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Janelle Yorke,1,2 Naimat Khan,1,3 Adam Garrow,1 Sarah Tyson,1 Dave Singh,1,3 Jorgen Vestbo,1,4 Paul W Jones5 1Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; 2Christie Patient Centred Research, The Christie NHS Foundation Trust, Whittington, Manchester, UK; 3Medicines Evaluation Unit, Wythenshawe, Manchester, UK; 4Department of Respiratory Medicine, Wythenshawe Hospital, Manchester, UK; 5St George’s Hospital, University of London, London, UKCorrespondence: Janelle Yorke, Tel +44920 264411, Email janelle.yorke@nhs.netPurpose: The modified-Medical Research Council (mMRC) breathlessness scale consists of five grades that contain of a description of different activities. It has wide utility in the assessment of disability due to breathlessness but was originally developed before the advent of modern psychometric methodology and, for example contains more than one activity per grade. We conducted an evaluation of the mMRC structure.Patients and Methods: Cognitive debriefing was conducted with COPD patients to elicit their understanding of each mMRC activity. In a cross-sectional study, patients completed the mMRC scale (grades 0– 4) and an MRC-Expanded (MRC-Ex) version consisting of 10-items, each containing one mMRC activity. Each activity was then given a 4-point response scale (0 “not at all” to 4 “all of the time”) and all 10 items were given to 203 patients to complete Rasch analysis and assess the pattern of MRC item severity and its hierarchical structure.Results: Cognitive debriefing with 36 patients suggested ambiguity with the term “strenuous exercise” and perceived severity differences between mMRC activities. 203 patients completed the mMRC-Ex. Strenuous exercise was located third on the ascending severity scale. Rasch identified the mildest term was “walking up a slight hill” (logit − 2.76) and “too breathless to leave the house” was the most severe (logit 3.42).Conclusion: This analysis showed tha

Naimat Khan,1 Jørgen Vestbo,2 Adam Garrow,3 Pradeep Karur,4 Umme Kolsum,5 Sarah Tyson,6 Dave Singh,7 Janelle Yorke8 1The Medicines Evaluation Unit, Wythenshawe Hospital, Manchester, UK; 2University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 3Division of Population Health, University of Manchester, Manchester, UK; 4Medicines Evaluation Unit, Manchester, UK; 5University of Manchester, Manchester, UK; 6University of Manchester, School of Health Sciences, Manchester Academic Health Sciences Centre, Manchester, UK; 7University of Manchester, The Medicines Evaluation Unit, Manchester, UK; 8University of Manchester, School of Health Sciences, Manchester, UK Background: In COPD disturbed sleep is related to exacerbation frequency, poor quality of life, and early mortality. We developed the Manchester Respiratory-related Sleep Symptoms scale (MaRSS) to assess sleep-time symptoms in COPD. Methods: Focus groups including COPD and age-matched controls were used to develop an item-list, which was then administered to COPD patients and age-matched controls in a cross-sectional study. Hierarchical and Rasch analysis informed item selection and scale unidimensionality. Construct validity was examined using Pearson’s correlation with the Sleep Problems Index, St George’s Respiratory Questionnaire (SGRQ), and FACIT-Fatigue scale. MaRSS change scores from baseline (stable) to exacerbation were assessed in a separate substudy of COPD patients. Results: Thirty-six COPD patients and nine age-matched controls produced an initial 26-item list. The cross-sectional study involved 203 COPD patients (male: 63%, mean age 64.7 years) and 50 age-matched controls (male: 56%, mean age 65.8 years). Eighteen items were removed to develop an eight-item unidimensional scale covering breathlessness, chest tightness, cough, sputum production, lack of sleep, and medication use. MaRSS scores significantly correlated with sleep problems, SGRQ To

Adam P Garrow,1,2 Janelle Yorke,2 Naimat Khan,1 Jørgen Vestbo,3 Dave Singh,1 Sarah Tyson1 1University of Manchester Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, 2School of Nursing, Midwifery and Social Work, University of Manchester, 3The University of Manchester Academic Health Science Centre, University Hospital South Manchester NHS Foundation Trust, Manchester, UK Background: Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. Methods: The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. Results: One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. Conclusion: The results highlight a need for existing non-disease-specific instruments to b

