Patient Reported Outcomes Measurements (PROM) of Cataract Surgery : Comparison of Outcomes between Hospital-Based versus Outreach Cataract Centre. A Prospective Cohort Study.

doi:10.21203/rs.3.rs-4969429/v1

Objectives: This study aims to compare the outcomes of cataract surgery using Patient reported outcome measures (PROM) between a general tertiary hospital setting and an outreach cataract centre. PROM reports the benefits of surgery from the point of view of the patient instead of a clinical evaluation, which reduces the biases by practitioners.

Methods: Prospective Cohort Analysis. Patients were recruited at Hospital Selayang and The Hospital Selayang-MAIWP Cataract Care Centre (Pusat Pembedahan Katarak Hospital Selayang-MAIWP or PPKM in Malay) prior to their cataract surgery between 1 July 2022 and 30 October 2022. Printed Questionnaires were given to patients according to their language preferences, ie, English, Malay language and Mandarin. The Catquest-9SF questionnaires were completed prior to their cataract surgery and 6 weeks post-surgery. Patient demography, visual acuity and data was retrieved from electronic medical records at both centres. Mean comparisons between centres were made for post-operative visual acuity in LogMar and post-operative Catquest-9SF. Logistics regression analysis was performed for each domain of the Catquest-9SF to the patient’s demographic data, underlying illnesses, first eye surgery, pre- , and post-operative visual acuity.

Results:

Both centres revealed identical demographic constitution of patients. By comparing means of post operative visual acuity and post operative Catquest-9SF scores, there were no significant differences between the two centres. This is also supported by the improvement/ non-improvements of Catquest-9SF scores, which showed no significant difference between the two centres. Patients from Hospital Selayang had higher percentages of improvements with subcategories Ca (difficulty in everyday life), Cb (satisfaction with current sight), C2 (Recognising faces), and C5 (Seeing to do handicrafts, woodwork).

Logistic regression analysis revealed that pre-op visual acuity appears to be associated with an improvement of functional daily fine visual acuity tasks, whilst patients with cardiovascular and cerebrovascular diseases are associated with leisure associated fine visual acuity tasks. Patients with hypertension however are associated with significant improvements in domains Ca (difficulty in everyday life), C3 (seeing prices of goods), C5 (Seeing to do handicrafts, woodwork) and C6 (Reading Subtitles).

Conclusion:

Improvements in patient reported visual functioning were not significantly different between the two centres. This validates the dedicated outreach cataract centres as places where good clinical and patient reported outcomes can be achieved.

Catquest-9sf

Visual Function

Vision Related Quality of Life

Patient reported outcomes

Cataract Surgery

Global blindness is estimated to be 61 million by 2050.¹ Cataract, a global eye problem is expected to increase in prevalence in an aged population.^1–3 Locally, National Eye Survery II 2014, estimated that, there were 413 000 individuals in the country with visual impairment, 43 000 individuals were blind in both eyes due to cataract.⁴ Improving services and effectively allocating resources will enable Malaysia to address the challenges posed by cataracts in the future.

Hospital is defined as an institution which is primarily engaged in providing to inpatients, by or under the supervision of physicians, diagnostic services, and therapeutic services for medical diagnosis; treatment and care of injured, disabled, or sick persons; or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Such term does not include psychiatric hospitals.⁵ Outreach clinic is defined as a facility or a specific location in a facility designated by a regional contractor to provide covered medical services or covered support services in a setting other than a regional clinic.⁶

Ophthalmology services in Malaysia are typically divided into hospital and outpatient clinic settings. The cataract surgery and ophthalmology services delivered in hospital settings are considered the standard of care expected by patients. However, due to the constraints of hospitals with multi-disciplinary requirements, the availability of operating theatre time for cataract surgeries is limited. Outreach clinic is a method to increase the specialised services rendered outside of a hospital.

A dedicated cataract centre has been established by the Ministry of Health of Malaysia to enhance the services provided to the population. The Hospital Selayang-MAIWP Cataract Care Centre (Pusat Pembedahan Katarak MAIWP -Hospital Selayang or PPKM-HS in Malay), initiated in response to the growing demand for cataract surgery due to the aging population, aims to improve the effectiveness and efficiency of cataract surgery⁷. Since January 2013, the PPKM-HS has been performing cataract surgeries in an outreach clinic setting. This specialized centre exclusively focuses on cataract cases, which receives referral from all over the country.

This pilot study aims to utilize the Catquest-9SF questionnaire to assess the patient reported outcomes of cataract surgery performed in an outreach clinic compared to a hospital. By employing a patient-reported outcome measure, this study eliminates biases that could potentially inflate the perceived success of clinic setting cataract surgery. The objective is to demonstrate that cataract surgeries conducted in an outreach setting is comparable to those performed in hospital setting, while offering advantages such as reduced waiting times, improved access, and better crowd control. Soundarajan et al found that the outreach clinic setting has superior cataract surgery outcomes as determined by visual acuity outcomes.⁸ Soundarajan et al. reported that outreach programme clinic setting has a higher percentage of patients achieving post operative refracted visual acuity of < 1.0 Dioptre.⁸ However, as mentioned, these perceived successes were measured based on clinical measures.

