A medication diary-book for pediatric patients with acute lymphoblastic leukemia in Indonesia.

BACKGROUND: Event-free survival of pediatric patients with acute lymphoblastic leukemia (ALL) in Yogyakarta, Indonesia was low (20%). The aim of the study was to evaluate the effectiveness of using a medication diary-book on the treatment outcome of childhood ALL. PROCEDURE: A randomized study was conducted with 109 pediatric patients with ALL in a pediatric oncology center in Yogyakarta, Indonesia. Both intervention and control groups received a structured parental education program and donated chemotherapy. The intervention group received a medication diary-book to remind parents and families to take oral chemotherapy and present for scheduled appointments or admissions. Event-free survival estimate (EFS) at 3 years was assessed. RESULTS: Among pediatric patients with ALL with highly educated mothers (senior high school or higher), the EFS-estimate at 3 years of the intervention group was significantly higher than the EFS-estimate at 3 years of the control group (62% vs. 29%, P = 0.04). Among pediatric patients with ALL with low-educated mothers, no significant difference was found in the EFS-estimates at 3 years between the intervention and control group (26% vs. 18%, P = 0.86). CONCLUSIONS: We conclude that a medication diary-book might be useful to improve the survival of pediatric patients with ALL in resource-limited settings, particularly in patients with highly educated mothers.

Patient-reported quality of life after stereotactic ablative radiotherapy for early-stage lung cancer.

BACKGROUND: Deterioration in health-related quality of life (HRQOL) is frequently observed after surgery for stage I non-small-cell lung cancer. As stereotactic ablative radiotherapy (SABR) can result in local control percentages exceeding 90%, we studied baseline and post-treatment HRQOL in SABR patients. METHODS: HRQOL data were collected prospectively using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire in 382 consecutive patients treated with SABR. Patients were referred from 68 Dutch centers, with 86% judged unfit for surgery, and 14% declining surgery. An SABR dose of 60 Gy was delivered in three-, five-, or eight treatment fractions, depending on tumor diameter and location. HRQOL data were available for 382 patients at baseline (pre-SABR), and for 282, 212, 144, 56, and 43 patients at 3, 6, 12, 18, and 24 months post-SABR, respectively. RESULTS: Median survival was 40 months, with a 2-year survival of 66%. Local, regional, and distant failure percentages at 2 years were 6%, 13%, and 22%, respectively. Mean baseline global HRQOL and physical functioning scores were 62.9 ± 1.1 and 61.7 ± 1.1, respectively. Baseline symptom scores were highest for dyspnea (47.1 ± 1.7) and fatigue (37.4 ± 1.3). Except for a nonsignificant decrease in 2 to 3 points per year in physical functioning, no statistically or clinically significant worsening of any of the HRQOL functioning or symptom scores at any follow-up time point was observed. CONCLUSIONS: Patients referred for SABR have substantially worse baseline HRQOL scores than those reported in the surgical literature. Clinically relevant deteriorations in HRQOL subscale scores were not observed after SABR.

Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy.

PURPOSE: Adjuvant chemotherapy for breast cancer can have adverse effects on cognition shortly after administration. Whether chemotherapy has any long-term effects on cognition is largely unknown, yet it becomes increasingly relevant because of the widespread use of chemotherapy for early-stage breast cancer and the improved survival. We investigated whether cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for breast cancer is associated with worse cognitive performance more than 20 years after treatment. PATIENTS AND METHODS: This case-cohort study compared the cognitive performance of patients with breast cancer who had a history of adjuvant CMF chemotherapy treatment (six cycles; average time since treatment, 21 years; n = 196) to that of a population-based sample of women never diagnosed with cancer (n = 1,509). Participants were between 50 and 80 years of age. Exclusion criteria were ever use of adjuvant endocrine therapy, secondary malignancy, recurrence, and/or metastasis. RESULTS: The women exposed to chemotherapy performed significantly worse than the reference group on cognitive tests of immediate (P = .015) and delayed verbal memory (P = .002), processing speed (P < .001), executive functioning (P = .013), and psychomotor speed (P = .001). They experienced fewer symptoms of depression (P < .001), yet had significantly more memory complaints on two of three measures that could not be explained by cognitive test performance. CONCLUSION: Survivors of breast cancer treated with adjuvant CMF chemotherapy more than 20 years ago perform worse, on average, than random population controls on neuropsychological tests. The pattern of cognitive problems is largely similar to that observed in patients shortly after cessation of chemotherapy. This study suggests that cognitive deficits following breast cancer diagnosis and subsequent CMF chemotherapy can be long lasting.

