden of stroke on health-related quality of life suffer from recall bias and selection bias.Using health-related quality-of-life data collected both before and after stroke, we sought to estimate the change in health-related quality of life after stroke using statistical methods that account for missing data.Comparisons of patients who did and did not complete health-related quality-of-life scales at both pre- and poststroke suggested that missing data may be missing not at random.Statistical methods that account for data that are missing not at random revealed more worsening in health-related quality of life after stroke than traditional methods such as complete case analysis or multiple imputation.

Changes in health-related quality of life in young-old and old-old patients undergoing elective orthopedic surgery: A systematic review.

There is a significant gap in research exploring changes in postoperative health-related quality of life (HRQoL) among patients aged 65 years and older undergoing hip or knee arthroplasty. To investigate the variations in HRQoL improvement, as evaluated by patient-reported outcome measures following total hip arthroplasty, total knee arthroplasty, and partial knee arthroplasty between the young-old and old-old adults. We searched six online databases (including MEDLINE, Embase) from their inception dates to May 15, 2023. We included studies using a validated HRQoL assessment tool to evaluate changes in HRQoL in patients aged ≥65 years undergoing hip or knee arthroplasty. These include the EuroQol five-dimension (EQ-5D), Short Form 36 (SF-36) and Short Form 12 (SF-12). The primary outcomes were postoperative HRQoL changes between young-old (65-74 years) and old-old groups (≥75 years). The secondary outcomes included complications, length of stay, and mortality. The search yielded 12,229 articles; twelve studies (n = 103,613) were included. Studies using EQ-5D found no significant differences between young-old and old-old patients after hip and knee arthroplasty. Analyses of SF-36 and SF-12 scales showed no significant age-related differences in postoperative improvements in physical and mental health. Our review of four studies that included multivariable analyses revealed inconsistent associations between age and EQ-5D. Comparisons between the young-old and old-old age groups in postoperative complications, hospital length of stay, and mortality revealed no associated age-related changes in HRQoL. The young-old and old-old patients exhibited comparable improvement in HRQoL following hip or knee arthroplasty. The older patients did not have higher postoperative complications rates, longer hospital length of stay, and increased mortality. While chronological age should be considered when planning hip and knee arthroplasty, greater emphasis should be placed on assessing the comorbidities and functional status of patients.

Longitudinal Health-Related Quality of Life Among Patients With High-Risk Pediatric Hodgkin Lymphoma Treated on the Children's Oncology Group AHOD 1331 Study.

PURPOSEThere have been no previous longitudinal assessments of health-related quality of life (HRQoL) during treatment for pediatric Hodgkin lymphoma (HL). The addition of brentuximab vedotin (BV) to a multidrug chemotherapy backbone demonstrated superior efficacy to standard chemotherapy for patients with pediatric high-risk HL in the AHOD 1331 trial. However, the impact on HRQoL is unknown.PATIENTS AND METHODSAfter treatment random assignment, 268 participants older than 11 years were enrolled in a prespecified, longitudinal, patient-reported outcomes substudy. HRQoL was assessed using the seven-item Child Health Ratings Inventories (CHRIs)-Global scale before treatment (T1) and at cycle 2 (T2), cycle 5 (T3), and end of treatment (T4). A clinically meaningful increase in HRQoL was considered 7 points on the CHRIs-Global. Multivariable linear regression estimated associations between demographic/clinical variables and HRQoL at T1. Linear mixed models estimated changes in HRQoL across the treatment arm.RESULTSParticipant characteristics were balanced by treatment arm. Ninety-three percent of participants completed the CHRIs at T1, 92% at T2, 89% at T3, and 77% at T4. At T1, female sex and fever (P < .05) were each associated with worse HRQoL. By T2, participants in the BV arm experienced a statistically and clinically significant improvement in HRQoL (β = 7.3 [95% CI, 3.2 to 11.4]; P ≤ .001), which was greater than the change in the standard arm (difference in change β = 5.1 [95% CI, -0.2 to 10.3]; P = .057). The standard arm did not experience a statistically or clinically significant increase in HRQoL until T4 (β = 9.3 [95% CI, 4.7 to 11.5]; P < .001).CONCLUSIONThese data demonstrate successful collection of serial HRQoL from youth with high-risk pediatric HL and improvement in HRQoL over the course of initial therapy, sooner and to a greater extent in the group receiving the novel agent BV.

