Objective: This study conducts an umbrella review of systematic reviews and meta-analyses of randomised clinical trials (RCTs) to evaluate the outcomes of early vs late tracheostomy, focusing on potential biases and the coherence of the evidence.
Data sources: Searches were conducted in the MEDLINE, Embase, Lilacs and Cochrane Library databases up to November 2024.
Study selection: Our analysis included studies meeting the following criteria: Population: patients admitted to intensive care units and receiving mechanical ventilation.
Intervention: early tracheostomy, as defined by the respective study.
Control: late tracheostomy, as defined by the respective study.
Primary outcomes: mortality and incidence of ventilator-associated pneumonia (VAP).
Study design: systematic reviews and meta-analysis of RCTs.
Data extraction: Two reviewers performed article inclusion, with consensus resolution by a third reviewer in case of disagreement. The quality of studies was assessed using the AMSTAR 2 tool. A random-effects meta-analysis was conducted with an algorithm based on the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) classification DATA SYNTHESIS: Out of 7664 articles identified, 60 articles were considered eligible for full-text reading, and 22 were included in the review. Most studies were rated as critically low quality. Our meta-analysis update with 19 RCTs showed a decrease in VAP (OR 0.65 (0.47 to 0.89), 95% CI; p=0.007) among early tracheostomy patients compared with late tracheostomy patients, but no significant difference in terms of mortality (OR 0.85 (0.70 to 1.03), 95% CI; p=0.09). A trial sequential analysis indicated that the current data are insufficient to reach a definitive conclusion.
Conclusion: In summary, despite extensive research on tracheostomy timing and its outcomes, as well as a correlation in our study between early tracheostomy and reduced VAP incidence, evidence remains weak. Besides that, no clear mortality benefits were observed. Further research using a different approach is crucial to identify the specific population that may derive benefits from early tracheostomy.
{"title":"Early versus late tracheostomy in critically ill patients: an umbrella review of systematic reviews of randomised clinical trials with meta-analyses and trial sequential analysis.","authors":"Aline Boni, Tiago Antonio Tonietto, Marcos Frata Rihl, Marina Verçoza Viana","doi":"10.1136/bmjresp-2024-002434","DOIUrl":"10.1136/bmjresp-2024-002434","url":null,"abstract":"<p><strong>Objective: </strong>This study conducts an umbrella review of systematic reviews and meta-analyses of randomised clinical trials (RCTs) to evaluate the outcomes of early vs late tracheostomy, focusing on potential biases and the coherence of the evidence.</p><p><strong>Data sources: </strong>Searches were conducted in the MEDLINE, Embase, Lilacs and Cochrane Library databases up to November 2024.</p><p><strong>Study selection: </strong>Our analysis included studies meeting the following criteria: Population: patients admitted to intensive care units and receiving mechanical ventilation.</p><p><strong>Intervention: </strong>early tracheostomy, as defined by the respective study.</p><p><strong>Control: </strong>late tracheostomy, as defined by the respective study.</p><p><strong>Primary outcomes: </strong>mortality and incidence of ventilator-associated pneumonia (VAP).</p><p><strong>Study design: </strong>systematic reviews and meta-analysis of RCTs.</p><p><strong>Data extraction: </strong>Two reviewers performed article inclusion, with consensus resolution by a third reviewer in case of disagreement. The quality of studies was assessed using the AMSTAR 2 tool. A random-effects meta-analysis was conducted with an algorithm based on the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) classification DATA SYNTHESIS: Out of 7664 articles identified, 60 articles were considered eligible for full-text reading, and 22 were included in the review. Most studies were rated as critically low quality. Our meta-analysis update with 19 RCTs showed a decrease in VAP (OR 0.65 (0.47 to 0.89), 95% CI; p=0.007) among early tracheostomy patients compared with late tracheostomy patients, but no significant difference in terms of mortality (OR 0.85 (0.70 to 1.03), 95% CI; p=0.09). A trial sequential analysis indicated that the current data are insufficient to reach a definitive conclusion.</p><p><strong>Conclusion: </strong>In summary, despite extensive research on tracheostomy timing and its outcomes, as well as a correlation in our study between early tracheostomy and reduced VAP incidence, evidence remains weak. Besides that, no clear mortality benefits were observed. Further research using a different approach is crucial to identify the specific population that may derive benefits from early tracheostomy.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-05DOI: 10.1136/bmjresp-2024-003023
Lena Reimann, Helga Preiss, Julian Müller, Pascale Huber, Laura Mayer, David Langleben, Silvia Ulrich, Mona Lichtblau
Introduction: In pulmonary arterial hypertension (PAH) and distal chronic thromboembolic pulmonary hypertension (CTEPH), the consistent use of disease-specific therapies is crucial. We aimed to investigate medication adherence to oral disease-specific medication and the impact on clinical outcome among patients with PAH or CTEPH to identify potential patient-related reasons for treatment incompliance.
Study design and methods: This prospective study focused on medication adherence using a multimeasure approach, including specialty pharmacy order data to calculate medication possession ratio (MPR) and self-reporting via questionnaire among patients with PAH or CTEPH. Adherence rates of ≥80% were considered adherent. Simplified four-strata risk categories according to the 2022 European Respiratory Society/European Society of Cardiology pulmonary hypertension (PH) guidelines were determined.
Results: We included 93 patients (66% women, 75% PAH, 25% CTEPH, 57±17 years), all on PH-targeted oral medication between 2013 and 2023. Overall, a number of 73 patients (78%) were classified as adherent. The mean MPR was 98±19% and the mean value of questionnaire responses was 89±10%. At the end of the observation period, adherent patients improved their risk category, while non-adherent patients did not. Factors associated with adherence were older age (OR=1.03, 95% CI=1.01 to 1.07) and being classified in a higher risk category (OR=2.13; 95% CI=1.11 to 4.64). Patients with adverse drug reactions were 75% more likely to be non-adherent to medication (OR=0.25; 95% CI=0.08 to 0.77).
