Differences In Patient-reported Outcomes Research Articles

Randomized Prospective Trial of Arthroscopic Rotator Cuff With or Without Acromioplasty: No Difference in Patient-Reported Outcomes at Long-term Follow-up

To evaluate long-term clinical outcomes after arthroscopic rotator cuff repair with and without acromioplasty.

Association between limb alignment and patient-reported outcomes after total knee arthroplasty using an implant that reproduces anatomical geometry

BackgroundA kinematically aligned (KA) total knee arthroplasty (TKA) is expected to improve patient satisfaction, but its effect remains controversial. We investigated differences in patient-reported outcomes (PROs) between KA and non-KA TKAs using an implant that reproduces anatomical geometry.MethodsTKAs for varus deformity were performed in consecutive 129 patients (149 knees) via a measured resection technique with conventional instruments. The femorotibial angle (FTA), hip-knee-ankle angle (HKAA), and the angle between the joint line and the line perpendicular to the mechanical axis (AJLMA) were measured postoperatively (mean 13.6 months), and an AJLMA of ≥ 2° was defined as kinematic alignment. Patients were assigned to two or three alignment categories in each measurement method, and the Knee Society Scores (KSS) and Japanese Knee Injury and Osteoarthritis Outcome Scores (J-KOOS) was compared among the groups.ResultsFor patients assessed by FTA, an ADL-related J-KOOS subscale (J-KOOS-A) showed a significant difference between valgus and varus outliers (p < 0.05). When assessed by HKAA, neither the KSS nor J-KOOS subscales were significantly different among groups. When assessed by AJLMA, J-KOOS-A was significantly different between groups, and a group for AJLMA of ≥ 2° had higher scores than a group for AJLMA of < 2° (95% CI 0.323–7.763; p < 0.05).ConclusionsPatients with an AJLMA of ≥ 2° reported significantly higher patient’s satisfaction regarding ADL. This suggests the importance of restoration of the physiological joint line which can be achieved via KA TKAs.

Tibial tunnel widening following anterior cruciate ligament reconstruction: A retrospective seven-year study evaluating the effects of initial graft tensioning and graft selection

PurposeTo investigate tibial tunnel widening in ACL reconstruction patients over seven years to establish the effects of initial graft tension on tibial widening and clinical outcomes when using both patellar tendon (BTB) and hamstring tendon (HS) grafts. MethodsNinety patients, who were reconstructed with BTB or HS autografts, were randomized using one of two initial graft tension protocols; 1) tensioned to restore normal anteroposterior laxity (“low-tension”; n = 46) and 2) tensioned to over-constrain anteroposterior (AP) laxity by two millimeters (“high-tension”; n = 44). Seventy patients had post-surgical data with 45 available for review at seven years. Tunnel widening was assessed via radiographs at one-, three-, and seven-year follow-up. Patient-reported outcomes were compared. ResultsThe mean ± 95% confidence intervals of the initial diameters for the BTB autografts were 10.3 ± 0.5 mm (Low-tension) and 10.2 ± 0.6 mm (High-tension) with final diameters of 10.8 ± 0.6 mm (Low-tension) and 9.9 ± 0.6 mm (High-tension). The initial diameters for HS autografts were 8.1 ± 0.9 mm (Low-tension) and 8.4 ± 0.7 mm (High-tension) with final diameters of 11.5 ± 1.1 mm (Low-tension) and 11.1 ± 0.9 mm (High-tension). For subjects with HS autografts, mean tunnel diameters significantly changed over time (p < .001); no significant changes were observed in BTB autografts (p = .29). Change in diameter of the HS autograft group remained significantly greater than the BTB group at all time points for both tension groups (p < .05). No differences in patient-reported outcomes were found between tension groups or graft types. ConclusionsPatients who underwent ACL-R with HS autograft exhibited tibial tunnel widening over seven years. Patients with BTB autografts did not experience widening, regardless of initial graft tension. Patient-reported outcomes were equivalent.

