Improvement In Physical Health-related Quality Research Articles

208. Should patients with lumbar stenosis and Grade I spondylolisthesis be treated differently based on spinopelvic alignment? A comparison of clinical and patient reported outcomes within a single health system

<h3>BACKGROUND CONTEXT</h3> Degenerative spondylolisthesis of the lumbar spine is one of the most common pathologies addressed by surgeons. Recently, high-level data demonstrated improved outcomes with fusion in conjunction with laminectomy compared to laminectomy alone. <h3>PURPOSE</h3> The present study is the first analysis to examine the effect of spinopelvic alignment on patient-reported outcomes following decompression alone versus decompression with fusion. <h3>STUDY DESIGN/SETTING</h3> Subgroup analysis of observational prospective cohort study. <h3>PATIENT SAMPLE</h3> A total of 679 patients with degenerative Grade I spondylolisthesis and stenosis treated with laminectomy alone or laminectomy with fusion at a tertiary care insitution. <h3>OUTCOME MEASURES</h3> Primary outcome was the change in Patient-Reported Outcome Measurement Information System (PROMIS), Global Physical Health (GPH), and Global Mental Health (GMH) scores at baseline and postoperatively at 6 and 12 months. <h3>METHODS</h3> Patients underwent laminectomy alone or laminectomy with instrumented fusion for degenerative Grade I lumbar spondylolisthesis and stenosis. Four cohorts were created based on pelvic incidence minus lumbar lordosis (PILL): (1) fusion with PILL>10°, (2) fusion with PILL10°, and (4) decompression alone with PILL <10°. The between-group comparisons of PROMIS GPH/GMH score changes were analyzed using mixed-effects models. Analyses were conducted independently for the following: (1) unmatched cohort, (2) 1:1 propensity score matched patients (PSM), (3) coarsened exact matched (CEM) patients. <h3>RESULTS</h3> A total of 49.9% (339) underwent lumbar decompression with fusion, while 50.1% (340) received decompression. When comparing low spinopelvic mismatch (PILL 10) patients, fusion-treated patients had improved postoperative PROs (GMH: 26.61 vs 20.75, p < 0.0001; GPH: 23.61 vs 18.13, p < 0.0001) at 10-12 months. Mixed effect modeling confirmed GPH score improvement was 5.11 (2.08 - 8.13) points higher at 10-12 months in the fusion group. <h3>CONCLUSIONS</h3> Among Grade I spondylolisthesis patients with PILL>10°, laminectomy with fusion was associated with greater improvement in physical health-related quality of life than laminectomy alone. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

A profile of patient response across surgical end-stage hip, knee and spine osteoarthritis

