Search

Background: Common mental disorders (CMDs) are highly prevalent and contribute significantly to the global burden of disease, yet there is evidence of a large treatment gap. We aimed to quantify this gap among young adults with symptoms of CMDs and examine the relationship between substance use and perceived need for care and mental health service utilization.Methods: In a nationally representative, cross-sectional survey of young Swiss adults' mental health and wellbeing, we assessed symptoms of anxiety, depression, and attention deficit hyperactivity disorder (ADHD) with widely used screening instruments and asked about participant suicidal ideation, suicide attempts, mental health-related quality of life, alcohol and drug use, perceived need for mental health care, and mental health service utilization. We used these variables to calculate the treatment gap and weighted all analyses according to the stratified sampling plan.Results: Around a quarter of young adults screened positive for at least one CMD. Participants who screened positive for anxiety and/or depression reported significantly more suicidal ideation and lifetime suicide attempts and reported worse mental health-related quality of life than participants who did not screen positive for a disorder. Women's prevalence of anxiety and depression symptoms was significantly higher than men's, while men were more likely to report most types of risky drug use. Among those with a CMD, only around half perceived lifetime need for care, and less than 20% reported currently utilizing mental health services. Young adults with a CMD reporting risky weekly use of alcohol were less likely to be currently using services.Conclusion: The high prevalence of CMD symptoms could reflect a rising prevalence of these disorders mirroring increasing trends observed in other countries. To address the large treatment gap, interventions promoting mental health literacy and more research on additional barriers to inform further interventions are needed. [ABSTRACT FROM AUTHOR]

Background: Older people with hypertension and multiple chronic conditions (MCC) receive complex treatments and face challenging trade-offs. Patients' preferences for different health outcomes can impact multiple treatment decisions. Since evidence about outcome preferences is especially scarce among people with MCC our aim was to elicit preferences of people with MCC for outcomes related to hypertension, and to determine how these outcomes should be weighed when benefits and harms are assessed for patient-centered clinical practice guidelines and health economic assessments.Methods: We sent a best-worst scaling preference survey to a random sample identified from a primary care network of Kaiser Permanente (Colorado, USA). The sample included individuals age 60 or greater with hypertension and at least two other chronic conditions. We assessed average ranking of patient-important outcomes using conditional logit regression (stroke, heart attack, heart failure, dialysis, cognitive impairment, chronic kidney disease, acute kidney injury, fainting, injurious falls, low blood pressure with dizziness, treatment burden) and studied variation across individuals.Results: Of 450 invited participants, 217 (48%) completed the survey, and we excluded 10 respondents who had more than two missing choices, resulting in a final sample of 207 respondents. Participants ranked stroke as the most worrisome outcome and treatment burden as the least worrisome outcome (conditional logit parameters: 3.19 (standard error 0.09) for stroke, 0 for treatment burden). None of the outcomes were always chosen as the most or least worrisome by more than 25% of respondents, indicating that all outcomes were somewhat worrisome to respondents. Predefined subgroup analyses according to age, self-reported life-expectancy, degree of comorbidity, number of medications and antihypertensive treatment did not reveal meaningful differences.Conclusions: Although some outcomes were more worrisome to patients than others, our results indicate that none of the outcomes should be disregarded for clinical practice guidelines and health economic assessments. [ABSTRACT FROM AUTHOR]

Objectives: Some people do not fully recover from an acute viral infection and experience persistent symptoms or incomplete recovery for months or even years. This is not unique to the SARS-CoV-2 virus and history shows that post-viral conditions like post COVID-19 condition, also referred to as Long Covid, are not new. In particular, during and after pandemics caused by respiratory viruses in which large parts of the population were infected or exposed, professional and public attention was increased, not least because of the large number of people affected. Methods: Given the current relevance of the topic, this article aims to narratively review and summarize the literature on post-viral symptoms during past pandemics and to supplement and illustrate it with Swiss examples from the pandemics of 1890, 1918-1920 and later. Results: Post-viral diseases were an increasingly emphasised health topic during and after past pandemics triggered by respiratory infections over the last 150 years. Conclusion: In the next pandemic, it should not be surprising that post-viral conditions will again play a role, and pandemic plans should reflect this. [ABSTRACT FROM AUTHOR]

Count outcomes occur in virtually all disciplines, such as medicine, epidemiology or biology, but they often contain error. Recently, it has been shown that self-reported numbers of exacerbations of Chronic Obstructive Pulmonary Disease patients can be considerably miscounted. Motivated by this result, we reanalysed data from the Towards a Revolution in Chronic Obstructive Pulmonary Disease Health trial, a large randomized controlled trial with the self-reported number of exacerbations of Chronic Obstructive Pulmonary Disease patients as outcome. To adjust for miscounting error in the response of Poisson and (zero-inflated) negative binomial models, we introduce novel, general methodology. The key idea is to formulate a zero-inflated negative binomial model to capture the error mechanism. This parametric approach automatically circumvents drawbacks of previously suggested methodology that treats miscounted outcomes in the misclassification framework. Prior information for the response error model parameters was elicited from validation data of an external study and adaptively weighted to account for potential prior-data conflict. The results of the Bayesian hierarchical modelling approach indicated that the treatment effect has been overestimated in the original study. However, closer inspection revealed that this unexpected result was an artefact of an unaccounted time dependency of the treatment effect. [ABSTRACT FROM AUTHOR]