Traditionally, the outcome of cataract surgery has been measured objectively. However, in recent years, there has been a shift towards prioritizing patient perception and patient-reported outcomes.^9–13 With the current tools available, we can collect patient-reported outcomes and gather feedback from patients. It is crucial that the services provided involve the patients themselves and not solely rely on one-sided reports of outcomes.^2,9–12,14

The Catquest-9SF questionnaire is widely used for patient-reported outcome measures (PROM) in various eye surgeries, including cataract and cornea surgeries..^9,15–17 Catquest-9SF is the questionnaire used in Swedish national cataract registry for the last decade as reported by Lundström et al.⁹ Claesson et al validated Catquest-9SF for the use to evaluate visual function after corneal transplant.¹⁵ It has been validated in Malay and Chinese versions in 2018, enabling objective feedback and qualitative measurements from patients.¹⁶ The utilization of this questionnaire serves as a valuable tool to enhance efficiency, improve services, and meet the needs of the population served.

Catquest-9SF has two global questions and seven categorical questions. All questions have five response options, namely: very great difficulty, great difficulty, some difficulty, no difficulty, and cannot decide. The two global questions are item A: “Do you find that your sight at present in some way causes you difficulty in your everyday life?” and item B: “Are you satisfied or dissatisfied with your sight at present?” These two questions reflect patients’ overall satisfaction of their visual function.

The subsequent seven questions reflect different types of visual function of the patient associated with cataract. The seven questions are item C1: “Reading text in newspapers”, item C2: “Recognising the faces of people you meet”, item C3: “Seeing the prices of goods when shopping”, item C4: “Seeing to walk on uneven surfaces, e.g., cobblestones”, item C5: “Seeing to do handicrafts, woodwork, etc.”, item C6: “Reading subtitles on TV”, and item C7: “Seeing to engage in an activity/hobby that you are interested in.” Each item in the questionnaire reflects a domain of visual function and is assessed separately.

It is hoped that the findings from this study will contribute to better planning, resource allocation, and the expansion of outreach programs like PPKM-HS in Malaysia.

2.1 Rationale of Study

This study intends to encourage mobilisation and deployment of outreach programmes for the benefit of Malaysian population. Catquest-9SF is proven to be a good measurement of the surgical and functional success of cataract surgery. This study intends to quantify the effectiveness of dedicated outreach Cataract Centre services in Malaysia in comparison with surgical services rendered in a hospital.

2.2 Study Objectives

2.2.1 Main Objective
To compare and evaluate the outcome of Cataract surgery by PROM between two centres – a hospital based and outreach cataract centre.

2.2.2 Specific Objectives

a. To compare mean change in PROM scores between the 2 centres

b. To analyse relationship between each PROM parameter and cataract centre, patient demographics and clinical factors.

c. To compare pre and post operative visual acuity outcomes between the two centres

3.1 Outreach programmes: Enhancing services in peripheral areas without specialist hospitals.

Limited resources are the main restricting factors of good healthcare standards in any country. Outreach programmes is an effective method to deliver services that were scarce or has poor accessibility. Gruen et. al. found that these programmes may improve access to care, quality of care, health outcomes, patient satisfaction, and use of specialised medical services.¹⁸

Soundararajan K et al. have proven and consolidated the fact that outreach programme clinic can have equivalent or superior surgical outcomes when compared to hospital settings in the local Malaysian setting.⁸ By consolidating and planning with limited resources and optimizing the allocation of manpower, outreach programs have the potential to enhance eye health services in our country. Patient feedback can further propel these programs, providing greater exposure to specialized eye care services.

3.2 Survey and data driven progress is key for improvements of eye health.

Questionnaires serve as a reliable method for assessing service performance. This method eliminates the biases that occur when data is measured by clinical outcomes, and therefore is more objective than analysis by visual acuity. There is a global need for effective and cost-efficient approaches to delivering eye health services.^1,9,11,13,17Continuous progression and improvement of eye health services are essential to achieving the World Health Organization's goal of integrating eye care into universal health coverage (UHC). By validating and enhancing these services, eye health interventions can become more effective and cost-efficient.^{9,11,12,14,17}

3.3 Catquest-9SF: A choice for Patient-Reported Outcome Measures (PROMs) and outcome comparison in cataract surgery.

Cataract surgery is a major eye health service aimed at restoring vision. Performing cataract surgery in various settings represents a significant milestone. By collecting PROMs, we can gather feedback on the services provided and measure their effectiveness. Catquest-9SF has a successful track record spanning over 10 years.^9,17Its effectiveness has been validated through numerous studies and research worldwide, comparing it to other cataract-related PROMs.¹⁴

McAlinden et al have found that Catquest-9SF is most concise and short questionnaire.¹⁴ They found that the most responsive questionnaire was the Catquest-9SF, with an Effect Size (ES) of 1.45 (95% CI 1.22,1.67), Other PROMs, such as Quality of Life (QoL), Visual Disability Assessment (VDA) also has their advantages, ie, VDA has higher responsiveness with mobility. However, other questionnaires are not as short and concise as Catquest-9SF. In Malaysia, Catquest-9SF has another advantage, Adnan et al have translated the questionnaires into Malay language and Mandarin version.¹⁶ In a multi racial setting like Malaysia, utilizing these questionnaires in patients' native languages may enhances comprehension and completion.¹⁶

4.1 Study Hypotheses

1. Null hypotheses: There are no differences in patient reported outcomes of surgical services rendered in an outreach cataract centre compared to hospital setting.

