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Brittany C Tsou,1 Kerry Smith,1 Rahul Shah,1 Fasika A Woreta,1 S Swaroop Vedula,2 Shameema Sikder1 1Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Malone Center for Engineering in Healthcare, Whiting School of Engineering, Johns Hopkins University, Baltimore, MD, USACorrespondence: Shameema Sikder, Wilmer Eye Institute, Johns Hopkins University School of Medicine, 600 N Wolfe St, Baltimore, MD, 21218, USA, Tel +1-240-482-1108, Email ssikder1@jhmi.eduPurpose: To estimate the opportunity cost to attending surgeons of teaching residents cataract surgery in the operating room.Patients and methods: Operating room records at an academic teaching hospital from July 2016 to July 2020 were analyzed in this retrospective review of cases. Cases were identified using Current Procedural Terminology (CPT) codes 66982 and 66984 for cataract surgery. Outcomes measured include operative time and work relative value units (wRVUs). Cost analysis was performed using the generic 2021 Medicare Conversion Factor.Results: Of 8813 cases, 2906 (33.0%) included resident involvement. For CPT 66982 cases, median (interquartile range (IQR)) operative time was 47 (22) minutes with resident involvement and 28 (18) minutes without (p< 0.001). For CPT 66984 cases, median (IQR) operative time was 34 (15) minutes with resident involvement and 20 (11) minutes without (p< 0.001). Median wRVUs was 78.5 (20.9) with resident involvement and 61.0 (14.4) without (p< 0.001) which converted to an opportunity cost (IQR) per case of &dollar;1393.72 (&dollar;1055.63). Among cases involving residents, median operative time was significantly higher during the first and second quarters (p< 0.001) and for every quarter when compared to cases performed by attendings only (p< 0.001).Conclusion: Teaching cataract surgery in the operating room is associated with a considerable opportunity cost for attending surgeons.Keywords: cataract surgery, resident involvement, opportunity cost, relative value units

Current virtual reality-based (VR) simulators for robot-assisted minimally invasive surgery (RAMIS) training lack effective teaching and coaching. Our objective was to develop an automated teaching framework for VR training in RAMIS. Second, we wanted to study the effect of such real-time teaching cues on surgical technical skill acquisition. Third, we wanted to assess skill in terms of surgical technique in addition to traditional time and motion efficiency metrics. We implemented six teaching cues within a needle passing task on the da Vinci Skills Simulator platform (noncommercial research version). These teaching cues are graphical overlays designed to demonstrate ideal surgical technique, e.g., what path to follow while passing needle through tissue. We created three coaching modes: teach (continuous demonstration), metrics (demonstration triggered by performance metrics), and user (demonstration upon user request). We conducted a randomized controlled trial where the experimental group practiced using automated teaching and the control group practiced in a self-learning manner without automated teaching. We analyzed data from 30 participants (14 in experimental and 16 in control group). After three practice repetitions, control group showed higher improvement in time and motion efficiency, while experimental group showed higher improvement in surgical technique compared to their baseline measurements. The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant. In a pilot randomized controlled trial, we observed that automated teaching cues can improve the performance of surgical technique in a VR simulator for RAMIS needle passing. Our study was limited by its recruitment of nonsurgeons and evaluation of a single configuration of coaching modes.

Endoscopic surgery has a considerable learning curve due to dissociation of the visual-motor axes, coupled with decreased tactile feedback and mobility. In particular, endoscopic sinus surgery (ESS) lacks objective skill assessment metrics to provide specific feedback to trainees. This study aims to identify summary metrics from eye tracking, endoscope motion, and tool motion to objectively assess surgeons' ESS skill.In this cross-sectional study, expert and novice surgeons performed ESS tasks of inserting an endoscope and tool into a cadaveric nose, touching an anatomical landmark, and withdrawing the endoscope and tool out of the nose. Tool and endoscope motion were collected using an electromagnetic tracker, and eye gaze was tracked using an infrared camera. Three expert surgeons provided binary assessments of low/high skill. 20 summary statistics were calculated for eye, tool, and endoscope motion and used in logistic regression models to predict surgical skill.14 metrics (10 eye gaze, 2 tool motion, and 2 endoscope motion) were significantly different between surgeons with low and high skill. Models to predict skill for 6/9 ESS tasks had an AUC0.95. A combined model of all tasks (AUC 0.95, PPV 0.93, NPV 0.89) included metrics from eye tracking data and endoscope motion, indicating that these metrics are transferable across tasks.Eye gaze, endoscope, and tool motion data can provide an objective and accurate measurement of ESS surgical performance. Incorporation of these algorithmic techniques intraoperatively could allow for automated skill assessment for trainees learning endoscopic surgery.N/A Laryngoscope, 2022.

Purpose: Surgery involves modifying anatomy to achieve a goal. Reconstructing anatomy can facilitate surgical care through surgical planning, real-time decision support, or anticipating outcomes. Tool motion is a rich source of data that can be used to quantify anatomy. Our work develops and validates a method for reconstructing the nasal septum from unstructured motion of the Cottle elevator during the elevation phase of septoplasty surgery, without need to explicitly delineate the surface of the septum. Approach: The proposed method uses iterative closest point registration to initially register a template septum to the tool motion. Subsequently, statistical shape modeling with iterative most likely oriented point registration is used to fit the reconstructed septum to Cottle tip position and orientation during flap elevation. Regularization of the shape model and transformation is incorporated. The proposed methods were validated on 10 septoplasty surgeries performed on cadavers by operators of varying experience level. Preoperative CT images of the cadaver septums were segmented as ground truth. Results: We estimated reconstruction error as the difference between the projections of the Cottle tip onto the surface of the reconstructed septum and the ground-truth septum segmented from the CT image. We found translational differences of 2.74(2.06-2.81) mm and a rotational differences of 8.95(7.11-10.55) deg between the reconstructed septum and the ground-truth septum [median (interquartile range)], given the optimal regularization parameters. Conclusions: Accurate reconstruction of the nasal septum can be achieved from tool tracking data during septoplasty surgery on cadavers. This enables understanding of the septal anatomy without need for traditional medical imaging. This result may be used to facilitate surgical planning, intraoperative care, or skills assessment.

This study was designed to determine the effect of a novel simulation-based training curriculum for scleral tunnel construction in manual small incision cataract surgery (MSICS) compared with traditional training. In this multicenter, investigator-masked, randomized clinical trial, resident surgeons within 3 months of matriculation with minimal or no prior experience with MSICS were assigned either to simulation-based training, the Experimental Group (EG), or to conventional training, the Control Group (CG). EG residents were trained to perform scleral tunnel construction using a simulation-based curriculum (HelpMeSee Eye Surgery Simulator), while residents in the CG followed institution-specific curriculum before progressing to live surgery. Surgical videos of the first 20 attempts at tunnel construction were reviewed by masked video raters. The primary outcome was the total number of any of 9 pre-specified errors. On average, the total number of errors was 9.25 (95% CI 0–18.95) in the EG and 17.56 (95% CI 6.63–28.49) in the CG (P = 0.05); the number of major errors was 4.86 (95% CI 0.13–9.59) in the EG and 10.09 (95% CI 4.76–15.41) in the CG (P = 0.02); and the number of minor errors was 4.39 (95% CI 0–9.75) in the EG and 7.47 (95% CI 1.43–13.51) in the CG (P = 0.16). These results support that novice surgeons trained using the novel simulation-based curriculum performed fewer errors in their first 20 attempts at tunnel construction compared to those trained with a conventional curriculum.

BACKGROUND: Ophthalmia neonatorum is an infection of the eyes in newborns that can lead to blindness, particularly if the infection is caused by Neisseria gonorrhoeae. Antiseptic or antibiotic medication is dispensed into the eyes of newborns, or dispensed systemically, soon after delivery to prevent neonatal conjunctivitis and potential vision impairment. OBJECTIVES: 1. To determine if any type of systemic or topical eye medication is better than placebo or no prophylaxis in preventing ophthalmia neonatorum. 2. To determine if any one systemic or topical eye medication is better than any other medication in preventing ophthalmia neonatorum. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, and three trials registers, date of last search 4 October 2019. We also searched references of included studies and contacted pharmaceutical companies. SELECTION CRITERIA: We included randomised and quasi‐randomised controlled trials of any topical, systemic, or combination medical interventions used to prevent ophthalmia neonatorum in newborns compared with placebo, no prophylaxis, or with each other. DATA COLLECTION AND ANALYSIS: We used standard methods expected by Cochrane. Outcomes were: blindness or any adverse visual outcome at 12 months, conjunctivitis at 1 month (gonococcal (GC), chlamydial (CC), bacterial (BC), any aetiology (ACAE), or unknown aetiology (CUE)), and adverse effects. MAIN RESULTS: We included 30 trials with a total of 79,198 neonates. Eighteen studies were conducted in high‐income settings (the USA, Europe, Israel, Canada), and 12 were conducted in low‐ and middle‐income settings (Africa, Iran, China, Indonesia, Mexico). Fifteen of the 30 studies were quasi‐randomised. We judged every study to be at high risk of bias in at least one domain. Ten studies included a comparison arm with no prophylaxis. There were 14 different prophylactic regimens and 12 different medications in the 30 included studies. Any prophylaxis compared to no prophylaxis Unless otherwise indicated, the following evidence comes from studies assessing one or more of the following interventions: tetracycline 1%, erythromycin 0.5%, povidone‐iodine 2.5%, silver nitrate 1%. None of the studies reported data on the primary outcomes: blindness or any adverse visual outcome at any time point. There was only very low‐certainty evidence on the risk of GC with prophylaxis (4/5340 newborns) compared to no prophylaxis (5/2889) at one month (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.24 to 2.65, 3 studies). Low‐certainty evidence suggested there may be little or no difference in effect on CC (RR 0.96, 95% CI 0.57 to 1.61, 4874 newborns, 2 studies) and BC (RR 0.84, 95% CI 0.37 to 1.93, 3685 newborns, 2 studies). Moderate‐certainty evidence suggested a probable reduction in risk of ACAE at one month (RR 0.65, 95% 0.54 to 0.78, 9666 newborns, 8 studies assessing tetracycline 1%, erythromycin 0.5%, povidone‐iodine 2.5%, silver nitrate 1%, colostrum, bacitracin‐phenacaine ointment). There was only very low‐certainty evidence on CUE (RR 1.75, 95% CI 0.37 to 8.28, 330 newborns, 1 study). Very low‐certainty evidence on adverse effects suggested no increased nasolacrimal duct obstruction (RR 0.93, 95% CI 0.68 to 1.28, 404 newborns, 1 study of erythromycin 0.5% and silver nitrate 1%) and no increased keratitis (single study of 40 newborns assessing silver nitrate 1% with no events). Any prophylaxis compared to another prophylaxis Overall, evidence comparing different interventions did not suggest any consistently superior intervention. However, most of this evidence was of low‐certainty and was extremely limited. AUTHORS' CONCLUSIONS: There are no data on whether prophylaxis for ophthalmia neonatorum prevents serious outcomes such as blindness or any adverse visual outcome. Moderate‐certainty evidence suggests that the use of prophylaxis may lead to a reduction in the incidence of ACAE in newborns but the evidence for effect on GC, CC or BC was less certain. Comparison of individual interventions did not suggest any consistently superior intervention, but data were limited. A trial comparing tetracycline, povidone‐iodine (single administration), and chloramphenicol for GC and CC could potentially provide the community with an effective, universally applicable prophylaxis against ophthalmia neonatorum.

