Evaluation of patients' satisfaction with bronchoscopy procedure.

BACKGROUND: The bronchoscopy (BS) experience provokes anxiety amongst some patients. It can have a negative impact on the course of the procedure and on the willingness of patients to undergo the next BS in the future.
OBJECTIVE: We aimed to identify factors influencing patients' satisfaction with BS.
METHODS: The prospective study had been conducted between January and June 2019. It included patients hospitalized in our Department, who underwent elective BS. Patients assessed their anxiety and satisfaction level before and after BS using the Visual Analogue Scale (VAS). Data concerning the course of the bronchoscopy was collected.
RESULTS: The median level of anxiety prior to the procedure was moderate, higher in women (p<0.0001). The majority of patients (116/125, 93%) were satisfied with appropriate information before the procedure. Almost one-third of the interviewees (39/125, 31%) declared complete satisfaction (VAS = 0) with their procedure, 17 patients (14%) were dissatisfied (VAS >5/10). Overall 113 (90%) patients declared unconditional consent for future bronchoscopy. Multivariate linear regression analysis revealed two factors affecting patients' satisfaction with bronchoscopy: anxiety prior to BS (standardized regression coefficient β = 0.264, p = 0.003) and discomfort (β = 0.205, p = 0.018). Neither age, degree of amnesia, duration of the procedure nor its type added any significant value as factors affecting patient satisfaction. The most common factors inducing patients' discomfort during BS were local anesthesia of the throat (56/125, 45%) and cough (47/125, 38%).
CONCLUSIONS: Low anxiety level before bronchoscopy and reduced discomfort during the procedure are associated with better patient satisfaction. Thus, it is important to reduce patient anxiety and discomfort during the procedure.

Introduction

Bronchoscopy (BS) is a common medical procedure used to diagnose or treat patients with a variety of respiratory diseases. Although it is considered safe and severe complications are rare [1], BS may be associated with significant distress and anxiety among patients [2-4]. Anxiety causes increased cortisol levels, blood pressure, heart rate and respiration rate [5, 6], which could influence the course of the procedure and cause an increased number of complications. In addition, discomfort produced by bronchoscopy is mostly related to cough, dyspnea, chest pain or nausea [3, 7]. The level of anxiety experienced by the patients before and during bronchoscopy is determined by numerous factors, including age, gender [8], insufficient information about the aim of the procedure, its course and possible complications [9].

Premedication plays a crucial role in reducing stress-related to any invasive procedures. It is an important issue as stress caused by the fear of bronchoscopy may negatively affect patients’ compliance during the procedure and their willingness to undergo potential re-examination in the future [10]. Due to the immense progress in interventional bronchoscopy used for advanced diagnostic and therapeutic purposes, the importance of premedication or anesthesia-related to BS is also growing [11].

Patients’ satisfaction with BS is a subjective feeling that depends on patients’ expectations and may be influenced by various factors. The level of patient satisfaction is increasingly emphasized as a significant outcome measure for bronchoscopy, along with its diagnostic and therapeutic efficacy. Hence, the knowledge of the factors which affect patients’ satisfaction is important in terms of an optimal preparation and conducting the procedure. Therefore, the aim of this study was to identify factors that influence patients’ satisfaction with bronchoscopy.

Material and methods

General study design

This was a prospective, single-center, observational, cross-sectional study performed in the Department of Internal Medicine, Pulmonary Diseases and Allergy of the Medical University of Warsaw, Poland between January and June 2019. Patients scheduled for an elective bronchoscopy understood as a non-emergency bronchoscopy procedure (diagnostic and therapeutic), scheduled in advance, were included. A written informed consent was obtained from all enrolled patients. The study was approved by the Ethics Committee of the Medical University of Warsaw (AKB/ 234/2018).

Patients

Patients with different malignant and nonmalignant pulmonary diseases who were admitted for elective diagnostic bronchoscopy were informed about the aim of the study and asked for their consent to participate. Patients were reassured that their disagreement would not change the course of the procedure. The inclusion criteria were: 1) age above 18 years, 2) indication for an elective bronchoscopy (scheduled non-emergency bronchoscopy procedures) performed on a hospital basis, 3) written informed and voluntary consent to participate in the study. The exclusion criteria were as follows: 1) age under 18 years, 2) urgent interventional bronchoscopy, 3) lack of agreement to participate in the study 4) inability to read, understand, complete surveys, or collaborate with the medical staff; 5) bronchoscopy under general anesthesia, 6) bronchoscopy on the out-patient basis.

Methods

All patients included in the study were asked to complete two original questionnaires:

Questionnaire B (= before) completed the day before the scheduled bronchoscopy.

Questionnaire P (= post) completed 24 hours after the procedure.

Questionnaire B included basic demographic data, data on the adequacy of information about the procedure provided by the attending physician and the nursing staff, patient’s expectations and the level of fear related to bronchoscopy (see S1 Table). Questionnaire P included questions aimed at assessing patient satisfaction with bronchoscopy (see S2 Table). Both questionnaires were originally created for the purpose of the current project and based on the British Thoracic Society (BTS) guideline for diagnostic flexible bronchoscopy in adults [12]. Satisfaction with bronchoscopy was defined as an overall subjective assessment of impressions and experiences, including complaints related to the procedure. It was measured using a 10 cm Visual Analogue Scale (VAS). Complete satisfaction was rated as 0, while complete dissatisfaction as 10 cm. Both questionnaires included patient identification data (ID) in order to link this data with factors possibly affecting the satisfaction from the procedure.

