Dataset Information

Impact of Trichiasis surgery on physical functioning in Ethiopian patients: STAR trial.

ABSTRACT:

Purpose

To evaluate the physical functioning of Ethiopian trichiasis surgery patients before and 6 months after surgery.

Design

Nested cohort study.

Methods

This study was nested within the Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) clinical trial conducted in Ethiopia. Demographic information, ocular examinations, and physical functioning assessments were collected before and 6 months after surgery. A single score for patients' physical functioning was constructed using Rasch analysis. A multivariate linear regression model was used to determine if change in physical functioning was associated with change in visual acuity.

Results

Of the 438 participants, 411 (93.8%) had both baseline and follow-up questionnaires. Physical functioning scores at baseline ranged from -6.32 (great difficulty) to +6.01 (no difficulty). The percentage of participants reporting no difficulty in physical functioning increased by 32.6%; the proportion of participants in the mild/no visual impairment category increased by 8.6%. A multivariate linear regression model showed that for every line of vision gained, physical functioning improves significantly (0.09 units; 95% CI: 0.02-0.16).

Conclusions

Surgery to correct trichiasis appears to improve patients' physical functioning as measured at 6 months. More effort in promoting trichiasis surgery is essential, not only to prevent corneal blindness, but also to enable improved functioning in daily life.

SUBMITTER: Wolle MA

PROVIDER: S-EPMC3079795 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Publications

Impact of Trichiasis surgery on physical functioning in Ethiopian patients: STAR trial.

Wolle Meraf A MA Cassard Sandra D SD Gower Emily W EW Munoz Beatriz E BE Wang Jiangxia J Alemayehu Wondu W West Sheila K SK

American journal of ophthalmology 20110217 5

<h4>Purpose</h4>To evaluate the physical functioning of Ethiopian trichiasis surgery patients before and 6 months after surgery.<h4>Design</h4>Nested cohort study.<h4>Methods</h4>This study was nested within the Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) clinical trial conducted in Ethiopia. Demographic information, ocular examinations, and physical functioning assessments were collected before and 6 months after surgery. A single score for patients' physical functioning wa ...[more]

PMID: 21333268

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Project description:BackgroundTrachomatous trichiasis significantly reduces vision and health related quality of life (QoL). Although trichiasis surgery is widely performed to treat trichiasis, there is little data on the effect of surgery on QoL. We measured the impact of trichiasis surgery on vision and health related QoL in a longitudinal study from Amhara Region, Ethiopia.Methodology/principal findingsWe recruited 1000 adult participants with trichiasis (cases) and 200 comparison participants, matched to every fifth trichiasis case on age (+/- two years), sex and location. Vision-related quality of life (VRQoL) and health-related quality of life (HRQoL) were measured using the WHO/PBD-VF20 and WHOQOL-BREF questionnaires respectively, at enrolment and 12 months after enrolment. All trichiasis cases received free standard trichiasis surgery immediately after enrolment. The mean difference in QoL scores between enrolment and follow-up for cases and comparison participants, and the difference-in-differences by baseline trichiasis status was analysed using random effects linear regression, the later adjusted for age, sex and socioeconomic status. At 12-months follow-up, data was collected from 980 (98%) and 198 (98%) trichiasis cases and comparison participants respectively. At this follow-up visit, VRQoL and HRQoL scores of trichiasis cases improved substantially in all subscales and domains by 19.1-42.0 points (p<0.0001) and 4.7-17.2 points (p<0.0001), respectively. In contrast, among the comparison participants, there was no evidence of improvement in VRQoL and HRQoL domain scores during follow-up. The improvement in VRQoL and HRQoL in cases was independent of the presence of visual acuity improvement at 12 months.Conclusions/significanceTrichiasis surgery substantially improves both VRQoL and HRQoL regardless of visual acuity change. Unprecedented effort is needed to scale-up trichiasis surgical programmes not only to prevent the risk of sight loss but also to improve overall wellbeing and health perception of affected individuals.

Project description:PurposeUnfavorable outcomes after trachomatous trichiasis (TT) surgery are undermining the global trachoma elimination effort. This analysis investigates predictors of postoperative TT (PTT), eyelid contour abnormalities (ECAs), and granuloma in the 2 most common TT surgery procedures: posterior lamellar tarsal rotation (PLTR) and bilamellar tarsal rotation (BLTR).DesignSecondary data analysis from a randomized, controlled, single-masked clinical trial.ParticipantsA total of 1000 patients with TT, with lashes touching the eye or evidence of epilation, in association with tarsal conjunctival scarring.MethodsParticipants were randomly allocated and received BLTR (n = 501) or PLTR (n = 499) surgery. Disease severity at baseline, surgical incisions, sutures, and corrections were graded during and immediately after surgery. Participants were examined at 6 and 12 months by assessors masked to allocation.Main outcome measuresPredictors of PTT, ECA, and granuloma.ResultsData were available for 992 (99.2%) trial participants (496 in each arm). There was strong evidence that performing more peripheral dissection with scissors in PLTR (odd ratio [OR], 0.70; 95% confidence interval [CI], 0.54-0.91; P = 0.008) and BLTR (OR, 0.83; 95% CI, 0.72-0.96; P = 0.01) independently protected against PTT. Baseline major trichiasis and mixed location lashes and immediate postoperative central undercorrection independently predicted PTT in both surgical procedures. Peripheral lashes in PLTR (OR, 5.91; 95% CI, 1.48-23.5; P = 0.01) and external central incision height ≥4 mm in BLTR (OR, 2.89; 95% CI, 1.55-5.41; P = 0.001) were independently associated with PTT. Suture interval asymmetry of >2 mm (OR, 3.18; 95% CI, 1.31-7.70; P = 0.01) in PLTR and baseline conjunctival scarring in BLTR (OR, 1.72; 95% CI, 1.06-2.81; P = 0.03) were independently associated with ECA. Older age was independently associated with ECA in both PLTR (P value for trend < 0.0001) and BLTR (P value for trend = 0.03). There was substantial intersurgeon variability in ECA rates for both PLTR (range, 19.0%-36.2%) and BLTR (range, 6.1%-28.7%) procedures. In PLTR surgery, irregular posterior lamellar incision at the center of the eyelid (OR, 6.72; 95% CI, 1.55-29.04; P = 0.01) and ECA (OR, 3.08; 95% CI, 1.37-6.94; P = 0.007) resulted in granuloma formation.ConclusionsPoor postoperative outcomes in TT surgery were associated with inadequate peripheral dissection, irregular incision, asymmetric suture position and tension, inadequate correction, and lash location. Addressing these will improve TT surgical outcomes.

