Original article

Authors

Yoo Jin Lee, Eun Soo Kim, Jae Hyuk Choi, Kyung In Lee, Kyung Sik Park, Kwang Bum Cho, Byoung Kuk Jang, Woo Jin Chung, Jae Seok Hwang

Institution

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea

submitted 10. December 2014 accepted after revision 13. April 2015

Background and study aims: High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by telephone or short message service (SMS) on the quality of bowel preparation. Patients and methods: A prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by telephone or SMS 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients. Results: A total of 390 patients were included. Total BBPS score was significantly higher in the reinforced education groups than in the control group (mean [SD] telephone vs. control: 7.1 [1.2] vs. 6.3

[1.4], P < 0.001; SMS vs. control: 6.8 [1.3] vs. 6.3 [1.4], P = 0.027). Between the two interventions, there was no significant difference in total BBPS score. PDR and ADR were not different among groups. Reinforced education groups showed lower anxiety and better tolerance compared with controls. A preparation-to-colonoscopy time of > 6 hours and < 80 % of the purgative ingested were independent factors associated with inadequate bowel preparation (BBPS < 5), whereas re-education by telephone was inversely related to inadequate bowel preparation. Conclusion: SMS was the optimal education modality, and was as effective as telephone reminders for the quality of bowel preparation. A reinforced educational approach via telephone or SMS should be individualized, depending on the resource availability of each clinical practice. Trial registration: ClinicalTrials.gov (NCT01911052).

Introduction

increased the risk of inadequate preparation by 4.76-fold [3]. In another study, compliance with dietary instructions was revealed to be a significant contributor to satisfactory preparation [4]. Education is therefore a valuable tool for guiding patients, enabling them to follow bowel preparation instructions properly and, ultimately, to achieve high quality bowel preparation. From this point of view, various methods of education in bowel preparation have been suggested to improve patient compliance with instructions [5 – 8]. However, the effectiveness and applicability of these interventions have been shown to be inconsistent, and they have not yet been validated. As increasing numbers of individuals use mobile phones across the world, there have been efforts to apply this technology to patient education in various medical settings [9 – 12]. One recent study showed that telephone-based re-education improved both the quality of bowel preparation and the polyp detection rate (PDR) [13]. The use

Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1392406 Published online: 2015 Endoscopy © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Eun Soo Kim, MD Division of Gastroenterology and Hepatology Department of Internal Medicine Keimyung University School of Medicine 56 Dalseong-ro, Jung-gu Daegu 700-712 Korea Fax: +82-53-250-7088 [email protected]

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High quality bowel preparation usually results in successful colonoscopy in terms of diagnostic accuracy, procedural safety, and cost effectiveness. However, the process of bowel preparation often requires considerable perseverance from patients. Given the discomfort experienced by patients, such as adverse gastrointestinal symptoms and large-volume diarrhea caused by ingesting burdensome amounts of purgatives, it is not surprising that bowel preparation is perceived by the majority of patients as a major impediment to undergoing colonoscopy [1]. Thus, as expected, inadequate bowel preparation is reported in up to 25 % of patients undergoing colonoscopy [2]. Although the quality of bowel preparation is influenced by various factors, it largely depends on the patient’s compliance with both purgative and dietary instructions. Chan et al. reported that nonadherence to bowel preparation instructions

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Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study

Original article

of a short message service (SMS) requires fewer resources and represents an inexpensive, highly accessible tool for the majority of users worldwide [10]. However, it remains unclear whether a reminder system using SMS would also be helpful, and therefore the best modality for increasing the quality of bowel preparation is unknown. Therefore, the aim of this study was to evaluate the impact of reinforced education via telephone and SMS reminders on the quality of bowel preparation. The PDR, adenoma detection rate (ADR), patient tolerance, and subjective feelings of patients were also assessed.

Patients and methods

in which 1 L of purgative was ingested at 20:00 on the day before the colonoscopy, and the remaining 1 L was ingested on the morning of the colonoscopy (at least 2 hours before the scheduled procedure time). All of the patients were advised to take 250 mL of PEG + ascorbic acid every 10 minutes and at least 80 % of the total dose of purgative. They were also asked to drink clear water until clear liquid stool without any particles was obtained. All patients were instructed to start a low-residue diet 2 days before colonoscopy. The list of foods to be avoided and those that were permitted was included in the written instructions. Patients were allowed to eat a regular diet for lunch and then they were instructed to consume a soft diet for dinner. Dinner was to be consumed at least 1 hour before starting the purgative.

Study design

Education

A prospective, endoscopist-blinded, randomized, controlled study was conducted at a tertiary hospital. Between August and December 2013, individuals over 18 years of age who were scheduled for screening colonoscopy at a health examination center in Daegu, South Korea, were enrolled in the study. Individuals were excluded from the study if the following applied: 1) pregnancy or breastfeeding, 2) allergy to purgatives, 3) suspected intestinal obstruction, stricture, or perforation, 4) hemodynamic instability, 5) impaired swallowing reflex or mental status, 6) severely compromised medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure, 7) illiteracy, 8) inability to use a mobile phone, and 9) participation declined. The study was approved by the Institutional Review Board of the Keimyung University Dongsan Medical Center, and was registered at ClinicalTrials.gov (NCT01911052). Written informed consent was obtained from all patients when the colonoscopy appointment was made.

