Changes In Quality Of Life Measures Research Articles

Reduced mouth opening in patients with head and neck cancer treated with radiation therapy: an analysis of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad)

ObjectivesTrismus/reduced mouth opening (RMO) is a common side effect of radiotherapy (RT) for head and neck cancer (HNC). The objective was to measure RMO, identify risk factors for RMO, and determine its impact on quality of life (QOL). Patients and MethodsOraRad is an observational, prospective multicenter cohort study of patients receiving curative intent RT for HNC. Interincisal mouth opening measurements (n = 565) and patient reported outcomes were recorded before RT and every 6 months for 2 years. Linear mixed-effects models were used to evaluate change in mouth opening and assess the relationship between trismus history and change in QOL measures. ResultsInter-incisal distance decreased from a mean (SE) of 45.1 (0.42) mm at baseline to 42.2 (0.44) at 6-months with slight recovery at 18-months (43.3, 0.46 mm), but no additional improvement by 24-months. The odds of trismus (opening <35mm) were significantly higher at 6 months (OR=2.21, 95% CI: 1.30 to 3.76) and 12 months (OR=1.87, 95% CI: 1.08 to 3.25) compared to baseline. Females were more likely to experience trismus at baseline and during follow up (p<0.01). Patients with oral cavity cancer had highest risk for trismus at baseline and post-RT (p<0.01). RMO was associated with higher RT dose to primary site and receiving concomitant chemotherapy (p<0.01). Trismus was associated with self-reported difficulty opening the mouth and dry mouth (p<0.01). ConclusionsDecrease in mouth opening is a common treatment-related toxicity after RT with some recovery by 18-months. Trismus has a significant impact on survivor QOL. Statement of Clinical RelevanceDecrease in mouth opening is a common treatment related toxicity after RT, which has a significant impact on survivor QOL. Variability in restricted mouth opening after RT is related to specific patient, cancer, or treatment characteristics.

THU664 Discontinuation Of Low-dose Levothyroxine Therapy For Patients With Subclinical Hypothyroidism Is Feasible: A Pilot, Randomized, Double-blind, Placebo-controlled Trial

Abstract Disclosure: S. Maraka: None. R. Owen: None. N.M. Singh Ospina: None. M. Knox: None. T. Dodds: None. H. Spencer: None. A. Albashaireh: None. A. Shah: None. S. Syed: None. S. Naqvi: None. H. Motahari: None. S. Thumma: None. E. Ambrogini: None. J.P. Brito: None. Objective: Levothyroxine (LT4) therapy has not been shown to improve quality of life (QoL), thyroid-related symptoms, cardiovascular events, or mortality for patients with subclinical hypothyroidism (SCH) in clinical trials. We conducted this pilot, double-blind, placebo-controlled clinical trial to evaluate the effects of LT4 discontinuation among adults with SCH. Methods: We aimed to randomize 50 adults 1:1 to continue receiving LT4 (25-75 mcg/day) for SCH or discontinue it (switch to placebo). The primary outcome was feasibility. Secondary outcomes included changes in QoL measures (Thyroid-specific QoL Patient-Reported Outcome [ThyPRO]-Hypothyroid Symptoms and Tiredness scores, EuroQoL 5-Dimension Self-Report Questionnaire [EQ-5D]) assessed at baseline and 6 months post-randomization, and incidence of adverse events (overt hypothyroidism, hyperthyroidism, atrial fibrillation, stroke, acute coronary syndrome, heart failure, fracture, mortality). Higher scores for ThyPRO indicate more symptoms and tiredness and for EQ-5D, better health state. Data are reported as mean (standard deviation). Analysis of covariance model adjusting for age and baseline measure of the variable was performed for the outcomes based on the intention-to-treat principle. Results: Fifty participants were enrolled (33% recruitment rate); 24 were randomized to the LT4 and 26 to the discontinuation group. Five patients were excluded post-randomization due to lack of ascertainment of SCH diagnosis (final N=45; 21 LT4, 24 discontinuation). There was no statistically significant difference at baseline between the discontinuation and LT4 groups in age [65.7 (10.6) vs. 71.0 (7.9) yrs], gender (male 75 vs. 86%), LT4 dose (25 mcg; 29.2 vs. 33.3%, 50 mcg; 54.2 vs. 47.6%, 75 mcg; 16.7 vs. 19.0%), TSH [3.1 (1.0) vs. 3.2 (1.4) mIU/L], TPOAb positivity (17 vs. 19%), ThyPRO-Hypothyroid Symptoms [27.1 (20.4) vs. 21.1 (18.4)] and Tiredness score [33.2 (23.7) vs. 31.1 (23.9)], and EQ-5D [0.746 (0.229) vs. 0.758 (0.193)]. A patient in the discontinuation group withdrew for personal reasons (98% completion rate). Two patients in the discontinuation group met study criteria to restart LT4 (TSH&amp;gt;10 mIU/L; n=1, fatigue; n=1). At final visit, 34.8% of patients in the discontinuation group had mild SCH compared to 9.5% of patients on LT4 (p=0.07). There was no statistically significant difference between the discontinuation and LT4 groups in ThyPRO-Hypothyroid Symptoms [28.3 (22.8) vs. 22.9 (19.5)], Tiredness [27.6 (22.8) vs. 32.8 (22.1)], and EQ-5D score [0.750 (0.232) vs. 0.741 (0.180)]. A patient suffered rib fracture (placebo); no other adverse event of interest was reported. Conclusion: This pilot clinical trial showed the feasibility and safety of discontinuing LT4 in patients with SCH. These findings support proceeding with a larger multi-site clinical trial to fully assess the effects of LT4 discontinuation. Presentation: Thursday, June 15, 2023

