Short Form-36 Physical Component Score Research Articles

Minimally Invasive versus Open Transforaminal Lumbar Interbody Fusion in Obese Patients: A Propensity Score-Matched Study.

Retrospective review of prospectively collected data. This study aimed to compare the clinical outcomes of obese patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and open TLIF. The perioperative benefits of minimally invasive surgery in obese patients have been described. However, there is limited literature on the patient-reported outcomes (PROs), satisfaction and return to work following MIS-TLIF and open TLIF in this subgroup of patients. Obese patients (BMI ≥30.0kg/m2) who underwent a primary, one- to two-level open and MIS-TLIF were stratified and matched using propensity scoring. Operative time, length of stay and perioperative outcomes were recorded. Patient-reported outcomes (PROs) including Oswestry Disability Index, Short Form-36 Physical Component Score, Mental Component Score, Visual Analogue Scale for back pain and leg pain were compared at each postoperative time point. Achievement of minimal clinically important difference (MCID), patient satisfaction and return to work were also assessed. Revision procedures were recorded at mean 10±3.3 years follow-up. In total, 236 obese patients were included: 118 open TLIF and 118 MIS-TLIF. Length of stay was longer in the Open TLIF cohort and there was a trend towards a higher complication rate. However, there was no difference in operative time, transfusions or readmissions. Patients who underwent open TLIF reported worse ODI (P=0.043) and VAS leg pain at 2 years, although the latter did not reach statistical significance (P=0.095). Achievement of MCID for each PRO, patient satisfaction and return to work were also comparable. Obese patients who underwent MIS-TLIF had a shorter length of stay and improved functional disability at 2 years compared those who underwent open TLIF. However, a similar proportion achieved a clinical meaningful improvement. Patient satisfaction and return to work were also comparable at 2 years. Level III, retrospective cohort study.

Correlation between preoperative cardiopulmonary exercise testing and six-minute walk test, five-times sit to stand test and Short Form-36 physical component score in patients undergoing cytoreductive surgery

IntroductionAssessment of preoperative function is important for determining fitness for surgery, preoperative optimisation and predicting postoperative morbidity in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). This study explored correlations between preoperative cardiopulmonary exercise testing (CPET) variables, and six-minute walk test (6MWT), five-times sit to stand test (5STS) and Short Form-36 (SF-36) physical component score in patients scheduled for elective CRS-HIPEC. MethodsThis study included patients who underwent preoperative CPET, 6MWT, 5STS and responded to the SF-36 survey prior to elective CRS-HIPEC at Royal Prince Alfred Hospital in Sydney. CPET was performed using a cycle ergometer and measured peak oxygen uptake (VO2 peak) and anaerobic threshold (AT). The associations between preoperative CPET variables and preoperative 6MWT, 5STS and SF-36 were assessed using correlation test. ResultsA total of 133 patients scheduled for elective CRS-HIPEC were included in this study. The median VO2, AT and VE/VCO2 were 20.3 [6.5] ml/kg/min, 13.1 [4.9] ml/kg/min and 29 [4.5], respectively. The median 6MWT, 5STS and SF-36 physical component score were 525 m, 9.2 s and 50.2, respectively. CPET variables were significantly correlated with 6MWT (VO2 r = 0.51; AT r = 0.35; VE/VCO2 r = −0.25; p < 0.01), 5STS (VO2 r = −0.32; AT r = −0.27; VE/VCO2 r = 0.24; p < 0.01) and SF-36 (VO2 r = 0.42; AT r = 0.38; VE/VCO2 r = −0.23; p < 0.01). Conclusions6MWT, 5STS and SF-36 are at best moderately correlated with CPET variables, which suggests that these tests may serve as adjuncts rather than a replacement to CPET in the clinical setting.

INVESTIGATION OF CLINICAL FACTORS AFFECTING PERCEIVED PAIN INTENSITY IN FEMALE PATIENTS WITH KNEE OSTEOARTHRITIS

Objective: The present study aimed to identify the clinical variables influencing perceived pain intensity at rest, during activity, and at night in female patients with knee osteoarthritis (OA). Method: One hundred-six female patients with knee OA (mean age, 58.50±9.48 years; mean BMI, 30.73±5.53 kg/m2) were included. The Visual Analogue Scale (VAS), active range of motion (AROM), strength of the iliopsoas, gluteus medius, quadriceps femoris, and hamstring muscles, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Short Form-12 (SF-12) were outcome measures. A multivariate or univariate regression analysis was conducted to examine the relationship between the VAS ratings and AROM, muscle strength, WOMAC, SF-12, and Kellgren-Lawrence classification. Results: The mean values for VAS-rest, VAS-activity, and VAS-night were 3.02±2.32, 6.62±1.96, and 3.89±2.72, respectively. A significant correlation was found between VAS-rest and quadriceps femoris muscle strength, as well as the WOMAC score. Similarly, VAS-activity showed a significant association with hip flexion and knee extension AROM, quadriceps femoris muscle strength, Grade 3 or Grade 4 OA, physical component score of SF-12, and WOMAC score (p

