Swiss chiropractic cohort (Swiss ChiCo) pilot study: feasibility for a musculoskeletal cohort study conducted within a nationwide practice-based research network.

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).

Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students.

STUDY DESIGN: Single-centre, two-parallel group, methodological randomised controlled trial to assess blinding feasibility. BACKGROUND: Trials of manual therapy interventions of the back face methodological challenges regarding blinding feasibility and success. We assessed the feasibility of blinding an active manual soft tissue mobilisation and control intervention of the back. We also assessed whether blinding is feasible among outcome assessors and explored factors influencing perceptions about intervention assignment. METHODS: On 7-8 November 2022, 24 participants were randomly allocated (1:1 ratio) to active or control manual interventions of the back. The active group (n = 11) received soft tissue mobilisation of the lumbar spine. The control group (n = 13) received light touch over the thoracic region with deep breathing exercises. The primary outcome was blinding of participants immediately after a one-time intervention session, as measured by the Bang blinding index (Bang BI). Bang BI ranges from -1 (complete opposite perceptions of intervention received) to 1 (complete correct perceptions), with 0 indicating 'random guessing'-balanced 'active' and 'control' perceptions within an intervention arm. Secondary outcomes included blinding of outcome assessors and factors influencing perceptions about intervention assignment among both participants and outcome assessors, explored via thematic analysis. RESULTS: 24 participants were analysed following an intention-to-treat approach. 55% of participants in the active manual soft tissue mobilisation group correctly perceived their group assignment beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control group (0.08 [95% CI, -0.37 to 0.53]). Bang BIs in outcome assessors were 0.09 (-0.12 to 0.30) and -0.10 (-0.29 to 0.08) for active and control participants, respectively. Participants and outcome assessors reported varying factors related to their perceptions about intervention assignment. CONCLUSIONS: Blinding of participants allocated to an active soft tissue mobilisation of the back was not feasible in this methodological trial, whereas blinding of participants allocated to the control intervention and outcome assessors was adequate. Findings are limited due to imprecision and suboptimal generalisability to clinical settings. Careful thinking and consideration of blinding in manual therapy trials is warranted and needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05822947 (retrospectively registered).

The Swiss chiropractic practice-based research network: a population-based cross-sectional study to inform future musculoskeletal research.

The Swiss chiropractic practice-based research network (PBRN) is a nationwide project developed in collaboration with patients, clinicians, and academic stakeholders to advance musculoskeletal epidemiologic research. The aim of this study was to describe the clinician population recruited and representativeness of this PBRN to inform future collaboration. A population-based cross-sectional study was performed. PBRN clinician characteristics were described and factors related to motivation (operationalised as VAS score ≥ 70) to participate in a subsequent patient cohort pilot study were assessed. Among 326 eligible chiropractors, 152 enrolled in the PBRN (47% participation). The PBRN was representative of the larger Swiss chiropractic population with regards to age, language, and geographic distribution. Of those enrolled, 39% were motivated to participate in a nested patient cohort pilot study. Motivation was associated with age 40 years or older versus 39 years or younger (OR 2.3, 95% CI 1.0-5.2), and with a moderate clinic size (OR 2.4, 95% CI 1.1-5.7) or large clinic size (OR 2.8, 95% CI 1.0-7.8) versus solo practice. The Swiss chiropractic PBRN has enrolled almost half of all Swiss chiropractors and has potential to facilitate collaborative practice-based research to improve musculoskeletal health care quality.Trial registration: Swiss chiropractic PBRN (ClinicalTrials.gov identifier: NCT05046249); Swiss chiropractic cohort (Swiss ChiCo) pilot study (ClinicalTrials.gov identifier: NCT05116020).

Development of a Communication Instrument to Address Sexuality in COPD: COSY.