Standard instructions were given to all patients during the initial colonoscopy appointment. The standard instructions were also provided in brief in written format to be read at home. The contents of the instructions were as follows: 1) colonoscopy appointment time, 2) the importance of adequate bowel preparation, 3) dietary restrictions, 4) adequate timing and method for consuming the purgative, and 5) additional water ingestion if necessary. Any questions were answered at this initial appointment. The control group received no further education. Reinforced education was provided to the telephone and SMS groups by one experienced endoscopy nurse. The reinforced education was conducted between 08:00 and 11:00 2 days before the colonoscopy. For colonoscopies that were scheduled for a Monday, the intervention was conducted on the previous Friday. The contents of the reinforced education messages were shorter and more concise than those of the previously provided standard instructions (see Appendix e1, available online).

Assessments Assignments and blinding A principal investigator (E.S.K.), who designed the study but was not involved in its progress, produced a random number table using a computer program that was kept secret until the end of the study. Patients were consecutively randomized when colonoscopy appointments were scheduled. Patients were allocated to one of the following three groups: the telephone group, which received reinforcement reminders by telephone; the SMS group, which received reinforcement reminders by SMS; and the control group, which received no reminder. At least two mobile phone numbers were collected from the patients or their family members in order to establish a network of contacts. Patients were asked not to reveal their group assignments to any of the physicians or nursing staff. Thus, all staff members involved in the colonoscopy procedure and data collection were unaware of the education allocation until the last participant had been enrolled.

Bowel preparation method Patients were prescribed a low-volume preparation regimen based on 2 L polyethylene glycol (PEG) + ascorbic acid (Coolprep; Taejoon Pharm. Inc., Seoul, Korea), which contained, per liter, 100.0 g PEG, 7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride, 4.7 g ascorbic acid, and 5.9 g sodium ascorbate. The bowel preparation procedure was a unified preparation regimen, which was based on previous reports that showed good colon cleanliness and patient tolerance [14, 15]. Patients were instructed to consume the solution following a split-dose regimen,

Lee Yoo Jin et al. Impact of reinforced education on bowel preparation … Endoscopy

On the day of colonoscopy, patients arrived 30 minutes before their scheduled appointment and were interviewed by an endoscopy nurse who was blinded to the patient’s assigned group. The endoscopy nurse obtained information from patients on demographic details, sleep quality, symptoms during bowel preparation, anxiety, satisfaction, and willingness to repeat bowel preparation. Patients were also asked about the amount of purgative they had ingested, compliance with preparation and dietary instructions, and compliance with additional water ingestion, if applicable.

Definitions Based on a previous report, sleep quality was measured as “the same” or “worse than usual” [16]. Patients were asked to report any adverse events encountered while preparing for colonoscopy, such as abdominal pain, bloating, nausea or vomiting. The level of anxiety and satisfaction with the preparation were graded according to a five-item scale as follows: very low, low, moderate, high or very high, as reported previously [8]. “Willingness to repeat bowel preparation if necessary” required a “Yes” or “No” answer [16]. The questions regarding compliance with purgatives and diet were scored on a three-point scale (the estimated percentage of fulfilled instructions; high = > 70 %, moderate = 40 % – 70 %, low = < 40 %). “Compliance with additional water ingestion, if any” was also assessed using the same three-point scale, with high, moderate, and low ratings. The time needed to complete each of the questionnaires was no more than 20 minutes, and the answers were recorded in a pre-formed database.

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Original article

Colonoscopy Before starting the study, the principal study investigator briefly explained the study context and the ratings of the Boston Bowel Preparation Scale (BBPS) scoring system to the participating endoscopists. During this introduction, an instructional video was used that was freely provided by the Boston University Medical Center (available at http://www.bmc.org/gastroenterology/research.htm). A pilot study of 20 colonoscopies was then carried out to ensure interobserver consistency. A resulting correlation coefficient of 0.9 was observed, indicating excellent interobserver agreement (data not shown) [17]. In addition, a brief schematic BBPS scale, showing representative colonoscopic images according to BBPS scores, was placed on the wall of the endoscopy room for the duration of the study. All colonoscopies were performed between 08:30 and 13:00 by six endoscopists (K. B. C., K. S. P., K. I. L., J. H. C., B. K. J., and W. J. C.) who each had experience of over 1000 colonoscopies. They were blinded to the patient’s assigned group. Immediately following colonoscopy, cecal intubation time, withdrawal time, amount of sedation agents used during colonoscopy, and colonoscopic findings were recorded by the endoscopist. The use of patient sedation was at the discretion of the endoscopist, and took account of the patient’s preference and general condition.

ysis of variance or Student’s t tests were used to assess any differences among noncategorical variables. To minimize type I error, Bonferroni correction was performed for multiple comparisons. Factors associated with inadequate bowel preparation (BBPS < 5) were evaluated using logistic regression analysis. All variables showing significance in the univariate analysis were included in a multivariate analysis. A P value of < 0.05 indicated statistical significance. All analyses were performed using the SPSS software (Ver. 20.0; IBM Corp., Armonk, New York, USA).

Results !

Baseline characteristics Overall, 472 patients were scheduled for screening colonoscopy during the study period. After exclusion of 51 individuals who declined to participate or who fulfilled the exclusion criteria, 421 eligible individuals were randomized to one of the three groups. A total of 31 individuals canceled their colonoscopy appointments and did not reschedule them. The remaining patients were included in the study: 126 in the telephone group, 127 in " Fig. 1). the SMS group, and 137 in the control group (● There were no significant differences among the three groups in baseline characteristics, including demographic information " Table 1). No serious complications or adverse events occurred (● during the study period.

