Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Pernilla Åsenlöf, Professor

Pernilla Åsenlöf

Pernilla Åsenlöf, Ph.D.

The goal of this observational study is to test psychometric properties of a clinical balance assessment scale, the Mini-BESTest, as well as to explore experiences and beliefs about balance and being balance tested. The main research questions are:

* What is the test-retest reliability of the Mini-BESTest balance assessment scale for individuals with long-term pain?
* What is the individual's subjective beliefs and experiences about their own balance and being balance tested with the Mini-BESTest?

Tow samples of participants will be included. One sample for a) the test-retest evaluation or b) an interview during and after performing the Mini-BESTest.

Individuals with chronic pain, i.e., pain \> 3 months, report balance problems and falls in their everyday lives. How balance affects daily functioning, and how to identify individuals with balance impairments are less studied. The Mini-BESTest has previously shown adequate construct validity in individuals with chronic pain, however, the test-retest reliability has not been explored. There is also a need of studies that have focus on the person's own experiences of balance and the balance tested.

In this observational study we aim to examine the psychometric properties of the Mini-BESTest, in individuals with chronic pain. Further we aim to explore individual subjective beliefs and experiences about own balance and being balance tested.

A convenience selection will be used to include two samples of participants. One sample for the test-retest evaluation, here after called the test-retest part of the study. And one sample for a think aloud interview, here after called the interview part of the study. At baseline the participants will be included to one of the two parts.

Participants in the test-retest part will be assessed with the Mini-BESTest on two occasions, the baseline and the re-test within approximately 2 weeks. The inclusion to the test-retest sample will continue until at least 50 individuals with no subjective experience of improvement or deterioration in balance status between the first and second occasions, according to the self-report measure the Patient global impression of change (PGIC), are included. This sampling is done in purpose to calculate test-retest reliability in individuals without subjective change in balance between the two occasions.

To the interview part, approximately ten to twenty individuals will be included for concurrent think aloud, i.e., think aloud during balance testing with the Mini-BESTest, and recurrent think aloud, i.e., an interview after the balance assessment. The interviews will cover questions about the participants experience of the testing with the Mini-BESTest and their balance.

Data will be collected by use of digitized questionnaires, physical performance tests, a structured interview and data from medical records.

Statistical tests will be used to evaluate test-retest reliability and internal consistency. The interviews will be analyzed using thematic analysis.

Test-retest and Experiences During Balance Assessment With the Mini-BESTest

Balance Assessment in Individuals With Chronic Pain: an Explorative Study of Psychometric Properties of the Mini-BESTest

Self-report. The measure reflects participant's beliefs about if there balance has changed between baseline and the re-test of Mini-BESTest. The participant indicates whether he/she feels that his/her balance has changed since the previous session of the study on a 7-point scale, 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', 'very much worse'.

Self-report questions on change in medication between baseline and the re-test of the Mini-BESTest. The participant indicates whether the type of medication or dose has changed since the previous study visit, the name of the changes medicine, and whether the medicine has been 'added' or 'removed', as well as if the dose has 'increased', 'decreased' or if the participant 'doesn't know'.

Self-report, Swedish version. Dynamic balance is measured with 14 items ranging from 0 = 'unable or requiring help to perform' to 2 = 'normal'. All items are summed up to a total score which ranges from 0 to 28, with higher scores reflecting better balance.

Self-report, oral question. Current pain intensity is measured with a scale that ranges from 0-10, where 0 = 'no pain' and 10 = 'pain as bad as can be'.

Self-report, question about fall frequencies over the last previous year and the last three weeks.

Self-report, Swedish version. Balance confidence is measured with 16 items ranging from 0 = 'No confidence' to 100 = 'Full confidence'. All items are summed up to a total score, which ranges from 0 to 100, with higher scores reflecting higher balance confidence while doing activities.

Self-report, Swedish version. Fear of falling is measured with 16 items ranging from 1 = 'Not at all concerned' to 4 = 'Very concerned'. All items are summed up to a total score, which ranges from 16 to 64, with higher scores reflecting more concerns about falling.

Self-report. Pain severity is measured with four scales where worst, least, average and current pain during the past week are scored. Each scale ranges from 0-10, where 0 = 'no pain' and 10 = 'pain as bad as can be'.

Self-report, Swedish version. Pain-related disability is measured with 7 items measuring family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care and life support activity. Every item ranges from 0 = 'No disability' to 10 = 'Worst disability'. All seven items are summed up in a total score, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.

Self-report, Swedish version. Pain self-efficacy is measured with 2 items ranging from 0 = 'Not at all confident' to 6 = ' Completely confident', with a higher combined scores indicating stronger self-efficacy beliefs.

Self-report, Swedish version. Fear of movement and reinjury is measured by 11 items ranging from 1 = 'Does not agree at al' to 4 = 'totally agree). A total score is calculated ranging from 11 to 44 where higher scores indicates higher fear of movement.

Self-report. Minutes of physical activity on low intensity and moderate intensity is measured with two ordinal scales.

Self-report. Hours of sedentary behavior measured on an ordinal scale.

Patterns of opioid use (type of opioid, dose, and duration) will be measured using a structured interview, calendar format, using 4 weeks intervals starting with the most recent complete week, week 1, working backward one week at time recording days of use for each opioid.

Uppsala University

Professor

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Patients complete the MyPOS questionnaire on quality of life

Myeloma Patient Outcome Scale (MyPOS)

Julia Dratva, Prof.Dr.med

In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to German. This translated version will be quantitatively and qualitatively validated with patients with multiple myeloma.

Patients with multiple myeloma (N=10) will be interviewed in the qualitative phase about their comprehension of the translated MyPOS. The questionnaire will be revised according to the results of the interviews. This culturally adapted Swiss-German MyPOS will be assessed in the quantitative phase for its' psychometric properties with 200 patients with multiple myeloma.

Quality of Life in Patients With Multiple Myeloma-validation Study

Validation of the Myeloma Patient Outcome Scale (MyPOS) Assessing the Quality of Life in Patients With Multiple Myeloma in the German Speaking Part of Switzerland

The primary outcome will be the scores on each item of the culturally-adapted Swiss-German MyPOS. Items are scored on a five-point Likert scale. For the analysis, the three subscales "Symptoms" (range: 0-52), "Emotions" (range:0-68) and "Healthcare Support" (range: 0-12) are assessed as well as the MyPOS total score (range: 0-132 ) by summing up the item scores ranging from 0-4. Higher scores reflect worse quality of life.

The scores will be used to evaluate the psychometric properties of the culturally-adapted Swiss-German MyPOS:

* Structural validity,
* Internal consistency,
* Construct validity,
* Convergent and divergent validity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Test-retest and Experiences During Balance Assessment With the Mini-BESTest	NCT06244602	Chronic Non-Can...		18 Years -	Uppsala University
Quality of Life in Patients With Multiple Myeloma-validation Study	NCT03537222	Multiple Myelom...	Myeloma Patient...	18 Years -	Zurich University of Applied Sciences
Quality of Life in Patients With Multiple Myeloma-validation Study	NCT03537222	Multiple Myelom...	Myeloma Patient...	18 Years -	Zurich University of Applied Sciences
Quality of Life in Patients With Multiple Myeloma-validation Study	NCT03537222	Multiple Myelom...	Myeloma Patient...	18 Years -	Zurich University of Applied Sciences

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