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Effectiveness of peer support to increase uptake of retinal examination for diabetic retinopathy: study protocol for the DURE pragmatic cluster randomized clinical trial in Kirinyaga, Kenya.
Mwangi, N, Ng'ang'a, M, Gakuo, E, Gichuhi, S, Macleod, D, Moorman, C, Muthami, L, Tum, P, Jalango, A, Githeko, K, et al
BMC public health. 2018;(1):871
Abstract
BACKGROUND All patients with diabetes are at risk of developing diabetic retinopathy (DR), a progressive and potentially blinding condition. Early treatment of DR prevents visual impairment and blindness. The natural history of DR is that it is asymptomatic until the advanced stages, thus annual retinal examination is recommended for early detection. Previous studies show that the uptake of regular retinal examination among people living with diabetes (PLWD) is low. In the Uptake of Retinal Examination in Diabetes (DURE) study, we will investigate the effectiveness of a complex intervention delivered within diabetes support groups to increase uptake of retinal examination. METHODS The DURE study will be a two-arm pragmatic cluster randomized clinical trial in Kirinyaga County, Kenya. Diabetes support groups will be randomly assigned to either the intervention or usual care conditions in a 1:1 ratio. The participants will be 700 PLWD who are members of support groups in Kirinyaga. To reduce contamination, the unit of randomization will be the support group. Peer supporters in the intervention arm will receive training to deliver the intervention. The intervention will include monthly group education on DR and individual member reminders to take the eye examination. The effectiveness of this intervention plus usual care will be compared to usual care practices alone. Participant data will be collected at baseline. The primary outcome is the proportion of PLWD who take up the eye examination at six months. Secondary outcomes include the characteristics of participants and peer supporters associated with uptake of eye examination for DR. Intention-to-treat analysis will be used to evaluate the primary and secondary outcomes. DISCUSSION Eye care programs need evidence of the effectiveness of peer supporter-led health education to improve attendance to retinal screening for the early detection of DR in an African setting. Given that the intervention combines standardization and flexibility, it has the potential to be adopted in other settings and to inform policies to promote DR screening. TRIAL REGISTRATION Pan African Clinical Trial Registry PACTR201707002430195 , registered 25 July 2017, www.pactr.org.
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Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial.
Mansberger, SL, Sheppler, C, Barker, G, Gardiner, SK, Demirel, S, Wooten, K, Becker, TM
JAMA ophthalmology. 2015;(5):518-25
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IMPORTANCE Minimal information exists regarding the long-term comparative effectiveness of telemedicine to provide diabetic retinopathy screening examinations. OBJECTIVE To compare telemedicine to traditional eye examinations in their ability to provide diabetic retinopathy screening examinations. DESIGN, SETTING, AND PARTICIPANTS From August 1, 2006, through September 31, 2009, 567 participants with diabetes were randomized and followed up to 5 years of follow-up (last date of patient follow-up occurred on August 6, 2012) as part of a multicenter randomized clinical trial with an intent to treat analysis. We assigned participants to telemedicine with a nonmydriatic camera in a primary care medical clinic (n = 296) or traditional surveillance with an eye care professional (n = 271). Two years after enrollment, we offered telemedicine to all participants. MAIN OUTCOMES AND MEASURES Percentage of participants receiving annual diabetic retinopathy screening examinations, percentage of eyes with worsening diabetic retinopathy during the follow-up period using a validated scale from stage 0 (none) to stage 4 (proliferative diabetic retinopathy), and percentage of telemedicine participants who would require referral to an eye care professional for follow-up care using a cutoff of moderate diabetic retinopathy or worse, the presence of macular edema, or an unable-to-determine result for retinopathy or macular edema. RESULTS The telemedicine group was more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group during the 6-month or less (94.6% [280/296] vs 43.9% [119/271]; 95% CI, 46.6%-54.8%; P < .001) and greater than 6-month through 18-month (53.0% [157/296] vs 33.2% [90/271]; 95% CI, 16.5%-23.1%; P < .001) time bins. After we offered telemedicine to both groups, we could not identify a difference between the groups in the percentage of diabetic retinopathy screening examinations. Diabetic retinopathy worsened by 2 stages or more in 35 (8.6%) of 409 participants (95% CI, 5.8%-11.2%) and improved by 2 stages or more in 5 (1.2%) of 409 participants (95% CI, 0.1%-2.3%) during the 4-year period. The percent of telemedicine participants requiring referral ranged from 19.2% (52/271) to 27.9% (58/208). CONCLUSIONS AND RELEVANCE Telemedicine increased the percentage of diabetic retinopathy screening examinations, most participants did not require referral to an eye care professional, and diabetic retinopathy levels were generally stable during the study period. This finding suggests that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for disease worsening over a long period. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01364129.
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The Impact of Multimedia Education on Uptake of Comprehensive Eye Examinations in Rural China: A Randomized, Controlled Trial.
