eCross-cultural adaptation of the spine oncology-specific SOSGOQ2.0 questionnaire to German language and the assessment of its validity and reliability in the clinical setting.

BACKGROUND: The recently developed Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) was proven a valid and reliable instrument measuring health-related quality of life (HRQOL) for patients with spinal malignancies. A German version was not available. OBJECTIVE: A cross-cultural adaptation of the SOSGOQ2.0 to the German language and its multicenter evaluation. METHODS: In a multistep process, a cross-cultural adaptation of the SOSGOQ2.0 was conducted. Subsequently, a multicenter, prospective observational cohort study was initiated to assess the reliability and validity of the German adaptation. To assess external construct validity of the cross-cultural adapted questionnaire, a comparison to the established questionnaire QLQ-C30 from the European Organisation for Research and Treatment of Cancer was conducted. Mean-difference plots were used to measure the agreement between the questionnaires in total score and by domain (deviation from mean up to 10% allowed). Further reliability and validity tests were carried out. Change to baseline was analysed 3-16 weeks later after different interventions occurred. Clinically relevant thresholds in comparison to the EORTC QLQ-C30 questionnaire were evaluated by ROC curve analysis. RESULTS: We could enroll 113 patients from four different university hospitals (58 females, 55 males). Mean age was 64.11 years (sd 11.9). 80 patients had an ECOG performance status of 2 or higher at baseline. External construct validity in comparison to the EORTC QLQ-C30 questionnaire in total score and by domain was confirmed (range of deviation 4.4 to 9.0%). Good responsiveness for the domains Physical Functioning (P < .001) and Pain (P < .001) could be shown. The group mean values also displayed a difference in the domains of Social Functioning (P = .331) and Mental Health (P = .130), but not significant. The minimum clinically relevant threshold values for the questionnaire ranged from 4.0 to 7.5 points. CONCLUSIONS: According to our results, the cross-cultural adapted questionnaire is a reliable and valid tool to measure HRQOL in German speaking patients with spinal malignancies. Especially the domains Physical Functioning and Pain showed overall good psychometric characteristics. In this way, a generic questionnaire, such as the EORTC QLQ-C30, can be usefully supplemented by spine-specific questions to increase the overall accuracy measuring HRQOL in patients with spinal malignancies.

Construct validity and reliability of the physical activity parenting questionnaire for children (PAP-C).

BACKGROUND: Children's perception of parenting is hypothesised to significantly affect their physical activity (PA). This study aimed to examine construct validity, factorial invariance and reliability of a new tool: Physical Activity Parenting questionnaire for Children (PAP-C). METHODS: PAP-C comprised 22 items hypothesised to cover 3 theory-guided factors of physical activity parenting (PAP)-namely, structure for activity, autonomy support and involvement. Construct validity and internal consistency of PAP-C were tested using confirmatory factor analysis (CFA) and composite reliability in a sample of Finnish first, second- and third graders (n = 456; mean age 8.77 ± 0.84 years, girls 51.1%). Factorial invariance of PAP-C across grade levels was investigated using sequential multigroup CFA. Intra-class correlation (ICC) coefficients of the sum factors were calculated in a sample of children who completed a 4-week PAP-C retest (n = 450; mean age 8.83 ± 0.87 years, girls 48.0%). RESULTS: A first-order 3-factor model of the structure for activity, autonomy support and involvement, with 20 items (two items removed), showed an acceptable fit. The model demonstrated configural, metric, and scalar invariance across grade levels. Composite reliabilities indicated moderate-to-good internal consistency (from .74 to .87) for the factors. ICCs (from .494 to .750, p < .001) showed moderate to excellent test-retest stability for all grade levels. CONCLUSIONS: PAP-C can be considered to be a promising tool for investigating 7-10-year-old children's perceptions of PAP.

Pathogenetic approach to the treatment of functional disorders of the gastrointestinal tract and their intersection: results of the Russian observation retrospective program COMFORT.

