Q.REC Manual

Multi-Language Management in REDCap, Part 1: Adding Languages

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Q.REC

Quality of Refractive Error Care Manual

Anthea Burnett

Last edited 191 days ago by Anthea Burnett

This manual was developed by Anthea Burnett PhD and Ling Lee PhD, with major contributions by Myra McGuiness PhD, Beatrice Varga, Yadira Perez Hazel and Suit May Ho.

This work was funded by The Fred Hollows Foundation with support from the Australia Government through the Australian NGO Cooperation Program (ANCP). In collaboration with The University of New South Wales

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Cover photos: Sam Phelps

Key Contacts

Anthea Burnett

Consultant, The Fred Hollows Foundation

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aburnett@hollows.org⁠

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Ling Lee

Consultant, The Fred Hollows Foundation

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linglee@hollows.org⁠

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Glossary

Dispensed spectacles: The glasses that have been prescribed, made and provided to a USP from an optical service.

Intra-service correlation: Describes how strongly the USP outcomes are from the same services.

Optical service: any place that provides refractive error services including refraction and optical dispensing. This might include privately owned stores, franchisee stores, vision centres, community health centre services, eye hospitals or secondary and tertiary hospitals.

Unannounced standardised patient (USP): An individual that has been trained to visit optical services in a standardised manner.

Index of acronyms & abbreviations

ANOVA

Analysis of variance

Dioptre

Dioptre cylinder

Dioptre sphere

HREC

Human research ethics committee

IRB

Institutional Review Board

MoE

Margin of Error

Q.REC

Quality of Refractive Error Care

USP

Unannounced standardised patient

WHO

World Health Organization

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Prism dioptres

There are no rows in this table

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Q.REC: A manual for investigating the quality of refractive error care

Introduction

Uncorrected refractive errors are the leading global cause of vision impairment, with 161 million people and an additional 510 million people living with distance and near vision impairment, respectively.1 In 2021, the United National General Assembly adopted a resolution committing the international community to provide eye health for all people living with vision impairment by 2030. To achieve such a target, the World Health Organization (WHO) stated that a commitment to Universal Health Coverage using an integrated people-centred eye care approach is the model of choice for quality and affordable eye care services, and that quality eye care services need to be provided according to population needs.2 To monitor progress and drive change towards Universal Health Coverage that includes the quality of eye care services, a broader set of measurement indicators are required.

Indicators should provide insights to shape change and stimulate action, track outcome progress and the quality of an intervention. Indicators have recently been established, to assess the ‘real world’ quality of refractive care, where care is a combination of prescribing and dispensing for refractive error. The Quality of Refractive Error Care (Q.REC) indicator provides information on the proportion of prescribed spectacles that are clinically optimal for patients, by comparing a baseline prescription to dispensed spectacles. The Q.REC study can also be used to assess core dimensions of quality, such as whether refractive error services are effective, equitable, safe and people-centred, and have the potential to identify aspects of clinical practice that require improvement, or further training.

Rationale

A Q.REC study employs simulated patients — the gold standard for evaluating quality in clinical practice3 — and can be easily administered in urban settings. Simulated patients, or Unannounced Standardised Patients (USPs), are ‘actors’ who are trained to act covertly as patients in a standardised fashion, while observing clinical techniques and services provided. USPs have been used extensively in low- and middle-income countries, often in evaluating family planning, pharmaceutical dispensing patterns, and clinical prescribing patterns.4 Studies employing USPs have also previously been conducted to evaluate refractive error outcomes.5-7

Advantages

It is anticipated that a Q.REC study will identify the proportion of people that are prescribed and dispensed spectacles appropriate for their refractive error needs. It can identify adherence to national guidelines or best practice and identify specific opportunities for quality improvement which can then be translated into policy changes or quality improvement initiatives. Q.REC studies can also be used to monitor ongoing delivery of quality refractive error care services, within the context of integrated people-centred eye care.

If a Q.REC study is executed well, the distinct advantage of employing USPs is that observation bias is minimised, as refractive error services are likely to modify their behaviours if they feel that they are being observed or assessed.

Disadvantages

This protocol is unlikely to provide specific information for each facility as only a few USPs visit each service. Also, as all USPs will be adults, the findings might not be applicable to the quality of children’s refractive error care.

There is a possibility that USPs might be detected, and if so, the data should be excluded that consequently might broaden the range on Q.REC measurement. If there is a significant proportion of USP visits detect (i.e. >5%), and the USP continues to complete the visit and data is included, then there could be an overestimation on the Q.REC. USPs might also inadvertently mislead optical service staff to either perform better or poorer than usual behaviour. To reduce these potential biases, well-delivered USP training is essential.

Phase 1: Planning a Q.REC Project

Feasibility assessment

The following sections help to determine whether it is feasible to conduct a Q.REC Project. The main things to consider are how many optical services can be visited, the amount of study personnel required, the available equipment for recruitment, training and data collection, the time available of all personnel, and the support from relevant stakeholders.

Study Personnel

Study coordinator

Study optometrist(s) / refractionist(s)

USPs

Additional support can be sought:

People to assist with mapping all optical service providers in your setting

People to assist with translating documents

People to assist in advertising for USPs

People to assist in providing equipment or resources for training

Biostatistician to assist with data analysis

We recommend the study coordinator and study optometrist (who can be one person responsible for both roles) should be the key people/person that familiarises themselves with all the study materials including protocol, sample size calculator, budgeting template, ethics application, recruitment forms, optometrist training materials, USP training materials, data collections forms, and data quality control procedures.

The ideal study personnel to be involved with USP training, monitoring USP data collection and also completing some data collection would be eye health professionals with significant experience in refraction techniques and dispensing, likely optometrists or refractionists. Additional desirable skills would include teaching and research experience. Three optometrists/refractionists are required at optometrist and USP training, however, based on budget, time and availability, only one study optometrist might only be required during data collection. An additional optometrist will need to be on standby to conduct any additional baseline refractions required.

The number of USPs to recruit depends on the number of optical services that need to be visited and the available time to complete data collection. More information on ideal USPs is available in USP recruitment, (see USP Recruitment).

Provider mapping

Mapping out all the optical services within the study’s area of interest is important for determining the potential sample size, identifying the potential travel required by USPs and therefore budget implications. Determining a comprehensive list of all the optical services can be approached in multiple ways and is likely context-specific. This might include requesting information from governmental departments of business or health, using Google Maps or equivalent, or even travelling around to manually capture all services.

When conducting this exercise, be aware of the time in between mapping and beginning data collection. Optical services can be dynamic businesses where some will close and move location, while other new services might open. This has potential impact on the logistics and organising the USPs visiting services.

