The DoloTest^® in a specialized headache center among patients receiving psychological treatment. A pilot study

2.1 Participants

All patients referred to the Danish Headache Center (DHC) who were offered psychological assessment at any time in the period from January 2012 to December 2012 were recruited to the study. The DHC is a tertiary headache center and receives patients with facial pain and headache from all over Denmark. Patients were referred directly from general practitioners or from neurologists.

2.2 DoloTest

The DoloTest consists of eight domains (Fig. 1); pain severity; problems sleeping; reduced social life; low spirit; reduced energy and strength; problems doing your job; problems with more strenuous physical activity; and problems with light physical activities. Patients were asked to score an average for each domain the past week. All domains were presented graphically. A sum score was computed from the scores for each domain.

2.3 Treatment plan, follow-up and testing

All patients who participated in this project received the usual multidisciplinary treatment offered at the DHC. Treatment plans consisted of different combinations of interventions: use of acute and preventive medications for headache, psychological interventions, physiotherapy, and health education.

Psychologists educated patients about the relationship between debilitating headache and mental health (psychoeducation). Psychologists aimed to assist patients on stress and energy management; to become more aware of thoughts, feelings and bodily sensations related to headache pain; and to accept and work through limitations posed by chronic illness.

The DoloTest was filled in four times; the first three times at the DHC and administered by psychologists, the last time by the patient at home (Fig. 2).

Fig. 2:

Flowchart showing follow-up of patients referred for psychological interventions, and periods when the DoloTest was administered. ^aPatients were interviewed and evaluated by a psychologist and psychological treatment was offered if this was deemed relevant. ^bThe appropriate intervention was selected by the psychologists according to their evaluation of the patients.

The test was filled in on paper. The points on the lines were connected by the psychologist to produce a graphic presentation of the test result. The patients did not have access to previous results when they filled in the test a second, third or fourth time. Previous results were shown only after the patient completed the new questionnaire.

2.4 Qualitative evaluation

Four psychologists qualitatively evaluated the DoloTest in terms of ease of implementation, usefulness as a patient educational tool, and usefulness for evaluating patient progress over time. Their evaluation was based on a structured interview first on an individual basis and then in a group format.

2.5 Statistical analyses

Age data were summarized as means and standard deviations. All other demographic data were summarized as proportions per category. Headache frequency was summarized in two ways: number of headache days per month and presence of chronic headache. In this study chronic headache is defined as headache present 15 or more days per month in the last 3 months.

Demographic characteristics and headache diagnoses of completers and non-completers were compared using t-test (for age), χ² test (for categorical variables), or Fisher’s exact test (for variables where expected counts in 50% or more categories were less than five). p-Values were two-tailed and considered significant if below 0.05.

Points on each of the eight scales of the DoloTest were measured and assigned a value from 0 to 100. These scores were then added up to a total score ranging from 0 to 800. A higher score indicated more severe disability or reduction in quality of life. The scores at start of treatment, end of treatment, and 6 months after treatment were compared using Wilcoxon Signed Ranks test for related samples. This non-parametric test was used instead of the paired t-test because the observations were not normally distributed.

Correlation between headache days and DoloTest scores were analyzed using linear regression.

All statistical analyses were carried out using SPSS version 22.

3.1 Implementation of the DoloTest

The DoloTest was administered to 185 patients referred for psychological treatment (Test 1) and to 135 at start of treatment (Test 2). Of the 105 completers, 94 (90%) filled in the DoloTest at end of treatment (Test 3) and 73 (70%) responded 6 months after treatment (Test 4) (Fig. 3).

3.2 Qualitative feedback from psychologists

In the structured interview the psychologists all reported that they found it easy to explain the scope of the test to patients and to register results. They observed that it was easy and quick for the patients to fill in the test, and all patients were able to do so correctly.