2. Alternative hypotheses: There are differences in outcome of surgical services rendered in an outreach Cataract centre compared to hospital setting.

4.2 Ethical Approval

This study was conducted in accordance to the Declaration of Helsinki. It was approved by the Medical Research Ethics of Malaysia. (NMRR-20-3258-5652, Research ID 56521)

4.3 Methodology

4.3.1 Study Design and Study Duration

This prospective cohort study was conducted at the Ophthalmology Clinic of PPKM (Cataract Outreach Centre) and Hospital Selayang from July 2022 to September 2022. It aimed to assess the impact of cataract surgery on visual function and quality of life among patients.

4.3.2 Study Population and Recruitment

The study population consisted of patients with unilateral or bilateral cataracts who were scheduled for cataract surgery. Convenience sampling was used to recruit participants from the clinics. Only patients who underwent phacoemulsification with monofocal intraocular lens implantation were included in this study.

Patients were included if they were adults (more than 18 years old) and capable of understanding Malay, English, or Mandarin languages.

Patients with other ocular pathologies or diseases that could affect visual acuity were excluded from the study. Patients who encountered intra-operative or post operative complications, i.e. posterior capsular rupture, vitreous loss, aphakia, cystoid macular oedema, cornea decompensation, significant astigmatism were excluded from this survey. Additionally, patients diagnosed with mental illness or those with unaided hearing impairment or muteness were also excluded.

To minimize patient attrition rates, efforts were made to interview patients who missed subsequent follow-up appointments via telephone. Their responses were obtained by primary investigator to ensure data completeness and accuracy.

Table 1 Summary of inclusion and exclusion criterias.

Inclusion Criteria

Exclusion criteria

1. Adult patient (age more than 18 years)

2. Malay, English, Mandarin speaking

3. Phacoemulsification

4. Monofocal intraocular lens Only

1. Underlying ocular pathology which affects visual acuity, ie macular degeneration, macular edema, etc

2. Intra-operative or post operative complications, i.e. Posterior capsular rupture, vitreous loss, aphakia, cystoid macular oedema, cornea decompensation, significant astigmatism

3. Mental illness or those with unaided hearing impairment or muteness

4. Refractive intraocular lenses

4.3.3 Sample Size

Based on the commonly used guideline in survey research, a rule of thumb suggests having a minimum of 10 participants per category in Catquest-9SF questionnaire. Since the questionnaire consists of 9 categories, a total sample size of at least 90 for each centre would be recommended. However, to ensure a more robust analysis and increase the statistical power, a larger sample size of 220 cataract patients was chosen.

4.3.4 Study Tools

A written consent form containing a description of the study was provided to the patients, and they signed it upon agreement (See Appendix A). Two questionnaires were administered as part of the study. The questionnaires were distributed on the operative day and again six(6) weeks after the surgery during the refraction examination.

Basic demographic information, underlying medical illnesses, cataract type, and visual acuity data were extracted from the electronic medical record (EMR) system. Patients with bilateral cataract who participated in this questionnaire was denoted as patients with first eye surgery and retrieved from these data.

4.3.5 Data Collection Procedure

Patients were recruited on the day of their cataract surgery in the pre-operative room. They were provided with the Catquest-9SF questionnaire and consent form to complete. In case of any inquiries, patients were directed to the designated person in charge on that day.

The second questionnaire was given to patients after the refraction examination conducted by the responsible optometrist at between week 4 to 6 after surgery. The completed questionnaires were collected on the same day. For patients who were missed during this period, telephone interviews were conducted to gather their responses regarding their experience after cataract surgery.

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

4.4 Statistical Methods

The data analysis was performed using IBM SPSS Statistics software version 27.0. Descriptive analysis was conducted to describe the demographic data and characteristics of the samples. The mean visual acuity was calculated and compared between the two centres. The mean of post operative Catquest-9SF scores was calculated and compared between the two centres. The correlation between underlying illnesses, age group, gender, existing eye disease, uni-/ bilateral cataract, post-operative and pre-operative visual acuity with improvements of each Catquest-9SF items was analysed with logistic regression analysis.

A total of 220 patients were selected and answered the questionnaire. However, 23 patients from Hospital Selayang and 3 patients from PPKM were subsequently noted to have underlying eye diseases that affected post-operative visual acuity and were excluded. 5 patients from Hospital Selayang and 1 patient from PPKM who had significant astigmatism, intra-operative and post operative complications were also excluded. Additionally, 1 patient from Hospital Selayang dropped out of the study due to lost to follow-up. So, in total data from 86 patients from Hosp Selayang and 106 patients from PPKM were analysed for this study.

Figure 1 Total number of patients recruited.

The demographic data is presented in Table 2. Both groups were generally equal in all aspects with exception of less co-morbidities and lack of co-existing eye disease in those undergoing cataract at the Outreach Cataract Centre.