Equipment and resources required

The majority of information required to develop a protocol can be obtained from this document. Several equipment and resource lists can be developed for the different components of the Q.REC study. This includes:

translating documents

Consider which documents and forms will need translation to your local language. We expect for settings where English is not regularly used by optical services and potentially USPs, the following documents will require translation:

Participant Information Statements,

Consent and withdrawal forms,

Advertising flyers,

Training materials,

Data collection forms.

The above list is likely to be the minimum documents that are likely to need translation.

Once the documents have been translated, we also recommend back-translation into English by a different translator. This is to ensure the initial translation is appropriate. Both translators should have a least basic knowledge of refraction and refractive error terms.

Advertising for USPs

Consider how many and where flyers might be placed and online advertisements. Any advertisement will most likely need to be approved by the ethics committee

Screening and recruiting USPs

Consider where the potential USPs be screened, and by whom. The basic equipment needed is likely:

Retinoscope or autorefractor, and

Direct ophthalmoscope or indirect ophthalmic lenses and

Slit lamp.

Training study optometrists

At least a day of training optometrists in the Q.REC protocol so they are capable of providing USP training, baseline data collection and post-visit data collection Paper, laptops or mobile devices, an appropriate facility and per diems are likely required when training optometrists in the Q.REC protocol.

Training USPs including baseline data collection

Similar to training the study optometrist(s), an appropriate facility, paper, laptops or mobile devices and per diems for all study personnel and USPs should be considered. It is likely that USPs will be using their own mobile devices during field data collection, therefore, provision of mobile data also need to be considered.

Depending on your local context and targeted optical services, some optical services, as part of their standard practice, might conduct eye tests that are not related to prescribing for refractive error. For example, in Australia, optometrists in optical stores most commonly prescribe glasses to patients. However, when patients attend optical stores in Australia it is also common for the optometrist as standard practice to provide an eye test that include tests that check the health of the eyes. Tests might include slit lamp examination for the front of the eye, examining pupil reactions, checking eye pressures with contact or non-contact tonometry, or even checking the health of the retina with fundoscopy or photography. It is important to consider the extra tests unrelated to refraction that USPs can undergo to minimise their detection, and identify the tests that USPs can safely and appropriately refuse.

This planning exercise (Annex 1: Q.REC Planning) is to be completed by the study coordinator, refractionists/optometrists and those who have experience with visiting the optical services in the selected area. The exercise aims to identify all the potential eye examination techniques and equipment USPs might encounter at the optical service visits. This will then inform the equipment and space requirements when training the USPs. It is possible that your own facilities have limited equipment, however it is important that if the external services have other equipment, consider borrowing from other sources to demonstrate the USPs. As a last resort, images and videos can be shown to the USPs during training.

Post-visits data collection

At a minimum, a distance and near VA chart, a focimeter, ruler and laptop/mobile device to enter the data are required. Please review Form D: Assessment of Glasses, and consider whether there is quality control checking or refresher refraction training with USPs will be conducted to determine if any additional equipment is required.

Practical considerations

While the protocol can appear to be straightforward, do not underestimate the time planning and logistics might take to execute a Q.REC project without creating unintended bias. This might include:

Translating documents for ethics approval including protocol, consent forms, data collection forms, training materials.

Advertising, screening and recruiting USPs with a range of refractive error profiles

Ensuring all optometrists, USPs and equipment required are available for training, assisting with USP data collection and completing post-visit assessments

Scheduling USP visits to minimise being identified by optical services

Becoming familiar with online data collection tools

Calculation of sample size

The Q.REC Sample Size Calculator

https://rebrand.ly/QREC-samplesize⁠

is used for estimating the proportion of spectacles that meet the selected/desired spectacle quality indicator for the targeted population. The calculation takes into account that there is clustering at the service level and clustering of the spectacles as USPs visit multiple stores. The Q.REC sample size calculator can be found here:

https://rebrand.ly/QREC-samplesize⁠

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There are a few assumptions or considerations that need to be taken when calculating sample size:

The estimated proportion of spectacles estimated to pass/fail the chosen indicator (see next point about criteria available) of ‘good quality’. If the study’s area of interest has services that are not required to have formally trained professionals or if optical services are thought to be not well-regulated, then set it at 50% or 0.5. For a more developed and regulated optical services industry, then the estimated proportion of ‘good quality’ could be updated to at least 70% pass.

Two types of indicators have been developed to select one as the primary outcome, ‘Optimally prescribed spectacles’ and ‘Adequately prescribed spectacles’. For most studies, we recommend using the ‘Optimally prescribed spectacles’ indicator as the primary outcome. However, for settings where sphero-cylindrical lenses are rarely prescribed or available, the ‘Adequately prescribed spectacles’ indicator can be selected. The criteria details for each indicator can be found in the Annex (see Q.REC indicators).

The intraclass coefficient (ICC) needs to be selected. This coefficient represents how much the spectacles within each store may be linked, i.e. if 3 USPs are attending 1 optical service, are they more likely to get the 2nd and 3rd spectacles right because the 1st one was right?

If the primary outcome is to use the ‘optimally prescribed spectacles’ indicator and unsure of the link between USP visits to the same store, we recommend selecting the ICC to be 0.2.

If the primary outcome is to use the ‘optimally prescribed spectacles’ indicator and there is little link between USP visits to the same store, we recommend selecting the ICC to be either 0 or 0.1.

If the primary outcome is to use the ‘adequately prescribe spectacles’ indicator, then we recommend selecting the ICC to be either 0.2 or 0.3.

The margin of error (MoE) means the range around the estimated proportion of spectacles that pass the selected indicator. We have provided the options of 4%, 7% and 10% for selection. The smaller MoE selected, the narrower the range of estimated quality of refractive error, and the more accurate the results are likely to be. For example, if 50% of spectacles are estimated to be optimal quality (Q.REC indicator 1: Optimally prescribed spectacles) with a MoE of 4%, this means that with 95% confidence, it is estimated that 46 – 54% (50 ± 4%) of spectacles will pass the indicator. If an MoE of 10% were selected, then 40 – 60% of spectacles are estimated to pass the indicator. Please be aware the smaller the MoE desired, the more USP visits are required.

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Figure 1 Example of Q.REC Sample Size Calculator

If there is an intention to compare sub-groups, for example, urban versus rural or private versus public services, the following calculator might not be sufficient. Additional sample size calculations will be required to ensure the sample size is sufficient to detect a differences between groups. However, clustering effects should also be taken into consideration.

Budgeting

The Q.REC Budget Template (Figure 2) can be used as a template for determining the study budget. The template will firstly require the number of spectacles per store, the number of optical services and total number of spectacles required (obtained from Q.REC Sample Size Calculator). There are a few assumptions or considerations that need to be taken when determining the study budget:

Reusing frames for budgeting purposes.