Conclusion: In this collective, mean MPR and self-reported adherence were overall high, with 78% of patients classified as adherent. Adherent patients improved clinical outcomes contrary to non-adherent patients. Insufficient adherence and potential contributing factors should be regularly considered, especially in patients without improvement after starting disease-specific therapy.
{"title":"Medication adherence and clinical outcome in patients with pulmonary arterial hypertension or distal chronic thromboembolic pulmonary hypertension.","authors":"Lena Reimann, Helga Preiss, Julian Müller, Pascale Huber, Laura Mayer, David Langleben, Silvia Ulrich, Mona Lichtblau","doi":"10.1136/bmjresp-2024-003023","DOIUrl":"10.1136/bmjresp-2024-003023","url":null,"abstract":"<p><strong>Introduction: </strong>In pulmonary arterial hypertension (PAH) and distal chronic thromboembolic pulmonary hypertension (CTEPH), the consistent use of disease-specific therapies is crucial. We aimed to investigate medication adherence to oral disease-specific medication and the impact on clinical outcome among patients with PAH or CTEPH to identify potential patient-related reasons for treatment incompliance.</p><p><strong>Study design and methods: </strong>This prospective study focused on medication adherence using a multimeasure approach, including specialty pharmacy order data to calculate medication possession ratio (MPR) and self-reporting via questionnaire among patients with PAH or CTEPH. Adherence rates of ≥80% were considered adherent. Simplified four-strata risk categories according to the 2022 European Respiratory Society/European Society of Cardiology pulmonary hypertension (PH) guidelines were determined.</p><p><strong>Results: </strong>We included 93 patients (66% women, 75% PAH, 25% CTEPH, 57±17 years), all on PH-targeted oral medication between 2013 and 2023. Overall, a number of 73 patients (78%) were classified as adherent. The mean MPR was 98±19% and the mean value of questionnaire responses was 89±10%. At the end of the observation period, adherent patients improved their risk category, while non-adherent patients did not. Factors associated with adherence were older age (OR=1.03, 95% CI=1.01 to 1.07) and being classified in a higher risk category (OR=2.13; 95% CI=1.11 to 4.64). Patients with adverse drug reactions were 75% more likely to be non-adherent to medication (OR=0.25; 95% CI=0.08 to 0.77).</p><p><strong>Conclusion: </strong>In this collective, mean MPR and self-reported adherence were overall high, with 78% of patients classified as adherent. Adherent patients improved clinical outcomes contrary to non-adherent patients. Insufficient adherence and potential contributing factors should be regularly considered, especially in patients without improvement after starting disease-specific therapy.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-05DOI: 10.1136/bmjresp-2024-002878
Timothy O Jenkins, Dan Stieper Karbing, Stephen Edward Rees, Mathias Krogh Poulsen, Brijesh V Patel, Michael I Polkey, Vicky MacBean
Background: Physical rehabilitation is advocated to improve muscle strength and function after critical illness, yet interventional studies have reported inconsistent benefits. A greater insight into patients' physiological response to exercise may provide an option to prescribe individualised, targeted rehabilitation, yet there is limited data measuring oxygen consumption (VO2) during physical rehabilitation. We aimed to test the feasibility of measuring VO2 during seated and standing exercise using the Beacon Caresystem and quantify within- and between-patient variability of VO2 percentage change.
Methods: We conducted a prospective observational study on patients mechanically ventilated for ≥72 hours and able to participate in physical rehabilitation in critical care. Oxygen consumption was measured continuously using indirect calorimetry. A total of 29 measurements were taken from ten participants performing active sitting and standing exercise.
Results: Median (IQR) first session baseline VO2 was 3.54 (2.9-3.9) mL/kg/min, increasing significantly to 4.37 (3.96-5.14) mL/kg/min during exercise (p=0.005). The median (IQR) coefficient of variation of VO2 percentage change in participants (n=7) who completed more than one rehabilitation session (range 2-7 sessions) was 43 (34-61)% in 26 measurements. The median (IQR) coefficient of variation of VO2 percentage change was 46 (26-63)% in participants performing >1 sitting exercise session (six participants, 19 sessions).
Conclusions: VO2 increases significantly with exercise but is highly variable between participants, and in the same participant on separate occasions, performing the same functional activity. These data suggest that simplified measures of function do not necessarily relate to oxygen consumption.
Trial registration number: NCT05101850.
