Factors Affecting Colonoscopy Comfort and Compliance: a Questionnaire Based Multicenter Study

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1 Factors Affecting Colonoscopy Comfort and Compliance: a Questionnaire Based Multicenter Study A. VOIOSU 1, ALINA TANŢĂU 2, CRISTINA GARBULEŢ 1, M. TANŢĂU, B. MATEESCU 1, C. BĂICUŞ 1, R. VOIOSU 1, TH. VOIOSU 1 1 Colentina Universitary Hospital, Bucharest, Romania 2 Tanţău Medical Center, Cluj-Napoca, Romania Aims. Colonoscopy screening reduces colorectal cancer-related mortality and incidence. However, many patients are reluctant to undergo colonoscopy or return for follow-up because of the investigation s cumbersome and unpleasant nature. We aimed to identify patient-related factors significantly influencing comfort and quality of colonoscopy analyzing responses to a selfadministered validated questionnaire. Methods. Patients undergoing colonoscopy under sedation in two high-volume endoscopy units were invited to answer a short prevalidated questionnaire regarding preprocedure anxiety, satisfaction with information provided, most worrisome aspect of the procedure and knowledge of the benefits of colonoscopy. Self-reported comfort during colonoscopy as graded on a 10 point visual analog scale was the main variable considered. Univariate analysis identified factors possibly associated with a higher degree of comfort during colonoscopy that were then tested through multivariate logistical regression. Results. 452 questionnaires were returned. Most patients reported an acceptable degree of discomfort during colonoscopy but 70.2% of the respondents considered the information provided prior to the procedure to be insufficient. On multivariate analysis older age, higher degree of satisfaction with information provided (p = 0.04), lower preprocedure anxiety levels (p < 0.01) and endoscopy center (p < 0.01) were shown to correlate with increased comfort during colonoscopy. Education level, previous colonoscopy, gender and bowel prep quality did not influence patient comfort. Conclusions. Patient comfort during colonoscopy is dependent on satisfaction with the information provided before the procedure. Higher availability of the physician and better interaction with the patient might decrease patient perceived burden of colonoscopy and lead to higher return rates in the screening and surveillance setting. Key words: colonoscopy; pain measurement; questionnaires; colorectal cancer; patient satisfaction. Colonoscopy screening reduces colorectal cancer-related mortality and incidence [1]. However, many patients are reluctant to undergo colonoscopy or return for follow-up because of the investigation s cumbersome and unpleasant nature [2]. Studies have tried to address various aspects of the preparation and colonoscopy practices in order to improve acceptability and screening rates. While a good deal of literature is continuously being published on the topic of the optimal bowel prep [3 6] and insufflation technique [7 10], there are comparatively few studies dealing with patientoriented factors. The unpleasantness of the examination and inconvenience of the bowel preparation regimen are frequently invoked by patients when discussing the burden of colonoscopy [11]. It is probable that certain cultural and social individual factors such as education, expectations and anxiety concerning the procedure, shame and pain perception have a role in shaping a patient s experience of colonoscopy. Certain groups, including ours [12], have looked into different aspects of the colonoscopy experience [13 18] in an effort to better understand and improve the general population s low compliance to this screening practice. The use of the selfadministered questionnaire, although plagued by biases and reliability issues, is one of the best available tools in the study of cultural and social factors affecting colonoscopy screening rates. We aimed to identify both patient-related and procedure-dependent factors that are associated with increased colonoscopy-related comfort and satisfaction by studying postprocedure patient responses to a self-administered questionnaire. METHODS AND MATERIALS The study was conducted in two high-volume colonoscopy centers in Romania: a tertiary referral academic center ( Colentina Clinical Hospital, ROM. J. INTERN. MED., 2014, 52, 3,

