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Chronic pain affects approximately 30% of the general population, severely degrades quality of life (especially in older adults) and professional life (inability or reduction in the ability to work and loss of employment), and leads to billions in additional health care costs. Moreover, available painkillers are old, with limited efficacy and can cause significant adverse effects. Thus, there is a need for innovation in the management of chronic pain. Better characterization of patients could help to identify the predictors of successful treatments, and thus, guide physicians in the initial choice of treatment and in the follow-up of their patients. Nevertheless, current assessments of patients with chronic pain provide only fragmentary data on painful daily experiences. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs can address this issue.
We hypothesized that regular patient self-monitoring using an mHealth app would lead physicians to obtain deeper understanding and new insight into patients with chronic pain and that, for patients, regular self-monitoring using an mHealth app would play a positive therapeutic role and improve adherence to treatment. We aimed to evaluate the feasibility and acceptability of a new mHealth app called eDOL.
We conducted an observational study to assess the feasibility and acceptability of the eDOL tool. Patients completed several questionnaires using the tool over a period of 2 weeks and repeated assessments weekly over a period of 3 months. Physicians saw their patients at a follow-up visit that took place at least 3 months after the inclusion visit. A composite criterion of the acceptability and feasibility of the eDOL tool was calculated after the completion of study using satisfaction surveys from both patients and physicians.
Data from 105 patients (of 133 who were included) were analyzed. The rate of adherence was 61.9% (65/105) after 3 months. The median acceptability score was 7 (out of 10) for both patients and physicians. There was a high rate of completion of the baseline questionnaires and assessments (mean 89.3%), and a low rate of completion of the follow-up questionnaires and assessments (63.8% (67/105) and 61.9% (65/105) respectively). We were also able to characterize subgroups of patients and determine a profile of those who adhered to eDOL. We obtained 4 clusters that differ from each other in their biopsychosocial characteristics. Cluster 4 corresponds to patients with more disabling chronic pain (daily impact and comorbidities) and vice versa for cluster 1.
This work demonstrates that eDOL is highly feasible and acceptable for both patients with chronic pain and their physicians. It also shows that such a tool can integrate many parameters to ensure the detailed characterization of patients for future research works and pain management.
ClinicalTrial.gov NCT03931694; http://clinicaltrials.gov/ct2/show/NCT03931694
Chronic pain affects approximately 30% of the general population [
Various reasons are given for this, including the relevance of animal research [
We hypothesized that regular self-monitoring by patients using a digital app would generate in-depth knowledge and new insights for physicians, and would allow patients to be active in their own care and benefit from web-based counseling. Regular self-monitoring would not only contribute to better patient characterization and help in choosing the most appropriate treatment but may also improve adherence to treatment. Moreover, recent studies [
The study was approved by the
Data were collected and managed using the eDOL app, developed by Bepatient and hosted by Avenir Télématique. In accordance with the provisions relating to the confidentiality of information concerning, in particular, the people who took part in the research and the results obtained [
Answers to questionnaires and medical data were transmitted in spreadsheet format (Excel 2013, Microsoft Inc). All anonymized data were accessible to the biostatisticians (BP, SC, and AJD), the coordinator (ND), and the project manager (NK). Only the investigators could access their patients' personal data to identify them. A dashboard linking patients’ identities and study IDs was available only on the investigators' professional interface on the eDOL web platform. The final database, used for statistical analyses, included only study IDs to preserve anonymity.
To evaluate the feasibility and acceptability of the eDOL app for the characterization, real-life monitoring of patients with chronic pain from 12 pain clinics in France took place between February 8, 2019 and January 8, 2020. The study was offered to all physicians in the investigating centers.