May need to have a couple of frames ‘on the go’.

The Q.REC Budget Template can be found here:

https://rebrand.ly/QREC-budget⁠

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Note: Unlike the Q.REC Sample Size Calculator, the Budget Template will need to be downloaded to be modifiable (shown in Figure 3).

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Figure 2: Example of Q.REC Budget Template

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Figure 3: How to download Q.REC Budget Template

Approvals, support and buy-in

Once the feasibility of the Q.REC study and an approximate plan has been determined, consider the stakeholders that are needed for approval and/or support for the project. For the Q.REC study to be recognised and findings to be trusted, support and buy-in from the Department/Ministry of Health, optical associations or refraction training institutions should be considered.

Ethical considerations

Applying for ethics approval should be submitted as soon as possible. All USPs should provide written consent to accept being trained to act as a standardised patient and allow their refractive error and demographics information to be collected and reported. There are three approaches when applying for ethics approval to collect information from optical service visits:

Opt-out approach

The opt-out approach is recommended. This approach involves providing a participant information statement to all services (not just the ones selected) to inform the study is occurring in their area, they might be selected and then should be offered the option to opt-out of participation. An example Participant Information Statement and Opt-out form is provided in Annex 2: Templates: Optical Services.

This option reduces the risk of USPs being detected and enables to actively review USP detection after all visits have been completed.

A disadvantage of using the opt-out approach is the potential delay of USP visits as enabling services to have enough time to decide to opt-out is required. We recommend a minimum of two weeks. Furthermore, if opt-out slips are received during USP visits, previous data already collected from the stores may have to be discarded. To avoid having to discard data, opt-out forms can be designed to allow for already collected information to be kept unless the services explicitly request for data removal.

Depending on your human research ethics committee (HREC) or institutional review board (IRB), they are significantly more likely to grant approval with this approach compared to not seeking any consent or notification.

No consent sought

The main advantage of not seeking consent from optical services is that there is less likelihood for USPs to be detected and optical services to change their behaviour. There is also less preparation required before training USPs and begin data collection. However, depending on the HREC or IRB applied to, they may or may not grant approval with this approach.

Opt-in approach – Informed signed consent

If the HREC/IRB insist on seeking informed signed consent, we would recommend the following:

Increase the amount of time from consent to the first USP attending to reduce the risk of USPs being detected.

Increase the sample size to account for more USPs being detected, as data will need to be excluded from analysis if USPs are detected.

Phase 2: Preparing for data management

REDCap customisation

The basic Q.REC data collection tools have been developed using REDCap (Research Electronic Data Capture), a secure, web-based software platform designed to support data capture for research studies.8, 9 We identify these data collection tools as the Q.REC REDCap project. If REDCap is unavailable, this study can be conducted on paper.

Uploading the Q.REC REDCap Project

The Q.REC REDCap project is available as an XML file that can be uploaded to your institution’s hosted REDCap for use. Guidance on how to create a new project and upload the data collection tools can be reviewed in the video here:

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https://www.loom.com/share/f6c7195d3ed547c6a85787329d3183c5⁠

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For those familiar or interested in pursuing this research with REDCap, we understand that each project might slightly differ, therefore there are opportunities to customise the project within REDCap. Several of the potential customisations to be considered are presented in the Project Setup section of the project (Figure 4).

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Figure 4: REDCap Project Setup Screen

REDCAP team roles

At a minimum, the study coordinator and study optometrist(s) should have an account to log into Redcap. Other co-investigators can be added. USPs are not required to have a Redcap account.

To add the study team and their individual accounts to the REDCap project, you will need to first request each of them to access to REDCap through your IT administration team that is hosting REDCap. Once provided access, each team member should receive an authentication link to activate their REDCap account. Once activated, then you can add them to the specific Q.REC REDCap project. Guidance on how to add study team members can be found here:

https://libguides.du.edu/c.php?g=948419&p=6838926⁠

The principal investigator can decide who within the study team has access to some or all ‘Instruments’/forms, as well as what capabilities they have within the project. Limiting what team members can see or do can sometimes help with making it simpler to use. To update each study team’s roles and capabilities, use the User Rights application (Figure 5 – black outline). Guidance on how to use the User Rights application can be found here:

https://www.ctsi.ufl.edu/files/2017/06/User-Rights-Guidance-Document.pdf⁠

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Figure 5: Relevant Applications in REDCap

Multi-site vs Single-site project

For a multi-site project, it is sometimes easier to keep track by entering the location(s) the USP has been allocated. A field within the “Project Admin” Instrument has been developed but will need to be updated with the location names.

If multiple sites have separate data collection teams, and each data collection team should only have access to the USP data for their site (recommended), then use the “DAGs” (Data Access Groups) application (Figure 5 – green outline). Guidance on how to use the DAGs application can be found here:

https://ctsi.wakehealth.edu/-/media/WakeForest/CTSI/Files/Services/Data/REDCap/Data/Data-Access-Groups.pdf?la=en⁠

Translating within Redcap

To translate the USP patient information statement and consent form, data collection forms, and survey settings, use the Multi-Language Management application (Figure 5 – orange outline).

Guidance on how to use the Multi-Language Management application can be found here:

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Part 1:

https://www.youtube.com/watch?v=w7Sd9LvJGKU⁠

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Part 2:

https://www.youtube.com/watch?v=h5KXQqjKwqE⁠

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Part 3:

https://www.youtube.com/watch?v=BXIKj7JvXVk⁠

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Part 4:

https://www.youtube.com/watch?v=bYB48beDQCU⁠

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Part 5:

https://www.youtube.com/watch?v=W6IYcIa9TmI⁠

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Making a duplicate project (for Form C only)

Before in-person training, the online training course should be accompanied with Form C: USP Optical Service Visit Checklist so USPs are introduced to what they will be using for data collection and have the opportunity to practice in their own time. To provide a practice form, there are two options

If USPs are collecting data in English: A separate REDCap project, ‘Q.REC Form C for Practice’ is available as an XML file can be uploaded to your institution’s hosted REDCap for use.

If USPs are collecting data in your local language: The most direct way is to duplicate your Q.REC REDCap project after the relevant forms have been translated using the Multi-Language Management application (see above), but only selecting Form C to be duplicated into a separate project and renaming the new project as ‘Q.REC Form C for Practice’.

Once Form C has been duplicated into a separate REDCap project, you can create a public link that will be emailed to the USPs. See the Section ‘Before in-person training’ for further details.

