Prevalence and determinants of shared decision-making for PSA testing in the United States.

BACKGROUND: Shared decision-making (SDM) is recommended for prostate-specific antigen (PSA) testing but appears underutilized. This population-based study assessed the prevalence and determinants of SDM for PSA testing among US men. METHODS: We assessed PSA testing rates and SDM engagement in men aged 40 and older without prostate cancer history using the 2019 National Health Interview Survey. SDM was defined as discussing the advantages and disadvantages of PSA testing with a physician. We used multivariable logistic regression with machine learning to identify factors associated with lack of SDM. RESULTS: Among 9723 eligible participants (mean age 58 years), lifetime PSA testing prevalence was 45.9% and the 1-year testing incidence was 29.1%. Only 24.1% reported engaging in SDM with a physician, while 62.9% never discussed PSA testing. Younger age and lower education levels were the primary determinants of decreased SDM engagement. Men with less education engaged in SDM less than half as often as those with higher education levels across all age groups. CONCLUSIONS: Societal guidelines recommend SDM for PSA testing. However, most men, regardless of age, have never engaged in SDM conversations with a healthcare provider about PSA testing, especially those with less education. More efforts are needed to improve patient-provider conversations about the potential benefits and harms of PSA testing.

Carcinoma of the axillary tail of Spence: A rare case report.

INTRODUCTION: Carcinoma arising from the axillary tail of Spence (CATS) is a rare entity that requires a high level of clinical suspicion. The clinicopathologic, prognostic, and imaging features of CATS are poorly understood. CASE SUMMARY: A 46-year-old woman presented to our hospital with right axillary swelling associated with bleeding and foul-smelling discharge. She had initially presented to a different hospital with a similar presentation where she was diagnosed with metastatic carcinoma, favouring adenocarcinoma on the FNAC report, following which she received 3 cycles of chemotherapy. MRI and PET-CT scan workups at our hospital showed a soft tissue mass likely arising from the axillary tail of the right breast with a few enlarged axillary lymph nodes and an unremarkable right breast. She underwent excision of the mass with axillary lymph node dissection and reconstruction with a pedicled Latissimus dorsi flap. The final diagnosis was based on immunohistochemistry, with tumor cells positive for GATA3 and CK-7, negative for estrogen and progesterone receptors (ER, PR), positive for human epidermal growth factor receptor 2 (Her2 neu), and having a Ki-67 labelling index of 45 %. DISCUSSION: Carcinoma of the axillary tail of Spence (CATS) has a reported incidence of 0.3 %. There have been only few papers till date that have reported the clinicopathologic, prognostic, and imaging features of CATS. MRI is an important imaging modality to localize CATS. Histologic examination aids in the diagnosis by identifying the presence of a histologic pattern of primary breast carcinoma and immunohistochemical characteristics such as ER, PR, Her2neu, and gross cystic disease fluid protein (GCDFP). Due to the rarity of CATS, no specific guidelines concerning management currently exist. Surgical management involves wide local excision of the axillary mass with axillary lymph node dissection. CONCLUSION: CATS, even though rare, should be considered in the differential diagnosis of a patient presenting with an axillary mass. MRI is a valuable tool to distinguish CATS from other lesions. Immunohistochemistry is essential to confirm the diagnosis.

A comparative analysis of features and outcome of breast cancer in younger versus older women: A single center experience from Eastern Indian subcontinent.

Purpose: Globally, breast cancer is the leading malignancy in females. Indeed, Asian cohorts show prevalence of breast cancer among women with ages below 40 years. Moreover, these younger cases are globally characterized by poorer prognostic features as well as survival outcomes, than older sufferers with ages above 40 years. Despite this, comparative analyses between older and younger cohorts are sparse from India, where data from the country's eastern part falls shortest. This study attempted a comprehensive analysis of breast cancer between these two cohorts representing the Eastern Indian subcontinent. Methods: Documenting retrospective case-files registered between 2010 and 2015, 394 cases of younger (<40 years) and 1250 older (≥40 years) sufferers of primary breast cancer were noted. The relevant features and follow-up information were also retrieved. Kaplan-Meier analyses were performed to evaluate the survival outcome. Results: The data, in general, revealed a high percentage of younger sufferers from Eastern Indian regions. Moreover, this younger cohort showed poor survival. Among the younger cohort, cases with poor pathological features (triple negative, node-positive, grade III) were proportionately higher than the older cohort. Indeed, survival among these categories scored significantly low, compared to the older cohort. Conclusion: This Eastern Indian subcontinental data matched the analyses from other parts of India as well as Asian data and clearly showed the prevalence of younger sufferers of breast cancer with poor clinico-pathological features and survival outcomes. Impact: Analyzing age-based features and outcomes from Eastern India, this study provides data in supplementing Indian and Asian scenarios of breast cancer.