Chemotherapy-induced nausea and vomiting in daily clinical practice: a community hospital-based study.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) are major adverse effects of cancer chemotherapy. This study investigated: (1) the impact of CINV on patients' health-related quality of life (HRQL) in daily clinical practice; (2) the association between patient characteristics and type of antiemetics and CINV; and (3) the role of CINV in physicians' decisions to modify antiemetic treatment. PATIENTS AND METHODS: This prospective, multicenter study was conducted in nine general hospitals in the Netherlands. During three consecutive chemotherapy cycles, patients used a diary to record episodes of nausea, vomiting and antiemetic use. For each cycle, these ratings were made 1 day prior to and 7 days after having received chemotherapy. The influence of CINV on patients' HRQL was evaluated with the Functional Living Index-Emesis (FLIE) questionnaire at day 6 of each treatment cycle. (Changes in) antiemetic use were recorded by the treating nurse. Patient inclusion took place between May 2005 and May 2007. RESULTS: Two hundred seventy-seven patients were enrolled in the study. Acute and delayed nausea during the first treatment cycle was reported by 39% and 68% of the patients, respectively. The comparable figures for acute and delayed vomiting were 12% and 23%. During the first and subsequent treatment cycle, approximately one-third of the patients indicated that CINV had a substantial impact on their daily lives. Female patients and younger patients reported significantly more CINV than male and older patients. At all treatment cycles, patients receiving treatment with moderately emetogenic chemotherapy, containing anthracycline, reported more acute nausea than patients receiving highly emetogenic chemotherapy. Acute vomiting was associated significantly with change in (i.e., additional) antiemetic treatment. Delayed CINV did not influence antiemetic treatment. CONCLUSION: CINV continues to be a problem that adversely affects the daily lives of patients. CINV is worse in women and in younger patients. In daily clinical practice, acute CINV, but not delayed CINV, results in changes in antiemetic treatment. In view of the effects of not only acute, but also delayed CINV on daily life, more attention should be paid to adjustment of antiemetic treatment to cover CINV complaints, later during the chemotherapy cycle.

Comparing higher order models for the EORTC QLQ-C30.

PURPOSE: To investigate the statistical fit of alternative higher order models for summarizing the health-related quality of life profile generated by the EORTC QLQ-C30 questionnaire. METHODS: A 50% random sample was drawn from a dataset of more than 9,000 pre-treatment QLQ-C30 v 3.0 questionnaires completed by cancer patients from 48 countries, differing in primary tumor site and disease stage. Building on a "standard" 14-dimensional QLQ-C30 model, confirmatory factor analysis was used to compare 6 higher order models, including a 1-dimensional (1D) model, a 2D "symptom burden and function" model, two 2D "mental/physical" models, and two models with a "formative" (or "causal") formulation of "symptom burden," and "function." RESULTS: All of the models considered had at least an "adequate" fit to the data: the less restricted the model, the better the fit. The RMSEA fit indices for the various models ranged from 0.042 to 0.061, CFI's 0.90-0.96, and TLI's from 0.96 to 0.98. All chi-square tests were significant. One of the Physical/Mental models had fit indices superior to the other models considered. CONCLUSIONS: The Physical/Mental health model had the best fit of the higher order models considered, and enjoys empirical and theoretical support in comparable instruments and applications.

Compromised health-related quality of life in patients with low-grade glioma.

