Abstract
Background: Daily documentation and maintenance of medical record
quality is a crucial issue in orthopaedic surgery. The purpose of the present
study was to determine whether the introduction of a handheld computer could
improve both the quantitative and qualitative aspects of medical records.
Methods: A series of consecutive patients who were admitted for the
first time to a thirty-six-bed orthopaedic ward of an academic teaching
hospital for a planned operation or any other treatment of an acute injury or
chronic condition were randomized to daily documentation of their clinical
charts on a handheld computer or on conventional paper forms. The electronic
documentation consisted of a specially designed software package on a handheld
computer for bedside use with structured decision trees for examination,
obtaining a history, and coding. In the control arm, chart notes were compiled
on standard paper forms and were subsequently entered into the hospital's
information system. The number of documented ICD (International Classification
of Diseases) diagnoses was the primary end point for sample size calculations.
All patient charts were reread by an expert panel consisting of two surgeons
and the surgical quality assurance manager. These experts assigned quality
ratings to the different documentation systems by scrutinizing the extent and
accuracy of the patient histories and the physical findings as assessed by
daily chart notes.
Results: Eighty patients were randomized to one of the two
documentation arms, and seventy-eight (forty-seven men and thirty-one women)
of them were eligible for final analysis. Documentation with the handheld
computer increased the median number of diagnoses per patients from four to
nine (p < 0.0001), but it produced some overcoding for false or redundant
items. Documentation quality ratings improved significantly with the
introduction of the handheld device (p < 0.01) with respect to the correct
assessment of a patient's progress and translation into ICD diagnoses. Various
learning curve effects were observed with different operators. Study
physicians assigned slightly better practicability ratings to the handheld
device.
Conclusions: The preliminary data from this study suggest that
handheld computers may improve the quality of hospital charts in orthopaedic
surgery.
Level of Evidence: Therapeutic study, Level I-1a
(randomized controlled trial [significant difference]). See Instructions to
Authors for a complete description of levels of evidence.
Documentation constitutes a considerable portion of the daily workload in
orthopaedic surgery. Whereas a chain of health-care professionals becomes
involved in the documentation process, surgeons, despite their other duties,
are ultimately responsible for the correctness and completeness of medical
records1.
The medical record is a legal document designed to provide an overview of
the patient's state of health before, during, and after a particular therapy.
This overview is normally compiled by different steps: (1) handwritten notes
are made during daily rounds, (2) particular events or changes in health
condition are subsequently entered into the hospital database and coded
according to the ICD (International Classification of Diseases)
system, and (3) the entire body of information is summarized in a cumulative
report at the time of patient discharge from the hospital. Each step depends
on the physician's time resources, experience, and routine with paperwork and
may be susceptible to neglect and data loss if documentation cannot be carried
out immediately.
One approach to overcome this problem is the introduction of handheld
computers to provide a structured guide for bedside
documentation2,3.
We investigated the impact of these devices on the coding quantity and the
quality of patient records in a clinical trial. A secondary objective was the
evaluation of the clinical practicality of electronic and conventional chart
documentation. We hypothesized that, in otherwise identical patient samples,
the number of diagnoses made with use of interactive coding software on a
microcomputer for bedside use would be greater than that made with use of
conventional paper documentation. A further hypothesis was that the overall
quality of the health records could be enhanced with the use of the electronic
device.
There is no accepted definition of the unambiguous or perfect medical
record. Furthermore, as far as we know, there are no data available on how
handheld computers might change daily practice. For the purpose of this study,
we performed both a confirmatory analysis on possible "hard" end
points (i.e., the number of coded diagnoses) as well as a rather exploratory
analysis of "soft" end points (i.e., the chart quality as assessed
by expert observers).
Study Setting
The present investigation was an open label, randomized, controlled trial
conducted on a single, thirty-six-bed orthopaedic ward in an academic teaching
hospital. The hospital information system (SMS Dataplan; Siemens, Erlangen,
Germany) was originally developed to produce an entirely computer-based
patient record.