Table 2 Demographic Data

Risk Factors		Centre				p-value
		Hospital Selayang		PPKM- HS
		n	(%)	n	(%)
Age Group	<40	1	1.2	1	0.9	0.435
	40-49	7	8.1	2	1.9
	50-59	10	11.6	16	15.1
	60-69	32	37.2	38	35.8
	70-79	34	39.5	45	42.5
	>80	2	2.3	4	3.8
Ethnicity	Malay	42	48.8	51	48.1	0.806
	Chinese	26	30.2	36	34.0
	Indian	18	20.9	19	17.9
Gender	Male	41	47.7	56	52.8	0.477
Gender	Female	45	52.3	50	47.2
No Known Medical illness		35	40.7	20	18.9	0.001^*
Diabetes Mellitus		36	41.9	51	48.1	0.387
Hypertension		37	43.0	63	59.4	0.240^*
Cardiovascular		9	10.5	11	10.4	0.984
Cerebrovascular		8	9.3	2	1.9	0.021^*
Renal		2	2.3	2	1.9	0.832
Other illnesses		11	12.8	12	11.3	0.755
First Eye		52	60.5	61	57.5	0.683
Existing eye diseases		39	45.4	9	8.5	0.000^*
PPKM-HS – Pusat Pembedahan Katarak MAIWP- Hospital Selayang
*. The Chi-square statistic is significant at the .05 level.

Table 3 Pre-operative and post operative Log-MAR visual acuity.

Centre		Mean	(SD)	p- value	95% C. I.
Centre		Mean	(SD)	p- value	Lower	Upper
Preop VA	Hospital Selayang	1.3	(0.92)	0.496	-0.341	0.165
Preop VA	PPKM-HS	1.4	(0.85)		-0.343	0.167
Postop VA	Hospital Selayang	0.2	(0.12)	0.802	-0.031	0.04
Postop VA	PPKM-HS	0.2	(0.13)		-0.031	0.04

PPKM-HS – Pusat Pembedahan Katarak MAIWP- Hospital Selayang
VA – Visual Acuity
SD – Standard Deviation,
C.I. – Confidence interval

Table 3 shows pre-operative and post-operative visual acuity in LogMar for both centres. Both centres have identical objective performance; however, among the study patients, those from Hospital Selayang had slightly better post-operative best-corrected visual acuity. Independent T-test revealed no significant differences between the post-operative visual acuity between the two centres.

Table 4 Pre- Cataract surgery Catquest–9SF questionnaire responses.

Number of respondents (n)
Score	0		1		2		3		4		Mean Score (SD)
Centre	A	B	A	B	A	B	A	B	A	B	A	B
Ca ‑ Difficulties in any way in daily life	0	0	15	31	38	34	25	31	8	10	2.3 (0.87)	2.2 (0.97)
Cb ‑ Satisfaction with vision/sight	0	1	25	38	38	43	20	18	3	6	2.0 (0.82)	2.0 (0.92)
C1- Reading text in newspaper	0	0	26	37	29	34	23	27	8	8	2.2 (0.96)	2.1 (0.95)
C2 - Recognizing faces of people you meet	0	0	13	19	27	29	30	27	16	31	2.6 (0.97)	2.7 (1.09)
C3- Seeing prices of shopping goods	1	1	19	34	33	33	18	22	15	16	2.3 (1.05)	2.2 (1.07)
C4- Seeing to walk on uneven ground	0	0	18	29	27	28	30	27	11	22	2.4 (0.96)	2.4 (1.11)
C5- Seeing to do needlework, handicraft	1	2	22	32	30	32	20	22	13	18	2.3 (1.05)	2.2 (1.11)
C6- Reading subtitles on the TV	1	1	24	38	27	34	28	26	6	7	2.2 (0.98)	2.0 (0.96)
C7- Seeing to carry out a preferred hobby	0	0	19	32	27	28	21	31	19	15	2.5 (1.07)	2.3 (1.05)

Response modalities: 1‑Very dissatisfied, 2‑Fairly dissatisfied, 3‑Fairly satisfied, 4‑Very satisfied, 0‑Cannot decide.
SD=standard deviation
Higher score indicates better visual functioning.
Centre Modalities : A -Hospital Selayang B-PPKM-HS

Table 4 revealed that the mean pre-operative score at Hospital Selayang were higher overall. However, there were higher standard deviation among PPKM patients.

Table 5 Post cataract surgery Catquest-9SF questionnaire responses

	Number of respondents
	Score	0		1		2			3		4		Mean Score (SD)
	Centre	A	B	A	B	A	B	A		B	A	B	A	B
Ca	Difficulties in any way in daily life	0	0	1	4	3	1	19		31	63	70	3.6 (0.60)	3.6 (0.70)
Cb	Satisfaction with vision/sight	0	0	0	2	5	5	21		33	60	66	3.6 (0.59)	3.5 (0.68)
C1	Reading text in newspaper	1	0	3	1	8	4	17		39	57	62	3.5 (0.89)	3.5 (0.62)
C2	Recognizing faces of people you meet	0	1	2	0	0	1	12		15	72	89	3.8 (0.57)	3.8 (0.54)
C3	Seeing prices of shopping goods	0	2	0	0	2	2	31		26	53	76	3.6 (0.54)	3.6 (0.71)
C4	Seeing to walk on uneven ground	1	0	0	0	5	3	19		24	61	79	3.6 (0.71)	3.7 (0.51)
C5	Seeing to do needlework, handicraft	1	4	0	0	8	4	22		31	55	67	3.5 (0.76)	3.5 (0.89)
C6	Reading subtitles on the TV	0	0	0	1	7	2	23		32	56	71	3.6 (0.64)	3.6 (0.57)
C7	Seeing to carry out a preferred hobby	0	0	0	0	3	4	18		26	65	76	3.7 (0.52)	3.7 (0.54)
Response modalities: 1‑Very dissatisfied, 2‑Fairly dissatisfied, 3‑Fairly satisfied, 4‑Very satisfied, 0‑Cannot decide. SD=standard deviation Higher score indicates better visual functioning. Centre Modalities : A -Hospital Selayang B- PPKM

