Patient-reported outcome measures for asthma:a systematic review

BACKGROUND: Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care. AIMS: To identify suitably validated PROMs for asthma and examine their potential for use in clinical settings. METHODS: We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs. RESULTS: We identifi ed 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child's caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments. CONCLUSIONS: We identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes. © 2014 Primary Care Respiratory Society/Macmillan Publishers Limited

Measuring Patient and Clinician Perspectives to Evaluate Change in Health-Related Quality of Life Among Patients with Chronic Obstructive Pulmonary Disease

CONTEXT: Many treatments aim to improve patients’ health-related quality of life (HRQoL), and many care guidelines suggest assessing symptoms and their impact on HRQoL. However, there is a lack of consensus regarding which HRQoL outcome measures are appropriate to assess, and how much change on those measures depict significant HRQoL improvement. OBJECTIVE: We used triangulation methods to identify and understand clinically important differences (CIDs) for the amount of change in HRQoL that reflects both health professionals and patients’ values, among patients with chronic obstructive pulmonary disease (COPD). DESIGN, SETTING, AND PARTICIPANTS: We incorporated three perspectives: (1) an expert panel of physicians familiar with the measurement of HRQoL in COPD patients; (2) 610 primary care COPD outpatients who completed baseline and bimonthly follow-up HRQoL interviews over the 12-month study; and (3) the primary care physicians (PCPs; n = 43) of these outpatients who assessed their patients’ disease at baseline and at subsequent PCP visits during the year long study. MEASUREMENTS: The Chronic Respiratory Disease Questionnaire (CRQ), the Medical Outcomes Study Short Form 36-item survey (SF-36, version 2.0), and global assessments of change from each of the three perspectives for all HRQoL domains. RESULTS: With few exceptions, the CRQ was able to detect small changes at levels reported by the patients (1–2 points) and their PCPs (1–5 points). These results confirm minimal important difference standards developed in 1989 by Jaeschke et al. anchored on patient-perceived changes in HRQoL. In general, the expert panel and PCP CIDs were larger than the patient CIDs. CONCLUSION: This triangulation methodology yielded improved interpretation, understanding, and insights on stakeholder perspectives of CIDs for patient-reported outcomes

A self-rating scale for patient-perceived side effects of inhaled corticosteroids

BACKGROUND: Patient-reported side effect questionnaires offer a simple method for the systematic measurement of drug-related side effects. In order to measure patients' inhaled corticosteroids (ICS) related side effect perceptions the 14-day retrospective Inhaled Corticosteroid Questionnaire (ICQ) was developed. In this research we aim to assess the construct validity and reliability of the ICQ and test its responsiveness to dose changes in adult asthma patients. METHODS: In a cross-sectional study, current inhaler users with asthma completed the ICQ (27 with non ICS inhaler; 61 BDP equivalent daily ICS low dose ≤400 μg; 62 mid dose 401–800 μg; and 105 with high dose >800 μg). We generated 3 construct validity hypotheses: 1) a hierarchical dose-response pattern for scoring of the individual items on the ICQ, and statistically significant differences in the scores of each of the 15 ICQ domains by ICS dose group 2) an association between ICS dose and ICQ scoring after adjusting for appropriate confounders in multiple regression; 3) greater convergence between local side effect domains than between systemic and local domains of the scale. Test-retest reliability was assessed on a randomly selected subgroup of patients (n = 73) who also completed the ICQ a second time after 7 days. In a separate longitudinal study, 61 patients with asthma completed the ICQ at baseline and after changing their daily ICS dose, at 2- and 6- months, in order to test the ICQ's responsiveness. RESULTS: All three construct validity hypotheses were well supported: 1) a statistically significant difference existed in scores for 14 domains, the high ICS dose group scoring highest; 2) ICS dose independently predicted ICQ scoring after adjusting for confounders; 3) greater convergence existed between local ICQ domains than between local and systemic domains. The ICQ had good reproducibility: test-retest intraclass correlation coefficients were ≥0.69 for all but the 'Facial Oedema' domain. In the longitudinal study, ICQ scores for 'Voice Problems' changed significantly at 2- and 6-months from baseline and other ICQ domains displayed trends in scoring change accordant with dose modulation at 6-months. CONCLUSION: The ICQ has good dose-related discriminative properties, is valid, reliable, and shows potential responsiveness to ICS dose change

A population-based study of asthma, quality of life, and occupation among elderly Hispanic and non-Hispanic whites: a cross-sectional investigation