Project description:ImportanceCervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results.ObjectiveTo determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year.Design, setting, and participantsRandomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020.InterventionsPatients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion.Main outcomes and measuresThe primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score.ResultsAmong 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%).Conclusions and relevanceAmong patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach.Trial registrationClinicalTrials.gov Identifier: NCT02076113.

Project description:Trachomatous trichiasis can cause corneal damage and visual impairment. WHO recommends surgery for all cases. However, in many regions surgical provision is inadequate and patients frequently decline. Self-epilation is common and was associated with comparable outcomes to surgery in nonrandomised studies for minor trichiasis (<six lashes touching eye). This trial investigated whether epilation is noninferior to surgery for managing minor trichiasis.1,300 individuals with minor trichiasis from Amhara Regional State, Ethiopia were recruited and randomly assigned (1:1) to receive trichiasis surgery or epilation. The epilation group were given new forceps and epilation training. The surgical group received trichiasis surgery. Participants were examined every 6 months for 2 years by clinicians masked to allocation, with 93.5% follow-up at 24 months. The primary outcome measure ("failure") was ?five lashes touching the eye or receiving trichiasis surgery during 24 months of follow-up, and was assessed for noninferiority with a 10% prespecified noninferiority margin. Secondary outcomes included number of lashes touching, time to failure, and changes in visual acuity and corneal opacity. Cumulative risk of failure over 24 months was 13.2% in the epilation group and 2.2% in the surgical group (risk difference?=?11%). The 95% confidence interval (8.1%-13.9%) includes the 10% noninferiority margin. Mean number of lashes touching the eye was greater in the epilation group than the surgery group (at 24 months 0.95 versus 0.09, respectively; p<0.001); there was no difference in change in visual acuity or corneal opacity between the two groups.This trial was inconclusive regarding inferiority of epilation to surgery for the treatment of minor trichiasis, relative to the prespecified margin. Epilation had a comparable effect to surgery on visual acuity and corneal outcomes. We suggest that surgery be performed whenever possible but epilation be used for treatment of minor trichiasis patients without access to or declining surgery.ClinicalTrials.gov NCT00522912.

Project description:BackgroundWhile surgical simulation is regularly used in surgical training in high-income country settings, it is uncommon in low- and middle-income countries, particularly for surgical training that primarily occurs in rural areas. We designed and evaluated a novel surgical simulator for improving trachomatous trichiasis (TT) surgery training, given that trichiasis is mostly found among the poorest individuals in rural areas.Methodology/principal findingsTT surgery programs were invited to incorporate surgical simulation with a new, high fidelity, low-cost simulator into their training. Trainees completed standard TT-surgery training following World Health Organization guidelines. A subset of trainees received three hours of supplemental training with the simulator between classroom and live-surgery training. We recorded the time required to complete each surgery and the number of times the trainer intervened to correct surgical steps. Participants completed questionnaires regarding their perceptions. We also assessed trainer and trainee perceptions of surgical simulation training as part of trichiasis surgery training. 22 surgeons completed standard training and 26 completed standard training plus simulation. We observed 1,394 live-training surgeries. Average time to first live-training surgery completion was nearly 20% shorter the simulation versus the standard group (28.3 vs 34.4 minutes; p = 0.02). Trainers intervened significantly fewer times during initial live-training surgeries in the simulation group (2.7 vs. 4.8; p = 0.005). All trainers indicated the simulator significantly improved training by allowing trainees to practice safely and to identify problem areas before performing live-training surgeries. Trainees reported that simulation practice improved their confidence and skills prior to performing live-training surgeries.ConclusionsA single high-fidelity surgical simulation session can significantly improve critical aspects of initial TT surgeries.

Dataset Information

Impact of Trichiasis surgery on physical functioning in Ethiopian patients: STAR trial.

Purpose

Design

Methods

Results

Conclusions

Publications

Impact of Trichiasis surgery on physical functioning in Ethiopian patients: STAR trial.

Similar Datasets

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