Colonoscopy outcome and quality of bowel preparation End points The primary outcome was the quality of bowel preparation as rated by the endoscopist using the BBPS. Colon regions were broadly divided into three segments as follows: the right side (cecum and ascending colon), the transverse (hepatic flexure, transverse colon, and splenic flexure), and the left side (descending colon, sigmoid colon, and rectum). Each of the three segments of the colon was assigned a score ranging from 0 to 3 (0 = inadequate, 1 = fair, 2 = good, 3 = excellent). Therefore, the summed total score ranged between 0 and 9, and a higher score indicated better preparation [18]. The quality of bowel preparation was determined to be “adequate” or “inadequate,” which was defined as BBPS < 5 based on a previous validation study [18]. Factors associated with “inadequate” bowel preparation were identified. The secondary end point included colonoscopic outcomes, which consisted of PDR and ADR, cecal intubation rate, amount of sedative agent administered, patient’s subjective feelings about preparation, and tolerability of instructions.

Statistical analysis A ~12 % difference between the telephone and control group was considered to be meaningful [13]. Patients in the telephone and SMS groups were expected to show an ~15 % improvement (from 70 % to 85 %) in the rate of adequate bowel preparation; thus, a sample size of 118 patients in each arm was required for a statistical power of 80 % at a two-tailed significance level of 0.05. Assuming a 10 % dropout rate, it was deemed that 130 patients per group would be required to obtain statistical significance for the primary outcome. Baseline characteristics and secondary outcomes were evaluated by intention-to-treat (ITT) analysis. Primary outcomes, cecal intubation, and withdrawal times were analyzed on a per-protocol basis. Chi-squared tests or Fisher’s exact tests were used to evaluate the associations between various categorical variables. Anal-

Successful cecal intubation was achieved in 99.2 % (125/126) of patients in the telephone group, 99.2 % (126/127) in the SMS group, and 98.5 % (135/137) in the control group, with no significant differences between them (P = 1.000). There were no significant differences in the reason for incomplete colonoscopy, cecal intubation time, withdrawal time, average dose of midazolam or propofol used during the procedure, or preparation-to-colonos" Table 2). copy time (● After correction of multiple comparisons, no significant difference remained among groups with regard to PDR and ADR, although both rates seemed higher in the telephone group than in " Fig. 2). In order to identify features of the other two groups (● polyps that were more likely to be observed in reinforced education groups, the characteristics of all polyps were assessed with " Table e3, regard to size, endoscopic appearance, and location (● available online). Overall, 272 polyps were found (110, 82, and 80 polyps in the telephone, SMS, and control groups, respectively). No significant differences were found in pathology, size, or the location of the polyps among the groups. However, Isp (semi-pedunculated) and Ip (pedunculated) polyps were detected more frequently in the SMS group compared with other groups, although the reason for this is unclear. Comparisons of BBPS scores were carried out among patients in " Fig. 3 a, b). Compared whom cecal intubation was achieved (● with the control group, the telephone group showed significantly better bowel preparations at each segment (mean [SD]: 2.3 [0.5] vs. 2.0 [0.5], P < 0.001 for left side; 2.6 [0.5] vs. 2.3 [0.7], P = 0.004 for transverse; and 2.2 [0.5] vs. 2.0 [0.6], P = 0.001 for right side). For SMS, significantly higher BBPS scores were observed only for the transverse section compared with controls (2.5 [0.6] vs. 2.3 [0.7], P = 0.032). When the BBPS score of each segment was compared between telephone and SMS, there was no difference in " Fig. 3 a). any of the segments of the colon (●

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In addition, the preparation-to-colonoscopy time, which was defined as the interval between the end of the last purgative ingestion and the start time of the procedure, was calculated [4].

Original article

472 scheduled for colonoscopy 8 met exclusion criteria 43 declined to participate

Fig. 1 Flow chart of study patients. ITT, intentionto-treat analysis; PP, per-protocol analysis; SMS, reinforced education with short message service.

Randomized

139 allocated to SMS group

9 canceled colonoscopy 126 allocated to telephone group

12 canceled colonoscopy ITT

127 allocated to SMS group

1 incomplete colonoscopy n = 125

Table 1

147 allocated to Control group 10 canceled colonoscopy ITT

137 allocated to Control group

1 incomplete colonoscopy PP

n = 126

2 incomplete colonoscopy PP

n = 135

Baseline characteristics of study population.

Characteristics Age, mean (SD), years

Telephone (n = 126)

SMS (n = 127)

Control (n = 137)

P1

46.0 (12.2)

45.7 (12.4)

47.1 (11.8)

Male

79 (62.7)

76 (59.8)

73 (53.3)

Female

47 (37.3)

51 (40.2)

64 (46.7)

24.1 (3.2)

24.0 (3.2)

24.5 (3.8)

12 (9.5)

16 (12.6)

13 (9.5)

114 (90.5)

111 (87.4)

124 (90.5)

< High school graduate

10 (7.9)

12 (9.4)

16 (11.7)

≥ High school graduate

116 (92.1)

115 (90.6)

121 (88.3)

Family history of CRC, n (%)

6 (4.8)

9 (7.1)

6 (4.4)

0.580

History of abdominopelvic surgery, n (%)