Outcome points

Primary outcome

The correlation between patient satisfaction with bronchoscopy and anxiety before the procedure both measured by VAS

Secondary outcome

Identification of factors affecting patient satisfaction with BS

Bronchoscopy

All patients scheduled for bronchoscopy received routine information on the procedure, including its aim, course, and possible complications, from the attending physician and the nursing staff. Importantly, in order to avoid changes in standards of informing the patients about the procedure, the staff was not informed, which patients were included in the study. Patients who had bronchoscopy performed under general anesthesia were excluded from analysis as general anesthesia may influence patients’ satisfaction related to the procedure. Thus, patients who had rigid bronchoscopy were not included in this study. All other types of fiberoptic bronchoscopic procedures were accepted in the study protocol. The oral route was used to introduce all types of bronchoscopes to the lower airways, which is the standard way of bronchoscope insertion in our Department.

The procedures performed during bronchoscopy were as follows: endobronchial secretion removal, bronchoalveolar lavage (BAL), endobronchial forceps biopsy, endobronchial brush biopsy, transbronchial lung biopsy, endobronchial ultrasound and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), endobronchial ultrasound with radial probe and transbronchial biopsy (rEBUS-TBB), and foreign body removal. All bronchoscopies were performed under local anesthesia and conscious sedation (midazolam orally or midazolam and fentanyl intravenously). Sprayed lidocaine (2% and 10%) was applied as a local anesthetic to the throat. Additional doses of 2% lidocaine were applied to the trachea and bronchi via the working channel of the bronchoscope.

In all patients, bronchoscopy was performed by a pulmonologist with 10–15 years of experience in performing bronchoscopy. In the vast majority of procedures, one or more of the following bronchoscopes was used: video bronchoscope BS-1TH190, EBUS scope BS-UC180F (Olympus, Tokyo, Japan). Patients were monitored closely during the procedure, as well as after the bronchoscopy with the use of a dedicated report form (see S3 Table). All adverse events up to 24 hours after the completion of the procedure were noted by the attending physician in a separate report form (see S4 Table). Criteria of serious adverse events related to BS were adopted from the BTS guideline for diagnostic flexible bronchoscopy in adults [12].

Statistical analysis and sample size calculation

Power analysis and sample size calculations for correlation analysis showed that a sample size of 85 patients would provide 80% statistical power to detect weak (r = 0.3) correlation (alpha = 0.05, beta = 0.20) [13]. The number of enrolled patients was increased by 15 to allow for a 15% drop-out. Thus, a total number of 100 patients was a minimum required to conduct this study.

As data did not have a normal distribution, non-parametric tests were used. Data are presented as the median and interquartile range (IQR) unless otherwise specified. Differences between satisfied (VAS rating < 1 cm) and unsatisfied patients (VAS rating >5 cm), between different types of bronchoscopy and different types of anesthesia were compared using a chi-square test for categorical variables and Mann Whitney U test for continuous variables. Spearman coefficient was used for correlation analysis. The factors affecting patients’ satisfaction with BS were evaluated using correlation analysis, univariate and multivariate linear regression analysis. All parameters (expressed in interval scale) were screened in univariate analysis and selected to build a multivariate linear regression model with backward stepwise analysis. The optimal model was chosen based on the highest adjusted R square value. All analyses were performed using Statistica 13.0 (StatSoft Inc., Tulsa, OK, USA) and MedCalc 13.2.2 (MedCalc Software bvba, Ostend, Belgium). A p-value lower than 0.05 was regarded as significant.

Results

From 200 patients admitted to our Department for elective bronchoscopy, 157 met the inclusion criteria and agreed to participate in the study. All questionnaires were completed by 125 patients and those patients were included in the final analysis (Fig 1).

Fig 1

Participants flow diagram.

There were 67 male (54%) and 58 female patients. The median age was 66 years (IQR 58–73); 32 (26%) patients were never smokers, while 39 (31%) and 54 (43%) were active smokers and ex-smokers, respectively. The median smoking history was 29 pack-years (IQR 10–40). Indications for bronchoscopy and comorbidities are stated in S1 and S2 Figs.

The median level of anxiety prior to bronchoscopy was moderate, i.e. 5/10 cm (IQR 2.5–6) according to VAS. Women were significantly more anxious before the procedure than men [5 (IQR 4.6–8) cm vs 3.5 (IQR 0.8–5) cm, respectively, p<0.0001]. As many as 116 patients (93%) were satisfied with the level of information received before bronchoscopy.

Midazolam was given orally as premedication in 125 patients (100%) (in 123–7.5 mg, in 2 patients -3.25 mg) and in 39 patients (31%) intravenous fentanyl was added (median dose 50 mg, IQR 50–87.5).

Seventy-four patients (59%) had flexible (fiberoptic) bronchoscopy (including 3 procedures via tracheostomy), while EBUS had 51 subjects (41%)–linear, radial or both (linear and radial) EBUS was performed 33, 10 and 8 patients, respectively (Table 1).

Table 1

Differences between different types of bronchoscopy procedures.

	VBS n = 74	EBUS n = 51	P value
Age (years)	65.5 (60–74)	66 (55–72)	0.379
Anxiety prior to BS	5 (1–5.9)	5 (3–6)	0.440
Duration of BS (min)	9 (6–12)	20 (15–27)	<0.0001
Any complication after BS (number of patients)	11 (15%)	7 (14%)	0.858
Number of ailments during BS	1 (1–2)	2 (1–2)	0.474
Satisfaction with BS in VAS (cm)	1 (0–3)	1 (0–4.3)	0.658
Unconditional consent for future BS (number of patients)	70 (95%)	43 (84%)	0.055

Data is presented as rank/ median and IQR (in parenthesis) or the number of patients and percentage (in parenthesis). Both groups were compared using the chi-squared test for categorical variables and the Mann-Whitney U test by rank for continuous variables.

n = number of patients, VBS—videobronchocopy, EBUS—endobronchial ultrasound, BS–bronchoscopy, VAS- Visual Analogue Scale, F—Female, M-Male

Subjective satisfaction with bronchoscopy was estimated as good by most patients (Fig 2). The median VAS satisfaction rating was 1 cm (IQR 0–4). Thirty-nine patients (31%) declared absolute satisfaction with their procedure (VAS 0/10), while 17 patients (14%) were unsatisfied (VAS > 5/10). The vast majority of patients (n = 113, 90%) declared unconditional consent for future bronchoscopy. There was a positive correlation between satisfaction and willingness for future bronchoscopy (rho = 0.404, p<0.0001). We did not find a difference in satisfaction after BS between younger and older patients (≤ 65 and >65 years of age, respectively) or those who had the first or a repeated BS. There were no differences in either anxiety level before the procedure or satisfaction with it between patients who had video bronchoscopy and those who had EBUS (Table 1). Similarly, no differences were found between patients who were sedated with midazolam alone or both with midazolam and fentanyl (Table 2).

