Benchmarking by cross-institutional comparison of student achievement in a progress test

OBJECTIVE: To determine the effectiveness of single-point benchmarking and longitudinal benchmarking for inter-school educational evaluation. METHODS: We carried out a mixed, longitudinal, cross-sectional study using data from 24 annual measurement moments (4 tests x 6 year groups) over 4 years for 4 annual progress tests assessing the graduation-level knowledge of all students from 3 co-operating medical schools. Participants included undergraduate medical students (about 5000) from 3 medical schools. The main outcome measures involved between-school comparisons of progress test results based on different benchmarking methods. RESULTS: Variations in relative school performance across different tests and year groups indicate instability and low reliability of single-point benchmarking, which is subject to distortions as a result of school-test and year group-test interaction effects. Deviations of school means from the overall mean follow an irregular, noisy pattern obscuring systematic between-school differences. The longitudinal benchmarking method results in suppression of noise and revelation of systematic differences. The pattern of a school's cumulative deviations per year group gives a credible reflection of the relative performance of year groups. CONCLUSIONS: Even with highly comparable curricula, single-point benchmarking can result in distortion of the results of comparisons. If longitudinal data are available, the information contained in a school's cumulative deviations from the overall mean can be used. In such a case, the mean test score across schools is a useful benchmark for cross-institutional comparison.     

Survival-weighted health profile for long-term survivors of acute myelogenous leukemia

The objective of this study was to use survival-weighted psychometric scores (SWPS) to construct a health profile for long-term survivors of acute myelogenous leukemia (AML). The study cohort included all patients who had been diagnosed and treated in our institution from 1985 to 1999 and achieved complete remission after standard chemotherapy (n = 259). One hundred and four patients were interviewed by the European Organization for the Research and Treatment of Cancer (EORTC)-QLQ-C30 questionnaire and the brief form of World Health Organization quality of life questionnaire (WHOQOL-BREF) to estimate the quality of life (QOL) function of the cohort. Forty-one patients underwent bone marrow transplantation (BMT) as consolidation or salvage therapy; 63 received chemotherapy alone. SWPS for every functioning domain and symptom item was obtained by direct integration of the mean QOL function with the survival function of the cohort. A Monte Carlo method was used to extrapolate the life-long SWPS beyond the follow-up limit. The mean scores of EORTC-QLQ-C30 and WHOQOL-BREF did not differ significantly between patients who received BMT or those who received chemotherapy only (p > 0.01). In mean SWPS, patients who received BMT had significantly (p < 0.01) better SWPS in all of the functioning domains and symptom items of EORTC-QLQ-C30 and all four domains of WHOQOL-BREF. However, when the life-long extrapolation of SWPS was made, these differences diminished in global health and several symptom items of EORTC-QLQ-C30 as well as in the social and environmental domains of WHOQOL-BREF. Patients' perspective on QOL may be domain-specific and may evolve over time. SWPS may be useful to evaluate the efficacy of different treatment strategies for AML. Confirmation of the relative merit of BMT vs. chemotherapy alone from prospective studies is needed.     

Quality of life as a predictor of overall survival after breast cancer treatment

Purpose

To describe quality of life (QoL) in a cohort of surviving women 4 years after breast cancer treatment and to analyze its role as a predictor of mortality within 2 years.

Methods

This is a prospective cohort study of 544 women who have undergone surgical treatment, from 2001 to 2002 and who answered a questionnaire about QoL in 2006. After, we conducted a survival study to evaluate the association between QoL and mortality within 2 years with the same population. We conducted factor analysis between the variables of the scales of function and symptoms. Survival analysis was conducted by Kaplan–Meier, and differences in survival curves were assessed with the log-rank test, assuming significant statistical level of 5 %. The Cox proportional hazards regression model was used to explore the relationship between QoL variables (functional scales) and prognostic value for survival.

Results

The mean age of the women was 59.1 years (SD 11.66). The mean of overall QoL score was 75.16 (SD 20.93). Using factor analysis, we identified three conditions that made up the construct of QoL in this group of patients: social, psycho-emotional, and physical. Social condition was the most important factor. After assessment of QoL, the mean survival was 23 months (SD 3.90). Women who reported worse future perspective had higher chance of death compared with women better prospect of future (HR = 3.46; 95 % CI 1.36–8.79; p value = 0.009).

