Patient-reported Quality Of Life Measures Research Articles

Associations Among Tremor Amplitude, Activities of Daily Living, and Quality of Life in Patients with Essential Tremor.

Essential tremor (ET) is a disabling syndrome consisting of tremor, primarily in the upper limbs. We assessed the correlation of The Essential Tremor Rating Assessment Scale (TETRAS) Performance Item 4 ratings of upper limb tremor with the TETRAS activities of daily living (ADL) subscale and with 2 quality of life (QoL) scales. This noninterventional, cross-sectional, point-in-time survey of neurologists(n = 60), primary care physicians (n = 38), and their patients with ET (n = 1,003) used real-world data collected through the Adelphi ET Disease Specific Programme™. Physician-reported measures (TETRAS Performance Item 4 and TETRAS ADL total) and patient-reported QoL measures (generic EuroQol-5 Dimension 5 Level [EQ-5D-5 L] and ET-specific Quality of Life in Essential Tremor Questionnaire (QUEST)) were assessed with bivariate and multivariable analyses. Sensitivity analyses were also conducted. The bivariate association between TETRAS Performance Item 4 score and TETRAS ADL total score was high (Pearson r = 0.761, P < 0.001). The bivariate associations between TETRAS Performance Item 4 score and EQ-5D-5 L index score (r = -0.410, P < 0.001) and between TETRAS ADL total score and EQ-5D-5 L index score (r = -0.543, P < 0.001) were moderate. The bivariate associations between TETRAS Performance Item 4 score and QUEST total score (r = 0.457, P < 0.001), and between TETRAS ADL total score and QUEST total score (r = 0.630, P < 0.001) were also moderate. These associations were unaltered by the inclusion of covariates. This study showed that greater tremor severity (TETRAS Performance Item 4) was positively correlated with ADL impairment (TETRAS ADL) and negatively associated with QoL (EQ-5D-5 L and QUEST). TETRAS Performance Item 4 score is a robust predictor of TETRAS ADL total score, and TETRAS Performance Item 4 and TETRAS ADL total scores were robust predictors of the 2 QoL scales. The results demonstrate the value of TETRAS scores as valid endpoints for future clinical trials. This real-world study assessed TETRAS scores as predictors of impaired QoL in ET. TETRAS Performance Item 4 and ADL were associated with EQ-5D-5 L and QUEST. TETRAS scores may serve as valid endpoints for future clinical trials.

Evaluating the Long-Term Outcomes of Periodontal Surgery vs. Non-Surgical Treatment in Aggressive Periodontitis.

Aggressive periodontitis is a severe form of periodontal disease characterized by rapid tissue destruction and tooth loss. The optimal treatment approach for managing this condition remains a topic of debate. A retrospective cohort study was conducted, involving patients diagnosed with aggressive periodontitis who received either surgical or non-surgical treatment between 2010 and 2020. Clinical and radiographic data were collected at baseline and regular intervals over a 5-year follow-up period. Surgical interventions included flap surgery, guided tissue regeneration, and bone grafting, while non-surgical treatments comprised scaling and root planning with or without adjunctive antibiotics. The primary outcomes assessed included changes in probing depth, clinical attachment level, tooth loss, and patient-reported quality of life measures. A total of 120 patients were included in the study, with 60 patients in each treatment group. The surgical group demonstrated significantly greater reductions in probing depth and gains in clinical attachment level compared to the non-surgical group (P < 0.05). Tooth loss was significantly lower in the surgical group over the 5 years (P < 0.01). Patient-reported outcomes also favored the surgical group, with improved oral health-related quality of life. However, the surgical group had a higher incidence of postoperative complications. This study suggests that periodontal surgery yields superior long-term outcomes in the management of aggressive periodontitis compared to non-surgical treatment.

Long-Term Quality-of-Life Outcomes After Prostate Radiation Therapy With or Without High-Dose-Rate Brachytherapy Boost: Post Hoc Analysis of TROG 03.04 RADAR

