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Background: A better understanding of coeliac disease can be achieved by assessing health-related quality of life alongside clinical factors. Existing patient-reported outcome measures (PROMs) evaluating quality of life in coeliac disease have not been developed in accordance with the US Food and Drug Administration guidelines., Aim: To develop a PROM in accordance with best practice guidelines, capturing all aspects of quality of life important to adults with coeliac disease., Methods: Candidate items for the Coeliac Disease Assessment Questionnaire (CDAQ) were refined through item appraisal, expert review, cognitive interviews, and a translatability assessment. A cross-sectional survey determined further item reduction and the CDAQ's structure. The final CDAQ was administered alongside the Short Form Health Survey Version 2 (SF?36v2) in a second survey to assess construct validity and test-retest reliability., Results: Pre-testing the 64 candidate items revealed a range of issues which guided their refinement and reduction, resulting in the final CDAQ with 32 items representing 5 subscales: stigma (eight items), dietary burden (eight items), symptoms (five items), social isolation (five items), and worries and concerns (six items). Cronbach's alpha ranged between 0.82 and 0.88 for all domains. Further results showed CDAQ scores were more strongly correlated with the SF-36v2's mental health dimensions, as expected. Intraclass correlation coefficients ranged from 0.79 to 0.89., Conclusion: The CDAQ is a reliable and valid coeliac-specific measure that captures all aspects of quality of life important to adults with coeliac disease. Further work is underway to assess the CDAQ's responsiveness to change., (© 2018 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Objective: The aim of this study was to validate a new generic patient-reported outcome measure, the Long-Term Conditions Questionnaire (LTCQ), among a diverse sample of health and social care users in England., Design: Cross-sectional validation survey. Data were collected through postal surveys (February 2016-January 2017). The sample included a healthcare cohort of patients recruited through primary care practices, and a social care cohort recruited through local government bodies that provide social care services., Participants: 1211 participants (24% confirmed social care recipients) took part in the study. Healthcare participants were recruited on the basis of having one of 11 specified long-term conditions (LTCs), and social care participants were recruited on the basis of receiving social care support for at least one LTC. The sample exhibited high multimorbidity, with 93% reporting two or more LTCs and 43% reporting a mental health condition., Outcome Measures: The LTCQ's construct validity was tested with reference to the EQ-5D (5-level version), the Self-Efficacy for Managing Chronic Disease scale, an Activities of Daily Living scale and the Bayliss burden of morbidity scale., Results: Low levels of missing data for each item indicate acceptability of the LTCQ across the sample. The LTCQ exhibits high internal consistency (Cronbach's α=0.95) across the scale's 20 items and excellent test-retest reliability (intraclass correlation coefficient=0.94, 95% CI 0.93 to 0.95). Associations between the LTCQ and all reference measures were moderate to strong and in the expected directions, indicating convergent construct validity., Conclusions: This study provides evidence for the reliability and validity of the LTCQ, which has potential for use in both health and social care settings. The LTCQ could meet a need for holistic outcome measurement that goes beyond symptoms and physical function, complementing existing measures to capture fully what it means to live well with LTCs., Competing Interests: Competing interests: Some authors had financial (salary) support from the two funding bodies: CMP, LK and EG from the NIHR via programme funding for CLAHRC Oxford, and LB, LG, DF, KJ and MP from the Department of Health England via programme funding for QORU policy research unit; the authors declare no financial relationships with any other organisations that might have an interest in the submitted work in the previous 3 years; the authors declare no other relationships or activities that could appear to have influenced the submitted work., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: Health-related websites have developed to be much more than information sites: they are used to exchange experiences and find support as well as information and advice. This paper documents the development of a tool to compare the potential consequences and experiences a person may encounter when using health-related websites., Methods: Questionnaire items were developed following a review of relevant literature and qualitative secondary analysis of interviews relating to experiences of health. Item reduction steps were performed on pilot survey data (n=167). Tests of validity and reliability were subsequently performed (n=170) to determine the psychometric properties of the questionnaire., Results: Two independent item pools entered psychometric testing: (1) Items relating to general views of using the internet in relation to health and, (2) Items relating to the consequences of using a specific health-related website. Identified sub-scales were found to have high construct validity, internal consistency and test-retest reliability., Conclusion: Analyses confirmed good psychometric properties in the eHIQ-Part 1 (11 items) and the eHIQ-Part 2 (26 items)., Practice Implications: This tool will facilitate the measurement of the potential consequences of using websites containing different types of material (scientific facts and figures, blogs, experiences, images) across a range of health conditions., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Background: The purpose of this study was to determine the extent to which summary index scores from the short form Parkinson's Disease Questionnaire (PDQ-8) replicate those from the parent form (PDQ-39) in a longitudinal study., Methods: Longitudinal data gained from the PD-MED trial were examined (n = 1867), to determine the extent the PDQ-8 replicates results from the PDQ-39 at baseline and follow up. The sensitivity to change of the PDQ-8 was also compared with that of the PDQ-39. Finally, results on the two measures were compared with those from the Hoehn and Yahr (HY) clinical staging scale., Results: Results of the Single Index summary score gained from the PDQ-8 were found to closely replicate those gained from the PDQ-39 at each of the three time points. Furthermore at each time point the intraclass correlation coefficient between the two measures was very high (ICC range 0.93-0.96). Similarly, the two measures gave very similar accounts of change (e.g. from baseline to follow up at one year effect sizes were 0.18 for the single index calculated using the PDQ-39, and 0.09 when calculated using the PDQ-8). Similar levels of correlation were found between the two indices when correlated with the HY scale., Conclusions: The PDQ-8 closely replicates results gained from the PDQ-39 when calculating single indices. In instances where a single summary score of the impact of PD on self-reported quality of life is needed, it is likely the PDQ-8 will provide reliable and accurate information., (Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.)