Fig 2

Distribution of patients’ satisfaction with bronchoscopy.

Table 2

Differences between different types of anesthesia.

	Midazolam only n = 86	Midazolam+ fentanyl n = 39	P value
Age (years)	67	67	0.964
	(59.5–75)	(58–71)
Anxiety prior to the BS	5	5	0.184
	(1–5.5)	(4–7.5)
Duration of BS (min)	10.5	19	< 0.001
	(7–16.25)	(11.5–26.5)
Any complications after BS (number of patients)	11 (13%)	8 (21%)	0.256
Number of ailments during BS	2	1	0.961
	(1–2)	(1–2)
Satisfaction with BS in VAS	1	2	0.833
	(0–3.75)	(1–5.5)
Unconditional consent for future	79	36	0.932
BS (number of patients)	(92%)	(92%)

Data are presented as median and IQR (in parenthesis) or the number of patients and percentage (in parenthesis). Both groups were compared using the chi-squared test for categorical variables and the Mann-Whitney U test by rank for continuous variables.

n = number of patients, BS–bronchoscopy, VAS- Visual Analogue Scale

The primary outcome of the study was a weak positive correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure (Spearman coefficient rho = 0.276, p = 0.0014) or patients’ discomfort during the procedure (rho = 0.309, p = 0.0005). The most common factors inducing patient discomfort during BS were local anesthesia of the upper airways (56/125, 45%) and cough (47/125, 38%), the remaining factors are shown in Fig 3. No other significant correlations between dissatisfaction with BS and other factors were found.

Fig 3

Factors associated with patients’ discomfort during bronchoscopy.

Univariate regression analysis revealed that anxiety prior to bronchoscopy and discomfort during the procedure were the only significant factors affecting patient satisfaction with bronchoscopy (Table 3). Then, multivariate linear regression analysis revealed only two factors affecting patients’ satisfaction with bronchoscopy: anxiety prior to BS (standardized regression coefficient β = 0.264, standard error 0.086, p = 0.003) and discomfort (β = 0.205, standard error 0.086, p = 0.018). Neither age, satisfaction with information about the bronchoscopy, its duration nor the degree of amnesia added any significant value as factors affecting patient satisfaction.

Table 3

Univariate and multivariate linear regression analysis of the variables associated with patient satisfaction with bronchoscopy.

Parameters	Univariate Analyses			Multivariate Analysis
	Beta	Standard error	P-value	Beta	Standard error	P-value
Anxiety before BS	0.306	0.086	0.0006	0.264	0.086,	0.003
Discomfort during BF	0.255	0.087	0.004	0.205	0.086	0.018
Age of patient	0.015	0.090	0.864	NI
Duration of BF	0.039	0.092	0.674	NI
Satisfaction with information about the BF	-0.096	0.090	0.288	NI
Not remembering BF	-0.136	0.090	0.135	NI

Abbreviations: NI, not included in the best multivariate linear regression model.

In 107 patients (86%) no complications during BS were noted. There was one serious adverse event during BS (1/125, 0.8%). The patient presented acute bradypnoea related to the administration of midazolam (<8 breaths/minute) during bronchoscopy and reversal dose of flumazenil was given with immediate positive effect. Other complications during bronchoscopy occurred rarely (17, 14%) and included: moderate bleeding associated with biopsy procedures (8 patients, 6%), fever (5 patients, 4%) transient oxygen desaturation < 85% (2 persons, 3%), COPD exacerbation (1 patient, 0.8%) and transient bradypnoea with spontaneous reversal (1 patient, 0.8%).

Comparison of satisfied and unsatisfied patients showed differences in the level of anxiety prior to bronchoscopy (p = 0.0009), patient discomfort during the procedure (p = 0.046) and not remembering the procedure due to premedication (p = 0.014) (Table 4).

Table 4

Differences between satisfied and unsatisfied patients.

	Satisfied VAS < 1 cm n = 46	Unsatisfied VAS > 5–10 cm n = 17	P value
Age (years)	67 (56–74)	61 (56–66)	0.123
Sex (F/M)	20/26	11/6	0.135
Smoking history (S/ExS/NS)	14/22/10	6/6/5	0.658
Pack-years	30 (15–40)	21 (1–34)	0.369
Being well informed before procedure	43 (93%)	17 (100%)	0.281
Anxiety prior to the bronchoscopy	3.5 (0–5)	6 (5–9.5)	0.0009
Previous bronchoscopy	12 (26%)	3 (18%)	0.485
Type of bronchoscopy
VBS	29	10	0.793
sEBUS	11	5	0.656
rEBUS	4	1	0.874
sEBUS+rEBUS	2	1	0.680
Duration of bronchoscopy (min)	14.5 (7–18.5)	14 (9–25)	0.535
Midazolam as only premedication	33 (72%)	12 (71%)	0.928
Midazolam+Fentanyl as premedication	13 (28%)	5 (29%)	0.928
Any complication related to BS	6 (13%)	6 (35%)	0.061
Number of factors inducing patient discomfort during BS	1 (0–2)	2 (1–3)	0.046
Not remembering BS	24 (52%)	3 (18%)	0.014
Procedures during bronchoscopy
Endobronchial secretion removal	16 (34%)	7 (41%)	0.640
Bronchoalveolar lavage	20 (43%)	7 (41%)	0.869
Forceps biopsy	13 (28%)	2 (12%)	0.172
Bronchial brushing	3 (6%)	0	0.680
EBUS -TBNA	13 (28%)	5 (29%)	0.928
rEBUS -TBB	4 (9%)	1 (6%)	0.714

