Immunotherapy for advanced or metastatic urothelial carcinoma: an abridged Cochrane review.

OBJECTIVES: To assess the effects of immunotherapy compared to chemotherapy as first- and second-line treatment of advanced or metastatic urothelial carcinoma. METHODS: Based on a published protocol, we performed a systematic search of multiple databases. Two review authors independently performed the literature selection, identified relevant studies, assessed the eligibility of studies for inclusion, and extracted data. We performed statistical analyses using a random-effects model and assessed the quality of the evidence on a per-outcome basis according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: We included five randomised controlled trials and also identified seven single-arm studies. When used as first-line therapy, immunotherapy probably has little to no effect on the risk of death from any cause compared to chemotherapy (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.87-1.07; moderate-certainty evidence). immunotherapy probably has little to no effect on health-related quality of life (mean difference [MD] 4.10, 95% CI 3.83-4.37; moderate). Immunotherapy probably reduces grade 3-5 adverse events (risk ratio [RR] 0.47, 95% CI 0.29-0.75; moderate). In the second-line setting immunotherapy may reduce the risk of death from any cause (HR 0.72, 95% CI 0.63-0.81; low). Immunotherapy may have little to no effect on health-related quality of life when compared to chemotherapy (MD 4.82, 95% CI -3.11 to 12.75; low). Immunotherapy may reduce grade 3-5 adverse events (RR 0.89, 95% CI 0.81-0.97; low). CONCLUSIONS: Compared to chemotherapy, immunotherapy has little to no effect on the risk of death from any cause in a first-line setting. Nevertheless, it may reduce the risk of death from any cause when used as second-line therapy. The health-related quality of life of participants receiving first- and second-line therapy does not appear to be affected by immunotherapy. Immunotherapy probably reduces or may reduce grade 3-5 adverse events when used as first- and second-line therapy, respectively.

Tibial derotational osteotomy for idiopathic tibial torsion: A systematic review of surgical indications based on clinical presentation and measurement technique.

PURPOSE: The aim of this systematic review was to identify the surgical indications of tibial derotational osteotomy (TDO) in patients with idiopathic external tibial torsion (ETT) and identify common measurement thresholds for surgical correction. METHODS: A systematic search of MEDLINE and Embase via Ovid, Cochrane Library via Wiley, Web of Science, Scopus, SPORTDiscus via EBSCOhost, ClinicalTrials.gov, WHO ICTRP and Global Index Medicus databases was performed with search terms reflecting the concepts of idiopathic tibial torsion, TDOs, and surgical indications. Studies reporting surgical indications and measurement methods of idiopathic tibial torsion in patients who underwent TDO were included. Two authors independently screened articles and extracted data that was characterized with descriptive statistics. RESULTS: Seventeen studies were identified for inclusion, with 460 tibias and 351 patients. Nearly all patients who underwent surgery had either anterior knee pain or patellar instability, even if other indications were present. Of all included patients, the most common surgical indications for TDO were anterior knee pain (88%), patellar instability (59%), gait dysfunction (41%) and cosmetic deformity (12%). Twelve studies (71%) cited multiple of these indications as reasons for surgery. On physical exam, tibial torsion was measured most commonly by thigh-foot angle (59%) (TFA) and transmalleolar axis (24%) (TMA). In terms of TFA, the most frequently reported cut-off for ETT was >30° (35%). Computerized tomography (CT) was used by nine studies (53%). The most common CT axes used to measure ETT were the TMA with respect to the posterior tibia condylar axis or the bicondylar tibia axis. CONCLUSION: Anterior knee pain and/or patellar instability are common indications for TDO in patients with idiopathic tibial torsion. Standardized TFA thresholds (>30°) and CT measurement methods (TMA and posterior tibia condylar or bicondylar tibial axis) may help further establish objective surgical indications. LEVEL OF EVIDENCE: IV.

Psychometric properties of body structures and functions measures in non-surgical thumb carpometacarpal osteoarthritis: A systematic review.

BACKGROUND: Measurement of treatment outcomes and change in health status over time is a critical component of clinical practice and research for people with osteoarthritis. Numerous clinical tools are used to assess the structures and function of the thumb in persons with thumb carpometacarpal osteoarthritis however their psychometrics have not yet been systematically explored. PURPOSE: The purpose of this study was to explore the psychometric properties of clinical tools used in persons with non-surgical thumb carpometacarpal osteoarthritis to objectively measure thumb structures and function, evaluate the quality of such studies, and subsequently make clinical and future research recommendations. STUDY DESIGN: Systematic review. METHODS: A systematic search and screening was conducted across nine databases. Original research published between 2002 and 2022 that involved the assessment of psychometric properties (validity, reliability, precision, responsiveness, sensitivity, specificity, and minimal clinically important difference) of clinical tools were included. Sample characteristics, methods, and psychometric findings from each study were compiled. The methodological quality of included studies was evaluated using the COnsensus-based Standards for the selection of health Measurement Instruments' checklist. Two independent researchers screened articles and assessed methodological quality and when not in agreement, a third party was consulted. RESULTS: Eleven studies were included in the review. The mean age of all participants in the studies was 69 years of age. The study designs included prospective case-control, prospective cohort, and cross-sectional to determine the psychometric properties of the measurements and tools. The included studies examined techniques to assess range of motion, strength, and pain-pressure thresholds, and screen for arthritis (ie, provocative tests). The intermetacarpal distance method, Kapandji index, pain-pressure threshold test, and pain-free grip and pinch dynamometry demonstrate excellent reliability and acceptable precision. Metacarpal extension, adduction, and pressure-shear provocative tests have superior sensitivity and specificity and the extension and adduction tests have excellent reliability. Other assessments included in the review yielded less robust psychometric properties. Studies were of variable methodological quality spanning from inadequate to very good. CONCLUSIONS: Based on the available literature on the psychometric properties of assessments of body structures and functions in persons with non-operative thumb carpometacarpal osteoarthritis, we offer a limited set of recommendations for use when screening for arthritis symptomology and measuring hand strength, thumb mobility, and pain thresholds. Additional psychometric research is needed in these domains as well as in dexterity, sensation, and objective measures of hand function. Future research should employ best practices in psychometric research.