Health-Related Quality of Life Over 6 Months in Patients With Major Depressive Disorder Who Started Antidepressant Monotherapy

ObjectivesMajor depressive disorder (MDD) is increasing worldwide and is associated with impaired quality of life (QOL). This study aimed to assess the QOL and its association with cognitive symptoms in patients with MDD who started antidepressant monotherapy. MethodsData from the PERFORM (Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder) study were analyzed. A descriptive epidemiological analysis on EQ-5D-5L utility score, the level of each dimension, and the EuroQoL visual analog scale value was conducted at 4 visits during 6 months’ follow-up. The association between cognitive complaints and changes in QOL measures was analyzed using multivariate linear regression analysis. ResultsThe median EQ-5D-5L utility score improved from 0.67 at baseline to 0.82 at month 6. Although the proportion of patients reporting level 1 (no problem) in every dimension of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression increased over time, less than half of the patients achieved level 1 in pain/discomfort and depression/anxiety, which were closely related to depression and usual activities at month 6. Patients with no cognitive complaints or no history of MDD at baseline showed greater improvement in EQ-5D-5L utility scores and EuroQoL visual analog scale value for measuring QOL than those with these characteristics. ConclusionsTreatment over 6 months improved QOL in patients with MDD although there remained room for improvement in dimensions of usual activities, pain/discomfort, and depression/anxiety. Cognitive complaints or history of MDD at baseline predicted less improvement in QOL at 6 months. Any history of MDD might delay improvement in QOL after treatment.

SERENA-4: A phase 3 comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease.

TPS1101 Background: More than two thirds of patients with advanced breast cancer (ABC) have estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) tumors. Current standard-of-care first-line treatments include an aromatase inhibitor (AI) or fulvestrant, a selective ER degrader (SERD), combined with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Concurrent use of luteinizing hormone-releasing hormone (LHRH) agonists is recommended for men and premenopausal women with ABC. Nevertheless, almost all ABCs eventually become resistant to endocrine therapy (ET) and the disease is incurable. New therapies are needed to combat ET resistance, maintain patient quality of life (QoL), and delay the need for chemotherapy. AZD9833 (camizestrant) is an orally bioavailable, highly potent, next-generation SERD that demonstrated anti-cancer properties across a range of preclinical models, including those with ER-activating mutations (Scott et al, 2020). A phase I study (SERENA-1) has demonstrated that AZD9833 is well tolerated and has a promising antitumor profile when administered alone or in combination with palbociclib, a CDK4/6 inhibitor (Baird et al, SABCS 2020). SERENA-4 (NCT04711252) is a randomized, multicenter, double-blind, phase III trial to evaluate the safety and efficacy of AZD9833 in combination with palbociclib for patients with ER+ HER2− ABC who have not received any systemic treatment in the advanced disease setting. Methods: SERENA-4 will enroll 1,342 patients with de novo or recurrent ER+ HER2– ABC who have not previously received systemic treatment for their locoregionally recurrent or metastatic disease. Patients with recurrent disease must have received adjuvant AI or tamoxifen therapy for at least 24 months without relapse. Patients will be randomized 1:1 to receive orally either (a) AZD9833 (75 mg, once daily), palbociclib (125 mg, once daily for 21 days followed by 7 days off treatment) and anastrozole-matching placebo (once daily) or (b) anastrozole (1 mg, once daily), palbociclib (same as active arm), and AZD9833-matching placebo (once daily). Premenopausal women and men will also receive LHRH agonists. The primary endpoint will be progression-free survival (PFS; up to 5 years). Secondary endpoints will include overall survival (up to 8 years), length of second PFS period, objective response, time to chemotherapy, and changes in QoL measures. Enrollment began in January 2021. Acknowledgments: We thank Rose Goodchild, PhD, of Oxford PharmaGenesis, UK, for providing medical writing assistance. Funding: The SERENA-4 trial is funded and overseen by AstraZeneca. Clinical trial information: NCT04711252 .

