Colonoscopy Satisfaction and Safety Questionnaire based on patient experience (CSSQP): A valuable quality tool for all colonoscopies

Abstract

Introduction

The Colonoscopy Satisfaction and Safety Questionnaire based on Patient experience (CSSQP) was recently developed and validated within a Bowel Cancer Screening Program. We aimed to identify factor related to patient experience through the CSSQP, including all indications for colonoscopy. Indicators of satisfaction and perceived safety with colonoscopy were also assessed to compare the different centers.

Methods

Multicenter study in nine Spanish hospitals. Consecutive patients who had undergone a colonoscopy completed the CSSQP adding a novel item on bowel preparation. Factors related to patient experiences and data from non-respondents were analyzed.

Results

Of 2200 patients, 1753 filled out the questionnaire (response rate 79.7%, sample error 2%). Patients whose colonoscopy indication was a primary colorectal cancer screening (OR: 1.68, 95% CI: 1.15–2.44, p = 0.007) or due to a +FIT (OR: 1.73, 95% CI: 1.18–2.53) reported higher satisfaction than patients with gastrointestinal symptoms. In addition, college-educated patients (OR: 2.11, 95% CI: 1.25–3.56) were more likely to report better overall satisfaction than patients with lower education level. Significant differences were observed in the majority of the CSSQP items between centers. Safety incidents were reported by 35 (2%) patients, and 176 (10%) patients reported that they received insufficient information.

Conclusion

The CSSQP identifies several significant factors on satisfaction and perceived safety in patients referred for colonoscopy for any reason. The CSSQP also allows comparison of patient-identified colonoscopy quality indicators between centers.

Resumen

Introducción

El Cuestionario de Satisfacción y Seguridad de la Colonoscopia basado en la experiencia del Paciente (CSSQP) ha sido desarrollado y validado recientemente en pacientes del Programa de cribado de cáncer colorrectal (CCR). El objetivo del estudio fue identificar los factores relacionados con la experiencia de los pacientes a través del CSSQP, incluyendo todas las indicaciones de la colonoscopia. Además, se evaluaron los factores relacionados con la satisfacción y la seguridad del paciente con el fin de comparar diferentes departamentos.

Métodos

Estudio multicéntrico de nueve hospitales españoles en el que se incluyeron pacientes consecutivos que completaron el CSSQP incorporando un nuevo ítem sobre la preparación intestinal. Se analizaron los factores relacionados con la experiencia de los pacientes y los datos de los no respondedores.

Resultados

De 2.200 pacientes, 1.753 completaron el cuestionario (tasa de respuesta del 79,7%, error muestral del 2%). Los pacientes en los que la indicación era por cribado de CCR (OR: 1,68; IC 95%: 1,15-2,44; p = 0,007) o por FIT positivo (OR: 1,73; IC 95%: 1,18-2,53) informaron mayor satisfacción que en aquellos que se solicitó la colonoscopia por síntomas gastrointestinales. Además, los pacientes con estudios universitarios (OR: 2,11; IC 95%: 1,25-3,56) informaron mayor satisfacción que aquellos con menor nivel de estudios. Se observaron diferencias significativas en la mayoría de los ítems del CSSQP entre los centros participantes. Treinta y cinco (2%) pacientes reportaron incidentes de seguridad y 176 (10%) reconocieron haber recibido información insuficiente.

Conclusiones

El CSSQP identifica los factores determinantes que influyen en la satisfacción y la seguridad de los pacientes a los que se les realiza colonoscopia por cualquier indicación. Además, permite comparar los indicadores de calidad de la colonoscopia desde la perspectiva del paciente entre los distintos centros.

Introduction

In recent years, the systematic evaluation of quality indicators has represented a significant change in clinical practice for most endoscopists.¹ Many studies have evaluated different key colonoscopy performance measures; however, they aimed to analyze the performance of the procedure, rather than improving the patient experience.^1–10 On the other hand, several non-procedural factors have been found to influence the patient's experience, like the colonoscopy unit environment, the lack of information provided before and after the procedure, and the technical skill of the endoscopist that performed the examination. Moreover, some factors have emerged as most important to patients, like the discomfort experienced during the bowel preparation period, pain during the procedure, or long waiting times^8–11). Nevertheless, the majority of studies have been conducted without significant patient input or feedback.^12,13

There is a need for colonoscopy services to implement improvements based on patient opinions, in addition to suggestions from health professionals.^14,15 Therefore, to improve the quality of colonoscopy procedures, patient experiences should be measured with questionnaires designed specifically for this purpose.