The Quality of Literature Search Reporting in Systematic Reviews Published in the Urological Literature (1998-2021).

PURPOSE: We evaluate to what extent systematic reviews published in the urological literature follow best practices for the reporting of searches. MATERIALS AND METHODS: Systematic reviews addressing questions of therapy/prevention were sought out in 5 major urological journals from January 1998 to December 2021. Two members performed study selection and data abstraction independently and in duplicate. The methodological and reporting quality of these systematic reviews was assessed using operationalized criteria based on the PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-analyses-literature search extension) and PRISMA 2020 checklists. Proportions of systematic reviews that satisfied each criterion were compared based on period (1998-2012, 2013-2016, and 2017-2021) and journal of publication. RESULTS: The search identified 483 systematic reviews that met inclusion criteria. Most systematic reviews searched 2 or more electronic databases (88.6%); few searched abstract proceedings (26.7%), clinical trial registries (15.1%), or dedicated databases of the "gray literature" (6.2%). Approximately 1 in 3 systematic reviews (32.3%) were explicit in not restricting searches by language. A few criteria demonstrated improved reporting over time including use of clinical trial registries (6.8% vs 14.4% vs 23.3%; P = .001), searches unrestricted by language (37.3% vs 49.3% vs 55.1%; P = .006), and flow diagram reporting (34.8% vs 82.9% vs 93.2%; P = .001) but not the search of abstract proceedings (28.6% vs 24.0% vs 27.3%; P = .647). Reporting characteristics across journals were similar. CONCLUSIONS: Systematic reviews published in the urological literature have considerable shortcomings regarding the reporting of their underlying search strategies. Efforts must be taken to improve search strategies in the form of better training in systematic review methods as well as the more stringent enforcement of reporting guidelines.

Reliability of visual review of intracranial electroencephalogram in identifying the seizure onset zone: A systematic review and implications for the accuracy of automated methods.

Visual review of intracranial electroencephalography (iEEG) is often an essential component for defining the zone of resection for epilepsy surgery. Unsupervised approaches using machine and deep learning are being employed to identify seizure onset zones (SOZs). This prompts a more comprehensive understanding of the reliability of visual review as a reference standard. We sought to summarize existing evidence on the reliability of visual review of iEEG in defining the SOZ for patients undergoing surgical workup and understand its implications for algorithm accuracy for SOZ prediction. We performed a systematic literature review on the reliability of determining the SOZ by visual inspection of iEEG in accordance with best practices. Searches included MEDLINE, Embase, Cochrane Library, and Web of Science on May 8, 2022. We included studies with a quantitative reliability assessment within or between observers. Risk of bias assessment was performed with QUADAS-2. A model was developed to estimate the effect of Cohen kappa on the maximum possible accuracy for any algorithm detecting the SOZ. Two thousand three hundred thirty-eight articles were identified and evaluated, of which one met inclusion criteria. This study assessed reliability between two reviewers for 10 patients with temporal lobe epilepsy and found a kappa of .80. These limited data were used to model the maximum accuracy of automated methods. For a hypothetical algorithm that is 100% accurate to the ground truth, the maximum accuracy modeled with a Cohen kappa of .8 ranged from .60 to .85 (F-2). The reliability of reviewing iEEG to localize the SOZ has been evaluated only in a small sample of patients with methodologic limitations. The ability of any algorithm to estimate the SOZ is notably limited by the reliability of iEEG interpretation. We acknowledge practical limitations of rigorous reliability analysis, and we propose design characteristics and study questions to further investigate reliability.

Immunotherapy for advanced or metastatic urothelial carcinoma.

