Changes In Quality Of Life Outcomes Research Articles

Quality of Life Instruments and Trajectories After Pancreatic Cancer Resection: A Systematic Review.

This systematic review aimed to investigate the instruments available to measure quality of life (QOL) after pancreatic cancer surgery and to describe short- and long-term QOL outcomes. A comprehensive literature search was completed using PubMed, Embase, and Medline from inception to March 2019. Studies investigating QOL outcomes in patients undergoing pancreatic cancer surgery who were 18 years or older were included. The main outcomes of interest were QOL instruments and short (≤6 months) and long term (>6 months) QOL outcomes. The overarching domains of physical, psychosocial, overall QOL, symptoms, and other were used to summarize QOL outcomes. Thirty-five studies reporting on 3573 patients were included. Fifteen unique QOL instruments were identified, of which 4 were disease-specific instruments. Most of the included studies reported no changes in QOL at short- and long-term follow-ups for the overarching domains. No difference in QOL outcomes was reported between different surgical approaches, except laparoscopic versus open distal pancreatectomy, and pancreaticoduodenectomy versus distal pancreatectomy. There are a wide range of instruments available to measure QOL outcomes in pancreatic cancer surgical patients, although only few are disease-specific. Most of the included studies reported no significant changes in QOL outcomes at short- or long-term follow-ups.

704-P: Adults with Type 1 Diabetes Report Improved Quality of Life with the Omnipod 5 Automated Insulin Delivery System

Type 1 diabetes (T1D) can lead to significant emotional distress and impaired quality of life (QoL). Hybrid closed-loop (HCL) technology seeks to relieve this burden, a goal with equal importance to improving glycemic outcomes. We evaluated change in QoL outcomes for adults (mean±SD, age 39±13y, T1D duration 19±12y, and baseline A1C 7.1±0.9%) before and after a 3-month outpatient study of HCL therapy with the Omnipod 5 System. Participants (N=115) completed validated assessment tools to capture various aspects of diabetes-related and generic QoL: the T1D Distress Survey (T1DDS), Hypoglycemic Confidence Scale (HCS), and World Health Organization Well-Being Index (WHO-5). Though QoL was relatively high at baseline across all 3 measures, we observed significant improvements in diabetes-related QoL with reduced T1DDS and increased HCS scores after 3 months of system use (Table). Among the T1DDS subscales, significant improvements were seen in powerlessness (change: ‑0.27), management distress (-0.18), hypoglycemia distress (-0.21), and eating distress (-0.24, all p<0.001). Generic QoL (WHO-5) was unchanged over the study period. In addition to glycemic efficacy and safety of the Omnipod 5 System (reported previously), these results reveal a significant improvement in QoL for adults with T1D and suggest features of the system may alleviate some of the burden associated with living with T1D.View largeDownload slideView largeDownload slide DisclosureC. J. Levy: Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Employee; Spouse/Partner; AbbVie Inc., Other Relationship; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. W. H. Polonsky: Advisory Panel; Self; Intarcia Therapeutics, Inc., Consultant; Self; Abbott Diabetes, ADOCIA, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Novo Nordisk, Onduo LLC., Sanofi US. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation.FundingInsulet Corporation

71-OR: Youth with Type 1 Diabetes and Their Parents Report Improved Quality of Life with the Omnipod 5 Automated Insulin Delivery System

Type 1 diabetes (T1D) can lead to significant emotional distress and impair quality of life (QoL). Hybrid closed-loop (HCL) technology seeks to relieve this burden, a goal with equal importance to improving glycemic outcomes. We evaluated change in QoL outcomes for children (6.0-11.9y) and teens (12.0-17.9y) with T1D and their parents/guardians before and after a 3-month study of HCL therapy with the Omnipod 5 System. Validated assessment tools administered included diabetes-related QoL (PAID and HCS) and generic QoL (PSQI and WHO-5) questionnaires. Children (n=83) and teens (n=42) were (mean±SD): age 9±2y and 14±2y, with T1D duration 4±2y and 7±3y and A1C 7.5±0.9% and 7.9±1.0%, respectively. Responses revealed significantly reduced diabetes distress for all groups (Table). Also, parents of children reported significant improvement in overall well-being (WHO-5), hypoglycemic confidence (HCS) and in 3 PSQI sleep subscales: quality (change: ‑0.43±0.83, p<0.01), disturbance (‑0.18±0.58, p<0.01), and duration (‑0.28±1.00, p<0.01). In this 3-month study, the Omnipod 5 System reduced diabetes distress for youth and their parents. The most striking improvements in QoL were seen in parents of children, a group in great need of solutions to help them care for their children without negatively affecting their own QoL.View largeDownload slideView largeDownload slide DisclosureK. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. W. H. Polonsky: Advisory Panel; Self; Intarcia Therapeutics, Inc., Consultant; Self; Abbott Diabetes, ADOCIA, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Novo Nordisk, Onduo LLC., Sanofi US. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. C. J. Levy: Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Employee; Spouse/Partner; AbbVie Inc., Other Relationship; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation.FundingInsulet Corporation

