Michael O’Leary
November 04, 2015 |
| HADS was developed specifically to avoid reliance on confounding factors that are present in depression and anxiety, but also occur as symptoms of illness or treatment side effects. |
HADS was developed specifically to avoid reliance on confounding factors that are present in depression and anxiety, but also occur as symptoms of illness or treatment side effects. (published site)
Although several studies have confirmed its validity in the general medical population, including patients with chronic pain, HADS has not previously been studied specifically in patients with acute lower back pain (aLBP) and radicular leg pain.
“The results…suggest that this measure may be an acceptable alternative in analgesic clinical trials to the Beck Depression Inventory (BDI) and Profile of Mood States (POMS), as recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMPAACT],” write Dennis Turk, PhD, director of the Center for Pain Research on Impact, Measurement and Effectiveness (C-PRIME) at the University of Washington, and colleagues.
For the study, researchers conducted a secondary analysis of data from a randomized, double-blind, parallel group study of 666 aLBP patients receiving immediate-release tapentadol immediate release or oxycodone over a 10-day period.
The patient population was 50.6% male; the majority were white (71.5%), and mean age was 45 years. Participants had been diagnosed with aLBP and associated radicular leg pain consistent with Quebec Task Force Classification (QTFC) category 3, 4, or 6.
The 14-item HADS questionnaire (7 for anxiety and 7 for depression) was compared with the Numeric Rating Scale (NRS), Brief Pain Inventory-Short Form (BPI-SF), Short-Form McGill Pain Questionnaire version 2 (SF-MPQ-2), and the Roland and Morris Disability Questionnaire (RMDQ).
Overall responses to the HADS revealed anxiety and depression levels that were on the upper edge of normal, but not pathological; levels were comparable to that of patients with chronic pain and substantially lower than those observed in psychiatric patients.
HADS anxiety and depression subscales both showed good psychometric properties, had high internal consistency, and displayed good convergent validity. They also had no unexpected biases, fit the a priori factor structure, and were highly sensitive to changes as a result of analgesic treatment.
“Based on the results of our analyses, we conclude that the HADS is a valid instrument for efficient, low-burden assessment of anxiety and depression in clinical trials with an aLBP population,” the authors write.
HADS offers quick, efficient assessment
The HADS study results are encouraging for clinicians seeking a quick, efficient assessment of anxiety and depression associated with acute pain, Robert Jamison, PhD, professor of anesthesia and psychiatry at Harvard Medical School and Brigham and Women's Hospital in Boston, Massachusetts, told Clinical Pain Advisor.
In terms of practicality, Dr. Jamison says that the HADS can be administered and scored quickly, making it easy to use.
As a psychiatrist, Philip Muskin, MD, notes the utility of a screening tool that allows efficient symptom identification and tracking, particularly for physicians and nurse practitioners under time constraints.
The HADS targets the doctor-patient discussion and makes it more time-effective by allowing the clinician to focus on relevant concerns, Dr. Muskin told Clinical Pain Advisor. Dr. Muskin is a professor of psychiatry at Columbia University Medical Center in New York.
Careful Patient Selection
“The good news about the HADS is that it was not devised with psychiatric and medical factors in mind,” Dr. Jamison said. “In other words, it doesn't tap into all those qualities that correlate with pain. There are a few items — energy level is one of them — but a lot of the other things, like [having] recurrent worried thoughts, or feeling tense and worked up, are not always associated with a medical problem. That helps to evaluate [a patient's] mood but doesn't overlap so much with medical problems.”
As to selecting patients, Dr. Jamieson notes that some patients have a history of multiple flare-ups, while others are at higher risk for anxiety and depression.
“Unfortunately, some people are predisposed to anxiety and depression. It either runs in the family or is a personality factor, and the HADS may not be the best for a real quick screen,” Dr. Jamison pointed out.
According to Dr. Jamison, patients with acute back pain and high anxiety levels can be identified by a number of indicators, such as bracing, guarding, kinesthesia phobia, and a tendency to do the opposite of what is recommended. Such patients often have recurrent worries that they will re-injure their backs.
Strengths and limitations
Strengths of the study include the relatively large sample size and specified inclusion and exclusion criteria for eligibility; including recent onset of aLBP (30 days) and no history of more than mild prior low back pain.
The short 10-day treatment duration is also a strength, because it precludes underlying anxiety or depressive disorder as a confounding factor, Dr. Muskin said. However, the findings are limited by the homogeneity of sample demographics, he added, noting that more than 70% were white.
Different ethnic groups do express symptoms in different ways, so one thing we have to keep in mind is whether HADS would perform the same way in African-American or Hispanic patients, Dr. Muskin concluded.
The clinical trial was funded by Janssen Scientific Affairs, which also provided a research grant to Analgesic Solutions to support data analyses and publication preparation.
The lead author reports receiving research grants from the US National Institutes of Health and Food and Drug Administration in the last 12 months, as well as consulting fees or honoraria from Lilly, Mallincrodt, Orexo, Ortho-McNeil Janssen, Pfizer, and Xdynia.
Three coauthors are full-time employees of Johnson & Johnson; another is the owner of Analgesic Solutions; and a fifth reports receiving, in the last 12 months, compensation for activities involving clinical trial research methods from Acetylon, Astellas, AstraZeneca, Avanir, Axsome, Biogen, Centrexion, Charleston, Chromocell, Daiichi Sankyo, Eli Lilly, Hydra, Johnson & Johnson, Lpath, Maxwell Biotech, Metys, Olatec, Phosphagenics, QRx, Relmada, Salix, Sorrento, Spinifex, Teva, and Virobay.
Reference
Turk, DC, Dworkin, RH, et al; “Validation of the Hospital Anxiety and Depression Scale in Patients With Acute Low Back Pain,” The Journal of Pain, Vol 16, No 10 (October), 2015: pp 1012-1021. doi:10.1016/j.jpain.2015.07.001
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