Adding high-dose-rate brachytherapy (BT) boost to external beam radiation therapy (EBRT) improves biochemical control but may affect patient-reported quality of life (QOL). We sought to determine long-term QOL outcomes for EBRT+BT versus EBRT alone. This was a post hoc analysis of the Trans-Tasman Radiation Oncology Group 03.04 Randomized Androgen Deprivation and Radiotherapy (TROG 03.04 RADAR) trial. Only patients who received 74 Gy conventionally fractionated EBRT (n=260) or 46 Gy conventionally fractionated EBRT plus 19.5 Gy in 3 fractions high-dose-rate BT boost (n=237) were included in this analysis. The primary endpoint was patient-reported QOL measured using the European Organisation for Research and Treatment of Cancer QOL (EORTC QLQ-C30) and prostate-specific QOL module (EORTC QLQ-PR25) questionnaires. We evaluated temporal changes in QOL scores, rates of symptom resolution, and the proportion of men who had decrements from baseline of >2×the threshold for minimal clinically important change (2×MCIC) for each domain. At 5, 17, and 29 months after radiation therapy, the EBRT+BT group had 2.5 times (95% confidence interval [CI], 1.4-4.2; P < .001), 2.9 times (95% CI, 1.7-4.9; P < .001), and 2.6 times (95% CI, 1.4-4.6; P=.002) greater odds of reporting 2×MCIC in urinary QOL score compared with EBRT. There were no differences beyond 29 months. EBRT+BT led to a slower rate of urinary QOL symptom score resolution up to 17 months after radiation therapy compared with EBRT (P < .001) but not at later intervals. In contrast, at the end of the radiation therapy period and at 53 months after radiation therapy, the EBRT+BT group had 0.65 times (95% CI, 0.44-0.96; P=.03) and 0.51 times (95% CI, 0.32-0.79; P=.003) the odds of reporting 2×MCIC in bowel QOL symptom scores compared with EBRT. There were no significant differences in the rate of bowel QOL score resolution. There were no significant differences in global health status or sexual activity scores between the 2 groups. There were no persistent differences in patient-reported QOL measures between EBRT alone and EBRT+BT. BT boost does not appear to negatively affect long-term, patient-reported QOL.

733-P: Diabetes Remission Outcomes Protocol (DROP)—Early Observation

A 12-week multidisciplinary intensive lifestyle intervention (ILI) was shown to induce diabetes remission (A1C &amp;lt;6.5%, on no medications for ≥3 months), particularly among participants with short diabetes duration. Diabetes remission was also achieved with very low-calorie diet (VLCD) or bariatric surgery. Diabetes Remission Outcomes Protocol (DROP) at Joslin Diabetes Center is an ILI designed to induce diabetes remission in patients with type 2 diabetes who meet 3 criteria: 1- duration of diabetes &amp;lt;5 years, 2- A1C &amp;lt;8%, 3- On up to 2 antihyperglycemic medications, but no insulin. It involves two phases: an intervention phase for 12 weeks and a maintenance phase for 9 months. During intervention phase, participants follow a time-restricted fasting for 16 hours and VLCD (800-1000 Kcal/day). Participants also receive cognitive behavioral support and perform exercises designed to maintain lean muscle mass (LMM). They stop all diabetes medications at the beginning of the program and are monitored by CGM. Reintroduction of medications is suggested if glucose time in range (70-180 mg/dL) (TIR) drops to &amp;lt;70%. During maintenance phase, participants return to 1500-1800 calorie diet with the aim of maintaining weight loss and diabetes remission. We tested feasibility of DROP in a pilot of 5 participants with mean age of 52.8±11.4 years, diabetes duration of 13.2±11.8 months, and A1C of 6.44±0.3% on 2 medications. By the end 12-weeks, average weight loss was 19.9 lbs (8.1%). A1C decreased to 6.14±0.48% (p=0.02) on no medications and TIR was 98%. LMM /total body weight significantly increased by 0.03±0.02 (p=0.03). Patient-reported quality of life measures showed significant improvements in the World Health Organization-5 Well-Being Index (p=0.03), Diabetes Distress Scale-17 (p=0.05) and 36-Item Short Form Survey (p=0.04) submodules. DROP is promising approach to induce diabetes remission and improve patients’ quality of life in selected patients with type 2 diabetes. Larger cohorts should be evaluated for longer duration. Disclosure K.Kibaa: None. A.Khater: None. R.Mccarragher: None. O.Hamdy: Advisory Panel; Abbott Nutrition, Nemaura Medical, L-Nutra Inc., Twin Health, Consultant; Sanofi, Research Support; Novo Nordisk, Eli Lilly and Company, Gilead Sciences, Inc., Stock/Shareholder; Healthimation. S.E.Dhaver: None. C.Johnson: None. J.L.Votta: None. J.I.Shahar: None. C.Mitchell: None. J.M.Beaton: None. T.Salah: None. M.Al-badri: None.

Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM).