Participation in the study was offered to patients with chronic pain who did not have cancer, who were owners and regular users of a smartphone, and who were followed up in a pain clinic. All adult (≥18 years old) patients able to read and understand French and provide consent to participate in the study were included (with a yes-or-no choice on the eDOL app). Participants were free to withdraw their consent at any time by informing the sponsor. Each patient had access to the information document (paper or electronic) detailing the purpose, content, and conduct of the study. If they agreed to participate, they were asked to download the eDOL app and complete the questionnaires using the eDOL app. The URL to access this app was sent by email from physicians to their patients. After downloading the app and creating their profile, patients could accept the general terms and conditions of use and confirm that they agree to the use of their medical data in this study.
Each patient had 1 initial study visit, during which, the physician introduced the study to the patient, checked their eligibility, explained the eDOL tool, and gave the patient a brief training document on how to use the eDOL smartphone app. Participants completed several questionnaires and assessments using the eDOL app over a period of 2 weeks (initial patient characterization) and then repeatedly over a period of 3 months and up to 6 months for patients who wished to continue using the app (weekly, quarterly, and half-yearly depending on the questionnaire). Physicians saw their patient at a follow-up visit that took place at least 3 months after the inclusion visit, with the possibility of continuing the follow-up for up to 6 months. The study was considered complete for patients who completed their questionnaires and assessments for at least 3 months and made a follow-up visit 3 to 6 months after the inclusion visit.
All data were collected using the eDOL digital health tool, which includes a smartphone app for patients that allows self-questionnaires and assessments to be completed for semiological monitoring (pain, anxiety, sleep quality), and a web interface for physicians, to allow them to graphically visualize the summary of data provided by their patients for clinical and therapeutic monitoring.
Patients completed questionnaires and weekly assessments (
For physicians, the eDOL internet platform included a simple and ergonomic dashboard which allowed the physician to find all of their patients included in the study, with the following tabs: (1) Management, in which all of the medical records completed by the physician could be found (history, pain diagnosis, initial characterization, next appointment, consultation sheets and treatment sheets); (2) Health Measures, which showed a graphic display of the real-life follow-up of all the weekly assessments; and (3) Questionnaires, which showed all the questionnaires completed by the patients (display of questionnaire scores and answers to all the questions). The eDOL platform enabled physicians to complete medical elements during consultation visits with various medical form (diagnosis, current treatments, examination results). The physicians could also activate new questionnaires to be filled in by their patients, either to complete the characterization (eg, specific questionnaires for pain diagnosis) or to evaluate other criteria (eg, evaluation of the Patients’ Global Impression of Change after the introduction of a new treatment [
eDOL features.
Feature | Included in | Assessment point or interval | Details |
Inclusion form | Investigator web platform | Initial visit | Last name, first name, email, ID number |
Initial visit | History (clinical, psychiatric, drug), clinical examination, medico-economic aspect (type of medical consultations), diagnosis of pain according to International Classification of Disease, 11th revision | ||
Personal information | Smartphone app | Initial visit | Sociodemographic (work, alcohol use, tobacco use) |
Initial visit | Pain characterization: frequency, duration, aggravating and alleviating factors | ||
Treatment forms | Investigator web platform | Updated at each consultation | Analgesics (name, dates, dosage, side effects); list of nonmedicinal techniques and other treatments (free text) |
Assessments | Smartphone app | Repeated weekly | 11-point numeric rating scale (0-10): sleep, morale, fatigue and energy, body comfort, anxiety, pain |
Self-questionnaires | Smartphone app | During the first 2 weeks | 5 sessions of questionnaires |
Not repeated | Fear-avoidance beliefsa, Injustice Experience Questionnaire, Maslach Burn-out Inventorya, Pain Beliefs and Perceptions Inventory, Evaluation of level of precariousness, Job Content Questionnairea, Life Orientation Test-Revised, Belief in a just world, Posttraumatic Stress Disorder Checklistb, Toronto Alexithymia Scale Big Five Inventory | ||
Every 3 months | Fibromyalgia Impact Questionnairec, Headache Impact Testc, irritable bowel severity scoring systemc, Prescription Opioid Misuse Indexb, Patients’ Global Impression of Changeb, Neuropathic Pain Scale Inventoryb, Rheumatoid Arthritis Impact of Diseaseb, Brief Pain Inventory, Medical Outcomes Study Sleep Scale | ||
Every 6 months | Tampa Scale of Kinesiophobia, Roland Morris Disability Questionnairec, Western Ontario and McMaster Universitiesc, Pain Catastrophizing Scale, EuroQol 5 dimensions 3 levels, Hospital Anxiety Depression Scale, Satisfaction With Life Scale, Subjective Cognitive Complaints | ||
Hetero-questionnaires | Investigator web platform | N/Ad | Diagnostic validation: Neuropathic pain 4 + NEUPSIG (neuropathy), Widespread pain index and Symptom severity scale and Fibromyalgia Rapid Screening Tool (fibromyalgia), ROME IV (irritable bowel syndrome) |
Updated at each consultation | Others: Opioid Risk Tool | ||
Consultation form | Investigator web platform | Updated at each consultation | clinical examination, medico-eco aspect, observance, benefit-risk ratio of treatments |
aWork-related questionnaires.