{"title":"Metabolic cost of physical rehabilitation in mechanically ventilated patients in critical care: an observational study.","authors":"Timothy O Jenkins, Dan Stieper Karbing, Stephen Edward Rees, Mathias Krogh Poulsen, Brijesh V Patel, Michael I Polkey, Vicky MacBean","doi":"10.1136/bmjresp-2024-002878","DOIUrl":"10.1136/bmjresp-2024-002878","url":null,"abstract":"<p><strong>Background: </strong>Physical rehabilitation is advocated to improve muscle strength and function after critical illness, yet interventional studies have reported inconsistent benefits. A greater insight into patients' physiological response to exercise may provide an option to prescribe individualised, targeted rehabilitation, yet there is limited data measuring oxygen consumption (VO<sub>2</sub>) during physical rehabilitation. We aimed to test the feasibility of measuring VO<sub>2</sub> during seated and standing exercise using the Beacon Caresystem and quantify within- and between-patient variability of VO<sub>2</sub> percentage change.</p><p><strong>Methods: </strong>We conducted a prospective observational study on patients mechanically ventilated for ≥72 hours and able to participate in physical rehabilitation in critical care. Oxygen consumption was measured continuously using indirect calorimetry. A total of 29 measurements were taken from ten participants performing active sitting and standing exercise.</p><p><strong>Results: </strong>Median (IQR) first session baseline VO<sub>2</sub> was 3.54 (2.9-3.9) mL/kg/min, increasing significantly to 4.37 (3.96-5.14) mL/kg/min during exercise (p=0.005). The median (IQR) coefficient of variation of VO<sub>2</sub> percentage change in participants (n=7) who completed more than one rehabilitation session (range 2-7 sessions) was 43 (34-61)% in 26 measurements. The median (IQR) coefficient of variation of VO<sub>2</sub> percentage change was 46 (26-63)% in participants performing >1 sitting exercise session (six participants, 19 sessions).</p><p><strong>Conclusions: </strong>VO<sub>2</sub> increases significantly with exercise but is highly variable between participants, and in the same participant on separate occasions, performing the same functional activity. These data suggest that simplified measures of function do not necessarily relate to oxygen consumption.</p><p><strong>Trial registration number: </strong>NCT05101850.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-31DOI: 10.1136/bmjresp-2024-002546
Catherine O'Leary, Alec Vinh, Mari Lea-Davies, John Weinman, Rob Horne, Jamie Duckers
Background: A person's beliefs about treatment influence their engagement and adherence to that treatment. The Necessity-Concerns Framework suggests that adherence is influenced by a person's judgement of their own need for treatment (necessity beliefs) and concerns about the potential adverse consequences of taking the treatment. This study was conducted to explore the Necessity-Concerns Framework for elexacaftor-tezacaftor-ivacaftor (ETI) therapy (Kaftrio) in adults with cystic fibrosis (CF).
Methods: A total of 64 adults with CF were maintained on ETI therapy as part of their routine CF care, and completed the Beliefs about Medicines Questionnaire. Patient demographics, lung function, body mass index and quality of life using the Cystic Fibrosis Questionnaire Revised were collected as part of routine clinical care. Duration of ETI therapy along with medicines possession ratio was recorded.
Results: Patients reported strong beliefs about the necessity of ETI therapy. The majority of patients (78%) reported low concerns about ETI therapy while 22% of patients reported high concerns. A small number of patients (n=4) had concerns which were stronger than their beliefs about necessity.
Discussion: Patients reported strong beliefs in the necessity of ETI therapy. Although concerns were lower, a significant proportion of the sample had strong concerns about their ETI therapy. By being aware of people with CF's necessity and concerns beliefs around ETI therapy clinical teams will be better armed to engage them in treatment decisions and support optimal adherence.
{"title":"Understanding beliefs about elexacaftor-tezacaftor-ivacaftor therapy in adults living with cystic fibrosis.","authors":"Catherine O'Leary, Alec Vinh, Mari Lea-Davies, John Weinman, Rob Horne, Jamie Duckers","doi":"10.1136/bmjresp-2024-002546","DOIUrl":"10.1136/bmjresp-2024-002546","url":null,"abstract":"<p><strong>Background: </strong>A person's beliefs about treatment influence their engagement and adherence to that treatment. The Necessity-Concerns Framework suggests that adherence is influenced by a person's judgement of their own need for treatment (necessity beliefs) and concerns about the potential adverse consequences of taking the treatment. This study was conducted to explore the Necessity-Concerns Framework for elexacaftor-tezacaftor-ivacaftor (ETI) therapy (Kaftrio) in adults with cystic fibrosis (CF).</p><p><strong>Methods: </strong>A total of 64 adults with CF were maintained on ETI therapy as part of their routine CF care, and completed the Beliefs about Medicines Questionnaire. Patient demographics, lung function, body mass index and quality of life using the Cystic Fibrosis Questionnaire Revised were collected as part of routine clinical care. Duration of ETI therapy along with medicines possession ratio was recorded.</p><p><strong>Results: </strong>Patients reported strong beliefs about the necessity of ETI therapy. The majority of patients (78%) reported low concerns about ETI therapy while 22% of patients reported high concerns. A small number of patients (n=4) had concerns which were stronger than their beliefs about necessity.</p><p><strong>Discussion: </strong>Patients reported strong beliefs in the necessity of ETI therapy. Although concerns were lower, a significant proportion of the sample had strong concerns about their ETI therapy. By being aware of people with CF's necessity and concerns beliefs around ETI therapy clinical teams will be better armed to engage them in treatment decisions and support optimal adherence.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11962799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-26DOI: 10.1136/bmjresp-2024-003044
Ruth Steinberg, Simone Troxler, Léa Ho Dac, Anne-Christianne Kentgens, Xenia Bovermann, Christoph Aebi, Urs Frey, Pascal Bittel, Philipp Agyeman, Philipp Latzin, Insa Korten
Background: Respiratory virus infections are a major cause of morbidity in early life. During the SARS-CoV-2 pandemic, non-pharmaceutical interventions (NPIs) lead to worldwide changes in respiratory virus epidemiology. However, evidence regarding virus circulation in the outpatient setting remains largely unknown. The aim of this study is to longitudinally assess respiratory viruses in healthy infants before and during the SARS-CoV-2 pandemic in Switzerland.
Methods: In this prospective observational birth cohort study, we followed 34 infants throughout the first year of life before and during the SARS-CoV-2 pandemic. We analysed 648 biweekly nasal swabs for nine different respiratory viruses by Multiplex-PCR and assessed respiratory symptoms, COVID-19 infections of family members and childcare status in weekly interviews. 712 nasal swabs from 32 infants analysed before the pandemic and published previously served as control group.
