Significant Changes In Quality Of Life Research Articles

Metronomic chemotherapy using capecitabine and cyclophosphamide in metastatic breast cancer – efficacy, tolerability and quality of life results from the phase II METRO trial

BackgroundChemotherapy is commonly used in metastatic breast cancer (MBC) to prolong life and improve quality of life (QoL). The optimal dosing and sequencing beyond the second line of treatment are unknown and pose a risk of overtreatment. Continuous low oral doses of metronomic chemotherapy using capecitabine 500 mg three times daily and cyclophosphamide 50 mg once daily (MCT-CX) may be an effective and tolerable treatment option for patients with MBC. MethodsIn this open-label, single-arm single-centre phase II trial patients with MBC received MCT-CX until disease progression or unacceptable toxicity. The primary endpoint was the clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of complete (CR) or partial response (PR) at any time, or stable disease (SD) for ≥ 24 weeks according to radiological evaluation. Toxicity was assessed according to the Common Toxicity Criteria v 4.0. QoL was assessed with the EORTC-30 questionnaire. ResultsIn total, 40 patients were included. Most participants (72%) presented with visceral disease and received MCT-CX beyond the second line (58%). The CBR was 45% (8 PR and 10 SD ≥ 24 weeks). Toxicities were low grade with hand-foot syndrome being the most common. There was no significant change in QoL over the first 24 weeks. ConclusionMCT-CX is a plausible treatment option in far advanced breast cancer, with almost half of trial participants responding to treatment without QoL impairments.

Impact of Supportive Care Interventions on Quality of Life in Pediatric Hematologic Disorders: Systematic Review and Meta-analysis

Abstract: Supportive care is employed in pediatric hematology to improve children’s quality of life (QoL). This study explores the impact of supportive care modalities on the QoL in pediatric hematologic disorders. Studies were searched from online databases and selected against predetermined eligibility criteria. A random-effects subgroup meta-analysis was conducted to calculate the standardized mean difference (SMD) at 95% confidence interval. Subgroups were based on physical, emotional, familial/social, and scholarly functionalities. Six studies met the requirements for inclusion. The meta-analysis reported a significant change in QoL when comparing initial QoL scores to final QoL scores (SMD −1.11 [−1.54, −0.68], P < 0.00001). When compared to a control standard treatment, the impact of these interventions lacks significance (SMD −0.01 [−0.67, 0.65] [P = 0.97]). Included studies explored interventions such as group creative art therapy, social support, adapted physical activity, and nurse-led interventions (custom). Standard hospital care and supportive care interventions have a relatively similar impact on the QoL of children hematologic patients.

Quality of life after risk-reducing salpingo-oophorectomy in women with a pathogenic BRCA variant.

Risk-reducing salpingo-oophorectomy (RRSO) is recommended to women with a pathogenic BRCA variant, but as a main side effect, RRSO could lead to an early onset of menopause. To evaluate the impact of RRSO and preoperative menopausal status on menopausal symptoms, sexual functioning, and quality of life (QOL). The study was conducted between November 2019 and April 2020. Women were included who tested positive for a pathogenic BRCA1/2 variant between 2015 and 2018. Depression levels, QOL, and global health status were measured and compared with those of women who opted against RRSO. Furthermore, women who underwent RRSO treatment were asked to report menopausal complaints that they experienced at 1 month postsurgery and any current complaints. RRSO had no significant impact on QOL, but women who were premenopausal at the time of surgery reported more sexual complaints than postmenopausal women. In total, 134 carriers of a BRCA mutation were included: 90 (67%) underwent RRSO and 44 (33%) did not. At the time of the survey, neither the control nor experimental group experienced significant changes in QOL (b = -0.18, P = .59). Women who underwent RRSO reported a significantly lower global health status (b = -0.66, P = .05). Women who were premenopausal at the time of surgery were bothered more by sexual symptoms (b = 0.91, P = .19) but experienced fewer vasomotor complaints (b = -1.09, P = .13) than women who were postmenopausal at the time of RRSO. The decrease of sexual functioning after RRSO should be an integral part of preoperative counseling because it is important for BRCA carriers, especially for premenopausal women. Some strengths of the present study were the long follow-up, a high response rate, and the existence of a control group, whereas defining menopausal status by last menstrual bleeding and self-report of data (eg, breast cancer history) increased the risk of errors. Our study indicated that women who underwent RRSO experienced no difference in QOL when compared with women without RRSO and that patients with premenopausal status seemed to be at higher risk to experience sexual complaints after surgery.