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.

Application of Ambulatory Phonation Monitoring (APM) in the measurement of daily speaking-time and voice intensity before and after cochlear implant in deaf adult patients

Objectiveto evaluate the changes in daily voice production, analysed through the Ambulatory Phonation Monitoring (APM), and their relationship with Quality of Life (QOL) measurements in a group of profound deaf patients treated with Cochlear Implant (CI). MethodsA total of 12 consecutive post-lingual deaf patients (8 females and 4 males) treated with CI for bilateral severe-to-profound hearing loss were enrolled. Each patient was evaluated before and after 6 months of CI use. In particular, the daily voice production evaluation was performed using the APM, while QOL information were gathered from the Italian version of the Nijmegen Cochlear Implant Questionnaire (I-NCIQ). ResultsSignificant differences in the APM results obtained before and after CI were found. In particular, a significant decrease of the mean amplitude and a significant increase of the daily phonation time and percentage of phonation time were demonstrated after CI use in all the patients. A significant improvement in the I-NCIQ scores was demonstrated after CI use and significant correlations among I-NCIQ scores and the APM parameters were found. ConclusionsThe APM could be useful in the evaluation of the benefits of cochlear implantation and may represents an indicator of deaf patient participation. In addition, the daily voice production’s modifications after CI and their significant relations with the changes in QOL measurements could be useful in treatment planning as well as during pre- and post-operative counselling.

Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts

ObjectiveThe objective of this study was to investigate changes in health-related quality of life (QOL) in patients treated for pararenal aortic aneurysms (PAAs) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated-branched endovascular aneurysm repair (F-BEVAR). MethodsA total of 159 consecutive patients (70% male; mean age, 75 ± 7 years) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (2013-2016). All patients were observed for at least 12 months (mean follow-up time, 27 ± 12 months). Patients' health-related QOL was assessed using the 36-Item Short Form Health Survey questionnaire at baseline (N = 159), 6 to 8 weeks (n = 136), 6 months (n = 129), and 12 months (n = 123). Physical component scores (PCSs) and mental component scores (MCSs) were compared with historical results of patients enrolled in the endovascular aneurysm repair (EVAR) 1 trial who were treated by standard EVAR for simple infrarenal abdominal aortic aneurysms. ResultsThere were 57 patients with PAAs and 102 patients with TAAAs (50 extent IV and 52 extent I-III TAAAs). There were no 30-day deaths, in-hospital deaths, conversions to open surgery, or aorta-related deaths. Survival was 96% at 1 year and 87% at 2 years. Major adverse events occurred in 18% of patients, and 1-year reintervention rate was 14%. There were no statistically significant differences between the groups in 30-day outcomes. Patients treated for TAAAs had lower baseline scores compared with those treated for PAAs (P < .05). PCS declined significantly 6 to 8 weeks after F-BEVAR in both groups and returned to baseline values at 12 months in the PAA group but not in the TAAA group. Patients with TAAAs had significantly lower PCSs at 12 months compared with those with PAAs (P < .001). There was no decline in mean MCS. Major adverse events were associated with decline in PCS assessed at 6 to 8 weeks (P = .021) but not in the subsequent evaluations. Reinterventions had no effect on PCS or MCS. Overall, patients treated by F-BEVAR had similar changes in QOL measures as those who underwent standard EVAR in the EVAR 1 trial, except for lower PCS in TAAA patients at 12 months. ConclusionsPatients treated for TAAAs had lower scores at baseline in their physical aspect of health-related QOL. F-BEVAR was associated with significant decline in PCSs in both groups, which improved after 2 months and returned to baseline values at 12 months in patients with PAAs but not in those with TAAAs. Patients treated for PAAs had similar changes in QOL compared with those treated for infrarenal aortic aneurysms with standard EVAR.

RS09 Prospective, Nonrandomized Assessment of Health-Related Quality of Life Changes in Patients Treated for Pararenal and Thoracoabdominal Aortic Aneurysms With Fenestrated and Branched Endografts

