Quality and accountability in the ESRD program

The quality of care received by patients with end-stage renal disease (ESRD) in the United States has received considerable public attention during the past several years because of a number of social, economic, and political factors. There has been a lingering impression that the poorer survival of dialysis patients in the United States, compared with their counterparts in other industrialized countries, is because of process factors for which there are opportunities for improvement, rather than just an adverse case mix. Recent reports by the Office of the Inspector General and the General Accounting Office have recommended that the Health Care Financing Administration (HCFA) improve its oversight of dialysis providers and hold the providers more accountable for their patient care outcomes. This requires the development of validated clinical performance measures that, in turn, should be derived from evidence-based clinical practice guidelines. The dual oversight model, with the state survey agencies agencies performing a quality assurance function to require facilities to meet minimal standards of operation (Medicare's conditions of participation) to prevent patient harm, and with the ESRD Networks performing a quality improvement function to bring processes and outcomes for all patients to a higher level, appears to be sound. HCFA's move toward increased provider accountability has included the development of facility-specific profiles for processes of care (dialysis adequacy) and outcomes (hemoglobin level and standardized mortality ratio), which may trigger state surveyor activities and that will be available for public scrutiny on a HCFA-sponsored web site. The adoption and application of continuous quality improvement methodologies at the dialysis provider level will be an important strategy for favorably positioning the facility in a competitive and demanding health care marketplace.     

What is expected of a medical director in the Centers for Medicare and Medicaid Services Conditions of Coverage?

The Medicare Conditions for Coverage for dialysis facilities, effective since 2008, make the medical director responsible for all levels of quality patient care in the facility. This includes issues such as water quality, infection control, staff education, policy/procedure development and implementation, dialyzer reuse, involuntary discharges, and patient safety. Most importantly, the medical director is the leader of the team responsible for quality assessment and performance improvement, which is central to the process of continuous quality improvement in the dialysis facility and the basis for much of Medicare's evaluation of facility performance. Through the measures assessment tool, the Conditions for Coverage specify the required domains for quality improvement activities in the dialysis facility, including dialysis adequacy, nutrition, bone disease, anemia management, vascular access, medical errors, patient satisfaction, and infection control. Under the leadership of the medical director, the quality assessment and performance improvement team identifies opportunities for improvement, tests and implements interventions, collects data, interprets results, and links system change with improved outcomes. These activities are rigorously documented and provide evidence to Medicare that the facility is acting responsibly to provide the best possible services for which it is being paid. The medical director is fairly compensated for his/her services by the facility, but must always act in the patients' best interest when evaluating policy changes directed at cost containment. The success of a medical director in shepherding positive change in a dialysis facility can be immensely satisfying as it impacts on patients other than his/her own.     

Subgroup analysis of a randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure

Background

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF ≤35% and narrow QRS randomized to optimal medical treatment (OMT) plus CCM (n = 215) versus OMT alone (n = 213) and found no significant effect on ventilatory anaerobic threshold (VAT), the study’s primary end point. In the present analysis, we sought to identify if there was a subgroup of patients who showed a response to CCM.

Methods and Results

The protocol specified that multiregression analysis would be used to determine if baseline EF, NYHA functional class, pVO₂, or etiology of heart failure influenced the impact of CCM on AT. Etiology and baseline pVO₂ did not affect efficacy. However, baseline NYHA functional class III and EF ≥25% were significant predictors of increased efficacy. In this subgroup (comprising 97 OMT and 109 CCM patients, ∼48% of the entire population) VAT increased by 0.10 ± 2.36 in CCM versus −0.54 ± 1.83 mL kg⁻¹ min⁻¹ in OMT (P = .03) and pVO₂ increased by 0.34 ± 3.11 in CCM versus −0.97 ± 2.31 (P = .001) at 24 weeks compared with baseline; 44% of CCM versus 23% of OMT subjects showed improvement of ≥1 class in NYHA functional class (P = .002), and 59% of CCM versus 42% of OMT subjects showed a ≥10-point reduction in Minnesota Living with Heart Failure Questionnaire (P = .01). All of these findings were similar to those seen at 50 weeks.

