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Cross-sectional studies on diffuse idiopathic skeletal hyperostosis have focused on its incidence and related factors. However, the long-term changes caused by the disease remain unclear. This longitudinal cohort study aimed to elucidate the progression of diffuse idiopathic skeletal hyperostosis and its effects on physical function, health-related quality of life, and spinal alignment. We recruited 255 older adults (87 men and 168 women; average age, 71.3 years in 2014) who attended local health checkups in 2014 and 2020. Height, body weight, body mass index, blood pressure, grip strength, functional reach, and bone mineral density were measured. The prevalence, location, number of ossified contiguous vertebrae, and spinopelvic parameters were estimated using whole-spine standing radiographs. For health-related quality of life assessment, the Oswestry disability index and EuroQuol-5D were obtained. We performed a 1:1 case-control study with age and sex-matched patients with and without diffuse idiopathic skeletal hyperostosis and analyzed progression over a 6-year period. In 2014, 39 (15.3%) of 255 patients were diagnosed with diffuse idiopathic skeletal hyperostosis (24 males and 15 females), which occurred more frequently in the elderly and males. In 2020, 12 (4.3%) patients were newly diagnosed with diffuse idiopathic skeletal hyperostosis, and 28 (71.7%) of 39 patients diagnosed in 2014 showed varying degrees of progression. Compared with age- and sex-matched patients without diffuse idiopathic skeletal hyperostosis, patients with the condition had higher body mass index and lumbar bone mineral density, larger sagittal vertical axis, and greater T1-pelvic angle. Changes in physical function and spinal-pelvic parameters during the 6-year period did not differ between the groups. Over a 6-year period, the prevalence of diffuse idiopathic skeletal hyperostosis increased by 4.3%, and it progressed in 71.7% of patients. However, it had little effect on longitudinal physical function, health-related quality of life, and spinopelvic parameters in older adults. [ABSTRACT FROM AUTHOR]

Cystic fibrosis (CF) limits survival and negatively affects health-related quality of life (HRQOL). Cost-effectiveness analysis (CEA) may be used to make reimbursement decisions for new CF treatments; nevertheless, generic utility measures used in CEA, such as EQ-5D, are insensitive to meaningful changes in lung function and HRQOL in CF. Here we develop a new, CF disease–specific, preference-based utility measure based on the adolescent/adult version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a widely used, CF-specific, patient-reported measure of HRQOL. Blinded CFQ-R data from 4 clinical trials (NCT02347657, NCT02392234, NCT01807923, and NCT01807949) were used to identify discriminating items for a classification system using psychometric (eg, factor and Rasch) analyses. Thirty-two health states were selected for a time trade-off (TTO) exercise with a representative sample of the UK general population. TTO utilities were used to estimate a preference-based scoring algorithm by regression analysis (tobit models with robust standard errors clustered on participants with censoring at −1). A classification system with 8 dimensions (CFQ-R-8 dimensions; physical functioning, vitality, emotion, role functioning, breathing difficulty, cough, abdominal pain, and body image) was generated. TTO was completed by 400 participants (mean age, 47.3 years; 49.8% female). Among the regression models evaluated, the tobit heteroscedastic–ordered model was preferred, with a predicted utility range from 0.236 to 1, no logical inconsistencies, and a mean absolute error of 0.032. The CFQ-R-8 dimensions is the first disease-specific, preference-based scoring algorithm for CF, enabling estimation of disease-specific utilities for CEA based on the well-validated and widely used CFQ-R. • Cost-effectiveness analysis (CEA) may guide reimbursement decisions for cystic fibrosis (CF) treatments; nevertheless, standard measures of utility used in CEA are insensitive to changes in lung function and health-related quality of life in CF. • We used blinded Cystic Fibrosis Questionnaire-Revised (CFQ-R) data from 4 clinical trials to develop the CFQ-R-8 dimensions (CFQ-R-8D), a new, CF disease–specific, preference-based utility measure with 8 dimensions (physical functioning, vitality, emotion, role functioning, breathing difficulty, cough, abdominal pain, and body image). • The CFQ-R-8D enables disease-specific utilities for use in CEA to be generated from the CFQ-R, a measure that is widely used in CF trials. [ABSTRACT FROM AUTHOR]

