Preference and Expectation for Treatment Assignment in a Randomized Controlled Trial of Once- vs Twice-weekly Yoga for Chronic Low Back Pain.

BACKGROUND: In studies involving nonpharmacological complementary and alternative medicine interventions, participant blinding is very difficult. Participant expectations may affect perceived benefit of therapy. In studies of yoga as treatment for chronic low back pain, little is known about the relationship between patient expectations and preferences on outcomes. This study was designed to identify baseline predictors of preference and to determine if expectations and preferences for different doses of yoga affect back-related function and low back pain intensity. METHODS: This was a secondary data analysis of a 12-week randomized controlled trial comparing once-weekly vs twice-weekly yoga for treatment of chronic low back pain in 93 adults from a predominantly low-income minority population. At baseline, participants were asked about back function, back pain, treatment expectations, and treatment preferences. We created a variable "concordance" to describe the matching of participant preference to randomized treatment. Our outcome variables were change in back function and pain intensity after 12 weeks of yoga instruction. We performed logistic regression to identify predictors of preference for once- or twice-weekly yoga instruction. We created linear regression models to identify independent associations between expectations, preference, concordance, and outcomes. RESULTS: Worse back function at baseline was associated with 20% higher odds of preferring twice-weekly yoga (OR 1.2, CI 1.1, 1.3). Individuals with higher expectation scores for twice-weekly yoga had 90% higher odds of preferring twice-weekly vs once-weekly yoga (OR 1.9, CI 1.3, 2.7). Individuals with higher expectation scores for once-weekly yoga had 40% less odds of preferring twice-weekly yoga (OR 0.6, CI 0.5, 0.9). After controlling for baseline characteristics, we found no statistically significant relationship between treatment outcomes, preference, expectation scores, or concordance. CONCLUSION: In a population of predominantly low-income minority participants with chronic low back pain, worse back function was associated with preference for more frequent yoga classes. Those who preferred more yoga classes had higher expectations for those classes. Twelve-week change in back pain intensity and back function were not affected by dosing preference, expectation score, or concordance. More research is needed to better measure and quantify preference, expectations, and their relationship to outcomes in yoga research.

Antecedentes: En estudios que incluyen intervenciones complementarias no farmacológicas y de medicina alternativa es muy difícil realizar estas de manera ciega para los participantes. Las expectativas de los participantes pueden afectar el beneficio percibido de la terapia. En estudios del yoga como tratamiento del dolor lumbar crónico, se sabe poco de la relación entre las expectativas del paciente y las preferencias sobre los resultados. Este estudio se diseñó para identificar los predictores iniciales de preferencia y para determinar si las expectativas y preferencias para dosis diferentes de yoga afectaban la funcionalidad relativa a la espalda y la intensidad de dolor lumbar.Métodos: Este fue un análisis de datos secundarios de un ensayo aleatorio controlado de 12 semanas que comparó yoga una vez a la semana frente a dos veces a la semana para el tratamiento del dolor lumbar crónico en 93 adultos de una población minoritaria predominantemente de ingresos bajos. En el momento inicial, se les preguntó a los participantes sobre el dolor y la funcionalidad de sus espaldas, las expectativas del tratamiento y las preferencias del mismo. Creamos una "concordancia" variable para describir la correspondencia entre las preferencias del paciente y el tratamiento aleatorizado. Nuestras variables de resultados fueron el cambio de la funcionalidad de la espalda y la intensidad del dolor después de 12 semanas de sesiones de yoga. Realizamos una regresión logística para identificar los predictores de preferencias para las sesiones semanales o bisemanales de yoga. Creamos modelos de regresión lineal para identificar las asociaciones independientes entre expectativas, preferencias, concordancia y resultados.Resultados: Una peor funcionalidad de la espalda en el inicio se asoció con un 20% de mayor probabilidad de preferir yoga dos veces a la semana (TP 1,2, IC 1,1, 1,3). Los individuos con mayores escalas de expectativas de yoga dos veces a la semana tuvieron un 90% más de probabilidades de preferir yoga dos veces a la semana que una vez a la semana (TP 1,9, IC 1,3, 2,7). Los individuos con mayores escalas de expectativas de yoga una vez a la semana tuvieron un 40% menos de probabilidades de preferir yoga dos veces a la semana (TP 0,6, IC 0,5, 0,9). Después de controlar las características iniciales, no hallamos relación estadísticamente significativa entre los resultados del tratamiento, preferencias, escalas de expectativas o concordancia.Conclusión: En una población de participantes de minorías predominantemente con bajos ingresos con dolor lumbar crónico, se asoció una peor funcionalidad de la espalda con la preferencia por una mayor frecuencia de clases de yoga. Aquellos que prefirieron más clases de yoga tenían más expectativas para esas clases. El cambio de doce semanas en la intensidad del dolor de espalda y la funcionalidad de la misma no se vio afectado por la preferencia de dosis, escala de expectativas o concordancia. Se necesita realizar más investigaciones para medir mejor y cuantificar las preferencias, las expectativas y su relación con los resultados en la investigación del yoga.

Experience with corrective surgery for postburn contractures in Mumbai, India.

