Robotic-Arm Assisted Technology's Impact on Knee Arthroplasty and Associated Healthcare Costs.

Background: The number of total knee arthroplasties (TKA) carried out globally is expected to substantially rise in the coming decades. Consequently, focus has been increasing on improving surgical techniques and minimizing expenses. Robotic arm-assisted knee arthroplasty has garnered interest to reduce surgical errors and improve precision. Objectives: Our primary aim was to compare the episode-of-care cost up to 90 days for unicompartmental knee arthroplasty (UKA) and TKA performed before and after the introduction of robotic arm-assisted technology. The secondary aim was to compare the volume of UKA vs TKA. Methods: This was a retrospective study design at a single healthcare system. For the cost analysis, we excluded patients with bilateral knee arthroplasty, body mass index >40, postoperative infection, or noninstitutional health plan insurance. Costs were obtained through an integrated billing system and affiliated institutional insurance company. Results: Knee arthroplasty volume increased 28% after the introduction of robotic-assisted technology. The TKA volume increased by 17%, while the UKA volume increased 190%. Post introduction, 97% of UKA cases used robotic arm-assisted technology. The cost analysis included 178 patients (manual UKA, n = 6; robotic UKA, n = 19; manual TKA, n = 58, robotic TKA, n = 85). Robotic arm-assisted TKA and UKA were less costly in terms of patient room and operating room costs but had higher imaging, recovery room, anesthesia, and supply costs. Overall, the perioperative costs were higher for robotic UKA and TKA. Postoperative costs were lower for robotic arm-assisted surgeries, and patients used less home health and home rehabilitation. Discussion: Surgeons performed higher volumes of UKA, and UKA comprised a greater percentage of total surgical volume after the introduction of this technology. The selective cost analysis indicated robotic arm-assisted technology is less expensive in several cost categories but overall more expensive by up to $550 due to higher cost categories including supplies and recovery room. Conclusions: Our findings show a change in surgeons' practice to include increased incidence and volume of UKA procedures and highlights several cost-saving categories through the use of robotic arm-assisted technology. Overall, robotic arm-assisted knee arthroplasty cost more than manual techniques at our institution. This analysis will help optimize costs in the future.

Evaluating Precision of a Trachomatous Trichiasis (TT) Super Survey with Modulating Sample Sizes in Tanzania.

As trachoma programs move towards eliminating trachoma as a public health problem, the number of surveys necessary to evaluate the status of trachomatous trichiasis (TT) increases. Currently, the World Health Organization endorses a district-level population-based prevalence survey for trachoma that involves a two-stage cluster design. We explored the validity of implementing this survey design in larger geographic areas to gain cost efficiencies. We evaluated the change in precision due to combining geographically contiguous and homogenous districts into single evaluation units (EUs) and modulating the sample size by running simulations on existing datasets. Preliminary findings from two opportunities in Tanzania show variability in the appropriateness in conducting this survey across larger geographies. These preliminary findings stress the importance of determining what is meant by homogeneity in terms of TT before combining multiple districts into a single EU.

The Timing of Obesity Matters: Associations Between Current Versus Chronic Obesity since Adolescence and Romantic Relationship Satisfaction Among Young Adult Women.

BACKGROUND: Although the social consequences of obesity for women are well-documented, its stigmatizing effect on romantic relationships across the life course has seldom been explored. We examined whether having current or chronic obesity since adolescence is associated with romantic relationship satisfaction among women in early adulthood. METHODS: This is a secondary analysis of data from the National Longitudinal Study of Adolescent Health. Female participants completing waves I and IV who self-reported their height and weight and were in a marital or cohabitating relationship at wave IV were included. Relationship satisfaction was assessed using a seven-item measure. Body mass index BMI at wave IV was categorized as normal weight, overweight, obesity, or chronic obesity (at waves I and IV). The odds of reporting low relationship satisfaction were estimated across body mass index categories using multivariate regression that controlled for key covariates (age, race, ethnicity, education, income, lifetime partners, relationship duration, and depression) and accounted for the complex sampling design. RESULTS: Among the 3,582 respondents, 74.8% were White, 65.5% had less than a college degree, and 61.8% were in their relationship for more than 3 years. At wave IV, 38.2% had a normal body mass index, 27.7% had overweight, 26.7% had obesity, and 7.5% had chronic obesity. Only having chronic obesity was associated with relationship satisfaction in early adulthood. Women with chronic obesity had 1.44 (95% confidence interval, 1.03-2.02) times the odds of reporting low relationship satisfaction compared with those categorized as normal weight. CONCLUSIONS: Chronic obesity since adolescence is associated with poor romantic relationship satisfaction in early adulthood.

