Clinical and Sociodemographic Factors Associated With Health-Related Quality of Life in Patients With Adult Congenital Heart Disease　- A Nationwide Cross-Sectional Multicenter Study.

BACKGROUND: Little is known about clinical or sociodemographic factors that influence health-related quality of life (HRQoL) in patients with adult congenital heart disease (ACHD).Methods and Results: We conducted a nationwide prospective cross-sectional multicenter study at 4 large ACHD centers in Japan. From November 2016 to June 2018, we enrolled 1,223 ACHD patients; 1,025 patients had an HRQoL score. Patients completed a questionnaire survey, including sociodemographic characteristics, and the 36-Item Short-Form Health Survey (SF-36). To determine factors associated with HRQoL, correlations between 2 SF-36 summary scores (i.e., physical component score [PCS] and mental component score [MCS]) and other clinical or sociodemographic variables were examined using linear regression analysis. In multivariable analysis, poorer PCS was significantly associated with 11 variables, including older age, higher New York Heart Association class, previous cerebral infarction, being unemployed, and limited participation in physical education classes and sports clubs. Poorer MCS was associated with congenital heart disease of great complexity, being part of a non-sports club, current smoking, and social drinking. Student status and a higher number of family members were positively correlated with MCS. CONCLUSIONS: This study demonstrates that HRQoL in ACHD patients is associated with various clinical and sociodemographic factors. Further studies are needed to clarify whether some of these factors could be targets for future intervention programs to improve HRQoL outcomes.

Curcuma longa extract improves serum inflammatory markers and mental health in healthy participants who are overweight: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: The dietary spice Curcuma longa, also known as turmeric, has various biological effects. Both a water extract and a supercritical carbon dioxide extract of C. longa showed anti-inflammatory activities in animal studies. However, the anti-inflammatory effect in humans of a mixture of these two C. longa extracts (CLE) is poorly understood. Therefore, we investigated the effect of CLE containing anti-inflammatory turmeronols on chronic inflammation and general health. METHODS: We performed a randomized, double-blind, placebo-controlled study in healthy subjects aged 50 to 69 years with overweight. Participants took two capsules containing CLE (CLE group, n = 45) or two placebo capsules (placebo group, n = 45) daily for 12 weeks, and serum inflammatory markers were measured. Participants also completed two questionnaires: the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) and the Profile of Mood States (POMS) scale. Treatment effects were analyzed by two way analysis of variance followed by a t test (significance level, p <  0.05). RESULTS: After the intervention, the CLE group had a significantly lower body weight (p <  0.05) and body mass index (p < 0.05) than the placebo group and significantly lower serum levels of C-reactive protein (p < 0.05) and complement component 3 (p < 0.05). In addition, the CLE group showed significant improvement of the MOS SF-36 mental health score (p < 0.05) and POMS anger-hostility score (p < 0.05). CONCLUSION: CLE may ameliorate chronic low-grade inflammation and thus help to improve mental health and mood disturbance. TRIAL REGISTRATION: UMIN-CTR, UMIN000037370. Registered 14 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042607.

The effect of parathyroidectomy on quality of life in primary hyperparathyroidism: evaluation with using sf-36 and phpqol questionnaire.

Quality of life (QoL) typically improves with a parathyroidectomy (PTx) in cases of primary hyperparathyroidism (PHPT), but the effect of surgery on QoL is not yet fully understood. This study evaluated the impact of PTx on health-related QoL (HRQoL). Patients who underwent PTx for PHPT between January 2016 and December 2019 were asked to complete the 36-Item Short Form Health Survey (SF-36) and the Primary Hyperparathyroidism Quality of Life (PHPQoL) questionnaire before surgery and 1 year later. A 5-point Likert scale was used: negative responses received a lower score and positive responses scored high. Forty-one of 50 patients completed the questionnaires before and 12 months after the surgery. The median patient age was 64 years (min-max: 32-83 years). In the study group, 33 were female, and 8 were male. The SF-36 results indicated that significant improvements had been observed in all 8 domains a year after surgery, particularly in the physical functioning and role, general health, energy, and mental health scales. The PHPQoL scores also improved significantly after PTx (p < 0.05). The improvement in the physical and mental health components was 50% and 76%, respectively. In conclusion, this study demonstrated that PTx for PHPT improved QoL.

