Open access colonoscopy in the training setting: which factors affect patient satisfaction and pain?

• Introduction
• Materials and methods
• Study design and questionnaires
• Patients
• Physicians
• Definitions
• Endoscopic equipment
• Statistical analysis
• Results
• Enrolment
• Patient and procedure characteristics
• Primary outcome: patient satisfaction
• Secondary outcome: pain scores
• Differences between in-hospital- and home post-procedure questionnaires (kappa analysis)
• Discussion
• References

Background and study aim: Patient satisfaction with colonoscopy is important for quality assurance; it may be affected by various factors, including patient characteristics, physician training level, and procedural or organizational features. We aimed to analyze how these factors influenced patient satisfaction and pain in an outpatient training setting.

Methods: Consecutive patients for open access colonoscopy (OAC) were enrolled in a prospective, single-blinded, controlled study. Primary and secondary outcomes were satisfaction and pain scores with and without trainee participation. A multivariate analysis was designed to achieve an 80 % power with an alpha value of 0.05.

Results: 368 patients were enrolled. Satisfaction with the procedure was high (mean score 1.36; 1 = best to 5 = worst). In the multivariate analysis only waiting time in the endoscopy suite was significantly associated with lower satisfaction scores (P = 0.024). Satisfaction was unaffected by patient factors (gender, American Society of Anesthesiologists’ [ASA] score, anxiety, etc). Higher pain scores were associated with higher anxiety levels (P = 0.02), female gender (P = 0.02), longer procedure (P< 0.001), and lower sedation levels (P = 0.001); trainee involvement (49 % of procedures) did not adversely affect satisfaction or pain scores.

Conclusions: Patient satisfaction with OAC using sedation appears to depend primarily on organizational factors (waiting time beforehand). In contrast, pain is associated with patient characteristics (female gender, anxiety) and procedural factors (lower sedation, longer procedure). Trainee participation did not affect satisfaction or pain scores, a finding which may help to reassure patients undergoing OAC with trainee participation.

Introduction

Patient satisfaction has been recognized as a critical measure of performance and has become a central focus of healthcare delivery and quality assurance efforts [1] [2]. Questionnaires assessing patient satisfaction are increasingly utilized for quality control in endoscopy suites worldwide [3] [4] [5] [6].

Satisfaction of patients with colonoscopy can be influenced by a variety of factors, including patient characteristics (e. g. age, gender, anxiety levels), organizational aspects (e. g. waiting times), or physician characteristics (e. g. level of training). The latter may be of particular interest for quality assurance efforts, because guidelines for colorectal cancer screening and public awareness campaigns have lead to increasing demands for training future colonoscopists [7] [8] [9] [10] [11]. While conflicting data exist regarding the effect of trainee participation on patient satisfaction with sigmoidoscopy [12] [13], such data are lacking for colonoscopy.

Using a validated instrument for the primary outcome, we conducted a prospective, single-blinded, controlled, questionnaire-based study of consecutive patients referred to a university hospital for open access colonoscopy (OAC). The primary aim of the study was to assess patient satisfaction scores for procedures with and without trainee participation. As a secondary aim, patient pain scores were compared in both groups. The effect of potential confounders on these outcomes was analyzed in a multivariate analysis.

Materials and methods

Study design and questionnaires

All consecutive patients scheduled for OAC were invited to participate in the study and were asked to fill out a total of three questionnaires (one pre-procedure and two identical post-procedure questionnaires at different time intervals). Intraprocedural data were recorded by nurses and study physicians.

Pre-procedure questionnaires: Patients, who were booked for OAC by central scheduling, were contacted by mail prior to the procedure. They received the usual instructions for colonoscopy and a short description of the study. Patients were asked to fill out a pre-procedure questionnaire inquiring about baseline characteristics, preparation tolerance and anxiety levels (see Appendix e1, online only). Participants were also allowed to fill out the pre-procedure questionnaire upon arrival at the endoscopy suite. Although patients were aware which outcomes were being assessed, they were blinded to the fact that we intended to compare groups with or without trainee participation.

