ORIGINAL ARTICLE
Which Factors Affect Daily Compliance With an Internet Headache Diary Among Youth With Migraine? Geoffrey L. Heyer, MD and Sean C. Rose, MD
Objective: To determine the specific factors that affect Internet headache diary compliance among youth with primary headaches. Materials and Methods: Patients aged 10 to 18 years completed a 90-day Internet-based headache diary with date-stamping and time-stamping features that allowed compliance monitoring. Eight potential predictors were assessed in a multilevel statistical model of headache diary compliance: age, sex, diary entries during the school year versus summer, entries on evenings preceding weekends (Friday or Saturday) versus evenings preceding weekdays (Sunday through Thursday), headache days versus nonheadache days, headache intensity ratings, use of an abortive headache medicine, and the first 2 weeks of diary use versus the latter 76 days. Results: Fifty-two patients generated 4680 diary entries; 3215 (68.7%) entries were compliant (completed via same-day diary entries). Compliance for each diary participant ranged from 39% to 97% (mean, 68.7%; median, 70%; SD = 0.15%). Three specific factors were associated with diary compliance in the multilevel model. Compliance was better on days when an abortive headache medicine was used (P < 0.001; odds ratio [OR], 33.7 [95% confidence interval [CI], 13.1-86.6]) and during the first 2 weeks of the diary period versus the remaining 76 days (P = 0.05; OR, 1.3 [95% CI, 1.03-1.68]). Compliance was worse on evenings proceeding weekends versus evenings preceding weekdays (P < 0.001; OR, 0.55 [95% CI, 0.46-0.66]). Patients who did not start the diary protocol (n = 12) or did not complete the 90 days (n = 14) were excluded from the analysis. Discussion: Specific factors predict Internet-based headache diary compliance. Further research about the factors related to diary compliance and the optimization of diary-based data collection is warranted. Key Words: migraine, pediatric, adolescent, diary, compliance, headache
(Clin J Pain 2015;31:1075–1079)
H
eadache diaries are used commonly in health care and clinical research as an accepted means of tracking headache characteristics and monitoring therapeutic effects. The International Headache Society guidelines for controlled trials of drugs in migraine recommend that some form of headache diary be used to evaluate drug trials
Received for publication July 25, 2014; revised January 22, 2015; accepted December 20, 2014. From the Departments of Pediatrics and Neurology, Nationwide Children’s Hospital, The Ohio State University, Columbus, OH. Supported by a Nationwide Children’s Hospital (Columbus, OH) Intramural Grant (Grant #278311: G.L.H.). The authors declare no conflict of interest. Reprints: Geoffrey L. Heyer, MD, Departments of Pediatrics and Neurology, Nationwide Children’s Hospital, The Ohio State University, 700 Children’s Drive, ED-5, Columbus, OH 43205 (e-mail: geoff[email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/AJP.0000000000000208
Clin J Pain
Volume 31, Number 12, December 2015
dealing with migraine prophylaxis.1 The headache diary should accurately capture migraine frequency over a minimum baseline period of 4 weeks and during at least 4 weeks of drug treatment. The International Headache Society did not recommend specific diary formats or address methods of evaluating diary accuracy. Recall errors can occur whenever a patient reports their experiences from a previous headache or pain episode.2,3 Several factors can affect recall accuracy: interference (diminishing recall accuracy of a single event in the setting of new events or increasing frequency of events), the length of time between the event and the recall attempt, the perceived salience of the event, and the respondent’s psychological state. Using a diary to collect daily patient experiences can help minimize recall bias, which is defined as the occurrence of systematic recall errors.4 For example, children aged 9 to 16 years greatly overestimated headache intensity and headache