P047 Mortality in patients with rheumatic disease over a three year period encompassing the COVID-19 pandemic: clinically extremely vulnerable status and short form 12 scores are predictive

Abstract Background/Aims In the United Kingdom (UK), to combat the coronavirus disease 2019 (COVID-19) pandemic, social distancing measures were implemented to varying degrees between March-2020 and December-2021. UK policy deemed patients with rheumatic disease (RD) at higher risk from COVID-19 and many were categorised as ‘clinically extremely vulnerable’ (CEV), these patients were required to follow more stringent social distancing measures. Social isolation and loneliness are implicated as predictors of mortality; the impact of these strict social distancing measures in patients with RD on mortality is unknown. In addition, Health related quality of life (HRQoL) measures provide useful insights into a patients physical and mental wellbeing. HRQoL is recognised as an important measure of health outcomes and there is limited evidence suggesting HRQoL measures such as the Health Assessment Questionnaire (HAQ) and the Short Form-36 questionnaire (SF-36) are associated with mortality in patients with rheumatoid arthritis. The predictive value of the SF-12 (a validated, shortened version of the SF-36) in RD patient’s mortality is unknown. In this UK-based, observational cohort study we evaluated the impact of stricter social distancing measures during the pandemic on 3-year mortality and assessed the utility of the SF-12 in predicting mortality in patients with RD. Methods We distributed a web-based survey via a linked mobile-phone SMS message, to all rheumatology patients, with a validated mobile number, under follow-up at the Royal Wolverhampton Trust, April-2020. We collected demographics, CEV status, and Short Form-12 mental (MCS) and physical health component scores (PCS) for health-related quality of life. Mortality was audited July-2023. Data were analysed using SPSS version 26 and R. Results There were 7,911 active follow up patients with linked mobile numbers. Survey responses were received from 1605 (20%); responders were female (69%), white (94%), CEV (47%), had a mean age of 61years, and most had autoimmune rheumatic disease (78%). Of the responders, 58 (4%) had died by July-2023 - compared to the alive group these patients had significantly worse MCS (p &amp;lt; 0.001) and PCS (p = 0.004) at baseline; significantly more in those that had died were CEV (p &amp;lt; 0.001), and older (p &amp;lt; 0.001), while gender, ethnicity, and diagnosis did not differ. Conclusion These data demonstrate in a large cohort of patients with RD over a 3-year period those patients considered CEV, advised to follow more stringent social isolation measures were at significantly greater risk of death. Further, baseline SF-12 scores for both mental and physical components were lower in patients that died over a 3-year period. These data potentially highlight the utility of the SF-12 and assessing social isolation and loneliness in patients with RD to predict mortality. In addition, our methods demonstrate the merits of communicating with patients through SMS-messaging and can be used in delivering important health-care communications in future. Disclosure N. Cox: None. J. Bateman: None.

Transtibial osseointegration following unilateral traumatic amputation: An observational study of patients with at least two years follow-up

ImportanceMost patients use a traditional socket prosthesis (TSP) to ambulate independently following transtibial amputation. However, these patients generally require prosthesis repairs more than twice annually and an entirely new prosthesis every two years. Furthermore, transtibial amputation patients have four times the skin ulceration rate of transfemoral patients, prompting more frequent prosthesis refitting and diminished use. Trans-Tibial osseointegration (TTOI) is a promising technique to address the limitations of TSP, but remains understudied with only four cohorts totaling 41 total procedures reported previously. Continued concerns regarding the risk of infection and questions as to functional capacity postoperatively have slowed adoption of TTOI worldwide. ObjectiveThis study reports the changes in mobility, quality of life (QOL), and the safety profile of the largest described cohort of patients with unilateral TTOI following traumatic amputation. DesignRetrospective observational cohort study. The cohort consisted of patients with data outcomes collected before and after osseointegration intervention. SettingA large, tertiary referral, major metropolitan center. ParticipantsTwenty-one skeletally mature adults who had failed socket prosthesis rehabilitation, with at least two years of post-osseointegration follow-up. Main outcomes and measuresMobility was evaluated by K-level, Timed Up and Go (TUG), and Six Minute Walk Test (6MWT). QOL was assessed by survey: daily prosthesis wear hours, prosthesis problem experience, general contentment with prosthesis, and Short Form 36 (SF36). Adverse events included any relevant unplanned surgery such as for infection, fracture, implant loosening, or implant failure. ResultsAll patients demonstrated statistically significant improvement post osseointegration surgery with respect to K-level, TUG, 6MWT, prosthesis wear hours, prosthesis problem experience, general prosthesis contentment score, and SF36 Physical Component Score (p < 0.01 for all). Three patients had four unplanned surgeries: two soft tissue refashionings, and one soft tissue debridement followed eventually by implant removal. No deaths, postoperative systemic complications, more proximal amputations, or periprosthetic fractures occurred. Conclusions and relevanceTTOI is likely to confer mobility and QOL improvements to patients dissatisfied with TSP rehabilitation following unilateral traumatic transtibial amputation. Adverse events are relatively infrequent and not further disabling. Judicious use of TTOI seems reasonable for properly selected patients. Level of evidence2 (Therapeutic investigation, Observational study with dramatic effect).

