Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies

Objective This study evaluated the effect of ixekizumab (IXE) on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biological disease-modifying antirheumatic drug (bDMARD)–naïve or failed at least 1 tumor necrosis factor inhibitor (TNFi). Methods In 2 multicenter, randomized, double-blind, placebo-controlled, and active‑controlled (bDMARD-naïve only) trials, patients with r-axSpA were randomly assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], placebo (PBO), or adalimumab (ADA; bDMARD-naïve only). After 16 weeks, patients who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 52. Functioning and health were measured by the generic 36-item Short Form Health Survey (SF‑36) and the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI). Societal health utility was assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L). Results At Week 16, both doses of IXE in bDMARD-naïve and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. A larger proportion of patients reaching improvement in ASAS HI ≥ 3 as well as an achievement of ASAS HI good health status was reported in patients treated with IXE. Improvements were maintained through Week 52. Conclusion IXE significantly improved functioning and health as assessed by both generic and disease-specific measures, as well as societal health utility values in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, and improvements were sustained through 52 weeks.

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P194 Response to ixekizumab by C-reactive protein level in patients with aadiographic axial spondyloarthritis: results from the COAST-V (biological-naïve) and COAST-W (TNF-α inhibitor-experienced) trials at 52 weeks

Rheumatology ◽

10.1093/rheumatology/keab247.189 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

John D Reveille ◽

Proton Rahman ◽

David M Sandoval Calderon ◽

Talia Muram ◽

Andris Kronbergs ◽

...

Keyword(s):

Axial Spondyloarthritis ◽

Activity Index ◽

Short Form ◽

Stock Ownership ◽

Continuous Measure ◽

C Reactive Protein ◽

Double Blind ◽

Reactive Protein ◽

Asas Criteria ◽

Sf 36

Abstract Background/Aims Tumor necrosis factor inhibitors (TNFis) are effective treatments for radiographic axial spondyloarthritis (r-axSpA), but may be less effective in patients (pts) without elevated C-reactive protein (CRP). This study evaluated the efficacy of ixekizumab (IXE), a high-affinity monoclonal antibody selectively targeting interleukin-17A, in pts with r-axSpA at 52 weeks (wks) with nonelevated (≤5mg/L) and elevated (>5mg/L) baseline (BL) CRP. Methods COAST-V (NCT02696785) and COAST-W (NCT02696798) were phase 3, multicenter, randomised, double-blind, PBO-controlled trials investigating efficacy of 80-mg IXE every 4 wks and every 2 wks in pts who met ASAS criteria for raxSpA, had radiographic sacroiliitis according to mNY criteria, and were biological diseasemodifying antirheumatic drug (bDMARDs)-naïve (COAST-V) or TNFiexperienced (COAST-W). Data from 157 COAST-V pts and 188 COAST-W pts treated with IXE from Wk0 to 52 were analyzed. Patients were stratified based on nonelevated (≤5mg/L) vs elevated (>5 mg/L) BL CRP. Additional analysis was done with BL CRP ≤10.0mg/L vs > 10.0mg/L. Efficacy was assessed by ASAS40, ≥50% improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), and change in Short Form 36 physical component summary (SF36 PCS) score. Missing data were imputed by nonresponder imputation for binary measures and modified BL observation carried forward for continuous measure. Week 16 data are presented for comparison. Results Of pts treated with IXE through Wk52, 34.4% had CRP ≤5.0mg/L, 65.6% had CRP >5.0mg/L, 61.8% had CRP ≤10.0mg/L, and 38.2% had CRP >10.0mg/L at BL in COASTV and 33.0% had CRP ≤5.0mg/L, 67.0% had CRP >5.0mg/L, 55.9% had CRP ≤10.0mg/L, and 44.1% had CRP >10.0mg/L at BL in COAST-W.At Wk16, the proportion of pts achieving ASAS40 in COAST-V was numerically higher with IXE in the ≤5mg/L group and significantly higher with IXE in the >5mg/L group vs PBO, as previously shown, and was significantly higher with IXE in the ≤10mg/L and >10mg/L groups vs PBO. Results were similar in COAST-W and significant in the >5mg/L and ≤10mg/L groups vs PBO. At Wk52, greater than 45% of COAST-V pts and greater than 35% of COAST-W pts treated with IXE achieved an ASAS40 response, greater than 40% of COAST-V pts and greater than 25% of COAST-W patients treated with IXE achieved a BASDAI50 response, and change from baseline in SF-36 PCS score in patients treated with IXE was greater than 5 points in both studies regardless of the BL CRP cutoffs evaluated. Conclusion A higher proportion of ASAS40 responders was observed in IXE treated arms versus PBO among bDMARD-naïve and TNFi-experienced pts with r-axSpA when the CRP cutoff of 10mg/L was evaluated, and the responses were consistent through Wk52. Furthermore, similar proportions of pts achieved BASDAI50 and SF-36 responses within each patient population regardless of the BL CRP cutoff evaluated. Disclosure J.D. Reveille: None. P. Rahman: None. D.M. Sandoval Calderon: Shareholder/stock ownership; D. Sandoval Calderon is a shareholder and employee of Eli Lilly and Company. T. Muram: Shareholder/stock ownership; T. Muram is a shareholder and employee of Eli Lilly and Company. A. Kronbergs: Shareholder/stock ownership; A. Kronbergs is a shareholder and employee of Eli Lilly and Company. R. Bolce: Shareholder/stock ownership; R.Bolce is a shareholder and employee of Eli Lilly and Company. V. Geneus: Shareholder/stock ownership; V. Geneus is a shareholder and employee of Eli Lilly and Company. T. Hunter: Shareholder/stock ownership; T. Hunter is a shareholder and employee of Eli Lilly and Company. S. Liu-Leage: Shareholder/stock ownership; S.L. League is a shareholder and employee of Eli Lilly and Company. M. Rudwaleit: None. J.A. Maldonado-Cocco: None. F. van den Bosch: None.