BACKGROUND: Immune checkpoint inhibitors are increasingly important in the treatment algorithm for locally advanced and metastatic bladder cancer. Numerous ongoing studies are investigating these agents as first- and second-line therapies, both alone and in combination with chemotherapy or in a maintenance therapy setting. OBJECTIVES: To assess the effects of immune checkpoint inhibitors compared to chemotherapy as first- and second-line treatment of advanced or metastatic urothelial carcinoma. SEARCH METHODS: We performed a comprehensive search including the Cochrane Library, MEDLINE, Embase, three other databases, several trial registers, other sources of gray literature, and conference proceedings, with no restrictions on language of publication. We limited the search period to run from 2000 until August 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) using immunotherapy versus chemotherapy and would have considered non-randomized trials in the absence of randomized trial data. Participants had locally advanced inoperable (cT4b or N+, or both) or metastatic (M1) (or both) urothelial carcinoma of the bladder or upper urinary tract. We excluded studies of people in whom immunotherapy was used in combination with chemotherapy or in a surveillance setting. DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies for inclusion and abstracted data from included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence on a per-outcome basis. MAIN RESULTS: We included five RCTs and identified seven single-armed studies. The RCTs included 3572 participants comparing immunotherapy versus chemotherapy for the treatment of locally advanced and metastatic bladder cancer. First-line therapy Immunotherapy probably has little to no effect on the risk of death from any cause when used as first-line therapy compared to chemotherapy (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.87 to 1.07; I2 = 0%; 3 studies, 2068 participants; moderate-certainty evidence). This corresponds to 750 deaths per 1000 participants with chemotherapy and 11 fewer (45 fewer to 26 more) deaths per 1000 participants with immunotherapy at 36 months. Immunotherapy probably has little to no effect on health-related quality of life (mean difference (MD) 4.10, 95% CI 3.83 to 4.37; 1 study, 393 participants; moderate-certainty evidence), when assuming a minimal clinically important difference (MCID) of at least 6 points (using the Functional Assessment of Cancer Therapy - Bladder [FACT-BL] tool; scale 0 to 156 with higher scores representing better quality of life). Immunotherapy probably reduces adverse events grade 3 to 5 (RR 0.47, 95% CI 0.29 to 0.75; I2 = 97%; 3 studies, 2046 participants; moderate-certainty evidence). This corresponds to 908 grade 3 to 5 adverse events per 1000 participants with chemotherapy, with 481 fewer (644 fewer to 227 fewer) grade 3 to 5 adverse events per 1000 participants with immunotherapy. We found no evidence for the outcome time to death from bladder cancer. Immunotherapy probably increases the risk of time to disease progression (HR 1.33, 95% CI 1.17 to 1.50; I2 = 0%; 2 studies, 1349 participants; moderate-certainty evidence). This corresponds to 660 events per 1000 participants with chemotherapy and 102 more (57 more to 152 more) events per 1000 participants with immunotherapy at 36 months. Immunotherapy may reduce discontinuations due to adverse effects (RR 0.47, 95% CI 0.20 to 1.10; I2 = 94%; 3 studies, 2046 participants; low-certainty evidence). This corresponds to 338 discontinuations per 1000 participants with chemotherapy and 179 fewer (271 fewer to 34 more) discontinuations per 1000 participants with immunotherapy. Second-line therapy Immunotherapy may reduce the risk of death from any cause when used as second-line therapy (HR 0.72, 95% CI 0.63 to 0.81; I2 = 0%; 2 studies, 1473 participants; low-certainty evidence). This corresponds to 920 deaths per 1000 participants with chemotherapy (vinflunine, paclitaxel, docetaxel) and 59 fewer (95 fewer to 28 fewer) deaths per 1000 participants with immunotherapy at 36 months. Immunotherapy may have little to no effect on health-related quality of life when compared to chemotherapy (MD 4.82, 95% CI -3.11 to 12.75; I2 = 85%; 2 studies, 727 participants; low-certainty evidence), assuming an MCID of at least 10 points (using the EORTC QLQ tool; scale 0 to 100 with higher scores representing better quality of life). Immunotherapy may reduce adverse events grade 3 to 5 in participants undergoing second-line therapy (RR 0.89, 95% CI 0.81 to 0.97; I2 = 9%; 2 studies, 1423 participants; low-certainty evidence). This corresponds to 630 grade 3 to 5 adverse events per 1000 participants with chemotherapy and 76 fewer (126 fewer to 25 fewer) grade 3 to 5 adverse events per 1000 participants with immunotherapy. We found no evidence for the outcome of time to death from bladder cancer. We are very uncertain if immunotherapy reduces the risk of disease progression (HR 0.99, 95% CI 0.84 to 1.16; I2 = 0%; 2 studies, 1473 participants; very low-certainty evidence). Immunotherapy may reduce discontinuations due to adverse events in participants undergoing second-line therapy (RR 0.35, 95% CI 0.17 to 0.72; I2 = 69%; 2 studies, 1473 participants; low-certainty evidence). This corresponds to 110 discontinuations per 1000 participants with chemotherapy and 72 fewer (91 fewer to 31 fewer) discontinuations per 1000 participants with immunotherapy. AUTHORS' CONCLUSIONS: Compared to chemotherapy, immunotherapy for treating advanced or metastatic urothelial carcinoma probably has little to no effect on the risk of death from any cause when used as first-line therapy. Still, it may reduce the risk of death from any cause when used as second-line therapy. Health-related quality of life for participants receiving first- and second-line therapy does not appear to be affected by immunotherapy. Immunotherapy probably reduces or may reduce adverse events grade 3 to 5 when used as first- and second-line therapy, respectively.

Systematic review of photodynamic therapy for the treatment of hidradenitis suppurativa.

OBJECTIVE: To perform a systematic review of available literature regarding the use of 5-aminolevulinic acid (ALA) and ALA derivative photodynamic therapy (PDT) in the treatment of hidradenitis suppurativa (HS) and provide recommendations on its use. METHODS: A systematic review was performed of all published studies up to September 1, 2019 from nine databases, including PubMed, that evaluated PDT in the treatment of HS. For each study, quality of evidence and risk of bias was evaluated. Recommendations from the body of evidence were created based on Strength of Recommendation and Taxonomy (SORT) criteria. RESULTS: Eighteen studies met inclusion criteria. The majority of studies had a high risk of bias. Blue light PDT with 20% ALA and red light PDT with 16% methyl aminolevulinate (MAL) demonstrated some benefit based on a small number of poor-quality studies with a high risk of bias (Grade C, level III evidence). The most promising results were for 1%-5% ALA with intralesional diode, with good to complete response in 78%-94% of anatomic sites treated (Grade B, level II evidence). LIMITATIONS: The majority of studies contained high levels of bias, with significant heterogeneity between studies. Conclusions are limited by small samples sizes, lack of randomized controlled trials, and differing protocols. CONCLUSION: Further studies are needed to determine the clinical efficacy of 20% ALA with blue light and MAL with red light. Intralesional diode PDT shows the most promise and warrants further investigation in larger, randomized controlled trials.