In patients affected by head and neck squamous cell carcinoma, the onset of severe oral mucositis is a decisive factor in completing concurrent chemo-radiotherapy, and few interventions have demonstrated a modest benefit. The primary aim of this clinical study was to evaluate the role of SAMITAL in reducing the incidence of severe mucositis induced by concurrent chemo-radiotherapy; the secondary aims were the tolerability and patient-reported quality of life measures. Patients were randomized to receive SAMITAL granules for oral suspension of 20 mL, four-time daily or matching placebo in a 1:1 fashion using a stratified-block randomization scheme by disease site and type of chemotherapy. The SAMITAL/placebo was dispensed at the baseline visit and at each weekly visit following radiotherapy initiation. Patients were subjected to weekly endoscopic evaluations to assess the presence of mucositis. In addition, patient-reported outcomes were measured. Among the 116 patients treated with a median total dose of 66 Gy, 59 were randomized to SAMITAL and 57 to placebo. Overall, the incidence of severe mucositis was 51.7%, with 45.8% in the SAMITAL and 57.9% in the placebo arm (OR = 0.6; 95% CI: 0.3-1.3). After chemo-radiotherapy, patients randomized to SAMITAL reported significantly lower xerostomia, coughing and swallowing scores and a better quality of life. SAMITAL did not significantly reduce the incidence of severe mucositis in all studied populations. However, the lower rate of mucositis, together with a significantly better quality of life, suggested that a clinical benefit existed. This trial is registered with the EU Clinical Trials Register database, number 2012-002046-20, and with ClinicalTrials.gov, NCT01941992.

Long-Term Health-Related Quality of Life of Autologous Hematopoietic Cell Transplantation Patients and Nontransplant Patients With Aggressive Lymphoma: A Prospective Cohort Analysis.

This study assessed the long-term quality of life (QOL) of patients with aggressive lymphoma subtypes treated with autologous hematopoietic cell transplant (autoHCT) compared with those without history of transplant. Patient-reported QOL measures were prospectively gathered from patients enrolled in the Iowa/Mayo Specialized Program of Research Excellence Molecular Epidemiology Resource cohort with aggressive lymphoma subtypes. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G), Functional Assessment of Chronic Illness Therapy-Fatigue Scale, State-Trait Anxiety Inventory (STAI), and Profile of Mood States instruments and with a numeric rating scale for overall QOL and spiritual QOL. The autoHCT group and no HCT groups were compared at 3 years (FU3) and 6 years (FU6) after lymphoma diagnosis. In total, 980 patients with lymphoma (106 autoHCT and 874 no HCT) diagnosed between 2002 and 2013 were included for analysis. The mean FACT-G total score was similar in the autoHCT and no HCT groups at FU3 (89.9 v 90.1, P = .64) and also at FU6 (91.5 v 89.6, P = .44). No differences between the autoHCT and no HCT groups were identified in the FACT subscales. The STAI identified lower anxiety in the autoHCT group by mean STAI1 (state) at FU3 (30.1 v 33.4, P < .01) and by mean STAI2 (trait) at FU6 (30.1 v 33.5, P = .02). No other clinically meaningful differences were identified between the two groups using the other QOL instruments. Patients remaining in remission at 3 and 6 years after diagnosis had a high level of QOL with no significant differences associated with history of treatment with autoHCT.

Prospective evaluation of a comprehensive geriatric assessment (CGA) in multidisciplinary bladder cancer care: Feasibility and impact on decisional conflict.

479 Background: Commonly utilized risk stratification tools demonstrate inconsistent associations with salient clinical outcomes in bladder cancer leading to a disproportionate reliance on providers’ subjective impression of a patient’s fitness for therapy. Current guidelines advocate for use of a CGA to quantify vulnerabilities in older ( &gt; 65 years) patients before treatment selection. Our objective was to prospectively evaluate CGA in our Bladder Cancer Multidisciplinary Clinic (BCMC). We hypothesized that CGA implementation would be feasible and that discussion of the results during shared decision-making would be associated with reduced patient-reported decisional conflict. Methods: Patients seen in BCMC were prospectively enrolled from 6/1/20 to 7/20/21. In the first 3 months, participants underwent non-standardized risk stratification (“Routine cohort”, N = 27). Between 9/1/20 and 7/20/21, participants completed a CGA incorporating validated assessments of frailty, functional status, multimorbidity, nutrition, cognition, and mental health (“CGA cohort”, N = 67). Results were shared with patients during BCMC visits. All patients and providers (three physicians per clinic from: Uro-Oncology, Medical Oncology, and Radiation Oncology) completed a follow-up survey including the Decisional Conflict Scale (DCS). Time required to complete the CGA, completion rates, and patient-reported burden were assessed. Concordance of patient- and provider-reported decisional conflict was compared between Routine and CGA cohorts. Results: Of 138 eligible patients, 94 patients were successfully enrolled (68%) with median age of 72 years, ECOG PS ≥3 in 13%, and Charlson Comorbidity Index ≥3 in 18%, of whom 18% were women. Most patients had pT2 bladder cancer (87%; cN+ and M1 in 23.4% and 9.6%, respectively). CGA component completion rates were 79-100%. Survey response rates were high (patients: 77%, providers: 86%), and most (86%) patients felt that the CGA was, at most, minimally burdensome. Vulnerabilities detected across CGA domains triggered relevant referrals. Patient-reported median (IQR) DCS scores were numerically higher (e.g. greater decisional conflict) for the CGA cohort: (27 [14-33] vs 16 [2-30] for Routine patients, p = 0.28). Provider- and provider reported DCS score was correlated in the CGA (p = 0.04), but not the Routine cohort (p = 0.07). Conclusions: We prospectively evaluated use of CGAs in bladder cancer care and found that CGAs were successfully implemented with high rates of completion and low rates of perceived burden. Notably, in this pilot cohort of 94 patients, DCS scores did not differ significantly between patients and providers with CGA use. Future work will evaluate associations between individual instruments, treatment decisions, clinical outcomes and patient-reported quality of life measures.