No differences in patient-reported outcomes between medial pivot insert and symmetrical insert in total knee arthroplasty: A randomized analysis

BackgroundAlthough total knee arthroplasty (TKA) using a medial pivot insert reportedly improves kinematics compared with a symmetrical insert, improvements in patient-reported outcomes have not yet been reported. The aim of this study was to determine whether insert designs influenced patient-reported outcomes. MethodsSeventy TKAs for osteoarthritis were randomly allocated to a symmetrical dish insert (SD group: 35 knees) or medial pivot insert (MP group: 35 knees). Thirty-two of the SD group (74.4 ± 6.6 years old) and 33 of the MP group (73.8 ± 6.0 years old) completed the two-year follow-up. The knee range of motion (ROM) and 2011 Knee Society score (2011KSS) were analyzed pre-operatively and postoperatively. ResultsThere was no difference in pre-operative ROM or 2011KSS (Symptom: 7.3 ± 5.9 in SD group, 8.4 ± 5.4 in MP group, P = 0.432; Satisfaction: 12.6 ± 6.9 in SD group, 11.8 ± 5.9 in MP group, P = 0.581; Activity: 35.8 ± 18.1 in SD group, 35.2 ± 18.6 in MP group, P = 0.883). At two years, although both group showed good improvement, there were no differences in ROM or 2011KSS (Symptom: 19.3 ± 5.0 in SD group, 18.3 ± 4.1 in MP group, P = 0.351; Satisfaction: 24.0 ± 7.6 in SD group, 22.9 ± 7.9 in MP group, P = 0.548; Activity: 60.3 ± 14.8 in SD group, 54.3 ± 17.3 in MP group, P = 0.137). ConclusionsThe medial pivot insert was not superior to the symmetrical insert in patient-reported outcomes at two years after TKA.

Effect of High-Grade Preoperative Knee Laxity on 6-Year Anterior Cruciate Ligament Reconstruction Outcomes

Background: Knee laxity in the setting of anterior cruciate ligament (ACL) injury is often assessed through physical examination using the Lachman, pivot shift, and anterior drawer tests. The degree of laxity noted on these examinations may influence treatment decisions and prognosis. Hypothesis: Increased preoperative knee laxity is associated with increased risk of revision ACL reconstruction, increased risk of contralateral ACL reconstruction, and poorer patient-reported outcomes at 6 years postoperatively. Study Design: Cohort study; Level of evidence, 2. Methods: 2333 patients who underwent primary isolated ACL reconstruction without additional ligament injury were identified. Patients reported by the operating surgeons to have an International Knee Documentation Committee (IKDC) grade D Lachman, anterior drawer, or pivot shift examination were classified as having a high-grade laxity. Multiple logistic regression models were used to evaluate whether having high-grade preoperative laxity was predictive of increased odds of undergoing subsequent revision or contralateral ACL reconstruction within 6 years of the index procedure, controlling for patient age, sex, body mass index, Marx activity level, sport, graft type, medial meniscal treatment, and lateral meniscal treatment. Multiple linear regression modeling was used to evaluate whether having high-grade preoperative laxity was predictive of poorer IKDC or Knee injury and Osteoarthritis Outcome Score Knee-Related Quality of Life (KOOS-QOL) scores at 6 years postoperatively, after controlling for baseline score, patient age, ethnicity, sex, body mass index, marital status, smoking status, sport participation, competition level, Marx activity rating score, graft type, and articular cartilage and meniscal status. Results: In total, 743 of 2325 patients (32.0%) were noted to have high-grade laxity on at least 1 physical examination test. High-grade Lachman was noted in 334 patients (14.4%), high-grade pivot shift was noted in 617 patients (26.5%), and high-grade anterior drawer was noted in 233 patients (10.0%). Six-year revision and contralateral ACL reconstruction data were available for 2129 patients (91.6%). High-grade prereconstruction Lachman was associated with significantly increased odds of ACL graft revision (odds ratio [OR], 1.76; 95% CI, 1.10-2.80, P = .02) and contralateral ACL reconstruction (OR, 1.68; 95% CI, 1.09-2.69; P = .019). High-grade prereconstruction pivot shift was associated with significantly increased odds of ACL graft revision (OR, 1.75; 95% CI, 1.19-2.54, P = .002) but not with significantly increased odds of contralateral ACL reconstruction (OR, 1.30; 95% CI, 0.89-1.87; P = .16). High-grade prereconstruction laxity was associated with statistically significantly lower 6-year IKDC (β = −2.26, P = .003), KOOS-QOL (β = −2.67, P = .015), and Marx activity scores (β = −0.54, P = .020), but these differences did not approach clinically relevant differences in patient-reported outcomes. Conclusion: High-grade preoperative knee laxity is predictive of increased odds of revision ACL reconstruction and contralateral ACL reconstruction 6 years after ACL reconstruction. Poorer patient-reported outcome scores in the high-grade laxity group were also noted, but the difference did not reach a level of clinical relevance.