To address the need for instruments designed to collect patient experiences and opinions, our group recently developed and validated the Colonoscopy Satisfaction and Safety Questionnaire based on patient experience (CSSQP).⁸ This tool covered the entire patient experience, from scheduling the procedure to discharge from the endoscopy unit. The CSSQP was designed to record the experience of patients undergoing a colonoscopy and was tested on a focus group selected from the Spanish Colorectal Cancer (CRC) Screening program. With this questionnaire, new indicators of quality and safety based on patient-reported outcomes (PROMs) were identified. Two recent systematic reviews have shown that, until now, only two existing PROMs designed to measure patient satisfaction have been validated. The authors identified the CSSQP with high potential for further use.^16,17 Furthermore, a novel meta-analysis of randomized controlled trials recommends their use as validated measures of patient satisfaction to improve comparisons between studies and meta-analyses.¹⁸ Innovate aspects of the CSSQP, compared to other questionnaires, were that it was based on the patient's perspective, it used qualitative methodology, and it included the safety from patient's perspective. However, the validation study was carried out in only two centers within the CRC screening program. In addition, patients who did not respond to the questionnaire were not included in the analysis.

The primary aim of this study was to identify factors related to patient experience (satisfaction and safety perceived by the patient) using the CSSQP, including all indications for colonoscopy. The secondary objectives were to investigate whether the CSSQP is a valid tool to compare satisfaction and safety indicators between centers; and to analyze the characteristics of non-responders to the questionnaire.

Patients and methods

Patients

This prospective, multicenter observational study enrolled 2200 consecutive outpatients, aged ≥18 years, who underwent a colonoscopy between February 2019 and June 2020 in nine hospitals within the National Spanish Health Care System. Exclusion criteria were: dementia and/or visual impairment; and voluntary refusal to participate in the study.

Methods

Patients were invited to participate in the study immediately before discharge from the endoscopy unit. Consenting patients received an envelope with the necessary materials for answering the questionnaire at home. They were instructed to send the completed CSSQP back to their endoscopy units by post. Patients were asked to respond the questionnaire at home, the day after the colonoscopy procedure, once the effect of the sedation had completely worn off (all examinations were performed under deep sedation, and Propofol was the most commonly used drug). Questionnaires were encoded with a number to ensure anonymity. Patients were reminded about the questionnaire by telephone, between 24 and 72 h after the colonoscopy, to increase the response rate.

The CSSQP includes a satisfaction section (15 items), where each item is rated on a 5-point Likert scale, and a safety section (3 items), where each item requires a dichotomous response.⁸ The satisfaction items are grouped into three categories: Information, Care, and Service and Facilities. The Information category includes all information received before and after the colonoscopy. The Care category includes the time in the waiting room, the experience during the procedure, and the attitudes of the endoscopy staff. The Service and Facilities category includes the comfort and environment of the endoscopy unit. The questionnaire also includes an item on overall satisfaction during the colonoscopy. For the present study, we added an item on bowel preparation to the Care category of the CSSQP satisfaction scale, as it was one of the key complaints that authors identified during the validation phase of the CSSQP (unpublished data). Fig. 1 shows the CSSQP with the aforementioned modification (CSSQP-M).

Figure 1.

CSSQP-M.

We collected baseline demographics of responders and non-responders, including age, sex, educational level, marital status, and prior experience with colonoscopy procedures. Other variables collected included (a) the colonoscopy indication, including specific indications (e.g., gastrointestinal symptoms, post-polypectomy surveillance, positive fecal immunochemical test [+FIT]) and general screens conducted by the National Bowel Screening Program or Primary Screening Program, and (b) post-procedure complications (collected up to 30 days after the colonoscopy).

The complications of colonoscopy considered relevant for this study were: an unscheduled admission; an unscheduled subsequent endoscopic procedure; an emergency intervention (e.g., blood transfusion; extreme, prolonged desaturation and/or bradycardia that required the administration of a reversal agent; or severe abdominal discomfort that did not resolve spontaneously after the colonoscopy); emergency surgery; or death of the patient.