Conclusion

Future perspectives were predictors of mortality, which reinforce the relevance of social support and psychological aspects for these women.     

Effect of health literacy on the quality of life of older patients with long-term conditions: a large cohort study in UK general practice

Purpose

The levels of health literacy in patients with long-term conditions (LTCs) are critical for better disease management and quality of life (QoL). However, the impact of health literacy on QoL in older adults with LTCs is unclear. This study examined the association between health literacy and domains of QoL in older people with LTCs, investigating key socio-demographic and clinical variables, as confounders.

Methods

A prospective cohort study was conducted on older adults (n?=?4278; aged 65 years and over) with at least one LTC, registered in general practices in Salford, UK. Participants completed measures of health literacy, QoL, multi-morbidity, depression, social support, and socio-demographic characteristics. Multivariate linear regressions were performed to examine the effects of health literacy on four QoL domains at baseline, and then changes in QoL over 12 months.

Results

At baseline, poor health literacy was associated with lower scores in all four QoL domains (physical, psychological, social relationships and environment), after adjusting for the effects of multi-morbidity, depression, social support and socio-demographic factors. At 12-month follow-up, low health literacy significantly predicted declines in the physical, psychological and environment domains of QoL, but not in social relationships QoL.

Conclusions

This is the largest, most complete assessment of the effects of health literacy on QoL in older adults with LTCs. Low health literacy is an independent indicator of poor QoL older patients with LTCs. Interventions to improve health literacy in older people with LTCs are encouraged by these findings.

     

Trial-based cost-utility comparison of percutaneous myocardial laser revascularisation and continued medical therapy for treatment of refractory angina pectoris

This study examined from a health service perspective whether percutaneous myocardial laser revascularisation (PMR) plus standard medical management is cost-effective when compared with standard medical management alone in the treatment of refractory angina. This involved a cost-utility analysis using patient-specific data from a single-centre, randomised, controlled trial carried out in the United Kingdom. Of 73 patients diagnosed as having refractory angina and not suitable for conventional forms of revascularisation, 36 were randomised to PMR plus medical management and 37 to medical management alone. We collected costs to the health service of PMR and all secondary sector health care contacts and cardiac-related medication in the 12 months following randomisation. Patient utility, measured using the EuroQol EQ-5D questionnaire, was combined with 12-month survival data to generate quality-adjusted life years (QALYs). The mean 12-month cost per patient for PMR was £8,307, and that for medical management was £1,888, giving a cost difference of £6,410. The mean QALY difference favoured PMR at 0.126, giving an incremental cost per QALY of £50,873. The cost-effectiveness acceptability curve indicates that the probability of PMR being cost-effective over the first 12 months is quite low. Whilst a longer period of follow-up might indicate continued benefit from PMR, which would make the intervention economically more attractive, PMR could not be considered cost-effective based on 1-year follow-up data.     

Efficient use of longitudinal CD4 counts and viral load measures in survival analysis

CD4 counts and viral loads are dynamic quantities that change with time in HIV-infected persons. Commonly used single summary measures, such as viral load set point or early CD4 count, do not explicitly account for changes in viral load or CD4 counts or other features of the overall time course of these measures. However, the efficient use of all repeated measurements within each subject is often a challenge made more difficult by sparse and irregular sampling over time. Here, we illustrate how functional principal component (FPC) analysis provides an effective statistical approach for exploiting the patterns in CD4 count and viral load data over time. We demonstrate the method by using data from Kenyan women who acquired HIV-1 during follow-up in a cohort that practices high-risk activities and were subsequently followed up prospectively from early infection. The FPC scores for each woman obtained using this method served as informative summary statistics for the CD4 count and viral load trajectories. Similar to baseline CD4 count or viral set point, the first FPC score can be interpreted as a single-value summary measure of an individual's overall CD4 count or viral load. However, unlike most single-value summaries of CD4 count or viral load trajectories, the first FPC score summarizes the dynamics of these quantities and is seen to reveal specific features of the trajectories associated with mortality in this cohort. Moreover, the FPC scores are shown to be a more powerful prognostic factor than other common summaries when used in survival analysis.     