2 152 A. Voiosu et al. 2 Bucuresti hereafter referred to as CH) and a private practice setting ( Dr Tantau Medical Center of Gastroenterology, Hepatology and Digestive Endoscopy, Cluj hereafter referred to as TC). We asked all patients who had undergone colonoscopy at the 2 sites to complete a simple self-administered questionnaire after the procedure, when sedation wore off completely. Patients with stenosing colorectal tumors or who were examined under Proprofol sedation were excluded from the study. The study was approved by the local Ethics commitees for the two sites. QUESTIONNAIRE DESIGN AND CONTENTS The questionnaire contained simple singlechoice questions regarding personal education level, previous number of colonoscopies, degree of information about colonoscopy and its role in colorectal cancer prevention, level of anxiety preceding the investigation and the most worrisome aspect of the procedure. The main variable assessed was comfort during colonoscopy which the patient graded on a 10 grade visual analog scale with 10 representing extreme discomfort. This questionnaire was previously developed on a cohort of patients undergoing first colonoscopy in CH and the questions and answer options were adjusted to increase clarity of the formulation and consistency of responses after discussions with the patients who completed the forms. Questions from this initial survey form were also later used in a study we conducted on the influence of bowel prep regimen on patient satisfaction and quality of bowel cleansing [12]. Patients assessed the quality of information pertaining to colonoscopy offered before the procedure as insufficient, adequate or very satisfactory. This 3 point scale was further dichotomized for analysis into a low (insufficient information received) or high (adequate or better) degree of satisfaction with the procedure-related information offered. The level of anxiety before the procedure was described as insignificant, neutral, significant and highly significant and further stratified into low ( insignificant and neutral anxiety) or high ( significant and highly signifycant ) for statistical analysis. Patients were asked to state the single most worrisome aspect related to colonoscopy by choosing between fear of unfavorable results, pain, embarrassment, necessity of bowel prep, procedure-associated risks, duration and time lost due to the procedure, sedation or anesthesia related risks, others. They were also asked to specify if they were aware of the role of colonoscopy in the prevention of colorectal cancer by answering a yes or no question. The question and answer variants are presented in Table I. Table I Self-administered questionnaire form and responses according to center (CH Colentina Clinical Hospital, Bucuresti; TC Dr Tantau Medical Center of Gastroenterology, Hepatology and Digestive Endoscopy, Cluj) Question How many colonoscopies have you previously had? Did you consider the information regarding the colonoscopy put at your disposal prior to the procedure to be: Which single aspect of the colonoscopy did you fear the most? How would you rate the degree of anxiety or fear you felt before the colonoscopy? Answer options None or more Very satisfactory Adequate Insufficient Necessity of bowel prep An unfavorable result Pain Embarrassment Procedure-related risks Duration and time lost Anesthesia or sedation related risks Other Very significant Significant Neutral Insignificant Yes Answer tally (CH/TC) 100/98 58/43 37/22 52/40 4/0 77/51 162/149 45/43 108/103 56/19 21/9 7/5 2/5 1/3 5/17 33/29 60/38 118/101 34/36 230/203 15/1 Were you aware that colonoscopy is important in detecting and preventing the development of colorectal cancer? No Please rate the discomfort experienced during colonoscopy on the scale from 1 to 10 provided (1 represents no discomfort and 10 - extreme discomfort)