Statistical analysis

Categorical variables are expressed as the frequency or percentage. Continuous variables are expressed as the median and interquartile range (IQR). Multivariate analyses with multiple logistic regression were performed to investigate the relationships between independent variables and CSSQP scores. The multivariate analysis was adjusted for the medical center, patient educational level, first colonoscopy, and colonoscopy indication. The logistic regression results are expressed as the odds ratio (OR) and 95% confidence intervals (95%CIs). The significance level was set at 5%, when applicable. To investigate more adequately the factors related to patient experience, 5-point Likert scales were converted to 2-point scales by grouping ‘excellent’ and ‘very good’ ratings into a positive or satisfied response group, and ‘good’, ‘regular’, and ‘poor’ ratings into a negative or dissatisfied response group. The satisfaction section was rated on a scale of 1 to 5, where poor = 1, regular = 2, good = 3, very good = 4, and excellent = 5. The overall CSSQP score was calculated only for patients that had responded to at least 50% of the questions. To calculate the final satisfaction score, the sum of the individual item scores was divided by the sum of all maximum scores. Statistical analyses were performed with SPSS version 20.0 software (IBM Corp., Armonk, New York, USA).

To determine the sample size, we focused on the main outcome: overall satisfaction (item 16). The expected number of patients required was calculated for a precision error of 2%, with an expected satisfaction rate of 80%, and an expected loss of 15%. The estimated sample size needed was 1780 responses, in total, and 1513 valid responses.

Ethical considerations

This study was part of the multicenter project called QUALISCOPIA approved by the Ethics board on May 27, 2015. This project aimed to evaluate different aspects of the quality of colonoscopy.¹⁹ The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki, as reflected in the prior approval by the institution's Human Research Committee.

All participants consented to participation in the study, and all were informed that their decision to participate in the study would not affect the standard of care.

The data reported and the results of the centers participating in this study have not been included in previous publications.

Results

Patient characteristics

For 16 months, the study recruited 2200 consecutive outpatients that underwent colonoscopies in 9 hospitals. Of these patients, 1753 (79.7%) filled out the questionnaire. We found that patients were more likely to respond to the questionnaire when the indication for colonoscopy was a +FIT (P < 0.001) and when they were diagnosed with colonic polyps (P < 0.01). However, patient sex, age, or repeated colonoscopy did not affect the likelihood of responding (Table 1). The median age was 61 years (IQR: 54–69), 54.8% were men, and 57.2% reported that this was their first colonoscopy.

Table 1.

Participant characteristics and CSSQP findings.

Variable	Total	CSSQP Responders		P value
Patients	2200 (100%)	Yes (1753)	No (447)
Sex				0.218
Men	1206 (54.8)	944 (54.0)	253 (57.2)
Women	994 (45.2)	805 (46.0)	189 (42.8)
AGE, years (Median, Quartiles 25–75)	61 (54–69)	62 (55–69)	61 (52–69)	0.332
First colonoscopy				0.338
Yes	1259 (57.2)	897 (51.3)	107 (54.9)
No	941 (42.8)	853 (48.7)	88 (45.1)
Indications				<0.001
Symptoms	728 (33.1)	552 (31.5)	176 (39.6)
+FIT	448 (20.4)	395 (22.5)	53 (11.9)
Post-polypectomy surveillance	503 (22.8)	406 (23.2)	97 (21.8)
CRC screening	439 (20)	375 (21.4)	64 (16.4)
NA	79 (3.6)
Findings (normal)				0.131
Yes	653 (30.9)	521 (30.2)	132 (34.1)
No	1460 (69.1)	1205 (69.8)	255 (65.9)
Findings (CRC)				0.924
Yes	64 (3.0)	52 (3.0)	12 (3.1)
No	2051 (97.0)	1676 (97.0)	375 (96.9)
Findings (polyps)				0.011
Yes	1124 (53.1)	941 (54.5)	183 (47.3)
No	991 (46.9)	787 (45.5)	204 (52.7)
Findings (other)				0.729
Yes	559 (25.4)	454 (26.3)	105 (27.1)
No	1556 (70.7)	1274 (73.7)	282 (72.9)
Complications				0.692
Yes	32 (1.5)	27 (1.6)	5 (1.3)
Not	2087 (94.9)	1704 (98.4)	383 (98.7)
NA	81 (3.7)

Values are the number of participants (%), unless otherwise indicated. NA: not available; +FIT: positive fecal immunochemical test; CRC: colorectal cancer.

