Quality Assurance and Quality Control in the Global Trachoma Mapping Project.

In collaboration with the health ministries that we serve and other partners, we set out to complete the multiple-country Global Trachoma Mapping Project. To maximize the accuracy and reliability of its outputs, we needed in-built, practical mechanisms for quality assurance and quality control. This article describes how those mechanisms were created and deployed. Using expert opinion, computer simulation, working groups, field trials, progressively accumulated in-project experience, and external evaluations, we developed 1) criteria for where and where not to undertake population-based prevalence surveys for trachoma; 2) three iterations of a standardized training and certification system for field teams; 3) a customized Android phone-based data collection app; 4) comprehensive support systems; and 5) a secure end-to-end pipeline for data upload, storage, cleaning by objective data managers, analysis, health ministry review and approval, and online display. We are now supporting peer-reviewed publication. Our experience shows that it is possible to quality control and quality assure prevalence surveys in such a way as to maximize comparability of prevalence estimates between countries and permit high-speed, high-fidelity data processing and storage, while protecting the interests of health ministries.

Oral doxycycline for the prevention of postoperative trachomatous trichiasis in Ethiopia: a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Trachomatous trichiasis is treated surgically to prevent sight loss. Unfavourable surgical outcomes remain a major challenge. We investigated the hypothesis that doxycycline might reduce the risk of postoperative trichiasis following surgery in patients with trachomatous trichiasis through anti-matrix metalloproteinase and anti-inflammatory activity. METHODS: In this randomised, double-blind, placebo-controlled trial, adults (aged >18 years) with upper lid trachomatous trichiasis in association with tarsal conjunctive scarring were recruited through community-based screening and surgical outreach campaigns in Ethiopia. Individuals who had previously had eyelid surgery were excluded. Participants were randomly assigned (1:1), with random block sizes of four or six, to receive oral doxycycline (100 mg once a day) or placebo for 28 days immediately after trichiasis surgery. Randomisation was stratified by surgeon. Patients, investigators, surgeons, and all other study team members were masked to study group allocation and treatment. Participants were examined at 10 days, and 1, 6, and 12 months after surgery. The primary outcome was the cumulative proportion of individuals who developed postoperative trichiasis by 12 months. Primary analyses were done in all participants who attended at least one of the four follow-up assessments. Safety analyses were done in all participants who attended either the 10 day or 1 month follow-up assessments. This trial is registered with the Pan African Clinical Trials Registry, number PACTR201512001370307. FINDINGS: Between Dec 21, 2015, and April 6, 2016, 1000 patients with trichiasis were enrolled and randomly assigned to treatment (499 patients to doxycycline, 501 patients to placebo). All but one participant attended at least one follow-up assessment. Thus, 999 participants were assessed for the primary outcome: 498 in the doxycycline group and 501 in the placebo group. By month 12, 58 (12%) of 498 patients in the doxycycline group and 62 (12%) of 501 patients in the placebo group had developed postoperative trichiasis (adjusted odds ratio 0·91, 95% CI 0·61 to 1·34, p=0·63), with a risk difference of -0·5% (-4·5% to 3·5%). Significantly more patients in the doxycycline group had an adverse event than in the placebo group (18 [4%] of 498 vs six [1%] of 501; odds ratio 3·09, 95% CI 1·21-7·84; p=0·02). The most frequent adverse events in the doxycycline group were gastritis symptoms (n=9), constipation (n=4), and diarrhoea (n=4). INTERPRETATION: Doxycycline did not reduce the risk of postoperative trichiasis and is therefore not indicated for the improvement of outcomes following trachomatous trichiasis surgery. Surgical programmes should continue to make efforts to strengthen surgical training and supervision to improve outcomes. FUNDING: The Wellcome Trust.

Epidemiology of trachoma and its implications for implementing the "SAFE" strategy in Somali Region, Ethiopia: results of 14 population-based prevalence surveys.