Productivity loss and productivity loss costs to United States employers due to priority conditions: a systematic review.

AIMS: To summarize published studies evaluating productivity loss and productivity loss costs associated with cancer, chronic lung disease, depression, pain, and cardiometabolic disease among US employees. MATERIALS AND METHODS: A PubMed search from the past 10 years was conducted using the terms productivity, absenteeism, presenteeism, cancer, bronchitis, asthma, chronic obstructive pulmonary disease, depression, pain, heart disease, hypertension, and diabetes (limited to English-language publications and studies of adults aged 19-64). Study endpoints included annual incremental time (work hours lost and Work Productivity and Impairment [WPAI] questionnaire overall work impairment) and monetary estimates of productivity loss. Studies were critically appraised using a modified Oxford Centre for Evidence-Based Medicine (OCEBM) Quality Rating Scheme. RESULTS: Of 2,037 records identified from the search, 183 studies were included. The most common observed condition leading to productivity loss was pain (24%), followed by cancer (22%), chronic lung disease (17%), cardiometabolic disease (16%), and depression (16%). Nearly three-quarters of the studies (n = 133, 72.7%) were case-control/retrospective cohort studies (OCEBM quality rating 3); the remainder were case series/cross-sectional studies (n = 28, 15.3%; quality rating 4), randomized clinical trials (n = 18, 9.8%; quality rating 1); and controlled trials without randomization/prospective comparative cohort trials (n = 4, 2.2%; quality rating 2). Samples sizes ranged from 18 patients to millions of patients for studies using the Medical Expenditure Panel Survey (MEPS). Most studies found employees lost up to 80 annual incremental work hours; employees with cancer and cardiometabolic disease had the greatest number of work hours lost. Overall percentage work impairment ranged from 10% to 70% and was higher for pain and depression. Annual incremental costs of lost work productivity ranged from $100 to $10,000 and were higher for cancer, pain, and depression. LIMITATIONS: Study heterogeneity. CONCLUSIONS: Despite some gaps in evidence for the cost of productivity loss, sufficient data highlight the substantial employer burden of lost productivity among priority conditions.

Investment in workforce health and well-being is a practice pursued by high-performing companies as health improvement strategies have produced excellent returns on investment. This literature review sought to gain a better understanding of employee productivity loss for important diseases (i.e. cancer, chronic lung disease [bronchitis, asthma, or chronic obstructive pulmonary disease], depression, pain, and cardiometabolic disease [heart disease, hypertension, or diabetes] to help employers and healthcare payers prioritize investment in workforce health. The findings highlight the substantial burden of lost productivity among these conditions. Most studies found employees lost up to 80 annual work hours and employees with cancer and cardiometabolic disease had the greatest annual incremental number of work hours lost. The proportion of work impairment ranged from 10% to 70% and was higher for employees with pain and depression. The annual cost of lost work productivity ranged from $100 to $10,000 and was higher among employees with cancer, pain, and depression.

Economic burden of complicated ureteral stent removal in patients with kidney stone disease in the USA.

Aim: To examine the medical costs of simple versus complicated ureteral stent removal. Materials & methods: We included adults with kidney stones undergoing simple or complicated cystoscopy-based stent removal (CBSR) post ureteroscopy from the 2014 to 2018 Merative™ MarketScan® Commercial Database. The medical costs of patients with complicated and simple CBSR were compared. Results: Among 16,682 patients, 2.8% had complicated CBSR. Medical costs for patients with complicated CBSR were higher than for simple CBSR ($2182 [USD] vs $1162; p < 0.0001). Increased stenting time, increased age, southern US geography and encrusted stent diagnoses were significantly associated with complicated CBSR. Conclusion: Complicated ureteral stent removal doubled the medical costs associated with CBSR. Ureteral stents with anti-encrustation qualities may reduce the need for complicated CBSR and associated costs.

Molecular crosstalk between CUEDC2 and ERα influences the clinical outcome by regulating mitosis in breast cancer.