Data are presented as median and IQR (in parenthesis) or the number of patients and percentage (in parenthesis). Both groups were compared using the chi-squared test for categorical variables and the Mann Whitney U test for continuous variables.

n = number of patients, VAS- Visual Analogue Scale, F—female, M-Male, NS—never smoker, S—smoker, Ex—ex-smoker, VBS- videobronchocopy, sEBUS -linear endobronchial ultrasound, rEBUS- radial endobronchial ultrasound, BS -bronchoscopy, EBUS-TBNA- endobronchial ultrasound-guided transbronchial needle aspiration, rEBUS-TBB—radial probe endobronchial ultrasound-guided transbronchial biopsy.

Discussion

Our study showed that a lower level of anxiety before bronchoscopy and during the procedure is associated with higher patient satisfaction after BS. It emphasizes that an adequate and comprehensive information on the procedure as well as premedication and sufficient anesthesia are important to reduce patient anxiety and discomfort during bronchoscopy. As the level of patient satisfaction is an important outcome measure for BS, the knowledge of the factors affecting bronchoscopy related patient discomfort is crucial to improve the level of patient tolerance of the procedure.

Our results are consistent with the results of previous studies [14-16]. Lechtzin et al. [15] reported that dissatisfaction after bronchoscopy was associated with anxiety prior to the procedure or its complications. The pre-bronchoscopy level of anxiety was identified as an important factor predicting patient satisfaction during and after the procedure by other authors as well [14, 16]. The results of the study by Yildirim et al. [14] suggested that the operator should adjust the course of BS to the patient’s anxiety level, i.e. by choosing the oral route or by shortening the procedure time with fewer interventions if the patient is very anxious. In addition, the operator’s experience may also influence the patient’s discomfort during BS [15, 16]. Mitsumune et al. [16] suggested that the more the patient is anxious, the more experienced bronchoscopist should perform the bronchoscopy. On the other hand, there have also been studies that found no correlation between the operator’s experience and patient satisfaction [17]. This aspect was not addressed in our study, as our aim was to evaluate other factors related to pre-bronchoscopy anxiety level and post-bronchoscopy satisfaction. Thus, all the bronchoscopists participating in the study had a comparable level of expertise.

Similarly to other authors [18], we have found that the female sex was associated with a higher level of anxiety before bronchoscopy. Albeit other authors [10, 14, 17] also reported a lower level of post-bronchoscopy satisfaction in women, this was not the case in our study. Gender differences in anxiety before and dissatisfaction after BS may be associated with gender differences in the perception of pain. Previous studies demonstrated that postoperative or procedural pain may be more severe in females than males [19].

Sun et al. [20] suggested that communication with patients and their education are critical for experiencing satisfaction with BS and readiness to undergo a repeated BS in the future. In our study, 93% of patients were satisfied with the adequate information about upcoming bronchoscopy. Such a high level of satisfaction with the provided information to the patients was certainly related to the elective nature of bronchoscopy applied in an in-patient setting. Some studies showed that the amount of information provided to the patient prior to BS may decrease the level of patient anxiety [2, 10, 15]. However, other studies showed no correlation between the quantity and quality of information given to patients and their satisfaction with the procedure [18, 21] or even demonstrated that patients who were provided with a greater amount of information on possible post-BS complications experienced significantly more anxiety compared with the patients who were less informed [22]. Nonetheless, bronchoscopy guidelines recommend giving patients both verbal and written precise information prior to the procedure [12]. Additionally, it is reasonable to evaluate patient satisfaction after the procedure and address the areas of dissatisfaction and discomfort to improve the quality of the service [12].

Although it is crucial to minimize discomfort during bronchoscopy, it cannot be completely eliminated. In this study, discomfort during bronchoscopy obviously affected patient satisfaction with BS. Furthermore, a correlation between dissatisfaction and discomfort was weak, but higher than with anxiety before the procedure. Among our patients, local anesthesia of the upper airways and cough were the most common factors that caused the discomfort. These results correspond to those reported by Fujimoto et al. [10] who also pointed out throat anesthesia as the most frequent cause of BS-related patient discomfort. Hence, it is crucial to inform patients about this unpleasant but important part of the procedure, which allows the insertion of the bronchoscope to the lower airways, decreases the severity of cough and throat pain. Warning of the patient beforehand is critical, as the unexpected discomfort was shown to enhance patient reluctance to undergo a re-examination [10]. Other factors related to patient discomfort in our study were cough, postnasal drip and shortness of breath. The better the control of cough, pain and shortness of breath, the more eager the patient is to return for a repeated BS [15].

Conscious sedation is regarded as an important factor that may reduce anxiety and improve the level of patient satisfaction with the procedure [23, 24]. In our study, conscious sedation was used in all patients. We found that satisfied patients declared amnesia more frequently than unsatisfied subjects, however, we did not document any significant correlation between the level of amnesia and patients’ satisfaction with bronchoscopy. Irrespective of the type of sedation, it is important to monitor the sedation effects and titrate the dose of sedatives to avoid respiratory depression [12].

Another factor that may influence patient satisfaction with bronchoscopy are complications related to the procedure. However, we did not observe such a relationship in our study, which may have resulted from a relatively low percentage of complications, noted in solely 18/125 patients (14%). Only one severe adverse event was noted in our group. Severe complications during bronchoscopy are very rare, and, in some cases cannot be prevented [1, 3]. However, it is vital to minimize the risk of complications, such as bleeding, oxygen desaturation, arrhythmia or bradypnoea. The experience of the operator performing the bronchoscopy is an important factor for lowering the number of complications [25, 26].