duration on a retrospective questionnaire when compared with a prospective headache diary.4 Despite the advantages of reducing recall bias, headache diaries have potential limitations, the most important being diary compliance. Adherence to a diary protocol cannot be verified without confirming the submission times of each diary entry. When using a simple paper and pencil diary without date-stamping and time-stamping, participants can complete diary entries after the designated time period (back-filling) or before the designated time period (forward-filling).5–7 Diary back-filling is subject to recall error as the length of time increases between the event and the recall attempt, whereas forward-filled entries represent mere guessing about future events. Stone et al6 demonstrated that patient-reported adherence to a diary protocol did not match their actual compliance. Using a paper diary that electronically tracked diary opening and closing, adult headache patients self-reported compliance with 90% of the assigned diary entries, but the electronic records suggested that actual compliance was only 11%.6 Thirty-two of 40 (75%) subjects had at least 1 day when the paper diary was not opened, but at least 1 entry was reported. Both backfilling and forward-filling of entries was observed. Selfreports of diary compliance are not reliable, and patient experiences are not accurately captured when diary compliance is poor. Headache diary applications with date-stamping and time-stamping allow investigators to monitor diary protocol compliance.5,6,8 Diary studies incorporating these features have demonstrated differing compliance rates related to differences in diary characteristics, study durations, and the strategies aimed at improving compliance.7,9–13 Shortterm diary participation over a period of only 1 week led to compliance rates of 98%10 and 74% (83.3% for an electronic diary and 46.7% for a paper diary),12 respectively. However, given the much longer recommended periods of diary capture for drug prophylaxis studies,1 headache diary www.clinicalpain.com |
Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
1075
Heyer and Rose
research that uses protocols of at least 8-week duration is necessary. Moloney et al11 assessed headache diary compliance among adult women over a 4-month period. With interval diary reminders, they found that only 68% of participants completed Z50% of their diary entries within 24 hours.11 The diary protocols that necessitate prolonged diary capture for migraine drug trials may suffer from poor compliance which can negatively impact study accuracy. Little is known about the factors that affect day-to-day headache diary compliance. The primary aim of this study was to use an Internet-based headache diary with date-stamping and time-stamping features to assess daily compliance and to identify the specific factors related to noncompliance among a cohort of youth with primary headaches. In this manuscript, we define diary compliance as completion of the diary entry during the corresponding 24-hour day. The term “compliance” is used as synonymous with “adherence.” Although diary compliance studies have been conducted in several populations with various medical diagnoses, this is the first longitudinal study exploring the specific factors related to daily diary compliance among pediatric migraine patients. We hypothesized that Z1 of the following factors could independently affect diary compliance: age, sex, time of year (school vs. summer), time of week (Friday or Saturday vs. weeknights), presence of a headache, headache intensity, use of an abortive headache medicine, and diary duration. Internet-based diary applications can incorporate a variety of features such as alarms and automated reminders that could bolster diary compliance. A better understanding of the factors that affect daily diary compliance from this study will help to inform the development of future Internet diary applications that can incorporate these diary features and further enhance diarybased data collection.