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Innate Immunity Stimulation During COVID-19 Pandemic: Challenge

10.21203/rs.3.rs-1106959/v1 ◽

2021 ◽

Author(s):

beniamino palmieri ◽

antonio manenti ◽

MARIA VADALA'

Keyword(s):

Innate Immunity ◽

Social Role ◽

Short Form ◽

Bodily Pain ◽

Evidence Based ◽

Complete Regression ◽

Role Functioning ◽

Double Blind ◽

Sf 36 ◽

Oncologic Patients

Abstract AIM: We report an open spontaneous anecdotical retrospective survey of Corynebacterium parvum administration to 4000 fragile immune-depressed and multimorbid patients treated with a killed C. parvum strain to enhance the innate immunity integrating the adaptative immune response for a long standing antinfectious resistance. METHODS: 4000 patients (1900 men and 2100 women) with mild, moderate or chronic disease, appealing to our Second Opinion Medical Consultation Network, signed an informed consent and were injected subcutaneously with C.parvum. The treatment was followed up at 6 months after therapy, filling the short form of the medical outcome health survey questionnaire (SF-36), directly by the patients or its parents and monitoring the health regularly via telemedicine (Skype, WhatsApp, mail, etc) or physician’s visit.RESULTS: The main efficacy endpoints, as assessed by the SF-36 questionnaire, are significant improvements in the mental and physical role functioning score (p< 0.02), in general health, in social role functioning (p < 0.02), vitality (p < 0.03), and a significant reduction in bodily pain (p< 0.03). There was a quick (48-72 hours) symptoms improvement and/or complete regression of the herpetic eruptions observed in 1000 affected patients and of herpetic neuralgia (reduced in 80% of cases), also full recovery or frequency reduction (30%) of recurrent cystitis and prostatitis in 120 affected patients, and last, but not least, a life quality improvement in 100 oncologic patients of overall 200 cases. A significant increase in the lymphocyte count (p<0.01), mainly Helper and Killer lymphocytes, was noted after 6 months by Parvulan injection vs. the baseline.The asymptomatic SARS-CoV-2 patients, incidentally, enrolled in our survey, were tested at sixth months for antibodies against SARS-CoV-2 and 14 patients occurred high level of SARS-CoV-2 antibodies. The incubating Covid infections in the Parvulan injected patients even if rail and multi-morbid recovered in a short term (48-96 hours) and with benign clinical course, usually no need of further drugs administration except for the variants, which lasted on average one week and required some antipyretics, and low dose steroid for a few days.CONCLUSIONS: Our results confirm that C.parvum is quite safe and effective to support immune-compromised patients when epidemic or pandemic events rise the life risk and any kind of infections and complications rate.Further double-blind placebo evidence-based studies are urgently required, and our numerically substantial not sponsored spontaneous observation aims exclusively to promote further evidence based double blind institutional studies.