Feasibility study of a health coaching intervention to improve contraceptive continuation in adolescent and young adult women in Philadelphia, Pennsylvania.

INTRODUCTION: Few interventions to improve contraceptive continuation are tailored to meet the developmental needs of young women under age 25 years. The Health Coaching for Contraceptive Continuation (HC3) intervention was designed to address this gap. In this special report, we describe the rationale for using health coaching, conceptual framework, intervention processes, and findings from a single-arm feasibility study of the intervention protocol. METHODOLOGY: Health coaching is a person-centered behavioral change approach organized around five main strategies: providing education relevant to health goals, building health self-management skills, offering patient-centered counseling, identifying barriers to adherence, and fostering personal accountability for achieving health goals. We used these strategies to affect theory-driven mediators delineated in the Integrative Model of Behavioral Prediction (intentions, knowledge, attitudes, perceived social norms, and self-efficacy) and clinical mediators posited to change through program participation (shared contraceptive decision-making, method satisfaction, quality of life, distress tolerance, experiential avoidance, patient-coach alliance, and expectations of treatment effect). Experienced sexual health educators completed a manualized, 4-week health training program adapted from the National Society of Health Coaches. Between March and December 2017, we recruited a convenience sample of sexually-active women ages 14-21 years who initiated a new contraceptive in the prior 14 days from three urban pediatric clinics in Philadelphia, Pennsylvania. At baseline, participants completed a socio-demographic questionnaire, contraceptive needs assessment interview, and prioritized reproductive topics to learn more about. We synthesized these data into a coaching plan that guided the monthly coaching sessions which occurred for 6 months following contraceptive initiation. We assessed method adherence and continuation with monthly follow-up questionnaires and corroborated the findings through electronic medical record and pharmacy refill data review. Exit interviews assessed program acceptability. Feasibility outcomes measured throughout the protocol administration included recruitment and retention success. We used descriptive statistics to assess baseline and follow up questionnaire measures and audio-recorded and transcribed exit interviews verbatim. Two independent coders used deductive and inductive content analysis coding approaches to identify themes related to program acceptability. RESULTS: Of 92 women approached for the longitudinal intervention, 33 enrolled. Participants' mean age was 17.4 ± 2.1 years. Most were Black (n = 24), in high school (n = 23), and single/never-married (n = 31). Twenty-one completed ≥4 coaching sessions. Among the 23 for whom 6-month contraceptive continuation could be determined, 20 continued their baseline method, 2 switched methods without a gap in use, and 1 discontinued contraceptive use. Five were lost to follow up after enrollment; continuation status was indeterminant for the remaining five. Among the 22 who completed exit interviews, all expressed high program acceptability citing that it provided knowledge-based benefits, nonknowledge-based benefits, and an opportunity to develop a positive, supportive relationship with a reproductive health expert. Participants provided feedback on logistical aspects of the program they enjoyed and made suggestions for improvements prior to embarking on a larger efficacy trial. DISCUSSION: Health coaching is a new approach for promoting contraceptive continuation in young women. The conceptual framework, program structure, and feasibility findings demonstrate strong support for the program among participants. Subsequent research must explore program effects on contraceptive continuation and prevention of unintended pregnancy.

Relationships between Pacific salmon and aquatic and terrestrial ecosystems: implications for ecosystem-based management.