Clinician-reported EHRA and NYHA scores only moderately reflect patient-reported quality of life in atrial fibrillation and heart failure

Abstract Background In the management of heart failure (HF) and atrial fibrillation (AF), treatment decisions are often made based on the amount and severity of symptoms. It is expected that treating the patients’ symptoms positively impacts the patients’ burden of disease. Clinician-reported symptoms are expected to agree with patient-perceived symptoms. However, patients may value (the impact of) symptoms on their quality of life (QoL) differently to clinicians. Purpose This study aimed to gain insights on how patients perceive the impact of AF and HF on QoL, compared to how clinicians perceive (the impact of) patients’ symptoms. To this end, the clinician-reported severity of symptoms was assessed in relationship with patient-reported QoL within 12 months after diagnosis. Methods Newly diagnosed AF and HF patients were included between November 2014 and January 2023 in four non-academic hospitals situated in the Southeast of the Netherlands. During routine visits to AF- and HF-outpatient clinics trained nurses collected information on among others symptoms and QoL at diagnosis and 12 months of follow-up. Severity of symptoms was determined through a clinician-reported NYHA classification for HF and EHRA score for AF. QoL was assessed through the use of the CareQol questionnaire for HF and AFEQT questionnaire for AF. Medians and interquartile-ranges (IQR) were used to assess symptoms and QoL at diagnosis and 12 months of follow-up. In addition, one-way ANOVA’s were employed to assess difference in symptoms and QoL over a period of 12 months. Results In total, 890 AF patients and 292 HF patients were available for analysis with complete 12 month follow-up information. A moderate correlation was observed between EHRA score and AFEQT at diagnosis and 12 months follow-up (Pearson’s R -0.357 and -0.302, respectively). A comparable correlation was observed between NYHA classification and CareQoL (Pearson’s R 0.290 and 0.491). A clinician-reported improvement in AF or HF symptoms from diagnosis to 12 months follow-up was associated with a patient-reported improvement in QoL (AF: F(762,3) = 25.86, p <.001, and HF: F(256,2) = 8.87, p <.001). When clinicians reported no change or worsening symptoms, no significant changes in QoL were reported by patients. Furthermore, a large variation was observed in patient-reported quality of life, even if clinicians reported no symptoms (i.e. EHRA I / NYHA I) for both AF and HF (Median (IQR); 84.3 (25.1) and 2.49 (1.05), respectively) (Figure 1 & 2). Conclusion In this study only a moderate correlation was observed between clinician-reported symptoms and patient-reported quality of life with large individual variation in patient reported QoL. A clinician-reported worsening of symptoms was not always reflected in a decrease of patients’ QoL. The clinician-reported EHRA and NYHA classification does often not accurately reflect the burden of disease as perceived by patients.

Sensitivity to clinical change in patients with syncope measured by the specific scale impact of syncope on quality of life

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): CHULC (Centro Hospitalar Universitário de Lisboa Central), Hospital de Santa Marta. Summary Recurrent syncope has a significant impact on the quality of life (QL). Patients (P) identify better with specific scales to report their perception of their QL. We believe that sensitivity to changes in the clinical condition is an asset of this type of scale. Objective To assess the sensitivity of the specific scale "Impact of Syncope on Quality of Life" (ISQL) for measuring QL in P with syncope who have undergone changes in their clinical condition. Population and methodology: 57 P, 21 men and 36 women, mean age 54.4±17.3 (19 to 83 years), most married (65%) working (36.2%) or retired (46, 6%) whose answers to the ISQL were used to analyze the psychometric properties of this instrument (18 more individuals than in the preliminary validation) and 22 P who performed a tilt training program (TTr), 9 men and 11 women, with a mean age of 50.3±18,1 (18 to 78 years), mostly married (55%) working (50%) or retired (35%) who reported perception of their QL before TTr and 6 months after, responding to the ISQL. Results Regarding fidelity, convergent validity and divergent validity, the statistically significant results measured in the validation of the scale for the Portuguese population that had 39 P are maintained, which strengthens this measure in relation to psychometric properties and its use in clinical context. The stability in time was tested in the preliminary validation by the test-retest method of the instrument at six months after tilt test with 22 P (from the initial sample of 39 P) not submitted to clinical intervention, which did not show statistically significant changes in QL. Sensitivity to clinical change was tested in a group of 20 P who integrated and completed a TTr, with statistically significant changes in QL reported using this specific measure referring worry, fear, doing less than they wanted and avoiding certain locations. Conclusions The results obtained reinforce the use of the ISQL in the evaluation of QL in the P with syncope and indicate that the ISQL identifies the alteration of the clinical condition, being a fundamental measure for the evaluation of the results of clinical interventions in these patients, as well as in others.