Considerations beyond spine pain: do different co-occurring lower body joint pains differentially influence physical function and quality of life ratings?

BackgroundPatients seeking medical care for back pain often have coexisting painful joints and the effects of different combinations and number of coexisting pain sites (hip, knee, foot/ankle) to back pain on physical function domains and quality of life rating are not yet established. The purpose of this study was to determine the differences in functional outcomes and QOL among individuals with back pain who have concurrent additional pain sites or no pain sites.MethodsData from the Osteoarthritis Initiative (OAI) cohort were used for this cross-sectional analysis. Men and women aged 45–79 years with back pain were binned into nine groups by presence or not of coexisting hip, knee, ankle/foot pain and combinations of these sites (N = 1,642). Healthy controls reported no joint pain. Main outcomes included Knee Injury and Osteoarthritis Outcome score (KOOS; quality of life and function-sports-and-recreation), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC; Activities of Daily Living, Pain), Medical Outcomes Short Form-12 (SF-12) Physical Component score, and self-reported function in last 7–30 days (lifting 25-pound objects, housework). 20-m and 400-m walk times and gait speed and repeated chair rise test times were collected.ResultsCompared to back pain alone, pain at all five sites was associated with 39%—86% worse KOOS, WOMAC, and SF-12 scores (p < .0001). Back-Hip and Back-Knee did not produce worse scores than Back pain alone, but Back-Hip-Knee and Back-Knee-Ankle/Foot did. The 20-m, 400-m walk, and repeated chair times were worse among individuals with pain at all five sites. Additional hip and knee sites to back pain, but not ankle/foot, worsened performance-based walk times and chair rise scores.ConclusionsThe number and type of coexistent lower body musculoskeletal pain among patients with back pain may be associated with perceived and performance-based assessments. Management plans that efficiently simultaneously address back and additional coexistent pain sites may maximize treatment functional benefits, address patient functional goals in life and mitigate disability.

Return to Sport After Unicompartmental Knee Arthroplasty and Patello-Femoral Arthroplasty

BackgroundData on sports/physical activity participation following unicompartmental knee arthroplasty (UKA) and patello-femoral arthroplasty (PFA) is variable and limited. The purpose of this study was to assess participations, outcomes, and limitations in sports following UKA and PFA. MethodsPatients who underwent UKA and PFA at a single institution from 2015 to 2020 were surveyed on sports participation before and after surgery. Data was correlated with perioperative patient characteristics and outcome scores. Among 776 patients surveyed, 356 (50%) patients responded. Of respondents, 296 (83.1%) underwent UKA, 44 (12.6%) underwent PFA, and 16 (4.5%) underwent both UKA/PFA. ResultsActivity participation rates were 86.5, 77.3, and 87.5% five years prior, and 70.9, 61.4, and 75% at one year prior to UKA, PFA, and UKA/PFA, respectively. Return to sports rates were 81.6, 64.7, and 62.3% at mean 4.6 years postoperatively, respectively. The most common activities were recreational walking, swimming, cycling, and golf. Patients returned to a similar participation level for low-impact activities, whereas participation decreased for intermediate- and high-impact activities. Patients participating in activities had higher postoperative Knee Injury and Osteoarthritis Outcome Score Joint Replacement (P < .001), 12-Item Short Form Physical Component Score (P = .045) and Mental Component Score (P = .012). Activity restrictions were reported among 25, 36.4, and 25% of UKA, PFA, and UKA/PFA patients, respectively, and were more commonly self-imposed than surgeon-directed. ConclusionsThough UKA patients’ postoperative sports participation may improve compared to one year preoperatively, participation for patients surgically treated for isolated osteoarthritis is decreased compared to 5 years preoperatively and varies among patient subsets.

Impact of American Society of Anesthesiologists' Classification on Postoperative Satisfaction and Clinical Outcomes Following Lumbar Decompression: Cohort-Matched Analysis.