Wearable Device–Based Intervention for Promoting Patient Physical Activity After Lung Cancer Surgery

ImportanceEmerging evidence suggests that wearable devices are feasible for monitoring physical activity among patients with lung cancer. However, the association between wearable devices and improvement in patient recovery after surgery remains underexplored.ObjectiveTo evaluate the effects of a wearable device intervention on the recovery of physical activity, cardiopulmonary function, and health-related quality of life (HRQOL) after lung cancer surgery.Design, Setting, and ParticipantsThis nonrandomized clinical trial with a historical control was conducted at a single tertiary cancer center (Samsung Comprehensive Cancer Center) in Seoul, South Korea, between October 18, 2018, and May 24, 2019. Patients were included if they had suspected or confirmed non–small cell lung cancer scheduled for curative surgery more extensive than lobectomy and had an Eastern Cooperative Oncology Group status of 0 or 1. Patients were compared with historical control participants from data collected between September 20, 2017, and September 10, 2018, as part of the Coordinated Approach to Cancer Patients’ Health for Lung Cancer (CATCH-LUNG) prospective cohort study. Data analysis was performed between June 21 and July 16, 2020.InterventionA personalized exercise regimen monitored via a wearable device was administered to intervention patients at home in 3 stages: preoperative (from diagnosis to surgery), immediate (from discharge to 2 months after surgery), and later postoperative (from 2 to 6 months after surgery). Control patients received usual care.Main Outcomes and MeasuresThe primary outcome was cardiopulmonary function, and the co–primary outcome was physical activity at 6 months after surgery, measured with 6-minute walking distance (6MWD) and number of daily steps, using a linear regression model. Secondary outcomes were changes in cardiopulmonary function, physical activity, and HRQOL, including function and symptoms from baseline to 2 weeks and 6 months after surgery. Additionally, cardiopulmonary function and physical activity (number of daily steps and time spent on moderate-to-vigorous physical activity [MVPA]) at 2 weeks after surgery, physical activity (time spent on MVPA) at 6 months after surgery, and HRQOL, including function and symptoms at 2 weeks and 6 months after surgery, were assessed as secondary outcomes.ResultsThis trial included 74 patients in the intervention group (mean [SD] age, 60.4 [8.7] years; 31 [41.9%] men and 43 [58.1%] women) and 120 in the control group (mean [SD] age, 60.2 [8.7] years; 65 [54.2%] men and 55 [45.8%] women). Daily steps, MVPA, and 6MWD decreased initially at 2 weeks after surgery but increased thereafter. The control group had a larger decrease in the number of daily steps from baseline compared with the intervention group (−4877 [95% CI, −5861 to −3893] steps vs −1753 [95% CI, −2968 to −539] steps) at 2 weeks after surgery. By 6 months after surgery, the intervention group increased their daily steps by 2220 (95% CI, 1006 to 3435) from baseline, whereas the control group did not return to their baseline number of steps. The intervention group had significantly more daily steps (12 321 [95% CI, 8749-15 761] vs 10 118 [95% CI, 7341-13 420]; P = .007) and had greater vigorous physical activity (33.6 [95% CI, 13.5 to 59.8] vs 18.5 [5.7 to 40.8] minutes; P = .003) at 6 months after surgery compared with the control group. No difference in 6MWD was found. However, the intervention group had better patient-reported physical function (mean [SD] score, 82.2 [17.3] vs 76.9 [17.5]; P = .04), less dyspnea (mean [SD] score, 24.8 [27.1] vs 34.5 [31.6]; P = .03), and less pain (mean [SD] score, 21.4 [20.2] vs 30.1 [26.8]; P = .01) at 2 weeks after surgery and less dyspnea (mean [SD] score, 5.4[12.4] vs 12[23.3]; P = .01) at 6 months after surgery compared with the control group.Conclusions and RelevanceIn this nonrandomized clinical trial, integration of perioperative exercise interventions using wearable devices improved physical activity (especially MVPA) and dyspnea at 6 months after lung cancer surgery compared with usual care. This finding suggests a promising role for wearable devices in personalizing perioperative rehabilitation strategies.Trial RegistrationClinicalTrials.gov Identifier: NCT03215537