Purpose: Orthopaedic surgical procedures for osteoarthritis (OA) are among the most frequently performed scheduled procedures in North America. Volumes are highest for hip and knee replacements and lumbar spinal surgery. However, patient reported response is variable with 10-40% of patients reporting persistent pain and subthreshold minimal clinical improvement. Given the potential patient and economic impact, an ability to predict whether a patient will ‘respond’ to surgery or not is of considerable interest. Unfortunately, predictive factors have been variable across studies and limited in dimension, making direct comparison across hip, knee and spine surgery for OA (HKS-OA) difficult. The Longitudinal Evaluation in the Arthritis Program (LEAP) is a large prospective observational cohort study of patients undergoing surgical intervention for HKS-OA (LEAP-OA). A bio-psycho-social prognostic framework was used to select patient factors/outcomes to profile patients and recovery trajectories over a 1-year period. This report represents the first ‘bird’s eye view’ of congruent and contemporaneous surgical HKS-OA patient profiles, examining similarities and differences across groups, and outcome response using a generic health status outcome. Methods: LEAP-OA recruited consecutive patients undergoing primary hip or knee replacement for OA or decompression (with/without fusion) surgery for back and leg symptoms due to lumbar spinal stenosis due to facet OA from Nov 2015 to Dec 2018. All patients provided written informed consent. Eligibility criteria included ≥35 years of age and English fluency. Exclusion criteria included acute trauma/injury, inflammatory arthritis, revision surgery. Clinical and self-reported sociodemographic, physical, mental and social health-related data were captured pre-surgery. The generic SF-12 health measure was collected pre-surgery and at 3 and 12 months post-surgery. Follow-up response rates were >80%. Descriptive analyses assessed baseline characteristics and change in the SF-12 physical component scores (PCS) over time across groups. The primary outcome was the proportion of responders at 3 and 12 months across groups achieving a minimally clinically important improvement (MCII) using PCS (>=4.6). Results: There were 547 hip, 625 knee and 140 spine OA patients with complete data. Mean ages were 65.1, 66.2, and 67.1 years, and 46.3%, 43.4% and 57.5% were female, among hip, knee and spine patients, respectively. The proportion of patients who were overweight or obese was highest for knee patients. Mean number of concurrent symptomatic joints were 2.3, 3.2 and 3.6 for hip, knee and spine patients, respectively. Clinically relevant levels of pain catastrophizing were reported by 18.8% of spine patients vs. 13.9% and 14.5% of hip and knee patients, respectively. While mean depressive symptom scores and anxiety scores were similar, rates of moderate/severe depressive symptoms were somewhat higher among spine patients, and moderate/severe anxiety symptoms among knee patients (Table 1). Approximately half of spine patients, and 35.2% and 29.6% of knee and hip patients had neuropathic pain scores indicative of possible/likely neuropathic pain using the painDETECT questionnaire. Average pain intensity ratings were similar across groups. Pre-surgery SF-12 PCS scores were similar across groups. Mean changes in PCS scores at 3 and 12 months post-surgery were greatest for hip patients and similar for knee and spine patients (Table 2). The majority of improvement in PCS scores occurred during the first 3 months, with continuing improvement to 12 months for all groups. By 3 months, hip patients were most likely to have achieved a SF-12 PCS MCII, and by 12 months achievement rates were 80.3%, 64.6% and 62.9% for hip, knee and spine, respectively. Reported rates of satisfaction with surgical results and willingness to have the surgery again were consistently high across groups at 90% or more. By 12 months, approximately 92% of hip patients, and 82% of knee and spine patients reported being able to cope with their current symptom state. Conclusions: A comprehensive set of patient and health-related factors provided the first opportunity to identify similarities and differences across a contemporaneous group of SHK-OA patients. Our Results are consistent with current literature and reflect that a significant proportion of patients, especially those undergoing knee and spine surgery for OA, do not reach a minimal response to improvement in physical health-related quality of life, despite a very high satisfaction rate. The baseline variables, response trajectories and rates varied between OA groups suggesting that there may be unique prognostic factors across groups that explain differences in responder rates. They may also represent distinct ‘classes’ of OA patients generally. Applied to the over 1.6 million inpatient spinal fusions, hip and knee replacements performed in the US in 2014, our non-response rates translate to approximately 500,000 SHK-OA surgeries a year at cost of $10billion USD. This represents a tremendous economic argument for improved pre-operative prognostic decision making (i.e. precision surgery). Advanced analytics techniques are the next steps to determine predictive phenotypes and improve point-of-care decision making.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Parathyroid Hormone Therapy for Managing Chronic Hypoparathyroidism: A Systematic Review and Meta-Analysis.

The efficacy and safety of parathyroid hormone (PTH) therapy for managing long-term hypoparathyroidism is being evaluated in ongoing clinical trials. We undertook a systematic review and meta-analysis of currently available randomized controlled trials to investigate the benefits and harms of PTH therapy and conventional therapy in the management of patients with chronic hypoparathyroidism. To identify eligible studies, published in English, we searched Embase, PubMed, and Cochrane CENTRAL from inception to May 2022. Two reviewers independently extracted data and assessed the risk of bias. We defined patients' important outcomes and used grading of recommendations, assessment, development, and evaluation (GRADE) to provide the structure for quantifying absolute effects and rating the quality of evidence. Seven randomized trials of 12 publications that enrolled a total of 386 patients proved eligible. The follow-up duration ranged from 1 to 36months. Compared with conventional therapy, PTH therapy probably achieves a small improvement in physical health-related quality of life (mean difference [MD] 3.4, 95% confidence interval [CI] 1.5-5.3, minimally important difference 3.0, moderate certainty). PTH therapy results in more patients reaching 50% or greater reduction in the dose of active vitamin D and calcium (relative risk [RR]= 6.5, 95% CI 2.5-16.4, 385 more per 1000 patients, high certainty). PTH therapy may increase hypercalcemia (RR=2.4, 95% CI 1.2-5.04, low certainty). The findings may support the use of PTH therapy in patients with chronic hypoparathyroidism. Because of limitations of short duration and small sample size, evidence from randomized trials is limited regarding important benefits of PTH therapy compared with conventional therapy. Establishing such benefits will require further studies. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Life after hepatitis C cure in HIV-infected people who inject drugs and men who have sex with men treated with direct-acting antivirals in France: Health perceptions and experiences from qualitative and quantitative findings (ANRS CO13 HEPAVIH).