Pacific salmon influence temperate terrestrial and freshwater ecosystems through the dispersal of marine-derived nutrients and ecosystem engineering of stream beds when spawning. They also support large fisheries, particularly along the west coast of North America. We provide a comprehensive synthesis of relationships between the densities of Pacific salmon and terrestrial and aquatic ecosystems, summarize the direction, shape, and magnitude of these relationships, and identify possible ecosystem-based management indicators and benchmarks. We found 31 studies that provided 172 relationships between salmon density (or salmon abundance) and species abundance, species diversity, food provisioning, individual growth, concentration of marine-derived isotopes, nutrient enhancement, phenology, and several other ecological responses. The most common published relationship was between salmon density and marine-derived isotopes (40%), whereas very few relationships quantified ecosystem-level responses (5%). Only 13% of all relationships tended to reach an asymptote (i.e., a saturating response) as salmon densities increased. The number of salmon killed by bears and the change in biomass of different stream invertebrate taxa between spawning and nonspawning seasons were relationships that usually reached saturation. Approximately 46% of all relationships were best described with linear or curved nonasymptotic models, indicating a lack of saturation. In contrast, 41% of data sets showed no relationship with salmon density or abundance, including many of the relationships with stream invertebrate and biofilm biomass density, marine-derived isotope concentrations, or vegetation density. Bears required the highest densities of salmon to reach their maximum observed food consumption (i.e., 9.2 kg/m2 to reach the 90% threshold of the relationship's asymptote), followed by freshwater fish abundance (90% threshold = 7.3 kg/m2 of salmon). Although the effects of salmon density on ecosystems are highly varied, it appears that several of these relationships, such as bear food consumption, could be used to develop indicators and benchmarks for ecosystem-based fisheries management.

Follow-Up Care and 6-Month Continuation Rates for Long-Acting Reversible Contraceptives in Adolescents and Young Adults: A Retrospective Chart Review.

STUDY OBJECTIVE: Describe follow-up care patterns and continuation rates during the first 6 months after initiating a long-acting reversible contraceptive (LARC) device among adolescent and young adult women. DESIGN: Retrospective chart review among patients who had an intrauterine device (IUD) or subdermal implant placed between January 2015 and December 2016. SETTING: Urban adolescent specialty care clinic. PARTICIPANTS: Women ages 13-23 years. MAIN OUTCOME MEASURES: Follow-up encounters were defined as scheduled and unscheduled phone calls, outpatient clinic visits, or emergency department visits during the 6 months after device placement. Continuation was defined as not having the device removed or expelled during the 6 months after initiation. Frequencies were calculated, and logistic regression was used to determine predictors of follow-up encounters and continuation. RESULTS: Among the 177 patients, 180 LARC devices were placed. Most were 13-17 years of age (56%), non-Hispanic black (64%), publicly insured (57%), and had an IUD placed (57%). Most (86%) had 1 or more clinical encounters during the 6 months: 70% attended a scheduled encounter and 53% had an unscheduled encounter. Approximately half (45%) attended the scheduled 2-week office visit; only 6% attended the 6-month office visit. The 6-month LARC continuation rate was 92% (n = 166), with most discontinuations among IUD users (n = 12; 7%). CONCLUSION: LARC continuation rates were high in our study population. Most adolescent and young adult women have at least 1 follow-up encounter in the 6 months after LARC placement. Clinical practices should be prepared to address issues that arise during follow-up encounters, whether in person or by phone.

Pre-operative trichiatic eyelash pattern predicts post-operative trachomatous trichiasis.

IMPORTANCE: Trichiasis surgery programs globally have faced high rates of poor surgical outcomes. Identifying correctable risk factors for improving long-term outcomes is essential for countries targeting elimination of trachoma as a public health problem. OBJECTIVE: To determine whether the location of trichiatic eyelashes prior to surgery influences development of post-operative trichiasis (PTT) within two years after surgery. DESIGN: Secondary data analysis of four randomized clinical trials evaluating methods to improve trichiasis surgery outcomes. These include the Surgery for Trichiasis, Antibiotics for Recurrence (STAR) trial, Partnership for Rapid Elimination of Trachoma (PRET-Surgery), absorbable versus silk sutures trial, and epilation versus surgery for minor trichiasis trial. SETTING: Primary trials were conducted in rural areas of Ethiopia and Tanzania. INTERVENTIONS OR EXPOSURES: Trichiasis surgery performed with either the bilamellar tarsal rotation procedure or posterior lamellar rotation procedure. MAIN OUTCOMES: Prevalence of PTT within two years after surgery, location of trichiatic eyelashes pre-operatively and post-operatively. RESULTS: 6,747 eyelids that underwent first-time trichiasis surgery were included. PTT rates varied by study, ranging from 10-40%. PTT was less severe (based on number of trichiatic eyelashes) than initial trichiasis for 72% of those developing PTT, and only 2% of eyelids were worse at follow up than pre-operatively. Eyelids with central only-trichiasis pre-operatively had lower rates of PTT than eyelids with peripheral only trichiasis in each of the three trials that included severe TT cases. 10% of eyelids with peripheral trichiasis pre-operatively that develop PTT have central TT post-operatively. CONCLUSIONS AND RELEVANCE: Pre-operative central trichiasis is less likely than peripheral trichiasis to be associated with subsequent PTT. Regardless of type of surgery, surgeon skill levels, or pre-operative trichiasis severity, the presence of peripheral trichiasis pre-operatively is associated with higher rates of PTT. Making an incision that extends the length of the eyelid and adequately rotating the nasal and temporal aspects of the eyelid when suturing may help to minimize the chance of developing peripheral PTT. TRIAL REGISTRATION: ClinicalTrials.gov PRET: NCT00886015; Suture: NCT005228560; Epilation: NCT00522912.