A single centre prospective study of three device-assisted therapies for Parkinson’s disease

Comparative studies assessing outcomes with the three device-assisted therapies could help to individualise treatment for patients living with Parkinson’s disease. We designed a single-centre non-randomised prospective observational study assessing the quality of life (QoL), motor and non-motor outcomes at 6 and 12-months in patients treated with subcutaneous apomorphine continuous 16-hours infusion (APO), levodopa-carbidopa intestinal gel (LCIG) or subthalamic nucleus deep brain stimulation (STN-DBS). In this study, 66 patients were included (13 APO; 19 LCIG; 34 STN-DBS). At baseline, cognitive, non-motor and motor scores were significantly less severe in the STN-DBS group, whereas the LCIG group had a longer disease duration and higher non-motor scores. In the APO group, there were no statistically significant changes in non-motor, motor and QoL scales. The LCIG group had significant changes in QoL and motor scales that were significant after multiple comparison analysis at 6 and 12-months. The STN-DBS group showed improvement in QoL scores and non-motor and motor scores at 6 and 12-months after multiple comparison analysis. In this real-life prospective study, device-assisted therapies showed differences in their effects on QoL and motor and non-motor function at 12-months. However, there were also differences in baseline characteristics of the patient groups that were not based on pre-determined selection criteria. Differences in characteristics of patients offered and/or treatment with different device-assisted therapies may reflect within-centre biases that may, in turn, influence perceptions of treatment efficacy or outcomes. Treatment centres should be aware of this potential confounder when assessing and offering device-assisted treatment options to their patients and potential baseline differences need to be taken into consideration when comparing the results of non-randomised studies.

0716 Quality of Life in Idiopathic REM Sleep Behavior Disorder and Isolated REM Sleep Without Atonia

Abstract Introduction Idiopathic rapid eye movement (REM) sleep behavior disorder (iRBD) can affect quality of life (QOL) for both patient and bed partner; isolated REM sleep without atonia (iRSWA) has been less well-studied. We aimed to investigate whether QOL changes over time in those with either iRBD or iRSWA, as well as compare these changes to one another. Additionally, we attempted to demonstrate whether certain QOL changes were associated with phenoconversion to neurodegenerative illness. Methods We prospectively analyzed data from the “REM Sleep Behavior Disorder Associations with Parkinson’s Disease Study (RAPiDS)” cohort both at baseline and then at follow-up evaluations. We utilized the Neuro-QOL self-reported questionnaire to ascertain subjects’ level of QOL. Results There were 6 with iRSWA and 33 with iRBD, with an average age of 61.9 ± 13.0 years, with 13 women and 26 men. Significant QOL changes were found in both iRSWA and iRBD group. Among those who phenoconverted, fatigue and social functioning were the main QOL issues that that worsened over time. Conclusion This is the first time the Neuro-QOL has been studied in iRBD and iRSWA. QOL can be affected in both conditions; fatigue and social functioning seem to be of particular importance as they may be associated with phenoconversion. Support (if any) Grant from a private individual

A-116 Impact of Cognitive Stimulation Therapy on Cognitive Functioning and Quality of Life in a Veteran Population