In January 2001, coding guidelines for German health-care professionals
switched from the ninth to the tenth revision of the International
Classification of Diseases (ICD) catalog, and classifications made on
behalf of the present work adhered to the latter coding scheme. However,
neither the experimental nor the control intervention applied in this study
specifically depends on one or the other classification, and both ICD-9-CM
(Ninth Revision, Clinical Modification) and ICD-10 codes are presented
throughout.
Study Design
All consecutive patients who were admitted to the study ward for the first
time for a planned operation or any other treatment of an acute injury or
chronic condition were eligible to participate in the trial, regardless of
demographic variables. Patients were excluded from the study if they had
already been treated and transferred from other peripheral wards or
intensive-care units or if they were transferred to another ward and/or
intensive-care unit. This was done to ensure the continuity of the
documentation by the study team for each subject available for final
analysis.
Patients or their closest relatives provided written informed consent for
data storage of the patient's medical records in accordance with national
regulations and laws on data handling and safety.
The present investigation is confined to the contributions made by
physicians to the medical charts. Both conventional and electronic
documentation were performed by the same team of surgeons. Data collection was
carried out seven days a week. It commenced with a complete medical history
and physical examination on admission and ended with the last visit shortly
before discharge.
During the study period, one male registrar, one male senior house officer,
two female house officers, and two male medical students were involved in the
documentation process. The median age of the participants was 30.5 years
(range, twenty-eight to thirty-five years). All of them had been working at
the study hospital for at least six months, and they were familiar with
conventional documentation routines. Each member of the study team privately
owned a personal computer and used the Internet at least once a week.
All contributors received a one-day training session with the handheld
computer. This lecture was held by one of the software codevelopers, who
introduced the participants to basic program structures, facilitation of
handling, and the different modes of data entry. Each participant completed
three electronic documentation procedures at the study ward prior to patient
recruitment.
Randomization
A balanced, concealed, central allocation method was performed at the
Department of Medical Controlling, which received a list of the patients
planned for admission to the ward on a day-to-day basis by the senior nurse on
duty. Patients were randomized to a group by drawing random codes from sealed
envelopes. The ward staff was informed about the designated documentation
procedure by telephone. Documentation was exclusively according to the
designated method throughout the study.
Conventional Documentation
On admission, the patient's history and physical findings were documented
on standard paper forms that are regularly used in the department. These forms
include spaces for free-text records, as well as a selection of frequent
physical findings (e.g., cardiac murmurs or abdominal tenderness) that can be
marked. During daily rounds, handwritten documentation was carried out with
use of the standard hospital charts that consist of foldable sheets (Optiplan,
Stuttgart, Germany) and allow for continuous recording of physiological data,
global health status, instructions, and interventions. Clinical findings were
translated into ICD-10 diagnoses with use of the coding tool ID DIACOS (ID,
Berlin, Germany) which has been an established and integrated part of the
hospital documentation and information system since 1997 and were finally
entered into the hospital database by the responsible surgeon.
Handheld Computer Documentation
Meditrace (Knowledge Intelligence, Cologne, Germany) is a C++ software
application that offers structured decision trees. The software runs on a
mobile Psion 5mx Pro computer (Psion Teklogix, Mississauga, Ontario, Canada)
with a tactile touch screen, which was used for the experimental documentation
procedure. The device weighs 300 g with dimensions of 17 × 9 × 3
cm (Fig. 1).
All entries can be made either by clicking the selection menu or by
free-text input. For study purposes, the program was tailored to local needs
and therefore employed the ICD-10. Coding catalogs such as the ICD-9-CM can be
embedded instead.
In this study, we did not specifically investigate formal coding of
procedures. The experimental software employed the OPS-301 2.1
catalog4, which
basically represents the German equivalent of the Current Procedural
Terminology (CPT) coding
system5,6.
The software offers a pattern of items that are related to clinical signs or
symptoms from which the clinically reasonable diagnoses can be selected. For
example, the physical finding "effusion" after total knee
replacement yields "effusion, joint, knee" (M25.4 for ICD-10 and
719.06 for ICD-9-CM) and "complication due to presence of joint
prosthesis" (T84.5 for ICD-10 and 996.77 for ICD-9-CM).