MATERIALS AND METHODS We conducted a longitudinal study of 52 patients, 10 to 18 years of age, with migraine, or probable migraine. Each patient completed a 90-day Internet-based headache diary. On headache days, they answered up to 11 diary questions (each with a drop-down menu for answer options) that addressed headache intensity (rated 1 to 10), headache disability, and whether abortive and prophylactic medicines were taken. On nonheadache days, they confirmed that there was no headache that day and answered whether a prophylactic headache medicine was taken. In addition, a 400-character comment section was available with each entry. A headache entry could take from 2 to 10 minutes to enter, depending on the length of the freehand description. Several study features have been described previously.14 We recruited patients who were referred to our neurology-based clinic for headache management. Recruitment took place on the initial day of consultation. All patients had episodic migraine (with or without aura) or probable migraine based on International Headache Society criteria (ICHD-II).15 Probable migraine was diagnosed when patients met all but 1 migraine criterion and did not fulfill criteria for any other headache syndrome. All facets of clinical headache management were determined by the respective neurology provider. Study participation did not alter headache care. Patients with >15 headaches monthly and those with probable medication overuse headache were excluded. Migraine patients who also had episodic tension-type headaches were
Clin J Pain
Volume 31, Number 12, December 2015
not excluded provided that their migraines occurred Z1 day per month and the frequency of all combined headaches remained r15 days per month. The sample size (goal of n = 50) was chosen for this exploratory study to include adequate variations in patient age, headache frequency, and migraine severity. We encouraged parents to remind their children to log on to the diary Web site each evening, but to let their child complete each diary entry. Patients were encouraged to complete their diary entries in the evening before going to bed so that each entry would encompass the full waking day. Entries received during the corresponding 24-hour day were deemed compliant; all entries submitted beyond 24 hours were deemed noncompliant. Study investigators had an administrative log-in feature that allowed daily monitoring of diary compliance. A reminder e-mail was sent to both parent and patient within 24 hours of missed entries. If 5 consecutive entries were missed the family was contacted by telephone. Entries could not be submitted directly through the diary after midnight for the given calendar day. Patients were able to complete a missed diary entry by responding to the email or telephone reminder or by using the comment section of the next diary entry. Except in cases of planned family holiday or brief loss of Internet, patients missing >7 consecutive diary entries were removed from the study. Those patients removed from the study either never started participating with the diary or stopped participating and did not respond to e-mail or telephone reminders. Unfortunately, it is not possible to identify the factors that led to nonparticipation using our study design. The study was approved by the Institutional Review Board at Nationwide Children’s Hospital. Written informed consent (parents and patients 18 y of age) and assent (patients less than 18 y) were obtained in all cases.
Statistics Descriptive statistics were calculated. Compliance was characterized overall, by patient, for different stages of diary progression (first week, first 2 wk, first 3 wk, etc.), and for each of the categorical factors studied. Statistical analysis using multilevel modeling was then performed to address the hierarchical data structure where repeated measures (diary entries; level 1) are nested within subjects (headache patients; level 2) and are not necessarily independent. The multilevel model assessed the dichotomous outcome of diary compliance using the binary logistic regression link function. An initial model without predictor variables showed that the intercept variance differed between diary participants (z = 4.41; P < 0.001), justifying the use of a multilevel analysis. Eight predictors were added en bloc: age, sex, school versus summer, evenings preceding weekends (Friday or Saturday) versus evenings preceding weekdays (Sunday through Thursday), headache day versus nonheadache day, headache intensity rating, use of an abortive headache medicine, and the first 2 weeks of diary use versus the latter 76 days. All predictors were determined a priori except the comparison of compliance over time. We chose to compare compliance from the first 2 weeks versus the remainder of the diary period because compliance peaked at 2 weeks. The first week versus the latter 83 days and the first 3 weeks versus the latter 69 days were not significantly different when analyzed in the model. All interaction terms were analyzed in the multilevel model, but none were found to be significant. Log odds coefficients
1076 | www.clinicalpain.com Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved. Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
Clin J Pain
Volume 31, Number 12, December 2015
Daily Compliance With an Internet Headache Diary
were exponentiated to produce odds ratios and 95% confidence intervals. All statistical analyses were performed using SPSS Version 21 (SPSS Inc., Chicago, IL). The significance threshold was set at 5%.