Gender differences in degenerative spine surgery: Do female patients really fare worse?

Prior data has set the precedent that female patients fare somewhat worse than men after spine surgery. We aimed to evaluate the effect of gender on patient-reported outcomes after lumbar spine surgery for degenerative pathologies. We identified a consecutive cohort of patients from a prospective registry. Absolute values, as well as change scores for back and leg pain severity (numeric rating scale [NRS]), functional disability (Oswestry disability index [ODI]), and health-related quality of life (HRQOL) as assessed by EQ-5D were compared among male and female patients. Of the 3279 included patients, 1543 (47%) were female. At baseline, women reported higher NRS for back and leg pain, higher ODI, but equal HRQOL (all p < 0.05). Otherwise, both groups had comparable baseline data. The absolute differences in patient-reported outcomes persisted at the 6-week, 12- and 24-months follow-up, with women now additionally reporting worse HRQOL as assessed by EQ-5D (all p < 0.05). For all outcome measures, change scores were equal among male and female patients, as were the incidences of complications and reoperations (all p > 0.05). Clinical success was achieved in 82% of men and 79% of women (p = 0.34). Female patients are generally scheduled for surgery with a more advanced disease state. While women seem to report more severe symptoms at long-term follow-up, the degree of improvement is equal among men and women. Female patients may thus fare worse in terms of absolute scores, but enjoy the same benefit from surgery in relative terms. These slides can be retrieved under Electronic Supplementary Material.

Friday, September 28, 2018 10:30 AM–12:00 PM abstracts: complications of cervical spine surgery: 157. Risk factors associated with failure to reach minimum clinically important difference in patient-reported outcomes after anterior cervical discectomy and fusion

BACKGROUND CONTEXT The minimum clinically importance difference (MCID) represents a threshold for improvements in patient-reported outcomes (PROs) that patients deem important following spine surgery. However, no study has comprehensively examined potential risk factors for failure to achieve MCID after anterior cervical discectomy and fusion procedures. PURPOSE To determine risk factors for failure to reach MCID for Neck Disability Index (NDI), Visual Analogue Scale (VAS) neck pain, and VAS arm pain in patients undergoing one- or two-level ACDF procedures. STUDY DESIGN/SETTING Retrospective analysis of a prospectively maintained surgical database. PATIENT SAMPLE A total of 229 patients who underwent primary, one- or two-level ACDF from 2005 to 2016. OUTCOME MEASURES NDI, CCI, ASA, VAS neck and VAS arm pain. METHODS Rates of overall MCID achievement for NDI, VAS neck pain, and VAS arm pain at final clinical follow up were calculated based on published MCID values. Bivariate testing via Poisson regression with robust error variance was used to test for association of demographic and procedural characteristics with failure to reach MCID for each PRO. The final multivariate model including all demographic and procedural categories as controls was created using backward, stepwise regression until only those variables with p RESULTS After exclusion of patients with incomplete PRO survey data, 78, 78, and 73 patients were included in the analysis for VAS neck, VAS arm, and NDI, respectively. Rates of MCID achievement for VAS neck, VAS arm, and NDI were 52.56%, 35.90%, and 73.97%, respectively. Upon bivariate analysis, patients with Charlson Comorbidity Index (CCI)≥2 were less likely to achieve MCID for NDI than patients with CCI 2 (RR 0.69, p=.017) were associated with failure to reach MCID for NDI. CONCLUSIONS The results of this study suggest that the majority of patients do not reach MCID for arm pain. Additionally, higher comorbidity burden as evidenced by higher CCI and ASA scores may be negative predictive factors for the achievement of MCID in neck disability following ACDF.