Development of endocrine resistance in hormone-receptor-positive (HR+ve) subtype and lack of definitive target in triple-negative subtype challenge breast cancer management. Contributing to such endocrine resistance is a protein called CUEDC2. It degrades hormone receptors, estrogen receptor-α (ERα) and progesterone receptor. Higher level of CUEDC2 in ERα+ve breast cancer corresponded to poorer disease prognosis. It additionally influences mitotic progression. However, the crosstalk of these two CUEDC2-driven functions in the outcome of breast cancer remained elusive. We showed that CUEDC2 degrades ERα during mitosis, utilising the mitotic-ubiquitination-machinery. We elucidated the importance of mitosis-specific phosphorylation of CUEDC2 in this process. Furthermore, upregulated CUEDC2 overrode mitotic arrest, increasing aneuploidy. Finally, recruiting a prospective cohort of breast cancer, we found significantly upregulated CUEDC2 in HR-ve cases. Moreover, individuals with higher CUEDC2 levels showed a poorer progression-free-survival. Together, our data confirmed that CUEDC2 up-regulation renders ERα+ve malignancies to behave essentially as HR-ve tumors with the prevalence of aneuploidy. This study finds CUEDC2 as a potential prognostic marker and a therapeutic target in the clinical management of breast cancer.

A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia.

Treatment options for men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) have variable efficacy, safety, and retreatment profiles, contributing to variations in patient quality of life and healthcare costs. This study examined the long-term cost-effectiveness of generic combination therapy (CT), prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), photoselective vaporization of the prostate (PVP), and transurethral resection of the prostate (TURP) for the treatment of BPH. A systematic literature review was performed to identify clinical trials of CT, PUL, WVTT, PVP, and TURP that reported change in International Prostate Symptom Score (IPSS) for men with BPH and a prostate volume ≤80 cm3. A random-effects network meta-analysis was used to account for the differences in patient baseline clinical characteristics between trials. An Excel-based Markov model was developed with a cohort of males with a mean age of 63 and an average IPSS of 22 to assess the cost-effectiveness of these treatment options at 1 and 5 years from a US Medicare perspective. Procedural and adverse event (AE)-related costs were based on 2021 Medicare reimbursement rates. Total Medicare costs at 5 years were highest for PUL ($9,580), followed by generic CT ($8,223), TURP ($6,328), PVP ($6,152), and WVTT ($2,655). The total cost of PUL was driven by procedural ($7,258) and retreatment ($1,168) costs. At 5 years, CT and PUL were associated with fewer quality-adjusted life years (QALYs) than WVTT, PVP, and TURP. Compared to WVTT, the incremental cost-effectiveness ratios (ICERs) for both TURP and PVP were above a willingness-to-pay threshold of $50,000/QALY (TURP: $64,409/QALY; PVP: $87,483/QALY). This study provides long-term cost-effectiveness evidence for several common treatment options for men with BPH. WVTT is an effective and economically viable treatment in resource-constrained environments.

Long-Term Risk of Surgery Following First Diagnosis of Benign Prostatic Hyperplasia in Middle-Aged Men.

Objective Pharmacotherapy is often used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), yet surgery may be indicated for persistent bothersome symptoms. BPH is common among older men, yet the burden of BPH among middle-aged men may be under-recognized. This study examined the 5-year risk of BPH surgery among middle-aged men following the first BPH diagnosis. Methods Using the IBM MarketScan Commercial Claims and Encounters Database, males aged 35 to 64 years with a first-time primary diagnosis of BPH who were prescribed oral medication for LUTS were identified. The primary outcome was the risk of BPH surgery within five years of the first BPH diagnosis, which was analyzed using Kaplan-Meier methods. The influence of patient demographics, comorbidities, and medication use on the risk of BPH surgery was explored using a Cox proportional hazards model.  Results Four thousand five hundred ten eligible men, 460 underwent BPH surgery within five years of BPH diagnosis. The most common surgical procedures were transurethral resection of the prostate and laser enucleation. The risk of BPH surgery over five years following BPH diagnosis was 10.2% (95% CI: 9.4% to 11.1%). In a multivariable Cox proportional hazards regression analysis, patient age was the primary factor associated with higher surgery risk. Compared to men aged 35 to 44 years, the hazard ratio for BPH surgery was 3.9 (95% CI: 1.9 to 8.4; p<0.001) among men aged 45 to 54 years, and 5.0 (95% CI: 2.4 to 10.6; p<0.001) among men aged 55 to 64 years. Conclusions In middle-aged men prescribed oral medication for LUTS secondary to BPH, the risk of BPH surgery was 10.2% over five years. This risk may be underappreciated and highlights the clinical need for surgical procedures with favorable risk-to-benefit profiles.

