Duloxetine and Cognitive Behavioral Therapy with Phone-based Support for the Treatment of Chronic Musculoskeletal Pain: Study Protocol of the PRECICE Randomized Control Trial.

Background: Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain conditions. While evidence exists for the efficacy of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, there is a clear need to consider study of treatment components that may complement each other. In addition, given the reported association between patient's adherence and treatment outcomes, strategies are needed to enhance participant's motivation to adopt and maintain continued use of newly learned pain coping skills from CBT. Methods: Two hundred eighty participants will be recruited from the primary care clinics of a large academic health care system in North Carolina. Participants with CMP will be randomized to one of 3 treatment arms: (1) combination treatment (duloxetine + web-based self-guided CBT) with phone-based motivational interviewing (MI), (2) combination treatment without phone-based MI and (3) duloxetine monotherapy. Participants will be in the study for 24 weeks and will be assessed at baseline, week 13, and week 25. The primary outcome is the Brief Pain Inventory (BPI)-Global Pain Severity score, which combines BPI pain severity and BPI pain interference. Secondary measures include between-group comparisons in mean BPI pain severity and BPI pain interference scores. Data collection and outcome assessment will be blinded to treatment group assignment. Discussion: This randomized controlled trial (RCT) will determine if combination treatment with duloxetine and web-based CBT is superior to duloxetine monotherapy for the management of CMP. Furthermore, this RCT will determine the effectiveness of phone-based motivational interviewing in promoting the continued practice of pain coping skills; thereby, enhancing treatment outcomes. Trial Registration: NCT04395001. Registered in ClinicalTrials.gov on May 15, 2020.

Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial.

BACKGROUND: Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain conditions. While evidence exists for the efficacy of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, there is a clear need to consider study of treatment components that may complement each other. In addition, given the reported association between patient's adherence and treatment outcomes, strategies are needed to enhance participant's motivation to adopt and maintain continued use of newly learned pain coping skills from CBT. METHODS: Two hundred eighty participants will be recruited from the primary care clinics of a large academic health care system in North Carolina. Participants with CMP will be randomized to one of three treatment arms: (1) combination treatment (duloxetine + web-based self-guided CBT) with phone-based motivational interviewing (MI), (2) combination treatment without phone-based MI, and (3) duloxetine monotherapy. Participants will be in the study for 24 weeks and will be assessed at baseline, week 13, and week 25. The primary outcome is the Brief Pain Inventory (BPI)-Global Pain Severity score, which combines BPI pain severity and BPI pain interference. Secondary measures include between-group comparisons in mean BPI pain severity and BPI pain interference scores. Data collection and outcome assessment will be blinded to treatment group assignment. DISCUSSION: This randomized controlled trial (RCT) will determine if combination treatment with duloxetine and web-based CBT is superior to duloxetine monotherapy for the management of CMP. Furthermore, this RCT will determine the effectiveness of phone-based motivational interviewing in promoting the continued practice of pain coping skills, thereby enhancing treatment outcomes. TRIAL REGISTRATION: NCT04395001 ClinicalTrials.gov. Registered on May 15, 2020.

Assessing the Accuracy, Quality, and Readability of Patient Accessible Online Resources Regarding Ocular Gene Therapy and Voretigene Neparvovec.

PURPOSE: To evaluate the accuracy, quality, and readability of online information regarding the Food and Drug Administration (FDA) approved ocular gene therapy voretigene neparvovec (Luxturna, Spark Therapeutics, Philadelphia, PA, USA). METHODS: Ten online resources about voretigene neparvovec were assessed in this cross-sectional study. A novel 25-question assessment was created to evaluate the information most relevant to patients. Each article was assessed by independent graders using the assessment and the DISCERN instrument. An online readability tool, Readable, was used to assess readability. Accountability was evaluated using the Journal of the American Medical Association (JAMA) benchmarks. RESULTS: The average questionnaire score for all the articles was 33.93 (SD 11.21, CI 95% ±6.95) out of 100 possible points with significant variation in the content accuracy and quality between the articles (P=0.017). EyeWiki achieved the highest score and MedicineNet the lowest. The mean reading grade for all articles was 12.88 (SD 1.93, CI 95% ±1.19) with significant variation between articles (P=0.001). Wikipedia was the most readable, and the FDA website was the least. None of the articles achieved all four JAMA benchmarks, and only one of the ten articles, EyeWiki, achieved three of the four JAMA benchmarks. CONCLUSION: The information available online regarding this FDA-approved ocular gene therapy is generally of low quality, above the average reading level of the general population, and varies significantly between sources. The articles provide incomplete information that is not entirely accurate or easy to read, and as a result, the material would not support patients adequately in their medical decisions and questions about this new therapeutic option.

Assessing the performance and satisfaction of medical residents utilizing standardized patient versus mannequin-simulated training.

BACKGROUND: Conducting simulations of rapidly decompensating patients are a key part of internal medicine (IM) residency training. Traditionally, mannequins have been the simulation tool used in these scenarios. OBJECTIVE: To compare IM residents' performance and assess realism in specific-simulated decompensating patient scenarios using standardized patients (SPs) as compared to mannequin. METHODS: Nineteen IM residents were randomized to undergo simulations using either a mannequin or an SP. Each resident in the two groups underwent four different simulation scenarios (calcium channel blocker overdose, severe sepsis, severe asthma exacerbation, and acute bacterial meningitis). Residents completed pretest and post-test evaluations as well as a questionnaire to assess the reality perception (realism score). RESULTS: Nine residents completed mannequin-based scenarios, whereas 10 completed SP-based scenarios. Improvement in the post-test scores was seen in both groups. However, there were significantly higher post-test scores achieved with SP simulations in three out of the four scenarios (P=0.01). When compared with the mannequin group, the SP simulation group showed a significantly higher average realism score (P=0.002). CONCLUSIONS: Applying SP-based specific-simulation scenarios in IM residency training may result in better performance and a higher sense of a realistic experience by medical residents.