Physician, patient, and caregiver experience of different wet age-related macular degeneration anti-VEGF treatment regimens in Japan: a qualitative assessment

Figures & data

Table 1 Background information of interviewees’ institutions

	All ophthalmologists	University hospital ophthalmologists	Nonacademic hospital ophthalmologists	Clinic ophthalmologists
Number of ophthalmologists in the institution
≥11	6	6	0	0
6–10	3	0	2	1
1–5	9	1	5	3
Number of ophthalmologists trained for intravitreal injections
≥11	2	2	0	0
5–10	2	2	0	0
2–4	10	3	6	1
1	4	0	1	3
Institution size (bed count)
≥1,000	3	3	0	0
500–999	5	3	2	0
20–499	5	0	5	0
Unknown or ≤19	5	1	0	4
Payment method
DPCa	14	7	7	0
Non-DPC	4	0	0	4
Designated treatment location for anti-VEGF injections
Outpatient treatment rooms	7	5	1	1
Operating rooms	9	1	6	2
Both	2	1	0	1
Need to reserve space to perform anti-VEGF injections
Necessary	10	2	7	1
Unnecessary	8	5	0	3

Note:

a An inpatient bundle payment system similar to the diagnosis-related groups used in Medicare in the US.

Abbreviations: anti-VEGF, anti-vascular endothelial growth factor; DPC, diagnosis procedure combination.

Table 2 Number of patients seen by the interviewees

	All ophthalmologists	University hospital ophthalmologists	Nonacademic hospital ophthalmologists	Clinic ophthalmologists
Weekly number of patients with ophthalmic conditions
≥201	4	1	1	2
101–200	8	3	4	1
≤100	6	3	2	1
Weekly number of wAMD patients (%)
≥70%	4	4	0	0
30%–69%	4	3	1	0
≤29%	10	0	6	4
Experience with proactive treatment (number of patients)a
≥101	10	7	2	1
11–100	3	0	2	1
≤10	5	0	3	2

Note:

a Proactive treatment includes both fixed-dosing and T&E.

Abbreviations: T&E, treat-and-extend; wAMD, wet age-related macular degeneration.

Table 3 Benefits and issues of T&E compared with PRN from the patient/caregiver perspective as understood by the treating ophthalmologist

Benefits
Able to tangibly experience treatment efficacy through the sustained period of macular dryness	• Patients know that their treatment is working when their injection intervals increase • Treatment intervals can be adjusted to meet patient needs while maximizing the period of dryness
Decrease in emotional burden associated with receiving intraocular injections	• Since their injection schedule is determined months ahead, patients are emotionally prepared on the day of injection, decreasing their emotional burden toward treatment • Patients become proactive toward treatment as their symptoms stabilize with the preventive injections
Decrease in patient/caregiver time burden	• Scheduling visits with patients’ family members is easier as the majority of patients are elderly and require accompaniment by their family members • The number of treatments that had to be postponed because family members were unable to accompany patients to the clinic has decreased • Visits only have to be once every few months
Issues
Increased financial burden for the patients	• The financial burden may increase since the number of injections increases with T&E • Explaining the administration method is difficult without any aides, which makes it more difficult for patients to accept the financial burden • It is difficult to explain to patients how long they need to continue their injections with the lack of long-term evidence
Worry of complications	• The risk of infections may increase with the increased number of injections

Abbreviations: PRN, pro re nata; T&E, treat-and-extend.