Patient-Reported Outcomes in Functioning Following Nursing Home or Inpatient Rehabilitation

ObjectivesOur study examines factors associated with patient-reported outcomes in functioning among Medicare beneficiaries who reported receiving rehabilitation services in a nursing home or inpatient (ie, hospital or rehabilitation facility) setting in the prior year. DesignData are from the 2015 and 2016 rounds of the National Health and Aging Trends Study (NHATS), a longitudinal study of a nationally representative sample of Medicare beneficiaries aged 65 years and older. Setting and ParticipantsA total of 479 participants in the 2016 sample who reported receiving rehabilitation services in a nursing home or inpatient setting in the past year. MeasuresBivariate and logistic regression analyses examined the association of demographic, socioeconomic status, and health variables (from the 2015 interview) and rehabilitation characteristics (from the 2016 interview) with patient-reported improvement in “functioning and ability to do activities” while receiving rehabilitation services in the past year. ResultsAmong Medicare beneficiaries who received rehabilitation services in nursing home or inpatient settings, 33.4% (weighted percent) reported no improvement in functioning while they were receiving rehabilitation. In a regression analysis that accounted for demographics, those with a high school education or less (compared with those with a college degree), instrumental activities of daily living impairments, certain primary conditions for rehabilitation, less than 1-month total duration of rehabilitation services, and no outpatient rehabilitation services had greater odds of reporting no improvement. Conclusions/ImplicationsOur weighted sample represents approximately 2.3 million Medicare beneficiaries who received rehabilitation services in nursing home or inpatient settings. In this sample, 1 in 3 reported no improvement in functioning, with differences in patient-reported outcomes across socioeconomic status, health status, and rehabilitation characteristics domains. Consideration of characteristics across these domains may be clinically pertinent, but investigation as to why these differences are present and whether services can be optimized to further improve patient-reported outcomes is warranted.

Randomized Prospective Trial of Arthroscopic Rotator Cuff With or Without Acromioplasty: No Difference in Patient-reported Outcomes at Long-term Follow-up

Objectives:To evaluate long-term clinical outcomes after arthroscopic rotator cuff repair with and without acromioplasty.Methods:Between 2007-2011, prospectively-enrolled patients undergoing arthroscopic repair for full-thickness rotator cuff tears were previously randomized into either acromioplasty or non-acromioplasty groups. Patients with death, advanced neurologic conditions, or subsequent shoulder arthroplasty were excluded. Baseline and long-term follow-up questionnaires, including the American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test (SST), University of California-Los Angeles (UCLA), Visual Analog Scale (VAS) for pain, and Constant scores were obtained. Rates of revision rotator cuff surgery, or secondary reoperation were recorded. Averages with standard deviation (SD) were calculated, and t-tests were utilized to compare outcomes of interest between cohorts.Results:After exclusion of 5 additional patients from the short-term follow-up study, 66 of 90 patients (73.3%) were available at 92.4 months (±10.5). Comparison of baseline demographics and intraoperative information revealed no significant differences, including age, gender, workers compensation, acute mechanism of injury, tear size, degree of retraction, and surgical technique (e.g. single- vs. double-row). At final follow-up, there were no statistically significant differences according to ASES (p=0.33), VAS pain (p=0.79), Constant (p=0.17), SST (p=0.05), UCLA (p=0.19), and SF-12 (p=0.79) in patients with and without acromioplasty (Figure 1). One patient with acromioplasty (2.9%) and two patients without acromioplasty (6.3%) sustained atraumatic recurrent rotator cuff tear with secondary repair (p=0.99).Conclusion:Combined acromioplasty and rotator cuff repair offer no significant long-term benefits in patient-reported outcomes or secondary surgery when compared to arthroscopic rotator cuff repair alone.Figure 1

Does partnership status affect the quality of life of men having robotic-assisted radical prostatectomy (RARP) for localised prostate cancer?