Abstract Objective: Cognitive Stimulation Therapy (CST) is a non-pharmacological intervention for dementia. The CST program developed by Spector and colleagues has proven effective in improving quality of life (QoL) and cognition in older adults with dementia. The purpose of the present study was to examine the effectiveness of CST in a veteran population. Method: A clinic-referred sample of veterans who completed a 7-week CST and pre/post-group assessments were selected for this study. This resulted in a sample of 25 male veterans, a majority of whom were diagnosed with a progressive dementia (Mean age = 74.44; Mean education = 13.7; 44% White, 44% Hispanic/Latinx, 8% Black). Paired-samples t-test were used to determine if group participation was associated with improvements in QoL or cognitive functioning. Results: Veterans who participated in the CST group did not demonstrate a significant change in MoCA scores from pre-test (M = 16.63, SD = 3.28) to post-test (M = 17.42, SD = 4.23), (t[23] = −1.44, p = 0.16, Cohen’s d = 0.296) or RBANS total scores from pre-test (M = 61.73, SD = 10.13) to post-test (M = 64.55, SD = 11.28), (t[21] = −1.89, p = 0.07, Cohen’s d = 0.263). Similarly, there was no significant change in QoL as measured by participants from pre-test (M = 35, SD = 7.60) to post-test (M = 36.22, SD = 7.16), (t[22] = −1.30, p = 0.21, Cohen’s d = 0.165) or as measured by a caregiver from pre-test (M = 30, SD = 7.37) to post-test (M = 28.75, SD = 7.46), (t[19] = 0.69, p = 0.50, Cohen’s d = 0.169). Conclusion: While CST did not significantly improve cognition or QoL in a diverse veteran sample, there was a small effect observed on cognitive functioning. Given that dementia is often a progressive disease, even stability of baseline cognition is suggestive of the protective effect of CST.

A Systematic Review and Meta-analysis of Randomized Controlled Trials of Stabilizing Exercises for Lumbopelvic Region Impact in Postpartum Women With Low Back and Pelvic Pain.

BackgroundCountless women experience lumbopelvic pain (LBPP) after pregnancy. Physical activity is revealed as a beneficial procedure to alleviate LBPP, yet it appears that individual investigations report mixed conclusions about its effectiveness. Objective: This systematic review and meta-analysis examined the impact of stabilizing exercises on pain intensity, disability, and quality of life (QoL) in postpartum women. Data sources: A systematic search was conducted in PubMed, MEDLINE, Google Scholar, Scopus, and reference lists of included studies up to September, 2021. Study selection: Eleven studies comprising 623 participants were included and analyzed using a random-effects model. Results: Data displayed that stabilizing exercises significantly reduced pain (standard mean difference; SMD: -0.76, 95% confidence interval (CI): -1.26 to -0.27, p = .002), and disability (SMD: -1.19, 95% CI: -1.7 to -0.68, p < .001). However, our study found no significant change in QoL following stabilizing exercises (MD: 4.42, 95% CI: -5.73, 14.57, p = .39). Conclusion: Our systematic review and meta-analysis demonstrated that stabilizing interventions had some benefits in postpartum women. While there is some evidence to display the efficacy of stabilizing exercises for relieving LBPP, additional longer-term and high-quality studies are required to confirm the current findings.

Sociodemographic and Clinical Characteristics Associated with Improvements in Quality of Life for Participants with Opioid Use Disorder.

Background: The Houston Emergency Opioid Engagement System was established to create an access pathway into long-term recovery for individuals with opioid use disorder. The program determines effectiveness across multiple dimensions, one of which is by measuring the participant’s reported quality of life (QoL) at the beginning of the program and at successive intervals. Methods: A visual analog scale was used to measure the change in QoL among participants after joining the program. We then identified sociodemographic and clinical characteristics associated with changes in QoL. Results: 71% of the participants (n = 494) experienced an increase in their QoL scores, with an average improvement of 15.8 ± 29 points out of a hundred. We identified 10 factors associated with a significant change in QoL. Participants who relapsed during treatment experienced minor increases in QoL, and participants who attended professional counseling experienced the largest increases in QoL compared with those who did not. Conclusions: Insight into significant factors associated with increases in QoL may inform programs on areas of focus. The inclusion of counseling and other services that address factors such as psychological distress were found to increase participants’ QoL and success in recovery.

