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Biomedical subjects

H Schipper

Publications and source records attributed to H Schipper.

At least 55 records · Page 3Linked to original sources

[Subclinical eye movements as an indicator for inheritance of congenital nystagmus and central nervous system disease].

Clinically unaffected relatives of families with a history of either inherited congenital nystagmus or inherited neurogenic muscular and cerebellar atrophy underwent electrooculographic examination under three distinct test conditions. We found an increase in the number of square wave jerks, a higher than normal intensity score (defined in terms of frequency X amplitude of an involuntary saccade, unit: o/s) and nystagmus as compared with 110 normal individuals ranging in age from 21 to 89 years. These findings suggest a possible autosomal dominant mode of inheritance in the case study of congenital nystagmus presented. The results show abnormal eye movements in some family members from a family with inherited cerebellar degeneration with acquired nystagmus, suggesting that these family members are affected with the disorder. This study documents the rarely described observation of a connection between inherited cerebellar degeneration with inherited distal neurogenic muscular atrophy.

Adult↗

Guidelines and caveats for quality of life measurement in clinical practice and research.

"Quality of Life" is rapidly becoming part of the clinical evaluation process, both as a specific outcome measure in formal clinical trials, and as a bedside concept. This paper provides an historical perspective on the development of the paradigm, and outlines its basic properties. Finally, some pragmatic guidelines for the design, conduct and interpretation of quality of life trials are offered in order that a standard for implementation and evaluation may be developed.

Clinical Trials as Topic↗

[Quality of life in cancer patients].

Quality of life (QOL) is defined as "representation of people's day-to-day function". It has four components: physical and occupational functions, social interaction, psychological state, and somatic sensation. QOL can be mathematical presentation of these four component factors. QOL measurement tools (questionnaires) should have core modules as well as disease-specificity, simplicity, validity and reliability. At present, several patients' self-assessment questionnaires are widely used practical at the aims to assess what happens in the cancer patients and to improve the cancer treatment. A QOL study trials should be scientific. However, QOL is popular terms that there is a tendency to abuse it, and, therefore, to set up the study to get contradictory results. The author would introduce a practical overview of the tactics to perform a QOL research trial.

Humans↗

Methotrexate-related multifocal axonopathy. Report of an autopsy case.

A case of multifocal axonopathy associated with intrathecal methotrexate (IT MTX) and radiation therapy is presented. A 33-year-old woman suffering from meningeal carcinomatosis of breast cancer origin had developed prominent multifocal axonal degeneration in the cerebral white matter after treatment with IT MTX therapy and cranial irradiation. The principal features of this axonal degeneration were segmental hydropic swellings, macrophage infiltration of swollen axons, and scattered spheroid formation associated with reactive astrocytosis. These features were similar to those observed in our previous experimental study using cats treated with IT MTX alone. This "multifocal axonopathy" without necrotizing lesions seems to be different from disseminated necrotizing leukoencephalopathy, and, therefore, may be another form of MTX-related leukoencephalopathy. IT MTX and cranial irradiation seem to have exerted synergistic effects in producing the "multifocal axonopathy" in this case.

Adult↗

Doxorubicin-containing regimens for the treatment of stage II breast cancer: The National Surgical Adjuvant Breast and Bowel Project experience.

Despite numerous reports of findings obtained following the use of doxorubicin (Adriamycin [A]; Adria Laboratories, Columbus, OH) for the postoperative treatment of patients with primary breast cancer and positive axillary nodes, no clear consensus exists regarding its worth when used in that setting. In June 1981, the National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented two randomized clinical trials aimed at evaluating the worth of doxorubicin when administered in conjunction with melphalan (L-PAM) and fluorouracil (5-FU) (PF). A prior NSABP study identified cohorts of patients who did or did not benefit from tamoxifen (TAM, T) when used with chemotherapy. That information was employed in the design of the present studies. Women considered responsive to TAM (1,106) were randomized between PFT and PAFT, and those nonresponsive to TAM (707) were randomized between PF and PAF. Findings through 6 years of follow-up (mean duration of potential time on study, 64 months and 63 months, respectively) indicate that non-TAM-responsive patients who received PAF had a significantly better disease-free survival (DFS) (P = .003) and survival (P = .05) than did those receiving PF. By contrast, there was no significant difference in DFS (P = .6) or survival (P = .7) between PFT- and PAFT-treated patients. No disparity in the amount of drug received, whether related to the median amount or to dose-intensity, is present to account for the difference in findings between the studies. Aside from alopecia and emesis, the toxicity from the doxorubicin-containing regimens was similar to those in which doxorubicin was omitted. Cardiomyopathy was not a significant finding; there were no deaths from cardiac toxicity. The incidence of arterial and venous complications in patients receiving TAM was less than reported by others.

Aged↗

MR imaging of pseudotumor cerebri.

Eleven obese young women with idiopathic pseudotumor cerebri were studied with high-field-strength (1.5 T) MR imaging to demonstrate increased water content in the brains of such patients. Heavily T2-weighted studies were obtained for 10 patients, and balanced (long TRs, short TEs, spin density, proton density) pulse sequences were obtained for four patients. We examined the studies of morphologically normal periventricular white matter and developed a white matter water index to determine if a slight increase in signal was present that could be ascribed to low levels of edema. Comparison was made to an age-matched control group. We also examined five patients with sodium MR imaging. Two of the 11 patients had focal areas of increased signal in their periventricular white matter. Presumably, these are areas of increased edema above the background that could not be detected on the CT scan. The white matter water index for the normal controls was an average of 0.479 (+/- 0.015), while that of the pseudotumor cerebri group was 0.520 (+/- 0.016). This indicates an increase in the white matter water signal. We believe this represents a diffuse low level of edema. These findings are consistent with previous estimates of the increase in brain water in patients with idiopathic pseudotumor cerebri. The patients with focally abnormal proton studies demonstrated similar abnormalities on their sodium studies.