40 (31.7)

29 (22.8)

49 (35.8)

0.067

Prior knowledge of bowel preparation, n (%)

78 (61.9)

76 (59.8)

66 (48.2)

0.051

Prior colonoscopy, n (%)

66 (52.4)

58 (45.7)

57 (41.6)

0.212

I

115 (91.3)

116 (91.3)

130 (94.9)

0.496

II

11 (8.7)

10 (7.9)

7 (5.1)

Sex, n (%)

BMI, mean (SD), kg/m 2

0.280

Marital status, n (%) Married Unmarried

0.598

0.633 0.647

Educational background, n (%)

0.607

ASA class, n (%)

III

0

1 (0.8)

0

Co-morbidity, n (%) Diabetes mellitus Hypertension Cerebrovascular disease

5 (4.0)

10 (7.9)

7 (5.1)

13 (10.3)

19 (15.0)

25 (18.2)

0.382 0.190

1 (0.8)

1 (0.8)

1 (0.7)

1.000

Liver cirrhosis

0

0

1 (0.7)

0.121

Thyroid disease

8 (6.3)

3 (2.4)

7 (5.1)

0.301

Kidney disease

1 (0.8)

1 (0.8)

1 (0.7)

1.000

Cardiovascular disease

2 (1.6)

1 (0.8)

0

0.212

Malignancy

0

1 (0.8)

1 (0.7)

1.000

16 (12.6)

14 (10.2)

0.699

Constipation

17 (13.5)

Medication, n (%) TCA Beta blocker

0 10 (7.9)

1 (0.8)

3 (2.2)

0.331

16 (12.6)

21 (15.3)

0.179

CCB

9 (7.1)

7 (5.5)

3 (2.2)

0.162

NSAID

5 (4.0)

0

2 (1.5)

0.055

136 (99.3)

0.313

Under conscious sedation, n (%)

124 (98.4)

123 (96.9)

BMI, body mass index; CRC, colorectal cancer; ASA, American Society of Anesthesiologists; TCA, tricyclic antidepressant; CCB, calcium-channel blocker; NSAID, nonsteroidal anti-inflammatory drug; SMS, short message service. 1 P values for all categorical variables are based on chi-squared tests or Fisher’s exact tests. P values for noncategorical variables are based on analysis of variance test.

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135 allocated to telephone group

Original article

Table 2

Comparison of colonoscopy outcomes.

Characteristics

Telephone (n = 126)

SMS (n = 127)

Control (n = 137)

Cecal intubation rates, n (%)

P1

125 (99.2)

126 (99.2)

135 (98.5)

1.000

Incomplete colonoscopy, n (%)

1 (0.8)

1 (0.8)

2 (1.5)

1.000

Technical difficulty, n (%)

1 (0.8)

1 (0.8)

1 (0.7)

Very poor preparation, n (%)

0

0

1 (0.7)

Cecal intubation time, mean (SD), minutes 2

3.1 (3.3)

3.5 (3.5)

3.4 (3.1)

0.626

Withdrawal time, mean (SD), minutes 2

8.3 (5.1)

9.8 (10.9)

9.1 (7.6)

0.352

Sedation agents, mean (SD) Midazolam, mg

3.5 (1.0)

3.6 (1.1)

3.6 (1.0)

0.701

Propofol, mL

9.0 (4.7)

8.8 (4.2)

8.7 (4.0)

0.841

5.6 (1.7)

5.2 (1.8)

5.4 (2.1)

0.201

Preparation-to-colonoscopy time, mean (SD), hours

SMS, short message service. 1 P values for all categorical variables are based on chi-squared tests or Fisher’s exact tests. P values for noncategorical variables are based on analysis of variance test. 2 Analyses of results for those with successful cecal intubation: telephone (125), SMS (126), control (135).

P = 0.004

P = n / s* P < 0.001

SMS

45.7

3

Control

40

32.1

BBPS

(%)

30

26.8 20

21.4

P = 0.085 P = 0.258

P = 0.264 P = 0.217

2.5

P = n / s* 34.1

2

2.6 2.5 2.3

2.1

P = 0.001

P = 1.000 P = 0.032

2.3

2.2

2.0

2.1

2.0

1.5 20.4 1

10 0.5 0

0 PDR

ADR

Fig. 2 Comparisons of polyp detection rates and adenoma detection rates among groups. *No significant differences were observed among three groups after correction for multiple comparisons using Bonferroni correction. SMS, reinforced education with short message service; NS, not significant; PDR, polyp detection rate; ADR, adenoma detection rate.

Left colon Telephone

a

Transverse colon SMS

Right colon

Control P < 0.001

P = 0.140

9

P = 0.027

8 7 Total BBPS

The total BBPS scores for the three groups are depicted in ●" Fig. 3 b. The total BBPS score was significantly higher in the telephone group compared with the control group (7.1 [1.2] vs. 6.3 [1.4]; P < 0.001). SMS also showed a significantly higher total BBPS score compared with the control group (6.8 [1.3] vs. 6.3 [1.4]; P = 0.027), indicating an overall better quality of bowel preparation in the reinforced education groups. However, no significant difference was observed in total BBPS score between telephone and SMS groups (7.1 [1.2] vs. 6.8 [1.3]; P = 0.140).