Table 4 Benefits and issues of T&E compared with PRN from the treating ophthalmologist perspective

Benefits
Shorter consultation time per patient	• With PRN, at every injection, the patients need to be informed that their symptoms have worsened, but with T&E, such explanations can be omitted since injections are administered regardless of symptoms • If the administration method of T&E and its meaning are explained thoroughly at the first consultation, subsequent consultations are shorter since patients already understand why they are receiving injections • Scheduling does not take as long as with PRN since the treatment goal is clear with T&E
Decrease in burden of developing patient-specific treatment plans Decrease in overall psychological stress	• With a predetermined injection schedule, there is no need to accommodate the patients’ and ophthalmologists’ schedules on a per-injection basis • Since the patients’ visit and injection schedules are based on the previous injection interval, scheduling is much easier • There is no need to explain why the patients require an injection. Moreover, worsening of symptoms does not occur frequently with T&E, so the treatment process is easier to handle • The patients’ disappointed expressions are not seen when they come in for an injection that is predetermined and is not administered because the symptoms have worsened • There is less burden of explaining the treatment process since injection intervals are constant or are even extended in certain cases
Easier to set injection schedules	• Injections can be provided months in advance, which makes it easier to set the injection schedules for patients and foresee capacity
Issues
Explaining the necessity of proactive injections as prevention	• The significance of proactive injections is not easily accepted by patients who have stabilized and entered maintenance phase since the effectiveness is less tangible than at the beginning of treatment. Patients with wAMD in only one eye or who have not experienced worsening of symptoms require more time in accepting continued preventive injections • Thorough explanation of the significance of proactive injections at the initial consultation is essential in getting patients to continue with long-term treatment • Without cost-effectiveness data, explaining the necessity of proactive injections as a preventive measure is difficult
Increased financial burden	• There have been cases where patients refuse T&E due to financial reasons • Thorough explanation of the financial burden is important in order for patients to be willing to undergo long-term treatment. However, this is especially difficult for first-time patients or for patients who have not experienced recurrence or worsening of symptoms
Insufficient area designated for injections	• Even though the number of patients has increased, the clinic space to provide injections remains unchanged
Insufficient human resources	• While patient numbers have increased with better treatment results and fewer dropouts, it has been difficult to increase the staff to match the increased demand
Increased number of appointments	• The time to process scheduling appointments has increased with the increase in patients receiving injections, which has cut into consultation times

Abbreviations: PRN, pro re nata; T&E, treat-and-extend; wAMD, wet age-related macular degeneration.

Figure 1 Issues arising from the introduction of T&E categorized by institution type.

Notes: Total number of respondents were 18 (university hospital: seven, nonacademic hospital: seven, and clinic: four). Respondents were asked to identify issues they faced when introducing T&E into their practice after already practicing PRN. Respondents were allowed to answer multiple issues.
Abbreviations: PRN, pro re nata; T&E, treat-and-extend.

Table 5 Issues arising from introducing T&E and their countermeasures as answered by university hospital ophthalmologists

Phase	Issues	Specific examples of issues	Countermeasures
Patient explanation phase	Explaining the necessity of proactive injections as prevention	• Since the impression of T&E is “more injections” than PRN, it is difficult to get the patient to accept the possible increased burden that comes with more injections	• Explained the efficacy/effectiveness in a more tangible way to the patient – Utilized OCT images so the patients could understand that they were undergoing the best treatment option – Clarified that without continuous injections, their symptoms would worsen
Operational phase	Insufficient space for injections	• Even though the number of patients has increased, the clinic space to provide injections remains unchanged	• Strengthened cooperation with other local institutions and referred patients – Suggested switching to local facilities by highlighting better transportation access and more attentive care than at a busy university hospital. Also, at local facilities, anti-VEGF therapy was considered an outpatient procedure, unlike our facility, which means less financial burden – Explained to patients that they will have to return to the university hospitals if they relapse, which resulted in greater acceptance of switching facilities
	Insufficient human resources	• It is difficult to increase the staff to match the increased number of patients • It takes time to manage both consultations and injections	• Strengthened cooperation with local facilities and referred appropriate patients • Employed part-time ophthalmologists – With part-time ophthalmologists from temporary agencies, it was possible to focus on injections on the designated injection days and have the part-time staff take on other consultations • Delegated tasks of the injection process and defined the roles of each ophthalmologist – Proactively included the younger staff into the rotations for their experience and to balance the burden of experienced members – Delegated specific tasks to each staff member: consultations, injections, processing appointments, OCT and fundoscopy, explanation of injections, and consultations prior to injections • Shortened the turnaround time of patients receiving injections – Changed the order of each room so that patients move efficiently in one direction: waiting room → examination room → OCT/fundoscopy → consultation room → treatment/injection room – Placed nurses both inside and outside of consultation rooms to efficiently guide patients to the next step in the treatment process – Changed the rules so that patients can step onto the injection table with their shoes on to shorten the time per patient for injections
	Increased burden of managing appointments	• The time to process scheduling appointments has increased with the increase in patients receiving injections, which has affected consultation times	• Strengthened cooperation with local facilities and referred appropriate patients • Implemented a scheduling system to manage appointments – Decreased the processing burden by implementing an original scheduling system