PROMIS measures can be used to assess symptoms and function in long-term hematopoietic cell transplantation survivors.

BACKGROUND: Patient-reported outcomes for hematopoietic cell transplantation (HCT) survivors are well characterized with established measures; however, there is little experience with the new, freely available Patient-Reported Outcomes Measurement Information System (PROMIS) measures in this population. The aim of this study was to compare the performance of the PROMIS measures in the HCT setting with the performance of the commonly used 36-Item Short Form Health Survey (SF-36). METHODS: Adult HCT survivors from the Fred Hutchinson Cancer Research Center (n = 4446) were mailed a survey that included the following as part of an annual follow-up survey: the Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH; 10 questions), the 29-Item Patient-Reported Outcomes Measurement Information System Profile (PROMIS-29), and the SF-36. RESULTS: Both the SF-36 and PROMIS measures were available for 1634 HCT recipients (503 autologous recipients and 1131 allogeneic recipients). The overall response rate was 46%. The median time after transplantation for allogeneic and autologous recipients was 12.0 years (range, 0.4-44.1 years) and 6.1 years (range, 0.4-30.1 years), respectively. With the SF-36 or PROMIS-GH, overall physical functioning was somewhat lower in comparison with the general population, but mental functioning was similar. Component and domain scores with similar contents were strongly correlated by Pearson correlation coefficients: the Global Health-Physical and SF-36 Physical Component Summary scores for autologous (r = 0.82) and allogeneic recipients (r = 0.83) and the PROMIS-29 and SF-36 physical function, pain, and vitality/fatigue scores for allogeneic (0.87, -0.82, and -0.82, respectively) and autologous recipients (0.84, -0.82, and -0.81, respectively). The correlation between the Global Health-Mental and SF-36 Mental Component Summary scores was lower (0.70 for autologous recipients and 0.72 for allogeneic recipients). CONCLUSIONS: Physical and mental symptoms and function in autologous and allogeneic HCT survivors can be adequately assessed with PROMIS-29 and PROMIS-GH. Cancer 2018;124:841-9. © 2017 American Cancer Society.

Centralized patient-reported outcome data collection in transplantation is feasible and clinically meaningful.

BACKGROUND: Allogeneic hematopoietic cell transplantation (HCT) cures many patients, but often with the risk of late effects and impaired quality of life. The value of quantifying patient-reported outcomes (PROs) is increasingly being recognized, but the routine collection of PROs is uncommon. This study evaluated the feasibility of prospective PRO collection by an outcome registry at multiple time points from unselected HCT patients undergoing transplantation at centers contributing clinical data to the Center for International Blood and Marrow Transplant Research (CIBMTR), and then it correlated the PRO data with clinical and demographic data. METHODS: The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), 36-Item Short Form Health Survey (SF-36), and Pediatric Quality of Life Inventory measures were administered before HCT, on day 100, and at 6 and 12 months. Patients were recruited by the transplant center, but posttransplant PRO collection was managed centrally by the CIBMTR. RESULTS: There were 580 eligible patients, and 390 (67%) enrolled. Feasibility was shown by high time-specific retention rates (176 of 238 at 1 year or 74%) and participant satisfaction. Factors associated with higher response rates were an age > 50 years (odds ratio [OR], 1.58; 95% confidence interval [CI], 1.03-2.41; P = .0355), white race (OR, 4.61; 95% CI, 2.66-7.99; P < .0001), and being married (OR, 2.28; 95% CI, 1.42-3.65; P = .0006) for adults and a higher family income for children (OR, 4.99; 95% CI, 2.12-11.75; P = .0002). Importantly, pre-HCT PRO scores independently predicted survival after adjustments for patient-, disease-, and transplant-related factors. The adjusted probabilities of 1-year survival were 56%, 67%, 75%, and 76% by increasing quartiles of the pre-HCT FACT-BMT score and 58%, 72%, 62%, and 82% by increasing quartiles of the pre-HCT SF-36 physical component score. CONCLUSIONS: A hybrid model of local consent for centralized PRO collection is feasible, and pretransplant PROs provide critical prognostic information for HCT outcomes. Cancer 2017;123:4687-4700. © 2017 American Cancer Society.