Intra-procedural or post-procedural complications, were observed in 32 patients (1.5%). These complications included intra- and post-procedural bleeding (n = 11, 0.5%), abdominal pain after the procedure (n = 8, 0.4%), desaturation that interrupted the colonoscopy (n = 5, 0.2%), bradycardia (n = 4, 0.2%), and colonic perforation (n = 1, 0.05%); the 3 remaining complications were unknown, as no data were recorded. Consequently, 10 patients (0.5%) required hospital admission, with an average hospital stay of 7.5 days (median of 2.5 days). Only one patient required urgent surgery, due to colon perforation.

CSSQP satisfaction scale outcomes

Table 2 summarizes the responses to the different items in the satisfaction section of the CSSQP. Overall satisfaction (item 16) was high in 79.9% of patients (47.2% excellent, 32.7% very good). The lowest-rated items were related to discomfort during the bowel preparation period (72.3% not satisfied), the clothes-changing area and space for storing personal items (64% not satisfied), the comfort of the waiting room (58.6% not satisfied), the time between the scheduling and the date of the colonoscopy (54.2% not satisfied), and the comfort and privacy of the recovery room (51.6% not satisfied). For each item, data were missing from 1.7 to 4.8% of the patients that responded to the questionnaire.

Table 2.

Satisfaction and Safety scales for the CSSQP.

Satisfaction scale items		Poor		Regular		Good		Very good		Excellent		NA
		N	%	N	%	N	%	N	%	N	%	N	%
Information
1	Clarity and usefulness of the information received in preparation for the colonoscopy	18	1.0	61	3.5	547	31.2	601	34.3	496	28.3	30	1.7
2	The explanations about the risks of the colonoscopy procedure and the reasons that it was recommended	29	1.7	121	6.9	608	34.7	560	31.9	388	22.1	47	2.7
9	The information given to the patient on the day of the colonoscopy, about what to do and what to expect (sensations, possible discomfort, etc.) to alleviate anxiety about the procedure	33	1.9	102	5.8	514	29.3	534	30.5	531	30.3	39	2.2
12	The information received from the doctor just after finishing the procedure, related to the results	88	5.0	107	6.1	432	24.6	458	26.1	584	33.3	84	4.8
13	The information received after the colonoscopy about what to expect once at home and what to do in case of any emergency (including a telephone contact to call when needed)	135	7.7	206	11.8	476	27.2	435	24.8	428	24.4	73	4.2
Care
4	Discomfort during the bowel preparation period (due to the laxative, dietary instructions, etc.)	179	10.2	484	27.6	604	34.5	264	15.1	157	9.0	65	3.7
5	The time spent in the endoscopy waiting room before I was called to undergo the procedure	42	2.4	144	8.2	522	29.8	513	29.3	491	28.0	41	2.3
7	The attitude of endoscopy staff in addressing my questions and anxiety before the colonoscopy	2	0.1	26	1.5	257	14.7	541	30.9	888	50.7	39	2.2
10	The efficacy of the methods for reducing pain during the colonoscopy (i.e., anesthesia)	12	0.7	35	2.0	244	13.9	438	25.0	988	56.4	36	2.1
14	The treatment provided and behavior of the endoscopy staff (i.e., nurses and assistants) on the day of the procedure	1	0.1	10	0.6	206	11.8	468	26.7	1037	59.2	31	1.8
15	The treatment provided and behavior of the doctor that performed the procedure	23	1.3	24	1.4	268	15.3	476	27.2	907	51.7	55	3.1
Service Environment and Facilities
6	The comfort of the waiting room in the endoscopy unit	55	3.1	225	12.8	748	42.7	412	23.5	272	15.5	41	2.3
8	The clothes-changing area and the space provided to store my personal items (security and comfort)	92	5.2	360	20.5	672	38.3	357	20.4	235	13.4	37	2.1
11	The comfort and privacy of the recovery room, where I waited after the procedure	53	3.2	207	11.8	641	36.6	446	25.4	329	18.8	77	4.4
Control external
3	The time between scheduling and the date of the colonoscopy	113	6.4	285	16.3	553	31.5	437	24.9	322	18.4	43	2.5
16	Overall satisfaction with the care and services provided during the colonoscopy	6	0.3	25	1.4	290	16.5	573	32.7	828	47.2	31	1.8

Safety scale items	Yes	No	NA
I received sufficient information about the colonoscopy before the procedure	1532 (87.4)	176 (10)	45 (2.6)
There was an incident on the day of the colonoscopy	35 (2)	1680 (95.8)	38 (2)
I experienced a complication during or after the colonoscopy	31 (1.8)	1677 (95.7)	45 (2.6)

NA: not available; positive or satisfied: ‘excellent’ and ‘very good’; negative or not satisfied: ‘poor’, ‘regular’ and ‘good’.

