Background
Inspiratory muscle training (IMT) aims to improve respiratory muscle strength and endurance. Clinical trials used various training protocols, devices and respiratory measurements to check ...the effectiveness of this intervention. The current guidelines reported a possible advantage of IMT, particularly in people with respiratory muscle weakness. However, it remains unclear to what extent IMT is clinically beneficial, especially when associated with pulmonary rehabilitation (PR).
Objectives
To assess the effect of inspiratory muscle training (IMT) on chronic obstructive pulmonary disease (COPD), as a stand‐alone intervention and when combined with pulmonary rehabilitation (PR).
Search methods
We searched the Cochrane Airways trials register, CENTRAL, MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCO, Physiotherapy Evidence Database (PEDro) ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 20 October 2022. We also checked reference lists of all primary studies and review articles.
Selection criteria
We included randomized controlled trials (RCTs) that compared IMT in combination with PR versus PR alone and IMT versus control/sham. We included different types of IMT irrespective of the mode of delivery. We excluded trials that used resistive devices without controlling the breathing pattern or a training load of less than 30% of maximal inspiratory pressure (PImax), or both.
Data collection and analysis
We used standard methods recommended by Cochrane including assessment of risk of bias with RoB 2. Our primary outcomes were dyspnea, functional exercise capacity and health‐related quality of life.
Main results
We included 55 RCTs in this review. Both IMT and PR protocols varied significantly across the trials, especially in training duration, loads, devices, number/ frequency of sessions and the PR programs. Only eight trials were at low risk of bias.
PR+IMT versus PR
We included 22 trials (1446 participants) in this comparison. Based on a minimal clinically important difference (MCID) of −1 unit, we did not find an improvement in dyspnea assessed with the Borg scale at submaximal exercise capacity (mean difference (MD) 0.19, 95% confidence interval (CI) −0.42 to 0.79; 2 RCTs, 202 participants; moderate‐certainty evidence).
We also found no improvement in dyspnea assessed with themodified Medical Research Council dyspnea scale (mMRC) according to an MCID between −0.5 and −1 unit (MD −0.12, 95% CI −0.39 to 0.14; 2 RCTs, 204 participants; very low‐certainty evidence).
Pooling evidence for the 6‐minute walk distance (6MWD) showed an increase of 5.95 meters (95% CI −5.73 to 17.63; 12 RCTs, 1199 participants; very low‐certainty evidence) and failed to reach the MCID of 26 meters. In subgroup analysis, we divided the RCTs according to the training duration and mean baseline PImax. The test for subgroup differences was not significant. Trials at low risk of bias (n = 3) demonstrated a larger effect estimate than the overall.
The summary effect of the St George's Respiratory Questionnaire (SGRQ) revealed an overall total score below the MCID of 4 units (MD 0.13, 95% CI −0.93 to 1.20; 7 RCTs, 908 participants; low‐certainty evidence).
The summary effect of COPD Assessment Test (CAT) did not show an improvement in the HRQoL (MD 0.13, 95% CI −0.80 to 1.06; 2 RCTs, 657 participants; very low‐certainty evidence), according to an MCID of −1.6 units.
Pooling the RCTs that reported PImax showed an increase of 11.46 cmH2O (95% CI 7.42 to 15.50; 17 RCTs, 1329 participants; moderate‐certainty evidence) but failed to reach the MCID of 17.2 cmH2O. In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.
One reported some adverse effects that were considered "minor and self‐limited".
IMT versus control/sham
Thirty‐seven RCTs with 1021 participants contributed to our second comparison. There was a trend towards an improvement when Borg was calculated at submaximal exercise capacity (MD −0.94, 95% CI −1.36 to −0.51; 6 RCTs, 144 participants; very low‐certainty evidence). Only one trial was at a low risk of bias.
Eight studies (nine arms) used the Baseline Dyspnea Index ‐ Transition Dyspnea Index (BDI‐TDI). Based on an MCID of +1 unit, they showed an improvement only with the 'total score' of the TDI (MD 2.98, 95% CI 2.07 to 3.89; 8 RCTs, 238 participants; very low‐certainty evidence). We did not find a difference between studies classified as with and without respiratory muscle weakness. Only one trial was at low risk of bias.