Objectives: Many trials conclude "no clinically meaningful detriment" to health-related quality of life (HRQL) or function between arms, even when notable differential toxicity is observed. Mean change from baseline analyses of function or HRQL can possibly obscure important change in subgroups experiencing symptomatic toxicity. We evaluate the impact of diarrhea, a key treatment arm toxicity, on patient-reported HRQL and functioning in clinical trials submitted to US Food and Drug Administration.Methods: This study used 4 randomized, breast cancer trials (adjuvant to late-line metastatic) as case examples. Diarrhea, physical functioning (PF), and global health status and quality of life (GHS/QoL) from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 were analyzed at baseline and approximately 3 and 6 months.Results: Generally, patients reporting very much diarrhea at months 3 and 6 had worse PF (9-19 points lower) and GHS/QoL (16-19 points lower) than patients reporting no diarrhea regardless of treatment arm. In the change from baseline analysis, patients reporting very much diarrhea also experienced a greater decrease in PF (6-13 points) and GHS/QoL (6-16 points) versus patients reporting no diarrhea in both arms.Conclusions: In trials with moderate to large differences in symptomatic toxicity by arm, reporting "no meaningful difference in functioning and HRQL between arms" based on mean change from baseline analysis is insufficient and may obscure important impacts on subgroups experiencing symptomatic adverse events. Additional exploratory analyses with simple data visualizations evaluating functioning or HRQL in patient subgroups experiencing expected symptomatic toxicities can further inform the safety and tolerability of an investigational agent. [ABSTRACT FROM AUTHOR]

Background: We aimed to investigate the impact of long corrective fusion to the ilium on the physical function in elderly patients with adult spinal deformity and its correlation with spinopelvic parameters and health-related quality of life outcomes.Methods: We included 60 female patients who underwent long corrective fusion from T9 or T10 to the pelvis for adult spinal deformities (mean age of 69.8 years, range 55-78 years). The radiographic parameters, health-related quality of life outcomes using the Scoliosis Research Society Outcome Instrument-22 and physical function assessments were reviewed preoperatively and at 1-year postoperatively.Results: All spinopelvic parameters, except for thoracolumbar kyphosis, and all domains of the Scoliosis Research Society Outcome Instrument-22 significantly improved at 1-year postoperatively (p < 0.0001). Physical function results, including those for one-leg standing time, timed up-and-go test, and 6-min walk tests, significantly improved at 1-year postoperatively (p < 0.005). Based on forward stepwise multivariate logistic regression, the predicted timed up-and-go test and 6-min walk test outcomes at 1-year postoperatively were as follows: timed up-and-go test, 7.8 + 0.47 × preoperative timed up-and-go test - 0.21 × 1-year postoperative grasping power +0.015 × 1-year postoperative C1 sagittal vertical axis (R2 = 0.6209, p < 0.0001); 6-min walk test, 309.2-9.1 × body mass index + 11.6 × 1-year postoperative grasping power + 3.3 × 1-year postoperative thoracolumbar kyphosis - 0.59 × 1-year postoperative C1 sagittal vertical axis (R2 = 0.4409, p < 0.0001).Conclusions: Corrective long fusion surgery for adult spinal deformity in normalizing sagittal alignment improves trunk balance and gait performance. Postoperative physical function depends on the preoperative physical performance status and skeletal muscle status; thus, preoperative interventions for improved physical function are recommended. [ABSTRACT FROM AUTHOR]

Background: Locomotive syndrome (LS) is a condition of decreased mobility caused by disorders of the locomotive organs. Lumbar spinal stenosis (LSS) is a LS disorder. The Japanese Orthopaedic Association score (JOA score) and the Zurich Claudication Questionnaire (ZCQ) are international evaluation tools for LSS. However, the relationship between LS and JOA score or ZCQ is unknown. This study aimed to clarify the correlations between LS progression and the values/parameters of the JOA score or ZCQ and to determine the critical cutoff point of the JOA score or ZCQ that indicates LS progression.Methods: We recruited preoperative LSS patients (n = 82). Patients' mean age was 73.4 years. The study participants were evaluated using the 25-question Geriatric Locomotive Function Scale (GLFS), JOA score, and ZCQ (which consists of symptom severity and physical function), and the patients' health-related quality of life was assessed using EuroQoL-5 dimension (EQ-5D) utility values and the EuroQoL-visual analog scale (EQ-VAS). We investigated the correlations between the 25-question GLFS and each clinical variable and evaluated the critical cutoff point of each international evaluation tool to detect LS.Results: There was a statistically significant correlation between 25-question GLFS and each clinical evaluation tool. LSS patients with LS showed significantly worse scores in the evaluation tools than LSS patients without LS. Moreover, we found that critical cutoff points of 17.5 on JOA score, 3.1 on ZCQ-symptom, and 2.3 on ZCQ-function could detect LS.Conclusions: A statistically significant correlation exists between the 25-question GLFS and the JOA score or ZCQ. It might be important to perform decompression surgery for LSS patients before they reach the cutoff values of the several clinical evaluation tools to avoid LS progression.Study Design: Clinical prospective case-control study. [ABSTRACT FROM AUTHOR]

