Roger T. Anderson

Developing and evaluating cross-cultural instruments from minimum requirements to optimal models.

In the age of increased international collaboration in medical research, the necessity of having at hand cross-culturally applicable instruments for the assessment of health-related quality of life (HRQL) in clinical trials has been voiced. Several important theoretical bases leading to cultural bias in HRQL measurement include differences in definitions of HRQL across national and cultural contexts, levels of observation relied upon to indicate HRQL states, and the significance or weight placed upon the various HRQL states or dimensions measured. Despite a growing literature on the development and evaluation of existing HRQL measures in other cultures, comprehensive sets of procedures or requirements for the international part of development and evaluation are lacking. This paper reviews major approaches to developing international HRQL measures, and discusses various methods and criteria that have been recommended for evaluating measurement equivalence in comparisons of research across national and cultural contexts. A summary of recent trends and advances in international HRQL assessment is presented.

Psychometric considerations in evaluating health-related quality of life measures.

How does one determine if a measure of health-related quality of life (HRQL) is adequate for clinical trials? Psychometric methods are frequently used to answer this question. What is psychometrics all about? In this paper we address these questions, discussing common psychometric evaluation procedures applied to HRQL measures. Specifically, we discuss issues regarding the evaluation of reliability and validity (including responsiveness).

Critical review of the international assessments of health-related quality of life

This paper reviews the international adaptation and use of generic health quality of life measures over the last several years, including the Nottingham Health Profile (NHP) the Sickness Impact Profile (SIP), the Medical Outcomes Short-Form 36 (MOS SF-36), the EuroQol, and Dartmouth COOP Charts. International work with disease or condition specific HRQL measures is exemplified with the European Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ), and the Spitzer Quality of Life (QL) Index. Progress towards cross national measurement equivalence in HRQL measures reported in the literature has been uneven. Results show that the development of language-adapted versions of HRQL measures to date have mostly concerned translation issues, within the context of independently conducted studies. Substantially less focus has been placed on psychometric equivalence across language versions necessary for coordinated international studies, such as multi-national clinical trials. However, this picture is rapidly changing with recent projects underway to develop and refine new or existing HRQL measures. Overall, the lack of prominent differences found between countries in ranking of health states in major HRQL measures supports the feasibility of developing internationally applicable HRQL instruments. Recommendations are made for additional data needed to better ascertain the degree of measurement equivalence developed in the various versions of each instrument reviewed.

Evolving Strategies for the Management of Hand–Foot Skin Reaction Associated with the Multitargeted Kinase Inhibitors Sorafenib and Sunitinib

The multitargeted kinase inhibitors (MKIs) sorafenib and sunitinib have shown benefit in patients with renal cell carcinoma, hepatocellular carcinoma (sorafenib), and gastrointestinal stromal tumor (sunitinib). Their efficacy in other malignancies is currently being investigated because of their broad range of activity. The effectiveness of these drugs is somewhat diminished by the development of a variety of toxicities, most notably hand-foot skin reaction (HFSR). Although HFSR does not appear to directly affect survival, it can impact quality of life and lead to MKI dose modification or interruption, potentially limiting the antitumor effect. Currently, no standard guidelines exist for the prevention and management of MKI-associated HFSR. To address this issue, an international, interdisciplinary panel of experts gathered in January 2008 to discuss and evaluate the best-practice management of these reactions. Based on these proceedings, recommendations for the management of HFSR have been provided to offer patients the best possible quality of life while taking these drugs and to optimize the patient benefit associated with MKI therapy.

Race, socioeconomic status, and cause-specific mortality.

PURPOSE Life expectancy for black Americans is five to eight years less than for Whites. The socioeconomic status (SES) of Blacks is also less than for Whites, and SES is associated with early mortality. This paper estimates the proportion of the racial difference in mortality attributable to SES by specific causes of death. METHODS Data on 453,384 individuals in the National Longitudinal Mortality Study were used to estimate the hazard ratio associated with black race, with and without adjustment for income and education (measures of SES), in 38 strata defined by cause of death and age. RESULTS For women, SES accounted for much (37-67%) of the black excess mortality for accidents, ischemic heart disease (ages 35-54), diabetes, and homicide; but not for hypertension, infections, and stomach cancers (11-17%). For men, SES accounted for much of the excess risk (30-55%) for accidents, lung cancer, stomach cancer, stroke, and homicide; but not for prostate cancer, pulmonary diseases, hypertension, and cardiomyopathy (0-17%). CONCLUSIONS These results confirm those specific causes of death likely to underlie the overall excess mortality of Blacks, and identify those causes where SES may play a large role.

Willing to wait?: The influence of patient wait time on satisfaction with primary care

BackgroundThis study examined the relationship between patient waiting time and willingness to return for care and patient satisfaction ratings with primary care physicians.MethodsCross-sectional survey data on a convenience sample of 5,030 patients who rated their physicians on a web-based survey developed to collect detailed information on patient experiences with health care. The survey included self-reported information on wait times, time spent with doctor, and patient satisfaction.ResultsLonger waiting times were associated with lower patient satisfaction (p < 0.05), however, time spent with the physician was the strongest predictor of patient satisfaction. The decrement in satisfaction associated with long waiting times is substantially reduced with increased time spent with the physician (5 minutes or more). Importantly, the combination of long waiting time to see the doctor and having a short doctor visit is associated with very low overall patient satisfaction.ConclusionThe time spent with the physician is a stronger predictor of patient satisfaction than is the time spent in the waiting room. These results suggest that shortening patient waiting times at the expense of time spent with the patient to improve patient satisfaction scores would be counter-productive.