3 3 Factors Affecting Colonoscopy Comfort and Compliance 153 COLONOSCOPY SETTING Bowel preparation was achieved by 4 liter split dose polyethylene glycol or sodium picosulphate/ magnesium citrate according to guidelines and the manufacturer s instruction. All endoscopies were performed less than 5 hours after completion of bowel preparation under Midazolam sedation. The two centers differed in insufflation technique available as air was employed for all procedures at CH while carbon dioxide was used at TC. Endoscopists recorded the indication for colonoscopy, quality of bowel preparation using a prevalidated 4 graded scale [12] (Table II), limit of examination, findings and procedure or sedation related complications. Patients with stenosing tumors were excluded from the final analysis. Table II Four-graded scale of bowel preparation quality used by the colonoscopist Grade Bowel cleanliness 1 Solid stool residue in large quantities throughout the colon making complete and correct examination of the mucosa impossible 2 Liquid and semisolid residue requiring an important amount of flushing and suctioning to achieve adequate visibility of the mucosa 3 Liquid residue requiring a moderate amount of suction to achieve good visibility 4 Little or no liquid residue, no supplimentary cleaning maneuvers required STATISTICAL ANALYSIS Statistical analysis was performed with SPSS version 16 (SPSS Inc., Chicago, Illinois, U.S.A) and the usual parameters of statistic significance (p < 0.05; 95% CI) were used. We used univariate analysis to select variables possibly associated with an increased level of comfort during colonoscopy as reported by patients on a 10 point visual analog scale and tested the findings through multivariate logistical regression. We then compared patient characteristics (age, sex, level of education, colonoscopy indication, bowel prep regimen) between the two services. RESULTS During the study period a total number of 452 questionnaires were returned at the two sites (248 from CH and 204 from TC). DEMOGRAPHICS Forty-six percent of respondents were male and the mean age was 56.3 years (SD = 15). A hundred ninety-eight subjects (43.8 %) were undergoing first colonoscopy while 252 (56.2 %) had at least one prior examination. Higher education was reported by 45.8% of respondents while 14.3% had attended general school and 40 % were high school graduates. The indication for colonoscopy was symptom oriented in 69.6% (iron-deficiency anemia 4.6%, hematochezia 20%, melena 0.2%, diarrhea 8.7%, constipation 6.2%, abdominal pain 14.2%, unexplained weight loss 3%, other 11.7%) and colorectal cancer screening or surveillance in 30.4% of cases. The main bowel prep regimen used was 4 liter polyethylene glycol (432 cases, 95.6%) while sodium picosulphate/magnesium citrate was used for 20 patients (4.4%). The overall cecal intubation rate was 94.5%. Complications occurred in 3 cases and consisted of bleeding that was controlled endoscopically. QUESTIONNAIRE RESPONSES The results of the questionnaire are presented in Table I. 70.2% of the respondents were dissatisfied with the information provided prior to the procedure, 28.9% considered it adequate while only 0.9% reported a high degree of satisfaction with the preprocedure instructional support offered. Anxiety before the procedure was described as insignificant by 15.6%, neutral by 48.8%, significant by 21.8% and highly significant by 13.8% of respondents. The main aspects patients reported fearing before the procedure were an unfavorable result (47%), the necessity for strict bowel prep (19.6%) and pain (16.7%) or embarrasssment (6.7%). Ninety-six percent of the patients reported knowledge of the role of colonoscopy in preventing colorectal cancer. PATIENT COMFORT DURING COLONOSCOPY Most patients reported an acceptable degree of discomfort during colonoscopy with a median value of 3 and interquartile range of 2 to 5 on the

4 154 A. Voiosu et al point visual analog scale. On univariate analysis better bowel cleansing was significantly associated with a lower level of discomfort during colonoscopy (p < Kruskall Wallis). Also, patients who considered themselves better informed about the procedure (p = 0.025, Mann Whitney) and reported lower procedure-related anxiety (p = 0.032) were more likely to have lower scores on the VAS scale indicating more comfort during the colonoscopy. Compared to patients investigated in the teaching hospital setting patients seen in the private practice reported lower levels of pain during colonoscopy (p < 0.01). The choice of bowel preparation regimen did not influence comfort levels as there were no differences between the split-dose 4 liter polyethylene glycol or sodium picosulphate/ magnesium citrate. On multivariate analysis age, satisfaction with information received regarding colonoscopy, preprocedure anxiety and endoscopy center were shown to correlate with comfort during