Stimulus deprivation amblyopia (SDA) develops due to an obstruction to the passage of light secondary to a condition such as cataract. The obstruction prevents formation of a clear image on the retina. SDA can be resistant to treatment, leading to poor visual prognosis. SDA probably constitutes less than 3% of all amblyopia cases, although precise estimates of prevalence are unknown. In developed countries, most patients present under the age of one year; in less developed parts of the world patients are likely to be older at the time of presentation. The mainstay of treatment is removal of the cataract and then occlusion of the better-seeing eye, but regimens vary, can be difficult to execute, and traditionally are believed to lead to disappointing results.Our objective was to evaluate the effectiveness of occlusion therapy for SDA in an attempt to establish realistic treatment outcomes. Where data were available, we also planned to examine evidence of any dose response effect and to assess the effect of the duration, severity, and causative factor on the size and direction of the treatment effect.We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2013), EMBASE (January 1980 to October 2013), the Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to October 2013), PubMed (January 1946 to October 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com ), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 October 2013.We planned to include randomized and quasi-randomized controlled trials of participants with unilateral SDA with visual acuity worse than 0.2 LogMAR or equivalent. We did not specify any restrictions for inclusion based upon age, gender, ethnicity, co-morbidities, medication use, or the number of participants.Two review authors independently assessed study abstracts identified by the electronic searches.We did not identify any trials that met the inclusion criteria specified in the protocol for this review.We found no evidence on the effectiveness of any treatment for SDA. Future randomized controlled trials are needed in order to evaluate the safety and effectiveness of occlusion, duration of treatment, level of vision that can be realistically achieved, effects of age at onset and magnitude of visual defect, optimum occlusion regimen, and factors associated with satisfactory and unsatisfactory outcomes with the use of various interventions for SDA.

Lumbar spine surgery suffers from high variability in patient outcomes,1–9 heterogeneous treatment patterns, and a high frequency of undesirable outcomes, such as revision surgery,8 failed back surgery,7 and recurrent lumbar disk herniations.10 This heterogeneity could be attributed to variable patient characteristics, surgeon preferences, hospital and surgeon volume, and complexity of the intervention.11–13 However, current understanding of the contributing factors that determine the outcome variability remains ambiguous and underexplored.14–16 In this context, models to predict patient outcomes provide a valuable resource for patient selection, treatment optimization, and rehabilitative pathway design.11,17–19 Previous studies that investigated variability in pain and functional outcomes were limited to analyzing patient demographic and preoperative clinical characteristics as the underlying factors.11,12,19 While such factors [e.g., age, body mass index (BMI), and smoking status] partially contribute to the outcome variability, additional surgery-specific features could further illuminate and improve the utility of prediction models. Some studies have tended toward development of increasingly complex modeling techniques (e.g., deep neural networks14,20) to improve accuracy, particularly for scenarios in which the predictor variables arise from a limited number of available preoperative characteristics (i.e., demographic data). In spite of devising complex machine learning algorithms, model generalizability is challenging to achieve with a limited set of predictor variables that may not fully explain the variability in clinical outcomes. Even though advanced learning methods perform better under conditions of sparse data and/or limited input variables, increasingly complex models also introduce challenges to explainability in the predictions and the ability to identify actionable features. A large number of images are routinely acquired for perioperative diagnostic and therapeutic evaluation purposes before, during, and after spine surgery. These images play a vital role in diagnosing spinal pathology, determining surgery indications, ensuring safe intervention via intraoperative guidance, and assessing the surgical product in postoperative and follow-up visits. Such images capture distinctive features related to anatomy, pathology, and the changes effected during surgery. In fact, qualitative radiological assessment has been an important basis for outcome measurement prior to (or complementary to) patient-reported outcomes (PROs). Thus, incorporating automatically derived image features in addition to previously investigated patient characteristics could improve the accuracy and utility of prediction models. Consequently, several studies have evaluated the relationship between individual measures manually obtained from images and patient outcomes in lumbar, thoracic, and cervical spine surgery. Example measures include Modic changes,21,22 signal intensity-based metrics,23–25 and the lowest instrumented vertebra take-off angle.26,27 In contrast to manually obtained features, recent advances facilitate the automatic extraction of several anatomical features from spine imaging.28–31 Example image-based features include automatic labeling of vertebral levels, global spinal alignment, endplate angles, intervertebral space, number of levels treated, and measurements of surgical instrumentation. To our knowledge, there are no previous studies evaluating statistical models to predict patient outcomes in lumbar spine surgery that use automatically derived quantitative measurements from radiological images. The objective of this study was to develop and validate a data-analytic framework referred to as “SpineCloud,” which includes quantitative features automatically derived from spine imaging in addition to patient demographic and clinical characteristics to predict function and pain improvement after lumbar spine surgery. A learning algorithm was trained and validated to make predictions by combining disparate features based on demographics and image analytics. In this work, we used a boosted decision tree algorithm that inherently handles ordinal and continuous variables in a common predictor variable space. The prediction task was modeled as a binary classification to estimate functional improvement or nonimprovement at 3- and 12-month intervals after surgery.

BACKGROUND: Nearsightedness (myopia) causes blurry vision when one is looking at distant objects. Interventions to slow the progression of myopia in children include multifocal spectacles, contact lenses, and pharmaceutical agents. OBJECTIVES: To assess the effects of interventions, including spectacles, contact lenses, and pharmaceutical agents in slowing myopia progression in children. SEARCH METHODS: We searched CENTRAL; Ovid MEDLINE; Embase.com; PubMed; the LILACS Database; and two trial registrations up to February 2018. A top up search was done in February 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs). We excluded studies when most participants were older than 18 years at baseline. We also excluded studies when participants had less than ‐0.25 diopters (D) spherical equivalent myopia. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. MAIN RESULTS: We included 41 studies (6772 participants). Twenty‐one studies contributed data to at least one meta‐analysis. Interventions included spectacles, contact lenses, pharmaceutical agents, and combination treatments. Most studies were conducted in Asia or in the United States. Except one, all studies included children 18 years or younger. Many studies were at high risk of performance and attrition bias. Spectacle lenses: undercorrection of myopia increased myopia progression slightly in two studies; children whose vision was undercorrected progressed on average ‐0.15 D (95% confidence interval [CI] ‐0.29 to 0.00; n = 142; low‐certainty evidence) more than those wearing fully corrected single vision lenses (SVLs). In one study, axial length increased 0.05 mm (95% CI ‐0.01 to 0.11) more in the undercorrected group than in the fully corrected group (n = 94; low‐certainty evidence). Multifocal lenses (bifocal spectacles or progressive addition lenses) yielded small effect in slowing myopia progression; children wearing multifocal lenses progressed on average 0.14 D (95% CI 0.08 to 0.21; n = 1463; moderate‐certainty evidence) less than children wearing SVLs. In four studies, axial elongation was less for multifocal lens wearers than for SVL wearers (‐0.06 mm, 95% CI ‐0.09 to ‐0.04; n = 896; moderate‐certainty evidence). Three studies evaluating different peripheral plus spectacle lenses versus SVLs reported inconsistent results for refractive error and axial length outcomes (n = 597; low‐certainty evidence). Contact lenses: there may be little or no difference between vision of children wearing bifocal soft contact lenses (SCLs) and children wearing single vision SCLs (mean difference (MD) 0.20D, 95% CI ‐0.06 to 0.47; n = 300; low‐certainty evidence). Axial elongation was less for bifocal SCL wearers than for single vision SCL wearers (MD ‐0.11 mm, 95% CI ‐0.14 to ‐0.08; n = 300; low‐certainty evidence). Two studies investigating rigid gas permeable contact lenses (RGPCLs) showed inconsistent results in myopia progression; these two studies also found no evidence of difference in axial elongation (MD 0.02mm, 95% CI ‐0.05 to 0.10; n = 415; very low‐certainty evidence). Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD ‐0.28 mm, 95% CI ‐0.38 to ‐0.19; n = 106; moderate‐certainty evidence). Two studies comparing spherical aberration SCLs with single vision SCLs reported no difference in myopia progression nor in axial length (n = 209; low‐certainty evidence). Pharmaceutical agents: at one year, children receiving atropine eye drops (3 studies; n = 629), pirenzepine gel (2 studies; n = 326), or cyclopentolate eye drops (1 study; n = 64) showed significantly less myopic progression compared with children receiving placebo: MD 1.00 D (95% CI 0.93 to 1.07), 0.31 D (95% CI 0.17 to 0.44), and 0.34 (95% CI 0.08 to 0.60), respectively (moderate‐certainty evidence). Axial elongation was less for children treated with atropine (MD ‐0.35 mm, 95% CI ‐0.38 to ‐0.31; n = 502) and pirenzepine (MD ‐0.13 mm, 95% CI ‐0.14 to ‐0.12; n = 326) than for those treated with placebo (moderate‐certainty evidence) in two studies. Another study showed favorable results for three different doses of atropine eye drops compared with tropicamide eye drops (MD 0.78 D, 95% CI 0.49 to 1.07 for 0.1% atropine; MD 0.81 D, 95% CI 0.57 to 1.05 for 0.25% atropine; and MD 1.01 D, 95% CI 0.74 to 1.28 for 0.5% atropine; n = 196; low‐certainty evidence) but did not report axial length. Systemic 7‐methylxanthine had little to no effect on myopic progression (MD 0.07 D, 95% CI ‐0.09 to 0.24) nor on axial elongation (MD ‐0.03 mm, 95% CI ‐0.10 to 0.03) compared with placebo in one study (n = 77; moderate‐certainty evidence). One study did not find slowed myopia progression when comparing timolol eye drops with no drops (MD ‐0.05 D, 95% CI ‐0.21 to 0.11; n = 95; low‐certainty evidence). Combinations of interventions: two studies found that children treated with atropine plus multifocal spectacles progressed 0.78 D (95% CI 0.54 to 1.02) less than children treated with placebo plus SVLs (n = 191; moderate‐certainty evidence). One study reported ‐0.37 mm (95% CI ‐0.47 to ‐0.27) axial elongation for atropine and multifocal spectacles when compared with placebo plus SVLs (n = 127; moderate‐certainty evidence). Compared with children treated with cyclopentolate plus SVLs, those treated with atropine plus multifocal spectacles progressed 0.36 D less (95% CI 0.11 to 0.61; n = 64; moderate‐certainty evidence). Bifocal spectacles showed small or negligible effect compared with SVLs plus timolol drops in one study (MD 0.19 D, 95% CI 0.06 to 0.32; n = 97; moderate‐certainty evidence). One study comparing tropicamide plus bifocal spectacles versus SVLs reported no statistically significant differences between groups without quantitative results. No serious adverse events were reported across all interventions. Participants receiving antimuscarinic topical medications were more likely to experience accommodation difficulties (Risk Ratio [RR] 9.05, 95% CI 4.09 to 20.01) and papillae and follicles (RR 3.22, 95% CI 2.11 to 4.90) than participants receiving placebo (n=387; moderate‐certainty evidence). AUTHORS' CONCLUSIONS: Antimuscarinic topical medication is effective in slowing myopia progression in children. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit. Orthokeratology contact lenses, although not intended to modify refractive error, were more effective than SVLs in slowing axial elongation. We found only low or very low‐certainty evidence to support RGPCLs and sperical aberration SCLs.

