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Introduction: Older patients are often deemed ineligible for clinical research, and many frequently-used endpoints and outcome measures are not as relevant for older patients for younger ones. This systematic review aimed to present an overview of outcomes used in clinical research regarding patients over the age of 65 years with prostate cancer., Materials and Methods: PubMed and Embase were systematically searched to identify studies on prostate cancer (treatment) in patients aged ≥65 between 2016 and 2023. Data on title, study design, number of participants and age, stage of disease, treatment, and investigated outcomes were synthesized and descriptively analyzed., Results: Sixty-eight studies were included. Of these most included patients over 65 years, while others used a higher age. Overall, 39 articles (57.3%) reported on survival-related outcomes, 22 (32.4%) reported on progression of disease and 38 (55.9%) used toxicity or adverse events as an outcome measure. Health-related quality of life and functional outcomes were investigated in 29.4%, and cognition in two studies. The most frequently investigated survival-related outcomes were overall and cancer-specific survival (51.3%); however, 38.5% only studied overall survival., Discussion: The main focus of studies included in this review remains survival and disease progression. There is limited attention for health-related quality of life and functional status, although older patients often prioritize the latter. Future research should incorporate outcome measures tailored to the aged population to improve care for older patients with prostate cancer., Competing Interests: Declaration of Competing Interest No conflict of interest for all authors., (Copyright © 2024. Published by Elsevier Ltd.)

Understanding health-related quality of life (HRQOL) in children and adolescents, during a pandemic and afterwards, aids in understanding how circumstances in their lives impact their well-being. We aimed to identify determinants of HRQOL from a broad range of biological, psychological, and social factors in a large longitudinal population-based sample. Data was taken from a longitudinal sample (n = 1843) of children and adolescents enrolled in the prospective school-based cohort study Ciao Corona in Switzerland. The primary outcome was HRQOL, assessed using the KINDL total score and its subscales (each from 0, worst, to 100, best). Potential determinants, including biological (physical activity, screen time, sleep, etc.), psychological (sadness, anxiousness, stress), and social (nationality, parents' education, etc.) factors, were assessed in 2020 and 2021 and HRQOL in 2022. Determinants were identified in a data-driven manner using recursive partitioning to define homogeneous subgroups, stratified by school level. Median KINDL total score in the empirically identified subgroups ranged from 68 to 83 in primary school children and from 69 to 82 in adolescents in secondary school. The psychological factors sadness, anxiousness, and stress in 2021 were identified as the most important determinants of HRQOL in both primary and secondary school children. Other factors, such as physical activity, screen time, chronic health conditions, or nationality, were determinants only in individual subscales., Conclusion: Recent mental health, more than biological, physical, or social factors, played a key role in determining HRQOL in children and adolescents during pandemic times. Public health strategies to improve mental health may therefore be effective in improving HRQOL in this age group., What Is Known: • Assessing health-related quality of life (HRQOL) in children and adolescents aids in understanding how life circumstances impact their well-being. • HRQOL is a complex construct, involving biological, psychological, and social factors. Factors driving HRQOL in children and adolescents are not often studied in longitudinal population-based samples., What Is New: • Mental health (stress, anxiousness, sadness) played a key role in determining HRQOL during the coronavirus pandemic, more than biological or social factors. • Public health strategies to improve mental health may be effective in improving HRQOL in children., (© 2024. The Author(s).)

Objectives: We investigated changes in adherence to physical activity (PA) and screen time (ST) recommendations of children and adolescents throughout the pandemic, and their association with health-related quality of life (HRQOL). Methods: 1,769 primary (PS, grades 1-6) and secondary (SS, 7-9) school children from Ciao Corona, a school-based cohort study in Zurich, Switzerland, with five questionnaires 2020-2022. HRQOL was assessed using the KINDL questionnaire. PA (≥60 min/day moderate-to-vigorous PA) and ST (≤2 h/day ST) recommendations followed WHO guidelines. Results: Adherence to PA recommendations dropped in 2020 (83%-59% PS, 77%-52% SS), but returned to pre-pandemic levels by 2022 (79%, 66%). Fewer children met ST recommendations in 2020 (74% PS, 29% SS) and 2021 (82%, 37%) than pre-pandemic (95%, 68%). HRQOL decreased 3 points between 2020 and 2022, and was 9.7 points higher (95% CI 3.0-16.3) in March 2021 in children who met both versus no recommendations. Conclusion: Adherence to WHO guidelines on PA and ST during the pandemic had a consistent association with HRQOL despite longitudinal changes in behavior., Competing Interests: The authors declare that they do not have any conflicts of interest., (Copyright © 2023 Haile, Gunz, Peralta, Ulytė, Raineri, Rueegg, Yasenok, Radtke, Puhan and Kriemler.)

Background: Most patients with COPD do not maintain exercise training after pulmonary rehabilitation (PR)., Research Question: Does a 12-month home-based, minimal-equipment strength training program after PR have an effect on dyspnea, exercise capacity, and patient-reported outcomes in patients with COPD?, Study Design and Methods: In a parallel-arm multicenter study across four Swiss PR clinics, patients with COPD were allocated randomly (1:1 ratio) into an intervention group (IG; home-based strength training program) or control group (CG; usual care). The primary outcome was change in Chronic Respiratory Questionnaire (CRQ) dyspnea scale score from baseline to 12 months. Secondary outcomes were change in exercise capacity (1-min sit-to-stand-test [1MSTST], 6-min walk test [6MWT]), health-related quality of life, exacerbations, and symptoms. We assessed the IG's experience by interviews at study end. Main analyses were based on the intention-to-treat approach, and adjusted linear regression models were used., Results: One hundred twenty-three patients with COPD (IG, n = 61; CG, n = 62) were randomized, 61 of whom were women and whose mean ± SD age was 66.8 ± 8.1 years and mean ± SD FEV 1 was 39.3 ± 15.3% predicted. One hundred four participants completed 12 months of follow-up (IG, n= 53; CG, n= 51). Of the 53 IG participants, 37 participants (70%) conducted the training until study end. We found no difference in change in CRQ dyspnea scale score over 12 months (adjusted mean difference, 0.28; 95% CI, -0.23 to 0.80; P = .27). We found moderate evidence for a difference in 1MSTST repetitions favoring the IG (adjusted mean difference, 2.6; 95% CI, 0.22-5.03; P = .033), but no evidence for an effect in other outcomes. Seventy-nine percent of the IG reported positive effects that they attributed to the training., Interpretation: The home exercise program had no effect on dyspnea, but improved 1MSTST performance and patient-perceived fitness. The supported program was well accepted by patients with COPD and may facilitate continued exercise training at home., Trial Registry: ClinicalTrials.gov; No.: NCT03461887; URL: www., Clinicaltrials: gov., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: To assess the associations between parents' working conditions during the lockdown period (March-May 2020) and children's health-related quality of life (HRQOL) over the first year of the COVID-19 pandemic in Zurich, Switzerland. Methods: We included 2211 children (6-16 years) and their parents from the prospective study Ciao Corona. Parents reported their employment status and working conditions during the lockdown. Children's HRQOL was assessed in June-July 2020, January and March 2021 using the parents-report of the KINDL®. We used mixed models to assess the associations between parents' working conditions and children's HRQOL at the three time points. Results: Children from families in which at least one parent changed their working conditions during the lockdown showed lower HRQOL in June-July 2020, than children from families in which neither parent experienced changes. Children from families in which at least one parent had to work remotely continued to show lower HRQOL in January and March 2021. Conclusion: Changes in parents' working conditions during lockdown were negatively associated with children's HRQOL. Public health policies aiming to support families susceptible to adverse changes are needed., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Muralitharan, Peralta, Haile, Radtke, Ulyte, Puhan and Kriemler.)