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 (STS 0 and STS 1 ) and three tests at the end (STS 2a–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 ± 6.1 years) were included. STS test performance increased significantly from STS 0 to STS 1 indicative of a learning effect. Test–retest reliability for the subsequent STS 2a–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. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines provide separate recommendations for different diseases that may be prevented or treated by the same intervention. Also, they commonly provide recommendations for entire populations but not for individuals. To address these two limitations, our aim was to conduct benefit-harm analyses for a wide range of individuals using the example of low dose aspirin for primary prevention of cardiovascular disease and cancer and to develop Benefit-Harm Charts that show the overall benefit-harm balance for individuals.Methods: We used quantitative benefit-harm modeling that included 16 outcomes to estimate the probability that low dose aspirin provides more benefits than harms for a wide range of men and women between 45 and 84 years of age and without a previous myocardial infarction, severe ischemic stroke, or cancer. We repeated the quantitative benefit-harm modeling for different combinations of age, sex, and outcome risks for severe ischemic and hemorrhagic stroke, myocardial infarction, cancers, and severe gastrointestinal bleeds. The analyses considered weights for the outcomes, statistical uncertainty of the effects of aspirin, and death as a competing risk. We constructed Benefit-Harm Charts that show the benefit-harm balance for different combinations of outcome risks.Results: The Benefit-Harm Charts ( http://www.benefit-harm-balance.com ) we have created show that the benefit-harm balance differs largely across a primary prevention population. Low dose aspirin is likely to provide more benefits than harms in men, elderly people, and in those at low risk for severe gastrointestinal bleeds. Individual preferences have a major impact on the benefit-harm balance. If, for example, it is a high priority for individuals to prevent stroke and severe cancers while severe gastrointestinal bleeds are deemed to be of little importance, the benefit-harm balance is likely to favor low dose aspirin for most individuals. Instead, if severe gastrointestinal bleeds are judged to be similarly important compared to the benefit outcomes, low dose aspirin is unlikely to provide more benefits than harms.Conclusions: Benefit-Harm Charts support individualized benefit-harm assessments and decision making. Similarly, individualized benefit-harm assessments may allow guideline developers to issue more finely granulated recommendations that reduce the risk of over- and underuse of interventions. The example of low dose aspirin for primary prevention of cardiovascular disease and cancer shows that it may be time for guideline developers to provide combined recommendations for different diseases that may be prevented or treated by the same intervention. [ABSTRACT FROM AUTHOR]

Men have not been the focus of health monitoring and reporting in Germanspeaking Switzerland so far and are a largely neglected target group of governmental preventive efforts. Without good reason. Men have a substantial preventive potential regarding health, health behaviour and use of health and medical services, as can be seen in the recently published global health report of the Canton Zurich. Men have a shorter life expectancy compared to women and a significantly higher mortality with regard to strongly behaviour-related chronic diseases as well as fatal traffic accidents and suicides. Men also show comparably unfavourable health behaviour and a reduced utilisation of health services. The stronger, but also less healthy and less healthy behaving sex should increasingly be the focus of health reporting and health monitoring in the future. [ABSTRACT FROM AUTHOR]

Obstructive sleep apnoea ( OSA) is a prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. Endothelial dysfunction is one of the proposed mechanistic links between OSA and the increased cardiovascular risk. Treatment with continuous positive airway pressure ( CPAP) may reverse this detrimental pathophysiological consequence of OSA. Most studies on the effect of CPAP on endothelial function in OSA are limited by their low sample size. The objective of this systematic review was to assess the effect CPAP therapy on endothelial function in patients with OSA. We conducted a systematic review and meta-analysis searching literature databases up to August 2013 for randomized controlled trials ( RCTs) on the effect of CPAP on endothelial function in OSA, assessed by flow-mediated dilatation ( FMD) and other validated techniques. The primary outcome for the meta-analysis (DerSimonian/Laird random-effects method) was the treatment effect on FMD. Eight RCTs comparing the effects of therapeutic CPAP versus subtherapeutic CPAP (or no intervention) on endothelial function involving 245 OSA patients were included in the systematic review. The studies are consistent in effect direction, showing an improvement of endothelial function by CPAP. Four RCTs involving 150 patients could be used for the meta-analysis. Compared to the control group, CPAP therapy (range 2-24 weeks) significantly increased absolute % FMD by 3.87% (95% confidence interval: 1.93-5.80, P < 0.001). In patients with OSA, CPAP therapy improves endothelial function significantly and to a clinically important extent. [ABSTRACT FROM AUTHOR]

Background: When faced with uncertainties about the effects of medical interventions regulatory agencies, guideline developers, clinicians, and researchers commonly ask for more research, and in particular for more randomized trials. The conduct of additional randomized trials is, however, sometimes not the most efficient way to reduce uncertainty. Instead, approaches such as value of information analysis or other approaches should be used to prioritize research that will most likely reduce uncertainty and inform decisions. Discussion: In situations where additional research for specific interventions needs to be prioritized, we propose the use of quantitative benefit-harm assessments that illustrate how the benefit-harm balance may change as a consequence of additional research. The example of roflumilast for patients with chronic obstructive pulmonary disease shows that additional research on patient preferences (e.g., how important are exacerbations relative to psychiatric harms?) or outcome risks (e.g., what is the incidence of psychiatric outcomes in patients with chronic obstructive pulmonary disease without treatment?) is sometimes more valuable than additional randomized trials. Summary: We propose that quantitative benefit-harm assessments have the potential to explore the impact of additional research and to identify research priorities Our approach may be seen as another type of value of information analysis and as a useful approach to stimulate specific new research that has the potential to change current estimates of the benefit-harm balance and decision making. [ABSTRACT FROM AUTHOR]

Background: When faced with uncertainties about the effects of medical interventions regulatory agencies, guideline developers, clinicians, and researchers commonly ask for more research, and in particular for more randomized trials. The conduct of additional randomized trials is, however, sometimes not the most efficient way to reduce uncertainty. Instead, approaches such as value of information analysis or other approaches should be used to prioritize research that will most likely reduce uncertainty and inform decisions. Discussion: In situations where additional research for specific interventions needs to be prioritized, we propose the use of quantitative benefit–harm assessments that illustrate how the benefit–harm balance may change as a consequence of additional research. The example of roflumilast for patients with chronic obstructive pulmonary disease shows that additional research on patient preferences (e.g., how important are exacerbations relative to psychiatric harms?) or outcome risks (e.g., what is the incidence of psychiatric outcomes in patients with chronic obstructive pulmonary disease without treatment?) is sometimes more valuable than additional randomized trials. Summary: We propose that quantitative benefit–harm assessments have the potential to explore the impact of additional research and to identify research priorities Our approach may be seen as another type of value of information analysis and as a useful approach to stimulate specific new research that has the potential to change current estimates of the benefit–harm balance and decision making. [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]

An abstract of the article "No Association of 25-Hydroxyvitamin D With Exacerbations in Primary Care Patients With COPD" by Milo A. Puhan and colleagues is presented.

