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Abstract

Paper diaries are commonly used in health care and clinical research to assess patient experiences. There is concern that patients do not comply with diary protocols, possibly invalidating the benefit of diary data. Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features. Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries. Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days. Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries (defined by comparing the written times and the electronically-recorded times of diary use). Actual compliance was recorded by the electronic diary. Participants submitted diary cards corresponding to 90% of assigned times (+/-15 min). However, electronic records indicated that actual compliance was only 11%, indicating a high level of faked compliance. On 32% of all study days the paper diary binder was not opened, yet reported compliance for these days exceeded 90%. For the electronic diary, the actual compliance rate was 94%. In summary, participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features. The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information.
Information in practice
Patient non-compliance with paper diaries
Arthur A Stone, Saul Shiffman, Joseph E Schwartz, Joan E Broderick, Michael R Hufford
Doctors often ask patients to recall recent health expe-
riences, such as pain, fatigue, and quality of life.1
Research has shown, however, that recall is unreliable
and rife with inaccuracies and biases.2Recognition of
recall’s shortcomings has led to the use of diaries,
which are intended to capture experiences close to the
time of occurrence, thus limiting recall bias and
producing more accurate data.3
The rationale for using diaries would be under-
mined if patients failed to complete diaries according
to protocol. In this study we used a newly developed
paper diary that could objectively record when patients
made diary entries in order to compare patients’
reported and actual compliance with diary keeping.
For comparison, we also used an electronic diary
designed to enhance compliance in order to assess
what compliance rates might be achieved.
Methods and results
We recruited 80 adults with chronic pain (pain for >3
hours a day and rated >4 on a 10 point scale) and
assigned 40 to keeping a paper diary and 40 to an
electronic diary. On satisfying the eligibility criteria,
each patient was assigned to the next training session
for which he or she was available, regardless of which
diary it was for. We conducted one training session for
each diary each week, with each training session for the
paper diary matched by time and day of the week with
an electronic diary training session. Participants were
paid $150 and gave their informed consent; patients
given the paper diary were not told that compliance
would be recorded electronically.
The paper diary comprised diary cards bound into
a DayRunner Organizer binder. The cards contained
20 questions drawn from several common pain instru-
ments and included fields to record time and date of
completion. The diary binders were unobtrusively
fitted with photosensors that detected light and
recorded when the binder was opened and closed;
these were extensively tested and validated. The
electronic diary was a Palm computer with software for
data collection in clinical trials and presented identical
pain questions via a touch screen and recorded time
and date of entries. This system (invivodata) incorpo-
rated several features to maximise compliance, includ-
ing auditory prompts, and has demonstrated good
compliance.4
Patients were instructed to complete daily entries at
10 am, 4 pm, and 8 pm within 15 minutes of the target
times. With the electronic diary, entries could not be
initiated outside the designated 30 minute windows.
We considered paper diary entries to be compliant if
they were made within the 30 minute windows.A more
liberal secondary outcome allowed a 90 minute
window around the target times. Reported compliance
was based on the time and date that patients recorded
on their paper diary cards. Actual compliance was
based on the electronic record (from the record of
diary binder openings for paper diaries). Paper diary
entries were deemed compliant if the binder was
opened or closed at any point during the target time
window. We also assessed “hoarding” with the paper
diary, defined as days when the diary binder was not
opened but for which diary cards were completed.
After three days’ familiarisation, the participants
began 21 days of diary keeping with weekly feedback.
Participants completed an average of 20.5 days, and
the table shows compliance rates. With the paper diary,
reported compliance was 90%, but actual compliance
was 11% (20% with the wider 90 minute window). With
the electronic diary, actual compliance was 94%.
Hoarding was common with the paper diary: 32% of
days contained no diary openings, yet reported
compliance (30 minute window) for these days was
92%. Most of the 40 patients (75%) had at least one day
of hoarding.