Introduction: Sexuality, an important aspect of quality of life, is often overlooked in COPD. Our aim was to develop an instrument that facilitates communication and counseling on sexuality in persons living with chronic obstructive pulmonary disease (COPD). Methods: We searched for publications on sexuality in COPD focusing on communication about sexuality and tools to support such communication. We also performed a survey asking 25 patients and 36 health care professionals (HCPs) about their attitudes, experiences, barriers, and facilitators when talking about sexuality. We set up a project expert team of HCPs and 3 persons with COPD. In a half-day workshop, the team discussed the results of the literature review and the survey as a basis for the contents, the "when and how" to address communication about sexuality, and the design of the communication instrument. Results: The survey showed that although patients and HCPs wanted to talk about sexuality, it rarely happened due to communication barriers, lack of self-confidence, and misconceptions on both sides. In review rounds of the expert team, feedback on the drafts was collected and integrated into the final version of the communication instrument: COmmunication about SexualitY in COPD (COSY). The COSY instrument resulted in 4 tools: a communication leaflet, an application guide, a pictorial representation of the spectrum of intimacy for HCPs, and a comprehensible, picturized information booklet for patients. Conclusions: Addressing sexuality in persons living with COPD should not be neglected. The COSY instrument could help to start and shape communication and consultations about sexuality and a more holistic consideration of quality of life.

Swiss chiropractic practice-based research network and musculoskeletal pain cohort pilot study: protocol of a nationwide resource to advance musculoskeletal health services research.

INTRODUCTION: Musculoskeletal (MSK) pain conditions, a leading cause of global disability, are usually first managed in primary care settings such as medical, physiotherapy, and chiropractic community-based practices. While chiropractors often treat MSK conditions, there is limited real-world evidence on the topic of health service outcomes among patients receiving this type of care. A nationwide Swiss chiropractic practice-based research network (PBRN) and MSK pain patient cohort study will have potential to monitor the epidemiological trends of MSK pain conditions and contribute to healthcare quality improvement. The primary aims of this protocol are to (1) describe the development of an MSK-focused PBRN within the Swiss chiropractic setting, and (2) describe the methodology of the first nested study to be conducted within the PBRN-an observational prospective patient cohort pilot study. METHODS AND ANALYSIS: This initiative is conceptualised with two distinct phases. Phase I focuses on the development of the Swiss chiropractic PBRN, and will use a cross-sectional design to collect information from chiropractic clinicians nationwide. Phase II will recruit consecutive patients aged 18 years or older with MSK pain from community-based chiropractic practices participating in the PBRN into a prospective chiropractic cohort pilot study. All data collection will occur through electronic surveys offered in the three Swiss official languages (German, French, Italian) and English. Surveys will be provided to patients prior to their initial consultation in clinics, 1 hour after initial consultation, and at 2, 6 and 12 weeks after initial consultation. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the independent research ethics committee of Canton Zurich (BASEC-Nr: 2021-01479). Informed consent will be obtained electronically from all participants. Findings will be reported to stakeholders after each study phase, presented at local and international conferences, and disseminated through peer-reviewed publications. STUDY PRE-REGISTRATION: Phase I-Swiss chiropractic PBRN (ClinicalTrials.gov identifier: NCT05046249); Phase 2-Swiss chiropractic cohort (Swiss ChiCo) pilot study (ClinicalTrials.gov identifier: NCT05116020).

Involving patients and clinicians in a pilot randomised clinical trial of spinal manual therapy versus nerve root injection for lumbar radiculopathy: protocol of a patient and public involvement project.

