Breast hypertrophy is associated with clinically important morbidity. A prospective study was conducted to assess the change in health-related quality of life (HRQL) following breast reduction mammoplasty. This paper describes the measurement properties of each of the HRQL questionnaires used.The reliability, responsiveness, and the construct validity of each HRQL instrument  and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO) instruments) were assessed. The BRAVO instruments are a set of separate instruments including the Short Form-36 (SF-36), the Multidimensional Body Self Relations Questionnaire Appearance Assessment (MBSRQ-AS), and the Breast Related Symptoms Questionnaire (BRSQ).The HUI2, the HUI3, the MBSRQ-AS, and the breast severity symptom (BSS) score from the BRSQ all demonstrated good test-retest reliability. The SF-36 physical component summary, the MBSRQ-AS, and the BSS score demonstrated high responsiveness. The SF-36 mental component summary and the HUI3 had a moderate effect size and the HUI2 had a small effect size. All of the changes in scales are correlated in the same direction except for the SF-36 physical component summary and the SF-36 mental component summary.All four instruments were found to be reliable and responsive. These instruments can be used in similar clinical settings to evaluate the change in patients' HRQL. Within the last decade the plastic surgical community has been encouraged to use health-related quality of life (HRQL) assessment instruments to report on the efficacy of surgical interventions -5. ThereBreast hypertrophy has been reported by patients to be associated with important burdens in pain and discomfort as well as emotion . EarlierIn a recent Canadian prospective study of patients with a body mass index (BMI) below 27, pre-surgery mammoplasty patients scored lower on the SF-36 compared to normative data and post-surgery these patients achieved scores similar to normative data . AlthougA number of different instruments have been used in previous studies to measure HRQL in patients with breast hypertrophy. In terms of the hierarchy of evidence in surgical studies, the studies which provide the higher strength of evidence are prospective cohort studies which address important patient outcomes. These studies have shown an improvement from pre-operative to post-operative, which have been statistically significant. Our study is similar to the design of some of the earlier prospective cohort studies measuring HRQL in patients with breast hypertrophy ,13-15,18The primary objective of this study is to look at the measurement properties, including the reliability and responsiveness, of each of the four HRQL instruments used. The secondary objective was to assess the concurrent validity of each of the four HRQL instruments.Consecutive patients seen by the senior author (AT) over a period of one-year, with the diagnosis of breast hypertrophy and who obtained government approval for reduction mammoplasty were invited to participate in this prospective study. After signing an informed consent form, patients were asked to complete several questionnaires at each assessment time: (one week (time one) and one day before surgery (time two) and at one month (time three), six months (time four), and 12 months after surgery (time five)). The questionnaires were the HUI -28, and The patients were provided with the questionnaires at their clinic visits and they either completed them while at the clinic or they completed them at home and returned them to the clinic by mail. The patients completed the questionnaires at one week before surgery and at one day before surgery to assess the test-retest reliability of each instrument. The questionnaires were completed at three post-operative time-points to measure change and to assess the stability of change over one-year of follow-up. The Research Ethics Board of McMaster University and St. Joseph's Hospital approved this study.2). Other baseline information collected included self-reported bra cup size, diabetes, history of depression, smoking history, shoulder grooving, shoulder pain, back pain, neck pain, breast pain, intertrigo, and history of headaches.In addition to completing the quality of life instruments (described in detail below), each patient underwent a physical examination and the baseline information was recorded. Demographic information including age, height, and weight was obtained which permitted the calculation of BMI  in clinical trials and other studies -28. The The HUI2 and HUI3 health status classification systems are complementary. Together they provide descriptive measures of ability or disability for health-state attributes, and descriptions of comprehensive health status . The HUIUtilities derived from responses to HUI questionnaires may be used to calculate quality adjusted life years (QALYs). QALYs are the measure of effectiveness in cost-utility analysis, a special type of cost-effectiveness analysis for comparing alternative surgical interventions -28,31.The SF-36 is a multi-purpose, short-form health survey with 36 questions . It is aThe SF-36 contains multi-function item scales to measure eight domains: physical function (10 items); role physical (4 items); bodily pain (2 items); general health (5 items); vitality (4 items); social functioning (2 items); role emotional (4 items); and mental health (5 items) . The twoThe MBSRQ is a well-validated self-report inventory for the assessment of body image . Body imIn this study, the shorter version of the MBSRQ-AS was used and only the appearance evaluation subscale was used, because we were concerned with measuring body image. Scores vary from one to five. A high score indicates emphasis on one's looks, attention to one's appearance, and engaging in extensive grooming behaviours. A low score indicates apathy about one's appearance, one's looks are not especially important, and not expending much effort to "look good". High scorers feel mostly positive and satisfied with their appearance; low scorers have a general unhappiness with their physical appearance .The BRSQ lists 13 breast related symptoms and the respondent indicates how much of the time she has the symptoms ,24. From® Health Survey Manual & Interpretation Guide, [Scores for the HUI2, the HUI3, and the SF-36 were generated according to algorithms from the developers  and the n Guide,  respectin Guide, ,24,30.A measure is reliable if it is sound and dependable. Reliability is assessed by tests of repeatability or reproducibility. Reliability is often assessed in terms of agreement between intra-subject test-retest measurements and inter-assessor measurements . There aTo estimate test-retest reliability, the same HRQL instrument is completed by the same patient on two different occasions. The assumption is that there would be no change in the scorers if there is no substantial change in health status of the patient being measured between the two occasions. The test-retest reliability of patients' responses is extremely important as we were most interested in determining that the difference in scores, between pre- and post-operative times reflected a real change in the patient's health is a result of the surgical intervention. If patient reporting is not reliable then one cannot truly capture the change in health status in patients using HRQL questionnaires.The reliability of a test is indicated by the reliability coefficient. Reliability is expressed as a number ranging between zero and one; as it approaches zero there is lower reliability and a reliability coefficient close to one indicates higher reliability. In other words, the larger a reliability coefficient is, the more repeatable or reliable the test scores. General guidelines exist for interpreting reliability coefficients. A reliability coefficient value of 0.90 and greater is said to be excellent; a reliability coefficient value of 0.80 to 0.89 is good; a reliability coefficient value of 0.70 to 0.79 is adequate; and a reliability coefficient value below 0.70 may have limited applicability .The validity and reliability of the HUI2, HUI3, and the SF-36 instruments have been demonstrated in various populations -29. The In this study we assessed the test-retest reliability of the HUI2, the HUI3, the MBSRQ-AS, and the BRSQ in patients diagnosed with breast hypertrophy prior to undergoing breast reduction mammoplasty. We did not assess the test-retest reliability of the SF-36 because we had used the four-week recall period for the SF-36. This study also provides some evidence about the concurrent validity of the BRSQ.We used two generic and two disease (condition) specific instruments in this prospective study. Generic health status measures seek a broad perspective that is not specifically related to the restricted score of the HRQL of a specific disease or condition. Using a generic instrument has the advantage of allowing comparisons of health status to be made across different diseases and health states . DiseaseThe effect size index is a statistical measure that can be used as an indicator of internal responsiveness. The mathematical formula for the effect size is the difference (Δ) of mean follow-up assessment scores minus mean baseline assessment score divided by the standard deviation of the baseline scores . Our basThe minimum important difference is a measure of clinically important or relevant change in health . In otheThere is no rule for determining what constitutes the minimum clinically important difference on the SF-36 subscales . A 10-poCorrelation analysis will provide information about the degree of redundancy from measurements using various instruments and evidence about the concurrent validity of the BSS score. Concurrent validity is a form of construct validity . With coIn the current study, the change score of each questionnaire was correlated with the change score of the other questionnaires to assess the degree of redundancy among measures and to assess the concurrent validity of the BSS score. We expected all of the change scores to be positively correlated with each other because they are all scored in a positive direction, measuring improvement.The patient characteristics were described using frequency distributions and means. The ICC of test-retest reliability was computed using data from one week prior to surgery (time one) and one day prior to surgery (time two) for each HRQL instrument named above. To measure responsiveness, effect size, and standardized response means  were calFifty-two consecutive patients initially consented to participate in the study. The first patient was enrolled in April 2001 and the last patient was enrolled in May 2002. Of the 52 patients who had initially agreed to participate, 49 patients completed the baseline assessment. Patients did not complete the study for various reasons. One patient could not sufficiently understand English to complete the questionnaires, another patient cancelled her surgery after it had been booked, and one patient decided not to participate. Although 49 patients completed the baseline assessment, some patients did not return their HRQL questionnaires at all time-points despite several telephone calls and mailings . Self-reported bra cup sizes ranged from D to H, with 65 percent of the patients having a cup size of DD. Eighteen percent of patients had a history of depression, eight percent experienced frequent headaches, and 12 percent were smokers. Prior to surgery, all of the patients experienced neck pain, 94 percent experienced back pain, 53 percent experienced shoulder grooving, 45 percent experienced shoulder pain, 14 percent had breast pain, and 39 percent had intertrigo. The mean tissue resection weight for the left breast was 757.8 grams and the mean tissue resection weight for the right breast was 822.6 grams.The mean age of the patients was 38 years . The mean BMI was 30.9 kg/mThe computed ICC for the HUI2 was 0.86, the HUI3 was 0.84, the MBSRQ-AS was 0.85, and BSS score was 0.87. The HUI2, the HUI3, the BMSRQ-AS, and the BSS score all demonstrated good test-retest reliability.The responsiveness of each instrument is shown in Table In the current study, the difference identified between the baseline (the day before surgery) and at six-months after surgery was 0.06 for the HUI2 which is twice the minimal important difference identified by Horseman et al  , in contrast to other jurisdictions, for example, Nova Scotia, Canada  and the A number of previous studies have reported that women who suffer from breast hypertrophy frequently present with heightened body image dissatisfaction -48. In CPatients completed the HUI2, the HUI3, and the BRAVO instruments  at one week and one day before surgery to measure the test-retest reliability of each instrument and at one, six, and 12 months after surgery to measure change in HRQL following breast reduction mammoplasty. The methodology used in this prospective study may interest those who wish to sponsor, design, or implement future HRQL studies in breast reduction surgery or other areas of plastic surgery.Of the 52 patients who had initially agreed to participate, 49 patients completed the baseline assessment. Despite multiple reminders, 30 patients completed all of the HRQL questionnaires at the 12-month follow up. This equates to a compliance rate of 57.7 percent. The response rate in this study is comparable to response rates obtained in previous studies on HRQL in patients with breast hypertrophy. For instance, several authors have reported response rates ranging from 32.5 percent to 80 percent ,12,14,16To measure the test-retest reliability of each instrument, scores were obtained for each instrument using the recommended algorithms and the ICC was computed from these scores. We found that all HRQL instruments demonstrated good reliability, which reinforces previous reliability testing of the HUI2, HUI3, SF-36, MBSRQ-AS, and BSS score.It is extremely important that there is low within-patient variability in stable patients, relative to the magnitude of change that is predicted following the intervention, while answering the various questions on quality of life questionnaires in surgical outcome studies. Absence of reliable reporting will reduce the ability of measures to assess the effectiveness of surgery. For the present study, the one-week interval (time one and time two) was chosen to assess patient reporting as it was not long enough for other adverse events to intervene and change the health status but appropriate to avoid recall bias.Marx et al noted that if multiple questionnaires were administered, each consisting of numerous items, the effect of memory may be minimized and the effect of memory may be greater if only a single questionnaire was used . In the The SF-36 physical component summary, the MBSRQ-AS, and the BSS score showed high responsiveness. The SF-36 mental component summary, the HUI2, and the HUI3 had a lower responsiveness summary statistics than the other HRQL instruments used in this study but all three instruments were able to detect clinically important changes in overall HRQL scores. The HUI3 showed a moderate effect size and detected a clinically important reduction in pain scores. All of the statistically significant correlations are positive except for the SF-36 physical component summary with the SF-36 mental component summary. The negative correlation may be a function of the problem with the algorithms for calculating SF-36 physical and mental component summary scores described in the published literature including reports by Simon et al  and CunnThis study demonstrates that patient reporting using the HUI2, the HUI3, the MBSRQ-AS, and the BSS score are reliable in a sample of patients diagnosed with breast hypertrophy who had breast reduction mammoplasty. All instruments were equally reliable. The HUI is the only preference-based instrument and it was shown to be responsive. The two disease (condition) specific instruments were the most responsive of all the HRQL instruments usedHaving established the reliability and responsiveness of two generic (HUI and SF-36) instruments and two disease (condition) specific (MBSRQ-AS and BSS score) instruments, and the concurrent validity of BSS score, the focus moves onto the clinical and policy implications of the prospective study by addressing the following question: Can the improvement in HRQL derived from breast reduction surgery be measured quantitatively? Research is underway to address four specific issues: 1) identifying health attributes affected most frequently in breast hypertrophy patients and describing the extent of the observed morbidity; 2) assessing the health status and HRQL of patients in short, intermediate, and long time periods after reduction mammoplasty ; 3) determining if there is a relationship between tissue resection weight and changes in health status and HRQL; and 4) determining if there is a relationship BMI and changes in health status and HRQL to address the ongoing BMI discrimination by third party payers.BRAVO Breast Reduction Assessment Value and OutcomesBRSQ Breast Related Symptoms QuestionnaireBSS Score Breast Symptom Summary ScoreHRQL Health-Related Quality of LifeHUI Health Utilities IndexHUI2 Health Utilities Index Mark 2HUI3 Health Utilities Index Mark 3ICC Intraclass Correlation CoefficientMBSRQ-AS Multidimensional Body Self Relations Questionnaire Appearance AssessmentMID Minimally Important DifferencesSF-36 Short Form-36SRM Standardized Response MeanAT: Conception of the study, design of the study, acquisition of data, drafting of the manuscript. SS: Drafting of the manuscript. KV: Study coordination, acquisition of data, critical review of the manuscript. ED: Design of the study, statistical analysis, critical review of the manuscript. BF: Study design, critical review of the manuscript. All authors have read and approved the final manuscript.


Tuberculosis remains a major public health problem worldwide. In recent years, increasing efforts have been dedicated to assessing the health-related quality of life experienced by people infected with tuberculosis. The objectives of this study were to better understand the impact of tuberculosis and its treatment on people's quality of life, and to review quality of life instruments used in current tuberculosis research.A systematic literature search from 1981 to 2008 was performed through a number of electronic databases as well as a manual search. Eligible studies assessed multi-dimensional quality of life in people with tuberculosis disease or infection using standardized instruments. Results of the included studies were summarized qualitatively.Twelve original studies met our criteria for inclusion. A wide range of quality of life instruments were involved, and the Short-Form 36 was most commonly used. A validated tuberculosis-specific quality of life instrument was not located. The findings showed that tuberculosis had a substantial and encompassing impact on patients' quality of life. Overall, the anti-tuberculosis treatment had a positive effect of improving patients' quality of life; their physical health tended to recover more quickly than the mental well-being. However, after the patients successfully completed treatment and were microbiologically 'cured', their quality of life remained significantly worse than the general population.Tuberculosis has substantially adverse impacts on patients' quality of life, which persist after microbiological 'cure'. A variety of instruments were used to assess quality of life in tuberculosis and there has been no well-established tuberculosis-specific instrument, making it difficult to fully understand the impact of the illness. The assessment of patient reported outcomes (PROs) has become more accepted and valued in the disease management and outcome evaluation. Health-related quality of life (HRQL) is a complex type of PRO that evaluates health status. HRQL broadly describes how well individuals function in daily lives and their own perception of well-being in physical, psychological, and social aspects ,2. AlthoAlthough effective therapy has long been available, TB remains a major public health threat globally, with one third of the world's population infected ,6. Many The objectives of this review were: (1) to identify HRQL instruments used in TB research; (2) to better understand the impact of TB disease or infection and the associated treatment on patients' HRQL; and (3) to examine demographic, socio-economic, and clinical factors associated with HRQL outcomes in TB patients.tuberculosis (TB), Quality of Life (QoL), Quality Adjusted Life Years (QALY), health utility, health status, life quality, and well-being. The limit feature was used to select human studies published between 1981 and 2008 written in English or Chinese . The last time electronic database search was conducted during July 22, 2008. The reference sections of the following key journals were manually searched for relevant articles: International Journal of Tuberculosis and Lung Disease, Chest, Quality of Life Research, and Health and Quality of Life Outcomes. Reference lists of included studies, review articles, letters, and comments were checked afterwards. We did not contact the authors of identified studies or relevant experts to locate unpublished studies. Each stage of the literature searching process is illustrated in Figure A systematic literature search was performed using the following electronic databases: Medline (1950-present), EMBASE (1980-present), Cochrane Register of Controlled Trials (CENTRAL), CINAHL, PsycINFO, and HaPI (1985-present). Key word searching and/or subject searching were performed, if applicable. The following keywords were used: All clinical trials and observational studies where multi-dimensional HRQL was evaluated, either as a primary or secondary outcome, using structured HRQL instruments were considered in this review. Participants were those diagnosed with active TB disease or latent TB infection (LTBI), regardless of the site and stage of the disease and the treatment status. There were no limitations on age, gender, race, the origin of birth, and other socio-economic status.For the purpose of this review, HRQL was defined as patients' self-evaluations of the impact of either active TB disease or LTBI and the associated treatments on their physical, mental, and social well-being and functioning. The following