Post-procedure questionnaires: Post-procedure questionnaires (see Appendix e2, online only) were given to the patients when they were fully awake and ready to be discharged from the endoscopy suite. Questionnaires were filled out in a private area. The following scales were used.

1. A previously validated satisfaction scale was used to assess the primary outcome [14] [15]. The satisfaction score was based on the following three statements: (a) “I was very satisfied with the care I received”; (b) “I would strongly recommend this procedure to friends who qualify for it”; (c) “I would be willing to repeat the exam in the future if necessary.” Each statement was coded on a 5-point ordinate scale that included the following choices: strongly agree, agree, not sure, disagree and strongly disagree. The average of the scores for the three statements was used as the satisfaction score for each study group (range 1-5).

2. For the assessment of the patients’ pain (secondary outcome) a pain scale by Rex et al. was used, which was originally designed as part of a sedation satisfaction survey [16].

The second post-procedure questionnaire, which was identical to the first, and a return envelope were added to the post-procedure instructions. Patients were asked to fill the questionnaire out the next day and mail it back to the study center. Study questionnaires were coded to assure anonymity. Reminder letters were sent to patients who did not respond.

Intraprocedural data: Besides standard pre-procedure evaluation, routine procedural monitoring for patients receiving conscious sedation [17], and documentation of procedural data (using software from ProVation Medical, Inc. Minneapolis, Minnesota, USA), the following data were also recorded: trainee participation; waiting time in the endoscopy suite from arrival to the beginning of the procedure (“waiting time”); time to cecal intubation, and total procedure time; type of interventions; complications; take-over by the experienced attending physician; use of music; sedative medications and their dose; type of endoscope; and physicians’ assessment of patients’ pain and depth of sedation.

The study was approved by the institutional review board at the University of Massachusetts School of Medicine.

Patients

Consecutive patients booked for OAC by central scheduling were invited to participate in the study. Central scheduling assigns patients to attending (trained and experienced) physicians on a rotation basis, and there are no known biases in referrals to clinic physicians for OAC procedures [18].

Exclusion criteria were such that the following were not included: minors (< 18 years), non-English-speaking patients, pregnant women, prisoners, and patients with mental impairment that prohibited informed consent or filling out a questionnaire.

Physicians

Three gastroenterology staff physicians (K.B., W.Y.W., and J.M.L.) with extensive experience in endoscopy (> 10 000 colonoscopies) performed or supervised all procedures. During the study period, seven trainees in their second or third year of training for gastroenterology or hepatology (each had performed at least 100 colonoscopies) spent their endoscopy time with the three staff physicians mentioned above. Trainees at our institution perform supervised colonoscopies throughout the week, usually in half-day sessions.

To allow for flexibility with the trainees’ rotation and service responsibilities, and to avoid compromising the number of procedures they would perform, randomization was not carried out. To avoid potential bias, all consecutive patients were included.

First-year trainees were excluded, because they are mostly involved in inpatient care (including inpatient endoscopy), but generally do not participate in OACs. Staff physicians were allowed to take control of the examination whenever this was deemed necessary (e. g. because of prolonged procedure, difficult intervention or intubation, or patient discomfort).

Definitions

The definitions for the primary outcome have been mentioned above. For the secondary outcome the following previously described 7-point pain scale was used: 1 = don’t remember the examination; 2 = mild pain, very acceptable, would do again with this sedation or less; 3 = moderate discomfort, could do again with this level of sedation, 4 = moderate plus, would have preferred somewhat more sedation; 5 = moderate plus plus, could not stand again without more sedation; 6 = very bad experience, not sure would do again even if more sedation; 7 = terrible experience, a nightmare, wouldn’t have it done again like this [16].

The American Society of Anesthesiologists’ (ASA) classification (I-V) was used for assessment of patients’ risk from conscious sedation [19].

Preparation quality. This was graded as follows:

• Excellent or good: preparation did not affect the quality of the procedure.