RESULTS Fifty-two subjects completed 90 consecutive diary entries for a total of 4680 diary days. Seventy-eight patients were initially recruited: 12 never began and 14 were removed during the study period (10 for missing Z7 consecutive entries, 3 for daily headaches, and 1 for long-term loss of home internet access). All 10 patients who missed Z7 days did so during the first 3 weeks of study, completing only 83 (9.2%) of the potential 900 diary entries. There were no statistical differences between the 52 study completers and the 26 noncompleters in terms of age, sex, migraine versus probable migraine, or initial patientreported headache frequencies (data not shown). Diary entries for all of the expected 4680 patient-diary days were completed; 3215 (68.7%) were compliant (completed via same-day diary entries). The remaining 1465 (31.3%) missed days were completed through the diary comment section of subsequent entries and through responses to email or telephone reminders.14 Adding back the 12 patients who did not start the diary and the 10 patients who were removed for Z7 days noncompliance, overall compliance was 3298 (49.5%) of 6660 potential diary entries. The mean participant age was 14.1 years; 38 (73%) were female. Migraine diagnoses comprised 8 (15.4%) migraine with aura, 30 (57.7%) migraine without aura, and 14 (26.9%) probable migraine. Probable migraine designations were related to brief headache duration or a total headache number 7 consecutive days without a diary entry and without a response to e-mail or telephone reminders). Overall diary compliance dropped from 68.7% to 49.5% when those patients who did not start or did not complete the diary protocol were included in the compliance calculation. Unfortunately, our study design focused on factors that affect daily diary compliance, so we required some degree of consistent compliance over the 90-day period. The factors that led to nonparticipation among these individuals were not studied. We did not study parental reminders as a factor related to their child’s diary compliance. It is possible that parents’ compliance in reminding their child to participate played a role in daily patient compliance. We used an Internet-based diary that has not been validated or compared with other diary applications. It is possible that other diary formats would have different overall compliance rates related to variations in diary features, the strategies used to improve compliance, diary duration, and the populations assessed. Finally, our study involved diary use without a study drug. It is possible that participants in headache medicine studies who are asked to use headache diaries may be more motivated to complete daily entries merely because of their drug-trial involvement.
CONCLUSIONS Specific factors predict headache diary compliance among youth with primary headaches. Compliance is better during the first 14 days of study and on days that an abortive headache medicine is taken. Compliance is worse on evenings preceding weekend days (Fridays and Saturdays) compared with evenings preceding weekdays (Sunday through Thursday). Studies that use diary applications to collect data should incorporate some form of date-stamping and time-stamping of entries to monitor compliance. We recommend further research addressing the specific factors that affect headache diary compliance. In addition, we recommend incorporating the factors derived from this study into experimental diary platforms and measuring compliance improvements. For example, do dedicated reminders on Friday and Saturday nights improve overall diary compliance? ACKNOWLEDGMENTS The authors would like to thank Aggie LeGros, RN, Department of Pediatrics, Nationwide Children’s Hospital, Columbus, OH for her coordination of this study and her numerous e-mail and telephone reminders to families. They
Copyright
r
Daily Compliance With an Internet Headache Diary
would also like to thank Drs John Mytinger, MD, Departments of Pediatrics and Neurology, Nationwide Children’s Hospital, Columbus, OH and Howard Jacobs, MD, Department of Pediatrics, Nationwide Children’s Hospital, Columbus, OH for their helpful recommendations regarding manuscript preparation.