Retrospective cohort. The aim was to compare patient-reported outcomes (PROMs), minimum clinically important difference (MCID) achievement, and postoperative satisfaction following minimally invasive lumbar decompression in patients stratified by American Society of Anesthesiologists (ASA) classification. Some guidelines recommend against performing elective procedures for patients with an ASA score of 3 or greater; however, long-term postoperative outcomes are not well described. Primary, single-level, minimally invasive lumbar decompression procedures were identified. PROMs were administered at preoperative, 6-week, 12-week, 6-month, 1-year, 2-year timepoints and included Patient-Reported Outcomes Measurement Information System-Physical Function, visual analog scale (VAS) back/leg, Oswestry disability index (ODI), and 12-item short form physical component score. Satisfaction scores were collected postoperatively for VAS back/leg, ODI, and individual ODI subcategories. Patients were grouped (ASA<3, ASA≥3), and propensity scores were matched to control for significant differences. Demographic and perioperative characteristics were compared using χ 2 and the Student's t test. Mean PROMs and postoperative satisfaction were compared at each time point by a 2-sample t test. Postoperative PROM improvement from the preoperative baseline within each cohort was calculated with a paired t test. MCID achievement was determined by comparing ΔPROMs to established thresholds and comparing between groups using simple logistic regression. One hundred and twenty-nine propensity-matched patients were included: 99 ASA<3 and 30 ASA≥3. No significant demographic differences were observed between groups. ASA≥3 patients experienced significantly increased length of stay and postoperative narcotic consumption on surgery day ( P <0.048, all). Mean PROMs and MCID achievement did not differ. The ASA<3 cohort significantly improved from the preoperative baseline for all PROMs at all postoperative time points. ASA<3 patients demonstrated higher levels of postoperative satisfaction at 6 weeks for VAS leg, VAS back, ODI, sleeping, lifting, walking, standing, sex, travel, and at 6 months for VAS back ( P <0.045, all). ASA≥3 patients may achieve similar long-term clinical outcomes to ASA<3 patients, though they may show poorer short-term satisfaction for disability, leg pain, and back pain, which could be related to differing preoperative expectations.

Functional Alignment Within the Fusion in Adult Spinal Deformity (ASD) Improves Outcomes and Minimizes Mechanical Failures.

Retrospective review of an adult deformity database. To identify pelvic incidence (PI) and age-appropriate physical function alignment targets using a component angle of T1-pelvic angle within the fusion to define correction and their relationship to proximal junctional kyphosis (PJK) and clinical outcomes. In preoperative planning, a patient's PI is often utilized to determine the alignment target. In a trend toward more patient-specific planning, age-specific alignment has been shown to reduce the risk of mechanical failures. PI and age have not been analyzed with respect to defining a functional alignment. A database of patients with operative adult spinal deformity was analyzed. Patients fused to the pelvis and upper-instrumented vertebrae above T11 were included. Alignment within the fusion correlated with clinical outcomes and PI. Short form 36-Physical Component Score (SF36-PCS) normative data and PI were used to compute functional alignment for each patient. Overcorrected, under-corrected, and functionally corrected groups were determined using T10-pelvic angle (T10PA). In all, 1052 patients met the inclusion criteria. T10PA correlated with SF36-PCS and PI (R=0.601). At six weeks, 40.7% were functionally corrected, 39.4% were overcorrected, and 20.9% were under-corrected. The PJK incidence rate was 13.6%. Overcorrected patients had the highest PJK rate (18.1%) compared with functionally (11.3%) and under-corrected (9.5%) patients ( P <0.05). Overcorrected patients had a trend toward more PJK revisions. All groups improved in HRQL; however, under-corrected patients had the worst 1-year SF36-PCS offset relative to normative patients of equivalent age (-8.1) versus functional (-6.1) and overcorrected (-4.5), P <0.05. T10PA was used to determine functional alignment, an alignment based on PI and age-appropriate physical function. Correcting patients to functional alignment produced improvements in clinical outcomes, with the lowest rates of PJK. This patient-specific approach to spinal alignment provides adult spinal deformity correction targets that can be used intraoperatively.

The Surgical Learning Curve for Cervical Disk Replacement.

Retrospective study. To characterize an experienced single surgeon learning curve for cervical disk replacement (CDR). A single surgeon learning curve has not been established for CDR. Patients undergoing CDR were included. The cumulative sum of operative time was utilized to separate cases into 3 phases: learning, practicing, and mastery. Demographics, perioperative characteristics, complications, patient-reported outcomes (PROs), and radiographic outcomes were collected preoperatively and up to 1 year postoperatively. PROs included Patient-reported Outcomes Measurement Information System Physical Function, 12-item Short Form-12 Physical Component Score, 12-item Short Form-12 Mental Component Score, visual analog scale (VAS) arm, VAS neck, Neck Disability Index. Radiographic outcomes included segmental angle/segmental range of motion/C2-C7 range of motion. Minimum clinically important difference achievement was determined through a comparison of previously established values. A total of 173 patients were identified, with 14 patients in the learning phase, 42 patients in the practicing phase, and 117 patients in the mastery phase. Mean operative time and mean postoperative day 0 narcotic consumption were significantly higher in the learning phase. The preoperative segmental angle was significantly lower for the learning phase, though these differences were eliminated at the final postoperative time point. Patients in the learning phase reported worse improvement to 6-week postoperative, final postoperative, and worse overall final postoperative VAS Arm scores compared with practicing and mastery phases. For an experienced spine surgeon, the learning phase for CDR was estimated to span 14 patients. During this phase, patients demonstrated longer operative times, higher postoperative narcotic consumption, and worse postoperative VAS Arm scores. Radiographically, no postoperative differences were noted between different phases of mastery. This single surgeon learning curve demonstrates that CDR may be performed safely and with comparable outcomes by experienced spine surgeons despite decreased operative efficiency in the learning phase.