Background The Institute of Medicine recently recommended that comparative effectiveness research (CER) should involve input from consumers. While systematic reviews are a major component of CER, little is known about consumer involvement. Objective To explore current approaches to involving consumers in US-based and key international organizations and groups conducting or commissioning systematic reviews ('organizations'). Design In-depth, semi-structured interviews with key informants and review of organizations' websites. Setting and participants Seventeen highly regarded US-based and international (Cochrane Collaboration, Campbell Collaboration) organizations. Results Organizations that usually involve consumers (seven of 17 in our sample) involve them at a programmatic level in the organization or in individual reviews through one-time consultation or on-going collaboration. For example, consumers may suggest topics, provide input on the key questions of the review, provide comments on draft protocols and reports, serve as co-authors or on an advisory group. Organizations involve different types of consumers (individual patients, consumer advocates, families and caregivers), recruiting them mainly through patient organizations and consumer networks. Some offer training in research methods, and one developed training for researchers on how to involve consumers. Little formal evaluation of the effects of consumer involvement is being carried out. Conclusions Consumers are currently involved in systematic reviews in a variety of ways and for various reasons. Assessing which approaches are most effective in achieving different aims of consumer involvement is now required to inform future recommendations on consumer involvement in CER. [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: 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 [ABSTRACT FROM AUTHOR]

Background: Several quantitative approaches for benefit-harm assessment of health care interventions exist but it is unclear how the approaches differ. Our aim was to review existing quantitative approaches for benefit-harm assessment and to develop an organizing framework that clarifies differences and aids selection of quantitative approaches for a particular benefit-harm assessment. Methods: We performed a review of the literature to identify quantitative approaches for benefit-harm assessment. Our team, consisting of clinicians, epidemiologists, and statisticians, discussed the approaches and identified their key characteristics. We developed a framework that helps investigators select quantitative approaches for benefit-harm assessment that are appropriate for a particular decisionmaking context. Results: Our framework for selecting quantitative approaches requires a concise definition of the treatment comparison and population of interest, identification of key benefit and harm outcomes, and determination of the need for a measure that puts all outcomes on a single scale (which we call a benefit and harm comparison metric). We identified 16 quantitative approaches for benefit-harm assessment. These approaches can be categorized into those that consider single or multiple key benefit and harm outcomes, and those that use a benefit-harm comparison metric or not. Most approaches use aggregate data and can be used in the context of single studies or systematic reviews. Although the majority of approaches provides a benefit and harm comparison metric, only four approaches provide measures of uncertainty around the benefit and harm comparison metric (such as a 95 percent confidence interval). None of the approaches considers the actual joint distribution of benefit and harm outcomes, but one approach considers competing risks when calculating profile-specific event rates. Nine approaches explicitly allow incorporating patient preferences. Conclusion: The choice of quantitative approaches depends on the specific question and goal of the benefit-harm assessment as well as on the nature and availability of data. In some situations, investigators may identify only one appropriate approach. In situations where the question and available data justify more than one approach, investigators may want to use multiple approaches and compare the consistency of results. When more evidence on relative advantages of approaches accumulates from such comparisons, it will be possible to make more specific recommendations on the choice of approaches. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes are measured in many epidemiologic studies using self- or intervieweradministered 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. [ABSTRACT FROM AUTHOR]

Background. Excess mortality has decreased among human immunodeficiency virus (HIV)-infected patients but without evidence of a decrease among patients with AIDS. We assessed temporal changes in excess mortality and elucidated risk factors for excess mortality in patients with AIDS diagnosed in the era of highly active antiretroviral therapy (HAART). Methods. We included 1188 patients of the Longitudinal Study of Ocular Complications in AIDS who were aged 25-64 years at enrollment and who received a diagnosis of AIDS after 1995. We calculated excess mortality as the age-, year-, and sex-adjusted difference in mortality rates between patients with AIDS and persons in the US general population during the period 1999-2007. We used a relative survival model to identify risk factors for excess mortality. Results. There were a mean of 50 excess deaths per 1000 person-years (95% confidence interval [CI], 44-57 excess deaths per 1000 person-years) during 1999-2007. Excess mortality almost halved, with an annual decrease of 8.0% per year (95% CI, 3.0%-12.7%; P = .002) but remained high at 36 excess deaths per 1000 person-years in 2007. Viral load >400 copies/mL (compared with ⩽400 copies/mL; risk ratio, 3.4; 95% CI, 2.3-5.0), CD4+ count <200 cells/μL (compared with ⩾200 cells/μL; risk ratio, 2.7; 95% CI, 1.9-3.9), and cytomegalovirus retinitis (risk ratio, 1.6; 95% CI, 1.2-2.1) were the strongest risk factors for excess mortality. Conclusions. Excess mortality among patients with AIDS was nearly halved in the HAART era and most strongly linked to stage of HIV disease. These results reflect the continuing improvements in AIDS management but also highlight that excess mortality remains ∼5 times higher in patients with AIDS than in HIV-infected patients without AIDS. [ABSTRACT FROM AUTHOR]

The article details a study which investigated the calibration of the body mass index, airflow obstruction, dyspnoea and exercise capacity (BODE) index. The study included 232 patients from the Swiss Barmelweid cohort with severe chronic obstructive pulmonary disease (COPD) and 342 patients from the Spanish Phenotype and Course of COPD cohort study. The observed three-year risk of all-cause mortality was compared with the risk predicted by the BODE index. Study authors concluded that updated BODE and ADO indices could assist in the prognostic assessment of COPD patients.