Quality of life in patients who underwent 125I brachytherapy, 125I brachytherapy combined with three-dimensional conformal radiation therapy, or intensity-modulated radiation therapy, for prostate cancer.

The purpose of this study was to evaluate quality of life (QOL) in prostate cancer patients treated with 125I brachytherapy (BT), 125I brachytherapy combined with 3D conformal radiation therapy (BT+3D-CRT), or intensity-modulated radiation therapy (IMRT). We evaluated disease-related QOL in patients who underwent BT, BT+3D-CRT, or IMRT, using the Expanded Prostate Cancer Index Composite questionnaire before treatment and at 3 and 24 months post-treatment. Multivariate analyses were conducted to determine factors associated with a minimum important difference (MID) in urinary, bowel, sexual, and hormone domain scores at 3 and 24 months post-treatment. Of 558 enrolled patients (IMRT, 123; BT, 230; and BT+3D-CRT, 205), urinary domain scores showed a MID after BT, BT+3D-CRT and IMRT at 3 months in 69%, 84% and 25% of patients, respectively, and at 24 months in 43%, 54% and 28% of patients, respectively. On multivariate analysis, BT+3D-CRT [3 months: odds ratio (OR) = 12.7; P < 0.001; 24 months: OR = 3.29; P = 0.001] and BT (3 months: OR = 6.28; P < 0.001 and 24 months: OR = 2.22; P = 0.027) were associated with more severely worsened urinary QOL than IMRT. Bowel domain scores showed a MID at 3 months after BT, BT+3D-CRT, and IMRT in 37%, 68% and 41% of patients, respectively, and at 24 months in 29%, 46% and 43% of patients, respectively. On multivariate analysis, BT+3D-CRT (3 months: OR = 4.20; P < 0.001 and 24 months: OR = 2.63; P < 0.001) and IMRT (24 months: OR = 1.98; P = 0.029) were associated with more severely worsened bowel QOL than was BT. Information about the changes in QOL outcomes associated with radiotherapy modalities could guide treatment decisions.

Preoperative Nomograms Predict Patient-Specific Cervical Spine Surgery Clinical and Quality of Life Outcomes.

Clinical and quality of life (QOL) outcomes vary depending on the patient's demographics, comorbidities, presenting symptoms, pathology, and surgical treatment used. While there have been individual predictors identified, no comprehensive method incorporates a patient's complex clinical presentation to predict a specific individual postoperative outcome. To create tool that predicts patient-specific outcomes among those undergoing cervical spine surgery. A total of 952 patients at a single tertiary care institution who underwent anterior or posterior cervical decompression/fusion between 2007 and 2013 were retrospectively reviewed. Outcomes included postoperative emergency department visit or readmission within 30 d, reoperation within 90 d for infection, and changes in QOL outcomes. Nomograms were modeled based on patient demographics and surgical variables. Bootstrap was used for internal validation. Bias-corrected c-index for emergency department visits, readmission, and reoperation were 0.63, 0.78, and 0.91, respectively. For the QOL metrics, the bias-corrected adjusted R-squared was EQ-5D (EuroQOL): 0.43, for PHQ-9 (Patient Health Questionnaire-9): 0.35, and for PDQ (Pain/Disability Questionnaire): 0.47. Variables predicting the clinical outcomes varied, but included race and median income, body mass index, comorbidities, presenting symptoms, indication for surgery, surgery type, and levels. For the QOL nomograms, the predictors included similar variables, but were significantly more affected by the preoperative QOL of the patient. These prediction models enable referring physicians and spine surgeons to provide patients with personalized expectations regarding postoperative clinical and QOL outcomes following a cervical spine surgery. After appropriate validation, use of patient-specific prediction tools, such as nomograms, has the potential to lead to superior spine surgery outcomes and more cost effective care.