INTRODUCTION: A patient and public involvement (PPI) project will be embedded within the SALuBRITY pilot trial, a two parallel group, double sham controlled, randomised clinical trial. The study aims to compare the effectiveness of spinal manual therapy and corticosteroid nerve root injections, two methods commonly used to treat patients with lumbar radiculopathy. We aim to gather patients' and clinicians' perspectives and involve them in decisions related to the research question and objectives, proposed trial recruitment processes and methods, and proposed outcome measures. METHODS AND ANALYSIS: A small group of patients with lived experience of lumbar radiculopathy and primary care clinicians with experience in the treatment of patients with lumbar radiculopathy are involved. An initial kickoff event will prepare and empower the advisors for involvement in the project, followed by semistructured patient group and one-on-one clinician interviews. We will follow the Critical Outcomes of Research Engagement framework for assessing the impact of patient engagement in research. We will summarise and feedback PPI content to the patient and clinician advisors during a member-checking process to ensure accurate interpretation of patient and clinician inputs. Inductive and deductive thematic analysis will be used for the qualitative analysis of the interviews. Two surveys will be completed at different points along the trial to track the advisors' and researchers' experiences over the course of the PPI project. Any modifications to the SALuBRITY trial methods due to PPI inputs will be thoroughly documented and recorded in an impact log. ETHICS AND DISSEMINATION: The independent research ethics committee of Canton Zurich confirmed that ethical approval for this PPI subproject was not required. PPI results will be disseminated in a peer-reviewed journal and presented at conferences.

Humidification of indoor air for preventing or reducing dryness symptoms or upper respiratory infections in educational settings and at the workplace.

BACKGROUND: Indoor exposure to dry air during heating periods has been associated with dryness and irritation symptoms of the upper respiratory airways and the skin. The irritated or damaged mucous membrane poses an important entry port for pathogens causing respiratory infections. OBJECTIVES: To determine the effectiveness of interventions that increase indoor air humidity in order to reduce or prevent dryness symptoms of the eyes, the skin and the upper respiratory tract (URT) or URT infections, at work and in educational settings. SEARCH METHODS: The last search for all databases was done in December 2020. We searched Ovid MEDLINE, Embase, CENTRAL (Cochrane Library), PsycINFO, Web of Science, Scopus and in the field of occupational safety and health: NIOSHTIC-2, HSELINE, CISDOC and the In-house database of the Division of Occupational and Environmental Medicine, University of Zurich. We also contacted experts, screened reference lists of included trials, relevant reviews and consulted the WHO International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA: We included controlled studies with a parallel group or cross-over design, quasi-randomised studies, controlled before-and-after and interrupted time-series studies on the effects of indoor air humidification in reducing or preventing dryness symptoms and upper respiratory tract infections as primary outcomes at workplace and in the educational setting. As secondary outcomes we considered perceived air quality, other adverse events, sick leave, task performance, productivity and attendance and costs of the intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles, abstracts and full texts for eligibility, extracted data and assessed the risks of bias of included studies. We synthesised the evidence for the primary outcomes 'dry eye', 'dry nose', 'dry skin', for the secondary outcome 'absenteeism', as well as for 'perception of stuffiness' as the harm-related measure. We assessed the certainty of evidence using the GRADE system. MAIN RESULTS: We included 13 studies with at least 4551 participants, and extracted the data of 12 studies with at least 4447 participants. Seven studies targeted the occupational setting, with three studies comprising office workers and four hospital staff. Three of them were clustered cross-over studies with 846 participants (one cRCT), one parallel-group controlled trial (2395 participants) and three controlled before-and-after studies with 181 participants. Five studies, all CTs, with at least 1025 participants, addressing the educational setting, were reported between 1963 and 1975, and in 2018. In total, at least 3933 (88%) participants were included in the data analyses. Due to the lack of information, the results of the risk of bias assessment remained mainly unclear and the assessable risks of bias of included studies were considered as predominantly high. Primary outcomes in occupational setting:  We found that indoor air humidification at the workplace may have little to no effect on dryness symptoms of the eye and nose (URT). The only cRCT showed a significant decrease in dry eye symptoms among working adults (odds ratio (OR) 0.54, 95% confidence interval (CI) 0.37 to 0.79) with a low certainty of the evidence. The only cluster non-randomised cross-over study showed a non-significant positive effect of humidification on dryness nose symptoms (OR 0.87, 95% CI 0.53 to 1.42) with a low certainty of evidence. We found that indoor air humidification at the workplace may have little and non-significant effect on dryness skin symptoms. The pooled results of two cluster non-RCTs showed a non-significant alleviation of skin dryness following indoor air humidification (OR 0.66, 95% CI 0.33 to 1.32) with a low certainty of evidence. Similarly, the pooled results of two before-after studies yielded no statistically significant result (OR 0.69, 95% CI 0.33 to 1.47) with very low certainty of evidence No studies reported on the outcome of upper respiratory tract infections. No studies conducted in educational settings investigated our primary outcomes. Secondary outcomes in occupational setting: Perceived stuffiness of the air was increased during the humidification in the two cross-over studies (OR 2.18, 95% CI 1.47 to 3.23); (OR 1.70, 95% CI 1.10 to 2.61) with low certainty of evidence. Secondary outcomes in educational setting: Based on different measures and settings of absenteeism, four of the six controlled studies found a reduction in absenteeism following indoor air humidification (OR 0.54, 95% CI 0.45 to 0.65; OR 0.38, 95% CI 0.15 to 0.96; proportion 4.63% versus 5.08%). AUTHORS' CONCLUSIONS: Indoor air humidification at the workplace may have little to no effect on dryness symptoms of the eyes, the skin and the URT. Studies investigating illness-related absenteeism from work or school could only be summarised narratively, due to different outcome measures assessed. The evidence suggests that increasing humidification may reduce the absenteeism, but the evidence is very uncertain. Future RCTs involving larger sample sizes, assessing dryness symptoms more technically or rigorously defining absenteeism and controlling for potential confounders are therefore needed to determine whether increasing indoor air humidity can reduce or prevent dryness symptoms of the eyes, the skin, the URT or URT infections at work and in educational settings over time.