Healthcare in general, and surgery/interventional care in particular, is evolving through rapid advances in technology and increasing complexity of care, with the goal of maximizing the quality and value of care. Whereas innovations in diagnostic and therapeutic technologies have driven past improvements in the quality of surgical care, future transformation in care will be enabled by data. Conventional methodologies, such as registry studies, are limited in their scope for discovery and research, extent and complexity of data, breadth of analytical techniques, and translation or integration of research findings into patient care. We foresee the emergence of surgical/interventional data science (SDS) as a key element to addressing these limitations and creating a sustainable path toward evidence-based improvement of interventional healthcare pathways. SDS will create tools to measure, model, and quantify the pathways or processes within the context of patient health states or outcomes and use information gained to inform healthcare decisions, guidelines, best practices, policy, and training, thereby improving the safety and quality of healthcare and its value. Data are pervasive throughout the surgical care pathway; thus, SDS can impact various aspects of care, including prevention, diagnosis, intervention, or postoperative recovery. The existing literature already provides preliminary results, suggesting how a data science approach to surgical decision-making could more accurately predict severe complications using complex data from preoperative, intraoperative, and postoperative contexts, how it could support intraoperative decision-making using both existing knowledge and continuous data streams throughout the surgical care pathway, and how it could enable effective collaboration between human care providers and intelligent technologies. In addition, SDS is poised to play a central role in surgical education, for example, through objective assessments, automated virtual coaching, and robot-assisted active learning of surgical skill. However, the potential for transforming surgical care and training through SDS may only be realized through a cultural shift that not only institutionalizes technology to seamlessly capture data but also assimilates individuals with expertise in data science into clinical research teams. Furthermore, collaboration with industry partners from the inception of the discovery process promotes optimal design of data products as well as their efficient translation and commercialization. As surgery continues to evolve through advances in technology that enhance delivery of care, SDS represents a new knowledge domain to engineer surgical care of the future.

IMPORTANCE: Daytime sleepiness in surgical trainees can impair intraoperative technical skill and thus affect their learning and pose a risk to patient safety. OBJECTIVE: To determine the association between daytime sleepiness of surgeons in residency and fellowship training and their intraoperative technical skill during septoplasty. DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study included 19 surgical trainees in otolaryngology–head and neck surgery programs at 2 academic institutions (Johns Hopkins University School of Medicine and MedStar Georgetown University Hospital). The physicians were recruited from June 13, 2016, to April 20, 2018. The analysis includes data that were captured between June 27, 2016, and April 20, 2018. MAIN OUTCOMES AND MEASURES: Attending physician and surgical trainee self-rated intraoperative technical skill using the Septoplasty Global Assessment Tool (SGAT) and visual analog scales. Daytime sleepiness reported by surgical trainees was measured using the Epworth Sleepiness Scale (ESS). RESULTS: Of 19 surgical trainees, 17 resident physicians (9 female [53%]) and 2 facial plastic surgery fellowship physicians (1 female and 1 male) performed a median of 3.00 septoplasty procedures (range, 1-9 procedures) under supervision by an attending physician. Of the 19 surgical trainees, 10 (53%) were aged 25 to 30 years and 9 (47%) were 31 years or older. The mean ESS score overall was 6.74 (95% CI, 5.96-7.52), and this score did not differ between female and male trainees. The mean ESS score was 7.57 (95% CI, 6.58-8.56) in trainees aged 25 to 30 years and 5.44 (95% CI, 4.32-6.57) in trainees aged 31 years or older. In regression models adjusted for sex, age, postgraduate year, and technical complexity of the procedure, there was a statistically significant inverse association between ESS scores and attending physician–rated technical skill for both SGAT (−0.41; 95% CI, −0.55 to −0.27; P

Background Surgeons who perform laparotomy have a number of decisions to make regarding abdominal closure. Material and size of potential suture types varies widely. In addition, surgeons can choose to close the incision in anatomic layers or mass ('en masse'), as well as using either a continuous or interrupted suturing technique, of which there are different styles of each. There is ongoing debate as to which suturing techniques and suture materials are best for achieving definitive wound closure while minimising the risk of short- and long-term complications. Objectives The objectives of this review were to identify the best available suture techniques and suture materials for closure of the fascia following laparotomy incisions, by assessing the following comparisons: absorbable versus non-absorbable sutures; mass versus layered closure; continuous versus interrupted closure techniques; monofilament versus multifilament sutures; and slow absorbable versus fast absorbable sutures. Our objective was not to determine the single best combination of suture material and techniques, but to compare the individual components of abdominal closure. Search methods On 8 February 2017 we searched CENTRAL, MEDLINE, Embase, two trials registries, and Science Citation Index. There were no limitations based on language or date of publication. We searched the reference lists of all included studies to identify trials that our searches may have missed. Selection criteria We included randomised controlled trials (RCTs) that compared suture materials or closure techniques, or both, for fascial closure of laparotomy incisions. We excluded trials that compared only types of skin closures, peritoneal closures or use of retention sutures. Data collection and analysis We abstracted data and assessed the risk of bias for each trial. We calculated a summary risk ratio (RR) for the outcomes assessed in the review, all of which were dichotomous. We used random-effects modelling, based on the heterogeneity seen throughout the studies and analyses. We completed subgroup analysis planned a priori for each outcome, excluding studies where interventions being compared differed by more than one component, making it impossible to determine which variable impacted on the outcome, or the possibility of a synergistic effect. We completed sensitivity analysis, excluding trials with at least one trait with high risk of bias. We assessed the quality of evidence using the GRADEpro guidelines. Main results Fifty-five RCTs with a total of 19,174 participants met the inclusion criteria and were included in the meta-analysis. Included studies were heterogeneous in the type of sutures used, methods of closure and patient population. Many of the included studies reported multiple comparisons. For our primary outcome, the proportion of participants who developed incisional hernia at one year or more of follow-up, we did not find evidence that suture absorption (absorbable versus non-absorbable sutures, RR 1.07, 95% CI 0.86 to 1.32, moderate-quality evidence; or slow versus fast absorbable sutures, RR 0.81, 95% CI 0.63 to 1.06, moderate-quality evidence), closure method (mass versus layered, RR 1.92, 95% CI 0.58 to 6.35, very low-quality evidence) or closure technique (continuous versus interrupted, RR 1.01, 95% CI 0.76 to 1.35, moderate-quality evidence) resulted in a difference in the risk of incisional hernia. We did, however, find evidence to suggest that monofilament sutures reduced the risk of incisional hernia when compared with multifilament sutures (RR 0.76, 95% CI 0.59 to 0.98, I2 = 30%, moderate-quality evidence). For our secondary outcomes, we found that none of the interventions reduced the risk of wound infection, whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.99, 95% CI 0.84 to 1.17, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.16, 95% CI 0.85 to 1.57, moderate-quality evidence), closure method (mass versus layered, RR 0.93, 95% CI 0.67 to 1.30, low-quality evidence) or closure technique (continuous versus interrupted, RR 1.13, 95% CI 0.96 to 1.34, moderate-quality evidence). Similarily, none of the interventions reduced the risk of wound dehiscence whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.78, 95% CI 0.55 to 1.10, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.55, 95% CI 0.92 to 2.61, moderate-quality evidence), closure method (mass versus layered, RR 0.69, 95% CI 0.31 to 1.52, moderate-quality evidence) or closure technique (continuous versus interrupted, RR 1.21, 95% CI 0.90 to 1.64, moderate-quality evidence). Absorbable sutures, compared with non-absorbable sutures (RR 0.49, 95% CI 0.26 to 0.94, low-quality evidence) reduced the risk of sinus or fistula tract formation. None of the other comparisons showed a difference (slow versus fast absorbable sutures, RR 0.88, 95% CI 0.05 to 16.05, very low-quality evidence; mass versus layered, RR 0.49, 95% CI 0.15 to 1.62, low-quality evidence; continuous versus interrupted, RR 1.51, 95% CI 0.64 to 3.61, very low-quality evidence). Authors' conclusions Based on this moderate-quality body of evidence, monofilament sutures may reduce the risk of incisional hernia. Absorbable sutures may also reduce the risk of sinus or fistula tract formation, but this finding is based on low-quality evidence. We had serious concerns about the design or reporting of several of the 55 included trials. The comparator arms in many trials differed by more than one component, making it impossible to attribute differences between groups to any one component. In addition, the patient population included in many of the studies was very heterogeneous. Trials included both emergency and elective cases, different types of disease pathology (e.g. colon surgery, hepatobiliary surgery, etc.) or different types of incisions (e.g. midline, paramedian, subcostal). Consequently, larger, high-quality trials to further address this clinical challenge are warranted. Future studies should ensure that proper randomisation and allocation techniques are performed, wound assessors are blinded, and that the duration of follow-up is adequate. It is important that only one type of intervention is compared between groups. In addition, a homogeneous patient population would allow for a more accurate assessment of the interventions.