Objectives: To identify generic, multidimensional patient-reported outcome measures (PROMs) for children up to 18 years old and describe their characteristics and content assessed using the International Classification of Functioning, Disability and Health Children and Youth version (ICF-CY)., Methods: The search strategy, developed by an information specialist, included four groups of terms related to "measure," "health," "children and young people," and "psychometric performance." The search was limited to publications from 1992. Five electronic databases and two online-specific PROM databases were searched. Two groups of reviewers independently screened all abstracts for eligible PROMs. Descriptive characteristics of the eligible PROMs were collected, and items and domains of each questionnaire were mapped onto the ICF-CY chapters., Results: We identified 35 PROMs, of which 29 were generic PROMs and 6 were preference-based measures. Many PROMs cover a range of aspects of health; however, social functioning is represented most often. Content covered differs both in which aspects of health are assessed and whether individual questions focus on functioning (what the subject can or does do) and/or well-being (how the subject feels about a certain aspect of his or her health)., Conclusions: A broad variety of PROMs is available to assess children's health. Nevertheless, only a few PROMs can be used across all age ranges to 18 years. When mapping their content on the ICF-CY, it seems that most PROMs exclude at least one major domain, and all conflate aspects of functioning and well-being in the scales., (Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: The objectives of this systematic review were 1) to identify studies that assess the psychometric performance of the English-language version of 35 generic multidimensional patient-reported outcome measures (PROMs) for children and young people in general populations and evaluate their quality and 2) to summarize the psychometric properties of each PROM., Methods: MEDLINE, EMBASE, and PsycINFO were searched. The methodological quality of the articles was assessed using the COnsensus-based Standards for selection of health Measurement INstruments checklist. For each PROM, extracted evidence of content validity, construct validity, internal consistency, test-retest reliability, proxy reliability, responsiveness, and precision was judged against standardized reference criteria., Results: We found no evidence for 14 PROMs. For the remaining 21 PROMs, 90 studies were identified. The methodological quality of most studies was fair. Quality was generally rated higher in more recent studies. Not reporting how missing data were handled was the most common reason for downgrading the quality. None of the 21 PROMs has had all psychometric properties evaluated; data on construct validity and internal consistency were most frequently reported., Conclusions: Overall, consistent positive findings for at least five psychometric properties were found for Child Health and Illness Profile, Healthy Pathways, KIDSCREEN, and Multi-dimensional Student Life Satisfaction Scale. None of the PROMs had been evaluated for responsiveness to detect change in general populations. Further well-designed studies with transparent reporting of methods and results are required., (Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: The 39-item Parkinson's Disease Questionnaire (PDQ-39) is the most thoroughly validated and extensively used self-report measure for the assessment of health-related quality of life in people with Parkinson's (PwP). Given the extent of its use and increasing emphasis on electronic data capture, an e-based version of the PDQ-39, the ePDQ, has recently been developed. The aim of this short report is to present some key reliability and validity data that confirm the psychometric quality of the ePDQ., Findings: Participants were emailed a unique link to an online survey incorporating the ePDQ and demographic questions. A total of 118 PwP fully completed the survey. Floor and ceiling effects were calculated to ensure responses were not biased to extreme values. Consequently, score reliability was assessed by item-total correlations with a range from 0.34 to 0.90. Cronbach's alpha was calculated at between 0.64 and 0.95 for the eight domains of the ePDQ. Construct validity was assessed by comparing domain scores in relation to disease duration and gender, with hypothesised differences being largely confirmed. Construct validity was further assessed following a higher order factor analysis which confirmed the appropriateness of calculating a summary index score. Subsequently, significant, but moderate correlations were calculated between the ePDQ summary index score and disease duration and age at diagnosis., Conclusions: Results indicate that the ePDQ largely mirrors the properties of its parent instrument, the PDQ-39, in terms of reliability and validity. Potential users can therefore incorporate the ePDQ into computer-based data capture systems with confidence.