There remains a substantial gap in our understandings of the life experiences of patients following HCV cure among HIV-HCV-co-infected people who inject drugs (PWID) and men who have sex with men (MSM), two key populations targeted for HCV elimination. We described the experiences and perspectives of HIV-positive PWID and MSM, HCV-cured following treatment with direct-acting antivirals (DAA). We used an exploratory sequential mixed approach using both qualitative data (semi-structured interviews with 27 PWID and 20 MSM) and quantitative data (self-administered questionnaires with 89 PWID) via the prospective ANRS CO13 HEPAVIH cohort. PWID reported improvements in physical health-related quality of life (HRQL) and self-reported symptoms following treatment, but no significant change in mental HRQL. During interviews, several MSM, more recently diagnosed with HCV, expressed less concern regarding HCV than HIV infection and interpreted improvements in their overall well-being after HCV cure to be more related to a closer connection with healthcare providers than with viral elimination. By contrast, PWID, particularly those previously exposed to interferon-based treatments, described major improvements in their physical HRQL. Both MSM and PWID reported improvements in cognitive or psychological wellbeing, and a majority of them reported some degree of concern over potential HCV reinfection. To conclude, though health benefits of HCV cure concern both groups, HIV-infected PWID and MSM may have different representations and experiences following DAA treatment, related to their history with HCV. They are thus likely to benefit from holistic, post-treatment follow-up care that is responsive to their evolving health and social contexts.

EXPOSURE IN VIVO VERSUS PAIN-CONTINGENT PHYSICAL THERAPY IN COMPLEX REGIONAL PAIN SYNDROME TYPE I: A COST-EFFECTIVENESS ANALYSIS.

The aim of this study was to evaluate the cost-effectiveness of exposure in vivo (EXP, a cognitive-behavioral treatment targeting pain-related fear) in Complex Regional Pain Syndrome Type I (CRPS-I), as compared to pain-contingent physical therapy (PPT). Data from a randomized controlled trial were used to compare the cost-effectiveness of EXP versus PPT from a societal perspective. Intervention costs, other healthcare costs, costs to patient and family, and productivity losses were included. The main outcomes were changes in the SF-36 physical component scale and quality-adjusted life-years. Changes were followed until 6 months after treatment. Uncertainty was estimated using nonparametric bootstrap analysis, cost-effectiveness acceptability curves and cost-effectiveness planes. Sensitivity analyses were performed to check robustness of findings. Forty-six patients were randomized and thirty-eight completed the study. Over 6 months, EXP resulted in greater improvement in physical health-related quality of life and quality-adjusted life-years than PPT. Despite higher initial treatment costs, EXP showed a tendency to reduce all costs compared with PPT; healthcare costs were significantly reduced. Furthermore, the cost-effectiveness planes were in favor of EXP. Sensitivity analyses, for different program costs and complete cases only, confirmed robustness of these findings. EXP, a cognitive-behavioral treatment, seems more cost-effective than PPT in CRPS patients with pain-related fear. The initial higher costs for EXP are offset by a long-term reduction of costs for healthcare use, and a tendency to lower work absenteeism and reduced societal costs. Due to low sample sizes, replication of findings is required to confirm results.

Bidirectional associations between alcohol consumption and health-related quality of life amongst young and middle-aged women.

Evidence from cross-sectional studies has suggested a positive association between moderate alcohol consumption and health-related quality of life but prospective data remain scarce. To examine the bidirectional relationships between alcohol consumption and health-related quality of life using a longitudinal study design. A total of 92 448 participants of the Nurses' Health Study II reported their alcohol consumption (in 1991, 1995, 1999 and 2003) and health-related quality of life (in 1993, 1997 and 2001). Using generalized estimating equations, we modelled the physical and mental component summary (PCS and MCS) scores as a function of alcohol consumption 2 years earlier (n = 88 363) and vice versa (n = 84 621). Greater alcohol consumption was associated with better PCS scores 2 years later in a dose-response manner up to ~1 serving daily [mean difference (β) = 0.67 ± 0.06 PCS units, for moderate versus infrequent drinkers]. After adjustment for previous PCS, a similar but attenuated pattern was observed (β = 0.33 ± 0.07). Moderate alcohol consumption was not related to MCS, whereas moderate-to-heavy alcohol consumption was associated with lower MCS scores (β = -0.34 ± 0.15). Higher PCS scores were associated with greater alcohol consumption 2 years later, also after adjustment for previous alcohol consumption (β = 0.53 ± 0.05 g day(-1) ). MCS was not associated with alcohol consumption 2 years later. Amongst young and middle-aged women, moderate alcohol intake was associated with a small improvement in physical health-related quality of life 2 years later and vice versa. Moderate alcohol consumption was not associated with mental health-related quality of life in either direction.