Pharmacokinetic and pharmacogenomic analysis of low-dose afatinib treatment in elderly patients with EGFR mutation-positive non–small cell lung cancer

PurposeAn increasing number of advanced non–small cell lung cancer (NSCLC) cases are being reported in the ageing population. However, studies on the use of afatinib in elderly patients are scarce. We conducted a prospective multicentre, single-arm, and open-label phase II trial for low-dose afatinib (30 mg/day) use in elderly patients with NSCLC with EGFR mutation to assess quality-of-life (QOL) and pharmacokinetic (PK)/pharmacogenomic (PGx) parameters. Patients and methodsThe primary end-point was the objective response rate (ORR), and the planned number of registered cases was 35, with a threshold ORR of 50%, an expected ORR of 75%, α of 0.05, and β of 0.1. Secondary end-points were progression-free survival (PFS), overall survival (OS), the incidence rate of adverse events (AEs), QOL survey (FACT-L), and trough plasma concentration of afatinib at steady state (Css) and at the occurrence of clinically significant AEs. ResultsThe median age of the patients was 79 years. The ORR was 80.0% and the disease control rate was 91.4%. The median PFS and OS were 15.6 and 29.5 months, respectively. Four patients discontinued because of AEs. Treatment-related death was not observed. No significant change in QOL was observed at baseline and after 4, 8, and 12 weeks. Css was comparable with those in previous reports and was significantly higher in patients with grade 3 AEs. Direct correlations between afatinib treatment and PGx profiles were not observed. ConclusionsAn afatinib starting dose of 30 mg/day could be an effective and safe treatment option for elderly patients.

Pediatric Patient-Reported Quality of Life Before and after Radiotherapy: A Prospective Registry Study

Pediatric Patient-Reported Quality of Life Before and after Radiotherapy: A Prospective Registry Study

Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes.

Many patients with myelodysplastic syndromes (MDS) receive red cell transfusions to relieve symptoms associated with anemia, with transfusions triggered by hemoglobin level. It is not known if patients' quality of life (QOL) improves after transfusion, nor if peri-transfusion QOL assessment (PTQA) can guide future transfusion decisions. We conducted a prospective pilot study of adults with MDS at three centers. Participants, who had to have hemoglobin ≥7.5, completed an MDS-specific measure of QOL (the Quality of Life in Myelodysplasia Scale, [QUALMS]) 1 day before and 7 days after red cell transfusion. A report was sent to each patient and provider before the next transfusion opportunity, indicating whether there were clinically significant changes in QOL. We assessed the proportion of patients experiencing changes in QOL, and with a follow-up questionnaire, whether they perceived their PTQA data were used for future transfusion decisions. From 2018 to 2020, 62 patients enrolled (mean age 73 years) and 37 completed both pre- and post-transfusion QOL assessments. Of these, 35% experienced a clinically significant increase in QUALMS score 7 days after transfusion; 46% no change; and 19% a decrease. Among those completing the follow-up questionnaire, 23% reported that PTQA results were discussed by their provider when considering repeat transfusion. These data suggest PTQA is feasible for patients with MDS. Moreover, while helpful for some, for many others, red cell transfusion may not achieve its intended goal of improving QOL. PTQA offers a strategy to inform shared decision-making regarding red cell transfusion.

The potential role of frailty in modifying quality-of-life related outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients receiving docetaxel, abiraterone, enzalutamine, and radium 223.