Four studies reported the mMRC, revealing a possible improvement in dyspnea in the IMT group (MD −0.59, 95% CI −0.76 to −0.43; 4 RCTs, 150 participants; low‐certainty evidence). Two trials were at low risk of bias.
Compared to control/sham, the MD in the 6MWD following IMT was 35.71 (95% CI 25.68 to 45.74; 16 RCTs, 501 participants; moderate‐certainty evidence). Two studies were at low risk of bias. In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.
Six studies reported theSGRQ total score, showing a larger effect in the IMT group (MD −3.85, 95% CI −8.18 to 0.48; 6 RCTs, 182 participants; very low‐certainty evidence). The lower limit of the 95% CI exceeded the MCID of −4 units. Only one study was at low risk of bias.
There was an improvement in life quality with CAT (MD −2.97, 95% CI −3.85 to −2.10; 2 RCTs, 86 participants; moderate‐certainty evidence). One trial was at low risk of bias.
Thirty‐two RCTs reported PImax, showing an improvement without reaching the MCID (MD 14.57 cmH2O, 95% CI 9.85 to 19.29; 32 RCTs, 916 participants; low‐certainty evidence). In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.
None of the included RCTs reported adverse events.
Authors' conclusions
IMT may not improve dyspnea, functional exercise capacity and life quality when associated with PR. However, IMT is likely to improve these outcomes when provided alone.
For both interventions, a larger effect in participants with respiratory muscle weakness and with longer training durations is still to be confirmed.
Objective
To develop updated guidelines for the pharmacologic management of rheumatoid arthritis.
Methods
We developed clinically relevant population, intervention, comparator, and outcomes (PICO) ...questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising clinicians and patients achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations.
Results
The guideline addresses treatment with disease‐modifying antirheumatic drugs (DMARDs), including conventional synthetic DMARDs, biologic DMARDs, and targeted synthetic DMARDs, use of glucocorticoids, and use of DMARDs in certain high‐risk populations (i.e., those with liver disease, heart failure, lymphoproliferative disorders, previous serious infections, and nontuberculous mycobacterial lung disease). The guideline includes 44 recommendations (7 strong and 37 conditional).
Conclusion
This clinical practice guideline is intended to serve as a tool to support clinician and patient decision‐making. Recommendations are not prescriptive, and individual treatment decisions should be made through a shared decision‐making process based on patients’ values, goals, preferences, and comorbidities.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Objective
To develop updated guidelines for the pharmacologic management of rheumatoid arthritis.
Methods
We developed clinically relevant population, intervention, comparator, and outcomes (PICO) ...questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising clinicians and patients achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations.
Results
The guideline addresses treatment with disease‐modifying antirheumatic drugs (DMARDs), including conventional synthetic DMARDs, biologic DMARDs, and targeted synthetic DMARDs, use of glucocorticoids, and use of DMARDs in certain high‐risk populations (i.e., those with liver disease, heart failure, lymphoproliferative disorders, previous serious infections, and nontuberculous mycobacterial lung disease). The guideline includes 44 recommendations (7 strong and 37 conditional).
Conclusion
This clinical practice guideline is intended to serve as a tool to support clinician and patient decision‐making. Recommendations are not prescriptive, and individual treatment decisions should be made through a shared decision‐making process based on patients’ values, goals, preferences, and comorbidities.
Full text
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence.
To develop a framework that characterizes the processes of ...development of living practice guidelines in health care.
First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders.
International.
Multidisciplinary group of 51 persons who have experience with guidelines.
Not applicable.
A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication.
This study does not provide detailed or practical guidance for how the described concepts would be best implemented.
The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines.
None.
Mechanical ventilation is used to treat respiratory failure in coronavirus disease 2019 (COVID-19).
To review multiple streams of evidence regarding the benefits and harms of ventilation techniques ...for coronavirus infections, including that causing COVID-19.