Impact of chronic Pseudomonas aeruginosa infection on health-related quality of life in Mycobacterium avium complex lung disease.

BACKGROUND: In bronchiectasis patients, chronic Pseudomonas aeruginosa (PA) infection has been associated with worse health-related quality of life (HRQL), but little is known about Mycobacterium avium complex lung disease (MACLD) patients in this context. This study aimed to evaluate HRQL and investigate the impact of chronic PA infection in MACLD patients. METHODS: This cross-sectional study was conducted using the Registry of Prospective Cohort Study including MACLD patients. The 36-item Short-Form health survey (SF-36) and St. George's Respiratory Questionnaire (SGRQ) were administered to assess clinical outcomes. Clinical variables included treatment and sputum culture status, pulmonary function tests, cavitary lesions, and modified Reiff scores on high-resolution computed tomography. RESULTS: The study included 244 MACLD patients (median age, 68 years; 196 women), 19 of whom had chronic PA infection. Modified Reiff score was higher in patients with chronic infection than in those without (P = 0.028). Regarding SF-36 scores, physical functioning subscale scores were significantly lower in patients with chronic infection (P = 0.029). Additionally, SGRQ symptoms, impact, and total scores were significantly higher in patients with chronic infection. During analysis of covariance comparisons, SGRQ symptoms and impact scores were significantly higher for patients with chronic infection (P = 0.043 and 0.021, respectively). CONCLUSIONS: MACLD patients with chronic PA infection exhibited significantly higher SGRQ scores, indicating impaired HRQL. Chronic PA infection was significantly associated with the severity of bronchiectasis.

Functional status, time to transplantation, and survival benefit of kidney transplantation among wait-listed candidates.

BACKGROUND: In the context of an aging end-stage renal disease population with multiple comorbid conditions, transplantation professionals face challenges in evaluating the global health of patients awaiting kidney transplantation. Functional status might be useful for identifying which patients will derive a survival benefit from transplantation versus dialysis. STUDY DESIGN: Retrospective cohort study of wait-listed patients using data for functional status from a national dialysis provider linked to United Network for Organ Sharing registry data. SETTING & PARTICIPANTS: Adult kidney transplantation candidates added to the waiting list between 2000 and 2006. PREDICTOR: Physical Functioning scale of the Medical Outcomes Study 36-Item Short Form Health Survey, analyzed as a time-varying covariate. OUTCOMES: Kidney transplantation; survival benefit of transplantation versus remaining wait-listed. MEASUREMENTS: We used multivariable Cox regression to assess the association between physical function with study outcomes. In survival benefit analyses, transplantation status was modeled as a time-varying covariate. RESULTS: The cohort comprised 19,242 kidney transplantation candidates (median age, 51 years; 36% black race) receiving maintenance dialysis. Candidates in the lowest baseline Physical Functioning score quartile were more likely to be inactivated (adjusted HR vs highest quartile, 1.30; 95% CI, 1.21-1.39) and less likely to undergo transplantation (adjusted HR vs highest quartile, 0.64; 95% CI, 0.61-0.68). After transplantation, worse Physical Functioning score was associated with shorter 3-year survival (84% vs 92% for the lowest vs highest function quartiles). However, compared to dialysis, transplantation was associated with a statistically significant survival benefit by 9 months for patients in every function quartile. LIMITATIONS: Functional status is self-reported. CONCLUSIONS: Even patients with low function appear to live longer with kidney transplantation versus dialysis. For wait-listed patients, global health measures such as functional status may be more useful in counseling patients about the probability of transplantation than in identifying who will derive a survival benefit from it.

