Gray 2012.
Methods | Randomized controlled trial | |
Participants | The study location was Manchester Royal Eye Hospital (MREH) clinics in Manchester, UK 64 participants were randomized to the intervention group and 63 participants were randomized to the control group The inclusion criteria were patients with newly diagnosed ocular hypertension (OHT), open‐angle glaucoma (POAG), normal tension glaucoma (NTG), pigment dispersion, or pseudo‐exfoliation glaucoma The exclusion criteria were inability to make an informed decision about participating in the study and having a co‐existing eye condition requiring a drop regimen |
|
Interventions | Intervention: INDIVIDUALIZED PATIENT CARE
Patients in the individualized care group received standard care plus an individualized care plan implemented by a glaucoma trained nurse. This included a 45‐minute assessment of healthcare needs and beliefs with supplied booklets and drop diaries, a 20‐minute educational session, and a 10‐minute training session on instilling eye drops. A 1‐year follow‐up care plan was designed and implemented according to healthcare needs, based on education and support, which was tailored to gaps in glaucoma knowledge, pre‐existing beliefs, and ability to manage an eye drop regimen. Patients were given the nurse's contact telephone for advice or assistance between consultation. Follow‐up involved ongoing training and support by both face‐to‐face and telephone consultations. This incorporated a review of drop diaries in the initial weeks of therapy (these were continued if found beneficial as a reminder tool), reminders to collect and use drops, and repetition of information as required. Needs were reassessed and the level of support adjusted accordingly at the end of each consultation. The intervention nurse was the same throughout, and the intervention was guided by prescriptive documentation Control: STANDARD CARE Standard of care is not definitively described. Education, advice, and support varies from clinic to clinic within Manchester Royal Eye Hospital but is limited for many patients. No further contact after initial consultation |
|
Outcomes | The measures of adherence were refill adherence, measured by contacting general practitioners and pharmacists for prescription dispensing information during the 1‐year follow‐up period, and self report adherence using the Revised Glaucoma Adherence Questionnaire (GAQ‐R) The patient outcomes were mean intraocular pressure (IOP), difference in IOP fluctuations at 12 months, and changed in clinical management at 12 months |
|
Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | (pg 408) Computer‐generated randomization was conducted by a statistician with no involvement in data collection |
Allocation concealment (selection bias) | Low risk | (pg 409, Figure 1) Allocations were concealed in opaque, sealed envelopes by personnel with no involvement in the study, and opened by a research co‐ordinator with no other involvement in the study |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified |
Other bias | Unclear risk | Author noted limitations in the article. (pg 415) "...refill adherence does not capture all aspects of refill behavior" ‐ refilling does not necessarily mean the previous bottle was used; could have been lost ‐ changes in visual field or optic nerve head not likely to reach significance during study length |
Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) REFILL ADHERENCE ‐ "The researcher and outcome assessor were masked to allocations until study completion." (pg 409, Figure 1) |
Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) MEAN IOP, IOP FLUCTUATION, AND CHANGE IN CLINICAL MANAGEMENT ‐ IOP level recordings and decisions regarding clinical management were made at routine clinic visits and were the responsibility of clinicians with no involvement in the study |
Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) REFILL ADHERENCE ‐ The lack of blinding of participants is not likely to affect the outcome |
Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) MEAN IOP, IOP FLUCTUATION, AND CHANGE IN CLINICAL MANAGEMENT ‐ The data were collected from the hospital records. The lack of blinding is not likely to affect the outcome |
Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) REFILL ADHERENCE ‐ "The researcher and outcome assessor were masked to allocations until study completion." (pg 409, Figure 1) |
Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) MEAN IOP, IOP FLUCTUATION, AND CHANGE IN CLINICAL MANAGEMENT ‐ The data were collected from the hospital records. The researcher and outcome assessor were masked to allocations until study completion |
Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) REFILL ADHERENCE ‐ 10 in intervention group did not receive full intervention but an ITT analysis was done; 9 intervention arm patients who did not receive the full intervention were classed as having poor refill adherence |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) MEAN IOP, IOP FLUCTUATION, AND CHANGE IN CLINICAL MANAGEMENT ‐ Few dropouts and balanced across intervention and control |