• Fair: preparation is not good enough for adequate assessment. If a surveillance or repeat screening procedure is planned, the time interval is affected/shortened secondary to the quality of the preparation.

• Poor or unsatisfactory: no assessment could be made or the procedure was terminated early. The same procedure needs to be repeated as soon as possible with an improved preparation.

Endoscopic equipment

All procedures were performed with either a pediatric, adjustable stiffness endoscope (Olympus PCF-160AL, Olympus America, Melville, New York, USA), or with an adult, nonadjustable endoscope (Olympus CF-Q160L). The choice of endoscope was left to the discretion of the physician.

Statistical analysis

For the statistical analysis Stata/SE 9.2 (Stata Statistical Software: Release 9; StataCorp LP, College Station, Texas, USA) was used. Kappa (κ) coefficients and percentage agreement (P _O) values were calculated to determine differences between the two post-procedure questionnaires [20]. Continuous variables were summarized using mean and standard deviation, and discrete variables were described using frequencies and percents. Differences in demographic and procedural data values between the patients with trainee participation in their colonoscopy (the TP group) and those whose examination was carried out only by experienced colonoscopists (the EO group) were assessed using the chi-squared (χ²) or Fisher exact tests for categorical variables and the t test for continuous variables.

Multivariate linear regression was used to analyze the influence of confounding factors on the measured outcomes. For the multivariate analysis, we calculated that a sample size of 270 (at least 135 in each group) was needed to achieve an 80 % power to detect an R ² of 0.10 attributed to 9 independent variables, using an F test with an alpha value of 0.05.

Results

Enrolment

Over 6 months, 620 patients were scheduled for OAC with the three participating staff physicians at our endoscopy suite ([Fig. 1]). Of these, 148 (24 %) either cancelled, rebooked or did not show for the procedure, and 13 patients (2.8 %) met the exclusion criteria. Of the remaining 459 eligible patients, 368 (80 %) patients were enrolled in the study and 20 % declined participation. Trainees were involved in 181 procedures, while 187 procedures were performed by the experienced physicians alone. Because of a potential influence of conscious sedation on the in-hospital questionnaire data, the study was continued until at least 135 patients in each group had completed their home post-procedure questionnaires. Complete data from the home post-procedure questionnaire were available from 75 % of the enrolled patients (135 in the TP group; 140 in the EO group). Data from patients who had returned both post-procedure questionnaires were used for the kappa analysis (124 TP; 116 EO).

Patient and procedure characteristics

Baseline characteristics and factors with a potential influence on patient satisfaction, including anxiety levels, previous experiences, type of preparation, music during the procedure, level of education, ethnicity, indication for the procedure, and type of intervention were similar in both groups ([Tables 1] and 2). Most referrals were for screening or surveillance (87 %). A combination of fentanyl and midazolam was used for sedation in 99 % of patients. The mean doses of fentanyl were 85.0 ± 27.5μg (TP) and 81.7 ± 23.5 μg (EO), and those for midazolam were 4.9 ± 1.6 mg (TP) and 4.9 ± 1.5 mg (EO) ([Table 2]).

A significant difference (P < 0.001) was found in the cecal intubation times (the TP group mean was 3.5 minutes longer than the EO group mean) and procedure times (TP mean 6.2 minutes longer than the EO mean). Despite the longer duration, 83 % of the TP procedures were completed to the cecum or ileum without assistance from a staff physician. In the remaining 17 % of TP procedures, staff physicians took control of the examination after an average of 12 ± 7 minutes, leading to an overall successful cecal intubation in 98 % of the TP group. If the experienced physician had to take over the examination, this usually happened when the instrument had reached the left colon, including the sigmoid and splenic flexure (70 %); another 23 % of take-overs happened at the hepatic flexure or beyond, and in only 2 % did the experienced colonoscopist take control to visualize the cecum or terminal ileum. Although the distribution of cases among the three experienced physicians was significantly different between the two groups (P = 0.015), this did not appear to affect the measured outcomes after adjustment in the multivariate analysis.