Some factors that have been previously reported to affect patient anxiety and satisfaction with bronchoscopy were not confirmed in our study. Those include patient age and previous bronchoscopies. Data on the relationship between patient age and anxiety are ambiguous. Poi et al. [18] demonstrated that younger patients were more “fearful”, whereas Aljohaney [8] found that older patients had a significantly higher anxiety score. According to Hehn et al. [27], elderly patients tolerate bronchoscopy as well as younger ones. Andrychiewicz et al. [21] showed that patients who had undergone BS in the past had a significantly better understanding of the rationale for performing the procedure and the type of procedure planned and anxiety was reported significantly more often in patients undergoing BS for the first time.

We are aware of several limitations in our study. Firstly, as it was a single-center study, the results may be specific for our facility and the institutional standards for performing bronchoscopy. The results are certainly highly dependent on the methods of sedation during bronchoscopy, throat anesthesia and preceding information of the examination as well as on the profile of patients including their cultural or ethnic backgrounds. Patients who were awaiting an elective bronchoscopy understood as a non-emergency bronchoscopy procedure (diagnostic and/or therapeutic), scheduled in advance, were included. Secondly, the study group was rather small due to single-center study, inclusion criteria and short duration of the study. Thirdly, we included only in-patients treated in our Department, which may have been associated with a selection bias and our results may not necessarily be extrapolated to BF performed in out-patients. Furthermore, although the questionnaires used in the study were checked for their comprehensibility, we did not validate them in advance, which is a limitation of this study. Next, as we did not use sedation score during the study it is difficult to estimate the influence of sedation on satisfaction with BS precisely. Finally, the sample size calculation was based on an assumption of linear Pearson correlation, but finally, we used Spearman correlation due to lack of normal distribution of data. Despite all these limitations, we believe that the results of our study are important as they indicate how essential it is to make an effort to reduce patient anxiety before BS and discomfort during it.

Conclusions

Low patient anxiety before bronchoscopy and reduced discomfort are associated with higher patient satisfaction after the procedure. Adequate and comprehensive information on the aim and course of bronchoscopy, as well as premedication, allow to reduce patient anxiety and discomfort during the procedure and thus increase their post-bronchoscopy satisfaction.

Questionnaire B (before bronchoscopy).

(PDF)

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Questionnaire P (post bronchoscopy).

(PDF)

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Course of bronchoscopy.

(PDF)

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Physician report after bronchoscopy.

(PDF)

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Indications for bronchoscopy.

(TIF)

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Comorbidities in population of the study.

(TIF)

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(XLSX)

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18 Aug 2021

PONE-D-21-03696

Evaluation of patients’ satisfaction with bronchoscopy procedure.

PLOS ONE

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Reviewers' comments:

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1. Is the manuscript technically sound, and do the data support the conclusions?

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Reviewer #1: Partly

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: No

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This study reported patient satisfaction with elective bronchoscopy and factors related to the bronchoscopy-related anxiety and satisfaction after the procedure. Authors found that low patient anxiety before bronchoscopy, less discomfort during the procedure, amnesia due to premedication and less complications are associated with a higher patient satisfaction after bronchoscopy. However, multivariate regression analysis revealed anxiety prior to BS (standardized regression coefficient β=0.243, p=0.003), discomfort (β=0.186, p=0.021) and complications (β=0.239, p=0.003) as the only significant factors affecting patient satisfaction with bronchoscopy.

There are some issues as below.

Major points

1. On primary endpoint

Authors aimed to identify factors influencing patients’ satisfaction with BS. However, they did sample size calculations for correlation analysis to show that a sample size of 85 patients would provide 80% statistical power to detect weak (r=0.3) correlation (alpha = 0.05, beta = 0.20). In general, sample size calculation should be used to clarify the main objective. I wonder why they use correlation analysis to detect weak (r=0.3) correlation. Furthermore, did they do this sample size calculation in order to find out which factors correlated with which factors?

2. Among the results of this manuscript, I think the result of multivariate regression analysis which described in line 246 is most important information. Authors concluded this result in the Conclusions session in line 379. However, they included “amnesia due to premedication” in Discussion session in line 276 to 278. If they included “amnesia due to premedication” from the results of Table 3, I think that “amnesia due to premedication” should be deleted because Table 3 included lots of confounds.

3. I think the result of multivariate regression analysis which described in line 246 should be presented by additional table.

4. In Statistical analysis and sample size calculation, the authors should present more detail on methods of multivariate regression analysis. That is, how they excluded the dependent factors from the selected factors and how they chose the best model among candidate models as final multivariate model.

5. In this study, questionnaire S1and S2 are very important. Questionnaire S1 include only two VAS on anxiety Q7, Q8. Questionnaire S2 include only one VAS on anxiety Q1. Authors used VAS for only anxiety scale. Other items were type of multiple-choice question. In case of multiple-choice question or Likert type question, they should validate them in order to detect the appropriate answers. Therefore, authors should give us the results of validation on these items.

Minor points

1) Line 74; “it is safe and severe complications are rare [1],”→Reference No.1 is too old. Please replace recent reference and recent information.

2) Line 78; “bronchoscopy is most commonly related to related to cough, dyspnea, chest pain or nausea” Is under lined part misprinted or not? Please correct the under lined part.

3) Line 99; Does “elective bronchoscopy” mean “only diagnostic bronchoscopy”? If this is correct it should be defined in the text at first use.

4) Line 108; Authors mentioned “The inclusion to the study was not limited by the type of the procedure”. Considering statistical view, I think they should balance the type of the procedure when they enrolled patients.

5) Line 129; Outcome points had two points. Which is primary endpoint? Which is secondary endpoint?

6) Line 136; “Importantly, the staff had not been informed which patients were included to the study.” Why had the staff not been informed? Please explain this is important.

7) Line 157 and 159; I think Table S3 and S4 are the clinical report form for bronchoscopists and attending physicians not questionnaire.