At the end of a working day, data entered into the mobile computer were
transferred to a desktop unit installed on the study ward. Within a single
step, daily documentation with the handheld device produced (1) a cumulative
patient history that, as a printout, replaced handwritten notes in the medical
record and (2) the ICD codes related to complaints and physical findings.
Outcome Measures
The primary outcome was the number of documented ICD diagnoses entered,
which, after a thorough cross-check of patient charts, reflected the true
conditions and diseases that were likely to influence the patient's
course.
A high level of redundant diagnoses was anticipated with the handheld
device (e.g., metabolic syndrome in patients with hypertension and diabetes),
and we conducted analyses on crude as well as on controller-corrected data. In
this study, we did not specifically investigate the ratio of diagnoses entered
by means of the selection menu and the free-text option.
As the reference standard for secondary end-point analysis, all patient
records obtained during the study period were cross-checked for coding quality
by the registrar, the senior house officer, and the surgical quality assurance
manager (who is a surgeon with formal training in quality assurance, coding
regulations, reimbursement practices, medical information technology, and
related scopes).
Decisions were made in accordance with the open-label design of the study
and by consensus. All ratings were made on continuous scales that ranged from
1, which denoted "excellent," to 5, which equated with "poor
documentation quality." In the expert ratings, three levels of
documentation quality were considered: (1) Does the medical chart contain
regular entries on the physical findings and symptoms gained from examination
on admission, morning rounds, and/or other daily visits? (2) Are these entries
described superficially or in detail? (3) Does the documentation reflect the
true clinical status and course of the particular patient, and how many of the
clinical findings have been correctly translated into ICD diagnoses?
Study physicians appraised the integration of the designated documentation
procedure into daily care, time consumption, and handling, with use of a
5-point ordinal scale (with 1 denoting "very practical in the clinical
situation" and 5 denoting "not practical at all").
Sample Size Considerations
During the planning of this study, the average number of diagnoses per
subject recorded with the conventional method was determined by reviewing the
charts of all thirty-nine consecutive patients who had been admitted to the
study ward within a one-month period. The patients had a mean (and standard
deviation) of 3.3 ± 1.8 documented diagnoses. With thirty-six patients
per study arm, this investigation yielded an 80% power to detect a difference
of 1.2 (or a 40% change) in the number of documented diagnoses at the
two-sided significance level of 5%. The sample size ensured the detection of a
mean difference (and standard deviation) of 1.0 ± 1.5 on the continuous
rating scale with similar type-I and II errors.
Statistical Methods
All analyses were performed with the Stata 8.0 statistical package (Stata,
College Station, Texas).
Binary data were evaluated with the chi-square test or the Fisher exact
test, where appropriate. Ninety-five percent confidence limits of the
differences between proportions were calculated according to the
Newcombe-Wilson hybrid-score
method7,8.
Discrete variables (i.e., the number of diagnoses) are presented as medians
with interquartile ranges. Bootstrapping routines with 1000 repetitions were
used to calculate 95% confidence intervals around the means (continuous
scales). Both measures were compared with the nonparametric Mann-Whitney U
test. Ordinal ratings were compared with the Cochran-Armitage test for
trend.
Learning curves with the experimental instrument were defined as the time
spent for data management with increasing numbers of documentation procedures.
Obtaining a history and performing a physical examination on admission
normally requires more time than subsequent documentation steps during the
hospital stay. To account for correlated data (i.e., the assessment of a
patient's physical status at multiple time-points), learning curves were
assessed by generalized estimating equations regression models.
Study Population
Eighty patients were referred to the study ward, were screened and
considered eligible to participate in the trial, and were randomized to one of
the two documentation arms. One patient who had been allocated to the
experimental arm was transferred to another ward because of a bed shortage.
Another patient in the control arm was admitted to the intensive-care unit for
uncontrollable postoperative hypertension after elective total hip
arthroplasty. The remaining seventy-eight patients (97.5%) formed the
population available for primary end-point analysis. One additional patient in
the conventional group could not be evaluated for secondary end points because
of a missing case report form.
A total of forty-seven men and thirty-one women with a mean age of 48.2
years (95% confidence interval, 44.2 to 51.5 years) participated in the study.