Table 5 shows the results of the post-operative Catquest-9SF questionnaire according to subcategories. Hospital Selayang had higher proportion of post-operative results that were not “no difficulty”. This was especially seen in the two global categories in questions A and B. However, PPKM had fewer poor sub-categorical results.

5.2 Mean comparison between two centres.

Table 6 Mean change (pre- vs post- operative PROM scores) and comparison between two centres: Hospital Selayang and PPKM-HS.

	Mean change %		Mean Change, p-value^a (95% CI)		Mean comparison ^b HS VS PPKM
	Hospital Selayang	PPKM-HS	Hospital Selayang	PPKM-HS	p-value	(95% C.I. )
Ca -Difficulties in any way in daily life	34.3	34.8	<0.001 (-1.56, -1.12)	<0.001 (-1.62, -1.16)	0.303	(-0.09, 0.29)
Cb -Satisfaction with vision/sight	40.8	40.8	< 0.001 (-1.85, -1.41)	<0.001 (-1.81, -1.37)	0.276	(-0.08, 0.29)

C1 -Reading text in newspaper	33.0	36.8	<0.001 (-1.60, -1.04)	<0.001 (-1.69, -1.25)	0.564	(-0.28, 0.15)

C2 -Recognizing faces of people you meet	30.5	28.5	<0.001 (-1.46, -0.98)	<0.001 (-1.37, -0.91)	0.639	(-0.15, 0.24)

C3- Seeing prices of shopping goods	32.0	36.8	<0.001 (-1.53, -1.03)	<0.001 (-1.71, -1.23)	0.601	(-0.23, 0.13)

C4 -Seeing to walk on uneven ground	30.5	33.0	<0.001 (-1.53, -1.03)	<0.001 (-1.54, -1.08)	0.513	(-0.25, 0.13)

C5-Seeing to do needlework, handicraft	31.3	31.8	<0.001 (-1.47, -0.93)	<0.001 (-1.54, -1.00)	0.297	(-0.14, 0.45)
C6- Reading subtitles on the TV	35.3	40.3	<0.001 (-1.60, -1.10)	<0.001 (-1.84, -1.42)	0.479	(-0.24, 0.11)
C7- Seeing to carry out a preferred hobby	31.3	35.3	<0.001 (-1.50, -1.00)	<0.001 (-1.64, -1.19)	0.651	(-0.19, 0.31)

^a-Paired T-test,

^b- Independent T-test for Equality of Means
PPKM-HS – Pusat Pembedahan Katarak MAIWP- Hospital Selayang

C.I. – Confidence interval

The mean comparison analysis compares the means of the post operative Catquest-9SF results between two centers, Hospital Selayang and PPKM-HS. It assessed whether there is a significant difference in the means of the variable across the two centers.

Mean change percentage revealed less than 5% difference in the changes of scores between Hospital Selayang and PPKM-HS. The significance level (p-value) associated with the F-value was higher than the typical threshold of 0.05. Therefore, there was no significant evidence to reject the null hypothesis, suggesting that there was no significant difference in means between Hospital Selayang and PPKM-HS for the post operative Catquest-9SF.

This result was supported by comparing means of post operative visual acuity, which revealed that there were no significant differences of the results.

5.3 Relationship between each PROM parameter and cataract centre, patient demographic and clinical factors

Table 7: Summary of p-values of Logistics Regression Analysis.