BACKGROUND: The U.S. population is aging and is expected to double by the year 2030. The current study evaluated the prevalence of asthma and its correlates in the elderly Hispanic and non-Hispanic white population. METHODS: Data from a sample of 3021 Hispanics and non-Hispanic White subjects, 65 years and older, interviewed as part of an ongoing cross-sectional study of the elderly in west Texas, were analyzed. The outcome variable was categorized into: no asthma (reference category), current asthma, and probable asthma. Polytomous logistic regression analysis was used to assess the relationship between the outcome variable and various socio-demographic measures, self-rated health, asthma symptoms, quality of life measures (SF-12), and various occupations. RESULTS: The estimated prevalence of current asthma and probable asthma were 6.3% (95%CI: 5.3–7.2) and 9.0% (95%CI: 7.8–10.1) respectively. The majority of subjects with current asthma (Mean SF-12 score 35.8, 95%CI: 34.2–37.4) or probable asthma (35.3, 34.0–36.6) had significantly worse physical health-related quality of life as compared to subjects without asthma (42.6, 42.1–43.1). In multiple logistic regression analyses, women had a 1.64 times greater odds of current asthma (95%CI: 1.12–2.38) as compared to men. Hay fever was a strong predictor of both current and probable asthma. The odds of current asthma were 1.78 times (95%CI: 1.24–2.55) greater among past smokers; whereas the odds of probable asthma were 2.73 times (95%CI: 1.77–4.21) greater among current smokers as compared to non-smokers. Similarly fair/poor self rated health and complaints of severe pain were independently associated with current and probable asthma. The odds of current and probable asthma were almost two fold greater for obesity. When stratified by gender, the odds were significantly greater among females (p-value for interaction term = 0.038). The odds of current asthma were significantly greater for farm-related occupations (adjusted OR = 2.09, 95%CI: 1.00–4.39); whereas the odds were significantly lower among those who reported teaching as their longest held occupation (adjusted OR = 0.36, 95%CI = 0.18–0.74). CONCLUSION: This study found that asthma is a common medical condition in the elderly and it significantly impacts quality of life and general health status. Results support adopting an integrated approach in identifying and controlling asthma in this population

A Wireless Health Outcomes Monitoring System (WHOMS): development and field testing with cancer patients using mobile phones

BACKGROUND: Health-Related Quality of Life assessment is widely used in clinical research, but rarely in clinical practice. Barriers including practical difficulties administering printed questionnaires have limited their use. Telehealth technology could reduce these barriers and encourage better doctor-patient interaction regarding patient symptoms and quality-of-life monitoring. The aim of this study was to develop a new system for transmitting patients' self-reported outcomes using mobile phones or the internet, and to test whether patients can and will use the system via a mobile phone. METHODS: We have developed a prototype of a Wireless Health Outcomes Monitoring System, which allows structured questionnaires to be sent to the patient by their medical management team. The patients' answers are directly sent to an authorised website immediately accessible by the medical team, and are displayed in a graphic format that highlights the patient's state of health. In the present study, 97 cancer inpatients were asked to complete a ten-item questionnaire. The questionnaire was delivered by display on a mobile phone, and was answered by the patients using the mobile phone keypad. RESULTS: Of the 97 patients, 56 (58%) attempted the questionnaire, and all of these 56 completed it. Only 6% of the total number of questions were left unanswered by patients. Forty-one (42%) patients refused to participate, mostly due to their lack of familiarity with mobile phone use. Compared with those who completed the questionnaire, patients who refused to participate were older, had fewer years of education and were less familiar with new communications technology (mobile phone calls, mobile phone SMS, internet, email). CONCLUSION: More than half of the patients self-completed the questionnaire using the mobile phone. This proportion may increase with the use of multichannel communications which can be incorporated into the system. The proportion may also increase if the patient's partner and/or family were able to assist the patient with using the technology. These preliminary results encourage further studies to identify specific diseases or circumstances where this system could be useful in patients' distance monitoring. Such a system is likely to detect patient suffering earlier, and to activate a well-timed intervention

Diagnostic tools in Rhinology EAACI position paper

This EAACI Task Force document aims at providing the readers with a comprehensive and complete overview of the currently available tools for diagnosis of nasal and sino-nasal disease. We have tried to logically order the different important issues related to history taking, clinical examination and additional investigative tools for evaluation of the severity of sinonasal disease into a consensus document. A panel of European experts in the field of Rhinology has contributed to this consensus document on Diagnostic Tools in Rhinology

The impact of illness in patients with moderate to severe gastro-esophageal reflux disease

BACKGROUND: Gastro-esophageal reflux disease (GERD) is a common disease. It impairs health related quality of life (HRQL). However, the impact on utility scores and work productivity in patients with moderate to severe GERD is not well known. METHODS: We analyzed data from 217 patients with moderate to severe GERD (mean age 50, SD 13.7) across 17 Canadian centers. Patients completed three utility instruments – the standard gamble (SG), the feeling thermometer (FT), and the Health Utilities Index 3 (HUI 3) – and several HRQL instruments, including Quality of Life in Reflux and Dyspepsia (QOLRAD) and the Medical Outcomes Short Form-36 (SF-36). All patients received a proton pump inhibitor, esomeprazole 40 mg daily, for four to six weeks. RESULTS: The mean scores on a scale from 0 (dead) to 1 (full health) obtained for the FT, SG, and HUI 3 were 0.67 (95% CI, 0.64 to 0.70), 0.76 (95% CI, 0.75 to 0.80), and 0.80 (95% CI, 0.77 to 0.82) respectively. The mean scores on the SF-36 were lower than the previously reported Canadian and US general population mean scores and work productivity was impaired. CONCLUSION: GERD has significant impact on utility scores, HRQL, and work productivity in patients with moderate to severe disease. Furthermore, the FT and HUI 3 provide more valid measurements of HRQL in GERD than the SG. After treatment with esomeprazole, patients showed improved HRQL

Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics

<p>Abstract</p> <p>Background</p> <p>Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits.</p> <p>Methods</p> <p>Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting.</p> <p>Discussion</p> <p>A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms.</p> <p>Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication.</p> <p>Trial Registration</p> <p>NCT00260663</p