The results of the comparison of patients’ subjective feelings are " Table 4. Compared with controls, patients in the presented in ● telephone (P = 0.028) and SMS (P = 0.024) groups were more likely to report a lower anxiety level. A significantly larger number of patients in the telephone group compared with the control group answered “Yes” to the question regarding the willingness to repeat bowel preparations if necessary (92.1 % vs. 81.8 %; P = 0.028); however, there was no significant difference between the SMS group and controls (P = 0.196). With regard to adverse symptoms experienced during bowel preparation, sleep quality prior to colonoscopy, and reported satisfaction with the prepara-

6.8

6.3

5 4 3 2 1 0

b

Patients’ subjective feelings and tolerance

7.1

6

Telephone

SMS

Control

Fig. 3 Bowel preparation qualities, as rated using the Boston Bowel Preparation Scale (BBPS). a BBPS scores according to each segment of the colon. b Total BBPS scores among the three groups. SMS, reinforced education with short message service.

tion, no important differences were observed among the three groups. ●" Table 5 shows tolerance during bowel preparation as reported by patients. Higher proportions of patients ingested ≥ 80 % of the purgative in the telephone group (96.8 %; P = 0.004) and the SMS group (96.1 %; P = 0.010), showing statistical significance compared with controls (86.1 %). When patients were asked whether

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Telephone

50

Original article

Table 4

Comparison of patients’ subjective feelings.

Characteristics

Telephone

SMS

Control

(n = 126)

(n = 127)

(n = 137)

Sleep quality, n (%)

P1

P for comparison with control2 Telephone

SMS

0.028

0.024

0.196

0.912

Same

78 (61.9)

81 (63.8)

84 (61.3)

Worse than usual

48 (38.1)

46 (36.2)

53 (38.7)

Symptoms during bowel preparation, n (%) 5 (3.6)

0.078

Abdominal discomfort/bloating

29 (23.0)

4 (3.2)

29 (22.8)

0

33 (24.1)

0.966

Nausea

50 (39.7)

36 (28.3)

56 (40.9)

0.070

Vomiting

11 (8.7)

7 (5.5)

15 (10.9)

0.282

41 (32.5)

37 (29.1)

40 (29.2)

Anxiety, n (%) Very low

0.013

Low

35 (27.8)

39 (30.7)

21 (15.3)

Moderate

48 (38.1)

44 (34.6)

65 (47.4)

High

2 (1.6)

7 (5.5)

8 (5.8)

Very high

0

0

3 (2.2)

Satisfaction, n (%) Very low

0.112 6 (4.8)

12 (9.4)

10 (7.3)

Low

34 (27.0)

34 (26.8)

51 (37.2)

Moderate

39 (31.0)

40 (31.5)

48 (35.0)

High

27 (21.4)

26 (20.5)

19 (13.9)

Very high

20 (15.9)

15 (11.8)

116 (92.1)

113 (89.0)

Willingness to repeat bowel preparation, n (%)

9 (6.6) 112 (81.8)

0.034

0.028

P1

P for comparison with control2

SMS, short message service. 1 P values were calculated by chi-squared test or Fisher’s exact tests. 2 Adjusted P values which were calculated for multiple comparisons using Bonferroni correction.

Table 5

Comparison of patients’ tolerance during bowel preparation.

Characteristics

≥ 80 % of purgative ingested, n (%)

Telephone

SMS

Control

(n = 126)

(n = 127)

(n = 137)

122 (96.8)

122 (96.1)

118 (86.1)

Compliance with purgative instructions, n (%) High

112 (88.2)

115 (83.9)

13 (10.3)

13 (10.2)

20 (14.6)

1 (0.8)

2 (1.6)

2 (1.5)

High

88 (69.8)

90 (70.9)

75 (54.7)

Moderate

31 (24.6)

31 (24.4)

45 (32.8)

7 (5.6)

6 (4.7)

17 (12.4)

Low Compliance with dietary instructions, n (%)

Low

SMS

0.004

0.010

0.019

0.052

0.024

0.011

0.068

0.022

0.740 112 (88.9)

Moderate

Telephone 0.001

Additional water ingestion, n/N (%) 3 High

31/61 (50.8)

44/69 (63.8)

30/67 (44.8)

Moderate Low

15/61 (24.6)

14/69 (20.3)

29/67 (43.3)

15/61 (24.6)

11/69 (15.9)

8/67 (11.9)

SMS, short message service. 1 P values were calculated by chi-squared test or Fisher’s exact tests. 2 Adjusted P values which were calculated for multiple comparisons using Bonferroni correction. 3 Includes 197 patients who replied that they had drunk additional water: telephone (61), SMS (69), control (67).

they followed the dietary instructions, those in the SMS group showed a higher compliance compared with controls (70.9 % vs. 54.7 %; P = 0.024), whereas there was no difference between telephone and control groups (69.8 % vs. 54.7 %; P = 0.052). Similarly, the instructions concerning additional water ingestion, if needed, were also followed more closely in the SMS group compared with the control group (63.8 % vs. 44.8 %; P = 0.022), whereas no statistical difference was found between telephone and control groups (50.8 % vs. 44.8 %; P = 0.068). The reported compliance with the instructions for the purgative was not significantly different among the groups (P = 0.740).