		Improvement		SLR				MLR
		n	%		95% C.I				95% C.I.
		n	%	Crude OR	Lower	Upper	p-value	Crude OR	Lower	Upper	p-value
Catquest Ca
Centre	Hospital Selayang	71	42.8	0.56	0.22	1.38	0.207
	PPKM	95	57.2
Hypertension		96	57.8	4.01	1.34	12.01	0.013	2.25	1.08	4.69	0.03
Catquest Cb
Centre	Hospital Selayang	76	42.9	0.61	0.22	1.71	0.35
	PPKM	101	57.1	0.77	0.46	1.3	0.337
Catquest C1
Centre	Hospital Selayang	63	40.4		0.48	2.3	0.902
	PPKM	93	59.6	0.91	0.61	1.34	0.632
Pre-op VA				1.57	1.01	2.46	0.048	1.75	1.14	2.69	0.011
(LogMar)				1.57	1.01	2.46	0.048	1.75	1.14	2.69	0.011
Catquest C2
Centre	Hospital	64	45.1	0.52	0.24	1.09	0.082
Centre	Selayang	64	45.1	0.52	0.24	1.09	0.082
	PPKM	78	54.9
Catquest C3
Centre	Hospital Selayang	62	40.3	0.52	0.24	1.087	0.679
	PPKM	92	59.7
Hypertension		91	59.1	1.68	0.67	4.22	0.017	2.13	1.09	4.17	0.028
Pre-op VA (LogMar)				1.45	0.98	2.16	0.011	1.925	1.24	2.99	0.003
Catquest C4
Centre	Hospital Selayang	66	42.9	0.735	0.34	1.6	0.425
	PPKM	88	57.1
Age Group	<40	2		0.61	0.4	0.94	0.025	0.655	0.45	0.96	0.032
	40-49	9
	50-59	25
	60-69	56
	70-79	61
	>80	1
Ethnicity	Malay	78	50.6	0.61	0.39	0.96	0.032	0.631	0.42	0.96	0.031
	Chinese	50	32.5
	Indian	26	16.9
Catquest C5
Centre	Hospital Selayang	63	42.3	0.87	0.41	1.85	0.712
	PPKM	86	57.7
Hypertension		81	54.4	2.85	1.08	7.48	0.034				0.615
Cardiovascular disease		11	7.4	0.23	0.07	0.79	0.02	0.4	0.16	1.02	0.056
Cerebrovascular Accident		6	4	0.19	0.04	0.85	0.03				0.186
First Eye		90	60.4	2.002	0.1	4.02	0.051				0.064
Catquest C6
Centre	Hospital Selayang	70	41.2	1.08	0.43	2.67	0.877
	PPKM	100	58.8
Hypertension		99	58.2	3.51	1.01	12.19	0.049	3.52	1.48	8.39	0.004
Cerebrovascular Accident		8	4.7	0.16	0.03	0.89	0.037	0.23	0.05	1.06	0.06
Catquest C7
Centre	Hospital Selayang	58	40.6	1.3	0.64	2.62	0.472
	PPKM	85	59.4
SLR – Univariate Logistics regression, MLR – Multivariate logistics Regression VA – Visual Acuity C.I. – Confidence interval OR – Odds Ratio

Logistics regression analysis was performed to investigate the relationships between the changes in scores of pre-operative and post-operative Catquest-9SF scores and the patients' demographic and clinical factors. (Table 7)

Logistic regression analysis revealed that different factors had different effect on the change of Catquest-9SF improvements. Pre-op visual acuity appears to have statistically significance in the improvement of fine visual acuity domains such as reading text in newspaper (C1) and seeing prices of shopping goods (C3), whilst patients with cardiovascular and cerebrovascular diseases are associated with improvement in leisure activities such as needlework (C5) and reading subtitles on the television (C6). Patients with hypertension have association with domains Ca (Difficulties in any way in daily life), C3, C5 and C6.

Our study compared patient outcomes for cataract surgery at Hospital Selayang and PPKM. Both centres revealed significant mean score changes after Cataract surgery as seen in table 5. However, by mean comparison, there are no significant differences in post operative Catquest-9SF score between the centres. While the patient populations were demographically similar except for a slightly younger age at Hospital Selayang. Younger patients and Malay patients showed predicted improvements in category C3 (Seeing prices of shopping goods), which is walking in uneven surfaces. This suggests that these patients experience improved mobility after cataract surgery. There were statistically significant differences in ocular co-morbidities (higher at Hospital Selayang),pre-existing hypertension and cerebrovascular accidents. Patients with existing eye disease (45.35% vs 8.5%) and patients with no known medical conditions are also seen more frequently in Hospital Selayang (40.7% vs 18.9%). However, these factors did not have significant impact on the Catquest-9SF scores.

Mean analysis of post-operative Catquest-9SF scores revealed no significant clinical differences between the centres. Furthermore, despite lower overall improvement rates in Catquest-9SF scores at PPKM, multivariate analysis showed no statistically significant difference in final scores between the centres. This could be due to several factors, including potentially better initial visual function and overall health in PPKM patients. Despite that PPKM have a less crowded environment and streamlined services compared to a tertiary hospital, the post operative scores of the questionnaire revealed no significant differences. The questions of Catquest-9SF are specific and patients’ responses to the questionnaire indicating their perceived improvements showed that the treatment weighted more significantly on patients’ satisfactions.

Moreover, excluding patients with complications might limit the generalizability of PROM results in our study, as these complications can influence patient perceptions. As a known factor that affects Catquest-9SF results, excluding these patients allows a fairer comparison of the work process between the centres. By excluding complication from cataract surgery, it also excludes the confounding factor of individual surgeon performances. The seniority, techniques, and skills of individual surgeons in each centre was not reviewed during this study. A detailed and structured study may provide better and fair comparisons by patients should be planned to further improve services.

The mean change and overall post operative scores were identical for both centres. Mean post operative visual acuity depicts a same result. This is also supported by multi-variate regression analysis which revealed no significant differences between the two centres on each category of visual function.

Exploratory analysis with regression analysis reveals association of improvements with specific factors. Younger patients and Malay-ethnic patients have showed improvements with visual function associated with mobility. Only patients with hypertension were associated with global satisfaction of visual function. Ezegwui et al revealed that satisfaction of patients may be affected by factors that are outside of the scope of this study.¹⁹ Ezegwui found that toilet facilities could impact patients’ satisfaction towards eye care services.¹⁹ However, it also shows that cultural differences and demographic differences may have effects on patients’ satisfaction. In our comparison between two centres, Malay patients may appreciate the association of visual function with mobility more than other races involved.

