Dyspepsia in the community: value of a community-based mailed survey to identify potential participants for a randomized clinical trial.

OBJECTIVE: To assess the usefulness of a community-based mailed survey to identify participants with functional dyspepsia (FD) for a clinical trial. MATERIAL AND METHODS: In 2008, a valid self-report questionnaire of gastrointestinal symptoms required for diagnosis of FD was mailed to randomly selected cohorts of Olmsted County, Minnesota, residents. From survey responses (54%), FD cases and controls were identified. Phone calls were completed in 2010 and 2011 to 54% of respondents offering participation to those meeting criteria. RESULTS: Of 937 people identified from the survey, 189 cases and 265 controls were contacted by phone using four questions similar to the written survey resulting in a moderate level of agreement (Kappa 0.43, 95% CI: 0.35- 0.51; p = 0.11). The proportion reporting FD symptoms by survey was 42%, while the proportion by phone was 38%. Comparing classification of cases and controls, 118 (62%) survey cases had dyspepsia symptoms on phone screening while 53 (20%) of the survey controls reported FD symptoms. Of 171 who had symptoms, 60 (35%) declined, 33 (19%) were over study age limit, 24 (14%) had inadequate symptom levels and 36 (21%) had comorbidities. Of survey respondents contacted, six (3%) people were enrolled with two screen fails resulting in four (1%) randomized. CONCLUSION: Agreement between survey and phone questions was modest. Classifications between case and control changed. People eligible and willing to participate were a fraction of people reporting symptoms. People participating in clinical trials do not broadly represent those in the population.

Minimum 20-Year Health-Related Quality of Life and Surgical Rates After the Treatment of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Longitudinal cohort. OBJECTIVES: To determine the patient-reported functional outcomes and need for related surgical procedures in a US cohort of adolescent idiopathic scoliosis (AIS) patients with minimum 20-year follow-up. SUMMARY OF BACKGROUND DATA: There is limited information regarding the long-term outcomes of scoliosis treatment in the US population. METHODS: A novel population of patients who underwent pediatric treatment for AIS with minimum 20-year follow-up was identified. Search of a single-center diagnostic registry generated 337 patients who fulfilled the inclusion criteria (AIS, curve magnitude >35°, and childhood treatment with bracing, surgery, or observation from 1975 to 1992). Any additional spine surgery as well as EQ5D, ODI, SRS 22, SAQ were determined. A total of 180 patients were included (mean of 30-year follow-up, range 20-37). Childhood treatment entailed bracing (41 patients), surgery (103 patients), and observation (36 patients). RESULTS: During the study period, only 1 of the 41 bracing patients underwent additional scoliosis-related spine surgery, whereas 5 of the 36 patients in the observation cohort underwent scoliosis surgery as adults. Seven of 103 childhood surgical patients required additional revision surgery as adults. Fifteen patients (4 braced, 7 fusion, and 4 observed) underwent chest wall surgery as adults. SRS scores were around 10% worse compared to population-based controls, with the exception of SRS mental health scores, which were similar to controls. Overall, 5.6% of patients were on disability, with no difference between operative and nonoperative groups. CONCLUSION: We found a low rate of adult scoliosis surgery in the braced population, and a low rate of revision surgery at the 30-year follow-up in patients undergoing spine fusion for AIS between 1975 and 1992. No detected differences in patient-reported outcomes were found between the braced, surgical, and observed populations at a mean of 30 years' follow-up. LEVEL OF EVIDENCE: Level III, therapeutic.

Prospective Evaluation of Radiculitis following Bone Morphogenetic Protein-2 Use for Transforaminal Interbody Arthrodesis in Spine Surgery.

Study Design: Prospective observational cohort study. Purpose: This study aims to evaluate the safety and efficacy of bone morphogenetic protein-2 (BMP-2) in transforaminal lumbar interbody fusion (TLIF) with regard to postoperative radiculitis. Overview of Literature: Bone morphogenetic protein (BMP) is being used increasingly as an alternative to iliac crest autograft in spinal arthrodesis. Recently, the use of BMP in TLIF has been examined, but concerns exist that the placement of BMP close to the nerve roots may cause postoperative radiculitis. Furthermore, prospective studies regarding the use of BMP in TLIF are lacking. Methods: This prospective study included 77 patients. The use of BMP-2 was determined individually, and demographic and operative characteristics were recorded. Leg pain was assessed using the Visual Analog Scale (VAS) for pain and the Sciatica Bothersome Index (SBI) with several secondary outcome measures. The outcome data were collected at each follow-up visit. Results: Among the 77 patients, 29 were administered with BMP. Postoperative leg pain significantly improved according to VAS leg and SBI scores for the entire cohort, and no clinically significant differences were observed between the BMP and control groups. The VAS back, Oswestry Disability Index, and Short-Form 36 scores also significantly improved. A significantly increased 6-month fusion rate was noted in the BMP group (82.8% vs. 55.3%), but no significant differences in fusion rate were observed at the 12- and 24-month follow-up. Heterotopic ossification was observed in seven patients: six patients and one patient in the BMP and control groups, respectively (20.7% vs. 2.1%). However, no clinical effect was observed. Conclusions: In this prospective observational trial, the use of BMP in TLIF did not lead to significant postoperative radiculitis, as measured by VAS leg and SBI scores. Back pain and other functional outcome scores also improved, and no differences existed between the BMP and control groups. The careful use of BMP in TLIF appears to be both safe and effective.

Does School Screening Affect Scoliosis Curve Magnitude at Presentation to a Pediatric Orthopedic Clinic?

BACKGROUND: With new data supporting the efficacy of bracing, the role of school screening for early detection of moderate scoliosis curves has been revisited. Because of a high rate of false-positive screening and cost concerns, a comprehensive county-wide school screening program was discontinued in 2004. We aim to determine the impact of a comprehensive school screening program on curve magnitude at presentation and initial scoliosis treatment for all local county patients presenting to a pediatric orthopedic clinic from all referral sources. METHODS: Between 1994 and 2014, a total of 761 county patients presented to a pediatric orthopedic clinic for new scoliosis evaluation. Curve magnitude and recommended treatment were recorded. Treatment indications for bracing, surgery, and observation were consistent over the study period. RESULTS: From January 1994 to July 2004 (school screening period), 514 children were seen by a pediatric orthopedic specialist for scoliosis evaluation compared to 247 patients from August 2004 to December 2014 (no school screening). There was a 48% decrease in the number of county children who were evaluated for idiopathic scoliosis by pediatric orthopedics once school screening was discontinued. Mean maximal Cobb angle at presentation increased from 20° (range, 4°-65°) to 23° (range, 7°-57°). At presentation, 5 of 514 (0.97%) patients in the screened group required surgery and 68 of 514 (13.2%) required bracing, compared to 3 of 247 (1.2%) patients in the nonscreened group requiring surgery and 47 of 247 (19%) requiring bracing (p>.05, p=.04, respectively). CONCLUSION: After school screening was discontinued, mean curve magnitude and rates of bracing at presentation statistically increased in county patients evaluated for new scoliosis, although the clinical significance is unclear. After school screening was discontinued, there were fewer patient referrals, braces prescribed, and unnecessary evaluations (patients discharged at first visit). This study provides data to evaluate the role of school screening for children with regular access to health care. LEVEL OF EVIDENCE: Level 3.