This study investigated changes in health-related quality of life (QOL) in patients treated for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated-branched endovascular aortic repair (F-BEVAR). A total of 165 patients (114 male; mean age, 75 ± 7 years) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (2013-2016). Patient health-related QOL measures were assessed using the Short-Form 36 Health Survey questionnaire prior to treatment and at 1 month, 6 months, and yearly follow-up. Physical component scores (PCS) and mental component scores were compared to historical results of patients enrolled in the EVAR 1 trial who were treated by open surgical repair (OSR) or standard endovascular aortic repair (EVAR) for AAAs. There were 58 PRAs, 52 extent IV and 55 extent I to III TAAAs. A total of 646 renal-mesenteric arteries were incorporated by fenestrations or branches with mean of 3.9 ± 0.2 vessels per patient. Technical success for branch vessel incorporation was 99.6%. There were no 30-day or in-hospital deaths, conversions to OSR, or aortic-related deaths. Mean follow-up was 14 ± 9 months. A total of 531 QOL questionnaires were completed (3.2 ± 0.8/patient). Follow-up >30 days was obtained in all patients, >6 months in 130, >12 months in 96, and >24 months in 38. Patient survival was 95% ± 2% at 1 year and 82% ± 4% at 2 years, without a difference between groups. PCS declined after the operation in all aneurysm groups, returning to baseline at 12 months for patients with PRAs but not for those with TAAAs (P < .05). Patients with PRAs had significantly higher PCS at 12 months when compared to those with TAAAs (P < .001, Fig 1). There were no changes in mental component scores. The only independent predictor for decline in PCS was a higher PCS prior to the operation (P < .0001). Major adverse events were associated with early decline in PCS at 30 days (P < .05) but were not associated with late QOL changes in subsequent evaluations. Reinterventions had no effect on QOL measures. Overall, patients treated by FEVAR had similar changes in QOL measures when compared to historical OSR and EVAR controls (Fig 2). PCS were lower at 12 months for patients treated by FEVAR for TAAAs compared to OSR or EVAR controls. F-BEVAR was associated with significant decline in PCS, which returned to baseline values at 12 months in patients with PRAs but not in those with TAAAs. Patients treated for PRAs had similar changes in QOL compared to those treated for AAAs.Fig 2Comparison of Short Form 36 Health Survey (SF-36) physical component score (PCS) score among patients who underwent to fenestrated-branched endovascular aortic repair (F-BEVAR; Mayo Clinic series) and EVAR1 trial groups (EVAR1 EVAR and EVAR1 open repair). EVAR, Endovascular aortic aneurysm repair.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Quality of life at 6 months in the Idiopathic Intracranial Hypertension Treatment Trial.

To examine the changes in vision-specific and overall health-related quality of life (QOL) at 6 months in participants with idiopathic intracranial hypertension (IIH) and mild visual loss enrolled in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to determine the signs and symptoms of IIH that mediate the effect of acetazolamide on QOL. We assessed QOL using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), the 10-Item NEI-VFQ-25 Neuro-Ophthalmic Supplement, and the 36-Item Short Form Health Survey (SF-36). We examined associations among changes in QOL measures over 6 months, treatment status, and changes in signs and symptoms using linear and structural equation models. Among the 165 participants with IIH (86 randomized to acetazolamide, 79 to placebo), beneficial effects of acetazolamide were seen on all QOL scales evaluated, as well as on the Near Activities (5.60 points, p = 0.03), Social Functioning (3.85 points, p = 0.04), and Mental Health (9.82, p = 0.04) subscales of the NEI-VFQ-25. Positive acetazolamide-related effects on QOL appeared to be primarily mediated by improvements in visual field, neck pain, pulsatile tinnitus, and dizziness/vertigo that outweighed the side effects of acetazolamide. The marked reductions in baseline QOL seen among patients with mild visual loss from IIH are improved by treatment with acetazolamide. When combined with acetazolamide-associated improvements in visual field and other aspects of IIH, our findings with respect to QOL provide further support from the IIHTT in favor of acetazolamide to augment a dietary intervention in the treatment of IIH with mild visual loss (clinicaltrials.gov: NCT01003639).

The impact of diabetes upon quality of life outcomes after lumbar decompression

Background ContextPatients with comorbid disease may experience suboptimal quality of life (QOL) improvement following decompression spinal surgery. Prior studies have suggested the deleterious effect of diabetes upon postoperative QOL; however, these studies have not used minimal clinically important differences (MCIDs) or multivariable statistical techniques. PurposeThe purpose of this study was to assess the effect of preoperative diabetes upon postoperative change in QOL. Study Design/SettingA retrospective cohort study at a single tertiary-care center was carried out. Patient SamplePatients who underwent lumbar decompression between 2008 and 2014 were included in the study. Inclusion necessitated a minimum follow-up of 6 months. Outcomes MeasuresPostoperative changes in the EuroQol 5-Dimensions (EQ-5D), Pain Disability Questionnaire (PDQ), and Patient Health Questionnaire 9 (PHQ-9) at last follow-up were the primary outcome measures. The secondary outcome variable was postoperative change in QOL measures exceeding the MCID. MethodsQuality of life data were collected using the institutional prospectively collected database of patient-reported health status measures. Simple and multivariable logistic regressions were used to assess the impact of diabetes upon normalized change in QOL and improvement exceeding the MCID. ResultsThere were 212 patients who met inclusion criteria. Whereas non-diabetics experienced significant improvements in EQ-5D, PDQ, and PHQ-9 (p<.01), diabetics experienced no significant changes in any measures. More non-diabetics achieved the EQ-5D MCID compared with diabetics (55% vs. 23%, p<.01). Following multivariable regression, chronic kidney disease (CKD, β=−0.15, p=.04) and diabetes (β=−0.05, p=.04) were identified as significant independent predictors of diminished improvement in EQ-5D postoperatively. Furthermore, diabetes was also identified as a significant independent predictor of failure to achieve an EQ-5D MCID (OR 0.20, p<.01), whereas CKD trended toward predicting diminished improvement (OR<0.01, p=.09). ConclusionThe burden of comorbidities may impact the QOL benefit of decompression spine surgery. In the present study, diabetes was found to independently predict diminished improvement in QOL after lumbar decompression.

