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J W Novak

Publications and source records attributed to J W Novak.

11 recordsLinked to original sources

Current concepts. Continuous ambulatory peritoneal dialysis.

As a long-term dialysis therapy, CAPD has attractive features for use in children (in whom access to the circulation and immobility are often problems), adults in whom blood access is difficult, patients with diabetes, patients prone to hypotension, and patients seeking independence from a machine or medical facility. CAPD and related procedures are still evolving and improving. Efforts to reduce the rates of peritonitis are ongoing and should decrease the rates of treatment dropout and increase the use of this alternative method of dialysis. Continued research toward improvements in catheter configuration and connection devices and the tailoring of technique to meet the particular needs of patients have made peritoneal dialysis an acceptable replacement therapy in patients with end-stage renal disease. Neither peritoneal dialysis nor hemodialysis is the superior long-term dialysis therapy for all patients; the choice depends on numerous medical, social, geographic, and life-style considerations.

Child↗

Perineal effects of postoperative treatment for adenocarcinoma of the rectum.

Nine (4%) first recurrences that involved the perineum were identified in a randomized study of 202 patients treated by no further therapy, chemotherapy only, radiotherapy only, combined radiotherapy and chemotherapy, following complete surgical excision of adenocarcinoma of the rectum. Six of these were in unirradiated patients and in two of the three irradiated patients the perineum was included in the treatment volume. Eight of the nine patients were male and all nine had received abdominoperineal resection (APR). Our quality assurance procedures identified 22 of 96 irradiated patients in whom the perineum was grossly outside the fields. Sixteen of these had undergone APR. As only one of these 16 relapsed in the perineum no definite effect of the surgical procedure on the likelihood of perineal recurrence could be demonstrated. Examination of the pathology reports revealed that 28 patients undergoing APR had tumors within 2 cm of the anorectal junction (pectinate line). Five (17.8%) developed perineal recurrence compared with 4 (3.6%) of 110 patients whose tumors were more than 2 cm from the anus (p less than 0.02-Fisher exact test). No survival differences could be demonstrated between those receiving perineal irradiation and those not but perineal irradiation was associated with toxicity with at least nine (12.2%) out of 74 developing severe complications directly related to the perineum. The routine inclusion of the perineum in postoperative pelvic irradiation fields for all cases of adenocarcinoma of the rectum is questioned. Our current policy following APR includes optional coverage of the perineum for those tumors more than 5 cm from the anorectal junction.

Adult↗

Continuous ambulatory peritoneal dialysis in the United States: a three-year study.

This report of the NIH-supported National Continuous Ambulatory Peritoneal Dialysis (CAPD) Registry summarizes data on 7,404 patients treated with CAPD during the three-year period 1981 through 1983, or nearly one-half of patients treated in the USA who were treated with CAPD during this time. While age and diabetes mellitus impact on mortality, they appear to have a limited influence on transfer or infection rate. There were 1.7 episodes of peritonitis, 0.7 exit site/tunnel infections, and 0.3 catheter replacements reported per patient year of observation. Patients averaged 10.2 hospital days per year for CAPD complications and 22.3 hospital days per year for all causes. Comparisons of these data with similar data reported for other therapies are subject to variations in the distribution of population and disease characteristics, as well as the length of the observation period.

Actuarial Analysis↗

Therapy of locally unresectable pancreatic carcinoma: a randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil: The Gastrointestinal Tumor Study Group.

One-hundred-ninety-four eligible and evaluable patients with histologically confirmed locally unresectable adenocarcinoma of the pancreas were randomly assigned to therapy with high-dose (6000 rads) radiation therapy alone, to moderate-dose (4000 rads) radiation + 5-fluorouracil (5-FU), and to high-dose radiation plus 5-FU. Median survival with radiation alone was only 51/2 months from date of diagnosis. Both 5-FU-containing treatment regimens produced a highly significant survival improvement when compared with radiation alone. Forty percent of patients treated with the combined regimens were still living at one year compared with 10% of patients treated with radiation only. Survival differences between 4000 rads plus 5-FU and 6000 rads plus 5-FU were not significant with an overall median survival of ten months. Significant prognostic variables, in addition to treatment, were pretreatment performance status and pretreatment CEA level.