requirements for HRQL measurement were set a priori for studies to be included in this review: (1) one multi-dimensional HRQL instrument or a combination of single-dimensional instruments had to be used to capture the broad framework of HRQL; (2) the HRQL instruments could be either generic or disease (or condition) -specific; (3) the origin of the applied instruments had to be identifiable and traceable; (4) the HRQL instruments had to have psychometric properties such as reliability and validity reported from previous studies or were assessed in the specific study being reviewed; (5) HRQL outcomes had to be self-reported by the specific participant, but HRQL measurement that were completed with help from proper proxies, such as family members and caregivers, were also accepted.Studies were excluded if (1) HRQL was evaluated using qualitative methodologies, such as focus groups; or (2) only one single dimension of HRQL  was assessed; or (3) HRQL was assessed using instruments designed for the specific study without psychometric properties evaluated and reported; or (4) a modified version of a previously validated instruments  was used as the psychometric properties of the original instrument could be changed by the modification.If the study was included in this review, the following information was collected: study design, inclusion and exclusion criteria of subjects, included subjects' socio-demographic characteristics and clinical features, HRQL instrument(s) used, the origin and structure of HRQL instrument(s), administration of HRQL instrument(s), and HRQL outcomes and validation results.The literature search identified 2540 articles which were narrowed to 26 -14,16-35Of the 12 included studies, one was published in 1998  and the To measure multiple-dimensional HRQL, a variety of instruments were involved in the included studies  and Social Support Rating Scale (SSRS) . The SCLIn the USA study, a series of instruments or questions were used to assess TB-infected homeless individuals' self-perceived physical health, psychological profile, emotional well-being, social support, and health care access and use . ExampleHealth utility, one generic measure of HRQL, reflects subjective preferences for health states and also provides quantitative estimates of HRQL under certain health states . The twoHUI currently consists of HUI-2 and HUI-3 . HUI-2 aThe SG is a classic technique to obtain individual preferences for health outcomes, based on the theory of von Neumann and Morgenstern . In the The SF-36 was used in 6 studies, and overall it showed acceptable validity and reliability. Chamla  validateValidity of the SF-36 was evaluated by examining the correlations between SF-36 outcomes with other external variables, including clinical criteria, responses from other HRQL measures, and physician's evaluations. It was reported that SF-36 scores were able to discriminate between TB patients with different severity levels ,26 and bThe structural validity of SF-36 was tested in two studies, but the results were not consistent. In Chamala , factor The application of SF-36 among TB patients also revealed some problems. In the study by Dion et. al. ,24, SF-3Ceiling and floor effects are a common problem for the application of health utility instruments in TB. In Dion et. al. ,24, 42–5Pasipanodya et. al.  administDhingra and Rajpal  applied Overall, active TB disease had significant and encompassing impacts on patients' HRQL. Using the SF-36, Chamla  found thIn the study by Marra et. al. , Beck-DIThe impaired HRQL experienced by TB patients may be a reflection of socio-demographic status  and other underlying co-morbid conditions, besides TB and its treatment. A few included studies explored the relationship between socio-demographic features and clinical factors and HRQL in TB patients. In general, the findings were consistent, but some discrepancies existed. Yang et. al.  and NyamChamla , DhingraAlthough anti-TB treatment improved HRQL overall, active TB patients still had poorer HRQL at the end of the treatment compared to the general population or people with LTBI, especially in psychological well-being and social functioning. Chamla  observedMuniyandi et. al.  assessedHRQL has been appreciated as an important health outcome measure in clinical research. We identified 12 original studies where multi-dimensional HRQL was assessed among people with TB disease or infection using structured instruments around the world. We found that TB and its treatment have a significant impact on patients' quality of life from various aspects and this impact tends to persist for a long time even after the successful completion of treatment and the microbiological 'cure' of the disease.The results suggest that TB disease has a negative and encompassing impact on active TB patients' self-perceived health status in physical, psychological, and social aspects. Overall, the anti-TB treatment showed positive effect on improving patients' HRQL. It appeared that physical health seemed to be more affected by the disease but improved more quickly after the treatment, while the impairment on mental well-being tended to persist for a longer term ,28. HoweMost studies have focused on assessing HRQL in active TB patients. Although people with LTBI do not present with clinical disease or symptoms, they are likely to be subjected to the same social and psychological impacts as active TB patients. The knowledge of a deadly and stigmatized disease lying dormant in his/her body may also induce anxiety and fear. As Marra et. al.  observedHRQL assessment in TB research is still a new area, and a valid and reliable TB-specific instrument is much needed. Currently, a wide range of HRQL instruments were utilized in the literature. The SF-36 was the most frequently used instrument and it appeared to be a valid and reliable tool to be used in TB. Although the SF-36 has been used extensively to assess both population health and specific health conditions for various medical conditions, as a generic health assessment instrument, it offers little information to help understand the unique experiences among TB patients, such as social stigma and anti-TB treatment related ADRs.Our review identified one TB-specific HRQL instrument, DR-12, which was developed in India ,21. UnfoIt should be also noted that most TB patients have very different cultural and socio-demographic backgrounds compared with the population in which many of these instruments were originally developed. Also, in the studies done in Canada and the USA -26,32,34Particular attention should be given to some methodological issues on assessing HRQL among people with active TB disease or LTBI. To comprehensively examine the impact of TB and its treatment on patients' HRQL, it is very important to include a proper comparison group from a similar demographic and socio-economic background. When conducting the study, researchers are recommended to seek statistical consultation regarding proper sample size estimating, missing data handling, and adjusting for potential confounders, such as socio-demographic status and presence of co-morbidities. Another concern is the lack of interpretation of HRQL outcomes in terms of clinical meaningfulness. Statistical significance is a useful way to interpret the result, but it fails to relate the HRQL outcome with clinical relevance. As such, more work needs to be done to relate changes in HRQL assessment in TB to concepts such as the minimal clinical difference ,49.Our review of the literature shows that TB diminishes patients' HRQL, as measured by various instruments. However, due to the heterogeneity of HRQL measurements, it was difficult to assimilate results across studies. A few studies used the SF-36 which appeared to be a valid instrument in the measurement of HRQL in TB. Other instruments require further psychometric testing to determine their suitability in measurement in this context. Our review suggests that HRQL assessment in people with TB is a growing research area and a psychometrically sound TB-specific HRQL instrument is lacking. A critical step in the future would be to design an applicable, reliable, and valid TB-specific HRQL instrument. Particular attention should be given to address the methodological issues when conducting a HRQL assessment study in TB patients.The authors declare that they have no competing interests.All authors contributed to the conception and design of the review. NG acquired and analyzed the data and drafted the manuscript. CAM and FM contributed to the analysis and interpretation of the data and finalizing the manuscript. All authors read and gave approval of the final manuscript.Table 1. Overview of included studiesClick here for fileTable 2. HRQL instruments used by included studiesClick here for file


The health-related quality of life (HRQL) is an important indicator of the burden of musculoskeletal disease. The Medical Outcome Study Short-Term 36 (SF-36) is the most used tool that evaluates HRQL as a subjective perception about psychological and physical limitations due to an underlying illness. The purpose of this study was to compare the HRQL scores among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) and a selected sample of health people and determine their relationship with measures of clinical condition.799 patients  accepted the invitation to participate. 1579 healthy controls were used for the comparison. We calculated scores for the eight SF-36 subscales, the Physical Component Summary (PCS) score, and the Mental Component Summary (MCS) score, according to published algorithms. Disease-related characteristics included disease duration, comorbidity, a measure for disease activity and for radiographic damage. The presence of comorbidity was ascertained through patient's self-reports by the Self-Administered Comorbidity Questionnaire (SCQ). Comparison were performed with respect to sex and age, and s-scores were calculated for comparison with the norm. Multivariate analyses were used to assess the relationship between HRQL and radiographic damage, disease activity, and socio-demographic data.The four inflammatory rheumatic diseases (IRD), compared to controls, significantly impaired all eight health concepts of the SF-36 (p < 0.0001) in both component PCS and MCS scores (p < 0.0001). Overall, the dimensions typically affected were physical functioning, limitations due to physical function, and bodily pain. The disease with the worst HRQL for those dimensions was RA. The multivariate analyses revealed that the physical component was influenced by a high disease activity and comorbidity. The severity of psoriatic lesions was associated with poor mental functioning in patients with PsA.Chronic IRD have a clearly detrimental effect on the HRQL in both sex and in age groups, and physical domain is more impaired than mental and social ones. Rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are three common types of inflammatory rheumatic diseases (IRD) associated with deformities and joint destruction. RA is the most frequent IRD, with a prevalence of 0.5% . PatientTraditional methods of evaluation, with a focus on the locomotor system and measures of impairment, may fail