This paper introduces Surgical Data Science as an emerging scientific discipline. Key perspectives are based on discussions during an intensive two-day international interactive workshop that brought together leading researchers working in the related field of computer and robot assisted interventions. Our consensus opinion is that increasing access to large amounts of complex data, at scale, throughout the patient care process, complemented by advances in data science and machine learning techniques, has set the stage for a new generation of analytics that will support decision-making and quality improvement in interventional medicine. In this article, we provide a consensus definition for Surgical Data Science, identify associated challenges and opportunities and provide a roadmap for advancing the field.

Background Aqueous shunts are employed to control intraocular pressure (IOP) for people with primary or secondary glaucomas who fail or are not candidates for standard surgery. Objectives To assess the effectiveness and safety of aqueous shunts for reducing IOP in glaucoma compared with standard surgery, another type of aqueous shunt, or modification to the aqueous shunt procedure. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 8), MEDLINE Ovid (1946 to August 2016), Embase.com (1947 to August 2016), PubMed (1948 to August 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to August 2016), ClinicalTrials.gov (www.clinicaltrials.gov); searched 15 August 2016, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 15 August 2016. We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 15 August 2016. We also searched the reference lists of identified trial reports and the Science Citation Index to find additional trials. Selection criteria We included randomized controlled trials that compared various types of aqueous shunts with standard surgery or to each other in eyes with glaucoma. Data collection and analysis Two review authors independently screened search results for eligibility, assessed the risk of bias, and extracted data from included trials. We contacted trial investigators when data were unclear or not reported. We graded the certainty of the evidence using the GRADE approach. We followed standard methods as recommended by Cochrane. Main results We included 27 trials with a total of 2099 participants with mixed diagnoses and comparisons of interventions. Seventeen studies reported adequate methods of randomization, and seven reported adequate allocation concealment. Data collection and follow-up times varied. Four trials compared an aqueous shunt (Ahmed or Baerveldt) with trabeculectomy, of which three reported one-year outcomes. At one-year, the difference in IOP between aqueous shunt groups and trabeculectomy groups was uncertain (mean difference (MD) 2.55 mmHg, 95% confidence interval (CI) -0.78 to 5.87; 380 participants; very low-certainty evidence). The difference in logMAR visual acuity was also uncertain (MD 0.12 units, 95% CI -0.07 to 0.31; 380 participants; very low-certainty evidence). In two trials, the difference in visual field score was uncertain (MD -0.25, 95% CI -1.91 to 1.40; 196 participants; very low-certainty evidence). The mean number of antiglaucoma medications was higher in the aqueous shunt group than the trabeculectomy group in one trial (MD 0.80, 95% CI 0.48 to 1.12; 184 participants; low-certainty evidence). The effect on needing additional glaucoma surgery was uncertain between groups in two trials (risk ratio (RR) 0.24, 95% CI 0.04 to 1.36; 329 participants; very low-certainty evidence). In one trial, fewer total adverse events were reported in the aqueous shunt group than the trabeculectomy group (RR 0.59, 95% CI 0.43 to 0.81; 212 participants; very low-certainty evidence). No trial reported quality-of-life outcomes at one-year follow-up. Two trials that compared the Ahmed implant with the Baerveldt implant for glaucoma found higher mean IOP in the Ahmed group at one-year follow-up (MD 2.60 mmHg, 95% CI 1.58 to 3.62; 464 participants; moderate-certainty evidence). The difference in logMAR visual acuity was uncertain between groups (MD -0.07 units, 95% CI -0.27 to 0.13; 501 participants; low-certainty evidence). The MD in number of antiglaucoma medications was within one between groups (MD 0.35, 95% CI 0.11 to 0.59; 464 participants; moderate-certainty evidence). More participants in the Ahmed group required additional glaucoma surgery than the Baerveldt group (RR 2.77, 95% CI 1.02 to 7.54; 514 participants; moderate-certainty evidence). The two trials reported specific adverse events but not overall number of adverse events. Neither trial reported visual field or quality-of-life outcomes at one-year follow-up. One trial compared the Ahmed implant with the Molteno implant for glaucoma over two-year follow-up. Mean IOP was higher in the Ahmed group than the Molteno group (MD 1.64 mmHg, 95% CI 0.85 to 2.43; 57 participants; low-certainty evidence). The differences in logMAR visual acuity (MD 0.08 units, 95% CI -0.24 to 0.40; 57 participants; very low-certainty evidence) and mean deviation in visual field (MD -0.18 dB, 95% CI -3.13 to 2.77; 57 participants; very low-certainty evidence) were uncertain between groups. The mean number of antiglaucoma medications was also uncertain between groups (MD -0.38, 95% CI -1.03 to 0.27; 57 participants; low-certainty evidence). The trial did not report the proportion needing additional glaucoma surgery, total adverse events, or quality-of-life outcomes. Two trials compared the double-plate Molteno implant with the Schocket shunt for glaucoma; one trial reported outcomes only at six-month follow-up, and the other did not specify the follow-up time. At six-months, mean IOP was lower in the Molteno group than the Schocket group (MD -2.50 mmHg, 95% CI -4.60 to -0.40; 115 participants; low-certainty evidence). Neither trial reported the proportion needing additional glaucoma surgery, total adverse events, or visual acuity, visual field, or quality-of-life outcomes. The remaining 18 trials evaluated modifications to aqueous shunts, including 14 trials of Ahmed implants (early aqueous suppression versus standard medication regimen, 2 trials; anti-vascular endothelial growth factor agent versus none, 4 trials; corticosteroids versus none, 2 trials; shunt augmentation versus none, 3 trials; partial tube ligation versus none, 1 trial; pars plana implantation versus conventional implantation, 1 trial; and model M4 versus model S2,1 trial); 1 trial of 500 mm2 Baerveldt versus 350 mm2 Baerveldt; and 3 trials of Molteno implants (single-plate with oral corticosteroids versus single-plate without oral corticosteroids, 1 trial; double-plate versus single-plate, 1 trial; and pressure-ridge versus double-plate with tube ligation, 1 trial). Authors' conclusions Information was insufficient to conclude whether there are differences between aqueous shunts and trabeculectomy for glaucoma treatment. While the Baerveldt implant may lower IOP more than the Ahmed implant, the evidence was of moderate-certainty and it is unclear whether the difference in IOP reduction is clinically significant. Overall, methodology and data quality among existing randomized controlled trials of aqueous shunts was heterogeneous across studies, and there are no well-justified or widely accepted generalizations about the superiority of one surgical procedure or device over another.

Training skillful and competent surgeons is critical to ensure high quality of care and to minimize disparities in access to effective care. Traditional models to train surgeons are being challenged by rapid advances in technology, an intensified patient-safety culture, and a need for value-driven health systems. Simultaneously, technological developments are enabling capture and analysis of large amounts of complex surgical data. These developments are motivating a “surgical data science” approach to objective computer-aided technical skill evaluation (OCASE-T) for scalable, accurate assessment; individualized feedback; and automated coaching. We define the problem space for OCASE-T and summarize 45 publications representing recent research in this domain. We find that most studies on OCASE-T are simulation based; very few are in the operating room. The algorithms and validation methodologies used for OCASE-T are highly varied; there is no uniform consensus. Future research should emphasize competency assessment in the operating room, validation against patient outcomes, and effectiveness for surgical training.

Ocular infestation with Toxoplasma gondii, a parasite, may result in inflammation in the retina, choroid, and uvea and consequently lead to complications such as glaucoma, cataract, and posterior synechiae.The objective of this systematic review was to assess the effects of adjunctive use of corticosteroids for ocular toxoplasmosis.We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE, (January 1950 to October 2012), EMBASE (January 1980 to October 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to October 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We searched the reference lists of included studies for any additional studies not identified by the electronic searches. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 11 October 2012.We planned to include randomized and quasi-randomized controlled trials. Eligible trials would have enrolled participants of any age who were immunocompetent and were diagnosed with active ocular toxoplasmosis. Included trials would have compared anti-parasitic therapy plus corticosteroids versus anti-parasitic therapy alone, or different doses or times of initiation of corticosteroids.Two authors independently screened titles and abstracts retrieved from the electronic searches. We retrieved full-text articles of studies categorized as 'unsure' or 'include' after review of the abstracts. Two authors independently reviewed each full-text article. Discrepancies were resolved through discussion.The electronic searches retrieved 368 titles and abstracts. We reviewed 20 full-text articles. We identified no trials eligible for inclusion in this systematic review.Although research has identified wide variation in practices regarding use of corticosteroids, our systematic review did not identify evidence from randomized controlled trials for the role of corticosteroids in the management of ocular toxoplasmosis. Several questions remain unanswered by well-conducted randomized trials in this context, including whether use of corticosteroids is more effective than use of anti-parasitic therapy alone, when corticosteroids should be initiated in the treatment regimen (early versus late course of treatment), and which dosage and duration of steroid use is best. These questions are easily amenable to research using a randomized controlled design and they are ethical due to the absence of evidence to support or discourage use of corticosteroids for this condition. The question of foremost importance, however, is whether they should be used as adjunct therapy (that is, additional) to anti-parasitic agents.