Scarf osteotomy for hallux valgus surgery: determining indications for an additional Akin osteotomy

IntroductionThere is a lack of clear indications to carrying out an Akin osteotomy in addition to scarf osteotomy. Recent studies have shown that a proximal distal phalangeal articular angle (PDPAA) of > 8° as an indication to carrying out additional Akin osteotomy correlates with better radiological outcomes with lesser risk of recurrence. Our study aimed to validate carrying out the additional Akin osteotomy at a PDPAA > 8° while looking into functional outcomes which have not been studied.MethodsPatients who underwent scarf and combined scarf and Akin osteotomy in our institutional registry was identified. Patient reported outcome measures were compared between patients who underwent scarf and combined scarf and Akin osteotomy. The Visual Analogue Scale (VAS), American Orthopedic Foot and Ankle Score (AOFAS), Short Form-36 Physical Component Score (PCS) and Mental Component Score (MCS) were measured pre-operatively and across a follow up period of 2 years.ResultsA total of 212 cases were identified. At a PDPAA > 8, there was no difference in VAS, AOFAS, PCS and MCS between patients that had isolated scarf osteotomy and those that received combined scarf and Akin osteotomy pre-operatively, and at 6 months. However, at 2 years post-operatively, patients that received scarf and Akin osteotomy had a significantly better AOFAS score as compared to patients with isolated scarf osteotomy (82.3 ± 15.3 vs 88.4 ± 13.0, p = 0.0224). On the contrary, at a PDPAA < 8, patients who underwent combined scarf and Akin osteotomy had a significantly lower VAS score at 6 months (1.16 ± 2.16 vs 0.321 ± 1.09, p = 0.00633) and 2 years (0.698 ± 1.73 vs 0.333 ± 1.46, p = 0.0466). They also had a higher AOFAS score at 6 months (80.7 ± 14.3 vs 85.4 ± 12.5, p = 0.0123) and 2 years (83.0 ± 14.0 vs 90.7 ± 9.9, p < 0.0001).ConclusionPDPAA > 8° can serve as a valid indication to carrying out additional Akin on top of scarf osteotomy based on functional outcomes. However, further studies should investigate a PDPAA threshold that is lower than 8°, which can potentially allow more patients to receive the additional Akin osteotomy that can bring better functional outcomes.

Postoperative clinical outcomes in patients undergoing MIS-TLIF versus LLIF for adjacent segment disease.

Few studies examine the clinical outcomes in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) versus lateral lumbar interbody fusion (LLIF) for adjacent segment disease (ASD). We aim to compare the postoperative clinical trajectory through patient-reported outcome measures (PROMs) and minimum clinically important difference (MCID) in patients undergoing MIS-TLIF versus LLIF for ASD. Patients were stratified into two cohorts based on surgical technique for ASD: MIS-TLIF versus LLIF. PROMs of 12-Item Short Form Physical Component Score (SF-12 PCS), visual analog scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI) were collected at preoperative and postoperative 6-week/12-week/6-month/1-year time points. MCID attainment was calculated through comparison to established thresholds. Cohorts were compared through nonparametric inferential statistics. Fifty-four patients were identified, with 22 patients undergoing MIS-TLIF after propensity score matching. Patients undergoing MIS-TLIF for ASD demonstrated significant postoperative improvement up to 1-year VAS back, up to 1-year VAS leg, and 6-month through 1-year ODI (p ≤ 0.035, all). Patients undergoing LLIF demonstrated significant postoperative improvement in 6-month SF-12 PCS, 6-month through 1-year VAS back, 12-week through 6-month VAS leg, and 6-month to 1-year ODI (p ≤ 0.035, all). No significant differences were calculated between surgical techniques for PROMs or MCID achievement rates. Patients undergoing either MIS-TLIF or LLIF for adjacent segment disease demonstrated significant postoperative improvement in pain and disability outcomes. Additionally, patients undergoing LLIF reported significant improvement in physical function. Both MIS-TLIF and LLIF are effective for the treatment of adjacent segment disease.