bOptional questionnaires.
cDisease-specific questionnaires
dN/A: not applicable.
The primary study endpoint reflected the acceptability of the eDOL app and the feasibility of its use and was assessed with a satisfaction survey (based on the Patient Satisfaction Questionnaire Short Form [
Secondary analyses to characterize participating patients, pain disorders, and related comorbidities, as well as clustering analysis of the participants to determine the profile determination of patients who adhered to the use of the app were undertaken to gain insight into the capabilities and added value of the tool for the characterization and the follow-up of patients with chronic pain.
A minimum of 100 patients were to be included and analyzed. Such a large number of patients is quite satisfactory in terms of descriptive analyses to study the feasibility of a multimodal eHealth tool. This number of patients is in line with that specified by Sundararaman et al [
We performed statistical analyses to determine if patients and physicians were satisfied with the tool and adhered to its use, and to identify interesting pain profiles of patients, and which profiles are most adherent (and for how long).
Patients were described according to epidemiological characteristics, clinical characteristics, and treatment characteristics. The key indicators for acceptability (patient and physician) were questionnaire completion and completion of follow-up medical forms. We determined the association between adherence and all baseline variables. A patient was defined as adherent if 100% of baseline questionnaires and 75% of assessments after 3 months follow-up were completed.
Continuous variables and scale variables (treated as ordinal data) were presented as mean and standard deviation (for normal distributions), or median and quartiles (for asymmetric distributions). The normality assumption was assessed with graphical criterion and the Shapiro-Wilk test. Categorical variables were expressed in number and percentage.
We performed clustering analysis. Patients were clustered according the symptoms and comorbidity information y. This clustering analysis included data imputation, principal component analysis of baseline data, and ascending hierarchical classification gathering 90% of total inertia. From these components, the hierarchical classification [
Comparisons (baseline vs 3-month follow-up, by patient adherence, and by cluster) were performed using the chi-square test or Fisher exact test when assumptions to apply chi-square were not met (minimal level of expected number of cases under independence assumption), for categorical variables, and using analysis of variance (or Kruskal-Wallis tests when the assumptions to apply analysis of variance were not met). When the omnibus
We used Stata (version 15, StataCorp LLC) and R (version 4.0.3) software. All statistical tests were 2-sided with type I error set at 5%.
Of 133 patients from 12 French pain clinics, 28 patients (28/133, 21.0%) did not install the eDOL app; data from 105 patients were analyzed. The first patient was enrolled on February 6, 2019, and the last patient was enrolled on October 31, 2019.
At baseline, participating patients were mostly middle-aged women, in a couple, nonsmoking, and professionals. Among these patients, 35.3% (30/85) were in work stoppage due to their chronic pain. A more detailed characterization of the patients, with the help of several validated questionnaires, mainly showed that a significant number were considered precarious (43.0%; 40/93), with kinesiophobia (72.0%; 67/93), alexithymia (51/100, 51%), degraded life satisfaction (51/92, 55.4%), catastrophism (47/100, 47.0%) and a possible cognitive disorder (77/93, 82.8%). More than 65% (63/94, 67.0%) of patients had impaired sleep, and 37.2% (35/94) and 27.7% (26/94) had proven anxiety or depressive disorders respectively.