colonoscopy. Patients who were more satisfied with the information offered before the procedure were more likely to report lower pain-scores on the VAS (p = 0.043). Lower self-reported anxiety levels (p = 0.006) and examinations completed in the private center (p < 0.001) were more likely to result in lower VAS scores. Age was also a significant factor, with older patients reporting less procedure associated discomfort (Table III). Table III Multivariate analysis using ordinal regression of factors influencing patient comfort on a 10-point VAS scale. Estimates are provided, with 95% confidence intervals and p values at a significant level of < 0.05 Variable Estimate (95% CI) p Value Age 0.22 ( 0.34, 0.10) < Gender ( 0.40, 0.32) 0.84 Bowel prep quality ( 0.13, 0.71) 0.18 Information level ( 0.78, 0.12) Anxiety level (0.14, 0.9) Center 2.25 (1.8, 2.68) < Examination of the data by endoscopy center resulted in significant differences in age, education level, bowel prep, and comfort with the private center having slightly younger patients, with higher education, better colon cleansing scores and less procedure-related discomfort. These results are presented in Table IV. There were no differences in the usual endoscopy quality indicators such as cecal intubation rate, adenoma detection rate or complications. Table IV Study population characteristics and comparisons between the study sites showing means and standard deviations for numerical variables, medians and interquartile range (IQR) for ordinal variables. Comfort during colonoscopy was assessed by the patient using a 10-point visual analog scale with 10 representing the worst pain. (CH Colentina Clinical Hospital, Bucuresti; TC Dr Tantau Medical Center of Gastroenterology, Hepatology and Digestive Endoscopy, Cluj) * t-test Mann Whitney U Chi-Square Colentina Hospital Tantau Medical Clinic Total p value Number of questionnaires N/A Sex (male/female) 111/ / / Age (mean,sd) 58.2 (15) 53.8 (14) 56.3 (15) 0.003* Higher education(/total) 92/ / / Previous colonoscopy (/total) 147/ / / Cecal intubation rate 93% 96.6% 94.5% 0.79 Quality of bowel prep (median, IQR) 3 (2 3) 4 (3 4) 3 (3 4) < Procedure-related complications Comfort (median, IQR) 5 (2 7) 1 (1 2) 3 (1 5) < DISCUSSION The main finding of our study is that colonoscopy-associated comfort is significantly influenced by the patients satisfaction with information regarding colonoscopy made available prior to the procedure. Preprocedure anxiety levels as reported by the patients also seem to correlate with a higher burden of colonoscopy and higher scores on the visual analog scale of pain.

5 5 Factors Affecting Colonoscopy Comfort and Compliance 155 This conclusion is all the more important as an unacceptably high number of responses rated the information received prior to the procedure as inadequate. Seeing that the level of discomfort perceived by the patients is linked to their satisfaction with the preprocedure consult and interaction with the physician this indicates an acute need for improvement on behalf of the endoscopy centres. The fact that more than half of the patients had undergone a prior examination, most of them in another service, supports the applicability of this finding to other centres in Romania and underlines the importance of better communication between patient and physician before the colonoscopy. Satisfaction with the colonoscopy procedure also impacts return rates. While colonoscopy is the guideline-preferred colorectal cancer screening method studies show a low return rate after the index procedure [11, 19]. This may in part be due to an unfavourable first experience and thus all steps must be taken to minimize this risk and increase patient acceptability and comfort with the procedure. Our results also reveal a difference in patient overall satisfaction between the two centers, with patients examined at a private practice reporting lower pain scores on the VAS. The colonoscopies performed in a teaching center are by nature more likely to generate dissatisfaction as the procedure can be assisted by students or residents with the patient s approval. While the private practice setting is probably a more comfortable and satisfying environment for colonoscopy we cannot disregard the impact of the differences in bowel prep quality and insufflation technique. Patients examined in the TC center had