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Patients Screening Positive for Body Dysmorphic Disorder Show No Significant Health-Related Quality of Life Gain after Functional Septorhinoplasty at a Tertiary Referral Center

Facial Plastic Surgery ◽

10.1055/s-0038-1632400 ◽

2018 ◽

Vol 34 (03) ◽

pp. 318-324 ◽

Cited By ~ 6

Author(s):

Frank Wallner ◽

Dare Oladokun ◽

Peter Plinkert ◽

Ingo Baumann ◽

Ralph Hohenberger ◽

...

Keyword(s):

Quality Of Life ◽

Behavioral Treatment ◽

Selective Serotonin Reuptake Inhibitors ◽

Body Dysmorphic Disorder ◽

Short Form ◽

Bodily Pain ◽

The Body ◽

Sf 36 ◽

Disease Specific

AbstractBody dysmorphic disorder (BDD) is a psychiatric disorder defined by an excessive concern about one's physical appearance, especially regarding slight or imagined abnormities of the body. This study was conducted to compare postoperative quality of life (QOL) changes after primary septorhinoplasty among patients screening positive and those screening negative for BDD. Two common instruments for the screening of BDD were used namely the Dysmorphic Concern Questionnaire (DCQ) and the BDD Concern Questionnaire (BDDQ). For the determination of QOL changes, three validated screening instruments were used. The Functional Rhinoplasty Outcome Inventory (FROI-17) and the Rhinoplasty Outcomes Evaluation (ROE) were used as disease-specific instruments and the Short Form 36 Health Survey (SF-36) was used as a general instrument. All patients completed the FROI-17, the ROE, and the SF-36 preoperatively and 60 months postoperatively. The BDD questionnaires were singularly obtained 60 months after surgery. The authors identified 9.8% of our patients with a possible BDD diagnosis. The patients screening positive for BDD showed significantly lower ROE scores postoperatively, compared with those screening negative for BDD. QOL gains detected by the disease-specific instruments (ROE and FROI-17) were only significant in the non-BDD group. No significant QOL gains were detectable with the FROI-17, the ROE, and the SF-36 in the BDD group. In patients screening negative for BDD, QOL, as measured with the SF-36, improved significantly in five categories: physical functioning, role-functioning physical, bodily pain, general health, and social functioning. Patients screening positive for BDD did not improve in any categories of the general SF-36 questionnaire. Instead, their score in the “mental health” category was significantly lower 5 years after their surgery compared with preoperatively. Patients retrospectively screening positive for BDD in our cohort did not improve in QOL postoperatively. Alternative nonsurgical treatments such as cognitive behavioral treatment and/or selective serotonin reuptake inhibitors have been reported to be effective and should be considered as the treatment of choice. Some studies suggest that a smaller subgroup of BDD patients may benefit from functional rhinoplasty. Further research and larger long-term prospective outcome studies are needed to understand the influence of BDD symptoms on postoperative satisfaction and QOL changes after septorhinoplasty.

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Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041666 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1666 ◽

Cited By ~ 1

Author(s):

Paulo Fávio Macedo Gouvêa ◽

Zélia Maria Nogueira Britschka ◽

Cristina de Oliveira Massoco Salles Gomes ◽

Nicolle Gilda Teixeira de Queiroz ◽

Pablo Antonio Vásquez Salvador ◽

...