Regarding the characterization of pain disorders and their treatments, most patients (76/83, 91.6%) had moderate to severe pain intensity, of which 20.5% (17/83) had a high chronic pain interference score (called “high impact chronic pain” [
There was no difference in any of these characteristics between baseline and the 3-month follow-up (
Among 105 patients, 65 (61.9%) adhered to the use of the eDOL tool and 50 patients continued using the eDOL tool up to 6-month follow-up (
In detail, the overall rate of patient who completed the baseline questionnaires was 89.3% (range 79.0%-95.2%). The quarterly questionnaires, Brief Pain Inventory and Medical Outcomes Study Sleep Scale, were repeatedly filled at 3-month follow-up by 63.8% (67/105) of patients. For the half-yearly questionnaires (Tampa Scale of Kinesiophobia; Pain Catastrophizing Scale; EQ-5D-3L; Hospital Anxiety Depression Scale; Satisfaction With Life Scale and Subjective Cognitive Complaints), 58.7% (range 53.8%-63.1%) of patients completed the questionnaires. The filling rate of the weekly assessments for the real-life monitoring of the different parameters (pain, moral, anxiety, fatigue, sleep and body comfort) was 88.6% (93/105) of patients at the end of the first week and 61.9% (65/105) at 3-month follow-up (
Study flowchart.
Questionnaire completion.
Assessment | Baseline (n=105), n (%) | 3-month follow-up (n=105), n (%) | 6-month follow-up (n=65), n (%) | ||||
|
|||||||
|
Inclusion form (baseline) | 77 (73.3) | N/Aa | N/A | |||
|
Diagnosis form (baseline) | 80 (76.2) | N/A | N/A | |||
|
Treatment form (baseline and follow-up) | 74 (70.5) | N/A | N/A | |||
|
Consultation form (follow-up) | 66 (62.9) | N/A | N/A | |||
|
|||||||
|
Weekly assessments | 93 (88.6) | 65 (61.9) | 50 (76.9) | |||
|
Toronto Alexithymia Scale | 100 (95.2) | N/A | N/A | |||
|
Injustice Experience Questionnaire | 100 (95.2) | N/A | N/A | |||
|
Pain Beliefs and Perceptions Inventory | 92 (87.6) | N/A | N/A | |||
|
Life Orientation Test-Revised | 94 (89.5) | N/A | N/A | |||
|
Belief in a just world | 94 (89.5) | N/A | N/A | |||
|
Evaluation of level of precariousness | 93 (88.6) | N/A | N/A | |||
|
Big Five Inventory | 92 (87.6) | N/A | N/A | |||
|
MOS-Sleep Scale | 94 (89.5) | 67 (63.8) | 39 (60.0) | |||
|
Brief Pain Inventory | 93 (88.6) | 67 (63.8) | 38 (58.5) | |||
|
Pain Catastrophizing Scale | 100 (95.2) | N/A | 40 (61.5) | |||
|
Satisfaction With Life Scale | 92 (87.6) | N/A | 35 (53.8) | |||
|
Subjective Cognitive Complaints | 93 (88.6) | N/A | 35 (53.8) | |||
|
EQ-5D-3L | 83 (79.0) | N/A | 36 (55.4) | |||
|
Hospital Anxiety Depression Scale | 94 (89.5) | N/A | 41 (63.1) | |||
|
Tampa Scale of Kinesiophobia | 93 (88.6) | N/A | 41 (63.1) |
aN/A: not applicable.
Completion rate over time.
Among the 12 pain clinics participating in the study, 10 (83.3%) included patients, and 2 withdrew from participation before the start of the study. The median inclusion number per center was 8 (IQR 5.0, 14.0) patients. The inclusion objective (at least 100 analyzable patients) was achieved in less than a year as requested from the investigating centers.