to describe the extensive multi-dimensional issues associated with chronic rheumatic conditions. Consideration of HRQL has become increasingly important in decisions regarding resource allocation, intervention design, and pharmacological treatment with biologic agents of individuals with chronic inflammatory disabling conditions -16. Two The main objective of this study was to examine the self-reported health status in patients with RA, AS and PsA, compared with a selected sample of health people. Furthermore, we wanted to explore the associations between health status and age, sex of the patients, and educational level in these IRD and to estimate the burden of the disease by controlling for the normal variations in health status in the general population.Participants at this study are part of an ongoing longitudinal project measuring rheumatic disease outcomes, approved by the local Ethical Committee for Medical Research. Consecutive adult rheumatic disease patients from the Rheumatology Clinic of the Università Politecnica delle Marche, who agreed to participate in the study, completed an informed consent form. The study population includes patients examined by two rheumatologists and fulfilling the American College of Rheumatology (ACR) classification criteria for RA , the modx-ray findings in patients with AS and with axial PsA. The mSASSS offers advantages in measurement properties and is the most appropriate method by which assessing progression of structural damage in AS [A comprehensive questionnaire package including socio-demographic data, quality of life items, and disease-related variables was administered to the patients. The socio-demographic variables were age, sex, and highest attained level of education . Disease-related characteristics included disease duration (years since fulfilment of the classification criteria of the IRD), comorbidity, a measure for disease activity and for radiographic damage. The Disease Activity Score (DAS)  was usedge in AS . The sevge in AS . The PASge in AS . The PASge in AS , an effige in AS .®, version 9.2 for Windows XP. Descriptive statistics are given as means and standard deviations (SD) for continuous data or as percentages for counts. Comparisons between groups were performed with chi-square tests for categorial variables and analysis of variance (ANOVA) for continuous variables. Standardized difference scores  were also calculated by subtracting the mean scores of the patients from the mean scores of the general population, followed by the division of these deviations by each scale's standard deviation in the general population. The standardized s-score is a rescaled score with a population average of 0 and a standard deviation of 1. The values of the s-scores were interpreted according to Cohen's effect size index, in which 0.2 refers to a small difference, 0.5 to a moderate difference, and 0.8 or more to a large difference [a priori included sex ; age (as a continuous variable); disease duration (years from disease onset as a continuous variable); educational level (years of education as a continuous variable); and the average score of the SCQ questionnaire (SCQ score as a continuous variable). All these factors were then introduced as covariates in multiple regression models in which PCS and MCS SF-36 scores were dependent variables. All variables were entered simultaneously. Owing to multiple comparisons with increasing risk of type 1 errors, the level of statistical significance was set at 0.01.The data were analysed using the SPSS version 11.0 , and MedCalcfference . A set oDemographics and disease characteristics of patients and healthy controls enrolled in the study are shown in Table Scores for respondents with IRD significantly impaired all eight health concepts of the SF-36 p < 0.0001) and in both component summary scores (PCS and MCS) (p < 0.0001), compared with their non-arthritic counterparts Table . General and in ba priori included the demographic variables, disease related characteristics and the and average score of the SCQ questionnaire. All these factors were introduced as covariates in multiple regression models in which PCS and MCS SF-36 summary scores  were dependent variables. The physical component of the SF-36 was influenced by a high disease activity (measured by DAS) and chronic comorbidity (both at a p level < 0.0001), and by radiographic damage (p = 0.004) in RA. A similar association of chronic comorbidity and high disease activity with AS, peripheral PsA, and axial PsA were also found. Concerning the mental component, an association was found in RA with the disease activity (p < 0.0001), and in AS and axial PsA with the low educational level . The severity of psoriatic lesions (assessed using PASI) was significantly associated with poor mental functioning in patients with peripheral and axial PsA .Multiple regression models were constructed to adjust for factors potentially associated with poor HRQL in the four IRD groups. Covariates chosen Patient-reported outcomes (PRO) are an attractive option in a busy medical practice, as the time burden is transferred from the clinician to the patient . The valThe results of this study show that adults with IRD have poorer self-reported health status than those without arthritis in all domains of living, but particularly with respect to scales measuring aspects of physical functioning or mobility, role limitation due to physical health problems and usual activities, and bodily pain. The disease with the worst HRQL for physical dimensions of SF-36 was RA. The mean PCS score for RA patients was 32.5, approximately two standard deviations below the mean observed in the Italian general population ,38. BaseThe findings of the multivariate analysis suggests that the SF-36 PCS scores may reflect both functional limitations due to current disease activity due to processes that do not respond to aggressive treatment with anti-rheumatic drugs and limitations due to the radiographic damage and coexisting conditions. Kirwin , similarThe outcomes of a chronic condition may be also affected by coexisting chronic conditions. It is important to incorporate assessment of comorbidity into studies involving HRQL outcomes for persons with multiple chronic medical conditions, as coexisting conditions may substantially affect outcomes of interest such as physical functioning, overall health status, depression and response rates in randomized controlled trials -55. Our Of the demographic factors studied, education level had the most important association with negative impact on patients' mental HRQL among patients with chronic pain-associated disability. Despite its recognized importance in health outcomes, education level and other measures of socioeconomic status have been infrequently examined as predictors of quality of life in IRD. Lower levels of formal education have been reported to be a risk factor for presence of chronic musculoskeletal pain and physical function in the community and has been associated with a higher prevalence of work disability and greater disease activity in patients with AS and RA ,38. The This study has several limitations that should be taken into account in interpreting the results. First, it is based in a tertiary referral Centre and patients with more severe IRD may be overrepresented. These results may, therefore, not be generalizable to all patients with IRD in the community. In addition, recall periods for the various measures differed. This discrepancy in recall time is common when using multiple self-report measures and is inherent in the measures. However self-report data are a valuable resource, and the problems encountered with self-report data are similar to those encountered in other forms of data collection. Second, the cross-sectional design limits the analysis about the associated factors with physical function and HRQL and does not allow to draw final conclusions about the strengths of the cause-effect relationships. The most of the literature on this issue are cross-sectional studies and not suited for statement or implications. Further, selection bias cannot be excluded. However, the relatively large group of patients was aged between 20 and 82 years, and the whole range of disease activity, physical functioning, and radiographic damage scores was represented, indicating a representative group of IRD patients.Despite to the limitations discussed above, our study confirms that the physical aspects of health seem to be most severely affected in patients with IRD although all dimensions of health were significantly affected, and in the PsA group of patients, the disease impact on mental health was considerable. A management programme for patients with IRD and the planning of the healthcare services should take these findings into account by maintaining the focus on impairment and physical function, but also focusing on the mental and social consequences of the disease. Longitudinal studies are, also, needed to examine how these quality of life measures change over time and respond to clinical and public health interventions.AS: Ankylosing Spondylitis; BASDAI: Bath Ankylosing Spondylitis Disease Activity index; BP: Bodily Pain; CI: Confidence Interval; DAS: Disease Activity Score; DMARDs: Disease Modyifing Anti-Rheumatic Drugs; GH: General Health; HRQOL: Health-Related Quality of Life; IRD: Inflammatory Rheumatic Diseases; MAPPING: MArche Pain Prevalence INvestigation Group; MCS: Mental Component Summary; MH: Mental Health; mSASSS: Modified Stoke Ankylosing Spondylitis Spine Score; PASI: Psoriasis Area and Severity Index; PCS: Physical Component Summary; PF: Physical Functioning; PRO: Patient-Reported Outcomes; PsA: Psoriatic Arthritis (PsA); RA: Rheumatoid Arthritis; RE: Role limitations due to emotional health; RP: Role limitations due to physical function; SCQ: Self-Administered Comorbidity Questionnaire; SD: Standard Deviation; SF: Social Functioning; SF-36: Short Form 36-item Health Survey; s-Score: Standardized difference scores; VT: Vitality.The authors would like to make the following statements with regard to their conflicts of interest/financial disclosures: MI was a full-time employee of Bristol-Myers Squibb's Italy, at the time of study completion. WG is a consultant for Bristol-Myers Squibb, Abbott Immunology, General Electric, Esaote and Shering-Plough, has received honorarium from Bristol-Myers Squibb, Abbott Immunology, General Electric, Schering-Plough and Wyeth, and has received research support from Abbott Immunology and Wyeth. The rest of the authors have any financial or other competing interests.FS was the primary researcher, was responsible for co-ordinating and managing the study on a day-to-day basis, for data collection, data analysis and input into writing the manuscript. MC provided radiological support for the study, was involved in designing the study and helped draft the manuscript. SG provided clinical support and was involved in designing the study. MI contributed to revising the manuscript. WG helped in the design and the interpretation and was involved in critically revising the important intellectual content of the document. All authors have read and approved the final manuscript.