Utilizing Patient-Reported Quality of Life Measures to Optimize Individualized Treatment Options for Patients with Cholangiocarcinoma

Introduction: Although surgery remains the only curative option for cholangiocarcinoma, for patients with oncologically high-risk disease, it is difficult to reconcile an attempt at resection with the risk of morbidity, recurrence, and impediment to health-related quality-of-life (HRQoL). Neoadjuvant chemotherapy (NAC) is increasingly being utilized for high-risk malignancies; however, its association with functional limitations related to toxicity and HRQoL is not known. Method: Patients engaged in the Cholangiocarcinoma Foundation completed two validated HRQoL surveys: Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary; COmprehensive Score for financial Toxicity (COST). Subscales and composite scores were calculated according to the FACIT-Manual, higher values indicating improved HRQoL. Results: 208pts were enrolled. 75% (n=156) had intrahepatic cholangiocarcinoma, 57% (n=119) underwent resection, of which 47% (n=56) had recurrence. 40% (n=42) received neoadjuvant or perioperative chemotherapy; 60% (n=64) received adjuvant chemotherapy (AC) alone. Among patients with localized non-metastatic unresectable disease, 38% (n=34) received chemotherapy/radiation as definitive treatment. Patients who underwent resection and had disease recurrence still reported improved functional-well-being compared to those who received only chemotherapy/radiation (effect size 0.46, p=0.04; Table1). Patients who received NAC prior to resection reported nearly equivalent HRQoL compared to those who underwent upfront resection followed by AC. Conclusions: Despite a surgeon’s desire to first “do-no-harm”, patients with expectedly poor oncologic outcomes still prefer an attempt at resection as depicted by increased functional-well-being, reflecting contentment with HRQoL and acceptance of their illness. Importantly, administering NAC, particularly in the context of high-risk disease, does not result in reduced HRQoL. Incorporating objective patient-reported outcomes data will aid in patient counseling and optimize individualized treatment plans.

Abstract 11751: Long Term Quality of Life Improvement After Peripheral Vascular Intervention- Insights From the Liberty 360 Study

Background: Improving patients’ quality of life (QoL) is a primary indication for peripheral endovascular intervention (PVI) for peripheral arterial disease (PAD). Little is known about the long-term improvement in QoL following PVI or predictors of those who may experience the greatest benefit. Methods: We studied 1204 patients enrolled in LIBERTY 360 Study, a prospective, multicenter study that evaluated clinical outcomes in symptomatic PAD patients undergoing lower extremity PVI. Patient reported QoL measures were assessed at 30 days, 12 months and 36 months using EuroQol and VascuQol-25. Multivariable regression was used to identify significant predictors of improved quality of life at 12 months. Results: For claudication patients (Rutherford 2-3), the baseline VascuQol total score was 4.3±1.3 and EuroQol composite score indicated that 21.5% had no/slight functional problems (NSFP). Health status significantly improved by 30 days, with VascuQol score 5.4±1.3 and 48.2% with NSFP), and persisted through 3 years (1 year: VascuQol score 5.3±1.3, 46.3% with NSFP; 3 years: VascuQol score 5.3±1.4, 46.9% with NSFP). For patients with critical limb ischemia (CLI; Rutherford 4-6), baseline VascuQol total score was 3.8±1.4 and 16.6% had NSFP. Health status significantly improved by 30 days, with VascuQol score 4.7±1.4 and 29.9% with NSFP, and persisted through 3 years (1 year: VascuQol score 5.0±1.4, 35.0% with NSFP; 3 years: VascuQol score 5.0±1.4, 38.0% with NSFP). In multivariable regression, baseline symptom severity, disease severity, BMI, gender, history of PVI, target lesion residual stenosis and renal disease were significant predictors of QoL improvement post-intervention (Figure 1). Conclusions: Endovascular intervention is associated with significant, long-term improvement in QoL measures across different disease severity. Baseline symptom severity and comorbidities were strong predictors of QoL improvement 1 year after intervention.