PURPOSE: Ethiopia is highly trachoma endemic. Baseline mapping was needed in Ethiopia's Somali Region to guide elimination efforts. METHODS: Cross-sectional community-based surveys were conducted in 34 suspected trachoma-endemic woredas, grouped as 14 evaluation units (EUs), using a standardised mapping methodology developed for the Global Trachoma Mapping Project. RESULTS: In total, 53,467 individuals were enumerated. A total of 48,058 (89.9%) were present at the time of survey teams' visits and consented to examination. The prevalence of trachomatous inflammation-follicular (TF) among children aged 1-9 years ranged from 4.1% in the EU covering Danot, Boh, and Geladin woredas in Doolo Subzone to 38.1% in the EU covering Kebribeyah and Hareshen woredas in Fafan Subzone (East). The trichiasis prevalence among adults aged over 15 years varied from 0.1% in the EU covering Afder, Bare, and Dolobay woredas in Afder Subzone (West) to 1.2% in the EU covering Awbere in Fafan Subzone (West). CONCLUSION: Mass drug administration (MDA) with azithromycin is needed in 13 EUs (population 2,845,818). Two EUs (population 667,599) had TF prevalences in 1-9-year-olds of ≥30% and will require at least 5 years of MDA; 5 EUs (population 1,1193,032) had TF prevalences of 10-29.9% and need at least three years of MDA; 6 EUs (population 985,187) had TF prevalences of 5-9.9% and need at least one round of azithromycin distribution before re-survey. In all 13 of these EUs, implementation of facial cleanliness and environmental improvement measures is also needed. Surveys are still needed in the remaining 34 unmapped woredas of Somali Region.

The Epidemiology of Trachoma in Mozambique: Results of 96 Population-Based Prevalence Surveys.

PURPOSE: Surveys are needed to guide trachoma control efforts in Mozambique, with WHO guidelines for intervention based on the prevalence of trachomatous inflammation-follicular (TF) in children aged 1-9 years and the prevalence of trichiasis in adults aged 15 years and above. We conducted surveys to complete the map of trachoma prevalence in Mozambique. METHODS: Between July 2012 and May 2015, we carried out cross-sectional surveys in 96 evaluation units (EUs) covering 137 districts. RESULTS: A total of 269,217 individuals were enumerated and 249,318 people were examined using the WHO simplified trachoma grading system. Overall, 102,641 children aged 1-9 years, and 122,689 individuals aged 15 years and above were examined. The prevalence of TF in children aged 1-9 years was ≥10% in 12 EUs, composed of 20 districts, covering an estimated total population of 2,455,852. These districts require mass distribution of azithromycin for at least 3 years before re-survey. The TF prevalence in children was 5.0-9.9% in 17 EUs (28 districts, total population 3,753,039). 22 EUs (34 districts) had trichiasis prevalences ≥0.2% in adults 15 years and above, and will require public health action to provide surgical services addressing the backlog of trichiasis. Younger age, more children resident in the household, and living in a household that had an unimproved latrine or no latrine facility, were independently associated with an increased odds of TF in children aged 1-9 years. CONCLUSIONS: Trachoma represents a significant public health problem in many areas of Mozambique.

Setting targets for human resources for eye health in sub-Saharan Africa: what evidence should be used?

With a global target set at reducing vision loss by 25% by the year 2019, sub-Saharan Africa with an estimated 4.8 million blind persons will require human resources for eye health (HReH) that need to be available, appropriately skilled, supported, and productive. Targets for HReH are useful for planning, monitoring, and resource mobilization, but they need to be updated and informed by evidence of effectiveness and efficiency. Supporting evidence should take into consideration (1) ever-changing disease-specific issues including the epidemiology, the complexity of diagnosis and treatment, and the technology needed for diagnosis and treatment of each condition; (2) the changing demands for vision-related services of an increasingly urbanized population; and (3) interconnected health system issues that affect productivity and quality. The existing targets for HReH and some of the existing strategies such as task shifting of cataract surgery and trichiasis surgery, as well as the scope of eye care interventions for primary eye care workers, will need to be re-evaluated and re-defined against such evidence or supported by new evidence.

Posterior lamellar versus bilamellar tarsal rotation surgery for trachomatous trichiasis in Ethiopia: a randomised controlled trial.