Key Points Question Are deep learning techniques sufficiently accurate to classify presegmented phases in videos of cataract surgery for subsequent automated skill assessment and feedback? Findings In this cross-sectional study including videos from a convenience sample of 100 cataract procedures, modeling time series of labels of instruments in use appeared to yield greater accuracy in classifying phases of cataract operations than modeling cross-sectional data on instrument labels, spatial video image features, spatiotemporal video image features, or spatiotemporal video image features with appended instrument labels. Meaning Time series models of instruments in use may serve to automate the identification of phases in cataract surgery, helping to develop efficient and effective surgical skill training tools in ophthalmology., This cross-sectional study evaluates machine learning and deep learning algorithms for automated phase classification of manually presegmented videos of cataract procedures., Importance Competence in cataract surgery is a public health necessity, and videos of cataract surgery are routinely available to educators and trainees but currently are of limited use in training. Machine learning and deep learning techniques can yield tools that efficiently segment videos of cataract surgery into constituent phases for subsequent automated skill assessment and feedback. Objective To evaluate machine learning and deep learning algorithms for automated phase classification of manually presegmented phases in videos of cataract surgery. Design, Setting, and Participants This was a cross-sectional study using a data set of videos from a convenience sample of 100 cataract procedures performed by faculty and trainee surgeons in an ophthalmology residency program from July 2011 to December 2017. Demographic characteristics for surgeons and patients were not captured. Ten standard labels in the procedure and 14 instruments used during surgery were manually annotated, which served as the ground truth. Exposures Five algorithms with different input data: (1) a support vector machine input with cross-sectional instrument label data; (2) a recurrent neural network (RNN) input with a time series of instrument labels; (3) a convolutional neural network (CNN) input with cross-sectional image data; (4) a CNN-RNN input with a time series of images; and (5) a CNN-RNN input with time series of images and instrument labels. Each algorithm was evaluated with 5-fold cross-validation. Main Outcomes and Measures Accuracy, area under the receiver operating characteristic curve, sensitivity, specificity, and precision. Results Unweighted accuracy for the 5 algorithms ranged between 0.915 and 0.959. Area under the receiver operating characteristic curve for the 5 algorithms ranged between 0.712 and 0.773, with small differences among them. The area under the receiver operating characteristic curve for the image-only CNN-RNN (0.752) was significantly greater than that of the CNN with cross-sectional image data (0.712) (difference, −0.040; 95% CI, −0.049 to −0.033) and the CNN-RNN with images and instrument labels (0.737) (difference, 0.016; 95% CI, 0.014 to 0.018). While specificity was uniformly high for all phases with all 5 algorithms (range, 0.877 to 0.999), sensitivity ranged between 0.005 (95% CI, 0.000 to 0.015) for the support vector machine for wound closure (corneal hydration) and 0.974 (95% CI, 0.957 to 0.991) for the RNN for main incision. Precision ranged between 0.283 and 0.963. Conclusions and Relevance Time series modeling of instrument labels and video images using deep learning techniques may yield potentially useful tools for the automated detection of phases in cataract surgery procedures.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: PRIMARY OBJECTIVES: The aim of this review is to evaluate the effects of MMC on the cornea and answer the question: is there sufficient evidence for using intraoperative topical MMC on the cornea in surface ablation (PRK or LASEK or epi‐LASIK) as prophylaxis for haze formation and to reduce refractive regression? This review will address the use of MMC in the prophylaxis of myopic patients who underwent PRK or LASEK or epi‐LASIK. SECONDARY OBJECTIVES: If sufficient data are available, a secondary objective of this review is to determine the refractive predictability and complications with different concentrations and times of exposure to MMC as well as to find out if there are differences in proportion of patients with haze among different laser platforms used for PRK, LASEK, and epi‐LASIK. Refractive predictability is defined as the difference between the attempted and achieved refractive change, in other words, the difference between the mean postoperative spherical equivalent (SE) and the target SE using the manifest refraction (Joo 2005).

We apply recurrent neural networks to the task of recognizing surgical activities from robot kinematics. Prior work in this area focuses on recognizing short, low-level activities, or gestures, and has been based on variants of hidden Markov models and conditional random fields. In contrast, we work on recognizing both gestures and longer, higher-level activites, or maneuvers, and we model the mapping from kinematics to gestures/maneuvers with recurrent neural networks. To our knowledge, we are the first to apply recurrent neural networks to this task. Using a single model and a single set of hyperparameters, we match state-of-the-art performance for gesture recognition and advance state-of-the-art performance for maneuver recognition, in terms of both accuracy and edit distance. Code is available at https://github.com/rdipietro/miccai-2016-surgical-activity-rec.

Background Surgical tasks are performed in a sequence of steps, and technical skill evaluation includes assessing task flow efficiency. Our objective was to describe differences in task flow for expert and novice surgeons for a basic surgical task. Methods We used a hierarchical semantic vocabulary to decompose and annotate maneuvers and gestures for 135 instances of a surgeon’s knot performed by 18 surgeons. We compared counts of maneuvers and gestures, and analyzed task flow by skill level. Results Experts used fewer gestures to perform the task (26.29; 95% CI = 25.21 to 27.38 for experts vs. 31.30; 95% CI = 29.05 to 33.55 for novices) and made fewer errors in gestures than novices (1.00; 95% CI = 0.61 to 1.39 vs. 2.84; 95% CI = 2.3 to 3.37). Transitions among maneuvers, and among gestures within each maneuver for expert trials were more predictable than novice trials. Conclusions Activity segments and state flow transitions within a basic surgical task differ by surgical skill level, and can be used to provide targeted feedback to surgical trainees.

Optic neuritis is an inflammatory disease of the optic nerve. It usually presents with an abrupt loss of vision and recovery of vision is almost never complete. It occurs more commonly in women than in men. Closely linked in pathogenesis, optic neuritis may be the initial manifestation for multiple sclerosis. In some people, no underlying cause can be found.The objective of this review was to assess the effects of corticosteroids on visual recovery in eyes with acute optic neuritis.We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2015, Issue 4), MEDLINE (January 1950 to April 2015), EMBASE (January 1980 to April 2015), Latin American and Caribbean Health Sciences Literature (LILACS) (January 1982 to April 2015), PubMed (January 1946 to April 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The metaRegister of Controlled Trials (mRCT) was last searched on 6 March 2014. The electronic databases were last searched on 7 April 2015. We also searched reference lists of identified trial reports for additional trials.We included randomized controlled trials (RCTs) that evaluated systemic corticosteroids, in any form, dose or route of administration, in people with acute optic neuritis.We used standard methodological procedures expected by Cochrane.We included six RCTs with a total of 750 participants. Each trial was conducted in a different country: Denmark, Germany, India, Japan, UK, and United States. Additionally, we identified two ongoing trials not due to be completed until 2016. Among the six trials included in this review, we judged one to be at high risk of bias. The remaining five trials were judged to be at either low or uncertain risk of biases.Five trials compared only two intervention groups and one trial had a three-arm comparison of oral corticosteroids or intravenous corticosteroids with placebo. Of the five trials with only two intervention groups, two trials compared oral corticosteroids versus placebo, two trials compared intravenous corticosteroids with placebo, and one trial compared intravenous dexamethasone with intravenous methylprednisolone plus oral prednisolone.Three trials evaluating oral corticosteroids used varying doses of corticosteroids versus placebo. In the meta-analyses to assess visual acuity, the risk ratio (RR) was 1.00 (95% confidence interval (CI) 0.82 to 1.23; participants = 398) at one month; 0.92 (95% CI 0.77 to 1.11; participants = 355) at six months; and 0.93 (95% CI 0.70 to 1.24; participants = 368) at one year. In the meta-analyses of two trials evaluating corticosteroids with total dose greater than 3000 mg administered intravenously, the RR of normal visual acuity (defined as 20/20 Snellen fraction or equivalent) in the intravenous corticosteroids group compared with the placebo group was 1.05 (95% CI 0.88 to 1.26; participants = 346) at six months. The RR of contrast sensitivity in the normal range for the same comparison was 1.11 (95% CI 0.92 to 1.33; participants = 346) at six months follow-up. The RR of normal visual field for this comparison was 1.08 (95% CI 0.96 to 1.21; 346 participants) at six months; and 1.01 (95% CI 0.86 to 1.19; participants = 316) at one year. Four trials reported adverse events primarily related to gastrointestinal symptoms and sleep disturbance; one trial reported minor adverse event of acne.There is no conclusive evidence of benefit in terms of recovery to normal visual acuity, visual field or contrast sensitivity six months after initiation with either intravenous or oral corticosteroids at the doses evaluated in trials included in this review.