Background: The Daily-PROactive and Clinical visit-PROactive Physical Activity (D-PPAC and C-PPAC) instruments in chronic obstructive pulmonary disease (COPD) combines questionnaire with activity monitor data to measure patients' experience of physical activity. Their amount, difficulty and total scores range from 0 (worst) to 100 (best) but require further psychometric evaluation., Objective: To test reliability, validity and responsiveness, and to define minimal important difference (MID), of the D-PPAC and C-PPAC instruments, in a large population of patients with stable COPD from diverse severities, settings and countries., Methods: We used data from seven randomised controlled trials to evaluate D-PPAC and C-PPAC internal consistency and construct validity by sex, age groups, COPD severity, country and language as well as responsiveness to interventions, ability to detect change and MID., Results: We included 1324 patients (mean (SD) age 66 (8) years, forced expiratory volume in 1 s 55 (17)% predicted). Scores covered almost the full range from 0 to 100, showed strong internal consistency after stratification and correlated as a priori hypothesised with dyspnoea, health-related quality of life and exercise capacity. Difficulty scores improved after pharmacological treatment and pulmonary rehabilitation, while amount scores improved after behavioural physical activity interventions. All scores were responsive to changes in self-reported physical activity experience (both worsening and improvement) and to the occurrence of COPD exacerbations during follow-up. The MID was estimated to 6 for amount and difficulty scores and 4 for total score., Conclusions: The D-PPAC and C-PPAC instruments are reliable and valid across diverse COPD populations and responsive to pharmacological and non-pharmacological interventions and changes in clinically relevant variables., Competing Interests: Competing interests: JG-A reports other from AstraZeneca, other from Esteve, other from Chiesi, other from Menarini, outside the submitted work. SC-R reports personal fees from AstraZeneca, outside the submitted work. DE reports personal fees from Boehringer Ingelheim, outside the submitted work. NI reports personal fees from Almirall, outside the submitted work. NK reports personal fees from AstraZeneca, outside the submitted work. MIP reports personal fees from Philips, grants, personal fees and non-financial support from GSK, during the conduct of the study. MS reports personal fees from Chiesi, outside the submitted work. MT reports personal fees and other from GSK, outside the submitted work. TT reports grants from IMI-JU PROactive grant, during the conduct of the study; other from Boehringer Ingelheim, other from AZ Belgium, outside the submitted work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To define "best possible" outcomes for bariatric surgery (BS)(Roux-en-Y gastric bypass [RYGB] and sleeve gastrectomy [SG])., Background: Reference values for optimal surgical outcomes in well-defined low-risk bariatric patients have not been established so far. Consequently, outcome comparison across centers and over time is impeded by heterogeneity in case-mix., Methods: Out of 39,424 elective BS performed in 19 high-volume academic centers from 3 continents between June 2012 and May 2017, we identified 4120 RYGB and 1457 SG low-risk cases defined by absence of previous abdominal surgery, concomitant procedures, diabetes mellitus, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, anticoagulation, BMI>50 kg/m and age>65 years. We chose clinically relevant endpoints covering the intra- and postoperative course. Complications were graded by severity using the comprehensive complication index. Benchmark values were defined as the 75th percentile of the participating centers' median values for respective quality indicators., Results: Patients were mainly females (78%), aged 38±11 years, with a baseline BMI 40.8 ± 5.8 kg/m. Over 90 days, 7.2% of RYGB and 6.2% of SG patients presented at least 1 complication and no patients died (mortality in nonbenchmark cases: 0.06%). The most frequent reasons for readmission after 90-days following both procedures were symptomatic cholelithiasis and abdominal pain of unknown origin. Benchmark values for both RYGB and SG at 90-days postoperatively were 5.5% Clavien-Dindo grade ≥IIIa complication rate, 5.5% readmission rate, and comprehensive complication index ≤33.73 in the subgroup of patients presenting at least 1 grade ≥II complication., Conclusion: Benchmark cutoffs targeting perioperative outcomes in BS offer a new tool in surgical quality-metrics and may be implemented in quality-improvement cycle.ClinicalTrials.gov Identifier NCT03440138.

Objectives: The aims of this study were to implement a novel, community-based physical activity (PA) intervention in a Swiss town with active participation of elderly participants and to evaluate its effectiveness, feasibility, acceptability and sustainability., Methods: The CAPACITY intervention combined important determinants of PA, used smartphone apps to provide feedback/facilitate interaction, and followed a citizen science approach to enable participants to organize walking groups. We targeted persons > 60 years from Wetzikon. Assessments took place at baseline and after 6 months, during this intervention period, and 11 months after step-wise withdrawal of the study team., Results: Twenty-nine persons were included in the study; 25 conducted 6-month follow-up. They had a significant increase in moderate-to-vigorous PA (p = 0.046) but not in daily steps (p = 0.331). After the intervention period, key participants took over organization, independently organized monthly get-togethers, added new walking routes and continuously recruit new participants. Eleven months after withdrawal of the study team, 61 people regularly walk in groups together., Conclusions: The novel CAPACITY intervention was successfully implemented, transferred to participants and is now self-sustainable for almost 1 year in the community.

