Health-care organization characteristics in cancer care delivery: an integrated conceptual framework with content validation.

Context can influence cancer-related outcomes. For example, health-care organization characteristics, including ownership, leadership, and culture, can affect care access, communication, and patient outcomes. Health-care organization characteristics and other contextual factors can also influence whether and how clinical discoveries reduce cancer incidence, morbidity, and mortality. Importantly, policy, market, and technology changes are transforming health-care organization design, culture, and operations across the cancer continuum. Consequently, research is essential to examine when, for whom, and how organizational characteristics influence person-level, organization-level, and population-level cancer outcomes. Understanding organizational characteristics-the structures, processes, and other features of entities involved in health care delivery-and their dynamics is an important yet understudied area of care delivery research across the cancer continuum. Research incorporating organizational characteristics is critical to address health inequities, test care delivery models, adapt interventions, and strengthen implementation. The field lacks conceptual grounding, however, to help researchers identify germane organizational characteristics. We propose a framework identifying organizational characteristics relevant for cancer care delivery research based on conceptual work in health services, organizational behavior, and management science and refined using a systematic review and key informant input. The proposed framework is a tool for organizing existing research and enhancing future cancer care delivery research. Following a 2012 Journal of the National Cancer Institute monograph, this work complements National Cancer Institute efforts to stimulate research addressing the relationship between cancer outcomes and contextual factors at the patient, provider, team, delivery organization, community, and health policy levels.

Diagnosis and Treatment of Early-Stage Testicular Cancer: AUA Guideline Amendment 2023.

PURPOSE: The purpose of this American Urological Association (AUA) guideline amendment is to provide a useful reference on the effective evidence-based treatment strategies for early-stage testicular cancer. METHODOLOGY/METHODS: The original methodology protocol included searches of PubMed®, Embase®, and the Cochrane Central Register of Controlled Trials (CENTRAL) from January 1980 through August 2018. The search strategy used medical subject heading (MeSH) terms and key words relevant to the diagnosis and treatment of early-stage testicular cancer. The searches conducted for the update presented herein utilized the same methodological protocol to capture literature published through March 2023. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. RESULTS: Updates were made to statements on imaging, seminoma management, non-seminoma management, surveillance for stage I testicular cancer, and additional survivorship. Further revisions were made to the methodology and reference sections as appropriate. CONCLUSIONS: This guideline seeks to improve clinicians' ability to evaluate and treat patients with early-stage testicular cancer based on currently available evidence. Future studies will be essential to further support or refine these statements to improve patient care.

Patient engagement strategies for adults with chronic conditions: an evidence map.

BACKGROUND: Patient and family engagement (PFE) has been defined as a partnership between patients, families, and health care providers to achieve positive health care outcomes. There is evidence that PFE is critical to improving outcomes. We sought to systematically identify and map the evidence on PFE strategies for adults with chronic conditions and identify areas needing more research. METHODS: We searched PubMed, CINAHL, EMBASE, and Cochrane, January 2015 to September 2021 for systematic reviews on strategies for engaging patients with chronic conditions and their caregivers. From each review, we abstracted search dates, number and type of studies, populations, interventions, and outcomes. PFE strategies were categorized into direct patient care, health system, and community-policy level strategies. We found few systematic reviews on strategies at the health system, and none at the community-policy level. In view of this, we also searched for original studies that focused on PFE strategies at those two levels and reviewed the PFE strategies used and study findings. RESULTS: We found 131 reviews of direct patient care strategies, 5 reviews of health system strategies, and no reviews of community-policy strategies. Four original studies addressed PFE at the health system or community-policy levels. Most direct patient care reviews focused on self-management support (SMS) (n = 85) and shared decision-making (SDM) (n = 43). Forty-nine reviews reported positive effects, 35 reported potential benefits, 37 reported unclear benefits, and 4 reported no benefits. Health system level strategies mainly involved patients and caregivers serving on advisory councils. PFE strategies with the strongest evidence focused on SMS particularly for patients with diabetes. Many SDM reviews reported potential benefits especially for patients with cancer. DISCUSSION: Much more evidence exists on the effects of direct patient care strategies on PFE than on the effects of health system or community-policy strategies. Most reviews indicated that direct patient care strategies had positive effects or potential benefits. A limitation of this evidence map is that due to its focus on reviews, which were plentiful, it did not capture details of individual interventions. Nevertheless, this evidence map should help to focus attention on gaps that require more research in efforts to improve PFE.