Purpose The Manchester Foot Pain and Disability Index (MFPDI) is a self-assessment 19-item questionnaire developed in the UK to measure foot pain and disability. This study aimed at conducting cross-cultural adaptation and validation of the MFPDI for use in Spain. Methods Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes measures were followed in the MFPDI adaptation into Spanish. The cross-cultural validation involved Rasch analysis of pooled data sets from Spain and the UK. Results Spanish data set comprised 338 patients, five used in the adaptation phase and 333 in the cross-cultural validation phase, mean age (SD) = 55.2 (16.7) and 248 (74.5 %) were female. A UK data set (n = 682) added in the cross-cultural validation phase; mean age (SD) = 51.6 (15.2 %) and 416 (61.0 %) were female. A preliminary analysis of the 17-item MFPDI revealed significant local dependency of items causing significant deviation from the Rasch model. Grouping all items into testlets and re-analysing the MFPDI as a 3-testlet scale resulted in an adequate fit to the Rasch model, v2 (df) = 15.945 (12), p = 0.194, excellent reliability and unidimensionality. Lack of cross-cultural invariance was evident on the functional and personal appearance testlets. Splitting the affected testlets discounted the cross-cultural bias and satisfied requirements of the Rasch model. Subsequently, the MFPDI was calibrated into interval-level scales, fully adjusted to allow parametric analyses and cross-cultural data comparisons when required. Conclusions Rasch analysis has confirmed that the MFPDI is a robust 3-subscale measure of foot pain, function and appearance in both its English and Spanish versions.

CONTEXT: Both positive and negative results have been reported in the literature from the use of acupressure at the P6 point, providing evidence of highly suggestive but not conclusive results. OBJECTIVES: To clarify whether acupressure is effective in the management of chemotherapy-related nausea and vomiting. METHODS: A randomized, three-group, sham-controlled trial was designed. Patients with cancer receiving chemotherapy were randomized to receive standardized antiemetics and acupressure wristbands, sham acupressure wristbands, or antiemetics alone. Primary outcome assessment (nausea) was carried out daily for seven days per chemotherapy cycle over four cycles. Secondary outcomes included vomiting, psychological distress, and quality of life. RESULTS: Five hundred patients were randomized. Primary outcome analysis (nausea in Cycle 1) revealed no statistically significant differences between the three groups, although nausea levels in the proportion of patients using wristbands (both real and sham) were somewhat lower than those in the proportion of patients using antiemetics-only group. Adjusting for gender, age, and emetic risk of chemotherapy, the odds ratio of lower nausea experience was 1.18 and 1.42 for the acupressure and sham acupressure groups, respectively. A gender interaction effect was evident (P = 0.002). No significant differences were detected in relation to vomiting, anxiety, and quality-of-life measures. CONCLUSION: No clear recommendations can be made about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting as results did not reach statistical significance. However, the study provided evidence of encouraging signals in relation to improved nausea experience and warrants further consideration in both practice and further clinical trials. TRIAL REGISTRATION: This trial is registered with the ISRCT register, number ISRCTN87604299.

CONTEXT: Both positive and negative results have been reported in the literature from the use of acupressure at the P6 point, providing evidence of highly suggestive but not conclusive results. OBJECTIVES: To clarify whether acupressure is effective in the management of chemotherapy-related nausea and vomiting. METHODS: A randomized, three-group, sham-controlled trial was designed. Patients with cancer receiving chemotherapy were randomized to receive standardized antiemetics and acupressure wristbands, sham acupressure wristbands, or antiemetics alone. Primary outcome assessment (nausea) was carried out daily for seven days per chemotherapy cycle over four cycles. Secondary outcomes included vomiting, psychological distress, and quality of life. RESULTS: Five hundred patients were randomized. Primary outcome analysis (nausea in Cycle 1) revealed no statistically significant differences between the three groups, although nausea levels in the proportion of patients using wristbands (both real and sham) were somewhat lower than those in the proportion of patients using antiemetics-only group. Adjusting for gender, age, and emetic risk of chemotherapy, the odds ratio of lower nausea experience was 1.18 and 1.42 for the acupressure and sham acupressure groups, respectively. A gender interaction effect was evident (P = 0.002). No significant differences were detected in relation to vomiting, anxiety, and quality-of-life measures. CONCLUSION: No clear recommendations can be made about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting as results did not reach statistical significance. However, the study provided evidence of encouraging signals in relation to improved nausea experience and warrants further consideration in both practice and further clinical trials. TRIAL REGISTRATION: This trial is registered with the ISRCT register, number ISRCTN87604299.