BAX326 (RIXUBIS): a novel recombinant factor IX for the control and prevention of bleeding episodes in adults and children with hemophilia B.

Hemophilia B management has improved considerably since the introduction of high-purity plasma-derived factor IX (pdFIX) products in the early 1990s. Recombinant FIX (rFIX) was introduced more recently and has potential safety advantages over the older blood-based products. Until recently, only one such product, nonacog alfa (BeneFIX(®), Pfizer, Inc.), has been available. However, a new rFIX product, BAX326 (RIXUBIS, Baxter Healthcare Corp.), has now been approved by the US Food and Drug Administration. BAX326 undergoes rigorous virus elimination and purification steps during manufacture, and has low activated FIX activity, which confers low thrombogenic potential in humans. Preclinical studies showed promising pharmacokinetic and safety profiles, and these early findings have since been expanded in a series of prospective, multicenter, clinical studies. Foremost among these is a pivotal phase I/III study of BAX326 and its use in routine prophylaxis or on-demand treatment in patients aged 12-65 years with severe (FIX level <1%) or moderately severe (FIX level ≤2%) hemophilia B. This study confirmed the pharmacokinetic equivalence of BAX326 and nonacog alfa, and showed a significant reduction in annualized bleeding rate with BAX326 prophylaxis compared with on-demand treatment (79% versus historic controls; p < 0.001). The hemostatic efficacy of BAX326 was rated as 'excellent' or 'good' in 96% of bleeds. BAX326 was also associated with statistically significant and clinically meaningful improvements in physical health-related quality of life. Results are similarly encouraging in a pediatric study in children aged up to 12 years and in a study in hemophilia B patients undergoing surgery. A further study showed safe transition, with no inhibitor formation in any patient, from treatment with a pdFIX product to BAX326. Overall, the safety profile of BAX326 in clinical trials has been strong, with no inhibitor or specific antibody formation, thrombosis, or treatment-related serious adverse events or anaphylaxis.

Do we increase the operative risk by adding the Cox Maze III procedure to aortic valve replacement and coronary artery bypass surgery?

Recent reports from Europe and the United States have suggested that patients presenting for open surgery with a significant history of atrial fibrillation (AF) have inferior early and late outcomes if AF is left untreated. On the other hand, there is reluctance among surgeons to treat AF surgically, especially when atriotomies may be required otherwise, which is the case with aortic valve replacement (AVR) or coronary artery bypass grafting (CABG). The objective of this study was to explore the potential impact of the addition of the Cox Maze III procedure on short- and long-term outcomes of patients when combined with AVR or CABG. Since 2005, 485 patients have undergone the Cox Maze III procedure at Inova Heart and Vascular Institute, 95 of whom had a full Cox Maze III with an AVR or CABG (Cox Maze III/AVR = 30; Cox Maze III/CABG = 47; Cox Maze III/AVR/CABG = 18). In addition, 4255 patients with no history of AF underwent AVR or CABG without surgical ablation (AVR = 422; CABG = 3518; AVR/CABG = 315). Data from our CABG, valve, and AF registries were used for analyses. Patients with and without the Cox Maze III were propensity score matched using a 0.10 caliper to improve balance on clinical and demographic variables. Differences in perioperative and postoperative outcomes by group were evaluated using the Fisher exact test, and a Kaplan-Meier survival analysis was completed. Health-related quality of life (Short Form 12) was obtained at baseline and 6 months post-surgery (n = 72). All 95 patients who underwent the Cox Maze III were propensity score matched with patients who did not undergo the Cox Maze III. Mean age (t = 0.3, P = .79) and European System for Cardiac Operative Risk Evaluation score (t = -1.8, P = .07) were similar between the groups. There were no significant differences in major postoperative morbidities between the groups despite the Cox Maze III group being on bypass longer (164.4 vs 108.8 minutes; t = -9.8, P < .001). Pacemaker implantation was significantly higher in the Cox Maze III group (P = .03). Survival during follow-up (mean = 35 months) was not different between patients who did and did not undergo the Cox Maze III procedure (log rank = 0.49, P = .48). Improvement in physical health-related quality of life was similar for both groups (F = 0.01, P = .94). At 1 year, 94% of the patients (60/64) who underwent the Cox Maze III procedure were in sinus rhythm (81% off class I and III antiarrhythmic drugs). The addition of the Cox Maze III procedure to AVR or CABG did not convey an increase in major morbidity and perioperative risk. Patients who underwent the Cox Maze III procedure demonstrated similar survival over time with improvement in health-related quality of life. The Cox Maze III should not be denied to patients in whom the cardiac surgical procedure does not include atriotomies because of the perceived increased operative risk. The Cox Maze III may significantly improve their outcome.