BACKGROUND: Eyelid surgery is done to correct trachomatous trichiasis to prevent blindness. However, recurrent trichiasis is frequent. Two procedures are recommended by WHO and are in routine practice: bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). This study was done to identify which procedure gives the better results. METHODS: A randomised, controlled, single masked clinical trial was done in Ethiopia. Participants had upper lid trachomatous trichiasis with one or more eyelashes touching the eye or evidence of epilation, in association with tarsal conjunctival scarring. Exclusion criteria were age less than 18 years, recurrent trichiasis after previous surgery, hypertension, and pregnancy. Participants were randomly assigned (1:1) to either BLTR or PLTR surgery, stratified by surgeon. The sequences were computer-generated by an independent statistician. Surgery was done in a community setting following WHO guidelines. Participants were examined at 6 months and 12 months by assessors masked to allocation. The primary outcome was the cumulative proportion of individuals who developed recurrent trichiasis by 12 months. Primary analyses were by modified intention to treat. The intervention effect was estimated by logistic regression, controlled for surgeon as a fixed effect in the model. The trial is registered with the Pan African Clinical Trials Registry (number PACTR201401000743135). FINDINGS: 1000 participants with trichiasis were recruited, randomly assigned, and treated (501 in the BLTR group and 499 in the PLTR group) between Feb 13, 2014, and May 31, 2014. Eight participants were not seen at either 6 month or 12 month follow-up visits and were excluded from the analysis: three from the PLTR group and five from the BLTR group. The follow-up rate at 12 months was 98%. Cumulative recurrent trichiasis by 12 months was more frequent in the BLTR group than in the PLTR group (110/496 [22%] vs 63/496 [13%]; adjusted odds ratio [OR] 1·96 [95% CI 1·40-2·75]; p=0·0001), with a risk difference of 9·50% (95% CI 4·79-14·16). INTERPRETATION: PLTR surgery was superior to BLTR surgery for management of trachomatous trichiasis, and could be the preferred procedure for the programmatic management of trachomatous trichiasis. FUNDING: The Wellcome Trust.

The Global Trachoma Mapping Project: Methodology of a 34-Country Population-Based Study.

PURPOSE: To complete the baseline trachoma map worldwide by conducting population-based surveys in an estimated 1238 suspected endemic districts of 34 countries. METHODS: A series of national and sub-national projects owned, managed and staffed by ministries of health, conduct house-to-house cluster random sample surveys in evaluation units, which generally correspond to "health district" size: populations of 100,000-250,000 people. In each evaluation unit, we invite all residents aged 1 year and older from h households in each of c clusters to be examined for clinical signs of trachoma, where h is the number of households that can be seen by 1 team in 1 day, and the product h × c is calculated to facilitate recruitment of 1019 children aged 1-9 years. In addition to individual-level demographic and clinical data, household-level water, sanitation and hygiene data are entered into the purpose-built LINKS application on Android smartphones, transmitted to the Cloud, and cleaned, analyzed and ministry-of-health-approved via a secure web-based portal. The main outcome measures are the evaluation unit-level prevalence of follicular trachoma in children aged 1-9 years, prevalence of trachomatous trichiasis in adults aged 15 + years, percentage of households using safe methods for disposal of human feces, and percentage of households with proximate access to water for personal hygiene purposes. RESULTS: In the first year of fieldwork, 347 field teams commenced work in 21 projects in 7 countries. CONCLUSION: With an approach that is innovative in design and scale, we aim to complete baseline mapping of trachoma throughout the world in 2015.

Epilation for minor trachomatous trichiasis: four-year results of a randomised controlled trial.

BACKGROUND: Trachomatous trichiasis (TT) needs to be managed to reduce the risk of vision loss. The long-term impact of epilation (a common traditional practice of repeated plucking of lashes touching the eye) in preventing visual impairment and corneal opacity from TT is unknown. We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT (fewer than six lashes touching the eye) in Ethiopia. Here we report the four-year outcome and the effect on vision and corneal opacity. METHODOLOGY/ PRINCIPAL FINDINGS: 1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision. Participants were examined six-monthly for two-years, and then at four-years after randomisation. At two-years all epilation arm participants were offered free surgery. At four-years 1151 (88.5%) were re-examined: 572 (88%) and 579 (89%) from epilation and surgery arms, respectively. At that time, 21.1% of the surgery arm participants had recurrent TT; 189/572 (33%) of the epilation arm had received surgery, while 383 (67%) declined surgery and had continued epilating ("epilation-only"). Among the epilation-only group, 207 (54.1%) fully controlled their TT, 166 (43.3%) had minor TT and 10 (2.6%) had major TT (>5 lashes). There were no differences between participants in the epilation-only, epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years. CONCLUSIONS/ SIGNIFICANCE: Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT. Change in vision and corneal opacity was comparable between surgery and epilation-only participants. This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment.

Non-physician cataract surgeons in Sub-Saharan Africa: situation analysis.