8) Line 182 to 193; Authors mentioned background characteristics in this part. Please provide the table of “background characteristics” in text or Supporting Information.

9) Line 200 to 204; “Rigid bronchoscopy was performed in 6 patients (4%)”. Therefore, it would better that authors should compare only between flexible (fiberoptic) bronchoscopy without EBUS and that without EBUS.

10) In Table 1 “Satisfaction with BS in VAS”; Please consider the significant digits. “0 – 4.375” means they measured the degree of tens μm.

11) Line 215 to 217 and 337; How many patients achieved the conscious sedation? Depth of anesthesia is very important to evaluation the satisfaction with BS. Please provide depth of sedation by use of sedation score.

12) Line 221; Authors defined VAS > 6/10 as “very unsatisfied”. However, in Table 3 and Figure 2, they defined VAS ≥ 5-10 as “unsatisfied”. I think there is discrepancy. Please explained it. Furthermore, how did they define these cutoff-value?

13) Line 223 and 238 to 240; Was “correlation between satisfaction and willingness for future bronchoscopy” basis for setting for sample size calculations? Or was “correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure” basis for setting for sample size calculations? Or was “correlation between dissatisfaction with bronchoscopy and patients discomfort during the procedure” basis for setting for sample size calculations? Which of them were basis for setting for sample size calculations? Was it primary endpoint?

14) Line 371; “Secondly, the study group was rather small due to single-center study, inclusion criteria and short period of study, however the number of included patient was based on sample size calculation.” If authors set the main objective as sample size calculation, sample size of the study group would seem to be more appropriate size. Why did they use correlation analysis to detect weak (r=0.3) correlation?

Reviewer #2: The authors have done a good work in trying to identify the factors that affect patient satisfaction during bronchoscopy in their study titled "Evaluation of patients’ satisfaction with bronchoscopy procedure". The topic and contents have been appropriately dealt with but the authors need to do some minor revisions for the article to be more suitable. First of all, there are many grammatical errors in the text that needs to be corrected. Secondly, the authors in justifying the use of oral route for bronchoscopy, made a statement of the nasal route being causing more discomfort. This justification is not accurate and the authors should just limit their statement to oral route being their preference. Thank you

**********

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Reviewer #1: Yes: Yuichiro Takeda

Reviewer #2: Yes: Adamu Issaka

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27 Oct 2021

We have applied the changes requested both by the editorial staff and the reviewers. We shared an updated cover letter covering the requested funding and COI information. We also shared a file with detailed responses to all of the reviewers' questions and remarks - see file Response to Reviewers.

Submitted filename: Response to Reviewers.docx

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8 Nov 2021

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We look forward to receiving your revised manuscript.

Kind regards,

Yuichiro Takeda, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments:

There are still some issues as below.

1, Primary outcome: The authors set “a relationship (correlation) between patients’ anxiety and satisfaction with bronchoscopy as the primary outcome. They based their sample size calculation on a study by Bujang MA and Baharum N and provided this article to references. In this provided reference, Bujang MA and Baharum N used Pearson coefficient for correlation analysis. Did they check null hypothesis is equal to zero in this study population? Even if null hypothesis is equal to zero, I wonder why they use Mann Whitney U test or Kruskal- Wallis test that are non-parametric test. Why did they delete Kruskal- Wallis test in Statistical analysis of revised manuscript?

2, Primary outcome: I guess the authors described the result of primary outcome in Line 274 of Manuscript - revised manuscript, clean version.

The authors should describe this study met the primary outcome in Results or Discussion part.

3, Author should describe how to perform the multivariate analysis in this study more detail in in Statistical analysis part. what parameters were they screening by univariate analyses, selection criteria of parameters, how to find independent parameters, how to select best model. Please describe this process in Statistical analysis part.

4. In revised manuscript, you mention only regression model in univariate and multivariate. There are lots of regression method. I think you should not delete “logistic”.

5. In general, univariate analyses are only the screening test for model construction. Table 3 should include multivariate model like below table. However, you should check statistical and clinical independency between “Anxiety before BS” and “Discomfort during what”.

Parameters Univariate Analyses Multivariate Analysis

Beta Standard error P-value Beta Standard error P-value

Anxiety before BS 0.306 0.086 0.0006 0.264 0.086, 0.003

Discomfort during ? 0.255 0.087 0.004 0.366, 0.087 0.00017

Age of patient 0.015 0.090 0.864 NI

Duration of BF 0.039 0.092 0.674 NI

Satisfaction with

information about the BF-0.096 0.090 0.288 NI

Not remembering BF -0.136 0.090 0.135 NI

Abbreviations: NI, not included in the best multivariate logistic regression model.

6. Table 4 is “Differences between satisfied and unsatisfied patients” Why did not authors check all parameters in table 4 by univariate analyses? I think authors should be screening all parameters in table 4. And then they construct some models for the multivariate models. After that, they choose best model and analyze this model as the result. How is it?

7. Although author added the limitation, it is serious issue that they did not validate questionnaires used in the study.

8. There are lots of reports that depth of anesthesia is very important to evaluation the satisfaction with BS. It is serious issue that they did not use sedation score during the study. At least, they should add this point to the study Limitations.

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Reviewers' comments:

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Submitted filename: Reviced paper_Commets and decision for author 20211106.docx

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23 Dec 2021

A file 'Response to Reviewers' has been sent to 'Attached Files'. Below I've copied the text from that file:

Warsaw, 22th December 2021

Dear Editor and Reviewers,

Thank you for reviewing our manuscript PONE-D-21-03696, titled Evaluation of patients’ satisfaction with bronchoscopy procedure. We appreciate Your comments which have certainly helped us improve the manuscript’s quality. The revised version of the manuscript re-submitted for reevaluation includes changes made strictly according to Your suggestions. We believe, all the points raised by the reviews were addressed. We would be grateful for re-considering our manuscript for publication.

Below, we include the specific responses to the Reviewers’ comments with the hope that they will find them adequate.