BACKGROUND: The aim of this study was to investigate the efficacy and safety of the novel complex drug, consisting of released-active form of antibodies to S-100 protein, tumor necrosis factor-α and histamine, (Kolofort) under outpatient conditions in patients with functional dyspepsia (FD), irritable bowel syndrome (IBS), and FD-IBS overlap. METHODS: The subjects of the observational noninterventional retrospective program were the data of 14,362 outpatient records of patients with diagnosed FD, IBS, and/or overlap, who were observed by gastroenterologists from November 01, 2017, through March 30, 2018, who received the drug Kolofort in monotherapy for 12 weeks, 2 tablets twice a day. To assess the presence and severity of symptoms of functional gastrointestinal disorders (FGID), the "7*7" questionnaire developed by a working group from the Russian Gastroenterological Association was used. The evaluated parameters included the proportion of patients: who had a 50% or more reduction in the total score; who have switched to the less severe category of the condition; who have switched to the "healthy" or "borderline ill" severity categories; and the change in the score in domains 1-7. RESULTS: The final efficacy analysis included data from 9254 patients. A decrease in the total score by 50% or more was observed in 80.45% of patients with FD, 79.02% of patients with IBS, and in 83% of patients with both IBS and FD. Switch to a lower severity category of the condition at the end of therapy was noted in 93.35% of patients with FD, in 93.80% of cases in patients with IBS, and in 96.17% of cases in patients with a combination of IBS and FD. A total of 94 adverse events (AEs) were reported in 80 patients (0.65%). CONCLUSION: The COMFORT program has demonstrated the positive effect of treatment in the majority of patients with IBS and FD and their combination in real clinical practice.

Translation and validation of the Chinese powerlessness assessment tool.

The objectives of this study were to translate the powerlessness assessment tool (PAT) into Chinese, and to evaluate its psychometric performance. The PAT was translated into Chinese and was evaluated in patients with chronic wounds. Mean PAT scores were compared between various wound types to evaluate the scale's power to differentiate wound severity (PUSH score). There were 154 consecutive patients included in this study. All items were included, and the results of item-domain correlation (r ranged from 0.838 to 0.967) and small-group analysis (critical ratio, p < 0.05) were satisfactory. Furthermore, the Chinese PAT also showed good criterion validity when correlated with the Cardiff wound impact schedule (r = 0.726, p < 0.01). Exploratory factor analysis of these items extracted only two domains instead of the hypothesized three domains: self-perception of behavioral control and decision making (9 items) and emotional responses to perceived control (3 items), explained 82.045% of the variance. Sensitivity was demonstrated between patients with different activity of daily living, wound severity (PUSH score) and wound types. The internal consistency of all scales of the Chinese PAT was consistently high (Cronbach's alpha ranged from 0.939 to 0. 965) and split-half reliability was 0.901. In conclusion, the validated Chinese PAT has good psychometric properties, and may be used to objectively evaluate the powerlessness experience of Chinese patients with chronic wounds.

Developing an Acoustic Sensing Yarn for Health Surveillance in a Military Setting.

Overexposure to high levels of noise can cause permanent hearing disorders, which have a significant adverse effect on the quality of life of those affected. Injury due to noise can affect people in a variety of careers including construction workers, factory workers, and members of the armed forces. By monitoring the noise exposure of workers, overexposure can be avoided and suitable protective equipment can be provided. This work focused on the creation of a noise dosimeter suitable for use by members of the armed forces, where a discrete dosimeter was integrated into a textile helmet cover. In this way the sensing elements could be incorporated very close to the ears, providing a highly representative indication of the sound level entering the body, and also creating a device that would not interfere with military activities. This was achieved by utilising commercial microelectromechanical system microphones integrated within the fibres of yarn to create an acoustic sensing yarn. The acoustic sensing yarns were fully characterised over a range of relevant sound levels and frequencies at each stage in the yarn production process. The yarns were ultimately integrated into a knitted helmet cover to create a functional acoustic sensing helmet cover prototype.

Does the pattern of occupational class inequalities in self-reported health depend on the choice of survey? A comparative analysis of four surveys and 35 European countries.