Objectives: To ascertain the smallest amounts of change for the three Manchester-Oxford Foot Questionnaire (MOXFQ) domains that are likely to be clinically meaningful and beyond measurement error for conditions affecting the foot/ankle. Estimates were compared with those from the Short-Form 36 (SF-36)., Study Design and Setting: A prospective observational study of 671 consecutive patients undergoing foot or ankle surgery at an orthopedic hospital. Before and 9 months after surgery, patients completed the MOXFQ and SF-36; transition items (anchor) asked about perceived changes in foot/ankle pain or problems since the surgery., Results: Four hundred ninety-one patients completed pre- and postoperative questionnaires. Anchor-based minimal clinically important change (MCIC) values were ~13 points for each of the MOXFQ Walking/standing (W/S), Pain, and Social Interaction (S-I) domains [and greater than the standard error of measurement (SEM)]. MCIC values for all SF-36 domains fell within the SEM. Between-group MCIDs for the MOXFQ were W/S, 16.2; Pain, 9.9; S-I, 9.3. Distribution-based minimal detectable change (MDC90) values for the MOXFQ were ~11, ~12, and ~16 score points for the W/S, Pain, and S-I scales, respectively., Conclusion: This article provides information for aiding the interpretability of MOXFQ outcomes data and for planning future studies. The SF-36 is not recommended as a primary outcome for foot/ankle surgery., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: No validated patient-reported outcome measure (PROM) exists specifically to assess quality of life in mild cognitive impairment (MCI); we report a study conducted to develop such a measure., Methods: Semi-structured in-depth interviews were carried out with 23 people with MCI in order to determine items for a draft questionnaire. These interviews were audio-recorded, transcribed, and content analyzed. The draft questionnaire was refined following feedback from a focus group. 280 questionnaires were posted to subjects recruited from memory clinics and research databases, the response rate was 56% i.e. 146 questionnaires were included in the final analysis. The completed questionnaires were analyzed using factor analytic techniques to produce the final measure; construct validity was assessed by correlation with a generic patient-reported outcome measure, the SF-12v2., Results: Factor analysis produced a 13-item measure tapping two domains of patient-reported quality of life ("Emotional Effects" and "Practical Concerns"). Internal consistency reliability was high for both domains (α was 0.91 and 0.85 respectively). Both dimensions were highly and significantly correlated with the Mental Component Summary score of the SF-12v2 ("emotional effects" ρ = -0.43, p < 0.001 and "practical concerns" ρ = -0.56, p < 0.001)., Conclusions: The Mild Cognitive Impairment Questionnaire (MCQ) is a 13-item measure developed specifically to measure patient-reported outcomes in people with MCI. It was created on the basis of patient report and has been shown to have good psychometric properties. It is likely to prove valuable in the evaluation of treatment regimes in this patient group.

Objective: The internet is a valuable resource for accessing health information and support. We are developing an instrument to assess the effects of websites with experiential and factual health information. This study aimed to inform an item pool for the proposed questionnaire., Methods: Items were informed through a review of relevant literature and secondary qualitative analysis of 99 narrative interviews relating to patient and carer experiences of health. Statements relating to identified themes were re-cast as questionnaire items and shown for review to an expert panel. Cognitive debrief interviews (n=21) were used to assess items for face and content validity., Results: Eighty-two generic items were identified following secondary qualitative analysis and expert review. Cognitive interviewing confirmed the questionnaire instructions, 62 items and the response options were acceptable to patients and carers., Conclusion: Using a clear conceptual basis to inform item generation, 62 items have been identified as suitable to undergo further psychometric testing., Practice Implications: The final questionnaire will initially be used in a randomized controlled trial examining the effects of online patient's experiences. This will inform recommendations on the best way to present patients' experiences within health information websites., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background and Purpose: The Stroke Impact Scale (SIS) covers 8 dimensions and a composite disability score. This study evaluates the SIS in the UK context, and develops a single index and an 8-item short form., Methods: Patients with a diagnosis of stroke were recruited through general practices in London and the North-West of England. Patients completed the SIS and the EQ-5D., Results: Internal consistency of the SIS dimensions and the disability score ranged from α 0.86 to 0.95. Complete data were available on 73 questionnaires (48.34%). Factor analysis suggested the 8 domains could be aggregated into a single index. A short-form SIS (SF-SIS) index was created by summing 1 item per dimension. Selected items were those that most highly correlated with their respective domain score (ρ ranged from 0.77-0.94, P<0.001). The SF-SIS index scores were highly correlated with those gained from the parent form (ρ=0.98; P<0.001). The correlation of the SIS index and SF-SIS index with the EQ-5D was identical (ρ=0.83; P<0.001). The disability score, whether scored from the dimensions of the SIS, or relevant items on the SF-SIS, were highly correlated (ρ=0.97; P<0.001)., Conclusions: The SIS covers aspects of health, which are of importance to stroke patients, and the dimensions were found to have high levels of internal consistency in the UK context. The amount of incomplete data suggests that the length of the questionnaire may present a substantial patient burden. In comparison to the parent form the SF-SIS can accurately provide the disability score and overall index score with considerable brevity.