Why do patients refuse trichiasis surgery? Lessons and an education initiative from Mtwara Region, Tanzania.

BACKGROUND: Trachomatous trichiasis is one of the leading causes of preventable blindness worldwide. A relatively simple surgery can spare vision. Although this surgery is usually performed free of charge in endemic regions, multiple studies indicate that surgical refusal is common. Prior studies have attempted to examine these reasons, although they generally rely on patient recall months to years after the surgery was offered. This study set out to determine major decision-making factors at the time of refusal. In addition, this study looked for ways to help increase surgical uptake by targeting modifiable factors. METHODOLOGY/PRINCIPAL FINDINGS: We used a combination of focus groups, interviews with community health workers, and individual interviews with trichiasis patients who refused surgery to understand their decision-making. We found that several factors influenced surgical refusals, including misconception regarding recovery time, inability to find a post-surgical caregiver, and the time of year of the surgical campaign. Fear of the surgery itself played a minimal role in refusals. CONCLUSIONS/SIGNIFICANCE: Trichiasis patients refuse surgery for many reasons, but a large percentage is due to lack of information and education, and is, therefore, modifiable within the structure of a surgical outreach project. To address this, we developed a "frequently asked questions" (FAQ) document aimed at community health workers, which may have helped to decrease some of the misconceptions that had led to prior refusals.

Satisfaction With the Intrauterine Device Insertion Procedure Among Adolescent and Young Adult Women.

OBJECTIVE: To evaluate satisfaction with intrauterine device (IUD) insertion procedures among adolescent and young adult women. METHODS: This secondary analysis of data from a multisite, single-blind, sham-controlled randomized trial of women having a levonorgestrel 13.5-mg IUD inserted enrolled participants from March 2015 through July 2016 at three family planning clinics in Philadelphia, Pennsylvania. Eligible participants were 14-22 years of age, nulliparous, not pregnant, and English-speaking. Randomization was computer-generated allocation in block sizes of four to a 1% lidocaine paracervical or sham block. Only patients were blinded. Satisfaction was measured with three items that assessed overall satisfaction with the procedure, whether participants would recommend the IUD to a friend, and the perception that the IUD was worth the discomfort. Predictors included demographics, sexual and reproductive history, pain after IUD insertion, and treatment group. RESULTS: Ninety-five women enrolled; 93 (97.9%) were included in the analysis. Forty-five (47.4%) were white, 34 (36.0%) were black, 62 (66.0%) were privately insured, and 75 (79.0%) had used contraception previously. Most (n=73 [76.8%]) reported high overall satisfaction with the procedure, 64 (67.4%) would recommend an IUD to a friend, and 79 (83.2%) perceived the IUD was worth the discomfort. The odds of reporting high overall satisfaction were lower among adolescents compared with young adults (odds ratio [OR] 0.07, 95% CI 0.008-0.68); those who never had a gynecologic examination compared with those who had (OR 0.26, 95% CI 0.07-0.99); and decreased as pain score increased (OR 0.96, 95% CI 0.94-0.99). Higher pain scores were negatively correlated with the odds of recommending an IUD to a friend and perceiving the IUD was worth the discomfort. CONCLUSION: Adolescent and young adult women report high levels of satisfaction after the IUD insertion procedure. Young age, lack of experience with gynecologic examinations, and high pain were inversely related to satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02352714.

Dynamic Production System Identification for Smart Manufacturing Systems.