63 Background: As the arsenal of therapeutic agents for mCRPC expands, frailty-informed care is emerging as a strategy for tailoring management decisions. Yet, data to guide this approach and to ascertain its impact on the mood, fatigue, pain, and quality of life (QoL) experienced by older men with mCRPC remain lacking. We examined patient-reported outcomes, stratified by a validated frailty index (FI), for mCRPC treatment with docetaxel chemotherapy (CHEMO), abiraterone (ABI), enzalutamide (ENZA), or radium 223 (RAD). Methods: Older (aged 65+) men starting one of four approved therapies for mCRPC were enrolled in a multicenter prospective cohort study. Assessing their mood, fatigue, pain, and QoL with PHQ-9, ESAS tiredness, ESAS pain, and FACT-G total as well as subscale scores, we used linear mixed effect models to determine change in each outcome over time (0, 3, 6 months). At end of treatment, we administered the Decisional Regret Scale. We then constructed a FI from 34 variables that span laboratory abnormalities, geriatric syndromes, instrumental activities of daily living, social support, as well as emotional, cognitive, and physical deficits. Following established cut-offs, we categorized patients as non-, pre-, and frail, then performed stratified linear mixed effects regression analyses to identify differences in outcomes by frailty status. Results: A total of 198 men (mean age 75.1) starting CHEMO (n = 70), ABI (n = 38), ENZA (n = 67), and RAD (n = 29) were included, of which 9.6%, 1.5%, 5.6%, and 2.5%, respectively, were determined frail. Frailty correlated only modestly with age (Pearson r = 0.27). Independent of frailty status, patients across treatment cohorts were similar in terms of baseline QoL-related measures, with the exceptions of mood (p = 0.033) and pain (p = 0.034). Over time, no significant change in QoL was reported, although all four therapies resulted in generally low levels of decisional regret and similar trends of improved pain but worsened mood (p = 0.006 and 0.02, respectively). At baseline, frailty status correlated with worse FACT-G total (p &lt; 0.001) and functional well-being (p &lt; 0.001), as well as worse depression scores (p &lt; 0.001). According to FI-stratified analysis, frail patients experienced similar QoL-related outcomes to fit patients for all measures aside from mood (p &lt; 0.001). Contrary to our hypotheses, frailty was not associated with significant worsening in emotional well-being or functional well-being in response to mCRPC treatment. Conclusions: Of the older men receiving care for mCRPC, frail patients may experience generally similar trends in QoL as fit patients. Interestingly, frailty status, rather than treatment modality, may play more of a contributory role to changes in QoL-related outcomes over time.

Quality of life and psychological assessment in patients with Fibromyalgia Syndrome during COVID-19 pandemic in Italy: prospective observational study

Introduction: Chronic pain patients who undergo to stressful events may experience worsening in pain, sleep, and quality of life (QoL). The primary objective of this observational study was to compare QoL and sleep parameters before and after the COVID-19 lockdown in patients with Fibromyalgia Syndrome (FMS). The psychological impact of lockdown was also assessed, as well as the emotional impact of the pandemic and its correlations with patient socio-demographics. Methods: Patients aged ≥18 years with FMS diagnosed according to ACR (American College of Rheumatology) 2016 Criteria with at least one pre-pandemic QoL and sleep evaluation were included. QoL and sleep disturbances were analyzed by comparing scores on the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), the 12-item Short Form Survey (SF-12), and the Pittsburgh Sleep Quality Index (PSQI) before and after the first lockdown in Italy (March to May 2020). Psychological impact was investigated via a 52-item survey of daily life changes in FMS management during the lockdown and emotional impact with the Impact Event Scale-Revised (IES-R) tool during the onset period after the lockdown. Questionnaire responses were correlated with patients’ socio-demographics. Results: Questionnaires were submitted via email to 54 patients; 37/54 patients (63.7%) returned them. QoL and sleep disturbances showed no statistically significant worsening. However, the psychological impact survey revealed that 3 out of 5 patients feared very much for their family members’ lives during lockdown. The emotional impact survey disclosed 72.7% of patients with psychological distress. Conclusions: While questionnaire responses showed no significant changes in QoL and sleep after the COVID-19 lockdown in this sample of FMS patients, the emotional investigation revealed moderate/severe psychological distress not detected by commonly used QoL tests in FMS.

Relationship between quality of life and burden of recurrent atrial fibrillation following ablation: CAPCOST multicentre cohort study.

Atrial fibrillation (AF) significantly impairs patients' quality of life (QOL). We performed this study to investigate the effect of AF-ablation success and atrial fibrillation burden (AFB) on QOL measures. Overall, 230 patients with paroxysmal AF refractory to antiarrhythmic drugs were enrolled and underwent ablation in a multicentre, prospective cohort. Electrocardiogram, 48-h Holter, Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF), short form-12 (SF-12), and Atrial Fibrillation Effect on Quality of life (AFEQT) scales were used to assess patients. Atrial fibrillation burden was defined as total duration of AF during the month prior to each visit (h/month). The change in AFB was calculated as the difference between the month prior to the 12-month post-ablation and the baseline pre-ablation. The Minimal Clinically Important Difference (MCID) was considered as a 19-point change for AFEQT and 3-5-point change for SF-12 scores. There was significant rise in the AFEQT and SF12 and decrease in CCS-SAF score post-AF ablation; however, the magnitude of these changes was greater in patients without AF recurrence (P < 0.05). The QOL score that best differentiated patients with and without recurrence was AFEQT, while, CCS-SAF was the most specific score. Patients with AFB decrease >19 h/month had significantly greater change in QOL scores. Atrial fibrillation burden < 24 h/month at 12-months post-ablation was associated with significant changes in QOL and CCS-SAF when adjusting for baseline scores and other covariates. These changes were consistent with the MCID of these measures. Patients experience significant improvements in QOL post-ablation, which correlate with a decrease in AFB despite ongoing brief recurrences of AF. NCT01562912. https://www.clinicaltrials.gov/ct2/show/NCT01562912? term=capcost&rank=1.