In 2005 a collaboration between public health and local government authorities performed an HIA on the Christchurch Urban Development Strategy Options paper in New Zealand. The findings of this were incorporated into the Greater Christchurch Urban Development Strategy;using multiple qualitative methodologies including key informant interviews, focus groups and questionnaires, this study performs process and impact evaluations of the Christchurch HIA including evaluation of costs and resource use;the evaluation found that the HIA had demonstrable direct impacts on planning and implementation of the final Urban Development Strategy as well as indirect impacts on understandings and ways of working within and between organisations. It also points out future directions and ways of working in this successful collaboration between public health and local government authorities. It summarises the modest resource use and discusses the important role HIA can play in urban planning with intersectoral collaboration and enhanced relationships as both catalysts and outcomes of the HIA process;as one of the few evaluations of HIA that have been published to date, this paper makes a substantial contribution to the literature on the impact, utility and effectiveness of HIA. Health impact assessment (HIA) has been promoted for over twenty years as a way to enhance the potential effects of a policy or strategy "on the health of a population, and the distribution of those effects within the population " . HIA useAlthough the term 'health inequalities' is relatively new, the effect of urbanisation to disadvantage the poor was noted over one hundred and fifty years ago. Urban planning plays an important role in shaping the environmental, social and economic health determinants in cities -9.Evaluations of Health Impact Assessments have been infrequently performed, and rarely published. Evaluation of HIA has been identified as the field of HIA research most urgently requiring attention ,10-15. WThe Greater Christchurch Urban Development Strategy HIA (UDS HIA) provided an opportunity for both a process and an impact evaluation. Process and impact evaluations allowed review of the HIA itself and its impacts on policy over a medium term time frame (two to three years). While outcome evaluation to determine validity of HIA predictions and changes in health and health determinants is the most desirable measure of success of an HIA, in reality the 20 – 30 year time frame required and numerous factors that impact on health outcomes make it difficult if not impossible to perform. The process evaluation was undertaken concurrently with the HIA being conducted in 2005, while the impact evaluation was undertaken in 2008.This report adds to the limited existing literature on evaluation of HIA. The process evaluation sought to answer whether this HIA achieved its objectives, identify success factors and to quantify resources use. The impact evaluation's objectives were to describe the impacts of the HIA on the final UDS, including possible reasons for inclusion, describe unintended impacts of the HIA and evaluate the effectiveness of HIA in policy. Points are discussed in detail and several conclusions made for future evaluations of HIAs.In New Zealand central, regional and local government each have a role in urban development and planning in New Zealand. The Regional Council has responsibility for preparing the Regional Policy Statement under the Resource Management Act. This sets the direction for managing the region's natural resources and outlines the settlement pattern for a region. Local councils must give effect to the Regional Policy Statement through their District Plans which provide the framework for the management of land use and subdivision.Incorporation of Treaty of Waitangi principles is implicit in HIA in New Zealand . HIA speThe Greater Christchurch UDS is an initiative in the Canterbury region of New Zealand, involving local government authorities (Christchurch City Council (CCC), Waimakariri and Selwyn District Councils, and Environment Canterbury  and Transit New Zealand . The Strategy seeks to guide urban growth in the Greater Christchurch region over the next forty years with predictions that the region's current population of 380000 will have grown to 500000 .In April 2005, a public consultation document on options for growth and development in the greater Christchurch region was made public. It summarised key issues and presented three options for managing growth as: concentration, consolidation and dispersal versus the 'business as usual' option (where urban growth is less regulated and driven by private developer demand). Of 3250 feedback forms received, 62% supported the Concentration option. This focussed 60% of new housing in urban renewal and 40% in new land release subdivisions.In June 2005 Community and Public Health, a division of the Canterbury District Health Board (CDHB) proposed to CCC staff that they perform a Health Impact Assessment on the options document of the Greater Christchurch UDS . The CCCThe specific aims and objectives of the HIA were:I. To provide evidence about the links between urban development and health for decision-making;II. To assess the positive and negative health impacts of the UDS and provide recommendations to increase positive and decrease negative inputs;III. To strengthen partnerships working between sectors and ensure appropriate participation of the community including those that are vulnerable due to social exclusion;IV. To involve Māori in all levels of the HIA process; andV. To build capacity and knowledge of HIAs in Christchurch and New Zealand.Interestingly the HIA did not explicitly include any aims and objectives relating to maximising the extent and distribution of positive health impacts and mitigating negative health impacts, though this may be because these objectives were regarded as axiomatic of all HIAs. The HIA followed the standard HIA process of screening, scoping, appraising and evaluation . An init• Screening the UDS to determine if it was suitable for an HIA to be conducted;• Scoping the HIA;• Eight rapid appraisal workshops in technical areas (two to four hours each);• Literature reviews and summaries• Report-back to workshop participants via the Internet and a summary meeting;• Circulating the draft HIA report to key stakeholders, then presenting it to the UDS Management Team and Forum • Concurrent process evaluation.Scoping led to a focus on six determinants of health: air, waste, water, social connectedness, housing and transport. Waste was subsequently omitted due to resource constraints. A further working group was developed around engaging with local Māori who were significantly under-represented in the UDS consultation process. Only 1.5% of the 3250 respondents to the UDS Options document were Māori, yet Māori make up 7.3% of the population of Canterbury and have the poorest health status of any ethnic group in New Zealand . The UDSThe process and impact evaluations followed published evaluation methodologies ,15,24. AProcess and impact evaluations used multiple qualitative research methodologies  as primary methods of data gathering to maximise data richness and understanding. Findings were analysed thematically and triangulated using different methods to examine the same issue, to increase the reliability of findings. Greater detail on methods and all aspects of the evaluations is available in the original evaluation reports ,26.Objectives of the process evaluation were to assess whether this HIA achieved its stated objectives, to identify critical success factors and opportunities for improvements in the process, and to quantify resource use.Four of the eight HIA workshops were evaluated by participant observation, a review of the workshop report and HIA outputs including reports and other documentation, and surveys completed by workshop participants. A single focus group was held. The surveys of workshop participants used open-ended questions and Likert scales. The documentary analysis was undertaken on working group minutes, key reports and background documents. Resource-use was measured and hours estimated by a questionnaire filled in by project and human resources staff of CDHB. Hourly rates were based on salaries in 2005 and all comparisons with international HIA costings use US Dollars at December, 2005 exchange rates.The objectives of the impact evaluation were to assess what changes to decision-making and implementation had occurred as a result of doing the HIA, and what other indirect impacts had eventuated, such as changes to cross-sectoral relationships, engagement with Māori, and knowledge and understanding of HIA. Key informant interviews used a semi-structured format. The interview schedule included in Table Stakeholders from the original key informant sample, as well as a local government politician from that time, and members of the Urban Forum and local government staff involved in implementation of the UDS were provided with a briefing report summarising findings from key informant interviews and the document analysis, and invited to a full-day HIA impact evaluation workshop in April 2008. Fourteen people attended the workshop. Data was thematically analysed to identify emerging patterns. Both evaluations specifically sought to identify unintended impacts of the HIA as well as to describe aspired impacts that had not been achieved.The document review included the final UDS , HIA repResults for both the process and impact evaluation will be presented in an integrated format which synthesises findings rather than separate reporting of each qualitative methodology used. Roman numerals used in reporting results relate to relevant HIA objectives.Findings of the process evaluation are described against the HIA objectives (listed earlier) as it sought to evaluate whether these had been fulfilled, and in a table summarising resources used Table .hui  and presentation of the UDSHIA report at the Urban Forum [Key stakeholders reported during the process evaluation that the HIA had fulfilled all five of its objectives. The HIA report was regarded as having provided a comprehensive literature review of evidence to support decision making. Each working group was supported by a literature review summarising the key health impacts of different urban development approaches which included literature search strategies and search terms used, and multiple citations of peer-reviewed literature . The recan Forum . The UDSMost participants were very positive about involvement in the HIA and felt it facilitated new cross-sectoral relationships, was enjoyable, and met its objectives. They described the HIA as important and groundbreaking in both Canterbury and New Zealand and commented on its importance in relationship-building, particularly in the Māori working group. There was strong support for the cross-sectoral workshops with several participants in both waste and water workshops  – a Crown Research Institute) describing workshops as a first ever occasion where all the people working on that issue were seated together in one room, and considered this led to opportunities for working together. Two participants in technical workshops felt the HIA added little new information and was a poor use of their time.Questionnaire respondents described the social connectedness workshops as particularly effective at ensuring a participatory process for the community. Three social connectedness workshops were held with many high-needs groups such as new immigrants, mental health consumers, Pacific people, and beneficiaries represented. A disabled group and representative of the Chinese association particularly described value in this workshop and felt it had increased their 'voice' for being heard in the UDS consultation process.The primary issues identified restricting the conduct of the HIA was the time limitation (only four months) and limited human resource .Most of the costs in Table This section details whether HIA objectives were met, impacts on policy, impacts of individual HIA objectives, indirect and aspired impacts and ideas for future directions of HIA in Canterbury.The final HIA report was presented to the Greater Christchurch Urban Forum in November 2005 and published in April 2006 . CCC's cThe final UDS Strategy  includesThe UDS document is nearly 200 pages long with an initial background and context section. It describes the Top Twenty Priority Actions for the next three years to ensure necessary governance structures and implementation frameworks (p34–36) . This is• Explanation (why an action is being undertaken);• Growth issues (summary of issues identified in consultation process);• Key approaches (policy approaches to be taken that will guide action implementation);• Actions – which use a tabular format and cover Action, Lead agency, Support agencies, Cost