This paper presents a methodology, called production system identification, to produce a model of a manufacturing system from logs of the system's operation. The model produced is intended to aid in making production scheduling decisions. Production system identification is similar to machine-learning methods of process mining in that they both use logs of operations. However, process mining falls short of addressing important requirements; process mining does not (1) account for infrequent exceptional events that may provide insight into system capabilities and reliability, (2) offer means to validate the model relative to an understanding of causes, and (3) updated the model as the situation on the production floor changes. The paper describes a genetic programming (GP) methodology that uses Petri nets, probabilistic neural nets, and a causal model of production system dynamics to address these shortcomings. A coloured Petri net formalism appropriate to GP is developed and used to interpret the log. Interpreted logs provide a relation between Petri net states and exceptional system states that can be learned by means of novel formulation of probabilistic neural nets (PNNs). A generalized stochastic Petri net and the PNNs are used to validate the GP-generated solutions. The methodology is evaluated with an example based on an automotive assembly system.

Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women.

OBJECTIVE: To estimate the effect of a 1% lidocaine paracervical nerve block on pain during intrauterine device (IUD) insertion compared with a sham block in adolescents and young women. METHODS: We conducted a multisite, single-blind, sham-controlled randomized trial in adolescents and young women having a 13.5-mg levonorgestrel IUD inserted. Enrollment occurred at three family planning clinics in Philadelphia, Pennsylvania. Eligible adolescents and young women were aged 14-22 years, nulliparous, not currently or recently pregnant, and English-speaking. Participants were randomized using computer-generated allocation in block sizes of four to receive a 10-mL 1% lidocaine paracervical block or a sham block (1 cm depression of the vaginal epithelium at paracervical block sites with a wooden cotton-tipped applicator). Only patients were blinded. The primary outcome was pain after IUD insertion measured with a 100-mm visual analog scale. Using a two-sided t test and assuming a 20-mm difference in visual analog scale scores, a SD of 28 mm, an α of 0.05, and 90% power, a sample of 43 participants per group was estimated. RESULTS: Between March 2015 and July 2016, 95 participants enrolled (47 lidocaine block group; 48 sham block group). All were included in the analysis. Forty-four percent were white, 36% black, 65% privately insured, and 79% previously used contraception. The median visual analog scale score after IUD insertion was 30.0 (95% CI 20.0-58.0) in the lidocaine block group and 71.5 (95% CI 66.0-82.0) in the sham block (P<.001). CONCLUSION: A 10-mL 1% lidocaine paracervical nerve block reduces pain during IUD insertion in adolescents and young women compared with a sham block with pressure on the vaginal epithelium. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02352714.

Corneal Sensitivity and Presence of Pathogenic Organisms Among Participants Who Have Undergone Trichiasis Surgery Differ by Surgical Outcome.

PURPOSE: To explore the potential association between reduced corneal sensation and/or conjunctival bacterial colonization and postoperative trichiasis and eyelid contour abnormalities after corrective eyelid surgery among participants with a history of trachomatous trichiasis. METHODS: As an ancillary study to the Partnership for Rapid Elimination of Trachoma (PRET) Surgery Trial in southern Tanzania, we collected data on 580 PRET participants who had undergone trichiasis surgery 1 year earlier and 200 age-group-matched individuals without trichiasis. Assessments included eyelid status evaluation (presence and severity of postoperative trichiasis and/or eyelid contour abnormality), corneal sensitivity by Cochet-Bonnet aesthesiometer, a questionnaire on symptoms of ocular irritation, and conjunctival microbiology. We divided PRET participants based on their eyelid status and compared results across PRET groups and versus normals. RESULTS: PRET participants had reduced corneal sensitivity compared with age-matched normals (mean sensitivity ranged from 2.8 to 3.8 cm in PRET participants vs. 5.9 cm in normals), and increasing severity of postoperative trichiasis was associated in a stepwise fashion with reduced corneal sensitivity (mean = 3.5 cm for mild and 2.6 cm for severe postoperative trichiasis). Conjunctival colonization with pathogenic bacteria was also associated with more severe postoperative trichiasis (Cochran-Armitage trend test P = 0.001) and with reduced corneal sensitivity (trend test P < 0.0001). Symptoms of ocular irritation were not associated with previous trichiasis surgery, postoperative trichiasis, or eyelid contour abnormality. CONCLUSIONS: These findings indicate that reduced corneal sensitivity accompanies trachomatous trichiasis and suggest that reduced corneal sensitivity may play an important role in the harboring of pathogenic bacteria on the ocular surface.

Laterality effects in cross-modal affective priming.