Dan, A, Raubvogel, G, Chen, T, Ye, T, Jin, L, Xiao, B, Sanchez, A, Congdon, N
Ophthalmic epidemiology. 2015;(4):283-90
Abstract
PURPOSE To study the effect of multimedia education on acceptance of comprehensive eye examinations (CEEs), critical for detecting glaucoma and diabetic eye disease, among rural Chinese patients using a randomized, controlled design. METHODS Patients aged ≥40 years were recruited from 52 routine clinic sessions (26 intervention, 26 control) conducted at seven rural hospitals in Guangdong, China. Subjects answered demographic questionnaires, were tested on knowledge about CEEs and chronic eye disease, and were told the cost of examination (range US$0-8). At intervention sessions, subjects were cluster-randomized to view a 10-minute video on the value of CEEs and retested. Control subjects were not retested. Trial outcomes were acceptance of CEEs (primary outcome) and final knowledge scores (secondary outcome). RESULTS At baseline, >70% (p = 0.70) of both intervention (n = 241, 61.2 ± 12.3 years) and control (n = 218, 58.4 ± 11.7 years) subjects answered no knowledge questions correctly, but mean scores on the test (maximum 5 points) increased by 1.39 (standard deviation 0.12) points (p < 0.001) after viewing the video. Intervention (73.0%) and control (72.9%) subjects did not differ in acceptance of CEEs (p > 0.50). In mixed-effect logistic regression models, acceptance of CEEs was associated with availability of free CEEs (odds ratio 18.3, 95% confidence interval 1.32-253.0), but not group assignment or knowledge score. Acceptance was 97.5% (79/81) when free exams were offered. CONCLUSIONS Education increased knowledge about but not acceptance of CEEs, which was generally high. Making CEEs free could further increase acceptance.
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Predicting adherence to diabetic eye examinations: development of the compliance withAnnual Diabetic Eye Exams Survey.
Sheppler, CR, Lambert, WE, Gardiner, SK, Becker, TM, Mansberger, SL
Ophthalmology. 2014;(6):1212-9
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OBJECTIVE To identify variables that predict adherence with annual eye examinations using the Compliance with Annual Diabetic Eye Exams Survey (CADEES), a new questionnaire designed to measure health beliefs related to diabetic retinopathy and annual eye examinations. DESIGN Questionnaire development. PARTICIPANTS Three hundred sixteen adults with diabetes. METHODS We developed the CADEES based on a review of the literature, the framework of the Health Belief Model, expert opinion, and pilot study data. To examine content validity, we analyzed participant responses to an open-ended question asking for reasons why people do not obtain annual eye examinations. We evaluated construct validity with principal components analysis and examined internal consistency with Cronbach's α. To assess predictive validity, we used multivariate logistic regression with self-reported adherence as the dependent variable. MAIN OUTCOME MEASURES Associations with self-reported adherence (defined as having a dilated eye examination in the past year). RESULTS The content analysis showed that CADEES items covered 89% of the reasons given by participants for not obtaining an annual eye examination. The principal components analysis identified 3 informative components that made up 32% of the variance. Multivariate logistic regression modeling revealed several significant predictors of adherence, including beliefs concerning whether insurance covered most of the eye examination cost (P < 0.01), whether there were general barriers that make it difficult to obtain an eye examination (P < 0.01), whether obtaining an eye examination was a top priority (P = 0.02), and whether diabetic eye disease can be seen with an examination (P = 0.05). Lower hemoglobin A1c levels (P < 0.01), having insurance (P = 0.01), and a longer duration of diabetes (P = 0.02) also were associated with adherence. A multivariate model containing CADEES items and demographic variables classified cases with 72% accuracy and explained approximately 24% of the variance in adherence. CONCLUSIONS The CADEES showed good content and predictive validity. Although additional research is needed before finalizing a shorter version of the survey, our findings suggest that researchers and clinicians may be able to improve adherence by (1) counseling newly diagnosed patients, as well as those with uncontrolled blood glucose, on the importance of annual eye examinations and (2) discussing perceived barriers and misconceptions.
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Relationship between feeding schedules and gastric distress during retinopathy of prematurity screening eye examinations.
Strube, YN, Bakal, JA, Arthur, BW
Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus. 2010;(4):334-9
Abstract
PURPOSE To determine whether a relationship exists between the timing of feeding before retinopathy of prematurity (ROP) eye examinations and gastric side effects or distress associated with this examination. METHODS A prospective, randomized, single-masked study was conducted involving infants in the neonatal intensive care unit who required an ROP eye examination and who received normal or full enteral feeding over a 1 year period. Infants were randomly assigned to 1 of 2 study arms: feeding 1 hour before examination (arm 1) or feeding schedule adjusted to ensure no feeding within 2 hours before examination (arm 2). Physiological data, including blood pressure and pulse rate, before, during and after examination, crying time during the examination, presence of vomiting and gastric aspirates, and gastric aspirates volume 24 hours after the examination, were recorded. RESULTS A total of 34 infants were enrolled, with 57 separate eye examinations conducted. There was 19% less crying (p = 0.016) in arm 1 versus arm 2. Vomiting was 3-fold less in arm 1 versus arm 2 (4.2% vs 12.5%, p = 0.38). Gastric aspirates was less in arm 1 versus arm 2 (p = 0.18). Diastolic blood pressure was lower and respiratory rate greater during the examination in arm 1 (p < 0.05), whereas pulse rate was greater at the start of the examination in arm 1 (p < 0.05). CONCLUSIONS Feeding neonatal intensive care unit infants 1 hour before compared with withholding feeding 2 or more hours before ROP examinations may reduce stress during the examination, as measured by percentage crying during the examination, with no increased incidence of vomiting or gastric aspirates.