PREDICTORS OF MINIMAL CLINICALLY IMPORTANT DIFFERENCE OF QUALITY OF LIFE AND SEVERITY SCORE POST ATRIAL FIBRILLATION ABLATION

Atrial fibrillation (AF) significantly impairs patients’ quality of life (QOL). We performed this study to investigate the effect of AF ablation success and AF burden (AFB) on change in QOL measures. Overall, 230 patients with paroxysmal AF refractory to anti-arrhythmic drugs were enrolled and underwent ablation in a multicenter, prospective cohort study. Electrocardiogram, 48-hour Holter monitoring, Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF), short-form12 (SF12) health survey, and Atrial Fibrillation Effect on Quality of life (AFEQT) scales were used to assess patients at 3, 6, 9 and 12-months post-ablation. AFB was defined as the total duration of AF during the month prior to each visit (hours/month). The change in AFB was calculated as the difference in AFB between the month prior to the 12-month post-ablation and the baseline pre-ablation visits. The Minimal Clinically Important Difference (MCID) was considered as a 19-point change for AFEQT and 3 to 5-point change for MCS and PCS scores. A total of 217 patients were followed for 12 months post-procedure. During the12-months post-ablation, freedom from any atrial tachyarrhythmia >30 seconds was 41.7%. Mean AFB at 12-months post ablation was 20.1±123.1 hours/month. In univariate regression analysis, baseline scores were significant predictors of change in QOL and severity score measures. Female gender was a significant predictor of change in AFEQT score, which predicted an increase of ΔAFEQT by 8.9 points. During 12-months of follow-up, complications predicted an increase in the CCS-SAF score by 1.2 points (P=0.003), redo-ablation significantly predicted a decrease in PCS score by 6.04 points (p=0.01), and cardioversion significantly predicted a decrease the AFEQT score by 9.6 points (p=0.009). Recurrence was a significant predictor of change in QOL and severity scores, which could predict and increase of 0.8 (P < 0.001) and decrease of 9.4 (P=0.008) and 4.8 (P=0.003) points in CCS-SAF, AFEQT and PCS, respectively. AFB < 24 hours/month at 12 months post-ablation significantly predicted a decrease in CCS-SAF by 1.9 (P < 0.001) points and increase in AFEQT and PSC scores by 19.5 (P < 0.001) and 5.5 (P=0.03) points respectively. Moreover, AFB < 24 hours/month at 12-months post-ablation was associated with significant changes in QOL and severity scale measures even when adjusting for baseline scores and other covariates in multivariate regression analysis, which were consistent with the MCID scores. (Table1) AFB less than 24 hours/month at 12-months post-procedure significantly improves QOL scores regardless of AF recurrence, to a degree consistent with the MCID of each QOL measure.

Quality of life after percutaneous vertebroplasty in patients after traumatic vertebral compression fractures

Objective. To analyze the effectiveness of percutaneous vertebroplasty (PV) based on the quality of life (QOL) evaluation in the short-term and long-term postoperative periods in patients with traumatic vertebral compression fractures (VCF). Materials and methods. The quality of life was analyzed in 160 patients after PV in the Department of Miniinvasive and Laser Spinal Neurosurgery in Romodanov Neurosurgery Institute of NAMS of Ukraine in 2002–2016. Results. Before the operation, the Oswestry Disability Index (ODI) was 57.7±1.6 % that corresponded to severe disability; in the early post-operative period, in 3 days after intervention, it significantly (p <0.001) decreased to 31.2±1.3 %, that corresponded to moderate disability. After 3 months, the ODI decreased to 18.8±1.4 % (p <0.05), demonstrating minimal disability. After 6 months, there was a tendency to further decreasing of ODI (18.5±1.4 %). In the long-term postoperative period, there were no significant changes in QOL and, consequently, the disability grade: after 1 year, ODI was 18.4±1.3; in 3 years — 18.2±1.3; in the period over 3 years — 18.3±1.3, that corresponded to the minimum disability. There was no significant difference in the short-term and long-term PV outcomes in patients from different age groups. Conclusions. This analysis showed that PV allows significantly reduce the disability grate in patients of any age with isolated traumatic VCF and significantly improve their QOL as soon as possible. The functional results of this pathology treatment with PV technique remain positive for a long (up to 12.5 years) observation period.