Dynamic changes in quality of life in older patients with chronic obstructive pulmonary disease: a 7-year follow up

Purposes: Chronic obstructive pulmonary disease (COPD) is a major cause of the rapid decline of health-related quality of life (HRQoL), associated with accelerated frailty in older populations. This study aimed to analyse the long-term dynamic changes of HRQoL and the predictive factors for the rapid decline of HRQoL in older patients with COPD.MethodsOverall 244 patients with COPD, aged ≧ 65 years from one medical centre were enrolled between March 2012 and July 2020. Further, we prospectively assessed HRQoL scores with utility values, using EuroQol Five-Dimension (EQ-5D) questionnaires. Additionally, long-term dynamic changes in HRQoL were analysed using the Kernel smoothing method and examined the factors contributing to the deterioration of HRQoL using a linear mixed effects model.ResultsOlder patients with COPD with forced expiration volume (FEV1) < 50% of prediction entered the phase of rapid and continuous decline of HRQoL ~ 2 years after enrolment, but patients with FEV1 ≥ 50% of prediction without rapidly declined HRQoL during 7 years follow up. Therefore, FEV1 < 50% of prediction is a novel predictor for the rapid decline of HRQoL. The course of rapidly declining HRQoL occurred, initially in the usual activities and pain/discomfort domains, followed by the morbidity, self-care, and depression/anxiety domains ~ 2 and 4 years after enrolment, respectively. The mixed effects model indicated that both FEV1 < 50% of prediction and a history of severe acute exacerbation (SAE) requiring hospitalisation were contributing factors for deterioration in HRQoL .ConclusionsBoth FEV1 < 50% of prediction and exacerbations requiring hospitalisation were contributing factors for the deterioration of HRQoL in long-term follow up. Additionally, FEV1 < 50% of prediction was a novel predictor for patients entering the phase of rapid decline of HRQoL.

Changes in health-related quality of life over the first three months of medical marijuana use

BackgroundThe psychosocial impact of medical marijuana use is not yet known. This study evaluated short-term changes in health-related quality of life (HRQoL) over the first three months of medical marijuana use.MethodsThis prospective, observational, longitudinal study followed adults newly recommended for medical marijuana by a physician for any of the more than 20 qualifying medical conditions in Pennsylvania. Participants (N = 438) provided their clinical status and demographic information, and completed semi-structured interviews prior to medical marijuana initiation (baseline) and at three months. HRQoL was assessed by the Short Form-36 (SF-36). Paired-samples t-tests evaluated changes in HRQoL over time.ResultsParticipants (M age = 46.4 years [15.6]; 66.4% female) were mostly commonly referred for medical marijuana to treat anxiety disorders (61.9%) or severe chronic or intractable pain (53.6%). Participants reported rapid and significant improvements in all of the domains of HRQoL from baseline to three months after initiating medical marijuana use (physical functioning, role limitations due to physical health problems, emotional well-being, role limitations due to emotional problems, bodily pain, social functioning, energy/fatigue and general health, P < .001 for all). Age was negatively predictive of level of improvement over time for the physical functioning (P < .0001), role limitations due to physical health problems (P < .001), and pain (P < .0001) domains after controlling for baseline, with older participants displaying less improvement than younger participants.ConclusionsGains were observed in all HRQoL domains assessed after three months of medical marijuana use. In several domains, age was a significant predictor of degree of improvement.