The Economic Burden of Cystoscopy-Based Ureteral Stent Removal in the United States: An Analysis of Nearly 30,000 Patients.

INTRODUCTION: Ureteral stents are commonly placed after ureteroscopy. We examined the rate of cystoscopy-based stent removal (CBSR) following ureteroscopy for stone disease and its economic burden in the United States. METHODS: Adults undergoing ureteroscopy and stenting (index surgery) for stone disease between 2014 and 2018 were identified using the IBM® MarketScan® Commercial Database. Patients were categorized as those with CBSR or without CBSR within 6 months post-index surgery. Rate and location of CBSR were assessed. To estimate the economic burden of CBSR, medical costs (2019 U.S. dollars) paid by insurers were calculated at 6 months post-index surgery. A generalized linear model examined the association of CBSR with total costs adjusting for patient characteristics. RESULTS: Among 29,535 patients meeting the inclusion criteria, 56.5% had CBSR within 6 months. Median time to CBSR was 9 days; 70% of patients with CBSR had their stent removed in the office. Medical costs for CBSR patients were significantly higher than those for nonCBSR patients ($7,808 vs $6,231; p <0.0001). The difference was driven by the cost of CBSR ($1,132 vs $0; p <0.0001) and health care utilization for stone disease ($2,464 vs $2,121; p <0.0001). CBSR was associated with a 17% increase in medical costs compared to nonCBSR (OR: 1.17; 95% CI 3.03, 3.46). CONCLUSIONS: Over 50% of patients had CBSR within 6 months following ureteroscopy. Medical costs for patients undergoing CBSR were significantly higher and driven by the cost of CBSR and resource utilization for stone disease. Ureteral stents that avoid CBSR can lower medical costs to the health care system.

SpaceOAR hydrogel spacer injection prior to stereotactic body radiation therapy for men with localized prostate cancer: A systematic review.

BACKGROUND: Conventionally fractionated radiotherapy is a common treatment for men with localized prostate cancer. A growing consensus suggests that stereotactic body radiation therapy (SBRT) is similarly effective but less costly and more convenient for patients. The SpaceOAR hydrogel rectal spacer placed between the prostate and rectum reduces radiation-induced rectal injury in patients receiving conventionally fractionated radiotherapy, but spacer efficacy with SBRT is unclear. The purpose of this research was to assess the clinical utility of the hydrogel rectal spacer in men receiving SBRT for prostate cancer. METHODS: We performed systematic searches of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies in men who received the SpaceOAR hydrogel spacer prior to SBRT (≥5.0 Gy fractions) for treatment of localized prostate center. Rectal irradiation results were compared to controls without spacer implant; all other outcomes were reported descriptively owing to lack of comparative data incuding perirectal separation distance, rectal irradiation on a dosimetric curve, gastrointestinal (GI) toxicity, and freedom from biochemical failure. GI toxicity was reported as the risk of a grade 2 or 3+ bowel complication in early (≤3 months) and late (>3 months) follow-up. RESULTS: In 11 studies with 780 patients, SBRT protocols ranged from 7 to 10 Gy per fraction with total dose ranging from 19 to 45 Gy. Perirectal distance achieved with the rectal spacer ranged from 9.6 to 14.5 mm (median 10.8 mm). Compared to controls receiving no spacer, SpaceOAR placement reduced the radiation delivered to the rectum by 29% to 56% across a dosimetric profile curve. In early follow-up, grade 2 GI complications were reported in 7.0% of patients and no early grade 3+ GI complications were reported. In late follow-up, the corresponding rates were 2.3% for grade 2 and 0.3% for grade 3 GI toxicity. Over 16 months median follow-up, freedom from biochemical failure ranged from 96.4% to 100% (pooled mean 97.4%). CONCLUSIONS: SpaceOAR hydrogel spacer placed between the prostate and rectum prior to SBRT is a promising preventative strategy that increases the distance between the prostate and rectum, reduces rectal radiation exposure, and may lower the risk of clinically important GI complications.

SpaceOAR Hydrogel Spacer for Reducing Radiation Toxicity During Radiotherapy for Prostate Cancer. A Systematic Review.