Personalising add-on treatment with inhaled corticosteroids in patients with chronic obstructive pulmonary disease: a benefit-harm modelling study.

BACKGROUND: Since the benefit-harm balance of adding inhaled corticosteroids to long-acting ß2-agonists (LABA) and long-acting muscarinic antagonists (LAMA) for patients with chronic obstructive pulmonary disease is unclear, we evaluated this addition for a range of patient profiles. METHODS: Analyses considered the effects of low-to-moderate doses of inhaled corticosteroids, LABA, and LAMA compared with LABA and LAMA alone, outcome incidences, and preference weights assigned to averted moderate-to-severe exacerbations (benefit) and severe pneumonia, candidiasis, and dysphonia (harm). Using exponential models, we estimated the preference weight-adjusted 2-year net clinical benefit (ie, benefits outweighing harms) indices. Exacerbation risk thresholds for triggering inhaled corticosteroids, LABA, and LAMA were established when the probability of a 2-year net clinical benefit reached 60%. We estimated the proportion of patients benefiting from added inhaled corticosteroids using an externally validated prediction model for acute exacerbations in primary care. FINDINGS: Adding low-to-moderate dose inhaled corticosteroids to LABA and LAMA provided a net clinical benefit in patients with a 2-year baseline exacerbation risk of 54-83%. Low-dose inhaled corticosteroids showed a net clinical benefit if the baseline risk was 40-91%, but not at higher doses. The benefit was modified by blood eosinophil count (BEC) and age. Although no net benefit was associated with a BEC of less than 150 cells per µL, patients with a BEC of 150 cells per µL or more had a net benefit from low-dose inhaled corticosteroids with a 2-year exacerbation risk of 32-95% in those aged 40-79 years and 41-93% in those older than 80 years. A moderate dose of inhaled corticosteroids showed a net benefit in patients younger than 80 years with a BEC of 150 cells per µL or more at 52-86% 2-year exacerbation risk. Depending on the subgroups, the proportion of patients with a net benefit from added inhaled corticosteroids ranged from 0 to 68%. INTERPRETATION: The net clinical benefit of adding different inhaled corticosteroid doses to LABA and LAMA varies greatly with exacerbation risk, BEC, and age. Personalised treatment decisions based on these factors and predicted exacerbation risks might reduce overtreatment and undertreatment with inhaled corticosteroids. FUNDING: None.