Quality of Life in Patients Who Underwent Intensity-Modulated Radiation Therapy, 125 I Brachytherapy, and Combined 125 I Brachytherapy Plus Three-Dimensional Conformal Radiation Therapy for Prostate Cancer

To evaluate quality of life (QOL) in patients who underwent intensity-modulated radiation therapy (IMRT), I125 brachytherapy (BT), and BT combined with three-dimensional conformal radiation therapy (BT + 3D-CRT) for prostate cancer (PCa) patients. We conducted a prospective trial to evaluate health-related QOL for patients who underwent IMRT, BT, and BT + 3D-CRT. QOL was estimated by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire before each treatment and at 1, 3, 6, 12, and 24 months. Multivariate analyses were conducted to determine factors associated with lowering urinary and bowel domain scores at 12 months from baseline. Data were analyzed from 555 (IMRT: n = 123, BT: n = 227, BT + 3D-CRT: n = 205) at 12 months. Mean change in the urinary summary score at 12 months was −0.01, −3.4, and −4.1 points among patients treated with IMRT, BT, and BT + 3D-CRT, respectively. Mean change in the bowel summary score at 12 months was −3.5, −1.1, and −2.8 points among patients treated with IMRT, BT, and BT + 3D-CRT, respectively.On multivariate analysis of factors that predict a lower EPIC score of the urinary domain at 12 months, BT (OR 1.91, 95% CI 1.11–3.28) and BT + 3D-CRT (OR 2.14, 95% CI 1.24–3.70) groups had lower urinary QOL at 12 months using the IMRT group as a reference. In addition, on multivariate analysis of factors that predict a lower EPIC score of the urinary domain at 24 months, BT (OR 1.82, 95% CI 1.04–3.20) and BT + 3D-CRT (OR 3.11, 95% CI 1.77–5.48) groups had lower urinary QOL using the IMRT group as a reference.On multivariate analysis of factors predicting a lower EPIC score in the bowel domain, the BT + 3D-CRT (OR 1.59, 95% CI 1.06–2.37) and IMRT (OR 2.22, 95% CI 1.33–3.74) groups had lower bowel QOL using the BT group as a reference at 12 months. In addition, on multivariate analysis of factors that predict a lower EPIC score of the bowel domain at 24 months, the BT + 3D-CRT (OR 1.59, 95% CI 1.02–2.49) and IMRT (OR 1.68, 95% CI 1.002–2.82) groups had lower bowel QOL using the BT group as a reference. Knowledge of changes in QOL outcomes associated with IMRT, BT, and BT + 3D-CRT may influence treatment recommendations and enable patients to make better-informed decisions.

The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial

Continuous glucose monitoring (CGM) improves glycemic control, but data are inconclusive about its influence on quality of life (QOL). We investigated the impact of 24 weeks of CGM use on QOL in adults with type 1 diabetes (T1D) who use multiple daily insulin injections. DIAMOND (Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes) was a prospective randomized trial that assessed CGM versus self-monitoring of blood glucose (SMBG) only in 158 adults with poorly controlled T1D. At baseline and study end, participants completed QOL measures that assessed overall well-being (WHO-5), health status (EQ-5D-5L), diabetes distress (DDS), hypoglycemic fear (worry subscale of the HFS-II), and hypoglycemic confidence (HCS). At study end, CGM participants completed the CGM Satisfaction Survey. Linear regression analyses compared treatment group changes in QOL outcomes over time. Associations between CGM satisfaction and change in QOL outcomes and in glycemic control indices were assessed. The CGM group demonstrated a greater increase in hypoglycemic confidence (P = 0.01) and a greater decrease in diabetes distress (P = 0.01) than the SMBG group. No significant group differences in well-being, health status, or hypoglycemic fear were observed. CGM satisfaction was not significantly associated with glycemic changes but was associated with reductions in diabetes distress (P < 0.001) and hypoglycemic fear (P = 0.02) and increases in hypoglycemic confidence (P < 0.001) and well-being (P = 0.01). CGM contributes to significant improvement in diabetes-specific QOL (i.e., diabetes distress, hypoglycemic confidence) in adults with T1D, but not with QOL measures not specific to diabetes (i.e., well-being, health status). CGM satisfaction was associated with most of the QOL outcomes but not with glycemic outcomes.