Outcomes of arthroscopic-assisted lateral tibial plateau fixation: a systematic review.

PURPOSE: The purpose of this study is to evaluate and summarize the current literature on outcomes of arthroscopic-assisted tibial plateau fixation (AATPF) when applied for only lateral tibial plateau fractures. METHODS: A comprehensive search of nine databases was conducted: ClinicalTrials.gov, Cochrane Library via Wiley, Embase and MEDLINE via Ovid, Global Index Medicus, PubMed, Scopus, SPORTDiscus via EBSCO, and Web of Science Core Collection. The study was performed in concordance with PRISMA guidelines. Studies eligible for inclusions included Schatzker I-III lateral tibial plateau fractures with a minimum of 6-month follow-up. Data extraction was performed by two authors independently using a predesigned form. RESULTS: A total of 17 studies, 7 prospective and 10 retrospective, including 565 patients (age 15-82 years old) treated with AATPF were included in this review with follow-up ranging from 6 to 138 months. All 10 studies that used categorical functional outcomes demonstrated excellent/very good or good outcomes in > 90% of patients. When compared to patients managed with the traditional open reduction internal fixation (ORIF), patients treated with AATPF had statistically significantly better range of motion mean difference [5.21° (95% CI - 2.50 to 12.92, p < 0.0001)], lower blood loss [66.19 mL (95% confidence interval (CI) 32.54-99.84 mL, p < 0.0001)], shorter hospital stay [- 1.41 days (95% CI - 3.39 to 0.58 days, p < 0.0001)], better Hospital Special Surgery score [11.31 (95% CI 6.49-16.12, p < 0.0001)], and higher Rasmussen radiographic score [1.26 (95% CI - 0.72 to 3.23, p < 0.0001)]. CONCLUSION: AATPF is a promising treatment of lateral tibial plateau fractures with some advantages over the traditional ORIF. LEVEL OF EVIDENCE: Therapeutic Level III.

Posterior musculofascial reconstruction in robot-assisted laparoscopic prostatectomy for the treatment of clinically localised prostate cancer: a Cochrane Review.

OBJECTIVES: To assess the effects of posterior musculofascial reconstruction robot-assisted laparoscopic prostatectomy (PR-RALP) compared to no PR during standard RALP (S-RALP) for the treatment of clinically localised prostate cancer. PATIENTS AND METHODS: We performed a systematic search with no restrictions including randomised controlled trials (RCTs) comparing variations of PR-RALP vs S-RALP for clinically localised prostate cancer. The quality of evidence was assessed on outcome basis according to Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Our search identified 13 records of eight unique RCTs, of which six were published studies, and two were abstract proceedings. There were 1085 randomised patients, of whom 963 completed the trials. All patients had either cT1c or cT2 or cT3a disease. RESULTS: A PR-RALP may improve urinary continence 1 week after catheter removal compared to no PR (risk ratio [RR] 1.25, 95% confidence interval [CI] 0.90-1.73; I2 = 42%, five studies, 498 patients, low certainty of evidence [CoE]). A PR-RALP may have little to no effect on urinary continence 3 months after surgery compared to no PR (RR 0.98, 95% CI 0.84-1.14; I2 = 67%, six studies, 842 patients, low CoE). A PR-RALP probably results in little to no difference in serious adverse events compared to no PR (RR 0.75, 95% CI 0.29-1.92; I2 = 0%, six studies, 835 patients, moderate CoE). CONCLUSIONS: This review found evidence that PR-RALP may improve early continence 1 week after catheter removal but not thereafter. Meanwhile, adverse event rates are probably not impacted and positive surgical margin rates are likely similar. There was no difference in our subgroup analysis for all outcomes with anterior reconstruction technique when combined with PR vs only PR.

Scoping review: Diagnostic reasoning as a component of clinical reasoning in the U.S. primary care nurse practitioner education.

AIMS: Diagnostic Reasoning (DR) is an essential competency requiring mastery for safe, independent Nurse Practitioner (NP) practice, but little is known about DR content included in NP education programs. The aims of this study were to identify whether and how the concept of DR is addressed in NP education. DESIGN: We conducted a scoping review on DR-related content and teaching innovations in U.S. primary care NP education programs, with implications for NP education programs worldwide. Concepts and principles with global applicability include: conducting focused and hypothesis-directed histories and exams, generating the problem statement, formulating the differential diagnosis, appropriate and relevant diagnostic testing, determining the working diagnosis and developing evidence-based, patient-centred management plans. DATA SOURCES: N = 1115 articles retrieved from Medline, Embase, PsycINFO, and CINAHL for the period 2005-2021. Forty-one scholarly articles met inclusion/exclusion criteria. REVIEW METHODS: Data were extracted, synthesized and grouped by theoretical frameworks, content included, educational interventions and assessment measures. RESULTS: Most articles provided descriptions of approaches for teaching NP clinical or diagnostic reasoning. Ten papers directly referenced the current science and theory of DR. CONCLUSION: The US NP education literature addressing DR is limited and demonstrates a lack of shared conceptualizations of DR. Whilst numerous components of DR are identifiable in the literature, a robust teaching/learning scholarship for DR has not yet been established in the US NP education literature. IMPACT: Whilst primary care NP education programs are beginning to incorporate DR education into their curricula, little research has been conducted to demonstrate the effectiveness of educational outcomes. Increased integration of DR content into NP education is needed, including increased educational research on teaching DR competencies. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution was included in this review, as the public is generally not familiar with DR or its teaching approaches.