Background: Exercise training is an important component of pulmonary rehabilitation (PR) programmes in chronic obstructive pulmonary disease (COPD), but the great majority of COPD patients who would benefit from PR never follow such programmes or fail to maintain exercise training after PR completion. Against this background, we developed an exercise training programme that requires minimal equipment and can be implemented long-term in the patient's home-setting. The aims of the HOMEX-1 and HOMEX-2 trials are to assess the effectiveness of this home-based exercise training programme in two groups of COPD patients over the course of one year: patients who have completed PR (HOMEX-1 trial) and patients who did not enrol in existing PR programmes within the last two years (HOMEX-2 trial)., Methods: HOMEX-1 and HOMEX-2 are multicentre, parallel group, randomised controlled trials. For both trials each, it is planned to include 120 study participants with a diagnosis of COPD. Participants will be randomised with a 1:1 ratio into the intervention group or the control group (usual care/no intervention). The intervention consists of minimal-equipment exercise training elements with progressive level of intensity, conducted by the participant during six days per week and instructed and coached by a trained health care professional during three home visits and regular telephone calls during one year. Primary outcome is change in dyspnoea (domain of Chronic Respiratory Questionnaire) from baseline to 12-months follow-up. Secondary outcomes are change in dyspnoea over the course of the year (assessed at 3, 6 and 12 month) and change in functional exercise capacity, physical activity, health-related quality of life, health status, exacerbations and symptoms from baseline to 12 months follow-up. In addition, explanatory, safety and cost-effectiveness outcomes will be assessed. We will conduct intention-to-treat analyses separately per trial and per protocol analyses as sensitivity analyses., Discussion: The HOMEX-1 and HOMEX-2 trials assess a novel intervention that provides an innovative way of making exercise training as accessible as possible for COPD patients. If the intervention proves to be effective long-term, it will fill the gap of providing an easily accessible and feasible intervention so that more COPD patients can follow an exercise programme., Trial Registration: ClinicalTrials.gov Identifier: HOMEX-1 NCT03461887 (registration date: March 12, 2018; retrospectively registered); HOMEX-2 NCT03654092 (registration date: August 31, 2018).

Background: MS symptoms affect many functional domains. Knowing the specific impact of symptoms on health-related quality of life (HRQoL) is vital for successful disease and symptom management in MS. We aimed at investigating how specific MS symptoms contribute to the disease burden in individuals and from a population perspective., Methods: We included 855 Swiss Multiple Sclerosis Registry participants with a relapsing-remitting form (RRMS) or a progressive form (PMS). HRQoL was measured with the EuroQol 5-Dimension EQ-5D-index and EQ-Visual Analogue Scale (EQ-VAS) on 0-100% scales. Their associations with 20 symptoms, socio-demographic and clinical information were explored in median regression models, stratified by RRMS and PMS., Results: We included 611 participants with RRMS and 244 with PMS. In RRMS, gait (-6.5%) and balance problems (-5.1%) had the largest EQ-5D-index reductions, and were also important at the population level (frequencies 45% and 52%). Fatigue, depression, and spasticity (frequencies 74.1%, 31%, 38%) also contributed to the population disease burden. In PMS, spasticity, paralysis, and bowel problems had the largest impact on EQ-5D-index, both at the individual and population levels. The largest impact on EQ-VAS at population level was associated in RRMS with balance problems, depression, dizziness, and spasticity, while in PMS with weakness, pain, and paralysis., Conclusions: While HRQoL at population level is most affected by balance problems, spasticity, and depression in RRMS, the biggest HRQoL losses in PMS are caused by spasticity, paralysis, weakness, and pain. Many symptoms with the largest effects in individuals substantially contribute to the population disease burden., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: No official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID., Methods: We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011. We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID., Results: For most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach's alpha 0.7-0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14-0.79, and 0.06-0.5 and 0.08-0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain., Conclusion: The German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.

The pivotal objective of chronic obstructive pulmonary disease (COPD) self-management programmes is behaviour change to avoid moderate and severe exacerbations and improve health related quality of life.In a prospectively planned, controlled study, COPD patients who participated in the "Living well with COPD" (LWWCOPD) self-management intervention were compared with usual care patients from the primary care COPD Cohort ICE COLD ERIC, who did not receive self-management intervention (NCT00706602) The primary outcome was behaviour change and disease-specific health related quality of life after 1 year. Secondary end-points included exacerbation rates. We calculated mixed linear, zero-inflated negative binomial and logistic regression models and used propensity scores to counteract confounding.467 patients, 71 from the LWWCOPD and 396 from the usual care cohort, were included. The differences between intervention and control were 0.54 (95% CI 0.13-0.94) on the Chronic Respiratory Questionnaire domain "mastery", 0.55 (95% CI 0.11-0.99) on "fatigue", 0.54 (0.14-0.93) on "emotional function" and 0.64 (95% CI 0.14-1.14) on "dyspnoea". The intervention considerably reduced the risk of moderate and severe exacerbations (incidence rate ratio 0.36, 95% CI 0.25-0.52).Self-management coaching in primary care improves health-related quality of life and lowers exacerbation rates and health care use., Competing Interests: Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com, (Copyright ©ERS 2018.)

Background: We aimed to assess the measurement properties and the minimal important difference (MID) of the 1-min sit-to-stand (STS) test in cystic fibrosis (CF)., Methods: Patients with CF were tested during a pulmonary rehabilitation program. Five STS tests were performed during the program; two tests at the beginning (STS0 and STS1) and three tests at the end (STS2a-2c). Exercise capacity, pulmonary function, and health-related quality of life (HRQoL) and patient-reported health status were measured at the beginning and end of the program. We calculated overall mean, standard deviation, coefficient of variation (CV), and intraclass correlation coefficient (ICC) of the STS test. The MID was calculated using anchor-based and distributional methods., Results: Fourteen participants (8 female, mean age 30.4±6.1years) were included. STS test performance increased significantly from STS0 to STS1 indicative of a learning effect. Test-retest reliability for the subsequent STS2a-2c tests was excellent (ICC 0.98, 95% CI 0.96-0.99). The estimated MID for the STS test was 5 repetitions. STS test performance was responsive to change (effect size of 0.97) and correlated with exercise capacity (r=0.63-0.73) and with the physical functioning HRQoL scale (r=0.72)., Conclusions: The 1-min STS test appears to be a reliable, valid, and feasible test to measure functional capacity in patients with CF., (Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.)

Background: Health-related quality of life (HRQL) is an important patient-reported outcome for chronic obstructive pulmonary disease (COPD)., Aim: We developed models predicting chronic respiratory questionnaire (CRQ) dyspnoea, fatigue, emotional function, mastery and overall HRQL at 6 and 24 months using predictors easily available in primary care., Methods: We used the "least absolute shrinkage and selection operator" (lasso) method to build the models and assessed their predictive performance., Results: were displayed using nomograms., Results: For each domain-specific CRQ outcome, the corresponding score at baseline was the best predictor. Depending on the domain, these predictions could be improved by adding one to six other predictors, such as the other domain-specific CRQ scores, health status and depression score. To predict overall HRQL, fatigue and dyspnoea scores were the best predictors. Predicted and observed values were on average the same, indicating good calibration. Explained variance ranged from 0.23 to 0.58, indicating good discrimination., Conclusions: To predict COPD-specific HRQL in primary care COPD patients, previous HRQL was the best predictor in our models. Asking patients explicitly about dyspnoea, fatigue, depression and how they cope with COPD provides additional important information about future HRQL whereas FEV1 or other commonly used predictors add little to the prediction of HRQL.