Assessing quality of care in the diagnosis and treatment of early-stage testicular cancer: A critical review and summary.

OBJECTIVE: To review the current literature on quality of care in the diagnosis and management of early-stage testicular cancer. METHODS: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched for studies on quality of care in testicular cancer diagnosis and management from January 1980 to August 2018. Major overlapping themes related to quality of care in the diagnosis and management of TGCT were identified and evidence related to these themes were abstracted. EVIDENCE: 62 studies were included in the review. A number of themes were identified including (1) trends in survival and outcomes, (2) management patterns, (3) adherence to evidence-based clinical guidelines, (4) delays in care, (5) treatment complications and toxicities, (6) sociodemographic factors, (7) volume of patients treated, (8) gaps in provider knowledge and medical errors, and (9) multidisciplinary approaches to care. EVIDENCE SUMMARY: As survival for patients with testicular cancer improves, there has been a greater emphasis on other components of quality of care, such as reducing treatment toxicity and minimizing delays in diagnosis. Efforts to meet these goals include encouragement of adherence to evidence-based guidelines, greater utilization of surveillance, and promotion of multidisciplinary team-based care. Although outcomes have improved, social determinants of health, such as insurance status, race, and geographical residence all may influence survival and cancer-related outcomes. Additionally, qualitative review indicates patients who receive care at high-volume institutions appear to experience better outcomes than those treated at smaller centers. CONCLUSIONS: As outcomes and survival improve for patients with testicular cancer, quality of care has become an important consideration. Future avenues of research on this topic include identifying an appropriate balance between centralization of care and expanding access to underserved areas, minimizing delays in care, ensuring greater adherence to clinical guidelines, and addressing sociodemographic and racial disparities in outcomes.

Pharmacologic Interventions for Breathlessness in Patients With Advanced Cancer: A Systematic Review and Meta-analysis.

Importance: Improved survival in patients with advanced cancer has increased the need for better understanding of how to manage common symptoms that they may experience, such as breathlessness. Objective: To assess the benefits and harms associated with pharmacologic interventions for breathlessness in adults with advanced cancer. Data Sources: PubMed, Embase, CINAHL, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for studies published from database inception through May 31, 2020, using predefined eligibility criteria within a PICOTS (population, intervention, comparator, outcome, timing, setting) format. Study Selection: Randomized clinical trials (RCTs), non-RCTs, and observational studies with a comparison group that evaluated benefits and/or harms and cohort studies that reported harms were selected. Data Extraction and Synthesis: Two reviewers independently screened studies for eligibility, serially abstracted data, independently assessed risk of bias, and graded strength of evidence (SOE). Main Outcomes and Measures: Benefits and harms of pharmacologic interventions were compared, focusing on breathlessness, anxiety, exercise capacity, and health-related quality of life. When possible, meta-analyses were conducted and standardized mean differences (SMDs) calculated. Results: In this systematic review and meta-analysis, a total of 7729 unique citations were identified, of which 19 studies (17 RCTs and 2 retrospective studies) that included a total of 1424 patients assessed the benefits of medications for management of breathlessness in advanced cancer or reported harms. The most commonly reported type of cancer was lung cancer. Opioids were not associated with more effectiveness than placebo for improving breathlessness (SMD, -0.14; 95% CI, -0.47 to 0.18) or exercise capacity ( SMD, 0.06; 95% CI, -0.43 to 0.55) (SOE, moderate); most studies examined exertional breathlessness. Specific dose and/or route of administration of opioids did not differ in effectiveness for breathlessness (SMD, 0.15; 95% CI, -0.22 to 0.52) (SOE, low). Anxiolytics were not associated with more effectiveness than placebo for breathlessness or anxiety (reported mean between-group difference, -0.52; 95% CI, -1.045 to 0.005) (SOE, low). Evidence for other pharmacologic interventions was limited. Pharmacologic interventions demonstrated some harms compared with usual care, but dropout attributable to adverse events was minimal in these short-term studies (range 3.2%-16%). Conclusions and Relevance: Evidence did not support the association of opioids or other pharmacologic interventions with improved breathlessness. Given that studies had many limitations, pharmacologic interventions should be considered in selected patients but need to be considered in the context of potential harms and evidence of an association of nonpharmacologic interventions with improved breathlessness.