Effects of microvascular decompression on quality-of-life in trigeminal neuralgia patients aged 70 years and older.

Background: Trigeminal neuralgia (TN) occasionally affects older adults, frequently worsens, and becomes refractory to medication. Older adult patients with TN may consider microvascular decompression (MVD) for their treatment. No study examines MVD effects on older adult TN patients' health-related quality of life (HRQoL). The present study evaluates the HRQoL of TN patients aged 70 years and older before and after MVD. Methods: Adult TN patients who underwent MVD evaluated their HRQoL using the 36-Item Short-form (SF-36) Health Survey before and 6 months after MVD. The patients were divided into four groups according to their decade of age. The clinical parameters and operative outcomes were analyzed statistically. The SF-36 physical, mental, and role social component summary scores and eight domain scale scores were analyzed using a twoway repeated-measures analysis of variance (ANOVA) to compare the effects of age group and preoperative and postoperative time points. Results: Among 57 adult patients (34 women, 23 men; mean age, 69 years; range, 30-89 years), 21 patients were in their seventies, and 11 were in their eighties. The SF-36 scores of patients in all age groups improved after MVD. Two-way repeated-measures ANOVA demonstrated a significant age group effect on the physical component summary and its physical functioning domain. A time point effect was significant on all component summaries and domains. There was a significant interaction between age group and time point effects on the bodily pain domain. These results suggested that patients 70 years and older had significant postoperative HRQoL improvement, but their improvement of physical-related HRQoL and multiple physical pain issues were limited. Conclusion: Impaired HRQoL in TN patients aged 70 years and older can improve after MVD. Careful management of multiple comorbidities and surgical risks enables MVD to be an appropriate treatment for older adult patients with refractory TN.

Patient-reported outcomes in patients with primary immunodeficiency diseases in Japan: baseline results from a prospective observational study.

Introduction: Primary immunodeficiency diseases (PIDs) are rare inherited diseases resulting in impaired immunity. People with PID experience lower health-related quality of life (HR-QOL) and disease-related burdens in daily activities. This ongoing, prospective observational study aims to evaluate disease activity, treatment status, treatment-related burden, daily activities, and HR-QOL in patients with PID in Japan over a 1-year period. In this interim report (database lock: July 29, 2022), we present baseline results. Methods: Participants were enrolled between November 2021 and May 2022; data were collected four times/year per participant until May 2023 using an online electronic patient-reported outcomes system. Patients with PID and healthy volunteers aged ≥12 years, residing in Japan, and with access to a smartphone were eligible. HR-QOL (primary endpoint) was assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Work productivity was assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Other aspects of PID and burden were assessed with a new questionnaire developed in-house. The study is registered at the University hospital Medical Information Network clinical trials registry (UMIN000045622). Results: The full interim analysis set comprised 71 patients with PID and 47 healthy volunteers. The most common International Union of Immunological Societies PID category was primary antibody deficiency (56.3% of patients). Complications were common, especially recurrent respiratory tract infections (63.4%). Most patients with PID were treated with immunoglobulin replacement therapy (73.2%); 22.4% of these patients had serum immunoglobulin levels <700 mg/dL. Among patients who did not undergo hematopoietic cell transplantation, EQ-5D-5L (n=67) and SF-36 (n=59) Physical and Mental Component Summary scores were significantly lower than in healthy volunteers (p < 0.001). WPAI absenteeism, work productivity loss, and activity impairment scores were significantly lower in 42 working patients with PID than in 37 working healthy volunteers (p < 0.05). Other results indicated that patients with PID experience substantial burdens related to medical visits, expenses, work, and daily activities. Discussion: This interim analysis confirms that patients with PID in Japan have lower HR-QOL and work productivity compared with healthy individuals and experience substantial limitations and burdens in their daily lives.

The 36-item short form health survey: reliability and validity in Chinese medical students.