Background: In research with long-term follow-up and repeated measurements, quick and complete response to questionnaires helps ensure a study's validity, precision and efficiency. Evidence on the effect of non-monetary incentives on response rates in observational longitudinal research is scarce., Objectives: To study the impact of two strategies to enhance completeness and efficiency in observational cohort studies with follow-up durations of around 2 years. METHOD AND INTERVENTION: In a factorial design, 771 children between 2 and 5 years old and their parents participating in a prospective cohort study were randomized to three intervention groups and a control group. Three types of lotteries were run: (i) daytrip tickets for the whole family to a popular amusement park if they returned all postal questionnaires, (ii) €12.50-worth gift vouchers for sending back the questionnaire on time after each questionnaire round and (iii) a combination of (i) and (ii)., Main Outcome Measures: Primary outcome was the proportion of participants who returned all questionnaires without any reminder. Secondary outcomes were '100% returned with or without reminder', 'probability of 100% non-response', 'probability of withdrawal', 'proportion of returned questionnaires' and 'overall number of reminders sent'., Statistical Analysis: After testing for interaction between the two lottery interventions, the two trials were analysed separately. We calculated risk differences (RD) and numbers needed to "treat" and their 95% confidence intervals., Results: Daytrip nor voucher intervention had an effect on the proportion of participants who returned all questionnaires (RD -0.01; 95% CI-0.07 - 0.06) and (RD 0.02; 95% CI-0.50 - 0.08), respectively. No effects were found on the secondary outcomes., Conclusion: Our findings do not support the idea that lottery-style incentives lead to more complete response to postal questionnaires in observational cohort studies with repeated data collection and follow-up durations of around 2 years.

Background: Many patients with chronic illness are limited in their physical activities. This systematic review evaluates the content and format of patient-reported outcome (PRO) questionnaires that measure physical activity in elderly and chronically ill populations., Methods: Questionnaires were identified by a systematic literature search of electronic databases (Medline, Embase, PsychINFO & CINAHL), hand searches (reference sections and PROQOLID database) and expert input. A qualitative analysis was conducted to assess the content and format of the questionnaires and a Venn diagram was produced to illustrate this. Each stage of the review process was conducted by at least two independent reviewers., Results: 104 questionnaires fulfilled our criteria. From these, 182 physical activity domains and 1965 items were extracted. Initial qualitative analysis of the domains found 11 categories. Further synthesis of the domains found 4 broad categories: 'physical activity related to general activities and mobility', 'physical activity related to activities of daily living', 'physical activity related to work, social or leisure time activities', and '(disease-specific) symptoms related to physical activity'. The Venn diagram showed that no questionnaires covered all 4 categories and that the '(disease-specific) symptoms related to physical activity' category was often not combined with the other categories., Conclusions: A large number of questionnaires with a broad range of physical activity content were identified. Although the content could be broadly organised, there was no consensus on the content and format of physical activity PRO questionnaires in elderly and chronically ill populations. Nevertheless, this systematic review will help investigators to select a physical activity PRO questionnaire that best serves their research question and context.

Background: Around the world, the timing of referral of chronic obstructive pulmonary disease (COPD) patients for pulmonary rehabilitation differs from immediately after exacerbation (early) to later on when patients are in a stable state (late). There are no trials comparing the different time points of referral for pulmonary rehabilitation., Objectives: Our aim was to compare the effects of early and late pulmonary rehabilitation on exacerbation rates and health-related quality of life (HRQOL) in COPD patients with exacerbations., Methods: We randomized COPD patients (Global Initiative for Chronic Obstructive Lung Disease stages II-IV) with a recent exacerbation to early (within 2 weeks) or late pulmonary rehabilitation (starting 6 months after randomization and in a stable state). The primary outcome was the exacerbation rate over 18 months, and secondary outcomes included HRQOL and mortality. We used multivariate analyses and an intention-to-treat analysis approach., Results: We randomized 36 patients to pulmonary rehabilitation. On average, patients with early rehabilitation (n = 19) had 2.61 (SD 2.96) exacerbations requiring systemic corticosteroids and/or antibiotics, compared to 2.77 (SD 3.41) in patients with late rehabilitation (adjusted incidence rate ratio 0.83, 95% confidence interval 0.43-1.63; p = 0.60). Over the 18-month period, patients with late rehabilitation experienced more dyspnea (difference on Chronic Respiratory Questionnaire dyspnea domain 0.74 and on the Medical Research Council dyspnea scale 0.37), but neither these differences nor any difference in HRQOL domains reached statistical significance., Conclusions: We did not find any statistically significant differences between early and late pulmonary rehabilitation. However, our trial indicates that early rehabilitation may lead to faster recovery of HRQOL after exacerbations compared to rehabilitation later on when patients are in a stable state., (Copyright © 2011 S. Karger AG, Basel.)

Background: Capturing dimensions of physical activity relevant to patients may provide a unique perspective for clinical studies of chronically ill patients. However, the quality of the development of existing instruments is uncertain. The aim of this systematic review was to assess the development process of patient-reported outcome (PRO) instruments including their initial validation to measure physical activity in chronically ill or elderly patient populations., Methods: We conducted a systematic literature search of electronic databases (Medline, Embase, Psychinfo, Cinahl) and hand searches. We included studies describing the original development of fully structured instruments measuring dimensions of physical activity or related constructs in chronically ills or elderly. We broadened the population to elderly because they are likely to share physical activity limitations. At least two reviewers independently conducted title and abstract screening and full text assessment. We evaluated instruments in terms of their aim, items identification and selection, domain development, test-retest reliability, internal consistency, validity and responsiveness., Results: Of the 2542 references from the database search and 89 from the hand search, 103 full texts which covered 104 instruments met our inclusion criteria. For almost half of the instruments the authors clearly described the aim of the instruments before the scales were developed. For item identification, patient input was used in 38% of the instruments and in 32% adaptation of existing scales and/or unsystematic literature searches were the only sources for the generation of items. For item reduction, in 56% of the instruments patient input was used and in 33% the item reduction process was not clearly described. Test-retest reliability was assessed for 61%, validity for 85% and responsiveness to change for 19% of the instruments., Conclusions: Many PRO instruments exist to measure dimensions of physical activity in chronically ill and elderly patient populations, which reflects the relevance of this outcome. However, the development processes often lacked definitions of the instruments' aims and patient input. If PROs for physical activity were to be used in clinical trials more attention needs to be paid to the establishment of content validity through patient input and to the assessment of their evaluative measurement properties.