Comparative Effectiveness of Surveillance, Primary Chemotherapy, Radiotherapy and Retroperitoneal Lymph Node Dissection for the Management of Early Stage Testicular Germ Cell Tumors: A Systematic Review.

PURPOSE: Cancer specific survival for men with early stage (I to IIB) testicular germ cell tumors is greater than 90% with any management strategy. The data regarding the comparative effectiveness of surveillance, primary chemotherapy, radiotherapy and retroperitoneal lymph node dissection were synthesized with a focus on oncologic outcomes, patient reported outcomes, and short and long-term toxicities. MATERIALS AND METHODS: PubMed®, Embase® and the Cochrane Central Register of Controlled Trials were searched from 1980 to 2018 for studies addressing the effectiveness of surveillance, chemotherapy, radiotherapy and retroperitoneal lymph node dissection, according to pathology and clinical stage, for men with an early stage testicular germ cell tumor. RESULTS: Cancer specific survival ranged from 94% to 100% for patients with early stage testicular germ cell tumors regardless of tumor histology and initial management strategy. For men with seminoma the median cancer specific survival was 99.7% (range 97% to 100%), 99.5% (96.8% to 100%) and 100% (100% to 100%) among those managed by surveillance, radiotherapy and chemotherapy, respectively. Median cancer specific survival for men with nonseminomatous testicular germ cell tumors was 100% (range 98.6% to 100%), 100% (96.9% to 100%) and 100% (94% to 100%) when managed by surveillance, retroperitoneal lymph node dissection and chemotherapy, respectively. Recurrence rates and toxicities varied by management strategy. For men with seminoma surveillance, chemotherapy and radiotherapy were associated with median recurrence rates of 15%, 2% and 3.7%, respectively. For men with nonseminomatous testicular germ cell tumors the median recurrence rates were 20.5%, 3.3% and 11.1% for surveillance, chemotherapy and retroperitoneal lymph node dissection, respectively. Surveillance was associated with minimal toxicities compared to other approaches. Primary chemotherapy had the highest rate of short-term toxicities and was associated with long-term risks of metabolic syndrome, hypogonadism, renal impairment, neuropathy, infertility and secondary malignancies. Toxicities with radiotherapy included acute dermatitis and long-term gastrointestinal complications, infertility and high rates of secondary malignancies (2% to 3%). Patients undergoing retroperitoneal lymph node dissection had significant risk of toxicity perioperatively and long-term infertility in men with anejaculation. Transient detriments in patient reported outcomes and quality of life were noted with all management options. CONCLUSIONS: Men with early stage testicular germ cell tumors experience excellent cancer specific survival regardless of management strategy. Management options, however, differ in terms of associated recurrence rates, short and long-term toxicities, and patient reported outcomes. The profile for each approach should be clearly communicated to patients and matched with patient preferences to offer the best individual outcome.

Nonpharmacological Interventions for Managing Breathlessness in Patients With Advanced Cancer: A Systematic Review.