Background: Despite increasing overall life expectancy, substantial differences in health between socioeconomic groups persist. Research on inequalities in health often draws on data from different, single surveys. An important question that arises is whether these surveys reflect health and inequalities in the same way. When occupational class is utilized, data are often not analysed for women. The aim of this study therefore is to investigate whether patterns of occupational class inequalities in self-reported health differ across sex and country, between four major European surveys. Methods: Data on self-reported health and occupational class are taken from the European Social Survey (ESS), the EU Statistics on Income and Living Conditions (EU-SILC), the European Working Conditions Survey (EWCS) and the International Social Survey Programme (ISSP). Data from 35 countries for men and women aged 25­65 years are analysed. Occupational class is measured according to manual and non-manual workers. Age-standardized prevalence rates, and prevalence ratios (PR) between non-manual and manual workers and likelihood ratio (LR) tests are estimated to determine occupational class inequalities in self-rated health in Europe. Results: Results show that prevalence rates of less than good health differ noticeably between countries and surveys. Furthermore, occupational class inequalities in health differ between countries. In some countries inequalities are larger for women than for men. This is especially true in Eastern, Central and Baltic European countries. Besides that no regional patterns, consistent over all surveys, in inequalities could be detected. Inequalities differed significantly between surveys. Conclusion: The magnitude of inequalities in all countries depend on the survey used in the analysis. When undertaking a comparative analysis of inequalities in health, or other determinants, these differences have to be taken into account, as results might differ according to the data source used.

Validation of electronic administration of knee surveys among ACL-injured patients.

PURPOSE: Knee-specific patient reported outcome measures (PROMs) are important tools in evaluating the effectiveness of sports medicine interventions. The PROMs were originally developed for paper administration, but electronic data capture technologies offer potential benefits such as increased efficiency and accuracy. The aim of this study was to assess the validity of touch screen versus paper administration using several common knee-specific and general health surveys. METHODS: Agreement between scores was compared for knee-specific PROMs administered on paper versus computer; paper versus tablet; computer versus tablet in 60 patients per group undergoing ACL reconstruction. Surveys were given at pre-operative assessment and between 1 and 7 days later. Weighted kappa statistic (κ) and intraclass correlation coefficients (ICC) were calculated to test agreement between the two modalities in: IKDC Subjective Knee Form, Marx Activity Scale, Tegner Activity Level Scale, and Lysholm Knee Scale. SF-12 Physical and Mental Component Summary scores were also assessed. RESULTS: Response rate was over 90 %. Mean age was 29.6 ± 10.9 years, with patients in the paper-computer cohort being 4 years older than in the other groups. Agreement was substantial or better for all PROMs collected: IKDC Subjective (ICC: 0.79); Marx (ICC: 0.70); Lysholm (ICC: 0.65); and Tegner (κ = 0.67). Agreement for the SF-12 PCS (ICC: 0.77) and MCS (ICC: 0.73) was also found to have substantial agreement. CONCLUSION: In conclusion, touch screen-based PROMs are a valid capture method, providing reliable results relative to traditional paper survey administration. Digital methods of direct data capture may also foster multi-centre collaborations and allow for more accurate comparisons of outcomes between patient groups in clinical practice and orthopaedic research. LEVEL OF EVIDENCE: II.

Feasibility of Audio-Computer-Assisted Self-Interviewing With Color-Coding and Helper Assistance (ACASI-H) for Hmong Older Adults.

Many older adult immigrants in the US, including Hmong older adults, have limited English proficiency (LEP), and cannot read or have difficulty reading even in their first language (non-literate [NL]). Little has been done to identify feasible data collection approaches to enable inclusion of LEP or NL populations in research, limiting knowledge about their health. This study's purpose was to test the feasibility of culturally and linguistically adapted audio computer-assisted self-interviewing (ACASI) with color-labeled response categories and helper assistance (ACASI-H) for collection of health data with Hmong older adults. Thirty dyads (older adult and a helper) completed an ACASI-H survey with 13 health questions and a face-to-face debriefing interview. ACASI-H survey completion was video-recorded and reviewed with participants. Video review and debriefing interviews were audio-recorded and transcribed. Directed and conventional content analyses were used to analyze the interviews. All respondents reported that ACASI-H survey questions were consistent with their health experience. They lacked computer experience and found ACASI-H's interface user-friendly. All used the pre-recorded Hmong oral translation except for one, whose helper provided translation. Some Hmong older adults struggled with the color labeling at first, but helpers guided them to use the colors correctly. All dyads liked the color-labeled response categories and confirmed that a helper was necessary during the survey process. Findings support use of oral survey question administration with a technologically competent helper and color-labeled response categories when engaging LEP older adults in health-related data collection. © 2017 Wiley Periodicals, Inc.