PURPOSE: To investigate the generic and condition-specific health-related quality of life (HRQL) of patients with low-grade glioma (LGG). PATIENTS AND METHODS: A total of 195 patients with LGG, which was diagnosed, on average, 5.6 years before the study, were compared with 100 patients with hematologic (non-Hodgkin's) lymphoma and chronic lymphatic leukemia cancer (NHL/CLL) and 205 general population controls who were comparable with patients with LGG at the group level for age, sex, and education (healthy controls). Generic HRQL was assessed with the Short Form-36 (SF-36) Health Survey, and condition-specific HRQL was assessed with the Medical Outcomes Study cognitive function questionnaire and the European Organisation for Research and Treatment of Cancer brain cancer module. Objective neurocognitive functioning was assessed with a standardized battery of neuropsychological tests. RESULTS: No statistically significant differences were observed between patients with LGG and patients with NHL/CLL in SF-36 scores. Patients with LGG scored significantly lower than healthy controls on six of eight scales and on the mental health component score of the SF-36. Approximately one quarter of patients with LGG reported serious neurocognitive symptoms. Female sex, epilepsy burden, and number of objectively assessed neurocognitive deficits were associated significantly with both generic and condition-specific HRQL. Clinical variables, including the time since diagnosis, tumor lateralization, extent of surgery, and radiotherapy, did not show a consistent relationship with HRQL. CONCLUSION: Patients with LGG experienced significant problems across a broad range of HRQL domains, many of which were not condition-specific. However, the neurocognitive deficits and epilepsy that were relatively prevalent among patients with LGG were associated with negative HRQL outcomes and, thus, contributed additionally to the vulnerability of this population of patients with cancer.

Predictors of neuropsychological improvement following cognitive rehabilitation in patients with gliomas.

This study investigated the specific patient factors that predict responsiveness to a cognitive rehabilitation program. The program has previously been demonstrated to be successful at the group level in patients with gliomas, but it is unclear which patient characteristics optimized the effect of the intervention at the individual level. Four categories of possible predictors of improvement were selected for evaluation: sociodemographic and clinical variables, self-reported cognitive symptoms, and objective neuropsychological test performance. Hierarchical logistic regression analyses were conducted, beginning with the most accessible (sociodemographic) variables and ending with the most difficult (baseline neuropsychological) to identify in clinical practice. Nearly 60% of the participants of the intervention were classified as reliably improved. Reliable improvement was predicted by age (p = .003) and education (p = .011). Additional results suggested that younger patients were more likely to benefit specifically from the cognitive rehabilitation program (p = .001), and that higher education was also associated with improvement in the control group (p = .024). The findings are discussed in light of brain reserve theory. A practical implication is that cognitive rehabilitation programs should take the patients' age into account and, if possible, adapt programs to increase the likelihood of improvement among older participants.

Treatment of vulvar intraepithelial neoplasia with topical imiquimod: seven years median follow-up of a randomized clinical trial.

OBJECTIVE: Recently we reported on the efficacy of imiquimod for treating vulvar intraepithelial neoplasia (VIN) in a placebo-controlled, double-blinded randomized clinical trial (RCT). Four weeks after treatment, a complete response was observed in 35% of patients and a partial response in 46%. All complete responders remained disease-free at 12 months follow-up. In the current investigations, we assessed long-term follow-up at least 5 years after the initial RCT. METHODS: Twenty-four of 26 imiquimod-treated patients who had participated in the initial RCT were seen for follow-up. Primary endpoint was durability of clinical response to imiquimod assessed by naked eye vulvar examination and histology. Long-term clinical response was correlated to lesion size before start of the initial RCT. Secondary endpoints were mental health, global quality of life, body image and sexual function in relation with long-term clinical response. RESULTS: Median follow-up period was 7.2 years (range 5.6-8.3 years). VIN recurred in one of nine complete responders. Of the initial partial responders, two became disease-free after additional imiquimod treatment. In the other partial responders, VIN recurred at least once after the initial RCT. In long-term complete responders, lesion size at study entry was smaller and these patients had a significantly better global quality of life at follow-up than patients with residual disease and/or recurrence after imiquimod treatment. CONCLUSIONS: In case of a complete response, imiquimod is effective in the long-term. Furthermore, patients with a long-term complete response had a significantly better global quality of life than patients who recurred after imiquimod treatment.