Associations between different independent variables and the items in the three categories of the CSSQP (Information, Care, and Service Environment and Facilities) are shown in Table 3. Women were less likely than men to be satisfied with items related to Information (OR: 0.77, 95% CI: 0.62–0.94). In addition, the education level was associated with a higher probability of satisfaction with items related to Care; patients at the university level were more satisfied than patients with lower education level (OR: 2.01, 95% CI: 1.31–3.11). Patients that had a previous colonoscopy had a lower probability of satisfaction with items related to Care (OR: 0.75, 95% CI: 0.62–0.91) and with items related to the Service Environment and Facilities (OR: 0.70, 95% CI: 0.55–0.89). Patients that underwent a colonoscopy for post-polypectomy surveillance were less likely than patients with symptoms to be satisfied with items related to the Service Environment and Facilities (OR: 0.66, 95% CI: 0.47–0.90). However, patients that underwent a colonoscopy for CRC screening were more likely than those with symptoms to be satisfied with items related to information and care (OR: 1.39, 95% CI: 1.05–1.84 and OR: 1.62, 95% CI: 1.24–2.12, respectively).

Table 3.

Univariate analysis of variables associated with patient satisfaction.

Characteristic	Satisfaction with information	P value	Satisfaction with care	P value	Satisfaction with service and facilities	P value
Sex
Male	1.00		1.00		1.00
Female	0.77 (0.62–0.94)	0.012	0.89 (0.73–1.07)	0.216	1.08 (0.85–1.36)	0.537
Age	0.99 (0.98–1.00)	0.072	0.99 (0.99–1.00)	0.126	0.99 (0.98–1.00)	0.089
Education level
No education	1.00		1.00		1.00
Primary education	1.09 (0.71–1.68)	0.694	1.25 (0.84–1.87)	0.273	0.72 (0.46–1.14)	0.724
Secondary education	1.20 (0.78–1.87)	0.410	1.35 (0.89–2.03)	0.155	0.66 (0.41–1.05)	0.079
University studies	1.09 (0.68–1.75)	0.712	2.01 (1.31–3.11)	0.002	0.92 (0.56–1.50)	0.734
First colonoscopy
Yes	1.00		1.00		1.00
No	0.86 (0.69–1.05)	0.142	0.75 (0.62–0.91)	0.003	0.70 (0.55–0.89)	0.003
Colonoscopy indication
Symptoms	1.00		1.00		1.00
+FIT	1.11 (0.83–1.47)	0.492	1.56 (1.20–2.03)	0.001	1.24 (0.91–1.70)	0.172
Post-polypectomy surveillance	0.87 (0.65–1.17)	0.353	0.86 (0.66–1.12)	0.257	0.66 (0.47–0.90)	0.019
Primary CRC screening	1.39 (1.05–1.84)	0.023	1.62 (1.24–2.12)	<0.001	0.98 (0.70–1.35)	0.881

Values are the odds ratio (95% confidence interval), unless otherwise indicated. NA: not available; +FIT: positive fecal immunochemical test; CRC: colorectal cancer.

A multivariate analysis was conducted to look for associations between patients’ characteristics and overall satisfaction (item 16) (Table 4). Patients that underwent a colonoscopy for primary screening (adjusted OR: 1.68, 95% CI: 1.15–2.44) or due to a +FIT (adjusted OR: 1.73, 95% CI: 1.18–2.53) were more likely to report a higher level of satisfaction than those that underwent a colonoscopy due to “symptoms”. In addition, patients with a university education (adjusted OR: 2.11, 95% CI: 1.25–3.56) were more likely to report a higher level of overall satisfaction than patients with lower education level.

Table 4.

Multivariate analysis of factors associated with overall satisfaction (item #16).

