Development of the Stanford Expectations of Treatment Scale (SETS): A tool for measuring patient outcome expectancy in clinical trials

Younger, Jarred; Gandhi, V.; Hubbard, Emily; Mackey, Sean

doi:10.1177/1740774512465064

Cited by 151 publications

(116 citation statements)

References 63 publications

Supporting

Mentioning

104

Contrasting

Unclassified

Order By: Relevance

“…Diagnostic ultrasound of both shoulders will be performed and the size and the location of the deposits, related to the long head of the biceps tendon, will be recorded. On the treatment day, prior to treatment, three patient related outcome scores (Oxford Shoulder Score (OSS) [14, 15], quickDASH upper extremity score [16, 17], EQ-5D-5L general health score [18, 19]) and three visual analogue scales (VAS) for pain at rest, during activity and at night will be completed by the patient, together with the Stanford expectations of treatment scale (SETS) [20]. …”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study

Moosmayer

Ekeberg

Hallgren

et al. 2017

BMC Musculoskelet Disord

View full text Add to dashboard Cite

BackgroundFor the treatment of calcific tendinitis of the shoulder a variety of treatment regimes exist. Commonly used treatment measures include medication with oral analgesics, corticosteroid injections, extracorporeal shockwave therapy, ultrasound guided needling and lavage, and surgical treatment. Earlier cohort studies suggest that patients may benefit from these treatments, but there are few randomized studies and conflicting evidence about the effectiveness of the various treatments. In the present study we aim to compare the effectiveness of ultrasound guided needling and lavage (barbotage) together with a steroid injection to sham barbotage with and without an additional steroid injection.MethodsThe study will be performed in six secondary-care institutions in Norway and Sweden. It is designed as a pragmatic, randomized, three-arm, parallel group, double-blinded, sham-controlled clinical trial with a 2-year follow-up. It will be performed on 210 patients, aged 30 years or older, presenting with painful arc, positive impingement sign and a calcium deposit > 5 mm. Randomization to one of the three treatment options will be performed by using an online central randomization system. The three treatment groups are barbotage together with a subacromial steroid injection (the barbotage group), sham barbotage together with a subacromial steroid injection (the steroid group) or sham barbotage without a subacromial steroid injection (the placebo group). In the placebo group the steroid injection will be replaced by a short-acting local anaesthetic. Standardized home-based post-treatment physiotherapy will be performed by all patients for 8 weeks. Follow-ups are at 2 and 6 weeks, 4, 8, 12 and 24 months after treatment was given and will be performed with the patients and the outcome assessors blinded for group assignment. Primary outcome will be the Oxford shoulder score at 4 month follow-up. Secondary outcome measures are the QuickDASH upper extremity score, the EQ-5D-5L general health score and visual analogue scales for pain at rest, during activity, and at night.DiscussionThe scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis.Trial registrationClinicalTrials.gov: NCT02419040, registered 10 April 2015EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered)Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-017-1501-9) contains supplementary material, which is available to authorized users.

show abstract

Section: Methodsmentioning

confidence: 99%

“…The SETS [20] is a quick and easy-to-administer tool for the measurement of positive and negative pretreatment expectancies. The score consists of six items, three of them measuring positive expectancy, and three of them negative expectancy.…”

Section: Methodsmentioning

confidence: 99%

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study

Moosmayer

Ekeberg

Hallgren

et al. 2017

BMC Musculoskelet Disord

View full text Add to dashboard Cite

show abstract

“…Prior to initiating treatment, clinicians caring for older adults with chronic pain are encouraged to assess patients’ treatment expectancies (e.g., degree of pain relief expected, degree of anticipated functional improvement). There are several validated questionnaires—e.g., Credibility/Expectancy Questionnaire 32 and the Stanford Expectations of Treatment Scale (SETS) 33 —that are used to identify expectations of individuals participating in clinical trials. Both scales are short enough to be considered for use in the clinical setting.…”

Section: Patient Expectationsmentioning

confidence: 99%

Expanding Targets for Intervention in Later Life Pain

Reid

2016

Clinics in Geriatric Medicine

View full text Add to dashboard Cite

“…Other studies have reported the importance of distinguishing between “probability expectations” (rational projections) and idealized expectations (hopes) [11]. Cognitive interviews have not been used when developing previously validated questionnaires of treatment expectations [13-15], even though cognitive interviews have been used when developing other questionnaires designed to assess patient reported outcomes [16,17]. A recent document from the United States Food and Drug Administration (FDA) recommends cognitive interviews be conducted when developing patient reported outcomes [18].…”

Section: Introductionmentioning

confidence: 99%

Cognitive interviews guide design of a new CAM patient expectations questionnaire

Sherman

Eaves

Ritenbaugh

et al. 2014

BMC Complement Altern Med

View full text Add to dashboard Cite

BackgroundNo consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire.MethodsWe reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions – verbs, nouns, response options, terms and phrases describing back pain – were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators.ResultsThe questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. “Back pain” was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as “complete relief”. The use of words to describe midpoints was found to be confusing. The word “expect” held different and shifting meanings for participants. Thus paired items comparing “hope” and “realistically expect” were chosen to evaluate 5 different aspects of treatment expectations (back pain; back dysfunction and global effects; impact of back pain on specific areas of life; sleep, mood, and energy; coping). “Impact of back pain” on various areas of life was found to be a consistently meaningful concept, and more global than “interference”.ConclusionsCognitive interviews identified wordings with considerable agreement among both participants and investigators. Some items widely used in clinical studies had different meanings to participants than investigators, or were confusing to participants. The final 18-item questionnaire is undergoing psychometric evaluation with goals of streamlining as well as identifying best items for use when questionnaire length is constrained.

show abstract

Development of the Stanford Expectations of Treatment Scale (SETS): A tool for measuring patient outcome expectancy in clinical trials

Abstract: The SETS may be used in clinical trials to improve statistical sensitivity for detecting treatment differences or in clinical settings to identify patients with poor treatment expectancies.

Cited by 151 publications

References 63 publications

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study

Expanding Targets for Intervention in Later Life Pain

Cognitive interviews guide design of a new CAM patient expectations questionnaire

Contact Info

Product

Resources

About