REFERENCES 1. Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000;20:765–786. 2. Lippman A, Mackenzie SG. What is “recall bias” and does it exist? Prog Clin Biol Res. 1985;163C:205–209. 3. Raphael KG, Cloitre M. Does mood-congruence or causal search govern recall bias? A test of life event recall. J Clin Epidemiol. 1994;47:555–564. 4. van den Brink M, Bandell-Hoekstra EN, Abu-Saad HH. The occurrence of recall bias in pediatric headache: a comparison of questionnaire and diary data. Headache. 2001;41:11–20. 5. Broderick JE, Schwartz JE, Shiffman S, et al. Signaling does not adequately improve diary compliance. Ann Behav Med. 2003;26:139–148. 6. Stone AA, Shiffman S, Schwartz JE, et al. Patient compliance with paper and electronic diaries. Control Clin Trials. 2003;24: 182–199. 7. Lauritsen K, Degl’ IA, Hendel L, et al. Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture. Control Clin Trials. 2004;25:585–597. 8. Stinson JN, Huguet A, McGrath P, et al. A qualitative review of the psychometric properties and feasibility of electronic headache diaries for children and adults: where we are and where we need to go. Pain Res Manag. 2013;18:142–152. 9. Goldberg J, Wolf A, Silberstein S, et al. Evaluation of an electronic diary as a diagnostic tool to study headache and premenstrual symptoms in migraineurs. Headache. 2007;47: 384–396. 10. Lewandowski AS, Palermo TM, Kirchner HL, et al. Comparing diary and retrospective reports of pain and activity restriction in children and adolescents with chronic pain conditions. Clin J Pain. 2009;25:299–306. 11. Moloney MF, Aycock DM, Cotsonis GA, et al. An Internetbased migraine headache diary: issues in Internet-based research. Headache. 2009;49:673–686. 12. Palermo TM, Valenzuela D, Stork PP. A randomized trial of electronic versus paper pain diaries in children: impact on compliance, accuracy, and acceptability. Pain. 2004;107: 213–219. 13. Sorbi MJ, Mak SB, Houtveen JH, et al. Mobile web-based monitoring and coaching: feasibility in chronic migraine. J Med Internet Res. 2007;9:e38. 14. Heyer GL, Perkins SQ, Rose SC, et al. Comparing patient and parent recall of 90-day and 30-day migraine disability using elements of the PedMIDAS and an Internet headache diary. Cephalalgia. 2014;34:298–306. 15. Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 (suppl 1): 9–160.
2015 Wolters Kluwer Health, Inc. All rights reserved.
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1079
Which Factors Affect Daily Compliance With an Internet Headache Diary Among Youth With Migraine? Geoffrey L. Heyer, MD and Sean C. Rose, MD
Objective: To determine the specific factors that affect Internet headache diary compliance among youth with primary headaches. Materials and Methods: Patients aged 10 to 18 years completed a 90-day Internet-based headache diary with date-stamping and time-stamping features that allowed compliance monitoring. Eight potential predictors were assessed in a multilevel statistical model of headache diary compliance: age, sex, diary entries during the school year versus summer, entries on evenings preceding weekends (Friday or Saturday) versus evenings preceding weekdays (Sunday through Thursday), headache days versus nonheadache days, headache intensity ratings, use of an abortive headache medicine, and the first 2 weeks of diary use versus the latter 76 days. Results: Fifty-two patients generated 4680 diary entries; 3215 (68.7%) entries were compliant (completed via same-day diary entries). Compliance for each diary participant ranged from 39% to 97% (mean, 68.7%; median, 70%; SD = 0.15%). Three specific factors were associated with diary compliance in the multilevel model. Compliance was better on days when an abortive headache medicine was used (P < 0.001; odds ratio [OR], 33.7 [95% confidence interval [CI], 13.1-86.6]) and during the first 2 weeks of the diary period versus the remaining 76 days (P = 0.05; OR, 1.3 [95% CI, 1.03-1.68]). Compliance was worse on evenings proceeding weekends versus evenings preceding weekdays (P < 0.001; OR, 0.55 [95% CI, 0.46-0.66]). Patients who did not start the diary protocol (n = 12) or did not complete the 90 days (n = 14) were excluded from the analysis. Discussion: Specific factors predict Internet-based headache diary compliance. Further research about the factors related to diary compliance and the optimization of diary-based data collection is warranted. Key Words: migraine, pediatric, adolescent, diary, compliance, headache
(Clin J Pain 2015;31:1075–1079)
H
eadache diaries are used commonly in health care and clinical research as an accepted means of tracking headache characteristics and monitoring therapeutic effects. The International Headache Society guidelines for controlled trials of drugs in migraine recommend that some form of headache diary be used to evaluate drug trials
Received for publication July 25, 2014; revised January 22, 2015; accepted December 20, 2014. From the Departments of Pediatrics and Neurology, Nationwide Children’s Hospital, The Ohio State University, Columbus, OH. Supported by a Nationwide Children’s Hospital (Columbus, OH) Intramural Grant (Grant #278311: G.L.H.). The authors declare no conflict of interest. Reprints: Geoffrey L. Heyer, MD, Departments of Pediatrics and Neurology, Nationwide Children’s Hospital, The Ohio State University, 700 Children’s Drive, ED-5, Columbus, OH 43205 (e-mail: geoff[email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/AJP.0000000000000208
Clin J Pain
Volume 31, Number 12, December 2015