ObjectiveTo investigate whether there are any differences in prostate cancer-specific QoL measures at baseline and at 12-months post-surgery between partnered and unpartnered men having robot-assisted radical prostatectomy (RARP) for localised prostate cancer. MethodsWe investigated differences in patient-reported outcomes using the Expanded Prostate cancer Index Composite-26 (EPIC-26) and the Clark et al. Prostate Cancer Quality of Life Scales. ResultsFive hundred and forty patients were eligible for this study, 56 of whom were unpartnered. We found few differences between partnered and unpartnered men in terms of patient-reported quality of life outcomes following RARP. In our sample of patients with a high socio-economic status, partnered men had lower 12-month postoperative EPIC sexual domain scores and clinical T-stage and were more likely to be sexually active preoperatively. Overall, our data show that men having RARP for prostate cancer have low sexual confidence, high PSA concern and a low outlook at 12-months post-RARP, irrespective of partnership status. ConclusionThe findings of this study suggest that the RARP patient could benefit from a healthcare system that assesses patient sexual outcome following prostatectomy beyond potency and ability to penetrate a partner. By remaining cognisant of other domains such as sexual intimacy, sexual confidence, masculine self-esteem, health worry, PSA concern, outlook and treatment regret, nursing staff may be able to benefit the prostatectomy patient. Where deficits in these domains are observed by the nurse, referral for specialist psychological review could be made. Whether this could work to improve sexual outcomes in men following RARP deserves further investigation.

Risk Factors Associated With Failure to Reach Minimal Clinically Important Difference in Patient-reported Outcomes Following Minimally Invasive Transforaminal Lumbar Interbody Fusion for Spondylolisthesis.

Retrospective cohort. To determine risk factors associated with failure to reach the minimal clinically important difference (MCID) in patient-reported outcomes (PROs) for patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) for spondylolisthesis. The MCID of PROs are often utilized to determine the benefit of spinal procedures. However, negative predictive factors for reaching MCID in patients surgically treated for lumbar spondylolisthesis have been difficult to elucidate. A prospectively maintained surgical database of patients who were diagnosed with lumbar spondylolisthesis and surgically treated with a single level MIS TLIF from 2010 to 2016 was reviewed. Patients with incomplete PRO survey data or <6-month follow-up were excluded from the analysis. MCID for visual analogue scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI) was obtained from established values in the literature. All risk factors were then assessed for association with failure to reach MCID using bivariate and multivariate regression adjusting for preoperative characteristics. A total of 165, 76, and 73 patients treated with MIS TLIF for spondylolisthesis had complete PRO data for VAS back, VAS leg, and ODI, respectively, and were thus included in the analysis for the respective PRO. Overall, 75.76%, 71.05%, and 61.64% of patients treated with a single level MIS TLIF for spondylolisthesis reached MCID for VAS back, VAS leg, and ODI, respectively. On multivariate analysis, patients were less likely to achieve MCID for VAS back following surgical treatment if they received workers' compensation (P<0.001). No other measured factors were noted to independently correlate with MCID achievement. The results of this study suggest that a majority of patients with spondylolisthesis achieve MCID for commonly measured PROs following MIS TLIF for spondylolisthesis. However, worker's compensation insurance status may serve as a negative predictive factor for reaching MCID.

Moderate hypofractionation for prostate cancer: A user's guide.

Three large randomised controlled trials have been published in the last year demonstrating the non-inferiority of moderate hypofractionation compared to conventional fractionation for localised prostate cancer with respect to both disease control and late toxicity at 5years. Furthermore, no clinically significant differences in patient-reported outcomes have emerged. More mature follow-up data are now also available from phase 2 studies confirming that moderate hypofractionation is associated with low rates of significant toxicity at 10years. Moving forward it is likely that appropriate patient selection, integration of androgen deprivation and attention to optimising technique will play a more important role than modest differences in dose-fractionation schedules. Here we briefly review the evidence, discuss issues of patient selection and provide an approach to implementing moderately hypofractionated radiation therapy for prostate cancer in clinical practice.

No Benefit of Computer-assisted TKA: 10-year Results of a Prospective Randomized Study.