Black-white mortality differences by family income

Death rates among US black men and women under 75 years of age are higher than for their white counterparts. The explanation for this excess risk, though attributed to socioeconomic factors, remains unclear. We calculated mortality rates by family income for blacks and whites in a representative sample of the US population (National Longitudinal Mortality Study). For persons aged less than 65 years of age, mortality rates are lower in those with higher family income for both blacks and whites, and both men and women. However, at each level of income, blacks have higher mortality than whites. Higher levels of family income are also associated with lower death rates from cardiovascular disease, cancer, and deaths from causes other than cardiovascular disease or cancer. After adjustment for income, blacks have higher death rates from each of these three general causes. For subjects below 65 years, the mortality gradient by income is larger than the gradient by race. The differences in mortality rates by race not accounted for by income may be due to other differences such as access to health care, type or quality of medical care, or behavioral risk factors that disadvantage black populations.

Adjuvant Hormonal Therapy Use Among Insured, Low-Income Women With Breast Cancer

PURPOSE Use of adjuvant hormonal therapy, which significantly decreases breast cancer mortality, has not been well described among poor women, who are at higher risk of cancer-related death. Here we explore use of adjuvant hormonal therapy in an insured, low-income population. METHODS A North Carolina Cancer Registry-Medicaid linked data set was used. Women with hormone receptor-positive or unknown, nonmetastatic breast cancer, diagnosed between 1998 and 2002, were included. Main outcomes were (1) prescription fill within 1 year of diagnosis, (2) adherence (medication possession ratio), and (3) persistence (absence of a 90-day gap in prescription fills over 12 months). Results The population consisted of 1,491 women (mean age, 67 years). Sixty-four percent filled prescriptions. Predictors of prescription fill included the following: older age (odds ratio [OR], 1.01; P = .017), greater number of prescription medications (OR, 1.06; P < .001), nonmarried status (OR, 1.82; P = .001), higher stage (OR, 1.83; P < .001), positive hormone receptor status (positive v unknown, OR, 1.98; P < .001), not receiving adjuvant chemotherapy (OR, 1.74; P = .001), receipt of adjuvant radiation (OR, 1.55; P = .004), and treatment in a small hospital (OR, 1.49; P = .024). Adherence and persistence rates were 60% and 80%, respectively. Nonmarried status predicted greater adherence (OR, 1.90; P = .006) and persistence (OR, 1.75; P = .031). CONCLUSION Prescription fill, adherence, and persistence to adjuvant hormonal therapy among socioeconomically disadvantaged women are low. Improving use of adjuvant hormonal therapy may lead to lower breast cancer-specific mortality in this population.

Ethnic differences in stroke mortality between non-Hispanic whites, Hispanic whites, and blacks. The National Longitudinal Mortality Study.

Although US blacks are known to have an excess stroke mortality compared with US whites, little is known about the stroke burden of the Hispanic white population. This report will provide estimates of the relative burden of stroke mortality in the US black and Hispanic population relative to the white population and examine the consistency of this relation across age. Methods Data were from participants aged >45 years from the National Longitudinal Mortality Study. There were 1844 stroke deaths among 239 734 non-Hispanic whites, 46 deaths among 12 527 Hispanic whites, and 234 deaths among 23 468 black participants. Standard statistical methods were used to examine the ethnic differences in stroke mortality. Resuts The hazard ratios for black men and women (relative to non-Hispanic whites) were nearly identical, at >4.0 at age 45 but marginally <1.0 by age 85. For both Hispanic men and women, the hazard ratios (relative to non-Hispanic whites) were approximately 1.0 at age 45 but were marginally significantly <1.0 at older ages. The ethnic differences in stroke death rates reveal differences in age distributions of age at fatal stroke between these groups. Approximately 6% of fatal strokes for non-Hispanic whites occurred before age 60, whereas > 15% occurred in both Hispanic whites and blacks. Conclusions These results suggest that (1) for Hispanics, stroke risk is similar to that for non- Hispanic whites at young ages but is marginally lower at older ages, (2) the excess stroke mortality in blacks mainly occurs at younger ages (between 45 and 55 years), and (3) the relation between stroke risk for blacks and Hispanics relative to whites is similar by sex. The impact of age on relative stroke mortality would argue against simple age adjustment for describing ethnic differences in stroke mortality. Finally, proportionally, more strokes occur at older ages in non-Hispanic whites than in either US blacks or Hispanic whites.

The relation of residential segregation to all-cause mortality : A study in black and white

OBJECTIVES This study investigated the influence of an aggregate measure of the social environment on racial differences in all-cause mortality. METHODS Data from the National Longitudinal Mortality Study were analyzed. RESULTS After adjustment for family income, age-adjusted mortality risk increased with increasing minority residential segregation among Blacks aged 25 to 44 years and non-Blacks aged 45 to 64 years. In most age/race/gender groups, the highest and lowest mortality risks occurred in the highest and lowest categories of residential segregation, respectively. CONCLUSIONS These results suggest that minority residential segregation may influence mortality risk and underscore the traditional emphasis on the social underpinnings of disease and death.