Fifty patients were admitted for surgery, whereas twenty-eight patients
received functional treatment of fractures, pain, or other musculoskeletal
disorders. The mean duration of hospitalization was twelve days (95%
confidence interval, ten to fourteen days).
No differences between the handheld computer group and the conventional
documentation group were found with respect to age (mean and standard
deviation, 49.5 ± 17.0 years compared with 46.8 ± 17.9 years,
respectively), American Society of
Anesthesiologists9
risk score (mean, 1.6 ± 0.5 compared with 1.6 ± 0.6), and length
of stay (mean, 11.6 ± 8.0 days compared with 12.5 ± 9.7 days).
There were slightly more men in the conventional documentation group
(twenty-six) than in the handheld computer group (twenty-one). Slightly more
patients undergoing surgery were randomized to the handheld computer group arm
(twenty-seven) than to the conventional documentation group
(twenty-three).
The major reason for hospital admission was surgery on an upper or lower
extremity. The diagnoses and procedures are summarized in the Appendix. There
were five total knee and two primary total hip replacements.
Primary End Point
A total of 411 diagnoses were collected in the experimental group compared
with 157 diagnoses in the control arm. Significantly more diagnoses per
patient were produced with documentation with use of the handheld device
(median, nine; interquartile range, six to fourteen) than with use of paper
charts (median, four; interquartile range, three to five) (p < 0.0001).
Seven ICD codes (4.5%) obtained by conventional documentation were judged
to be either false or redundant (i.e., different ICD codes were documented for
virtually the same diagnosis) compared with forty-eight (11.7%) in the
experimental arm (risk difference, 7.2%; 95% confidence interval, 2.0% to
11.4%). After correction for these quasi false-positives, the difference
between coded diagnoses remained significant in favor of the handheld device
(p < 0.0001) (Fig. 2).
During the study period, no diagnoses were subsequently denied by payers of
health-care services.
Secondary End Points
The ratings on all three investigated aspects of documentation quality were
better for the electronic device than for conventional documentation
(Table I).
The participating physicians found the handheld computer to be more
practical than conventional documentation; however, this trend did not reach
significance (Table II).
A significant decrease in the time required for handheld computer
documentation was observed during the study period (beta, —0.54; p <
0.0001). After stratification for individual operators, similarly flat slopes
were observed for three of the four participants, whereas another demonstrated
a considerable learning curve (Fig.
3). The learning effect was still detectable when the latter
outlier was excluded from regression analysis (beta, —0.07; 95%
confidence interval, —0.11 to —0.03) (p < 0.0001).
Diagnoses and procedures in medicine must be specified to relate care to
outcomes. However, the time needed for high-quality documentation stands in
overwhelming contrast to the time available to the busy
physician10,11.
Little attention has been paid to the form in which medical data are
recorded12,13.
This is in strong contrast to the expanding role projected for hospital
charts, which go far beyond their basic function of storing patient data for
retrieval by professionals who are directly involved in patient
care14. There are,
however, the conflicting information priorities of insurance carriers,
health-care policy makers, economists, and caregivers. Accurate estimates of
cost-effectiveness require data formats that are different from those of
patient-centered outcomes.
Under these premises, and the growing pressures for managed care,
computer-based patient record-keeping systems were conceptualized as
instruments that could meet both clinical and administrative needs.
New-generation handheld computers, as well as personal digital assistants,
unceremoniously meet key components of future data record systems as
identified by the study committee of the Institute of
Medicine14.
Patients present with problems, not
diagnoses15. This
underlines the need for instruments that can compile and translate clinical
findings into items suitable for hospital
databases16-19.
In this study, the introduction of a handheld computer into the daily routine
of a busy orthopaedic ward increased the number of diagnoses recorded and
improved the overall quality of the patient records. Whereas the difference in
the number of diagnoses was slightly offset by the accompanying load of
redundant (or quasi false-positive) items, it remained significant in favor of
the experimental handheld documentation system.