implications, Implementation tools, Links to strategy and Timing.The process of assessing and incorporating HIA recommendations into the UDS was described by key informants as informal. Responsibility for decision-making rested with planning and policy making staff at CCC responsible for the UDS. They described having read and considered the HIA report while preparing the policy document. In some sections the HIA recommendations were directly translated into UDS 'policy approaches' but not necessarily into the action tables. For example, in the transport section the HIA recommended "Minimise adverse effects on communities when constructing and developing arterial roads (p 50) . The UDSA key impact of the HIA within the final UDS was the inclusion of a new section in the final Strategy titled "Health and Well-being" authored by the HIA project leader. This section includes an explanation of Health's inclusion in the strategy. Health indicators, however, were not mentioned in Priority Action Number Thirteen where other similar indicators were located.Of four general recommendations, only the one recommending that HIA is incorporated into the development and analysis of UDS policy was included in the final UDS.four of six recommendations were included in the UDS, but only two translated into action points. A recommendation on the need for cross-sectoral collaborative working groups was not included.four of five recommendations, with two related action points, were included in the UDS. The HIA recommendation advocating for a cross-sectoral steering group for water resource management in the region, with Ngāi Tahu (the Māori tribe or 'iwi' who are 'tangata whenua' (people of the land) in Canterbury) representation, was not included in the UDS.all six HIA recommendations with five linked action points were included in the UDS. The Top Twenty Priority Actions also included two generic actions around social connectedness (Numbers Sixteen and Nineteen).three of four HIA recommendations with two action points were included.five of seven HIA recommendations were included in the UDS with four action points linked to these.the single HIA recommendation, with a linked action point was included in the UDS. None of the Top Twenty Priority Actions deals explicitly with Māori development/concerns.Other impacts of the HIA on local government policy were also described by key informants and workshop attendees. A key informant described that the HIA catalysed partnerships that contributed to amendments made to the Natural Resources Regional Plan (NRRP) .Some policies were described to have had a direct and attributable link to the HIA  . Other pSeveral key informants described the HIA and its process as leading to a deeper consideration of health and inequalities in City Council policies. They described the HIA as giving permission for social and health principles to be included to a greater extent in CCC strategies and programmes."We realised there was another whole sector that could swing in support of the UDS... to have health people there mucking in behind in support of densification and consolidated urban design option was really fantastic." Senior Policy Maker, Environment CanterburyImpact evaluation workshop participants and key informants described ongoing frequent contact between the key organisations which had been facilitated by relationships developed during the HIA. Local government and health board key informants described the HIA as facilitating different sectors in learning a new vocabulary and language. For example, where local government have talked of 'social development' and 'equity', health people would use the terms 'health outcomes' and 'health inequalities'.Key informants described relationships built during the HIA as contributing to the launching of the electronic network, the South Island Public Health Analysis Information Base. This provides an interactive bulletin board, archive, and e-discussion for public health and local government throughout the South Island, with administration resting with Environment Canterbury and CDHB. Analysis of use of the SIPHAN information base on 8 April, 2008 showed there were 71 registered users and 152 posts, viewed a total of 1793 times.Key informants in both local government and CDHB described the creation of a new public health physician post within local government as an impact attributable to the HIA. The HIA was considered to have given local government a new perspective on the skills and knowledge a public health person could provide as well as a clear track record that illustrated the benefits of input from a public health trained person. Serendipitous factors at play in particular included the support of a local government manager with core training in health as well as experience in management in the health sector and strong interest expressed in filling this role by the HIA project manager."It was not so much the event but the process of the HIA which has cemented relationships" Māori consultation stream leader, CDHBNgāi Tahu had been invited to be part of the UDS Forum but their contribution and role prior to the process of the HIA was limited. The HIA Māori working group was led by a Māori public health physician who used the opportunity of the HIA to build relationships between the CDHB and Māori in Canterbury through meetings, hui and particularly through facilitating the visit of a Māori urban design specialist. Several key informants described the HIA's strong focus on Māori and felt this facilitated the subsequent re-engagement of Māori in the UDS Forum and final policy.This engagement was illustrated with the participation of Ngāi Tahu in the Urban Forum, subsequent to the HIA, as well as the endorsement of the UDS by Mark Solomon, Kaiwhakahaere of Te Runanga o Ngāi Tahu (CEO of the Governing body of the Ngāi Tahu tribe) ."This has been the most ambitious HIA done in New Zealand to date – and what's more, the ambitious size and scope of it were matched by its delivery."HIA consultant, CanterburyDissemination of the HIA results and process followed resulted in publications and presentations with national and international recognition of the HIA. Many of the key informants felt that this HIA had given credibility to the approach of HIA among local government policy makers both regionally and nationally. Key informants described this HIA as high profile and successful.Key informants as well as workshop participants described what they saw as the success factors coming out of this HIA. The factors most frequently identified were strong leadership of the project and the creation of a public health physician position in the CCC and CDHB, jointly funded by both organisations. Several key informants reported that this nurtured many of the impacts of the HIA. This is the first joint appointment by a health board and local authority in New Zealand, and was described as a good example of the goodwill and effective relationships between health and local government developed through the HIA.A third success factor described was strong cross-sectoral relationships. The entire HIA used collaborative process between CDHB, CCC and Environment Canterbury. Working and steering groups included members of different organisations and successful cross-sectoral relationships such as the CCC guide for Health Promotion and Sustainability  jointly A fourth success factor described was the thorough documentation and dissemination of the HIA – which included writing up of the HIA in peer-reviewed journals ,23 as weIt 'feels' like we're bringing health into our planning more consistently and organically – especially at the CCC office level – but there's lots more to do at an executive and political level." Programme Manager – CCCKey informants described a change in ways of working attributable to the HIA. In the CDHB, HIAs are described as now being formally part of core business for the Division of Community and Public Health within CDHB. This HIA was felt to have catalysed a new focus on sustainability issues and for the CDHB Risk Management Committee to work on higher level policies. The HIA was considered to have led to further HIAs including the Central Plains Water Scheme (CPWS) HIA  and the Within the CCC, the HIA was described as a tool that has synergised well with the Local Government Act 2002 which provides the general framework and powers under which New Zealand's 85 democratically elected and accountable local authorities operate . The LocMany of those involved in policy making described increased understanding of health impacts. Examples of this include the use of the Healthy Housing Index on Council housing stock , in the Several key informants and workshop participants described a strategic plan like the UDS as limited by regulatory mechanisms within New Zealand's Resource Management Act 1991 . This liUniversally, workshop attendees felt that greater dedicated human and financial resourcing for the HIA could have allowed the identification and appraisal of a broader range of determinants of health. For example, the 'waste' health determinant stream was withdrawn due to resource constraints. This would have provided a more comprehensive assessment of potential positive and negative, intended and unintended health impacts.Several key informants felt that HIA as a practice has achieved minimal integration into the larger CDHB's core business. This theme recurred within the CCC, where HIA was considered to be useful and part of practice in some areas yet unheard of in others. Concern around lack of diffusion of HIA within organisations is repeated at the national level where disappointment was expressed that HIA has been used minimally by central government in New Zealand.One key informant described inequalities as inadequately explored by the HIA process, with examples such as the differential equity impacts of urban densification on private outdoor space, and increased storm water run-off possibly leading to damp housing. A concern expressed at the workshop was that using a participatory HIA approach can increase the time required for policy formation, limiting potential responsiveness and agility of policy development processes.A final section of the HIA impact evaluation workshop focussed on what should be done differently by partner organisations to achieve significant changes in health determinants in the future. Ideas arising from the workshop included:• Requiring public organisations, such as local government and DHBs, to engage with strategic partner organisations before writing Long Term Council Community Plans (LTCCP) and District Annual Plans so that policy impacts on health determinants are considered routinely. This would embed HIA in these processes at an early stage, which it is not required for the end product;• Leaders of key partner organisations invite other leaders to share in formation of strategic vision and planning. This could expand to make collaborative work requisite, such as a percentage of each employees time is allocated to work in another organisation to achieve mutual shared objectives, secondments, and the development of common public information portals e.g. linked Intranet for all public agencies.The paper sets out the process and impact evaluations of the UDS HIA providing a valuable addition to the sparse area of HIA research. Evaluation indicates the HIA was carried out with an effective process, requiring moderate resources to achieve significant direct and indirect impacts. These impacts are related to: policy change and organisational culture change among organisations involved in the HIA; improved cross-sectoral relationships; and increasing recognition of the HIA tool more widely in Canterbury and New Zealand. There are a number of important issues arising from these evaluations including the cost-effectiveness of HIAs, the role of HIAs in cross-sectoral work, enabling factors to increase uptake of HIA recommendations by decision makers, possible factors limiting further HIA impacts as well as methodological issues with these evaluations.Resource use is rarely described, but has been summarised in three papers -45. Othe. This would be one method to standardise cost calculation and allow legitimate comparison between HIAs. The method used for cost calculation in the UDS HIA was very similar to that used in this online calculator. A summary of costs of HIAs in Europe in the last decade ranged from $US 5720 to $US180325 depending on the level and type of HIA but excluding desktop HIAs [Costs for HIAs are calculated in diverse ways and these are infrequently described, however attempts to summarise costing have been performed -45,48. Ttop HIAs . Other Htop HIAs  to $US15top HIAs . As detaDetails of cost are included in this paper to provide transparent information about the resources investment and to assist future cost utility analyses of completed HIAs.The