OBJECTIVE: The 36-Item Short Form Health Survey (SF-36) is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public. The aim of the study is to assess the psychometric properties of the 36-Item Short Form Health Survey (SF-36) in medical students in mainland of China. METHODS: The reliability and validity of the 36-Item Short Form Health Survey (SF-36) questionnaire were assessed by conducting a cross-sectional study of Chinese medical students in December 2011. All 1358 3(rd) year and 4(th) year medical students from 46 classes at China Medical University were investigated. RESULTS: The overall Cronbach's α coefficient of the SF-36 questionnaire was 0.791, while the respective Cronbach's α coefficients for each of the seven dimensions were > 0.70, except where the social function dimension was 0.631. Results showed that the SF-36 questionnaire was reliable and valid. CONCLUSION: In general, this study provides evidence that the SF-36 questionnaire is suitable measures for assess the QOL of medical students in China.

CYP7A1, NPC1L1, ABCB1, and CD36 Polymorphisms Associated with Coenzyme Q10 Availability Affect the Subjective Quality of Life Score (SF-36) after Long-Term CoQ10 Supplementation in Women.

The single nucleotide polymorphisms (SNPs) rs3808607, rs2072183, rs2032582, and rs1761667 are associated with coenzyme Q10 (CoQ10) bioavailability in women after long-term CoQ10 supplementation. However, the beneficial aspects of the association between these SNPs and CoQ10 supplementation remain unknown. We investigated their relationship using the subjective quality of life score SF-36 by reanalyzing previous data from 92 study participants who were receiving ubiquinol (a reduced form of CoQ10) supplementation for 1 year. Two-way repeated-measures analysis of variance revealed a significant interaction between rs1761667 and the SF-36 scores of role physical (p = 0.016) and mental health (p = 0.017) in women. Subgrouping of participants based on the above four SNPs revealed significant interactions between these SNPs and the SF-36 scores of general health (p = 0.045), role emotional (p = 0.008), and mental health (p = 0.019) and increased serum CoQ10 levels (p = 0.008), suggesting that the benefits of CoQ10 supplementation, especially in terms of psychological parameters, are genotype-dependent in women. However, significant interactions were not observed in men. Therefore, inclusion of SNP subgrouping information in clinical trials of CoQ10 supplementation may provide conclusive evidence supporting other beneficial health effects exerted by the association between these SNPs and CoQ10 on women.

Patient-Reported Outcome on Quality of Life and Pain after Revision Arthroplasty for Periprosthetic Joint Infection: A Cross-Sectional Study.

This study aims to explore the quality of life (QOL) and pain after revision surgery for periprosthetic joint infection (PJI) based on patients' reported outcomes. A cross-sectional questionnaire survey was conducted and 137 valid responses were included (response rate 64.0%). A total of 42 patients underwent debridement with implant retention (DAIR), 31 underwent one-stage revision, and 64 underwent two-stage revision. The average overall SF-36 score was 70.3. The DAIR group had significantly higher SF-36 than the two-stage revision group (p = 0.01). There was no significant difference between the one-stage revision group and the other two groups. A total of 74.5% of patients reported pain with an average McGill Pain Questionnaire (MPQ) score of 8.6. There was no significant difference in the MPQ scores among the three groups. Simple linear regression analyses demonstrated that higher preoperative PMN%, VAS, and shorter hospital stay were associated with pain (adjusted R2 = 4%, p = 0.020; adjusted R2 = 2.1%, p = 0.048; adjusted R2 = 2.1%, p = 0.049; respectively). We concluded that the overall QOL of patients after revision surgery for PJI is generally satisfactory. Persistent pain is prevalent, but the severity was mostly mild. Preoperative PMN%, VAS, and hospital stay were associated with postoperative pain.

Quantities of comorbidities affects physical, but not mental health related quality of life in type 1 diabetes with confirmed polyneuropathy.