Keyword(s):

Quality Of Life ◽

Knee Osteoarthritis ◽

Short Form ◽

Serum Levels ◽

Double Blind ◽

Sf 36 ◽

Radiographic Grade ◽

Physical Functions ◽

Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

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EVALUATION OF QUALITY OF LIFE IN BRACHIAL PLEXUS INJURY PATIENTS AFTER RECONSTRUCTIVE SURGERY

Hand Surgery ◽

10.1142/s0218810406003279 ◽

2006 ◽

Vol 11 (03) ◽

pp. 103-107 ◽

Cited By ~ 27

Author(s):

Izuru Kitajima ◽

Kazureru Doi ◽

Yasunori Hattori ◽

Semih Takka ◽

Emmanuel Estrella

Keyword(s):

Quality Of Life ◽

Brachial Plexus ◽

Upper Extremity ◽

Brachial Plexus Injury ◽

Short Form ◽

Bodily Pain ◽

Summary Score ◽

Joint Function ◽

Sf 36

To evaluate the subjective satisfaction of brachial plexus injury (BPI) patients after surgery based on the medical outcomes study 36-item short form health survey (SF-36) and to correlate their SF-36 scores with upper extremity functions. Four items were assessed statistically for 30 patients: SF-36 scores after BPI surgery were compared with Japanese standard scores; the correlation between SF-36 scores and objective joint functions; difference in SF-36 scores between each type of BPI; and influence of each joint function on the SF-36 scores. The SF-36 subscale: PF — physical functioning, RP — role-physical, BP — bodily pain, and the summary score PCS — physical component summary, were significantly inferior to the Japanese standard scores. SF-36 is more sensitive to shoulder joint function than to elbow and finger joint functions. Little correlation was found between SF-36 scores and objective evaluations of joint functions. Greater effort is needed to improve the quality of life (QOL) of BPI patients. This study showed that SF-36 is not sensitive enough to evaluate regional conditions. A region- or site-specific questionnaire is required to evaluate upper extremity surgery.

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Reliability of the SF-36 in Japanese patients with systemic lupus erythematosus and its associations with disease activity and damage: a two-consecutive year prospective study

Lupus ◽

10.1177/0961203317725586 ◽

2017 ◽

Vol 27 (3) ◽

pp. 407-416 ◽

Cited By ~ 8

Author(s):

S Baba ◽

Y Katsumata ◽

Y Okamoto ◽

Y Kawaguchi ◽

M Hanaoka ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Mental Component Summary ◽

Short Form ◽

Bodily Pain ◽

Damage Index ◽

Japanese Patients ◽

Systemic Lupus ◽

Sf 36

We aimed to validate the reliability of the Medical Outcomes Study Short Form-36 (SF-36) among Japanese patients with systemic lupus erythematosus (SLE). Japanese patients with SLE ( n = 233) completed the SF-36 and other related demographic questionnaires, and physicians simultaneously completed the SLE Disease Activity Index 2000 (SLEDAI-2K) and the Systemic Lupus International Collaborating Clinics Damage Index (SDI). Patients were prospectively followed for a repeat assessment the following year. The SF-36 subscales demonstrated acceptable internal consistency (Cronbach’s α of 0.85–0.89), and an overall good test–retest reliability (intraclass correlation coefficient >0.70). The average baseline SF-36 subscale/summary scores except for “bodily pain” were significantly lower than those of the Japanese general population ( p < 0.05). The SDI showed an inverse correlation with the SF-36 subscale/summary scores except for “vitality” and “mental component summary” at baseline, whereas the SLEDAI-2K did not. In the second year, “social functioning” and “mental component summary” of the SF-36 deteriorated among patients whose SDI or SLEDAI-2K score increased (effect sizes < −0.20). In conclusion, the SF-36 demonstrated acceptable reliability among Japanese patients with SLE. Health-related quality of life measured by the SF-36 was reduced in Japanese patients with SLE and associated with disease damage, rather than disease activity.