Long-term effect of coffee consumption on autosomal dominant polycystic kidneys disease progression: results from the Suisse ADPKD, a Prospective Longitudinal Cohort Study.

BACKGROUND: Previous in vitro experiments of human polycystic kidney disease (PKD) cells reported that caffeine is a risk factor for the promotion of cyst enlargement in patients with autosomal dominant PKD (ADPKD). The relentless progression of ADPKD inclines the majority of physicians to advocate minimization of caffeine consumption despite the absence of clinical data supporting such a recommendation so far. This is the first clinical study to assess prospectively the association between coffee consumption and disease progression in a longitudinal ADPKD cohort. METHODS: Information on coffee consumption and disease progression was collected at each follow-up visit using standardized measurement methods. The main model for the outcomes, kidney size (height-adjusted total kidney volume, htTKV) and kidney function (estimated glomerular filtration rate, eGFR), was a linear mixed model. Patients entered the on-going Swiss ADPKD study between 2006 and June 2014 and had at least 1 visit every year. The sample size of the study population was 151 with a median follow-up of 4 visits per patient and a median follow-up time of 4.38 years. RESULTS: After multivariate adjustment for age, smoking, hypertension, sex, body mass index and an interaction term (coffee*visit), coffee drinkers did not have a statistically significantly different kidney size compared to non-coffee drinkers (difference of -33.03 cm3 height adjusted TKV, 95% confidence interval (CI) from -72.41 to 6.34, p = 0.10). After the same adjustment, there was no statistically significant difference in eGFR between coffee and non-coffee drinkers (2.03 ml/min/1.73 m2, 95% CI from -0.31 to 4.31, p = 0.089). CONCLUSION: Data derived from our prospective longitudinal study do not confirm that drinking coffee is a risk factor for ADPKD progression.

No association of 25-hydroxyvitamin D with exacerbations in primary care patients with COPD.

BACKGROUND: Cross-sectional studies suggest an association of 25-hydroxyvitamin D with exacerbations in patients with COPD, but longitudinal evidence from cohort studies is scarce. The aim of this study was to assess the association of serum 25-hydroxyvitamin D with exacerbations and mortality in primary care patients with COPD. METHODS: In the main analysis, we included 356 patients with COPD (GOLD [Global Initiative for Chronic Obstructive Lung Disease] stages II-IV, free from exacerbations for ≥ 4 weeks) from a prospective cohort study in Dutch and Swiss primary care settings. We used negative binomial and Cox regression to assess the association of 25-hydroxyvitamin D with (centrally adjudicated) exacerbations and mortality, respectively. RESULTS: Baseline mean ± SD serum 25-hydroxyvitamin D concentration was 15.5 ± 8.9 ng/dL, and 274 patients (77.0%) had 25-hydroxyvitamin D deficiency (< 20 ng/dL). Compared with patients with severe 25-hydroxyvitamin D deficiency (< 10 ng/dL, n = 106 [29.8%]), patients with moderately deficient (10-19.99 ng/dL, n = 168 [47.2%]) and insufficient (20-29.99 ng/dL, n = 58 [16.3%]) concentrations had the same risk for exacerbations (incidence rate ratio, 1.01 [95% CI, 0.77-1.57] vs 1.00 [95% CI, 0.62-1.61], respectively). In patients with desirable concentrations (> 30 ng/dL, n = 24 [6.7%]), the risk was lower, although not significantly (incidence rate ratio, 0.72 [95% CI, 0.37-1.42]). In patients taking vitamin D supplements, using different cutoffs for 25-hydroxyvitamin D or competing risk models did not materially change the results. We did not find a statistically significant association of 25-hydroxyvitamin D concentration with mortality. CONCLUSIONS: This longitudinal study in a real-world COPD population that carefully minimized misclassification of exacerbations and the influence of confounding did not show an association of 25-hydroxyvitamin D with exacerbations and mortality.

Pharmacotherapies for chronic obstructive pulmonary disease: a multiple treatment comparison meta-analysis.