The impact of surgical trainee participation on sinus surgery outcomes.

To determine the effect of otolaryngology trainee participation on clinical outcomes in patients who undergo endoscopic sinus surgery (ESS) for chronic rhinosinusitis. Secondary analysis of prospectively collected data. Patients enrolled in a sinus surgery outcomes study between May 2011 and March 2013 were stratified into two groups--those who were operated on by an attending alone and those operated on by an attending with a trainee present (resident, fellow, or both). Patients completed quality of life (QOL) surveys including the Chronic Sinusitis Survey (CSS), 22-item Sino-Nasal Outcome Test (SNOT-22), and EuroQol 5-dimension survey preoperatively and 1 year postoperatively. Operative time, estimated blood loss (EBL), complication rates, and survey scores were compared between groups. The study population consisted of 452 patients. The attending alone (n = 119) and trainee (n = 333) groups were statistically comparable in terms of patient demographics, disease severity, and extent of surgery. Mean operative time was significantly shorter in the attending-alone group (80.0 vs. 90.6 minutes, P < .01). Mean EBL (105 mL attending vs. 117 mL trainee, P = .39) and complication rates (3.3% attending vs. 0.6% trainee, P = .07) were similar between groups. Observed changes in QOL measures following ESS were comparable between groups, although absolute improvement in the SNOT-22 scores (19.0 attending vs. 24.5 trainee, P = .05) did show a trend toward greater improvement in the trainee group. Trainee participation in ESS is associated with prolongation in surgical time; however, such participation was not found to adversely affect patient safety or clinical outcomes. 2b.

Statin withdrawal in stable heart failure patients results in no change in clinical status or quality of life

Background: The current role of statins in heart failure with reduced ejection fraction (HFREF) is unclear. We therefore sought to investigate the effect of statin withdrawal in such patients, while taking optimal doses of proven heart failure medications. Methods: This was a prospective, randomised, single-blind, placebo-controlled, two-arm cross-over trial. Participants were randomised to either statin continuation (“statin on”) or unmatched placebo (“statin off”) and crossed over at 3 months. Study statin was the participants’ regular statin at their usual dose. Standard HF clinical status and quality of life (QoL) endpoints were evaluated. Groups were compared using Student's paired t-test. Results: The 13 study participants had a mean age of 64±11 years, 62% male, duration of HF was 7.7±5.7 years, and mean ejection fraction was 38.1±10.4%. Aetiology of HF was idiopathic (12) and ischaemic (1). Compared with taking statin, withdrawal of statin resulted in no significant changes in plasma brain natriuretic peptide (BNP, statin on: 130±49 vs statin off: 129±50ng/L, p=0.92) and no change in 6 minute walk distance (statin on: 455±52 vs statin off: 450±55m, p =0.80). No changes in QoL measures were observed, including Minnesota Living with HF score (statin on: 32±7 vs statin off: 31±9, p=0.41), Cardiac Depression Score (statin on: 77±6 vs statin off: 81±6, p=0.44) and SF-36 (statin on: 93±5 vs statin off: 94±5, p=0.25). Conclusions: Withdrawal of statins in stable HFREF patients receiving optimal background heart failure therapy did not alter HF clinical status including plasma BNP levels, submaximal exercise capacity or quality of life measures.

Effect of contralateral prophylactic mastectomy on quality of life in women undergoing surgery for breast cancer: A prospective study.

9566 Background: There has been a marked increase in the use of contralateral prophylactic mastectomy (CPM) for women with unilateral breast cancer. Previous studies on quality of life (QoL) measures for women who have undergone CPM are mixed. Most surveys were conducted only post-operatively. This analysis reports QoL changes within the same patient before and after surgery, using a validated tool. Methods: This study includes women who were prospectively enrolled in the University of Iowa Breast Molecular Epidemiologic Resource. We included all women who had mastectomy on the affected side. Patients completed a validated QoL survey (FACT-B) which covered: overall QoL and additional cancer-specific concerns. Responses followed a five-point scale. Surveys must have been completed any time before surgery and 6-18 months after surgery. A Fixed Effects linear regression model was used to discern within-person changes in QoL measures before and after surgery. Analysis was stratified by unilateral mastectomy (...