The satisfaction questionnaire was filled in by 65.7% (69/105) of patients at the end of the study. The median acceptability score was 7.0 (IQR 6.1, 7.6), with only 9.5% (10/105) of the patients providing a rating less than 5.0 out of 10. Moreover, 88.6% (93/105) of the patients who responded wanted to participate in the further development of the eDOL app. The items with the lowest scores corresponded to the patients’ perception of the physicians’ use of eDOL in their follow-up (mean 5.7, SD 3.1), patients’ perception of the potential positive impact of eDOL on their pain management (mean 5.8, SD 2.7), and quality of life (mean 5.6, SD 2.4).
A total of 21 physicians participated in the study and included at least one patient, and 15 (71.4%) answered the satisfaction questionnaire. The physicians were mostly women (14/21, 66.7%), approximately 50.1 years old (range 33-61), and were from various specialties (2 neurologists, 2 psychiatrists, 3 anesthesiologists, 3 rheumatologists, and 5 general practitioners). The median acceptability score was 7.2 (IQR 6.8, 8.3), with only 6.7% (1/15) of physicians rating less than 5.0 out of 10. The items with the lowest scores corresponded to the compatibility of eDOL with the electronic medical file systems (mean 5.0, SD 2.3) and the possibility of eventually replacing the electronic medical files with the eDOL tool (mean 4.4, SD 1.9) (
Physician and patient acceptability of eDOL.
Acceptability questionnaire | Score (out of 10), mean (SD) | ||
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The training and support provided was sufficient to use eDOL correctly | 7.3 (1.4) | |
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After the first training session, it is easy to use eDOL on a daily basis | 6.9 (2.3) | |
|
The technical support (email and phone) was available to assist me if needed | 8.3 (1.2) | |
|
eDOL offers questionnaires and assessments adapted to the multidimensional characterization of my patients | 8.3 (1.2) | |
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The forms I had to fill in for each patient are adapted and they correspond to the information I usually collect | 6.8 (2.0) | |
|
Thanks to the export function provided in eDOL, I was able to retrieve the completed information for my patients. I was then able to print it (for my patient records) and/or import it into my hospital's electronic management system | 5.0 (2.3) | |
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The eDOL platform is complete enough to be able to replace my medical records one day | 4.4 (1.9) | |
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I would like to continue using eDOL in the future | 7.3 (2.0) | |
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eDOL will be useful in my daily medical practice | 6.8 (1.6) | |
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eDOL will allow me to better monitor my patients to improve their care | 7.1 (1.6) | |
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eDOL will be useful for developing clinical research on pain (creation of an e-cohort of patients with chronic pain) | 9.0 (0.9) | |
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eDOL will be useful for the clinical research projects conducted by my pain clinic | 8.5 (1.7) | |
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|
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After reading the explanatory document provided by the physician, it was easy for me to use eDOL | 8.4 (2.1) | |
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After the first use, it is easy to use eDOL on a daily basis | 8.7 (1.9) | |
|
The technical support was responsive enough when I asked for it | 7.0 (2.7) | |
|
eDOL offers questionnaires and assessments that I feel are suitable for monitoring my pain and its impact on my daily life | 7.0 (2.1) | |
|
I believe that the information I have entered in eDOL allows my doctor to better understand my pain and improve its management | 6.9 (2.5) | |
|
During the time that I have been using eDOL, I feel that my doctor has better monitored my symptoms and that my pain has been better managed | 5.7 (3.1) | |
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I believe that the information I have entered in eDOL will also help researchers to better understand chronic pain and to identify new avenues of research | 7.5 (2.3) | |
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I think that eDOL will help me in my daily life to better manage my pain and its impact on my daily life | 5.8 (2.7) | |
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I think that eDOL will gradually improve my quality of life | 5.6 (2.4) | |
|
I would like to continue using eDOL in the future | 7.6 (2.8) |
a88.5% indicated they would participate in the next phase of study on the new version of eDOL.