Bias of health estimates obtained from chronic disease and risk factor surveillance systems using telephone population surveys in Australia: results from a representative face-to-face survey in Australia from 2010 to 2013.

BACKGROUND: Emerging communication technologies have had an impact on population-based telephone surveys worldwide. Our objective was to examine the potential biases of health estimates in South Australia, a state of Australia, obtained via current landline telephone survey methodologies and to report on the impact of mobile-only household on household surveys. METHODS: Data from an annual multi-stage, systematic, clustered area, face-to-face population survey, Health Omnibus Survey (approximately 3000 interviews annually), included questions about telephone ownership to assess the population that were non-contactable by current telephone sampling methods (2006 to 2013). Univariable analyses (2010 to 2013) and trend analyses were conducted for sociodemographic and health indicator variables in relation to telephone status. Relative coverage biases (RCB) of two hypothetical telephone samples was undertaken by examining the prevalence estimates of health status and health risk behaviours (2010 to 2013): directory-listed numbers, consisting mainly of landline telephone numbers and a small proportion of mobile telephone numbers; and a random digit dialling (RDD) sample of landline telephone numbers which excludes mobile-only households. RESULTS: Telephone (landline and mobile) coverage in South Australia is very high (97%). Mobile telephone ownership increased slightly (7.4%), rising from 89.7% in 2006 to 96.3% in 2013; mobile-only households increased by 431% over the eight year period from 5.2% in 2006 to 27.6% in 2013. Only half of the households have either a mobile or landline number listed in the telephone directory. There were small differences in the prevalence estimates for current asthma, arthritis, diabetes and obesity between the hypothetical telephone samples and the overall sample. However, prevalence estimate for diabetes was slightly underestimated (RCB value of -0.077) in 2013. Mixed RCB results were found for having a mental health condition for both telephone samples. Current smoking prevalence was lower for both hypothetical telephone samples in absolute differences and RCB values: -0.136 to -0.191 for RDD landline samples and -0.129 to -0.313 for directory-listed samples. CONCLUSION: These findings suggest landline-based sampling frames used in Australia, when appropriately weighted, produce reliable representative estimates for some health indicators but not for all. Researchers need to be aware of their limitations and potential biased estimates.

SF-36v2 norms and its' discriminative properties among healthy households of tuberculosis patients in Malaysia.

BACKGROUND: The aim of the study was to obtain norms of the SF-36v2 health survey and the association of summary component scores with socio-demographic variables in healthy households of tuberculosis (TB) patients. DESIGN: All household members (18 years and above; healthy; literate) of registered tuberculosis patients who came for contact tracing during March 2010 to February 2011 at the respiratory clinic of Penang General Hospital were invited to complete the SF-36v2 health survey using the official translation of the questionnaire in Malay, Mandarin, Tamil and English. Scoring of the questionnaire was done using Quality Metric's QM Certified Scoring Software version 4. Multivariate analysis was conducted to uncover the predictors of physical and mental health. RESULTS: A total of 649 eligible respondents were approached, while 525 agreed to participate in the study (response rate = 80.1 %). Out of consenting respondents, 46.5 % were male and only 5.3 % were over 75 years. Internal consistencies met the minimum criteria (α > 0.7). Reliability coefficients of the scales were always less than their own reliability coefficients. Mean physical component summary scale scores were equivalent to United States general population norms. However, there was a difference of more than three norm-based scoring points for mean mental component summary scores indicating poor mental health. A notable proportion of the respondents was at the risk of depression. Respondents aged 75 years and above (p = 0.001; OR 32.847), widow (p = 0.013; OR 2.599) and postgraduates (p < 0.001; OR 7.865) were predictors of poor physical health while unemployment (p = 0.033; OR 1.721) was the only predictor of poor mental health. CONCLUSION: The SF-36v2 is a valid instrument to assess HRQoL among the households of TB patients. Study findings indicate the existence of poor mental health and risk of depression among family caregivers of TB patients. We therefore recommend that caregivers of TB patients to be offered intensive support and special attention to cope with these emotional problems.