better bowel prep scores and were examined using CO 2 insufflation. It is known that a cleaner colon takes less time and effort to examine and that additional maneuvers required to inspect an improperly prepared colon add to the patient s discomfort. As quality of bowel prep is dependent on the adherence to the regimen requirements this also points to the need for better communication between physician and patient. Insufflation technique has been proven to impact satisfaction and it surely is an important factor in determining the different levels of comfort reported. A difference between the quality of the endoscopists performance between the centers does not seem to be significant as the usual quality indicators such as cecal intubation rate, adenoma detection rate and complication rate do not vary. We also confirmed that older age correlates with less discomfort during the investigation, but contrary to other reports our data does not show gender or bowel prep to influence comfort. The main limitation of our study is due to the expected unreliability of questionnaire-based reporting. While all diligence was used to provide a setting conducive to honest and precise responses the inherent biases of the questionnaire method such as social-desirability bias cannot be overlooked. Thus the responses may overestimate the comfort during the procedure in an attempt to please the physician. However, seeing that the reported satisfaction with the preprocedure consult is low, it stands to reason that the social-desirability bias is also low. We tried to minimize the effect of the recall bias specific to post-procedure appraisal by having the patients complete the survey before discharge and not at a later time. The importance of this study, to our knowledge the first in our country to address these issues, stems from its finding that comfort during colonoscopy is influenced by satisfaction with the information received beforehand, which is the responsibility of the medical team. Colonoscopy performance evaluations using the Global Rating Scale [20] such as the one reported by Sint Nicolaas et al. [21] are important in assessing the experience of patients undergoing colonoscopy in various settings but are also cumbersome and costly to employ. Simple survey-based evaluations can reveal systemic deficiencies and prompt necessary changes. Considering the higher than expected percentage of patients reporting what seem to be inadequate preprocedure consults, further studies aimed at patient-related comfort and satisfaction become mandatory. An essential component of any informed consent process spending an adequate amount of time on explaining the procedure, with all its steps and risks, might lead to a better doctorpatient rapport and thus to lower preprocedure anxiety, increased comfort during the procedure and higher colonoscopy return rates. Obiective. Colonoscopia de screening reduce incidenţa şi mortalitatea asociate cancerului colorectal. Totuşi, mulţi pacienţi refuză colonoscopia sau nu se întorc la reevaluare din cauza aspectului neplăcut şi dificil de suportat al

6 156 A. Voiosu et al. 6 investigaţiei. Am încercat să identificăm factorii dependenţi de pacient care influenţează semnificativ confortul şi calitatea colonoscopiei analizând răspunsurile la un chestionar validat autoadministrat. Metode. Pacienţii care au fost investigaţi colonoscopic în două mari centre de endoscopie au fost invitaţi să completeze un scurt chestionar prevalidat privind anxietatea preprocedurală, satisfacţia cu informaţia oferită înainte de procedură, aspectul cel mai neplăcut al investigaţiei şi gradul de cunoştiinţe despre beneficiile colonoscopiei. Variabila principală considerată a fost gradul de confort din timpul procedurii, evaluat pe o scală vizual analog de 10 puncte. Analiza univariată a identificat factorii posibil asociaţi cu un grad ridicat de confort în timpul colonoscopiei, aceştia fiind apoi evaluaţi prin analiză multivariată folosind regresie logistică. Rezultate. 