Compliance rates for 80 patients’ record keeping in paper and
electronic diaries
Paper diary
(n=40)
Electronic diary
(n=40)
30 minute window
Total No of episodes* 2445 2435
No of excluded episodes 126 7
Mean per cent compliance (95% CI)†:
Actual‡ 11 (8 to 14) 94 (92 to 96)
Reported 90 (86 to 94)
90 minute window
Total No of episodes 2445
No of excluded episodes 134
Mean per cent compliance (95% CI)†:
Actual 20 (14 to 25)
Reported 95 (92 to 98)
*Participants using paper diaries should have completed 2445 diary entries within
the designated time windows. Of these, 114 were eliminated because the diary
was open for more than 45 minutes, and 12 were eliminated because laboratory
visits overlapped with time windows. Participants using electronic diaries should
have completed 2435 entries, but 7 overlapped with laboratory visits.
†Compliance statistics were calculated separately for each participant and then
averaged.
‡Compliance was significantly higher in the electronic diary group (t(73)=29.97,
P<0.0001).
Department of
Psychiatry and
Behavioral Science,
Stony Brook
University, Stony
Brook, NY,
11794-8790, USA
Arthur A Stone
professor and
vice-chair
Joseph E Schwartz
associate professor
Joan E Broderick
assistant professor
invivodata,
Pittsburgh, PA,
15203, USA
Saul Shiffman
chief science officer
Michael R Hufford
director of scientific
affairs
Correspondence to:
AAStone
arthur.stone@
sunysb.edu
BMJ 2002;324:1193–4
1193BMJ VOLUME 324 18 MAY 2002 bmj.com
Commentary
This study shows that concerns about compliance with
paper diaries are justified.5Although patients reported
high compliance, actual compliance was low and
hoarding was common. The excellent compliance
achieved with the electronic diary indicates that low
compliance was not due to this particular sample or to
an overly burdensome protocol. Overall, these results
call into question the validity of paper diary records.
We thank Jill Jackowsky, Dan Arnold, J Corey Harmon, Julie
Grassell, and Doyle Carney for help with completing this study.
We also thank Jackie Dunbar-Jacob, Jeffery Katz, Eva Krusinska,
Dennis Turk, and Michael Weintraub for their comments on an
early draft of the manuscript.
Contributors: Development of the original concept was by
all of the authors. JES analysed the data. The manuscript was
drafted by AAS and extensively modified by all the other
authors. AAS is guarantor for the study.
Funding: This study was supported by a grant from the
National Cancer Institute (CA-85819; Arthur A. Stone, principal
investigator) and by support in kind from invivodata.
Competing interests: AAS is vice-chair of the Scientific
Advisory Board of invivodata, SS is a founder of invivodata, and
MRH is director of scientific affairs at invivodata, which provides
electronic diary support for clinical trials.
1 Stone AA, Turkkan J, Jobe J, Bachrach C, Kurtzman H, Cain V. The science
of self report. Mahwah, NJ: Erlbaum, 2000.
2 Gorin AA, Stone AA. Recall biases and cognitive errors in retrospective
self-reports: A call for momentary assessments. In: Baum A, Revenson T,
Singer J, eds. Handbook of health psychology. Mahwah, NJ: Erlbaum,
2001:405-13.
3 Shiffman S, Hufford M, Paty J. Subject experience diaries in clinical
research. Part 1. The patient experience movement. Appl Clin Trials
2001;10:46-56.
4 Hufford MR, Shiffman S, Paty J, Stone AA.Ecolog ical momentary assess-
ment: Real world, real-time measurement of patient experience. In:
Fahrenberg J, Myrtek M, eds. Progress in ambulator y assessment.Seattle, WA:
Hogrefe and Huber, 2001:69-92.
5 Hyland ME, Kenyon CA, Allen R, Howarth P. Diary keeping in asthma:
comparison of written and electronic methods. BMJ 1993;306:487-9.
(Accepted 24 January 2002)
Improving the use of clinical databases
The need for high quality clinical databases has been
thoroughly documented.1–3 They offer the opportunity
to carry out evaluative research and clinical audit,
inform the planning and management of services, and
provide individual clinicians with accurate estimates of
the outcome of care that can be shared with prospective
patients.