Background: Randomised trials comparing different drugs head-to-head are extremely valuable for clinical decision-making. However, it is scientifically and ethically sensible to demand strong evidence that a drug is effective by showing superiority over a placebo before embarking on head-to-head comparisons of potentially ineffective drugs. Our aim was to study the evolvement of evidence from placebo-controlled and head-to-head trials on the effects of antibiotics for the treatment of mild to moderate exacerbations of chronic obstructive pulmonary disease. Methods: We conducted a historical systematic review. Through electronic databases and hand-searches, we identified placebo-controlled and head-to-head antibiotic trials for the treatment of mild to moderate chronic obstructive pulmonary disease exacerbations. We compared the numbers of patients recruited in placebo-controlled and head-to-head trials between 1957 and 2005. Using cumulative meta-analysis of placebo-controlled trials, we determined when, if ever, placebo-controlled trials had shown convincing evidence that antibiotics are effective in preventing treatment failure in patients with mild to moderate chronic obstructive pulmonary disease exacerbations. Results: The first head-to-head trial was published in 1963. It was followed by another 100 trials comparing different antibiotics in a total of 34,029 patients with mild to moderate chronic obstructive pulmonary disease exacerbations. Over time, the cumulative odds ratio in placebo-controlled trials remained inconclusive throughout with odds ratios ranging from 0.39 (95% confidence intervals 0.04-4.22) to the most recent estimate (1995) of 0.81 (95% confidence intervals 0.52-1.28, P = 0.37). Conclusion: Placebo-controlled trials do not support the use of antibiotics in chronic obstructive pulmonary disease patients with mild to moderate exacerbations. Conducting head-to-head trials is, therefore, scientifically and ethically questionable. This underscores the requirement to perform or study systematic reviews of placebo-controlled trials before conducting head-to-head trials. [ABSTRACT FROM AUTHOR]

Background: Interpretation of the Hospital Anxiety and Depression Scale (HADS), commonly used to assess anxiety and depression in COPD patients, is unclear. Since its minimal important difference has never been established, our aim was to determine it using several approaches.Methods: 88 COPD patients with FEV1 /= 0.5 we performed linear regression analyses to predict the minimal important difference from the anchors. As distribution-based approach we used the Effect Size approach.Results: Based on CRQ emotional function and mastery domain as well as on total scores, the minimal important difference was 1.41 (95% CI 1.18-1.63) and 1.57 (1.37-1.76) for the HADS anxiety score and 1.68 (1.48-1.87) and 1.60 (1.38-1.82) for the HADS total score. Correlations of the HADS depression score and CRQ domain and Feeling Thermometer scores were < 0.5. Based on the Effect Size approach the MID of the HADS anxiety and depression score was 1.32 and 1.40, respectively.Conclusion: The minimal important difference of the HADS is around 1.5 in COPD patients corresponding to a change from baseline of around 20%. It can be used for the planning and interpretation of trials. [ABSTRACT FROM AUTHOR]

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 (≥ 0.3) to strongly (≥ 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. [ABSTRACT FROM AUTHOR]

Abstract: 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. [Copyright &y& Elsevier]

Background: For decades, there is an unresolved debate about adequate prescription of antibiotics for patients suffering from exacerbations of chronic obstructive pulmonary disease (COPD). The aim of this systematic review was to analyse randomised controlled trials investigating the clinical benefit of antibiotics for COPD exacerbations. Methods: We conducted a systematic review of randomised, placebo-controlled trials assessing the effects of antibiotics on clinically relevant outcomes in patients with an exacerbation. We searched bibliographic databases, scrutinized reference lists and conference proceedings and asked the pharmaceutical industry for unpublished data. We used fixed-effects models to pool results. The primary outcome was treatment failure of COPD exacerbation treatment. Results: We included 13 trials (1557 patients) of moderate to good quality. For the effects of antibiotics on treatment failure there was much heterogeneity across all trials (I2 = 82%). Metaregression revealed severity of exacerbation as significant explanation for this heterogeneity (p = 0.016): Antibiotics did not reduce treatment failures in outpatients with mild to moderate exacerbations (pooled odds ratio 1.09, 95% CI 0.75-1.59, I2 = 18%). Inpatients with severe exacerbations had a substantial benefit on treatment failure rates (pooled odds ratio of 0.25, 95% CI 0.16-0.39, I2 = 0%; number-needed to treat of 4, 95% CI 3-5) and on mortality (pooled odds ratio of 0.20, 95% CI 0.06-0.62, I2 = 0%; number-needed to treat of 14, 95% CI 12-30). Conclusion: Antibiotics effectively reduce treatment failure and mortality rates in COPD patients with severe exacerbations. For patients with mild to moderate exacerbations, antibiotics may not be generally indicated and further research is needed to guide antibiotic prescription in these patients. [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]

Background: Some people believe that likelihood ratios provide diagnostic information that is more useful than sensitivity and specificity estimates. Objective: To assess how physicians' estimates about probability of illness are affected by the presentation of a diagnostic test's value as an estimate of sensitivity and specificity versus a likelihood ratio or an inexact numerical graphic. Design: Random assignment of vignettes with different presentation formats of diagnostic test accuracy. Setting: Auditorium at a continuing medical education conference. Participants: 183 physicians. Intervention: After estimating probabilities of 6 common illnesses described in patient vignettes, physicians reviewed pertinent test results presented in 1 of 3 formats. Measurements: Physicians' probability estimates of illness before and after receiving test information, and post-test probability estimates based on the Bayes theorem. Results: Absolute percentage point differences between the physicians' estimated and the Bayes-based post-test probabilities varied from -7 to 31, from -7 to 28, and from 1 to 29 for the sensitivity and specificity, likelihood ratio, and graphical groups, respectively. Mean differences of probability estimates between the sensitivity and specificity and the likelihood ratio groups were small for all vignettes (-2 to 3 percentage points; summary mean z value across the 6 vignettes, 0.04 [95% CI, -0.14 to 0.21]). Limitations: The small pool of participants (who were potentially selected) and the limited number of vignettes prevented a more detailed analysis of relationships between the interpreted strength of diagnostic evidence and estimations of illness probability. Conclusions: These findings suggest that presenting diagnostic test accuracy with likelihood ratios does not affect some physicians' estimates of illness probability compared with presenting diagnostic test results as sensitivity and specificity. [ABSTRACT FROM AUTHOR]