Background: Patient-reported outcomes are measured in many epidemiologic studies using self- or interviewer-administered questionnaires. While in some studies differences between these administration formats were observed, other studies did not show statistically significant differences important to patients. Since the evidence about the effect of administration format is inconsistent and mainly available from cross-sectional studies our aim was to assess the effects of different administration formats on repeated measurements of patient-reported outcomes in participants with AIDS enrolled in the Longitudinal Study of Ocular Complications of AIDS., Methods: We included participants enrolled in the Longitudinal Study of Ocular Complications in AIDS (LSOCA) who completed the Medical Outcome Study [MOS] -HIV questionnaire, the EuroQol, the Feeling Thermometer and the Visual Function Questionnaire (VFQ) 25 every six months thereafter using self- or interviewer-administration. A large print questionnaire was available for participants with visual impairment. Considering all measurements over time and adjusting for patient and study site characteristics we used linear models to compare HRQL scores (all scores from 0-100) between administration formats. We defined adjusted differences of ≥0.2 standard deviations [SD]) to be quantitatively meaningful., Results: We included 2,261 participants (80.6% males) with a median of 43.1 years of age at enrollment who provided data on 23,420 study visits. The self-administered MOS-HIV, Feeling Thermometer and EuroQol were used in 70% of all visits and the VFQ-25 in 80%. For eight domains of the MOS-HIV differences between the interviewer- and self- administered format were < 0.1 SD. Differences in scores were highest for the social and role function domains but the adjusted differences were still < 0.2 SD. There was no quantitatively meaningful difference between administration formats for EuroQol, Feeling Thermometer and VFQ-25 domain scores. For ocular pain (VFQ-25), we found a statistically significant difference of 3.5 (95% CI 0.2, 6.8), which did, however, not exceed 0.2 SD. For all instruments scores were similar for the large and standard print formats with all adjusted differences < 0.2 SD., Conclusions: Our large study provides evidence that administration formats do not have a meaningful effect on repeated measurements of patient-reported outcomes. As a consequence, longitudinal studies may not need to consider the effect of different administration formats in their analyses.

Background: Few epidemiologic studies have assessed health-related quality of life (HRQL) of asthma patients from a general population and it is unclear which instrument is best suitable for this purpose. We investigated the validity of the Asthma Quality of Life Questionnaire (AQLQ) and the SF-36 completed by individuals with asthma from the population-based SAPALDIA (Swiss study on air pollution and lung diseases in adults) cohort., Methods: The study included 258 participants with a physician-diagnosed asthma who had completed the AQLQ and SF-36. We assessed floor and ceiling effects, internal consistency reliability and cross-sectional validity with a priori hypotheses that correlations between the specific HRQL domains (e.g. "symptoms" or "physical functioning") and the corresponding external validation measures (respiratory symptoms, need for doctor visits, limitation in activities due to asthma and lung function) would capture similar aspects and be correlated moderately (> or = 0.3) to strongly (> or = 0.5), whereas non-corresponding domains be correlated weakly with each other (<0.3)., Results: The AQLQ showed pronounced ceiling effects with all median domain scores above 6 (scores varied from 1-7). For the SF-36, ceiling effects were present in 5 out of 8 domains. Cronbach's alpha was >0.7 for all AQLQ and SF-36 domains. Correlations between the AQLQ domains "respiratory symptoms", "activity limitation" and "environmental exposure", and the validation measures ranged from 0.29-0.57. Correlations between the "emotional function" domain and the validation measures were also in this range (0.31-0.55) and not as low as we hypothesized. For the SF-36, correlations between "physical functioning" and "role physical", and the validation measures ranged from 0.25-0.56, whereas "role emotional" and "mental health" correlated with these measures from 0.01-0.23., Conclusion: The AQLQ and the SF-36 showed fairly good internal consistency. Both instruments are limited by ceiling effects, but they appear less pronounced in the SF-36, which also shows a better discrimination between different aspects of HRQL. The SF-36 may therefore be a more valid measure of HRQL than the AQLQ when applied to individuals with asthma from the general population.

Background and Objective: There is little evidence for the relative cross-sectional validity of the standard gamble (SG) and time trade-off (TTO). We compared these preference-based instruments in patients with Irritable Bowel Syndrome (IBS)., Methods: Patients rated their own health on the SG and TTO and completed the disease-specific IBS questionnaire, the Brief Pain Inventory, the SF-36, the Sickness Impact Profile, and a global rating of disease severity., Results: Mean scores of the 96 enrolled patients (mean age 39.5 years, 84.4% women) were 0.84 (standard deviation 0.16) for the SG and 0.76 (0.22) for the TTO. The correlation of the SG with the TTO was 0.36. For the SG, correlation coefficients with the IBS questionnaire domain scores ranged from 0.36 to 0.47, whereas those of the TTO were substantially lower (0.15-0.42). The SG also had higher correlations than the TTO with generic questionnaires (0.18-0.34 versus 0.13-0.26), Brief Pain Inventory (0.27 versus 0.11), global rating of disease severity (0.22 versus 0.10) as well as with SF-36-derived patient preferences (0.31-0.43 versus 0.27-0.31)., Conclusions: The higher correlations of the SG with validation measures indicate that the SG better reflects health-related quality of life and patient preferences compared to the TTO.

Background: Selection of heath-related quality of life (HRQL) instruments that are most responsive to changes in HRQL prevents investigators from drawing false-negative conclusions about the effectiveness of an intervention. The objective of this study was to compare the responsiveness of the Chronic Respiratory Questionnaire (CRQ), the St. Georges Respiratory Questionnaire (SGRQ) and four other HRQL instruments., Methods: We enrolled 177 patients with chronic lung disease, primarily COPD (93%), who completed 8 weeks of respiratory rehabilitation. Patients completed the CRQ, the SGRQ and four generic measures (SF-36, Feeling Thermometer, Standard Gamble and Health Utilities index 3) at the beginning of the rehabilitation program and 12 weeks thereafter. We calculated standardized response means (SRMs) for each instrument, from the change score divided by the standard deviation of the change score., Results: We observed the largest SRM for the CRQ (0.24-0.66 for the four CRQ domains on the interviewer-administered and 0.56-0.84 for the self-administered format) and the SGRQ (0.33-0.51 for the three SGRQ domains and total score). The CRQ dyspnea domain was statistically significantly more responsive than any other instrument including the SGRQ. For the SGRQ, the total and impacts domain were significantly more responsive than the generic and preference-based instruments., Conclusions: This study confirms that the CRQ and SGRQ are substantially more responsive than generic measures, and suggests particularly strong responsiveness for the self-administered CRQ.