Previously published studies reported benefits of computer-assisted surgery (CAS) in terms of radiographic implant position in TKA, but whether these improvements result in clinically important survival differences or functional differences that a patient might perceive at a minimum 10-year followup remains largely unknown. We performed a prospective randomized trial and asked whether CAS (1) improved survival free from aseptic loosening; and (2) demonstrated any clear difference in patient-reported outcomes at latest followup using validated outcome measures at minimum 10-year followup. Between January 2004 and December 2005, 80 patients scheduled for TKA were randomly assigned either to the CAS group or to the conventional technique group by the Hospital Informatics Department. The patient inclusion criteria were age 20 to 80 years old, weight < 100 kg, and consent to receive a primary knee arthroplasty performed through a medial parapatellar approach by the senior author. The exclusion criteria were a history of prior knee surgery, TKA performed for a posttraumatic indication, or revision knee surgery. The first 80 patients meeting these criteria were included in the study. There were 21 women and 19 men and in each group; mean age was 66 years (range, 58-77 years), and mean body mass index was 27 ± 4 kg/m. An initial published study using this patient group investigated only differences regarding implant positioning in the coronal and sagittal planes. This is a secondary analysis of patients from the earlier study protocol at a minimum of 10-year followup with different endpoints. Kaplan-Meier survivorship was compared between groups, and functional patient-reported outcome measures (PROMs) were evaluated using the SF-12, Knee Injury and Osteoarthritis Outcome Score (KOOS), Forgotten Joint Score, and the new Knee Society Score. Those PROMs were not available at the time of the original randomized controlled trial and we therefore do not have baseline preoperative values demonstrating that our two groups were comparable. However, our groups were created using strict randomization and were similar in terms of demographic parameters and knee deformities. Our secondary analysis was not powered for survival analysis but had 80% power to detect a difference > 6 points on the SF-12 components and > 6 points out of 100 on the KOOS subscores (published minimal clinically important difference: 8 points) at the p < 0.05 level. With the numbers available, there was no difference between the CAS group and the conventional TKA group in terms of survivorship free from aseptic loosening 10 years after TKA (97%, 95% confidence interval [CI], 95%-99% versus 97%, 95% CI, 95%-99%; p = 0.98). Investigation of the latest followup PROM scores showed no difference between SF-12 scores (respectively, for CAS and control patients, physical SF-12: 72 ± 12 versus 73 ± 13 mean difference 0, 95% CI -3 to 3, p = 0.9; mental SF-12: 75 ± 8 versus 73 ± 10, mean difference 2, 95% CI 0-4, p = 0.3) as well as for all KOOS subscores (all p > 0.1). Forgotten Joint Scores were similar in both groups with 83 ± 4 for CAS and 82 ± 5 for control patients (mean difference 1, 95% CI 0-2, p = 0.2). Finally, the new Knee Society Scores were not statistically different between groups with a mean objective score of 82 ± 13 for CAS patients versus 79 ± 12 for control patients (mean difference 2, 95% CI 0-5, p = 0.5) and a mean subjective score of 83 ± 11 versus 85 ± 12, respectively (mean difference 2, 95% CI 0-5, p = 0.5). Our observations suggest that CAS used for TKA alignment with restoration of a neutral mechanical axis as the goal did not confer any substantial advantage in survivorship, function, or quality of life at 10 years after TKA. Larger studies with longitudinal collection of PROMs for functional assessment and greater numbers to assess survivorship are needed to confirm these findings. Level III, therapeutic study.

Posterior versus direct anterior approach in total hip arthroplasty: difference in patient-reported outcomes measured with the Forgotten Joint Score-12

Introduction: When the postoperative outcome of primary total hip arthroplasty (THA) was compared with the direct anterior approach (DAA) and the posterior approach (PA), there was no significant difference of the clinical outcome at 6 months to 1 year after surgery in many studies. This study was performed to compare the medium-term outcome of THA via the DAA or PA and clarify which approach achieves better quality of life (QOL).Methods: We investigated 61 hips receiving primary THA (30 via DAA and 31 via PA), using hip function scores such as the Harris Hip Score (HHS) and patient-reported outcomes such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ), and the Forgotten Joint Score-12 (FJS).Results: The mean duration of postoperative follow-up was 36.8 months in the DAA group and 40.5 months in the PA group. There was no difference in preoperative or postoperative HHS between the two groups. Although there was no difference of postoperative WOMAC and JHEQ, the postoperative FJS-12 score was significantly higher in the DAA group than in the PA group (75.2 ± 15.9 versus 60.1 ± 24.4, p = 0.01).Conclusion: When forgetting the artificial joint in daily life is the target, better QOL can be achieved by performing THA via the DAA.

A population-based approach to compare patient-reported outcomes of long-term Hodgkin's lymphoma survivors according to trial participation: a joint study from the Patient-Reported Outcomes Following Initial Treatment and Long-term Evaluation of Survivorship registry and European Organisation for Research and Treatment of Cancer.