Objectives: Assessment of patient-reported outcomes (PROs) in oncology is of critical importance because it provides unique information that may also predict clinical outcomes.Methods: We conducted a systematic review of prognostic factor studies to examine the prognostic value of PROs for survival in cancer. A systematic literature search was performed in PubMed for studies published between 2013 and 2018. We considered any study, regardless of the research design, that included at least 1 PRO domain in the final multivariable prognostic model. The protocol (EPIPHANY) was published and registered in the International Prospective Register of Systematic Reviews (CRD42018099160).Results: Eligibility criteria selected 138 studies including 158 127 patients, of which 43 studies were randomized, controlled trials. Overall, 120 (87%) studies reported at least 1 PRO to be statistically significantly prognostic for overall survival. Lung (n = 41, 29.7%) and genitourinary (n = 27, 19.6%) cancers were most commonly investigated. The prognostic value of PROs was investigated in secondary data analyses in 101 (73.2%) studies. The EORTC QLQ-C30 questionnaire was the most frequently used measure, and its physical functioning scale (range 0-100) the most frequent independent prognostic PRO, with a pooled hazard ratio estimate of 0.88 per 10-point increase (95% CI 0.84-0.92).Conclusions: There is convincing evidence that PROs provide independent prognostic information for overall survival across cancer populations and disease stages. Further research is needed to translate current evidence-based data into prognostic tools to aid in clinical decision making. [ABSTRACT FROM AUTHOR]

• Distances from hematopoietic cell transplantation (HCT) centers exceed 100 miles for 44% of survivors. • We examined driving distances, distress, and physical function among HCT survivors. • Chronic graft-versus-host disease and low income predicted worsened distress and function. • Interestingly, lack of Internet access also predicted worsened distress and function. • Surprisingly, driving distance had no impact on distress or physical function. Long driving distances to transplantation centers may impede access to care for hematopoietic cell transplantation (HCT) survivors. As a secondary analysis from the multicenter INSPIRE study (NCT01602211), we examined baseline data from relapse-free HCT adult survivors (2 to 10 years after allogeneic or autologous HCT) to investigate the association between driving distances and patient-reported outcome (PRO) measures of distress and physical function. We analyzed predictors of elevated distress and impaired physical function using logistic regression models that operationalized driving distance first as a continuous variable and separately as a dichotomous variable (<100 versus 100+ miles). Of 1136 patients available for analysis from 6 US centers, median driving distance was 82 miles and 44% resided 100+ miles away from their HCT centers. Elevated distress was reported by 32% of patients, impaired physical function by 19%, and both by 12%. Driving distance, whether operationalized as a continuous or dichotomous variable, had no impact on distress or physical function in linear regression modeling (95% confidence interval, 1.00 to 1.00, for both PROs with driving distance as a continuous variable). In contrast, chronic graft-versus-host-disease, lower income, and lack of Internet access independently predicted both elevated distress and impaired physical function. In summary, we found no impact of driving distance on distress and physical function among HCT survivors. Our results have implications for how long-term follow-up care is delivered after HCT, with regard to the negligible impact of driving distances on PROs and also the risk of a "digital divide" worsening outcomes among HCT survivors without Internet access. [ABSTRACT FROM AUTHOR]

Effects of exercise in patients with breast cancer have been thoroughly investigated. The aim was to explore differences in effects regarding type, delivery mode and extensiveness (e.g. intensity; volume) of the interventions. We searched for randomised controlled trials including patients with breast cancer receiving systemic treatment, exercise-based interventions, and measures on patient reported- and objectively measured outcomes. Exercise showed significant and moderate effects on the primary outcomes quality of life and physical function, Standardised Mean Difference: 0.52 (95 % CI 0.38–0.65) and 0.52 (95 % CI 0.38–0.66), respectively. Type of exercise had little influence on the effects, however combined aerobic- and resistance exercise seemed superior for increasing physical function, compared to aerobic or resistance exercise. Supervised interventions were superior to partly and unsupervised. Extensiveness of the intervention only influenced physical function. Supervised interventions, more than type or extensiveness of interventions, seem to increase effects. [Display omitted] • Exercise effectively increases quality of life, irrespective of exercise type. • Supervised exercise interventions are most effective. • Extensiveness of exercise interventions has very little influence on the effects. [ABSTRACT FROM AUTHOR]

