Table 10 Characteristics of humanistic burden studies included in the review

Miedinger et al. 2011 [51] 2004 - 2006

Longitudinal study - subjects who claimed compensation for OA in Quebec

Examine association between clinical and socioeconomic variables and psychological and cost outcomes in patients with OA

Claimed compensation for OA at CSST, not exposed to offending allergens causing OA for ≥2 years

Workplace-associated respiratory symptoms and positive results in specific inhalation test

Lavoie et al. 2010 [52] NR

Prospective cohort, self-report questionnaires

Assess level of psychological distress and range of disease-relevant emotional and behavioural coping styles in patients with severe vs. moderate asthma

Patients aged 18–69 years recruited from 2 tertiary care outpatient asthma clinics

Standard ATS criteria; Severe asthma - received adequate therapy and verified treatment adherence, with patients meeting ATS major and minor criteria for severe asthma

Bacon et al. 2009 [53] Jun 2003 - Jan 2007

Cross-sectional study; patients administered questionnaires

Assess associations between adult SES (measured according to educational level) and asthma morbidity, including asthma control; asthma-related emergency health service use; asthma self-efficacy, and asthma-related QoL

Patients aged 18–75 years, recruited from outpatient asthma clinic of Hôpital du Sacré-Coeur de Montréal

Physician-diagnosed asthma - charted 20% fall in FEV1 after methacholine challenge and/or bronchodilator reversibility in FEV1 of ≥20% predicted; severity based on GINA guidelines (mild intermittent, mild persistent, moderate persistent, and severe persistent)

McTaggart-Cowan et al. 2008 [54] NR

Cross-sectional - self-administered questionnaire

Evaluate validity of HUI-3, EQ-5D, SF-6D, and AQL-5D to distinguish between different levels of asthma control

Patients aged 19–49 years,no other concurrent respiratory conditions

Self-reported, physician-diagnosed asthma

Rowe et al. 2007 [55] NR

RCT (double-blind) -structured telephone interviews

Examine effect of adding a LABA (salmeterol) to fixed dose of oral prednisone and ICS (fluticasone)

Patients aged 18–55 years, PEF of <80% predicted before treatment, discharged from ED

Clinically diagnosed acute asthma in ED; PEF of <80% predicted before treatment

Yacoub et al. 2007 [56] 2004 - 2006

Retrospective cohort study; questionnaire administered to subjects

Evaluate utility of adding assessment of airway inflammation to standard assessment of impairment in subjects with OA; to evaluate psychological and QoL impact of OA

Workers' Compensation Agency of Quebec claimants

OA claimants

Lavoie et al. 2006 [57] 2003 - 2005

Cross-sectional study; structured psychiatric interview

Evaluate relative impact of having a depressive and/or anxiety disorder on asthma control and QoL

Patients aged 18–75 years with primary diagnosis of asthma

Physician-diagnosed asthma - chart evidence of 20% fall in FEV1 after methacholine challenge and/or bronchodilator reversibility in FEV1 20% predicted; severity classified according to international GINA guidelines

Lavoie et al. 2006 [58] Jun 2003 to Apr 2004

Cross-sectional study; patients completed ACQ and AQLQ questionnaires

Assess BMI in a Canadian sample of asthma outpatients, and evaluate associations between BMI and levels of asthma severity, asthma control, and asthma-related QoL

Patients aged 18–75 years with primary diagnosis of asthma, fluency in either English or French

Physician diagnosed asthma - chart evidence of 20% fall in FEV1 after methacholine challenge and/or bronchodilator reversibility in FEV1 20% predicted; severity classified according to GINA guidelines

Lavoie et al. 2005 [52] NR

Cross-sectional study; patients completed ACQ and AQLQ questionnaires

Evaluate prevalence of psychiatric disorders in adult asthma patients and associations between psychiatric status, levels of asthma control, and asthma-related QoL

Patients aged 18–75 years with primary diagnosis of asthma, fluency in either English or French

Physician diagnosed asthma - confirmed by chart evidence of 20% fall in FEV1 after methacholine challenge and/or bronchodilator reversibility in FEV1 20% predicted; severity classified according to GINA guidelines

Mo et al. 2004 [59] 2000 - 2001

Cross-sectional study; HUI used to measure QoL

Measure HRQL of chronic disease and detect associations between HUI system and various chronic conditions

All household residents aged ≥12 years in all provinces and territories

NR

FitzGerald et al. 2000 [60]

RCT - AQLQ administered to assess QoL

Compare effectiveness of prednisone and budesonide on relapse rate

Patients aged 15–70 years, recruited after discharge from ED after acute asthma exacerbation

Asthma exacerbation - progressive increase in dyspnea and history of asthma as per ATS criteria

Williams et al. 2010 [61] Baseline to week 12

RCT AQLQ data from first 12 weeks of the GOAL study

Compare AQLQ data across 16 countries (17 languages)

Patients aged 12 to <80 years with ≥6-month history of asthma

NR

Miedinger et al. 2011 [51] 2004 to 2006

Cross-sectional study; participants completed validated French versions of QoL questionnaires

Assess correlation between asthma-specific QoL and levels of psychological distress and psychiatric disorders in patients with OA

Patients who claimed compensation for OA at CSST; no longer exposed to sensitizing agents ≥2 years

OA - asthma caused and maintained by conditions attributable to the occupational environment and not to stimuli encountered outside the workplace

Zimmerman et al. 2004 [50] 12-week study

RCT (double-blind); patients administered PAQLQ

Examine efficacy and safety of adding regular formoterol at 2 different doses to maintenance treatment with ICS in children with asthma not optimally treated by ICS alone

Patients aged 6–11 years with clinical diagnosis of asthma as per ATS criteria for ≥6 months; FEV1 50-90% of predicted normal; documented post-bronchodilator reversibility of ≥15%, ≥9% of predicted normal; treatment with regular ICS for ≥3 months before trial entry; asthma symptoms sufficient to suggest additional therapy may be needed; ability to use peak flow meter and Turbuhaler®, able to answer questions from PAQLQ; parent/guardian to complete daily diary

Clinical diagnosis of asthma defined according to ATS criteria; severe asthma exacerbation defined as asthma symptoms requiring oral corticosteroids or increase in dose of ICS as judged by the investigator