Cancer-related fatigue: clinical practice versus practice guidelines.

PURPOSE: This study investigated adherence to treatment guidelines on cancer-related anaemia and fatigue (CRA/CRF) and factors influencing the choice of intervention. METHODS: In this prospective, observational study, 136 cancer patients being treated with chemotherapy in a large community hospital completed a questionnaire at consecutive outpatient visits assessing fatigue (the Functional Assessment of Chronic Illness Therapy-Fatigue) and fatigue-related counselling and advice received. Data on administration of chemotherapy and use of epoetin or blood transfusions were abstracted from the medical records. RESULTS: Fifty-three percent of patients with severe anaemia (Hb < 10 g/dl) and 6% of patients with less severe anaemia (Hb levels 10-12 g/dl) received treatment (epoetin and/or blood transfusions). Half of the patients with less severe anaemia reported clinically relevant levels of fatigue. More than 50% of all patients received fatigue-related counselling, primarily at the start of chemotherapy. Most counselling was directed at energy conservation. Fatigue was not associated significantly with the use of epoetin or blood transfusion. Patients receiving palliative treatment (17%), male patients (16%) and patients with a low Hb level (<6.2 g/dl, 38%) were treated significantly more often with epoetin. CONCLUSIONS: In daily clinical practice, guidelines concerning the use of epoetin or blood transfusion in severe CRA are adhered to in about half of the cases. In patients with less severe anaemia, the level of fatigue did not play a significant role in the use of epoetin. According to current guidelines, counselling on CRF should be directed primarily at activity enhancement. However, only a minority of patients receive such counselling.

Psychological distress and quality of life of partners of individuals with familial adenomatous polyposis.

OBJECTIVE: Familial adenomatous polyposis (FAP) is a genetic condition characterized by the development of multiple adenomas in the colorectum that could lead to colorectal cancer. Our aim was to assess levels and predictors of psychological distress and quality of life (QOL) among partners of FAP-patients. METHODS: A nationwide, cross-sectional survey using validated self-report questionnaires assessing psychological distress and QOL. RESULTS: One hundred and twenty-nine partners completed the questionnaire (84% response rate), 30% of whom reported moderate-to-severe levels of distress. The partners' distress was associated significantly with the patients' distress, having children, and feelings of guilt. Fifty-seven percent of the partners with moderate-to-severe distress levels had received professional psychosocial support. Partners did not differ significantly from the general population in QOL. However, 9-21% reported that FAP had affected their work, leisure time activities, and relationships. CONCLUSIONS: Clinicians should be particularly alert for heightened distress levels in partners of patients who are themselves distressed, and among those with children.

Normative data for the EORTC QLQ-C30 and EORTC-sexuality items in the general Dutch population.

AIM: The aim of the present study was to generate Dutch reference data for the EORTC QLQ-C30 and for five sexuality items from the EORTC QL-item bank. Furthermore, to evaluate the relative impact of self-reported health problems on these outcomes and compare the Dutch normative EORTC QLQ-C30 overall QoL with available Scandinavian and German normative data. METHODS: QLQ-C30 and sexual item normative data were obtained from the Health and Health Complaints project from CentERdata. The CentERpanel is an online household panel consisting of more than 2000 Dutch households, representative of the Dutch-speaking population in the Netherlands. RESULTS: The questionnaire was completed by 1731 (78%) CentERpanel members. For both men and women, functional health (except emotional functioning) decreased with age, and the symptoms pain and fatigue increased with age. Men scored statistically but never clinically significantly better on most functional scales than women. Men reported higher levels of sexual interest and activity than women. All subgroups of participants with health problems reported lower physical and role functioning and overall quality of life (QoL). Those with depression (n=79) reported functioning scores 20-30 points lower than participants without any condition. Dutch men and women reported high levels of overall QoL as compared to previously published Scandinavian and German normative data. CONCLUSION: Age, gender and other health problems are important when comparing QoL and sexuality among different cancer cohorts. Normative data on QoL and sexuality are needed to interpret QoL issues among the growing group of (long-term) cancer survivors.