The present investigation must be regarded as preliminary, and various
aspects of the setting, design, and attempted sample size further limit
generalization of our findings. We admit that several aspects of the study
population and the depicted work flow do not fit the realities of orthopaedic
surgery in other countries such as the United States. We assume that this will
affect the external, rather than the internal, validity of our results.
With this preliminary study, we hope to provide a conceptual framework and
prior probability of efficacy that may help to generate hypotheses and to
stimulate future research. Both the experimental hardware and software merely
represent individual members of a growing family of mobile tools increasingly
used by clinical practitioners for a variety of
reasons20,21.
The problem that we had to deal with is that handheld computers have rarely
been evaluated in a controlled setting with regard to their impact on daily
work flow. We sought to clarify whether they have the potential to produce
measurable changes in one of the many tasks tackled by orthopaedic surgeons in
daily practice.
One might argue with the chosen primary end point of the number of
documented diagnoses. We considered the overall number of diagnoses collected
during in-hospital treatment as at least an available and reproducible index
to determine the influence of the electronic device on the completeness and
structure of the medical history and clinical examination, i.e.,
physician-centered outcomes.
Handheld computers principally share the characteristics of a diagnostic
test and a therapeutic intervention. From a methodological point of view,
reliable accuracy estimates are best obtained in a prospective cohort study in
which patients independently undergo both the index test and the reference
standard. In the present scenario, this would have required the documentation
of each patient twice (on the computer and in the handwritten record), which
also means dual medical histories and physical examinations performed by
independent investigators. Daily dual documentation for study purposes (in
addition to the regular tasks to be accomplished by the participating
surgeons) was considered cumbersome and time-consuming, and it might have led
to a lower degree of protocol acceptance. In an analogy to quality-of-life
research, the reliability of dual interviews is susceptible to
attrition22.
Patients may also refuse a second examination of a painful wound or joint.
Bird et al. equipped first-year emergency medicine residents with a
personal digital assistant and retrospectively compared their documented
number of procedures with that of a cohort of previous
trainees23. They
found a substantial difference in favor of the personal digital assistant, but
they raised the question of whether this was due to more fastidious
documentation or simply to a greater number of procedures performed by the
study group.
A similar source of bias in the present trial is unlikely in the light of
the randomized format that was chosen. Charts of rather healthy patients with
an uncomplicated course probably contain fewer daily remarks and notes than do
those of subjects who present with a broad range of underlying diseases and,
for example, postoperative wound infections.
Comorbidity and complications assessed by surgeons using competing
modalities represented the outcomes of this trial, and they were, therefore,
not available as indicators of proper randomization.
By chance, more patients in the handheld computer arm underwent surgery,
for a difference of 10%. We do not believe that the large effect observed with
the experimental device was induced by this imbalance, especially since the
remaining items were evenly distributed. However, the actual sample size is
still too small to definitely exclude a type-II error.
We admit that randomization generates two or more populations of patients
who might resemble each other in their main demographic criteria but could
nevertheless show very different patterns of known and unknown biological risk
factors. Basically, small randomized trials are more likely to be affected by
persisting imbalances than are large ones.
As a clear disadvantage of the chosen design, we had to trust in the
statistical principle of randomization, without having the opportunity to
prove its success. However, the concept works generally well if concealment of
random codes is maintained and drop-out rates remain in an acceptable range.
We concluded that the chosen format was the second-best option from a
methodological point of view, but it was the best way to obtain relatively
unbiased estimates in a realistic setting.
We must emphasize that we do not believe in a strategy in which "more
diagnoses are better." The present work was conducted in a
diagnosis-related-group environment, in which the severity of the illness
correlates with the charges. We did not intend to perform a formal
cost-utility analysis, and further trials are needed to demonstrate possible
advantages of the handheld device in securing reimbursement.
Although desirable from the perspective of the hospital administration in
this particular setting, quantity does not necessarily provide a reliable
proxy for the quality of patient charts. Expert ratings were considered a more
sensible approach to this issue, since a detailed characterization of the
severity of the illness in an individual patient and the reasons given for
certain interventions still have to be carried out at bedside by the
responsible physician.
Blinding is an important factor when comparing the efficacy of two
interventions in a controlled clinical trial, and the open-label design used
for secondary end-point analysis remains an important concern.