Updating Project Status from Development to Production Mode

When Q.REC REDCap Project has been uploaded into your host institution’s REDCap, it is currently set in “Development” mode. This means customisations can be made, changes can be tested and practice data can be entered without impacting data collection. Once familiar and happy with the project, “Move [the] project to production” mode, which can be found in the Project Setup section.

Phase 3: Recruiting for a Q.REC Project

Optical Services Recruitment

In this section, choosing the opt-out approach to recruiting optical services has been assumed.

Optical service inclusion/exclusion criteria

Table 1 Optical service inclusion and exclusion criteria

Inclusion

Exclusion

Provide refractive error services; both refraction and dispensing services

Optical service owner/manager opted out of the study

Personally known to the USP

Optical service had staff working across multiple services that have already been selected

There are no rows in this table

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Once a comprehensive list of optical services has been compiled, all services should be sent a Letter of Invitation accompanied with the Participant Information Statement and Withdrawal Form. Once the information is received, a minimum of two weeks should be provided to services to allow for them to ask questions and/or withdraw (i.e. no USP visits, but this time period is a good opportunity to conduct optometrist and USP training). For all the services that do not return a Withdrawal Form, they can be selected to be part of the study by using a simple randomisation technique.

Please be aware, services should still able to withdraw even once USP visits and data collection has begun. If you suspect a significant proportion of services will withdraw after data collection has started, consider increasing the sample size by 5-10%.

If no consent is sought from optical services, no waiting period for data collection is required. If an opt-in approach (where services sign a consent form) is chosen, then we recommend similar waiting periods as the opt-out approach to minimise USPs being detected.

USP Recruitment

The ideal USP is someone with refractive error and no other ocular complications, is detail-oriented, capable of retaining reasonable volumes of information, is prepared to undergo training and be undercover when visiting optical services. If REDCap data collection is to be used, we also recommend the USP to be familiar with using mobile devices.

Including emmetropes as USPs are useful to assess the effectiveness of quality of care, where optical services acknowledge that spectacles would not benefit the patient and would not recommend that upon them.

USP inclusion/exclusion criteria

Table 2 Unannounced standardised patient inclusion and exclusion criteria

Inclusion

Exclusion

Age 18 years or above

Fluent native speaker of the primary language of the district

Good ocular health

Either in need of spectacle correction or emmetropic

Prior refractive eye surgery

Eye surgery within the past 3 months

Manifest or intermittent strabismus

Amblyopia

An ocular or health condition that can cause variable spectacle prescription. Examples include (but not exhaustive): latent hyperope – where the amount of accommodation masks the hyperopia varies, keratoconus, pellucid’s marginal degeneration or other irregular corneal conditions, ocular surface disease, hydrops, glaucoma, binocular vision disorders, uncontrolled diabetes

Prior training in refraction or currently an eye care provider student

There are no rows in this table

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Example Recruitment Advertisement

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Recruitment Advertisement_Template.docx

8.4 MB

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Screening and ocular health assessment

The screening is conducted by an eye health professional to assess whether the USP passes the inclusion and exclusion criteria for recruitment. As a variety of refractive error types are desired, assessing a potential USP’s current spectacles, a quick retinoscopy or an autorefraction will suffice for the screening.

Note: Retinoscopy is the only technique of the three capable of detecting keratoconus, except if your autorefractor is combined with a corneal topographer.

The ocular health examination includes an anterior and posterior eye examination. Anterior eye examination should be conducted with a slit lamp, and the posterior eye examination can be conducted dilated or undilated with direct or indirect ophthalmoscopy techniques.

Successful recruitment of USPs

Once potential USPs have been screened and identified as suitable, all should be invited to participate and provide consent to ensure they are clear on what being a USP involves, what the benefits and risks are, and information on data privacy. A sample USP consent form can be found in Annex 3: Templates: USPs.

We have developed electronic consent forms in REDCap. The content of the consent forms should match the consent forms submitted to the HREC/IRB and therefore might need to be edited if USP consent is to be completed electronically.

Generally a copy of the signed consent form should be provided to the USP. If REDCap for electronic signing of the consent forms is used, download each copy manually and email this to the USP. This will allow them the opportunity to provide written withdrawal if they choose to. If any USP decides to withdraw verbally, this should also be considered acceptable. However, please check with the HREC/IRB that this is an appropriate procedure.

Phase 4: Training for a Q.REC Project

Study Optometrist/Refractionist Training

Study optometrists are responsible for:

Conducting USP baseline refractions

Provide training to USPs on observing refraction equipment and techniques

Assessing whether USPs are ready to visit optical services and act as a USP

Assessing the quality of the spectacles that the USPs order and collect from optical services

Manage (can be with the study coordinator) ongoing data collection by USPs

It is important for study optometrists to understand what is also expected of the USPs to be able to assist with training and quality control. A checklist of what the study optometrists need to familiarise themselves with can be found in Annex 4: Study optometrists’ training checklist. This includes familiarising with the protocol, study materials and electronic data collection resources.

Training for the study optometrists should take approximately 1 day. The study team can also use this training as an opportunity to discuss any uncertainties and potential issues.

USP Training

When USPs are carefully and systematically trained, they are very capable of high accuracy over time. USP training is a blended program approach (i.e. part online, part in-person). In-person training should take approximately 3 days and USPs should bring a mobile or tablet device they will also use during data collection that can access WiFi or mobile phone data. A basic training schedule (that can be adjusted for your context) is outlined below:

Table 3 Example of Unannounced standardised patient training schedule

Before in-person training

Day 1

Day 2

Day 3

Online training course

Study overview

USP Q.REC quiz

Group discussion

Baseline refraction - data collection

Remaining Baseline refractions

Introducing other eye examination techniques

USP scripts and ‘entry plan’

Data entry (REDCap training and Form C)

QC: quality control

Additional baseline refractions (If need 4th refractions)

Scheduling optical service visits

There are no rows in this table

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Before in-person training

It is recommended after USPs complete study consent and before in-person training, each USP reviews the online training materials and practices entering information into Form C. This will be the first introduction to the data collection form they will be using throughout the study. Two links should be emailed to them:

The online training course:

https://qrec.s3.ap-southeast-2.amazonaws.com/2022/index.html⁠

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The Form C for Practice: Your project will have a unique link that can be copied and pasted into the USP emails.

The online training course is currently only available in English. If you do not think USPs would benefit from an online course in English, then consider adding an additional day to in-person training for the study team to go through the online training materials in your local language. If continuing to have a blended learning approach is preferred, then consider having the online training course translated into your local language. Please contact Dr Ling Lee at linglee@hollows.org.

In-Person Training

Study overview

This session is to provide USPs an overview of the entire Q.REC study, to either introduce the project to those who did not complete the online training course, or to recap Unit 1 from the online training course. It is also an opportunity to provide the setting’s specific details such as areas the USP are visiting, number of stores and visits.