A multivariate score objectively assessed health of depressed elderly

BACKGROUND AND OBJECTIVE: The self-report health measures commonly used may be biased in depressed persons. We introduce a method to assess physical health objectively in prospective studies of elderly persons. STUDY DESIGN AND SETTING: Longitudinal and cross-sectional analyses in the Rotterdam Study, a population-based cohort. Under the assumption that good health is related to survival, all baseline variables independently associated with mortality were included in a global health index. A multivariate score function for this index was derived from a Cox proportional hazard model. RESULTS: Information on risk factors, disabilities, medical conditions, and physiologic measurements was combined into one score. This made it possible to compare the health of persons with depression to those with other diseases. Physical health of persons with depression and stroke was equally poor. Furthermore, in persons with established depression, worse health was related to more severe symptoms. Finally, we found that the association between an inflammation marker and depression is modified by health status as measured by our index. CONCLUSION: Late-life depression is strongly associated with poor health as measured by an objective global health index. The index makes it possible to quantify health and to study potential etiological risk factors for depression in health strata.     

Cumulative lead exposure and cognitive performance among elderly men

BACKGROUND: Recent evidence suggests that cumulative lead exposure among adults in nonoccupational settings can adversely affect cognitive function. Which cognitive domains are affected has not been explored in detail. METHODS: We used nonlinear spline regressions and linear repeated-measures analysis to assess the association between scores on a battery of cognitive tests over time and both blood and bone lead concentrations in the Normative Aging Study, a cohort of community-dwelling elderly men. Bone lead was measured from 1991 through 1999 with K-shell x-ray fluorescence. A total of 1089 men with a mean (+/-standard deviation) age of 68.7 (+/-7.4) years with blood lead measurements, 761 of whom also had valid bone lead measurements, completed at least one of a battery of cognitive tests. Approximately 3.5 years later, 69% of the men had at least one repeat test. Cognitive testing was performed from 1993 through 2001. RESULTS: On a cross-sectional basis, there was little association between blood or bone lead and cognitive test scores. Change in performance over time on virtually all tests worsened as bone lead increased, with the most robust effects on performance and reaction time scores on visuospatial/visuomotor tests. CONCLUSIONS: Low-level cumulative exposure to lead in nonoccupational settings may adversely affect cognitive function, particularly in the visuospatial/visuomotor domain.     

The association between frailty and quality of life among rural community-dwelling older adults in Kegalle district of Sri Lanka: a cross-sectional study

Purpose

The objective of this study was to estimate the cross-sectional association of frailty status with overall and domain-specific quality of life (QoL) in rural community-dwelling older adults in Kegalle district of Sri Lanka.

Methods

A population-based cross-sectional study was conducted with 746 community-dwelling older adults aged?≥?60 years living in the rural areas of Kegalle district of Sri Lanka in 2016. A three-stage probability sampling design was used to recruit participants. Frailty and QoL were assessed using the Fried phenotype and Older People’s Quality of Life Questionnaire, respectively. Multivariable linear regression was used to estimate the association of frailty with QoL after accounting for the complex sampling design.

Results

The median (IQR) age of the sample was 68 (64:75) years and comprised of 56.7% women. 15.2% (95% CI 12.4%, 18.7%) were frail and 48.5% (95% CI 43.9%, 53.2%) were pre-frail. The unadjusted means (SE) of the total QoL score for the robust, pre-frail and frail groups were 139.2 (0.64), 131.8 (1.04) and 119.2 (1.35), respectively. After adjusting for covariates in the final multivariable model, the estimated differences in mean QoL were lower for both frail and pre-frail groups versus robust. The estimated reduction in the total QoL score was 7.3% for those frail and 2.1% for those pre-frail. All QoL domains apart from ‘social relationships and participation’, ‘home and neighbourhood’ and ‘financial circumstances’ were associated with frailty.

Conclusions

Frailty was associated with a small but significant lower quality of life in this rural Sri Lankan population, which appears largely explained by ‘health’ and ‘independence, control over life and freedom’ QoL domains. Interventions aiming to improve quality of life in frail older adults should consider targeting these aspects.