Treatments for early breast cancer have side effects that affect quality of life (QoL) and cause deconditioning. Physical exercise might have a supportive and coadjuvant role in the rehabilitation of breast cancer survivors. We aimed to analyse the preliminary results of a community-based supervised exercise training program on QoL and muscle strength in breast cancer survivors. Twenty breast cancer female survivors were recruited to a single-arm clinical trial consisting of sequential 16 weeks (wk) of control phase (CP) and 16 wk intervention phase (IP). Four evaluations were carried out: M1 (8 wk on CP), M2 (immediately previous IP), M3 (8 wk CP) and M4 (16 wk IP). The IP consisted of 3 sessions per week of combined aerobic and strength exercise (60min) at moderate to vigorous exercise (65-85% of maximum heart rate or 6-8 points on OMNI scale). The primary endpoint was QoL, which was evaluated by EORTC QLQ-C30 questionnaire. Secondary endpoints included handgrip strength and sit-to-stand (STS) test. Of the 20 recruited women, 19 initiated and 15 concluded the program, with a mean compliance to the exercise intervention of 63.6%. The median age was 59 years old (39-72). All but 3 were diagnosed with invasive carcinoma. After surgery, 13 (62%) underwent radiotherapy, 15 (71%) chemotherapy and 18 (86%) were under hormonotherapy. During the control phase, no significant differences were observed in the efficacy variables. There was no changes over time for any domain of QoL, except for physical functioning scale (p = 0.038), where it was observed a trend to increase between M2 and M3 (77.3±14.0 to 85.3±10.1, p = 0.051). A significant increase in handgrip strength of non-operated (22.2±3.9 to 25.6±5.3 kg.f, p = 0.004) and operated limb (22.6±4.7 to 26.9±6.6 kg.f, p = 0.001) was shown after exercise training. Similar results were also observed for STS test [12 (11-13.5) to 17 (13-21) repetitions, p = 0.002]. An exercise program appears to be beneficial for QoL, particularly in the physical functioning of breast cancer survivors. Moreover, it seems to have an important role on strength levels. Associação de Investigação e Cuidados de Suporte em Oncologia. Liga Portuguesa Contra o Cancro. All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]

In this study we aimed to examine the independent effect of baseline QoL and persistent CRT among pts with early BC. We included data stage I-III BC pts treated with chemotherapy who were included in the CANTO prospective cohort study (NCT-01993498) from 03/2012 to 12/2014. The primary outcome was CRT defined as the presence at 3-6 months after the end of treatment, of any of the following toxicities (NCI-CTC-AE): infection, venous or arterial thrombosis, neurological G2-4, digestive G3-4 or pulmonary toxicities G3-4). Treatment deliver including chemotherapy dose reductions were also examined. The independent variable of this study was baseline Qol defined by the EORTC QLQ-C30 subscales of general global health status (GHS) (< or ≥ 70) and physical functioning PF (< or ≥ 90). The defined cutoffs correspond to the average values in the French general population. Clinical relevant adjustment covariates included stage, age, performance status (PS), body mass index (BMI), HR and HER2 status, baseline lymphopenia, albumin, creatinine clearance, alcohol consumption, and smoking status. Multivariable logistic models were performed. Among 3079 BC pts included in this analysis, 33% received neoadjuvant and 77% adjuvant treatment. Median age at diagnosis was 53 years, median BMI= 25 kg/m2, 94% of patients had a PS = 0 and 83% stage I-II disease. Pts reported on average a good GHS = 68 (±19) and PF = 90 (±14). GHS and PF were higher in women with better performance status PS = 0 vs 1+, (68 vs 60 p < 0.001) and 91 vs 78 p < 0.001) respectively. 952 (31%) BC pts developed ≥1 CRT: 23% had an infection, 7% thrombosis, 0.3% G3-4 diarrhea, nausea or vomiting, 4% G2-4 neurological and 0.2% G3-4 pulmonary toxicities. 16% had chemotherapy dose reduction. Pts with a baseline GHS <70 had 19 % higher odds of CRT vs to those with GHS≥70, OR = 1.19 [95% CI 1.02-1.41] and similarly those with a PF < 90 had a 23% higher odds of CRT when compared to those with PF ≥ 90 (OR = 1.23 [95% CI 1.03-1.49]). Global and physical QoL before BC treatments are independently associated with CRT. QoL should be assessed before any treatment to identify patients at risk CRT. NCT01993498. UNICANCER/Villejuif, France, 94805 Principal Investigator: Fabrice André Gustave Roussy – Villejuif. Has not received any funding. All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]