Despite these potential benefits, clinical databases
have generally had few supporters and have attracted
considerable scepticism and criticism. Much of the
doubt about their value arises from a tendency to treat
them all alike. As with all forms of information or meth-
ods of inquiry, both good and bad examples exist.
In an attempt to promote both the quality of clinical
databases and their use, we have created a website
where visitors can find out what databases exist (initially
restricted to the United Kingdom) and be provided with
an independent assessment of their scope and quality.
To enable us to achieve the latter, a multidisciplinary
group developed and tested an assessment instrument
designed to achieve three objectives
to inform
potential users of a database’s scope (inclusion criteria,
geographical area and time period covered, and
mandatory and optional variables included), how it can
be accessed (contact details of custodian), and its meth-
odological strengths and weaknesses. All this infor-
mation is obtained by a trained interviewer to ensure an
independent assessment is obtained.
This Directory of Clinical Databases (DoCDat)
allows visitors to search for and identify databases that
may be suitable for their purpose, whether that be
evaluative research, clinical audit, supporting shared
decision making models, or strategic planning of
services. The website allows searches to be made on the
basis of one or more medical conditions, a healthcare
intervention, and a geographical area. The information
provided on the coverage and accuracy of the identified
databases enables an assessment to be made as to their
suitability.The need for such a service has recently been
recognised by the UK government.4
DoCDat provides only an overview of each clinical
database, albeit one based on an independent
assessment rather than on the views of the database
custodians. To delve deeper it is necessary for a
potential user to find out more from the database
custodian, whose contact details are provided in the
DoCDat entry. While adding more databases is the top
priority, it is also essential to update and maintain all the
entries. This is done by requesting information of
changes from database custodians as they are instituted
and by an annual inquiry initiated by DoCDat staff.
Enabling greater access and use of existing clinical
databases is the immediate aim of DoCDat, but another
aim is to improve their quality. Our experience suggests
that some database custodians have rather limited
knowledge and understanding of the methodological
issues relating to database quality. DoCDat aims to
advise, where appropriate, on how quality can be
improved. This can be facilitated by putting database
custodians in contact with one another to enable practi-
cal experiences to be shared.
The Directory of Clinical Databases (DoCDat) is available at
www.lshtm.ac.uk/docdat
Nick Black professor of health services research
Mary Payne research fellow
Department of Public Health and Policy, London School of
Hygiene and Tropical Medicine, London WC1E 7HT
Funding: Establishment of the website has been supported by
the Nuffield Trust and the Department of Health.
Competing interests: Both authors work on DoCDat and
wish to see it succeed.
1 Pryor DB, Califf RM, Harrell FE, Hlatky MA, Lee KL, Mark DB, et al.
Clinical databases. Accomplishments and unrealized potential. Med
Care 1985;23:623-47.
2 McGlynn EA, Damberg CL, Kerr EA, Brook RH. Health information
systems: design issues and analytic applications. Santa Monica: RAND
Health, 1998.
3 Black NA. High-quality clinical databases: breaking down barriers.
Lancet 1999;353:1205-6.
4 Department of Health. Learning from Bristol: The Department of Health’s
response to the report of the public inquiry into children’s heart surger y at the
Bristol Royal Infirmary 1984-1995. London: DoH, 2002
(www.doh.gov.uk/bristolinquiryresponse/).
BMJ 2002;324:1194
Information in practice
1194 BMJ VOLUME 324 18 MAY 2002 bmj.com
... outcomes (pPRO), [18,19] including administrative burden, secondary data entry errors, challenges translating responses into easily-accessible information, and incomplete data sets. [20][21][22][23][24] In the orthopaedic trauma patient population, the PRO capture rate is commonly low because of the limited number of clinic followups when the surveys are administered, and many patients are not able to return to all postoperative visits. [25,26] Because email and smart devices have become ubiquitous, electronic data collection for PROs becomes a possibility allowing PRO delivery even without clinic visits. ...
... Higher capture rates from ePROs have been reported in internal medicine and arthroplasty surgery when compared with traditional pPRO methods. [18,23,32] Similar to our institution, other health systems and hospitals have made the transition of PRO collection to electronic platforms such as patient smart device or websites. [20][21][22]24,27,32] Several studies have reported advantages of ePRO over traditional pPRO including real-time data availability, decreased response burden, increased satisfaction, and fewer missing data. ...