sums in Table The importance of cross-sectoral collaboration described in key informant interviews and by workshop attendees is one of the key impacts of this HIA. It has facilitated further shared work, a joint position funded by health and local government and multiple examples of collaborative work. Cross-sectoral collaboration is a key indirect impact identified in other HIA papers -52. HowePossible reasons for non-inclusion of the cross-sectoral recommendations are: the time and energy required for such groups to be representative and function well; feared loss of control by local government; regulatory restriction on cross-sectoral work ; and individual organisations' reporting constraints and tight timelines for projects meaning low priority for cross-sectoral work. These omissions in the UDS could lead to negative health impacts over time.In New Zealand legislation (as elsewhere) there is a lack of clarity about which agencies have overall responsibility for determinants of health as they are intrinsically cross-sectoral in nature. Yet individual legislation such as the Land Transport Act 2003, the Building Act 2004 and the Local Government Act 2002 do include public health objectives . These pThe potential for HIA as a bridge to increase cross-sectoral work has been increasingly recognised internationally and by the key players in this HIA. An analysis of a container port development that used a cross-sectoral approach  found beOver two thirds (24 of 33) of the HIA recommendations were included in the final UDS policy. This HIA included all the enablers related to decision makers and policy process described by Davenport et al in their review of enablers in 88 HIAs . These iThe absence of a health determinants focus in the Twenty Priority Actions of the UDS suggests that monitoring health determinants and outcomes is not considered a key responsibility of local authorities. Some local government planners argue health indicators are a sub-set of social indicators, yet explicit inclusion of health indicators could increase focus on health outcomes.HIA has been described as particularly effective at increasing understanding of health determinants in local government settings in Australia  and New This paper finds that the UDS HIA was an important tool which has supported changes in planning and policy among partner organisations, but also describes that impacts have been less than hoped for. Lack of diffusion of HIA within and across larger organisations was reported by CCC and CDHB, yet other informants suggest significant gains were achieved with this single HIA and subsequent HIAs in the region promise to build on this base. Others have described HIA uptake in "silos" in local government but suggest that effective HIAs lead to wider dissemination within organisations .The concern expressed at the impact evaluation workshop that HIA can reduce responsiveness of policy making and increase time-frames for policy development has been described elsewhere ,52,57. YWorking party members described that while the HIA itself had strong leadership , leaders of the HIA's partner organisations also needed conviction and enthusiasm for the HIA to achieve greater adoption. A review of ways that HIA can be made most useful to local government in New South Wales (NSW) echoes this. The author suggests selecting the best HIA steering committee and overcoming 'silos' in councils as two factors for HIA success in local government . This reThis evaluation used a multi-method qualitative methodology to gather information on the impacts of the HIA. The depth and breadth of the analysis was potentially limited by the unavailability of three identified key informants for interview and competing work priorities limiting participation at workshops. The evaluator was an employee of CDHB at the time of the process evaluation, which may have influenced the candour of participants and therefore influenced the analysis.The HIA of the Draft Greater Christchurch UDS was broadly successful and effective with significant direct and indirect impacts. It strengthened cross-sectoral partnerships which have led onto further initiatives, including a new position created for a Public Health Physician in the Christchurch City Council, and work commenced by CDHB and CCC on a City Health Plan and subsequent HIAs.This HIA has contributed to a more prominent role for health on the local government agenda and improved knowledge of a social determinants model of health by non-health professionals and the public. Significantly, the majority of the HIA recommendations have been adopted by the policy body – the Greater Christchurch Urban Development Forum. The HIA process has also contributed to policy implementation such as amendments to the NRRP . There hPermeation of a health determinants approach (as provided by the HIA tool) into the tissue of the larger UDS partner organisations is yet to happen. Currently 'health' organisations continue to be dominated by health services provision with little focus on changing health determinants. Ongoing and even greater commitment to changing health determinants by health and local government is essential to achieve long-term health outcomes.The inclusion of the health determinants defined in this HIA into the long-term Greater Christchurch UDS increases opportunity for a healthy urban environment, and therefore healthy citizens of the Greater Christchurch area. This paper adds to the limited literature that evaluates HIAs. It evaluates the UDS HIA as a generally highly successful process, with significant impacts that achieved its purposes. This in turn can increase the confidence of policy makers and funders in the value HIA as a tool that can lead to improved health for the community.CCC: Christchurch City Council; CDHB: Canterbury District Health Board; HIA: Health Impact Assessment; UDS: Urban Development Strategy.The authors declare that they have no competing interests.KM responsible for methods, primary research and first draft of paper and revision of subsequent drafts. BHR supported with literature review, drafting of the paper and revision of subsequent drafts.The pre-publication history for this paper can be accessed here:


Health-related quality of life (HRQL) is poor in obese subjects and is a relevant outcome in intervention studies. We aimed to determine factors associated with poor HRQL in obese patients seeking weight loss in medical units, outside specific research projects.2) patients aged 20-65 years attending 25 medical units scattered throughout Italy. The clinics provide weight loss treatment using different programs. General psychopathology (SCL-90 questionnaire), the presence of binge eating , previous weight cycling and somatic comorbidity (Charlson's index) were also determined. Scores on SF-36 and PGWB were compared with Italian population norms, and their association with putative determinants of HRQL after adjustment for confounders was assessed through logistic regression analysis.HRQL, together with a number of demographic and clinical parameters, was studied with generic  and disease-specific (ORWELL-97) questionnaires in an unselected sample of 1,886  obese  was associated with lower HRQL scores on both psychosocial and somatic domains; somatic diseases and higher BMI, after adjustment for confounders, were associated with impairment of physical domains, while binge eating and weight cycling appeared to affect psychosocial domains only.Psychopathological disturbances are the most relevant factors associated with poor HRQL in obese patients, affecting not only psychosocial, but also physical domains, largely independent of the severity of obesity. Psychological/psychiatric interventions are essential for a comprehensive treatment of obesity, and to improve treatment outcome and to reduce the burden of disease. Obesity is associated with impairment of health-related quality of life (HRQL) in psychological, social, and physical domains ,2. ImproThe QUOVADIS Study  is a mulWe aimed to identify the factors associated with poor HRQL in obese subjects, with special reference to the possible role of psychological distress and psychiatric comorbidity which might make psychological support essential to improve treatment outcome.The philosophy of the QUOVADIS study and the general characteristics of the population have been partly published in a previous report . BrieflyThe weight history was checked according to a pre-defined structured interview . PatientTo facilitate handling of data, the Case Report Forms were implemented in an extranet database provided by CINECA , an Interuniversity Consortium of 15 Italian Universities, using the AMR (Advanced Multicenter Research) methodology, which allows the management of the whole research using standard web-browsers.All subjects signed an informed consent to take part in the study, which was approved by the ethical committees of the individual centers, after approval by the committee of the coordinating center (University of Bologna)Quality of life was measured using 3 different tools. The Obesity-Related Well-Being questionnaire (ORWELL-97), an obesity-specific tool, was used with the specific aim to collect data useful in a longitudinal evaluation of HRQL following treatment . It measA score in the ORWELL-97 questionnaire ≥ 70, corresponding to the 75° percentile of the population, was considered indicative of a clinically significant burden of obesity on HRQL.The Medical Outcome Survey Short-Form 36 (SF-36) was used as a generic measure of HRQL, with the specific aim to measure the extent of the defect in HRQL in both physical and mental domains . The queThe Psychological General Well-Being (PGWB) questionnaire was used to score psychological distress . The resFor both SF-36 and PGWB, the values of individual domains of each patient were compared to the age- and sex-matched Italian population norms ,19 usingThe Binge Eating Scale was used to detect binging ; values The Symptom Check List-90 questionnaire was used to identify subjects with a psychopathological profile . A valueThe presence of somatic diseases was used to calculate a composite score, according to Charlson et al , with moWeight history was defined at interview on the basis of body weight at the age of 20 years, age at first dieting and the number of times patients had lost weight as an effect of dietary programs, and scored according to previously-published cut-offs . One poiA first descriptive analysis was carried out on all tested variables. Scores of HRQL (and their relative Z-scores) were grouped according to sex, age, clinical status, complications of disease and eating behavior disorders, and the means and 95% confidence intervals for each patient group and for each domain were calculated.2 test.Differences between obese classes were tested using unpaired t test or Mann-Whitney or Kruskall-Wallis test, due to non-gaussian distribution of data, as appropriate. Differences in the prevalence of categorical data were tested by R × C χMultivariate logistic regression analyses were run using dichotomized Z-scores on individual domains of SF-36 and PGWB as dependent variables. The cut-off value vas set at -1.0, but a sensitivity analysis, using the cut-offs of -0.5 and -1.5 was also performed, and the results were qualitatively confirmed (not reported in details). In the ORWELL-97 model, the dependent variable was an ORWELL score >70. Independent variables were BMI classes, the scores of somatic and mental diseases, the BES grade, and the score of weight history. All models were adjusted for age, gender and BMI.The Variance Inflation Factor was calculated to assess correlation between independent variables and to exclude multicolinearity.Of the 1,886 patients  included in the analysis, 723, 529, and 634 had obesity class I, II and III, respectively. Their age ranged from 20 to 65 years . Subjects in Class I were characterized by a higher educational status  compared with Class II  and Class III . No differences were observed in civil status (single/divorced vs. married/cohabitating or widowed). A larger proportion of subjects in Class III were either housewives (26%) or unemployed (4.4%) compared with Class II (19 and 3.5%) or Class I . Patients in higher classes of obesity showed a significantly greater prevalence of several concurrent illnesses, such as diabetes, hypertension, biliary diseases, and osteoarticular problems, but not of hyperlipidemia, coronary heart and peripheral vascular disease, thyroid disorders, or previously diagnosed psychopathological distress , all other domains being in the moderate range  or in the small range . The Z-scores on all domains of PGWB, except Vitality (-0.51), were indicative of a small defect .SF-36 and PGWB Z-scores in women and men are summarized in Figure Z-scores on SF-36 and PGWB in relation to obesity class are summarized in Figure Logistic regression