Introduction
Quality assurance (QA) is a prerequisite for modern health care services, but we have
limited knowledge to define the quality of quality registers. Reporting may be selective,
causing selection bias in QA databases. When this happens to reporting of important
outcomes like adverse events (AEs), it may seriously jeopardize the validity of QA
registers. Not being sufficiently aware of their possible shortcomings, QA registers
may do unwarranted harm to the health service [1]. Also, underreporting of sub-standard performance may create “feel-good” registers
unable to reveal the true need for quality improvement.
There is no standard to define a reliable quality register. Ninety percent may be
arbitrarily described as good and less than 70 % to 80 % as inadequate [2]
[3]. Adequate completeness may also depend on whether we are dealing with high-frequency
events like the proportion of patients sedated for colonoscopy (quality of process)
and the proportion of colonoscopies reaching the cecum (quality of results) or low-frequency
AE. A register with 90 % completeness may be of little help if disproportionately
many low-frequency AEs occur among the 10 % not reported. It is known from the software
industry that a linear increase in coverage or completeness may result in an exponential
increase in errors detected [4]. Thus, a high degree of register completeness may not by itself prevent selection
bias of clinical importance.
The requirement for patients’ written consent and underreporting from doctors and
hospital staff are sources of bias with unknown effects on the validity of QA registers.
“Limited resources” and “time squeeze” have been identified as major reasons for not
reporting to quality registers [5]. In the current study, we have used data on colonoscopies from the Norwegian national
quality register Gastronet to demonstrate consent-dependent bias and explore the hypothesis
of endoscopist time-squeeze-dependent underreporting to estimate what possible effect
this may have on registration of AEs.
Materials and methods
Gastronet is one of 54 national medical quality registers in Norway. It includes registration
of colonoscopies and endoscopic retrograde cholangiopancreatography examinations.
The current study comprised colonoscopies only. Gastronet is granted a waiver from
the ethics committee of South-East Norway to which this national register is affiliated.
Reporting colonoscopies to Gastronet is based on two paper forms – one colonoscopy
form to be filled in by the endoscopist or nurse immediately after the procedure and
a patient-reported experience measures (PREM) form to be filled in by the patient
on the day after the examination (English translation in the supplement). The Norwegian
Directorate of Health has permitted hospitals to submit colonoscopy forms to Gastronet
without patients’ consent, but the patients’ PREM form serves as written consent to
keep patient identification for register linkage studies. This access to colonoscopy
reports without consent allowed us to study selection bias in relation to consent
(authorization bias). In the current study, patients who had their colonoscopy reported
to Gastronet and returned the PREM form are referred to as the “consent” group, and
the “no-consent” group comprised patients with a colonoscopy report to Gastronet who
did not return the form.
In Norway, it is compulsory for public hospitals to report all clinical activity to
the Norwegian National Patient Register (NPR). Non-reported procedures are not reimbursed.
Thus, completeness of the NPR is considered to be 100 %. NPR does not include quality
variables, but can be used to estimate completeness (coverage) of medical quality
registers. Completeness can be assessed per hospital/endoscopy center, but not per
endoscopist because the performing endoscopist is not reported to NPR.
In this study, Gastronet completeness was defined as the proportion of NPR-registered
outpatient colonoscopies reported to Gastronet from January to December 2015. Hospitals
reporting at least 100 outpatient colonoscopies in this 1-year period were included.
A cut-off of 100 colonoscopies to receive hospital-specific results was arbitrarily
chosen by participating centers in Gastronet. Two endoscopy centers were excluded,
reporting 13 and 66 colonoscopies, respectively. The hospitals included were categorized
into four groups according to observed completeness, less than 50 %, 50 % to 69 %,
70 % to 89 % and 90 % to 100 %, respectively. These categories were chosen based on
relevance to published data from quality registers [2]
[6] and our focus on few events (AEs) requiring high numbers. Patient and colonoscopy
characteristics and results were described for each hospital completeness category,
including time spent per colonoscopy and number of AEs. Information on AEs was obtained
from the colonoscopy forms and by interpretation of negative (critical) free-texts
provided by the patients in the PREM form as described in a recent publication [7]. Briefly, severe AEs were defined as events requiring admission to hospital and/or
some intervention beyond what could be done during the current colonoscopy. We also
included cases with post-colonoscopy pain when this was combined with fever and poor
general condition and cases with loss of consciousness related to the colonoscopy
itself or the bowel-preparation procedure. Patients’ free-text comments in the PREM
form were characterized as positive or negative by consensus of three secretaries
in Gastronet. All negative free-text comments were then scrutinized by one of the
authors (GH) according to whether the text expressed possible
AEs or not and events were further evaluated as severe or not severe AEs independently
by GH and TdL [7].