OBJECTIVES: Non-physician cataract surgeons (NPCS) provide cataract surgical services in some Sub-Saharan African (SSA) countries. However, their training, placement, legal framework and supervision have not been documented. We sought to do so to inform decision-making regarding future training. METHODS: Standard questionnaires were sent to national eye coordinators and other ophthalmologic leaders in Africa to collect information. Face-to-face interviews were conducted at training programmes in Ethiopia, Tanzania and Kenya, and email interviews were conducted with directors at training programmes in the Gambia and Malawi. RESULTS: Responses were provided for 31/39 (79%) countries to which questionnaires were sent. These countries represent about 90% of the population of SSA. Overall, 17 countries have one or more NPCS; two-thirds of the total 245 NPCS are found in only three countries. Thirty-six percent of NPCS work alone, but a formal functioning supervision system was reported to be present in only one country. The training centres are similar and face similar challenges. CONCLUSIONS: There is considerable variation across SSA in the use and acceptance of NPCS. The placement and support of NPCS after training generally does not follow expectations, and training centres have little role in this. Overall, there was no consensus on whether the cadre, as it is currently viewed, is necessary, desirable or will contribute to addressing cataract surgical needs in SSA.

Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: a randomised controlled noninferiority trial.

BACKGROUND: 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 (

Absorbable versus silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomised controlled trial.

BACKGROUND: Trachoma causes blindness through an anatomical abnormality called trichiasis (lashes touching the eye). Trichiasis can recur after corrective surgery. We tested the hypothesis that using absorbable sutures instead of silk sutures might reduce the risk of recurrent disease among patients with major trichiasis in a randomised trial. METHODS AND FINDINGS: 1,300 individuals with major trichiasis from rural villages in the Amhara Region of Ethiopia were recruited and assigned (1:1) by computer-generated randomisation sequence to receive trichiasis surgery using either an absorbable suture (polyglactin-910) or silk sutures (removed at 7-10 days) in an otherwise identical surgical technique. Participants were examined every 6 months for 2 years by clinicians masked to allocation. The primary outcome measure was recurrent trichiasis (≥one lash touching the eye) at 1 year. There was no difference in prevalence of recurrent trichiasis at 1 year (114 [18.2%] in the absorbable suture group versus 120 [19.7%] in the silk suture group; odds ratio = 0.90, 95% CI 0.68-1.20). The two groups also did not differ in terms of corneal opacification, visual acuity, conjunctival inflammation, and surgical complications. CONCLUSIONS: There was no evidence that use of absorbable polyglactin-910 sutures was associated with a lower prevalence of trichiasis recurrence at 1 year postsurgery than silk sutures. However, from a programmatic perspective, polyglactin-910 offers the major advantage that patients do not have to be seen soon after surgery for suture removal. The postoperative review after surgery using absorbable polyglactin-910 sutures can be delayed for 3-6 months, which might allow us to better determine whether a patient needs additional surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT00522860.

Rates and risk factors for unfavorable outcomes 6 weeks after trichiasis surgery.

PURPOSE: Several studies of trichiasis recurrence suggest an association between surgical factors and long-term recurrence, yet data on short-term risk factors are limited. This study was conducted to evaluate risk factors for early trichiasis recurrence and other unfavorable short-term outcomes. METHODS: Trichiasis patients presenting for surgery were evaluated for presence of active trachoma and signs of cicatricial outcomes of trachoma, including number of trichiatic lashes, epilation, and entropion. Surgical factors recorded included incision length, surgery duration, and the surgeon performing the operation. Participants were followed up for 6 weeks after surgery and evaluated for eyelid closure defect and trichiasis recurrence; in addition, in two thirds of the patients, eyelid contour abnormality and granuloma formation were evaluated. RESULTS: First-time trichiasis surgery was performed on 2615 eyelids. Of these, 2601 eyelids without surgical failure were followed up 6 weeks after surgery. Of the eyelids treated, 2.3% had recurrent trichiasis and 1.3% had an eyelid closure defect. Data on eyelid contour abnormalities and granuloma formation were recorded for 1881 eyes, with rates of 1.2% and 10.5%, respectively. Associated risk factors differed by outcome. Surgeon was predictive of eyelid closure defect and granuloma formation. Eyelids with short incisions were nearly four times more likely to have recurrent trichiasis (95% confidence interval, 1.7-9.3). Baseline trichiasis severity was predictive of eyelid contour abnormalities and recurrent trichiasis. Epilation was associated with granuloma formation, but was protective against eyelid closure defect. CONCLUSIONS: Surgical factors are important predictors of unfavorable outcomes in the weeks immediately after surgery. Although the overall rate of serious uncorrectable unfavorable outcomes was very low, the high rate of granuloma formation, which can be treated by removal, highlights the need for follow-up of patients after trichiasis surgery. (ClinicalTrials.gov number, NCT00347776.).