Hypertension showed a predicted improvements in domain of Ca, C3 (Seeing prices of shopping goods), C5 (Seeing to do needlework, handicraft) and C6 (Reading subtitles on the TV). Patients with cerebrovascular accidents also showed a predicted improvement in the domains of C5 (Seeing to do needlework, handicraft) & C6 (Reading subtitles on the TV). Both groups of patients showed satisfaction and improvements in near and fine visual functions, which may be significantly affected by cataract prior to surgery. Presbyopia and significant relieve from it after cataract surgery may have caused these responds. However, this study did not review the target refraction and lens power selection.

In categories that involves near and fine visual functions, patients with hypertension, cerebrovascular accidents, cardiovascular illnesses, and bilateral cataract showed significant association with improvements in satisfaction. These patients might be the patients with the greatest improvements of visual acuity after cataract surgery. Possible lower expectations and subsequent improvements of these patients’ visual function may have played a role in their satisfaction. However, these groups of patients did not showed association with other categories. This may be the perceived success was different when compared with other patients, ie patients with no known medical illnesses. It may also show that the global satisfaction was identical among all patients.

Pre-operative visual acuity has predicted improvements in category C1 (Read newspapers) & C3 (Seeing prices of shopping goods), which are category which involves reading, i.e. reading newspapers and seeing price tags. These categories are significant in patients’ daily activities, and specific questions prompted these patients to show significant satisfactions in these categories.

Adnan et al found during validation of Malay language and mandarin versions of Catquest-9SF, that the difficulty of answering specific questions were comparable with other countries, with the hardest questions being question C2 (Recognizing faces of people you meet) & C7 (Seeing to carry out a preferred hobby). ¹⁶ Whilst Seth et al found that domain Cb (Satisfaction with vision/sight Improvement) & C6 (Reading subtitles on the TV) were hardest questions.¹⁷ This suggests that culture, daily activities, socio-economic status, and education may affect the difficulty and results of the questionnaires. This is further strengthened with specific Malay and younger patient showed association with improvements with score associated with mobility.

Soundarajan et al. reported superior refractive outcomes at PPKM in 2021, but both centres showed identical mean post-operative visual acuity in our study.⁷ This suggests potential improvements at Hospital Selayang over the past 3 years. However, the smaller cohort size in our study limits direct comparability. Notably, their analysis focused on surgical outcomes, while PROM assesses patient experience, influenced by factors beyond technical success.

Findings from Seth et al. and Lundström et al. regarding associations between specific factors and PROM scores weren't replicated in this study, highlighting the potential influence of methodological differences and study populations.^{8, 17}

Seth et al proved that patients with bilateral cataract have better improvements of Catquest-9SF scores.¹⁶ Multivariate analysis of our study did not reproduce these results. Lundström et al have proven that ocular co-morbidity and second-eye surgery were also significantly related to postoperative Rasch score. There was an exception in the early year of analysis in 2008. This result was also not observed in our smaller study.

The demographic differences of these studies with our study may depict a difference of expectations with cultural and demographic differences. The timing of surgery and the severity of cataract may also play a role in the patient satisfaction. Generally, Lundström et al had patient demographic with age >74 years, while in our study, the mean age was 66.12 years (SD 8.751), had a younger population of patients.⁸

The study was conducted during the COVID-19 pandemic, which might have influenced patients' perception and expectations, potentially affecting their survey responses. Many patients were not able to undergo the cataract surgery and had to wait for 2 years. These patients may have progressed in the severity of their cataract prior to this study and skewed the pre-operative PROM to a poorer answer. This factor should be considered when interpreting the results.

This pilot study represents the first attempt to compare Catquest-9SF scores between these centers. While the sample size of 10 could statistically analyze individual categories, it's insufficient for meaningful comparisons between centers' overall results. Further research with a larger sample size, especially to explore subcategories, is recommended.

Ideally, surgeon consistency within each center would have minimized variations in surgical outcomes and patient experiences. However, scheduling constraints and patient volume across both centers prevented this control. This limitation should be acknowledged when drawing conclusions.

Data collection for Catquest-9SF scores occurred at the six-week post-operative refraction instead of the typical three-month follow-up used in other studies. This difference could potentially impact results and should be explicitly noted.^9,14

While patient selection was meticulous, the prevalence of severe underlying ocular diseases in Hospital Selayang patients proved challenging to predict, leading to lower recruitment and participant dropout from this centre.

Hospital Setting and Outreach Clinic Setting cataract surgery both achieved similar improvements in PROM scores. This shows that improvement in patient reported visual functioning is comparable in dedicated outreach cataract centre settings when compared to hospital setting. This may also be related to the similar good visual acuity outcomes in the two centres.

Catquest-9SF is a robust tool to compare centres for cataract surgery in terms of patient reported visual functioning. PROM scores were significantly higher post cataract surgery in all parameters in both centres. The PPKM outreach centre achieved a higher on average post operative scores in almost all PROM parameters however this difference was not significant.

Pre-op visual acuity appears to have statistically significance in the improvement of fine visual acuity domains such as reading text in newspaper (C1) and seeing prices of shopping goods (C3), whilst patients with cardiovascular and cerebrovascular diseases are associated with improvement in leisure activities such as needlework (C5) and reading subtitles on the television (C6). Patients with hypertension have association with general vision difficulties in daily life (Ca), prices of shopping goods (C3) and leisure activities (C5 and C6).

