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Background: There has been limited evaluation of health-related quality of life (HRQOL) in rectal cancer patients receiving neoadjuvant chemoradiotherapy. HRQOL outcomes in the National Surgical Adjuvant Breast and Bowel Project R-04 trial are examined in this article., Methods: Between 2004 and 2010, R-04 patients were invited to enroll in the HRQOL substudy, with questionnaires administered before randomization, after completion of chemoradiotherapy, and 1-year after surgery. HRQOL measures included: Functional Assessment of Cancer Therapy for colorectal cancer (FACT-C); Short Form-36v.2 Vitality scale; a treatment-specific symptom scale; and the FACT neurotoxicity scale. A 5-year postsurgery assessment was added to the protocol in 2012. Mixed-effects models examined neoadjuvant therapy treatment effects in the 1-year sample and models that explored associations of host factors and treatment impact on 5-year HRQOL., Results: A total of 1373 patients completed baseline HRQOL and at least one additional assessment. The average age was 58 years (range, 23-85 years), male (68%), and 59% Stage II. There were no statistically significant differences in HRQOL outcomes by treatment arm, but HRQOL worsened from baseline to postneoadjuvant chemoradiotherapy, with statistically significant effect sizes changes ranging from 0.6 (Vitality) to 0.9 (FACT-C Trial Outcome Index). Neurotoxicity was greater in the oxaliplatin-treated groups. Obese/overweight patients had statistically significantly worse FACT-C Trial Outcome Index scores than did underweight/normal weight groups. At 5 years, younger patients and those with normal baseline weight had statistically significantly better physical function scores and older patients had better mental health outcomes., Conclusions: HRQOL did not differ across the four R-04 treatment arms; however, host factors explained significant variation in posttreatment HRQOL., Clinicaltrials: gov: NCT00058474 (https://ClinicalTrials.gov/ct2/show/NCT00058474)., Lay Summary: This article reports on the health-related quality of life (HRQOL) outcomes of patients treated with four different chemotherapy regimens combined with radiation in rectal cancer patients before definitive surgical treatment. There were no significant differences in HRQOL by treatment regimen, but all patients experienced decreased vitality (energy) and physical functioning. By 1 year after treatment, most patients had returned to pretreatment vitality and physical functioning, with the exception of increased neurotoxicity. In a subsample of patients assessed at 5 years after surgery, physical function was better in those who at pretreatment were younger, normal weight, and had better performance status. Mental function was better in those who at pretreatment were older and had better performance status., (© 2022 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Objective: This study examines Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v1.0 outcomes of chiropractic care in a multi-site, pragmatic clinical trial and compares the PROMIS measures to: 1) worst pain intensity from a numerical pain rating 0-10 scale, 2) 24-item Roland-Morris Disability Questionnaire (RMDQ); and 3) global improvement (modified visual analog scale)., Design: A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC)., Setting: Three military treatment facilities., Subjects: 750 active-duty military personnel with low back pain., Methods: Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change., Results: We found statistically significant mean group differences favoring UMC+CC for all PROMIS®-29 scales and the RMDQ score. Area under the curve estimates for global improvement for the PROMIS®-29 scales and the RMDQ, ranged from 0.79 to 0.83., Conclusions: Findings from this pre-planned secondary analysis demonstrate that chiropractic care impacts health-related quality of life beyond pain and pain-related disability. Further, comparable findings were found between the 24-item RMDQ and the PROMIS®-29 v1.0 briefer scales., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.)

Objective: The purpose of this study was to estimate the significance of individual change using 5 statistical indicators in 2 samples of patients treated for low back pain., Methods: This secondary analysis used observational and clinical trial data from 2 samples of patients with low back pain to compare 5 ways of estimating significant individual change on the Impact Stratification Score (ISS) administered at the following 2 time points: 3 months apart in an observational study of 1680 patients undergoing chiropractic care, and 6 weeks apart in a randomized trial of 750 active-duty military personnel with low back pain. The following 5 methods were compared: (1) standard deviation index; (2) standard error of measurement (SEM); (3) standard error of estimate (SEE); (4) standard error of prediction (SEP); and (5) the reliable change index (RCI). The ISS is the sum of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 physical function, pain interference, and pain intensity scores and is scored to have a possible range of 8 (least impact) to 50 (greatest impact)., Results: The amount of change on the ISS needed for significant individual change in both samples was 5 for the SEM and for the SEE and 7 for the SEP and RCI., Conclusions: The results of the current study provide some preliminary support for use of the SEP or the RCI to identify significant individual change and provide estimated thresholds of individual change that can be used for the ISS. The SEP and RCI estimates of significant change were consistent with retrospective ratings of change of at least moderately better in prior research. These 2 were less likely than other methods to classify people with low back pain as responders who have not actually gotten better (false positive). In contrast, the SEM and SEE were less likely to miss real change (false negative)., (Copyright © 2022. Published by Elsevier Inc.)