IMPORTANCEIn the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs. OBJECTIVE To assess the use and safety of outpatient management of acute appendicitis. DESIGN, SETTING, AND PARTICIPANTS This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25
Background: This study investigates the psychometric properties of patient-reported outcome instruments for assessing outcomes in postsurgical traumatic digit amputation patients. The authors hypothesize that the Michigan Hand Outcomes Questionnaire (MHQ) and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are the most valid and reliable instruments. Methods: The authors studied traumatic digit amputation patients as part of the Finger Replantation and Amputation Challenges in Assessing Impairment, Satisfaction, and Effectiveness (FRANCHISE) study initiated by The Plastic Surgery Foundation. The MHQ, DASH questionnaire, Patient-Reported Outcomes Measurement Information System (PROMIS), and 36-Item Short-Form Health Survey were used to assess patients at least 1 year postoperatively. Internal consistency was measured by Cronbach’s alpha and criterion validity with Pearson correlation coefficient (r). Construct validity was tested with four predefined hypotheses. Discriminant validity was analyzed by receiver operating characteristic curves. Results: One hundred sixty-eight replantation and 74 revision amputation patients met the inclusion criteria. All instruments demonstrated fair to good internal consistency in both cohorts (0.7 < α < 0.9). The MHQ and DASH questionnaire scores correlated strongly (r > 0.60) in both cohorts. The 36-Item Short-Form Health Survey had moderate to weak correlation with the remaining instruments, and its mental component had poor discriminant validity (area under the curve, 0.64 to 0.67). The MHQ, DASH questionnaire, and PROMIS demonstrated good construct validity confirming 75 to 100 percent of predefined hypotheses, whereas the 36-Item Short-Form Health Survey confirmed only 25 percent. Conclusions: The authors recommend using the Michigan Hand Outcomes Questionnaire or the Disabilities of the Arm, Shoulder and Hand questionnaire when assessing patient-reported outcomes in digit amputation patients based on good internal consistency and validity. The Patient-Reported Outcomes Measurement Information System has fair validity and reliability but should be an adjunct instrument. The 36-Item Short-Form Health Survey should not be used as a primary assessment tool, but as an adjunct to assess overall quality of life.
ImportanceA patient’s belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials.ObjectiveTo examine the association between patients’ baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial.Design, Setting, and ParticipantsThis was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis.InterventionsParticipants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful.Main Outcomes and MeasuresThree outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors.ResultsOf the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13–percentage point lower risk of appendectomy (aRD, −13.49; 95% CI, −24.57 to −2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was −5.68 (95% CI, −16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, −15.72; 95% CI, −29.71 to −1.72), with directionally similar results for the completely successful group (aRD, −15.14; 95% CI, −30.56 to 0.28).Conclusions and RelevancePositive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation.Trial RegistrationClinicalTrials.gov Identifier: NCT02800785
Writing Group for the CODA Collaborative IMPORTANCE For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ.OBJECTIVE To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. DESIGN, SETTING, AND PARTICIPANTSThe CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. INTERVENTIONS Appendectomy vs antibiotics.MAIN OUTCOMES AND MEASURES Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment.RESULTS Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, −1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup.CONCLUSIONS AND RELEVANCE This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large.
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