Primary outcome: patient satisfaction

As shown in [Fig. 2], there was no significant difference between patient satisfaction scores, whether staff physicians or trainees performed the procedure (P = 0.978), even after controlling for potential confounders (P = 0.234). The satisfaction scores were identical (1.36 ± 0.52) in both groups.

Agreement with the three individual statements that comprised the satisfaction score was as follows in the home post-procedure questionnaires: “I was very satisfied with the care I received” 98 % (TP) and 97 % (EO); “I would strongly recommend this procedure to friends who qualify for it” 96 % (TP) and 98 % (EO), and “I would be willing to repeat the exam in the future if necessary” 88 % (TP) and 92 % (EO).

In the multivariate analysis only waiting time was significantly associated with lower satisfaction scores ([Table 3]). In the univariate and multivariate analyses, satisfaction scores were not affected by other factors, such as age, gender, ethnicity, level of education, previous colonoscopy, anxiety levels, ASA classification, time to cecal intubation, sedation depth, preparation quality, type of endoscope, regular use of pain medications, or the provision of music during the procedure,. Although bowel preparation was poorly tolerated in 21 % of all patients, this did not affect satisfaction scores (P = 0.59).

Secondary outcome: pain scores

Pain scores were not significantly different between the groups (P = 0.28), even after controlling for potential confounders (P = 0.662). A comparison of pain scores for patients with and without trainee participation during their colonoscopy is shown in [Fig. 3]. Of those, who remembered the procedure, overall 73 % had mild pain and 17 % had moderate discomfort, but were willing to repeat the procedure at the same level of sedation. Only 10 % of patients would have preferred more sedation. As shown in [Table 3], higher pain scores were significantly associated with greater levels of anxiety (P = 0.022), female gender (P = 0.023), longer procedure duration (P < 0.001) and lower depth of sedation (P = 0.001). Finally, the physicians’ assessment of patients’ pain did not differ significantly between the EO and TP groups (P = 0.402).

Differences between in-hospital- and home post-procedure questionnaires (kappa analysis)

Patients’ answers in the post-procedure questionnaires completed in the hospital differed from those in the home questionnaires. The κ coefficients for answers to the three statements “I was very satisfied with the care I received”, “I would strongly recommend this procedure to friends who qualify for it,” and “I would be willing to repeat the exam in the future if necessary,” were 0.19, 0.28 and 0.47, respectively, when the questionnaires were compared ([Table 4]). Although this was consistent with only slight to moderate agreement between the hospital and the home post-procedure questionnaires, the vast majority of patients “agreed” or “strongly agreed” with these statements.

Because the home post-procedure questionnaires were more likely to reflect the long-term satisfaction of patients, these questionnaires were used for the final analysis. Although the patients who did not return the home questionnaire, were not included in the final analysis, their satisfaction and pain scores recorded on the hospital questionnaires were not significantly different from those of patients who had completed both post-procedure questionnaires (P = 0.756 and P = 0.292, respectively).

Discussion

Patient satisfaction is a crucial parameter for quality management in endoscopy, because it directly reflects patient acceptance of procedures and possibly patient compliance with regard to screening and surveillance. Training future endoscopists in OAC is common practice in academic centers in the United States. Until now, it has remained unknown which factors are most important regarding patient satisfaction and pain in this type of training context.

In this prospective, single-blinded, controlled trial of 368 patients presenting for OAC, we found that waiting time in the endoscopy suite prior to the procedure was the only factor that adversely affected patient satisfaction in a multivariate analysis. Thus, if sedation is used in the majority of patients, organizational aspects appear to be more important to patient satisfaction than patient or physician characteristics.