Background Diabetic retinopathy is a common complication of diabetes and a leading cause of visual impairment and blindness. Research has established the importance of blood glucose control to prevent development and progression of the ocular complications of diabetes. Simultaneous blood pressure control has been advocated for the same purpose, but findings reported from individual studies have supported varying conclusions regarding the ocular benefit of interventions on blood pressure. Objectives The primary aim of this review was to summarize the existing evidence regarding the effect of interventions to control or reduce blood pressure levels among diabetics on incidence and progression of diabetic retinopathy, preservation of visual acuity, adverse events, quality of life, and costs. A secondary aim was to compare classes of anti-hypertensive medications with respect to the same outcomes. Search methods We searched a number of electronic databases including CENTRAL as well as ongoing trial registries. We last searched the electronic databases on 25 April 2014. We also reviewed reference lists of review articles and trial reports selected for inclusion. In addition, we contacted investigators of trials with potentially pertinent data. Selection criteria We included in this review randomized controlled trials (RCTs) in which either type 1 or type 2 diabetic participants, with or without hypertension, were assigned randomly to intense versus less intense blood pressure control, to blood pressure control versus usual care or no intervention on blood pressure, or to different classes of anti-hypertensive agents versus placebo. Data collection and analysis Pairs of review authors independently reviewed titles and abstracts from electronic and manual searches and the full text of any document that appeared to be relevant. We assessed included trials independently for risk of bias with respect to outcomes reported in this review. We extracted data regarding trial characteristics, incidence and progression of retinopathy, visual acuity, quality of life, and cost-effectiveness at annual intervals after study entry whenever provided in published reports and other documents available from included trials. Main results We included 15 RCTs, conducted primarily in North America and Europe, that had enrolled 4157 type 1 and 9512 type 2 diabetic participants, ranging from 16 to 2130 participants in individual trials. In 10 of the 15 RCTs, one group of participants was assigned to one or more anti-hypertensive agents and the control group received placebo. In three trials, intense blood pressure control was compared to less intense blood pressure control. In the remaining two trials, blood pressure control was compared with usual care. Five of the 15 trials enrolled type 1 diabetics, and 10 trials enrolled type 2 diabetics. Six trials were sponsored entirely by pharmaceutical companies, seven trials received partial support from pharmaceutical companies, and two studies received support from government-sponsored grants and institutional support. Study designs, populations, interventions, and lengths of follow-up (range one to nine years) varied among the included trials. Overall, the quality of the evidence for individual outcomes was low to moderate. For the primary outcomes, incidence and progression of retinopathy, the quality of evidence was downgraded due to inconsistency and imprecision of estimates from individual studies and differing characteristics of participants. For primary outcomes among type 1 diabetics, one of the five trials reported incidence of retinopathy and one trial reported progression of retinopathy after 4 to 5 years of treatment and follow-up; four of the five trials reported a combined outcome of incidence and progression over the same time interval. Among type 2 diabetics, 5 of the 10 trials reported incidence of diabetic retinopathy and 3 trials reported progression of retinopathy; one of the 10 trials reported a combined outcome of incidence and progression during a 4- to 5-year follow-up period. One trial in which type 2 diabetics participated had reported no primary (or secondary) outcome targeted for this review. The evidence from these trials supported a benefit of more intensive blood pressure control intervention with respect to 4- to 5-year incidence of diabetic retinopathy (estimated risk ratio (RR) 0.80; 95% confidence interval (CI) 0.71 to 0.92) and the combined outcome of incidence and progression (estimated RR 0.78; 95% CI 0.63 to 0.97). The available evidence provided less support for a benefit with respect to 4- to 5-year progression of diabetic retinopathy (point estimate was closer to 1 than point estimates for incidence and combined incidence and progression, and the CI overlapped 1; estimated RR 0.88; 95% CI 0.73 to 1.05). The available evidence regarding progression to proliferative diabetic retinopathy or clinically significant macular edema or moderate to severe loss of best-corrected visual acuity did not support a benefit of intervention on blood pressure: estimated RRs and 95% CIs 0.95 (0.83 to 1.09) and 1.06 (0.85 to 1.33), respectively, after 4 to 5 years of follow-up. Findings within subgroups of trial participants (type 1 and type 2 diabetics; participants with normal blood pressure levels at baseline and those with elevated levels) were similar to overall findings. The adverse event reported most often (7 of 15 trials) was death, yielding an estimated RR 0.86 (95% CI 0.64 to 1.14). Hypotension was reported from three trials; the estimated RR was 2.08 (95% CI 1.68 to 2.57). Other adverse ocular events were reported from single trials. Authors' conclusions Hypertension is a well-known risk factor for several chronic conditions in which lowering blood pressure has proven to be beneficial. The available evidence supports a beneficial effect of intervention to reduce blood pressure with respect to preventing diabetic retinopathy for up to 4 to 5 years. However, the lack of evidence to support such intervention to slow progression of diabetic retinopathy or to prevent other outcomes considered in this review, along with the relatively modest support for the beneficial effect on incidence, weakens the conclusion regarding an overall benefit of intervening on blood pressure solely to prevent diabetic retinopathy.

Background Age-related macular degeneration (AMD) is the most common cause of uncorrectable severe vision loss in people aged 55 years and older in the developed world. Choroidal neovascularization (CNV) secondary to neovascular AMD accounts for most AMD-related severe vision loss. Anti-vascular endothelial growth factor (anti-VEGF) agents, injected intravitreally, aim to block the growth of abnormal blood vessels in the eye to prevent vision loss and, in some instances, improve vision.

Background: A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. Purpose: To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. Methods: We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. Results: We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$—International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. Limitations: We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Conclusions: Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials.

Background Cataract formation or acceleration can occur after intraocular surgery, especially following vitrectomy, a surgical technique for removing the vitreous that is used in the treatment of many disorders that affect the posterior segment of the eye. The underlying problem that led to vitrectomy may limit the benefit from removal of the cataractous lens. Objectives To evaluate the effectiveness and safety of surgery versus no surgery for postvitrectomy cataract with respect to visual acuity, quality of life, and other outcomes. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 5), MEDLINE Ovid (1946 to 17 May 2017), Embase.com (1947 to 17 May 2017), PubMed (1946 to 17 May 2017), Latin American and Caribbean Health Sciences Literature database (LILACS) (January 1982 to 17 May 2017), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com); last searched May 2013, ClinicalTrials.gov (www.clinicaltrials.gov); searched 17 May 2017, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 17 May 2017. We did not use any date or language restrictions in the electronic searches for trials. Selection criteria We planned to include randomized controlled trials (RCTs) and quasi-RCTs that had compared surgery versus no surgery to remove the lens from eyes of adults in which cataracts had developed following vitrectomy. Data collection and analysis Two review authors independently screened the search results according to the standard methodological procedures expected by Cochrane. Main results We found no RCTs or quasi-RCTs that had compared surgery versus no surgery to remove the lens from eyes of adults in which cataracts had developed following vitrectomy. Authors' conclusions There is no evidence from RCTs or quasi-RCTs on which to base clinical recommendations for surgery for postvitrectomy cataract. There is a clear need for RCTs to address this evidence gap. Such trials should stratify participants by their age, the retinal disorder leading to vitrectomy, and the status of the underlying disease process in the contralateral eye. Outcomes assessed in such trials may include changes (both gains and losses) of visual acuity, quality of life, and adverse events such as posterior capsular rupture and retinal detachment. Both short-term (six-month) and long-term (one- or two-year) outcomes should be examined.

Using documents obtained through litigation, S. Swaroop Vedula and colleagues compared internal company documents regarding industry-sponsored trials of off-label uses of gabapentin with the published trial reports and find discrepancies in reporting of analyses., Background Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. Methods and Findings For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses). Conclusions Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards for randomized controlled trials should recommend transparent descriptions and definitions of analyses performed and which study participants are excluded. Please see later in the article for the Editors' Summary, Editors' Summary Background To be credible, published research must present an unbiased, transparent, and accurate description of the study methods and findings so that readers can assess all relevant information to make informed decisions about the impact of any conclusions. Therefore, research publications should conform to universally adopted guidelines and checklists. Studies to establish whether a treatment is effective, termed randomized controlled trials (RCTs), are checked against a comprehensive set of guidelines: The robustness of trial protocols are measured through the Standard Protocol Items for Randomized Trials (SPIRIT), and the Consolidated Standards of Reporting Trials (CONSORT) statement (which was constructed and agreed by a meeting of journal editors in 1996, and has been updated over the years) includes a 25-point checklist that covers all of the key points in reporting RCTs. Why Was This Study Done? Although the CONSORT statement has helped improve transparency in the reporting of the methods and findings from RCTs, the statement does not define how certain types of analyses should be conducted and which patients should be included in the analyses, for example, in an intention-to-treat analysis (in which all participants are included in the data analysis of the group to which they were assigned, whether or not they completed the intervention given to the group). So in this study, the researchers used internal company documents released in the course of litigation against the pharmaceutical company Pfizer regarding the drug gabapentin, to compare between the internal and published reports the reporting of the numbers of participants, the description of the types of analyses, and the definitions of each type of analysis. The reports involved studies of gabapentin used for medical reasons not approved for marketing by the US Food and Drug Administration, known as “off-label” uses. What Did the Researchers Do and Find? The researchers identified trials sponsored by Pfizer relating to four off-label uses of gabapentin and examined the internal company protocols, statistical analysis plans, research reports, and the main publications related to each trial. The researchers then compared the numbers of participants randomized and analyzed for the main (primary) outcome and the type of analysis for efficacy and safety in both the internal research report and the trial publication. The researchers identified 21 trials, 11 of which were published RCTs that had the associated documents necessary for comparison. The researchers found that in three out of ten trials there were differences in the internal research report and the main publication regarding the number of randomized participants. Furthermore, in six out of ten trials, the researchers were unable to compare the internal research report with the main publication for the number of participants analyzed for efficacy, because the research report either did not describe the primary outcome or did not describe the type of analysis. Overall, the researchers found that seven different types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including intention-to-treat analysis. However, the protocol or publication used six different descriptions for the intention-to-treat analysis, resulting in several important differences between the internal and published documents about the number of patients included in the analysis. What Do These Findings Mean? These findings from a sample of industry-sponsored trials on the off-label use of gabapentin suggest that when compared to the internal research reports, the trial publications did not always accurately reflect what was actually done in the trial. Therefore, the trial publication could not be considered to be an accurate and transparent record of the numbers of participants randomized and analyzed for efficacy. These findings support the need for further revisions of the CONSORT statement, such as including explicit statements about the criteria used to define each type of analysis and the numbers of participants excluded from each type of analysis. Further guidance is also needed to ensure consistent terminology for types of analysis. Of course, these revisions will improve reporting only if authors and journals adhere to them. These findings also highlight the need for all individual patient data to be made accessible to readers of the published article. Additional Information Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001378. For more information, see the CONSORT statement website The EQUATOR Network website is a resource center for the good reporting of health research studies and has more information about the SPIRIT initiative and the CONSORT statement