Results: During the period with strict NPIs (pandemic I), most common respiratory viruses were not detected, with a rebound (driven by Adenovirus and Parainfluenza virus) after most NPIs were relaxed (pandemic II): prepandemic: 27%, pandemic I: 19%, pandemic II: 33%; historic: 36% of collected swabs per period, p<0.001. Human rhinovirus (HRV) prevalence persisted during NPIs presence, mainly in the form of asymptomatic HRV detection: prepandemic=24%, pandemic I=19%, pandemic II=25%, historic: 25%, p=0.3. SARS-CoV-2 detection (asymptomatic and symptomatic) was low, and only present after NPIs were relaxed: pandemic II=2.4%. No severe COVID-19 infections were reported.
Discussion: In our cohort, infants did not contribute largely to spread of SARS-CoV-2. The role of persisting asymptomatic HRV prevalence is still unclear, but it might help to maintain population immunity to prevent more severe infections. Our results underscore the importance of capturing asymptomatic viruses via longitudinal community-based data assessment to better understand virus transmission.
{"title":"Changes in respiratory viruses in infancy during the SARS-CoV-2 pandemic: a prospective cohort study.","authors":"Ruth Steinberg, Simone Troxler, Léa Ho Dac, Anne-Christianne Kentgens, Xenia Bovermann, Christoph Aebi, Urs Frey, Pascal Bittel, Philipp Agyeman, Philipp Latzin, Insa Korten","doi":"10.1136/bmjresp-2024-003044","DOIUrl":"10.1136/bmjresp-2024-003044","url":null,"abstract":"<p><strong>Background: </strong>Respiratory virus infections are a major cause of morbidity in early life. During the SARS-CoV-2 pandemic, non-pharmaceutical interventions (NPIs) lead to worldwide changes in respiratory virus epidemiology. However, evidence regarding virus circulation in the outpatient setting remains largely unknown. The aim of this study is to longitudinally assess respiratory viruses in healthy infants before and during the SARS-CoV-2 pandemic in Switzerland.</p><p><strong>Methods: </strong>In this prospective observational birth cohort study, we followed 34 infants throughout the first year of life before and during the SARS-CoV-2 pandemic. We analysed 648 biweekly nasal swabs for nine different respiratory viruses by Multiplex-PCR and assessed respiratory symptoms, COVID-19 infections of family members and childcare status in weekly interviews. 712 nasal swabs from 32 infants analysed before the pandemic and published previously served as control group.</p><p><strong>Results: </strong>During the period with strict NPIs (pandemic I), most common respiratory viruses were not detected, with a rebound (driven by Adenovirus and Parainfluenza virus) after most NPIs were relaxed (pandemic II): prepandemic: 27%, pandemic I: 19%, pandemic II: 33%; historic: 36% of collected swabs per period, p<0.001. Human rhinovirus (HRV) prevalence persisted during NPIs presence, mainly in the form of asymptomatic HRV detection: prepandemic=24%, pandemic I=19%, pandemic II=25%, historic: 25%, p=0.3. SARS-CoV-2 detection (asymptomatic and symptomatic) was low, and only present after NPIs were relaxed: pandemic II=2.4%. No severe COVID-19 infections were reported.</p><p><strong>Discussion: </strong>In our cohort, infants did not contribute largely to spread of SARS-CoV-2. The role of persisting asymptomatic HRV prevalence is still unclear, but it might help to maintain population immunity to prevent more severe infections. Our results underscore the importance of capturing asymptomatic viruses via longitudinal community-based data assessment to better understand virus transmission.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143728366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-26DOI: 10.1136/bmjresp-2024-002718
Layan Sukik, Hiam Chemaitelly, Houssein H Ayoub, Peter Coyle, Patrick Tang, Mohammad R Hasan, Hadi M Yassine, Asmaa A Al Thani, Zaina Al-Kanaani, Einas Al-Kuwari, Andrew Jeremijenko, Anvar Hassan Kaleeckal, Ali Nizar Latif, Riyazuddin Mohammad Shaik, Hanan F Abdul-Rahim, Gheyath K Nasrallah, Mohamed Ghaith Al-Kuwari, Adeel Butt, Hamad Eid Al-Romaihi, Mohamed H Al-Thani, Abdullatif Al-Khal, Roberto Bertollini, Laith J Abu-Raddad
Background: SARS-CoV-2 infection is associated with protection against reinfection. This study analysed this protection across different reinfection symptoms and severities, comparing the preomicron and omicron eras.
Methods: A nationwide, matched, test-negative, case-control study was conducted in Qatar from 5 February 2020 to 12 March 2024. The preomicron analysis used a sample of 509 949 positive and 8 494 782 negative tests, while the omicron analysis included 682 257 positive and 6 904 044 negative tests. Data were sourced from Qatar's national databases for COVID-19 laboratory testing, vaccination, hospitalisation and death.
Results: Effectiveness of preomicron infection against preomicron reinfection was estimated at 80.9% (95% CI: 79.1% to 82.6%) for asymptomatic reinfection, 87.5% (95% CI: 86.1% to 88.9%) for symptomatic reinfection, 97.8% (95% CI: 95.7% to 98.9%) for severe COVID-19 reinfection, 100.0% (95% CI: 97.5% to 100.0%) for critical COVID-19 reinfection and 88.1% (95% CI: 50.3% to 97.2%) for fatal COVID-19 reinfection. For omicron infection against omicron reinfection, the estimates were 46.4% (95% CI: 36.9% to 54.4%) for asymptomatic reinfection, 52.8% (95% CI: 44.4% to 60.0%) for symptomatic reinfection, 100.0% (95% CI: 55.4% to 100.0%) for severe COVID-19 reinfection, 100.0% (95% CI: 15.1% to 100.0%) for critical COVID-19 reinfection, and 75.2% (95% CI: -58.8% to 97.5%) for fatal COVID-19 reinfection. Effectiveness over time since previous infection showed no discernible decline in protection against all forms of reinfection in the preomicron era, but a rapid decline against asymptomatic and symptomatic reinfections in the omicron era.