BACKGROUND: Most patients with moderate and severe chronic obstructive pulmonary disease (COPD) receive long-acting bronchodilators (LABA) for symptom control. It is, however, unclear if and what drug treatments should be added to LABAs to reduce exacerbations, which is an important goal of COPD management. Since current guidelines cannot make strong recommendations yet, our aim was to determine the relative efficacy of existing treatments and combinations to reduce the risk for COPD exacerbations. METHODS: We included randomized clinical trials (RCTs) evaluating long-acting ß(2) agonists (LABA), long-acting muscarinic antagonists (LAMA), inhaled glucocorticosterioids (ICS), and the phosphodiesterase-4 (PDE4) inhibitor roflumilast, and combinations of these interventions in moderate to severe COPD populations. Our primary outcome was the event rate of exacerbations. We conducted a random-effects Bayesian mixed-treatment comparison (MTC) and applied several sensitivity analyses. In particular, we confirmed our findings using a binomial MTC analysis examining whether a patient experienced at least one exacerbation event or not during the trial. We also used an additive assumption to calculate the combined effects of treatments that were not included in the systematic review. RESULTS: Twenty-six studies provided data on the total number of exacerbations and/or the mean annual rate of exacerbations among a combined 36,312 patients. There were a total of 10 treatment combinations in the MTC and 15 in the additive analysis. Compared with all other treatments, the combination of roflumilast plus LAMA exhibited the largest treatment effects, and had the highest probability (45%) of being the best first-line treatment. This was consistent whether applying the incidence rate analysis or the binomial analysis. When applying the additive assumption, most point estimates suggested that roflumilast may provide additional benefit by further reducing exacerbations. CONCLUSIONS: Using various meta-analytic approaches, our study demonstrates that depending on the choice of drug, combined treatments offer a therapeutic advantage.

Efficacy of motor imagery in post-stroke rehabilitation: a systematic review.

BACKGROUND: Evaluation of how Motor Imagery and conventional therapy (physiotherapy or occupational therapy) compare to conventional therapy only in their effects on clinically relevant outcomes during rehabilitation of persons with stroke. DESIGN: Systematic review of the literature METHODS: We conducted an electronic database search in seven databases in August 2005 and also hand-searched the bibliographies of studies that we selected for the review. Two reviewers independently screened and selected all randomized controlled trials that compare the effects of conventional therapy plus Motor Imagery to those of only conventional therapy on stroke patients. The outcome measurements were: Fugl-Meyer Stroke Assessment upper extremity score (66 points) and Action Research Arm Test upper extremity score (57 points). Due to the high variability in the outcomes, we could not pool the data statistically. RESULTS: We identified four randomized controlled trials from Asia and North America. The quality of the included studies was poor to moderate. Two different Motor imagery techniques were used (three studies used audiotapes and one study had occupational therapists apply the intervention). Two studies found significant effects of Motor Imagery in the Fugl-Meyer Stroke Assessment: Differences between groups amounted to 11.0 (1.0 to 21.0) and 3.2 (-4 to 10.3) respectively and in the Action Research Arm Test 6.1 (-6.2 to 18.4) and 15.8 (0.5 to 31.0) respectively. One study did not find a significant effect in the Fugl-Meyer Stroke Assessment and Color trail Test (p = 0.28) but in the task-related outcomes (p > 0.001). CONCLUSION: Current evidence suggests that Motor imagery provides additional benefits to conventional physiotherapy or occupational therapy. However, larger and methodologically sounder studies should be conducted to assess the benefits of Motor imagery.

Interval versus continuous high-intensity exercise in chronic obstructive pulmonary disease: a randomized trial.

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 health-related 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. International Standard Randomized Controlled Trial number: SRCTN11611768.

Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial.

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. Trial registration ISRCTN: 31571714.

Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality -- a systematic review.

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 < or = 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.

Value of supplemental interventions to enhance the effectiveness of physical exercise during respiratory rehabilitation in COPD patients. A systematic review.

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.