Retracted publications in pharmacy systematic reviews.

OBJECTIVE: Systematic reviews and other evidence syntheses, the pinnacle of the evidence pyramid, embody comprehensiveness and rigor; however, retracted data are being incorporated into these publications. This study examines the use of retracted publications in the field of pharmacy, describes characteristics of retracted publications cited by systematic reviews, and discusses factors associated with citation likelihood. METHODS: Using data from Retraction Watch, we identified retracted publications in the pharmacy field. We identified all articles citing these retracted publications in Web of Science and Scopus and limited results to systematic reviews. We classified the retraction reason, determined whether the citation occurred before or after retraction, and analyzed factors associated with the likelihood of systematic reviews citing a retracted publication. RESULTS: Of 1,396 retracted publications, 283 were cited 1,096 times in systematic reviews. Most (65.0%) (712/1096) citations occurred before retraction. Citations were most often to items retracted due to data falsification or manipulation (39.2%), followed by items retracted due to ethical misconduct including plagiarism (30.4%), or concerns about or errors in data or methods (26.2%). Compared to those not cited in systematic reviews, cited items were significantly more likely to be retracted due to data falsification and manipulation, were published in high impact factor journals, and had longer delays between publication and retraction. CONCLUSIONS: Further analysis of systematic reviews citing retracted publications is needed to determine the impact of flawed data. Librarians understand the nuances involved and can advocate for greater transparency around the retraction process and increase awareness of challenges posed by retractions.

Rigor and reproducibility instruction in academic medical libraries.

Background: Concerns over scientific reproducibility have grown in recent years, leading the National Institutes of Health (NIH) to require researchers to address these issues in research grant applications. Starting in 2020, training grants were required to provide a plan for educating trainees in rigor and reproducibility. Academic medical centers have responded with different solutions to fill this educational need. As experienced instructors with expertise in topics relating to reproducibility, librarians can play a prominent role in providing trainings, classes, and events to educate investigators and trainees, and bolstering reproducibility in their communities. Case Presentations: This special report summarizes efforts at five institutions to provide education in reproducibility to biomedical and life sciences researchers. Our goal is to expand awareness of the range of approaches in providing reproducibility services in libraries. Conclusions: Reproducibility education by medical librarians can take many forms. These specific programs in reproducibility education build upon libraries' existing collaborations, with funder mandates providing a major impetus. Collaborator needs shaped the exact type of educational or other reproducibility support and combined with each library's strengths to yield a diversity of offerings based on capacity and interest. As demand for and complexity of reproducibility education increases due to new institutional and funder mandates, reproducibility education will merit special attention.

Retzius-sparing versus standard robot-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

OBJECTIVES: To assess the effects of Retzius-sparing (RS) robotic-assisted laparoscopic prostatectomy (RALP) compared to standard RALP for the treatment of clinically localized prostate cancer. METHODS: We performed a systematic search of multiple databases and the grey literature with no restrictions on the language of publication or publication status, up until June 2020. We included randomized controlled trials (RCTs) comparing RS-RALP with standard RALP. We performed a meta-analysis using a random-effect model. The quality of evidence was assessed on an outcome basis according to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. RESULTS: Our search identified six records of five unique RCTs, of which two were published studies, one was in press, and two were abstract proceedings. There were 571 randomized participants, of whom 502 completed the trials. The mean age of participants was 64.6 years and the mean prostate-specific antigen level was 6.9 ng/mL. Approximately 54.2% of participants had cT1c disease, 38.6% had cT2a-b disease, and 7.1% had cT2c disease. RS-RALP probably improves continence within 1 week after catheter removal (risk ratio [RR] 1.74, 95% confidence interval [CI] 1.41-2.14; I2 = 0%; studies = 4; participants = 410; moderate-certainty evidence). Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 248 more men per 1000 (137 more to 382 more) reporting continence recovery. RS-RALP may increase continence at 3 months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06-1.68; I2 = 86%; studies = 5; participants = 526; low-certainty evidence). Assuming 750 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 224 more men per 1000 (41 more to 462 more) reporting continence recovery. We are very uncertain about the effects of RS-RALP on serious adverse events compared to standard RALP (RR 1.40, 95% CI 0.47-4.17; studies = 2; participants = 230; very low-certainty evidence). CONCLUSIONS: The findings of this review indicate that RS-RALP may result in better continence outcomes than standard RALP up to 6 months after surgery. Continence outcomes at 12 months may be similar. The disadvantages of RS-RALP may be higher positive surgical margin rates. We are very uncertain about the effect on biochemical recurrence-free survival and potency outcomes. Longer-term oncological and functional outcomes are lacking, and no preplanned subgroup analyses could be performed to explore the observed heterogeneity. Surgeons should discuss these trade-offs and the limitations of the evidence with their patients when considering this approach.