Conclusions: A gradient of protection against reinfection is evident, with the highest protection observed against severe forms of COVID-19. Over time, this gradient becomes more pronounced, as protection against asymptomatic and symptomatic reinfections decreases, while protection against severe outcomes remains strong.
{"title":"Protection conferred by SARS-CoV-2 infection across a spectrum of reinfection symptoms and severities.","authors":"Layan Sukik, Hiam Chemaitelly, Houssein H Ayoub, Peter Coyle, Patrick Tang, Mohammad R Hasan, Hadi M Yassine, Asmaa A Al Thani, Zaina Al-Kanaani, Einas Al-Kuwari, Andrew Jeremijenko, Anvar Hassan Kaleeckal, Ali Nizar Latif, Riyazuddin Mohammad Shaik, Hanan F Abdul-Rahim, Gheyath K Nasrallah, Mohamed Ghaith Al-Kuwari, Adeel Butt, Hamad Eid Al-Romaihi, Mohamed H Al-Thani, Abdullatif Al-Khal, Roberto Bertollini, Laith J Abu-Raddad","doi":"10.1136/bmjresp-2024-002718","DOIUrl":"10.1136/bmjresp-2024-002718","url":null,"abstract":"<p><strong>Background: </strong>SARS-CoV-2 infection is associated with protection against reinfection. This study analysed this protection across different reinfection symptoms and severities, comparing the preomicron and omicron eras.</p><p><strong>Methods: </strong>A nationwide, matched, test-negative, case-control study was conducted in Qatar from 5 February 2020 to 12 March 2024. The preomicron analysis used a sample of 509 949 positive and 8 494 782 negative tests, while the omicron analysis included 682 257 positive and 6 904 044 negative tests. Data were sourced from Qatar's national databases for COVID-19 laboratory testing, vaccination, hospitalisation and death.</p><p><strong>Results: </strong>Effectiveness of preomicron infection against preomicron reinfection was estimated at 80.9% (95% CI: 79.1% to 82.6%) for asymptomatic reinfection, 87.5% (95% CI: 86.1% to 88.9%) for symptomatic reinfection, 97.8% (95% CI: 95.7% to 98.9%) for severe COVID-19 reinfection, 100.0% (95% CI: 97.5% to 100.0%) for critical COVID-19 reinfection and 88.1% (95% CI: 50.3% to 97.2%) for fatal COVID-19 reinfection. For omicron infection against omicron reinfection, the estimates were 46.4% (95% CI: 36.9% to 54.4%) for asymptomatic reinfection, 52.8% (95% CI: 44.4% to 60.0%) for symptomatic reinfection, 100.0% (95% CI: 55.4% to 100.0%) for severe COVID-19 reinfection, 100.0% (95% CI: 15.1% to 100.0%) for critical COVID-19 reinfection, and 75.2% (95% CI: -58.8% to 97.5%) for fatal COVID-19 reinfection. Effectiveness over time since previous infection showed no discernible decline in protection against all forms of reinfection in the preomicron era, but a rapid decline against asymptomatic and symptomatic reinfections in the omicron era.</p><p><strong>Conclusions: </strong>A gradient of protection against reinfection is evident, with the highest protection observed against severe forms of COVID-19. Over time, this gradient becomes more pronounced, as protection against asymptomatic and symptomatic reinfections decreases, while protection against severe outcomes remains strong.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143728367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-22DOI: 10.1136/bmjresp-2024-002541
Leanne-Jo Holmes, Siobhan Ludlow, Stephen Fowler, Marie Marshall, Karina Lovell
Background: Living with severe and uncontrolled asthma can negatively impact on well-being, yet little is known about the psychosocial impact on young adults (age 12-25).
Aim: To identify, appraise and synthesise current literature pertaining to the psychosocial experience of living with severe and uncontrolled asthma as a young adult, to generate new knowledge, further conceptual understanding and provide recommendations to help improve long-term outcomes.
Methods: We followed a predefined protocol, registered on PROSPERO. We systematically searched for qualitative research which captured the psychosocial impact of living with severe and uncontrolled asthma as a young adult. Using thematic synthesis, data was coded and developed into descriptive and analytical themes.
Results: 10 studies with 219 participants were identified and included in the synthesis. 73 codes were then developed into 17 descriptive themes, subsequently forming 5 analytical themes: 'Living with a constant uncertainty', 'The deleterious impact of asthma', 'Acquiescence', 'A need for support & understanding' and 'The constraints of living with asthma'.Young adults with severe and uncontrolled asthma live with a significant negative impact on their psychosocial well-being. Reported emotions described living with a burden of shame, embarrassment, anxiety, isolation, uncertainty, fear, conflict, lack of control, restriction on life choices and a perceived desire to be normal. These emotions influenced lifestyle choices and adherence to treatment, compounding on physical symptomology. This resulted in a cyclical interplay between the physical and psychological impact of living with severe and uncontrolled asthma.
Conclusion: There is clear evidence of a negative psychosocial impact of living with severe and uncontrolled asthma as a young adult. We have also highlighted the paucity of recent literature and provide the rationale for further research, to increase our understanding of the impact and support requirements of young adults with severe asthma to help improve long-term outcomes and quality of life.
Prospero registration number: CRD42022363201.