IMPORTANCE: Breathlessness is a frequent and debilitating symptom in patients with advanced cancer. Often, in the context of breathlessness, aggressive cancer treatment is not beneficial, feasible, or aligned with goals of care. Targeted symptom-focused interventions may be helpful in this scenario. OBJECTIVE: To evaluate the advantages and harms of nonpharmacological interventions for managing breathlessness in adults with advanced cancer. EVIDENCE REVIEW: PubMed, Embase, CINAHL, Web of Science, and the Cochrane Central Register of Controlled Trials were searched from inception through May 2020 for published randomized clinical trials (RCTs), nonrandomized controlled trials, and observational studies of the advantages and/or harms of nonpharmacological interventions on alleviating breathlessness in adults with advanced cancer. Only English-language studies were screened for eligibility, titles, abstracts, and full text. Risk of bias and strength of evidence (SOE) were independently assessed. The key outcomes reported in studies were breathlessness, anxiety, exercise capacity, health-related quality of life, and harms. Data were analyzed from October 1, 2019, to June 30, 2020. FINDINGS: A total of 29 RCTs (2423 participants) were included. These RCTs evaluated various types of interventions, such as respiratory (9 RCTs), activity and rehabilitation (7 RCTs), behavioral and psychoeducational (3 RCTs), integrative medicine (4 RCTs), and multicomponent (6 RCTs). Several nonpharmacological interventions were associated with improved breathlessness, including fan therapy (standardized mean difference [SMD], -2.09; 95% CI, -3.81 to -0.37; I2 = 94.3%; P for heterogeneity = .02; moderate SOE) and bilevel ventilation (estimated slope difference, -0.58; 95% CI, -0.92 to -0.23; low SOE), lasting for a few minutes to hours, in the inpatient setting. In the outpatient setting, nonpharmacological interventions associated with improved breathlessness were acupressure and reflexology (integrative medicine) (low SOE) and multicomponent interventions (combined activity and rehabilitation, behavioral and psychoeducational, and integrative medicine) (low SOE) lasting for a few weeks to months. Five of the 29 RCTs (17%) reported adverse events, although adverse events and study dropouts were uncommon. CONCLUSIONS AND RELEVANCE: Findings of this review include the safety and association with improved breathlessness of several nonpharmacological interventions for adults with advanced cancer. Guidelines and clinical practice should evolve to incorporate nonpharmacological interventions as first-line treatment for adults with advanced cancer and breathlessness.

Testis-sparing surgery and scrotal violation for testicular masses suspicious for malignancy: A systematic review and meta-analysis.

Radical inguinal orchiectomy is the standard of care for men diagnosed with a testicular mass suspicious for germ cell tumor (TGCT). Nontraditional approaches to management, including testis-sparing surgery (TSS) and scrotal orchiectomy, occur in clinical practice. We systematically reviewed studies evaluating outcomes after TSS and scrotal violation for the management of a suspected TGCT. We used PubMed, Embase, and the Cochrane Central Register of Controlled Trials (January 1980-December 2018) to search for studies addressing morbidity and oncologic outcomes after TSS or scrotal violation for testicular masses concerning for TGCT. Paired reviewers independently screened abstracts for inclusion, sequentially extracted data, and assessed study quality. Twenty-one studies were included (10 TSS, 11 scrotal violation). Risk of local recurrence after TSS on meta-analysis was 7.5% after 3 to 5 years (absolute proportion reported in studies: 10.9%). Aggregated rates of positive margins (1.4%) and testicular atrophy (2.8%) across studies were low with 7.1% of patients requiring subsequent androgen therapy. Scrotal violation led to a higher aggregate risk of local recurrence compared to no scrotal violation (2.5% vs. 0.0%, P < 0.001) but did not appear to impact subsequent metastasis and survival in the short term (3-5 years). Most patients received adjuvant therapy after scrotal violation with 9.3% found to harbor residual primary tumor after scrotal scar excision. TSS carries a quantifiable risk of local recurrence after 3 to 5 years despite the majority receiving adjuvant radiation or chemotherapy. Scrotal violation carries a risk of local recurrence but does not appear to impact subsequent metastasis and survival in the short term.

Diagnosis and Management of Intratubular Germ Cell Neoplasia In Situ: A Systematic Review.