Previous studies have shown contradictory results regarding patient satisfaction with unsedated sigmoidoscopy, when performed by a trainee. In a study by Schoen et al, 97 % of patients agreed that they were very satisfied with their care and 93.1 % were willing to undergo the procedure in the future [12]. However, trainee participation was associated with lower satisfaction scores. In contrast, Jackson et al. reported that 94 % of patients were fully satisfied with unsedated sigmoidoscopy, whether a trainee participated or not [13]. However, these studies examined patients undergoing unsedated sigmoidoscopy, not colonoscopy. Colonoscopy is a more complex procedure, likely to require far more than 100 procedures for an examiner to reach competence. Furthermore, it can be expected that the learning curve for minimizing patient discomfort continues even after technical proficiency is achieved [21] [22] [23] [24]. In our study, agreement with the statement “I was very satisfied with the procedure” was found in 97 % (EO group) and 98 % (TP group). This level of satisfaction may be partially explained by the use of conscious sedation in the overwhelming majority of our patients. However, despite the use of sedation, a significant number of patients recalled the procedure (41 % TP and 45 % EO). In addition, patients did not receive more sedation when trainees participated. Therefore, an equal effect of conscious sedation should be expected in both the groups. Because the study was designed to reflect patients’ experience under “real-life” conditions, including the use of conscious sedation, it remains unclear whether the satisfaction and pain scores would have been different if unsedated procedures had been carried out. However, this may not be clinically relevant, since the use of conscious sedation is standard in most endoscopy centers in the United States.

Organizational aspects, such as waiting time are mostly independent of conscious sedation, because they affect the patient before antegrade amnesia occurs. This may explain why waiting time was the only factor associated with lower satisfaction scores, whereas a number of other variables, such as age, gender, anxiety level, procedure duration, or the presence of music had no influence. Previous studies have shown that the effect of waiting time on patient satisfaction depends on several factors, such as practice setting, excessive delays or lack of explanation to the patient. Chung et al. showed that the personal manner of the physician, time spent with the physician, length of time to get an appointment, and adequate explanation were all associated with increased satisfaction, whereas shorter waiting time was not [25]. In contrast, prolonged waiting times in the emergency department do appear to affect satisfaction [26]. Again, satisfaction improved when explanations were given to the patient [27]. In our study, the interaction of trainees with the patients may have contributed to the excellent satisfaction scores. Such interactions may outweigh the lower technical proficiency of trainees.

A high level of patient satisfaction was found despite the fact that the majority of patients complained of some degree of pain. Previous studies have identified a number of factors that affect pain (lower body mass index [BMI], younger age, first colonoscopy for the patient, poor preparation, use of antispasmodics, pre-procedure anxiety, lower levels of sedation, female gender, and non-white ethnicity) [28] [29]. Similarly to these studies, we found that patient factors (pre-procedure anxiety, female gender) and procedural characteristics (lower level of sedation and longer procedure duration) were significantly associated with pain during the procedure. In contrast, trainee participation was not associated with increased pain scores. It seems contradictory that prolongation of the procedure led to higher pain scores, whereas trainee participation did not, although trainee participation caused an average prolongation of nearly 6 minutes. A possible explanation for this may be that only excessive prolongations are associated with increased pain, while smaller delays are not. Staff physicians in our institution take control of the exam before extensive delays in the procedure occur, thus possibly avoiding difficulty in reaching the cecum or excessive pain (e. g. from overinflation of the colon). However, it should be noted that the vast majority of procedures were completed by the trainees themselves without a significant effect on pain scores. In addition, assessment of pain by the staff physician was not significantly different, whether the procedure was performed by himself, or by a trainee under his supervision.

A few minor complications occurred in our study (two each in the EO and TP groups). These were primarly cardiovascular events of short duration or reversible oxygen desaturations. Only one major complication (perforation) occurred, and happened during a procedure in the EO group. Although the study was not designed to evaluate complication rates, there does not appear to be an immediate additive risk with trainee participation. However, studies in the training setting have shown that some adverse events cannot be immediately assessed, although they still may influence patient satisfaction [30].

