Role of insole material in treatment of plantar fasciitis: A randomized clinical trial.

BACKGROUND: In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and Carbon Fiber insoles in the treatment of PF using a set of patient-reported outcomes. METHODS: Patients were randomly allocated one of the three prefabricated insoles - Carbon Fiber (n = 14), PU (n = 14), or PE (n = 17) for regular use. Their response was recorded using PROMIS 3a (for pain intensity), PROMIS 4a (for pain interference), FAOS (Foot and Ankle Outcome Score), and VAS for pain at baseline, two, six, and twelve weeks. RESULTS: The PROMIS pain intensity scores improved in both the Carbon Fiber and the PE groups starting at the 6th week (p = 0.04) and 2nd week (p = 0.002), respectively. PROMIS pain interference scores also showed positive trends in these two groups (p = 0.02, p = 0.004, respectively). CONCLUSION: Prefabricated Carbon Fiber and PE insoles showed significant pain-reducing effects in patients with PF. LEVELS OF EVIDENCE: Level I, Randomized controlled trial.

A Comparison of Treatment Outcomes after Standard Dose (70 Gy) versus Reduced Dose (50 Gy) Proton Radiation in Patients with Uveal Melanoma.

OBJECTIVE: To compare outcomes in a large patient cohort with small-medium tumors located within 1 disc diameter (DD) of the optic nerve and/or fovea treated with 50 Gy or 70 Gy proton therapy. DESIGN: Retrospective cohort study. SUBJECTS: A total of 1120 patients with uveal melanomas ≤ 15 mm in largest basal diameter, ≤ 5 mm in height, located within 1 DD of the optic nerve and/or fovea, who received primary treatment with protons between 1975 and 2016 at Massachusetts Eye and Ear/Massachusetts General Hospital. METHODS: The rates of outcomes were estimated using the Kaplan-Meier method. Differences between the radiation dose groups were tested using the log-rank test. MAIN OUTCOME MEASURES: Local tumor recurrence, melanoma-related mortality, and visual acuity preservation (≥ 20/200, ≥ 20/40). RESULTS: Local tumor recurrence was observed in 1.8% of the 50 Gy group and 1.5% of the 70 Gy group. The median time to recurrence was 30.7 months for patients treated with 50 Gy and 32.0 months for those treated with 70 Gy (P = 0.28). Five-year rates of vision retention (≥20/40, ≥ 20/200) were 19.4% and 49.3% for patients treated with 50 Gy and 16.4% and 40.7% in those treated with 70 Gy. Ten-year rates of melanoma-related mortality were 8.4% in the 50 Gy group and 8.9% in the 70 Gy group (P = 0.47). CONCLUSIONS: Comparable rates of local control are achieved treating small-medium tumors near the optic nerve and/or fovea with 50 Gy or 70 Gy proton therapy, supporting the use of the lower dose in patients with these tumor characteristics.

Single-arm oncology trials and the nature of external controls arms.

Aim: Single-arm trials with external control arms (ECAs) have gained popularity in oncology. ECAs may consist of primary data from previous trials, electronic health records (EHRs) or aggregate data from the literature. We sought to provide a description of how such studies achieve similarity of patients, comparability of data quality and outcome assessment. Materials & methods: In a stratified convenience sample of 15 studies, five used primary data from trials as ECAs, five used secondary data from EHRs and five used aggregate data from the literature. Data were collected from the published literature and public web resources, blinded to the eventual approval decision. Results: Studies using ECAs from primary data and EHR data displayed methods to achieve comparability of information, including matched baseline characteristics. Aggregate data from published studies did not attempt to match covariates. The EHR controls often showed calendar time overlap for collecting information while trial data were mostly historic. Outcome data were not consistently reported across studies. US FDA approval was only seen when primary data from trials or EHR data were used as the ECA, however no ECA in this sample directly contributed to approval. Discussion: In this nonsystematic review of ECAs for single-arm trials, the ECAs derived from primary data collected by other trials or EHRs show patterns of patient comparability, time overlap, and realistic methodological approaches to achieving balance between treatment arms. They are often submitted to regulators while literature-derived aggregate findings as ECA may serve as benchmarks for pipeline decisions.