PURPOSE: We performed a systematic review of studies assessing the diagnosis and effectiveness of management strategies for germ cell neoplasia in situ. MATERIALS AND METHODS: Paired investigators independently searched for studies on the diagnosis and management of testicular germ cell neoplasia in situ using PubMed®, Embase® and the Cochrane Central Register of Controlled Trials from January 1, 1980 through August 2018. The reviewers then extracted data and assessed quality. RESULTS: Eighteen studies met inclusion criteria. Among patients with a testicular germ cell tumor the prevalence of contralateral germ cell neoplasia in situ was 4.0% to 8.1%. No significant difference in the risk of metachronous malignancy was identified between unscreened groups vs those with routine contralateral testicular screening (cumulative incidence 1.9% vs 3.1%, p=0.097, respectively). Patients who presented with a history of testicular atrophy, age less than 40 years or cryptorchidism had an elevated risk of germ cell neoplasia in situ. In patients with germ cell neoplasia in situ the use of 18 to 20 Gy radiation therapy demonstrated the lowest rate of disease on followup biopsies (0% to 2.5%), compared to a median of 30% on biopsies in patients treated with cisplatin based chemotherapy. Carboplatin based treatment regimens demonstrated positive disease in 66% to 75% on repeat biopsies. Rates of treatment related hypogonadism were 30.8% to 38.5% and 13% to 20% for patients treated with 18 to 20 Gy and cisplatin based chemotherapy, respectively. CONCLUSIONS: In patients with a testicular germ cell tumor the risk of having contralateral germ cell neoplasia in situ is 4% to 8%, with a greater risk in patients with testicular atrophy, cryptorchidism or age less than 40 years. The risk is high enough to support use of contralateral testicular biopsy in patients with these risk factors for germ cell neoplasia in situ. However, routine screening is not advised. Radiation therapy with 18 to 20 Gy was associated with much better eradication of germ cell neoplasia in situ than chemotherapy. Chemotherapy may eradicate germ cell neoplasia in situ in up to two-thirds of patients undergoing chemotherapy as adjuvant treatment for a primary germ cell tumor. Further research and data are needed to strengthen many aspects of the evidence base.

Magnetic Resonance Imaging to Differentiate the Histology of Testicular Masses: A Systematic Review of Studies With Pathologic Confirmation.

Ultrasound is the imaging modality of choice to evaluate scrotal pathology. However, differentiating malignant and benign testicular tumors is not always possible, and there is interest in evaluating magnetic resonance imaging (MRI) as a potential adjunct for diagnosis. We conducted a systematic review and found 9 studies related to MRI diagnosis of testicular masses. A total of 220 testicular masses (217 patients) undergoing MRI were identified. Notable findings include malignant masses having a lower apparent diffusion coefficient compared to benign masses (3 of 4 studies) and that quantitative enhancement patterns could differentiate Leydig cell tumors from germ cell tumors in 2 studies. While there were some distinct qualitative characterizations of testicular masses on MRI, further research is needed to identify appropriate clinical contexts for use.

Performance Characteristics of Clinical Staging Modalities for Early Stage Testicular Germ Cell Tumors: A Systematic Review.

PURPOSE: We synthesized evidence on the comparative performance characteristics, benefits and harms of diagnostic imaging modalities used in combination with serum tumor markers for clinical staging of testicular germ cell tumors. The diagnostic imaging modalities included computerized tomography, magnetic resonance imaging, positron emission tomography and chest radiographs. MATERIALS AND METHODS: Paired reviewers independently searched PubMed, Embase® and the Cochrane Central Register of Controlled Trials from 1980 to 2018 using title-abstract and full-text screening to identify original studies of the use of computerized tomography, magnetic resonance imaging, positron emission tomography, chest radiographs and serum tumor markers for the clinical staging of early stage testicular germ cell tumors. RESULTS: We found 21 studies of a total of 1,702 patients. With significant bias and limitations to the data, the performance characteristics of computerized tomography, magnetic resonance imaging and positron emission tomography for staging of the retroperitoneum were similar, with median sensitivity ranging from 67% to 80% and median specificity ranging from 95% to 100%. Computerized tomography of the chest (median sensitivity 100%) was more sensitive than a chest radiograph (median sensitivity 76%), especially in men with nonseminomatous germ cell tumors. The addition of serum tumor markers to diagnostic imaging improved staging sensitivity from 38% to 41% to 59% to 60%. No study specifically reported on harms of the imaging modalities. CONCLUSIONS: The combination of axial imaging with computerized tomography or magnetic resonance imaging and serum tumor markers demonstrates optimal performance characteristics for staging early stage testicular germ cell tumors. There is little use for chest computerized tomography in men with seminoma, negative abdominal imaging and negative serum tumor markers.

Diagnosis and Treatment of Early Stage Testicular Cancer: AUA Guideline.