Estimating the burden of vaccine preventable lower respiratory tract disease in primary care, UK: protocol for a prospective surveillance study (AvonCAP GP2)

BackgroundThe true burden of acute lower respiratory tract diseases (aLRTD; includes acute lower respiratory tract infection, acute exacerbation of pre-existing heart failure and chronic lung disease) among adults presenting to primary care, and the proportion that are potentially vaccine preventable, is unknown.AimsTo describe aLRTD incidence in adults presenting to primary care; estimate proportions caused by RSV, SARS-CoV-2 and pneumococcus; and investigate disease burden from patient and NHS perspectives.Design &amp; settingPrimary care prospective cohort study conducted in six representative General Practices (total ̴83 000 registered adults) in Bristol, UK.MethodAdults (aged≥18 years) registered at participating General Practices and presenting to primary care (in-hours or out-of-hours) or emergency department (if not admitted) with aLRTD will be eligible and identified by real-time primary care record searches. Researchers will screen electronic GP records, including free text, contact patients to assess eligibility, and offer enrolment in a surveillance study and an enhanced diagnostic study (urine, saliva and respiratory samples; physical examination; and symptom diaries). Data will be collected for all aLRTD episodes, with patients assigned to one of three arms: surveillance, embedded diagnostic, and descriptive dataset. Outcome measures will include clinical and pathogen defined aLRTD incidence rates, symptom severity and duration, NHS contacts and costs, health-related quality of life changes, and mortality (≤30 days post identification).ConclusionThis comprehensive surveillance study of adults presenting to primary care with aLRTD, with embedded detailed data and sample collection, will provide an accurate assessment of aLRTD burden due to vaccine preventable infections.

Demonstrating responsiveness of the pediatric cardiac quality of life inventory in children and adolescents undergoing arrhythmia ablation, heart transplantation, and valve surgery.

Pediatric Cardiac Quality of Life Inventory (PCQLI) is a disease-specific pediatric cardiac health-related quality of life (HRQOL) instrument that is reliable, valid, and generalizable. We aim to demonstrate PCQLI responsiveness in children undergoing arrhythmia ablation, heart transplantation, and valve surgery before and after cardiac intervention. Pediatric cardiac patients 8-18 years of age from 11 centers undergoing arrhythmia ablation, heart transplantation, or valve surgery were enrolled. Patient and parent-proxy PCQLI Total, Disease Impact and Psychosocial Impact subscale scores were assessed pre- and 3-12 months follow-up. Patient clinical status was assessed by a clinician post-procedure and dichotomized into markedly improved/improved and no change/worse/much worse. Paired t-tests examined change over time. We included 195 patient/parent-proxies: 12.6 ± 3.0 years of age; median follow-up time 6.7 (IQR = 5.3-8.2) months; procedural groups - 79 (41%) ablation, 28 (14%) heart transplantation, 88 (45%) valve surgery; clinical status - 164 (84%) markedly improved/improved, 31 (16%) no change/worse/much worse. PCQLI patient and parent-proxies Total scores increased (p ≤ 0.013) in each intervention group. All PCQLI scores were higher (p < 0.001) in the markedly improved/improved group and there were no clinically significant differences in the PCQLI scores in the no difference/worse/much worse group. The PCQLI is responsive in the pediatric cardiac population. Patients with improved clinical status and their parent-proxies reported increased HRQOL after the procedure. Patients with no improvement in clinical status and their parent-proxies reported no change in HRQOL. PCQLI may be used as a patient-reported outcome measure for longitudinal follow-up and interventional trials to assess HRQOL impact from patient and parent-proxy perspectives.

Short-term impact of cardiovascular screening by traditional risk assessment or coronary artery calcium score on health-related quality of life: the ROBINSCA trial.