A Case Management System for Integrating Patient-reported Outcome Assessment in Clinical Practice: The Beacon Tool.

What if you could only ask one question of the patient during a clinic visit? Further, suppose the patient's biggest concern can pragmatically be incorporated into routine clinical care and clinical pathways that can address the patient's single biggest concern can be identified. If the principal concern can be dealt with efficiently at each visit through key stakeholder case management, positive outcomes should result. Therefore, motivated by the need for patient-centered health care visits, the Beacon electronic patient-reported outcomes (PRO) quality of life (QOL) tool was developed. Central to the tool is that at each health care visit, the patient's biggest concern is electronically communicated to the health care team. Therefore, the tool can help catalyze important discussions between the health care team and the patient, perhaps on topics that would not have been discussed otherwise at a routine visit. In recognition of the community of resources needed to provide comprehensive care, the tool generates clinical pathways or actions that can be pursued to address the patient's biggest concern. The concern is efficiently triaged such that members of the health care community with appropriate expertise and resources are identified to address and manage that single biggest concern signaled by the patient. A report, which can be uploaded into the patient's medical chart, is created and provides a list of resources for a case manager to assist the patient and contains graphical presentations of the patient's QOL and a history of prior concerns. The report also labels potentially significant changes in QOL. The tool, which has been applied successfully in several health conditions, acts as a beacon to health care providers so that a patient's self-reported concern can be consistently and effectively integrated into their care. It is impractical to try to deal with every patient concern in every visit. The key to the Beacon tool is that at each visit the patient's biggest concern is identified, clinical pathways indicated, and resources efficiently matched to address the patient's biggest concern.

Mobile Phone App-Based Pulmonary Rehabilitation for Chemotherapy-Treated Patients With Advanced Lung Cancer: Pilot Study.

BackgroundAdvanced lung cancer patients often have chronic lung disease with reduced exercise capacities and various symptoms leading to altered quality of life (QoL). No studies have assessed pulmonary rehabilitation (PR) employing a mobile app and an Internet of Things device in advanced lung cancer patients undergoing chemotherapy.ObjectiveThis study aimed to determine the feasibility and efficacy of smartphone app–based PR on exercise capacity, symptom management, and QoL in patients with advanced lung cancer undergoing chemotherapy.MethodsA total of 100 patients were recruited in a prospective, single-arm intervention study using a smartphone app–based PR program for 12 weeks. Exercise capacity (6-min walking distance, 6MWD), QoL, symptom scale scores, and distress indexes were investigated.ResultsA total of 90 patients completed the PR program. The most common cause of drop out was hospitalization because of cancer progression. After PR, there was significant improvement in the 6MWD; 380.1 m (SD 74.1) at baseline, 429.1 m (SD 58.6) at 6 weeks (P<.001), and 448.1 m (SD 50.0) at 12 weeks (P<.001). However, the dyspnea scale score showed no significant improvement in the patients overall, but there was a trend for improvement in those with a stable tumor response (P=.07). Role (P=.02), emotional (P<.001), and social functioning (P=.002) scale scores showed significant improvement after PR. Symptom scale scores for fatigue (P<.001), anorexia (P=.047), and diarrhea (P=.01) also showed significant improvement. There was significant improvement in depression (P=.048) and anxiety (P=.01), whereas there was no significant change in QoL (P=.06) and severity of pain (P=.24).ConclusionsSmartphone app–based PR represents an effective and feasible program to improve exercise capacity and to manage symptoms and distress in patients with advanced lung cancer who are undergoing chemotherapy.