Posterior musculofascial reconstruction in robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

BACKGROUND: Delayed recovery of urinary continence is a major adverse effect of robotic-assisted laparoscopic prostatectomy (RALP) in men undergoing prostate cancer treatment. To address this issue, a number of surgical techniques have been designed to reconstruct the posterior aspect of the rhabdosphincter, which is responsible for urinary continence after removal of the prostate; however, it is unclear how well they work.  OBJECTIVES: To assess the effects of posterior musculofascial reconstruction RALP compared to no posterior reconstruction during RALP for the treatment of clinically localized prostate cancer. SEARCH METHODS: We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to 12 March 2021. We applied no restrictions on publication language or status. SELECTION CRITERIA: We included randomized controlled trials (RCTs) in which participants were randomized to undergo variations of posterior musculofascial reconstruction RALP versus no posterior reconstruction during RALP for clinically localized prostate cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery at six and twelve months after surgery, potency recovery twelve months after surgery, positive surgical margins (PSM), and biochemical recurrence-free survival (BCRFS). We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach. MAIN RESULTS: Our search identified 13 records of eight unique RCTs, of which six were published studies and two were abstract proceedings. We included 1085 randomized participants, of whom 963 completed the trials (88.8%). All participants had either cT1c or cT2 or cT3a disease, with a mean prostate-specific antigen level of 8.15 ng/mL. Primary outcomes Posterior reconstruction RALP (PR-RALP) may improve urinary continence one week after catheter removal compared to no posterior reconstruction during RALP (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.90 to 1.73; I2 = 42%; studies = 5, participants = 498; low CoE) although the CI also includes the possibility of no effect. Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 84 more men per 1000 (33 fewer to 244 more) reporting urinary continence recovery.  Posterior reconstruction may have little to no effect on urinary continence three months after surgery compared to no posterior reconstruction during RALP (RR 0.98, 95% CI 0.84 to 1.14; I2 = 67%; studies = 6, participants = 842; low CoE). Assuming 701 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 14 fewer men per 1000 (112 fewer to 98 more) reporting urinary continence after three months. PR-RALP probably results in little to no difference in serious adverse events compared to no posterior reconstruction during RALP (RR 0.75, 95% CI 0.29 to 1.92; I2 = 0%; studies = 6, participants = 835; moderate CoE). Assuming 25 per 1000 men undergoing standard RALP experience a serious adverse event at this time point, this corresponds to six fewer men per 1000 (17 fewer to 23 more) reporting serious adverse events.  Secondary outcomes PR-RALP may result in little to no difference in recovery of continence 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.98 to 1.07; I2 = 25%; studies = 3, participants = 602; low CoE). Assuming 918 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 18 more men per 1000 (18 fewer to 64 more) reporting urinary continence recovery.  We are very uncertain about the effects of PR-RALP on recovery of potency 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.82 to 1.26; I2 = 3%; studies = 2, participants = 308; very low CoE). Assuming 433 per 1000 men undergoing standard RALP are potent at this time point, this corresponds to nine more men per 1000 (78 fewer to 113 more) reporting potency recovery.  PR-RALP may result in little to no difference in positive surgical margins compared to no posterior reconstruction during RALP (RR 1.24, 95% CI 0.65 to 2.33; I2 = 50%; studies = 3, participants = 517; low CoE). Assuming 130 per 1000 men undergoing standard RALP have a positive surgical margin, this corresponds to 31 more men per 1000 (46 fewer to 173 more) reporting positive surgical margins.  PR-RALP may result in little to no difference in biochemical recurrence compared to no posterior reconstruction during RALP (RR 1.36, 95% CI 0.74 to 2.52; I2 = 0%; studies = 2, participants = 468; low CoE). Assuming 70 per 1000 men undergoing standard RALP have experienced biochemical recurrence at this time point, this corresponds to 25 more men per 1000 (18 fewer to 107 more) reporting biochemical recurrence.  AUTHORS' CONCLUSIONS: This review found evidence that PR-RALP may improve early continence one week after catheter removal but not thereafter. Meanwhile, adverse event rates are probably not impacted and surgical margins rates are likely similar. This review was unable to determine if or how these findings may be impacted by the person's age, nerve-sparing status, or clinical stage. Study limitations, imprecision, and inconsistency lowered the certainty of evidence for the outcomes assessed.

Reconstruction of Perioral Defects After Mohs Micrographic Surgery or Excision: A Systematic Review of the Literature.

BACKGROUND: Although many repair methods for postsurgical lip defects have been described, the literature lacks a comprehensive review of these methods. OBJECTIVE: To perform a systematic review of lip defect repair methods after Mohs surgery or excisions. MATERIALS AND METHODS: Terms related to perioral anatomy, Mohs surgery and excision, and reconstruction were used to search 8 databases. Articles were included if they reported postsurgical lip repair data for 4 or more patients, were in English, and were published from 2004 onward. Two reviewers screened all titles and abstracts, followed by the full texts of the remaining articles. Data were then extracted including author specialties, study design, demographic, tumor, and defect information, surgical procedures, outcomes, and complications. RESULTS: Forty-two studies were eligible, including a randomized trial, 25 case series, and 16 cohort studies. Most were written by dermatologic or plastic surgeons, and most studies were small, with an average subject number of 61. Very few studies used structured outcome measures. Many repair methods were described, the most common of which were linear closures and various flaps. CONCLUSION: Many repair methods for lip defects have been published, but overall, the quality of the available evidence is low.