Differential item functioning (DIF) analyses of health-related quality of life instruments using logistic regression.

BACKGROUND: Differential item functioning (DIF) methods can be used to determine whether different subgroups respond differently to particular items within a health-related quality of life (HRQoL) subscale, after allowing for overall subgroup differences in that scale. This article reviews issues that arise when testing for DIF in HRQoL instruments. We focus on logistic regression methods, which are often used because of their efficiency, simplicity and ease of application. METHODS: A review of logistic regression DIF analyses in HRQoL was undertaken. Methodological articles from other fields and using other DIF methods were also included if considered relevant. RESULTS: There are many competing approaches for the conduct of DIF analyses and many criteria for determining what constitutes significant DIF. DIF in short scales, as commonly found in HRQL instruments, may be more difficult to interpret. Qualitative methods may aid interpretation of such DIF analyses. CONCLUSIONS: A number of methodological choices must be made when applying logistic regression for DIF analyses, and many of these affect the results. We provide recommendations based on reviewing the current evidence. Although the focus is on logistic regression, many of our results should be applicable to DIF analyses in general. There is a need for more empirical and theoretical work in this area.

Interpretation of differential item functioning analyses using external review.

Differential item functioning (DIF) analyses are used to determine whether certain groups respond differently to a particular item of a test or questionnaire; however, these do not explain the reasons for observed response differences. Many studies have used external reviews of items, sometimes using blinded reviewers, to help interpret these results. The authors conducted a literature review of this topic to describe the current usage of external reviews alongside DIF analyses. It concentrated on studies of health-related quality of life instruments, but studies in other fields were also considered. Relatively few examples of blinded item reviews were identified, and these were mostly from educational studies. A case study using blinded bilingual reviewers alongside translation DIF analyses of a health-related quality of life instrument is described. Future researchers should consider conducting external item reviews alongside DIF analyses.

Effects of mode of administration (MOA) on the measurement properties of the EORTC QLQ-C30: a randomized study.

BACKGROUND: While modern electronic data collection methods (e.g., computer touch-screen or web-based) hold much promise, most current studies continue to make use of more traditional data collection techniques, including paper-and-pencil administration and telephone interviews. The present randomized trial investigated the measurement properties of the EORTC QLQ-C30 under three different modes of administration (MOA's). METHODS: A heterogeneous sample of 314 cancer patients undergoing treatment at a specialized treatment center in Amsterdam were randomized to one of three MOA's for the QLQ-C30: paper-and-pencil at home via the mail, telephone interview, and paper-and-pencil at the hospital clinic. Group differences in internal consistency reliabilities (Cronbach's alpha coefficient) for the scale scores were compared. Differences in mean scale scores were also compared by means of ANOVA, with adjustment for potential confounders. RESULTS: Only one statistically significant, yet minor, difference in Cronbach's alpha between the MOA groups was observed for the Role Functioning scale (all 3 alphas >0.80). Significant differences in group means -after adjustment- were found for the Emotional Functioning (EF) scale. Patients completing the written questionnaire at home had significantly lower levels of EF as compared to those interviewed via the telephone; EF scores of those completing the questionnaire at the clinic fell in-between those of the other two groups. These differences, however, were small in magnitude. CONCLUSIONS: MOA had little effect on the reliability or the mean scores of the EORTC QLQ-C30, with the possible exception of the EF scale.

Effects of tamoxifen and exemestane on cognitive functioning of postmenopausal patients with breast cancer: results from the neuropsychological side study of the tamoxifen and exemestane adjuvant multinational trial.