The present study pursued M. P. Bryden's legacy by investigating how contextual factors can affect laterality effects. Specifically, a cross-modal affective priming paradigm was used in two experiments to determine whether priming with facial expressions would affect responses to emotional sounds. Experiment 1 established that cross-modal priming could be obtained when presenting the emotional sounds binaurally by showing more accurate responses when prime and target were congruent than when they were incongruent, although this extended to response time only for the happy emotion. This priming effect justified Experiment 2, in which the priming paradigm was integrated into a dichotic listening task. The central finding of Experiment 2 was a congruency by ear interaction on number of correct reports, showing that presentation of a facial emotion congruent with a left target produced a large left ear advantage that was reduced when a right ear congruent prime or an incongruent pairing was used. Implications of these findings for emotion processing in the context of Bryden's legacy are discussed.

Patients' Perceptions of Trichiasis Surgery: Results from the Partnership for Rapid Elimination of Trachoma (PRET) Surgery Clinical Trial.

PURPOSE: While quality of life surveys have been conducted in trachomatous trichiasis (TT) surgery populations, little is known about patients' perceptions of the surgical experience and outcomes. METHODS: We interviewed a subset of Partnership for the Rapid Elimination of Trachoma (PRET) surgery trial participants 24 months after surgery. Questions focused on current ocular symptoms, perceived daily functioning, physical appearance, and overall perception of surgery. We stratified participants based on surgical outcomes: normal upper eyelid, postoperative TT, or eyelid contour abnormality (ECA) in one or both eyelids. We compared responses between sexes and surgical outcome groups using contingency tables and Fisher's exact tests. RESULTS: A total of 483 individuals participated and 86% were very satisfied with surgery results; 96% reported ocular symptom improvement. Participants with moderate to severe ECA or postoperative TT were more likely to report current ocular problems than those with normal eyelids (46% and 58% vs 34%, respectively; p = 0.01 for each comparison). The most common symptom among participants with moderate to severe postoperative TT was feeling lashes touching (blurred vision was the most common among participants with moderate to severe ECA). Overall, 83% stated surgery improved daily life; participants with ECA were less likely to report improvement than others (p = 0.002). Participants who had moderate or severe postoperative TT were least likely to state that they would undergo repeat surgery (80%), followed by participants with ECA (86%). CONCLUSIONS: Postoperative TT and ECA both reduced satisfaction with surgery, but appeared to influence different aspects of life. Improving surgical outcomes both by reducing recurrence rates and limiting ECAs are essential.

Response procedure, memory, and dichotic emotion recognition.

Three experiments investigated the role of memory and rehearsal in a dichotic emotion recognition task by manipulating the response procedure as well as the interval between encoding and retrieval while taking into account order of report. For all experiments, right-handed undergraduates were presented with dichotic pairs of the words bower, dower, power, and tower pronounced in a sad, angry, happy, or neutral tone of voice. Participants were asked to report the two emotions presented on each trial by clicking on the corresponding drawings or words on a computer screen, either following no delay or a five second delay. Experiment 1 applied the delay conditions as a between-subjects factor whereas it was a within-subject factor in Experiment 2. In Experiments 1 and 2, more correct responses occurred for the left than the right ear, reflecting a left ear advantage (LEA) that was slightly larger with a nonverbal than a verbal response. The LEA was also found to be larger with no delay than with the 5s delay. In addition, participants typically responded first to the left ear stimulus. In fact, the first response produced a LEA whereas the second response produced a right ear advantage. Experiment 3 involved a concurrent task during the delay to prevent rehearsal. In Experiment 3, the pattern of results supported the claim that rehearsal could account for the findings of the first two experiments. The findings are interpreted in the context of the role of rehearsal and memory in models of dichotic listening.

Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial.