Introduction: The socio-economic impact of critical illnesses on patients and their families in Europe has yet to be determined. The aim of this exploratory study was to estimate changes in family circumstances, social and economic stability, care requirements and access to health services for patients during their first 12 months after ICU discharge., Methods: Multi-center questionnaire-based study of survivors of critical illness at 6 and 12 months after ICU discharge., Results: Data for 293 consenting patients who spent greater than 48 hours in one of 22 UK ICUs were obtained at 6 and 12 months post-ICU discharge. There was little evidence of a change in accommodation or relationship status between pre-admission and 12 months following discharge from an ICU. A negative impact on family income was reported by 33% of all patients at 6 months and 28% at 12 months. There was nearly a 50% reduction in the number of patients who reported employment as their sole source of income at 12 months (19% to 11%) compared with pre-admission. One quarter of patients reported themselves in need of care assistance at 6 months and 22% at 12 months. The majority of care was provided by family members (80% and 78%, respectively), for half of whom there was a negative impact on employment. Amongst all patients receiving care, 26% reported requiring greater than 50 hours a week. Following discharge, 79% of patients reported attending their primary care physician and 44% had seen a community nurse. Mobility problems nearly doubled between pre-admission and 6 months (32% to 64%). Furthermore, 73% reported moderate or severe pain at 12 months and 44% remained significantly anxious or depressed., Conclusions: Survivors of critical illness in the UK face a negative impact on employment and commonly have a care requirement after discharge from hospital. This has a corresponding negative impact on family income. The majority of the care required is provided by family members. This effect was apparent by 6 months and had not materially improved by 12 months. This exploratory study has identified the potential for a significant socio-economic burden following critical illness.

Our objective was to develop a validated questionnaire that can measure the extent to which dimensions of caring affect the health of carers of patients with motor neuron disease. An initial 190-item questionnaire was developed from in-depth interviews, focus groups and two pilot studies with carers. Factor analysis was applied to the data obtained from a large survey in the UK that identified the underlying dimensions of caring. The newly formed scales were tested for reliability using Cronbach's alpha, and for construct validity. The SF36-v2 was the benchmark instrument on which correlations were made to ascertain the relationship with carers' health. A 34-item instrument was developed which has demonstrated promising evidence of internal reliability and validity for six scales: emotional well-being, physical well-being, self care, disturbed sleep, carers' support needs and statutory services. High correlations were found with the Mental Component Score summary scale of the SF-36v2 (0.40-0.66). The development and testing of the MNDCQ indicates that as the carers' score on the MNDCQ increases, suggesting a higher level of burden, they are more likely to report poor health. Further longitudinal studies are needed to further test the instruments' ability to detect change over time.

Objectives: Health status instruments, which measure the subjective functioning and well-being of respondents, are increasingly being used in international, multi-centre trials of new treatments. If the results of such trials in different countries are to be pooled, it is vitally important for researchers to know how comparable the instruments are across cultures. In this study, we evaluated the response rate, data quality, score reliability and scaling assumptions of the 30-item Endometriosis Health Profile (EHP-30) in the USA., Methods: Data were obtained from a multi-centre study which recruited 225 patients from 43 clinic sites in the United States of America. It was a randomised, evaluator-blinded, Phase III study. In the evaluation of the EHP-30 reported here, the two groups (Depot Medroxyprogesterone Acetate [DMPA] and Leuprolide Acetate [LA]) are combined, and analyses are based on the data gained at baseline. Questionnaires were self-completed by patients when they visited the clinics., Results: Data completeness was very high, with 97.33% of respondents completing all of the items on the EHP-30. Furthermore, there were no more than a maximum of two missing responses for any given item. No floor and ceiling effects were found for any of the dimensions of the questionnaire. Internal consistency reliability was high for all dimensions (alpha ranged from 0.84 to 0.91). The psychometric properties of the instrument, outlined in the development of the UK version, are supported in the American context., Conclusions: The data presented here suggest that the EHP-30 is a valid and reliable measure that can be appropriately and meaningfully used in studies that include respondents from the USA.

The psychometric properties of the Dutch version of the Parkinson's disease questionnaire 39 (PDQ39-DV) were tested in 177 patients with Parkinson's disease (PD). Internal consistency of 7 of the 8 scales was adequate (>or=0.70), but was insufficient for 'bodily discomfort' (0.59). Correlation between the PDQ39 and other instruments in this study, the SCOPA-psychosocial questionnaire, Euroqol-5D, hospital anxiety and depression scale, and a visual analogue scale for quality of life, were 0.82, 0.74, 0.63 and -0.54, respectively. The factor analysis yielded 8 factors, which accounted for 65% of the variance and revealed only small differences with the original UK version. We conclude that the PDQ39-DV displays satisfactory psychometric properties and is an appropriate instrument to assess quality of life in Dutch patients with PD.

