Determining the value of the abdominal core health quality collaborative to support regulatory decisions.

PURPOSE: The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. METHODS: Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. RESULTS: 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. CONCLUSIONS: Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

Use of real-world registry data: a hernia mesh example.

PURPOSE: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices. METHODS: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types. RESULTS: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results. CONCLUSIONS: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.

Understanding the patient perspective after ventral hernia repair.

PURPOSE: More than 350,000 ventral hernia repairs are performed in the U.S. each year. However, long-term quality of life of patients living with hernia repair is less known. Follow-up using patient-reported outcomes (measures) is an important representation of the patient experience and can inform quality improvements of hernia treatments. This study aims to understand the patients' experience after ventral hernia repair, to enhance quality of care and long-term hernia treatment outcomes. METHODS: To better understand long-term outcomes of ventral hernia repair and to enhance an existing PRO tool, two rounds of semi-structured interviews and focus groups were conducted. In total, 22 patients who had ventral hernia repair were enrolled. The patient perspectives obtained were grouped into themes to inform the further development of the PRO tool. Data were transcribed and analyzed using atlas.ti and Microsoft Word. RESULTS: Ten major themes were identified in this analysis. Patients' quality of life was impacted by hernia repairs and hernia recurrences, including chronic pain, effects on daily activities and social relationships, and the challenge in finding new treatments. The lack of provider-patient communication and patient understanding of hernia repairs highlighted the need for providing patients with more comprehensive information regarding repair options and outcomes prior to surgery. CONCLUSION: PRO assessments and meaningful communications between the physician and the patient can provide a comprehensive benefit-risk assessment prior to surgery, and may also improve patient understanding of what to expect during recovery from surgery.

Late-presenting appendicitis: a laparoscopic approach to a complicated problem.

BACKGROUND: Acute appendicitis is the most common abdominal condition necessitating urgent surgical intervention in the United States. The objective of this study was to determine if interval laparoscopic appendectomy after initial nonoperative treatment for late appendicitis presenting as an appendiceal mass is a safe alternative to immediate appendectomy. METHODS: Thirty two consecutive patients (aged 16-74 years) during a 5-year period presented with appendiceal mass. Seventeen received initial nonsurgical treatment followed by interval laparoscopic appendectomy (aged 16-60 years; group 1). Fifteen underwent immediate appendectomy (aged 16-74 years; group 2). RESULTS: All patients in the interval laparoscopic appendectomy group improved with initial therapy and underwent surgery an average of 4.9 months later. Although the operative time and the complication rate were similar between groups 1 and 2, the time to return to baseline activities was significantly less in group 1 after adjusting for age (p = 0.02 or less). CONCLUSIONS: Interval laparoscopic appendectomy is safe in patients with chronic appendicitis and allows for judicious diagnostic evaluation of the appendiceal mass and planned surgery under controlled conditions.

Correlates of psychological dimensions in talker similarity.

This investigation identifies correlates of psychological dimensions in talker similarity. Twenty adult male talkers recorded a monosyllabic word, and 13 acoustic measurements were made from spectrograms of each talker's production. All possible pairs of voices were presented to 11 adult listeners for similarity judgments via a paired-comparison paradigm. A four-dimensional INDSCAL analysis of the similarity ratings was employed to derive psychological dimensions of talker similarity. Correlations between the acoustic measurements and the INDSCAL dimensions revealed that fundamental frequency and word duration were moderately correlated with two of the psychological dimensions. The other two dimensions were not convincingly correlated with any of the acoustic measurements, but are best described as representing voice quality and talker age. A listener's familiarity with the talkers did not seem to influence his judgment of voice similarity.