Abstract: Background and Objective: Participants rated clinical marker states (CMS) to make respondents familiar with the task of preference instruments, ground their ratings in relation to other health states, and help investigators interpret patient ratings. The objective was to assess the reliability of CMS using appropriate reliability statistics. Study Design and Setting: Eighty-one patients rated CMSs for mild, moderate, and severe chronic respiratory disease using the feeling thermometer (FT) and the standard gamble (SG) before and after a 3-month respiratory rehabilitation program. To assess reliability we used (a) intraclass correlation coefficients (ICC) with the variance between CMSs as signal and the variance between raters, the variance within raters, and the signal as noise; (b) scatter plots; and (c) Bland–Altman plots. Results: ICCs were 0.47 for the FT and 0.37 for the SG. Scatter and Bland–Altman plots showed large between- and within-person variability; 64.2% and 11.3% of the CMSs ratings were in the correct order on both occasions on the FT and SG, respectively. Conclusion: Our results suggest moderate reliability of CMSs ratings for the FT and poor reliability for the SG, which may explain their lack of improving the SG''s measurement properties. Investigators should use appropriate reliability statistics when addressing related issues. [Copyright &y& Elsevier]

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: Acute exacerbations of chronic obstructive pulmonary disease (COPD) represent a major burden for patients and health care systems. Respiratory rehabilitation may improve prognosis in these patients by addressing relevant risk factors for exacerbations such as low exercise capacity. To study whether respiratory rehabilitation after acute exacerbation improves prognosis and health status compared to usual care, we quantified its effects using meta-analyses. Methods: Systematic review of randomized controlled trials identified by searches in six electronic databases, contacts with experts, hand-searches of bibliographies of included studies and conference proceedings. We included randomized trials comparing the effect of respiratory rehabilitation and usual care on hospital admissions, health-related quality of life (HRQL), exercise capacity and mortality in COPD patients after acute exacerbation. Two reviewers independently selected relevant studies, extracted the data and evaluated the study quality. We pooled the results using fixed effects models where statistically significant heterogeneity (p = 0.1) was absent. Results: We identified six trials including 230 patients. Respiratory rehabilitation reduced the risk for hospital admissions (pooled relative risk 0.26 [0.12-0.54]) and mortality (0.45 [0.22-0.91]). Weighted mean differences on the Chronic Respiratory Questionnaire were 1.37 (95% CI 1.13-1.61) for the fatigue domain, 1.36 (0.94-1.77) for emotional function and 1.88 (1.67-2.09) for mastery. Weighted mean differences for the St. Georges Respiratory Questionnaire total score, impacts and activities domains were -11.1 (95% CI -17.1 to -5.2), -17.1 (95% CI -23.6 to -10.7) and -9.9 (95% CI -18.0 to -1.7). In all trials, rehabilitation improved exercise capacity (64-215 meters in six-minute walk tests and weighted mean difference for shuttle walk test 81 meter, 95% CI 48-115). Conclusion: Evidence from six trials suggests that respiratory rehabilitation is effective in COPD patients after acute exacerbation. Larger trials, however, are needed to further investigate the role of respiratory rehabilitation after acute exacerbation and its potential to reduce costs caused by COPD. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: There is a controversy about the additional benefit of various supplemental interventions used in clinical practice to further enhance the effectiveness of respiratory rehabilitation in patients with Chronic obstructive pulmonary disease (COPD). The aim of this research was to assess randomised controlled trials (RCTs) testing the additional benefit of supplemental interventions during respiratory rehabilitation in COPD patients. Methods: Systematic review with literature searches in six electronic databases, extensive hand-searching and contacting of authors. Two reviewers selected independently eligible RCTs, rated the methodological quality and extracted the data, which were analyzed considering the minimal important difference of patient-important outcomes where possible. Findings: We identified 20 RCTs whereof 18 provided sufficient data for analysis. The methodological quality was low and sample sizes were too small for most trials to produce meaningful results (median total sample size = 28). Data from five trials showed that supplemental oxygen during exercise did not have clinically meaningful effects on health-related quality of life while improvements of exercise capacity may be even larger for patients exercising on room air. RCTs of adding assisted ventilation, nutritional supplements or a number of anabolically acting drugs do not provide sufficient evidence for or against the use any of these supplemental interventions. Interpretation: There is insufficient evidence for most supplemental interventions during respiratory rehabilitation to estimate their additional value, partly due to methodological shortcomings of included RCTs. Current data do not suggest benefit from supplemental oxygen during exercise, although the methodological quality of included trials limits conclusions. To appropriately assess any of the various supplemental interventions used in clinical practice, pragmatic trials on respiratory rehabilitation of COPD patients need to consider methodological aspects as well as appropriate sample sizes. [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]

One-stage meta-analysis of individual participant data (IPD) poses several statistical and computational challenges. For time-to-event outcomes, the approach requires the estimation of complicated nonlinear mixed-effects models that are flexible enough to realistically capture the most important characteristics of the IPD. We present a model class that incorporates general normally distributed random effects into linear transformation models. We discuss extensions to model between-study heterogeneity in baseline risks and covariate effects and also relax the assumption of proportional hazards. Within the proposed framework, data with arbitrary random censoring patterns can be handled. The accompanying $\textsf{R}$ package tramME utilizes the Laplace approximation and automatic differentiation to perform efficient maximum likelihood estimation and inference in mixed-effects transformation models. We compare several variants of our model to predict the survival of patients with chronic obstructive pulmonary disease using a large data set of prognostic studies. Finally, a simulation study is presented that verifies the correctness of the implementation and highlights its efficiency compared to an alternative approach. [ABSTRACT FROM AUTHOR]