The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) is the most widely validated measure of health status for use with patients diagnosed with motor neuron disease/amyotrophic lateral sclerosis (MND/ALS). The questionnaire was designed to be used in studies evaluating treatment regimes where missing data may cause problems with data analyses. The purpose of this paper is to evaluate an algorithm for the imputation of missing dimension scores on the ALSAQ-40. We used a postal survey of patients diagnosed with MND/ALS. One thousand, nine hundred and seventy-nine patients were surveyed and 1093 (55.2%) questionnaires returned. Of these, complete ALSAQ-40 data was available in 854 (85.8%) cases. Data were deleted from this complete dataset, and in a randomly selected subset of 100 cases, and then imputed using the Expectation Maximization (EM) algorithm: results were then compared to the dataset prior to data deletion. Descriptive statistics, mean scores and spread of scores were almost identical between original and imputed datasets. Furthermore, the two datasets were highly correlated (intra-class correlation coefficient = 0.95 or greater), and mean differences were small (+/-1.00). We concluded that EM imputation for the ALSAQ-40 provides data that closely mirrors the original when this has been deliberately removed. Consequently, EM is likely to be appropriate for studies using the ALSAQ-40 that contain missing data points.

Objective: The purpose of this study was to evaluate the psychometric properties of a short form health survey, the Parkinson's Disease Questionnaire (PDQ-8), cross-culturally, by comparing results gained from this instrument to the original longer form instrument-the PDQ-39., Design: Data are from the Global Parkinson's Disease Survey., Outcomes: The 8-item Parkinson's Disease Questionnaire Single Index Score (PDQ-8-SI). In this study, we evaluate response rate, scaling assumptions, and data quality, in terms of comparability of results with the parent form from which the PDQ-8 was derived, of the instrument in the USA, Canada, Spain, Italy and Japan., Results: The PDQ-8 was found to produce results that were very similar to the parent form across all five countries. However, it should be borne in mind that the PDQ-8 was nested within the PDQ-39, and results may be influenced by this., Conclusions: Results suggest that the PDQ-8 is a valid and reliable measure that can be appropriately and meaningfully used in cross-cultural studies.

Background: The SF-36 has been used in a number of previous studies that have investigated the health status of childhood cancer survivors, but it never has been evaluated regarding data quality, scaling assumptions, and reliability in this population. As health status among childhood cancer survivors is being increasingly investigated, it is important that the measurement instruments are reliable, validated and appropriate for use in this population. The aim of this paper was to determine whether the SF-36 questionnaire is a valid and reliable instrument in assessing self-perceived health status of adult survivors of childhood cancer., Methods: We examined the SF-36 to see how it performed with respect to (1) data completeness, (2) distribution of the scale scores, (3) item-internal consistency, (4) item-discriminant validity, (5) internal consistency, and (6) scaling assumptions. For this investigation we used SF-36 data from a population-based study of 10,189 adult survivors of childhood cancer., Results: Overall, missing values ranged per item from 0.5 to 2.9 percent. Ceiling effects were found to be highest in the role limitation-physical (76.7%) and role limitation-emotional (76.5%) scales. All correlations between items and their hypothesised scales exceeded the suggested standard of 0.40 for satisfactory item-consistency. Across all scales, the Cronbach's alpha coefficient of reliability was found to be higher than the suggested value of 0.70. Consistent across all cancer groups, the physical health related scale scores correlated strongly with the Physical Component Summary (PCS) scale scores and weakly with the Mental Component Summary (MCS) scale scores. Also, the mental health and role limitation-emotional scales correlated strongly with the MCS scale score and weakly with the PCS scale score. Moderate to strong correlations with both summary scores were found for the general health perception, energy/vitality, and social functioning scales., Conclusion: The findings presented in this paper provide support for the validity and reliability of the SF-36 when used in long-term survivors of childhood cancer. These findings should encourage other researchers and health care practitioners to use the SF-36 when assessing health status in this population, although it should be recognised that ceiling effects can occur.