Adenocarcinoma↗

Analysis of survival data with nonproportional hazard functions.

The log-rank test or the proportional hazard model is a valuable, widely accepted method for analyzing time-to-response data from comparative clinical trials. When the hazard ratio is constant in time, this procedure is optimal. Indiscriminate or unthinking use of this approach results in problems in the determination of treatment differences. For example, when the true survival curves intersect, the hazard ratio cannot be constant, i.e., the hazard functions are not proportional. It is shown that by considering time-by-treatment interactions we gain flexibility in describing the relationships among hazard functions. In this paper we demonstrate with the results of a clinical trial how available methodology can be used to permit tests for the appropriateness of the model and to enable informative analysis of such data.

Clinical Trials as Topic↗

A survey of the NIH CAPD Registry population with end-stage renal disease attributed to diabetic nephropathy.

A survey of CAPD/CCPD patients with end-stage renal disease attributed to diabetes mellitus done by the USA NIH CAPD Registry obtained information from 499 patients. These data suggest that in diabetics with renal insufficiency, the time interval from age at diagnosis of diabetes to initiation of dialysis decreases as the age of diagnosis increases. Mean interval from the time of diabetes diagnosis to CAPD or CCPD initiation was 25 years for patients less than 20 years of age at diagnosis and 17 years for patients greater than or equal to 30 years of age. This trend is independent of the type of diabetes management and appeared to be independent of the type of diabetes. Patients were categorized on the basis of pre- and post-CAPD management of hyperglycemia. There were several associations noted between type of diabetes therapy and clinical findings: A higher proportion of legally blind patients had used insulin only (33%) compared with patients never using insulin (10%) and 78% of patients using insulin only were white compared with 49% among the never on insulin group. This latter result indicates that race influences the type of diabetes and/or progression of diabetes to renal insufficiency. Patients on insulin only reported parents and/or siblings with diabetes less often than did patients using insulin and oral agents, some insulin, or never any insulin to manage their diabetes. The authors also noted that peritonitis rates were not increased in those patients who added insulin to dialysis solutions.

Adult↗

Factors associated with morbidity and mortality among patients on CAPD.

Since 1981, the National CAPD Registry, sponsored by the National Institute of Arthritis, Diabetes, Digestive, and Kidney Diseases of the National Institutes of Health, has been systematically collecting demographic and follow-up data on patients receiving continuous ambulatory peritoneal dialysis (CAPD) as maintenance therapy for end-stage renal disease. Using life-table methods, this study has identified the association of diabetic glomerulosclerosis with age over 60 or under 20 years as factors jointly relevant in predicting peritonitis, hospitalization, or death. In addition, these outcomes were more likely to occur if patients were black and had been exposed to other dialytic therapy earlier on. The latter two were the only factors jointly predictive of transfer from CAPD onto hemodialysis. Careful monitoring of patients with the above mentioned characteristics may reduce complications, and lead to greater success with this increasingly popular dialysis modality.

Adult↗

The 1987 USA National CAPD Registry report.

The National CAPD Registry has noted encouraging trends in CAPD therapy in the U.S. Recently, trained patients have reported lower peritonitis rates, fewer days hospitalized for dialysis-related events, and lower probability of developing a first episode of a complication. If accumulating experience, better patient selection, and new technologic developments further these trends, then the relatively high transfer rates should begin to decrease since many transfers are related to peritonitis and other complications. The Registry's observations suggest that CAPD is an evolving therapy and that as complication rates and transfer rates decrease, CAPD may play an even greater role in the treatment of patients with end-stage renal disease.

Female↗