Predictive factor for failure of conservative management in the treatment of calcific tendinitis of the shoulder

Objectives:Calcific tendinitis of the shoulder is a painful condition characterized by the presence of calcium deposits within the tendons of the rotator cuff (RTC) and accounts for up to 7% of all presentations of shoulder pain. Conservative treatment with physical therapy (PT) and corticosteroid injection is often the first line treatment. When conservative management fails, arthroscopic surgery for removal of the calcium may be considered. Surgical removal is often followed by rotator cuff repair to address the resulting tendon defect. This study was performed to assess predictive factors for failure of conservative management as well as to characterize the rate of rotator cuff repair in the setting of calcific tendinitis. We hypothesize that larger calcific lesion would have a higher likelihood to fail conservative treatment and the majority of patients requiring surgery will require a concomitant rotator cuff repair.Methods:A retrospective review of patients who were diagnosed with calcific tendinitis at our institution between 2009 and 2019 was performed. Demographics, comorbidities, pain score (VAS), ASES, ROM and patient-reported quality of life measures were recorded and analyzed. All patients underwent a radiograph and MRI. Size of the calcific lesion was measured based on its largest diameter on radiograph. Statistical analysis included chi-square, independent t test and ANOVA. Descriptive statistics were used to report data. p<0.05 was considered to be statistically significant.Results:239 patients were identified in the study period; 127 (53.1%) were female. Mean age was 54 years and BMI 29.2 with mean follow up of 6 months. Preoperative pain score was 6.3 and ASES score was 47.9. 160 had an intact RTC (67.2%) and 78 had a partial RTC tear (32.8%). The calcific lesion was located in the supraspinatus in 148 patients (63.8%), infraspinatus in 32 patients (13.8%), subscapularis in 9 patients (3.9%), teres minor in 1 patient (0.4%) and combined tendons in 42 patients (18.1%). 93/239 (38.9%) patients failed conservative treatment after an average of 4.4 months necessitating surgical management. Failure rate for PT was 36.6% (24/71), for subacromial corticosteroid injection was 31.6% (25/79) and 33.8% (24/71) for ultrasound guided aspiration. Among patients who underwent surgery the majority of patients, 77/93 (82.8%) required a concomitant rotator cuff repair. Sub-analysis demonstrates that calcific lesions > 1 cm was significantly associated with failure of conservative treatment (odds ratio=2.81, 95% CI 1.25-6.29, p<0.05). All patients who underwent surgery demonstrated significant improvements in pain scores (6.3 to 2.3 VAS), ASES (47.9 to 90.49), forward flexion (133° to 146.8°) and external rotation (49.2° to 57.6°) (p<0.05) postoperatively.Conclusions:Patients with calcific lesions >1 cm have a 2.8x-increased likelihood of failing conservative treatment in the setting of calcific tendinitis of the shoulder. The majority of patients who undergo surgical management for removal of the calcific deposit will require a concomitant rotator cuff repair and have significant improvements in shoulder pain and function. While conservative management is often considered a first-line treatment, the size of the lesion may play a significant role regarding whether conservative treatment will be successful, and patients should be counseled accordingly. Once surgery is decided, orthopedic surgeons should also be aware of the high likelihood of concomitant rotator cuff repair for preoperative planning and discussion.

The influence of clinical stage, race, and gender on factors which impact quality of life in multiple myeloma.

e24126 Background: Multiple myeloma (MM) is unique among hematologic malignancies as an incurable disease. Patients are affected long-term by the disease symptoms as well as psychological, financial burden, and social impact, which may affect overall quality of life (QOL). The current literature related to QOL in MM is largely limited to a single clinical stage, impact concurrent with a specific treatment regimen, or focused on a single QOL factor. Changes in impact on QOL based on longitudinal follow up during the disease course have not been readily assessed. Here, we evaluated patient-reported QOL measures utilized by one time validated questionnaires. Methods: The study enrolled 100 participants in a sequential manner from the Myeloma Clinic at UMGCC with a diagnosis of plasma cell disorders at various stages: MGUS, smoldering myeloma, or multiple myeloma: newly diagnosed, maintenance, relapsed. Participants provided verbal responses to a series of questions listed in Table. Questions aligned with three main domains: physical symptoms and function, mental health, and social systems. The following is an interim analysis of the first 50 patients. Results: This sample of myeloma patients (N=50; males n=26), felt their QOL was impacted by myeloma symptoms (70%). More African American participants reported impact from financial burden (6, 50%) in comparison to Caucasian and other races (10, 26%). Interestingly, males reported less impact on sexual intimacy (3, 15%) than females (6, 43%). Females also reported more impact from financial burden (10, 42%) compared to males (6, 23%). Conclusions: Changes to impact on QOL as a function of clinical MM stage, race, and/or gender will be fully evaluated. Planned analyses include correlation statistics by age and social demographics to determine patterns in patient-reported outcomes. Finally, second interviews with current participants will be conducted to determine changes to impact across the same QOL variables over time.[Table: see text]

QOL assessment after palliative surgery for malignant bowel obstruction caused by peritoneal dissemination of gastric cancer: a prospective multicenter observational study.