PURPOSE: Testis cancer is the most common solid malignancy in young males. The purpose of this guideline is to provide a useful reference on the effective evidence-based treatment of early stage testicular cancer. METHODS: The systematic review utilized to inform this guideline was conducted by a methodology team at the Johns Hopkins University Evidence-based Practice Center. The methodology team searched using PubMed®, Embase®, and the Cochrane Central Register of Controlled Trials (CENTRAL) from January 1980 through August 2018. The evidence review team also reviewed relevant systematic reviews and references provided by the panel to identify articles that may have been missed by the database searches. RESULTS: When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low). Such evidence-based statements are provided as Strong, Moderate, or Conditional Recommendations. In instances of insufficient evidence, additional guidance is provided as Clinical Principles and Expert Opinions. CONCLUSIONS: This guideline attempts to improve a clinician's ability to evaluate and treat patients with testicular cancer, but higher quality evidence in future trials will be essential to improve level of care for these patients.

Role of Patient- and Surgery-Specific Risk in Receipt of Outpatient Preoperative Testing.

OBJECTIVE: To determine the independent association of patient- and surgery-specific risk with receipt of outpatient preoperative testing. METHODS: Using administrative data from 2010-2013 (Marketscan® Commercial Claims and Encounters), we constructed a retrospective cohort of 678,368 privately-insured, non-elderly US adults who underwent one of ten operations, including one lower-risk and one higher-risk operation from five surgical specialties. Outcomes were receipt of nine outpatient tests in the 30 days before surgery and cost of those tests. Patient-specific risk was based on Revised Cardiac Risk Index (RCRI) and, alternatively, the Charlson Comorbidity Index (CCI). Surgery-specific risk was based on operation (higher- versus lower-risk within each specialty). Multivariable logistic regression models were constructed to measure the independent association of patient- and surgery-specific risk with the receipt of tests. RESULTS: Receipt of tests ranged from 0.9% (pulmonary function tests) to 46.8% (blood counts), and 65.2% of patients received at least one test. Mean cost per patient for all tests was $124.38. Higher RCRI was strongly associated (Odds Ratio (OR) >2) with receipt of stress tests and echocardiograms, and more modestly associated [OR <2] with receipt of most other tests. Undergoing higher-risk operations was strongly associated with receipt of most tests. Results were similar using the CCI for patient-specific risk. CONCLUSION: Surgery-specific risk is strongly associated with receipt of most preoperative tests, which is consistent with preoperative testing protocols based as much or more on the planned operation as on patient-specific risk factors. Whether this pattern of preoperative testing represents optimal care is uncertain.

Renal Mass and Localized Renal Cancer: AUA Guideline.

PURPOSE: This AUA Guideline focuses on evaluation/counseling and management of adult patients with clinically localized renal masses suspicious for cancer, including solid-enhancing tumors and Bosniak 3/4 complex-cystic lesions. MATERIALS AND METHODS: Systematic review utilized research from the Agency for Healthcare Research and Quality and additional supplementation by the authors and consultant methodologists. Evidence-based statements were based on body of evidence strength Grade A/B/C (Strong/Moderate/Conditional Recommendations, respectively) with additional statements presented as Clinical Principles or Expert Opinions. RESULTS: Great progress has been made since the previous guidelines on management of localized renal masses were released (2009). The current guidelines provide updated, evidence-based recommendations regarding evaluation/counseling of patients with clinically localized renal masses, including the evolving role of renal mass biopsy. Given great variability of clinical, oncologic and functional characteristics, index patients are not utilized and the panel advocates individualized counseling/management. Management options (partial nephrectomy/radical nephrectomy/thermal ablation/active surveillance) are reviewed including recent data about comparative effectiveness and potential morbidities. Oncologic issues are prioritized while recognizing that functional outcomes are of great importance for survivorship for most patients with localized kidney cancer. A more restricted role for radical nephrectomy is recommended following well-defined selection criteria. Priority for partial nephrectomy is recommended for clinical T1a lesions, along with selective use of thermal ablation, particularly for tumors ≤3.0 cm. Important considerations for shared decision-making about active surveillance are explicitly defined. CONCLUSIONS: Several factors should be considered during counseling/management of patients with clinically localized renal masses, including general health/comorbidities, oncologic potential of the mass, pertinent functional issues and relative efficacy/potential morbidities of various management strategies.

Renal Functional Outcomes after Surgery, Ablation, and Active Surveillance of Localized Renal Tumors: A Systematic Review and Meta-Analysis.