• Primary outcome: The authors set “a relationship (correlation) between patients’ anxiety and satisfaction with bronchoscopy as the primary outcome. They based their sample size calculation on a study by Bujang MA and Baharum N and provided this article to references. In this provided reference, Bujang MA and Baharum N used Pearson coefficient for correlation analysis. Did they check null hypothesis is equal to zero in this study population? Even if null hypothesis is equal to zero, I wonder why they use Mann Whitney U test or Kruskal- Wallis test that are non-parametric test.

Thank you for this comment and suggestion. The manuscript by Bujang MA and Baharum N is a sample size guideline for Pearson correlation coefficient. However, when estimating for sample size, we could not predict whether the assumption for Pearson correlation would be met or not. Thus, our sample size analysis was based on estimation by Bujang et al.

In our study neither the satisfaction from bronchoscopy (BS) nor anxiety before BS have a normal distribution of values (line 203). Thus we changed the correlation coefficient for Spearman (line 209 and 287, 288) and we used non- parametric tests.

• Why did they delete Kruskal- Wallis test in Statistical analysis of revised manuscript?

Thank you for this remark. As we had excluded patients who had BS under general anesthesia, we compared only two groups (satisfied vs unsatisfied; midazolam vs midazolam +fentanyl; VBS vs EBUS) using Mann-Whitney U test ( Table 1,2,4).

• Primary outcome: I guess the authors described the result of primary outcome in Line 274 of Manuscript - revised manuscript, clean version. The authors should describe this study met the primary outcome in Results or Discussion part.

Thank you for this valuable comment. We changed the text (line 285) to emphasized the primary outcome of the study.

• Author should describe how to perform the multivariate analysis in this study more detail in in Statistical analysis part. what parameters were they screening by univariate analyses, selection criteria of parameters, how to find independent parameters, how to select best model. Please describe this process in Statistical analysis part.

Thank you for this comment. We screened all parameters from the table 4 (that were expressed in interval scale) in univariate analysis. Then we build multivariate linear regression model with backward stepwise analysis with all parameters and choose the model with optimal adjusted R square value (line 215-217).

• In revised manuscript, you mention only regression model in univariate and multivariate. There are lots of regression method. I think you should not delete “logistic”.

Thank you for this issue. We corrected the description of statistical methods for multivariate linear regression analysis (line 215-217).

• In general, univariate analyses are only the screening test for model construction. Table 3 should include multivariate model like below table.

Parameters Univariate Analyses Multivariate Analysis

Beta Standard error P-value Beta Standard error P-value

Anxiety before BS 0.306 0.086 0.0006 0.264 0.086 0.003

Discomfort during procedure 0.255 0.087 0.004 0.205 0.086 0.018

Age of patient 0.015 0.090 0.864 NI

Duration of BF 0.039 0.092 0.674 NI

Satisfaction with

information about the BF -0.096 0.090 0.288 NI

Not remembering BF -0.136 0.090 0.135 NI

Abbreviations: NI, not included in the best multivariate logistic regression model.

Thank you for your comment and suggestion, which is very helpful. We changed Table 3 according to your proposal.

• However, you should check statistical and clinical independency between “Anxiety before BS” and “Discomfort during procedure”.

We found very low non-significant correlation between anxiety prior to BS and discomfort during the procedure (r=0.173, p=0.055), so we used both factors in model of multivariate regression analysis.

• Table 4 is “Differences between satisfied and unsatisfied patients” Why did not authors check all parameters in table 4 by univariate analyses? I think authors should be screening all parameters in table 4. And then they construct some models for the multivariate models. After that, they choose best model and analyze this model as the result. How is it?

Thank you for your suggestion. We screened all parameters with univariate analysis finding only two significant parameters (anxiety before BS and discomfort during procedure), which were selected for multivariate logistic regression analysis.

• Although author added the limitation, it is serious issue that they did not validate questionnaires used in the study.

Thank you for your comment. Indeed, it is an important issue. We emphasized it in limitation of the study (line 489)

• . There are lots of reports that depth of anesthesia is very important to evaluation the satisfaction with BS. It is serious issue that they did not use sedation score during the study. At least, they should add this point to the study Limitations.

Thank you for your important remark. We added it to limitations of the study (line 490-491)

Submitted filename: Response to Reviewers - second review.docx

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26 Dec 2021

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

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If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Yuichiro Takeda, M.D., Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

I think your manuscript improved now.

Minor points

1) “In our study neither the satisfaction from bronchoscopy (BS) nor anxiety before BS have a normal distribution of values (line 203). Thus we changed the correlation coefficient for Spearman (line 209 and 287, 288) and we used non-parametric tests.”

Does this mean sample size calculation was incorrect in your study? You should include this information as a limitation. This is very important.

2) “The primary outcome of the study was a week positive correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure (Spearman coefficient r=0.276, p=0.0014) or patients’ discomfort during the procedure (r=0.309, p=0.0005)” Although the correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure was statistically significant, coefficient rho was 0.276 that was below 0.3. On the other hand, the correlation between dissatisfaction with bronchoscopy and patients’ discomfort during the procedure was statistically significant and its coefficient rho was 0.309 that was beyond 0.3. Is the latter the only one that met the main outcome? You should explain this result in the discussion part.

3) I think the coefficient is generally rho (ρ) in the Spearman rank test.

4) Although PLOS one is an open-access journal, the discussion part is slightly long. Can you summarize it?

5) I have a comment for your future study. There is a book that explained how to use Multivariable Analysis: A Practical Guide for Clinicians and Public Health Researchers Second edition by Mitchell H. Katz. He said as below: Whenever possible, "do not use variable selection technique." This is because there is a danger that any variable selection method will select confounders into the model and remove variables that are causally related to the outcome. Also, in both the forward and the backward selection, each variable is evaluated individually, so there is a possibility that two variables that start out as a set and have an important effect on the outcome will not be selected as a set in the final model. There is also the possibility that a variable that is very important in explaining the outcome may not be selected for the model because it is related to a variable that has already been adopted in the model. My opinion is the same as above.