OBJECTIVE: To evaluate the association between SpaceOAR and radiation dosing, toxicity and quality-of-life vs no spacer across all radiotherapy modalities for prostate cancer. METHODS: A systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase was performed from database inception through May 2020. Two reviewers independently screened titles/abstracts and full papers. Data extraction was performed, and quality assessed by 1 reviewer and checked by a second, using a third reviewer as required. The synthesis was narrative. RESULTS: 19 studies (3,622 patients) were included (only 1 randomized controlled trial, in image-guided intensity-modulated radiotherapy (IG-IMRT), 18 comparatives non-randomized controlled trials in external-beam radiotherapy (EBRT), brachytherapy, and combinations thereof). No hypofractionation studies were found. Regardless of radiotherapy type, SpaceOAR significantly reduced rectal radiation dose (eg, V40 average difference -6.1% in high dose-rate brachytherapy plus IG-IMRT to -9.1% in IG-IMRT) and reduced gastrointestinal and genitourinary toxicities (eg, late gastrointestinal toxicity 1% vs 6% (P = .01), late genitourinary toxicity of 15% vs 32% (P < .001) in stereotactic body radiotherapy). Improvements were observed in most Expanded Prostate Cancer Index Composite quality-of-life domains (eg, bowel function score decrease at 3 and 6 months: Average change of zero vs -6.25 and -3.57 respectively in low dose-rate brachytherapy plus EBRT). CONCLUSION: The randomized controlled trial in IG-IMRT demonstrated that SpaceOAR reduces rectal radiation dose and late gastrointestinal and genitourinary toxicities, with urinary, bowel, and sexual quality-of-life improvement. These advantages were verified in observational studies in various radiotherapy types. Further research is required in hypofractionation.

Risk Factors for Urosepsis After Ureteroscopy for Stone Disease: A Systematic Review with Meta-Analysis.

Introduction: Urosepsis is a serious potential complication of ureteroscopic procedures for stone disease, yet the risk factors for this complication are not well characterized. The purpose of this systematic review with meta-analysis was to identify potential risk factors for urosepsis after ureteroscopy (URS) for stone disease. Materials and Methods: We performed systematic searches of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies reporting at least one prospectively defined risk factor for urosepsis after URS. Studies that only reported rates of isolated fever, urinary tract infection (UTI), or pooled infectious complications were excluded. The risk factors evaluated in this review were age, sex, body mass index, diabetes mellitus, ischemic heart disease, recent UTI, pyuria, hydronephrosis, stone history, stone size, preoperative stent placement, preoperative positive urine culture, and procedure time. A random effects meta-analysis model with inverse variance weighting was used where the statistic of interest was the odds ratio for dichotomous variables and the mean difference for continuous outcomes. Results: In 13 studies (5 prospective) with 5597 patients, the pooled incidence of postoperative urosepsis was 5.0% (95% confidence interval: 2.4-8.2). Six risk factors were statistically associated with increased postoperative urosepsis risk-preoperative stent placement (odds ratio = 3.94, p < 0.001, 6 studies), positive preoperative urine culture (odds ratio = 3.56, p < 0.001, 6 studies), ischemic heart disease (odds ratio = 2.49, p = 0.002, 2 studies), older age (mean difference = 2.7 years, p = 0.002, 6 studies), longer procedure time (mean difference = 9 minutes, p = 0.02, 1 study), and diabetes mellitus (odds ratio = 2.04, p = 0.04, 6 studies). Conclusions: Current evidence suggests that among patients undergoing URS for treatment of stone disease, the risk of postoperative urosepsis was 5.0%. Older age, diabetes mellitus, ischemic heart disease, preoperative stent placement, a positive urine culture, and longer procedure time were associated with increased postoperative urosepsis risk. These results will assist urologists with preoperative risk stratification before ureteroscopic procedures.

Water vapor thermal therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: Systematic review and meta-analysis.