USP Q.REC quiz and group discussion

The USP Q.REC quiz has been developed in REDCap. An example can be found in Annex 5: USP Q.REC Quiz. During study optometrist training, the study team should have learnt how to send out the USP Q.REC quiz to each USP. Email the quiz to each USP for them to complete it on their phone. Once complete, USPs receive a score out of 10 and the study team can also review their responses within their own REDCap account in the Reports section. Review the results of the quiz and discuss any errors with the USPs as a group. The USPs should also be given the opportunity to ask questions about the quiz, refraction techniques and the study protocol.

Baseline Refraction – data collection

The baseline refraction is essential for this study as all spectacles ordered from optical services will be compared to the baseline refraction. Each USP is to have a minimum of three subjective refractions conducted by three different optometrists/refractionists in the same setting. For each USP, the three refractions will be averaged to determine the baseline refraction. If two refractions have at least a 0.75 dioptre difference in the spherical or cylindrical power, a fourth refraction should be conducted to determine which refraction should not be included for the averaged baseline refraction. Additionally, if the lowest and highest pupillary distances (distance and near separately) recorded are greater than 2mm difference,10 repeat measurements are recommended and to be updated in Form A.

To assess and compare the three refractions (spherical and cylindrical powers, and pupillary distances only), a ‘Baseline Refraction Report’ in REDCap as an instrument is available to determine whether a fourth refraction is required.

Although the main goal of conducting baseline refractions is to obtain the spectacle prescription for each USP, it is also a training opportunity for USPs. This will be the first practical experience of how a comprehensive refraction examination is conducted after theoretical training.

It is important for the optometrists to perform the procedures and explain to the USP what they are doing at each point. While these might be more than what the optometrists perform in regular practice, this is to be as comprehensive as possible to introduce USPs to as many possibilities they might experience at optical service visits.

It is also important to complete the eye examination by discussing the USP’s vision needs to determine the spectacle lens types they would be suitable for (which might be more than one lens type). The discussion should demonstrate to the USP the level of communication appropriate for optimal patient-centred care.

At some points, and if possible, each optometrist will conduct and demonstrate different techniques to introduce USPs to the variation they might observe on their optical service visits. An example can be found in Annex 6: Baseline Refraction Data Collection. It is important to consider the resources required to offer all the different options for USPs to observe, and that the optometrists are confident in conducting the techniques with less frequently used equipment.

Introducing other eye examination techniques

This session is guided by the planning exercise (Annex 1: Q.REC Planning) conducted prior to training where the study team identified all the potential eye examination techniques and equipment USPs might encounter on their optical service visits. Examples might include (and not necessarily in this order): non-contact tonometry, slit lamp examination, direct ophthalmoscopy, binocular vision testing.

Here the optometrists/refractionists will explain to them the differences in refraction equipment and techniques, and which of those they should continue to undergo to avoid detection and other tests they should refuse. Examples of what to say to avoid detection should also be provided.

USP visit Scripts

The goal of the USP visit script is to ensure the approach into every store by each USP is consistent. When entering a service, each USP will need to request an eye test. If public health services that provides other speciality eye care services are being attended, for example cataract or laser surgery, then make sure USPs only request for a test for glasses. As symptoms are often different for different refractive error profiles, suggested USP responses have been developed for each refractive error type in Annex 7: USP Scripts.

If the USP observes they have been detected during the optical service visit, they should do the following:

If detected at entering and before any eye tests: Leave the service as smoothly and quickly as possible. Do not undergo any tests or order glasses. No data will be used except the acknowledgement of detection.

If detected during the eye tests: Do not order glasses and leave the service as smoothly and quickly as possible. No data will be used except the acknowledgement of detection.

If detected after glasses have been order: Continue to pick up glasses and request a written prescription. Only the written prescription and USP observation data will be used for analysis.

If detected during pick up of glasses: Continue to pick up glasses and request a written prescription. All data collected, including glasses assessment, will be used in the analysis.

Data entry (REDCap training and Form C)

This session is for USPs to gain practical experience in how to access Form C: USP Optical Service Visit Checklist on their phones and have more practice with data entry. Showing the video, How to enter in Form C, is a good demonstration. The USPs can then practice entering data from accessing the public link created in the REDCap Project, ‘Q.REC Form C for Practice’. Please ensure you separate entering mock data from the real data and live project.

QC: Quality Control

This session is to assess USPs’ readiness to conduct optical service visits and data collection. There are two options:

External Optical Service Visits

Here each USP and the study optometrist are to visit external optical services that are not selected as part of the Q.REC study data collection. These may be services that are within walking distance from where USP training has been conducted. Please also attempt to select services where the study optometrist is not known to the staff.

The study optometrist and the USP will go to the optical service together. The USP will request for an eye examination and have a refraction. The study optometrist, if possible, would request to be present during the eye examination. The USP should complete the examination as per the external optometrist’s procedures. Here the study optometrist observes whether the USP behaviour might lead to being exposed. Examples of behaviour might include:

Asking too many technical questions

Asking questions that might lead the optometrist to change their regular consultation procedures.

After the examination is complete, the USP should only ask for a prescription. No spectacles should be ordered. Once the USP and study optometrist leave the service, they both should complete the checklist in Form B: USP Practice and Quality Control.

Review Form B and discuss where the visit and observations could have been improved. Following the discussion, the study optometrist should complete the bottom section of Form B.

In some contexts, eye examination fees are required. If so, please consider this when you budget for a Q.REC project.

Internal Quality Control

Here each USP are to complete refractions with the study optometrists who have conducted training and baseline data collection within the training facilities. Here the study optometrist(s) will not explain the procedure to the USP and will follow the list of procedures outlined in Annex 9: Internal Quality Control Procedures and Scenarios. Following the refraction, the USP should request for a prescription and then complete the visit checklist in Form B: USP Practice and Quality Control.

This option is only possible if you can ensure the study optometrist(s) conducting the refractions can consistently include and exclude the procedures as outlined in Annex 9: Internal Quality Control Procedures and Scenarios.

This option is most efficiently completed when there are multiple refraction stations so more than one USP can be completing practice optical service visit at the same time. If the study optometrist is also conducting refraction(s), an additional observer to assess whether USPs are acting covertly should also be present. The additional observer can be another study optometrist or study coordinator or peer USP.

The USP should compare their checklist to a pre-filled “correct” form and discuss with the additional observer in areas where it can be improved. Following the discussion, the study optometrist/additional observer should complete the bottom section of Form B.

Scheduling optical service visits

The study team and USPs should work together to organise the optical service visit schedules. Some things to consider when scheduling:

Whether all recruited USPs will be visiting all optical services or will the USPs be grouped into teams to attend some of the optical services.