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Health-related quality-of-life assessment in patients with low back pain using SF-36 questionnaire

Medicina ◽

10.3390/medicina43080077 ◽

2007 ◽

Vol 43 (8) ◽

pp. 607 ◽

Cited By ~ 15

Author(s):

Kotryna Vereščiagina ◽

Kazys Ambrozaitis ◽

Bronius Špakauskas

Keyword(s):

Quality Of Life ◽

Low Back Pain ◽

Short Form ◽

Bodily Pain ◽

Low Back ◽

Health Related Quality ◽

Sf 36 ◽

Related Quality ◽

Health Related

Objective. For complete assessment of benefits of the surgical intervention, it is essential to provide evidence of the impact on patients in terms of health status and healthrelated quality of life. In the present study, the preoperative 36-item Short Form (SF-36) Health Survey scores were determined in patients before lumbar microdiscectomy due to better preoperative screening likewise in the control group – almost healthy population taken into account any habitual ailments experienced in an appropriate age. Patients and methods. In the present study, we investigated a cohort of 100 patients with disc herniation causing low back pain and another hundred of the control subjects, matched by age and gender. The short form 36 general health questionnaire (SF-36) was applied. Results. Estimation of the SF-36 scores showed that (1) all of the domain values were considerably lower in the preoperative patient group than in the second one (P<0.01); (2) the bodily pain scores were closely correlated to the social function scores (R=0.7, P<0.01), whereas the physical function was less related to the bodily pain (R=0.6, P<0.01). The weakest correlation was observed between bodily pain and mental health and general health (R=0.4, P<0.01). Conclusion. The present study showed that the generic instrument, SF-36 Health Survey, was optimized paraclinical method for patients predisposed to surgical treatment of the lumbar disc herniation disease likewise for normal population individuals, matched by age and sex, in the assessment of health-related quality of life.

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Predictors of itch and pain in the 12 months following burn injury: results from the Burns Registry of Australia and New Zealand (BRANZ) Long-Term Outcomes Project

Burns & Trauma ◽

10.1093/burnst/tkz004 ◽

2020 ◽

Vol 8 ◽

Cited By ~ 2

Author(s):

Lincoln M Tracy ◽

Dale W Edgar ◽

Rebecca Schrale ◽

Heather Cleland ◽

Belinda J Gabbe ◽

...

Keyword(s):

Quality Of Life ◽

Severe Pain ◽

Burn Injury ◽

Short Form ◽

Bodily Pain ◽

Health Related Quality ◽

Sf 36 ◽

Related Quality ◽

Health Related

Abstract Background Itch and pain are common complaints of patients with burn injuries. This study aimed to describe the prevalence and predictors of itch and moderate to severe pain in the first 12 months following a burn injury, and determine the association between itch, moderate to severe pain, work-related outcomes, and health-related quality of life following a burn injury. Methods Burn patients aged 18 years and older were recruited from five Australian specialist burn units. Patients completed the 36-item Short Form Health Survey Version 2 (SF-36 V2), the Sickness Impact Profile (SIP) work scale, and a specially developed questionnaire relating to itch at 1, 6, and 12 months post-injury. Moderate to severe pain was defined as a score less than 40 on the bodily pain domain of the SF-36 V2. Multivariate mixed-effects regression models were used to identify patient and burn injury predictors of itch and moderate to severe pain. Results Three hundred and twenty-eight patients were included. The prevalence of itch decreased from 50% at 1 month to 27% at 12 months. Similarly, the prevalence of moderate to severe pain decreased from 23% at 1 month to 13% at 12 months. Compared to patients aged 18-34, the adjusted odds of experiencing any itch were 59% (95% CI: 0.20, 0.82) and 55% (95% CI: 0.22, 0.91) lower for patients aged between 35 and 49 and ≥ 50 years, respectively. Compared to patients aged 18-34, the adjusted odds of experiencing moderate to severe pain were 3.12 (95% CI: 1.35, 7.20) and 3.42 (95% CI: 1.47, 7.93) times higher for patients aged 35-49 and ≥ 50 years, respectively. Conclusions Less than 15% of patients reported moderate or severe pain at 12 months, while approximately one-quarter of the patients reported itch at the same period. The presence of moderate to severe pain was associated with a greater negative impact on health-related quality of life and work outcomes compared to itch. Further research is needed to improve our ability to identify patients at higher risk of persistent itch and pain who would benefit from targeted review and intervention studies.

