Outcomes Measurement Information System Survey Research Articles

A Prospective Study of Mucosal Sparing Radiation Therapy in Resected Oropharyngeal Cancer Patients

Our objective was to report the prospective results of mucosal sparing radiation therapy in human papillomavirus-related oropharyngeal squamous cell carcinoma. From March 2016 through May 2019, patients were enrolled in this institutional review board-approved prospective cohort study at a multisite institution. Inclusion criteria included p16+ American Joint Committee on Cancer seventh edition pathologic T1 or T2, N1 to N3, and M0 oropharyngeal cancers. Proton therapy (PT) was delivered to at-risk nodal regions, excluding the primary mucosal site. Secondary to insurance denial for PT, intensity modulated radiation therapy (IMRT) was allowed. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module and Patient-Reported Outcomes Measurement Information System surveys (quality of life [QOL]) and modified barium swallowing impairment profiles (MBSImP) were obtained at baseline before radiation therapy, then 3 and 12 months after radiation therapy. Kaplan-Meier estimates were calculated for time-to-event clinical outcomes, and repeated measures mixed models were used to explore changes in QOL over time. A comparison of QOL and swallowing outcomes with standard-of-care treatment was analyzed. There were 61 evaluable patients with a median follow-up of 38 months (range, 10-64); 44 (72%) were treated with PT and 17 (28%) were treated with IMRT. The 2-year local control, locoregional control, distant metastasis-free survival, and overall survival were 98%, 97%, 98%, and 100%, respectively. There were 6 grade ≥3 events related to treatment. Two IMRT patients required percutaneous endoscopic gastrostomy tube placement during treatment secondary to significant nausea due to dysgeusia. Patients noted significant QOL improvement over time in the pain, swallowing, speech, social eating, social contact, mouth opening, and use of pain medication domains (all P < .02). The MBSImP overall severity score as well as oral and pharyngeal impairment scores showed stability with no significant change over time. For the 44 patients treated with PT, the mean D95 to the primary target was 10.7 Gy (standard deviation=12.5 Gy). Mucosal sparing radiation is well tolerated in select resected human papillomavirus-related oropharyngeal squamous cell carcinoma with a low risk of recurrence at the mucosal primary site, a low rate of percutaneous endoscopic gastrostomy tube placement, and few radiation-related grade ≥3 adverse events.

Gray-Scale and Power Doppler Ultrasound Findings Predictive of Cubital Tunnel Syndrome Severity.

The use of ultrasound in the diagnosis of cubital tunnel syndrome (CuTS) is an attractive alternative to electrodiagnostic (EDX) studies, but its utility is binary with poor severity correlation. We hypothesize that increasing ulnar nerve cross-sectional area (CSA) and power Doppler measurement of intraneural vascularity may predict the extent of disease. We identified 20 elbows from patients with a history of CuTS and 20 elbows in 10 asymptomatic controls. Electrodiagnosis was performed for symptomatic patients. Gray-scale ultrasound and power Doppler ultrasound were performed to measure CSA and intraneural vascularity in all participants. Functional measures, Boston Carpal Tunnel Questionnaire (BCTQ), and Patient-Reported Outcomes Measurement Information System surveys were also completed. A strong positive correlation was found between CSA and motor nerve conduction velocity (MNCV) decrease between elbow and forearm, which increased when BCTQ >2 was used as a screening criterion. Increased CSA also demonstrated a high positive predictive value (PPV) in predicting MNCV changes, but poor ability to predict axonal loss. In contrast, power Doppler ultrasound demonstrated 100% PPV and 94% negative predictive value (NPV) in predicting severe CuTS (defined as compound motor action potential [CMAP] amplitude <6 mV and electromyography [EMG] findings). Cross-sectional area is a sensitive method for identifying changes in MNCV and amplitude but does not stratify disease severity, as defined by diminished CMAP amplitude and/or evidence of denervation on EMG. The presence of increased intraneural vascularity is relatively sensitive but highly specific for axonal loss. The combination of nerve CSA, BCTQ screening, and power Doppler ultrasound may provide an alternative means for CuTS assessment.