Musculoskeletal conditions are often managed in primary care settings. To facilitate research and healthcare quality, practice-based research networks offer sustained collaborations between clinicians and researchers. A scoping review was conducted to describe characteristics of practice-based research networks used for musculoskeletal research and musculoskeletal research conducted through practice-based research networks. Practice-based research networks were identified from 1) musculoskeletal-studies identified in OVID Medline, CINAHL, and Embase databases from inception to 5 February 2023 and in ClinicalTrials.gov and 2) from practice-based research network registries and websites. Among active musculoskeletal-focused practice-based research networks (i.e., currently recruiting and conducting research), an assessment of practice-based research network research good practices was performed. After screening 3025 records, 85 studies from 46 unique practice-based research networks met our eligibility criteria. Common conditions studied were low back pain (28%), musculoskeletal conditions not otherwise specified (25%), and osteoarthritis (19%). Thirty-two practice-based research networks (70%) were deemed to be active. Among active musculoskeletal-focused practice-based research networks, best practice data management information was retrievable for most (53%). Because of the scarcity of publicly available information, a large proportion of practice-based research network research good practice items was not assessable. Practice-based research networks have provided an avenue to assess clinical practice and patient outcomes related to musculoskeletal conditions. Further work to increase the transparency of musculoskeletal practice-based research network research practices is warranted. [ABSTRACT FROM AUTHOR]

Objectives To determine sample sizes in studies on diagnostic accuracy and the proportion of studies that report calculations of sample size. Design Literature survey. Data sources All issues of eight leading journals published in 2002. Methods Sample sizes, number of subgroup analyses, and how often studies reported calculations of sample size were extracted. Results 43 of 8999 articles were non-screening studies on diagnostic accuracy. The median sample size was 118 (interquartile range 71-350) and the median prevalence of the target condition was 43% (27-61%). The median number of patients with the target condition--needed to calculate a test's sensitivity--was 49 (28-91). The median number of patients without the target condition--needed to determine a test's specificity--was 76 (27-209). Two of the 43 studies (5%) reported a priori calculations of sample size. Twenty articles (47%) reported results for patient subgroups. The number of subgroups ranged from two to 19 (median four). No studies reported that sample size was calculated on the basis of preplanned analyses of subgroups. Conclusion Few studies on diagnostic accuracy report considerations of sample size. The number of participants in most studies on diagnostic accuracy is probably too small to analyse variability of measures of accuracy across patient subgroups. [ABSTRACT FROM AUTHOR]

Objective To assess the effects of didgeridoo playing on daytime sleepiness and other outcomes related to sleep by reducing collapsibility of the upper airways in patients with moderate obstructive sleep apnoea syndrome and snoring. Design Randomised controlled trial. Setting Private practice of a didgeridoo instructor and a single centre for sleep medicine. Participants 25 patients aged > 18 years with an apnoea-hypopnoea index between 15 and 30 and who complained about snoring. Interventions Didgeridoo lessons and daily practice at home with standardised instruments for four months. Participants in the control group remained on the waiting list for lessons. Main outcome measure Daytime sleepiness (Epworth scale from 0 (no daytime sleepiness) to 24), sleep quality (Pittsburgh quality of sleep index from 0 (excellent sleep quality) to 21), partner rating of sleep disturbance (visual analogue scale from 0 (not disturbed) to 10), apnoea-hypopnoea index, and health related quality of life (SF-36). Results Participants in the didgeridoo group practised an average of 5.9 days a week (SD 0.86) for 25.3 minutes (SD 3.4). Compared with the control group in the didgeridoo group daytime sleepiness (difference -3.0, 95% confidence interval -5.7 to -0.3, P = 0.03) and apnoea-hypopnoea index (difference -6.2, -12.3 to -0.1, P = 0.05) improved significantly and partners reported less sleep disturbance (difference -2.8, -4.7 to -0.9, P < 0.01). There was no effect on the quality of sleep (difference -0.7, -2.1 to 0.6, P = 0.27). The combined analysis of sleep related outcomes showed a moderate to large effect of didgeridoo playing (difference between summary z scores -0.78 SD units, -1.27 to -0.28, P < 0.01). Changes in health related quality of life did not differ between groups. Conclusion Regular didgeridoo playing is an effective treatment alternative well accepted by patients with moderate obstructive sleep apnoea syndrome. [ABSTRACT FROM AUTHOR]

Objective To assess the accuracy and effectiveness of the screening of all newborn infants for developmental dysplasia of the hip (DDH) using ultrasound imaging, as is standard practice in some European countries but not in the United Kingdom, the United States, or Scandinavia. Design Systematic review. Data sources Twenty three medical, economic, and grey literature databases (to March 2004), with no limitations of design or language; some references were provided by experts. Selection of studies Only diagnostic accuracy studies and comparative studies conducted in an unselected newborn population were eligible for the review. Two reviewers independently selected the studies and performed the quality assessment. Results The review identified one diagnostic accuracy study, and this was of limited quality. In this study the reference standard was treatment up to age of 8 months or an abnormal ultrasound finding at age 8 months. Ultrasound screening had a sensitivity of 88.5% (95% confidence interval 84.1% to 92.1%), specificity of 96.7% (96.4% to 97.4%), a positive predictive value of 61.6% and a negative predictive value of 99.4%. Ten studies evaluated the impact of ultrasound in screening, but these too had various methodological weaknesses, limiting the reliability of their findings. Compared with clinical screening, general ultrasound screening in newborns may increase overall treatment rates, but ultrasound screening seems to be associated with shorter and less intrusive treatment. Conclusions Clear evidence is lacking either for or against general ultrasound screening of newborn infants for DDH. Studies that investigate the natural course of the disorder, the optimal treatment for DDH, and the best strategy for ultrasound screening are needed. [ABSTRACT FROM AUTHOR]