Survival discrepancy between patients treated in a clinical trial and routine practice is well recognized. No study has assessed the health-related quality of life (HRQL) of long-term Hodgkin's lymphoma survivors (HLS) according to trial participation. We applied a population-based approach to examine the differences in HRQL, healthcare utilization, and satisfaction with healthcare among long-term HLS who had participated in a trial (tHLS) and those treated in routine care (rHLS). All HLS diagnosed during the period 1989-1998 and living in southern Netherlands were selected from the Netherlands Cancer Registry in 2004 to participate in the Patient Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship registry study. Data linkage with the European Organisation for Research and Treatment of Cancer was performed in 2015 to identify trial participation. The 65 tHLS and 67 rHLS had comparable demographic and clinical characteristics. Unadjusted and adjusted models indicated no association between trial participation and HRQL. There was no evidence of differences in healthcare satisfaction. Trial participation was associated with 48% more visits to specialists in the past year (adjusted 95% confidence interval: 10-99). No association of trial participation with cancer-related contacts was observed. tHLS and rHLS had comparable long-term HRQL. Although trial participation was associated with more specialist visits, there was no evidence of an association with healthcare satisfaction and the number of cancer-related visits. Identification of trial participation in population-based cancer registry through data linkage with clinical trials enables a population-based approach to examine patient-reported outcomes differences between tHLS and rHLS.

A Network Meta-Analysis of Long-Acting Muscarinic Antagonist (LAMA) and Long-Acting β2-Agonist (LABA) Combinations in COPD.

IntroductionComparative data on the efficacies of long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) combinations for the treatment of moderate-to-very-severe chronic obstructive pulmonary disease (COPD) are limited. The aim of this Bayesian network meta-analysis (NMA) is to assess the relative efficacies of available open combinations (delivered via separate inhalers) and fixed-dose combinations (FDCs, delivered via a single inhaler).MethodsWe conducted a systematic literature review with the aim of identifying randomized controlled trials (RCTs) of ≥8-week duration in adults aged ≥40 years with COPD that compared LAMA + LABA combinations with each other, with tiotropium (TIO), or with placebo. Data on changes from baseline in trough forced expiratory volume in 1 s (FEV1) and on St George’s Respiratory Questionnaire (SGRQ) total score, the Transition Dyspnea Index (TDI) focal score, and rescue medication use at 12 and 24 weeks were extracted from these RCTs and analyzed using a NMA in a Bayesian framework.ResultsData from 44 RCTs were included in the NMA. All FDCs showed improvements relative to placebo in terms of trough FEV1, SGRQ total score, and TDI focal score above clinically relevant thresholds, with the exception of TIO/olodaterol and aclidinium/formoterol, both of which failed to show clinically relevant improvements in SGRQ score at 24 weeks. All FDCs demonstrated reduced rescue medication use versus placebo. Open combinations demonstrated improved efficacy in all outcomes versus placebo, but these improvements did not consistently exceed clinically relevant thresholds for SGRQ and TDI scores. All once-daily FDCs showed improved efficacy versus TIO, but improvements were less consistently observed versus TIO with open dual combinations and combinations containing formoterol or salmeterol administered twice daily. Relative probabilities of improvement between FDCs highlighted potential between-class differences for trough FEV1 but suggested little potential for differences in patient-reported outcomes.ConclusionLAMA + LABA combinations generally showed improved outcomes versus placebo and TIO. FDCs appeared to perform better than open dual combinations. A potential effectiveness gradient was observed between FDCs for objectively assessed functional outcomes, although further prospective trials are required to confirm these findings.FundingGSK.Electronic supplementary materialThe online version of this article (doi:10.1007/s41030-017-0048-0) contains supplementary material, which is available to authorized users.

Differences in patient-reported outcomes between unicompartmental and total knee arthroplasties: A propensity score-matched analysis

Differences in patient-reported outcomes between unicompartmental and total knee arthroplasties: A propensity score-matched analysis

Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study

PurposeWhen postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weakened by targeting the cholinergic anti-inflammatory pathway, with nicotine as essential regulator. Chewing gum, already known to stimulate gastrointestinal motility itself, combined with nicotine is hypothesised to improve gastrointestinal recovery and prevent PPOI. This pilot study is the first to assess efficacy and safety of nicotine gum in colorectal surgery.MethodsPatients undergoing elective oncological colorectal surgery were enrolled in this double-blind, parallel-group, controlled trial and randomly assigned to a treatment protocol with normal or nicotine gum (2 mg). Patient reported outcomes (PROMS), clinical characteristics and blood samples were collected. Primary endpoint was defined as time to first passage of faeces and toleration of solid food for at least 24 h.ResultsIn total, 40 patients were enrolled (20 vs. 20). In both groups, six patients developed PPOI. Time to primary endpoint (4.50 [3.00–7.25] vs. 3.50 days [3.00–4.25], p = 0.398) and length of stay (5.50 [4.00–8.50] vs. 4.50 days [4.00–6.00], p = 0.738) did not differ significantly between normal and nicotine gum. There were no differences in PROMS, inflammatory parameters and postoperative complications.ConclusionsWe proved nicotine gum to be safe but ineffective in improving gastrointestinal recovery and prevention of PPOI after colorectal surgery. Other dosages and administration routes of nicotine should be tested in future research.

Urinary continence recovery after radical prostatectomy - anatomical/reconstructive and nerve-sparing techniques to improve outcomes.

In an editorial board-moderated debate format, two experts in prostate cancer surgery are challenged with presenting the key strategies in radical prostatectomy that improve urinary functional outcomes. Dr Bernardo Rocco was tasked with arguing the facts that support the anatomical preservation and reconstruction steps that improve urinary continence. Drs Christian Pavlovich and Sasha Druskin were tasked with arguing the facts supporting neurovascular bundle and high anterior release surgical planes that improve urinary continence. Associate Editor John Davis moderates the debate, and outlines the current status of validated patient questionnaires that can be used to evaluate urinary continence, and recent work that allows measuring what constitutes a 'clinically significant' difference that either or both of these surgical techniques could influence. A review of raw data from a publication from Dr Pavlovich's team demonstrates how clinically relevant differences in patient-reported outcomes can be correlated to technique. A visual atlas is presented from both presenting teams, and Dr Davis demonstrates further reproducibility of technique. A linked video on this concept is available as a supplementary file.

“Proprietary Processed” Allografts: Clinical Outcomes and Biomechanical Properties in Anterior Cruciate Ligament Reconstruction

Background: The processing of allograft tissues in anterior cruciate ligament (ACL) reconstruction continues to be controversial. While high-dose irradiation of grafts has received scrutiny for high failure rates, lower dose irradiation and “proprietary-based” nonirradiated sterilization techniques have become increasingly popular, with little in the literature to evaluate their outcomes. Recent studies have suggested that the specifics of allograft processing techniques may be a risk factor for higher failure rates. Purpose: To assess these proprietary processes and their clinical outcomes and biomechanical properties. Study Design: Systematic review. Methods: A systematic review was performed using searches of PubMed, EMBASE, Google Scholar, and Cochrane databases. English-language studies were identified with the following search terms: “allograft ACL reconstruction” (title/abstract), “novel allograft processing” (title/abstract), “allograft anterior cruciate ligament” (title/abstract), “anterior cruciate ligament allograft processing” (title/abstract), or “biomechanical properties anterior cruciate ligament allograft” (title/abstract). Duplicate studies, studies not providing the allograft processing technique, and those not containing the outcomes of interest were excluded. Outcomes of interest included outcome scores, complication and failure rates, and biomechanical properties of the processed allografts. Results: Twenty-four studies (13 clinical, 11 biomechanical) met inclusion criteria for review. No demonstrable difference in patient-reported outcomes was appreciated between the processing techniques, with the exception of the Tutoplast process. The clinical failure rate of the Tutoplast process was unacceptably high (45% at 6 years), but no other difference was found between other processing techniques (BioCleanse: 5.4%; AlloTrue: 5.7%; MTF: 6.7%). Several studies did show an increased failure rate, but these studies either combined processing techniques or failed to delineate enough detail to allow a specific comparison for this study. The biomechanical studies showed overall maintenance of satisfactory biomechanical properties throughout multiple testing modes with normalization to the percentage of control specimens. Conclusion: A comparison of proprietary allograft processing techniques is difficult because of the variability and lack of specificity of reporting in the current literature. Among the available literature, except for the Tutoplast process, no notable differences were found in the clinical outcomes or biomechanical properties. Future study with a longer follow-up is necessary to determine the role and limitations of these grafts in the clinical setting.