Patient-Reported Outcomes after Syndactyly Reconstruction

There is scant literature regarding patient-reported outcomes after reconstruction for congenital hand syndactyly. Understanding patient perceptions of the postoperative outcome may facilitate a more evidence-based discussion of expectations after reconstruction. All patients undergoing congenital syndactyly reconstruction at Ann and Robert H. Lurie Children's Hospital of Chicago between January of 2007 and December of 2015 were identified. Patient-Reported Outcomes Measurement Information System questionnaires were completed by patients; parent-proxy questionnaires were completed for patients 10 years of age and younger and those unable to complete the questionnaire independently. A retrospective chart review was also performed to capture demographic and clinical information. The authors identified 124 patients meeting inclusion criteria; 51 completed the Patient-Reported Outcomes Measurement Information System surveys (response rate, 41.1 percent). The survey score for upper extremity function was 41.8 ± 11. Upper extremity function was further impaired in patients with a documented history of developmental delay (23.8 ± 6.2 versus 44.2 ± 10.2). Parents completing surveys on behalf of their children reported higher pain interference scores than self-responders. The Patient-Reported Outcomes Measurement Information System is a valuable tool for measuring patient-reported outcomes in patients with syndactyly. Patients who have undergone reconstruction for syndactyly experience minor impairments in upper extremity function, but other aspects of their health-related quality of life are comparable to those of the general population. Developmental delay may be associated with additional impairments in upper extremity function and should be discussed when considering surgical reconstruction.

Prevalence of Gastroesophageal Reflux Disease and Proton Pump Inhibitor-Refractory Symptoms

There are few data on the prevalence of gastroesophageal reflux disease (GERD) in the United States. We performed a population-based study to determine the prevalence of GERD symptoms and persistent GERD symptoms despite use of proton pump inhibitors (PPIs). We conducted the National Gastrointestinal Survey in 2015 using MyGiHealth, an app that guides participants through National Institutes of Health gastrointestinal Patient-Reported Outcomes Measurement Information System surveys. Primary outcomes were prevalence of GERD symptoms in the past and persistence of GERD symptoms (heartburn or regurgitation 2 or more days in past week) among participants taking PPIs. Population weights were applied to the data and multivariable regression was used to adjust for confounding. Among 71,812 participants, 32,878 (44.1%) reported having had GERD symptoms in the past and 23,039 (30.9%) reported having GERD symptoms in the past week. We also found that 35.1% of those who had experienced GERD symptoms were currently on therapy (55.2% on PPIs, 24.3% on histamine-2 receptor blockers, and 24.4% on antacids). Among 3229 participants taking daily PPIs, 54.1% had persistent GERD symptoms. Younger individuals, women, Latino individuals, and participants with irritable bowel syndrome or Crohn's disease were more likely to have continued symptoms, even when taking PPIs. Using a population-based survey, we found GERD symptoms to be common: 2 of 5 participants have had GERD symptoms in the past and 1 of 3 had symptoms in the past week. We also found that half of PPI users have persistent symptoms. Given the significant effect of GERD on quality of life, further research and development of new therapies are needed for patients with PPI-refractory GERD symptoms.

A Protocol to Assess Feasibility, Acceptability, and Usability of Mobile Technology for Symptom Management in Pediatric Transplant Patients.