Conclusions

The results of this retrospective hypothesis-generating analysis indicate that CCM significantly improves objective parameters of exercise tolerance in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and EF >25%.     

Erythropoiesis-stimulating agents and pure red-cell aplasia: you can't fool Mother Nature

Subtle alterations in the properties of biopharmaceutical agents may increase their immunogenicity and lead to the production of autoantibodies. Biosimilar agents may not undergo the same quality control in their production, packaging, storage, and distribution as their patented competitors. The extensive use of biosimilar erythropoiesis-stimulating agents led to an epidemic of pure red-cell aplasia in Thailand. The response of Thai regulators may be a model for other countries as the use of biosimilar agents expands.     

Diurnal changes in retinal nerve fiber layer thickness with obstructive sleep apnea/hypopnea syndrome

AIM: To compare the retinal nerve fiber layer (RNFL) thickness in the morning and evening in Thai patients with varying degrees of obstructive sleep apnea/hypopnea syndrome (OSAHS). METHODS: In this cross-sectional study, potential OSAHS patients at Siriraj Hospital underwent polysomnography to determine the severity of OSAHS and an eye examination (including best corrected visual acuity, slit-lamp examination, and Goldmann applanation tonometry). RNFL thickness was recorded once in the morning and once in the evening, using spectral domain optical coherence tomography. Thickness was expressed as an average and given for each quadrant. Patients with ocular or systemic diseases that might affect RNFL thickness were excluded. RESULTS: Forty-one eyes of 41 patients were classified into 4 OSAHS groups. The average and mean RNFL thickness in most of the four quadrants of the severe OSAHS group trended toward being less than those in the comparable quadrants of the other groups in both the morning and evening. In the moderate OSAHS group, the average RNFL thickness and temporal and superior quadrant thickness in the morning were significantly higher than in the evening (P=0.01, P=0.01, and P=0.03, respectively). In the severe OSAHS group, the inferior quadrant thickness in the morning was significantly higher than in the evening (P=0.03). CONCLUSION: The RNFL thickness in the morning was higher than in the evening in moderate OSAHS.     

Endoscopic sinus surgery for benign and malignant nasal and sinus neoplasm

PURPOSE OF REVIEW: Endoscopic sinus surgery has become widely accepted as the standard of treatment for chronic inflammatory diseases of the paranasal sinuses unresponsive to medical treatment. With increased skill with endoscopic surgical technique, advanced technologies such as intraoperative imaging systems, and a better understanding of the complex anatomy of the paranasal sinuses and surrounding vital structures, many otolaryngologists have increasingly applied their expertise in endoscopic sinus surgery to the resection of nasal and sinus neoplasms. The following represents a review of the recent literature on the latest trends regarding endoscopic resection of nasal and paranasal sinus neoplasms. RECENT FINDINGS: There has been an increasing popularity in the removal of nasal and paranasal sinus neoplasms through an endoscopic approach. In the recent literature, emphasis has been on the endoscopic surgery of benign tumors, especially inverted papilloma and nasopharyngeal angiofibroma. Other benign neoplasms have also been reported, but only in small case reports. There have been a few recent reports supporting endoscopic removal of malignant neoplasms as well. However, the follow-up is too short and study groups too small to make definitive conclusions. SUMMARY: In the hand of experienced and skilled surgeons, complete endoscopic removal is attainable in most cases. Especially for the more common benign neoplasms, such as inverted papilloma and early stage angiofibroma. En bloc resection is not necessary to achieve oncologic cure. However, several factors have to be considered before selection of this surgical approach. Large tumor size, intracranial or orbital extension, and extensive frontal or infratemporal fossa involvement are relative, but not absolute limitations.