Evidence on the impact of screening for cardiovascular diseases (CVDs) on health-related quality of life (HRQoL) is important for policy decisions about screening implementation and to uncover teachable moments to motivate healthy lifestyle choices. It is unknown whether screening by cardiac computed tomography (CT) scan has a stronger impact on HRQoL than screening by traditional risk prediction models. The study aims to investigate differences in HRQoL across the screening process between participants who were randomized to CVD risk estimation by coronary artery calcium score or Systematic COronary Risk Evaluation. A subset of 2687 ROBINSCA participants filled in questionnaires at (T0) randomization, (T1) invitation, (T2) 1-3 days before screening, (T3) 1-3 days after, and (T4) screening result. Generic HRQoL (SF-12; EQ-5D) and anxiety (STAI-6) were measured. We investigated the differences in changes in HRQoL across the screening process with linear mixed models. We found comparable levels of HRQoL at all screening moments for the two intervention groups. Mental health scores were worse at invitation and randomization than at the later time points, irrespective of screening group (all P < 0.001). A result indicating a heightened CVD risk was associated with increased anxiety in the CT screening group. Computed tomography screening for CVD risk has no detrimental impact on HRQoL and anxiety levels compared to screening by traditional risk assessment. Receiving an invitation to screenning or a result implying increased CVD risk could function as teachable moments for high-risk individuals. ROBINSCA trial registration number: NTR6471 in Dutch Trial Register (NTR).

Association of baseline and changes in health-related quality of life with mortality following myocardial infarction: multicentre longitudinal linked cohort study.

Health-related quality of life (HRQoL) for patients following myocardial infarction (MI) is frequently impaired. We investigated the association of baseline and changes in HRQoL with mortality following MI. Nationwide longitudinal study of 9474 patients admitted to 77 hospitals in England as part of the Evaluation of the Methods and Management of Acute Coronary Events study. Self-reported HRQoL was collected using EuroQol EQ-5D-3L during hospitalization and at 1, 6, and 12 months following discharge. The data was analysed using flexible parametric and multilevel survival models. Of 9474 individuals with MI, 2360 (25%) were women and 2135 (22.5%) died during the 9-year follow-up period. HRQoL improved over 12 months (baseline mean, mean increase: EQ-5D 0.76, 0.003 per month; EQ-VAS 69.0, 0.5 per month). At baseline, better HRQoL was inversely associated with mortality [Hazard ratio (HR) 0.55, 95% CI 0.47-0.63], and problems with self-care (HR 1.73, 1.56-1.92), mobility (1.65, 1.50-1.81), usual activities (1.34, 1.23-1.47), and pain/discomfort (1.34, 1.22-1.46) were associated with increased mortality. Deterioration in mobility, pain/discomfort, usual activities, and self-care over 12 months were associated with increased mortality (HR 1.43, 95% CI 1.31-1.58; 1.21, 1.11-1.32; 1.20, 1.10-1.32; 1.44, 1.30-1.59, respectively). After MI, poor HRQoL at baseline, its dimensions, and deterioration over time are associated with an increased risk of mortality. Measuring HRQoL in routine clinical practice after MI could identify at-risk groups for interventions to improve prognosis.

Health-related quality of life in vibrant soundbridge patients: generic and specific measures, short-term and long-term outcomes.

The goal of the study was to determine the short- and long-term outcome of health-related quality of life (HRQoL) in adults implanted with a Vibrant Soundbridge (VSB). Twenty-one adults (8 females, 13 males; mean age at implantation: 57 ±10 years) who received a unilateral VSB for combined or conductive hearing loss, were administered two questionnaires: the Nijmegen Cochlear Implant Questionnaire (NCIQ) as a measure of hearing-specific HRQoL, and the Health Utility Index 3 (HUI 3) as a measure of generic HRQoL. The questionnaires were administered before implantation and three, six, 12 and 24 months after processor activation. The NCIQ total score raised significantly from 62 points before implantation to 76 points at three months after processor activation (p < 0.005). Thereafter, no significant increases occurred anymore. The HUI 3 multi-attribute score (MAUS) increased from 0.59 before implantation to 0.70 at three months and at six months after processor activation and then declined slightly to 0.68 at 24 months after processor activation. Similar values were observed with the HUI 3 single-attribute score (SAUS) of Hearing. The increases of the HUI 3 scores were not statistically significant, but all pre-post-implantation differences were clinically relevant. VSB recipients experienced a quick improvement of their HRQoL. After just three months of device use, a significant improvement of hearing-specific HRQoL and a clinically relevant improvement of generic HRQoL were seen. After three months, no essential changes of HRQoL occurred in our sample, suggesting that the achieved level of HRQoL may remain stable in the long term.