Patients with peritoneal dissemination of gastric cancer have poor oral intake caused by malignant bowel obstruction (MBO). Palliative surgery has often been undertaken to improve quality of life (QOL), but few prospective studies on palliative surgery in this patient population have been published. We prospectively investigated the significance of palliative surgery using patient-reported QOL measures. Patients underwent palliative surgery by small intestine/colon resection or small intestine/colon bypass or ileostomy/colostomy for MBO. The primary endpoint was change in QOL assessed at baseline, 14days, 1month, and 3months following palliative surgery using the Euro QoL Five Dimensions (EQ-5D™) questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (QLQ-STO22). Secondary endpoints were postoperative improvement in oral intake and surgical complications. Between April 2013 and March 2018, 63 patients were enrolled from 14 institutions. The mean EQ-5D™ utility index baseline score of 0.6 remained consistent. Gastric-specific symptoms mostly showed statistically significant improvement from baseline. Forty-two patients (67%) were able to eat solid food 2weeks after palliative surgery and 36 patients (57%) tolerated it for 3months. The rate of overall morbidity of ≥ grade III according to the Clavien-Dindo classification was 16% (10 patients) and the 30-day postoperative mortality rate was 3.2% (2 patients). In patients with MBO caused by peritoneal dissemination of gastric cancer, palliative surgery did not improve QOL while improving solid food intake, with an acceptable postoperative morbidity and mortality rate.

Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers".

ObjectiveMost SARS‐CoV‐2‐infected individuals never require hospitalization. However, some develop prolonged symptoms. We sought to characterize the spectrum of neurologic manifestations in non‐hospitalized Covid‐19 “long haulers”.MethodsThis is a prospective study of the first 100 consecutive patients (50 SARS‐CoV‐2 laboratory‐positive (SARS‐CoV‐2+) and 50 laboratory‐negative (SARS‐CoV‐2‐) individuals) presenting to our Neuro‐Covid‐19 clinic between May and November 2020. Due to early pandemic testing limitations, patients were included if they met Infectious Diseases Society of America symptoms of Covid‐19, were never hospitalized for pneumonia or hypoxemia, and had neurologic symptoms lasting over 6 weeks. We recorded the frequency of neurologic symptoms and analyzed patient‐reported quality of life measures and standardized cognitive assessments.ResultsMean age was 43.2 ± 11.3 years, 70% were female, and 48% were evaluated in televisits. The most frequent comorbidities were depression/anxiety (42%) and autoimmune disease (16%). The main neurologic manifestations were: “brain fog” (81%), headache (68%), numbness/tingling (60%), dysgeusia (59%), anosmia (55%), and myalgias (55%), with only anosmia being more frequent in SARS‐CoV‐2+ than SARS‐CoV‐2‐ patients (37/50 [74%] vs. 18/50 [36%]; p < 0.001). Moreover, 85% also experienced fatigue. There was no correlation between time from disease onset and subjective impression of recovery. Both groups exhibited impaired quality of life in cognitive and fatigue domains. SARS‐CoV‐2+ patients performed worse in attention and working memory cognitive tasks compared to a demographic‐matched US population (T‐score 41.5 [37, 48.25] and 43 [37.5, 48.75], respectively; both p < 0.01).InterpretationNon‐hospitalized Covid‐19 “long haulers” experience prominent and persistent “brain fog” and fatigue that affect their cognition and quality of life.

Predictive factors for failure of conservative management in the treatment of calcific tendinitis of the shoulder.

BackgroundCalcific tendinitis of the shoulder is a painful condition characterized by the presence of calcium deposits within the tendons of the rotator cuff (RTC). When conservative management fails, arthroscopic surgery for removal of the calcium may be considered. Surgical removal is often followed by RTC repair to address the resulting tendon defect. This study was performed to assess predictive factors for failure of conservative management and to characterize the rate of RTC repair in the setting of calcific tendinitis. We hypothesize that larger calcific lesion would have a higher likelihood to fail conservative treatment.MethodsA retrospective review of patients who were diagnosed with calcific tendinitis at our institution between 2009 and 2019 was performed. Demographics, comorbidities, pain score (visual analog scale), American Shoulder and Elbow Surgeons score, range of motion, and patient-reported quality of life measures were recorded and analyzed. All patients underwent a radiograph and magnetic resonance imaging. Size of the calcific lesion was measured based on its largest diameter on magnetic resonance imaging. Statistical analysis included chi-square test, independent t-test, and analysis of variance.ResultsTwo hundred thirty-nine patients were identified in the study period; 127 (53.1%) were women. The mean age was 54 years, and body mass index was 29.2 with a mean follow-up of 6 months. One hundred and sixty had an intact RTC (67.2%) and 78 had a partial RTC tear (32.8%). Ninety-three of 239 (38.9%) patients failed conservative treatment after an average of 4.4 months, necessitating surgical management. Among patients who underwent surgery, the majority of patients (77 of 93 [82.8%]) required a concomitant RTC repair. Subanalysis demonstrates that calcific lesions >1 cm was significantly associated with failure of conservative treatment (odds ratio = 2.86, 95% confidence interval 1.25-6.29, P < .05). All patients who underwent surgery demonstrated significant improvements in pain scores (6.3 to 2.3 visual analog scale), American Shoulder and Elbow Surgeons score (47.9 to 90.49), forward flexion (133° to 146.8°), and external rotation (49.2° to 57.6°) (P < .05) postoperatively.ConclusionPatients with calcific lesions >1 cm had a 2.8× increased likelihood to undergo operative treatment in the setting of calcific tendinitis of the shoulder. Most patients who undergo surgical management for removal of the calcific deposit required a concomitant RTC repair and had significant improvements in shoulder pain and function. This information can be helpful to guide orthopedic surgeons on preoperative planning and discussion when treating calcific tendinitis of the shoulder.