Effects of Darbepoetin Alfa with exercise in cancer patients undergoing chemotherapy: an explorative study

Fatigue is frequent in cancer patients undergoing chemotherapy. Erythropoietins (EPO) have shown well-documented effects on these patients, and administered in pharmacological doses, may reduce the need for transfusion of blood cells and improve quality of life (QoL). An explorative, descriptive, non-randomised intervention study using semi-structured interviews was conducted with the aim to gain an insight into the effects and experiences associated with EPO treatment in combination with a structured 6-week physical exercise intervention. Sixteen cancer patients with evidence of disease, who had received at least one cycle chemotherapy, participated. Participants received 500 μg Darbepoetin Alfa (DA) every 3 weeks during the intervention. Four typologies of patients were identified with regard to DA effects. The interviews revealed that eleven patients experienced some kind of immediate improvement in cognitive and emotional functioning, and subjective daily well-being. Furthermore physical improvement and changes in QoL outcomes showed no significant differences between the study group and a reference group. A significant increase in the hemoglobin concentration (7.14-7.87 mmol/L, P<0.05) was found in the study group. The future use of EPO in cancer patients is hampered by the reported negative influence of EPO on the prognosis in some diagnoses and should be based on randomized studies.

Changes in quality of life among breast cancer patients three years post-diagnosis

To evaluate changes in quality of life (QOL) and identify medical and socio-demographic predictors of QOL among breast cancer survivors 3 years after diagnosis. Between April 2002 and March 2004 2,232 women with breast cancer were recruited into the Shanghai Breast Cancer Survival Study, a population-based cohort study, approximately 6 months after cancer diagnosis. QOL was evaluated at 6 and 36 months post-diagnosis using the General Quality of Life Inventory. Multiple linear regression models were used to evaluate changes in QOL and their associations with socio-demographic and medical factors. In general, breast cancer patients showed significant improvement over time in the physical, psychological, and social well-being domains, as well as overall QOL. However, QOL scores in several facets did not improve or even deteriorated, including increased negative feelings, reduced social support and interpersonal relationships, and worsened financial situation and living environment. Age at diagnosis was inversely associated with QOL changes in physical and psychological well-being and overall QOL scores. Compared with those who were disease-free, patients with a recurrence of disease had significantly poorer QOL scores across all well-being domains and almost all facets. Patients who received radiotherapy experienced significant improvements in physical and social well-being and overall QOL. Mixed ER/PR status was associated with improved scores in physical and psychological well-being and overall QOL. Education, body mass index, Charlson comorbidity score, TNM stage, type of surgery, chemotherapy, and immunotherapy were only associated with changes in certain well-being domains and/or facets, but not overall QOL. Tamoxifen use was not associated with changes in QOL outcomes. Our study provides valuable information for developing strategies/interventions for improving the QOL of breast cancer patients.

Quality of life after heart transplantation: are things really better?

Studies of quality of life (QOL) in heart transplant recipients have been published during the last 2 decades. More recent studies of QOL outcomes have built on previous research. Relationships between posttransplant complications and QOL, longitudinal studies of intermediate and long-term QOL, QOL in patients awaiting transplant (bridged to transplant with a left ventricular assist device), and intervention studies to improve QOL have been published recently. Is QOL better from before to after heart transplantation? The current body of literature suggests that QOL is better overall. However, change in QOL (both positive and negative) is variable based on demographic characteristics, clinical problems, QOL domain, time posttransplant, and other life events. Moreover, although more recent reports have begun to examine unanswered questions, much work remains to be done. Future studies need to be scientifically rigorous, using definitions of QOL with identification of domains to be studied; prospective, multisite, longitudinal study designs; large sample sizes; reliable and valid instruments; and appropriate statistical techniques. As changes in QOL outcomes and risks for poor QOL outcomes are identified, more intervention studies need to be developed to assist patients toward better QOL.

The Clinical Significance of Quality-of-Life Results: Practical Considerations for Specific Audiences