Trajectory of Health-Related Quality of Life Following Pediatric Concussion

To assess changes in health-related quality of life (HRQOL) across a 12-month period following pediatric concussion and to explore whether psychological factors (ie, pre-injury mental health history, current symptoms of anxiety and depression, sleep disturbance, or grit) were associated with HRQOL. Prospective cohort study design using data collected from patients presenting to a speciality care concussion program, with each patient followed for 12 months after initial presentation. Comparison data were collected from non-concussed controls recruited from the community. A total of 49 concussed patients (median=15.4 years of age) completed the Pediatric Quality of Life Inventory (PedsQL), Patient-Reported Outcome Measure Information Systems (PROMIS) Anxiety and Depressive Symptoms short forms, Pediatric Sleep Disturbance forms, and a Short Grit Scale. Mixed effects models explored change in HRQOL across time. Total HRQOL at initial clinic presentation was significantly lower for concussed adolescents (Peds QL Total Score mean=72 [SD=16 ]) compared with non-concussed controls (mean=88 [SD=11], p <.001). HRQOL improved in the patients with concussion over a 6-month period after initial assessment with no significant changes thereafter. Pre-injury history of anxiety (coefficient= -11.388, CI=-18.49 - -4.28, p<0.001), current depressive symptoms (coefficient= -0.317, CI= -0.62 - -0.01, p<0.01), and sleep disturbance (coefficient=-0.336, CI=-0.71 - 0.04, p<0.05) all predicted lower HRQOL. HRQOL is significantly lower in the acute phase of pediatric concussion and steadily improves over the following 6 months. Psychological factors are linked to lower HRQOL and may serve as important indicators of risk for poor outcome.

Predictors of six-month change in health-related quality of life in people with multiple sclerosis: A secondary data analysis of a randomized controlled trial

BackgroundSymptomatic treatment in people with multiple sclerosis (pwMS) requires multidisciplinary rehabilitation to alleviate disease progression and increasing health-related quality of life (HRQoL). However, the participant- and disease-specific factors that predict sustained improvement in HRQoL in pwMS undergoing inpatient rehabilitation remain unclear. Identifying these factors can help individually tailor inpatient rehabilitation programmes. Therefore, the aim of this study was to identify factors of pwMS at clinic entry for a three-week multidisciplinary inpatient rehabilitation that predict the change in physical and mental HRQoL over six months. MethodsThis is a secondary data analysis of a randomized controlled trial (NCT04356248) conducted at the Valens Rehabilitation Centre, Switzerland. HRQoL was assessed with the Medical Outcome Study 36-item Short Form Health Survey (SF-36) at clinic entry (T0; baseline) and six months after (T3; six-month follow-up). Data for 99 pwMS (mean age in years: 49.60 ± 10.17 SD, mean Expanded Disability Status Scale (EDSS) score: 4.62 ± 1.33 SD, 68.7 % female) were analysed using multiple linear regression. Outcome variables were six-month change in SF-36 Physical (ΔPCS) and Mental Component Scale (ΔMCS) scores. Predictor variables included baseline scores of PCS or MCS, fatigue, anxiety, depressive mood, cardiorespiratory fitness (V̇O2peak/kg), self-efficacy, smoking status, education level, age, EDSS, sex, time since diagnosis and MS phenotype. ResultsThe regression model with ΔPCS as outcome variable explained 18.6 % of the variance of the ΔPCS score (p = .003). Lower PCS score (p < .001) and lower depressive mood (p = .032) at baseline predicted higher ΔPCS score. The regression model with ΔMCS as outcome variable explained 26.8 % of the variance of the ΔMCS score (p < .001). Lower MCS score (p < .001) and longer time since diagnosis (p = .048) at baseline predicted higher ΔMCS score. ConclusionPwMS with lower physical HRQoL and better mood at clinic entry improved most in physical HRQoL over six months. PwMS with lower mental HRQoL and longer time since diagnosis at clinic entry improved most in mental HRQoL over six months. The results of this study contribute to the development of individualized rehabilitation programmes with the aim of maintaining and/or improving HRQoL of pwMS beyond the inpatient rehabilitation stay.