The study was performed in two steps: First, we investigated whether reporting of
AEs was associated with low completeness (coverage) and whether low completeness was
associated with procedure time (duration). All hospitals reporting > 100 colonoscopies
were included in this analysis. Second, we analyzed data from hospitals with near
complete data (≥ 90 % completeness) to investigate whether procedure time was associated
with frequency of AEs. In this sub-cohort, cut-offs for progressively increasing procedure-times
were set to cover up to 50 % of the shortest procedures (< 20 minutes), the next 50 %
to 69 % (20 – 25 minutes), 70 % to 89 % (26 – 41 minutes) and the last 10 % (90 %
to 100 %) with the longest procedure times (≥ 41 minutes, Supplementary Table 1). Our hypothesis was that time-squeeze leads to low completeness in some centers.
Then, if procedure time is an independent risk factor for AEs, centers with low completeness
due to time constraints may have greater underreporting of AEs than centers with high
completeness.
Statistics
Continuous, normally distributed data were analyzed with the Student’s t-test and chi squared statistics were applied for categorical variables. One-way analysis
of variance (ANOVA) was used for repeated measures. In the analysis of procedure-time-dependent
AEs within hospitals with ≥ 90 % reporting completeness, univariable and multivariable
logistic regression analyses were performed for AEs with the following co-variables:
gender, age, cecum intubation failure, severe pain, type of colonoscopy (diagnostic/therapeutic).
Statistical significance was defined as P < 0.05 using two-sided tests. The statistical package IBM SPSS 19.0 was used.
Results
A total of 22,364 colonoscopies were performed during the study period according to
the Norwegian patient register, of which 15,855 (71 %) were reported to Gastronet
([Fig. 1]). Eight of 20 hospitals had ≥ 90 % completeness ([Table 1]). The PREM questionnaire was returned by 11,079 patients (50 %). In addition, 402
PREM forms were received without accompanying colonoscopy forms and not included in
the analyses. One (0.2 %) out of these 402 cases was registered with an AE which was
abdominal pain for 3 days with no further information.
Fig. 1 Flowchart showing sub-study distribution of 22,364 colonoscopies performed in 20
hospitals January to December 2015.
Table 1
Categorization of hospital reporting completeness (groups 1 – 4) expressed as the
ratio of colonoscopies in the National Patient Register (NPR) that are also reported
to Gastronet.
Hospital
|
Group 1, < 50 % completeness
|
Group 2, 50 – 69 % completeness
|
Group 3, 70 – 89 % completeness
|
Group 4, ≥ 90 % completeness
|
Total
|
Skien
|
|
|
1216/1550 (79)
|
|
|
Tønsberg + Larvik
|
|
1694/3023 (56)
|
|
|
Kristiansand
|
|
|
|
1552/1649 (94)
|
Arendal
|
|
|
|
1092/1199 (91)
|
Notodden
|
|
|
587/801 (73)
|
|
Flekkefjord
|
|
|
216/278 (78)
|
|
Fredrikstad
|
|
|
|
1114/1149 (97)
|
Kongsberg
|
|
|
|
475/481 (99)
|
Moss
|
|
|
|
668/701 (95)
|
Stavanger
|
|
1194/2236 (53)
|
|
|
Kragerø
|
|
|
|
1224/1274 (96)
|
Bærum
|
|
|
1336/1560 (86)
|
|
Molde
|
|
|
|
938/932 (101)
|
Volda
|
245/614 (40)
|
|
|
|
Diakonhjemmet
|
324/1174 (28)
|
|
|
|
Kristiansund
|
|
|
|
753/730 (103)
|
Drammen
|
188/1440 (13)
|
|
|
|
Harstad
|
|
|
552/673 (82)
|
|
Namsos
|
128/421 (30)
|
|
|
|
Stord
|
|
|
359/479 (75)
|
|
Total
|
885/3649 (24)
|
2888/5259 (55)
|
4266/5341 (80)
|
7816/8115 (96)
|
15 855/22 364 (71)
|
Authorization bias
Patients in the consent group were older and more often female ([Table 2]). Cecal intubation failure was more frequent in colonoscopies with no consent (5.7 %)
compared to colonoscopies with consent (3.5 %), P < 0.001. Use of sedoanalgesia was more frequent in the no-consent group ([Table 2]). The rate of AEs reported in the colonoscopy form were similar (1.0 %) in both
groups. When the AEs from the PREM form were included in the analyses (free-text comments
indicating an AE, only available in the consent group), there were 189 AEs (1.7 %)
in the consent group and 50 (1.0 %) in the no-consent group, P < 0.001.