Health-Related Quality of Life in Double Umbilical Cord Blood versus Haploidentical Marrow Transplantation: A Quality of Life Analysis Report of BMT CTN 1101

The Blood and Marrow Transplant Clinical Trials Network study 1101 (BMT CTN 1101; ClinicaTrials.gov identifier NCT01597778) was a multicenter phase III randomized trial comparing the clinical outcomes and quality of life (QoL) of patients with hematologic malignancies undergoing double umbilical cord blood transplantation (dUCBT) or HLA-haploidentical bone marrow transplantation (haplo-BMT) after reduced-intensity conditioning. At a 5-year follow-up, there were no significant differences in progression- free survival (PFS) or overall survival (OS) between the 2 cohorts. The impact of alternative donor source on QoL is unknown, however. English- and Spanish-speaking patients completed the Functional Assessment of Cancer Therapy-General (FACT-G), Short Form 36 (SF-36), EuroQoL-5 Dimensions EQ-5D, and Global QoL patient-reported outcome (PRO) assessments pretransplantation and at 12 and 24 months post-transplantation. We compared longitudinal QoL measures between the dUCBT and haplo-BMT cohorts and investigated the association of QoL and clinical outcomes using an inverse probability weighted-independent estimating equations method, accounting for missingness and baseline variables. We found no significant differences between the 2 cohorts in any of the QoL scores pretransplantation and at 12 and 24 months post-transplantation. Pretransplantation scores were the only significant predictors of post-transplantation QoL scores. Relapse and grade III-IV acute graft-versus-host disease (GVHD) were associated with significant declines in mean FACT-BMT and SF-36 Physical Component scores, and chronic GVHD was associated with a decline in mean EQ-5D utility scores. There were no significant associations between pretransplantation QoL scores and OS or PFS. Donor type did not impact post-transplantation QoL. Pretransplantation QoL scores and clinical events of GVHD and relapse were the only predictors of post-transplantation QoL. QoL was not associated with survival in either treatment arm. PROs may be valuable tools in pretransplantation risk assessment strategies to improve QoL outcomes.

Poor mental health scores correlate with inferior outcomes following minimally invasive transforaminal lumbar interbody fusion.

Limited spine literature has studied the strength of association of mental health with other outcomes at time of survey collection. We aim to evaluate the degree to which mental health correlates with outcomes in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) at several postoperative periods. Patients having undergone elective MIS-TLIF were searched within a retrospective single-surgeon database. Five hundred eighty-five patients were included. Patient-reported outcomes (PROs) including Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF), 12-item Short Form Physical Component Score (SF-12 PCS) and Mental Component Score (SF-12 MCS), Patient Health Questionnaire-9 (PHQ-9), Visual Analog Scale (VAS) back and leg pain, and Oswestry Disability Index (ODI) scores were collected preoperatively and at 6-week, 12-week, 6-month, 1-year, and 2-year periods. Pearson's correlation tests were used to evaluate the association between both SF-12 MCS and PHQ-9 scores to other PROs at each period. SF-12 MCS correlated with PROMIS PF (|r|= 0.308-0.531), SF-12 PCS (|r|= 0.207-0.328), VAS back (|r|= 0.279-0.474), VAS leg (|r|= 0.178-0.395), and ODI (|r|= 0.450-0.538) at all time points (P ≤ 0.021, all) except for preoperative SF-12 PCS and 1-year VAS leg. PHQ-9 correlated with PROMIS PF (|r|= 0.366-0.701), SF-12 PCS (|r|= 0.305-0.568), VAS back (|r|= 0.362-0.714), VAS leg (|r|= 0.319-0.694), and ODI (|r|= 0.613-0.784) at all periods (P < 0.001, all). Poor mental health scores were correlated with lower physical function, elevated pain scores, and higher disability. PHQ-9 scores demonstrated stronger correlation in all relationships compared to SF-12 MCS. Optimization of patient mental health may lead to improved patient perception regarding function, pain, and disability following MIS-TLIF.

Patient-Reported Allergies Do Not Affect Long-Term Patient-Reported Outcome Measures After Spine Surgery.

A gap in the literature exists regarding the association between number of allergies and patient-reported outcomes measures (PROMs) for patients undergoing spine surgery. Consecutive cervical or lumbar spine surgery patients were identified from a prospective registry from April 2017 to July 2020. Patients were grouped into those with 0, 1, 2, or ≥3 allergies. Demographics were compared between the groups. PROMs included Neck Disability Index, Oswestry Disability Index, visual analog scale (VAS) neck pain, VAS arm pain, VAS back pain, VAS leg pain, short form 12 (SF-12) physical component score, SF-12 mental component score, and patient-reported outcomes measurement information system physical function (PROMIS-PF), and outcomes were compared between the groups through multivariable analysis at up to 1-year follow-up. Associations between number of allergies and achieving a minimal clinically important difference (MCID) in the 9 aforementioned PROMs at 1-year follow-up were assessed. This study included 148 cervical and 517 lumbar patients. After controlling for demographic differences, a higher number of allergies was associated with less improvement in VAS neck pain, SF-12 physical component score, and PROMIS-PF at 12 weeks following cervical surgery and less improvement in PROMIS-PF at 2 weeks following lumbar surgery (P < 0.05). However, these associations failed to persist after 6 months and 12 weeks following surgery in cervical and lumbar patients, respectively (P > 0.05). No association was identified between number of allergies and achievement of MCID in any of the 9 studied PROMs at 1-year follow-up. The higher number of allergies was associated with less improvement in PROMs in the early postoperative period but not at longer-term follow-up. These findings provide data that can be utilized while counseling patients and setting postoperative expectations.