Topic To summarize the relative effects of bevacizumab (Avastin; Genentech, Inc, South San Francisco, CA) and ranibizumab (Lucentis; Genentech, Inc.), using findings from a Cochrane Eyes and Vision Group systematic review. Clinical Relevance Neovascular age-related macular degeneration (NVAMD) is the most common cause of uncorrectable vision loss among the elderly in developed countries. Bevacizumab and ranibizumab are the most frequently used anti–vascular endothelial growth factor (VEGF) agents injected intravitreally to treat NVAMD. Methods For this systematic review, we included only randomized controlled trials in which the 2 anti-VEGF agents had been compared directly. The primary outcome was 1-year gain in best-corrected visual acuity (BCVA) of ≥15 letters. We followed Cochrane methods for trial selection, data extraction, and data analyses. Relative effects of bevacizumab versus ranibizumab are presented as estimated risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). Results We identified 6 eligible randomized controlled trials with 2809 participants. The proportion of eyes that gained ≥15 letters of BCVA by 1 year was similar for the 2 agents when the same regimens were compared (RR, 0.90; 95% CI, 0.73–1.11). The mean change in BCVA from baseline also was similar (MD, −0.5 letter; 95% CI, −1.6 to +0.6). Other BCVA and quality of life outcomes were similar for the 2 agents. One-year treatment cost with ranibizumab was 5.1 and 25.5 times the cost for bevacizumab in the 2 largest trials. Ocular adverse events were uncommon ( Conclusions We found no important difference in effectiveness or safety between bevacizumab and ranibizumab for NVAMD treatment, but there was a large cost difference.

Background Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. The objective of this study was to build on previous studies to illustrate implementation of a publication strategy by the drug manufacturer for four off-label uses of gabapentin (Neurontin®, Pfizer, Inc.): migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. Methods We included in this study internal company documents, email correspondence, memoranda, study protocols and reports that were made publicly available in 2008 as part of litigation brought by consumers and health insurers against Pfizer for fraudulent sales practices in its marketing of gabapentin (see http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=saris/pdf/ucl%20opinion.pdf for the Court’s findings). We reviewed documents pertaining to 20 clinical trials, 12 of which were published. We categorized our observations related to reporting biases and linked them with topics covered in internal documents, that is, deciding what should and should not be published and how to spin the study findings (re-framing study results to explain away unfavorable findings or to emphasize favorable findings); and where and when findings should be published and by whom. Results We present extracts from internal company marketing assessments recommending that Pfizer and Parke-Davis (Pfizer acquired Parke-Davis in 2000) adopt a publication strategy to conduct trials and disseminate trial findings for unapproved uses rather than an indication strategy to obtain regulatory approval. We show internal company email correspondence and documents revealing how publication content was influenced and spin was applied; how the company selected where trial findings would be presented or published; how publication of study results was delayed; and the role of ghost authorship. Conclusions Taken together, the extracts we present from internal company documents illustrate implementation of a strategy at odds with unbiased study conduct and dissemination. Our findings suggest that Pfizer and Parke-Davis’s publication strategy had the potential to distort the scientific literature, and thus misinform healthcare decision-makers.

BACKGROUND: Age‐related macular degeneration (AMD) is the most common cause of uncorrectable severe vision loss in people aged 55 years and older in the developed world. Choroidal neovascularization (CNV) secondary to AMD accounts for most cases of AMD‐related severe vision loss. Intravitreous injection of anti‐vascular endothelial growth factor (anti‐VEGF) agents aims to block the growth of abnormal blood vessels in the eye to prevent vision loss and, in some instances, to improve vision. OBJECTIVES: • To investigate ocular and systemic effects of, and quality of life associated with, intravitreous injection of three anti‐VEGF agents (pegaptanib, ranibizumab, and bevacizumab) versus no anti‐VEGF treatment for patients with neovascular AMD • To compare the relative effects of one of these anti‐VEGF agents versus another when administered in comparable dosages and regimens SEARCH METHODS: To identify eligible studies for this review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (searched January 31, 2018); MEDLINE Ovid (1946 to January 31, 2018); Embase Ovid (1947 to January 31, 2018); the Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to January 31, 2018); the International Standard Randomized Controlled Trials Number (ISRCTN) Registry (www.isrctn.com/editAdvancedSearch ‐ searched January 31, 2018); ClinicalTrials.gov (www.clinicaltrials.gov ‐ searched November 28, 2018); and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en ‐ searched January 31, 2018). We did not impose any date or language restrictions in electronic searches for trials. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that evaluated pegaptanib, ranibizumab, or bevacizumab versus each other or versus a control treatment (e.g. sham treatment, photodynamic therapy), in which participants were followed for at least one year. DATA COLLECTION AND ANALYSIS: Two review authors independently screened records, extracted data, and assessed risks of bias. We contacted trial authors for additional data. We compared outcomes using risk ratios (RRs) or mean differences (MDs). We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 16 RCTs that had enrolled a total of 6347 participants with neovascular AMD (the number of participants per trial ranged from 23 to 1208) and identified one potentially relevant ongoing trial. Six trials compared anti‐VEGF treatment (pegaptanib, ranibizumab, or bevacizumab) versus control, and 10 trials compared bevacizumab versus ranibizumab. Pharmaceutical companies conducted or sponsored four trials but funded none of the studies that evaluated bevacizumab. Researchers conducted these trials at various centers across five continents (North and South America, Europe, Asia, and Australia). The overall certainty of the evidence was moderate to high, and most trials had an overall low risk of bias. All but one trial had been registered prospectively. When compared with those who received control treatment, more participants who received intravitreous injection of any of the three anti‐VEGF agents had gained 15 letters or more of visual acuity (risk ratio [RR] 4.19, 95% confidence interval [CI] 2.32 to 7.55; moderate‐certainty evidence), had lost fewer than 15 letters of visual acuity (RR 1.40, 95% CI 1.27 to 1.55; high‐certainty evidence), and showed mean improvement in visual acuity (mean difference 6.7 letters, 95% CI 4.4 to 9.0 in one pegaptanib trial; mean difference 17.8 letters, 95% CI 16.0 to 19.7 in three ranibizumab trials; moderate‐certainty evidence) after one year of follow‐up. Participants treated with anti‐VEGF agents showed improvement in morphologic outcomes (e.g. size of CNV, central retinal thickness) compared with participants not treated with anti‐VEGF agents (moderate‐certainty evidence). No trial directly compared pegaptanib versus another anti‐VEGF agent and followed participants for one year; however, when compared with control treatments, ranibizumab and bevacizumab each yielded larger improvements in visual acuity outcomes than pegaptanib. Visual acuity outcomes after bevacizumab and ranibizumab were similar when the same RCTs compared the same regimens with respect to gain of 15 or more letters of visual acuity (RR 0.95, 95% CI 0.81 to 1.12; high‐certainty evidence) and loss of fewer than 15 letters of visual acuity (RR 1.00, 95% CI 0.98 to 1.02; high‐certainty evidence); results showed similar mean improvement in visual acuity (mean difference [MD] ‐0.5 letters, 95% CI ‐1.5 to 0.5; high‐certainty evidence) after one year of follow‐up, despite the substantially lower cost of bevacizumab compared with ranibizumab. Reduction in central retinal thickness was less among bevacizumab‐treated participants than among ranibizumab‐treated participants after one year (MD ‐11.6 μm, 95% CI ‐21.6 to ‐1.7; high‐certainty evidence); however, this difference is within the range of measurement error, and we did not interpret it to be clinically meaningful. Ocular inflammation and increased intraocular pressure (IOP) after intravitreal injection were the most frequently reported serious ocular adverse events. Researchers reported endophthalmitis in less than 1% of anti‐VEGF‐treated participants and in no cases among control groups. The occurrence of serious systemic adverse events was comparable across anti‐VEGF‐treated groups and control groups; however, the numbers of events and trial participants may have been insufficient to show a meaningful difference between groups (evidence of low‐ to moderate‐certainty). Investigators rarely measured and reported data on visual function, quality of life, or economic outcomes. AUTHORS' CONCLUSIONS: Results of this review show the effectiveness of anti‐VEGF agents (pegaptanib, ranibizumab, and bevacizumab) in terms of maintaining visual acuity; studies show that ranibizumab and bevacizumab improved visual acuity in some eyes that received these agents and were equally effective. Available information on the adverse effects of each medication does not suggest a higher incidence of potentially vision‐threatening complications with intravitreous injection of anti‐VEGF agents compared with control interventions; however, clinical trial sample sizes were not sufficient to estimate differences in rare safety outcomes. Future Cochrane Reviews should incorporate research evaluating variable dosing regimens of anti‐VEGF agents, effects of long‐term use, use of combination therapies (e.g. anti‐VEGF treatment plus photodynamic therapy), and other methods of delivering these agents.