Examining Relationships Between GRBAS Ratings and Acoustic, Aerodynamic and Patient-Reported Voice Measures in Adults With Voice Disorders

To determine if auditory-perceptual voice ratings performed using the GRBAS scale correlate with acoustic and aerodynamic measures of voice. A secondary aim was to examine the relationship between GRBAS ratings and patient-reported quality of life scales. GRBAS ratings, acoustic, aerodynamic and patient-reported quality of life ratings were collected from the University of Wisconsin Madison Voice and Swallow Outcomes Database for 508 adults with voice disorders. Acoustic measures included noise to harmonic ratio, jitter%, shimmer%, highest fundamental frequency (F0) of vocal range, lowest F0 of vocal range, maximum phonation time and dysphonia severity index. Aerodynamic measures included phonation threshold pressure, subglottal pressure, mean transglottal airflow and laryngeal airway resistance. Patient-reported quality of life measures included the Vocal Handicap Index (VHI) and Glottal Function Index (GFI). GRBAS ratings were significantly correlated with several acoustic and aerodynamic measures, VHI and GFI. The strongest significant correlations for acoustic measures were observed between GRBAS ratings of overall voice quality and perturbation measures (jitter% r = 0.58, shimmer% r = 0.45, noise to harmonic ratio r = 0.36, Dysphonia Severity Index r=-0.56). The strongest significant correlation for aerodynamic voice measures was observed between GRBAS ratings of breathiness and transglottal airflow (r = 0.23), subglottal pressure (r = 0.49), and phonation threshold pressure (r = 0.26). GRBAS ratings were also significantly correlated with both VHI and the GFI scales. R values were higher for the VHI, but remained largely in low range for both scales. Although GRBAS ratings were significantly correlated with multiple objective voice and patient related quality of life ratings, r values were low. These findings support the need for multiple voice measures when performing voice evaluations as no single voice measure was highly correlated with voice quality as measured by the GRBAS scale.

Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: protocol design of COVID-HEART\u2014a UK, multicentre, observational study

BackgroundAlthough coronavirus disease 2019 (COVID-19) is primarily a respiratory illness, myocardial injury is increasingly reported and associated with adverse outcomes. However, the pathophysiology, extent of myocardial injury and clinical significance remains unclear.MethodsCOVID-HEART is a UK, multicentre, prospective, observational, longitudinal cohort study of patients with confirmed COVID-19 and elevated troponin (sex-specific > 99th centile). Baseline assessment will be whilst recovering in-hospital or recently discharged, and include cardiovascular magnetic resonance (CMR) imaging, quality of life (QoL) assessments, electrocardiogram (ECG), serum biomarkers and genetics. Assessment at 6-months includes repeat CMR, QoL assessments and 6-min walk test (6MWT). The CMR protocol includes cine imaging, T1/T2 mapping, aortic distensibility, late gadolinium enhancement (LGE), and adenosine stress myocardial perfusion imaging in selected patients. The main objectives of the study are to: (1) characterise the extent and nature of myocardial involvement in COVID-19 patients with an elevated troponin, (2) assess how cardiac involvement and clinical outcome associate with recognised risk factors for mortality (age, sex, ethnicity and comorbidities) and genetic factors, (3) evaluate if differences in myocardial recovery at 6 months are dependent on demographics, genetics and comorbidities, (4) understand the impact of recovery status at 6 months on patient-reported QoL and functional capacity.DiscussionCOVID-HEART will provide detailed characterisation of cardiac involvement, and its repair and recovery in relation to comorbidity, genetics, patient-reported QoL measures and functional capacity.Clinical Trial registration: ISRCTN 58667920. Registered 04 August 2020.

Presence and Perceptions of Menstrual Dysfunction and Associated Quality of Life Measures Among High School Female Athletes.