Background: Whether responsiveness represents a measurement property of health-related quality of life (HRQL) instruments that is distinct from reliability and validity is an issue of debate. We addressed the claims of a recent study, which suggested that investigators could rely on internal consistency to reflect instrument responsiveness., Methods: 516 patients with chronic obstructive pulmonary disease or knee injury participating in four longitudinal studies completed generic and disease-specific HRQL questionnaires before and after an intervention that impacted on HRQL. We used Pearson correlation coefficients and linear regression to assess the relationship between internal consistency reliability (expressed as Cronbach's alpha), instrument type (generic and disease-specific) and responsiveness (expressed as the standardised response mean, SRM)., Results: Mean Cronbach's alpha was 0.83 (SD 0.08) and mean SRM was 0.59 (SD 0.33). The correlation between Cronbach's alpha and SRMs was 0.10 (95% CI -0.12 to 0.32) across all studies. Cronbach's alpha alone did not explain variability in SRMs (p = 0.59, r2 = 0.01) whereas the type of instrument was a strong predictor of the SRM (p = 0.012, r2 = 0.37). In multivariable models applied to individual studies Cronbach's alpha consistently failed to predict SRMs (regression coefficients between -0.45 and 1.58, p-values between 0.15 and 0.98) whereas the type of instrument did predict SRMs (regression coefficients between -0.25 to -0.59, p-values between <0.01 and 0.05)., Conclusion: Investigators must look to data other than internal consistency reliability to select a responsive instrument for use as an outcome in clinical trials.

Introduction: To provide optimal care for patients with chronic obstructive pulmonary disease physicians need to understand if their patients benefit from an intervention. The objective of this study was to assess agreement between patients and physicians on health-related quality of life (HRQL) changes in response to respiratory rehabilitation and to explore sources for disagreement., Methods: Sixty-one patients rated their health states on a validated preference-based instrument, the feeling thermometer (FT). In an analogous manner, the eight treating physicians rated the patients' health states on the FT. Patients and physicians were blinded to each other's ratings. We calculated intraclass correlation coefficients (ICC) to assess agreement between patients and physicians and used HRQL instruments and the 6-min walking test to assess the evaluative properties of the FT., Results: We found moderate agreement at baseline (ICC 0.40, P = 0.018) and follow-up (ICC 0.49, P = 0.008) but large disagreement about change scores (ICC 0.02, P = 0.46). Patients' FTchange scores correlated well with change scores of the Chronic Respiratory Questionnaire, SF-36 and the Borg scale for dyspnoea whereas physicians' FT change scores correlated significantly with the change score of the 6- min walking test (r = 0.33). Physicians' ratings showed an inconsistent pattern for correlations with HRQL measures., Conclusions: There is large disagreement between patients and physicians on HRQL changes in response to respiratory rehabilitation. Investigators should assess whether the introduction of HRQL instruments into clinical practice raises the awareness of physicians towards HRQL and improves agreement with their patients.

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be the lack of time and training of surgeons and anaesthesiologists. We therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery.Methods: The present study is a single-centre, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. We plan to randomize 251 patients. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting 4 weeks before surgery compared to patients in the advice-only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include the length of hospital stay, cost of care, quality of life, smoking abstinence, and reduction in nicotine consumption.Discussion: The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing surgery.Trial Registration: BASEC #2021-02004; ClinicalTrials.gov: NCT05192837 . Registered on January 14, 2022. [ABSTRACT FROM AUTHOR]

Background Mobility is defined as the ability to independently move around the environment and is a key contributor to quality of life, especially in older age. The aim of this study was to evaluate the use of mobility as a decisive outcome for the marketing authorisation of drugs by the European Medicines Agency (EMA). Methods Fifteen therapeutic areas which commonly lead to relevant mobility impairments and alter the quantity and/or the quality of walking were selected: two systemic neurological diseases, four conditions primarily affecting exercise capacity, seven musculoskeletal diseases and two conditions representing sensory impairments. European Public Assessment Reports (EPARs) published by the EMA until September 2020 were examined for mobility endpoints included in their 'main studies'. Clinical study registries and primary scientific publications for these studies were also reviewed. Results Four hundred and eighty-four EPARs yielded 186 relevant documents with 402 'main studies'. The EPARs reported 153 primary and 584 secondary endpoints which considered mobility; 70 different assessment tools (38 patient-reported outcomes, 13 clinician-reported outcomes, 8 performance outcomes and 13 composite endpoints) were used. Only 15.7% of those tools distinctly informed on patients' mobility status. Out of 402, 105 (26.1%) of the 'main studies' did not have any mobility assessment. Furthermore, none of these studies included a digital mobility outcome. Conclusions For conditions with a high impact on mobility, mobility assessment was given little consideration in the marketing authorisation of drugs by the EMA. Where mobility impairment was considered to be a relevant outcome, questionnaires or composite scores susceptible to reporting biases were predominantly used. [ABSTRACT FROM AUTHOR]

Abstract Background Patient-reported outcomes are measured in many epidemiologic studies using self- or interviewer-administered questionnaires. While in some studies differences between these administration formats were observed, other studies did not show statistically significant differences important to patients. Since the evidence about the effect of administration format is inconsistent and mainly available from cross-sectional studies our aim was to assess the effects of different administration formats on repeated measurements of patient-reported outcomes in participants with AIDS enrolled in the Longitudinal Study of Ocular Complications of AIDS. Methods We included participants enrolled in the Longitudinal Study of Ocular Complications in AIDS (LSOCA) who completed the Medical Outcome Study [MOS] -HIV questionnaire, the EuroQol, the Feeling Thermometer and the Visual Function Questionnaire (VFQ) 25 every six months thereafter using self- or interviewer-administration. A large print questionnaire was available for participants with visual impairment. Considering all measurements over time and adjusting for patient and study site characteristics we used linear models to compare HRQL scores (all scores from 0-100) between administration formats. We defined adjusted differences of ≥0.2 standard deviations [SD]) to be quantitatively meaningful. Results We included 2,261 participants (80.6% males) with a median of 43.1 years of age at enrolment who provided data on 23,420 study visits. The self-administered MOS-HIV, Feeling Thermometer and EuroQol were used in 70% of all visits and the VFQ-25 in 80%. For eight domains of the MOS-HIV differences between the interviewer- and self- administered format were < 0.1 SD. Differences in scores were highest for the social and role function domains but the adjusted differences were still < 0.2 SD. There was no quantitatively meaningful difference between administration formats for EuroQol, Feeling Thermometer and VFQ-25 domain scores. For ocular pain (VFQ-25), we found a statistically significant difference of 3.5 (95% CI 0.2, 6.8), which did, however, not exceed 0.2 SD. For all instruments scores were similar for the large and standard print formats with all adjusted differences < 0.2 SD. Conclusions Our large study provides evidence that administration formats do not have a meaningful effect on repeated measurements of patient-reported outcomes. As a consequence, longitudinal studies may not need to consider the effect of different administration formats in their analyses.