Abbreviations: anti-VEGF, anti-vascular endothelial growth factor; OCT, optical coherence tomography; PRN, pro re nata; T&E, treat-and-extend.

Table 6 Issues arising from introducing T&E and their countermeasures as answered by nonacademic hospital ophthalmologists

Phase	Issues	Specific examples of issues	Countermeasures
Patient explanation phase	Explaining the necessity of proactive injections as prevention	• Since the impression of T&E is “more injections” than PRN, it is difficult to get the patient to accept the possible increased burden that comes with more injections • Cannot explain the cost-effectiveness of the injections during the maintenance phase	• Explained the efficacy/effectiveness in a more tangible way to the patient – The importance of reducing risk before symptoms worsen was explained to the patient using their OCT images – The patient was also advised that restarting treatment after symptoms have worsened has reduced effects – Although no reports have been presented at academic congresses for high-risk patients on the verge of dropping out, extending their injection interval for >3 months was considered
Operational phase	Insufficient space for injections	• Even though the number of patients has increased, the clinic space to provide injections remains unchanged	• Provided injections in outpatient treatment rooms instead of operating rooms
	Insufficient human resources	• It is difficult to increase the staff to match the increased number of patients • It takes time to manage both consultations and injections	• Designated roles within the staff – Roles were separated for consultations, which require more experienced staff, and injections, which can be administered uniformly by any of the ophthalmologists, in order to make the process more efficient – The nurses took the patient’s history prior to consultations

Abbreviations: OCT, optical coherence tomography; PRN, pro re nata; T&E, treat-and-extend.

Table 7 Issues arising from introducing T&E and their countermeasures as answered by clinic ophthalmologists

Phase	Issues	Specific examples of issues	Countermeasures
Patient explanation phase	Explaining the necessity of proactive injections as prevention	Since the impression of T&E is “more injections” than PRN, it is difficult to get the patient to accept the possible increased burden that comes with more injections	• Explained the efficacy/effectiveness in a more tangible way to the patient – To patients who were concerned with the financial burden, OCT images of before and after treatment were shown during the initial consultation, so that they could understand the effectiveness of the injections – While the actual number of injections may not differ compared with PRN, it was explained to the patients that the number of visits are fewer with T&E, which can decrease their time and financial burden – Tried to keep patients motivated by discussing the possibility of a cure from IPS research in the future and telling them that they may not have to continue the injections forever
	Handling concerns of financial burden from long-term treatment	• It is difficult to get patients who have never experienced relapse or worsening of symptoms to understand • Without cost-effectiveness data, explaining the necessity of the financial burden is difficult	• Prioritized patients who were referred from other hospitals and understood T&E – Patients who have been treated at university hospitals have already received a thorough explanation of T&E and have a better understanding of the treatment as the ophthalmologists tend to be AMD specialists at these hospitals. These patients were prioritized because they tended to be more accepting of the treatment regimen

Abbreviations: AMD, age-related macular degeneration; OCT, optical coherence tomography; PRN, pro re nata; T&E, treat-and-extend.