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Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebo-controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/ard.2009.108159 ◽

2009 ◽

Vol 69 (2) ◽

pp. 413-416 ◽

Cited By ~ 103

Author(s):

J H Coombs ◽

B J Bloom ◽

F C Breedveld ◽

M P Fletcher ◽

D Gruben ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Health Status ◽

Short Form ◽

Controlled Trial ◽

Health Assessment ◽

Janus Kinase ◽

Inadequate Response ◽

Double Blind ◽

Sf 36 ◽

Factor Α

Objectives:To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor α inhibitor.Methods:Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks’ follow-up. The patient’s assessment of arthritis pain (pain), patient’s assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded.Results:At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (⩾0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components.Conclusions:CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.

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Long-term quality of life in patients with vestibular schwannoma: an international multicenter cross-sectional study comparing microsurgery, stereotactic radiosurgery, observation, and nontumor controls

Journal of Neurosurgery ◽

10.3171/2014.11.jns14594 ◽

2015 ◽

Vol 122 (4) ◽

pp. 833-842 ◽

Cited By ~ 91

Author(s):

Matthew L. Carlson ◽

Oystein Vesterli Tveiten ◽

Colin L. Driscoll ◽

Frederik K. Goplen ◽

Brian A. Neff ◽

...

Keyword(s):

Quality Of Life ◽

Stereotactic Radiosurgery ◽

Short Form ◽

Individual Treatment ◽

Control Group ◽

Treatment Groups ◽

Sf 36 ◽

Disease Specific

OBJECT The optimal treatment for sporadic vestibular schwannoma (VS) is highly controversial. To date, the majority of studies comparing treatment modalities have focused on a narrow scope of technical outcomes including facial function, hearing status, and tumor control. Very few publications have investigated health-related quality of life (HRQOL) differences between individual treatment groups, and none have used a disease-specific HRQOL instrument. METHODS All patients with sporadic small- to medium-sized VSs who underwent primary microsurgery, stereotactic radiosurgery (SRS), or observation between 1998 and 2008 were identified. Subjects were surveyed via postal questionnaire using the 36-Item Short Form Health Survey (SF-36), the 10-item Patient-Reported Outcomes Measurement Information System short form (PROMIS-10), the Glasgow Benefit Inventory (GBI), and the Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale. Additionally, a pool of general population adults was surveyed, providing a nontumor control group for comparison. RESULTS A total of 642 respondents were analyzed. The overall response rate for patients with VS was 79%, and the mean time interval between treatment and survey was 7.7 years. Using multivariate regression, there were no statistically significant differences between management groups with respect to the PROMIS-10 physical or mental health dimensions, the SF-36 Physical or Mental Component Summary scores, or the PANQOL general, anxiety, hearing, or energy subdomains. Patients who underwent SRS or observation reported a better total PANQOL score and higher PANQOL facial, balance, and pain subdomain scores than the microsurgical cohort (p < 0.02). The differences in scores between the nontumor control group and patients with VS were greater than differences observed between individual treatment groups for the majority of measures. CONCLUSIONS The differences in HRQOL outcomes following SRS, observation, and microsurgery for VS are small. Notably, the diagnosis of VS rather than treatment strategy most significantly impacts quality of life. Understanding that a large number of VSs do not grow following discovery, and that intervention does not confer a long-term HRQOL advantage, small- and medium-sized VS should be initially observed, while intervention should be reserved for patients with unequivocal tumor growth or intractable symptoms that are amenable to treatment. Future studies assessing HRQOL in VS patients should prioritize use of validated disease-specific measures, such as the PANQOL, given the significant limitations of generic instruments in distinguishing between treatment groups and tumor versus nontumor subjects.

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