Background: There is a general notion that stressful life events may cause mental and physical health problems. Objectives: We aimed to describe stressful life events reported by patients with chronic obstructive pulmonary disease (COPD) and to assess their impact on health outcomes and behaviors. Methods: Two hundred and sixty-six primary care patients who participated in the ICE COLD ERIC cohort study were asked to document any stressful life events in the past 3 years. We assessed the before-after (the event) changes for symptoms of depression and anxiety, health status, dyspnea-related quality of life, exacerbations, cigarette use, and physical activity. We used linear regression analysis to estimate the crude and adjusted magnitude of the before-after changes. Results: About 41% (110/266) of patients reported the experience of any stressful life events and “death of relatives/important persons” was most common (31%). After accounting for age, sex, living status, lung function, and anxiety/depression status at baseline, experiencing any stressful life events was associated with a 0.9-point increase on the depression scale (95% CI 0.3 to 1.4), a 0.8-point increase on the anxiety scale (95% CI 0.3 to 1.3), and a 0.8-point decrease in the physical activity score (95% CI –1.6 to 0). Conclusions: Experiencing stressful life events was associated with a small to moderate increase in symptoms of depression and anxiety in COPD, but no discernable effect was found for other physical outcomes. However, confirmation of these results in other COPD cohorts and identification of patients particularly vulnerable to stressful life events are needed. [ABSTRACT FROM AUTHOR]

The 1-min sit-to-stand (1-min STS) test and handgrip strength test have been proposed as simple tests of functional exercise performance in chronic obstructive pulmonary disease (COPD) patients. We assessed the long-term (5-year) predictive performance of the 1-min sit-to-stand and handgrip strength tests for mortality, health-related quality of life (HRQoL) and exacerbations in COPD patients. In 409 primary care patients, we found the 1-min STS test to be strongly associated with long-term morality (hazard ratio per 3 more repetitions: 0.81, 95% CI 0.65 to 0.86) and moderately associated with long-term HRQoL. Neither test was associated with exacerbations. Our results suggest that the 1-min STS test may be useful for assessing the health status and long-term prognosis of COPD patients. This study was registered at http://www.clinicaltrials.gov/ (NCT00706602, 25 June 2008). [ABSTRACT FROM AUTHOR]

Importance: Comorbidities are common in COPD, but quantifying their burden is difficult. Currently there is a COPD-specific comorbidity index to predict mortality and another to predict general quality of life. We sought to develop and validate a COPD-specific comorbidity score that reflects comorbidity burden on patient-centered outcomes. Materials and Methods: Using the COPDGene study (GOLD II-IV COPD), we developed comorbidity scores to describe patient-centered outcomes employing three techniques: 1) simple count, 2) weighted score, and 3) weighted score based upon statistical selection procedure. We tested associations, area under the Curve (AUC) and calibration statistics to validate scores internally with outcomes of respiratory disease-specific quality of life (St. George's Respiratory Questionnaire, SGRQ), six minute walk distance (6MWD), modified Medical Research Council (mMRC) dyspnea score and exacerbation risk, ultimately choosing one score for external validation in SPIROMICS. Results: Associations between comorbidities and all outcomes were comparable across the three scores. All scores added predictive ability to models including age, gender, race, current smoking status, pack-years smoked and FEV1 (p<0.001 for all comparisons). Area under the curve (AUC) was similar between all three scores across outcomes: SGRQ (range 0·7624–0·7676), MMRC (0·7590–0·7644), 6MWD (0·7531–0·7560) and exacerbation risk (0·6831–0·6919). Because of similar performance, the comorbidity count was used for external validation. In the SPIROMICS cohort, the comorbidity count performed well to predict SGRQ (AUC 0·7891), MMRC (AUC 0·7611), 6MWD (AUC 0·7086), and exacerbation risk (AUC 0·7341). Conclusions: Quantifying comorbidity provides a more thorough understanding of the risk for patient-centered outcomes in COPD. A comorbidity count performs well to quantify comorbidity in a diverse population with COPD. [ABSTRACT FROM AUTHOR]

Chronic Obstructive Pulmonary Disease (COPD) coexists with co-morbidities. While co-morbidity has been associated with poorer health status, it is unclear which conditions have the greatest impact on self-rated health. We sought to determine which, and how much, specific co-morbid conditions impact on self-rated health in current and former smokers with self-reported COPD. Using the 2001-2008 National Health and Nutrition Examination Survey we characterized the association between thirteen co-morbidities and health status among individuals self-reporting COPD. Adjusted odds ratios (ORs) were generated using ordinal logistic regression. Additionally we evaluated the impact of increasing number of co-morbidities with self-rated health. Eight illnesses had significant associations with worse self-rated health, however after mutually adjusting for these conditions, congestive heart failure (OR 3.07, 95% CI 1.69-5.58), arthritis (OR 1.69, 95% CI 1.13-2.52), diabetes (OR 1.63, 95% CI 1.01-2.64), and incontinence/prostate disease (OR 1.63, 95% CI 1.01-2.62) remained independent predictors of self-rated health. Each increase in co-morbidities was associated with a 43% higher chance of worse self-rated health (95% CI 1.27-1.62). Individuals with COPD have a substantial burden of co-morbidity, which is associated with worse self-rated health. CHF, arthritis, diabetes and incontinence/prostate disease have the most impact on self-rated health. Targeting these co-morbidities in COPD may result in improved self-rated health. [ABSTRACT FROM AUTHOR]

Background: Guidelines recommend high-intensity continuous exercise to reduce peripheral muscle dysfunction in patients with chronic obstructive pulmonary disease but acknowledge that interval exercise might be an equally effective alternative that is better tolerated by patients. Objective: To assess whether interval exercise is no less effective than high-intensity continuous exercise and whether it is tolerated better by patients with severe chronic obstructive pulmonary disease. Design: Randomized, noninferiority trial. Setting: Publicly funded rehabilitation hospital in Switzerland. Patients: 98 patients with severe chronic obstructive pulmonary disease, with or without recent exacerbations. Intervention: 12 to 15 supervised interval or high-intensity continuous exercise sessions (over 3 weeks) followed by exercise at home. Measurements: Health-related quality of life determined by using the Chronic Respiratory Questionnaire (CRQ) (scores from 1 [most severe impairment] to 7 [no impairment]) after 5 weeks and number of unintended breaks during supervised exercise. Results: Both groups experienced large improvements in healthrelated quality of life (increase of CRQ total scores of 1.00 [SD, 0.98] for the interval exercise group and 1.02 [SD, 1.05] for the continuous exercise group). Adjusted between-group differences between the interval exercise group and the continuous exercise group (-0.05 [95% CI, -0.42 to -0.32] for CRQ and 1.1 meters [CI, -25.4 to 27.6 meters] for 6-minute walking distance) were within the a priori defined boundaries of noninferiority (0.5 for CRQ and 45 meters for 6-minute walking distance). Twenty-one (47.9%) patients using interval exercise and 11 (24.0%) patients using continuous exercise were able to adhere to the protocol (difference, 23.9 percentage points [CI, 5.0 to 42.8 percentage points]; P = 0.014). The median number of unintended breaks lasting 1 minute or more was 2 (interquartile range, 0 to 16) for patients in the interval exercise group and 11 (interquartile range, 2 to 26) for patients in the continuous exercise group (P = 0.023). Limitations: The study focused on initiation of exercise and not on outpatient or home-based maintenance of exercise. Conclusions: Clinicians and patients can choose either of the 2 exercise plans to initiate physical exercise. [ABSTRACT FROM AUTHOR]