{"title":"Psychosocial experience of living with severe and uncontrolled asthma as a young adult: a qualitative synthesis.","authors":"Leanne-Jo Holmes, Siobhan Ludlow, Stephen Fowler, Marie Marshall, Karina Lovell","doi":"10.1136/bmjresp-2024-002541","DOIUrl":"10.1136/bmjresp-2024-002541","url":null,"abstract":"<p><strong>Background: </strong>Living with severe and uncontrolled asthma can negatively impact on well-being, yet little is known about the psychosocial impact on young adults (age 12-25).</p><p><strong>Aim: </strong>To identify, appraise and synthesise current literature pertaining to the psychosocial experience of living with severe and uncontrolled asthma as a young adult, to generate new knowledge, further conceptual understanding and provide recommendations to help improve long-term outcomes.</p><p><strong>Methods: </strong>We followed a predefined protocol, registered on PROSPERO. We systematically searched for qualitative research which captured the psychosocial impact of living with severe and uncontrolled asthma as a young adult. Using thematic synthesis, data was coded and developed into descriptive and analytical themes.</p><p><strong>Results: </strong>10 studies with 219 participants were identified and included in the synthesis. 73 codes were then developed into 17 descriptive themes, subsequently forming 5 analytical themes: 'Living with a constant uncertainty', 'The deleterious impact of asthma', 'Acquiescence', 'A need for support & understanding' and 'The constraints of living with asthma'.Young adults with severe and uncontrolled asthma live with a significant negative impact on their psychosocial well-being. Reported emotions described living with a burden of shame, embarrassment, anxiety, isolation, uncertainty, fear, conflict, lack of control, restriction on life choices and a perceived desire to be normal. These emotions influenced lifestyle choices and adherence to treatment, compounding on physical symptomology. This resulted in a cyclical interplay between the physical and psychological impact of living with severe and uncontrolled asthma.</p><p><strong>Conclusion: </strong>There is clear evidence of a negative psychosocial impact of living with severe and uncontrolled asthma as a young adult. We have also highlighted the paucity of recent literature and provide the rationale for further research, to increase our understanding of the impact and support requirements of young adults with severe asthma to help improve long-term outcomes and quality of life.</p><p><strong>Prospero registration number: </strong>CRD42022363201.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11931952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Background: </strong>Severe pneumonia has a poor prognosis and high mortality. Current severity scores such as Acute Physiology and Chronic Health Evaluation (APACHE-II) and Sequential Organ Failure Assessment (SOFA), have limited ability to help clinicians in classification and management decisions. The goal of this study was to analyse the clinical characteristics of severe pneumonia and develop a machine learning-based mortality-prediction model for patients with severe pneumonia.</p><p><strong>Methods: </strong>Consecutive patients with severe pneumonia between 2013 and 2022 admitted to Beijing Chaoyang Hospital affiliated with Capital Medical University were included. In-hospital all-cause mortality was the outcome of this study. We performed a retrospective analysis of the cohort, stratifying patients into survival and non-survival groups, using mainstream machine learning algorithms (light gradient boosting machine, support vector classifier and random forest). We aimed to construct a mortality-prediction model for patients with severe pneumonia based on their accessible clinical and laboratory data. The discriminative ability was evaluated using the area under the receiver operating characteristic curve (AUC). The calibration curve was used to assess the fit goodness of the model, and decision curve analysis was performed to quantify clinical utility. By means of logistic regression, independent risk factors for death in severe pneumonia were figured out to provide an important basis for clinical decision-making.</p><p><strong>Results: </strong>A total of 875 patients were included in the development and validation cohorts, with the in-hospital mortality rate of 14.6%. The AUC of the model in the internal validation set was 0.8779 (95% CI, 0.738 to 0.974), showing a competitive discrimination ability that outperformed those of traditional clinical scoring systems, that is, APACHE-II, SOFA, CURB-65 (confusion, urea, respiratory rate, blood pressure, age ≥65 years), Pneumonia Severity Index. The calibration curve showed that the in-hospital mortality in severe pneumonia predicted by the model fit reasonably with the actual hospital mortality. In addition, the decision curve showed that the net clinical benefit was positive in both training and validation sets of hospitalised patients with severe pneumonia. Based on ensemble machine learning algorithms and logistic regression technique, the level of ferritin, lactic acid, blood urea nitrogen, creatine kinase, eosinophil and the requirement of vasopressors were identified as top independent predictors of in-hospital mortality with severe pneumonia.</p><p><strong>Conclusion: </strong>A robust clinical model for predicting the risk of in-hospital mortality after severe pneumonia was successfully developed using machine learning techniques. The performance of this model demonstrates the effectiveness of these techniques in creating accurate predictive models, and the use of this model