The efficacy of mobile health interventions used to manage acute or chronic pain: A systematic review.

Chronic pain is a significant health issue that affects approximately 50 million adults in the United States. Traditional interventions are not always an effective treatment strategy for pain control. However, the wide adoption of smartphones and the rapid growth of health information technologies over the past decade have created opportunities to use mobile health (mHealth) applications (apps) for pain tracking and self-management. In this PRISMA-compliant systematic review, we assessed the current U.S.-based research on pain-related mHealth apps to describe the app components and determine the efficacy of these interventions for persons with acute or chronic pain. We conducted a comprehensive search of five databases based on methodological guidelines from the Joanna Briggs Institute. We included articles reporting original data on mHealth interventions with pain intensity as a primary or secondary outcome and excluded articles that utilized multimodal interventions. Of the original 4959 articles, only five studies met the eligibility criteria. Most of the interventions included feasibility or pilot studies, and all studies were published between 2015 and 2018. Two of the five studies used visual analog scales. Only two of the studies reported statistically significant pain intensity outcomes, and considerable heterogeneity between the studies limited our ability to generalize findings or conduct a meta-analysis. Research investigating the components and efficacy of pain-related mHealth apps as interventions is an emerging field. To better understand the potential clinical benefits of mHealth apps designed to manage pain, further research is needed.

Diagnosis and Treatment of Femoral Head Osteonecrosis: A Protocol for Development of Evidence-Based Clinical Practice Guidelines.

INTRODUCTION: There are many treatment options for patients who have osteonecrosis of the femoral head (ONFH) and management strategies vary widely both among and within individual countries. Although many researchers have attempted to elucidate the optimal strategies for managing this disease, the lack of large-scale randomized control trials and the lack of agreement on disease staging have curtailed the development of clear-cut guidelines. MATERIALS AND METHODS: The Association Research Circulation Osseous (ARCO) group sought to address three questions for the management of patients who have ONFH: 1) What imaging studies are most sensitive and specific for the diagnostic evaluation of patients who have ONFH?; 2) What is the best treatment strategy for preventing disease progression in patients who have pre-collapse lesions?; and 3) What is the best treatment strategy for patients who have post-collapse disease? The Patient, Intervention, Comparison, and Outcome (PICO) format was used to formulate the search strategy for each research question. A systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. ARCO participants have been allocated to three groups, each representing one of the PICO questions. After qualitative and quantitative analysis of the data extracted from studies pertaining to each of the three research questions, a set of evidence-based clinical practice guidelines will be proposed for the management of patients who have ONFH. DISCUSSION: It is not always clear which treatment method is optimal for the management of ONFH. Thus, many surgeons have developed and performed various procedures based on patient-specific factors. As there is no consensus on the optimal treatment for various stages of disease, it was clear that developing evidence-based clinical practice guidelines would provide more structure and uniformity to management of these patients. Therefore, the results of this systematic review will lead to the development guidelines that may improve patient-care strategies and result in better outcomes for patients who have ONFH.

Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

BACKGROUND: Robotic-assisted laparoscopic prostatectomy (RALP) is widely used to surgically treat clinically localized prostate cancer. It is typically performed using an approach (standard RALP) that mimics open retropubic prostatectomy by dissecting the so-called space of Retzius anterior to the bladder. An alternative, Retzius-sparing (or posterior approach) RALP (RS-RALP) has been described, which is reported to have better continence outcomes but may be associated with a higher risk of incomplete resection and positive surgical margins (PSM). OBJECTIVES: To assess the effects of RS-RALP compared to standard RALP for the treatment of clinically localized prostate cancer. SEARCH METHODS: We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to June 2020. We applied no restrictions on publication language or status. SELECTION CRITERIA: We included trials where participants were randomized to RS-RALP or standard RALP for clinically localized prostate cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently classified and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery six and 12 months after surgery, potency recovery 12 months after surgery, positive surgical margins (PSM), biochemical recurrence-free survival (BCRFS), and urinary and sexual function quality of life. We performed statistical analyses using a random-effects model. We rated the certainty of evidence using the GRADE approach. MAIN RESULTS: Our search identified six records of five unique randomized controlled trials, of which two were published studies, one was in press, and two were abstract proceedings. There were 571 randomized participants, of whom 502 completed the trials. Mean age of participants was 64.6 years and mean prostate-specific antigen was 6.9 ng/mL. About 54.2% of participants had cT1c disease, 38.6% had cT2a-b disease, and 7.1 % had cT2c disease. Primary outcomes RS-RALP probably improves continence within one week after catheter removal (risk ratio (RR) 1.74, 95% confidence interval (CI) 1.41 to 2.14; I2 = 0%; studies = 4; participants = 410; moderate-certainty evidence). Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 248 more men per 1000 (137 more to 382 more) reporting continence recovery. RS-RALP may increase continence at three months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06 to 1.68; I2 = 86%; studies = 5; participants = 526; low-certainty evidence). Assuming 750 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 224 more men per 1000 (41 more to 462 more) reporting continence recovery. We are very uncertain about the effects of RS-RALP on serious adverse events compared to standard RALP (RR 1.40, 95% CI 0.47 to 4.17; studies = 2; participants = 230; very low-certainty evidence). Secondary outcomes There is probably little to no difference in continence recovery at 12 months after surgery (RR 1.01, 95% CI 0.97 to 1.04; I2 = 0%; studies = 2; participants = 222; moderate-certainty evidence). Assuming 982 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 10 more men per 1000 (29 fewer to 39 more) reporting continence recovery.  We are very uncertain about the effect of RS-RALP on potency recovery 12 months after surgery (RR 0.98, 95% CI 0.54 to 1.80; studies = 1; participants = 55; very low-certainty evidence).  RS-RALP may increase PSMs (RR 1.95, 95% CI 1.19 to 3.20; I2 = 0%; studies = 3; participants = 308; low-certainty evidence) indicating a higher risk for prostate cancer recurrence. Assuming 129 per 1000 men undergoing standard RALP have positive margins, this corresponds to 123 more men per 1000 (25 more to 284 more) with PSMs. We are very uncertain about the effect of RS-RALP on BCRFS compared to standard RALP (hazard ratio (HR) 0.45, 95% CI 0.13 to 1.60; I2 = 32%; studies = 2; participants = 218; very low-certainty evidence). AUTHORS' CONCLUSIONS: Findings of this review indicate that RS-RALP may result in better continence outcomes than standard RALP up to six months after surgery. Continence outcomes at 12 months may be similar. Downsides of RS-RALP may be higher positive margin rates. We are very uncertain about the effect on BCRFS and potency outcomes. Longer-term oncologic and functional outcomes are lacking, and no preplanned subgroup analyses could be performed to explore the observed heterogeneity. Surgeons should discuss these trade-offs and the limitations of the evidence with their patients when considering this approach.