Lee Yoo Jin et al. Impact of reinforced education on bowel preparation … Endoscopy

Factors associated with inadequate bowel preparation To identify the factors related to inadequate bowel preparation, patients were categorized into two groups: adequate bowel preparation (BBPS ≥ 5, n = 361) and inadequate bowel preparation (BBPS < 5, n = 25). The variables analyzed included: demographic information, assigned reinforced education group, preparationto-colonoscopy time, the amount of purgative administered, and compliance with instructions regarding purgative, diet, and additional water ingestion. Univariate analysis showed that younger age (P = 0.040), lower level of education (P = 0.023), longer preparation-to-colonoscopy

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Abdominal pain

time (P = 0.004), no reminder (P = 0.001), and < 80 % purgative ingested (P = 0.001) were associated with inadequate bowel prepa" Table 6). In multivariate analysis, a preparation-to-coration (● lonoscopy time of > 6 hours (odds ratio [OR] 4.064; 95 % confidence interval [CI] 1.602 – 10.309; P = 0.003) and < 80 % of purgative ingested (OR 5.417, 95 %CI 1.748 – 16.780; P = 0.003) were independent predictors of inadequate bowel preparation for colonoscopy, whereas re-education by telephone was protective against inadequate bowel preparation (OR 0.061, 95 %CI 0.008 – " Table 7). 0.480; P = 0.008) (●

Discussion !

As the use of colonoscopy for colon cancer screening has increased, growing attention has been paid to quality issues pertaining to this modality. Guidelines issued by the American Society for Gastrointestinal Endoscopy state that the quality of bowel preparation should be documented for each colonoscopy [19]. The quality of bowel preparation mainly relies on a patient’s compliance with purgative intake and dietary instructions, and thus many educational interventions have been developed to improve compliance [3, 4, 13, 20]. However, previous interventions have focused exclusively on the contents of the preparation itself, and on booklets, cartoon visual aids, or educational video clips [5 – 7]. Recently, one study identified that a prolonged appointment waiting time of over 16 weeks increased the risk of poor bowel preparation [3]. The authors postulated that the preparation instructions are forgotten over time, suggesting the importance of an effective reminder system for better bowel preparation. Wroe suggested that nonadherence to medications is divided into two separate classes, “intentional” and “unintentional (forgetting)” [21]. The latter is known to be one of the most frequently reported obstacles to adherence in a diverse patient population [22]. In support of this concept, reminder systems have been used in an attempt to improve patient adherence in many medical fields [9 – 11]. Reinforcement reminders enable patients to follow instructions more precisely and decrease the likelihood of the original standard instructions being misunderstood. However, there have been few studies on the effects of reminding patients of their instructions in terms of bowel preparation. Therefore, the current study aimed to evaluate the effectiveness of reinforced education using telephone and SMS 2 days before colonoscopy with respect to bowel preparation quality. The study showed that reinforced education enhanced bowel preparation quality and improved the tolerance and subjective feelings of patients. Furthermore, re-education by telephone showed better efficacy than SMS in terms of bowel preparation adequacy. To keep pace with the rapid increase in mobile phone use, the utility and benefits of mobile phones for disseminating health information have been widely studied. One recent meta-analysis noted that out of 111 articles, SMS (59.5 %) was the most frequently used tool, followed by direct telephone calls (12.6 %) and applications (12.6 %). A large number of studies (86 of 111) have supported the utility of mobile technology for healthcare [12]. The current study revealed that not only telephone but also SMS were effective tools for improving bowel preparation quality. Both resulted in lower anxiety and better tolerance to the amount of purgative ingested than the control group, whereas willingness to repeat the bowel preparation, compliance with dietary instructions, and additional water ingestion improved in

one of the reinforced education groups compared with the controls. The multivariate analysis identified telephone-based education as the independent factor inversely related to inadequate bowel preparation (BBPS < 5), suggesting a superior efficacy of the telephone method for optimal quality of preparation compared with SMS. The direct contact with individuals that the telephone provides may be more effective for relaying information, resulting in decreased patient ignorance of preparation instructions. In addition, several studies have demonstrated that a majority of individuals would prefer to receive health information via a telephone call rather than a text message [23, 24]. Nonetheless, educational intervention using a telephone call might be a challenge in a real clinical practice, particularly with the high burden of procedures and limited personnel resources. In this context, SMS may be more feasible in actual clinical practice because of its lower demand on resources. Thus, we conclude that telephone contact is the superior method for reinforced education on bowel preparation and that SMS constitutes the best alternative plan. However, these reinforced educational approaches using telephone or SMS reminders should be individualized, depending on the resources available at each healthcare facility. For instance, telephone-based education for bowel preparation can be used in the health promotion center where only a limited number of screening colonoscopies for asymptomatic patients are performed, whereas automatically delivered SMS education may be more appropriate in specialized endoscopy units where a large volume of colonoscopies are performed. Several studies have suggested that the interval between the end of bowel preparation and the colonoscopy procedure affects the adequacy of bowel preparation [4, 25]. This is in accordance with the current results, which showed that longer preparation-to-colonoscopy time was an independent predictor of inadequate bowel preparation. In the current study, the amount of purgative ingested was also significantly associated with bowel preparation quality. This result has already been proven in published literature, and emphasizes the importance of the complete ingestion of purgatives for bowel preparation quality [4, 26]. However, other variables, such as level of education, age, sex, marital status, history of abdominal surgery, prior knowledge of bowel preparation, and co-morbidities, were not shown to contribute to inadequate bowel preparation, even though some researchers have advocated the impact of these factors on bowel preparation quality [3, 27 – 29]. In the majority of studies, the reminder system was conducted on the day of, or on the day before, the scheduled event [9 – 11]. In their study evaluating the efficacy of telephone re-education on bowel preparation quality, Liu et al. suggested that reminders provided 1 day before colonoscopy are appropriate for increasing patient compliance with bowel preparation instructions [13]. However, we believe that 1 day may leave insufficient time for patients to adequately follow the dietary instructions for bowel preparation. The ingestion of a low-residue diet for 2 days prior to colonoscopy has been shown to be advantageous for bowel preparation, implying that the timing of dietary instructions has an important effect on bowel preparation quality [20]. Indeed, physicians frequently encounter poor bowel preparation in clinical practice when unplanned colonoscopy is performed at short notice, and patients have not been provided with preliminary dietary restrictions. Hence, the timing of reinforced education for reminders in the current study was set at 2 days prior to colonos-