BACKGROUND: A large number of adults with long-term type 1 diabetes are affected by symmetrical peripheral neuropathy. These complications increase socioeconomic expenses and diminish the individual quality of life. The 36-Item Short Form Health Survey (SF-36) is a generic patient reported questionnaire, measuring mental and physical health related quality of life. We hypothesized that diabetic neuropathy would decrease physical and mental quality of life measured with SF-36, and that clinical appearance may be associated with the decline. AIM: To investigate if diabetic neuropathy would decrease physical and mental quality of life measured with SF-36, and if clinical appearance may be associated with the decline. METHODS: Forty-eight adults [age 50 ± 9 years, 10 females, disease duration 32 (14-51) years] with verified diabetic symmetrical peripheral neuropathy and 21 healthy participants (age 51 ± 6 years, 6 females) underwent standardised nerve conduction testing and completed the SF-36 questionnaire. Furthermore, disease duration, number of comorbidities, both diabetes related and nondiabetes related, vibration perception threshold, number of hypoglycaemic events, HbA1c and administration way of insulin was notified. RESULTS: In comparison to healthy subjects, patients' mental composite score was not significantly diminished (51.9 ± 8.9 vs 53.1 ± 5.5, P = 0.558), while the physical composite score was (46.3 ± 11.7 vs 54.6 ± 3.3, P = 0.002). As expected, the overall physical health related symptoms in patients were associated to total number of comorbidities (P < 0.0001), comorbidities relation to diabetes (P = 0.0002) and HbA1c (P = 0.005) as well as comorbidities not related to diabetes (P = 0.0006). CONCLUSION: The finding of this study emphasises the importance of focusing on quality of life in adults with diabetes and especially in those with multiple comorbidities as well as the possibility of HbA1c as a biomarker for severe complication.

Quality of life and influencing factors of coal miners in Xuzhou, China.

BACKGROUND: Coal industry is one of the national pillar industries in China. A large number of coal miners are exposed to various occupational hazards, which might cause occupational disease. The aim of the study was to assess the quality of life (QOL) of coal miners in Xuzhou, China and explore influencing factors to QOL of coal miners. METHODS: Six hundred and twelve underground miners and 354 ground workers in one of coal mines of Xuzhou were enrolled in our study. The 36-item Short-Form Health Survey (SF-36) questionnaires were applied to evaluate the QOL of coal miners. Multivariate stepwise regression analysis was used to assess the potential impact factors on QOL. RESULTS: The score of role limitations due to physical health problems (RP) dimension in underground miners was significantly lower than that of ground workers (P=0.005). Multivariate stepwise regression analysis showed that longer job tenure for dust exposure significantly lower coal miners' RP score. Comparing with normal populations, our subjects scored lower in both the physical health components (PHC) and the mental health components (MHC), and many factors accounted for it including job tenure for dust exposure, chronic disease, medical insurance, etc. CONCLUSIONS: QOL of coal miners has been affected. Some measures might be taken by enterprise and coal miners themselves to protect the health of coal miners and improve their quality of life.

Quantitative assessment of erector spinae muscles in patients with Mycobacterium avium complex lung disease.

BACKGROUND AND OBJECTIVE: No reports exist regarding skeletal muscle involvement in patients with Mycobacterium avium complex lung disease (MAC-LD). The cross-sectional area of the erector spinae muscles (ESMCSA) reflects physical activity and can be assessed by computed tomography (CT). We investigated the relationship between ESMCSA and physiological parameters and prognosis in MAC-LD patients. MATERIAL AND METHODS: In this prospective observational study, the ESMCSA was measured on single-slice axial CT images. MAC-LD patients and sex- and age-matched controls (non-MAC-LD participants) were evaluated. We evaluated the relationship between the ESMCSA and physiological parameters and prognosis. RESULTS: A total of 260 patients (209 female; median age, 69 years; 190 with nodular/bronchiectatic disease; 74 with cavitary lesions) were enrolled. The ESMCSA was not different between MAC-LD patients and controls. In MAC-LD patients, the ESMCSA was significantly associated with age, body mass index (BMI), pulmonary function, CT severity, and health-related quality of life (HRQL). Multivariate Cox proportional hazards analyses revealed that an ESMCSA < -1 standard derivation (hazards ratio [HR], 2.76; P = 0.047) was significantly associated with all-cause mortality, along with BMI < 18.5 kg/m2 (HR, 3.67; P = 0.02) and presence of cavitary lesions (HR, 5.84; P = 0.001). However, the ESMCSA was not significantly associated with all-cause mortality when current treatment status, % predicted functional vital capacity, and forced expiratory volume in 1 s were added to the analyses. CONCLUSIONS: Although the prognostic impact was limited, ESMCSA was significantly associated with HRQL and prognostic physiological parameters, such as BMI and pulmonary function.