Background: Combining outcomes and the use of standardized effect measures such as effect size and standardized response mean across instruments allows more comprehensive meta-analyses and should avoid selection bias. However, such analysis ideally requires that the instruments correlate strongly and that the underlying assumption of similar responsiveness is fulfilled. The aim of the study was to assess the correlation between two widely used health-related quality of life instruments for patients with chronic obstructive pulmonary disease and to compare the instruments' responsiveness on a study level. Methods: We systematically identified all longitudinal studies that used both the Chronic Respiratory Questionnaire (CRQ) and the St. George's Respiratory Questionnaire (SGRQ) through electronic searches of MEDLINE, EMBASE, CENTRAL and PubMed. We assessed the correlation between CRQ (scale 1 - 7) and SGRQ (scale 1 - 100) change scores and compared responsiveness of the two instruments by comparing standardized response means (change scores divided by their standard deviation). Results: We identified 15 studies with 23 patient groups. CRQ change scores ranged from -0.19 to 1.87 (median 0.35, IQR 0.14-0.68) and from -16.00 to 3.00 (median -3.00, IQR -4.73-0.25) for SGRQ change scores. The correlation between CRQ and SGRQ change scores was 0.88. Standardized response means of the CRQ (median 0.51, IQR 0.19-0.98) were significantly higher (p < 0.001) than for the SGRQ (median 0.26, IQR -0.03-0.40). Conclusion: Investigators should be cautious about pooling the results from different instruments in meta-analysis even if they appear to measure similar constructs. Despite high correlation in changes scores, responsiveness of instruments may differ substantially and could lead to important between-study heterogeneity and biased meta-analyses. [ABSTRACT FROM AUTHOR]

The chronic respiratory questionnaire, available as an interviewer and a self-administered instrument, includes 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). When completing this instrument, patients rate their experience on a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment). The Chronic Respiratory Questionnaire has demonstrated excellent measurement properties for both discriminative and evaluative purposes and served as a model in numerous methodological studies in chronic airflow limitation and patients with chronic obstructive pulmonary disease. We performed a systematic review of the literature on the chronic respiratory questionnaire to summarize the key qualities of the chronic respiratory questionnaire and to appraise the work regarding the minimal important difference of the chronic respiratory questionnaire. This paper includes a revision of our initial definition of the minimal important difference and a methodological framework for using anchor based approaches to establish the minimal important difference pioneered by Jaeschke and colleagues. Other approaches to evaluate the minimal important difference include distribution-based methods and panel-based methods. Investigators have used all of these approaches to establish the minimal important difference for the chronic respiratory questionnaire and the results are in general agreement with the minimal important difference of 0.5 for the mean domain scores of the chronic respiratory questionnaire. As a result of this literature review and discussion at the workshop, we established several research objectives. These objectives include the exploration of presentation of quality of life information and prospective anchor-based approaches. [ABSTRACT FROM AUTHOR]

Background: Assessment of health-related quality of life (HRQL) is important in patients with chronic obstructive pulmonary disease (COPD). Despite the high prevalence of COPD in Germany, Switzerland and Austria there is no validated disease-specific instrument available. The objective of this study was to translate the Chronic Respiratory Questionnaire (CRQ), one of the most widely used respiratory HRQL questionnaires, into German, develop an interviewer- and self-administered version including both standardised and individualised dyspnoea questions, and validate these versions in two randomised studies. Methods: We recruited three groups of patients with COPD in Switzerland, Germany and Austria. The 44 patients of the first group completed the CRQ during pilot testing to adapt the CRQ to German-speaking patients. We then recruited 80 patients participating in pulmonary rehabilitation programs to assess internal consistency reliability and cross-sectional validity of the CRQ. The third group consisted of 38 patients with stable COPD without an intervention to assess test-retest reliability. To compare the interviewer- and self-administered versions, we randomised patients in groups 2 and 3 to the interviewer- or self-administered CRQ. Patients completed both the standardised and individualised dyspnoea questions. Results: For both administration formats and all domains, we found good internal consistency reliability (Crohnbach's alpha between 0.73 and 0.89). Cross-sectional validity tended to be better for the standardised compared to the individualised dyspnoea questions and cross-sectional validity was slightly better for the self-administered format. Test-retest reliability was good for both the interviewer-administered CRQ (intraclass correlation coefficients for different domains between 0.81 and 0.95) and the self-administered format (intraclass correlation coefficients between 0.78 and 0.86). Lower within-person variability was responsible for the higher test-retest reliability of the interviewer-administered format while between person variability was similar for both formats. Conclusions: Investigators in German-speaking countries can choose between valid and reliable self-and interviewer-administered CRQ formats. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the nationwide implementation of the "Living well with COPD" program by the Swiss Lung Association in various cantons in Switzerland.Methods: For the process evaluation, we used qualitative (interview, focus group) and quantitative (questionnaires, documentation analysis) methods to assess the implementation outcomes reach, dose, fidelity and acceptability. For the effectiveness, we performed a pre-post analysis of patient data collected at baseline and program end (after 14 months).Results: Seven Cantonal Lung Associations implemented the program into their services according to plan, conducted it 13 times and included 122 COPD patients. Patients' attendance rate was 81% and coaches' fidelity to protocol 94%. Acceptance and satisfaction of all involved persons was high. Integration of the coaches' additional workload, uncertainties regarding roles and responsibilities and sustainable reimbursement were major challenges. Patients significantly improved in COPD specific quality of life and increased exercise capacity with on average 3.2 more repetitions in the 1-minute sit-to-stand test.Conclusion: The program was successfully implemented throughout Switzerland with high acceptability and positive association with patients' quality of life.Practice Implications: Our findings support the broader multiplication throughout Switzerland and serves the international community since it is one of the first nationwide implementations beyond study settings. [ABSTRACT FROM AUTHOR]