Janelle Yorke

Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12

Rationale: Dyspnoea is a debilitating and distressing symptom that is reflected in different verbal descriptors. Evidence suggests that dyspnoea, like pain perception, consists of sensory quality and affective components. The objective of this study was to develop an instrument that measures overall dyspnoea severity using descriptors that reflect its different aspects. Methods: 81 dyspnoea descriptors were administered to 123 patients with chronic obstructive pulmonary disease (COPD), 129 with interstitial lung disease and 106 with chronic heart failure. These were reduced to 34 items using hierarchical methods. Rasch analysis informed decisions regarding further item removal and fit to the unidimensional model. Principal component analysis (PCA) explored the underlying structure of the final item set. Validity and reliability of the new instrument were further assessed in a separate group of 53 patients with COPD. Results: After removal of items with hierarchical methods (n = 47) and items that failed to fit the Rasch model (n = 22), 12 were retained. The “Dyspnoea-12” had good internal reliability (Cronbach’s alpha = 0.9) and fit to the Rasch model (χ2 p = 0.08). Items patterned into two groups called “physical”(n = 7) and “affective”(n = 5). In the separate validation study, Dyspnoea-12 correlated with the Hospital Anxiety and Depression Scale (anxiety r = 0.51; depression r = 0.44, p<0.001, respectively), 6-minute walk distance (r = −0.38, p<0.01) and MRC (Medical Research Council) grade (r = 0.48, p<0.01), and had good stability over time (intraclass correlation coefficient = 0.9, p<0.001). Conclusion: Dyspnoea-12 fulfills modern psychometric requirements for measurement. It provides a global score of breathlessness severity that incorporates both “physical” and “affective” aspects, and can measure dyspnoea in a variety of diseases.

Development and validity testing of an IPF-specific version of the St George's Respiratory Questionnaire

Rationale The St Georges Respiratory Questionnaire (SGRQ) is often applied to assess health-related quality of life in patients with idiopathic pulmonary fibrosis (IPF). Some SGRQ items will inevitably have weaker measurement properties than others when applied to this population. This study was conducted to develop an IPF-specific version of the SGRQ. Methods Data from a recently completed trial that enrolled subjects with IPF (n=158) who completed the SGRQ and other measures were analysed at baseline and 6 months. There were four phases to the study: (1) removing items with missing responses and using Rasch analysis on retained items to identify fit and refine item response categories; (2) development of a new scoring scheme; (3) testing agreement between original and revised versions and testing construct validity of the revised SGRQ; and (4) rewording to finalise the IPF-specific version (SGRQ-I). Results Items were removed due to missing responses (6 items) and misfit to the Rasch model (10 items); 34 items from the original 50 were retained. For certain items, disordered response thresholds were identified and corrected by collapsing response categories. A scoring algorithm was developed to place SGRQ-I scores on a scale with SGRQ scores. For any given outcome measure (eg, forced vital capacity (% predicted) and lung carbon monoxide transfer factor (% predicted), 6-min walk distance and patient-reported questionnaires), Pearson correlations were similar between pairs that included original SGRQ scores and corresponding pairs that included SGRQ-I scores. Internal reliability (Cronbach α) for each SGRQ-I component was comparable to the original SGRQ (Symptoms 0.62; Activities 0.80; Impacts 0.85). Conclusions The SGRQ-I contains items from the original SGRQ that are the most reliable for measuring health-related quality of life in patients with IPF.

Dyspnea-12 Is a Valid and Reliable Measure of Breathlessness in Patients With Interstitial Lung Disease

OBJECTIVE In this study, we aimed to determine the validity and reliability of the Dyspnea-12 questionnaire (D-12) for the assessment of breathlessness in patients with interstitial lung disease (ILD). METHODS A total of 101 patients with ILD completed the D-12 (scale range, 0-36, with a high score indicating worse dyspnea), Medical Research Council (MRC) dyspnea scale, St. George Respiratory Questionnaire (SGRQ), and Hospital Anxiety and Depression Scale (HADS) at baseline, and 84 patients completed the D-12 and a global health transition score at follow-up 2 weeks later. D-12 psychometric properties, including floor and ceiling effects, internal consistency, test-retest reliability, and construct validity were examined. RESULTS The D-12 showed good internal consistency (Cronbach α, 0.93) and repeatability (intraclass correlation coefficient, 0.94). Its scores were significantly associated with MRC grade (r = 0.59; P < .001), SGRQ (symptoms, r = 0.57; activities, r = 0.78; impacts, r = 0.75; total, r = 0.79; P < .001). Factor analysis confirmed the previously determined structure of the D-12 in this patient group. CONCLUSION In patients with ILD, the D-12, a patient-reported measure of dyspnea severity that requires no reference to activity, is a reliable and valid instrument. It is short, simple to complete, and easy to score.