Table 2
Patient and endoscopy characteristics for 15,855 colonoscopies reported with and without
patient reply form (consent) received at the Gastronet secretariat (%).
|
Consent group (colonoscopy and PREM form) (n = 11079)
|
No-consent group (colonoscopy form only) (n = 4776)
|
P value
|
Sex
|
|
5047 (46)
|
2307 (48)
|
< 0.001
|
|
6022 (54)
|
2445 (51)
|
|
10 (0.1)
|
24 (0.5)
|
Age (mean yrs [95 %CI])
|
62.7 (62.4 – 62.9)
|
53.9 (53.4 – 54.4)
|
< 0.001
|
Type of colonoscopy
|
|
5593 (51)
|
2525 (53)
|
< 0.001
|
|
1629 (15)
|
511 (11)
|
|
3857 (35)
|
1740 (36)
|
Total exam. time (min) (mean [95 %CI])
|
24.9 (24.7 – 25.2)
|
24.0 (23.6 – 24.4)
|
< 0.001
|
Total time not stated
|
847 (7.6)
|
489 (10)
|
< 0.001
|
Sedoanalgesia
|
3844 (35)
|
1873 (39)
|
< 0.001
|
Cecal intubation status
|
|
9887 (89)
|
4077 (85)
|
< 0.001
|
|
389 (3.5)
|
271 (5.7)
|
|
93 (0.8)
|
65 (1.4)
|
|
710 (6.4)
|
363 (7.6)
|
Adverse events (total)
|
|
113 (1.0)
|
50 (1.0)
|
|
|
76 (0.7)
|
0[2]
|
|
|
189 (1.7)
|
50 (1.0)
|
< 0.001
|
PREM, Patient-Reported Experience Measures
1 A colonoscopy including a therapeutic procedure (e. g. polypectomy)
2 No patients’ forms in this group, hence no statistics
Reporting completeness and time-dependent reporting bias
Hospitals with low reporting completeness had longer colonoscopy procedure times and
fewer AEs compared to hospitals with high completeness ([Table 3], [Fig. 2a]). Other variables like patient age, type of colonoscopy (diagnostic or therapeutic)
and frequency of returned PREM forms did not show a clear, progressive completeness-dependent
pattern ([Table 3]). In particular, PREM-forms (the source of many AE registrations; [Table 2]) were returned to Gastronet equally often (72 %) from patients in the highest and
lowest completeness categories of hospitals ([Table 3]).
Table 3
Demographics and colonoscopy characteristics according to Gastronet completeness groups
of hospitals.