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Improving preventive service delivery at adult complete health check-ups: the Preventive health Evidence-based Recommendation Form (PERFORM) cluster randomized controlled trial.
Dubey, V, Mathew, R, Iglar, K, Moineddin, R, Glazier, R
BMC family practice. 2006;:44
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BACKGROUND To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting. METHODS A prospective cluster randomized controlled trial was conducted at four urban family practice clinics among 38 primary care physicians affiliated with the University of Toronto. Preventive Care Checklist Forms were created to be used by family physicians at adult health check-ups over a five-month period. The sex-specific forms incorporate evidence-based recommendations on preventive health services and documentation space for routine procedures such as physical examination. The forms were used in two intervention clinics and two control clinics. Rates and relative risks (RR) of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups. RESULTS Randomly-selected charts were reviewed at baseline (n = 509) and post-intervention (n = 608). Baseline rates for provision of preventive health services ranged from 3% (fecal occult blood testing) to 93% (blood pressure measurement), similar to other settings. The percentage of up-to-date preventive health services delivered per patient at the end of the intervention was 48.9% in the control group and 71.7% in the intervention group. This is an overall 22.8% absolute increase (p = 0.0001), and 46.6% relative increase in the delivery of preventive health services per patient in the intervention group compared to controls. Eight of thirteen preventive health services showed a statistically significant change (p < 0.05) in favor of the intervention (adjusted RR (95% C.I.)): counseling on brushing/flossing teeth (9.2 (4.3-19.6)), folic acid counseling (7.5 (2.7-20.8)), fecal occult blood testing (6.7 (1.9-24.1)), smoking cessation counseling (3.9 (2.2-7.2)), tetanus immunization (3.0 (1.7-5.2)), history of alcohol intake (1.33 (1.2-1.5)), history of smoking habits (1.28 (1.2-1.4)) and blood pressure measurement (1.05 (1.00-1.10)). CONCLUSION This simple, low cost, clinically relevant intervention improves the delivery of preventive health services by prompting physicians of evidence-based recommendations in a checklist format that incorporates existing practice patterns. Periodic updates of the Preventive Care Checklist Forms will allow a feasible and easy-to-use tool for primary care physicians to provide evidence-based preventive health services to adults at routine health check-ups. The forms can also be incorporated into an electronic health record. The Preventive Care Checklist Forms are accessible in English and French at the College of Family Physicians of Canada web site.
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Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial.
Kiefe, CI, Allison, JJ, Williams, OD, Person, SD, Weaver, MT, Weissman, NW
JAMA. 2001;(22):2871-9
Abstract
CONTEXT Performance feedback and benchmarking, common tools for health care improvement, are rarely studied in randomized trials. Achievable Benchmarks of Care (ABCs) are standards of excellence attained by top performers in a peer group and are easily and reproducibly calculated from existing performance data. OBJECTIVE To evaluate the effectiveness of using achievable benchmarks to enhance typical physician performance feedback and improve care. DESIGN Group-randomized controlled trial conducted in December 1996, with follow-up through 1998. SETTING AND PARTICIPANTS Seventy community physicians and 2978 fee-for-service Medicare patients with diabetes mellitus who were part of the Ambulatory Care Quality Improvement Project in Alabama. INTERVENTION Physicians were randomly assigned to receive a multimodal improvement intervention, including chart review and physician-specific feedback (comparison group; n = 35) or an identical intervention plus achievable benchmark feedback (experimental group; n = 35). MAIN OUTCOME MEASURE Preintervention (1994-1995) to postintervention (1997-1998) changes in the proportion of patients receiving influenza vaccination; foot examination; and each of 3 blood tests measuring glucose control, cholesterol level, and triglyceride level, compared between the 2 groups. RESULTS The proportion of patients who received influenza vaccine improved from 40% to 58% in the experimental group (P<.001) vs from 40% to 46% in the comparison group (P =.02). Odds ratios (ORs) for patients of achievable benchmark physicians vs comparison physicians who received appropriate care after the intervention, adjusted for preintervention care and nesting of patients within physicians, were 1.57 (95% confidence interval [CI], 1.26-1.96) for influenza vaccination, 1.33 (95% CI, 1.05-1.69) for foot examination, and 1.33 (95% CI, 1.04-1.69) for long-term glucose control measurement. For serum cholesterol and triglycerides, the achievable benchmark effect was statistically significant only after additional adjustment for physician characteristics (OR, 1.40 [95% CI, 1.08-1.82] and OR, 1.40 [95% CI, 1.09-1.79], respectively). CONCLUSION Use of achievable benchmarks significantly enhances the effectiveness of physician performance feedback in the setting of a multimodal quality improvement intervention.