Background: A patient-based outcome measure with good measurement properties is urgently needed for use in clinical trials of foot surgery., Methods: We evaluated an existing foot pain and disability questionnaire (the Manchester Foot Pain and Disability Questionnaire) for its suitability as an outcome measure in the context of hallux valgus corrective surgery. Interviews with patients led to initial changes, resulting in 20 candidate questionnaire items with five response categories each. These were tested in a prospective study of 100 patients (representing 138 foot operations) undergoing hallux valgus corrective surgery. Analysis of underlying factor structure, dimensionality, internal reliability, construct validity and responsiveness of the questionnaire items in relation to (i) SF-36 general health survey and (ii) American Orthopaedic Foot & Ankle Society (AOFAS) hallux clinical scale resulted in a final 16 item questionnaire (the 'Manchester-Oxford Foot Questionnaire' (MOXFQ)), consisting of three domains/scales: 'Walking/standing' (seven items), 'Pain' (five items) and 'Social interaction' (four items) each having good measurement properties. All three domains were unidimensional., Conclusions: The new 16-item MOXFQ has good measurement properties in the context of outcomes assessment of surgery for hallux valgus. Future studies should assess the MOXFQ in the context of surgery for other foot and ankle conditions.

Background: The Parkinson's Disease Questionnaire (PDQ-39) is the most widely used Parkinson's specific measure of health status. It is increasingly used in treatment trials, sometimes as a primary end-point, where any missing data can potentially cause difficulties in analyses., Objectives: The purpose of this article is to evaluate the Expectation Maximisation (EM) algorithm for the imputation of missing dimension scores on the 39-item PDQ-39., Methods: A postal survey of patients diagnosed with Parkinson's disease (PD). A total of 1,372 patients were surveyed and 839 (61.15%) questionnaires returned completed or partially completed. Of these, complete PDQ data were available in 715 (85.22%) cases. Data were deleted from this complete dataset and a sub-set of 200 respondents from this dataset and then imputed using the EM algorithm; results were then compared to the dataset before data deletion., Results: Results gained from imputation of data closely mirrored that of the complete dataset in each case. Descriptive statistics, mean scores and spread of scores were almost identical between original and imputed datasets. Furthermore, original and imputed datasets were highly correlated [intra-class correlation coefficient (ICC) = 0.93 or greater], and mean differences were small (+/-1.00)., Conclusions: The results suggest that the use of EM for the PDQ-39 provides data that closely mirrors the original when this has been deliberately removed. Consequently, EM is likely to be appropriate for trials using the PDQ that contains missing data points.

Objective: To develop a questionnaire to assess patients' views of clinical trials, and to report the results from the questionnaire in two patient groups: asthma and cancer., Design: A 43 item questionnaire asking patients about their views to clinical trials was developed on the basis of interviews with trialists and focus groups with patients. The questionnaire was mailed to patients with a diagnosis of either asthma or cancer. A set of items was then selected, via statistical analyses, to form the core of the questionnaire., Participants: Patients with a diagnosis of cancer in one NHS Hospital Trust, and patients with a diagnosis of asthma in two NHS Hospital Trusts., Results: Completed questionnaires were received from 353 cancer patients and 578 asthma patients. Factor analyses of the data indicated that 22 items contributed to five dimensions: 'positive beliefs', 'safety', 'information needs', 'negative expectations' and 'patient involvement'. Differences between asthma and cancer patients on these dimensions were small. A regression of these dimension scores against a variable asking if patients would be willing to take part in trials found that 'safety' and 'information needs' did not contribute significantly to the model for either asthma or cancer patients., Conclusions: A questionnaire has been developed for use in assessing patients' views towards clinical trials. Results from the surveys reported here suggest that patient views about the importance of trials and beliefs about the value of patient involvement are likely to be predictive of whether or not patients will agree to take part in a study.

Objective: to explore and describe the impact of endometriosis upon quality of life., Setting: Nuffield Department of Obstetrics and Gynaecology, University of Oxford., Design: qualitative study., Sample: twenty-four women with a laparoscopic diagnosis of endometriosis., Methods: face to face, individual, in-depth interviews., Results: analysis of the data revealed 15 descriptive categories. Pain, physical functioning, role performance, social functioning, emotional well-being, relationship with the medical profession, treatment, sexual intercourse, energy and vitality, employment and infertility were found to be a particular concern for women with endometriosis. Physical appearance, lack of control and powerlessness, feelings of social isolation and concerns that their daughters might develop endometriosis were new areas found to be negatively affected by the condition., Conclusions: the impact of endometriosis-associated symptoms upon quality of life is multidimensional and more complex than just negatively affecting psychosocial parameters. Conducting in-depth interviews to explore the subjective experiences of patients with endometriosis enabled the diverse areas of quality of life to be identified. Adopting a qualitative methodology is essential for item generation on disease specific health status questionnaires.