The availability of USPs (i.e. some might have part-time jobs or are studying)

Whether USPs will be visiting optical services on weekends and availability of study optometrists.

Days and times at which optical services might be closed

Whether appointments need to be arranged

Not all USPs visiting the same service visit at once or within a small timeframe to minimise risk of detection

Include travel time required – to each service and remote locations

For visiting services within the same city/town, we recommend a maximum of 4 service visits can be completed per day without significant fatigue experienced by the USP

For the first couple days of data collection, consider scheduling fewer service visits in one day for USPs to become comfortable and familiar with the processes.

A document detailing all USP schedules should be kept by the study coordinator. It is important that these are followed as closely as possible so the quality of data entry can be assessed appropriately.

Phase 5: Conducting field work

Field work includes USP visits and USPs returning to the study optometrist to have the spectacles assessed. After the first couple days of field work and data collection, it is important for the entire study team including USPs to reflect on their experiences, identify and resolve any issues for smoother running of the project.

Study staff will need to develop a system of tracking dispensed spectacles, so that they can be linked to the USP and Optical Service ID. However, to ensure the privacy of the optical services, no business names or their addresses should be kept once the study is complete.

If USPs return to the study optometrists with multiple pairs of glasses, it is important to continue to complete focimetry after vision and comfort are checked. It might practically appear more efficient to check vision and comfort with all pairs of glasses followed by focimetry. However, we do not recommend consecutively checking vision and comfort with all pairs of glasses at the same visit as checking vision and comfort with multiple pairs of glasses in a row is unlikely to provide reliable outcomes.

Assessing data quality

A Q.REC study is only as good as the quality of data collected and recorded. It is important to be familiar with each data collection form and the type or expected data for each variable/field, and to regularly conduct data quality control. We recommend data quality should be assessed at the following points and who is needed to be followed up with:

Table 4 Data quality assessment recommendations

Data collection tool

When to conduct data quality control

Data recorder, i.e. who should I follow up with

Form A: Baseline USP Data Record Form

As soon as baseline refractions are complete and entered into REDCap

Study optometrists

Form C: USP Optical Service Visit Checklist

During USP data collection to minimise USP recall bias.

USPs

Form D: Assessment of Glasses

During spectacle assessment when study optometrists record or enter and upload the data into REDCap.

Study optometrists

There are no rows in this table

⁠

Things to look out for across all data collection forms:

Missing data

REDCap has been designed where some fields/variables are compulsory to enter, therefore minimising missing data. However, it is still important to review the forms to see if there are any missing data, and to follow up with the corresponding person who entered the data.

Letters or symbols (string data) where there should be numbers

Most data are easier to analyse when numbers are entered in. Some typing errors (such as including letters or symbols) can cause number data to become text when downloaded as spreadsheets or data files for data analysis software like SPSS or STATA. Examples to look out for during data quality control include optometrists entering in ‘plano’ for spherical component of a prescription, or ‘N/A’ or ‘-‘ for no cylinder power or a near addition. All should be entered as ‘0’ or ‘0.00’

Entering in data electronically also increases risk of typing errors.

Examples include:

Additional ‘.’ in the number, i.e. “+5..00”

A space before or after a number

Text comments

Some data collection forms will have variables/fields where the data recorder can include some text. This might be in spaces where they select ‘Other’ and a new box appears to add some sort of description or note, or an ‘Additional Notes’ section. It is important to review the text comments to see if it can be updated to an existing checkbox, whether the context of the description is clearly understood, and to observe for signs where the data recorder might need additional assistance.

Additional things to look out for in Form A: Baseline USP Data Record Form

Inconsistency in the recorded USP age and/or gender across the (minimum) 3 Form A’s completed. You need to be certain that each study optometrist has entered the right information corresponding to the correct USP ID.

Missing or incorrect positive or negative signs in front of spherical power or near addition

Incorrect number data entry e.g. +12.5 entered rather than +1.25

Both distance and near (binocular) pupillary distances should be entered in (i.e. there should be no missing data) , even if only one type of single vision lenses is recommended.

Pupillary distances appear to be outside normal ranges of (47 – 75mm).

Near viewing distances appear to be outside traditional ranges of (30 – 55cm).

Optometrists should tick all the spectacle lens types, not just one, that they think the USP would be suitable for after they discuss with the USP their refractive error correction needs.

Additional things to look out for in Form C: USP Optical Service Visit Checklist:

Any variables where ‘Unsure’ has been selected. Follow up with the USP to go through their experience and determine whether a 'Yes’, ‘No’ or other checkbox can be selected.

Any procedures of the refractionist/optometrist that do not appear to make sense. Examples:

If the USP selected ‘Yes’ that a distance subjective refraction was completed, but reported ‘No’ phoropter or trial frame were used, then how was subjective refraction completed?

If the USP selected ‘Yes’ that a distance subjective refraction was completed, and ‘Yes’ a trial frame was used, but ‘No’ spherical or cylindrical component were completed, then what occurred during the distance subjective refraction completed?

If the USP recorded they were ‘Unsure’ what type of glasses they were recommended yet recorded ‘Yes’ to clear communication about the which glasses (lenses or frames) they needed.

Consistency of clinician gender and qualification certificates amongst the USPs that attend the same store. This does depend on the size of the service. It is possible USPs see different clinicians on different days and/or are tested in different consultation rooms. However, it should be followed up with all USPs when all forms for the same store are entered and compared.

Additional things to look out for in Form D: Assessment of Glasses

Ensure the type of glasses lenses are selected correctly

Missing or incorrect positive or negative signs in front of spherical power or near addition

Incorrect number data entry e.g. +12.5 entered rather than +1.25

Lens centration distances are outside normal ranges of 47 – 75mm.

Near viewing distances appear to be outside traditional ranges of 30 – 55cm.

Visual acuity and/or comfort levels for all spectacles dispensed are the same.

Cylindrical axes from the written prescription are missing

Written prescriptions have not been uploaded into REDCap

Phase 6: Analysis and reporting

About the data

After the data are cleaned, analysis is recommended to be conducted by either a biostatistician or a researcher with statistical analysis experience.

What data should be excluded?

If more than 3 baseline refractions were conducted on a USP, exclude the refraction(s) that are the most different to the others.

If USPs were identified by certain optical services, the number and percentage of visits should be reported, however their data should be removed from all other analysis.

Q.REC indicators

The Q.REC indicator(s) are used to compare the dispensed spectacles from optical services to the USP’s baseline prescription.