     

Development of a client-generated health outcome measure for community nursing

OBJECTIVE: To develop a client-generated outcome measure for use in community nursing. METHOD: Participants for the study were identified from the case load of community health nurses, from a nursing home service and from residents of a retirement village. All participants had a diagnosis of venous leg ulcer (VLU) and/or type 2 diabetes. Preliminary development of the measure involved focus groups of community clients and health professionals, and pilot testing of an existing quality of life (QoL) measure, the Patient-Generated Index. The resulting Client-Generated Index was tested for reliability and validity. RESULTS: The Pearson's correlation coefficient between administration of the CGI at T1 and T2 was 0.526 (n = 51; p = 0.0001). The CGI correlated significantly with four of eight dimensions of the SF-36, and with pain as a clinical marker for VLU r = 0.54 (p = 0.001). Overall, participants with VLU reported a lower QoL (mean CGI score 2.8) compared to those with diabetes (mean CGI score 4.1). CONCLUSIONS: The CGI was developed to measure outcomes in community health settings. Some measures of its reliability and validity are demonstrated and further research is needed to validate the instrument using other client groups. IMPLICATIONS: If routine assessment and evaluation is to contribute to measures of outcome, the instruments need to be concise and acceptable to health care providers. The CGI has all these properties.     

胃癌根除术同步放化疗患者的生活质量及影响因素研究

目的 了解胃癌根除术经同步放化疗患者的生活质量及其相关影响因素.方法 选取某医院门诊随访的胃癌根除术后经同步放化疗后6~24个月的患者128例,使用中文版EORTC QLQ-C30量表评估其生活质量,采用多重线性回归分析其影响因素.结果 胃癌根除术者年龄为（50.36±9.73）岁,总体生活质量得分为（75.13±19.64）分.功能领域中以角色功能得分较高为（86.98±14.58）分,症状领域中以疲倦得分较高为（30.47±12.44）分,单一条目中以经济困难得分较高为（38.29±14.78）分.多重线性回归分析显示收入情况、病理分期和文化程度与胃癌患者生活质量有关联.结论 该组患者总体生活质量得分较高,与收入情况、病理分期和文化程度有关.     

Community mental healthcare in England: associations between service organisation and quality of life

The present authors set out to explore the relationship between different forms of service organisation and quality of life (QoL) for service users. Four mental health trusts and their corresponding social services departments were recruited to exemplify: (1). high and low levels of integration between health and social services; and (2). high and low levels of targeting at users with severe mental health problems. The authors used the Lancashire Quality of Life Profile, and chose their sample size to be able to detect a difference of 0.5 in subjective satisfaction scales. Analysis of covariance was used to investigate the simultaneous impact of variables representing user characteristics, objective and subjective QoL, and service organisation. Two hundred and sixty users selected at random from the active caseloads of mental health services in the four districts were interviewed at time 1 and 232 people were interviewed 6 months later (time 2). No bias was detected in the non-respondents at time 2. The authors found few differences between districts. As in other similar studies, QoL seemed to be stable for the whole sample over time. In 6 months, general satisfaction with leisure increased and the number of people who had been in hospital fell. Negative affect score was the only variable found to be associated with subjective QoL, and no predictors of objective QoL were identified. There was some evidence of better objective outcomes for people in receipt of integrated mental health services. They socialised more, and seemed to have less difficulty accessing police and legal services. The results also suggest that interventions targeted at negative affect could have benefits for subjective QoL.     

Familial aggregation of body mass index and subcutaneous fat measures in the longitudinal Québec family study

Family resemblance for several measures of body fat and fat distribution was explored in the longitudinal Québec Family Study (QFS), including an overall measure of adiposity (body mass index, BMI), total subcutaneous fat (the sum of 6 skinfolds, SF6), and subcutaneous fat distribution (the trunk to extremity ratio, TER). Repeated measures were taken twice approximately 12 years apart. A longitudinal familial correlation model was used to assess familial resemblance at each of times 1, 2, and cross-time, and a univariate model was used for the change score. The change score was assumed to index the degree to which different familial factors impacted on the longitudinal resemblance, while the cross-time comparisons indexed similar familial factors across time. For BMI, the maximal heritability was 44 and 36% at times 1 and 2, respectively, 37% for the change score, and 33-43% for the cross-time comparison. While the etiology of the BMI familial effect at times 1, 2, and cross-time was assumed to be primarily polygenic, that for the change score was a function of cohort effects (environmental). For SF6, the maximal heritability (primarily genetic) was low at time 1 and for the change score (16%), but was nonsignificant at time 2 and cross-time. For TER, the maximal heritabilities were significant for each of times 1 (42%), 2 (40%), change score (59%), and cross-time comparisons (35-36%). In summary, simple univariate familial correlation analysis of the change scores and bivariate analysis of the longitudinal measures are useful in delineating the underlying factors leading to both change and stability across time.     