Variables	OR (95% CI)	p value	aOR* (95% CI)	p value
Sex		0.061
Male	1.00
Female	0.79 (0.62–1.01)
Age	0.99 (0.98–1.00)	0.152
Education level
No education	1.00		1.00
Primary education	1.67 (1.07–2.59)	0.023	1.61 (1.02–2.53)	0.040
Secondary education	1.75 (1.12–2.75)	0.015	2.00 (1.25–3.22)	0.004
University studies	2.66 (1.59–4.44)	<0.001	2.11 (1.25–3.56)	0.005
First colonoscopy
Yes	1.00		1.00
No	0.73 (0.57–0.94)	0.012	0.86 (0.64–1.15)	0.301
Colonoscopy indication
Symptoms	1.00		1.00
+FIT	1.97 (1.38–2.82)	<0.001	1.73 (1.18–2.53)	0.005
Post-polypectomy surveillance	1.01 (0.75–1.38)	0.927	1.05 (0.74–1.49)	0.800
Primary screening CRC	1.71 (1.20–2.42)	0.003	1.68 (1.15–2.44)	0.007
Center
Alicante	1.00		1.00
Asturias	2.34 (1.16–4.73)	0.017	1.98 (0.96–4.01)	0.063
Canarias	0.65 (0.37–1.15)	0.137	0.66 (0.37–1.16)	0.150
Barcelona	0.73 (0.43–1.24)	0.238	0.67 (0.39–1.17)	0.158
Orihuela	1.35 (0.70–2.61)	0.381	1.44 (0.74–2.81)	0.286
Ourense	1.03 (0.59–1.82)	0.915	1.03 (0.58–1.85)	0.909
Valladolid	0.72 (0.41–1.25)	0.246	0.69 (0.40–1.22)	0.200
Vigo	0.66 (0.39–1.12)	0.125	0.62 (0.35–1.09)	0.096
Zaragoza	1.08 (0.60–1.94)	0.797	1.03 (0.57–1.88)	0.917

+FIT: positive fecal immunochemical test. CRC: colorectal cancer; a OR*: odds ratio adjusted for the medical center, patient sex, patient age, and colonoscopy indication.

Supplementary Table 1 shows the association between clinical and sociodemographic variables and the items in the satisfaction scale through a multivariate analysis. It should be noted that women were less likely than men to be satisfied with items related to Information (OR: 0.77, 95% CI: 0.63–0.96)

Differences between centers

Table 5 shows the percentages of patients in all nine centers that answered positively (i.e., excellent or very good) to each item. The ranges significant differences between centers were observed in all the items except one:” the treatment provided and behavior of the endoscopy staff (i.e., nurses and assistants) on the day of the procedure” (item 14) indicate the variations between the nine centers. Items with the largest differences between centers were: “the information about what to expect once at home and what to do in case of emergency” (item 13), and “the time spent in the endoscopy waiting room before undergoing the procedure” (item 5).

Table 5.

Percentages of patients that were satisfied with each aspect of the colonoscopy procedure included in the Satisfaction scale.

		N (%)	Range %	p value
Information
Clarity and usefulness of the information received in preparation for the colonoscopy (item 1)		1097 (64.3)	58.7–73.4	0.019
Explanations about the risks of the colonoscopy procedure and the reasons that it was recommended (item 2)		948 (55.6)	44.9–69.8	<0.001
The information given to the patient on the day of the colonoscopy, about what to do and what to expect to avoid anxiety about the procedure (item 9)		1426 (83.1)	71.0–90.5	<0.001
The information received from the doctor just after finishing the procedure, related to the results (item 12)		1042 (62.4)	50.3–79.6	<0.001
The information received after the colonoscopy about what to expect once at home and what to do in case of any emergency (item 13)		863 (51.4)	33.2–72.7	<0.001
Care
The time spent in the endoscopy waiting room before I was called to undergo the procedure (item 5)		1004 (58.6)	37.5–76.6	<0.001
The attitude of endoscopy staff in resolving my questions and anxiety before the colonoscopy (item 7)		1429 (83.4)	76.8–90.2	0.006
The efficacy of the methods for reducing pain during the colonoscopy (i.e., anesthesia) (item 10)		1065 (62.1)	52.2–74.7	<0.001
The treatment provided and behavior of the endoscopy staff (i.e., nurses and assistants) on the day of the procedure (item 14)		1505 (87.4)	83.3–93.3	0.094
The treatment provided and behavior of the doctor that performed the procedure (item 15)		1383 (81.4)	76.0–92.0	<0.001
Service environment and facilities
The time between scheduling and the date of the colonoscopy (item 3)		759 (44.4)	29.6–54.0	<0.001
Discomfort during the bowel preparation period (due to the laxative, dietary instructions, etc.) (item 4)		421 (24.9)	14.6–36.5	<0.001
The comfort of the waiting room in the endoscopy unit (item 6)		684 (40.0)	23.8–51.5	<0.001
The clothes-changing area and the space provided to store my personal items (security and comfort) (item 8)		592 (34.5)	18.3–47.4	<0.001
The comfort and privacy of the recovery room, where I waited after the procedure (11)		775 (46.2)	27.1–59.1	<0.001
Overall satisfaction
Overall satisfaction with the care and services provided during the colonoscopy.		1401 (81.4)	75.9–89.2	0.014