Our analysis emphasizes the importance of considering various factors when comparing cataract surgery outcomes across settings. While statistically significant differences in demographics and PROM scores were limited, potential trends and insights emerged, paving the way for further research and nuanced interpretations.

I. Ethics approval and consent to participate
This study was conducted in accordance to the Declaration of Helsinki. It was approved by the Medical Research Ethics of Malaysia. (NMRR-20-3258-5652, Research ID 56521)

II. Consent for publication
Consent for publication is obtained from Clinical Reseach Centre, Malaysia.

III. Availability of data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

IV. Competing interests
There are not competing interests vested in this study

V. Funding
This Study was self-funded.

VI. Authors' contributions
Dr Yeoh Boon Juan was the main investigator, supervised by Dr Mohd Aziz b. Salowi, Prof Dr Norlina Ramli, and A. Prof Dr Amir bin Samsudin.

VII. Acknowledgements

Datuk Dr. Muhammad Radzi Abu Hassan, Director General of Ministry of Health, Malaysia for the opportunity to conduct this study at its facilities.
Dr Mohd Aziz bin Husni as the head of Ophthalmology services for guidance and consent to conduct this study.

Miss Nurakmal binti Baharum for her biostatistics research consultation. ChatGPT was utilized for proofreading purposed in this study.

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Health Organization W. World Report on Vision.
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Chew FLM, Salowi MA, Mustari Z, et al. Estimates of visual impairment and its causes from the National Eye Survey in Malaysia (NESII). PLoS One. 2018;13(6):e0198799. doi:10.1371/journal.pone.0198799
Hospital Definition: 13k Samples | Law Insider. Accessed August 6, 2023. https://www.lawinsider.com/dictionary/hospital?cursor=ClUST2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjELEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3YzOCIRaG9zcGl0YWwjMDAwMDAwMjgMogECZW4YACAA
Outreach clinic Definition | Law Insider. Accessed August 6, 2023. https://www.lawinsider.com/dictionary/outreach-clinic
PUSAT PEMBEDAHAN KATARAK MAIWP-HOSPITAL SELAYANG. Accessed April 26, 2023. https://www.maiwp.gov.my/i/index.php/en/nbos/pusat-pembedahan-katarak-maiwp-hospital-selayang
Soundararajan K, Aziz Salowi M, Ramli N, Fariza Ngah N. Comparison of Cataract Surgery Refractive Outcomes in a Tertiary Hospital and an Outreach Cataract Service Centre.
Lundström M, Kugelberg M, Montan P, et al. Catquest-9SF functioning over a decade – a study from the Swedish National Cataract Register. Eye and Vision. 2020;7(1). doi:10.1186/s40662-020-00220-4
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ICHOM Connect. Accessed June 11, 2023. https://connect.ichom.org/
McAlinden C, Gothwal VK, Khadka J, Wright TA, Lamoureux EL, Pesudovs K. A head-to-head comparison of 16 cataract surgery outcome questionnaires. Ophthalmology. 2011;118(12):2374-2381. doi:10.1016/j.ophtha.2011.06.008
Claesson M, Armitage WJ, Byström B, et al. Validation of Catquest-9SF-A Visual Disability Instrument to Evaluate Patient Function After Corneal Transplantation.; 2017. www.corneajrnl.com
Adnan TH, Mohamed Apandi M, Kamaruddin H, et al. Catquest-9SF questionnaire: validation of Malay and Chinese-language versions using Rasch analysis. Health Qual Life Outcomes. 2018;16(1):5. doi:10.1186/s12955-017-0833-3
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No competing interests reported.

Patient Reported Outcomes Measurements (PROM) of Cataract Surgery : Comparison of Outcomes between Hospital-Based versus Outreach Cataract Centre. A Prospective Cohort Study.

Status:

Version 1

Abstract

Figures

CHAPTER ONE : INTRODUCTION

CHAPTER TWO : STUDY RATIONALE AND OBJECTIVES

2.1 Rationale of Study

2.2 Study Objectives

2.2.2 Specific Objectives

CHAPTER THREE: LITERATURE REVIEW

3.1 Outreach programmes: Enhancing services in peripheral areas without specialist hospitals.

3.2 Survey and data driven progress is key for improvements of eye health.

3.3 Catquest-9SF: A choice for Patient-Reported Outcome Measures (PROMs) and outcome comparison in cataract surgery.

CHAPTER FOUR : METHODOLOGY

4.1 Study Hypotheses

4.2 Ethical Approval

4.3 Methodology

4.3.1 Study Design and Study Duration

4.3.2 Study Population and Recruitment

4.3.3 Sample Size

4.3.4 Study Tools

4.3.5 Data Collection Procedure

4.4 Statistical Methods

CHAPTER FIVE : RESULTS AND ANALYSIS

5.2 Mean comparison between two centres.

5.3 Relationship between each PROM parameter and cataract centre, patient demographic and clinical factors

CHAPTER SIX : DISCUSSION

CHAPTER SEVEN : LIMITATIONS

CHAPTER EIGHT: CONCLUSION AND IMPLICATIONS

Declarations

References

Additional Declarations

Status:

Version 1