dealing with migraine prophylaxis.1 The headache diary should accurately capture migraine frequency over a minimum baseline period of 4 weeks and during at least 4 weeks of drug treatment. The International Headache Society did not recommend specific diary formats or address methods of evaluating diary accuracy. Recall errors can occur whenever a patient reports their experiences from a previous headache or pain episode.2,3 Several factors can affect recall accuracy: interference (diminishing recall accuracy of a single event in the setting of new events or increasing frequency of events), the length of time between the event and the recall attempt, the perceived salience of the event, and the respondent’s psychological state. Using a diary to collect daily patient experiences can help minimize recall bias, which is defined as the occurrence of systematic recall errors.4 For example, children aged 9 to 16 years greatly overestimated headache intensity and headache duration on a retrospective questionnaire when compared with a prospective headache diary.4 Despite the advantages of reducing recall bias, headache diaries have potential limitations, the most important being diary compliance. Adherence to a diary protocol cannot be verified without confirming the submission times of each diary entry. When using a simple paper and pencil diary without date-stamping and time-stamping, participants can complete diary entries after the designated time period (back-filling) or before the designated time period (forward-filling).5–7 Diary back-filling is subject to recall error as the length of time increases between the event and the recall attempt, whereas forward-filled entries represent mere guessing about future events. Stone et al6 demonstrated that patient-reported adherence to a diary protocol did not match their actual compliance. Using a paper diary that electronically tracked diary opening and closing, adult headache patients self-reported compliance with 90% of the assigned diary entries, but the electronic records suggested that actual compliance was only 11%.6 Thirty-two of 40 (75%) subjects had at least 1 day when the paper diary was not opened, but at least 1 entry was reported. Both backfilling and forward-filling of entries was observed. Selfreports of diary compliance are not reliable, and patient experiences are not accurately captured when diary compliance is poor. Headache diary applications with date-stamping and time-stamping allow investigators to monitor diary protocol compliance.5,6,8 Diary studies incorporating these features have demonstrated differing compliance rates related to differences in diary characteristics, study durations, and the strategies aimed at improving compliance.7,9–13 Shortterm diary participation over a period of only 1 week led to compliance rates of 98%10 and 74% (83.3% for an electronic diary and 46.7% for a paper diary),12 respectively. However, given the much longer recommended periods of diary capture for drug prophylaxis studies,1 headache diary www.clinicalpain.com |
Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
1075
Heyer and Rose
research that uses protocols of at least 8-week duration is necessary. Moloney et al11 assessed headache diary compliance among adult women over a 4-month period. With interval diary reminders, they found that only 68% of participants completed Z50% of their diary entries within 24 hours.11 The diary protocols that necessitate prolonged diary capture for migraine drug trials may suffer from poor compliance which can negatively impact study accuracy. Little is known about the factors that affect day-to-day headache diary compliance. The primary aim of this study was to use an Internet-based headache diary with date-stamping and time-stamping features to assess daily compliance and to identify the specific factors related to noncompliance among a cohort of youth with primary headaches. In this manuscript, we define diary compliance as completion of the diary entry during the corresponding 24-hour day. The term “compliance” is used as synonymous with “adherence.” Although diary compliance studies have been conducted in several populations with various medical diagnoses, this is the first longitudinal study exploring the specific factors related to daily diary compliance among pediatric migraine patients. We hypothesized that Z1 of the following factors could independently affect diary compliance: age, sex, time of year (school vs. summer), time of week (Friday or Saturday vs. weeknights), presence of a headache, headache intensity, use of an abortive headache medicine, and diary duration. Internet-based diary applications can incorporate a variety of features such as alarms and automated reminders that could bolster diary compliance. A better understanding of the factors that affect daily diary compliance from this study will help to inform the development of future Internet diary applications that can incorporate these diary features and further enhance diarybased data collection.