Bars indicate the mean and range of minimum and maximum percentages of patients, from all the participant centers, that responded “excellent” or “very good” to the corresponding questionnaire item.

CSSQP safety scale outcomes

A total of 176 (10%) patients reported that the information received about the colonoscopy before the procedure was insufficient (i.e., the bowel preparation, possible complications, interactions with medicines, anesthesia, appropriate indications, and consistent instructions among all health professionals). The patients reported a total of 35 (2%) safety incidents that occurred during or after the colonoscopy (item 2 of the safety scale). In addition, 31 (1.8%) patient-detected complications were reported during or after the procedure (item 3 of the safety scale) (Table 2).

Associations between the independent variables and the item 1, “I received sufficient information about the colonoscopy before the procedure”, are shown in Table 6. The multivariate analysis, (adjusted for medical center, patient sex, patient age, and colonoscopy indication) showed that women were less likely than men to report insufficient information (adjusted OR: 0.68, 95% CI: 0.49–0.95). Patients that underwent a colonoscopy for a primary CRC screening were more likely to report insufficient information than patients whose indication was gastrointestinal symptoms (adjusted OR: 2.26, 95% CI: 1.36–3.75, p = 0.002). In addition, age was associated with insufficient information (adjusted OR: 1.02, 95% CI: 1.01–1.04).

Table 6.

Multivariate analysis of factors associated with information adequacy (safety scale).

Variables	OR (95% CI)	P value	aOR* (95% CI)	P value
Sex
Male	1.00		1
Female	0.77 (0.62–0.94)	0.004	0.68 (0.49–0.95)	0.022
Age	1.03 (1.02–1.05)	<0.001	1.02 (1.01–1.04)	0.001
Colonoscopy indication
Symptoms	1.00		1.00
+FIT	1.78 (1.17–2.73)	0.008	1.33 (0.84–2.13)	0.227
Post-polypectomy surveillance	1.76 (1.15–2.68)	0.009	1.37 (0.88–2.16)	0.168
Primary CRC screening	2.47 (1.53–3.98)	<0.001	2.26 (1.36–3.75)	0.002
Center
Alicante	1.00		1.00
Asturias	1.35 (0.65–2.81)	0.418	1.03 (0.48–2.23)	0.869
Canarias	0.86 (0.43–1.71)	0.663	0.72 (0.43–1.20)	0.618
Barcelona	0.94 (0.49–1.79)	0.851	0.78 (0.49–1.26)	0.598
Orihuela	0.89 (0.44–1.84)	0.765	0.79 (0.37–1.67)	0.473
Ourense	6.98 (2.28–21.36)	0.001	4.96 (1.58–15.52)	0.006
Valladolid	0.74 (0.38–1.42)	0.361	0.66 (0.33–1.29)	0.245
Vigo	1.02 (0.53–1.96)	0.964	0.72 (0.35–1.49)	0.384
Zaragoza	1.67 (0.79–3.54)	0.183	1.02 (1.01–1.04)	0.464

+FIT: positive fecal immunochemical test. CRC: colorectal cancer; aOR*: odds ratio adjusted for the medical center, patient sex, patient age, and colonoscopy indication.

Discussion

In this multicenter study, we used a validated instrument, the CSSQP, for patients referred for colonoscopy for any reason. With this patient-reported outcomes measures (PROM) questionnaire, several significant factors on patients’ satisfaction and perceived safety were identified. Moreover, we found that the questionnaire can detect differences between medical centers.

