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P H Bagley

Publications and source records attributed to P H Bagley.

7 recordsLinked to original sources
PubMed2001

Limitations of randomized clinical trials for evaluating emerging operations: the case of lung volume reduction surgery.

Although unanswered questions remain, scores of observational studies and several small randomized clinical trials (RCTs) indicate that lung volume reduction surgery (LVRS) offers safe and effective palliation for a relatively well defined subset of patients with advanced emphysema. Nonetheless, Medicare and other insurers stopped reimbursement for the procedure. Subsequently, two multicenter RCTs on LVRS, the National Emphysema Treatment Trial (NETT) and the Overholt-BlueCross Emphysema Surgery Trial (OBEST), were launched with the stipulation that the procedure would not be paid for outside these trials. Thus access to LVRS has been denied to patients who could benefit but do not wish to participate in an RCT. Emerging operations, unlike new drugs or devices, pass through evolutionary changes and frequently fail to produce data that meet the scientific rigor required by randomized studies. In such a setting, the observational approach is more appropriate. Indeed, almost all operations in the present surgical armamentarium have been evaluated and have evolved through observational studies without the use of RCTs. By the time new operations are standardized and qualify for RCTs, benefits for certain patients may be demonstrated and randomization could involve unacceptable health hazards. Patients from this population should be offered the choice between participating in RCTs and having the operation outside the study. Imposition of financial restrictions that bars access to a therapy with known benefit is a questionable practice.

Bias↗
PubMed1997

A community-based regional ventilator weaning unit: development and outcomes.

STUDY OBJECTIVE: Description of the development of a community-based weaning unit and the outcomes from that unit. DESIGN: Review of admissions, classified by etiology of ventilator dependence, with attention to disposition, length of stay, and time to wean. SETTING: Long-term acute-care facility in Worcester, Mass. PATIENTS: Two hundred seventy-eight ventilator-dependent patients admitted to a ventilator unit from 1988 through May 1995. Admissions criteria did not include prognostic considerations. INTERVENTIONS: Selected patients were entered into a formal weaning program beginning in 1992. MEASUREMENTS: Through the study period, there was a substantial growth in annual admissions, primarily due to increases in patients surviving a catastrophic acute illness. Overall, 107 of 278 (38%) patients were liberated from mechanical ventilation for at least 7 consecutive days and nights. Of the patients admitted 1993 to 1995, 31% died, 20% were discharged to a long-term care facility, 29% returned home, and 18% either remained as residents of the unit or had been transferred to acute-care facilities and were unavailable for follow-up. The highest weaning success was seen in patients with ventilator dependence from postoperative causes (58%) and acute lung injury (57%); the least success was seen in patients with ventilator dependence from COPD and neuromuscular diseases (22% each). The average time from admission to weaning fell within each diagnostic category throughout the study period. CONCLUSIONS: Rehabilitation-based ventilator weaning units play an important role in the spectrum of medical care necessary in population centers. Excellent results can result from community-based units with open admissions policies.

Adult↗
PubMed1997

Lung volume reduction surgery at a community hospital: program development and outcomes.

STUDY OBJECTIVES: Description of the development and results of a program in lung volume reduction surgery (LVRS) at a community hospital. DESIGN: Prospective data collection. SETTING: A 320-bed community hospital. PATIENTS: Fifty-five patients consecutively discharged from the hospital following LVRS. The mean preoperative FEV1 averaged 28% (+/-8%) of predicted values, while the preoperative PaCO2 averaged 49 mm Hg (+/-11.5 mm Hg). Forty-eight patients completed a preoperative conditioning regimen and underwent the procedure on an elective basis. Seven patients underwent the procedure during a hospital admission for a COPD exacerbation. Eight patients required mechanical ventilation preoperatively, including three who had required long-term mechanical ventilatory support. RESULTS: Three patients (5%) died in the hospital following surgery. One patient developed chronic ventilator dependence. All three of the patients who required long-term mechanical ventilation preoperatively were weaned from the ventilator and returned home. Follow-up pulmonary function testing is available for 42 patients 3 months after surgery, and for 20 patients 6 months after the operation. At 3 months, the mean FEV1 improved 0.19 L (p=0.0002), the mean improvement for FVC was 0.37 L (p=0.0001), and the mean drop in residual volume was 0.97 L (p=0.0001). Similar changes are seen at 6 months. Highly significant improvements were also seen in quality of life measurements and exercise performance. The benefits of surgical treatment of emphysema seemed similar in both elective and urgent groups. CONCLUSIONS: LVRS can be done safely and effectively at a community hospital, with significant improvement in pulmonary function and quality of life.

Adult↗