Pediatric blood and marrow transplant (PBMT) patients experience significant symptom distress, and the use of mobile health (mHealth) technologies may enhance symptom management by providing patient-generated health data to foster personalized health strategies. The aim of this study was to present a study protocol to explore feasibility, acceptability, and usability of integrating mHealth technologies to collect and monitor symptom data for PBMT patients. An exploratory mixed-methods design is employed for 20 PBMT patients to monitor symptoms using real-time data from two mHealth devices: (a) a self-developed mHealth application and (b) a wearable tracking device. Patient-Reported Outcomes Measurement Information System surveys for fatigue, pain, and sleep disturbance are obtained monthly. Interviews are conducted to obtain further feasibility and usability data. The study began in October 2017; data collection should be completed in 2018. Feasibility and usability results to monitor and record symptom-related data daily via mobile devices will be reported. Patient-Reported Outcomes Measurement Information System surveys and interviews will further explore patients' symptoms and experiences with the mobile devices. This study will be among the first to explore the feasibility, acceptability, and usability of integrating multiple mHealth technologies to obtain patient-generated symptom data for the PBMT population. Results will enhance our understanding of how these data present, interact, and cluster together throughout the posttransplant period for these children and lead to symptom management strategies. Results will focus on a high-risk population that potentially stands to benefit from the use of mobile technologies.

Patient-reported goal attainment and comprehensive functioning outcomes after surgery compared with pessary for pelvic organ prolapse

Pelvic organ prolapse can have a negative impact on a woman's overall functioning. When choosing between surgery or pessary, many women have information needs about long-term expectations. Whereas it has been shown that both surgery and pessary can improve prolapse symptoms, there is less information comparing comprehensive functioning outcomes and goal attainment between the 2 treatments. Our primary objective was to compare patient-reported goal attainment and comprehensive physical, social, and emotional functioning outcomes after surgery vs pessary for symptomatic prolapse. We conducted a prospective, observational, cohort study including women choosing surgery or pessary for symptomatic stage 2 or greater prolapse. Women undergoing any modality of prolapse surgeryor those anticipating using a pessary long-term to avoid surgery were eligible. Women completed questionnaires at baseline (before treatment) and up to 12 months after treatment including the following: (1) pretreatment goals and actual posttreatment goals achieved; (2) 5 functioning outcomes encompassing physical, social, and emotional function using the Patient-Reported Outcomes Measurement Information System surveys; and (3) validated symptom and quality-of-life questionnaires. Treatment goals were categorized into symptom goals (prolapse, urinary, bowel, pain) and function goals (physical, social, emotional, sexual). Goals achieved were compared using a χ2 test. Multiple logistic regression was used to identify variables associated with not achieving all pretreatment goals. Mean improvements in functioning scores were compared within groups and between groups using paired and independent Student t tests. Assuming 80% of women would achieve complete goal attainment in the surgery group, 64 women per group would be needed to detect a 20% difference at an alpha of 0.05. We recruited 80 women per group to account for dropout. A total of 160 women were enrolled and 72 surgical (90%) (mean follow-up 12 months) and 64 pessary patients (80%) (mean follow up 8 months) had posttreatment data. Fourteen discontinued pessary use and 8 ultimately crossed over to surgery. At follow-up, a higher proportion of women in the surgery arm reported successfully achieving symptom goals and function goals compared with women who chose pessary (P<.05). Women who continued pessary use had comparable goal attainment with women in the surgery group for almost all goal categories, whereas women who discontinued the pessary or crossed over to surgery had significantly lower goal attainment compared with both the surgery and pessary continuation groups. On multiple logistic regression, only college education or higher was associated with an increased odds of not achieving all pretreatment goals (odds ratio, 2.70, 95% confidence interval,1.1-6.6, P= .03). Regarding functioning outcomes, within groups, there were statistically significant improvements between pre-and posttreatment Patient-Reported Outcomes Measurement Information System functioning scores in all 5 domains for the surgery group and 4 of 5 domainsin the pessary group (P < .05). When comparing between groups, women who had surgery reported significantly greater improvements in the physical function, social roles, and depression domains compared with the pessary group (P < .05). Women undergoing either surgery or pessary for symptomatic prolapse experience goal attainment and improvements in physical, social, and emotional functioning, although surgery is associated with greater improvements.