The present study overcame some limitations of the original questionnaire and others questionnaire validation studies.^2,20 First, this study included the main indications for colonoscopy. The original CSSQP was previously validated in two medical centers for patients within the CRC screening program only. Second, we included professional-reported complications and the characteristics of data from non-responders. Third, in this study, we introduced a novel item in the satisfaction scale that was not included in the CSSQP validation procedure: discomfort during the bowel preparation period. This parameter was shown to be one of the most important elements related to colonoscopy satisfaction in previous studies.^2,12

Our patient response rate was higher (global response rate: 79.7%) than the rates reported in other studies. This rate was probably due to the high level of acceptance, ease of use of this instrument,^8,21 and the telephone calls made to patients after the colonoscopy to remind them about the questionnaire. Among the questionnaires returned for analysis, missing data were minimal, ranging from 1.7 to 4.8% for each item. As a result, imputed models were considered realistic and highly plausible.⁹

We observed that patients were more likely to respond to the questionnaire when the indication for colonoscopy was a +FIT or the diagnosis was colonic polyps. Several studies have shown that patients with a +FIT had elevated anxiety about their perceived risk of CRC.^8,22–25 Thus, these patients most likely considered the colonoscopy a relevant diagnostic test, which might explain their high response rate to the questionnaire.

Although the overall results indicated a positive patient experience, the instrument also detected areas for improvement. The most dissatisfaction was associated with the prior bowel preparation, consistent with findings from previous studies.^2,26–28 However, it is important to note that, in Spain, colonoscopies are typically performed under deep sedation with propofol administered by the endoscopist.^29,30 Consequently, the satisfaction in pain reduction was very high, and no safety concerns were detected related to this aspect of the procedure. Dissatisfaction was also associated with the comfort and intimacy experienced during different parts of the colonoscopy procedure. These results were consistent with results from other studies that showed that patients tended to focus on discomfort, anxiety, and embarrassment.^3,12

We also found that patients with a higher level of education were more satisfied with the information received before the colonoscopy. These findings might be explained by the notion that these patients probably had a better understanding of the procedure and its appropriateness.³¹ Consistent with findings in previous reports, we found that satisfaction scores were lower among women than among men.^8,32–35

One important finding of our study was that the questionnaire detected a significant variability in the response to almost all the items among the nine participant centers. Therefore, the CSSQP provides a means to compare centers according to patient experience in colonoscopy. With this instrument, centers can identify areas for improvement; moreover, continuous evaluations of patient experience with the CSSQP might be useful for monitoring the implemented improvements in those areas.

The CSSQP is the first validated colonoscopy questionnaire to include a patient-reported assessment of safety measures.^8,36,37 As a result, the present study reported a number of patient-detected safety incidents that had not been included in previous studies. Moreover, many patient-identified events were not captured in the incident reporting system, probably because professionals underestimate them or do not perceive them as relevant adverse events. Therefore, it is important to take patient opinions into account when considering adverse events in colonoscopy.^8,21 Involving patients as partners in safety incidents identification is a potentially promising approach to improving patient safety.^38,39

This study had some limitations. The instrument was conducted within the Spanish National Health System; other countries may have differences in the health systems, such as the performance and accessibility of colonoscopies, or in the characteristics of the population. In addition, the CSSQP was initially validated in Spanish, but it was submitted to a rigorous translation into English (translation and back-translation). Therefore, it can be applied in English language.⁴⁰ Also, safety incidents and complications reported by patients cannot be contrasted. These items were collected as a dichotomous variable (yes/no) and, as the questionnaire was anonymous, it was not possible to contact these patients.

In conclusion, this multicenter study was the first to implement the CSSQP for assessing patient experience and patient perceived safety of the colonoscopy for all the procedure indications. From a healthcare management viewpoint, the CSSQP instrument could be used to identify areas that need improvement in colonoscopy units, to assist in refining processes from the patient's perspective, to provide a means to monitor the procedure and to make comparisons between centers. Finally, the CSSQP may be a valuable tool in clinical trials that aim to incorporate measurements from the patient's point of view.

Author's contributions

AB, CMS, JJM, JSV, and RJ were involved with the study concept and the design and drafting of the manuscript; AB, CMS, JC, LCG, PDR, AS, SGM, AS, and DNP were responsible for the acquisition of data; AB, JJM, and BL were in charge of the analysis, the interpretation of data, and the statistical analysis. All authors were involved with the critical revision of the manuscript for important intellectual content and all approved of the final manuscript.

Conflicts of interest

The authors declare no conflict of interest.

Acknowledgments

The authors thank the patients and the professionals for their generosity participating in this study.