|
Gastronet observed completeness
|
|
|
Group 1, < 50 % completeness (n = 885)
|
Group 2, 50 %-69 % completeness (n = 2888)
|
Group 3, 70 %-89 % completeness (n = 4266)
|
Group 4, > 90 % Completeness (n = 7816)
|
P value
|
Sex
|
|
396 (45)
|
1307 (45)
|
1982 (47)
|
3669 (47)
|
0.21
|
|
488 (55)
|
1573 (55)
|
2280 (53)
|
4126 (53)
|
|
1 (0.1)
|
8 (0.3)
|
4 (0.1)
|
21 (0.3)
|
Age (yrs)
(mean [95 %CI])
|
59.4 (58.3 – 60.4)
|
58.9 (58.3 – 59.5)
|
59.8 (59.3 – 60.3)
|
60.7 (60.4 – 61.0)
|
< 0.001
|
Type of colonoscopy
|
|
400 (45)
|
1581 (55)
|
2005 (47)
|
4132 (53)
|
< 0.001
|
|
165 (19)
|
317 (11)
|
413 (9.7)
|
1245 (16)
|
|
320 (36)
|
990 (34)
|
1848 (43)
|
2439 (31)
|
Cecum intub.failure
|
23 (2.6)
|
104 (3.6)
|
145 (3.4)
|
255 (3.3)
|
0.51
|
Polyp detection[2]
|
248 (28)
|
703 (24)
|
1122 (26)
|
1945 (25)
|
0.05
|
Total exam. time (min)
(mean [95 %CI])
|
28.1 (27.3 – 28.9) (n = 834)
|
25.9 (25.4 – 26.3) (n = 2701)
|
25.1 (24.7 – 25.5) (n = 3775)
|
23.6 (23.3 – 23.9) (n = 7209)[3]
|
< 0.001[4]
|
Adverse events
|
|
3 (0.3)
|
2 (0.1)
|
12 (0.3)
|
22 (0.3)
|
|
|
2 (0.2)
|
32 (1.1)
|
64 (1.5)
|
101 (1.3)
|
|
5 (0.6)
|
34 (1.2)
|
76 (1.8)
|
123 (1.6)
|
0.02
|
PREM form returned
|
636 (72)
|
1926 (67)
|
2912 (68)
|
5605 (72)
|
< 0.001
|
Severe pain
|
66/636 (10)
|
221/1926 (12)
|
355/2912 (12)
|
714/5605(13)
|
0.22
|
Negative free text, patients’ reply form
|
20 (2.3)
|
83 (2.9)
|
132 (3.1)
|
189 (2.5)
|
0.12
|
PREM, Patient-Reported Experience Measures
1 A colonoscopy including a therapeutic procedure (e. g. polypectomy).
2 Detection of at least one polyp ≥ 5 mm regardless of histology.
3 Number used for time-dependent modelling (Table 4)
4 One-way ANOVA
Fig. 2 a Adverse events and colonoscopy (CS) reporting coverage. The figure shows categories
of hospitals according to proportion of colonoscopies reported to Gastronet (hospital
coverage groups 1 – 4) and the frequency of adverse events (AE) limited to colonoscopy
reports received in Gastronet. The width of the blue columns visualize differences
in mean total time spent per colonoscopy (values presented in [Table 3]). b This illustrates how the nearly complete dataset from hospital group 4 (90 % – 100 %
reporting completeness) can be used to estimate variations in frequency of adverse
events dependent on a progressive time-squeeze on procedure times spent on colonoscopy
(Supplementary Table 1). c This shows the four time-squeeze groups in [Fig. 2b] presented as separate columns with corresponding frequencies of adverse events.
Time-squeeze dependent reporting bias
To explore the effect of procedure time on AEs, we used data from hospitals with ≥ 90 %
completeness ([Fig. 2b], Supplementary Table 1). There was very little variation in percentage of PREM-forms received between the
four procedure-time groups consisting of the 50 % shortest procedures, the 50 % to
69 % and 70 % to 89 % succeeding and the 90 % to 100 % with the longest procedures
(71 %, 73 %, 72 % and 76 % PREM completeness, respectively) ([Table 4]). This was shown both for combined diagnostic and therapeutic colonoscopies ([Table 4]) and separately for diagnostic colonoscopies only (data not shown).