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Original article

Original article

Univariate analysis of factors associated with inadequate bowel preparation.

Characteristics

Age, mean (SD), years

Adequate preparation, BBPS ≥ 5

Inadequate preparation, BBPS < 5

(n = 361)

(n = 25)

51.0 (13.3)

45.9 (11.8)

Sex, n (%) 210 (58.2)

Female

151 (41.8) 24.54 (3.42)

15 (60.0) 10 (40.0) 24.07 (3.38)

Marital status, n (%) Married

0.508 0.323

324 (89.8)

21 (84.0)

37 (10.2)

4 (16.0)

< High school graduate

31 (8.6)

6 (24.0)

≥ High school graduate

330 (91.4)

19 (76.0)

Family history of CRC, n (%)

21 (5.8)

Unmarried

0.040 0.858

Male BMI, mean (SD), kg/m 2

P

Educational level, n (%)

0.023

0

0.383

History of abdominal surgery, n (%)

111 (30.7)

7 (28.0)

0.773

Prior knowledge of bowel preparation, n (%)

206 (57.1)

12 (48.0)

0.377

Prior colonoscopy, n (%)

167 (46.3)

11 (44.0)

0.826

I

333 (92.2)

24 (96.0)

II

27 (7.5)

1 (4.0)

III

1 (0.3)

0

ASA class, n (%)

1.000

Co-morbidity, n (%) Diabetes mellitus

21 (5.8)

1 (4.0)

1.000

Hypertension

55 (15.2)

2 (8.0)

0.399 0.182

Cerebrovascular disease

2 (0.6)

1 (4.0)

Liver cirrhosis

1 (0.3)

0

1.000

2 (8.0)

0.328

Thyroid disease

16 (4.4)

Kidney disease

3 (0.8)

0

1.000

Cardiovascular disease

3 (0.8)

0

1.000

Malignancy

2 (0.6)

0

1.000

4 (16.0)

0.527

Constipation

43 (11.9)

Medication, n (%) TCA Beta blocker NSAID Under conscious sedation, n (%) Preparation-to-colonoscopy time, mean (SD), hours

4 (1.1) 44 (12.2) 7 (1.9) 354 (98.1) 5.3 (1.8)

0

1.000

2 (8.0)

0.753

0 25 (100) 6.4 (2.3)

Reinforced education, n (%) Telephone

1 (4.0)

119 (33.0)

7 (28.0)

Control

118 (32.7)

17 (68.0)

340 (94.2)

18 (72.0)

Compliance with purgative instructions, n (%) High Moderate Low

317 (87.8) 39 (10.8) 5 (1.4)

19 (76.0) 6 (24.0) 0 0.513

High

233 (64.5)

17 (68.0)

Moderate

102 (28.3)

5 (20.0)

26 (7.2)

3 (12.0)

Additional water ingestion, n/N (%) 1 High

0.001 0.152

Compliance with diet instructions, n (%)

Low

0.004 0.001

124 (34.3)

SMS ≥ 80 % of purgative ingested, n (%)

1.000 1.000

0.222 101/184 (54.9)

4/13 (30.8)

Moderate

52/184 (28.3)

6/13 (46.2)

Low

31/184 (16.8)

3/13 (23.1)

BMI, body mass index; CRC, colorectal cancer; ASA, American Society of Anesthesiologists; TCA, tricyclic antidepressant; CCB, calcium-channel blocker; NSAID, nonsteroidal antiinflammatory drug; SMS, short message service. 1 Includes 197 patients who replied that they had drunk additional water: telephone (61), SMS (69), control (67).

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Table 6

Original article

Variable

Odds ratio

95 % confidence interval

P

Reinforced education Control

Reference

Telephone

0.061

0.008 – 0.480

0.008

SMS

0.520

0.195 – 1.390

0.193

Age

1.018

0.978 – 1.060

0.389

< 80 % of purgative ingested

5.417

1.748 – 16.780

0.003

Preparation-to-colonoscopy time > 6 hour

4.064

1.602 – 10.309

0.003

Level of education < high school graduation

1.980

0.564 – 6.952

0.286

Table 7 Multivariate analysis of factors associated with inadequate bowel preparation (Boston Bowel Preparation Scale score < 5).