PURPOSE: To evaluate the influence of adjuvant tamoxifen and exemestane on cognitive functioning in postmenopausal patients with breast cancer (BC). PATIENTS AND METHODS: Neuropsychological assessments were performed before the start (T1) and after 1 year of adjuvant endocrine treatment (T2) in Dutch postmenopausal patients with BC, who did not receive chemotherapy. Patients participated in the international Tamoxifen and Exemestane Adjuvant Multinational trial, a prospective randomized study investigating tamoxifen versus exemestane as adjuvant therapy for hormone-sensitive BC. RESULTS: Participants included 80 tamoxifen users (mean age, 68.7 years; range 51 to 84), 99 exemestane users (mean age, 68.3 years; range, 50 to 82), and 120 healthy controls (mean age, 66.2 years; range, 49 to 86). At T2, after adjustment for T1 performance, exemestane users did not perform statistically significantly worse than healthy controls on any cognitive domain. In contrast, tamoxifen users performed statistically significantly worse than healthy controls on verbal memory (P < .01; Cohen's d = .43) and executive functioning (P = .01; Cohen's d = .40), and statistically significantly worse than exemestane users on information processing speed (P = .02; Cohen's d = .36). With respect to visual memory, working memory, verbal fluency, reaction speed, and motor speed, no significant differences between the three groups were found. CONCLUSION: After 1 year of adjuvant therapy, tamoxifen use is associated with statistically significant lower functioning in verbal memory and executive functioning, whereas exemestane use is not associated with statistically significant lower cognitive functioning in postmenopausal patients with BC. Our results accentuate the need to include assessments of cognitive effects of adjuvant endocrine treatment in long-term safety studies.

Attitudes toward genetic testing in childhood and reproductive decision-making for familial adenomatous polyposis.

Childhood DNA testing, prenatal diagnosis (PND) and preimplantation genetic diagnosis (PGD) are available for familial adenomatous polyposis (FAP). However, the use of PND and PGD is controversial. The purpose of this study was to investigate attitudes toward, and experiences with, childhood DNA testing, PND and PGD among members of families at high risk for FAP. In this nationwide, cross-sectional study, questionnaires were sent to individuals from families at high risk for FAP assessing attitudes toward and experiences with childhood testing, PND and PGD, as well as several sociodemographic, clinical and psychosocial variables. Of the individuals from FAP families invited to participate in the study, 525 members participated (response rate=64%). Most parents who had children who were minors (n=93) (82%) were satisfied with the DNA testing procedure. One-third of all individuals wanted DNA testing for their children before age 12. Forty percent of FAP patients indicated that the disease influenced their desire to have children. Only 15% considered termination of pregnancy for FAP acceptable. Approximately 30% of individuals with a FAP diagnosis and their partners considered PND and PGD as acceptable for themselves. A positive attitude was associated with higher levels of guilt and a positive attitude toward termination of pregnancy. Importantly, of those with FAP at childbearing age, 84% had had no previous information at all about either PND or PGD. Future efforts should be aimed at educating FAP family members about reproductive options, allowing them to make an informed choice about family planning. Routine discussion of all reproductive options with a medical specialist should be encouraged.

The impact of different definitions and reference groups on the prevalence of cognitive impairment: a study in postmenopausal breast cancer patients before the start of adjuvant systemic therapy.

OBJECTIVE: Several prospective studies into the effects of adjuvant systemic therapy on cognitive functioning suggest that a proportion of breast cancer patients show cognitive deficits already before the start of systemic therapy. Owing to, among others, methodological inconsistency, studies report different rates of this pre-treatment cognitive impairment. We examined the impact of four different criteria of cognitive impairment and two types of reference groups (a study-specific healthy reference group versus published normative data) on the prevalence of cognitive impairment. METHODS: Two hundred and five postmenopausal breast cancer patients underwent a battery of neuropsychological tests before the start of endocrine therapy, 124 healthy subjects underwent the same tests. Proportions of cognitive impaired patients were calculated for each of four criteria for cognitive impairment, using (1) study-specific healthy controls and (2) published norms of healthy controls as reference groups. RESULTS: The prevalence of cognitive impairment varied greatly with the strictness of the criterion, as expected, but also was dependent on the reference group used. Cognitive impairment, relative to published norms, ranged from 1% for the strictest to 36.6% for the less strict criterion, cognitive impairment relative to study-specific healthy controls, ranged from 13.7 to 45.4% for the same criteria. CONCLUSION: This study highlights contrasting proportions of cognitive impairment by using different criteria for cognitive impairment and different reference groups. (Dis)advantages of the methods using a criterion for cognitive impairment, and of the use of published norms versus a study-specific reference group are discussed.