Q.REC indicator 1: Optimally prescribed spectacles

Q.REC Indicator 1 is the key primary outcome for this study. It has been demonstrated that when glasses pass this indicator that USPs have significantly better vision and comfort compared to glasses that do not pass this indicator.5 This shows us the quality of refractive error care and information to plan and monitor optical services.

Table 5 Q.REC Indicator 1 criteria

Spectacle component

Tolerance limits compared to baseline prescription

Spherical power

± 0.50 dioptre

Cylindrical power

± 0.50 dioptre

Cylindrical axis (if baseline |cylindrical power| ≤ -0.50 DC)

± 7 degrees

Cylindrical axis (if baseline |cylindrical power| > -0.50 DC - ≤ -1.50 DC)

± 5 degrees

Cylindrical axis (if baseline |cylindrical power| > -1.50 DC)

± 2 degrees

Horizontal prism (total)

< 1 prism dioptre (in/out direction)

Vertical prism (total)

< 0.50 prism dioptre (up/down direction)

There are no rows in this table

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Q.REC indicator 2: Adequately prescribed spectacles

For settings where sphero-cylindrical lenses are rarely prescribed or available, Q.REC indicator 2 can be used as the primary outcome that shows the quality of refractive error care. Similarly, it can help with planning and monitoring optical services, however is not as accurate as Q.REC indicator 1. For projects that use Q.REC indicator 1 as the primary outcome, Q.REC indicator 2 can be a secondary outcome or not used at all.

Table 6 Q.REC Indicator 2 criteria

Spectacle component

Tolerance limits compared to the baseline prescription

Spherical equivalent power

± 0.50 dioptre

Horizontal prism (total)

< 1 prism dioptre (in/out direction)

Vertical prism (total)

< 0.50 prism dioptre (up/down direction)

There are no rows in this table

⁠

Data transformation

Baseline refractions

For each eye, all components of the refraction should be averaged, this includes the distance spherical power, near spherical power (particularly if the USP has a near addition with their prescription) cylindrical power, cylindrical axes, distance and near pupillary distances, and distance and near visual acuities.

Categorising into refractive error types

Each USP can be grouped into at least one refractive error type based on the baseline refraction. The following definitions for each type are recommended:

Myopia: spherical equivalent < -0.50 DS in at least one eye

Hyperopia: spherical equivalent > +0.50 DS in at least one eye

Astigmatism: > 0.50 DC in at least one eye

Emmetropia: spherical equivalent ≥ -0.50 DS and ≤ +0.50 DS in both eyes

Presbyopia (objective definition): ≥ 1.00 D added to the best optical distance correction

Note: To calculate spherical equivalent, the following formula can be used

Visual acuities

Distance and near visual acuity for the right, left and both eyes should be converted into logMAR decimal format. As each USP is likely to have unique near working/viewing distances, near visual acuity should be recalculated to account for their working distance.

Categorical variables of ‘good vision’ can be created for the right and left eyes separately and with both eyes open. USP while wearing dispensed spectacles is considered to achieve ‘good vision’ if the corrected visual acuity is <1.5 lines worse than baseline best-corrected visual acuity at distance or near.

suitability of spectacle lens types

A USP is considered suitable for a spectacle lens type (either single vision distance / single vision near / bifocal / multifocal) if at least one of the study optometrists ticks that they are suitable for that lens type.

Q.REC Indicator 1: Optimally prescribed spectacles

To compare the dispensed spectacles to the baseline refraction on whether the spectacles pass Q.REC Indicator 1, data are required to be transformed and calculated

(Table 7⁠

Table 7 To determine whether dispensed spectacles are within Q.REC Indicator 1 and its components

Component / Indicator

Steps

Spherical power

For each eye:

Calculate the absolute difference of spherical power (in dioptres) between the dispensed spectacles and the baseline spherical power of most plus axis).

Is the absolute difference ≤ 0.50 D ?

If the answer is “Yes” for both eyes, then the spectacles pass the spherical power component

Cylindrical power

For each eye:

Calculate the absolute difference of cylindrical power (in dioptres) between the dispensed spectacles and the baseline cylindrical power.

Is the absolute difference ≤ 0.50 D ?

If the answer is “Yes” for both eyes, then the spectacles pass the cylindrical power component

Cylindrical axis

For each eye:

Comparison can only be performed with USPs that have astigmatism in their baseline prescription. For each eye:

Calculate the absolute difference of cylindrical axis (in degrees) between the dispensed spectacles and baseline cylindrical axis of the most minus meridian. Note: It is important to consider the range of tolerance particularly if baseline cylindrical axis is around the horizontal meridian. E.g. If baseline refraction were -1.00/-0.50x180, the axes that would pass this component criteria are 1 – 7 degrees, and 173 – 180 degrees

If the baseline cylindrical power was ≤ -0.50 DC, was the absolute difference of cylindrical axis within 7 degrees of the baseline axis?

If the baseline cylindrical power was > -0.50 DC - ≤ -1.50 DC, was the absolute difference of cylindrical axis within 5 degrees of the baseline axis?

If the baseline cylindrical power was > -1.50 DC, was the absolute difference of cylindrical axis within 2 degrees of the baseline axis?

If the answer is “Yes” in both eyes (assuming both eyes have some astigmatism), then the spectacles pass the cylindrical axis component

Horizontal prism

For each eye:

Calculate the monocular decentration amount (cm) by subtracting the lens centration distance (mm) from baseline pupil distance (mm) and dividing by 20 (takes into account halving for each eye and converting into centimetres)

Calculate the spectacle lens power at the horizontal meridian (180 degrees). If baseline axis is 180, then it should be the spherical power of the baseline prescription. If the baseline axis is 90, then it should be the spherical + cylindrical power of the baseline prescription. If it is an oblique axis, additional calculation

Calculate the magnitude of horizontal prism using Prentice’s rule: p=c x F

Determine the direction of the prism, is it base-in or base-out in each eye?

Calculate the total amount of induced prism. If both eyes have prism in the same direction (i.e both base-in or both base-out, then add the magnitude together. If the prism direction is different between the eyes (i.e. base-in in the right eye and base-out in the left eye, or vice versa), then subtract one magnitude from the other.

Is the total amount of induced horizontal prism less than 1 prism dioptre (△)?

If the answer is “Yes”, then the spectacles pass the horizontal prism component

Vertical prism

If you are using a digital focimeter, this can be automatically determined for you, so long as the glasses remain on the same plane as you move between the right and left lenses.

If you are using a manual focimeter, first centre and clamp the right lens so that the optical centre is in the middle of the graticule and adjust the lens table to the bottom of the spectacle frame so it is resting on the table. Unclamp the lens and move the frame over to measure the left lens. Be sure not to change the height of the frame table. Looking at the target through the eyepiece, If the target of the left lens looks higher or lower than the graticule centre, then there is vertical prism. You use the markings within the graticule to determine the amount of vertical prism – depending on your machine, some markings indicate 0.5△ steps, others indicate 1.0△ steps.