Brace-Free Rehabilitation after Isolated Anterior Cruciate Ligament Reconstruction with Hamstring Tendon Autograft Is Not Inferior to Brace-Based Rehabilitation-A Randomised Controlled Trial.

The postoperative use of a rehabilitative knee brace after isolated primary anterior cruciate ligament (ACL) reconstruction (ACLR) using a hamstring tendon (HT) autograft is controversial. A knee brace may provide subjective safety but can cause damage if applied incorrectly. The aim of this study is to evaluate the effect of a knee brace on clinical outcomes following isolated ACLR using HT autograft. In this prospective randomised trial, 114 adults (32.4 ± 11.5 years, 35.1% women) underwent isolated ACLR using HT autograft after primary ACL rupture. Patients were randomly assigned to wear either a knee brace (n = 58) or no brace (n = 56) for 6 weeks postoperatively. An initial examination was performed preoperatively, and at 6 weeks and 4, 6, and 12 months. The primary endpoint was the subjective International Knee Documentation Committee (IKDC) score to measure participants' subjective perceptions. Secondary endpoints included objective knee function assessed by IKDC, instrumented knee laxity measurements, isokinetic strength tests of the knee extensors and flexors, Lysholm Knee Score, Tegner Activity Score, Anterior Cruciate Ligament-Return to Sport after Injury Score, and quality of life determined by Short Form-36 (SF36). There were no statistically significant or clinically meaningful differences in IKDC scores between the two study groups (3.29, 95% confidence interval (CI) -1.39 to 7.97, p = 0.03 for evidence of non-inferiority of brace-free compared with brace-based rehabilitation). The difference in Lysholm score was 3.20 (95% CI -2.47 to 8.87); the difference in SF36 physical component score 0.09 (95% CI -1.93 to 3.03). In addition, isokinetic testing did not reveal any clinically relevant differences between the groups (n.s.). Brace-free rehabilitation is non-inferior to a brace-based protocol regarding physical recovery 1 year after isolated ACLR using HT autograft. Consequently, the use of a knee brace might be avoided after such a procedure. Level I, therapeutic study.

Risk factors for poorer quality of life in patients with neovascular age-related macular degeneration: a longitudinal clinic-based study.

To examine the risk factors for poor vision-related and health-related quality of life (QoL) in patients with neovascular age-related macular degeneration (nAMD) who present for anti-vascular endothelial growth factor (anti-VEGF) therapy. In a clinic-based cohort of 547 nAMD patients who presented for treatment, the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ25), Short-Form 36 (SF-36) and EuroQoL EQ-5D-5L questionnaires were administered to assess vision-related and health-related QoL. Of these, 83 participants were followed up one-year later to provide longitudinal data. Individuals with mild or moderate visual impairment or blindness at baseline had significantly lower NEI-VFQ-25 scores at follow-up. The presence of ≥3 chronic diseases was associated with lower SF-36 mental component scores (MCS) (p = 0.04) and EQ-VAS scores (p = 0.05). Depressive symptoms were associated with significantly lower MCS (p < 0.0001) and EQ-VAS scores (p = 0.02). Individuals with versus without impaired basic activities of daily living (ADLs) exhibited NEI-VFQ-25 and EQ-VAS scores that were 10.96 (p = 0.03) and 0.13 (p = 0.02) points lower. Those with impaired instrumental ADLs scored 11.62 (p = 0.02), 13.13 (p < 0.0001) and 15.8 (p = 0.0012) points lower in the NEI-VFQ-25, SF-36 physical component score and EQ-5D-5L summary score, respectively. The QoL of nAMD patients is affected by visual acuity as well as patients' medical history, mental health and functional status.

Minimal Clinically Important Difference in the 6-minute-walk Distance for Patients with Pulmonary Arterial Hypertension.