Importance of questionnaire context for a physical activity question.

Adequate information about physical activity habits is essential for surveillance, implementing, and evaluating public health initiatives in this area. Previous studies have shown that question order and differences in wording result in systematic differences in people's responses to questionnaires; however, this has never been shown for physical activity questions. The aim was to study the influence of different formulations and question order on self-report physical activity in a population-based health interview survey. Four samples of each 1000 adults were drawn at random from the National Person Register. A new question about physical activity was included with minor differences in formulations in samples 1-3. Furthermore, the question in sample 2 was included in sample 4 but was placed in the end of the questionnaire. The mean time spent on moderate physical activity varied between the four samples from 57 to 100 min/day. Question order was associated with the reported number of minutes spent on moderate-intensity physical activity and with prevalence of meeting the recommendation, whereas physical inactivity was associated with the differences in formulation of the question. Questionnaire context influences the way people respond to questions about physical activity significantly and should be tested systematically in validation studies of physical activity questionnaires.

Comparing health status in Belarus between 2001-10: a novel method using surveys with different response categories.

BACKGROUND: Two population surveys were conducted in Belarus: The Living Conditions, Lifestyle and Health (LLH) in 2001 (n = 2000) and The Health in Times of Transition (HITT) in 2010 (n = 1800). Each survey included a question on health status. The LLH questionnaire provided a 4-point Verbal Response Scale, but the HITT questionnaire used a 5-point scale. When translated into Russian, only two response categories of these scales had identical wording. These differences made a direct comparison of self-reported health status between 2001 and 2010 difficult. METHODS: We conducted a Health Category Response Scale (HCRS) survey in 2010 (n = 570) using a 100ths graduated Visual Analogue Scale (VAS) to understand how the response categories of different scales are perceived by Russian speakers. We implemented the HCRS survey's data to calculate the weighted health status (WHS) for each of the original surveys and to compare health status in Belarus between 2001and 2010. RESULTS: The WHS in Belarus showed a small, but statistically significant, improvement of 2.9 points on a 0-100 scale between 2001 and 2010 (56.2 vs. 59.1). Identical response categories were perceived differently on a 4-point and 5-point VAS. The category 'good' ('Хорошее') measured ∼12 points higher, and the category 'bad/poor' ('Плохое') measured ∼16 points lower, on the 4-point compared with the 5-point VAS. CONCLUSION: Our HCRS survey and novel method enabled a direct comparison of questions with different response options. When applied to the LLH and HITT projects, we concluded that health status in Belarus has improved between 2001 and 2010.

Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI).

PURPOSE: To translate the Core Outcome Measures Index (COMI) into Simplified Chinese and then validate it for Mainland Chinese patients with low back pain (LBP). METHODS: A total of 120 consecutive patients with LBP >3 months who visited our outpatient clinic from December 2011 to March 2012 were asked to complete a questionnaire booklet including the following: (1) the Roland Morris disability questionnaire (RMQ) (Fan et al. in Spine 37(10):875-880, 2012), (2) the Short Form Health Survey (SF-36) (Zhang et al. in Int J Med Sci 9(7):521-526, 2012), (3) the Oswestry Disability Index (ODI) (Liu et al. in Spine 34(11):1211-1216, 2009), (4) visual analogue scale (VAS) measure of pain, and (5) COMI. These patients were also asked to complete a second COMI questionnaire and a transition questionnaire (5-point Likert scale: better, a little better, no change, a little worse, worse) and to return the second COMI questionnaire via mail within 1 month. RESULTS: The floor effects for the COMI items ranged from 5.8 to 12.5 %. High values (28.3, 27.5, and 25.8 %, respectively) were found for symptom-specific quality of life, social disability, and work disability. Regarding the ceiling effects, the social and work disabilities were relatively high at 17.5 and 24.2 %, respectively. For other items, the values ranged from 0 to 14.2 %. Neither floor nor ceiling effects were found for the COMI summary score. Excellent correlations were found between the COMI pain scores and VAS scores (Rho = 0.89) and between the COMI pain and the SF-36 bodily pain domain (Rho = 0.84). Other individual items and summary scores showed a very good correlation (Rho = 0.54-0.72) with the corresponding questionnaires except for "symptom-specific well-being" (0.31-0.45). One-way repeated measures ANOVA was used to determine the intraclass correlation coefficient (ICC). The ICC for the entire COMI score was 0.91 (95 % CI 0.85-0.94) and 0.81-0.86 for the two pain scores (back and leg). The "minimum detectable change'' (MDC 95 %) for the COMI summary score was 1.91 points. No significant difference in the mean values was found for the repeated scores of individual items or the summary score. CONCLUSION: The Simplified Chinese version of COMI showed satisfactory reliability and good psychometric properties. This concise questionnaire is suitable for widespread use in Mainland China.