Table 4
Characteristics of colonoscopies performed with successive variations in procedure
times. Data are based on total time spent per colonoscopy (n = 7209) in the group
of hospitals with ≥ 90 % completeness (procedure times are missing for 607 out of
7816 colonoscopies in this group of hospitals).
|
Procedure time-dependent categorization of colonoscopies in hospital group 4
|
|
|
|
Group I, 50 % with shortest procedure times
|
Group II, 50 % – 69 % (20 % succeeding procedure times)
|
Group III, 70 % – 89 % (20 % succeeding procedure times)
|
Group IV, > 90 % (10 % with longest procedure times)
|
Total
|
P value
|
Procedure time range (min.)
|
< 20
|
20 – 25
|
26 – 41
|
> 41
|
|
|
Colonoscopy form data
|
Colonoscopy reports
|
3557
|
1501
|
1412
|
739
|
7209
|
|
Cecum intubation failure (%)
|
54 (1.5)
|
24 (1.6)
|
47 (3.3)
|
27 (3.7)
|
152 (2.1)
|
< 0.001
|
On-site adverse events(%)
|
29 (0.8)
|
12 (0.8)
|
20 (1.4)
|
19 (2.6)
|
80 (1.1)
|
< 0.001
|
Total adverse events (%)[1]
|
38 (1.1)
|
18 (1.2)
|
31 (2.2)
|
27 (3.7)
|
114 (1.6)
|
< 0.001
|
PREM form data
|
PREM forms(%)
|
2541 (71)
|
1101 (73)
|
1017 (72)
|
564 (76)
|
5223 (73)
|
0.04
|
Severe pain
|
202 (7.9)
|
155 (14.1)
|
173 (17.0)
|
101 (17.9)
|
631 (12.1)
|
< 0.001
|
Negative comments(%)
|
67 (2.6)
|
29 (2.6)
|
53 (5.2)
|
30 (5.3)
|
179 (3.4)
|
< 0.001
|
1 Combination of adverse events registered in colonoscopy reports (“on site” adverse
events extracted from colonoscopy form) and events extracted from free text comments
in patients´ reply form.
Cecum intubation failure was more frequent in the groups with long compared to short
procedure time ([Table 4]). The same applied to on-site registered AEs reported in the colonoscopy form –
increasing further when adding patient-reported events to provide “total AEs” ([Table 4]).
In the hospital group with > 90 % completeness, mean total time spent on colonoscopies
with “on-site” registration of AEs was 31.3 minutes (95 % CI: 26.6 – 36.0). This was
similar to colonoscopies with events emerging clinically after the colonoscopy and
reported only by the patients (31.3 minutes [95 % CI: 25.3 – 37.3]) while mean total
time was shorter in colonoscopies with no AE 24.6 minutes (95 % CI 23.2 – 23.8)
Multivariable logistic regression analysis showed that procedure time was the only
independent risk factor for AEs after adjusting for gender, age, cecum intubation
failure, patient-reported pain and whether polypectomy was performed ([Table 5]).
Table 5
Odds ratio (OR) for adverse events in a multivariable logistic regression model adjusting
for gender, age, caecum intubation failure, patient reported pain, type of colonoscopy
(CS) and modelled registration completeness categories.
|
|
Unadjusted OR
|
Adjusted OR
|
|
No. of CS
|
Mean (95 % CI)
|
P-value
|
Mean (95 % CI)
|
P value
|
Gender
[1]
|
Men
|
3408
|
1.0 (reference)
|
|
1.0 (reference)
|
|
Women
|
3780
|
1.0 (0.7 – 1.5)
|
0.91
|
0.6 (0.4 – 1.0)
|
0.07
|
Age
[1]
|
7186
|
1.0 (1.0 – 1.0)
|
0.31
|
1.0 (1.0 – 1.0)
|
0.13
|
Complete examination
|
Cecum or aim reached
|
7057
|
1.0 (reference)
|
|
1.0 (reference)
|
|
Cecum intubation failure
|
152
|
2.2 (0.9 – 5.4)
|
0.10
|
3.0 (1.0 – 8.9)
|
0.46
|
Pain
[2]
|
None, slight/moderate pain
|
4592
|
1.0 (reference)
|
|
1.0 (reference)
|
|
Severe pain
|
631
|
1.8 (1.1 – 3.0)
|
0.02
|
1.8(1.0 – 3.3)
|
0.65
|
Type of colonoscopy
[1]
|
Diagnostic
|
3867
|
1.0 (reference)
|
|
1.0 (reference)
|
|
Therapeutic
|
1198
|
1.8 (1.1 – 2.8)
|
0.01
|
1.3 (0.8 – 2.3)
|
0.31
|
Percentage completeness
|
< 50 %
|
3557
|
1.0 (reference)
|
|
1.0 (reference)
|
|
50 %-69 %
|
1501
|
1.1 (0.6 – 2.0)
|
0.69
|
0.8 (0.4 – 1.9)
|
0.64
|
70 %-89 %
|
1412
|
2.1 (1.3 – 3.4)
|
0.003
|
2.6 (1.4 – 4.8)
|
0.003
|
≥ 90 %
|
739
|
3.5 (2.1 – 5.8)
|
< 0.001
|
3.6 (1.8 – 7.1)
|
< 0.001
|
1 Figures do not add up to 7209 due to missing data
2 These add up to 5223 – the total number of filled-in patient reply forms after 7209
colonoscopies
Discussion
Safety in health care has been defined as “freedom from potentially preventable complications,
iatrogenic events, accidental injury, or illness resulting from the process of care,”
[8]
[9] i. e. freedom from AEs.