OBJECTIVE: To determine whether a new surgical clamp reduces unfavorable postoperative outcomes. METHODS: Patients with trachomatous trichiasis (TT) were randomized to surgery with standard bilamellar tarsal rotation (BLTR) instrumentation or the TT clamp and were followed up for 2 years. MAIN OUTCOME MEASURES: Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually. RESULTS: A total of 1917 participants who had surgery (3345 eyes) were enrolled. Rates of at least 1 unfavorable outcome were similar for the participants who underwent surgery with the TT clamp and those who underwent surgery with standard BLTR (60.9% vs 63.0%, respectively; adjusted odds ratio [AOR] = 0.88; 95% CI, 0.66-1.18). Granuloma was less common in the TT clamp arm than in the standard BLTR arm (16.8% vs 22.4%, respectively; AOR = 0.67; 95% CI, 0.46-0.97). There was a trend toward increased postoperative TT in the TT clamp arm compared with the standard BLTR arm (43.2% vs 36.6%, respectively; AOR = 1.36; 95% CI, 0.96-1.93). The TT clamp decreased the risk of mild eyelid contour abnormalities compared with standard BLTR (9.1% vs 13.3%, respectively; AOR = 0.64; 95% CI, 0.42-0.97) and showed a trend for a decrease in moderate abnormalities (5.3% vs 7.8%, respectively; AOR = 0.63; 95% CI, 0.39-1.01). CONCLUSIONS: Overall, rates of unfavorable outcomes were similar between groups. Although our results are similar to other programmatic settings, such high rates of unfavorable outcomes are unacceptable; future research is needed to identify ways to improve TT surgery outcomes. APPLICATION TO CLINICAL PRACTICE: A new clamp for TT surgery appears to offer protection against granuloma formation and some eyelid contour abnormalities, but it does not reduce postoperative TT. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00886015.

Relationship between immediate post-operative appearance and 6-week operative outcome in trichiasis surgery.

BACKGROUND: Surgical technique, including suture placement and tension, is believed to contribute to the outcome of bilamellar tarsal rotation surgery for trachomatous trichiasis. However, the immediate post-operative appearance that minimizes the chance of recurrence and other adverse outcomes has not been investigated. METHODOLOGY/PRINCIPAL FINDINGS: To explore whether the degree of correction immediately after surgery is predictive of surgical outcome at the 6-week post-operative visit, photographs taken immediately after surgery were used to predict surgical outcomes, including the severity of eyelid contour abnormality and trichiasis recurrence. Both eyelid contour abnormalities and recurrence were accurately predicted from the immediate post-operative photographs by an experienced oculoplastic surgeon 85% and 70% of the time, respectively. Participants with a "slight over-correction" that resulted in no eyelid contour abnormality and no recurrence were used to identify immediate post-operative contours that lead to a successful surgical outcome. CONCLUSIONS/SIGNIFICANCE: The immediate post-operative eyelid contour is an important indicator of post-operative success of BLTR surgery. Based upon our findings, we developed a Surgery Photocard. This card illustrates some examples of immediate post-surgical appearances, which led to a successful outcome, as well as sub-optimal appearances, which led to poor surgical outcomes. The card also provides suggestions for improving the appearance by adjusting the suture placement or tension based upon standard oculoplastic principles.

Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery.

BACKGROUND: Clear definitions of outcomes following trichiasis surgery are critical for planning program evaluations and for identifying ways to improve trichiasis surgery. Eyelid contour abnormality is an important adverse outcome of surgery; however, no standard method has been described to categorize eyelid contour abnormalities. METHODOLOGY/PRINCIPAL FINDINGS: A classification system for eyelid contour abnormalities following surgery for trachomatous trichiasis was developed. To determine whether the grading was reproducible using the classification system, six-week postoperative photographs were reviewed by two senior graders to characterize severity of contour abnormalities. Sample photographs defining each contour abnormality category were compiled and used to train four new graders. All six graders independently graded a Standardization Set of 75 eyelids, which included a roughly equal distribution across the severity scale, and weighted kappa scores were calculated. Two hundred forty six-week postoperative photographs from an ongoing clinical trial were randomly selected for evaluating agreement across graders. Two months after initial grading, one grader regraded a subset of the 240 photographs to measure longer-term intra-observer agreement. The weighted kappa for agreement between the two senior graders was 0.80 (95% CI: 0.71-0.89). Among the Standardization Set, agreement between the senior graders and the 4 new graders showed weighted kappa scores ranging from 0.60-0.80. Among 240 eyes comprising the clinical trial dataset, agreement ranged from weighted kappa 0.70-0.71. Longer-term intra-observer agreement was weighted kappa 0.86 (95% CI: 0.80-0.92). CONCLUSIONS/SIGNIFICANCE: The standard eyelid contour grading system we developed reproducibly delineates differing levels of contour abnormality. This grading system could be useful both for helping to evaluate trichiasis surgery outcomes in clinical trials and for evaluating trichiasis surgery programs.