Effect of an IT-supported home-based exercise programme on metabolic syndrome in India

Summary We studied the effectiveness of a home-based exercise programme with information technology (IT) support in people with metabolic syndrome in India. Ninety-four participants with metabolic syndrome (mean age 50 years) were randomized into two groups. Both groups received a 12-week home exercise programme and Group 2 received additional IT support for health education. Before and after the exercise programme, participants were measured for arterial stiffness using applanation tonometry, exercise capacity using an incremental shuttle walk test and quality of life (QoL) using the SF-36 questionnaire. Sixty-one participants completed the post intervention tests. There was a significant reduction in systolic blood pressure, mean pressure and aortic systolic pressure in both groups. Pulse wave velocity, aortic pulse pressure and aortic diastolic pressure showed significant reductions only in Group 2. There were no significant changes in QoL measures, except vitality in Group 2. There was significant improvement in fasting blood glucose in Group 2, cholesterol in Group 1 and triglycerides in both groups. The participants’ exercise capacity did not change significantly, although the mean duration of regular exercise was 7.2 weeks for Group 1 and 10.0 weeks for Group 2 (P = 0.019). Metabolic syndrome was reversed in 16% of the participants in both groups. IT support, through mobile text messages and phone calls, may be helpful in metabolic syndrome. Longer-term studies are now required.

Calculated NIH Response Correlates with Changes in Patient-Reported Symptoms but Not with Quality of Life: Results From the Chronic Gvhd Consortium

Abstract 1988Background: In 2005, the National Institutes of Health (NIH) Consensus Conference recommended measurement tools to capture clinician or patient-assessed chronic GVHD manifestations. The NIH Conference also proposed a set of provisional definitions to calculate response using these measures. The correlation of the calculated NIH responses with patient-reported quality of life (QOL) or symptoms has not been examined. Ideally, improvement according to NIH response criteria would be associated with better QOL and fewer symptoms compared to patients who have stable disease or progress. Patients and methods: We studied 274 patients with chronic GVHD requiring systemic treatment who were enrolled in a multi-center, prospective, longitudinal, observational cohort. Treatment of chronic GVHD was not uniform for this study. 256 patients had follow-up visits at 6 months after enrollment. The 6 month time point was chosen to be consistent with many earlier phase II studies. Responses were classified according to the calculated NIH response algorithm (BBMT 2006;12:491) as complete, partial, stable or progression, separately in skin, eye, mouth, lung, liver and gastrointestinal (GI) tract as well as overall by comparing organ manifestations reported at the follow-up visit to the enrollment visit. Complete or partial response was considered “response”, and stable disease or progression as “no response”. QOL measures included the SF-36, FACT-BMT and Human Activities Profile (HAP) score. Symptom measures included the Lee symptom scale and 10-point global rating of symptoms. Linear regression models were used to estimate the change in measures associated with response vs. no response, adjusting for case type (incident vs. prevalent), donor/patient gender and NIH global severity at enrollment. Results: Patients with a median age of 52 years were enrolled at a median of 13 months from transplant. Of 274 patients, 247 (90%) had mobilized blood cell transplant, 132 (48%) had HLA-matched related donors, 138 (50%) had unrelated donors, and 153 (56%) had myeloablative conditioning. At 6 months, overall response rates were 10 (4%) CR, 72 (28%) PR, 14(6%) SD, and 157(62%) PD, for a CR+PR rate of 32%. Organ-specific CR+PR response rates were 31% for skin, 16% for eye, 26% for mouth, 23% for GI, and 31% for liver. Compared with no response, overall response was associated with improved overall symptom burden measures, but not with changes in QOL measures. For example, the Lee overall score was estimated to be 4.6 points lower in responders than in non-responders (Table 1). Organ-specific analyses showed that organ response was associated with improved symptom burden in skin, eye, mouth and GI except for mouth dryness (Table 2). Conclusion: The calculated organ-specific and overall NIH responses by the provisional algorithm correlated with corresponding organ-specific and overall changes in patient-reported symptom burden, but calculated overall response did not correlate with changes in patient-reported QOL. Our results suggest that the calculated NIH response is a surrogate measure for patient symptom burden in clinical trials.Table 1Estimated change in QOL and symptom measures associated with overall responseOutcomeClinically meaningful change1R vs. NR Estimated change (95% CI)PSF-36 PCS4.80.8 (−1.9–3.5).57SF-36 MCS5.20.1 (−2.7–2.9).93FACT-BMT102.7 (−1.8–7.1).24HAP MAS6.20.7 (−3.2–4.6).73HAP AAS8.41.6 (−2.6–5.8).45Lee symptom overall score6.2−4.6 (−7.3–−1.9).001Patient-rated overall symptoms2−0.9 (−1.6–−0.3).003R, response; NR, no response; PCS, physical component score; MCS, mental component score; MAS, maximum activity score; AAS, adjusted activity score.1Half-standard deviation of baseline score or 2-point change on a 10-point scale.Table 2Estimated change in symptom measures for each organ associated with organ responseOrganClinically meaningful changeR vs. NR Estimated change (95% CI)PLee symptom scaleSkin10.4−7.3 (−14–−0.8).03Eye14.8−16 (−27–−4.7).005Mouth13.8−16 (−24–−7.6)<.001GI (nutrition)6.2−7.1 (−13–−1.1).02Patient-rated symptomsSkin itching2−1.0 (−1.8–−0.1).03Eye problem2−1.3 (−2.4–−0.2).03Mouth dryness2−0.1 (−1.1–0.8).81Mouth pain2−1.1 (−1.9–−0.2).02Mouth sensitivity2−1.0 (−1.9–−0.1).03R, response; NR, no response. Disclosures:No relevant conflicts of interest to declare.

Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy

Noninvasive repetitive transorbital alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage, but it is not known if this is of subjective relevance. We now assessed patient reported outcomes to determine the association between visual field changes and vision-related quality of life (QoL). Patients having visual field impairments long after optic nerve damage (mean lesion age 5.5 years) were randomly assigned to a rtACS (n = 24) or sham stimulation group (n = 18). Visual fields and patient reported outcome measures (vision-related QoL: National Eye Institute Visual Function Questionnaire, NEI-VFQ and health-related QoL: Short Form Health Survey, SF-36) were collected before and after a 10-day treatment course with daily sessions of 20 to 40 minutes. The primary outcome measure was the percent change from baseline of detection ability (DA) in defective visual field sectors as defined by computer-based high resolution perimetry (HRP). Secondary outcome parameters included further HRP parameters as well as static and kinetic perimetry results. Changes in QoL measures were correlated with changes in primary and secondary outcome measures in both groups. DA increase in the defective visual field was significantly larger after rtACS (41.1 ± 78.9%, M ± SD) than after sham stimulation (13.6 ± 26.3%), P < 0.05. While there was a significant increase of DA in the whole tested HRP visual field after rtACS (26.8 ± 76.7%, P < 0.05), DA in sham-stimulation patients remained largely unchanged (2.7 ± 20.2%, ns). Results of secondary outcome measures (static and kinetic perimetry) provided further evidence of rtACS efficacy. Improvements in NEI-VFQ subscale "general vision" were observed in both groups but were larger in the rtACS group (11.3 ± 13.5, Z = -3.21, P < 0.001) than in the sham group (4.2 ± 9.4, Z = -1.73, P < 0.05) with a significant difference between groups (Z = -1.71, P < 0.05). DA change and some NEI-VFQ domains were correlated (r = 0.29, P < 0.05), but no significant correlations were observed between DA and SF-36 results. rtACS facilitates vision restoration after unilateral, long-term optic nerve lesion as assessed both by objective DA changes and improvements in some NEI-VFQ subscales. Both were positively but low correlated, which suggests that factors other than visual field size also contribute to improved vision-related QoL.

A Review of Health-Utility Data for Osteoarthritis

The objective of this review was to describe the performance of health-utility measures in valuing the quality-of-life (QOL) impact of changes in osteoarthritis (OA)-related chronic pain when administered within a clinical trial setting. Because the collection of utility data within a clinical trial is not always feasible in the development of health economic models, utility data from prior non-randomised studies conducted among patients with OA were also summarized.We conducted a literature review using the MEDLINE, EMBASE and PsycINFO databases. We selected studies employing validated direct and multi-attribute measures of health utility: the standard gamble, time trade-off, EuroQol index, Health Utilities Index, SF-6D, 15D and the Assessment of Quality of Life measure.We identified four randomized controlled trials and 17 observational studies. The results of prior clinical trials in which these health utility measures were used in evaluating OA are summarized and attributes of the utility measures such as the clinical importance and statistical significance of the results obtained are noted. Furthermore, the sensitivity of the utility measure to changes in co-administered non-utility based measures of health-related quality of life (e.g. visual analogue scale for pain, WOMACtrade mark) are also reported. Five findings emerged.First, the EQ-5D system was the most widely used metric to derive utilities. Second, for whatever utility measure was used, reported mean utilities for patient groups spanned a rather wide range of values across studies, potentially reflecting variation in illness severity, patient co-morbidities and/or patient treatment. Third, when studies reported more than one utility-based statistic, the utility valuations frequently differed by measure, suggesting that the choice of metric can potentially have an effect on QALY calculations. However, there was no consistent pattern as to which measure yielded the highest and lowest utility valuations. Fourth, changes in health-related QOL (HR-QOL) and utility measures displayed the expected relationships. When HR-QOL declined, the utility values also moved in this direction. The reverse was also true. In some instances, statistically significant changes in QOL measures were not mirrored by statistically significant changes in utility measures, suggesting that some studies may have been underpowered for the latter purpose. Finally, the body of clinical trial-based utility literature in OA was found to be relatively modest, with considerably more observational studies collecting utility data.Based on the limited number of trial-based health-utility evaluations in OA to date, there can potentially be divergent findings with respect to clinical and statistical significance of changes in utility measures and corresponding measures of health status. Analysts should carefully evaluate issues of statistical power and clinical sensitivity in utilizing these measures in clinical trials of OA interventions.

