Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials.

OBJECTIVES: Unblinded trials are common in oncology, but patient knowledge of treatment assignment may bias response to questionnaires. We sought to ascertain the extent of possible bias arising from patient knowledge of treatment assignment. METHODS: This is a retrospective analysis of data from 2 randomized trials in multiple myeloma, 1 double-blind and 1 open label. We compared changes in patient reports of symptoms, function, and health status from prerandomization (screening) to baseline (pretreatment but postrandomization) across control and investigational arms in the 2 trials. Changes from prerandomization scores at ~2 and 6 months on treatment were evaluated only across control arms to avoid comparisons between 2 different experimental drugs. All scores were on 0- to 100-point scales. Inverse probability weighting, entropy balancing, and multiple imputation using propensity score splines were used to compare score changes across similar groups of patients. RESULTS: Minimal changes from screening were seen at baseline in all arms. In the control arm, mean changes of <7 points were seen for all domains at 2 and 6 months. The effect of unblinding at 6 months in social function was a decline of less than 6 points (weighting: -3.09; 95% confidence interval -8.41 to 2.23; balancing: -4.55; 95% confidence interval -9.86 to 0.76; imputation: -5.34; 95% confidence interval -10.64 to -0.04). CONCLUSION: In this analysis, we did not find evidence to suggest that there was a meaningful differential effect on how patients reported their symptoms, function or health status after knowing their treatment assignment.

The Effect of a "Class Smoke Free Pledge" on Breath Carbon Monoxide in Arabic Male Adolescents.

Introduction: Arabic male adolescents have a high smoking prevalence. Introduction of "Class smoke-free" pledges have been successful amongst European adolescents but have not been evaluated using objective valid measures. We tested the impact of adding a smoke free pledge strategy to a proven peer-led asthma and smoking prevention program on breath carbon monoxide level (BCO) in male high-school students in Jordan. Methods: We enrolled male students from four high-schools in Irbid, Jordan. Schools were randomly assigned to receive either TAJ (Triple A in Jordan, n = 218) or TAJ-Plus (with added class smoke-free pledge, n = 215). We hypothesized that students receiving TAJ-Plus would have greater reduction in BCO levels than those only receiving the TAJ intervention. Asthma and smoking status were assessed by self-administered questionnaires. Smoking outcomes were collected using a BCO Monitor. Results: Both groups had significant reductions in BCO levels post-intervention (p < .0001), however, decreases were greater in TAJ-Plus group (3.9 ± 0.2 vs. 4.8 ± 0.2, p < .0001). Intervention effects on BCO over time did not vary by smoking status (p = .085), asthma status (p = .602), or a combination of the two (p = .702). Conclusions: An added smoke-free pledge strategy to a proven peer-led asthma education program appears to be a promising approach to motivate adolescents to abstain from smoking in Jordan. Future research is required to determine if these results can be extended to Jordanian adolescent females. Implications: A commitment by students via a "class smoke-free" pledge can be an added incentive to motivate adolescents in Arabic-speaking countries to abstain from smoking. Social influence approaches in schools can be useful in countering the aggressive tobacco marketing campaigns targeting Jordanian and other Arabic-speaking youth. The combination of "class smoke-free" pledges and an evidence-based peer-led asthma and smoking education can be implemented in schools to influence adolescents with asthma to abstain from smoking.

The information needs of patients with head and neck cancer and their caregivers: a short report of instrument development and testing.

PURPOSE: The study aimed to assess the reliability and scaling assumptions of an information needs questionnaire for patients with head and neck cancer (HNC) and their caregivers. BACKGROUND: Patients with HNC have specific information needs but no tools exist that can simultaneously assess the needs among these patients and their caregivers. METHODS: The Head and Neck Information Needs Questionnaire (HaNiQ) was adapted from a validated information needs questionnaire for breast cancer patients. Participants were recruited from two regionally-defined cancer services in NSW, Australia. Internal consistency reliability was assessed using Cronbach's alpha. Scaling assumptions, specifically item convergent and discriminant validity, were assessed using multi-trait scaling analysis. RESULTS: The HaNiQ showed good internal consistency reliability for both patients and caregivers (Cronbach's alpha=0.94 for both) and scaling assumptions were met, with acceptable item convergent and discriminant validity. CONCLUSIONS: The HaNiQ appears reliable, and would benefit from further testing.

East meets West: a brief report of a culturally sensitive breast health education program for Chinese-Australian women.

Chinese-Australian women are less likely to undergo breast health examination compared to women born in Australia, and cultural beliefs have been identified as a barrier to screening participation and breast health practices. We sought to promote awareness using trained lay health advisers (breast health advocates). This paper discusses the impact of the training program on advocate knowledge and beliefs, and women's experience as advocates. Thirty-seven of 50 women approached participated in an education program. The education was delivered over one full day and one half-day follow-up. Data were collected using questionnaires, focus groups and interviews. The program increased participant knowledge of breast health, decreased misperceptions about breast cancer and enhanced participants' readiness to discuss these topics with other Chinese women. Advocates enjoyed the role but did not always remember to promote awareness. The program appears effective and is suitable for further, more widespread testing.

Hospital churn and casemix instability: implications for planning and educating the nursing workforce.

Health workforce planning is a priority for Australian governments at both state and federal levels. Nursing shortages are a significant problem and addressing these shortages is likely to be a component of any workforce plan. This paper looks at the case of hospital nursing and argues that casemix, workforce and management instability inhibit workforce planning for hospital nursing. These issues are related and any efforts to objectively plan the hospital nursing workforce must seek to address them in order to succeed.