Adult↗

Prolonging tamoxifen therapy for primary breast cancer. Findings from the National Surgical Adjuvant Breast and Bowel Project clinical trial.

OBJECTIVE: To determine whether prolonging the duration of tamoxifen administration beyond the cessation of a combined chemotherapy regimen benefits patients with primary breast cancer with positive findings in axillary nodes who benefit initially from the combined regimen. DESIGN: Nonrandomized, nonconcurrent cohort study. SETTING: National Surgical Adjuvant Breast and Bowel Project, conducted in 68 institutions in North America. PATIENTS: Women were included if they had breast cancer with positive nodes and were aged 49 years or less with both estrogen and progesterone receptor levels of 10 fmol or more, aged 50 to 59 years with progesterone receptor levels of 10 fmol or more, or aged 60 to 69 years. Two cohorts were compared: patients who were randomly assigned to the tamoxifen arm of the adjuvant chemotherapy trial (randomized patients) and women who were added to this arm after randomization had ceased (registered patients). Three hundred seventy-seven women in each group who were disease free at the end of the initial 2-year treatment period were followed for an additional 3 years. INTERVENTIONS: All received melphalan, fluorouracil, and tamoxifen (10 mg twice daily by mouth) for 2 years. Registered patients (but not randomized patients) were offered tamoxifen for a third year after the initial 2-year treatment period, and 273 (72%) agreed. MEASUREMENTS AND MAIN RESULTS: Women receiving a third year of tamoxifen had a better disease-free survival rate (odds ratio, 1.54; 95% confidence interval, 1.14 to 2.07; p = 0.004) and survival rate (odds ratio, 1.56; 95% Cl, 1.02 to 2.37; p = 0.04) through their fifth postoperative year. Women aged 50 years or more benefited, but those aged 49 years or less did not. CONCLUSIONS: The benefit of tamoxifen given to tamoxifen-responsive patients in conjunction with melphalan and fluorouracil appears to be enhanced when the tamoxifen treatment is continued beyond cessation of treatment with these agents.

Actuarial Analysis↗

Measuring quality of life: risks and benefits.

Quality of life research is an emerging science of particular relevance to clinical cancer research. The development and utilization of valid and reliable quality of life measures as outcome parameters may profoundly alter the clinical trials process. Such measures, contrary to prevailing opinion, may be as accurate and precise as conventional measures, but considerably more relevant to the trials process. However, lack of rigor in the evaluation of such indices and uncritical interpretation of results may seriously compromise the credibility of the concept. This overview of the current status of quality of life research is designed to provide a perspective from which to evaluate ongoing development.

Acute Disease↗

Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation.

The classical criteria for the evaluation of clinical trials in cancer reflect alterations in physical well-being, but are insensitive to other important factors, such as psychosocial state, sociability, and somatic sensation that may play a critical role in determining the patients' functional response to their illness and its treatment. The Functional Living Index-Cancer is designed for easy, repeated patient self-administration. It is a 22-item questionnaire that has been validated on 837 patients in two cities over a three-year period. Criteria for validity include stability of factor analysis, concurrent validation studies against the Karnofsky, Beck Depression, Spielberger State and Trait Anxiety, and Katz Activities of Daily Living scales, as well as the scaled version of The General Health Questionnaire and The McGill/ Melzack Pain Index. The index is uncontaminated by social desirability issues. The validation studies demonstrate the lack of correlation between traditional measures of patient response and other significant functional factors such as depression and anxiety (r = 0.33), sociability and family interaction, and nausea. These findings elucidate the frequently observed discrepancies between traditional assessments of clinical response and overall functional patient outcome. The index is proposed as an adjunct to clinical trials assessment and may provide additional patient functional information on which to analyse the outcome of clinical trials or offer specific advice to individual patients.

Canada↗

Randomized study of cyclophosphamide, doxorubicin, and etoposide (VP16-213) with or without cisplatinum in non-small cell lung cancer.

Sixty-eight patients with non-small cell lung cancer were treated in a prospectively randomized study with cyclophosphamide, doxorubicin (Adriamycin), and etoposide (VP16-213) with cisplatinum (CAE +/- P). Response rate, time to progression, and survival of CAE-P treated patients were each superior compared to those of patients who received CAE therapy. Of 36 patients, 10 (4 complete remissions, 6 partial remissions) responded to CAE-P and of 29 patients 3 (1 complete remission, 2 partial remissions) responded to CAE (p = 0.073). The median time to treatment failure was 22.9 wk for the CAE-P regimen and 15.0 wk for CAE (p = 0.032). The median survival for patients treated on the regimen with and without cisplatinum was 34.5 and 22.5 wk, respectively (p = 0.04). There were two CAE-P and one CAE drug-related deaths. Toxic effects were more severe in the CAE-P regimen. The addition of cisplatinum to the CAE combination produced an increase in response rate with significant prolongation in both time to progression and survival, but did add morbidity. These results suggest that the combined use of cisplatinum with at least one of the chemotherapeutic agents in the CAE regimen is synergistic.

Adenocarcinoma↗