MATERIALS AND METHODS We conducted a longitudinal study of 52 patients, 10 to 18 years of age, with migraine, or probable migraine. Each patient completed a 90-day Internet-based headache diary. On headache days, they answered up to 11 diary questions (each with a drop-down menu for answer options) that addressed headache intensity (rated 1 to 10), headache disability, and whether abortive and prophylactic medicines were taken. On nonheadache days, they confirmed that there was no headache that day and answered whether a prophylactic headache medicine was taken. In addition, a 400-character comment section was available with each entry. A headache entry could take from 2 to 10 minutes to enter, depending on the length of the freehand description. Several study features have been described previously.14 We recruited patients who were referred to our neurology-based clinic for headache management. Recruitment took place on the initial day of consultation. All patients had episodic migraine (with or without aura) or probable migraine based on International Headache Society criteria (ICHD-II).15 Probable migraine was diagnosed when patients met all but 1 migraine criterion and did not fulfill criteria for any other headache syndrome. All facets of clinical headache management were determined by the respective neurology provider. Study participation did not alter headache care. Patients with >15 headaches monthly and those with probable medication overuse headache were excluded. Migraine patients who also had episodic tension-type headaches were
Clin J Pain
Volume 31, Number 12, December 2015
not excluded provided that their migraines occurred Z1 day per month and the frequency of all combined headaches remained r15 days per month. The sample size (goal of n = 50) was chosen for this exploratory study to include adequate variations in patient age, headache frequency, and migraine severity. We encouraged parents to remind their children to log on to the diary Web site each evening, but to let their child complete each diary entry. Patients were encouraged to complete their diary entries in the evening before going to bed so that each entry would encompass the full waking day. Entries received during the corresponding 24-hour day were deemed compliant; all entries submitted beyond 24 hours were deemed noncompliant. Study investigators had an administrative log-in feature that allowed daily monitoring of diary compliance. A reminder e-mail was sent to both parent and patient within 24 hours of missed entries. If 5 consecutive entries were missed the family was contacted by telephone. Entries could not be submitted directly through the diary after midnight for the given calendar day. Patients were able to complete a missed diary entry by responding to the email or telephone reminder or by using the comment section of the next diary entry. Except in cases of planned family holiday or brief loss of Internet, patients missing >7 consecutive diary entries were removed from the study. Those patients removed from the study either never started participating with the diary or stopped participating and did not respond to e-mail or telephone reminders. Unfortunately, it is not possible to identify the factors that led to nonparticipation using our study design. The study was approved by the Institutional Review Board at Nationwide Children’s Hospital. Written informed consent (parents and patients 18 y of age) and assent (patients less than 18 y) were obtained in all cases.
Statistics Descriptive statistics were calculated. Compliance was characterized overall, by patient, for different stages of diary progression (first week, first 2 wk, first 3 wk, etc.), and for each of the categorical factors studied. Statistical analysis using multilevel modeling was then performed to address the hierarchical data structure where repeated measures (diary entries; level 1) are nested within subjects (headache patients; level 2) and are not necessarily independent. The multilevel model assessed the dichotomous outcome of diary compliance using the binary logistic regression link function. An initial model without predictor variables showed that the intercept variance differed between diary participants (z = 4.41; P < 0.001), justifying the use of a multilevel analysis. Eight predictors were added en bloc: age, sex, school versus summer, evenings preceding weekends (Friday or Saturday) versus evenings preceding weekdays (Sunday through Thursday), headache day versus nonheadache day, headache intensity rating, use of an abortive headache medicine, and the first 2 weeks of diary use versus the latter 76 days. All predictors were determined a priori except the comparison of compliance over time. We chose to compare compliance from the first 2 weeks versus the remainder of the diary period because compliance peaked at 2 weeks. The first week versus the latter 83 days and the first 3 weeks versus the latter 69 days were not significantly different when analyzed in the model. All interaction terms were analyzed in the multilevel model, but none were found to be significant. Log odds coefficients
1076 | www.clinicalpain.com Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved. Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
Clin J Pain
Volume 31, Number 12, December 2015
Daily Compliance With an Internet Headache Diary
were exponentiated to produce odds ratios and 95% confidence intervals. All statistical analyses were performed using SPSS Version 21 (SPSS Inc., Chicago, IL). The significance threshold was set at 5%.