The psychologists reported that patients found the DoloTest useful in depicting their actual state of health and headache. The visual analog scales made it possible for patients to describe their situation both quantitatively (marking the line) as well as qualitatively (go into detail with examples from daily life). The psychologists were immediately able to help patients interpret the results for the past week, and to focus on possible future interventions. The graphical output made it easier for the psychologists to monitor changes in HRQoL, and to educate patients in terms of progression and relapse.

The psychologists observed that most patients experienced large fluctuations in their headache duration, frequency and intensity and therefore found it difficult to give a score for the 1-week evaluation period.

3.3 Reduction in headache days

At the start of treatment, 135 patients reported an average of 22 headache days per month (SD 9.1, median 30, range 2–30 days/month). Among the 105 who completed treatment, the average headache frequency dropped significantly from 22 to 18 days per month (SD 10.8, median 19, p<0.001). There was a further drop after 6 months from end of treatment to 17 days per month (SD 10.8, median 17), though this was not significant (p=0.443).

3.4 DoloTest scores

All domains in the DoloTest scores decreased at end of treatment, although improvement was significant only in relation to pain (p=0.015) and reduced energy and strength (p=0.034) (Table 2). Six months after treatment, there was a significant improvement in total scores from 364 to 333 points (p=0.034) and in the following domains: pain (p=0.010), problems with strenuous activity (p=0.045) and reduced energy and strength (p=0.012) (Table 2).

3.5 Relationship between reduction in headache days and improvement in DoloTest scores

A large number of patients still had chronic headaches after treatment. There was no significant difference in the proportion of patients suffering from chronic headache at start of and at end of treatment (77.1% and 78.7%). Linear regression models were created using reduction in DoloTest score as the outcome variable, and reduction in headache days as the explanatory variable (Table 3). R-squared values were low (below 10%). The coefficients were significant for total score, pain, problems with strenuous activity, reduced energy and strength and reduced social life (p<0.05). The coefficient for reduced energy and strength was not significant once adjusted for age.

4.1 Strengths and limitations of the instrument

The main strength of the DoloTest is that it is easy to translate scores into a graphical image that patients and health care personnel can easily interpret and understand. It can be filled in within 1–2 min. The scoring is not complex. Data can be summarized as a continuous variable, and requires only addition to compute a total score. Scores can then be used to quantify HRQoL visually and document change over time for specific domains. In contrast to other HRQoL instruments, the DoloTest includes a domain about sleep problems which is highly relevant for headache patients [16].

The main limitation of the test is that it has not been validated for headache disorders and that the criterion validity was not tested in the present pilot study only in patients with nociceptive pain [11]. The test was designed to monitor patients with nociceptive pain in general, and was not designed to be sensitive to the specific burden of headaches. The test period only includes the last week. A longer evaluation period is preferred for headache monitoring and evaluation.

DoloTest is copyrighted and a license must be purchased prior to use. This could present a limitation for larger scale implementation in many centers.

4.2 Prospects for future research

Among this group of patients with medically refractory and frequent headaches, it may have been more useful to monitor not just headache days but also headache intensity and duration. This would likely allow for a better description of patients’ disability and impairment. Analysis using compound parameters as Area under the Headache Curve (Intensity×Duration) or Headache Indexes have been proposed [17], [18]. These data should be gathered in future studies.

The present study was a feasibility study to test the clinical acceptability for patients and psychologists. A proper validation against other headache disability instruments such as MIDAS [8], HIT-6 [9] and HURT [10] are recommended in future studies.

The eight domains are considered equally important, but some patients with headache may rank some domains as being more important than others. This could also be explored in future studies.

The DoloTest has now been developed as an app for mobile devices. Applicability of this app for headache or other chronic pain should be examined.

5.1 Clinical implications

• The DoloTest is a newer HRQoL measurement instrument for pain patients. The instrument is not yet validated for headache patients, but may prove useful in the clinical setting.

• The test is easy for patients to understand and complete. Psychologists found test results useful for psychoeducation.

• The test is useful for multimodal monitoring of effect of headache treatment.

• Further validation studies are recommended.