Objectives: To evaluate the sensitivity to change of the Endometriosis Health Profile-30 (EHP-30) questionnaire., Setting: The Women's Center, John Radcliffe Hospital, Oxford., Design: Postal survey to 66 women undergoing conservative surgery for the treatment of endometriosis-associated pain. The EHP-30 and the Short Form-36 (SF-36) were administered 2 weeks before the operation, and 4 months post-operatively. At T2 a transition question was included to evaluate changes in patients health status. To evaluate responsiveness effect sizes, standardised response means, the index of responsiveness and the minimally and clinically important differences were calculated., Results: Forty (66.6%) patients returned the questionnaires at time 1 and 2. Overall less responsive effect size scores were found for the SF-36 (0.1-0.5) compared to the EHP-30 (-0.1-1.1) for all patients who had undergone treatment. Minimally important differences and the index of responsiveness were overall higher for the EHP-30 (0.4-2.0) compared to the SF-36 (0.1-1.0). Change scores for four of the five scales were significantly correlated with women's responses to the transition question., Conclusions: Results suggest that the EHP-30 is sensitive to change. Its application in clinical trials should prove beneficial in assessing the impact of medical and surgical interventions upon quality of life for women with endometriosis.

Objective: To develop and validate a short form version of the Endometriosis Health Profile-30 questionnaire which consists of a 30-item core questionnaire and a 23 item modular questionnaire., Methods: Three studies were carried out to develop the Endometriosis Health Profile-5. Study 1: a short form version of the Endometriosis Health Profile-30 core questionnaire was developed. Study 2: the results were verified in a new data set. Study 3: a short form version of the 23 item modular questionnaire was produced. The modular questionnaire contains six dimensions which may not be applicable to every woman with endometriosis and is used to supplement the five scales on the core questionnaire when required., Results: The final instrument contained 11 items: five items from the core questionnaire and six items from the modular questionnaire. The 95% confidence intervals for Study 1 indicated that the scale scores overlapped with each item score and were confirmed in the second analysis (study 2). Each item was most highly correlated to its parent scale and less with the remaining four core questionnaire scales which was verified in study 2. In both studies all correlations were significant at the 0.01 level (two tailed test)., Conclusion: The Endometriosis Health Profile-5 is a reliable and valid short form questionnaire which can also be supplemented with a short form version of the modular questionnaire when required. It will be especially useful in clinical settings where a short and economical endometriosis health status measure is required.

Objectives: To compare alternative Rasch-based approaches to the assessment of change over time through the example of an outcome measure used in total hip replacement surgery., Subjects: Preoperative data were collected on 1424 patients receiving total hip replacement surgery; 1221 (86%) were sent follow-up questionnaires 1 year after surgery., Measures: The 12-item Oxford Hip Score (OHS) questionnaire administered preoperatively and 1-year postoperatively., Methods: Subscales of the OHS for pain and functional impairment were examined for unidimensionality and item invariance. Two criteria were used to examine Rasch-based measurement of the 2 subscales. Advantages of Rasch measurement were examined in terms of whether it produced improved discrimination of outcomes of patients (1) undergoing different levels of complexity of surgery; and (2) reporting different retrospective judgments of the success of their surgery. Using the method of relative precision in relation to groups of patients distinguished in these 2 ways, change scores using Likert scoring methods were compared with 2 Rasch scoring methods: (1) separate analyses of the 2 time points; and (2) a common scale analysis obtained by stacking patients from the 2 time points., Results: Less evidence for item invariance over time was found for the pain subscale. Other evidence supported treating subscales as unidimensional. Whichever Rasch scoring method was used, some gains in precision over standard Likert scoring were obtained in discriminating between groups of patients., Conclusions: The evidence from the current study suggests that there may be some gains in sensitivity to change of outcome measures from different Rasch-based scoring approaches.

Background: The purpose of this study was to compare the performance of the 15-item Picker Patient Experience questionnaire (PPE-15) when embedded in a short form instrument as compared with a longer form measure., Methods: A postal questionnaire survey of patients recently discharged from two hospital trusts was carried out. Patients were randomized to receive the PPE-15 in either a four-page or a 12-page survey instrument., Results: A total of 1445 questionnaires were mailed to patients in either four- or 12-page formats. A total of 949 (65.67 per cent) forms were returned. No difference in response rate was found between the two versions of the questionnaire. Item completion and psychometric properties of the PPE-15 were not found to differ significantly between the two arms of the trial., Conclusion: In this survey the length of questionnaire in which the PPE-15 was embedded had no impact in terms of response rate or data quality. Consequently, the results suggest that length of questionnaire, up to the 108 items included in the 12-page survey, is unlikely to adversely affect results on the PPE-15.

We examined whether there are advantages in terms of outcome assessment of using Rasch methods of scoring the 12-item Oxford Hip Score questionnaire over conventionally summed scores. Data were collected on patients receiving total hip replacement surgery. Three patient groups were created according to surgery type: primary, revision, and re-revision; two groups were created according to satisfaction with surgery: very satisfied and dissatisfied. Analyses were performed to test the relative precision (RP) of Rasch scoring versus conventionally summed scores in discriminating the groups experiencing different types of surgery and level of satisfaction. At the 1-year follow-up, RP ratios favored the Rasch scoring method in both tests of discrimination. Considerable gains in precision were achieved with Rasch scoring methods when groups were compared in a cross-sectional way. Alternative approaches to scoring questionnaires should be investigated to better assess comparisons over time.