Longitudinal Assessment of Quality of Life in Patients With Type 2 Diabetes and Self-Reported Erectile Dysfunction

In the context of the QuED (Quality of Care and Outcomes in Type 2 Diabetes) project, we evaluated the longitudinal changes over 3 years in quality of life (QoL) in patients with type 2 diabetes according to the presence or the development of erectile dysfunction (ED). Patients were requested to fill in a questionnaire investigating the presence of ED and QoL (SF-36 Health Survey, depression symptoms [Center for Epidemiologic Studies-Depression], and quality of sexual life) every 6 months for 3 years. The analyses were based on multilevel models, adjusted for patient clinical and sociodemographic characteristics. The study involved 1,456 patients, of whom 34% reported frequent erectile problems at baseline; 192 developed ED during the follow-up. No changes in QoL measures were detected in patients without ED; in those with ED at baseline, a worsening in all SF-36 scales was observed, reaching statistical significance for physical functioning (P = 0.03). Among patients who developed ED during the study, a deterioration in all SF-36 dimensions and a worsening in depressive symptoms preceded the development of ED. The onset of ED was associated with a further marked worsening in physical functioning (P = 0.0008), general health perception (P = 0.02), and social functioning (P = 0.04) on SF-36 subscales, as well as in the summary physical and mental components scores (P = 0.04 and P = 0.07, respectively). The development of ED was also associated with a highly significant increase in depressive symptoms (P = 0.001) and a marked decrease in quality of sexual life (P < 0.0001). This longitudinal study documents for the first time the impact of ED onset on several aspects of QoL in patients with type 2 diabetes. The study also shows that QoL tended to further decrease during 3 years in patients with ED at baseline but not in those without this condition.

A Prospective Study of Quality of Life in Adults with Newly Diagnosed High-grade Gliomas: The Impact of the Extent of Resection on Quality of Life and Survival

To describe the quality of life (QOL) over time for adults with newly diagnosed high-grade gliomas and to examine the relationship between QOL and outcome data collected in three prospective cooperative group clinical trials. The QOL study was a companion protocol for three Phase II high-grade glioma protocols. Five self-administered forms were completed by patients to assess QOL at study entry, 2 months, and 4 months after enrollment. QOL data were available for baseline, first, and second subsequent follow-up evaluations for 89%, 71%, and 69% of patients, respectively. A significant proportion of patients (47.1%) experienced impaired QOL (QOL < or = 50) in at least one measure at subsequent evaluations, whereas most patients (88%) with impaired QOL at baseline continued to have impaired QOL at subsequent evaluations. On multivariable analyses, baseline QOL measures were predictive of QOL at the time of follow-up. In addition, patients who underwent a gross total resection were much less likely to have impaired QOL (P = 0.006), were less likely to experience worsening depression (P = 0.0008), and were more likely to have improved QOL (P = 0.003) at their first follow-up evaluation. Changes in QOL measures over time were not found to be associated with survival in multivariable analyses that adjusted for known prognostic variables; variables that were independently associated with improved survival were better performance status (P < 0.001), younger age (P < 0.001), and greater extent of resection (P < 0.001). Baseline QOL was predictive of QOL over time. Gross total resection was associated with longer survival and improved QOL over time for patients with high-grade gliomas.

Sensitivity to Change Following Liver Transplantation

There is an increasing focus on the importance of quality-of-life (QOL) factors in evaluating the efficacy of medical and surgical interventions. There are a wide number of instruments currently available, and the aim of the present study was to evaluate the relative sensitivity to change of three widely used QOL measures, the WHOQOL-100, the SF-36 and the Rotterdam Symptom Checklist, focusing on psychological and physical components of life quality. Fifty patients were assessed pre- and 3 months post-liver transplantation. In addition, 21 patients with liver disease but who were not transplanted were assessed twice, separated by a 3-month interval, in order to serve as a comparison group. All QOL measures showed significant improvement following liver transplantation, whereas the control group showed no significant within-subject change on any measure. We employed the Standardised Response Mean (SRM) effect size as our index of clinically meaningful change in QOL measures. Large SRM effect sizes were obtained following liver transplantation for WHOQOL-100 and SF-36 summary measures, and for the Rotterdam physical subscale. In contrast, the traditional SF-36 scale scores and Rotterdam psychological subscale exhibited only moderate sensitivity to change.