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About

NIH PROMIS Emotional Distress

NIH PROMIS for Emotional Distress (Depression, Anxiety) is an electronic standard assessment patient reported subjective outcomes. The electronic delivery is often beneficial compared to paper assessments as they reduce data entry errors and increase enrollment. Qolty PROMIS Emotional Distress is the ePRO system, and can be configured as a PRO tool that provides a short and reliable assessment for emotional distress with only the most informative items for an individual patient from an item bank based on the prior answers given by the patient.

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PROMIS Emotional distress item bank is used to assess the depression, anxiety, and anger in the adult population. It is modeled on the basis of the item response theory (IRT). It can be carried out with the use of minimal resources, in the form of computer aided tests (CATs), using apps on various devices, or just on paper.

Depression, anxiety, and anger are different mental problems, but they are part of the negative mental state or emotional distress. No doubt that there are many similarities between their symptoms and presentation. During the creation of question bank, the difference between these three states has to be taken into consideration. In depression, symptoms of mood are more widely seen as compared to physical signs. Whereas, in anxiety, physical symptoms like sleep disturbances or irritability are equally intense as symptoms of mood and changes in behavior.

Thus when creating the emotional distress questionnaires for depression, anxiety, and anger, questions regarding the physical condition were removed from the depression item bank, and most of the questions included in it were related to disturbances in mood and thinking ability. While in anxiety item bank questions related to physical well being and cognition were given equal weighting. In anger, item bank stress is on cognition, mood, and behavior (Pilkonis et al. 2011).PROMIS emotional distress questionnaire items were chosen after comprehensive literature review. The expert panel went through the few thousands of items and brought down the number of items to 168 for three constructs. Later after calibration, by using the response of 15000 respondents, a final number of questionnaire items were reduced to 28 for depression and 29 for anxiety and anger each. Furthermore, PROMIS-Cancer-anxiety and depression have 22, and 30 items respectively. Short forms, containing less than eight questions for each construct were also developed, providing results comparable to legacy measure systems (Pilkonis et al. 2011).

The questions are kept as simple as possible for easy comprehension. A person has to answer about the feelings during the last seven days on the scale of 5, like, I felt depressed (never, rarely, sometimes, often, always). The item bank helps to evaluate the degree of fluctuation in cognition, mood, behavior, and physical health caused due to depression, anxiety, and anger. T-score metric is used to measure the severity of these symptoms.PROMIS provides tools for healthcare professionals that can be utilized in clinical trials, epidemiological research and observational studies to measure three domains of emotional distress, that is, depression, anxiety, and anger. Use of short form or CAT can help to get precise results in brief time (Riley et al. 2011).

PROMIS emotional distress measures have a special place in the evaluation of the mental health in chronic disease conditions like diabetes, cystic fibrosis, asthma, and cancer.PROMIS emotional distress tools were calibrated and compared with other commonly used tools. For depression, it was compared with Center for Epidemiologic Studies Depression Scale (CES-D), for anxiety with Mood and Anxiety Symptom Questionnaire (MASQ), and for anger with Aggression Questionnaire (AQ). Statistical analysis demonstrated PROMIS emotional distress question banks to be better, more reliable, and responsive as compared to the older, traditional, methods that assess the various aspects of emotional distress. More importantly, a short form of emotional distress question bank produces similar results as the traditional tools, but with fewer questions.PROMIS emotional distress assessment bank is also available in Dutch, Spanish, and Traditional Chinese. Depression and anxiety measures are also available in German. Additionally, short forms are also available in several other languages like Russian, Polish, Ukrainian, Portuguese, Italian and Hungarian. Efforts are being made to make this tools accessible in a maximum number of languages.These sample data show the T-score of a person, measured on depression and anxiety scale by using PROMIS emotional distress item bank.

 

Before treatment person had moderate depression (indicated by T-score of 63.3). When the depression was assessed after the therapy, T-score of below 50 demonstrated the success of treatment.

Similarly, above is the case of severe anxiety with T-score being above 70, and the second column in a graph showing the excellent response to treatment, with T-score being much below to 50.

Reliability

Emotional distress items have been validated for high reliability surpassing the traditional legacy scales (Wenzel et al. 2013).

Floor/Ceiling effect

Floor and ceiling effect with emotional distress scale for depression, anxiety and anger should be taken into consideration in participants with very low or extremely high scores. Driban et al. 2015 demonstrated flooring effects in participants for both anxiety (17%) and depression (24%) subdomains.

Responsiveness

It has been demonstrated that responsiveness of first (never vs. rarely) and last (sometimes vs. always) is higher as compared to other parts of distinction scale (rarely vs. sometimes) (Preston, et al. 2011).

  • Qolty allows the individuals to fill in the questionnaires at any place and using any platform, including the mobile devices. The clinicians and researchers can get the immediate results.Emotional distress item bank is one of the most efficient, flexible, and precise tools to measure the changes in items being measured (in this case depression, anxiety, and anger). It provides the single standard of measurement for clinical trials, epidemiological studies, and observational research, thus comparing results from studies that use these tools would be more accurate.The item banks can be administered to both healthy population or those having affective disorders due to its wide applicability. However, the results are more trustworthy for the population having affective disorders.

  • Emotional distress tools are non-disease specific tools used to assess the three domains of mental health, that is, depression, anxiety, and anger.
  • Assessment can be done either on paper, computer or by using apps on various devices.
  • Short forms are having questions less than eight are available for quick assessment, though they are less precise, but are similar to legacy tools in preciseness.
  • They can be used in the clinical trial or various studies, but are not approved for screening or diagnosis. In the clinical setting, they can provide additional information.

Cella, D., Yount, S., Rothrock, N., Gershon, R., Cook, K., Reeve, B., … Rose, M. (2007). The Patient-Reported Outcomes Measurement Information System (PROMIS). Medical Care, 45(5 Suppl 1), S3–S11. https://doi.org/10.1097/01.mlr.0000258615.42478.55

Driban, J. B., Morgan, N., Price, L. L., Cook, K. F., & Wang, C. (2015). Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity. BMC Musculoskeletal Disorders, 16. https://doi.org/10.1186/s12891-015-0715-y

Pilkonis, P. A., Choi, S. W., Reise, S. P., Stover, A. M., Riley, W. T., & Cella, D. (2011). Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger. Assessment, 18(3), 263–283. https://doi.org/10.1177/1073191111411667

Preston, K., Reise, S., Li Cai, & Hays, R. D. (2011). Using the Nominal Response Model to Evaluate Response Category Discrimination in the PROMIS Emotional Distress Item Pools. Educational and Psychological Measurement, 71(3), 523–550. https://doi.org/10.1177/0013164410382250

Riley, W. T., Pilkonis, P., & Cella, D. (2011). Application of the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) to Mental Health Research. The Journal of Mental Health Policy and Economics, 14(4), 201–208.

Wenzel, L. B., Osann, K., Hsieh, S., Nelson, E. L., & Cella, D. (2013). Validation of PROMIS emotional distress short form scales for cervical cancer trials. Journal of Clinical Oncology, 31(15_suppl), 6633–6633. https://doi.org/10.1200/jco.2013.31.15_suppl.6633