Objective: The purpose of this study was to develop and test a core set of questions to measure patients' experiences of in-patient care. Questions were selected from the bank of items developed for use in in-patient surveys undertaken by the Picker Institute for the purposes of assessing the quality of care., Design: The data reported here come from surveys of patients who had attended acute care hospitals in five countries: the United Kingdom, Germany, Sweden, Switzerland, and the USA. Questionnaires were mailed to patients' homes within 1 month of discharge, either to all patients, or to a random sample, discharged during a specified period., Sample: A total of 62 925 questionnaires were returned, with response rates of 65% (UK), 74% (Germany), 63% (Sweden), 52% (Switzerland), and 46% (USA)., Results: Fifteen items were selected from the bank of questions included in the Picker in-patient questionnaires. These items have a high degree of face validity and when summed to an index they show a high degree of construct validity and internal reliability consistency., Discussion: Fifteen items derived from the longer form Picker in-patient survey have been found to provide a meaningful picture of patient experiences of health care, and constitute the 15-item Picker Patient Experience Questionnaire. These questions comprise a core set that should be measured in all in-patient facility surveys. The Picker Patient Experience Questionnaire represents a step forward in the measurement of patient experience as it provides a core set of questions around which further optional modules may be added. Scores are easy to interpret and actionable., Conclusion: This small set of questions could be incorporated into in-patient surveys in different settings, enabling the comparison of hospital performance and the establishment of national or international benchmarks.

Analysis of data from a survey of patients with musculoskeletal problems (mainly back and neck pain) to develop a core measure of patients' experiences of health care. A secondary purpose was to determine whether a single summary index figure could be generated from the instrument. The data reported here comes from a postal survey of patients attending a spine clinic in Stockholm, Sweden. After attending the clinic patients were mailed a questionnaire. Up to two reminders were sent to nonresponders. Questionnaires were sent to 342 patients. Totally 173 (51%) questionnaires were returned, of which 38.1% respondents were male and 61.2% female. The mean age of patients was 54 years (SD 13.84), ranging from 16 to 88. Sixteen items on the questionnaire were found to constitute a reliable index of patient experience and which seem to be tapping the most important aspects of patient experience. The index score was found to have high construct validity. The instrument provides a core set of issues that should be covered when assessing the quality of care patients attending clinics for musculoskeletal disorders.

Background: The aim of this study was to gain population norms for the COOP Charts in a large community sample, and to explore the construct validity, and whether the inclusion of the illustrations influences response rates., Methods: A postal survey was carried out using a questionnaire booklet, containing the COOP Charts and a number of other items concerned with lifestyles and illness, sent to 6007 randomly selected subjects over the age of 18 years. Respondents were randomized to receiving the questionnaire booklet with a copy of the COOP Charts including illustrations, or the same booklet but including the COOP items without illustrations. The sample was drawn from the Family Health Services Authority (FHSA) computerized register for Oxfordshire. Outcome measures were scores for the eight dimensions of the COOP Charts., Results: The survey achieved an adjusted response rate of 56.72 per cent. There was no difference in response rate or scores on the eight dimensions of the COOP Charts when broken down by those who received the illustrated Charts or simply the items from the measure without illustrations. Normative data for the COOP Charts are reported, broken down by age, sex, social class and whether respondent reported chronic illness or not., Conclusion: The illustrations included in the original charts do not appear to influence response rates, or responses given to the questions. The evidence suggests that items of the COOP Charts provide a short and comprehensive survey of health status. The normative data provided in this paper may further facilitate their validation and use.

Objectives: To evaluate response rate, data quality, score reliability and scaling assumptions of the 36 item Short Form Health Survey (SF-36) in a large scale pan European survey of amyotrophic lateral sclerosis (ALS) patients., Design: A questionnaire based survey of patients diagnosed with ALS across 15 European countries. SAMPLE PATIENTS: presenting at neurological clinics for treatment of their condition were asked to partake in the survey., Results: 948 patients have been recruited into the survey, from whom responses have been gained in 754 (79.5%). Scores on the eight dimensions of the SF-36 were found to manifest high internal consistency reliability. Items were, in most instances, found to be most highly correlated with their own (corrected) scale score than with other scale scores. However, on two dimensions (role-physical and role-emotional) there was high levels of missing data, together with substantial floor and ceiling effects. The two factor model (of underlying constructs of physical and emotional health) for the SF-36 suggested by the developers was not supported in this patient group. CONCLUSION The SF-36 appears to provide reliable information for this patient group, and for the most part there are high levels of item completeness and good spread of scores. This is not, however, true for the role functioning dimensions. Furthermore, the underlying two factor model for the SF-36 was not supported. The implications for measuring health status in this patient group are discussed.