452 chestionare au fost returnate. Cei mai mulţi pacienţi au raportat un grad acceptabil de disconfort în timpul colonoscopiei dar 70,2% dintre respondenţi au considerat că informaţiile oferite înainte de procedură nu au fost suficiente. La analiza multivariată vârsta avansată, gradul mai mare de satisfacţie privind informaţia disponibilă (p = 0,04), nivelurile scăzute de anxietate preprocedurală (p < 0,01) şi centrul endoscopic (p < 0,01) s-au demonstrat a se corela cu confortul crescut în timpul colonoscopiei. Nivelul de educaţie, o colonoscopie anterioară în antecedente, sexul şi calitatea pregătirii colonice nu au influenţat confortul pacienţilor. Concluzii. Confortul pacienţilor în timpul colonoscopiei este dependent de gradul de satisfacţie privind informaţia pusă la dispoziţie înainte de procedură. Disponibilitatea doctorului şi interacţiunea mai bună cu pacientul pot îmbunătăţi percepţia acestuia asupra colonoscopiei şi pot contribui la acceptarea mai facilă a acestei proceduri ca instrument de screening şi urmărire periodică. Corresponding author: Th. VOIOSU, Colentina Clinical Hospital, 19 21, Şos. Ştefan cel Mare, Bucharest, Romania Tel/fax: theodor.voiosu@gmail.com REFERENCES 1. ZAUBER AG, WINAWER SJ, O BRIEN MJ, et al., Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N. Engl. J. Med Feb. 23; 366(8): SENORE C, EDERLE A, FANTIN A, et al., Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting. J. Med. Screen. 2011; 18(3): KATZ PO, REX DK, EPSTEIN M, et al., A dual-action, low-volume bowel cleanser administered the day before colonoscopy: results from the SEE CLEAR II study. Am. J. Gastroenterol. 2013; 108(3): HASSAN C, BRETTHAUER M, KAMINSKI MF, et al., Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: JULURI R, ECKERT G, IMPERIALE TF, Polyethylene glycol vs. sodium phosphate for bowel preparation: a treatment arm metaanalysis of randomized controlled trials. BMC Gastroenterol. 2011; 11: RENAUT AJ, RANIGA S, FRIZELLE FA, PERRY RE, GUILFORD L, A randomized controlled trial comparing the efficacy and acceptability of phospo-soda buffered saline (Fleet) with sodium picosulphate/magnesium citrate (Picoprep) in the preparation of patients for colonoscopy. Colorectal Dis. 2008; 10: WU J, HU B, The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012; 44(2): CHEN PJ, LI CH, HUANG TY, et al., Carbon dioxide insufflation does not reduce pain scores during colonoscope insertion in unsedated patients: a randomized, controlled trial. Gastrointest. Endosc. 2013; 77(1): BRETTHAUER M, THIIS-EVENSEN E, HUPPERTZ-HAUSS G, et al., NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy. Gut. 2002; 50(5): BASSAN MS, HOLT B, MOSS A, WILLIAMS SJ, SONSON R, BOURKE MJ, Carbon dioxide insufflation reduces number of postprocedure admissions after endoscopic resection of large colonic lesions: a prospective cohort study. Gastrointest. Endosc. 2013; 77(1): 90 5.

7 7 Factors Affecting Colonoscopy Comfort and Compliance DE WIJKERSLOOTH TR, DE HAAN MC, STOOP EM, et al., Reasons for participation and nonparticipation in colorectal cancer screening: a randomized trial of colonoscopy and CT colonography. Am. J. Gastroenterol. 2012; 107(12): VOIOSU T, RATIU I, VOIOSU A, et al., Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J. Gastrointestin. Liver Dis. 2013; 22(2): PRAKASH SR, VERMA S, MCGOWAN J, et al., Improving the quality of colonoscopy bowel preparation using an educational video. Can. J. Gastroenterol. 2013; 27(12): ROSTOM A, ROSS ED, DUBÉ C, et al., Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest. Endosc. 2013; 77(2): DENTERS MJ, SCHREUDER M, DEPLA AC, et al., Patients' perception of colonoscopy: patients with inflammatory bowel disease and irritable bowel syndrome experience the largest burden. Eur. J. Gastroenterol. Hepatol. 2013; 25(8): LAWRANCE IC, WILLERT RP, MURRAY K, A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig. Dis. Sci. 2013; 58(4): STOOP EM, DE WIJKERSLOOTH TR, BOSSUYT PM, et al., Face-to-face vs telephone pre-colonoscopy consultation in colorectal cancer screening; a randomised trial. Br. J. Cancer. 2012; 107(7): CHUNG SH, PARK SJ, HONG JS, et al., Comparison of double pants with single pants on satisfaction with colonoscopy. World J. Gastroenterol. 2013; 19(26): KHALID-DE BAKKER CA, JONKERS DM, HAMEETEMAN W, et al., Opportunistic screening of hospital staff using primary colonoscopy: participation, discomfort and willingness to repeat the procedure. Digestion 2011; 84(4): Endoscopy Rating Scale (UK). Available from: SINT NICOLAAS J, DE JONGE V, KORFAGE IJ, et al., Benchmarking patient experiences in colonoscopy using the Global Rating Scale. Endoscopy. 2012; 44(5): Received August 4, 2014

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