copy, and resulted in adequate efficacy and tolerability of the bowel preparation. A national mobile utility survey has shown that the accessibility of text messages (35.8 %) is lower than that of mobile phones (74.2 %) in people aged over 60 years [30]. Thus, the use of SMS reminders for elderly patients may be impractical. To clarify the impact of reinforced education in the elderly group, particularly using SMS, we carried out subgroup comparisons of BBPS among " Table e8, available online). Despite patients aged over 60 years (● the small number of patients included in this subanalysis (n = 57), the preparation qualities in the telephone and SMS groups were significantly greater than those in the control group (mean [SD]: 6.8 [1.3] and 6.7 [1.3] vs. 5.7 [1.7]; P = 0.026), emphasizing the effectiveness of reinforced education, even in elderly patients. Further research is needed to develop an optimal method of improving bowel preparation, with a focus on elderly patients. The strengths of the study lie in its design as a prospective, endoscopist-blinded, randomized, controlled study. In addition, a validated scale (BBPS) was adapted to rate the quality of bowel preparation after adjusting for interobserver consistency. This process is essential for enhancing the validity of the current findings. The standardization of preparation protocols also contributed to strengthening the validity of the comparisons among groups. Previous studies have not been conducted using a standardized protocol for bowel preparations. Diverse types of purgatives have been used in previous studies, including PEG or PEG with bisacodyl, PEG or sodium phosphate, and sodium phosphate with magnesium citrate or PEG [5, 7, 13]. Although the superiority of the split-dose over the full-dose regimen in improving bowel preparation quality has been proven for colonoscopy in outpatients, the latter regimen has still been used in several studies [7, 13, 14]. These methodological discordances may lead to inconclusive results. In addition, patient education is believed to have a synergistic effect when combined with an optimal bowel preparation regimen [7]. Thus, in the current study, a unified protocol of bowel preparation (i. e. a split-dose of PEG + ascorbic acid) was applied for all enrolled patients based on current recommendations, although some of these recommendations are controversial. Furthermore, recommendations regarding the timing of the last purgative dose relative to the colonoscopy procedures were followed and were described in the current study as preparation-to-colonoscopy times [4]. The use of the standardized regimen enabled a more reliable evaluation of the impact of reinforced education on the quality of bowel preparation. In addition, many factors associated with bowel preparation quality, and details regarding the compliance and subjective feelings of patients were evaluated. A unique strength of the study was the comparison of telephone and SMS modalities; to the best of our knowledge, this is the first report to compare the impact of reinforced education on bowel

preparation quality between telephone and SMS, both of which are used as e-health education modalities worldwide. The study does contain certain limitations. First, patients who were assigned to the SMS group were expected to have read the message; however, the study did not confirm whether they had actually read the message, which potentially limits the accuracy of the assessment of the impact and feasibility of SMS. Second, because the study was a single-center study, difficulties may be encountered in generalizing the findings. Third, the issue of privacy is unavoidable with regard to the use of SMS and telephone contact. Finally, despite the outstanding advantages of these educational reinforcements modalities, some issues persist regarding the costs of SMS and telephone, the instability within the mobile network, and the lack of sufficient bidirectional communication [23]. Considering the importance of bowel preparation for colonoscopy, more trials are required to identify the best and optimal methods of improving patient compliance with instructions that will be feasible in clinical practice. Numerous studies support the association of good bowel preparation with high ADR, as an optimal level of preparation enables the endoscopist to visualize the full colonic mucosa leading to better detection of adenomas [2, 31, 32]. Interestingly, however, the results of the current study did not show a significant difference in ADR among groups despite a clear distinction in the quality of preparation. The lack of association between the quality of bowel preparation and ADR could have several explanations. First, the current study was designed for bowel preparation, not for ADR. Thus, the sample size may not have had adequate power to identify differences in detection rate. In fact, a much larger sample size has been required in studies focusing on ADR [32, 33] than in studies primarily designed for the quality of bowel preparation [4 – 6]. Second, the number of patients with inadequate preparation (n = 25) may have been too small to make a difference in ADR among the groups. It has been reported that ADR was obviously unsatisfactory in patients with an “inadequate” level (poor/insufficient) of preparation compared with ADR in patients with “adequate” preparation (fair/good/excellent), whereas there was no difference in ADR between intermediate quality (fair) and high quality preparation (excellent/good) [34]. Excellent and good categories in the Aronchick scale correspond to scores of 3 and 2, respectively, for each colonic segment in the BBPS [18]. In the current study, the most common score of quality " Fig. 3 a), which is analogous to the in each segment was 2 (● “good” category in the Aronchick scale. Therefore, the short range of difference in the level of quality of preparation may not have a great influence on the difference in ADR. In conclusion, this randomized controlled trial demonstrated that the use of telephone and SMS reminders 2 days before colonoscopy improved the quality of bowel preparation, and the tolerance and subjective feelings of patients. More strict prepara-

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SMS, short message service.

tion instructions, particularly with regard to the amount of purgative to be ingested (> 80 % of full amount), a preparation-to-colonoscopy time of within 6 hours, and the reinforced educational reminders of these instructions are necessary to ensure successful colonoscopy. Between the two reinforced education modalities, the telephone appeared to be more effective than SMS for improved bowel preparation in healthy screening individuals. However, SMS was the best alternative plan, given its convenience and reduced demand on resources. Therefore, a reinforced educational approach using telephone or SMS should be individualized to take account of the resource availability at each clinical practice.

14

15

16

17 18

Competing interests: None 19

Acknowledgment

20

!

21

This paper was presented as an oral presentation at United European Gastroenterology Week (UEGW) 2014, Vienna, Austria.

22

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Appendix e1, Table e3, e8 online content viewable at: http://dx.doi.org/10.1055/s-0034-1392406

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Original article

Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study.

High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by telephone or ...
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