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Objective: To compare the capture rates and costs of paper patient-reported outcomes (pPRO) administered in-clinic and electronic PROs (ePRO) collected through emails and texts. Design: Retrospective review. Setting: Level 1 trauma center. Patients/Participants: The pPRO program enrolled 2164 patients for postsurgical follow-up in 4 fracture types: ankle, distal radius, proximal humerus, and implant removal from 2012 to 2017. The ePRO program enrolled 3096 patients in 13 fracture types from 2018 to 2020. Among the patients enrolled in the ePRO program, 1296 patients were matched to the 4 original fracture types and time points. Main Outcome Measures: PRO capture rates in 4 fracture types by matched time point and estimated cost of each program per enrolled patient. Results: At first follow-up, pPRO provided a higher capture rate than ePRO for 3 of 4 fracture types except for implant removal (P < 0.05). However, at 6-month and 1-year follow-ups, ePRO demonstrated statistically significant higher capture rates when compared with pPRO for all applicable modules (P < 0.05). The average cost for the pPRO program was $171 per patient versus $56 per patient in the ePRO program. Patients were 1.19 times more likely to complete ePRO compared with pPRO (P = 0.007) after controlling for age, sex, fracture type, and time point. Conclusion: The electronic PRO service has improved long-term capture rates compared with paper PROs, while minimizing cost. A combined program that includes both in-clinic and out of clinic effort may be the ideal model for collection of PROs. Level of Evidence: Level 3.
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Doctors often ask patients to recall recent health experiences, such as pain, fatigue, and quality of life.1 Research has shown, however, that recall is unreliable and rife with inaccuracies and biases.2 Recognition of recall's shortcomings has led to the use of diaries, which are intended to capture experiences close to the time of occurrence, thus limiting recall bias and producing more accurate data.3The rationale for using diaries would be undermined if patients failed to complete diaries according to protocol. In this study we used a newly developed paper diary that could objectively record when patients made diary entries in order to compare patients' reported and actual compliance with diary keeping. For comparison, we also used an electronic diary designed to enhance compliance in order to assess what compliance rates might be achieved. Methods and results We recruited 80 adults with chronic pain (pain for ≥3 hours a day and rated ≥4 on a 10 point scale) and assigned 40 to keeping a paper diary and 40 to an electronic diary. On satisfying the eligibility criteria, each patient was assigned to the next training session for which he or she was available, regardless of which diary it was for. We conducted one training session for each diary each week, with each training session for the paper diary matched by time and day of the week with an electronic diary training session. Participants were paid $150 and gave their informed consent; patients given the paper diary were not told that compliance would be recorded electronically. The paper diary comprised diary cards bound into a DayRunner Organizer binder. The cards contained 20 questions drawn from several common pain instruments and included fields to record time and date of completion. The diary binders were unobtrusively fitted with photosensors that detected light and recorded when the binder was opened and closed; these were extensively tested and validated. The electronic diary was a Palm computer with software for data collection in clinical trials and presented identical pain questions via a touch screen and recorded time and date of entries. This system (invivodata) incorporated several features to maximise compliance, including auditory prompts, and has demonstrated good compliance.4 Patients were instructed to complete daily entries at 10 am, 4 pm, and 8 pm within 15 minutes of the target times. With the electronic diary, entries could not be initiated outside the designated 30 minute windows. We considered paper diary entries to be compliant if they were made within the 30 minute windows. A more liberal secondary outcome allowed a 90 minute window around the target times. Reported compliance was based on the time and date that patients recorded on their paper diary cards. Actual compliance was based on the electronic record (from the record of diary binder openings for paper diaries). Paper diary entries were deemed compliant if the binder was opened or closed at any point during the target time window. We also assessed “hoarding” with the paper diary, defined as days when the diary binder was not opened but for which diary cards were completed. Compliance rates for 80 patients' record keeping in paper and electronic diaries
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