AEs after colonoscopy are underreported [7]
[10] and patient involvement has been recommended to capture all AEs, particularly late
events presenting after the patient has left the endoscopy premises [10]. Also by nature of infrequent occurrence and a wide range of subjective severity,
reporting of AEs may be particularly prone to underreporting and selection bias. This
is paralleled in industry and fault detection measures where coverage over 90 % usually
shows better fault detection than random sample testing [4]
[11].
Dependency on patients’ consent is one important source of selection bias named “authorization
bias” [12]
[13]. Authorization bias was apparent in this study with a higher cecal intubation failure
rate in colonoscopies not accompanied by a PREM (consent) form (5.7 % intubation failure
compared to 3.5 % in the group with consent). The no-consent group was also more often
subjected to sedoanalgesia, suggesting more difficult procedures as on-demand medication
is the standard in these centers. Challenging procedures may thus divert attention
from handing out the PREM/consent form to the patient who would then more easily evade
consent-dependent registration in Gastronet. This is unfortunate because challenging
colonoscopies may carry a particularly high risk of AEs. Thus, consent-dependency
may give a false impression of no need for quality improvement. This is not in the
interest of patients [14]. Interestingly, even ethicists have challenged the need for consent when the issue
is purely non-interventional observation through a QA register to improve services
[15].
This study also showed that hospitals with low frequency of reporting colonoscopies
to Gastronet were registered with longer mean procedure times than hospitals with
high reporting completeness. This provided support to the hypothesis that time may
indeed restrict reporting to quality registers, as claimed by doctors not reporting.
We also found that the frequency of reported AE was reduced as the reporting completeness
dropped ([Fig. 2a]). Thus, AE reports are not linear functions of completeness with equal percentages
irrespective of degrees of completeness.
Pursuing the squeeze-time hypothesis on data from the subgroup of hospitals with 90 %
to 100 % reporting completeness, we observed a pattern of AE frequencies ([Fig. 2c]) very similar to hospitals with less degrees of completeness ([Fig. 2a]) only with higher frequencies of AEs ([Fig. 3]). This suggests that the frequency of AEs may be higher in colonoscopies not reported,
irrespective of coverage. Among the 402 PREMs not accompanied by a colonoscopy report,
there was, however, only one report suggesting an AE. Particularly on-site complications
may be underreported in this group lacking information from colonoscopy reports.
Fig. 3 Visualization of complications as observed in [Fig. 2a] (dark blue columns) and when applying progressive time-limits to procedure times
in the dataset from hospital group 4 in [Fig. 2c] (pale blue columns).
Because the frequencies of AEs may be driven disproportionally by changes in reporting
completeness and colonoscopy procedure time, it is difficult to define cut-off values
for adequate completeness of quality assurance registers. Thus, selection bias for
clinically important endpoints may be a problem whether completeness is 50 %, 70 %
or even 90 % and we have gained only limited knowledge as to the reasons for this
(Supplementary Table 2). There was no difference between hospitals with low and high reporting completeness
regarding cecal intubation rates, but a non-significant trend for higher detection
rates for polyps ≥ 5 mm in hospitals with low registry input (data not shown).