Rationale: The 6-minute-walk distance (6MWD) is an important clinical and research metric in pulmonary arterial hypertension (PAH); however, there is no consensus about what minimal change in 6MWD is clinically significant. Objectives: We aimed to determine the minimal clinically important difference in the 6MWD. Methods: We performed a meta-analysis using individual participant data from eight randomized clinical trials of therapy for PAH submitted to the U.S. Food and Drug Administration to derive minimal clinically important differences in the 6MWD. The estimates were externally validated using the Pulmonary Hypertension Association Registry. We anchored the change in 6MWD to the change in the Medical Outcomes Survey Short Form physical component score. Measurements and Main Results: The derivation (clinical trial) and validation (Pulmonary Hypertension Association Registry) samples were comprised of 2,404 and 537 adult patients with PAH, respectively. The mean ± standard deviation age of the derivation sample was 50.5 ± 15.2 years, and 1,849 (77%) were female, similar to the validation sample. The minimal clinically important difference in the derivation sample was 33 meters (95% confidence interval, 27-38), which was almost identical to that in the validation sample (36 m [95% confidence interval, 29-43]). The minimal clinically important difference did not differ by age, sex, race, pulmonary hypertension etiology, body mass index, use of background therapy, or World Health Organization functional class. Conclusions: We estimated a 6MWD minimal clinically important difference of approximately 33 meters for adults with PAH. Our findings can be applied to the design of clinical trials of therapies for PAH.

Minimum Clinically Important Difference in Patients Undergoing Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Few studies have established the minimum clinically important difference (MCID) in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) for physical function and pain. To establish MCID for physical function and pain patient-reported outcome measures (PROMs) for MIS-TLIF through anchor- and distribution-based methods using the Oswestry Disability Index (ODI) as the anchor. Ninety-eight patients undergoing primary MIS-TLIF with preoperative and 1-year postoperative ODI scores were identified. MCID was calculated using anchor- and distribution-based methods. ODI responders were classified as patients who decreased by 1 disability classification. PROMs of Patient-Reported Outcome Measurement Information System-Physical Function (PROMIS-PF), 12-Item Short Form Physical Component Score (SF-12 PCS), Visual Analog Scale (VAS) back/leg, and ODI were collected preoperatively and 1-year postoperatively. Anchor-based methods were average change, minimum detectable change, change difference, receiver operating characteristic curve, and cross-sectional analysis. Distribution-based methods were standard error of measurement, receiver change index, effect size, and 0.5 ∗ ΔSD. Anchor-based methods ranged from 4.2 to 11.9 for PROMIS-PF, 6.0 to 15.8 for SF-12 PCS, 1.8 to 4.6 for VAS back, and 2.1 to 4.0 for VAS leg. The area under the curve for receiver operating characteristic analysis ranged from 0.66 to 0.81. Distribution-based methods ranged from 1.1 to 3.9 for PROMIS-PF, 1.6 to 10.4 for SF-12 PCS, 0.5 to 1.6 for VAS back, and 0.6 to 1.8 for VAS leg. Patients undergoing MIS-TLIF had a wide range of MCID values. The receiver operating characteristic curve was selected as the most clinically appropriate method. The corresponding MCID values were 4.2 for PROMIS-PF, 6.8 for SF-12 PCS, 1.8 for VAS back, and 2.4 for VAS leg.

Establishing minimum clinically important difference for patient-reported outcome measures in patients undergoing lateral lumbar interbody fusion.

The minimum clinically important difference (MCID) has not been established in lateral lumbar interbody fusion (LLIF). Our study aims to establish MCID for patient-reported outcome measures (PROMs) of physical function and pain for LLIF through anchor-based and distribution-based approaches. Patients undergoing LLIF with preoperative and 6-month postoperative Oswestry Disability Index (ODI) scores were identified. PROMs of Patient-Reported Outcome Measurement Information System Physical Function (PROMIS-PF), 12-Item Short Form Physical Component Score (SF-12 PCS), Veterans RAND 12-Item Short Form Physical Component Score (VR-12 PCS), visual analog scale (VAS) back, and VAS leg were collected at preoperative and 6-month postoperative time points. Anchor-based MCID calculations were average change, minimal detectable change, change difference, receiver operating characteristic curve, and cross-sectional analysis using ODI as the anchor. Distribution-based calculations were standard error of measurement, reliable change index, effect size, and 0.5 ∗ ΔSD. Fifty patients were included. Anchor-based approaches MCID ranges were PROMIS-PF 1.1-9.6, SF-12 PCS 6.4-16.5, VR-12 PCS 5.9-12.9, VAS Back 1.4-4.6, and VAS Leg 1.3-4.3. The area under curve for receiver operating characteristics (ROC) analysis ranged from 0.63 to 0.71. Distribution-based MCID ranges were PROMIS-PF 1.4-4.5, SF-12 PCS 1.9-12.7, VR-12 PCS 2.0-6.6, VAS Back 0.4-1.4, and VAS Leg 0.5-2.0. MCID thresholds varied widely depending on the calculation method. The closest to (0,1) ROC approach was the most clinically appropriate MCID calculation. The corresponding MCID values for LLIF were PROMIS-PF at 7.8, SF-12 PCS at 6.4, VR-12 PCS at 9.3, VAS Back at 4.6, and VAS Leg at 4.3.