The development and psychometric testing of East Asian Acculturation Scale among Asian immigrant women in Taiwan.

OBJECTIVE: This is a report of development and psychometric testing of the East Asian Acculturation Measure-Chinese version (EAAM-C) scale. DESIGN: An instrument validation design with a cross-sectional survey was conducted. The process was carried in two phases. In Phase 1, Barry's East Asian Acculturation Measure was translated and back translated to evaluate its content, face validity, and feasibility validity. In Phase 2, the 16-item EAAM-C was pilot-tested among 485 female immigrants for test-retest reliability, internal consistency, theoretically-supported construct validity and concurrent validity. RESULTS: The pilot work and the survey results indicated the tools possessed adequate content and face validity. The Cronbach's Alphas for the EAAM-C was 0.72, and 0.76-0.79 for its subscales, and the correlation of test-retest reliability (at 3 weeks) was 0.75. After dropping one item, four theoretically-supported factors which explained 61.82% of the variance were abstracted using exploratory factor analysis: assimilation, integration, separation, and marginalization. Based on the underlying four-factor theoretical structures of the EAAM, the confirmatory factor analysis of the EAAM-C was further examined. The analysis revealed that the four-factor model was an acceptable fit for the data which demonstrated adequate finding in its construct validity. These factors were inter-correlated, and showed statistically significant correlation with the Chinese Health Questionnaire, indicating adequate concurrent validity. CONCLUSIONS: The scale shows acceptable validity and consistency, and suggests that immigrant acculturation is a complex construct. This quick evaluation instrument can be applied to assess clients' acculturation and in further developing certain interventions to improve their health.

Women's experiences in a community-based participatory research randomized controlled trial.

Integrating community-based participatory research (CBPR) into traditional study designs can enhance outcomes in studies with disadvantaged groups. Little is known, however, about study participants' experiences with these approaches, the underlying processes involved in creating more positive outcomes, and whether undesirable effects on study outcomes occur simultaneously. We conducted focus group interviews with 31 disadvantaged women who participated in a CBPR-driven randomized controlled trial (RCT) both to explore their study experiences and to obtain their interpretations of select study findings. Using dimensional analysis, we found the tailored health questionnaire, treatment by study staff members, and RCT participants' understandings of and responses to randomization were salient to what women described as transformative experiences that occurred over the course of the RCT. These findings have implications for understanding how CBPR and non-CBPR aspects of interventions and study designs have the potential to affect both process and endpoint study outcomes.

A systematic review of reliability and objective criterion-related validity of physical activity questionnaires.

Physical inactivity is one of the four leading risk factors for global mortality. Accurate measurement of physical activity (PA) and in particular by physical activity questionnaires (PAQs) remains a challenge. The aim of this paper is to provide an updated systematic review of the reliability and validity characteristics of existing and more recently developed PAQs and to quantitatively compare the performance between existing and newly developed PAQs.A literature search of electronic databases was performed for studies assessing reliability and validity data of PAQs using an objective criterion measurement of PA between January 1997 and December 2011. Articles meeting the inclusion criteria were screened and data were extracted to provide a systematic overview of measurement properties. Due to differences in reported outcomes and criterion methods a quantitative meta-analysis was not possible.In total, 31 studies testing 34 newly developed PAQs, and 65 studies examining 96 existing PAQs were included. Very few PAQs showed good results on both reliability and validity. Median reliability correlation coefficients were 0.62-0.71 for existing, and 0.74-0.76 for new PAQs. Median validity coefficients ranged from 0.30-0.39 for existing, and from 0.25-0.41 for new PAQs.Although the majority of PAQs appear to have acceptable reliability, the validity is moderate at best. Newly developed PAQs do not appear to perform substantially better than existing PAQs in terms of reliability and validity. Future PAQ studies should include measures of absolute validity and the error structure of the instrument.