The Role of Social Media in Enhancing Clinical Trial Recruitment: Scoping Review.

BACKGROUND: Recruiting participants into clinical trials continues to be a challenge, which can result in study delay or termination. Recent studies have used social media to enhance recruitment outcomes. An assessment of the literature on the use of social media for this purpose is required. OBJECTIVE: This study aims to answer the following questions: (1) How is the use of social media, in combination with traditional approaches to enhance clinical trial recruitment and enrollment, represented in the literature? and (2) Do the data on recruitment and enrollment outcomes presented in the literature allow for comparison across studies? METHODS: We conducted a comprehensive literature search across 7 platforms to identify clinical trials that combined social media and traditional methods to recruit patients. Study and participant characteristics, recruitment methods, and recruitment outcomes were evaluated and compared. RESULTS: We identified 2371 titles and abstracts through our systematic search. Of these, we assessed 95 full papers and determined that 33 studies met the inclusion criteria. A total of 17 studies reported enrollment outcomes, of which 9 achieved or exceeded their enrollment target. The proportion of participants enrolled from social media in these studies ranged from 0% to 49%. Across all 33 studies, the proportion of participants recruited and enrolled from social media varied greatly. A total of 9 studies reported higher enrollment rates from social media than any other methods, and 4 studies reported the lowest cost per enrolled participant from social media. CONCLUSIONS: While the assessment of the use of social media to improve clinical trial participation is hindered by reporting inconsistencies, preliminary data suggest that social media can increase participation and reduce per-participant cost. The adoption of consistent standards for reporting recruitment and enrollment outcomes is required to advance our understanding and use of social media to support clinical trial success.

Social Media Coverage of Scientific Articles Immediately After Publication Predicts Subsequent Citations - #SoME_Impact Score: Observational Analysis.

BACKGROUND: Social media coverage is increasingly used to spread the message of scientific publications. Traditionally, the scientific impact of an article is measured by the number of citations. At a journal level, this conventionally matures over a 2-year period, and it is challenging to gauge impact around the time of publication. OBJECTIVE: We, therefore, aimed to assess whether Web-based attention is associated with citations and to develop a predictive model that assigns relative importance to different elements of social media coverage: the #SoME_Impact score. METHODS: We included all original articles published in 2015 in a selection of the highest impact journals: The New England Journal of Medicine, The Lancet, the Journal of the American Medical Association, Nature, Cell, and Science. We first characterized the change in Altmetric score over time by taking a single month's sample of recently published articles from the same journals and gathered Altmetric data daily from the time of publication to create a mixed effects spline model. We then obtained the overall weighted Altmetric score for all articles from 2015, the unweighted data for each Altmetric component, and the 2-year citation count from Scopus for each of these articles from 2016 to 2017. We created a stepwise multivariable linear regression model to develop a #SoME_Score that was predictive of 2-year citations. The score was validated using a dataset of articles from the same journals published in 2016. RESULTS: In our unselected sample of 145 recently published articles, social media coverage appeared to plateau approximately 14 days after publication. A total of 3150 articles with a median citation count of 16 (IQR 5-33) and Altmetric score of 72 (IQR 28-169) were included for analysis. On multivariable regression, compared with articles in the lowest quantile of #SoME_Score, articles in the second, third, and upper quantiles had 0.81, 15.20, and 87.67 more citations, respectively. On the validation dataset, #SoME_Score model outperformed the Altmetric score (adjusted R2 0.19 vs 0.09; P<.001). Articles in the upper quantile of #SoME_Score were more than 5 times more likely to be among the upper quantile of those cites (odds ratio 5.61, 95% CI 4.70-6.73). CONCLUSIONS: Social media attention predicts citations and could be used as an early surrogate measure of scientific impact. Owing to the cross-sectional study design, we cannot determine whether correlation relates to causation.