Towards an expert consensus to delineate a clinical syndrome of chronic breathlessness

Breathlessness that persists despite treatment for the underlying conditions is debilitating. Identifying this discrete entity as a clinical syndrome should raise awareness amongst patients, clinicians, service providers, researchers and research funders. Using the Delphi method, questions and statements were generated via expert group consultations and one-to-one interviews (n=17). These were subsequently circulated in three survey rounds (n=34, n=25, n=31) to an extended international group from various settings (clinical and laboratory; hospital, hospice and community) and working within the basic sciences and clinical specialties. The a priori target agreement for each question was 70%. Findings were discussed at a multinational workshop. The agreed term, chronic breathlessness syndrome, was defined as breathlessness that persists despite optimal treatment of the underlying pathophysiology and that results in disability. A stated duration was not needed for “chronic”. Key terms for French and German translation were also discussed and the need for further consensus recognised, especially with regard to cultural and linguistic interpretation. We propose criteria for chronic breathlessness syndrome. Recognition is an important first step to address the therapeutic nihilism that has pervaded this neglected symptom and could empower patients and caregivers, improve clinical care, focus research, and encourage wider uptake of available and emerging evidence-based interventions. Chronic breathlessness syndrome: breathlessness and disability despite an optimally treated underlying pathophysiology http://ow.ly/V0g2309z4tF

Assessment of Dyspnea in Asthma: Validation of the Dyspnea-12

Background. Dyspnea is a prominent symptom in asthma. The Dyspnea-12 (D-12), an instrument that quantifies breathlessness using 12 descriptors that tap the physical and affective aspects, has shown promise for the measurement of dyspnea in cardiorespiratory disease. Objective. We report the results of a study designed to test the validity and reliability of the D-12 in a population of patients with asthma. Methods. This cross-sectional study included 102 patients with asthma. Subjects completed the D-12, Hospital Anxiety and Depression scale, St. George’s Respiratory Questionnaire (SGRQ), and Medical Research Council scale. Confirmatory factor analysis confirmed the two-component structure of the D-12 (i.e., seven items that tap the physical aspects of breathlessness and five items that tap the affective aspects). Results. The D-12 subscales had excellent internal reliability (Cronbach’s alpha for the “physical” score was 0.94 and the affective score was 0.95). The D-12 physical component was more strongly correlated with SGRQ Symptoms (r = 0.648), SGRQ Activities (r = 0.635) and Medical Research Council grade (r = 0.636), while the affective component was more strongly correlated with SGRQ Impacts (r = 0.765) and Hospital Anxiety and Depression scale scores (anxiety r = 0.641 and depression r = 0.602). Conclusion. This study supports validity of the D-12 for use in the assessment of dyspnea of patients with asthma. It assesses one of the most pertinent symptoms of asthma from two viewpoints—physical and affective.

Assessing dyspnea and its impact on patients with connective tissue disease-related interstitial lung disease

RATIONALE Dyspnea is the cardinal symptom in patients with any type of interstitial lung disease (ILD); however, there are limited data on dyspnea among patients with connective tissue disease-related ILD (i.e., CTD-ILD). OBJECTIVES To explore the utility of two dyspnea instruments (the University of California San Diego Shortness of Breath Questionnaire [UCSD] and the Dyspnea-12 [D-12]) and use their scores to examine the impact of dyspnea on the lives of patients with CTD-ILD. METHODS Subjects were enrolled from the Autoimmune Lung Database (ALD) at National Jewish Health. Chronbachs alpha was used to assess the internal consistency reliability of the two dyspnea questionnaires. We used the Multi-Dimensional Health Assessment Questionnaire [MDHAQ] as a measure of health status and examined associations between health status and dyspnea by using Pearson product-moment correlation and linear regression. RESULTS The internal consistency reliability of each of the two dyspnea questionnaires was excellent (alpha=0.9 for each). There were significant correlations between either of the two dyspnea measures and MDHAQ components. While controlling for ILD severity, dyspnea as assessed by the UCSD, was a significant predictor of physical function (p=0.04), psychological well-being (p=0.005), and fatigue (p=0.02); dyspnea as assessed the D-12, was a significant predictor of psychological well-being (p=0.01) and global status (p=0.03). CONCLUSION Dyspnea significantly affects day-to-day functioning and global well-being in patients with CTD-ILD. The UCSD and D-12 yield meaningful information about these patients that measures of pulmonary physiology cannot. Future studies should examine other performance characteristics of these self-report measures in patients with CTD-ILD.

emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension

The aim of this study was to develop a measure of the impact of pulmonary hypertension (PH) on health-related quality of life (HRQoL) as there is a need for a short, validated instrument that can be used in routine clinical practice. Interviews were conducted with 30 PH patients to derive 32 statements, which were presented as a semantic differential six-point scale (0–5), with contrasting adjectives at each end. This item list was completed by patients attending PH clinics across the UK and Ireland. Rasch analysis was applied to identify items fitting a uni-dimensional model. 226 patients (mean age 55.6±14 years; 70% female) with PH (82% had pulmonary arterial hypertension) completed the study questionnaires. 10 of the 32 items demonstrated fit to the Rasch model (Chi-squared 16; p>0.05) and generated the emPHasis-10 questionnaire. Test–retest (intraclass correlation coefficient 0.95, n=33) and internal consistency (Chronbach’s &agr;=0.9) were strong. emPHasis-10 scores correlated consistently with other relevant measures and discriminated subgroups of patients stratified by World Health Organization functional class (ANOVA F=1.73; p<0.001). The emPHasis-10 is a short questionnaire for assessing HRQoL in pulmonary arterial hypertension. It has excellent measurement properties and is sensitive to differences in relevant clinical parameters. It is freely available for clinical and academic use. emPHasis-10 is a short, valid tool for routine assessment of health-related quality of life in pulmonary hypertension http://ow.ly/qv75v

Randomised controlled feasibility trial on the use of medical grade honey following microvascular free tissue transfer to reduce the incidence of wound infection.

The aim of this study was to assess the feasibility of using Leptospermum honey in a randomised trial to reduce the incidence of wound infection after microvascular free tissue reconstruction for cancer of the head and neck. During the one-year study period 70 consecutive patients were admitted to the regional maxillofacial ward for free tissue reconstruction. Of these, 56 (80%) consented to be randomised and 49 (70%) were actually randomised, 25 into the honey dressings group, and 24 into the conventional dressings group (control). Six patients were missed when consent was required, 8 did not consent, and 7 who had given consent were missed at the randomisation stage in theatre. Results of wound swabs were positive in 36% of the honey group and 38% of the control group. Methicillin-resistant Staphylococcus aureus (MRSA) was found in 28% and 25%, respectively. Of these, 38% were deemed to require intervention. Honey dressings were acceptable to both patients and nurses. There was a reduction (p<0.05) in duration of hospital stay in the honey group (median 12 days, IQR 10-21) compared with the control (median 18 days, IQR 13-28). The cost of standard and honey dressings was similar. This feasibility study has shown that a randomised controlled trial (RCT) is possible and that several hundreds of patients would be required to show a clinical benefit for honey. Further research is needed to confirm a shorter duration of hospital admission and if so, whether this is due to more rapid healing.

Examining fatigue in COPD: development, validity and reliability of a modified version of FACIT-F scale

IntroductionFatigue is a disruptive symptom that inhibits normal functional performance of COPD patients in daily activities. The availability of a short, simple, reliable and valid scale would improve assessment of the characteristics and influence of fatigue in COPD.MethodsAt baseline, 2107 COPD patients from the ECLIPSE cohort completed the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale. We used well-structured classic method, the principal components analysis (PCA) and Rasch analysis for structurally examining the 13-item FACIT-F.ResultsFour items were less able to capture fatigue characteristics in COPD and were deleted. PCA was applied to the remaining 9 items of the modified FACIT-F and resulted in three interpretable dimensions: i) general (5 items); ii) functional ability (2 items); and iii) psychosocial fatigue (2 items). The modified FACIT-F had high internal consistency (Cronbachs α = 0.91) and it did not fit a uni-dimensional Rasch model, confirming the prior output from the PCA. The correlations between total score and each dimension were ≥ 0.64 and within dimensions ≥0.43 (p < 0.001 for all).The original and modified FACIT-F had significant convergent validity; its scores were associated with SGRQ total score (0.69 and 0.7) and mMRC dyspnoea scores (0.48 and 0.47), (p = <0.001 for all). The scale had meaningful discriminating ability in identifying patients with poor exercise performance and more depressive symptoms.ConclusionThe original and modified FACIT-F are valid and reliable scales in COPD. The modified version is shorter and measures not only total fatigue but also its sub-components in COPD.

The assessment of breathlessness in pulmonary arterial hypertension: Reliability and validity of the Dyspnoea-12

Breathlessness is a cardinal symptom of pulmonary arterial hypertension (PAH); yet no breathlessness instrument has been previously tested for reliability and validity for this population. Using a cross-sectional design, we tested the psychometric properties of the Dyspnoea-12 (D-12), for the assessment of breathlessness in PAH. Pearson’s correlations with World Health Organization functional class (WHO FC), Minnesota Living with Heart failure – pulmonary hypertension modified version (MLHF-PH), Hospital Anxiety and Depression scale (HADS) and 6-minute walk distance test (6MWD) were conducted. Participants (n = 176) were mostly female (70.5%), mean age 54.3±14 years; diagnosed with idiopathic PAH (48.9%), congenital heart disease (27.8%) and connective tissue disease (23.3%); and most were WHO FC II (32.4%) and III (52.3%). The D-12 showed excellent internal consistency for the total and two-component scores for physical and emotional (Cronbach’s α 0.95, 0.93 and 0.94, respectively). D-12 total score was significantly associated with MLHF-PH (r = 0.70), HADS (anxiety r = 0.54 and depression r = 0.68), WHO FC (r = 0.49), and 6MWD (r = -0.26). In patients with PAH, the D-12 - a short patient reported measure of breathlessness severity that taps the physical and emotional components, is a reliable and valid instrument.