Patients' perceptions of the side-effects of prostate cancer treatment--a qualitative interview study

Primary prostate cancer treatment often results in suboptimal urinary, bowel and/or sexual function. These effects are not inevitable. After treatment patients typically report high health related quality of life (QoL) scores. This discrepancy between disease-specific and generic results raises the question which meaning side effects actually have to patients. In a qualitative study we explored two mechanisms which could possibly explain the discrepancy: insensitivity of generic QoL measures to these specific symptoms and adaptation to changed health (response shift). In semi-structured interviews with 33 prostate cancer patients in the Netherlands we collected data on their opinions regarding health and QoL, we observed how respondents behaved when completing health status and QoL questionnaires, and solicited comments on a QoL questionnaire, its items, and its content validity. We observed that patients trivialized sexual (dys) function referring to old age. We found that while they might consider sexual, urinary, and bowel dysfunctions as problems, they did not take such dysfunctions into account when completing QoL measures because they did not view these dysfunctions as aspects of health. This finding reveals a so far unidentified cause of the insensitivity of generic measures of health status. Furthermore, response shift appeared to be present: many patients accepted the side effects as inevitable consequences of having been treated for prostate cancer, a condition they perceived as life threatening. We conclude that generic QoL measures cannot reveal the impact of sexual, urinary and bowel dysfunctions on patients because such dysfunctions are not perceived as health problems. By presenting these findings we want to draw attention to issues that complicate QoL assessments in general and in prostate cancer patients in particular.     

Life-course financial strain and health in African–Americans

Differential exposure to financial strain may explain some differences in population health. However, few studies have examined the cumulative health effect of financial strain across the life-course. Studies that have are limited to self-reported health measures. Our objective was to examine the associations between childhood, adulthood, and life-course, or cumulative, financial strain with disability, lung function, cognition, and depression. In a population-based cross-sectional cohort study of adult African–American twins enrolled in the US Carolina African American Twin Study of Aging (CAATSA), we found that participants who reported financial strain as children and as adults are more likely to be physically disabled, and report more depressive symptoms than their unstrained counterparts. Participants who reported childhood financial strain had lower cognitive functioning than those with no childhood financial strain. We were unable to detect a difference in lung function beyond the effect of actual income and education in those who reported financial strain compared to those who did not. Financial strain in adulthood was more consistently associated with poor health than was childhood financial strain, a finding that suggests targeting adult financial strain could help prevent disability and depression among African–American adults.     

Evaluating high dose therapy in Multiple Myeloma: Use of quality-adjusted survival analysis

Purpose: To incorporate quality-of-life considerations in assessing high dose therapy (HDT) for patients with Multiple Myeloma (MM). Patients and methods: A quality-adjusted survival analysis, using the quality-adjusted time without symptoms or toxicity (Q-TWiST) method, was applied to two randomized clinical trials conducted in patients with MM which compared randomized assignment to HDT vs. conventional chemotherapy (CCT) alone (MAG91) or followed by HDT (MAG90). Treatment benefit in terms of mean Q-TWiST was assessed through threshold utility analyses, i.e., sensitivity analyses of the choice of the utility coefficients over all possible values of utility weights. Results: In both trials, results slightly favored the first-line HDT group over the first-line CCT group, with an average gain in TWiST of about 5.5 months over the 58 month-median follow-up period (27.8 vs. 22.3 months, respectively) in the MAG90 trial and 5.8 months over the 56 month-median follow-up period (19.1 vs. 13.3 months, respectively) in the MAG91 trial. The utility threshold analyses revealed that the first-line HDT group had a statistically increased mean quality-of-life adjusted time compared to the other group for a broad range of utility coefficient values. Conclusion: The development of such understandable and intuitive measures of expressing the relative benefit of complex treatment strategies is expected to be used in clinical decision making in the near future.     

Health state utility and quality of life measures in patients with chronic myeloid leukemia in France

Purpose

Tyrosine kinase inhibitors (TKIs) have dramatically improved the prognosis of chronic myeloid leukemia (CML). We aimed to assess health state utility and quality of life (QoL) in French patients with CML in real-life setting, to study the determinants of utility score and to compare health-related QoL values to general population norms.