21 standard, World Health Organization-specific and COVID-19-specific databases, without language restrictions, until 1 May 2020.
Studies of any design and language comparing different oxygenation approaches in patients with coronavirus infections, including severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), or with hypoxemic respiratory failure. Animal, mechanistic, laboratory, and preclinical evidence was gathered regarding aerosol dispersion of coronavirus. Studies evaluating risk for virus transmission to health care workers from aerosol-generating procedures (AGPs) were included.
Independent and duplicate screening, data abstraction, and risk-of-bias assessment (GRADE for certainty of evidence and AMSTAR 2 for included systematic reviews).
123 studies were eligible (45 on COVID-19, 70 on SARS, 8 on MERS), but only 5 studies (1 on COVID-19, 3 on SARS, 1 on MERS) adjusted for important confounders. A study in hospitalized patients with COVID-19 reported slightly higher mortality with noninvasive ventilation (NIV) than with invasive mechanical ventilation (IMV), but 2 opposing studies, 1 in patients with MERS and 1 in patients with SARS, suggest a reduction in mortality with NIV (very-low-certainty evidence). Two studies in patients with SARS report a reduction in mortality with NIV compared with no mechanical ventilation (low-certainty evidence). Two systematic reviews suggest a large reduction in mortality with NIV compared with conventional oxygen therapy. Other included studies suggest increased odds of transmission from AGPs.
Direct studies in COVID-19 are limited and poorly reported.
Indirect and low-certainty evidence suggests that use of NIV, similar to IMV, probably reduces mortality but may increase the risk for transmission of COVID-19 to health care workers.
World Health Organization. (PROSPERO: CRD42020178187).
There are uncertainties about mitigating strategies for swimming-related activities in the context of the COVID-19 pandemic. There is an opportunity to learn from the experience of previous ...re-openings to better plan the future one. Our objectives are to systematically review the evidence on (1) the association between engaging in swimming-related activities and COVID-19 transmission; and (2) the effects of strategies for preventing COVID-19 transmission during swimming-related activities.
We conducted a rapid systematic review. We searched in the L·OVE (Living OVerview of Evidence) platform for COVID-19. The searches covered the period from the inception date of each database until April 19, 2021. We included non-randomized studies for the review on association of COVID-19 transmission and swimming-related activities. We included guidance documents reporting on the strategies for prevention of COVID-19 transmission during swimming-related activities. We also included studies on the efficacy and safety of the strategies. Teams of two reviewers independently assessed article eligibility. For the guidance documents, a single reviewer assessed the eligibility and a second reviewer verified the judgement. Teams of two reviewers extracted data independently. We summarized the findings of included studies narratively. We synthesized information from guidance documents according to the identified topics and subtopics, and presented them in tabular and narrative formats.
We identified three studies providing very low certainty evidence for the association between engaging in swimming-related activities and COVID-19 transmission. The analysis of 50 eligible guidance documents identified 11 topics: ensuring social distancing, ensuring personal hygiene, using personal protective equipment, eating and drinking, maintaining the pool, managing frequently touched surfaces, ventilation of indoor spaces, screening and management of sickness, delivering first aid, raising awareness, and vaccination. One study assessing the efficacy of strategies to prevent COVID-19 transmission did not find an association between compliance with precautionary restrictions and COVID-19 transmission.
There are major gaps in the research evidence of relevance to swimming-related activities in the context of the COVID-19 pandemic. However, the synthesis of the identified strategies from guidance documents can inform public health management strategies for swimming-related activities, particularly in future re-opening plans.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction
Increased abdominal visceral adipose tissue (VAT) implies an adverse cardio-metabolic profile. We examined the association of abdominal VAT parameters and all-cause mortality risk.
...Methods
We systematically searched four databases. We performed citations/articles screening, data abstraction, and quality assessment in duplicate and independently (CRD42020205021).