Background: A significant proportion of the global population has been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at some point since the onset of the pandemic. Although most individuals who develop coronavirus disease 2019 (COVID-19) recover without complications, about 6% have persistent symptoms, referred to as post-COVID-19 condition (PCC). Intervention studies investigating treatments that potentially alleviate PCC-related symptoms and thus aim to mitigate the global public health burden and healthcare costs linked to PCC are desperately needed. The PYCNOVID trial investigates the effects of Pycnogenol®, a French maritime pine bark extract with anti-inflammatory and antioxidative properties, versus placebo on patient-reported health status in people with PCC. Methods: This is a single-center, placebo-controlled, quadruple blind, randomized trial. We aim to randomly assign 150 individuals with PCC (1:1 ratio) to receive either 200 mg Pycnogenol® or placebo daily for 12 weeks. Randomization is stratified for duration of PCC symptoms (≤ 6 months versus > 6 months) and presence of symptomatic chronic disease(s). The primary endpoint is perceived health status at 12 weeks (EuroQol—Visual Analogue Scale) adjusted for baseline values and stratification factors. Secondary endpoints include change in self-reported PCC symptoms, health-related quality of life, symptoms of depression and anxiety, cognitive function, functional exercise capacity, physical activity measured with accelerometry, and blood biomarkers for endothelial health, inflammation, coagulation, platelet function, and oxidative stress. Investigators, study participants, outcome assessors, and data analysts are blinded regarding the intervention assignment. Individuals with PCC were involved in the design of this study. Discussion: This is the first trial to investigate the effects of Pycnogenol® versus placebo on patient-reported health status in people with PCC. Should the trial proof clinical effectiveness, Pycnogenol® may serve as a therapeutic approach to mitigate symptoms associated with PCC. Trial registration: The study is registered at ClinicalTrials.gov. :NCT05890534, June 6, 2023. [ABSTRACT FROM AUTHOR]

This study aimed to examine whether acute myocardial infarction (AMI) patients in Switzerland return to work and identify factors associated therewith. Data of 4315 working-age AMI patients enrolled in the Swiss AMIS Plus registry between 01/2006 and 09/2021 with 1-year follow-up and self-reported work status were analyzed. Patient characteristics were compared between those who did not reduce their work hours, those who reduced, and those who were no longer working 1 year after AMI. Multinomial logistic regression was used to analyze independent predictors of working ability. Of the patients, 3204 (74.3%) did not reduce their work hours, 592 (13.7%) reduced and 519 (12.0%) were no longer working 1 year after AMI. Women were more likely to reduce or stop working. Patients who did not reduce were more frequently young and male. Multinomial logistic regression showed that work reduction was associated with female sex and a Killip class > 2 at admission whereas stopping work was associated with female sex and comorbidities. A high rate of AMI patients in Switzerland (88%) return to work 1 year after AMI. Approximately 1 in 8 did not return to work and approximately 1 in 7 reduced their work hours. Important factors associated with reducing or no longer working after AMI were female sex, older age and a higher proportion of comorbidities. [ABSTRACT FROM AUTHOR]

Teaching epidemiological concepts in academic settings poses a challenge due to the intricate nature of the discipline as both a science and a practice. Whereas traditional classroom-based teaching methods are commonly employed, evidence suggests they may not be the most effective approach for fostering core competencies and skills required in real-life scientific work. In this article, we describe our process of transitioning from traditional classroom teaching of epidemiology towards practice-based coaching to convey epidemiological concepts to bachelor's and master's students in Biomedicine. We chose the framework of randomized controlled trials (RCT) since they offer a great opportunity to teach epidemiological concepts in a hands-on course. This practice-based course encompasses the entire life cycle of a study, allowing students to design and conduct a short-term experiment, analyse its data and prepare a scientific paper. We provide a comprehensive overview of the course structure, content, learning objectives and course evaluation, while also discussing the advantages and disadvantages of this innovative format. Our approach offers a promising alternative to classroom teaching by incorporating practical, hands-on experiences offering students a high level of independence and self-determination, as well as facilitation and coaching by faculty. It has the potential to be applied across diverse academic settings, providing students with valuable skills and competencies in epidemiology. [ABSTRACT FROM AUTHOR]

Introduction: Blinding is a methodologically important aspect in randomised controlled trials yet frequently overlooked in trials of spinal manual therapy interventions for back pain. To help inform the blinding methods of a future, double-placebo-controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain, we set four objectives: (1) to assess the feasibility of blinding participants, randomly allocated to an active or placebo-control spinal manual therapy intervention protocol, (2) to assess the feasibility of blinding outcome assessors within the trial, (3) to explore the influence of spinal manual therapy experience and low back pain on blinding, and (4) to explore factors contributing to perceptions about intervention assignment among participants and outcome assessors. Methods and analysis: Two-parallel-group, single-centre, placebo-controlled, methodological blinding feasibility randomised trial. We will recruit between 60 and 100 adults with or without back pain and with or without experience of spinal manual therapy from Zurich, Switzerland. Participants will be randomised to either an active spinal manual therapy or a placebo-control spinal manual therapy protocol—both interventions delivered over two study visits, up to two weeks apart. The primary outcome is participant blinding using the Bang blinding index within each intervention arm immediately after each of the two study visits. Secondary outcomes are participant blinding using the James blinding index, outcome assessor blinding (Bang and James blinding indices), self-reported factors influencing perceived intervention assignment among participants and outcome assessors, and participant-reported credibility and expectancy of study interventions. Other outcomes—included to blind the study objective from participants—are lumbar spine range of motion, self-rated general health, satisfaction with care, pain intensity, and function. Intervention provider outcomes include intervention component fidelity and quality of intervention delivery. Ethics and dissemination: The independent ethics commission of Canton Zurich granted ethical approval for this study (KEK 2023–00381). Written informed consent will be obtained from all participants. Findings will be disseminated in scientific conferences and a peer-reviewed publication and inform the blinding methods of a future double-placebo controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain—the SALuBRITY trial. Trial registration: NCT05778396. [ABSTRACT FROM AUTHOR]

Machine learning (ML) has been successfully implemented for classification tasks (e.g., cancer diagnosis). ML performance for more challenging predictions is largely unexplored. This study's objective was to compare machine learning vs. expert-informed predictions for surgical outcome in patients undergoing major liver surgery. Single tertiary center data on preoperative parameters and postoperative complications for elective hepatic surgery patients were included (2008–2021). Expert-informed prediction models were established on 14 parameters identified by two expert liver surgeons to impact on postoperative outcome. ML models used all available preoperative patient variables (n = 62). Model performance was compared for predicting 3-month postoperative overall morbidity. Temporal validation and additional analysis in major liver resection patients were conducted. 889 patients included. Expert-informed models showed low average bias (2–5 CCI points) with high over/underprediction. ML models performed similarly: average prediction 5–10 points higher than observed CCI values with high variability (95% CI −30 to 50). No performance improvement for major liver surgery patients. No clinical relevance in the application of ML for predicting postoperative overall morbidity was found. Despite being a novel hype, ML has the potential for application in clinical practice. However, at this stage it does not replace established approaches of prediction modelling. [ABSTRACT FROM AUTHOR]