Some limitations apply to the results of our study. First, we did not randomly assign patients to the EO or the TP group. This led to an uneven distribution among the individual staff physicians. However, enrolment of consecutive patients did lead to an even distribution of patient characteristics among the study groups, and furthermore, experienced physicians are likely to have comparable technical competence. In addition, we adjusted for the individual staff physicians in the multivariate analysis and found that this variable did not affect the primary or secondary outcomes.

Second, we only included second- and third-year trainees, all of whom had performed more than 100 colonoscopies. This is also reflected by the cecal or ileal intubation rate of 83 %. First-year trainees would likely have taken longer or would have required more assistance. However, participation by even the most inexperienced trainees might not affect patients’ satisfaction or pain if the supervising physician takes control of the examination when necessary and sedation is used. Furthermore, the aim of this study was to analyze satisfaction and pain in a typical OAC setting, which excludes first-year trainees at our institution. To assess these factors, future studies should include trainees at an early point in their learning curve.

Third, selection bias may be present on different levels. We studied only patients referred for OAC. These patients are usually healthier and may have better bowel preparation than inpatients. Thus, we may have selected a study population that is more likely to show no difference between the two groups. However, most of the training in colonoscopy occurs with this population, and therefore our results reflect a typical training setting. Selection bias also could have occurred by including in the final analysis only the patients who returned the home post-procedure questionnaires. One could argue that the patients who did not return the home post-procedure questionnaire had a particularly bad experience. However, there was no significant difference in the hospital satisfaction and pain scores between those patients who returned their home questionnaire and those who did not. Therefore, we believe that using only the home post-procedure questionnaires did not introduce a selection bias with regard to the measured outcomes.

In conclusion, patient satisfaction with OAC in the training setting appears to primarily depend on organizational factors (waiting time) if conscious sedation is used in the majority of cases. In contrast, pain is associated with patient factors (female gender and anxiety), or procedural factors (lower level of sedation and procedure duration). Participation of second- or third-year trainees did not affect satisfaction or pain scores, which may help to reassure patients undergoing OAC procedures with trainee participation.

Competing interests: None

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A. J. Eckardt, MD

Central Interdisciplinary Endoscopy Unit, Department of Gastroenterology

Charité University Medicine, Campus Virchow Hospital

Augustenburger Platz 1

13353 Berlin

Germany

Fax: +49-30-450553917

Email: alexander.eckardt@charite.de

References

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  CrossrefPubMedSearch in Google Scholar
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  PubMedSearch in Google Scholar
• 3 Yacavone R F, Locke R, Gostout C J. et al . Factors influencing patient satisfaction with GI endoscopy.  Gastrointest Endosc. 2001;  53 703-710
  CrossrefPubMedSearch in Google Scholar
• 4 Sincock J, Dunn S V, Pretty L. Patient satisfaction with an outpatient endoscopic service.  Gastroenterol Nurs. 1999;  22 193-198
  CrossrefPubMedSearch in Google Scholar
• 5 Harewood G C, Wiersema M J, de Groen P C. Utility of web-based assessment of patient satisfaction with endoscopy.  Am J Gastroenterol. 2003;  98 1016-1021
  CrossrefPubMedSearch in Google Scholar
• 6 Larsen I K, Grotmol T, Bretthauer M. et al . Continuous evaluation of patient satisfaction in endoscopy centres.  Scand J Gastroenterol. 2002;  7 850-855
  PubMedSearch in Google Scholar
• 7 Winawer S, Fletcher R, Rex D. et al . Colorectal cancer screening and surveillance: clinical guidelines and rationale-update based on new evidence.  Gastroenterology. 2003;  124 544-560
  CrossrefPubMedSearch in Google Scholar
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  CrossrefPubMedSearch in Google Scholar
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  CrossrefPubMedSearch in Google Scholar
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A. J. Eckardt, MD

Central Interdisciplinary Endoscopy Unit, Department of Gastroenterology

Charité University Medicine, Campus Virchow Hospital

Augustenburger Platz 1

13353 Berlin

Germany

Fax: +49-30-450553917

Email: alexander.eckardt@charite.de

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