This is the sixth article in a series intended to summarize the state of the science for assessing the clinical significance of quality-of-life (QOL) assessments. The previous 5 articles dealt with specific methodological issues, whereas this article addresses practical considerations in implementing the methods and presenting the results to various audiences with differing perspectives. Proposals for how to interpret the "clinical significance" or "clinical meaningfulness" of changes in QOL scores were addressed in previous articles within this series. Within this article, 4 audiences-patients and physicians, clinical researchers, health policymakers, and private- and public-sector employees who work in health-related fields-are examined because each is a unique stakeholder with a distinct vantage point and each can interpret QOL outcomes differently. A clinician may attempt to explain to a patient potential treatment alternatives for his or her QOL; a health policymaker may try to describe to elected officials the financial impact on a patient population with reduced QOL; a researcher may try to obtain the vital messages from a clinical trial that included QOL end points; and a regulatory agency and/or pharmaceutical company may try to ascertain the appropriate level of evidence required for a successful research study. For each of the 4 audiences, concrete examples and practical guidelines are offered by which changes in QOL outcomes can be interpreted meaningfully. Ultimately, both determining and disseminating the meaning of clinical significance are functions of the outlook of the audience because the perspective of the audience determines its ability to comprehend, evaluate, and convey the context within which such outcomes appear meaningful. Among the audiences described within this article, a commonality of interests exist that mandates a careful exposition of the scientific rigor involved in describing the clinical significance of QOL assessments. Collectively, this series attempts to provide methods and means for making such determinations.

Quality-of-life measures as leading indicators of adverse clinical events after bone marrow and stem cell transplantation

OBJECTIVE: The aim of this paper was to summarize the state of the science for assessing the clinical significance of quality-of-life (QOL) assessments. The previous 5 papers dealt with specific methodological issues, whereas this paper addresses practical considerations in implementing the methods and presenting the results to various audiences with differing perspectives. Proposals for how to interpret the “clinical significance” or “clinical meaningfulness” of changes in QOL scores were put forward in previous manuscripts within this series. Within this paper, 4 audiences-patients and physicians; clinical researchers; health policy makers; and private and public sector employees who work in health-related fields-are examined because each is a unique stakeholder with a distinct vantage point, and each can interpret QOL outcomes differently. A clinician may attempt to explain to a patient potential treatment alternatives for his or her QOL; a health policy maker may try to describe to elected officials the financial impact on a patient population of reduced QOL; a researcher may try to glean the vital messages from a clinical trial that included QOL end points; and a regulatory agency and/or pharmaceutical company may try to ascertain the appropriate level of evidence required for a successful research study. For each of the 4 audiences, concrete examples and practical guidelines are offered by which changes in QOL outcomes can be meaningfully interpreted. Ultimately, both determining and disseminating the meaning of clinical significance are functions of the outlook of the audience because the perspective of the audience determines its ability to comprehend, evaluate, and convey the context within which such outcomes appear meaningful. Among the audiences described within this paper, a commonality of interests exist that mandates a careful exposition of the scientific rigor involved in describing the clinical significance of QOL assessments. Collectively, this series attempts to provide methods and means for making such determinations.

Change in physical and psychosocial domains of quality of life from before to after discharge post left ventricular assist device implantation

Quality of life (QOL)outcomes of left ventricular assist device (LVAD) implantation before and after discharge have only been examined in a very small sample of patients. The purpose of this study was to describe change in QOL outcomes (symptoms, functional ability, stress, and coping) from before to after hospital discharge in 33 VE (vented electric) LVAD patients (94% male, mean age=51 years, 81% white) awaiting heart transplantation. The 33 VE LVAD patients completed the following questionnaires: Heart Failure Symptom Checklist, Sickness Impact Profile, LVAD Stressor Scale, and Jalowiec Coping Scale at 1-2 weeks, 1, 2, 3, 6, 9, and/or 12 months post implant. Average total and subscale scores were determined for each instrument, and data were analyzed using one sample t-tests. A more stringent level of significance was set (0.01) due to the use of multiple comparisons. Functional disability decreased from before to after discharge (physical disability: rate of change=0.07 units/month, t=-2.95, p=0.006; and self-care disability: rate of change=0.14 units/month, t=-3.83, p=0.001). Stress also decreased from before to after discharge: total stress (rate of change=0.09 units/month, t=-3.617, p=0.001), self-care stress (0.09 units/month, t=-2.73, p=0.01), family-related stress (rate of change=0.17 units/month, t=-3.45, p=0.002), work-related stress (rate of change=0.14 units/month, t=-2.92, p=0.006), and psychological stress (rate of change=0.10, t=-4.00, p<0.001). Effectiveness of optimistic coping strategies decreased from before to after discharge (rate of change=0.10 units/month, t=-2.99, p=0.006). No change in symptom distress was found from before to after discharge. In conclusion, physical and psychosocial domains of QOL improved when patients were discharged from the hospital. Long-term QOL research in LVAD patients is important especially as LVADs become destination therapy.