Adolescent female athletes are at risk for menstrual dysfunction in the setting of exercise and low energy availability. Education regarding menstrual dysfunction and its associated consequences is important to promote athlete wellbeing. The primary aim was to determine the prevalence and characteristics of female athletes who believed that losing their period was a normal response to high training demands. The secondary aim was to explore the relationship between menstrual dysfunction and patient-reported quality of life measures. Cross-sectional study. Preparticipation evaluations for a local high school district. Female athletes, 13-18 years old (n = 90). Health history, family affluence, and patient-reported quality of life measures. Forty four percent (n = 40) of 90 adolescent athletes answered that losing their period was a normal response to a high level of training, and this group had a lower body mass index, were less likely to report being worried about their current weight, and had a higher family affluence level than those who answered that losing their period was not a normal response to training. The overall prevalence of menstrual dysfunction was 28%. After adjusting for age and body mass index, we found that menstrual dysfunction was significantly associated with higher levels of anxiety, fatigue, and pain interference. Nearly half of our sample of adolescent female athletes perceived losing their period was a normal response to high training demands. Females with menstrual dysfunction reported higher levels of anxiety, fatigue, and pain interference than those without menstrual dysfunction. Understanding adolescent perceptions of menstrual dysfunction and the characteristics of those with menstrual dysfunction can guide the development of future educational interventions aimed at athletes at risk for the female athlete triad.

Expanding the indications for the bone anchored hearing system (BAHS) in patients with single sided deafness

PurposeProvide data to support expansion of FDA indications for the Bone anchored hearing system (BAHS). Materials and methodsThis retrospective study in a tertiary otologic referral center included106 consecutive subjects who were implanted with a Bone Anchored Hearing System (BAHS) between January 2009 and January 2015 for single sided deafness. Subjects were divided into three groups by bone conduction pure tone average (PTA) of the better hearing ear: 0–20 dB (group 1), 21–40 dB (group 2) and 41–55 dB (group 3). All patients underwent BAHS implantation. Speech perception data (Hearing In Noise Test and Consonant-Nucleus-Consonant testing) was collected before and after surgical intervention. Patient-reported quality of life measures were obtained at least 6 months after activation. These included the Abbreviated Profile of Hearing Aid Benefit and Glasgow Benefit Inventory. ResultsAll three groups of subjects demonstrated statistically significant improvement in outcome measures following BAHS. Subject reported quality of life outcome measures demonstrated significant improvement in disability from hearing loss and in quality of life. ConclusionsPatients with single sided deafness who have bone conduction thresholds worse than 20 dB in their contralateral ear are still able to benefit significantly from BAHS.

Comprehensive Evaluation of Voice-Specific Outcomes in Patients With Essential Tremor Before and After Deep Brain Stimulation

Deep brain stimulation (DBS) is a treatment for medically refractory essential tremor (ET), but there is a paucity of literature examining the effects of DBS on voice in patients with ET pre-DBS and post-DBS. This study aimed to report a comprehensive evaluation of voice in patients with ET pre-DBS and 6-months post-DBS. Case series. Five patients receiving DBS for ET underwent voice evaluations pre-DBS and 6-months post-DBS. One patient had concurrent ET of the vocal tract (ETVT). The evaluation included patient-reported, perceptual, acoustic, and phonatory aerodynamic analyses of voice. Voice Handicap Index-10, Grade, Roughness, Breathiness, Asthenia, Strain Scale, perturbation measures, cepstral spectral index of dysphonia, cepstral peak prominence, and mean phonatory airflow measures were also among the data collected. Patients with ET presented with minimal changes in perceptual, acoustic, and phonatory aerodynamic parameters. Perceived vocal roughness significantly increased 6-months post-DBS (P = 0.047). The patient with ETVT presented with clinically significant improvement in almost all collected voice parameters 6-months post-DBS. This is the first study to provide data encompassing auditory perceptual voice analysis, voice-specific patient-reported quality of life measures, acoustic, and phonatory aerodynamic outcomes in patients pre-DBS and 6-months post-DBS for ET. The results of our preliminary study have implications for the use of a comprehensive voice assessment to identify and measure change in voice outcomes in patients with ET and ETVT pre- and postsurgery.

Chapter 30 - Quality of life outcomes in meningioma surgery

Patient-reported quality of life measures hold the potential to capture the results of meningioma surgery in a more patient-centered and sensitive way than common morbidity measures. However, quality of life measures have not so far been used much in meningioma studies. Disease specific instruments are also lacking along with validation studies in patients with meningioma. While patient-reported quality of life measures may overestimate improvements and underestimate surgery-related deteriorations, quality of life studies still report worse outcomes than the common retrospective review of hospital records. A more widespread use of longitudinal assessment of quality of life would also have the benefit in moving meningioma research from retrospective to prospective, which would lead to superior data quality. Comparisons across studies would also be more valid as the assessment bias resulting from surgeons judging their own results would be avoided.