{"title":"Machine learning-based model for predicting all-cause mortality in severe pneumonia.","authors":"Weichao Zhao, Xuyan Li, Lianjun Gao, Zhuang Ai, Yaping Lu, Jiachen Li, Dong Wang, Xinlou Li, Nan Song, Xuan Huang, Zhao-Hui Tong","doi":"10.1136/bmjresp-2023-001983","DOIUrl":"10.1136/bmjresp-2023-001983","url":null,"abstract":"<p><strong>Background: </strong>Severe pneumonia has a poor prognosis and high mortality. Current severity scores such as Acute Physiology and Chronic Health Evaluation (APACHE-II) and Sequential Organ Failure Assessment (SOFA), have limited ability to help clinicians in classification and management decisions. The goal of this study was to analyse the clinical characteristics of severe pneumonia and develop a machine learning-based mortality-prediction model for patients with severe pneumonia.</p><p><strong>Methods: </strong>Consecutive patients with severe pneumonia between 2013 and 2022 admitted to Beijing Chaoyang Hospital affiliated with Capital Medical University were included. In-hospital all-cause mortality was the outcome of this study. We performed a retrospective analysis of the cohort, stratifying patients into survival and non-survival groups, using mainstream machine learning algorithms (light gradient boosting machine, support vector classifier and random forest). We aimed to construct a mortality-prediction model for patients with severe pneumonia based on their accessible clinical and laboratory data. The discriminative ability was evaluated using the area under the receiver operating characteristic curve (AUC). The calibration curve was used to assess the fit goodness of the model, and decision curve analysis was performed to quantify clinical utility. By means of logistic regression, independent risk factors for death in severe pneumonia were figured out to provide an important basis for clinical decision-making.</p><p><strong>Results: </strong>A total of 875 patients were included in the development and validation cohorts, with the in-hospital mortality rate of 14.6%. The AUC of the model in the internal validation set was 0.8779 (95% CI, 0.738 to 0.974), showing a competitive discrimination ability that outperformed those of traditional clinical scoring systems, that is, APACHE-II, SOFA, CURB-65 (confusion, urea, respiratory rate, blood pressure, age ≥65 years), Pneumonia Severity Index. The calibration curve showed that the in-hospital mortality in severe pneumonia predicted by the model fit reasonably with the actual hospital mortality. In addition, the decision curve showed that the net clinical benefit was positive in both training and validation sets of hospitalised patients with severe pneumonia. Based on ensemble machine learning algorithms and logistic regression technique, the level of ferritin, lactic acid, blood urea nitrogen, creatine kinase, eosinophil and the requirement of vasopressors were identified as top independent predictors of in-hospital mortality with severe pneumonia.</p><p><strong>Conclusion: </strong>A robust clinical model for predicting the risk of in-hospital mortality after severe pneumonia was successfully developed using machine learning techniques. The performance of this model demonstrates the effectiveness of these techniques in creating accurate predictive models, and the use of this model","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-22DOI: 10.1136/bmjresp-2023-001747
Rachel L Byrne, Ghaith Aljayyoussi, Konstantina Kontogianni, Karina Clerkin, Mathew McIntyre, Jahanara Wardale, Christopher T Williams, Richard Body, Emily R Adams, Margaretha de Vos, Camille Escadafal, Ana I Cubas Atienzar
Objective: To conduct a head-to-head diagnostic accuracy evaluation of anterior nares (AN) and nasopharyngeal (NP) swabs for SARS-CoV-2 antigen detection using two brands of rapid diagnostic tests (Ag-RDT).
Methods: Two prospective diagnostic evaluations were carried out at different time points and participant cohorts to evaluate the performance of paired AN and NP swabs in two Ag-RDT brands: Sure-Status (PMC, India) and Biocredit (RapiGEN, South Korea). The sensitivity and specificity of AN and NP swabs for each of the index test cohorts were calculated against the reverse transcription quantitative PCR (RT-qPCR) TaqPath COVID-19 (ThermoFisher, UK) using NP swabs as reference standard.
Results: A total of 372 participants were recruited for the Sure-Status cohort and 232 for the Biocredit, of which 119 (32.1%) and 122 (53.7%) were SARS-CoV-2 positive by RT-qPCR, respectively. Sensitivity and specificity of AN swabs were equivalent to those obtained with NP swabs in both cohorts: 83.9% (95% CI 76.0-90.0) and 98.8% (95% CI 96.6-9.8) using NP swabs and 85.6% (95% CI 77.1-91.4) and 99.2% (95% CI 97.1-99.9) with AN swabs for Sure-Status and; 81.2% (95% CI 73.1-87.7) and 99.0% (95% CI 94.7-86.5) with NP swabs and 79.5% (95% CI 71.3-86.3) and 100% (95% CI 96.5-100) with AN swabs for Biocredit. The agreement of the AN and NP swabs was high for both brands with an inter-rater reliability (κ) of 0.918 and 0.833 for Sure-Status and Biocredit, respectively. The overall 50% limits of detection (LoD50) and 95% LoD (LoD95) were 0.9-2.4×104 and 3.0-3.2×108 RNA copies/mL for NP swabs and 0.3-1.1×105 and 0.7-7.9×107 RNA copies/mL for AN swabs, with no significant difference in LoD for any of the swab types or test brands.
Conclusions: The diagnostic accuracy of the two SARS-CoV-2 Ag-RDT brands evaluated in this study was equivalent using AN swabs than NP swabs. However, test line intensity was lower when using AN swabs, which could negatively influence the interpretation of the Ag-RDT results by lay users.
Trail registration number: NCT04408170.