There are several weaknesses and uncertainties to this study which mainly emerge from
its sole purpose: trying to disclose what is happening in procedures not being reported
to quality registers. This requires a number of assumptions which may or may not be
supported by observational data. In disclosing the authorization bias, we were fortunate
to have information on procedures reported both with and without consent (authorization)
and the analyses exposed selection bias with regard to age, cecal intubation and need
for sedoanalgesia. These were, however, mere surrogates for the main outcome: AEs,
data on which were not available from patients’ forms in the no-consent group. This
represents a weakness since 76 of 189 AEs (40 %) were reported only in the patient’s
PREM/consent form in the consent group ([Table 2]).
Excessive time spent on each colonoscopy is a plausible explanation for failing to
hand out patient reply forms and down-prioritizing a task of no relevance for the
current treatment of the patient. Apparently, this was not the case in this study
showing little variation in patient reply form coverage ranging from 67 % to 72 %
of reported colonoscopies in the four categories of hospitals ([Table 3]). This does not support the down-prioritizing of tasks due to shortage of time,
unless handing out the patient reply form is a staff task unrelated to the endoscopist
time-squeeze, but it strengthens the comparison of AEs between hospital groups because
patient reply forms contributed so strongly to registration of AEs. A prerequisite
for PREM coverage is to hand out the form to the patient. If this is a task for the
nurse while time-squeeze shortcuts are more prevalent for the endoscopist, then this
may explain similar PREM coverage irrespective of the time-dependent grouping of hospitals
in this study.
The endoscopy units’ reporting completeness varied greatly between hospitals, ranging
from 13 % to 100 % ([Table 1]). For low-completeness hospitals, it is assumed that endoscopists have the possibility
of not reporting their procedures. We do not know if this may be due to a few endoscopists
with high colonoscopy activity and/or many with less activity. Also, we do not know
the characteristics of endoscopists not reporting, but a frequently presented argument
for not reporting has been “We do not have the time for this,” in spite of less than
2 minutes being required for the endoscopist to fill in the colonoscopy form (unpublished
data).
Total colonoscopy examination time as a proxy for time-squeeze may be a poor surrogate
for the highly subjective sense of stressful shortage of time and a need to cut down
on reporting. Stressful time-squeeze depends not only on time spent for the current
colonoscopy, but also on lagging behind after the previous patient in the list. Poor
organization may further contribute to competing urgent tasks needing to be addressed
during and immediately after the current examination. An already stressful atmosphere
may escalate when you are 10 to 15 minutes into your next 30-minute timeslot in a
very tight clinical list. These factors, not necessarily reflected in the time spent
on the current patient, may contribute additionally towards underreporting of sub-performance
and AEs.
The main driving force for public health services is to provide equal access and quality
of services irrespective of socioeconomic status and place of living. In this study,
all endoscopy centers were public hospitals. To verify a national aim of equal service
provision and low risk of AEs for patients, you need a QA register with national coverage
and completeness. Without this, it cannot be documented that the political aim of
equality has been reached. Our study suggests that incomplete QA registers do not
provide valid information on AEs.
For many registers, it will be very resource-intensive to achieve 100 % completeness.
Singular focus to achieve anything short of 100 % completeness may still be insufficient
to satisfy valid skepticism about data quality. We believe that both from a resource
and data quality perspective, electronic medical records (EMRs) should be adequately
structured with integrated registration of relevant quality data as part of routine
medical recording [16]. These data should be automatically loaded into real-time display of quality register
data [17]. Informed consent should not be a prerequisite for research on quality register
data [15]
[18] as this itself will create bias. It takes time to develop such integrated tools
and overcome regulations. Meanwhile, we suggest that quality registers reporting on
medical procedure performance aim to improve insight into the extent of uncertainties
and possible biases in their data. Exposure of QA shortcomings may inspire extra efforts
to accommodate QA registers as a natural, integrated part of routine EMRs. This process
is long overdue.
Conclusion
In conclusion, the current study has verified authorization bias in a colonoscopy
QA register and observed a procedure-time-dependent bias in registration of AEs while
the reasons for this time-dependency remain unknown. Data from a group of public hospitals
with almost 100 % reporting completeness could be used to estimate the degree of underreporting
in groups of hospitals with less reporting completeness. Register data should be used
to estimate type and degrees of bias and expose challenges in obtaining valid data
for QA when legislation and reporting technologies do not facilitate 100 % completeness.