To determine the direction of vertical prism:

If the target for the left lens is higher than the right lens, there is base-up prism in the left lens (compared to the right lens)

If the target for the left lens is lower than the right lens, there is base-down prism in the left lens (compared to the right lens)

Is the total amount of induced horizontal prism less than 0.5△?

If the answer is “Yes”, then the spectacles pass the vertical prism component

QREC Indicator 1

Spectacles are optimal if:

Spherical power component = PASS AND

Cylindrical power component = PASS AND

Cylindrical axis ponent = PASS OR Both eyes did not require cylinder powers at baseline (i.e. no astigmatism in either eye) AND

Horizontal prism component = PASS AND

Vertical prism component = PASS

There are no rows in this table

⁠

To compare the written prescription to the baseline refraction on whether the spectacles pass Q.REC Indicator 1, at a minimum, the steps of spherical power, cylindrical power and cylindrical axis components in Table 7 are applied. The horizontal prism component can be considered for inclusion if pupil distance(s) are provided in the written prescription.

Q.REC Indicator 2: Adequately prescribed spectacles

To compare the dispensed spectacles to the baseline refraction on whether the spectacles pass Q.REC Indicator 2, data will require transformation (Table 8).

Table 8 To determine whether dispensed spectacles are within Q.REC Indicator 2 and its components

Component / Indicator

Steps

Spherical equivalent power

For each eye:

Calculate the spherical equivalent power (in dioptres) from the baseline prescription

Calculate the spherical equivalent power (in dioptres) from the dispensed spectacles

Calculate the absolute difference of spherical equivalent power (in dioptres) between the dispensed spectacles and the baseline.

Is the absolute difference ≤ 0.50D ?

If the answer is “Yes” for both eyes, then the spectacles pass the spherical equivalent power component

Horizontal prism

Refer to Table 7

Vertical prism

Refer to Table 7

QREC Indicator 2

Spectacles are adequate if:

Spherical equivalent power component = PASS AND

Horizontal prism component = PASS AND

Vertical prism component = PASS

There are no rows in this table

⁠

To compare the written prescription to the baseline refraction on whether the spectacles pass Q.REC Indicator 2, the steps of spherical equivalent power component in Table 8 are applied. The horizontal prism component can be considered for inclusion if pupil distance(s) are provided in the written prescription.

Analysing and presenting the data

The following section is a recommendation of data that can be analysed and presented. This initial analysis might produce emerging outcomes that are of interest to your context and warrant further analysis.

Flowchart

A flowchart of the optical services sampling frame, the ones excluded, recruited, USPs recruited, services visited and the number of spectacles dispensed are the minimum details to be included (Example in Figure 6).

All optical services

[Location]

N = [number]

Optical services withdrawn n = [number]

Selected optical services

[Location]

n = [number]

Visits attempted

[number] USPs [number] visits

Unsuccessful visits n = [number]

Dispensed spectacles

[total number] of spectacles SVD n=[number] SVN n=[number]

Excluded from primary analysis [number and reasons why spectacles excluded]

Included in primary analysis

[number] USPs [number] optical services [total number] spectacles SVD n=[number] SVN n=[number]

There are no rows in this table

⁠

Figure 6 Example Q.REC Flowchart

USP characteristics

Describing USP characteristics can be presented in a table. Examples of descriptors include:

Age – mean and standard deviation or categorised into groups

Gender

Refractive error type

Presence of presbyopia

Pupil distances – mean and standard deviation

Types of spectacle lenses the USPs are suitable for

The table can be presented as the total group or disaggregated. If USPs are disaggregated, Fisher’s exact tests or Chi-square tests for categorical variables or ANOVA for continuous variables can be used to test USP differences by their disaggregated groups.

Optical service characteristics

Describing optical service characteristics, such as who provided care and testing procedures used, can be presented in a table. Examples of descriptors include:

Gender of clinician who conducted refraction

Whether certification of refraction or health department registration observed

Focimetry conducted

Components of distance refraction

Components of near refraction

Pupil measurement conducted

Clarity of communication

Primary analysis of spectacle quality – Q.REC Indicator(s)

The main outcome of the Q.REC study is the proportion of spectacles that are optimal and/or adequate in quality (i.e. pass Q.REC Indicator 1 and/or Q.REC Indicator 2) including a 95% confidence interval. This can be disaggregated by location, or spectacle type (if there is a hypothesis that there might be a quality difference in the way distance and near spectacles are dispensed). Sampling weights should also be considered if any particular sub-groups are much larger than others, and the number of spectacles dispensed for each sub-group differ. The confidence intervals should be estimated by using robust standard errors to account for intra-service correlation.

Q.REC Indicator 1 or 2 can also be presented on the proportion of glasses that pass each indicator component, and the patterns of whether each component are met or not.

The written prescription outcome would be the proportion of written prescriptions that are optimal or adequate in quality. The proportion and 95% confidence interval can be disaggregated, and also compared to the main spectacle outcomes above. The confidence intervals should be estimated by using robust standard errors to account for intra-service correlation.

Association between spectacle quality and USP and/or optical service characteristics

The association between spectacle quality and USP and/or optical service characteristics can be assessed via univariable logistic regression. Multivariable regression models can also be considered. Robust standard errors should also be used within all logistic regression models to account for intra-service correlation. Results can be presented with odds ratios, 95% confidence intervals and p-values.

Association between written prescriptions and optical service characteristics

Similarly, the association between written prescriptions and USP and/or optical service characteristics can be assessed via univariable logistic regression. Multivariable regression models can also be considered. Robust standard errors should also be used within all logistic regression models to account for intra-service correlation. Results can be presented with odds ratios, 95% confidence intervals and p-values.

Association between dispensed spectacles and written prescriptions

Data enables you to assess whether the written prescriptions provided to the USP match the dispensed spectacles.

Unnecessary prescribing with emmetropes

If emmetropes are recruited to be USPs in the Q.REC study, the proportion of visits where emmetropes were recommended spectacles can be described. The association between emmetropes being recommended spectacles and optical service characteristics can also be assessed with logistic regression. Results can be presented with odds ratios, 95% confidence intervals and p-values.

Phase 7: Finding meaning

A wide range of information can be obtained from the Q.REC study. Some examples can be found below (Table 9). The Q.REC outcomes should be able to identify:

Areas of refractive error services or clinical practice measures that might need improvement and to support evidence-based interventions

Evidence for advocacy, awareness creation for potential policy changes

Gaps in information that would benefit from further research