We obtained 4 clusters that did not differ with respect to sociodemographic and chronic pain characteristics (except for pain interference with daily life) and their treatments (
In Cluster 4, 80.0% (24/30) of patients adhered to the use of the tool, compared with 51.0% (19/37), 64.3% (9/14), and 43.5% (10/23) in clusters 1, 2, and 3, respectively (
With reference to the profile of patients in cluster 4, the most severe patients, with a significant impact of pain on their daily life (
As this was primarily a feasibility study, we first discuss considerations regarding the data collection and acceptability, and then our exploratory results with respect to conducting future works and improving eDOL. Because of the low number of patients (and thus the limited longitudinal outcome data collected), we did not explore the impact of eDOL on pain disorders and related comorbidities.
Our results showed a rate of adherence, after 3-month follow-up, of approximately 60% (65/105, 61.9%) of patients using eDOL. Three similar recent studies [
The good acceptability score, from both patients and physicians, reflects the interest expressed for eDOL and its contribution to the follow-up. Thus, eDOL could meet the urgent need to develop self-management and chronic pain management strategies through eHealth programs (internet, smartphone apps), and their therapeutic interest, as described by several studies [
In our exploratory analyses, our study population was similar to the profile of patients suffering from chronic pain in France [
With our smartphone app, we were able to collect data on precariousness, kinesiophobia, catastrophism, alexithymia, feelings of injustice, personality, life satisfaction, beliefs about pain, anxiety-depression, sleep, quality of life, cognitive disorders, optimism and belief in a just world. We made this choice because all of these factors are related to chronic pain [
Finally, the multifactorial analysis of all our data enabled us to group our study population into 4 clusters. Interestingly, subpopulations of our patients could be distinguished only on the basis of biopsychosocial questionnaires and impact of pain on daily life whereas sociodemographic aspects, symptomatology, seniority and treatment of pain did not differ between our clusters. Cluster 4 represented patients with more disabling chronic pain, more severe comorbidities, and more pronounced psychological disorders, while cluster 1 represented patients with chronic pain that has little impact on their daily life, as well as a lower presence of comorbidity. Cluster 4 had a higher proportion of adherent patients. Our findings were similar results to those in a recent study [
In addition, our results support the importance of questionnaires assessing the biopsychosocial aspect of chronic pain in addition to the biomedical aspect in the medical follow-up and characterization of patients with chronic pain. Moreover, in a classical medical follow-up, patients typically only see their pain specialist every 3 to 6 months. During these interviews, patients often have difficulties recalling their various symptoms and the impact of their pain over the past few months, which corresponds to a recall or memory bias [
There was a selection bias mainly because requiring the use of a smartphones excludes patients who do not have or do not know how to use this tool. This could exclude the older or more precarious patients. Nevertheless, in view of our results, the age of the participants and the rate of precariousness were similar to those found in the general French population, with and without chronic pain [
Moreover, our satisfaction survey was not a standardized but was a custom-made tool. We built this tool based on existing tools, such as the Patient Satisfaction Questionnaire [
Finally, only physicians were involved in this feasibility study; other members of the care team, such as nurses, physiotherapists, and psychologists, did not participate in the study. The absence of the point of view of the rest of care teams is a limitation to the interpretation of the acceptability of the eDOL tool. In future studies of the eDOL tool, we plan to include all the members of the care team as well as the addition of a chatbot and a new therapeutic education tool.
The study demonstrated the feasibility and acceptability of eDOL for both patients with chronic pain and their physicians. These points justify continuing the deployment of the tool while providing information to improve its use and adherence to provide patients with chronic pain and their physicians with a better longitudinal characterization of pain and its impacts for an optimized and more personalized therapeutic management.
Patient and physician satisfaction questionnaires.
eDOL features.
Questionnaire completion data.
Study population details.
mobile health
We thank all the medical and research staff of the investigating centers for their involvement in the inclusion and follow-up of patients. We thank Mr. Keith Hudson of Accent Europe for proofreading the manuscript.
None declared.