BACKGROUND: Water vapor thermal therapy (WVTT) is a minimally invasive procedure for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). There are no known systematic reviews reporting the effectiveness and safety of this increasingly common BPH therapy. METHODS: We performed a systematic review and meta-analysis of studies utilizing WVTT for symptomatic BPH. The international prostate symptom score (IPSS), IPSS-quality of life (IPSS-QOL), BPH impact index (BPHII), and maximum flow rate (Qmax) were calculated as the weighted mean difference relative to baseline and reported in minimal clinically important difference (MCID) units. MCID thresholds were -3 for IPSS, -0.5 for IPSS-QOL, -0.5 for BPHII, and 2 mL/s for Qmax. The surgical retreatment rate was calculated using life-table methods. RESULTS: We identified 5 cohorts treated with WVTT from 4 studies (514 patients; 40% with median lobe obstruction) with 2 years median follow-up (range: 6 months to 4 years). The IPSS, IPSS-QOL, BPHII, and Qmax significantly improved at all intervals between 3 months and 4 years; this benefit ranged from 3.3 to 3.8 MCID units for IPSS, 3.9 to 4.6 MCID units for IPSS-QOL, 6.8 to 8.2 MCID units for BPHII, and 1.5 to 3.0 MCID units for Qmax. The surgical retreatment rate was 7.0% at 4 years of follow-up data. Most adverse events were nonserious and transient; dysuria, urinary retention, and urinary tract infection were most common. No cases of de novo erectile dysfunction occurred. CONCLUSIONS: WVTT provided improvement in BPH symptoms that exceeded established MCID thresholds, preserved sexual function, and was associated with low surgical retreatment rates over 4 years.

High-concentration nonavian high-molecular weight hyaluronan injections and time-to-total knee replacement surgery.

Aim: To examine the time-to-total knee replacement (TKR) surgery among patients with high-concentration nonavian high-molecular-weight hyaluronan injection (HMW-HA) compared with those without HA injections. Materials & methods: Using MarketScan® Commercial claims all patients aged 18-64 who underwent TKR surgery between 2008 and 2017 were identified. Time-to-TKR surgery was compared between patients receiving Orthovisc® (Anika Therapeutics Inc. Bedford MA, USA, referred to as nonavian HMW-HA) injections and patients who did not receive an HA injection. Results: The median time-to-TKR surgery was 893 days in the nonavian HMW-HA cohort and 399 days in the non-HA cohort (p < 0.001), a difference of 494 days (16.2 months). Conclusion: This study demonstrates that the time-to-TKR surgery is 16.2 months longer in patients who received treatment with nonavian HMW-HA injections.

Association of the Placement of a Perirectal Hydrogel Spacer With the Clinical Outcomes of Men Receiving Radiotherapy for Prostate Cancer: A Systematic Review and Meta-analysis.

Importance: Perirectal spacers are intended to lower the risk of rectal toxic effects associated with prostate radiotherapy. A quantitative synthesis of typical clinical results with specific perirectal spacers is limited. Objective: To evaluate the association between perirectal hydrogel spacer placement and clinical outcomes of men receiving radiotherapy for prostate cancer. Data Sources: A systematic search was performed of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for articles published through September 2019. Study Selection: Studies comparing men who received a hydrogel spacer vs men who did not receive a spacer (controls) prior to prostate radiotherapy. Data Extraction and Synthesis: Via random-effects meta-analysis, group comparisons were reported using the weighted mean difference for continuous measures and the risk ratio for binary measures. Main Outcomes and Measures: Procedural results, the percentage volume of rectum receiving at least 70 Gy radiation (v70), early (≤3 months) and late (>3 months) rectal toxic effects, and early and late changes in bowel-related quality of life on the Expanded Prostate Cancer Index Composite (minimal clinically important difference, 4 points). Results: The review included 7 studies (1 randomized clinical trial and 6 cohort studies) involving 1011 men (486 who received a hydrogel spacer and 525 controls), with a median duration of patient follow-up of 26 months (range, 3-63 months). The success rate of hydrogel spacer placement was 97.0% (95% CI, 94.4%-98.8% [5 studies]), and the weighted mean perirectal separation distance was 11.2 mm (95% CI, 10.1-12.3 mm [5 studies]). Procedural complications were mild and transient, occurring in 0% to 10% of patients within the studies. The hydrogel spacer group received 66% less v70 rectal irradiation compared with controls (3.5% vs 10.4%; mean difference, -6.5%; 95% CI, -10.5% to -2.5%; P = .001 [6 studies]). The risk of grade 2 or higher rectal toxic effects was comparable between groups in early follow-up (4.5% in hydrogel spacer group vs 4.1% in control group; risk ratio, 0.82; 95% CI, 0.52-1.28; P = .38 [6 studies]) but was 77% lower in the hydrogel spacer group in late follow-up (1.5% vs 5.7%; risk ratio, 0.23; 95% CI, 0.06-0.99; P = .05 [4 studies]). Changes in bowel-related quality of life were comparable between groups in early follow-up (mean difference, 0.2; 95% CI, -3.1 to 3.4; P = .92 [2 studies]) but were greater in the hydrogel spacer group in late follow-up (mean difference, 5.4; 95% CI, 2.8-8.0; P < .001 [2 studies]). Conclusions and Relevance: For men receiving prostate radiotherapy, injection of a hydrogel spacer was safe, provided prostate-rectum separation sufficient to reduce v70 rectal irradiation, and was associated with fewer rectal toxic effects and higher bowel-related quality of life in late follow-up.