Mapping the Functional Assessment of Cancer Therapy-general or -Colorectal to SF-6D in Chinese patients with colorectal neoplasm.

OBJECTIVES: To map Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Cancer Therapy-Colorectal (FACT-C) subscale scores onto six-dimensional health state short form (derived from short form 36 health survey) (SF-6D) preference-based values in patients with colorectal neoplasm, with and without adjustment for clinical and demographic characteristics. These results can then be applied to studies that have used FACT-G or FACT-C to predict SF-6D utility values to inform economic evaluation. METHODS: Ordinary least square regressions were estimated mapping FACT-G and FACT-C onto SF-6D by using cross-sectional data of 537 Chinese subjects with different stages of colorectal neoplasm. Mapping functions for SF-6D preference-based values were developed separately for FACT-G and FACT-C in four sequential models for addition of variables: 1) main-effect terms, 2) squared terms, 3) interaction terms, and 4) clinical and demographic variables. Predictive performance in each model was assessed by the R(2), adjusted R(2), predicted R(2), information criteria (Akaike information criteria and Bayesian information criteria), the root mean square error, the mean absolute error, and the proportions of absolute error within the threshold of 0.05 and 0.10. RESULTS: Models including FACT variables and clinical and demographic variables had the best predictive performance measured by using R(2) (FACT-G: 59.98%; FACT-C: 60.43%), root mean square error (FACT-G: 0.086; FACT-C: 0.084), and mean absolute error (FACT-G: 0.065; FACT-C: 0.065). The FACT-C-based mapping function had better predictive ability than did the FACT-G-based mapping function. CONCLUSIONS: Models mapping FACT-G and FACT-C onto SF-6D reached an acceptable degree of precision. Mapping from the condition-specific measure (FACT-C) had better performance than did mapping from the general cancer measure (FACT-G). These mapping functions can be applied to FACT-G or FACT-C data sets to estimate SF-6D utility values for economic evaluation of medical interventions for patients with colorectal neoplasm. Further research assessing model performance in independent data sets and non-Chinese populations are encouraged.

Quality-of-life impact of sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer patients.

OBJECTIVES: Controversy about quality-of-life (QOL) benefits of sentinel lymph node biopsy (SLNB) versus axillary lymph node dissection (ALND) in patients with breast cancer remains. Our aim was to compare the impact of SLNB and ALND on QOL and arm symptoms of patients with early breast cancer, using generic (short form 36 health survey) and tumor site-specific (FACT-B+4) instruments. METHODS: This was a prospective longitudinal observational study of 93 patients (64 SLNB, 29 ALND). Patients were evaluated presurgery and 1, 6, and 12 months postsurgery. Generalized estimation equation models were constructed to assess the effect of treatment on QOL. The relative risks of edema, dysesthesia, and heaviness were calculated comparing ALND to SLND. RESULTS: Most patients presented T1 (67.7%) and underwent breast-conserving surgery (92.5%). At 12 months, the SLNB group presented deterioration on the FACT-B+4 Arm Scale (beta coefficient estimated a change of -1.6 score points; P < 0.01) while, compared with SLNB, the deterioration in the ALND group was almost 2 additional score points higher (P = 0.009). FACT-B+4 global summary and short form 36 health survey did not show statistically significant differences between groups. Relative risk of dysesthesia and subjective edema was higher for the ALND group than for the SLNB group (1.97 and 2.11 at month 12; P < 0.01). CONCLUSION: These results confirm the benefit of SLNB due to its lower arm morbidity impact on QOL, compared with ALND. There are clinically relevant between-treatment differences in the Arm Scale of FACT-B+4, while there were no relevant differences in general well-being, measured with the disease-specific FACT-B+4 and the generic short form 36 health survey.