Purpose: Practice-based research networks are collaborations between clinicians and researchers to advance primary care research. This study aims to assess the feasibility for longitudinal data collection within a newly established chiropractic PBRN in Switzerland. Methods: A prospective observational cohort feasibility study was performed. PBRN participating chiropractors were asked to recruit patients seeking new conservative health care for musculoskeletal pain from March 28, 2022, to September 28, 2022. Participants completed clinically oriented survey questions and patient-reported outcome measures before the initial chiropractic assessment as well as 1 h, 2 weeks, 6 weeks, and 12 weeks thereafter. Feasibility was assessed through a variety of process, resource, and management metrics. Patient clinical outcomes were also assessed. Results: A total of 76 clinicians from 35 unique primary care chiropractic clinics across Switzerland participated. A total of 1431 patients were invited to participate, of which 573 (mean age 47 years, 51% female) were enrolled. Patient survey response proportions were 76%, 64%, 61%, and 56%, at the 1-h, 2-, 6-, and 12-week survey follow-ups, respectively. Evidence of an association was found between increased patient age (OR = 1.03, 95%CI 1.01–1.04), patient from a German-speaking region (OR = 1.81, 95%CI 1.17–2.86), non-smokers (OR = 1.89, 95%CI 1.13–3.17), and increased pain impact score at baseline (OR = 1.18, 95%CI 1.01–1.38) and response to all surveys. Conclusion: The Swiss ChiCo pilot study exceeded its prespecified feasibility objectives. Nationwide longitudinal data capture was highly feasible. Similar to other practice-based cohorts, participant retention remains a challenge. Trial registration Swiss chiropractic cohort (Swiss ChiCo) pilot study (ClinicalTrials.gov identifier: NCT05116020). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Although there are guidelines and ideas on how to improve public health education, translating innovative approaches into actual training programs remains challenging. In this article, we provide an overview of some initiatives that tried to put this into action in different parts of the world, and present the Emerging Health Care Leader (EHCL), a novel training program developed in Switzerland. Policy Options and Recommendations: Looking at the experience of the EHCL, we propose policymakers and other interested stakeholders who wish to help reform public health education to support these initiatives not only through funding, but by valuing them through the integration of early career healthcare leaders in projects where their developing expertise can be practically applied. Conclusion: By openly sharing the experiences, strengths, weaknesses, and lessons learned with the EHCL program, we aim to foster a transparent debate on how novel training programs in public health can be organised. [ABSTRACT FROM AUTHOR]

Qualitative research and mixed methods are core competencies for epidemiologists. In response to the shortage of guidance on graduate course development, we wrote a course development guide aimed at faculty and students designing similar courses in epidemiology curricula. The guide combines established educational theory with faculty and student experiences from a recent introductory course for epidemiology and biostatistics doctoral students at the University of Zurich and Swiss Federal Institute of Technology, Zurich. We propose a student-centred course with inverse classroom teaching and practice exercises with faculty input. Integration of student input during the course development process helps align the course syllabus with student needs. The proposed course comprises six sessions that cover learning outcomes in comprehension, knowledge, application, analysis, synthesis and evaluation. Following an introductory session, the students engage in face-to-face interviews, focus group interviews, observational methods, analysis and how qualitative and quantitative methods are integrated in mixed methods. Furthermore, the course covers interviewer safety, research ethics, quality in qualitative research and a practice session focused on the use of interview hardware, including video and audio recorders. The student-led teaching characteristic of the course allows for an immersive and reflective teaching-learning environment. After implementation of the course and learning from faculty and student perspectives, we propose these additional foci: a student project to apply learned knowledge to a case study; integration in mixed-methods; and providing faculty a larger space to cover theory and field anecdotes. [ABSTRACT FROM AUTHOR]

To facilitate informed decision making on participating in colorectal cancer (CRC) screening, we assessed the benefit-harm balance of CRC screening for a wide range of subgroups over different time horizons. The study combined incidence proportions of benefits and harms of (not) participating in CRC screening estimated by the Adenoma and Serrated pathway to CAncer microsimulation model, a preference eliciting survey, and benefit-harm balance modeling combining all outcomes to determine the net health benefit of CRC screening over 10, 20, and 30 years. Probability of net health benefit was estimated for 210 different subgroups based on age, sex, previous participation in CRC screening, and lifestyle. CRC screening was net beneficial in 183 of 210 subgroups over 30 years (median probability [MP] of 0.79, interquartile range [IQR] of 0.69-0.85) across subgroups. Net health benefit was greater for men (MP 0.82; IQR 0.69-0.89) than women (MP 0.76; IQR 0.67-0.83) and for those without history of participation in previous screenings (MP 0.84; IQR 0.80-0.89) compared with those with (MP 0.69; IQR 0.59-0.75). Net health benefit decreased with increasing age, from MP of 0.84 (IQR 0.80-0.86) at age 55 to 0.61 (IQR 0.56-0.71) at age 75. Shorter time horizons led to lower benefit, with MP of 0.70 (IQR 0.62-0.80) over 20 years and 0.54 (IQR 0.48-0.67) over 10 years. Our benefit-harm analysis provides information about net health benefit of screening participation, based on important characteristics and preferences of individuals, which could assist screening invitees in making informed decisions on screening participation. • Colorectal cancer (CRC) screening programs are perceived, on average, as beneficial for population health. However, not every individual will benefit from screening. The benefit-harm balance for a specific individual depends on CRC risk factors such as age, sex and lifestyle, the risk of potential harms of the screening procedure, and individual preferences regarding benefits and harms. • Our benefit-harm analysis shows that CRC screening is beneficial for most subgroups when considering a time horizon of 30 years. The most important factor in determining net health benefit was previous participation. The benefits were more pronounced over long-term periods. • This study provides stratified information about the net health benefit of screening based on the characteristics and preferences of individuals, which could help individuals invited for screening to make informed decisions about screening participation. [ABSTRACT FROM AUTHOR]