Results
We included 12 cohorts, the majority used computed tomography to assess abdominal VAT area. Six cohorts with a mean age ≤ 65 years, examining all-cause mortality risk per increment in VAT area (cm
2
) or volume (cm
3
), showed a 11-98% relative risk increase with higher VAT parameters. However, the association lost significance after adjusting for glycemic indices, body mass index, or other fat parameters. In 4 cohorts with a mean age >65 years, the findings on mortality were inconsistent. Conversely, in two cohorts (mean age 73-77 years), a higher VAT density, was inversely proportional to VAT area, and implied a higher mortality risk.
Conclusion
A high abdominal VAT area seems to be associated with increased all-cause mortality in individuals ≤ 65 years, possibly mediated by metabolic complications, and not through an independent effect. This relationship is weaker and may reverse in older individuals, most likely secondary to confounding bias and reverse causality. An individual participant data meta-analysis is needed to confirm our findings, and to define an abdominal VAT area cutoff implying increased mortality risk.
Systematic Review Registration
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=205021
, identifier CRD42020205021.
Background
Patients and consumers are increasingly engaged in health policymaking, research and drug regulation. Having financial relationships with the health industry creates situations of ...conflicts of interest (COI) and might compromise their meaningful and unbiased participation.
Objective
To synthesize available evidence on the financial relationships between the health industry and patient and consumer representatives and their organizations.
Methods
We systematically searched MEDLINE and EMBASE. We selected studies and ed data in duplicate and independently. We reported on outcomes related to financial relationships of individuals with, and/or funding of organizations by the health industry.
Results
We identified a total of 14 510 unique citations, of which 24 reports of 23 studies were eligible. Three studies (13%) addressed the financial relationship of patient and consumer representatives with the health industry. Of these, two examined the proportion of public speakers in drug regulatory processes who have financial relationships; the proportions in the two studies were 25% and 19% respectively. Twenty studies (87%) addressed funding of patient and consumer organizations. The median proportion of organizations that reported funding from the health industry was 62% (IQR: 34%‐69%) in questionnaire surveys, and 75% (IQR: 58%‐85%) in surveys of their websites. Among organizations for which there was evidence of industry funding, a median proportion of 29% (IQR: 27%‐44%) acknowledged on their websites receiving that funding.
Conclusion
Financial relationships between the health industry and patient and consumer representatives and their organizations are common and may not be disclosed. Stricter regulation on disclosure and management is needed.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
There is increased awareness of the negative impact of large multinational corporations - the 'industry' - on public health. These corporations have established different types of relationships with ...a number of actors in the field of health research. This Commentary explores the different types of relationships between the industry and the actors of health research, how they intersect with the different research steps, and how these relationships allow the industry to exert influence. The types of relationships discussed consist of funding of research, direct relationships with the actors of research (namely advocacy groups, funding agencies, experts, professional organisations, regulatory agencies and health practitioners), and the influencing research standards. The potentially influenced research steps either precede the research (i.e. the prioritisation of research question), relate to it directly (i.e. its planning, conduct, reporting, dissemination and evaluation), or build on it (i.e. regulatory approval, integration into guidelines and adoption into practice). In conclusion, the industry has successfully fostered relationships with almost every actor of the health research enterprise and is using these relationships to influence the different steps of health research. The degree of influence the industry is having on health research calls for more work on managing the relationships discussed herein.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
The objectives of this study are to describe the characteristics of living systematic reviews (LSRs) and to understand their life cycles.
We conducted a comprehensive search up to April 2021 then ...selected articles and abstracted data in duplicate and independently. We undertook descriptive analyses and calculated delay in version update and delay since the last published version.
We included 76 eligible LSRs with a total of 279 eligible versions. The majority of LSRs was from the clinical field (70%), was COVID-19 related (63%), and had a funding source specified (62%). The median number of versions per LSR was 2 (interquartile range (IQR) 1–4; range 1–19). The median and IQR for the ratio of the actual period of update to the planned period of update was 1.12 (0.81; 1.71). Out of all reviews with a ‘planned period of update’ and at least one update (N = 19), eight LSRs (42%) had a period since last published version greater than 3 times the planned period of update. No LSR included a ‘retirement notice’ in their latest published version.
While most LSR complied with the planned period of producing updates, a substantive proportion lagged since their last update.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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