Methods

We conducted a cross-sectional study in 412 patients with CML. Data were collected by electronic survey. Three patient-reported outcomes questionnaires were used: EORTC QLQ-C30, EORTC QLQ-CML24 and EuroQol EQ-5D-3L. Health state utility values were computed using the French value set. We computed deviations from reference norms from the general population. We studied the determinants of health utility score using multiple regression models.

Results

The mean utility score (SD) was 0.72 (0.25) in the chronic phase and 0.84 (0.21) in treatment-free remission, with marked variations by gender. Patients with CML had a deviation from the reference norm of ?0.15 on average (SD: 0.25). In terms of QoL, social functioning, role functioning and cognitive functioning were notably impacted with a mean difference of ?16.0, ?13.1 and ?11.7 respectively. Fatigue, dyspnea and pain were the symptoms with the highest deviation from general population norms (mean difference of 20.6, 14.0 and 8.3 respectively). In the multiple regression analysis, fatigue was the most important independent predictor of the utility score.

Conclusion

Although TKIs prevent the disease from progressing and even allow remission without treatment, QoL in patients with CML is notably altered. The utility scores deteriorate with CML symptoms.

     

Longitudinal versus cross-sectional estimation of lung function decline--further insights

This paper explores the extent to which differences in longitudinal versus cross-sectional inference may be influenced by the choice of statistical models. Using lung function data on 524 working men, we first compare the goodness-of-fit and implication for longitudinal decline of a variety of cross-sectional models. We then compare the predicted longitudinal patterns from these models with those observed over a period of four years. In general, both approaches provide qualitatively, if not quantitatively, similar messages concerning the relative effects of smoking and age on lung function decline. Nonetheless, we acknowledge the existence of real selection and cohort effects. Although we recognize the utility of cross-sectional designs, we discourage quantitative comparisons between studies, especially longitudinal versus cross-sectional.     

An evaluation of the effectiveness of tobacco-control legislative policies in European Community countries

The purpose of this paper was to assess the effectiveness of anti-tobacco smoking legislation from 1948 onwards in reducing actual per capita tobacco consumption in the twelve countries of the European Economic Community (EEC). In order to undertake these assessments a score was assigned to every legislative measure, indicating the a priori likely impact of this measure on tobacco consumption. Two approaches were then utilized. In the first, it was found that the cumulative anti-tobacco legislative score correlates well in time with a reduction of tobacco consumption. In the second, cross-sectional data from the EEC countries and multiple regression modelling were used to estimate the elasticities of tobacco price, per capita income and cumulative anti-tobacco legislation score; it was found that legislation has an impact on tobacco consumption which, although considerably smaller than the corresponding impact of tobacco price levels, is nominally significant and potentially important. The evaluative approaches utilized in this paper are based on observational data of ecologic nature and can provide only weak evidence about the causal nature of the reported associations. Nevertheless, this limited evidence suggests that legislative measures may be effective both by affecting price levels and through other mechanisms, including health education and the formation of a more general anti-smoking ethos.     

Optimal survey design for community intervention evaluations: Cohort or cross-sectional?

Community intervention evaluations that measure changes over time may conduct repeated cross-sectional surveys, follow a cohort of residents over time, or (often) use both designs. Each survey design has implications for precision and cost. To explore these issues, we assume that two waves of surveys are conducted, and that the goal is to estimate change in behavior for people who reside in the community at both times. Cohort designs are shown to provide more accurate estimates (in the sense of lower mean squared error) than cross-sectional estimates if (1) there is strong correlation over time in an individual's behavior at time 0 and time 1, (2) relatively few subjects are lost to followup, (3) the bias is relatively small, and (4) the available sample size is not too large. Otherwise, a repeated cross-sectional design is more efficient. We developed methods for choosing between the two designs, and applied them to actual survey data. Owing to drop-outs and losses to followup, the cohort estimates were usually more biased than the cross-sectional estimates. The correlations over time for most of the variables studied were also high. In many instances the cohort estimate, although biased, is preferred to the relatively unbiased cross-sectional estimate because the mean squared error was smaller for the cohort than for the cross-sectional estimate. If these results are replicated in other data, they may result in guidelines for choosing a more efficient study design.