6) This manuscript still has some grammatical errors in the text that needs to be corrected. Please check English in the text carefully.

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Reviewers' comments:

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

15 Feb 2022

Warsaw, 15th February 2022

Dear Editor and Reviewers,

Thank you for reviewing our manuscript PONE-D-21-03696, titled Evaluation of patients’ satisfaction with bronchoscopy procedure once again. We truly appreciate Your comments which have helped us improve the manuscript’s quality. We believe that all the points raised by the reviewer were addressed. We would be grateful for re-considering our manuscript for publication.

Below, we include the specific responses to the Reviewers’ comments with the hope that they will find them adequate.

1) “In our study neither the satisfaction from bronchoscopy (BS) nor anxiety before BS have a normal distribution of values (line 203). Thus we changed the correlation coefficient for Spearman (line 209 and 287, 288) and we used non-parametric tests.”

Does this mean sample size calculation was incorrect in your study? You should include this information as a limitation. This is very important.

Thank you for this remark. We added this information in limitations of the study (line 201-223).

2) “The primary outcome of the study was a week positive correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure (Spearman coefficient r=0.276, p=0.0014) or patients’ discomfort during the procedure (r=0.309, p=0.0005)” Although the correlation between dissatisfaction with bronchoscopy and the level of anxiety before the procedure was statistically significant, coefficient rho was 0.276 that was below 0.3. On the other hand, the correlation between dissatisfaction with bronchoscopy and patients’ discomfort during the procedure was statistically significant and its coefficient rho was 0.309 that was beyond 0.3. Is the latter the only one that met the main outcome? You should explain this result in the discussion part.

Thank you for your suggestion. We emphasized that correlations were weak, but according to your suggestion we drew more attention to the correlation between dissatisfaction and discomfort (line 406-407). We tried to discuss the significance of discomfort as a factor influencing patients satisfaction with bronchoscopy in detail (line 400-421).

3) I think the coefficient is generally rho (ρ) in the Spearman rank test.

Thank you for this remark. We corrected it for rho (line 286-287).

4) Although PLOS one is an open-access journal, the discussion part is slightly long. Can you summarize it?

Thank you for this hint. We tried to shorten the discussion.

5) I have a comment for your future study. There is a book that explained how to use Multivariable Analysis: A Practical Guide for Clinicians and Public Health Researchers Second edition by Mitchell H. Katz. He said as below: Whenever possible, "do not use variable selection technique." This is because there is a danger that any variable selection method will select confounders into the model and remove variables that are causally related to the outcome. Also, in both the forward and the backward selection, each variable is evaluated individually, so there is a possibility that two variables that start out as a set and have an important effect on the outcome will not be selected as a set in the final model. There is also the possibility that a variable that is very important in explaining the outcome may not be selected for the model because it is related to a variable that has already been adopted in the model. My opinion is the same as above.

Thank you for this remark. We appreciate all comments and suggestion concerning the statistical analysis. We will certainly read this book and use this knowledge in future studies.

6) This manuscript still has some grammatical errors in the text that needs to be corrected. Please check English in the text carefully.

Thank you for this suggestion. We checked and corrected the manuscript.

Submitted filename: Response to Reviewers.February 2022.docx

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21 Feb 2022

21 Mar 2022

Dear Editor and Reviewers,

Thank you for reviewing our manuscript PONE-D-21-03696, titled Evaluation of patients’ satisfaction with bronchoscopy procedure once again. We are grateful for Your comments and suggestions which have helped us improve the manuscript’s quality. We hope that all the points raised by the reviewer were addressed. We would be grateful for re-considering our manuscript for publication.

Below, we included the specific responses to the Reviewers’ comments with the hope that they will find them adequate.

#1; In Manuscript – revised version. February 2022.

Line 260 to 262; “There was a positive correlation between satisfaction and willingness for future bronchoscopy (r=0.487, p<0.0001)”.

I wonder if this “r” is Spearman coefficient rho or not. Please correct or explain it.

Response:

Thank you for this apt remark. In line 260-262 Pearson correlation r=0.487, p< 0.0001 was given, but as distribution of data were not normal, we changed it for Spearman correlation rho= 0.404, p<0.0001 (p=0.000003).

#2; And you also need clear and correct Figures and Tables without any misprints (“diabetes; diabetes mellitus,” “arhytmia; arrhythmia,” “asthma; bronchial asthma” in Supplementary Figure 2 and so on) or any additional linear (Q1 in S2 table and so on) to publish. Therefore, you should check all figures and tables and supplementary tables and figures again.

Response:

Thank you for a thorough review. We have revised the supplementary files and tabels and provided the required changes.

#3; According to Submission Guidelines, manuscripts must be submitted in English. Your supporting information included the Polish version of the S1 Table to S4 Table. Therefore, you should delete them.

Respone:

Thank you for this remark. Files in Polish have been deleted.

Thank you for those suggestions.

Yours sincerely

Katarzyna Faber

Marta Dąbrowska

Submitted filename: Response to Reviewers.March 2022.docx

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28 Aug 2022

Evaluation of patients’ satisfaction with bronchoscopy procedure.

PONE-D-21-03696R4

Dear Dr. Faber,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Yuichiro Takeda, M.D., Ph.D.

Guest Editor

PLOS ONE

Additional Editor Comments (optional):

Through several revisions, I think your manuscript has improved.

ACADEMIC EDITOR:

congratulations to the authors and thanks to the reviewers for the suggestions provided which really helped improve the quality of the manuscript

Silvia Fiorelli

Plos One

Academic Editor

19 Sep 2022

PONE-D-21-03696R4

Evaluation of patients’ satisfaction with bronchoscopy procedure.

Dear Dr. Faber:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

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Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Silvia Fiorelli

Academic Editor

PLOS ONE