Pain palliation measurement in cancer clinical trials: the US Food and Drug Administration perspective.

BACKGROUND: Pain palliation resulting from antitumor therapy provides direct evidence of treatment benefit when combined with evidence of antitumor activity. The US Food and Drug Administration (FDA) previously issued guidance regarding the use of patient-reported outcome (PRO) measures to support labeling claims. The purpose of this article is to identify common challenges and key design strategies when measuring pain palliation in antitumor therapy clinical trials that are consistent with PRO Guidance principles. METHODS: Antitumor clinical protocols submitted to the FDA between 1995 and 2012 that included pain palliation as a primary or secondary endpoint were reviewed. Challenges in critical trial design components were identified. Design strategies consistent with PRO Guidance principles are proposed. RESULTS: The challenges identified were measurement of pain intensity and analgesic use, enrollment eligibility criteria, data collection methods, responder definitions, missing data, and blinding. Strategies included the use of well-defined, reliable, PRO assessments of pain intensity and analgesics; ensuring that enrollment criteria define patients with clinically significant pain attributable to cancer on an optimal analgesic regimen; defining responders using both pain and analgesic use criteria; incorporating an analysis of tumor response to support evidence of pain response; and minimizing missing data and inadvertent unblinding. CONCLUSIONS: Improvement in cancer-related pain resulting from antitumor therapy is an important treatment benefit that can support drug approval and labeling claims when adequately measured if study results demonstrate statistically and clinically significant findings. Sponsors are encouraged to discuss pain palliation assessment methods with the FDA early in and throughout product development.

Gender schema and prostate cancer: veterans' cultural model of masculinity.

Coming to terms with disease, chronic illness, and aging may be challenging for men who adhere to an inflexible gender schema. In this study of elder U.S. veterans' ideas about masculinity, we find that prostate cancer patients reaffirm a strongly moral normalizing discourse about "being a man" yet tend to separate roles and values from male physical and sexual attributes. Using systematic data collection methods taken from cognitive anthropology, we map veterans' schema of masculinity and examine the relative importance that cancer patients and non-patients give to gender attributes. The results demonstrate the complementarity between cognitive and narrative approaches in medical anthropology. This research also suggests the hypotheses that (1) coming to terms with iatrogenesis may involve a subtle reformulation of masculinity and that (2) men with a fixed view of masculinity may have worse health outcomes than do those who accept the changes accompanying their treatment for prostate cancer.

Nutritional status of children undre 5 years of age in three hurricane-affected areas of Honduras / Estado nutricional de niños menores de 5 años en tres zona de Honduras azotadas por un huracán

Hurricanes and other natural disasters can produce crop destruction, population displacement, infrastructure damage, and long-term public health consequences that include increased malnutrition among the affected populations. This paper presents the results of anthropometric measurements taken of 295 children under 5 years of age from three regions of Honduras that were affected by Hurricane Mitch, a major storm that struck Central America in the fall of 1998. The children in our study were sampled in three shelters in the capital city of Tegucigalpa; in the resettlement zone of Nueva Choluteca, Choluteca; and in the small urban area of Catacamas, Olancho. Our data indicated that, in comparison to the period before the hurricane, there was an elevated prevalence of wasting in all three of the study areas, and that there were also high levels of underweight in the Tegucigalpa and Nueva Choluteca study areas. There were statistically significant differences between the mean values of malnutrition indicators for Catacamas and those for the Tegucigalpa and Nueva Choluteca settlements. These differences suggest that resettled families were confronting a nutritional crisis in July and August of 1999, some 9 months after the hurricane struck

Los huracanes y otros desastres naturales pueden destruir cosechas, desplazar a poblaciones enteras, causar daños infraestructurales y acarrear consecuencias a largo plazo para la salud pública, entre ellas un aumento de la desnutrición en las poblaciones afectadas. Este trabajo presenta los resultados de las mediciones antropométricas de 295 niños menores de 5 años de tres zonas de Honduras que fueron azotadas por el huracán Mitch, tempestad que azotó Centroamérica en el otoño de 1998. Los niños que participaron en nuestro estudio provinieron de tres alojamientos provisionales, uno en la capital del país, Tegucigalpa; otro en la zona de asentamiento para refugiados de Nueva Choluteca, Choluteca; y otro en la pequeña zona urbana de Catacamas, Olancho. Según indican nuestros datos, en comparación con el período anterior al huracán, la frecuencia de emaciación en las tres zonas fue alta, como también lo fue la de peso subnormal en las zonas de estudio de Tegucigalpa y Nueva Choluteca. Hubo diferencias estadísticamente significativas entre los valores promedio de los indicadores de desnutrición en Catacamas y los de los asentamientos de Tegucigalpa y Nueva Choluteca. Estas diferencias indican que las familias desplazadas enfrentaban una crisis nutricional en julio y agosto de 1999, alrededor de 9 meses después de la llegada del huracán