1.
Assessing Adherence, Competence and Differentiation in a Stepped-Wedge Randomised Clinical Trial of a Complex Behaviour Change Intervention.
Beck, AK, Baker, AL, Carter, G, Wratten, C, Bauer, J, Wolfenden, L, McCarter, K, Britton, B
Nutrients. 2020;(8)
Abstract
BACKGROUND A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). PURPOSE To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of "EAT: Eating As Treatment", a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. METHODS Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. RESULTS Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. CONCLUSIONS Although what level of fidelity is "good enough" remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.
2.
The added value of musculoskeletal ultrasound to clinical evaluation in the treatment decision of rheumatoid arthritis outpatients: physician experience matters.
Sifuentes-Cantú, C, Contreras-Yáñez, I, Saldarriaga, L, Lozada, AC, Gutiérrez, M, Pascual-Ramos, V
BMC musculoskeletal disorders. 2017;(1):390
Abstract
BACKGROUND Musculoskeletal ultrasound improves the accuracy of detecting the level of disease activity (DA) in RA patients, although its impact on the final treatment decision in a real clinical setting is uncertain. The objectives were to define the percentage of clinical scenarios from an ongoing cohort of RA outpatients in which the German Ultrasound Score on 7 joints (GUS-7) impacted the treatment and to explore if the impact differed between a senior rheumatologist (SR) vs. a trainee (TR). METHODS Eighty-five consecutive and randomly selected RA outpatients underwent 170 assessments, 85 each by the SR and the TR. Initially, both physicians (blinded to each other) performed a rheumatic assessment and recommended a preliminary treatment. Then, the patients underwent the GUS-7 evaluation by an experienced rheumatologist blinded to clinical evaluations; selected joints of the clinically dominant hand were assessed by gray-scale and power Doppler (PD). In the final step, the TR and the SR integrated the GUS-7 findings with their previous evaluation and reviewed their recommendations. The patients received the final recommendation from the SR to avoid patient confusion. The study was approved by the Internal Review Board and all the patients signed informed consent. GUS-7 usefulness was separately evaluated by the SR and the TR according to a visual analogue scale (0 = not useful at all, 10 = very useful). Descriptive statistics were used. RESULTS The patients were primarily middle-aged females (91.4%) with (mean ± SD) disease duration of 7.5 ± 3.9 years. The majority of them (69.2% according to TR and 71.8% to SR) were in DAS28-ESR-remission. In 34 of 170 clinical scenarios (20%), the GUS-7 findings modified the final treatment proposal; 24 of these scenarios were determined by the TR vs. 10 by the SR: 70.5% vs. 29.5%, p = 0.01. Treatment changes (increase, decrease and joint injection) were similar between both specialists. As expected, the TR rated the GUS-7 usefulness higher than the SR, particularly in the clinical scenarios where the GUS-7 findings impacted treatment. CONCLUSIONS Musculoskeletal ultrasound added to standard rheumatic assessments impacted the treatment proposal in a limited number of patients; the impact was greater in the TR.
3.
Management of coronary risk factors by registered nurses versus usual care in patients with unstable angina pectoris (a chest pain evaluation in the emergency room [CHEER] substudy).
Allison, TG, Farkouh, ME, Smars, PA, Evans, RW, Squires, RW, Gabriel, SE, Kopecky, SL, Gibbons, RJ, Reeder, GS
The American journal of cardiology. 2000;(2):133-8
Abstract
This study examined whether nurses could manage coronary risk factors in patients with unstable angina more effectively than physicians practicing usual care. Three hundred twenty-six patients were randomized in the emergency room to a 6-month program of risk factor management by a registered nurse versus participation in usual care. The nurse intervention consisted of a 30-minute counseling visit at 6 to 10 days after the chest pain episode and a second 30-minute session 1 month later. Multiple risk factors were assessed and addressed: smoking, blood lipids, blood pressure, blood glucose, physical inactivity, weight, psychological stress, and social isolation. Compared with usual care, nurse intervention patients significantly reduced both triglycerides (-29 +/- 8 vs 5 +/- 6 mg/dl; p <0.0004) and weight (-0.9 +/- 3.3 vs +0.1 +/- 2.1 kg; p = 0.0071), and had corresponding improvements in self-reported diet compliance and exercise (+34 +/- 106 vs +9 +/- 98 minutes, p = 0.0491). No significant differences between groups were observed in terms of 6-month changes in total, high-density lipoprotein, or low-density lipoprotein cholesterol, blood pressure, fasting blood glucose, percent body fat or waist-hip ratio, or psychological distress scores. The 6-month rate of recurrent events (cardiac death, out-of-hospital cardiac arrest, myocardial infarction) and/or revascularizations (coronary artery bypass surgery or coronary angioplasty) was lower in the nurse intervention group (1% vs 9%; p = 0.002). We conclude that a nurse-delivered risk factor intervention program for patients with chest pain is feasible and more effective than usual care in terms of fostering lifestyle changes that may lower coronary risk.