RESULTS Fifty-two subjects completed 90 consecutive diary entries for a total of 4680 diary days. Seventy-eight patients were initially recruited: 12 never began and 14 were removed during the study period (10 for missing Z7 consecutive entries, 3 for daily headaches, and 1 for long-term loss of home internet access). All 10 patients who missed Z7 days did so during the first 3 weeks of study, completing only 83 (9.2%) of the potential 900 diary entries. There were no statistical differences between the 52 study completers and the 26 noncompleters in terms of age, sex, migraine versus probable migraine, or initial patientreported headache frequencies (data not shown). Diary entries for all of the expected 4680 patient-diary days were completed; 3215 (68.7%) were compliant (completed via same-day diary entries). The remaining 1465 (31.3%) missed days were completed through the diary comment section of subsequent entries and through responses to email or telephone reminders.14 Adding back the 12 patients who did not start the diary and the 10 patients who were removed for Z7 days noncompliance, overall compliance was 3298 (49.5%) of 6660 potential diary entries. The mean participant age was 14.1 years; 38 (73%) were female. Migraine diagnoses comprised 8 (15.4%) migraine with aura, 30 (57.7%) migraine without aura, and 14 (26.9%) probable migraine. Probable migraine designations were related to brief headache duration or a total headache number 7 consecutive days without a diary entry and without a response to e-mail or telephone reminders). Overall diary compliance dropped from 68.7% to 49.5% when those patients who did not start or did not complete the diary protocol were included in the compliance calculation. Unfortunately, our study design focused on factors that affect daily diary compliance, so we required some degree of consistent compliance over the 90-day period. The factors that led to nonparticipation among these individuals were not studied. We did not study parental reminders as a factor related to their child’s diary compliance. It is possible that parents’ compliance in reminding their child to participate played a role in daily patient compliance. We used an Internet-based diary that has not been validated or compared with other diary applications. It is possible that other diary formats would have different overall compliance rates related to variations in diary features, the strategies used to improve compliance, diary duration, and the populations assessed. Finally, our study involved diary use without a study drug. It is possible that participants in headache medicine studies who are asked to use headache diaries may be more motivated to complete daily entries merely because of their drug-trial involvement.
CONCLUSIONS Specific factors predict headache diary compliance among youth with primary headaches. Compliance is better during the first 14 days of study and on days that an abortive headache medicine is taken. Compliance is worse on evenings preceding weekend days (Fridays and Saturdays) compared with evenings preceding weekdays (Sunday through Thursday). Studies that use diary applications to collect data should incorporate some form of date-stamping and time-stamping of entries to monitor compliance. We recommend further research addressing the specific factors that affect headache diary compliance. In addition, we recommend incorporating the factors derived from this study into experimental diary platforms and measuring compliance improvements. For example, do dedicated reminders on Friday and Saturday nights improve overall diary compliance? ACKNOWLEDGMENTS The authors would like to thank Aggie LeGros, RN, Department of Pediatrics, Nationwide Children’s Hospital, Columbus, OH for her coordination of this study and her numerous e-mail and telephone reminders to families. They
Copyright
r
Daily Compliance With an Internet Headache Diary
would also like to thank Drs John Mytinger, MD, Departments of Pediatrics and Neurology, Nationwide Children’s Hospital, Columbus, OH and Howard Jacobs, MD, Department of Pediatrics, Nationwide Children’s Hospital, Columbus, OH for their helpful recommendations regarding manuscript preparation.
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