As expected, very different outputs were produced by conventional
documentation and by documentation with use of a handheld computer. When
patient histories of otherwise comparable quantity and quality were compared,
the improved readability of the charts produced with the handheld computer
could have influenced the expert ratings. Sufficient masking of records would
have required the transcription of all daily chart notes to an indifferent
format.
We believe that the enhanced readability and clarity of the daily entries
are major advantages of electronic documentation over handwritten notes, which
independently contribute to the quality of a hospital chart. Differences
between both modalities might become particularly noticeable if physicians who
are not involved in the regular treatment of a certain patient must obtain a
rapid overview of the clinical progress and the most recent physical status of
the patient.
An unexpected observation was that the improvement of patient charts in the
handheld computer arm was accompanied by only slightly better practicality
ratings assigned by the coding physicians. This is in contrast to the findings
of Dillon et al., who investigated the perceived ease of use, perceived
usefulness, and attitude of the nursing staff with regard to bedside computer
technology24. These
differences underscore the fact that the level of comfort attainable with new
medical information technology strongly correlates with the varying
backgrounds and the scope of the duties of those who use the electronic
devices.
Although they have not been specifically investigated up to now in a
clinical trial, age and professional experience appear to be important
confounding variables to the acceptance of the use of a mobile computer in
daily practice. Consequently, Butler and Bender recommended documentation of
the changes in the mix of new staff members to old staff members during future
studies of bedside data management
systems25.
All surgeons who participated in our trial were between twenty-eight and
thirty-five years of age, were familiar with the use of personal computers and
the Internet, and received similar one-day training sessions. Thus, we
anticipated much higher convenience with the experimental device. As an
unexpected finding, comparable ratings for time consumption for daily
documentation were assigned to both modalities.
This issue might be related either to difficulties in computer handling
(which would require technical modifications), hidden resentments against the
electronic tool, or high skills gained in conventional documentation. In our
study, the best ratings for practicality were assigned to the handheld
computer by the participant who demonstrated the largest learning effects.
Again, the actual sample size prohibits more sophisticated analysis of this
topic.
For logistical reasons, it was impossible to randomize physicians instead
of patients to both study arms since the presence of the staff depended on
operation schedules and other responsibilities (e.g., consulting hours and
emergency duties). The study team represented the typical personnel of the
hospital's trauma wards, whereas patients were sampled consecutively from the
study base. It is therefore unclear what kind of design causes more bias: the
partial availability of doctors assigned to a certain documentation procedure
(which would have led to nonconsecutive patient sampling) or the assignment of
both procedures to the same physician team. An argument in support of the
chosen allocation format is the observed study (or Hawthorne) effect in the
conventional arm, i.e., the increase in documented diagnoses and the more
detailed handwritten notes among traditional paper charts compared with those
seen in the review performed in the earlier time-period to assess sample-size
calculations.
In conclusion, the preliminary findings of this randomized study suggest
that handheld computers are effective in facilitating and improving selected
tasks in orthopaedic surgery. Although it is plausible that the elimination of
redundant paperwork releases considerable resources of physician time,
hospital administrators will demand reliable cost-effectiveness data before
agreeing to a wide implementation of these seemingly comfortable but expensive
tools.
Further research is warranted to (1) design appropriate trial formats; (2)
define relevant outcomes from the point of view of the surgeon, the patient,
and the health-care economist; and (3) gain confidence in the efficacy
estimates with this innovative technique. Handheld computers show potential
not only as centerpieces of the computerized patient record but also as
multitasking platforms in daily clinical routine.
A table showing the reasons for hospital admission for all study patients
is available with the electronic versions of this article, on our web site at
(go to the article citation and click on "Supplementary Material")
and on our quarterly CD-ROM (call our subscription department, at
781-449-9780, to order the CD-ROM).
Note: The authors thank Ulrike Götsch, MD, Katrin Schikora,
MD, Sebastian Hentsch, MD, and Peter Heumann, MD, for their assistance in data
collection and technical support. We are indebted to Barbara Herzberger, MD,
for editorial assistance.
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