BACKGROUND AND OBJECTIVES: Management strategies for localized renal masses suspicious for renal cell carcinoma include radical nephrectomy, partial nephrectomy, thermal ablation, and active surveillance. Given favorable survival outcomes across strategies, renal preservation is often of paramount concern. To inform clinical decision making, we performed a systematic review and meta-analysis of studies comparing renal functional outcomes for radical nephrectomy, partial nephrectomy, thermal ablation, and active surveillance. DESIGN, SETTINGS, PARTICIPANTS, & MEASUREMENTS: We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 1997 to May 1, 2015 to identify comparative studies reporting renal functional outcomes. Meta-analyses were performed for change in eGFR, incidence of CKD, and AKI. RESULTS: We found 58 articles reporting on relevant renal functional outcomes. Meta-analyses showed that final eGFR fell 10.5 ml/min per 1.73 m2 lower for radical nephrectomy compared with partial nephrectomy and indicated higher risk of CKD stage 3 or worse (relative risk, 2.56; 95% confidence interval, 1.97 to 3.32) and ESRD for radical nephrectomy compared with partial nephrectomy. Overall risk of AKI was similar for radical nephrectomy and partial nephrectomy, but studies suggested higher risk for radical nephrectomy among T1a tumors (relative risk, 1.37; 95% confidence interval, 1.13 to 1.66). In general, similar findings of worse renal function for radical nephrectomy compared with thermal ablation and active surveillance were observed. No differences in renal functional outcomes were observed for partial nephrectomy versus thermal ablation. The overall rate of ESRD was low among all management strategies (0.4%-2.8%). CONCLUSIONS: Renal functional implications varied across management strategies for localized renal masses, with worse postoperative renal function for patients undergoing radical nephrectomy compared with other strategies and similar outcomes for partial nephrectomy and thermal ablation. Further attention is needed to quantify the changes in renal function associated with active surveillance and nephron-sparing approaches for patients with preexisting CKD.

A Systematic Review of Research Gaps in the Evaluation and Management of Localized Renal Masses.

The management of clinically localized renal masses suspicious for renal cell carcinoma varies, partially because of gaps in the evidence base. We conducted a systematic review to summarize research gaps for the evaluation of composite models for predicting malignancy; use of percutaneous renal sampling for diagnosis; and comparative effectiveness of surgery, thermal ablation, and active surveillance. A total of 147 studies, published in 150 articles, were identified. To promote improved patient care and health outcomes, we recommend incorporation of emerging biomarkers into validated composite models, standardization of biopsy protocols, standard reporting of clinical stage, and performance of prospective studies with objective selection criteria.

Distinguishing malignant and benign renal masses with composite models and nomograms: A systematic review and meta-analysis of clinically localized renal masses suspicious for malignancy.

Solid renal masses and cystic lesions with solid components are suspicious for renal cell carcinoma. Without an effective screening test, composite models and nomograms rely on patient and tumor characteristics to stratify the risk of benign disease versus malignant disease. To guide decisions about the use of renal mass sampling or excision, a systematic review and meta-analysis of the ability of composite models to predict the likelihood of malignancy on the basis of preoperative clinical variables was performed. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from January 1, 1997, through May 1, 2015, according to the Preferred Reporting Items for Systematic Review and Meta-Analyses statement. Composite models necessarily included imaging results and at least 1 element from the following to be compared with surgical pathology: demographic characteristics, clinical characteristics, and blood or urine tests. Two independent reviewers screened citations and extracted data. Quality Assessment Tool for Diagnostic Accuracy Studies 2 was used to assess the risk of bias. The strength of evidence was graded with the scheme recommended by Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Twenty studies (12,149 patients) were included in this review. The only significant predictors of malignancy in the composite models were tumor size (effect size, 1.33-fold increased risk per centimeter; 95% confidence interval [CI], 1.22-1.43) and male sex (effect size, 2.71; 95% CI, 2.39-3.02). The results were inconclusive or not significant for tumor characteristics, age, body mass index, and incidental presentation. In conclusion, composite models currently have a limited ability to distinguish malignant renal masses from benign renal masses, with increased tumor size and male sex associated with malignancy. Cancer 2016;122:3267-3276. © 2016 American Cancer Society.