Prospective randomized controlled trial of The Stabilis Stand Alone Cage (SAC) versus Bagby and Kuslich (BAK) implants for anterior lumbar interbody fusion.

BACKGROUND: Degenerative disc disease is common and debilitating for many patients. If conservative extensive care fails, anterior lumbar interbody fusion has proven to be an alternative form of surgical management. The Stabilis Stand Alone Cage(SAC) was introduced as a method to obtain stability and fusion. The purpose of this study was to determine whether the Stabilis Stand Alone Cage (SAC) is comparable in safety and efficacy to the Bagby and Kuslich (BAK) device. METHODS: As part of a prospective, randomized, controlled FDA trial, 73 patients underwent anterior interbody fusion using either the SAC(56%) or the BAK device (44%). RESULTS: Background characteristics were similar between the two groups. There was no significant difference between the SAC and BAK groups in mean operative time or mean blood loss during surgery. Adverse event rates did not differ between the groups. Assessment of plain radiographs could not confirm solid fusion in 63% of control and 71% of study patients. Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up. There were no significant differences between the SAC and BAK patients with respect to outcome. CONCLUSIONS: Both the Stabilis Stand Alone Cage and the BAK Cage provided satisfactory improvement in function and pain relief, despite less than expected radiographic fusion rates. The apparent incongruency between fusion rates and functional outcomes suggests that either radiographs underestimate the true incidence of fusion, or that patients are obtaining good pain relief and improved function despite a lower rate of fusion than previously reported. This was a Level III study.

Construct domain analysis of patient health-related quality of life: physical and mental trajectory profiles following open versus endovascular repair of abdominal aortic aneurysm.

PURPOSE: Many clinical trials comparing the outcomes of open surgical repair (OSR) versus endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) have been conducted, with varying results. Surprisingly, few outcomes studies have closely examined perceived physical and mental health-related quality of life (HRQOL) factors through a validated survey tool. The purpose of this prospective observational study was to describe the trajectory of HRQOL measures, from baseline to 1 year after surgery, in patients undergoing OSR or EVAR for AAA, and to explore for differences in physical and mental composite scores and their construct domains (subscales) using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36(®)) tool. PATIENTS AND METHODS: Over an 18-month period, a small sample of patients undergoing elective AAA repair in a community hospital setting were prospectively enrolled. Fifteen patients undergoing OSR and twenty patients undergoing EVAR were studied. Physical and mental HRQOL parameters were assessed using the SF-36. RESULTS: No significant differences in demographic and clinical variables were found between the OSR and EVAR groups. In the multivariable linear models with repeated measures, both groups showed a significant decline in physical health composite scores 30 days after the surgical procedure (P < 0.01). However, although the OSR group showed a statistically significant decline in three of the four physical health domains, the EVAR group declined in only one physical health domain. Only the OSR group showed a significant decline in three of the four mental health domains at 30 days; however, the decline of these domains was not reflected in the group's mental health composite scores. By 90 days after surgery, both groups were not significantly different from their baseline in physical or mental health composite scores, or in any of their respective physical health domains. CONCLUSION: In this small sample of patients undergoing AAA repair, EVAR resulted in less physical and emotional decline than OSR in the early postoperative period. However, patients in both groups may return to near baseline status at 90 days.