Postburn contracture is a source of significant morbidity in India, even though its occurrence can be reduced significantly by comprehensive postburn injury care, including surgical intervention. This study investigates whether limited access to initial medical care after burn injury has been associated with increased contracture formation among lower socioeconomic class patients in Mumbai, India. During a surgical mission in Mumbai, India, patients presenting with functionally debilitating burn contractures and minimal income were surveyed for initial care received immediately after burn injury. The survey consisted of questions regarding the history of burn injury and details of any initial treatment. Demographic data were collected by chart review. Thirty-eight patients from the state of Maharashtra participated in the study (mean age 28.1 years). The most common etiology of burn injury was from kerosene stove blasts (74%), and the most common morbidities were contractures of the neck and upper extremity. On average, time elapsed since the original injury was 2.8 years. Nearly all patients sought initial medical care at hospitals (97%) with the majority receiving only dressing changes for their full-thickness or deep-dermal burns (61%). The most common reason for not seeking out delayed burn reconstruction was perceived cost (65%). Ultimately, 60 operations were performed, of which 9 (15%) developed postsurgical complications. These data suggest that a subset of lower socioeconomic class burn patients in Maharashtra received suboptimal initial intervention. Comprehensive initial therapy after burn injury may provide better outcomes and limit the number of patients requiring delayed reconstruction.

EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer.

PURPOSE: To prospectively identify markers of response to therapy and outcome in an organ-sparing trial for advanced oropharyngeal cancer. PATIENTS AND METHODS: Pretreatment biopsies were examined for expression of epidermal growth factor receptor (EGFR), p16, Bcl-xL, and p53 as well as for p53 mutation. These markers were assessed for association with high-risk human papillomavirus (HPV), response to therapy, and survival. Patient variables included smoking history, sex, age, primary site, tumor stage, and nodal status. RESULTS: EGFR expression was inversely associated with response to induction chemotherapy (IC) (P = .01), chemotherapy/radiotherapy (CRT; P = .055), overall survival (OS; P = .001), and disease-specific survival (DSS; P = .002) and was directly associated with current smoking (P = .04), female sex (P = .053), and lower HPV titer (P = .03). HPV titer was significantly associated with p16 expression (P < .0001); p16 was significantly associated with response to IC (P = .008), CRT (P = .009), OS (P = .001), and DSS (P = .003). As combined markers, lower HPV titer and high EGFR expression were associated with worse OS (rho(EGFR) = 0.008; rho(HPV) = 0.03) and DSS (rho(EGFR) = 0.01; rho(HPV) = 0.016). In 36 of 42 biopsies, p53 was wild-type, and only one HPV-positive tumor had mutant p53. The combination of low p53 and high Bcl-xL expression was associated with poor OS (P = .005) and DSS (P = .002). CONCLUSION: Low EGFR and high p16 (or higher HPV titer) expression are markers of good response to organ-sparing therapy and outcome, whereas high EGFR expression, combined low p53/high Bcl-xL expression, female sex, and smoking are associated with a poor outcome. Smoking cessation and strategies to target EGFR and Bcl-xL are important adjuncts to the treatment of oropharyngeal cancer.

Targeting apoptosis to overcome cisplatin resistance: a translational study in head and neck cancer.

PURPOSE: Cisplatin resistance remains a barrier to organ-sparing and survival of patients with advanced head and neck squamous cell carcinoma (HNSCC). Targeted therapies to overcome cisplatin-resistant HNSCC are being developed. METHODS AND MATERIALS: Cisplatin-sensitive parental HNSCC cell lines and cisplatin-resistant progeny were studied. Pretreatment HNSCC biopsies were used to construct tissue microarrays which were stained for p53 and Bcl-xL. RESULTS: HNSCC cell lines selected for cisplatin resistance had wild-type p53 and high levels of Bcl-xL. Expression of wild-type p53 in cell lines with low Bcl-xL enhanced cisplatin sensitivity. Expression of both Bcl-xL and wild-type p53 caused tumor cells to become cisplatin resistant. Patients whose tumors expressed low levels of p53 and Bcl-xL enjoyed the best organ preservation and disease-free survival whereas patients whose tumors expressed low levels of p53 and high levels of Bcl-xL had the worst outcome. Novel agents that inhibit Bcl-xL or activate p53 function may target cisplatin-resistant HNSCC. CONCLUSION: Cisplatin resistance in HNSCC is mediated, at least in part, by high Bcl-xL and functional p53.

Response to therapy and outcomes in oropharyngeal cancer are associated with biomarkers including human papillomavirus, epidermal growth factor receptor, gender, and smoking.

Induction chemotherapy and concurrent chemoradiation for responders or immediate surgery for non-responders is an effective treatment strategy head and neck squamous cell carcinoma (HNSCC) of the larynx and oropharynx. Biomarkers that predict outcome would be valuable in selecting patients for therapy. In this study, the presence and titer of high risk human papilloma virus (HPV) and expression of epidermal growth factor receptor (EGFR) in pre-treatment biopsies, as well as smoking and gender were examined in oropharynx cancer patients enrolled in an organ sparing trial. HPV16 copy number was positively associated with response to therapy and with overall and disease specific survival, whereas EGFR expression, current or former smoking behavior, and female gender (in this cohort) were associated with poor response and poor survival in multivariate analysis. Smoking cessation and strategies to target EGFR may be useful adjuncts for therapy to improve outcome in the cases with the poorest biomarker profile.