Management of Renal Masses and Localized Renal Cancer: Systematic Review and Meta-Analysis.

PURPOSE: Several options exist for management of clinically localized renal masses suspicious for cancer, including active surveillance, thermal ablation and radical or partial nephrectomy. We summarize evidence on effectiveness and comparative effectiveness of these treatment approaches for patients with a renal mass suspicious for localized renal cell carcinoma. MATERIALS AND METHODS: We searched MEDLINE®, Embase® and the Cochrane Central Register of Controlled Trials from January 1, 1997 through May 1, 2015. Paired investigators independently screened articles to identify controlled studies of management options or cohort studies of active surveillance, abstracted data sequentially and assessed risk of bias independently. Strength of evidence was graded by comparisons. RESULTS: The search identified 107 studies (majority T1, no active surveillance or thermal ablation stratified outcomes of T2 tumors). Cancer specific survival was excellent among all management strategies (median 5-year survival 95%). Local recurrence-free survival was inferior for thermal ablation with 1 treatment but reached equivalence to other modalities after multiple treatments. Overall survival rates were similar among management strategies and varied with age and comorbidity. End-stage renal disease rates were low for all strategies (0.4% to 2.8%). Radical nephrectomy was associated with the largest decrease in estimated glomerular filtration rate and highest incidence of chronic kidney disease. Thermal ablation offered the most favorable perioperative outcomes. Partial nephrectomy showed the highest rates of urological complications but overall rates of minor/major complications were similar among interventions. Strength of evidence was moderate, low and insufficient for 11, 22 and 30 domains, respectively. CONCLUSIONS: Comparative studies demonstrated similar cancer specific survival across management strategies, with some differences in renal functional outcomes, perioperative outcomes and postoperative harms that should be considered when choosing a management strategy.

Comparative Effect of Contrast Media Type on the Incidence of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

BACKGROUND: Iodine contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). PURPOSE: To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. DATA SOURCES: PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. STUDY SELECTION: Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. DATA EXTRACTION: Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. DATA SYNTHESIS: None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. LIMITATIONS: Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. CONCLUSION: No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Effectiveness of Prevention Strategies for Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

BACKGROUND: N-acetylcysteine, sodium bicarbonate, statins, and ascorbic acid have been studied for reducing contrast-induced nephropathy (CIN). PURPOSE: To evaluate the comparative effectiveness of interventions to reduce CIN in adults receiving contrast media. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and Scopus databases through June 2015. Risk of bias and overall strength of evidence (SOE) of studies were assessed. STUDY SELECTION: Randomized, controlled trials of N-acetylcysteine, sodium bicarbonate, statins, or ascorbic acid that used intravenous (IV) or intra-arterial contrast media and defined CIN with enough data for meta-analysis. DATA EXTRACTION: Two reviewers independently extracted data and assessed study quality. DATA SYNTHESIS: Low-dose N-acetylcysteine plus IV saline compared with IV saline (risk ratio [RR], 0.75 [95% CI, 0.63 to 0.89]; low SOE), N-acetylcysteine plus IV saline compared with IV saline in patients receiving low-osmolar contrast media (RR, 0.69 [CI, 0.58 to 0.84]; moderate SOE), and statins plus N-acetylcysteine plus IV saline versus N-acetylcysteine plus IV saline (RR, 0.52 [CI, 0.29 to 0.93]; low SOE) had clinically important and statistically significant benefits. The following 3 comparisons suggested a clinically important difference that was not statistically significant: sodium bicarbonate versus IV saline in patients receiving low-osmolar contrast media (RR, 0.65 [CI, 0.33 to 1.25]; low SOE), statins plus IV saline versus IV saline (RR, 0.68 [CI, 0.39 to 1.20]; low SOE), and ascorbic acid versus IV saline (RR, 0.72 [CI, 0.48 to 1.01]; low SOE). Strength of evidence was generally insufficient for comparisons of the need for renal replacement, cardiac events, and mortality. LIMITATION: Too few studies were done in patients receiving IV contrast media. CONCLUSION: The greatest reduction in CIN was seen with N-acetylcysteine plus IV saline in patients receiving LOCM and with statins plus N-acetylcysteine plus IV saline. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.