analysis was applied to identify factors associated with poor HRQL Table . For botBMI class was systematically associated with poor HRQL in the ORWELL-97 score and in the physical domains of SF-36, namely in Physical functioning, but it had almost no effect on PGWB domains with the exception of General health. This association was confirmed at multivariate analysis, after adjustment for concurrent somatic and psychiatric diseases. In correlation analysis, the highest value was observed between BMI and the Z-score of Physical functioning (r = -0.405).A BES score above the selected cut-offs was associated with poor HRQL in nearly all domains of HRQL measures, whereas a history of weight cycling was associated with poor HRQL only in a few domains of SF-36, namely in Role-Physical, General Health and Social Functioning.In all models the Variance Inflation Factor was < 5, indicating the absence of multicolinearity.In our study sample, obesity was associated with a relevant impairment of HRQL, in comparison with population norms, standardized for age and sex. This result is in keeping with previous reports of overweight-induced deterioration of HRQL across a wide age range ,25-27. TThe study has several strengths. It was based on a very large sample of obese men and women in different centers, thus being representative of the "real world" of treatment-seeking obesity, outside specific research centers where a selection bias may be expected. As expected, obese women experienced a greater impairment of HRQL than their male counterparts. This confirms previous reports in clinic-based samples ,15,25, aNot surprisingly, subjects with higher BMI reported a greater impairment of HRQL, as previously reported ,8. This vs. medical weight loss programs in the majority of centers of the present survey). In addition, the present study included obese subjects belonging to the whole spectrum of obesity classes, including a large group of subjects with obesity class III. These individuals are scarcely represented in medical settings, and may have a different psychopathological profile [Somatic comorbidities, assessed through a score derived from Charlson's index , were as profile . FinallyBinge eating disorder was previously reported to be associated with poor scores on disease-specific HRQL questionnaires ,15. ThisFinally, weight cycling is known to be associated with binge eating  and psycThe broad spectrum of questionnaires used in the study may also help identify which instruments should be preferred to detect impairment in HRQL in different settings. It is noteworthy that scores on both generic  and disease-specific (ORWELL-97) questionnaires appeared to be affected by the very same factors and in a similar manner. As expected, PGWB appeared to be more sensitive to psychological disturbances, while SF-36 and ORWELL-97 could detect to a greater extent the impact of physical conditions on HRQL. The choice of questionnaires in different settings should take into consideration the domains of greater interest  in individual studies. The choice of instruments for the assessment of the effects of treatment on HRQL should also consider reliability, which is assumed to be greater for generic questionnaires, and sensitivity to change, which is thought to be superior for disease-specific questionnaires; these characteristics were not assessed in the present study.Our study has relevant clues to obesity treatment. HRQL is now considered a priority in the treatment of chronic diseases, and may be selected as clinical-relevant outcome in treatment programs . The finThe authors declare that they have no competing interests.EM drafted the manuscript and participated in study design; MLP drafted the manuscript and participated in study coordination; NV contributed to study discussion and performed the statistical analysis; CR conceived the study and participated in study design and coordination; GA conceived and designed the study; GM participated in study design and coordination, contributed to the statistical analysis, and wrote the manuscript; all the participants of the QUOVADIS Study Group collected the data. All authors read and approved the final manuscript.16:115-124).A complete list of the participants in the QUOVADIS study has been previously published (Diab Nutr Metab 2003,


Health-related quality of life (HRQL) outcome measures are complex and for further application in clinical practice and health service research the meaning of their scorings should be studied in depth. The aim of this study was to increase the interpretability of the Spanish VSP-A and KINDL-R scores.A representative sample of adolescents aged 12 to 18 years old was selected in Spain. The Spanish VSP-A and KINDL-R, two generic HRQL measures (range: 0–100), were self-administered along with other external anchor measures  and sent by post. Percentiles of both HRQL questionnaires were obtained by gender, and age group and effect sizes (ES) were calculated. Receiver Operating Characteristic curves and related sensitivity (SE) and specificity (SP) values were also computed.The Spanish VSP-A and KINDL-R were completed by 555 adolescents. A moderate ES was shown in Psychological well-being between younger and older girls (ES: 0.77) in the VSP-A and small ES in the KINDL (ES: 0.41) between these groups. A SE and SP value close to 0.70 was associated to a global HRQL score of 65 in the VSP-A and 70 in the KINDL-R, when compared to anchors measuring mental and psychosocial health. Adolescents with scores bellow these cut-off points showed a moderate probability of presenting more impairment in their HRQL.The results of this study will be of help to interpret the VSP-A AND KINDL-R questionnaires by comparing with the general population and also provide cut-off points to define adolescents with health problems. Measurement of health related quality of life (HRQL) started in the 70's as a complement to traditional clinical outcomes. As a consequence of the increase in the survival of chronic conditions and life expectancy, healthcare has gone beyond the cure of illness. These facts and also a greater implication of patients in clinical decision making, have lead to the use of more subjective outcomes to measure the effectiveness of treatments such as HRQL . The mosSeveral authors have argued ,4, that Vecú Santé Perçue de l'Adolescent (VSP-A) and the German Questionnaire for measuring health-related quality of life in children and adolescents (KINDL), two generic HRQL questionnaires, were adapted in parallel and were included in the Kidscreen project as validation instruments [Finally, the simultaneous comparison of questionnaires also has proved to be of use in gaining interpretation of their scorings . Issues truments . As partThis study was based on a cross-sectional descriptive telephone and postal survey carried out simultaneously in 13 European countries in the context of the Kidscreen project. The first stage of sample selection was carried out by telephone using the random digital dialling technique. A sample size of 1800 children and adolescents per country was considered necessary to detect a minimally important difference of half a standard deviation (SD) in HRQL scores, and it has been described in more detail elsewhere . The samThe Spanish versions of the VSP-A and KINDL-R were administered together with other demographic and health status variables.The VSP-A and the KINDL-R are two generic HRQL measures that were developed in France and Germany respectively ,14. The Socio-demographic variables were also collected from adolescents such as sex and age  and perceived socio-economic status using the Family Affluence Scale (FAS) ,17. The Descriptive statistics of the Spanish VSP-A and KINDL-R domain scores were computed.Reference values of the Spanish VSP-A and KINDL-R were described in a sample of adolescents after stratification by gender and two age groups (12–15 and 16–18 years old) as differences were expected based on finding of the original versions and existing literature ,14,20. MIn this study, 3 external anchors were used: the SDQ , the self-declaration of a chronic condition (yes versus no); and the Oslo Social Support Scale (categorized as poor versus moderate-high). To incorporate the information from these external anchors to the Spanish VSP-A and KINDL-R, their frequencies were computed for each of the 10 points of global HRQL scores in each questionnaire. Receiver Operating Characteristics (ROC) curves and the Area under the Curve (AUC) were computed to assess the discrimination ability of selected VSP-A and KINDL-R scores in relation to these external anchors .Sensitivity (SE) and specificity (SP) values related to an "optimal" HRQL cut-off-point were also described. These values are used in epidemiological studies, and especially in diagnostic tests . A SE vaMost adolescents were 12–15 years old (63.5%) and half of the sample were girls (50.8%), while most declared being from a middle socio-economic background (51.6%), measured by the FAS  scores in all domains of HRQL for both girls and boys  it provides with information on the amount of HRQL impairment of an individual or a group by comparing the score obtained, with the distribution of scores of the corresponding population; 2) differences in percentile position may help to determine the size of score differences, observed either in a child over time or between two groups or individuals. On the other hand, reference norms could also help to fix therapeutic objectives taking into account that the maximum theoretical score of a questionnaire would not be considered the maximum attainable. In fact, although the VSP-A and the KINDL-R have scores ranging from 0 to 100 (the best HRQL), very few teenagers score this maximum. When interpreting longitudinal changes ,27, thesDifferences in age and gender should be taken into account when assessing the meaning of "healthy" or "ill" HRQL scores. Girls in this study have reported lower vitality, physical and psychological well-being and lower scores in general, compared to boys. These results are consistent with the original version results and other studies that have applied HRQL measures in adolescents and also imply that the same score could have different meaning according to the individual or group evaluated. Consistent findings in the literature have presented a gender pattern in favour of boys and younger teens in several international studies ,29. ThesThe use of cut-off points also help in the interpretation of HRQL scores together with the use of norm values ,5. The cLimitations of this study should be mentioned. Even if the sample design aimed to obtain a representative, non-institutionalised sample of adolescents in Spain, the sampling method based on a telephone interview and postal survey caused a lower response rate than other administration methods (ex. school based) in the Spanish context. More detail of the representativeness of this sample can be found in another published study of the Kidscreen project . A shortThe applicability of HRQL measures for children and adolescents are similar for those in adult ages such as the identification of health needs, studies to determine risk factors, assessment of effectiveness and efficacy of health services, monitoring of health at population and clinical level, health planning or priority setting ,3,31. NeThe results of this study will be of use for future users of the Spanish VSP-A and KINDL-R questionnaires, especially to assess how close or not scores are from those considered as "healthy" HRQL. Moreover, the increase in the use of HRQL in the evaluation of health-care makes it necessary not only to assess if scores improve after an intervention, but also if they reach similar population reference values.VSP-A: Vecú Santé Perçue de l'Adolescent;KINDL: Questionnaire for measuring health-related quality of life in children and adolescents; HRQL: Health-Related Quality of Life; CBCL: Child Behaviour Checklist; SDQ: Strength and Difficulties Questionnaire; SD: Standard Deviation; ES: Effect Size; ROC: Receiver Operating Characteristic; AUC: Area under the Curve; SE: Sensitivity; SP: Specificity; CI95%: Confidence interval 95%; WB: Well-BeingThe authors declare that they have no competing interests.VSS, MF contributed to the design of this study, analysed data and co-wrote this paper. LR is the Principal Investigator, contributed to the design of this study and commented on this paper.CT, MCS and URS commented on this paper. MCS and URS are the original authors of the VSP-A and KINDL-R respectively. URS is also the coordinator of the Kidscreen project.Population reference values of the Spanish VSP-A by age and gender (P: Percentiles. Spain n = 555). Additional tableClick here for filePopulation reference values of the Spanish KINDL-R by age and gender (P: Percentiles. Spain n = 555). Additional tableClick here for file