A novel metric for treatment durability in clinical trials of minimally invasive treatments for benign prostatic hyperplasia.

Introduction: Clinical trial manuscripts commonly report results of individual endpoints. However, durability of a medical treatment may be difficult to determine when evaluating endpoint outcomes individually. We reviewed pivotal trial manuscripts of two minimally invasive benign prostatic hyperplasia (BPH) treatments and estimated the rate of treatment durability using a composite, symptom-centric metric.Methods: Data were derived from published pivotal trial reports of two minimally invasive BPH treatments - water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL). We estimated the risk of medical or surgical retreatment using life-table methods, and the number of patients achieving the minimal clinically important difference (MCID) for the International Prostate Symptom Score (IPSS) using z-score methods. Treatment durability was defined as a MCID on the IPSS at the 4-year follow-up visit while free from medical or surgical retreatment.Results: Comparing WVTT to PUL, the rate of medical or surgical retreatment was 10.6% vs. 31.8%, the IPSS MCID was achieved in 82.2% vs. 79.5%, and treatment durability rates were 71.8% vs. 51.7%.Conclusions: Utilization of a composite treatment durability metric derived from endpoints commonly reported in the BPH literature may allow patients and their providers to make better informed treatment decisions.

Preoperative Behavioral Health, Opioid, and Antidepressant Utilization and 2-year Costs After Spinal Fusion-Revelations From Cluster Analysis.

STUDY DESIGN: Retrospective administrative claims database analysis. OBJECTIVE: Identify distinct presurgery health care resource utilization (HCRU) patterns among posterior lumbar spinal fusion patients and quantify their association with postsurgery costs. SUMMARY OF BACKGROUND DATA: Presurgical HCRU may be predictive of postsurgical economic outcomes and help health care providers to identify patients who may benefit from innovation in care pathways and/or surgical approach. METHODS: Privately insured patients who received one- to two-level posterior lumbar spinal fusion between 2007 and 2016 were identified from a claims database. Agglomerative hierarchical clustering (HC), an unsupervised machine learning technique, was used to cluster patients by presurgery HCRU across 90 resource categories. A generalized linear model was used to compare 2-year postoperative costs across clusters controlling for age, levels fused, spinal diagnosis, posterolateral/interbody approach, and Elixhauser Comorbidity Index. RESULTS: Among 18,770 patients, 56.1% were female, mean age was 51.3, 79.4% had one-level fusion, and 89.6% had inpatient surgery. Three patient clusters were identified: Clust1 (n = 13,987 [74.5%]), Clust2 (n = 4270 [22.7%]), Clust3 (n = 513 [2.7%]). The largest between-cluster differences were found in mean days supplied for antidepressants (Clust1: 97.1 days, Clust2: 175.2 days, Clust3: 287.1 days), opioids (Clust1: 76.7 days, Clust2: 166.9 days, Clust3: 129.7 days), and anticonvulsants (Clust1: 35.1 days, Clust2: 67.8 days, Clust3: 98.7 days). For mean medical visits, the largest between-cluster differences were for behavioral health (Clust1: 0.14, Clust2: 0.88, Clust3: 16.3) and nonthoracolumbar office visits (Clust1: 7.8, Clust2: 13.4, Clust3: 13.8). Mean (95% confidence interval) adjusted 2-year all-cause postoperative costs were lower for Clust1 ($34,048 [$33,265-$34,84]) versus both Clust2 ($52,505 [$50,306-$54,800]) and Clust3 ($48,452 [$43,007-$54,790]), P < 0.0001. CONCLUSION: Distinct presurgery HCRU clusters were characterized by greater utilization of antidepressants, opioids, and behavioral health services and these clusters were associated with significantly higher 2-year postsurgical costs. LEVEL OF EVIDENCE: 3.

Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion for Single-Level Degenerative Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVE: We compared the safety and effectiveness of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) to open TLIF (O-TLIF) for lumbar degenerative disease. METHODS: We systematically searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for randomized trials of MI-TLIF versus O-TLIF. The perioperative outcomes included the procedure time, fluoroscopy time, blood loss, complications, and hospital stay. The midterm outcomes included pseudarthrosis, the Oswestry Disability Index, and pain severity-all reported at 1-year minimum follow-up. RESULTS: A total of 7 randomized trials including 496 patients (246 MI-TLIF; 250 O-TLIF) were included in our review. No statistically significant group differences in procedure time (mean difference [MD], -4 minutes; P = 0.70) were found. However, the fluoroscopy time was significantly longer with MI-TLIF (MD, 48 seconds; P < 0.001). MI-TLIF resulted in less perioperative blood loss (MD, -200 mL; P < 0.001) and shorter hospitalization (MD, -2.2 days; P < 0.001) compared with O-TLIF. The risk of perioperative complications was comparable between the 2 groups (risk ratio, 1.03; P = 0.94). No group differences were found in the incidence of pseudarthrosis at the 1-year minimum follow-up (risk ratio, 0.84; P = 0.67). Pain severity at midterm follow-up was comparable between the 2 groups (MD, -1; P = 0.59), and the ODI was slightly lower in the MI-TLIF group (MD, -3; P = 0.01). CONCLUSION: Relative to O-TLIF, MI-TLIF was associated with less blood loss, a shorter hospital stay, and slightly less disability, at the expense of longer fluoroscopy times.

Does Surgical Approach Affect Outcomes in Total Hip Arthroplasty Through 90 Days of Follow-Up? A Systematic Review With Meta-Analysis.

BACKGROUND: The choice between anterior approach (AA) and posterior approach (PA) in primary total hip arthroplasty (THA) is controversial. Previous reviews have predominantly relied on data from retrospective studies. METHODS: This systematic review included prospective studies comparing postoperative outcomes through 90 days of AA vs PA in primary THA. Outcomes were pain severity, narcotic usage, hip function using Harris Hip Score, and complications. Random effects meta-analysis was performed for all outcomes. Efficacy data were reported as standardized mean difference (SMD) where values of 0.2, 0.5, 0.8, and 1.0 were defined as small, medium, large, and very large effect sizes, respectively. Complications were reported as the absolute risk difference (RD) where a positive value implied higher risk with AA and a lower value implied lower risk with AA. RESULTS: A total of 13 prospective comparative studies (7 randomized) with patients treated with AA (n = 524) or PA (n = 520) were included. The AA was associated with lower pain severity (SMD = -0.37, P < .001), lower narcotic usage (SMD = -0.36, P = .002), and improved hip function (SMD = 0.31, P = .002) compared to PA. No differences between surgical approaches were observed for dislocation (RD = 0.2%, P = .87), fracture (RD = 0.2%, P = .87), hematoma (RD = 0%, P = .99), infection (RD = 0.2%, P = .85), thromboembolic event (RD = -0.9%, P = .42), or reoperation (RD = 1.3%, P = .26). Conclusions of this study were unchanged when subjected to sensitivity analyses. CONCLUSION: In this systematic review and meta-analysis of prospective studies comparing postoperative outcomes through 90 days of AA vs PA in primary THA, patients treated with AA reported less pain, consumed fewer narcotics, and reported better hip function. No statistical differences in complication rates were detected between AA and PA. Ultimately, the choice of surgical approach in primary THA should consider preference and experience of the surgeon as well as preference and anatomy of the patient.

Biocomposite Implants Composed of Poly(Lactide-co-Glycolide)/ß-Tricalcium Phosphate: Systematic Review of Imaging, Complication, and Performance Outcomes.

PURPOSE: To determine the degradation and performance outcomes of poly(lactide-co-glycolide)/ß-tricalcium phosphate (PLGA/ß-TCP) implants. METHODS: A MEDLINE and Embase search for randomized or nonrandomized controlled studies and prospective or retrospective case series that used biocomposite interference screws or suture anchors composed of PLGA/ß-TCP was performed. Main outcomes included volume of implant resorption and incidence of osteoconductivity at implant sites, imaging findings, adverse events, and the frequency of reoperations. RESULTS: A total of 13 studies representing 668 patients with either knee or shoulder implants were included. Median follow-up was 28 months (range: 12-37 months). Biocomposite implants lost 88% of their original volume during follow-up. Osteoconductivity at the implant site was identified in 63% of cases. Adverse events included tunnel widening (3%), effusion (5%), and cyst formation (4%). Synovitis was not reported. CONCLUSIONS: Biocomposite interference screws or suture anchors composed of PLGA/ß-TCP almost fully absorb over 3 years while promoting osteoconductivity with few reported adverse events. LEVEL OF EVIDENCE: Level IV, systematic review of Level I-IV studies.