Psychological distress and use of psychosocial support in familial adenomatous polyposis.

OBJECTIVE: Familial adenomatous polyposis (FAP) is characterized by multiple adenomas in the colorectum with a high risk to develop colorectal cancer. It is unclear whether individuals at risk of FAP experience distress due to this potentially life-threatening disease. This nationwide study assessed: (1) the prevalence of psychological distress; and (2) the need for and use of specialized professional psychosocial support. METHODS: In this cross-sectional study, all individuals from families at high risk for FAP registered at the Netherlands Foundation for the Detection of Hereditary Tumours were invited to complete a questionnaire assessing, among other issues, generalized, cancer-specific and FAP-specific distress. RESULTS: In total, 525 individuals completed the questionnaire. Approximately 20% of the respondents had moderate to severe levels of FAP-specific distress. Levels of generalized distress were comparable to the general Dutch population. Significantly more individuals with a FAP diagnosis had frequent cancer worries than those at risk of FAP or non-carriers (p=0.02). Distress levels were more strongly associated with psychosocial variables (e.g. perceived cancer risk), than with sociodemographic or clinical variables. Up to 43% of the variance in distress could be explained by all variables combined. Of those moderately to severely distressed, 26% had received specialized professional psychosocial support, while 30% of those did not receive the support they wanted. CONCLUSIONS: A substantial minority of individuals reported moderate to severe distress levels associated with FAP. However, only one-third of those received specialized professional psychosocial support. We recommend the use of a screening questionnaire to identify individuals in need of such support.

Chemotherapy-related side effects in childhood acute lymphoblastic leukemia in Indonesia: parental perceptions.

Noncompliance with prescribed medication has been associated with increased chance of relapse and poor outcome. Side effects may be an important cause of noncompliance. Fifty-one parents of children with acute lymphoblastic leukemia in a tertiary care hospital in Indonesia were interviewed about their perception of side effects and their impact on treatment noncompliance and daily activities. A symptom checklist assessing 13 common symptoms was used to examine side effects. During chemotherapy, childhood acute lymphoblastic leukemia patients suffered from psychological as well as physical side effects. The most frequent side effect reported by parents was behavior alteration (92%). Second and third in frequency were increased appetite and infections, reported by 88% and 83% of parents, respectively. The most severe side effects were leg weakness, increased appetite, and behavior alteration. The overall frequency of side effects was weakly correlated to noncompliance. Reducing the impact of side effects may increase compliance with the treatment.

The practical impact of differential item functioning analyses in a health-related quality of life instrument.

INTRODUCTION: Differential item functioning (DIF) analyses are commonly used to evaluate health-related quality of life (HRQoL) instruments. There is, however, a lack of consensus as to how to assess the practical impact of statistically significant DIF results. METHODS: Using our previously published ordinal logistic regression DIF results for the Fatigue scale of a HRQoL instrument as an example, the practical impact on a particular Norwegian clinical trial was investigated. The results were used to determine the difference in mean Fatigue scores assuming that the same trial was conducted in the UK. The results were then compared with published information on what would be considered a clinically important change in scores. RESULTS: The item with the largest DIF effect resulted in differences between the mean English and Norwegian Fatigue scores that, although small, could be considered clinically important. Sensitivity analyses showed that larger differences were found for shorter scales, and when the proportions in each response category were equal. DISCUSSION: Our scenarios suggest that translation differences in an item can result in small, but clinically important, differences at the scale score level. This is more likely to be problematic for observational studies than for clinical trials, where randomised groups are stratified by centre.