{"title":"Head-to-head comparison of anterior nares and nasopharyngeal swabs for SARS-CoV-2 antigen detection in a community drive-through test centre in the UK.","authors":"Rachel L Byrne, Ghaith Aljayyoussi, Konstantina Kontogianni, Karina Clerkin, Mathew McIntyre, Jahanara Wardale, Christopher T Williams, Richard Body, Emily R Adams, Margaretha de Vos, Camille Escadafal, Ana I Cubas Atienzar","doi":"10.1136/bmjresp-2023-001747","DOIUrl":"10.1136/bmjresp-2023-001747","url":null,"abstract":"<p><strong>Objective: </strong>To conduct a head-to-head diagnostic accuracy evaluation of anterior nares (AN) and nasopharyngeal (NP) swabs for SARS-CoV-2 antigen detection using two brands of rapid diagnostic tests (Ag-RDT).</p><p><strong>Methods: </strong>Two prospective diagnostic evaluations were carried out at different time points and participant cohorts to evaluate the performance of paired AN and NP swabs in two Ag-RDT brands: Sure-Status (PMC, India) and Biocredit (RapiGEN, South Korea). The sensitivity and specificity of AN and NP swabs for each of the index test cohorts were calculated against the reverse transcription quantitative PCR (RT-qPCR) TaqPath COVID-19 (ThermoFisher, UK) using NP swabs as reference standard.</p><p><strong>Results: </strong>A total of 372 participants were recruited for the Sure-Status cohort and 232 for the Biocredit, of which 119 (32.1%) and 122 (53.7%) were SARS-CoV-2 positive by RT-qPCR, respectively. Sensitivity and specificity of AN swabs were equivalent to those obtained with NP swabs in both cohorts: 83.9% (95% CI 76.0-90.0) and 98.8% (95% CI 96.6-9.8) using NP swabs and 85.6% (95% CI 77.1-91.4) and 99.2% (95% CI 97.1-99.9) with AN swabs for Sure-Status and; 81.2% (95% CI 73.1-87.7) and 99.0% (95% CI 94.7-86.5) with NP swabs and 79.5% (95% CI 71.3-86.3) and 100% (95% CI 96.5-100) with AN swabs for Biocredit. The agreement of the AN and NP swabs was high for both brands with an inter-rater reliability (κ) of 0.918 and 0.833 for Sure-Status and Biocredit, respectively. The overall 50% limits of detection (LoD50) and 95% LoD (LoD95) were 0.9-2.4×10<sup>4</sup> and 3.0-3.2×10<sup>8</sup> RNA copies/mL for NP swabs and 0.3-1.1×10<sup>5</sup> and 0.7-7.9×10<sup>7</sup> RNA copies/mL for AN swabs, with no significant difference in LoD for any of the swab types or test brands.</p><p><strong>Conclusions: </strong>The diagnostic accuracy of the two SARS-CoV-2 Ag-RDT brands evaluated in this study was equivalent using AN swabs than NP swabs. However, test line intensity was lower when using AN swabs, which could negatively influence the interpretation of the Ag-RDT results by lay users.</p><p><strong>Trail registration number: </strong>NCT04408170.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-22DOI: 10.1136/bmjresp-2024-002327
Michael George Crooks, Caroline Wright, Simon Hart, Victoria Allgar, Anne English, Flavia Swan, Judith Dyson, Gerry Richardson, Maureen Twiddy, Judith Cohen, Andrew Simpson, Chao Huang, Dominic L Sykes, Miriam Johnson
Introduction: Breathlessness is common and impairs the quality of life of people with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrotic interstitial lung diseases (ILD). We report the findings of a multicentre, fast-track (wait-list), mixed-methods, randomised controlled, feasibility study of a complex breathlessness intervention in breathless IPF and non-IPF fibrotic ILD patients.
Methods: Breathless IPF and non-IPF fibrotic ILD patients were randomised to receive the intervention within 1 week (fast-track) or after 8 weeks (wait-list). The intervention comprised two face-to-face and one telephone appointment during a 3-week period covering breathing control, handheld fan-use, pacing and breathlessness management techniques, and techniques to manage anxiety. Feasibility and clinical outcomes were assessed to inform progression to, and optimal design for, a definitive trial. A qualitative substudy explored barriers and facilitators to trial and intervention delivery.
Results: 47 patients (M:F 38:9, mean (SD) age 73.9 (7.2)) were randomised with a recruitment rate of 2.5 participants per month across three sites. The adjusted mean differences (95% CI) for key clinical outcomes at 4 weeks post randomisation were as follows: Chronic Respiratory Questionnaire breathlessness mastery domain (0.45 (-0.07, 0.97)); and numerical rating scales for 'worst' (-0.93 (-1.95, 0.10)), 'best' (-0.19 (-1.38, 1.00)), 'distress caused by' (-1.84 (-3.29, -0.39)) and 'ability to cope with' (0.71 (-0.57, 1.99)) breathlessness within the past 24 hours. The qualitative substudy confirmed intervention acceptability and informed feasibility and acceptability of study outcome measures.
Conclusion: A definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.
{"title":"Complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): a feasibility, wait-list design randomised controlled trial.","authors":"Michael George Crooks, Caroline Wright, Simon Hart, Victoria Allgar, Anne English, Flavia Swan, Judith Dyson, Gerry Richardson, Maureen Twiddy, Judith Cohen, Andrew Simpson, Chao Huang, Dominic L Sykes, Miriam Johnson","doi":"10.1136/bmjresp-2024-002327","DOIUrl":"10.1136/bmjresp-2024-002327","url":null,"abstract":"<p><strong>Introduction: </strong>Breathlessness is common and impairs the quality of life of people with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrotic interstitial lung diseases (ILD). We report the findings of a multicentre, fast-track (wait-list), mixed-methods, randomised controlled, feasibility study of a complex breathlessness intervention in breathless IPF and non-IPF fibrotic ILD patients.</p><p><strong>Methods: </strong>Breathless IPF and non-IPF fibrotic ILD patients were randomised to receive the intervention within 1 week (fast-track) or after 8 weeks (wait-list). The intervention comprised two face-to-face and one telephone appointment during a 3-week period covering breathing control, handheld fan-use, pacing and breathlessness management techniques, and techniques to manage anxiety. Feasibility and clinical outcomes were assessed to inform progression to, and optimal design for, a definitive trial. A qualitative substudy explored barriers and facilitators to trial and intervention delivery.</p><p><strong>Results: </strong>47 patients (M:F 38:9, mean (SD) age 73.9 (7.2)) were randomised with a recruitment rate of 2.5 participants per month across three sites. The adjusted mean differences (95% CI) for key clinical outcomes at 4 weeks post randomisation were as follows: Chronic Respiratory Questionnaire breathlessness mastery domain (0.45 (-0.07, 0.97)); and numerical rating scales for 'worst' (-0.93 (-1.95, 0.10)), 'best' (-0.19 (-1.38, 1.00)), 'distress caused by' (-1.84 (-3.29, -0.39)) and 'ability to cope with' (0.71 (-0.57, 1.99)) breathlessness within the past 24 hours. The qualitative substudy confirmed intervention acceptability and informed feasibility and acceptability of study outcome measures.</p><p><strong>Conclusion: </strong>A definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.</p><p><strong>Trial registration number: </strong>ISRCTN13784514.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11931949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}