Getting started

Approvals and buy-in

Before advancing with the detailed planning or implementation of a Q.REC study, securing approvals, support, and buy-in must be prioritised as a foundational step. Establishing stakeholder engagement and buy-in early on is critical to ensure that there is trust, and long-term success of the project.

Once the feasibility of the Q.REC study and an approximate plan have been assessed, it is essential to identify and involve key stakeholders who will play a pivotal role in granting approval or providing necessary support for the study. These stakeholders may include the Department or Ministry of Health, optical associations, and institutions involved in refraction training. Without their endorsement and engagement, the study may face significant challenges in recognition, trust in findings, and successful execution.

Engaging with these stakeholders early ensures alignment with national or regional health priorities and standards. It also fosters ownership of the project among those who will be critical for implementation and scaling of its recommendations. This step involves building relationships, presenting the proposed study’s objectives and anticipated impact, and addressing potential concerns or barriers to participation.

Additionally, support and buy-in from these stakeholders contribute to the legitimacy of the study and its findings. Ministries of Health or equivalent bodies can lend the necessary authority to integrate the study’s outcomes into broader health policies, while optical associations and training institutions can help ensure that the recommendations are practical, implementable, and widely accepted within the field.

By securing approvals, support, and buy-in as a first step, the Q.REC study lays the groundwork for a trusted and impactful initiative that aligns with the needs and expectations of all key stakeholders.

Feasibility assessment

Essential Study Personnel

• Study coordinator. Must be familiar with all study materials & protocol. Responsible for sample size calculator, budgeting template, ethics application, recruitment forms, optometrist training materials, USP training materials, data collections forms, and data quality control procedures.

The study coordinator can also be a study optometrist

• Study optometrists/refractionists: Must have experience in refraction techniques and dispensing. Teaching and research experience is desirable. Responsible for USP training, data collection, baseline refractions. An additional optometrist will need to be on standby to conduct any additional baseline refractions required.

A minimum of three study optometrists/refractionists are needed for USP training

• USPs: Ideally has refractive error but no other ocular complications. Must be detail oriented, capable of retaining information, must complete training. Responsible for visiting optical services and collecting observation data use a mobile device (REDCap). 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.

Additional Study Support Personnel

• 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

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

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.

USPs

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 smartphone 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.

For each refractive error type, we recommend recruiting more than USP. Training more USPs shares the demand and workload of data collection, but also reduces the potential of having individuals that are more challenging to refract that underestimates Q.REC.

Advertising for USPs

Consider how many and where flyers might be placed and online advertisements.

We have provided a USP Recruitment Advertisement Template that can be modified as needed.

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.

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.

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.

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.

Planning exercise: Eye Examination Techniques for USPs

This planning exercise 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

Study optometrists

What is needed for training?

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.

Calculating sample size

The Q.REC sample size calculator 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.

1. Anticipated Proportion: The estimated proportion of spectacles estimated to pass/fail the chosen indicator. 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.
2. Optimal versus Adequate: 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. Review the Q.REC Indicators:
3. Intraclass correlation coefficient (ICC): This coefficient indicates the degree of correlation between spectacles within the same store. For instance, if three USP visits occur at one optical service, does getting the first pair of spectacles correct increase the likelihood of the second and third being correct as well. If the primary outcome is the ‘optimally prescribed spectacles’ indicator and there is uncertainty about the linkage between USP visits to the same store, an ICC value of 0.2 is recommended. If the primary outcome is the ‘optimally prescribed spectacles’ indicator and there is minimal linkage between USP visits to the same store, an ICC value of 0 or 0.1 is recommended. If the primary outcome is the ‘adequately prescribed spectacles’ indicator, an ICC value of 0.2 or 0.3 is recommended.
4. Margin of Error (MoE): The margin of error 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 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.

If you intend to compare sub-groups as your primary outcome, for example, urban versus rural or private versus public services, the Q.REC sample size 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 budget template 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).

Some studies elect to ‘reuse’ frames, as purchasing new frames every time can be very expensive. If you decide to ruse frames, you may need to have a couple of frames for each USP so, they can visit multiple optical services within a short time period.

The Budget Template will need to be downloaded to be modifiable.

Ethical considerations

USP Consent:

Optical Service Consent:

There are three approaches when applying for ethics approval to collect information from optical service visits:

1. 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 Sheet and Opt-out form is provided. 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.

2. 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.

3. 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.

Relevant documents