Neovascular age-related macular degeneration (AMD) is associated with rapid vision loss due to choroidal neovascularization (CNV), leakage, and scarring. Steroids have gained attention in their role for the treatment of neovascular AMD for their antiangiogenic and anti-inflammatory properties.This review aims to examine effects of steroids with antiangiogenic properties in the treatment of neovascular AMD.We searched for trials in CENTRAL, MEDLINE, EMBASE, and LILACS on 2 October 2006.We included randomised controlled clinical trials of intra- and peri-ocular steroids in people diagnosed with neovascular AMD.Review authors extracted the data and assessed trial quality independently. We did not pool data since the included studies evaluated difference comparisons.We report the risk of losing three or more lines vision at 12 months - "vision loss". One trial (139 people randomized) reported that a single dose of intravitreal triamcinolone (n = 75) (4 mg) had no significant effect on the risk of vision loss compared to placebo (n = 76). (Risk ratio vision loss 0.97, 95% confidence interval (CI) 0.74 to 1.26). Eyes treated with triamcinolone were more likely to develop cataracts and experience increased intraocular pressure (IOP) compared to untreated eyes. One trial (128 people randomized) reported the effects of anecortave acetate (3 mg (n = 32), 15 mg (n = 33) or 30 mg (n = 33) single dose with retreatment every six months if indicated) compared to placebo (n = 30). Risk ratio vision loss 0.80 (95% CI 0.45 to 1.45) in the 3 mg group, 0.45 (95% CI 0.21 to 0.97) in the 15 mg group and 0.91 (95% CI 0.52 to 1.58) in the 30 mg group. Side effects were similar in all treatment groups with the anecortave group having a slightly higher incidence of foreign body sensation compared to placebo. There was a high loss to follow-up. The final analysis may have been subject to selection bias as participants who were not selected for retreatment, possibly with worsening disease, were excluded. There was also a possibility of type I error due to multiple statistical comparisons. The sample size was estimated on the basis of a single 2-way comparison but three 2-way comparisons were analysed and presented. One trial reported that anecortave acetate (n = 263) (15 mg administered at beginning of study and six months) gave similar results to photodynamic therapy (n = 267) (risk ratio vision loss 1.08, 95% CI 0.91 to 1.29).Overall there is weak evidence as to the benefits and harms of steroids with antiangiogenic properties for treating neovascular AMD with only three published trials of variable quality. Intravitreal triamcinolone injection for neovascular AMD does not appear to prevent severe vision loss and is associated with increased IOP and higher risk of cataract formation. Anecortave acetate 15 mg may have a mild benefit in stabilizing vision, but further better quality evidence is needed. The role of steroids in combination with other treatment modalities is yet to be determined.

Background Stimulus deprivation amblyopia (SDA) develops due to an obstruction to the clear passage of light, preventing clear formation of an image on the retina for example, cataract, ptosis (droopy eyelid). It is particularly severe and can be resistant to treatment and the visual prognosis is often poor. Stimulus deprivation amblyopia is rare and precise estimates of prevalence difficult to come by; it probably constitutes less than 3% of all cases of amblyopia. In developed countries most patients present under the age of one; in less developed parts of the world presentation is likely to be significantly later than this.The mainstay of treatment is patching of the better-seeing eye but regimes vary, treatment is difficult to execute and results are often disappointing. Objectives The objectives of this review were to evaluate the effectiveness of occlusion treatment for SDA, determine the optimum treatment regime and factors that may affect outcome. Search strategy We searched the Cochrane Central Register of Controlled Trials - CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) on The Cochrane Library (2006, Issue 1), MEDLINE (1996 to April 2006), EMBASE (1980 to April 2006) and LILACS (Latin American and Caribbean Literature on Health Sciences) (to November 2004). There were no date or language restrictions. Selection criteria We aimed to include randomised and quasi-randomised controlled trials of subjects with unilateral SDA defined as worse than 0.2 LogMAR or equivalent. There were no restrictions with respect to age, gender, ethnicity, co-morbidities, medication use, and the number of participants. Data collection and analysis Two authors independently assessed study abstracts identified by the electronic searches. Main results No trials were identified that met the inclusion criteria. Authors' conclusions It is not possible to conclude how effective treatment for SDA is or which treatment regime produces the best results. There is a need for further study in this area.

BACKGROUND: Primary angle‐closure glaucoma (PACG) is characterized by a rise in intraocular pressure (IOP) secondary to aqueous outflow obstruction, with relative pupillary block being the most common underlying mechanism. There is increasing evidence that lens extraction may relieve pupillary block and thereby improve IOP control. As such, comparing the effectiveness of lens extraction against other commonly used treatment modalities can help inform the decision‐making process. OBJECTIVES: To assess the effectiveness of lens extraction compared with other interventions in the treatment of chronic PACG in people without previous acute angle‐closure attacks. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, one other database, and two trials registers (December 2019). We also screened the reference lists of included studies and the Science Citation Index database. We had no date or language restrictions. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing lens extraction with other treatment modalities for chronic PACG. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. MAIN RESULTS: We identified eight RCTs with 914 eyes. We obtained data for participants meeting our inclusion criteria for these studies (PACG only, no previous acute angle‐closure attacks), resulting in 513 eyes included in this review. The participants were recruited from a diverse range of countries. We were unable to conduct meta‐analyses due to different follow‐up periods and insufficient data. One study compared phacoemulsification with laser peripheral iridotomy (LPI) as standard care. Participants in the phacoemulsification group were less likely to experience progression of visual field loss (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.13 to 0.91; 216 eyes; moderate certainty evidence), and required fewer IOP‐lowering medications (mean difference [MD] ‐0.70, 95% CI ‐0.89 to ‐0.51; 263 eyes; moderate certainty evidence) compared with standard care at 12 months. Moderate certainty evidence also suggested that phacoemulsification improved gonioscopic findings at 12 months or later (MD ‐84.93, 95% CI ‐131.25 to ‐38.61; 106 eyes). There was little to no difference in health‐related quality of life measures (MD 0.04, 95% CI ‐0.16 to 0.24; 254 eyes; moderate certainty evidence), and visual acuity (VA) (MD 2.03 ETDRS letter, 95% CI ‐0.77 to 4.84; 242 eyes) at 12 months, and no observable difference in mean IOP (MD ‐0.03mmHg, 95% CI ‐2.34 to 2.32; 257 eyes; moderate certainty evidence) compared to standard care. Irreversible loss of vision was observed in one participant in the phacoemulsification group, and three participants in standard care at 36 months (moderate‐certainty evidence). One study (91 eyes) compared phacoemulsification with phaco‐viscogonioplasty (phaco‐VGP). Low‐certainty evidence suggested that fewer IOP‐lowering medications were needed at 12 months with phacoemulsification (MD ‐0.30, 95% CI ‐0.55 to ‐0.05). Low‐certainty evidence also suggested that phacoemulsification may have improved gonioscopic findings at 12 months or later compared to phaco‐VGP (angle grading MD ‐0.60, 95% CI ‐0.91 to ‐0.29; TISA500 MD ‐0.03, 95% CI ‐0.06 to ‐0.01; TISA750 MD ‐0.03, 95% CI ‐0.06 to ‐0.01; 91 eyes). Phacoemulsification may result in little to no difference in best corrected VA at 12 months (MD ‐0.01 log MAR units, 95% CI ‐0.10 to 0.08; low certainty evidence), and the evidence is very uncertain about its effect on IOP at 12 months (MD 0.50 mmHg, 95% CI ‐2.64 to 3.64; very low certainty evidence). Postoperative fibrin reaction was observed in two participants in the phacoemulsification group and four in the phaco‐VGP group. Three participants in the phaco‐VGP group experienced hyphema. No data were available for progression of visual field loss and quality of life measurements at 12 months. Two studies compared phacoemulsification with phaco‐goniosynechialysis (phaco‐GSL). Low‐certainty evidence suggested that there may be little to no difference in mean IOP at 12 months (MD ‐0.12 mmHg, 95% CI ‐4.72 to 4.48; 1 study, 32 eyes) between the interventions. Phacoemulsification did not reduce the number of IOP‐lowering medications compared to phaco‐GSL at 12 months (MD ‐0.38, 95% CI ‐1.23 to 0.47; 1 study, 32 eyes; moderate certainty evidence). Three eyes in the phaco‐GSL group developed hyphemas. No data were available at 12 months for progression of visual field loss, gonioscopic findings, visual acuity, and quality of life measures. Three studies compared phacoemulsification with combined phaco‐trabeculectomy, but the data were only available for one study (63 eyes). In this study, low‐certainty evidence suggested that there was little to no difference between groups in mean change in IOP from baseline (MD ‐0.60 mmHg, 95% CI ‐1.99 to 0.79), number of IOP‐lowering medications at 12 months (MD 0.00, 95% CI ‐0.42 to 0.42), and VA measured by the Snellen chart (MD ‐0.03, 95% CI ‐0.18 to 0.12). Participants in the phacoemulsification group had fewer complications (risk ratio [RR] 0.59, 95% CI 0.34 to 1.04), and the phaco‐trabeculectomy group required more IOP‐lowering procedures (RR 5.81, 95% CI 1.41 to 23.88), but the evidence was very uncertain. No data were available for other outcomes. AUTHORS' CONCLUSIONS: Moderate certainty evidence showed that lens extraction has an advantage over LPI in treating chronic PACG with clear crystalline lenses over three years of follow‐up; ultimately, the decision for intervention should be part of a shared decision‐making process between the clinician and the patient. For people with chronic PACG and visually significant cataracts, low certainty evidence suggested that combining phacoemulsification with either viscogonioplasty or goniosynechialysis does not confer any additional benefit over phacoemulsification alone. There was insufficient evidence to draw any meaningful conclusions regarding phacoemulsification versus trabeculectomy. Low certainty evidence suggested that combining phacoemulsification with trabeculectomy does not confer any additional benefit over phacoemulsification alone, and may cause more complications instead. These conclusions only apply to short‐ to medium‐term outcomes; studies with longer follow‐up periods can help assess whether these effects persist in the long term.

Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond

The authors developed and tested a framework for identifying evidence gaps and prioritizing comparative effectiveness research by using a combination of clinical practice guidelines and systematic reviews. In phase 1 of the project, reported elsewhere, 45 clinical questions on the management of primary open-angle glaucoma were derived from practice guidelines and prioritized by using a 2-round Delphi survey of clinicians. On the basis of the clinicians' responses, 9 questions were classified as high-priority. In phase 2, reported here, systematic reviews that addressed the 45 clinical questions were identified. The reviews were classified as at low, high, or unclear risk of bias, and evidence gaps (in which no systematic review was at low risk of bias) were identified. The following comparative effectiveness research agenda is proposed: Two of the 9 high-priority questions require new primary research (such as a randomized, controlled trial) and 4 require a new systematic review. The utility and limitations of the framework and future adaptations are discussed.